CRRT Market to 2022

CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) MARKET - FORECAST TO 2022
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July 2017 © MarketsandMarkets
TABLE OF CONTENTS
1 INTRODUCTION ........................................................................................................ 16
1.1 OBJECTIVES OF THE STUDY ...........................................................................................................16
1.2 MARKET DEFINITION .....................................................................................................................16
1.3 MARKET SCOPE............................................................................................................................17
1.3.1 MARKETS COVERED ....................................................................................................... 17
1.3.2 GEOGRAPHIC SCOPE...................................................................................................... 18
1.3.3 YEARS CONSIDERED FOR THE STUDY .............................................................................. 18
1.4 CURRENCY ...................................................................................................................................19
1.5 LIMITATIONS ................................................................................................................................19
1.6 STAKEHOLDERS ...........................................................................................................................19
2 RESEARCH METHODOLOGY ...................................................................................... 20

2.1 RESEARCH APPROACH .................................................................................................................20
2.2 SECONDARY AND PRIMARY RESEARCH METHODOLOGY ................................................................22
2.2.1 SECONDARY RESEARCH ................................................................................................. 22
2.2.1.1 Key data from secondary sources ....................................................................... 22
2.2.2 PRIMARY RESEARCH ...................................................................................................... 24
2.2.2.1 Key data from primary sources ........................................................................... 25
2.2.2.2 Key industry insights .......................................................................................... 26
2.3 MARKET SIZE ESTIMATION METHODOLOGY ...................................................................................27
2.4 MARKET DATA VALIDATION AND TRIANGULATION ..........................................................................30
2.5 ASSUMPTIONS FOR THE STUDY ....................................................................................................32
3 EXECUTIVE SUMMARY .............................................................................................. 33
4 PREMIUM INSIGHTS ................................................................................................ 36

4.1 CRRT: MARKET OVERVIEW (2017) .................................................................................................36
4.2 GLOBAL CRRT MARKET, BY PRODUCT, 2017 VS. 2022 ..................................................................37
4.3 CRRT MARKET, BY MODALITY AND REGION (2017) ........................................................................37
4.4 GEOGRAPHIC SNAPSHOT: CRRT MARKET (2017) ..........................................................................38
5 MARKET OVERVIEW.................................................................................................. 39
5.1 INTRODUCTION ............................................................................................................................40
5.2 MARKET DYNAMICS......................................................................................................................40
5.2.1 DRIVERS ........................................................................................................................ 41
5.2.1.1 Increasing global incidence of AKI ..................................................................... 41
5.2.1.2 Growing number of ICU patients......................................................................... 42
5.2.1.3 Clinical advantages of CRRT over intermittent blood purification
techniques ........................................................................................................ 42
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5.2.1.4 Technological advancements and new product launches .................................... 43

5.2.1.5 Increasing incidence of sepsis ........................................................................... 43
5.2.1.6 Growing prevalence of diabetes and hypertension .............................................. 44
5.2.2 RESTRAINTS...................................................................................................................44
5.2.2.1 High procedural cost of CRRT ............................................................................. 44
5.2.2.2 Stringent regulatory guidelines for CRRT in North America .................................. 45
5.2.3 OPPORTUNITIES ............................................................................................................. 45
5.2.3.1 Emerging markets ............................................................................................. 45
5.2.3.2 Increasing applications of CRRT ......................................................................... 45
5.2.3.2.1 Evolution of CRRT from a simple renal replacement
treatment to a multi-organ support therapy (MOST) .............................. 45
5.2.3.2.2 Progression of CRRT from adaptive renal devices to
multipurpose treatment machines ....................................................... 46
5.2.3.3 Ongoing research to establish the safety and efficacy profile of CRRT .................. 47
5.2.3.4 Development of a CRRT system for pediatric patients ......................................... 47
5.2.3.4.1 The CARPEDIEM project ...................................................................... 47
5.2.3.5 Untapped market growth opportunities in North America .................................... 48
5.2.4 CHALLENGES ................................................................................................................. 48
5.2.4.1 High complexity of the therapy ........................................................................... 48
5.2.4.1.1 Lack of standard treatment guidelines in developing
countries ............................................................................................ 49
5.2.4.1.2 Complications associated with CRRT ................................................... 49
5.2.4.2 Shortage of trained ICU nurses in developed countries ....................................... 50
5.2.4.3 Poor reimbursement scenario in developing countries ........................................ 50
5.2.4.4 Lack of awareness about the benefits of CRRT .................................................... 50
6 INDUSTRY INSIGHTS ................................................................................................ 51

6.1 INTRODUCTION ............................................................................................................................51
6.2 REIMBURSEMENT SCENARIO .......................................................................................................52
6.2.1 NORTH AMERICA ............................................................................................................ 53
6.2.2 EUROPE ......................................................................................................................... 53
6.2.3 ASIA-PACIFIC (EXCLUDING JAPAN) ................................................................................. 54
6.2.4 JAPAN ............................................................................................................................ 55
6.2.5 REST OF THE WORLD ...................................................................................................... 55
6.3 REGULATORY LANDSCAPE ............................................................................................................56
6.3.1 NORTH AMERICA ............................................................................................................ 57
6.3.2 EUROPE ......................................................................................................................... 57
6.3.3 ASIA-PACIFIC .................................................................................................................57
6.3.4 REST OF THE WORLD ...................................................................................................... 58
6.3.5 INDUSTRY TRENDS ......................................................................................................... 58
6.3.5.1 Training programs for the operation of CRRT devices .......................................... 58
6.3.5.2 Rising adoption of user-friendly CRRT machines ................................................. 59
6.3.5.3 Development of a CRRT system for pediatric patients ......................................... 59
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6.4 PORTER’S FIVE FORCES ANALYSIS ................................................................................................60

6.4.1 COMPETITIVE INTENSITY ................................................................................................. 60
6.4.2 BARGAINING POWER OF BUYERS ................................................................................... 60
6.4.3 BARGAINING POWER OF SUPPLIERS .............................................................................. 61
6.4.4 THREAT OF SUBSTITUTES................................................................................................ 61
6.4.5 THREAT OF NEW ENTRANTS ............................................................................................ 61
6.5 PRICING AND COST ANALYSIS ......................................................................................................61
6.6 STRATEGIC RECOMMENDATIONS..................................................................................................63
6.6.1 DESIGN RECOMMENDATIONS ........................................................................................ 63
6.6.2 KEY STRATEGIES FOR PLAYERS SEEKING TO ENTER THE CRRT MARKET ............................ 64
7 ADOPTION OF CONTINUOUS RENAL REPLACEMENT THERAPY, BY REGION ................. 65

7.1 INTRODUCTION ............................................................................................................................65
7.2 UTILIZATION OF CRRT PROCEDURES, BY REGION ..........................................................................65
7.3 NUMBER OF CRRT PATIENTS, BY REGION ......................................................................................68
8 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT ...................... 69

8.1 INTRODUCTION ............................................................................................................................70
8.1.1 DIALYSATES AND REPLACEMENT FLUIDS ........................................................................ 71
8.1.2 DISPOSABLES................................................................................................................ 73
8.1.2.1 Hemofilters ....................................................................................................... 75
8.1.2.2 Bloodline sets (tubing sets) ............................................................................... 76
8.1.2.3 Other disposables ............................................................................................. 76
8.1.3 SYSTEMS .......................................................................................................................77
9 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY ..................... 80

9.1 INTRODUCTION ............................................................................................................................81
9.2 CONTINUOUS VENOVENOUS HEMOFILTRATION (CVVH) ..................................................................83
9.3 CONTINUOUS VENOVENOUS HEMODIAFILTRATION (CVVHDF) ........................................................85
9.4 CONTINUOUS VENOVENOUS HEMODIALYSIS (CVVHD) ...................................................................87
9.5 SLOW CONTINUOUS ULTRAFILTRATION (SCUF) ..............................................................................89
10 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY REGION ......................... 92

10.1 INTRODUCTION ............................................................................................................................93
10.2 EUROPE .......................................................................................................................................94
10.2.1 APPROVAL OF CRRT MACHINES FOR MULTIPLE APPLICATIONS ....................................... 95
10.2.2 INTENSIVIST PREFERENCE FOR CRRT FOR AKI TREATMENT .............................................. 95
10.2.3 PLAYERS FOCUS ON LEVERAGING GROWTH OPPORTUNITIES IN EUROPE ......................... 95
10.2.4 GERMANY ......................................................................................................................97
10.2.4.1 Rising focus of players on the German CRRT market ........................................... 97
10.2.4.2 Favorable reimbursement for CRRT .................................................................... 97
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10.2.5 U.K. ............................................................................................................................... 98

10.2.5.1 Rising awareness about AKI in the U.K. .............................................................. 99
10.2.6 FRANCE .......................................................................................................................100
10.2.6.1 Significant number of ongoing clinical studies..................................................100
10.2.7 REST OF EUROPE .........................................................................................................101
10.3 NORTH AMERICA ........................................................................................................................103
10.3.1 HIGH PREFERENCE FOR OTHER DIALYSIS MODALITIES ..................................................103
10.3.2 REGULATORY POLICIES, A KEY HINDRANCE TO MARKET GROWTH ..................................103
10.3.3 U.S. .............................................................................................................................106
10.3.3.1 Growth in AKI prevalence .................................................................................106
10.3.3.2 New product development to boost the demand for CRRT products ...................106
10.3.3.3 Ongoing clinical trials to prove the safety and efficacy of CRRT
products .........................................................................................................107
10.3.3.4 Shortage of registered nurses in ICU settings....................................................107
10.3.4 CANADA.......................................................................................................................108
10.3.4.1 Rising AKI prevalence ......................................................................................109
10.3.4.2 High cost of CRRT as compared to IHD .............................................................109
10.4 ASIA-PACIFIC .............................................................................................................................111
10.4.1 INCREASING NUMBER OF SEPSIS CASES IN INDIA........................................................111
10.4.2 STUDIES AND CLINICAL TRIALS TO ESTABLISH THE SAFETY AND EFFICACY
PROFILE OF CRRT .........................................................................................................113
10.4.3 UNFAVORABLE REIMBURSEMENT SCENARIO ...............................................................113
10.4.4 JAPAN ..........................................................................................................................115
10.4.4.1 Increasing use of CRRT for non-renal indications ..............................................115
10.4.4.2 Well-established healthcare system .................................................................115
10.4.4.3 Large number of domestic manufacturers—a barrier to the entry of
major players ..................................................................................................115
10.4.5 CHINA ..........................................................................................................................117
10.4.5.1 Rising incidence of AKI and ESRD in China .......................................................117
10.4.5.2 Ongoing research studies ................................................................................117
10.4.6 INDIA ...........................................................................................................................118
10.4.6.1 Rising sepsis cases in India .............................................................................118
10.4.6.2 Increase in the number of dialysis patients .......................................................119
10.4.6.3 Rising number of patients admitted to ICUs......................................................119
10.4.6.4 Unfavorable reimbursement scenario ...............................................................119
10.4.6.5 Lack of randomized trials and dearth of technical expertise ..............................119
10.4.6.6 Dearth of indigenous manufacturers for CRRT products in India ........................119
10.4.7 REST OF ASIA-PACIFIC .................................................................................................121
10.4.7.1 Taiwan, a lucrative market for CRRT players ......................................................122
10.5 REST OF THE WORLD (ROW) ........................................................................................................123
10.5.1 LATIN AMERICA AND THE MIDDLE EAST ........................................................................123
10.5.2 NEW AMENDMENTS OPEN BRAZILIAN HEALTHCARE INDUSTRY TO FOREIGN
INVESTMENT ................................................................................................................125
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11 COMPETITIVE LANDSCAPE ..................................................................................... 126

11.1 INTRODUCTION ..........................................................................................................................126
11.1.1 VISIONARY LEADERS ....................................................................................................126
11.1.2 INNOVATORS ...............................................................................................................126
11.1.3 DYNAMIC DIFFERENTIATORS ........................................................................................126
11.1.4 EMERGING COMPANIES ...............................................................................................126
11.2 STRENGTH OF PRODUCT PORTFOLIO ...........................................................................................128
11.3 BUSINESS STRATEGY EXCELLENCE .............................................................................................129
11.4 COMPETITIVE INTENSITY .............................................................................................................130
11.4.1 EVALUATION PARAMETERS AND SCORES .....................................................................130
11.4.2 SCORING METHODOLOGY ............................................................................................131
11.4.3 COMPETITIVE INTENSITY SCORE, BY COMPANY .............................................................131
11.4.3.1 Baxter International Inc. ..................................................................................131
11.4.3.2 Fresenius Medical Care AG & Co. KGaA............................................................132
11.4.3.3 Nikkiso Co., Ltd. ..............................................................................................133
11.4.3.4 B. Braun Melsungen AG ...................................................................................134
11.4.3.5 NxStage Medical, Inc.......................................................................................135
11.4.4 COMPETITIVE INTENSITY – MAPPING OF BAXTER INTERNATIONAL INC.,
FRESENIUS MEDICAL CARE AG & CO. KGAA, NIKKISO CO., LTD., B. BRAUN
MELSUNGEN AG, AND NXSTAGE MEDICAL, INC. ............................................................136
12 COMPANY PROFILES .............................................................................................. 138

12.1 BAXTER INTERNATIONAL INC.......................................................................................................138
12.1.1 OVERVIEW....................................................................................................................138
12.1.2 PRODUCTS OFFERED....................................................................................................139
12.1.3 PRODUCT OFFERING SCORECARD ................................................................................140
12.1.4 BUSINESS STRATEGY SCORECARD ...............................................................................140
12.1.5 RECENT DEVELOPMENTS (2014-2017).........................................................................141
12.2 FRESENIUS MEDICAL CARE AG & CO. KGAA ................................................................................142
12.2.1 OVERVIEW....................................................................................................................142
12.3 NIKKISO CO., LTD. ......................................................................................................................146
12.3.1 OVERVIEW....................................................................................................................146
12.3.3 PRODUCT OFFERINGS SCORECARD ..............................................................................147
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12.4 NXSTAGE MEDICAL, INC. ............................................................................................................149

12.4.1 OVERVIEW....................................................................................................................149
12.5 B. BRAUN MELSUNGEN AG .........................................................................................................152
12.5.1 OVERVIEW....................................................................................................................152
12.6 ASAHI KASEI MEDICAL CO., LTD. (A SUBSIDIARY OF ASAHI KASEI CORPORATION) .......................155
12.6.1 OVERVIEW....................................................................................................................155
12.7 BELLCO S.R.L. (A PART OF MEDTRONIC PLC) ...............................................................................158
12.7.1 OVERVIEW....................................................................................................................158
12.7.2 PRODUCT OFFERED ......................................................................................................158
12.8 TORAY MEDICAL CO., LTD. ..........................................................................................................161
12.8.1 OVERVIEW....................................................................................................................161
12.9 INFOMED SA ..............................................................................................................................164
12.9.1 OVERVIEW....................................................................................................................164
12.9.2 PRODUCT OFFERED ......................................................................................................164
12.10 MEDICA S.P.A. ...........................................................................................................................166
12.10.1 OVERVIEW....................................................................................................................166
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12.11 MEDICAL COMPONENTS, INC. ....................................................................................................168

12.11.1 OVERVIEW....................................................................................................................168
12.12 MEDITES PHARMA SPOL. S.R.O. .................................................................................................170
12.12.1 OVERVIEW....................................................................................................................170
12.13 MEDTRONIC PLC ........................................................................................................................172
12.13.1 OVERVIEW....................................................................................................................172
12.13.4 BUSINESS SCORECARD ...............................................................................................173
12.14 SWS HEMODIALYSIS CARE CO. LTD.............................................................................................175
12.14.1 OVERVIEW....................................................................................................................175
12.15 NINGBO TIANYI MEDICAL APPLIANCE CO., LTD. ...........................................................................177
12.15.1 OVERVIEW....................................................................................................................177
13 APPENDIX .............................................................................................................. 179

13.1 INSIGHTS OF INDUSTRY EXPERTS ...............................................................................................179
13.2 DISCUSSION GUIDE ...................................................................................................................180
13.3 KNOWLEDGE STORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL.......................................183
13.4 INTRODUCING RT: REAL-TIME MARKET INTELLIGENCE .................................................................185
13.5 AVAILABLE CUSTOMIZATIONS .....................................................................................................186
13.6 RELATED REPORTS .....................................................................................................................187
13.7 AUTHOR DETAILS ........................................................................................................................188
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LIST OF TABLES
TABLE 1 AVERAGE SELLING PRICE OF CRRT MACHINES, BY MANUFACTURER, 2016 (USD) 62
TABLE 2 AVERAGE SELLING PRICE OF CRRT BLOODLINES AND DIALYSATE BAGS,
2016 (USD) 62
TABLE 3 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,
2015–2022 (USD MILLION) 70
TABLE 4 CONTINUOUS RENAL REPLACEMENT THERAPY DIALYSATES & REPLACEMENT
FLUIDS MARKET, BY REGION, 2015–2022 (USD MILLION) 71
TABLE 5 EUROPE: CONTINUOUS RENAL REPLACEMENT THERAPY DIALYSATES &
REPLACEMENT FLUIDS MARKET, BY COUNTRY, 2015–2022 (USD MILLION) 72
TABLE 6 NORTH AMERICA: CONTINUOUS RENAL REPLACEMENT THERAPY DIALYSATES &
TABLE 7 ASIA-PACIFIC: CONTINUOUS RENAL REPLACEMENT THERAPY DIALYSATES &
TABLE 8 CONTINUOUS RENAL REPLACEMENT THERAPY DISPOSABLES MARKET,
BY TYPE, 2015–2022 (USD MILLION) 73
TABLE 9 CONTINUOUS RENAL REPLACEMENT THERAPY DISPOSABLES MARKET,
BY REGION, 2015–2022 (USD MILLION) 74
TABLE 10 EUROPE: CONTINUOUS RENAL REPLACEMENT THERAPY DISPOSABLES MARKET,
BY COUNTRY, 2015–2022 (USD MILLION) 74
TABLE 11 NORTH AMERICA: CONTINUOUS RENAL REPLACEMENT THERAPY DISPOSABLES
MARKET, BY COUNTRY, 2015–2022 (USD MILLION) 75
TABLE 12 ASIA-PACIFIC: CONTINUOUS RENAL REPLACEMENT THERAPY DISPOSABLES
TABLE 13 CONTINUOUS RENAL REPLACEMENT THERAPY SYSTEMS MARKET, BY REGION,
2015–2022 (USD MILLION) 78
TABLE 14 EUROPE: CONTINUOUS RENAL REPLACEMENT THERAPY SYSTEMS MARKET,
TABLE 15 NORTH AMERICA: CONTINUOUS RENAL REPLACEMENT THERAPY SYSTEMS
TABLE 16 ASIA-PACIFIC: CONTINUOUS RENAL REPLACEMENT THERAPY SYSTEMS MARKET,
TABLE 17 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,
2015–2022 (USD MILLION) 82
TABLE 18 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR CVVH, BY REGION,
2015–2022 (USD MILLION) 84
TABLE 19 EUROPE: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR CVVH,
TABLE 20 NORTH AMERICA: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR
CVVH, BY COUNTRY, 2015–2022 (USD MILLION) 84
TABLE 21 ASIA-PACIFIC: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR CVVH,
TABLE 22 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR CVVHDF, BY REGION,
2015–2022 (USD MILLION) 86
TABLE 23 EUROPE: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR CVVHDF,
CVVHDF, BY COUNTRY, 2015–2022 (USD MILLION) 86
TABLE 25 ASIA-PACIFIC: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR
CVVHDF, BY COUNTRY, 2015–2022 (USD MILLION) 87
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TABLE 26 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR CVVHD, BY REGION,

2015–2022 (USD MILLION) 88
TABLE 27 EUROPE: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR CVVHD,
CVVHD, BY COUNTRY, 2015–2022 (USD MILLION) 88
TABLE 29 ASIA-PACIFIC: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR CVVHD,
TABLE 30 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR SCUF, BY REGION,
2015–2022 (USD MILLION) 90
TABLE 31 EUROPE: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR SCUF,
SCUF, BY COUNTRY, 2015–2022 (USD MILLION) 90
TABLE 33 ASIA-PACIFIC: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR SCUF,
TABLE 34 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY REGION,
2015–2022 (USD MILLION) 93
TABLE 35 EUROPE: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET,
BY PRODUCT, 2015–2022 (USD MILLION) 96
BY MODALITY, 2015–2022 (USD MILLION) 96
TABLE 38 GERMANY: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET,
BY PRODUCT, 2013-2020 (USD MILLION) 98
TABLE 39 GERMANY: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET,
TABLE 40 U.K.: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,
2015–2022 (USD MILLION) 99
TABLE 41 U.K.: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,
2015–2022 (USD MILLION) 99
TABLE 42 FRANCE: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,
2015–2022 (USD MILLION) 100
TABLE 43 FRANCE: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,
2015–2022 (USD MILLION) 101
TABLE 44 ROE: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET SIZE, BY PRODUCT,
2015–2022 (USD MILLION) 102
TABLE 45 ROE: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET SIZE, BY MODALITY,
2015–2022 (USD MILLION) 102
TABLE 46 NORTH AMERICA: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET,
TABLE 49 U.S.: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,
2015–2022 (USD MILLION) 107
TABLE 50 U.S.: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,
2015–2022 (USD MILLION) 108
TABLE 51 CANADA: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,
2015–2022 (USD MILLION) 110
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TABLE 52 CANADA: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET,

TABLE 53 ASIA-PACIFIC: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET,
TABLE 56 JAPAN: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,
2015–2022 (USD MILLION) 116
TABLE 57 JAPAN: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,
2015–2022 (USD MILLION) 116
TABLE 58 CHINA: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,
2015–2022 (USD MILLION) 117
TABLE 59 CHINA: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,
2015–2022 (USD MILLION) 118
TABLE 60 INDIA: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,
2015–2022 (USD MILLION) 120
TABLE 61 INDIA: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,
2015–2022 (USD MILLION) 120
TABLE 62 ROAPAC: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,
2015–2022 (USD MILLION) 122
TABLE 63 ROAPAC: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,
2015–2022 (USD MILLION) 122
TABLE 64 ROW: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,
2015–2022 (USD MILLION) 125
TABLE 65 ROW: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,
2015–2022 (USD MILLION) 125
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LIST OF FIGURES
FIGURE 1 GLOBAL CONTINUOUS RENAL REPLACEMENT THERAPY MARKET: RESEARCH

METHODOLOGY STEPS 20
FIGURE 2 RESEARCH DESIGN 21
FIGURE 3 BREAKDOWN OF PRIMARY INTERVIEWS: BY COMPANY TYPE, DESIGNATION,
AND REGION 24
FIGURE 4 SUPPLY SIDE 26
FIGURE 5 DEMAND SIDE 27
FIGURE 6 ESTIMATION OF CRRT PROCEDURAL VOLUME 28
FIGURE 7 RESEARCH METHODOLOGY: TOP-DOWN APPROACH [FOR MARKET SIZE
ESTIMATION OF DISPOSABLES (BLOODLINE SETS, HEMOFILTERS, AND OTHER
DISPOSABLES)] 28
FIGURE 8 RESEARCH METHODOLOGY: TOP-DOWN APPROACH (FOR MARKET SIZE
ESTIMATION OF CRRT SYSTEMS) 29
FIGURE 9 RESEARCH METHODOLOGY: BOTTOM-UP APPROACH 29
FIGURE 10 DATA TRIANGULATION STEPS (TOP-DOWN AND BOTTOM-UP APPROACHES) 30
FIGURE 11 DATA TRIANGULATION METHODOLOGY 31
FIGURE 12 GLOBAL CRRT MARKET BY PRODUCT, 2017 VS. 2022 33
FIGURE 13 HEMOFILTERS TO FORM THE LARGEST SEGMENT OF CRRT DISPOSABLES MARKET
IN 2017 34
FIGURE 14 CVVHDF EXPECTED TO BE THE FASTEST-GROWING SEGMENT DURING 2017-2022 34
FIGURE 15 ASIA-PACIFIC TO GROW AT THE HIGHEST GROWTH RATE IN THE FORECAST PERIOD 35
FIGURE 16 RISING PREVALENCE OF AKI TO DRIVE THE GLOBAL CRRT MARKET DURING THE
FORECAST PERIOD 36
FIGURE 17 DIALYSATES & REPLACEMENT FLUIDS TO DOMINATE THE GLOBAL CRRT MARKET
DURING THE FORECAST PERIOD 37
FIGURE 18 EUROPE TO DOMINATE CRRT MODALITY SEGMENTS IN 2017 37
FIGURE 19 EUROPE TO DOMINATE THE GLOBAL CRRT MARKET DURING THE FORECAST
PERIOD 38
FIGURE 20 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET: DRIVERS, RESTRAINTS,
OPPORTUNITIES, AND CHALLENGES 40
FIGURE 21 GLOBAL INCIDENCE OF ACUTE KIDNEY INJURY (AKI), 2010 VS. 2015 VS. 2020 41
FIGURE 22 KEY FACTORS AFFECTING THE REIMBURSEMENT RATES FOR CRRT PROCEDURES 51
FIGURE 23 REIMBURSEMENT SCENARIO FOR CRRT (AS OF 2016) 52
FIGURE 24 REIMBURSEMENT STRUCTURES IN EUROPE 54
FIGURE 25 KEY REGULATORY BODIES INVOLVED IN THE APPROVAL OF NEW CRRT PRODUCTS 56
FIGURE 26 PORTER’S FIVE FORCES ANALYSIS – GLOBAL CRRT MARKET 60
FIGURE 27 DESIGN RECOMMENDATIONS FOR CRRT MACHINES 63
FIGURE 28 UTILIZATION OF CONTINUOUS RENAL REPLACEMENT THERAPY AND DIALYSIS FOR
THE TREATMENT OF RENAL PATIENTS IN ICUS, BY REGION (2016) 66
FIGURE 29 RATE OF SWITCHING FROM CRRT TO IHD, BY REGION, 2016 67
FIGURE 30 NUMBER OF CRRT PATIENTS ACROSS THE GLOBE, 2016 68
FIGURE 31 GLOBAL CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT
(2017 VS. 2022) 70
FIGURE 32 TYPES OF CRRT MODALITIES 81
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FIGURE 33 GLOBAL CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY

(2017 VS. 2022) 82
PERIOD 93
FIGURE 35 EUROPE: CRRT MARKET SNAPSHOT 94
FIGURE 36 NORTH AMERICA: CRRT MARKET SNAPSHOT 104
FIGURE 37 ASIA-PACIFIC: CRRT MARKET SNAPSHOT 112
FIGURE 38 ROW: CRRT MARKET SNAPSHOT 124
FIGURE 39 COMPETITIVE LEADERSHIP MAPPING 127
FIGURE 40 GLOBAL CRRT MARKET SHARE, BY KEY PLAYERS (2016) 127
FIGURE 41 SCORING METHODOLOGY 131
FIGURE 42 COMPARISON OF COMPETITIVE INTENSITY SCORES 136
FIGURE 43 RELATIVE POSITIONING OF COMPANIES BASED ON COMPETITIVE INTENSITY
SCORE AND CRRT FOCUS 136
FIGURE 44 BAXTER INTERNATIONAL INC.: COMPANY SNAPSHOT (2016) 138
FIGURE 45 FRESENIUS MEDICAL CARE AG & CO. KGAA: COMPANY SNAPSHOT (2016) 142
FIGURE 46 NIKKISO CO., LTD.: COMPANY SNAPSHOT (2015) 146
FIGURE 47 NXSTAGE MEDICAL, INC.: COMPANY SNAPSHOT (2016) 149
FIGURE 48 B. BRAUN MELSUNGEN AG: COMPANY SNAPSHOT (2016) 152
FIGURE 49 ASAHI KASEI CORPORATION: COMPANY SNAPSHOT (2015) 155
FIGURE 50 TORAY INDUSTRIES, INC.: COMPANY SNAPSHOT (2016) 161
FIGURE 51 MEDTRONIC PLC.: COMPANY SNAPSHOT (2016) 172
13
LIST OF ABBREVIATIONS
ABBREVIATION FULL FORM
AAKP The American Association of Kidney Patients

ACHSi Australian Council on Healthcare Standards International
AKI Acute Kidney Injury
AKIN Acute Kidney Injury Network

ARA Asian Renal Association
ARF Acute Kidney Failure

ASN American Society of Nephrology
ASP Average Selling Price
BGMP Brazil Good Manufacturing Practice

BRH Brazil Registration Holder
CARPEDIEM The Cardio-Renal, Pediatric Dialysis Emergency Machine
CCC China Compulsory Certification
CDC Centers for Disease Control and Prevention
CF Conversion Factor
CHDF Continuous Hemodiafiltration
CHF Congestive Heart Failure
CMS Centers for Medicare and Medicaid Services
CRRT Continuous Renal Replacement Therapy
CSN Canadian Society of Nephrology

CVVH Continuous Venovenous Hemofiltration
CVVHD Continuous Venovenous Hemodialysis
CVVHDF Continuous Venovenous Hemodiafiltration
DOU Diário Oficialda União
ERA-EDTA The European Renal Association – European Dialysis and Transplant Association
ESRD End Stage Renal Disease
FB Fluid Balance
FOA Funding Opportunity Announcement

HDF Hemodiafiltration
IHD Intermittent Haemodialysis
IRRIV International Renal Research Institute of the San Bortolo Hospital in Vicenza
IRRT Intermittent Renal Replacement Therapy
ISN International Society of Nephrology

IV Intravenous
KHI Kidney Health Initiative
MOF Multiple Organ Failure
MOH Ministry of Health
14
ABBREVIATION FULL FORM
MOST Multi-Organ Support Therapy

NICE National Institute for Health and Clinical Excellence
NIH National Institutes of Health
PD Peritoneal Dialysis
PHC Philippine Heart Center
PICUs Pediatric Intensive Care Units
PMA Premarket Approval
PMDL Pharmaceutical and Medical Device Law

R&D Research And Development
RCA Regional Citrate Anticoagulation
RCCSA Indian Society of Nephrology, Renal Care Society of South Africa

RF Replacement Fluid
RoW Rest of the World

RRT Renal Replacement Therapy
RVU Relative Value Unit
SAP Severe Acute Pancreatitis
SBN Sociedade Brasileira de Nefrologia
SCUF Slow Continuous Ultrafiltration
SFDA State Food and Drug Administration
SHF-CVVHD Super-High Flux Continuous Venovenous Hemodialysis
SLEDD Sustained Low-Efficiency Daily Dialysis
SMEs Subject-Matter Experts
TKDC The Kidney Dialysis Centre

TPE Therapeutic Plasma Exchange
U.K. United Kingdom

U.S. United States
UF Ultrafiltrate
USRDS The United States Renal Data System
15
1 INTRODUCTION
1.1 OBJECTIVES OF THE STUDY

To define, describe, and forecast the continuous renal replacement therapy (CRRT) market on
the basis of products and modalities
To provide detailed information on the major factors influencing market growth (drivers,
restraints, opportunities, and industry-specific challenges)
To strategically analyze the micromarkets1 with respect to their individual growth trends, future
prospects, and contributions to the market
To analyze the market opportunities for stakeholders and provide details of the competitive
landscape for market leaders
To forecast the market size (by value) in North America (U.S. and Canada), Europe (Germany,
France, U.K., and the Rest of Europe), Asia-Pacific (China, India, Japan, and the Rest of Asia-
Pacific), and the Rest of the World
To profile key players and comprehensively analyze their market shares and core
competencies2
To track competitive developments such as new product launches; agreements, partnerships,
and joint ventures; mergers and acquisitions; and research and development activities in the
CRRT market
1.2 MARKET DEFINITION

Continuous renal replacement therapy (CRRT) is a dialysis modality used to treat critically ill, hospitalized
patients in ICUs who develop acute kidney injury (AKI). It is designed to provide treatment for impaired
renal function over an extended period. CRRT is considered as a gold standard for treatment of
hemodynamically unstable AKI patients as it provides better hemodynamic stability and improved
efficiency of solute removal compared to other dialysis techniques.
_________________________
1. Micromarkets are defined as segments and subsegments of the CRRT market included in the report.
2. Core competencies of the companies are captured in terms of the key developments and key strategies adopted by them to mai ntain their market positions.
16
1.3 MARKET SCOPE

To arrive at the CRRT market size (by product and modality) from 2017 to 2022, this study
covers the market for CRRT products used in the treatment of AKI patients in ICUs.
The number of procedures for each region/country has been estimated on the basis of the
circuit life of CRRT systems in a particular region.
The market size of CRRT services is not covered under the study scope.
The market size of CRRT products that are used off-label (without regulatory approval) in a few
countries is not considered under the scope of the study.
The market size of CRRT products used in the treatment of patients other than CRRT is covered
under the scope of the study.
The market for medications used during CRRT is not covered.
1.3.1 MARKETS COVERED
PRODUCT
Dialysates and Replacement Fluids
Disposables
Hemofilters
Bloodline Sets
Other Disposables
Systems
CRRT MARKET
SEGMENTATION
MODALITY
Continuous Venovenous Hemofiltration (CVVH)
Continuous Venovenous Hemodialysis (CVVHD)
Continuous Venovenous Hemodiafiltration (CVVHDF)
Slow Continuous Ultrafiltration (SCUF)
17
1.3.2 GEOGRAPHIC SCOPE
EUROPE
Germany
France
U.K.
Rest of Europe
NORTH AMERICA
U.S. ASIA-PACIFIC
Canada
Japan
China
India
Rest of APAC
REST OF THE WORLD
1.3.3 YEARS CONSIDERED FOR THE STUDY
2022-p
2017-e
2016
2015
HISTORICAL YEAR BASE YEAR ESTIMATED YEAR PROJECTED YEAR
18
1.4 CURRENCY
The base currency used in the report is USD, with market size indicated in USD million.
For companies reporting their revenue in U.S. dollars (USD), revenues were picked up from their
annual reports.
For companies reporting their revenues in other currencies, the average annual currency
conversion rate was used for the particular year to convert the value to USD.
1.5 LIMITATIONS
PARAMETER LIMITATION
Some companies in the CRRT market are privately held;

REVENUE OF MARKET PLAYERS hence, the revenues of these players are not available in
the public domain.
A limited positive response was received from primaries in

PRIMARY INTERVIEWS the Middle East and Africa. Some primaries were reluctant
to share the sales volume data of their CRRT products.
To overcome these limitations and to maintain the effectiveness of the research study, several strategic
approaches and recommendations of industry experts were utilized.
1.6 STAKEHOLDERS
CRRT manufacturers, suppliers, and distributors
CRRT service providers
Renal research laboratories
Renal associations and organizations
Hospitals and critical care units
Academic medical centers and universities
Business research and consulting service providers
19
2 RESEARCH METHODOLOGY
2.1 RESEARCH APPROACH

This research study involved the extensive use of secondary sources, directories, and databases such as
Hoovers, Bloomberg Business, Factiva, and Avention, along with government databases to identify and
collect information useful for this technology-based, market-oriented, and commercial study of the CRRT
market. In-depth interviews were conducted with various primary respondents that mainly include key
industry participants, subject-matter experts (SMEs), C-level executives of key market players, and industry
consultants to obtain and verify critical qualitative and quantitative information as well as to assess future
prospects. The following figure shows the market research methodology applied in making this report on
the CRRT market:
FIGURE 1 GLOBAL CONTINUOUS RENAL REPLACEMENT THERAPY MARKET: RESEARCH

METHODOLOGY STEPS
Classification of the overall CRRT market

Secondary
Technical information on the CRRT market, by product, modality, and region
Research
Identification of the key players in the CRRT market
Analysis of technological developments and adoption of CRRT across various regions
Analysis of the regulatory landscape
Reference to annual reports, SEC filings/investor presentations, and press releases
of the key industry players
Primary
Validation of market drivers, restraints, challenges, and opportunities
Research
Analyzing the regional markets
Providing an overview of the reimbursement scenario
Studying market trends and forecasts
Value validation
CRRT products market segmentation Market

Top-down approach Breakdown
Bottom-up approach
Data triangulation
Market estimation
Market forecast
Qualitative and quantitative analysis
20
FIGURE 2 RESEARCH DESIGN
HISTORICAL DATA ADOPTION TRENDS COMPETITIVE LEADERSHIP MAPPING

FOR THE CRRT
MARKET
REGULATORY LANDSCAPE COST OF CRRT SYSTEMS
MARKET DRIVERS: MARKET CHALLENGES:

Increasing global incidence of AKI High complexity of therapy
Growing number of ICU patients Shortage of trained ICU nurses in developed
INFLUENCING Clinical advantages of CRRT over
countries
FACTORS intermittent blood purification techniques Poor reimbursement scenario in developing
countries
(Market Trends and Technological advancements and new
product launches
Dynamics) NEW PRODUCT LAUNCHES: About 9 in the
Increasing incidence of sepsis
last three years
Growing prevalence of diabetes and
hypertension ACQUISITIONS: About 5 in the last three years
MARKET RESTRAINTS: MARKET OPPORTUNITIES:

High procedural cost of CRRT Emerging markets
Complications associated with CRRT Increasing applications of CRRT
Stringent regulatory guidelines for CRRT in Ongoing research to establish the safety and
North America efficacy profile of CRRT
Development of a CRRT system for pediatric
patients
HISTORICAL DATA OF
THE MARKET MARKET SIZE & FORECAST ARRIVE AT THE MARKET
FORECAST By Product SIZE, SHARE, AND
(2017–2022) IMPACT ANALYSIS OF
By Modality CAGR FOR THE CRRT
By Region PRODUCTS MARKET
MARKET OVERVIEW
21
2.2 SECONDARY AND PRIMARY RESEARCH METHODOLOGY
2.2.1 SECONDARY RESEARCH

The secondary sources referred to for this research study include publications from government sources
(such as the National Institutes of Health (NIH), U.S. FDA, World Bank, and WHO); corporate filings (such as
annual reports, SEC filings, investor presentations, and financial statements); research journals; press
releases; and trade, business, and professional associations. Secondary sources were used to identify and
collect useful information for this extensive, technical, and commercial study of the global CRRT market.
Secondary research was mainly used to obtain key information about the industry’s total pool of key
players, market classification, and segmentation according to industry trends to the bottom-most level,
global market trends, and key developments by both public and private organizations in the CRRT market.
2.2.1.1 Key data from secondary sources
PARAMETER SOURCE
Company Financials
Magazines
Journals
MARKET SIZE
Press Releases
Paid Databases
MarketsandMarkets Data Repository
Annual Reports
Company Websites
REVENUE OF COMPANIES Public Databases
Company Websites
Annual Reports
QUALITATIVE INFORMATION Press Releases
22
The following non-exclusive list of secondary sources was referred to:
Associations/Organizations/Institutes:
Centers for Medicare and Medicaid Services (CMS), the United States Renal Data System (USRDS),
American Society of Nephrology (ASN), the American Association of Kidney Patients (AAKP), the Canadian
Society of Nephrology, International Society of Nephrology (ISN), American Nephrology Nurses' Association,
The Renal Association, the National Kidney Foundation, International Federation of Kidney Foundations,
Critical Care Canada Forum, World Congress of Nephrology, European Society of Paediatric and Neonatal
Intensive Care, the European Renal Association – European Dialysis and Transplant Association (ERA-
EDTA), the Intensive Care Society, Renal Association, European Society of Paediatric Nephrology, the Asian
Pacific Society of Nephrology, Singapore Society of Nephrology, Asian Renal Association (ARA), Taiwan
Society of Nephrology, Japanese Society of Nephrology, Chinese Society of Nephrology, Indian Society of
Nephrology, Renal Care Society of South Africa (RCCSA), and Sociedade Brasileira de Nefrologia (SBN),
among others.
Secondary research involved three major activities:
Background Study
Building a basic understanding of the CRRT market
Analyzing the MarketsandMarkets data repository and drawing and updating data tables using
recent information
Identifying data gaps and key players in each segment
Market Understanding
Identifying market stakeholders and key decision makers across different regions
Identifying the selection criteria of key decision makers
Analyzing the competitive landscape
z Major players with their product portfolios
z Strategies adopted by players to position their products
Analyzing the market dynamics at the regional/country level
Trends
Identifying and analyzing key products and trends to draw notes and include considerations in
the final forecasts
Identifying the major drivers, restraints, challenges, and opportunities prevailing in the market
Providing an overview of the reimbursement scenario
Analyzing the regulatory landscape
Pricing and cost analysis
23
2.2.2 PRIMARY RESEARCH

Extensive primary research was conducted after acquiring knowledge about the CRRT market scenario
through secondary research. More than 40 primary interviews were conducted with both the demand and
supply sides (CRRT product manufacturers and distributors). The primaries interviewed for this study
include experts from the CRRT industry, such as CEOs, VPs, directors, sales heads, and marketing
managers of the tier 1, 2, and 3 companies engaged in offering CRRT products across the globe;
nephrologists, intensivists, ICU and renal nurses, purchase managers, and administrators of hospitals and
heads of research universities. Approximately 64% and 36% primary interviews were conducted with both
the demand and supply sides, respectively.
A robust primary research methodology has been adopted to validate the contents of the report
and to fill gaps.
Telephonic and email communication was adopted to conduct interviews (questionnaires were
designed and sent to primary participants as per their convenience).
FIGURE 3 BREAKDOWN OF PRIMARY INTERVIEWS: BY COMPANY TYPE, DESIGNATION, AND

REGION
BY COMPANY TYPE BY DESIGNATION BY REGION
17%
26%
35% 34%
40%
44%
23%
25% 30%
26%
Tier-1 Companies Tier-2 Companies C Level Director Level Others* North America Europe Asia-Pacific RoW
Tier-3 Companies
Note: *Others include sales managers, marketing managers, business development managers, product managers, distributors, and
suppliers.
Company categorization according to revenue: Tier 1 (Revenue: More than USD 1 billion), Tier 2 (Revenue: USD 1 billion to USD 500
million), and Tier 3 (Revenue: Less than USD 500 million).
24
2.2.2.1 Key data from primary sources
TYPE PARAMETER DATA
Overall market and subsegments in 2017 Global CRRT, by region [North America,
Europe, Asia-Pacific, and the Rest of the
REGIONAL SPLIT CAGR of each region and country in the
World (RoW)]
forecast period (2017–2022)
The global market size for 2017 Global CRRT market

GLOBAL
MARKET SIZE CAGR for the forecast period CRRT market, by segment (product,
(2017–2022) modality, and region)
Dialysates and replacement fluids,

disposables (bloodline sets, hemofilters,
and other disposables), and systems CRRT market, by product
MARKET
SPLIT Slow continuous ultrafiltration, continuous CRRT market, by modality
venovenous hemofiltration, continuous
venovenous hemodialysis, and continuous
venovenous hemodiafiltration
25
2.2.2.2 Key industry insights

FIGURE 4 SUPPLY SIDE
“ Most companies
operating in the North American CRRT
“
market prefer direct sales for domestic
markets and rely on distributors for sales
“ The Asia-Pacific
CRRT market is projected to grow at
the highest CAGR during the forecast year.
This is due to the exclusive use of CRRT as
in international markets.
a treatment modality for AKI patients in

“
Australia and Japan as well as the rising
patient population in developing
regions such as India
and China.
Supplier,
CRRT Products
“ The type of purchase agreement
(single or bulk/with or without service
“
agreement) and manufacturing
expenses are key criteria for the
determination of the cost of
CRRT products.
CEO,
Key Player in the CRRT Disposable Products Market
Marketing Director,
Leading CRRT company
“ The CRRT market

is consolidated, with Baxter
International (after the acquisition of
“
Gambro) and NxStage accounting for
a significant share of the
“ The high procedural cost
of CRRT as compared to other RRT
modalities (SLED and IHD) and the
market in 2016. “
dearth of clinical evidence to support the
efficacy of CRRT are the key restraints to
Sales Manager,
Leading CRRT Company
“ The development of new
wearable and miniaturized CRRT“
machines with user-friendly features
unfolds new growth opportunities for
manufacturers in the market.
the growth of the market.
Product Manager,
Senior Scientist, R&D,

26
FIGURE 5 DEMAND SIDE
“ The utilization of CRRT in

North American hospitals is lesser than
other regions. This is because most
nephrologists in the U.S. prefer IHD or
“
SLEDD over CRRT due to their lower
procedural cost and comparable
“
clinical outcomes.
Currently, most hospitals
“ The reimbursement scenario

for CRRT is well-established in most
“
developed countries. However, in
developing and underdeveloped
countries, reimbursement for CRRT
Senior Nephrologist in a U.S.
Hospital
in the European region use Baxter’s
Prismaflex CRRT machine. However, the
adoption of Nxstage’s System One
“
machine for CRRT is expected to
increase in the future due to its
is still poor.
ease of operation.
Independent Renal Consultant

Intensivist,
(Germany)
Leading Kidney Care Hospital (U.K.)
“ The high cost of disposables

(bloodline sets and fluids),
coupled with expensive labor
(nurses and technicians) costs
“
are the key parameters that
“ The rise in the number of
AKI/AKF patients across the globe is
a key driver of market growth. This is
used for the treatment of

“
because CRRT is the only modality
contribute to the procedural cost hemodynamically unstable AKI

of CRRT. patients in intensive care.
Renal Nurse,
Nephrologist, Hospital (India)
Leading Canadian Hospital
2.3 MARKET SIZE ESTIMATION METHODOLOGY

Both, top-down and bottom-up approaches were used to estimate and validate the size of the global
market and to estimate the size of various other dependent submarkets in the overall CRRT market. The
research methodology used to estimate the market size includes the following details:
Key players in the market were identified through secondary research, and their market shares were
determined through primary and secondary research. This entire procedure includes the study of the
annual and financial reports of the top market players and extensive interviews for key insights with
industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares, splits, and
breakdowns were determined using secondary sources and verified through primary sources. All the
possible parameters that affect the markets covered in this research study have been accounted for,
viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and
qualitative data. This data was consolidated and added with detailed inputs and analysis from
MarketsandMarkets, and presented in this report.
The following figure shows the overall number of procedures and the market size estimation process
employed for the purpose of this study:
27
FIGURE 6 ESTIMATION OF CRRT PROCEDURAL VOLUME
Total number of AKI patients in the region (C

C)
Percentage utilization of CRRT for the treatment of AKI patients in the

D)
region (D
Total number of CRRT procedures performed in the region (E

E) = C*D
ESTIMATION OF PROCEDURAL* VOLUME Percentage contribution of individual countries in the region (F

F)
Total number of CRRT procedures at the country level = E*F M
Total number of procedures performed at the country level (P) = A*B
Average number of procedures performed in these facilities (B

B)
Total number of leading hospitals performing medical procedures at the

country level (A
A)
Note: *Procedures are calculated based on epidemiology data gathered from interviews conducted with key nephrologists and
intensivists, utilization of CRRT across various regions, and incidence & prevalence data reported by governments/public
organizations.
FIGURE 7 RESEARCH METHODOLOGY: TOP-DOWN APPROACH [FOR MARKET SIZE

ESTIMATION OF DISPOSABLES (BLOODLINE SETS, HEMOFILTERS, AND OTHER
DISPOSABLES)]
Number of CRRT procedures at the country level = (M) DATA SOURCING TABLE
Secondary Research (Indicative List
of Sources Used):
Annual Reports
Average amount/number of disposables required in one
SECONDARY & PRIMARY
CRRT procedure = (N) Investor Presentations

Press Releases
RESEARCH
Magazines
Associations/Institutions
(M)*(N) = Volume Market (O)
Paid Databases
MarketsandMarkets Data
Repository
Average selling price (ASP) of a particular product in an
individual country = (P)
Primary Research: Interviews with
Industry Experts/Key Opinion
Leaders (KOLs)/Subject-matter
(O)*(P) = Value market size of CRRT disposables in an Experts (SMEs) from the Demand
individual country and Supply Sides
X (a)
28
FIGURE 8 RESEARCH METHODOLOGY: TOP-DOWN APPROACH (FOR MARKET SIZE

ESTIMATION OF CRRT SYSTEMS)
Total number of installations of CRRT systems globally = (S) DATA SOURCING TABLE
of Sources Used):
Annual Reports
SECONDARY & PRIMARY
Percentage split of installations, by country = (T) Investor Presentations

Press Releases
RESEARCH
Magazines
(S)*(T) = Volume market size of CRRT systems in an Associations/Institutions
individual country = (U)
Paid Databases
Repository
Average selling price (ASP) of CRRT systems in an
individual country = (V)
(U)*(V) = Value market size of CRRT systems, by country Experts (SMEs) from the Demand
and Supply Sides
X (b)
Total value size of the CRRT market in an individual country (X) : X = X (a) + X (b)
FIGURE 9 RESEARCH METHODOLOGY: BOTTOM-UP APPROACH
Generating a list of players operating in the CRRT product segments DATA SOURCING TABLE
of Sources Used):
Annual Reports
Mapping the value sales of a particular CRRT product per year,
SECONDARY & PRIMARY
Investor Presentations
by company and by country
Press Releases
RESEARCH
Magazines
Mapping value sales per year, by company, to the extent that Associations/Institutions
75% to 80% of the market is covered
Paid Databases
Repository
Extrapolation of the market to 100% to arrive at the value market

Value market of a particular CRRT product, per country Experts (SMEs) from the Demand
and Supply Sides
29
2.4 MARKET DATA VALIDATION AND TRIANGULATION

To complete the overall market engineering process and to arrive at the exact statistics for all the market
segments and subsegments, the data triangulation and market validation procedures explained below
were implemented, wherever applicable.
FIGURE 10 DATA TRIANGULATION STEPS (TOP-DOWN AND BOTTOM-UP APPROACHES)
MARKET SIZE ESTIMATION: CRRT DISPOSABLES (BLOODLINE SETS,

MARKET SIZE ESTIMATION: CRRT SYSTEMS
HEMOFILTERS, AND OTHER DISPOSABLES)
Number of CRRT procedures at the country-level = (M) Total number of installations of CRRT systems globally = (S)
Average amount/number of disposables required in

one CRRT procedure = (N) Percentage split of installations, by country = (T)
(M)*(N) = Volume market (O)

(S)*(T) = Volume market size of CRRT systems in an individual country =
(U)
Average selling price (ASP) of a particular CRRT product in an
individual country = (F)
Average selling price (ASP) of CRRT systems in an individual country = (V)
((O)*(F) = Value market size for CRRT disposables in an
individual country = Xa (U)*(V) = Value market size of CRRT systems, by country = Xb
Xa + Xb
TOP-DOWN COUNTRY-WISE VALUE MARKET SIZE OF CRRT PRODUCTS (SUM OF ALL COUNTRY-WISE CRRT MARKETS = BOTTOM-UP
APPROACH GLOBAL CRRT VALUE MARKET)
APPROACH
Value Market for a particular product, per country
Extrapolation of the market to 100% to arrive at the value market
Mapping the value sales per year, by company, to the extent that
75% to 80% of the market is covered
Mapping the value sales of a particular CRRT product per year, by company and by country
Generating the list of players operating in the CRRT product segments
30
FIGURE 11 DATA TRIANGULATION METHODOLOGY
PRIMARY SOURCES SECONDARY SOURCES
INTERVIEWS WITH:
Hospitals and Clinics Annual Reports, Presentations,
DEMAND SIDE
Nephrologists, Intensivists, ICU Websites and Press Releases

and Renal Nurses of Top Players, News Articles,
Chief Information Officers Journals, Kidney Care Associations,
Government Databases,
Purchase Managers in
Healthcare Provider
and Paid Databases
Organizations MnM KNOW*
INTERVIEWS WITH: The United States Renal Data System

Presidents, CEOs, Vice (USRDS)
Presidents, Directors, General DATA
International Society of Nephrology
Managers, and Senior PRIMARY TRIANGULATION
SOURCE The American Association of Kidney
SUPPLY SIDE
Managers of CRRT product

manufacturers Patients (AAKP)
SECONDARY
Product/Sales/Marketing/Busi SOURCE International Federation of Kidney
ness Development/Client Foundations
Portfolio Managers or The Intensive Care Society
Specialists
The European Renal Association
Distributors/Suppliers/Channe
l Partners and Business The Asian Pacific Society of
Intelligence Consultants Nephrology
INFORMATION SOURCED
Opportunities and Market Size (2017) and

Key Players Competitive Landscape
Challenges Market Share (2016)
Geographical
Drivers and Restraints Forecast
Analysis
MnM KNOW* stands for MarketsandMarkets’ 'Knowledge Asset Management' framework. In this context, it stands for existing
market research knowledge repository of over 5,000 granular markets, our flagship competitive intelligence and market
research platform "RT", subject matter experts, and independent consultants. MnM KNOW acts as an independent source
that helps us validate information gathered from primary and secondary sources .
31
2.5 ASSUMPTIONS FOR THE STUDY
PARAMETERS ASSUMPTIONS
There will be no drastic changes in the market scenario during the

forecast period
The increase/decrease in demographic conditions (such as
General Assumptions population, obesity, and age) is expected to continue in the next
five years in key geographies
There will be no changes in regulations and reimbursements that
have a huge impact on the industry
For market estimation, variations in prices across geographies are

considered
Financial Calculations
For market size estimation, the average selling prices (ASPs) of
products were considered
It has been assumed that dollar fluctuations will not affect the
Exchange Rates forecast to a significant extent
The revenues of private companies acquired from paid databases

Company Financials were assumed to be in line with actual company financials
A positive economic climate will continue in Asia-Pacific countries

till the end of 2022
Economy Current government R&D spending patterns are assumed to be
persistent in major countries across the four regions during the
forecast period
Note 1: Regionwise inflation/deflation of prices of CRRT products in the next five years has been considered while forecasting the
market size.
Note 2: Market values have been rounded off to the second decimal. Due to this, there may be a slight difference in the actual total
and the total mentioned in market tables.
32
3 EXECUTIVE SUMMARY
CRRT is an extracorporeal blood purification therapy used to treat critically ill AKI/AKF patients. It is
designed to substitute impaired renal function over an extended period. This therapy is considered to be a
gold standard for treatment of hemodynamically unstable AKI patients as it provides better hemodynamic
stability and improved efficiency of solute removal as compared to other dialysis techniques.
The global CRRT market is projected to reach USD 1,532.3 million by 2022 from USD 1,092.5 million in
2017, at a CAGR of 7.0% from 2017 to 2022. Factors such as the increasing prevalence of AKI and renal
disorders, growing number of ICU patients, rapid growth in the aging population, and clinical advantages of
CRRT over intermittent blood purification techniques are driving the growth of the CRRT market. However,
factors such as high procedural cost and stringent regulatory guidelines for CRRT are restraining the
growth of the CRRT market.
FIGURE 12 GLOBAL CRRT MARKET BY PRODUCT, 2017 VS. 2022
800
Market Size (USD Million)
700
600
500
400
300
200
100
0
Dialysates and Replacement
Disposables Systems
Fluids
2017 534.2 391.1 167.2
2022 746.2 571.5 214.5
CAGR 6.9% 7.9% 5.1%
Source: Acute Kidney Injury Network (AKIN), ClinicalTrials.gov, American Society of Nephrology (ASN), International Society of
Nephrology, The United States Renal Data System (USRDS), Canadian Society of Nephrology (CSN), European Renal Association –
European Dialysis and Transplant Association [ERA-EDTA], Asian Renal Association, U.S. FDA, Annual Reports, SEC Filings, Press
Releases, Investor Presentations, Journals, Expert Interviews, and MarketsandMarkets Analysis
On the basis of products, the global CRRT market is segmented into dialysates & replacement fluids,
disposables, and systems. The dialysates & replacement fluids segment is expected to account for the
largest share of the global CRRT market in 2017. The large market share of this segment is primarily
attributed to the high volume requirement of dialysates and replacement fluids during a CRRT procedure
since it is provided as a continuous 24-hour-per-day therapy. The disposables segment is expected to grow
at the highest CAGR of 7.9% from 2017 to 2022.
33
FIGURE 13 HEMOFILTERS TO FORM THE LARGEST SEGMENT OF CRRT DISPOSABLES

MARKET IN 2017
2017 2022
Hemofilters 161.9 223.8
104.4 156.9
Bloodline Sets
Other Disposables 124.8 190.9
The CRRT disposables market is further segmented into hemofilters, bloodline sets (tubing sets), and other
disposables (including vascular access catheters, adsorbents, and CRRT accessories). The hemofilters
segment is estimated to account for the largest share of 41.4% of the CRRT disposables market in 2017.
The growth in this segment is primarily attributed to the large and regular demand for consumables owing
to their short work life.
FIGURE 14 CVVHDF EXPECTED TO BE THE FASTEST-GROWING SEGMENT DURING

2017-2022
Best Markets to
10.0% Invest in
9.0%
8.0%
7.0%
CAGR (2017-2022)
6.0%
5.0%
4.0%
3.0%
2.0%
1.0%
0.0%
0 1 2 3 4 5
Rank (in Terms of Market Value in 2017)
CVVH CVVHDF CVVHD SCUF
On the basis of the modality, the CRRT market is segmented into slow continuous ultrafiltration (SCUF),
continuous venovenous hemofiltration (CVVH), continuous venovenous hemodialysis (CVVHD), and
continuous venovenous hemodiafiltration (CVVHDF). The CVVH segment is expected to account for the
largest share of 51.9% of the market in 2017. The widespread adoption of this modality among critical
34
care providers owing to its superior removal performance for high-molecular-weight solutes as compared to
other CRRT techniques is a major driver for the growth of this segment.
FIGURE 15 ASIA-PACIFIC TO GROW AT THE HIGHEST GROWTH RATE IN THE FORECAST

PERIOD
EUROPE
37.7%
5.4%
NORTH AMERICA
29.3% ASIA-PACIFIC
6.7% 21.6%
9.4%
REST OF THE WORLD

11.4%
MARKET SHARE (2017)
8.0% CAGR (2017–2022)
Europe is expected to account for the largest share of 37.7% of the global CRRT market in 2017, followed
by North America (~29.3%). Factors such as the increasing incidences of AKI coupled with growth in the
aging population, high utilization rate of CRRT, and growing number of approvals for CRRT machines for
multiple applications are driving the growth of the CRRT market in the European region.
The market in Asia-Pacific is projected to register the highest CAGR of 9.4% during the forecast period. The
high growth rate in this region can be attributed to factors such as the growing patient population,
increasing sepsis incidence, increasing prevalence of hypertension and diabetes (which are the major
causes for developing AKI), high use of CRRT in Australia and Japan, improving healthcare expenditure,
and increasing accessibility to CRRT for AKI treatment.
The prominent players in the global CRRT market include Baxter International Inc. (U.S.), Fresenius Medical
Care AG & Co. KGAA (Germany), Nikkiso Co., Ltd. (Japan), B. Braun Melsungen AG (Germany), Nxstage
Medical, Inc. (U.S.), Asahi Kasei Medical Co., Ltd. (Japan), Bellco S.R.L. (Italy) Infomed SA (Switzerland),
Medica S.p.A (Italy), Medical Components, Inc. (U.S.), and Toray Medical Company Limited (Japan).
A majority of the leading market players are pursuing the strategies of product development and launches
as a key strategy to expand their CRRT product offerings. Market players are also focusing on acquisitions
& mergers, and entering into strategic agreements & partnerships to enhance their market shares and
strengthen their presence across the globe.
35
4 PREMIUM INSIGHTS
4.1 CRRT: MARKET OVERVIEW (2017)

FIGURE 16 RISING PREVALENCE OF AKI TO DRIVE THE GLOBAL CRRT MARKET DURING THE
FORECAST PERIOD
The global CRRT market is projected to reach USD

1,532.3 million by 2022, at a CAGR of 7.0% during
the forecast period (2017–2022).
Market growth is primarily attributed to the

USD 1,532.3 increasing prevalence of AKI; clinical advantages of
Million CRRT over intermittent blood purification techniques
USD 1,092.5 and technological advancements in CRRT products
Million are further driving market growth in this segment.
Emerging markets offer high growth opportunities

owing to their developing healthcare infrastructure
and rising per capita healthcare expenditure.
2017 2022
36
4.2 GLOBAL CRRT MARKET, BY PRODUCT, 2017 VS. 2022

FIGURE 17 DIALYSATES & REPLACEMENT FLUIDS TO DOMINATE THE GLOBAL CRRT MARKET
DURING THE FORECAST PERIOD
Continuous Renal Replacement Therapy Continuous Renal Replacement

Market, by Product, 2017 Therapy Market, by Product, 2022
15.3% 14.0%
2017 48.9% 2022 48.7%
35.8% 37.3%
Dialysate and Replacement Fluids Disposables

CRRT Disposables CRRT Systems
Systems
4.3 CRRT MARKET, BY MODALITY AND REGION (2017)

FIGURE 18 EUROPE TO DOMINATE CRRT MODALITY SEGMENTS IN 2017
Total CRRT Market: USD 1,092.5 Million in 2017
USD 567.0 Million USD 344.1 Million USD 125.6 Million USD 55.7 Million
100%
RoW 11.7% 10.8% 11.2% 11.2%
Asia-Pacific 80% 20.7% 21.7%

22.1% 22.0%
60%
North America 29.0% 29.5%
29.1% 31.3%
40%
Europe 20% 37.1% 39.5% 35.5% 37.6%
0%
CVVH CVVHDF CVVHD SCUF
Note: Numbers denote % shares of each region in the specific CRRT modality segment, as of 2017.
37
4.4 GEOGRAPHIC SNAPSHOT: CRRT MARKET (2017)

PERIOD
Market Share (2017):

37.7%
Market Share (2017):

29.3%
Market Share (2017): 21.6%
North America
Market Share (2017): 11.4%
Europe
Asia-Pacific
RoW
Note: Numbers in bubbles denote estimated market shares of individual regions in the global CRRT market, as of 2017.
38
5 MARKET OVERVIEW
KEY FINDINGS
The global CRRT market is projected to reach USD 1,532.3 million by 2022 from USD 1,092.5
million in 2017, at a CAGR of 7.0% from 2017 to 2022.
Factors such as the increasing global incidence of AKI, growing number of ICU patients, clinical
advantages of CRRT over intermittent blood purification techniques, technological advancement
and new product launches, increasing incidence of sepsis, and growing prevalence of diabetes
and hypertension are the key drivers responsible for the growth of the CRRT market.
On the other hand, the high procedural cost of CRRT and stringent regulatory guidelines for
CRRT in North America are the major factors restraining the growth of this market.
Emerging markets (Such as India, China, and Brazil,), increasing applications of CRRT, ongoing
research to establish the safety and efficacy profile of CRRT, the development of a CRRT system
for pediatric patients, and untapped market opportunities in North America are expected to
provide significant growth opportunities for players in this market.
The high complexity of therapy, shortage of trained ICU nurses in developed countries, poor
reimbursement scenario in developing countries, and lack of awareness about the benefits of
CRRT are the major challenges faced by the key players in the global CRRT market.
39
5.1 INTRODUCTION
The global CRRT market is projected to reach USD 1,532.3 million by 2022 from USD 1,092.5 million in
2017, at a CAGR of 7.0% from 2017 to 2022. Clinical advantages such as better hemodynamic tolerability
and efficient solute clearance offered by CRRT over intermittent blood purification techniques are expected
to drive its adoption across the globe in the coming years. Additionally, factors such as the increasing
number of AKI patients, technological advancements and new product launches, and increasing incidence
of sepsis are also expected to support market growth.
5.2 MARKET DYNAMICS

FIGURE 20 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET: DRIVERS, RESTRAINTS,
OPPORTUNITIES, AND CHALLENGES
Increasing global incidence of AKI
D
Growing number of ICU patients
DRIVERS
Clinical advantages of CRRT over intermittent blood purification techniques

Technological advancements and new product launches
Growing prevalence of diabetes and hypertension
RESTRAINTS
R

High procedural cost of CRRT
Stringent regulatory guidelines for CRRT in North America
OPPORTUNITIES
Emerging markets
O
Increasing applications of CRRT
Ongoing research to establish the safety and efficacy profile of CRRT
Development of a CRRT system for pediatric patients
Untapped market growth opportunities in North America
CHALLENGES
High complexity of the therapy
C

Shortage of trained ICU nurses in developed countries
Poor reimbursement scenario in developing countries
Lack of awareness about the benefits of CRRT
Source: Company Websites, Press Releases, Investor Presentations, Expert Interviews, and MarketsandMarkets Analysis
40
5.2.1 DRIVERS
5.2.1.1 Increasing global incidence of AKI
Nephrologists/intensivists prefer CRRT for the treatment of AKI patients in ICUs; it is considered as the
gold standard for the treatment of hemodynamically unstable AKI patients as it provides better
hemodynamic stability and improved efficiency of solute removal compared to other dialysis techniques.
The growing worldwide incidence of AKI/AKF is therefore expected to increase the demand for CRRT. The
number of global AKI cases is expected to reach 1.7 million by 2020 from 800,000 cases in 2010, at a
CAGR of ~8% (Source: Baxter, 2015 Investor Conference). In the U.S. alone, an estimated 200,000 cases
of acute kidney failure are registered each year (Source: NxStage Annual Report, 2013). Every year,
approximately 50 million patients are admitted to intensive care units (ICUs) in U.S. hospitals; nearly 50%
of these patients develop AKI (Source: Society of Critical Care Medicine). Similarly, approximately 20% of
hospitalized patients in the European Union reportedly develop AKI with a high rate of mortality (Source:
International Society of Nephrology). In the U.K., approximately 13% to 18% of hospitalized patients
develop AKI (Source: National Health Service, U.K.).
FIGURE 21 GLOBAL INCIDENCE OF ACUTE KIDNEY INJURY (AKI), 2010 VS. 2015 VS. 2020
2.0
AKI Cases (Million)
1.5
1.0
0.5
0.8 1.1 1.7

0.0
2010 2015 2020
Source: Baxter’s Investor Presentation 2015
With age, the risk of developing AKI also increases. In 2011, the incidence rate of AKI among Medicare
patients aged between 66 and 69 years was 14.9 cases per 1,000 patients, increasing to 18.8 for ages
70–74, 26.4 for ages 75–79, 35.9 for ages 80–84, and 49.6 for 85 years and older (Source: United
States Renal Data System, USRDS). Additionally, factors such as decrease in blood volumes (as aging
causes a reduction in total body water due to which there is less fluid in the bloodstream which results in a
decrease in the blood volume); past medical complications such as heart abnormalities, weight issues, and
issues related to diabetes and liver disease management; and increased intake of medicines can further
exacerbate age-related renal changes.
With the rapid growth in the geriatric population globally, the prevalence of kidney-related diseases is
expected to increase significantly. This, in turn, is expected to drive the growth of the CRRT market.
41
5.2.1.2 Growing number of ICU patients

The incidence of AKI in ICU patients is increasing; severe AKI is mostly treated by renal replacement
therapy (RRT). Approximately 30% to 65% of ICU patients experience an episode of AKI, and around 5%-
15% of these patients require RRT (Source: European Patient’s Kidney Federation; E Hoste, PEACE protocol
draft version 1.9, 05 December 2014). CRRT is the most preferred therapy in ICU patients suffering from
AKI due to their hemodynamic instability.
Thus, the global increase in the number of patient admissions in ICUs is expected to drive the demand for
CRRT, thereby driving market growth. The following are some important statistics in this regard:
The number of ICU admissions in the U.S. is expected to increase by ~50% from 2015 to 2030,
resulting in 330,000 cases of ICU admissions annually by 2030 (Source: Textbook of Post-ICU
Medicine: The Legacy of Critical Care).
In the U.K., the total number of patients admitted to ICUs increased to 181,155 in 2014 from
179,157 in 2013 (Source: National Health Service, U.K.).
An estimated 14.3 million patients are admitted to ICUs in India each year (Source: LIFE).
5.2.1.3 Clinical advantages of CRRT over intermittent blood purification

techniques
CRRT offers some key clinical advantages over intermittent blood purification techniques such as IHD
(intermittent hemodialysis), SLEDD (sustained low-efficiency daily dialysis), and PD (peritoneal dialysis).
Some of these advantages are listed below:
Technical advantages: CRRT offers better hemodynamic tolerability, more efficient solute
clearance, better control of intravascular volume, reduced need for infusion controls, and better
clearance of middle and large molecular weight substances compared to intermittent blood
perfusion techniques.
Reduced mortality: In a 160-patient study of CRRT vs. IHD, the mortality rate was reduced by
40% in the therapy using CRRT (Source: The New England Journal of Medicine, 346, 305-310).
Short-term benefits: CRRT supports the renal system through continuous, gentle removal of
excess metabolic waste products while returning normal electrolyte and acid-base balance.
Long-term benefits: CRRT improves patient survival rates and increases renal recovery rates.
Furthermore, a number of clinical studies conducted in different countries have demonstrated better renal
recovery results in CRRT over other therapies, which further fosters its adoption among healthcare
providers.
According to a study published in the Chinese Medical Journal (May 2017), CRRT improves the
hemodynamic stability in critically ill patients and also maintains circulatory stability during the
therapy, thereby improving the overall therapeutic outcomes.
As per a study published by the Center for Kidney Disease (China) in May 2015, CRRT is a good
model for critically ill patients, which helps in reducing the mortality rate and improves renal
recovery.
A study circulated by Critical Care Medicine (China) in May 2014, shows that patients starting
treatment of AKI with CRRT are associated with significantly better recovery of their renal
function and a lower incidence of chronic dialysis dependence.
These benefits have resulted in a considerable increase in the adoption of CRRT by nephrologists across
the globe.
42
5.2.1.4 Technological advancements and new product launches

The key players in the global CRRT market are increasingly focusing on developing and commercializing
technologically advanced, more intuitive, and easy-to-use CRRT devices and disposables. Some key
developments in this regard are listed below:
In November 2016, B. Braun Melsungen AG (Germany) introduced OMNI, a new device for CRRT
which provides an improved user interface, minimizes downtime, and optimizes renal dose
delivery.
In January 2015, Baxter International Inc. (U.S.) received U.S. FDA approval for its PHOXILLUM
solution for electrolyte management during CRRT. Hypophosphatemia is a common electrolyte
disturbance that occurs in patients undergoing CRRT, and PHOXILLUM is the only FDA-approved
pre-mixed solution comprising phosphate. It is designed to facilitate electrolyte management
during CRRT by allowing the use of a single type of solution across a wide clinical spectrum of
AKI patients.
In May 2015, Fresenius Medical Care launched multiFiltratePRO, a new therapy system for
CRRT for the treatment of acute kidney failure. User-friendly operations, reliability, and usage in
various extracorporeal therapies are the key features of this new therapy system.
Baxter is expected to launch a new CRRT machine Prismax in 2017. This intuitive platform with
touchscreen and step-by-step automated instructions enhances usability.
These new devices are equipped with user-friendly interfaces that allow easy monitoring. This, in turn, is
expected to drive the adoption of these devices across the globe.
5.2.1.5 Increasing incidence of sepsis

Sepsis is a severe infection that spreads via the bloodstream. Acute kidney injury (AKI) is a common sequel
to sepsis in the ICU, accounting for ~40% of the patients worldwide (Source: Indian J Nephrol. 2014 Sep-
Oct; 24(5): 280–285.). AKI occurs in about 19% of patients with moderate sepsis, 23% with severe sepsis,
and 51% with septic shock, when blood cultures are positive (Source: Indian J Crit Care Med. 2010 Jan-
Mar; 14(1): 14–21.). Listed below are a few statistics regarding the increasing incidence of sepsis globally:
Sepsis affects an estimated 30 million people worldwide every year (Source: Sepsis Fact Sheet).
In developing countries, sepsis accounts for 60%–80% of deaths annually, affecting more than
6 million newborns and children per year. Over 100,000 women are affected with sepsis during
pregnancy and childbirth, every year (Source: Sepsis Fact Sheet).
According to the Centers for Disease Control and Prevention (CDC), sepsis is a serious medical
issue in the U.S., affecting more than 1 million patients annually, and its incidence continues to
rise.
In Germany, the incidence of sepsis increased to 314 cases per 100,000 population in 2013
from 134 cases per 100,000 population in 2007, which shows that the incidence rate grew by
a mean of 15% per year during this period (Source: A study published in Intensive Care
Medicine Experimental Journal).
In 2013, in the U.K., approximately 150,000 new cases of sepsis were registered, of which
~44,000 patient deaths were registered (Source: The UK Sepsis Trust).
CRRT is one of the most widely used modalities for the treatment of patients with sepsis as this therapy
provides an immune-modulatory effect, which is very essential for sepsis management. Thus, with the
rising incidence of sepsis globally, the need for CRRT is expected to rise.
43
5.2.1.6 Growing prevalence of diabetes and hypertension

Hypertension and diabetes (other than cardiovascular disease, high cholesterol, and obesity) are among
the major risk factors for AKI. According to a study published by Kato et al. Renal Replacement Therapy in
October 2016, hypertension is one of the key risk factors for the development of AKI. According to an
article published by Clinic of Nephrology and Rheumatology & University Hospital of Göttingen, Göttingen
(Germany), diabetes is also an independent risk factor for AKI. The rising global prevalence of hypertension
and diabetes is, therefore, a major growth driver for the global CRRT market.
Globally, the number of patients who have diabetes is expected to reach 642 million by 2040
from ‫׽‬415 million in 2015 (Source: International Diabetes Federation).
According to the International Diabetes Federation, in 2015, ~29 million people had diabetes in
the U.S., making it one of the prime causes of new kidney failure cases.
According to the Centers for Disease Control and Prevention, around 75 million adults (which
account for 32% of the total U.S. population) suffer from high blood pressure. It was considered
as the major cause contributing to around 410,000 deaths in 2014 in the U.S.
According to the American Heart Association, the prevalence of hypertension in the U.S. is
expected to increase by 8.4% from 2012 to 2030, which will account for ~41.4% of the U.S.
adult population in 2030.
In 2014, the number of people who have diabetes in France was 3.2 million, which increased to
3.3 million in 2015 (Source: International Diabetes Federation). The national prevalence of
diabetes in France was about 7.4% in 2015 (Source: IDF DIABETES ATLAS Seventh Edition
2015).
According to the International Diabetes Federation, around 62 million people had diabetes in
India in 2015, as compared to 50.8 million in 2011.
With the increasing prevalence of hypertension and diabetes, the risk of developing AKI is also expected to
rise. This will result in an increase in the demand for CRRT, thereby driving market growth.
5.2.2 RESTRAINTS
5.2.2.1 High procedural cost of CRRT
The average cost for overall CRRT is USD 4,046, whereas the same for performing IRRT is estimated to be
USD ~1,423 (Source: A Study Published by Nephrology Dialysis Transplantation, 2015). Nephrologists,
especially in the emerging economies, are less inclined towards CRRT in comparison to IHD because of this
high cost. The various factors contributing to the high cost of CRRT compared to other blood perfusion
techniques are listed below:
High nursing and technician cost for performing CRRT in ICU settings
Higher cost of filter sets and dialysates used in CRRT compared to other modalities
In ICUs, for performing CRRT, the nurse to patient ratio is 1:1, whereas for other treatments this
ratio is 1:2. Thus, the requirement of extra nurses further adds to the operation cost of CRRT
44
5.2.2.2 Stringent regulatory guidelines for CRRT in North America

CRRT product manufacturers in North America face several regulatory barriers due to multilayered
regulations set by the FDA. This negatively impacts the demand for various CRRT products. Due to high
regulatory barriers, many CRRT products approved in other countries are still not approved by the FDA. For
instance, in Europe, CRRT is approved for multiple indications such as liver support, elevated ICP,
intoxication, cardiac failure, rhabdomyolysis, tumor lysis syndrome, and post-cardiac surgery. However, in
North America, no CRRT machine is approved by the FDA for the treatment of multiple indications.
Similarly, no anticoagulating agent for blood infusion during a CRRT procedure is approved by the FDA to
date, whereas it is approved in Europe.
The significant market share of the U.S. in the global CRRT market is mainly due to the huge AKI population
base. Thus, the presence of stringent and time-consuming regulatory policies for the approval of new CRRT
products in the region poses a key hindrance to the growth of the global market.
5.2.3 OPPORTUNITIES
5.2.3.1 Emerging markets
Emerging markets such as China, India, Brazil, and Mexico present significant growth opportunities for the
players involved in the CRRT market. According to the International Society of Nephrology, the incidence
rate for AKI is significantly higher in emerging countries compared to the developed countries, with an
estimated 11.3 million patients registered annually.
AKI is relatively widespread in China and is associated with severe morbidity and mortality. The overall
incidence rate of AKI in China is ~11.6%. Around 40% of AKI cases in the country were found to be drug-
related, and 16% were induced by Chinese traditional medicines or remedies. Similarly, the incidence of
AKI in India is 17.3 cases per 100 persons every year (Source: Indian Journal of Nephrology, Vol. 24, No. 5,
September-October, 2014, pp. 280-285). This high prevalence of AKI in various emerging markets is
expected to propel the demand for CRRT as a treatment option.
In addition to this, regulatory policies in the Asia-Pacific region are more adaptive and business friendly due
to less stringent data requirements. This, along with the increasing competition in mature markets (Europe,
Japan, and Australia), will further trigger CRRT product manufacturers to focus on emerging markets.
5.2.3.2 Increasing applications of CRRT

CRRT is a broadly accepted treatment for AKI patients in critical care units. With continuous research and
development in this field, alternative indications for extracorporeal blood circulation are becoming popular.
The ongoing development of an ideal multipurpose CRRT machine is expected to open a new era for critical
care nephrology and will lead to further expansion of CRRT applications in ICUs.
5.2.3.2.1 Evolution of CRRT from a simple renal replacement treatment

to a multi-organ support therapy (MOST)
Multiple organ failure (MOF) is the leading cause of mortality in critically ill AKI patients and accounts for a
large percentage of the healthcare expenditure. CRRT acts as a “multiple organ support system” in AKI
patients affected with multiple organ failure by eliminating humoral mediators of systemic inflammatory
response and sepsis from the blood. This improves treatment results in patients with multiple organ
dysfunctions. Various observational studies have revealed that the mortality rate among AKI patients with
multiple organ failure is lower among those treated with CRRT than IHD. Evidence obtained from various
clinical trials shows that CRRT improves survival rates in AKI patients with MOF as compared to IHD due to
improvements in pulmonary gas exchange, hemodynamic instability, azotemia control, fluid overload, and
nutritional support (Source: World J Surg. 2001 May;25(5):669-76).
45
The positive clinical outcomes associated with the use of CRRT in AKI patients with MOF are expected to
drive its adoption among healthcare providers in the coming years.
5.2.3.2.2 Progression of CRRT from adaptive renal devices to

multipurpose treatment machines
The capability of CRRT to maintain the hemodynamic stability in AKI patients has contributed to its use in
situations in which fluid loss is desired but the patient’s condition restricts the use of standard dialysis or
other therapeutic interventions. In addition, the ability of CRRT to manipulate continuous extracorporeal
blood circuit has opened up new opportunities for a variety of non-renal applications. The most cited area
for the use of CRRT in non-renal conditions is congestive heart failure (CHF). CRRT can be successfully
used for treating patients suffering from hypernatremia with severe CHF, without observing any fluid
overload.
Life-threatening Hemofiltration for poisoning (such as; lactic

hyperthermia acidosis and lithium poisoning)
Sepsis Cytokine removal: Acute

respiratory distress syndrome
Congestive heart failure
refractory to diuretics Elevated ICP
Lactic acidosis Overhydration during &

after cardiac surgery
KEY NON-RENAL
Crush syndrome
APPLICATIONS OF CRRT Chemofiltration and
chemoperfusion
Systemic inflammatory
response syndrome Elevated ICP
Intoxication
Cardiac failure
Rhabdomyolysis
Tumor lysis
syndrome
CRRT machines are approved for non-renal indications in Europe and other regions such as (Japan and
Australia); however, they are not FDA-approved for any conditions other than renal indications in North
America. This is also one of the key reasons for the higher utilization of CRRT in Europe as compared to
North America. The rise in the use of CRRT machines for non-renal conditions will lead to an increase in the
use of single CRRT machines for multiple treatments; this, in turn, will cause a substantial decrease in the
installation and maintenance costs for hospitals using machines for other indications as well.
46
5.2.3.3 Ongoing research to establish the safety and efficacy profile of

CRRT
A large number of research projects and clinical trials related to CRRT are being conducted globally. These
projects aim to provide substantial clinical evidence of the better safety and efficacy profile of CRRT as
compared to other dialysis techniques. Positive outcomes of these studies are expected to drive the
adoption of CRRT.
In March 2017, St. Louis University (U.S.) initiated a new clinical trial study, “Hemodynamic
Effects of Blood Flow Variation in Continuous Renal Replacement Therapy.” The study aims to
evaluate the short-term hemodynamic effects of changes in blood flow rates in critically ill
patients receiving CRRT (Source: Clinical Trials.Gov).
In December 2016, Mayo Clinic (U.S.) initiated a clinical trial study, “Systemic Metabolic
Contribution from Continuous Renal Replacement Therapy (CRRT).” This study intended to
measure the number of calories delivered from fluids used in CRRT (Source: Clinical Trials.Gov).
In January 2015, the Peking University First Hospital (China) initiated a clinical trial study,
“Efficacy and Safety of Heparin-coated Surface-treated Polyacrylonitrile Membrane Hemofilter in
Critical Ill CRRT Patients.” This study aims to establish the safety and efficacy of the AN69 ST
hemofilter, a surface-treated polyacrylonitrile membrane hemofilter in critical CRRT patients
(Source: Clinical Trials.Gov).
5.2.3.4 Development of a CRRT system for pediatric patients

CRRT can also be used to support children with kidney failure and fluid overload which cannot be treated
with traditional dialysis. The current CRRT machines used during the treatment are applicable for both
children and adults, with modifications in dosages and delivering techniques.
Using these CRRT devices in children can result in complications because of inaccurate fluid balance (FB)
between the volumes of ultrafiltrate (UF) removed, and replacement fluid (RF) delivered. Additionally,
children are at a higher risk than adults of developing complications associated with CRRT due to te
difficulties in venous catheterization with the large-caliber catheters required for the technique, the large
extracorporeal volume of the system (filters and lines), and the need for a more accurate control of
volumes in order to avoid fluid and electrolyte disturbances. Thus, due to the urgent need of a dedicated
system for children, various researchers across the globe are focusing on developing a pediatric CRRT
system.
5.2.3.4.1 The CARPEDIEM project

The Cardio-Renal, Pediatric Dialysis Emergency Machine (CARPEDIEM) is a project developed by the
Department of Nephrology and International Renal Research Institute of the San Bortolo Hospital in
Vicenza (Italy). The aim of the project is to design the first neonatal CRRT monitor specifically for newborns
and infants with the help of modern miniaturization engineering skills. The project has been financed by an
unrestricted grant from a non-profit organization [Associazione Amici del Rene di Vicenza (A.A.R.VI)], and
the apparatus was conceived in Vicenza and built in Mirandola, Italy, with the collaboration of two
industrial companies (Bellco and Medica). The system has also received CE mark certification.
The CARPEDIEM network is expected to develop into a multinational study group when the clinical phase
comes into place. The approval and marketing of this pediatric CRRT system will open new growth
opportunities for the players involved in this market.
47
5.2.3.5 Untapped market growth opportunities in North America

Currently, the prevalence of AKI in the North American region is predominantly higher as compared to other
regions. However, at present, North America (U.S. and Canada) accounts for the lowest utilization of CRRT
across the globe. This is mainly due to the dearth of compelling evidence with regards to the efficacy and
safety from controlled clinical trials in favor of CRRT and the high procedural costs associated with CRRT
compared to traditional dialysis (due to high nursing as well as consumable costs in North America
compared to other regions). Consequently, in approximately ~50%–55% of the AKI cases, nephrologists
prefer other RRT modalities (IHD and SLEDD) for the treatment of patients.
Additionally, since there are only two prominent manufacturers (Baxter and NxStage) of CRRT systems in
North America, hospitals are looking for better options regarding quality and cost for the supply of CRRT
products in the region. Hence, there is a substantial growth potential in North America for new or existing
CRRT players. Owing to this, various players are focusing on this region.
In January 2015, Baxter obtained FDA approval for Phoxillum Renal Replacement Solutions to
correct electrolyte and acid-base imbalances during CRRT. Phoxillum is the only FDA-approved
pre-mixed solution comprising phosphate.
With the aim of entering the North American market, Nikkiso acquired Baxter’s legacy CRRT
portfolio, including its acute renal therapy product line—the Aquarius System, Aqualine and
Aquaset tubing sets, Aquamax hemofilters, and Accusol solution. The acquisition also includes
the transfer of proprietary Baxter ClearFlex CRRT pharmaceutical solution manufacturing
technology and equipment, marketing and distribution rights, intellectual property, and
associated agreements.
In October 2013, B. Braun Medical Inc. formed a new subsidiary, B. Braun of Canada, Ltd. This
subsidiary enabled the company to work more closely with customers and group purchasing
organizations in Canada.
5.2.4 CHALLENGES
5.2.4.1 High complexity of the therapy
CRRT is a technically complex and high-risk therapy. Some of the major complexities involved in CRRT are
listed below.
Descriptions of the dosage and methods for the delivery of anticoagulants (heparin and citrate)
differ significantly depending on the patient’s condition and may cause confusion about the
selection of the CRRT modality and procedural time in everyday practice. For instance, the use
of citrate as an anticoagulant provides a longer circuit-run as compared to heparin during CRRT.
The use of citrate is an effective strategy for the anticoagulation of the CRRT circuit. The
success of the technique depends on careful monitoring of citrate and supplemental calcium to
prevent the development of metabolic derangements. The careful and continuous monitoring of
citrate and supplemental calcium adds up to the complexity of the therapy.
The need to maintain a balance between the dialysate buffer or electrolyte concentration with
the replacement fluid further intensifies the complexity of the CRRT technique.
Electrolyte problems, circuit clotting & explosion, line-catheter disconnection, and hypothermia
are other major complications associated with CRRT.
48
5.2.4.1.1 Lack of standard treatment guidelines in developing

countries
CRRT has been used as a mode of therapy for AKI patients for more than a decade; however, many
emerging countries lack standard operating procedures for this technique. As a result, each institution has
to develop local working protocols that significantly hamper the quality of the therapy. Standard protocols,
orders, or policies are required for the consistent, successful, and safe care of CRRT patients while
achieving the prescribed goals.
Lack of an accepted complete CRRT 'set' impedes implementation and increases the complexity of the
technique in clinical practice. The optimal timing for CRRT initiation is a critical issue in the treatment of
AKI. Appropriate cessation of CRRT is crucial for proper clinical and economic outcomes. However, due to
lack of information and standard guidelines, current practices, regarding cessation of CRRT, vary as per the
institution. This further adds to the complexity of the therapy.
5.2.4.1.2 Complications associated with CRRT

CRRT is a highly specialized and complicated therapy. Various technical and clinical complications
associated with CRRT are the leading causes of mortality among AKI patients in ICUs. This, in turn, hinders
the growth of the CRRT market. Some of the key technical and clinical complications associated with CRRT
are mentioned below.
TECHNICAL CLINICAL
COMPLICATIONS COMPLICATIONS COMPLICATIONS
ASSOCIATED WITH CRRT
Vascular access Bleeding, hematomas
malfunction Thrombosis
Circuit clotting Infection and sepsis
Circuit explosion Allergic reactions
Catheter and circuit kinking Hypothermia
Insufficient blood flow Nutrient losses
Line-catheter disconnection Insufficient blood purification
Fluid balance errors Hypotension and arrhythmia
Loss of efficiency
Owing to these complexities associated with CRRT, switching from CRRT to other dialysis modalities (such
as IHD and SLED) is expected to increase. However, manufacturers are increasingly focusing on the
development of technologically advanced, safe, and easy-to-use products that will decrease the complexity
of the therapy to some extent.
49
5.2.4.2 Shortage of trained ICU nurses in developed countries

CRRT is a highly specialized and critical therapy that involves complex nursing care. Successful outcomes
in CRRT heavily rely on the ability of the ICU nurses to manage this extracorporeal blood purification
therapy. Properly trained ICU nurses are required for continuous assessment of the indications, ensuring
good vascular access, avoiding unnecessary interruptions, and preventing complications in patients during
CRRT. However, currently, there is a dearth of registered nurses in ICU settings. According to the Australian
Health Ministers Advisory Council, there is a shortage of ~600 critical care nurses across Australia.
The looming retirement of baby boomer nurses will leave a shortfall of 260,000 nurses by 2025 in the
country. Furthermore, there is limited availability of specific nursing research to guide the management of
CRRT, which further restricts market growth. According to a recently conducted survey by the American
Nurse Today, only 10% of nurse executives believe that new graduate nurses were fully prepared to
practice safely and effectively. However, ongoing training programs are expected to curtail the shortage of
trained ICU nurses to some extent.
5.2.4.3 Poor reimbursement scenario in developing countries

The reimbursement scenario for CRRT is well-established in developed countries. However, developing
countries such as China and India, which account for a huge AKI population base, do not have a well-
established system for the full reimbursement of and insurance coverage for CRRT. In India, a significant
percentage of patients are not covered by insurance or any other reimbursement modality; expenses are
borne out of pocket. In China, the reimbursement rates for RRT vary from 50% to 90% across regions with
different socioeconomic statuses.
Reimbursement is essential for the wider acceptability of CRRT, owing to the high cost of the treatment.
Consequently, most AKI patients in developing countries prefer IHD over CRRT due to its low procedural
cost. Thus, lack of proper reimbursement in developing countries poses a key challenge to the growth of
the market in these regions.
5.2.4.4 Lack of awareness about the benefits o f CRRT

CRRT is underutilized in patients with AKI due to lack of awareness and education among patients as well
as nephrologists. Most nephrologists and intensivists are not fully aware of the benefits of CRRT over other
intermittent therapies due to lack of education as well as insufficient clinical evidence in favor of CRRT.
In spite of a variety of innovations in the field, very little standard information is available about the
initiation and implementation of this therapy among AKI patients. This results in low awareness about the
treatment among healthcare providers.
50
6 INDUSTRY INSIGHTS
6.1 INTRODUCTION
CRRT is performed in acute care settings of hospitals and costs higher than other dialysis modalities
(hemodialysis and peritoneal dialysis). As a result, reimbursement plays a critical role in the adoption of
CRRT among AKI patients. The reimbursement provided by payers for CRRT primarily includes physician
(nephrologists and intensivists) and facility (nursing time, support staff time, and supplies) costs. Thorough
documentation and correct coding are the key requirements for the timely and appropriate reimbursement
of CRRT procedures.
FIGURE 22 KEY FACTORS AFFECTING THE REIMBURSEMENT RATES FOR CRRT PROCEDURES
Provider Type Treatment Mode
Components Duration of
REIMBURSEMENT
Included Patient’s Stay
RATES
Location of
Quality
Treatment
In developed countries, the cost of AKI treatment does not have a major impact on its adoption rate as a
result of the favorable reimbursement scenario in these countries. In countries such as the U.S., Japan,
Australia, and Germany, full reimbursement for CRRT procedures is provided by hospital-based
reimbursement and patient self-payment policies. However, in developing and underdeveloped countries
(such as India, South Africa, and Middle Eastern countries), full reimbursement coverage for CRRT patients
is not provided. As a result, in developing and underdeveloped countries, the cost of dialysis is borne out-
of-pocket by patients. However, considering the growing AKI population and increasing demand for CRRT,
governments in developing and underdeveloped countries are focusing on improving the CRRT
reimbursement landscape in their respective healthcare systems.
51
6.2 REIMBURSEMENT SCENARIO

FIGURE 23 REIMBURSEMENT SCENARIO FOR CRRT (AS OF 2016)
High Level of Reimbursement Medium Level of Reimbursement
Low Level of Reimbursement
Source: Centers for Medicare & Medicaid Services (CMS), Institute of Health Economics, European Medicines Agency (EMA),
Pharmaceuticals and Medical Devices Agency (PMDA), Medical Technology Association of Australia (MTAA), Expert Interviews, and
MarketsandMarkets Analysis
52
6.2.1 NORTH AMERICA

The reimbursement scenario for CRRT in North America (U.S. and Canada) is favorable. In the U.S., CMS is
the major reimbursement provider for CRRT in ICU settings. Documentation of the degree of hemodynamic
stability is necessary for the full reimbursement of CRRT procedures in acute settings. Medicare pays
physicians for services based on the submission of a claim using one or more specific CPT codes. Each CPT
code has a Relative Value Unit (RVU) assigned to it, which, when multiplied by the conversion factor (CF)
and geographical adjustments (GPCI), creates the compensation level for a particular service. For the
reimbursement of CRRT treatment by CMS, CPT codes 90945 and 90947 are applicable, and the RVU is
1.256. Code 90945 is billed in the case of patients who require only one visit; however, if an ICU patient
requires multiple reassessments, then code 90947 is billed. Total reimbursement for a particular CRRT
procedure depends on hospital charges, type of therapy, amount, type of fluids and anticoagulants used,
types of nurses performing the therapy, the condition of the patient, and total duration of hospital stay.
Additionally, according to the new payment structure announced by CMS, end-stage renal disease facilities
can provide treatment for AKI patients as of January 2017; previously, treatment for AKI patients was
provided only in hospital-based settings. The part B of Medicare policy includes these services for AKI
patients.
6.2.2 EUROPE
The adoption of CRRT is increasing in Europe, and it is the preferred technique for most intensivists in the
region. Most European countries provide full reimbursement coverage for CRRT. However, reimbursement
structures and rates vary widely across European countries. For instance, dialysis services (including CRRT)
are provided in 16 languages with ~50 different rates by a large number of players (Source: Capitals
Market Day; Fresenius Medical Care). The reimbursement for CRRT in countries such as Austria and
Germany is independent of provider type (public or private); while in other countries, such as France,
Spain, and Italy, it is dependent on provider type. However, there is no reimbursement for private providers
in countries such as Finland and Denmark. Components such as core disposables, machines,
infrastructure, and physician and nursing fees are included in the base reimbursement in most European
countries. However, diagnostics, special pharmaceuticals, transportation, and nutritional products are
separately reimbursed and not covered under base reimbursement.
In Germany, AKI treatments are reimbursed under G-DRGs (Diagnosis Related Groups). The reimbursement
process in the country involves a fixed payment to hospitals for an in-patient episode of AKI; this also
includes the cost of the corresponding stay in the hospital. L71Z (for a one-day hospital stay) and L60 (for
severe conditions) are the DRG codes for AKI treatment. The reimbursement amount ranges from USD
3,355 (EUR 3,000) to USD 12,302 (EUR 11,000), depending on the severity of comorbidities and the
patient’s age (Source: Translucency Limited, U.K.).
In France, the reimbursement for AKI treatment is provided under the tarification à l’activité (T2A, DRG
tariff) prospective payment system for inpatient candidates. The reimbursement amount varies in both
public as well as private hospitals. The amount ranges between USD 2,392 (EUR 2,139) to USD 15,093
(EUR 13,496) in public hospitals; whereas, in private-sector hospital, the amount ranges between USD
1,931 (EUR 1,727) to USD 7,803 (EUR 6,978) (Source: Translucency Limited, U.K.).
The DRG system, based on ICD-9-CM diagnosis and procedure codes, provides and regulates
reimbursement for AKI treatment in Italy. The Italian healthcare system is highly regionalized, and DRG
tariffs vary from region to region within the country.
53
FIGURE 24 REIMBURSEMENT STRUCTURES IN EUROPE
PROVIDER STRUCTURE: PRIVATE PROVIDERS PLAY A

PROVIDER STRUCTURE: MAINLY PUBLIC
SIGNIFICANT ROLE
Global budget allocated Flat rate

Reimbursement structure based mainly on:
Fee-for-service Fee-for-service
Finland Belgium
Luxemburg
Denmark
Netherlands
Austria
Sweden
Slovenia
France
Ireland
Czech Republic
U.K. Poland
Greece
Italy Turkey
Germany
Portugal
Hungary
0% 50% 100% 0% 50% 100%
Public Private Healthcare Organizations
Source: European Renal Association – European Dialysis and Transplant Association [ERA-EDTA], National Health Service, and
National Kidney Foundation, and Secondary Literature
6.2.3 ASIA-PACIFIC (EXCLUDING J APAN)

Developing and underdeveloped countries in the Asia-Pacific region still lack full reimbursement coverage
for CRRT procedures. Universally reimbursed and equitable Renal Replacement Therapy (RRT) programs
are rare in Asia. Moreover, a majority of Asian countries are dependent on expensive imported
technologies for RRT. In India, a significant percentage of patients is not covered by insurance or any other
reimbursement modality and is required to cover medical expenses out-of-pocket. Similarly, in Myanmar,
RRT is available only in major cities, and patients have to bear out-of-pocket expenses for treatments. This
is a major factor limiting the adoption of CRRT in several Asian countries. Private healthcare forms the
backbone of RRT reimbursement in the developing world. However, South Korea, Hong Kong, Australia,
Taiwan, Singapore, and some West Asian countries have RRT programs supported by governments. In
Korea, for example, the government reimburses 90% of the total cost of dialysis, irrespective of the
modality. In China, the reimbursement rates for RRT vary from 50% to 90% across regions with different
socioeconomic statuses.
Despite these limitations, the demand for CRRT is increasing in Asian countries due to the rising patient
population and growing awareness about advanced medical treatments. This is resulting in the expansion
of existing facilities and establishment of new ones. However, due to government neglect, dialysis facilities
in these countries are largely dependent on private "for-profit" reimbursement providers.
54
6.2.4 JAPAN
In Japan, CRRT is used exclusively for the treatment of critically ill AKI patients. The Japanese healthcare
system, consisting primarily of the Social Health Insurance Organization and the Governmental Health
Insurance Organization, provides reimbursements to all renal patients in the country. Acute renal patients
in Japan receive 100% reimbursement from the government, irrespective of the modality. The
reimbursement system in the country covers the ICU management fees of patients up to 14 days.
Considering CRRT’s clinical benefits, it is highly preferred over other renal replacement modalities in Japan.
For reimbursement, a fee-for-service system is adopted, in which a fixed fee (counted from the number of
points for each item of service) is paid toward the monthly bill from care providers.
6.2.5 REST OF THE WORLD

The Rest of the World region includes Latin America and the Middle Eastern countries. In Latin America,
reimbursement for RRT varies extensively from country to country. Only a few countries in the region offer
universal coverage based on a public (Brazil, Chile, Uruguay) or private healthcare system (Argentina).
Some countries in this region, such as Bolivia, Ecuador, and Peru, still have major restrictions regarding
offering access to RRT.
Argentina: Access to RRT is universal, and all patients have a healthcare provider. A majority of
patients are covered by PAMI (Argentina's state-funded medical care system); less than 5% are
in the private system (Source: Perit Dial Int February 2009 vol. 29 no. Supplement 2 S222-
S226)
Brazil: The public health system universally covers around 90% of RRT patients. In Brazil, CRRT
reimbursement is paid in a fee-for-service structure.
Central America and the Caribbean: In a few countries, such as in Guatemala, the reimbursement
system allows universal access to RRT through social security. However, in most other
countries, reimbursement is limited and not well-defined.
In a majority of underdeveloped Middle Eastern countries, only a few renal patients are reimbursed by
private insurance companies.
55
6.3 REGULATORY LANDSCAPE

Regulatory approval for the commercialization of CRRT products is essential to ensure that devices and
drugs that enter the human body are safe and are of a high quality. CRRT products include monitors,
bloodline sets, and dialysate fluids. The approval procedures for CRRT monitors and bloodline sets are
similar to those of dialysis products across various geographies.
Intermittent therapy (IHD and SLEDD) uses an online dialysate production system, whereas CRRT uses pre-
prepared fluids. Thereby, CRRT fluids are regulated differently as compared to other dialysis fluids in
various regions.
FIGURE 25 KEY REGULATORY BODIES INVOLVED IN THE APPROVAL OF NEW CRRT PRODUCTS
U.K. France Germany

Medicines and Agence Nationale
de Sécurité du Federal Institute
Healthcare for Drugs and
Products Médicament et
des Produits de Medical Devices
Regulatory Agency (BfArM)
(MHRA) Santé
Korea
Canada Korea Food and
Health Drug
Canada
China Administration
State Food and (KFDA)
Drug
U.S. Administration
(SFDA)
Food and Drug Japan
Administration
(FDA) Ministry of Health,
Labor and
Welfare (MHLW)
Egypt
Mexico Brazil
Agência Egyptian Drug
Comisión Federal Nacional de Authority India
para la Protección Vigilância (EDA)
Central Drugs
contra Riesgos Sanitária Standard Control
Sanitarios (ANVISA) Organization
(CDSCO)
South Africa Australia

Department of Therapeutic Goods
Health Administration
Argentina
(TGA)
Administracion Nacional de
Medicamentos, Alimentosy
Tecnología Médica (ANMAT)
56
6.3.1 NORTH AMERICA

The U.S. is a major market for CRRT products. For product approval in the U.S., CRRT manufacturers have
to submit a premarket notification or 510(k) to the FDA to prove substantial equivalence to a legally
marketed device. If there is no substantially equivalent device in the market, the manufacturer must
secure premarket approval (PMA) from the FDA. Compared to regulatory bodies in other countries, FDA
regulations are more stringent (in terms of clinical trial data requirements) for the approval of new CRRT
products. As a result, in the U.S., no CRRT machine is approved by the FDA for the treatment of multiple
indications, unlike Europe. Similarly, no anti-coagulating agent for blood infusion has been approved by the
FDA to date, although some have been approved in Europe.
6.3.2 EUROPE
The European Medical Device Directives (CE) mark is required for the distribution and marketing of any
medical device (including CRRT) in the European (EU) region. The manufacturer must be certified by the
notified body to annex II, V, or VI of Medical Device Directives and comply with the requirements of these
directives. A certified body conducts a technical review, and if all requirements are met, a CE clearance
letter is issued permitting the sale of a particular CRRT product in Europe.
6.3.3 ASIA-PACIFIC
India:
In India, the manufacturing of hemodialysis bloodline sets requires the approval of the Ministry of Health
and Family Welfare. According to the ministry, CRRT bloodline sets/components are to be considered as
drugs under Section 3 (b) (iv) of the Drugs and Cosmetics Act. The regulatory policies for medical devices
considered as a drug are less stringent as compared to pharmaceutical and biotechnological moieties.
Also, all CRRT blood tubing sets and related devices should display the CE mark, which signifies
compliance with the requirements of the statutory Medical Device Directive and national (ISO 8638:2009)
as well as international standards.
China:
In China, approvals for CRRT sets and components are overseen by the State Food and Drug
Administration (SFDA), Ministry of Health (MOH), and the Administration of Quality Supervision, Inspection
and Quarantine (AQSIQ). The two legal requirements for the approval of hemodialysis (bloodline) sets in
China include the SFDA registration and the China Compulsory Certification (CCC) mark. The SFDA provides
registration certificates for all CRRT components sold in China, and CCC applies to a broad range of
medical devices (including CRRT monitors) with electrical components for safety conformity.
Japan:
CRRT manufacturers must abide with Japan’s Pharmaceutical and Medical Device Law (PMDL). As per
PMDL, CRRT products are considered as Class III medical devices. The PMDL approval process for a new
product is time-consuming (can take ~5 years) and cumbersome.
South Korea:
Medical devices, including dialysis products, in South Korea are governed by the Korean Food and Drug
Administration [within the Ministry of Health and Welfare (MoHW)]. The legal framework of KFDA is based
on the medical device act no. 10564. Dialysis products should meet the requirements of the Medical
Devices Act and obtain registration with the KFDA before being sold in the country. If manufacturers do not
have a local business in the country, they need to appoint a Korean License Holder (KLH) for the
submission of product registration. KFDA often accepts clinical trial data for a particular renal product that
has been approved by any of the OECD countries.
57
6.3.4 REST OF THE WORLD

Brazil:
In Brazil, resolution RDC No. 185 of October 22, 2001 is the primary regulation applicable for the
registration of all medical devices, including CRRT products. Under RDC No. 185 published by the Agência
Nacional de Vigilância Sanitária (ANVISA), CRRT sets are considered as Class II medical devices. RDC No.
185 defines the applicable device registration protocols and lists the documents required for the legal
registration of a medical device in Brazil. Initially, manufacturers are required to appoint a company that
holds a Company Working Allowance permit from ANVISA as a Brazil Registration Holder (BRH). However,
foreign manufacturers do not require this permit unless they are planning to import and distribute their
products in Brazil. For the manufacturing of an electromedical device (such as CRRT equipment), electrical
safety testing and INMETRO certification (valid for five years) is required in Brazil. Proof of compliance with
the Brazil Good Manufacturing Practice (BGMP) and Technical File (information of the device in accordance
with Annex III, Part A/B/C in RDC 185/2001, along with proposed labeling and instructions for use) is also
required to be submitted. ANVISA reviews all submitted details. If approved, ANVISA publishes the
registration number of the device (valid for five years) in the Diário Oficialda União (DOU).
Argentina:
Administracion Nacional de Medicamentos is the key authority involved in the regulation of medical
devices (including dialysis instruments) in the country. According to Administracion Nacional de
Medicamentos, Alimentos y Tecnología Médica (ANMAT) Disposition No. 5031/09, a particular medical
device is not allowed for sale in the country without a valid license. ANMAT Disposition No. 5267/06
requires the listing of dialysis products, manufacturers, importers, and distributors in the Register of
Producers and Medical Technology Products (RPPTM). ANMAT Disposition No. 191/99 specifies GMP
standards for dialysis products and applies to local and foreign manufacturers. Statutory review time is
180 days for all risk classes of medical devices, and the actual review timeline is approximately one year.
Marketing approval is valid for five years for a particular dialysis product in the country.
The approval of CRRT products in China, Taiwan, Japan, and Korea is similar to that of the U.S. FDA
approval process. On the other hand, the approval of CRRT products in countries such as Canada and
Australia is similar to that of the EU system.
6.3.5 INDUSTRY TRENDS

6.3.5.1 Training programs for the operation of CRRT devices
The requirement of trained nurses is one of the critical aspects of the safe and effective operation of CRRT
machines. Nurses operating CRRT devices must be proficient and competent in the technical skills
necessary to provide care and manage this complicated therapy. However, no universal competencies exist
for a CRRT program. Each institution develops its education program and troubleshooting mechanisms.
Policies and procedures are developed by nurse managers and specialists involved with the therapy.
Training in CRRT is typically performed by representatives of machine manufacturers. However, onsite

training sessions are carried out by ICU nurse managers. Typical training sessions include theory, setup,
takedown, and troubleshooting of the machine. Currently, various government and nongovernment
organizations, as well as market players, are increasingly taking initiatives to provide training to ICU nurses
for CRRT usage. Some training programs have been listed below:
In August 2015, a three-day CRRT training program was organized by the Philippine Heart
Center (PHC) in Quezon City, Philippines. This training program was aimed at preparing nurses
to competently provide care to patients with renal failure who are managed and treated using
CRRT.
58
In September 2015, the Wisconsin Nurses Association organized a CRRT course at the
University of Wisconsin Hospital and Clinics. This one-day course was aimed to prepare ICU
nurses and clinicians to take care of patients receiving CRRT.
In June 2014, Gambro organized a CRRT training course titled “CRRT Review and Refresh” at
Los Angeles, California (U.S.). This training program for nurses and clinicians was aimed to
discuss basic CRRT principles; describe evidence-based practice; support research; and explain
a CRRT machine’s safety management features, pressure monitoring, as well as fluid balance
principles.
In January 2014, Aesculap Akademie GmbH (Germany) organized a five-day intensive training
program to provide technical and management skills and knowledge on handling and
troubleshooting CRRT machines to registered nurses in Taguig (Philippines)
6.3.5.2 Rising adoption of user -friendly CRRT machines

The demand for user-friendly CRRT machines is high due to the complexity of the therapy. Both
nephrologists/intensivists and nurses prefer CRRT machines that are easy to handle (with a wide range of
functionalities) and intuitive in nature. As a result, several major CRRT manufacturers are focusing on the
development of new CRRT products or upgrading existing ones with user-friendly functionalities.
The increasing demand for user-friendly CRRT machines is evident from the rising adoption of Nxstage’s
System one CRRT set across the globe. The growing acceptability of NxStage’s CRRT machine is primarily
attributed to its advanced features (no effluent collection needed), low maintenance requirements,
enhanced patient comfort, and ease of use for ICU nurses (high flexibility and simplicity) in acute settings.
On the other hand, B. Braun’s Diapact CRRT system is less preferred among nephrologists for AKI
treatment due to its complex features.
6.3.5.3 Development of a CRRT system for pediatric patients

The Department of Nephrology and International Renal Research Institute of the San Bortolo Hospital
developed the Cardio-Renal, Pediatric Dialysis Emergency Machine (CARPEDIEM) in Vicenza (Italy) to
support CRRT in children with kidney failure and fluid overload. The device received CE approval in 2012.
Previously, the usage of CRRT devices in children carried a risk of complications because of inaccurate
fluid balance (FB) between the volumes of ultrafiltrate (UF) removed and replacement fluid (RF) delivered.
Additionally, children are at a higher risk than adults for developing complications associated with CRRT
due to the difficulty of venous catheterization with the large-caliber catheters required for the technique.
Also, the large extracorporeal volume of the system (filters and lines) can result in complications. The newly
developed system for pediatric patients (CARPEDIEM) overcomes all these complications related to
pediatric CRRT.
59
6.4 PORTER’S FIVE FORCES ANALYSIS

The competitive environment prevailing in the global CRRT industry has been analyzed through Porter’s
Five Forces analytical framework.
Competitive Intensity: Medium to High

Bargaining Power of Buyers: Low to Medium
Bargaining Power of Suppliers: Medium
Threat of Substitutes: High
Threat of New Entrants: Low
FIGURE 26 PORTER’S FIVE FORCES ANALYSIS – GLOBAL CRRT MARKET
Competitive Intensity
4
2
Threat of New Entrants Bargaining Power of Buyers
1
Threat of Substitutes Bargaining Power of Suppliers
Note: Score for a force ranges from 0 to 4 (Absolute terms) where 0 = Least Important & 4 = Most Important.
Source: Secondary Literature, Expert Interviews, and MarketsandMarkets Analysis
6.4.1 COMPETITIVE INTENSITY

The CRRT market is marked by medium-to-high competitive intensity as it is a consolidated market with top
five players accounting for more than ~80% of the market share. The market is dominated by a few players
but has a high segmental rivalry with similar product offerings at comparable costs. Players operating in
this market are competing for a larger market share, which is resulting in aggressive pricing and
advertising, incessant product launches, and a greater focus on customer service and warranties. The
competitive environment in the industry is expected to intensify further with the entry of small firms (which
in spite of the high entry barrier are expected to enter the industry with advanced and user-friendly CRRT
machines). Additionally, established market players find it difficult to divest from their business, as there is
a significant amount of investments involved.
6.4.2 BARGAINING POWER OF BUYERS

The bargaining power of buyers is rated as low-to-medium in the market. This is because top players
account for a very large share of the market (the top two players hold more than ~60% of the products
market) and the products offered by these players are majorly covered under reimbursement policies in
different countries. As a result, in terms of product selection, healthcare providers have limited options for
treating AKI patients. Also, even though switching costs are low, product selection is majorly influenced by
the preference of nephrologists. Buyers usually prefer firms that provide products along with disposables
60
and good services at the lowest cost due to the high costs involved in the purchase and maintenance of
CRRT systems.
6.4.3 BARGAINING POWER OF SUPPLIERS

The bargaining power of suppliers is rated as medium in the CRRT market. This is primarily because there
are several suppliers with similar product offerings. The differentiating factor is price, product quality,
timely delivery, and after-sales services. However, the bargaining power of suppliers increases if their
products are highly differentiated, endowed with a breakthrough user-friendly technology, and are very
important for the buyer. For instance, Nxstage’s System One CRRT machine has a competitive advantage
over other CRRT systems due to its intuitive and user-friendly features.
6.4.4 THREAT OF SUBSTITUTES

IHD and SLEDD are common substitutes for CRRT. In this market, the threat of substitutes is high as IHD or
SLEDD are preferred over CRRT for the treatment of AKI patients due to the high procedural cost of CRRT.
Also, there is a dearth of clinical evidence to support the efficacy of CRRT over IHD and SLEDD in ICU renal
patients. CRRT is the most preferred treatment only in the case of hemodynamically unstable patients for
whom none of the other dialysis procedures are feasible.
6.4.5 THREAT OF NEW ENTRANTS

The CRRT market is capital-intensive and demands significant investments in R&D to come up with new
innovative products and technologies constantly. The industry is marked by stringent government
regulations and policies related to CRRT product approval and usage. Moreover, the documentation and
processing time for product filing and approval is colossal, which can be cumbersome at times. The
industry has dominant players that have established their operations over several decades and have
access to the best sources of raw materials, proprietary technologies, wide distribution channels, and
offices at strategic locations. These well-established and financially stable players, on account of their
experience and learning curve, can achieve economies of scale and offer products at lower costs. Thus, the
chances of a new entrant penetrating the CRRT market and competing with already established players are
bleak.
6.5 PRICING AND COST ANALYSIS

Cost and quality are the most important parameters for the purchase of CRRT machines. The cost of CRRT
machines and disposables depends on various factors—manufacturing expenses, type of modality, brand,
purchase type (bulk or single), type of agreement (with or without consumables/with or without a service
agreement), and reimbursement scenario. Thus, based on all these factors, the price of CRRT machines
varies from region to region.
Manufacturing expenses are a key criterion for the bargain margin that a manufacturer can offer. For
instance, Baxter International, Inc. provides a wide bargain margin for its machines as compared to
NxStage Medical, Inc.; however, the company does not offer discounts on tubing sets. On the other hand,
NxStage Medical, Inc. (no large margins as they do not have large facilities to manufacture their machines)
bargains on the cost of its blood tubing sets to a larger extent as compared to Gambro. In the U.S.,
previously, the sales of CRRT machines through manufacturers were mostly performed by charging the
cost of the machine on the disposables. However, due to recent changes in laws, sales are mostly done
along with disposables. In this scenario, manufacturers have to charge at least the manufacturing cost of
the machine along with disposables. If this is not followed, the government considers it as unfair business
practices and can sue the manufacturer for the same. For instance, Gambro has to charge a minimum of
USD 12,000 (manufacturing cost) to hospitals for its Prismaflex machine.
The type of agreement (with or without consumables/with or without a service agreement) is also a critical
determinant of the cost of CRRT products. Also, bulk purchases of machines and disposables from the
61
same manufacturer decreases the overall cost of products. Some manufacturers offer a service contract if
both machines, as well as disposables, are purchased from them. The average selling price (ASP) of CRRT
machines, at a global level, varies from USD 35,000 to USD 46,350 (Source: WHO). However, the ASP of
refurbished CRRT machines is ~30% to 40% less than new machines.
The ASP of CRRT machines can increase in the future with their growing adoption and the launch of new
user-friendly devices. Baxter is expected to launch a new CRRT machine, Prismax, in 2017. This product
will include an intuitive platform with a touchscreen and step-by-step automated instructions to simplify its
operation.
TABLE 1 AVERAGE SELLING PRICE OF CRRT MACHINES, BY MANUFACTURER, 2016 (USD)
Baxter International, Inc. ~27,000–40,000
NxStage Medical, Inc. ~22,000–32,000
B. Braun Melsungen AG ~20,000–23,000
Fresenius Medical Care AG & Co. KGaA ~20,000–25,000
Nikkiso Co., Ltd. ~20,000–25,000
The cost of consumables, such as dialyzers and bloodline sets, is mainly dependent on the cost of raw
materials (such as PVC). Thus, consumable manufacturers do not have as much control over the cost of
their products. The cost of PVC is expected to witness a slight decrease over the next five years, which may
reduce the cost of consumables.
The cost of dialysate and replacement bags used in CRRT depends on the demand of a particular bag, type
of brand, and exclusive product feature. For instance, the cost of PHOXILLUM (the only FDA-approved pre-
mixed solution containing phosphate designed to facilitate electrolyte management during CRRT) is
expected to be USD 100 per case.
TABLE 2 AVERAGE SELLING PRICE OF CRRT BLOODLINES AND DIALYSATE BAGS, 2016 (USD)
Bloodlines ~170–220
Dialysate Bags ~35–80
62
6.6 STRATEGIC RECOMMENDATIONS

The CRRT market is consolidated, with two to three key players accounting for a major market share.
Thereby, to enter the market or gain market share, new or established players should offer CRRT machines
and disposables with additional features.
6.6.1 DESIGN RECOMMENDATIONS

FIGURE 27 DESIGN RECOMMENDATIONS FOR CRRT MACHINES
CRRT MACHINES
INTUITIVE
EASY TO SET
OPERATING
UP
SCREENS
ADDITIONAL
LINKED TO
SPECIAL
EMRs
FEATURES
SPECIAL
COATINGS
ON BLOOD
TUBES
The new CRRT machines can offer the following features to help manufacturers gain a competitive
advantage in the market:
The machine should have an easy setup process.

The operating screens of the machines should be functional and intuitive. This is necessary as it
provides nurses/physicians quick and easy access to case-related data.
CRRT machines should be linked to electronic medical records, allowing all relevant patient-
related information to be available automatically.
Anti-clotting coatings should be applied to blood tubes. This technology is used widely in
cardiology, but its use is negligible in dialysis.
Special features that will ease machine setup and reduce workload will significantly help in
attracting customers while ensuring differentiation of products. For example, the NxStage CRRT
machine is a volumetric machine (it has volumetric balancing chambers incorporated into a
disposable cartridge).
63
6.6.2 KEY STRATEGIES FOR PLAYERS SEEKING TO ENTER THE CRRT

MARKET
As there are only a few CRRT system manufacturers across the globe, hospitals are looking for better
(regarding quality and cost) options. Therefore, to strengthen their footprint in the CRRT market,
manufacturers can focus on the below-mentioned points:
Manufacturers can attend and participate in nephrology conferences across the globe to build
visibility and presence; this will also help in the promotion of their CRRT products (awareness
among healthcare providers regarding the available CRRT products is low. Thus, this can be a
key factor to help increase revenue growth of companies from CRRT products).
Contact stakeholders and advertise products through social media campaigns and emails.
Interact with prominent personalities in the field (nephrologists/intensivists) and provide
presentations at hospitals to brief staff on product features. Manufacturers could also request
said personalities to refer their CRRT systems to hospitals.
Manufacturers can focus on the development of cost-effective miniaturized and wearable CRRT
devices as the high cost of the existing CRRT systems is a key factor limiting their adoption over
alternative treatment modalities available for AKI patients.
Manufacturers should focus on expanding their presence in emerging countries such as India,
China, Brazil, Taiwan, Mexico, and Indonesia, among other countries, as they are witnessing
substantial economic growth. Furthermore, these emerging countries are expected to offer
significant growth opportunities owing to their large patient population and improving
healthcare infrastructure.
64
7 ADOPTION OF CONTINUOUS RENAL REPLACEMENT THERAPY,

BY REGION
7.1 INTRODUCTION
Globally, continuous renal replacement therapy (CRRT) is gaining popularity for the management of AKI
patients in acute settings. However, wide variations regarding utilization and adoption of CRRT exist in
various countries. These variations are mainly due to:
Cost of labor (nurses and technicians): CRRT is a labor-intensive technique, owing to which
regions with low labor costs are shows higher adoption of CRRT as compared to regions with
high labor costs.
Physicians involved in the treatment (nephrologists or intensivists): Nephrologists prefer clinical

evidence-based renal treatments such as IHD and SLEDD. This is due to the lack of sufficient
compelling evidence from clinical trials to prove the higher efficacy of CRRT over other dialysis
modalities. On the other hand, intensivists are more comfortable with the prescription of CRRT
over dialysis because the prescription of SLEDD or IHD requires consultations with
nephrologists and dialysis nurses. In regions where the involvement of nephrologists in AKI
treatments is higher as compared to intensivists, CRRT adoption is lower.
Procedural cost of CRRT in a region/country: The procedural cost of CRRT is significantly higher as
compared to other dialysis modalities such as IHD or SLEDD. This is mainly due to the higher
cost of filter sets and dialysates used in CRRT. Thus, regions with low cost of disposables are
more inclined towards the use of CRRT.
Access to CRRT products in a region/country: Healthcare providers in some underdeveloped and

developing countries are still unaware of the benefits of CRRT. Access to CRRT products is
restricted owing to their high cost as well as the poor healthcare infrastructure in these
countries.
Reimbursements: Reimbursements play an important role in CRRT adoption owing to the high
costs involved. CRRT is mostly used in countries with a favorable reimbursement scenario.
Subsequently, its adoption is lower in countries with poor insurance coverage.
7.2 UTILIZATION OF CRRT PROCEDURES, BY REGION

In North and South America, nephrologists typically manage acute renal failure patients with intermittent
renal replacement therapy (IRRT). On the other hand, in Asia, Australia, and Europe, intensivists are
commonly responsible for managing these patients with continuous renal replacement therapy (CRRT). In
2016, North America (U.S. and Canada) accounted for the lowest utilization of CRRT across the globe.
Australia, on the other hand, accounted for the highest utilization of CRRT mainly due to the perceived
advantages of CRRT over IHD in treating critical illnesses. These advantages include proper management
of nutrition volume (without compromising fluid balance), increased hemodynamic stability, decreased
vasopressor requirement during fluid removal, and continuous control of fluid balance. The key reasons for
the low utilization of CRRT in North America as compared to other regions are as follows:
Dearth of substantial compelling evidence from controlled clinical trials regarding efficacy and
safety of CRRT
High procedural costs associated with CRRT as compared to traditional dialysis owing to the
high nursing as well as consumable costs in North America
65
Most ICU patients for AKI treatment in North America are treated under the guidance of
nephrologists. In this region, nephrologists prefer modalities which have clinical evidence of
their efficacy and safety. Thus, the preference for dialysis is higher among nephrologists in
North America
IHD is preferred in ICU settings owing to higher material and nursing requirements in CRRT as
compared to IHD
Dearth of trained ICU nurses to operate CRRT machines
Unavailability (due to lack of FDA approvals) of anticoagulating agents such as (citrate) for
CRRT. This negatively affects the confidence of nephrologists regarding the safety of CRRT in
AKI patients
At present, no CRRT machine has been approved for the treatment of multiple indications,
which is not the case in other regions where these machines are approved for multiple
indications (renal and non-renal). As a result, hospitals in North America require significant
investments for the installation and maintenance of multiple CRRT machines
FIGURE 28 UTILIZATION OF CONTINUOUS RENAL REPLACEMENT THERAPY AND DIALYSIS FOR

THE TREATMENT OF RENAL PATIENTS IN ICUS, BY REGION (2016)
GLOBAL UTILIZATION OF RRT
28%
72%
CRRT Other Dialysis Modalities (IHD and SLEDD)
13% 5%
25%
60%
77%
95%
87%
85%
40%
23%
North America Latin America Europe Australia Asia
66
The median time for the treatment of patients using CRRT varies from region to region. For instance, in
South America, patients with AKI are treated with CRRT only for ~1.9 days; whereas, in Europe, patients
with AKI are treated with CRRT for a much longer period (~5 days). Likewise, several patterns for the
termination of CRRT exist across various countries. In most countries, CRRT is ended once the patient is
out of danger, post which the patient is switched to IHD. This is primarily done due to the high cost of CRRT
and improvements in patient condition (to tolerate traditional dialysis modalities).
FIGURE 29 RATE OF SWITCHING FROM CRRT TO IHD, BY REGION, 2016
50%
Rate of Switching from CRRT to IHD
40%
30%
20%
10%
40% 18% 25% 38% 33%

0%
Asia Australia Europe North America South America
The rate of switching from CRRT to IHD is the highest in Asia due to the poor reimbursement scenario, high
procedural costs, and dearth of trained nurses for effective management of CRRT. On the other hand, the
rate of switching is the lowest in Europe and Australia due to the high preference of nephrologists and
intensivists in these regions towards CRRT as compared to other dialysis modalities. Moreover, the
favorable reimbursement scenario and the presence of trained ICU nurses are also other major factors
supporting this trend.
67
7.3 NUMBER OF CRRT PATIENTS, BY REGION

CRRT is the most preferred modality for the treatment of AKI/AKF patients in acute care settings. CRRT is
also preferred for the treatment of critically ill ESRD patients who cannot tolerate traditional dialysis due to
their hemodynamic instability. Approximately, 2%–5% of the total ESRD patients undergo CRRT treatments
each year across the globe. Therefore, the total number of CRRT patients in a particular region includes the
total number of AKI/AKF patients undergoing CRRT and the number of critically ill ESRD patients who
cannot tolerate traditional dialysis.
FIGURE 30 NUMBER OF CRRT PATIENTS ACROSS THE GLOBE, 2016
GLOBAL AKI PATIENT POPULATION IN 2016 = ~1.19 MILLION
NORTH AMERICA EUROPE ASIA-PACIFIC ROW
AKI Patients= AAKI Patients= A

AK
AKI Patients= AAKI Patients=
380,160 (~32% of 3368,280 (~31% of 29
2297,000 (~25% of 1142,560 (~12% of
global AKI population) gglobal AKI population) ggl
global AKI population) gglobal AKI population)
No of CRRT N No of CRRT NNo of CRRT N No of CRRT
Procedures= 87,437 Procedures= 313,038
P Procedures= 249,480
Pr
P Procedures= 42,768
P
(as utilization rate of ((a
(as utilization rate of (aa utilization rate of
(as ((as
a utilization rate of
CRRT is ~23% for AKI C
CRRT is ~30% for AKI
Treatment) TTreatment) Treatment)
TTr TTreatment)
Source: American Society of Nephrology (ASN), The United States Renal Data System (USRDS), Canadian Society of Nephrology
(CSN), European Renal Association – European Dialysis and Transplant Association [ERA-EDTA], National Health Service, Asian Renal
Association, National Kidney Foundation, and ClinicalTrial.gov
In 2016, Europe had the highest number of CRRT patients across the globe. This is primarily due to factors
such as the rising incidence of AKI in Europe, use of CRRT for non-renal indications, and high adoption of
CRRT for the treatment of AKI patients in this region. On the other hand, the number of CRRT patients is
expected to grow at the highest CAGR in the Asia-Pacific region during the next five years. This is majorly
due to the rising patient population, high use of CRRT in Australia and Japan, rising healthcare expenditure
on renal diseases, and increasing access to CRRT for the treatment of AKI.
68
8 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET,

BY PRODUCT
KEY FINDINGS
The dialysates and replacement fluids segment is estimated to account for the largest share of
48.9% of the global CRRT market in 2017. This segment is projected to reach USD 746.2
million by 2022 from USD 534.2 million in 2017.
The large share of the dialysates and replacement fluids segment can be attributed to the large
volume requirement of these products during CRRT procedures, and technological innovations.
The disposables segment is expected to grow at the highest CAGR of 7.9% during the forecast
period.
The key reason for the high growth rate of the disposables market segment is the large and
regular demand for consumables owing to their short work life while CRRT machines have a
longer life cycle (around 6 to 7 years).
The hemofilters segment is estimated to account for the largest share of 41.4% of the
disposables market in 2017. This segment is projected to reach USD 223.8 million by 2022
and is expected to grow at a CAGR of 6.7% from 2017 to 2022.
69
8.1 INTRODUCTION
On the basis of products, the continuous renal replacement therapy (CRRT) market is segmented into
CRRT systems, disposables, and dialysates and replacement fluids. Of all these product segments,
dialysates and replacement fluids is estimated to account for the largest share of the global CRRT products
market in 2017.
The disposables segment, on the other hand, is expected to register the highest growth during the forecast
period. Growth in this product segment can primarily be attributed to the growing requirement for
disposables, especially bloodline sets and hemofilters, in CRRT procedures.
FIGURE 31 GLOBAL CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT

(2017 VS. 2022)
2017 2022
14.0%
15.3%
48.9% 48.7%
35.8% 37.3%
Dialysate and Replacement Fluids Disposables

CRRT Disposables CRRT Systems
Systems
TABLE 3 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,

2015–2022 (USD MILLION)
CAGR
Product 2015 2016 2017-e 2022-p
(2017–2022)
469.1 500.6 534.2 746.2 6.9%
Fluids
Disposables 337.1 363.1 391.1 571.5 7.9%
Systems 151.5 159.2 167.2 214.5 5.1%
Total 957.8
9 57.8 1,022.9 1,092.5 1,532.3 7.0%
The dialysates and replacement fluids segment is estimated to account for the largest share of 48.9% of
the global CRRT market in 2017. This product segment is projected to reach USD 746.2 million by 2022
from USD 534.2 million in 2017, at a CAGR of 6.9% during the forecast period.
70
8.1.1 DIALYSATES AND REPLA CEMENT FLUIDS

Dialysates and replacement fluids are used to provide diffusion (small molecules) and convection (small,
medium, and large molecules). They help in removing undesired solutes and restoring electrolytes and the
acid-base balance in the blood. CRRT procedures utilize lactate-buffered solutions or sterilized
bicarbonate-buffered solutions as replacement fluids. The consumption of these fluids varies with different
CRRT modalities.
Since CRRT is a continuous process, it requires larger volumes of dialysates and replacement fluids than
intermittent hemodialysis. This high volume requirement of dialysates and replacement fluids, along with
the high cost of these components, is a key factor driving the growth of this product segment in the overall
CRRT market. The development and commercialization of novel renal replacement solutions are another
key factors supporting market growth. In January 2015, Baxter received FDA approval for its Phoxillum
renal replacement solution. These solutions can be used as replacement solutions during CRRT
procedures to correct electrolyte and acid-base imbalances. After the acquisition of Gambro, Baxter is the
only player in the market with FDA-approved CRRT fluids (PrismaSol and Phoxillum) for blood infusion.
Thus, the core competency of a particular company related to CRRT products will act as a key parameter
for success in the market.
The demand for CRRT for the treatment of hemodynamically unstable patients has also increased
significantly over the years. A major advantage of CRRT in hemodynamically unstable patients is the ability
to adjust substitution fluid and dialysate fluid compositions to achieve the desired change in plasma
composition, depending on the clinical condition of the patient. This adjustment process is further
expected to increase the volume of dialysate fluids utilized in CRRT procedures.
However, CRRT is a highly complex procedure, and maintaining a balance between dialysate buffers and
replacement fluids further intensifies the complexity of the technique. Also, the cost of dialysate and
replacement bags used in CRRT depends on the demand of a particular bag, type of brand, and exclusive
product feature. For instance, the cost of Phoxillum (the only FDA-approved pre-mixed solution containing
phosphate to facilitate electrolyte management during CRRT) is expected to be USD 100 per case. Hence,
the high cost of dialysates is one of the major factors restraining the growth of this market segment.
Product recalls by various regulatory bodies and manufacturers are also expected to negatively impact
market growth. In May 2016, Baxter International Inc. (U.S.) initiated a Class 1 recall for its PrismaSate
BGK2/0 dialysis solution for CRRT. The recall was carried out owing to the presence of leaks near the top
of the PrismaSate bags. In May 2012, the FDA initiated a Class 2 recall of PrismaSate, a dialysis solution
for CRRT manufactured by Gambro AB (Sweden), due to the product stability expiration.
TABLE 4 CONTINUOUS RENAL REPLACEMENT THERAPY DIALYSATES & REPLACEMENT FLUIDS

MARKET, BY REGION, 2015–2022 (USD MILLION)
CAGR
Region 2015 2016 2017-e 2022-p
(2017–2022)
Europe 180.1 189.5 199.3 257.8 5.3%
North America 135.6 144.2 153.3 210.4 6.5%
Asia-Pacific 99.0 108.4 118.6 186.2 9.4%
RoW 54.4 58.6 63.0 91.8 7.8%
Total 469.1 500.6 534.2 746.2 6.9%
71
In 2017, Europe is estimated to account for the largest share of 37.3% of the CRRT dialysates &
replacement fluids market. This regional segment is projected to reach USD 257.8 million by 2022 from
USD 199.3 million in 2017, at a CAGR of 5.3% from 2017 to 2022.
TABLE 5 EUROPE: CONTINUOUS RENAL REPLACEMENT THERAPY DIALYSATES & REPLACEMENT

FLUIDS MARKET, BY COUNTRY, 2015–2022 (USD MILLION)
CAGR
Country/Region 2015 2016 2017-e 2022-p
(2017–2022)
Germany 65.7 69.0 72.5 93.3 5.2%
France 40.5 43.0 45.6 61.9 6.3%
U.K. 37.2 39.3 41.4 54.7 5.7%
RoE 36.8 38.2 39.7 48.0 3.9%
Total 180.1
180.1 189.5 199.3 257.8 5.3%
In 2017, Germany is estimated to account for the largest share of 36.4% of the European CRRT dialysates
& replacement fluids market. This market is projected to reach USD 93.3 million by 2022 from USD 72.5
million in 2017, at a CAGR of 5.2% from 2017 to 2022.
TABLE 6 NORTH AMERICA: CONTINUOUS RENAL REPLACEMENT THERAPY DIALYSATES &

REPLACEMENT FLUIDS MARKET, BY COUNTRY, 2015–2022 (USD MILLION)
CAGR
Country 2015 2016 2017-e 2022-p
(2017–2022)
U.S. 123.3 131.0 139.2 190.4 6.5%
Canada 12.3 13.2 14.1 20.0 7.2%
Total 135.6 144.2 153.3 210.4 6.5%
In 2017, the U.S. is estimated to account for the largest share of 90.8% of the North American CRRT
dialysates & replacement fluids market. This market is projected to reach USD 190.4 million by 2022 from
72
TABLE 7 ASIA-PACIFIC: CONTINUOUS RENAL REPLACEMENT THERAPY DIALYSATES &

REPLACEMENT FLUIDS MARKET, BY COUNTRY, 2015–2022 (USD MILLION)
CAGR
(2017–2022)
Japan 38.5 41.8 45.3 67.7 8.4%
China 21.3 23.7 26.3 44.6 11.1%
India 10.8 11.7 12.8 19.8 9.1%
RoAPAC 28.4 31.2 34.2 54.1 9.6%
Total 99.0
99.0 108.4 118.6 186.2 9.4%
In 2017, Japan is estimated to account for the largest share of 38.2% of the CRRT dialysates &
replacement fluids market in Asia-Pacific. This market is projected to reach USD 67.7 million by 2022 from
8.1.2 DISPOSABLES
CRRT disposables include bloodline sets (tubing sets), hemofilters, and other disposables such as vascular
access catheters and CRRT accessories, including drainage bags (collection bags), ancillaries, stop cocks,
syringes, and priming solutions.
This product segment is expected to register the highest growth during the forecast period due to the
rapidly growing requirement for disposables, especially bloodlines and hemofilters, in CRRT procedures.
Since CRRT is a continuous therapy, disposables are required to be replaced after every procedure,
depending on the circuit shelf-life. The circuit shelf-life of a CRRT system depends on the type of
anticoagulant (heparin or citrate) used; around 2 to 3 bloodlines are required in a single CRRT procedure
lasting ~35 to 45 hours.
The hemofilters segment accounted for the largest share of the CRRT disposables market in 2016 and is
expected to grow at the highest CAGR during the forecast period. The large share of this segment can be
attributed to the development of novel hemofilters and their increasing use in CRRT procedures.
Additionally, the rising adoption of catheters for vascular access, which is one of the basic requirements to
perform any extracorporeal therapy, also acts as a major driver for the growth of this market.
TABLE 8 CONTINUOUS RENAL REPLACEMENT THERAPY DISPOSABLES MARKET, BY TYPE,

CAGR
Type 2015 2016 2017-e 2022-p
(2017–2022)
Hemofilters 142.6 152.0 161.9 223.8 6.7%
Bloodline Sets 89.0 96.4 104.4 156.9 8.5%
Other Disposables 105.5 114.8 124.8 190.9 8.9%
Total 337.1 363.1 391.1 571.5 7.9%
73
In 2017, the hemofilters segment is estimated to account for the largest share of 41.4% of the global
CRRT disposables market. This segment is projected to reach USD 223.8 million by 2022 from USD 161.9
million in 2017, at a CAGR of 6.7% during the forecast period.
TABLE 9 CONTINUOUS RENAL REPLACEMENT THERAPY DISPOSABLES MARKET, BY REGION,

CAGR
Region 2015 2016 2017-e 2022-p
(2017–2022)
Europe 131.0 139.2 147.8 200.9 6.3%
North America 100.3 108.0 116.2 168.9 7.8%
Asia-Pacific 69.5 76.4 84.1 135.7 10.1%
RoW 36.3 39.5 43.0 66.0 8.9%
Total 337.1
337.1 363.1 391.1 571.5 7.9%
In 2017, Europe is estimated to account for the largest share of 37.8% of the global CRRT disposables
market. This regional segment is projected to reach USD 200.9 million by 2022 from USD 147.8 million in
2017, at a CAGR of 6.3% from 2017 to 2022.
TABLE 10 EUROPE: CONTINUOUS RENAL REPLACEMENT THERAPY DISPOSABLES MARKET,

BY COUNTRY, 2015–2022 (USD MILLION)
CAGR
(2017–2022)
Germany 47.0 49.7 52.6 70.3 6.0%
France 30.2 32.5 35.0 50.8 7.7%
U.K. 28.2 30.2 32.2 45.0 6.9%
RoE 25.6 26.8 27.9 34.8 4.5%
Total 131.0 139.2 147.8 200.9 6.3%
In 2017, Germany is estimated to account for the largest share of 35.6% of the European CRRT
disposables market. This market is projected to reach USD 70.3 million by 2022 from USD 52.6 million in
74
TABLE 11 NORTH AMERICA: CONTINUOUS RENAL REPLACEMENT THERAPY DISPOSABLES MARKET,

CAGR
Country 2015 2016 2017-e 2022-p
(2017–2022)
U.S. 91.5 98.4 105.8 153.4 7.7%
Canada 8.8 9.5 10.3 15.5 8.5%
Total 100.3
100.3 108.0 116.2 168.9 7.8%
disposables market. This market is projected to reach USD 153.4 million by 2022 from USD 105.8 million
in 2017, at a CAGR of 7.7% from 2017 to 2022.
TABLE 12 ASIA-PACIFIC: CONTINUOUS RENAL REPLACEMENT THERAPY DISPOSABLES MARKET,

CAGR
(2017–2022)
Japan 27.0 29.3 31.8 47.6 8.4%
China 15.2 17.1 19.3 34.6 12.4%
India 7.4 8.1 8.8 13.8 9.3%
RoAPAC 19.9 21.9 24.2 39.8 10.4%
Total 69.5 76.4 84.1 135.7 10.1%
In 2017, Japan is estimated to account for the largest share of 37.8 % of the CRRT disposables market in
Asia-Pacific. This market is projected to reach USD 47.6 million by 2022 from USD 31.8 million in 2017, at
a CAGR of 8.4% from 2017 to 2022.
8.1.2.1 Hemofilters
Hemofilters, or artificial kidneys, are one of the major components in a CRRT system. These filters usually
contain a semipermeable membrane in a hollow-fiber design. This design enables blood to flow inside the
hollow fibers and, at the same time, allows the dialysate to flow outside the fibers. The membrane type and
surface area help to determine solute and fluid removal during a CRRT procedure.
The hemofilters market is mainly driven by the development of new hemofilters and the rise in the number
of CRRT procedures. Additionally, the growing focus of manufacturers on expanding their distribution
channels is expected to help generate more sales for hemofilters. In 2014, Toray Medical Company
Limited (Japan) entered into a distribution agreement with Fresenius Medical Care AG & Co. KGaA
(Germany) to market and sell TORAYMYXIN (an acute blood purification device) and PMMA hemofilters in 8
European countries (Germany, Denmark, Sweden, Finland, Norway, Poland, Hungary, and the Czech
Republic).
Furthermore, a large number of clinical studies are currently underway to understand the effects of
hemofilters on anticoagulating agents during CRRT procedures in critically ill patients. For instance, in
75
January 2015, Peking University First Hospital (China) initiated a research study to establish the safety and
efficacy of heparin-coated surface-treated polyacrylonitrile membrane hemofilters in patients with AKI. In
March 2013, Zhongda Hospital (China) started a clinical study to evaluate the effects of the AN69 ST
hemofilter on coagulation during CRRT in critically ill patients. The positive outcomes obtained from these
studies are expected to result in an increase in the demand for hemofilters in various CRRT procedures.
However, the high cost of hemofilters, coupled with complications such as clotting of filters and
thrombocytopenia associated with their use during CRRT procedures, is restraining the growth of the CRRT
hemofilters market. According to a clinical study published by The International Journal of Artificial Organs
in October 2013, hemofilters used in CRRT may contribute to the development of thrombocytopenia by
destroying or retaining blood platelets during passage. Annually, excessive anticoagulation leads to
deterioration and clotting of filters in 5% to 26% of CRRT treatments worldwide (Source: A Study Published
by Therapeutics and Clinical Risk Management, June 2005).
Additionally, hemofiltration is not sufficient for the treatment of severe lactic acidosis, which is very
commonly developed by AKI patients. This further limits its adoption in patients with severe lactic acidosis.
According to a study published in the Clinical Kidney Journal in August 2015, CRRT alone is not
recommended for AKI patients with severe lactic acidosis as hemofiltration is not effective for the
management of severe lactic acidosis.
8.1.2.2 Bloodline sets (tubing sets)

Bloodline sets are used to carry blood and fluids through the hemofilter and in the CRRT circuit. Factors
such as the high demand for bloodlines in CRRT procedures, growing demand for superior quality renal
replacement services with a high degree of safety, and increasing focus of key players on expanding their
production capacity for tubing sets are expected to drive the growth of the bloodline sets market.
On the other hand, clotting is a major complication associated with the use of bloodline sets in CRRT
procedures. Its circuit life mainly determines the procedural time and cost of CRRT. The circuit of CRRT
consists of bloodlines and hemofilters. However, in many cases, the CRRT circuit gets clotted before its
optimal shelf life due to the complexity of therapy and improper use of anticoagulants, which leads to an
increase in procedural costs and decrease in the adoption of CRRT among AKI patients. Thus, in the
coming years, the development of blood tubing with special coding to prevent clotting will unfold new
growth opportunities in the CRRT market.
8.1.2.3 Other disposables

Other CRRT disposables include vascular access catheters, adsorbents, and CRRT accessories. Vascular
access catheters are one of the basic requirements to perform any extracorporeal therapy. Large-bore,
double-lumen catheters are the most commonly used catheters during CRRT procedures. Double-lumen
catheters are placed in a large central vein, such as the internal jugular vein, the femoral vein, and the
subclavian vein, to have vascular access. CRRT accessories include drainage bags (collection bags),
ancillaries, stop cocks, syringes, and priming solutions. Market growth of vascular access catheters is
mainly due to the increasing number of CRRT procedures, new product launches, and the development of
new advanced catheters for CRRT.
Technical complications associated with the use of catheters during CRRT procedures, such as catheter
and circuit kinking and line-catheter disconnection, which may limit its adoption for pediatric patients. This
is a major factor hindering the growth of this market.
76
8.1.3 SYSTEMS
CRRT systems consist of monitors, blood & fluid pumps, and user-friendly interfaces to perform procedures
on critically ill patients. These systems are automatic, and multifunctional blood purification equipment is
used for continuous solute and fluid removal in critically ill patients suffering from acute kidney failure and
fluid overload. Ideally, a CRRT system should have the following functions:
Adapt to different modalities such as CVVH (continuous venovenous hemofiltration), CVVHD

(continuous venovenous hemodialysis), CVVHDF (continuous venovenous hemodiafiltration),
and SCUF (slow continuous ultrafiltration)
Individualize the replacement fluid, dialysate flow, blood flow, and filtrate
Control the temperature of replacement and dialysate fluids to help manage patient
temperature
Offer portability to enable its usage across different departments in a hospital
Should have low extracorporeal volume to decrease the risk of hemodynamic instability
Should have a backup battery for blood recovery in case of power failure
Many leading players in the market are increasingly focusing on developing and commercializing innovative
and technologically advanced CRRT systems. The availability of technologically advanced, easy-to-use,
safer, and more efficient CRRT systems will, in turn, boost the adoption of CRRT among healthcare
providers. This is evident from the number of product launches in recent years.
May 2017: Asahi Kasei Corporation (Japan) developed a new system for CRRT—Kibou, a
multifunction system with advanced features which enables dynamic prescription and reduces
the nursing load.
November 2016: B. Braun Melsungen AG (Germany) introduced OMNI, a new device for CRRT,
which provides improved user interface, diminishes downtime, and optimizes renal dose
delivery.
May 2015: Fresenius Medical Care AG & Co. KGaA (Germany) launched multiFiltratePRO. This
new system is featured with a large touch screen monitor (which comprehensively displays all
required information), fully integrated fluid heaters (that manages required fluid temperature),
and Care-Mode function (which prevents unnecessary alarms to allow easy mobility).
September 2013: NxStage Medical, Inc. (U.S.) updated the NxStage System One the Dosing
Calculator, which is designed to be used with the system. This online tool enables physicians to
develop prescriptions as per the patients' clinical and lifestyle requirements.
Various CRRT system manufacturers are also focusing on establishing strong distribution networks to
market their products across the globe. This enables the key players to increase their customer base
across the globe and thereby increase revenue growth from CRRT products. For instance, in April 2013,
NxStage Medical, Inc. (U.S.) established a direct sales model with the formation of a subsidiary—NxStage
Medical UK, Ltd.—in the U.K., to market its System One and other related CRRT products across the
country.
The rising adoption of CRRT for the treatment of AKI patients and clinical advantages of CRRT over
intermittent hemodialysis techniques are some of the other factors driving the growth of the CRRT systems
market. Additionally, nephrologists are prescribing CRRT with an increasing level of confidence due to its
short- and long-term benefits, taking into account studies that support its success in treating critically ill
AKI patients who are hemodynamically unstable. Moreover, the rising adoption of CRRT for pediatric
patients owing to the capability of these systems in volumetric balancing during therapy is also expected to
increase demand. According to a clinical study published by The International journal of Artificial Organs in
77
April 2014, in lighter pediatric AKI patients, CRRT systems deliver accurate ultrafiltration over prolonged
periods of time.
However, the procedural cost of CRRT is significantly higher as compared to other alternative modalities
available for treatment of AKI such as IHD or SLEDD. This is one of the major challenges for the adoption of
CRRT systems worldwide. The impact of this challenge is more in developing countries owing to lower
accessibility towards CRRT systems, high installation and maintenance costs, and poor reimbursement
scenario in developing countries for CRRT procedures.
TABLE 13 CONTINUOUS RENAL REPLACEMENT THERAPY SYSTEMS MARKET, BY REGION,

CAGR
Region 2015 2016 2017-e 2022-p
(2017–2022)
Europe 60.1 62.3 64.5 77.2 3.7%
North America 46.6 48.8 51.0 63.9 4.6%
Asia-Pacific 29.0 31.3 33.8 49.1 7.8%
RoW 15.8 16.8 17.9 24.2 6.3%
Total 151.5 159.2 167.2 214.5 5.1%
Europe is estimated to account for the largest share of 38.6% of the global CRRT systems market in 2017.
This regional segment is projected to reach USD 77.2 million by 2022 from USD 64.5 million in 2017, at a
CAGR of 3.7% from 2017 to 2022.
TABLE 14 EUROPE: CONTINUOUS RENAL REPLACEMENT THERAPY SYSTEMS MARKET, BY COUNTRY,

CAGR
(2017–2022)
Germany 21.2 21.9 22.6 26.7 3.3%
France 13.9 14.6 15.4 19.5 4.9%
U.K. 12.7 13.2 13.7 16.4 3.7%
RoE 12.2 12.5 12.8 14.6 2.6%
Total 60.1 62.3 64.5 77.2 3.7%
Germany is estimated to account for the largest share of 35.1% of the European CRRT systems market in
2016. This market is projected to reach USD 26.7 million by 2022 from USD 22.6 million in 2017, at a
CAGR of 3.3% from 2017 to 2022.
78
TABLE 15 NORTH AMERICA: CONTINUOUS RENAL REPLACEMENT THERAPY SYSTEMS MARKET,

CAGR
Country 2015 2016 2017-e 2022-p
(2017–2022)
U.S. 42.7 44.6 46.6 58.3 4.6%
Canada 4.0 4.2 4.4 5.7 5.2%
Total 46.6
46.6 48.8 51.0 63.9 4.6%
The U.S. is estimated to account for the largest share of 91.4% of the North American CRRT systems
market in 2017. This market is projected to reach USD 58.3 million by 2022 from USD 46.6 million in
TABLE 16 ASIA-PACIFIC: CONTINUOUS RENAL REPLACEMENT THERAPY SYSTEMS MARKET,

CAGR
(2017–2022)
Japan 11.2 12.0 12.8 17.4 6.4%
China 6.3 6.9 7.6 12.2 9.9%
India 3.0 3.2 3.4 4.9 7.3%
RoAPAC 8.5 9.2 10.0 14.7 8.1%
Total 29.0 31.3 33.8 49.1 7.8%
Japan is estimated to account for the largest share of 37.8% of the Asia-Pacific CRRT systems market in
CAGR of 6.4% from 2017 to 2022.
79

BY MODALITY
KEY FINDINGS
The CVVH modality is estimated to account for the largest share of 51.9% of the global CRRT
market in 2017. This market segment is projected to reach USD 796.0 million by 2022 from
USD 567.0 million in 2017.
The large market share of the CVVH segment is primarily due to the wide adoption of this
modality among healthcare providers owing to its wide range of advantages over other CRRT
modalities.
The CVVHDF modality, on the other hand, is expected to be the fastest-growing segment in the
global CRRT market. This segment is projected to grow at a CAGR of 7.9% during the forecast
period.
The high growth rate of the CVVHDF segment can be attributed to its flexibility as compared to
SCUF, CVVH, and CVVHD. The CVVHDF modality also combines the benefits of convection and
diffusion for the removal of solutes, which is another major factor supporting market growth.
80
9.1 INTRODUCTION
Based on modality, the continuous renal replacement therapy (CRRT) market is segmented into slow
continuous ultrafiltration (SCUF), continuous venovenous hemofiltration (CVVH), continuous venovenous
hemodialysis (CVVHD), and continuous venovenous hemodiafiltration (CVVHDF). These blood purification
modalities differ significantly based on the mechanism of solute transport, type of membrane, type of
vascular access, and presence/absence of dialysates.
The selection of a particular CRRT modality depends on the physician’s preference and the patient’s
needs.
FIGURE 32 TYPES OF CRRT MODALITIES
CRRT Blood SCUF

Purification CVVHDF
Modalities CVVH CVVHD
HEMOFILTRATION HEMODIALYSIS
CONVECTION DIFFUSION
Source: Baxter International Inc.
The CVVH segment is estimated to account for the largest share of 51.9% of the global CRRT market in
2016. The large share of this segment can primarily be attributed to the widespread adoption of this
modality among critical care providers because of its superior removal performance for high-molecular-
weight solutes as compared to other CRRT techniques. CVVH is also an ideal approach for patients with
severe renal impairment with a need to increase or maintain fluid volume status.
81
FIGURE 33 GLOBAL CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY

(2017 VS. 2022)
567.0
CVVH
796.0
344.1
CVVHDF
504.1
125.6
CVVHD
167.8
55.7
SCUF
64.4
Nephrology, The United States Renal Data System (USRDS), Canadian Society of Nephrology (CSN), European Societies of Nephrology
[ERA-EDTA], Asian Renal Association, U.S. FDA, Annual Reports, SEC Filings, Press Releases, Investor Presentations, Journals, Expert
Interviews, and MarketsandMarkets Analysis
The CVVHDF segment is expected to be the fastest-growing segment of the global CRRT market during the
forecast period, mainly due to its high flexibility as compared to other modalities and its use of both
convection and diffusion for the removal of solutes.
TABLE 17 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,

CAGR
Modality 2015 2016 2017-e 2022-p
(2017–2022)
CVVH 496.9 530.8 567.0 796.0 7.0%
CVVHDF 296.3 319.4 344.1 504.1 7.9%
CVVHD 112.3 118.8 125.6 167.8 6.0%
SCUF 52.3 54.0 55.7 64.4 2.9%
Total 957.8
9 57.8 1,022.9 1,092.5 1,532.3 7.0%
The CVVH segment is estimated to account for the largest share of 51.9% of the global CRRT market in
2017. This segment is projected to reach USD 796.0 million by 2022 from USD 567.0 million in 2017, at a
CAGR of 7.0% during the forecast period.
82
9.2 CONTINUOUS VENOVENOUS HEMOFILTRATION (CVVH)

CVVH removes large volumes of fluid through convection. As compared to other CRRT modalities, this
therapy is more effective for the removal of large molecules from patients with reduced renal function or
kidney failure. In this therapy, blood is passed through a hemofilter that filters water with other substances
such as salts, urea, creatinine, or other medium-sized substances. This resulting fluid is known as an
ultrafiltrate. This ultrafiltrate is removed at a rate of 1L–2L/hour. A substitute fluid is injected into the
blood during the process to compensate for the unwanted losses of desired substances. The intravenous
crystalloid replacement fluid is added either pre-filter or post-filter; a dialysate is not used in this process.
CVVH is performed continuously until renal functions are recovered. This process may take between two to
three days or two to three weeks.
CVVH is widely used in application areas such as in fluid overloads, congestive heart failure, acute renal
failure, crush syndrome, and lactic acidosis. The amount of fluid collected in the effluent bag is equal to
the sum of the amount of fluid removed from the patient and the volume of replacement fluids
administered. However, as large fluid volumes are removed, this therapy may result in volume contraction,
loss of electrolytes, and hypotension.
The large share of the CVVH segment is primarily due to the widespread adoption of this modality for the
treatment of AKI due to the high filtrate flow in CVVH that enhances the performance of solute removal. As
per a study published by the Canadian Respiratory Journal in May 2014, 61% of intensive care units (ICUs)
in the U.K. utilize CVVH as a first-line therapy for the treatment of AKI. Similarly, according to a survey by
Intensive Care Medicine (September 2007) in 54 ICUs across 23 countries across the globe, CVVH is more
commonly used than CVVHDF for the treatment of AKI due to its wide range of advantages that result in
superior outcomes.
One major advantage of CVVH is that solutes can be removed in large quantities while easily maintaining a
net zero or even a positive fluid balance in the patient. This flexibility makes CVVH an ideal approach for
patients with severe renal impairment who need to increase or maintain their fluid volume status.
Additionally, its effectiveness in removing big molecules while maintaining a positive fluid balance in
patients and a large number of ongoing research studies and clinical trials to establish the safety and
efficacy profile for CRRT products are further stimulating the growth of the global CVVH market. CVVH is
also very effective in clearing medium-sized molecules such as inflammatory cytokines. It increases the
clearance of medium-to-larger molecules compared to CVVHD, which in turn successfully reduces the
effects of systemic inflammatory response syndrome. The removal of such mediators may play a role in
improving sepsis outcomes in patients. In line with this, CVVH in AKI patients with severe sepsis shows
considerably improved renal recovery compared to extended daily hemofiltration (EDHF) despite the
clinical condition of patients (Source: A clinical study published by Critical Care in April 2014).
CVVH also improves the survival rate of AKI patients with congestive heart failure and cardiorenal
syndrome compared to SCUF (Source: A clinical study published by Therapeutic Apheresis and Dialysis in
April 2017). This, in turn, increases CVVH adoption among AKI patients with congestive heart failure and
cardiorenal syndrome, and thereby drives market growth.
However, there is no significant difference in mortality rates for CVVH compared to other CRRT modalities,
which may negatively affect its adoption and thereby limit market growth. According to a clinical study
published by Critical Care in April 2014, which is based on the comparison between CVVH and EDHF, there
is no significant difference in mortality rate using both modalities. A study conducted by the Canadian
Respiratory Journal on a comparison between CVVH and CVVHDF also found that mortality rates in both
modalities are similar (Source: A clinical study published by Canadian Respiratory Journal in June 2014).
Also, CVVH requires a costly set of tubing systems with special hemofilters, which increases the overall cost
of the therapy. Thus, the high cost of the therapy may restrict market growth to a certain extent.
83
TABLE 18 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR CVVH, BY REGION,

CAGR
Region 2015 2016 2017-e 2022-p
(2017–2022)
Europe 190.3 200.0 210.1 270.4 5.2%
North America 145.8 155.1 164.9 226.5 6.6%
Asia-Pacific 103.7 114.1 125.5 201.2 9.9%
RoW 57.1 61.6 66.5 97.9 8.1%
Total 496.9
496.9 530.8 567.0 796.0 7.0%
In 2017, Europe is estimated to account for the largest share of 37.1% of the global CRRT market for
CVVH. This regional segment is projected to reach USD 270.4 million by 2022 from USD 210.1 million in
TABLE 19 EUROPE: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR CVVH, BY COUNTRY,
CAGR
(2017–2022)
Germany 69.2 72.6 76.1 96.9 4.9%
France 43.0 45.8 48.7 66.6 6.5%
U.K. 39.5 41.7 44.0 58.1 5.7%
RoE 38.6 39.9 41.3 48.9 3.4%
Total 190.3 200.0 210.1 270.4 5%
In 2017, Germany is estimated to account for the largest share of 36.2% of the European CRRT market for
CVVH. This market is projected to reach USD 96.9 million by 2022 from USD 76.1 million in 2017, at a
CAGR of 4.9% from 2017 to 2022.
TABLE 20 NORTH AMERICA: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR CVVH,
CAGR
Country 2015 2016 2017-e 2022-p
(2017–2022)
U.S. 132.5 140.8 149.6 204.6 6.5%
Canada 13.3 14.2 15.3 21.9 7.4%
Total 145.8 155.1 164.9 226.5 6.6%
84
market for CVVH. This market is projected to reach USD 204.6 million by 2022 from USD 149.6 million in
TABLE 21 ASIA-PACIFIC: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR CVVH,

CAGR
(2017–2022)
Japan 41.0 44.4 47.9 70.7 8.1%
China 21.5 24.4 27.7 50.2 12.6%
India 11.2 12.3 13.4 21.0 9.4%
RoAPAC 30.0 33.1 36.5 59.4 10.2%
Total 103.7
103.7 114.1 125.5 201.2 10%
In 2017, Japan is estimated to account for the largest share of 38.1% of the Asia-Pacific CRRT market for
CVVH. This market is projected to reach USD 70.7 million by 2022 from USD 47.9 million in 2017, at a
CAGR of 8.1% from 2017 to 2022.
9.3 CONTINUOUS VENOVENOUS HEMODIAFILTRATION (CVVHDF)

This therapy combines the benefits of both diffusion (CVVHD) and convection (CVVH) for solute removal. In
this technique, blood is passed through a hemofilter and a dialysate is injected on the other side of the
semi-permeable membrane, combining the filtration and dialysis processes. CVVHDF requires intravenous
fluid replacement due to its high rate of ultrafiltration. This approach is effective for the removal of small to
medium-sized molecules. This therapy is used in patients with fluid overload, congestive heart failure, and
acute renal failure.
The overall growth of this segment is primarily due to its key advantages such as better clearance of
medium-sized solutes as compared to hemodialysis (due to the combination of hemofiltration with the
continuous HD procedure), proper acid-base balance without additional intervention, and a significant
reduction in CRRT-related phosphate depletion.
On the other hand, its limited role in renal recovery in AKI patients is expected to hinder the growth of this
market segment.
85
TABLE 22 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR CVVHDF, BY REGION,

CAGR
Region 2015 2016 2017-e 2022-p
(2017–2022)
Europe 119.9 127.7 135.9 187.0 6.6%
North America 86.1 92.7 99.8 145.7 7.9%
Asia-Pacific 59.0 64.8 71.2 114.4 9.9%
RoW 31.4 34.2 37.2 57.0 8.9%
Total 296.3
296.3 319.4 344.1 504.1 7.9%
CVVHDF. This regional segment is projected to reach USD 187.0 million by 2022 from USD 135.9 million in
TABLE 23 EUROPE: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR CVVHDF,

CAGR
(2017–2022)
Germany 43.3 46.0 48.8 66.3 6.3%
France 27.5 29.6 31.8 46.1 7.7%
U.K. 25.6 27.4 29.2 40.9 6.9%
RoE 23.6 24.8 26.1 33.8 5.3%
Total 119.9 127.7 135.9 187.0 6.6%
CVVHDF. This market is projected to reach USD 66.3 million by 2022 from USD 48.8 million in 2017, at a
CAGR of 6.3% from 2017 to 2022.
TABLE 24 NORTH AMERICA: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR CVVHDF,
CAGR
Country 2015 2016 2017-e 2022-p
(2017–2022)
U.S. 78.6 84.7 91.1 132.7 7.8%
Canada 7.4 8.0 8.7 13.0 8.4%
Total 86.1 92.7 99.8 145.7 7.9%
86
market for CVVHDF. This market is projected to reach USD 132.7 million by 2022 from USD 91.1 million in
TABLE 25 ASIA-PACIFIC: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR CVVHDF,

CAGR
(2017–2022)
Japan 22.9 25.0 27.4 42.4 9.1%
China 13.2 14.7 16.2 27.6 11.3%
India 6.0 6.5 7.2 11.3 9.5%
RoAPAC 16.9 18.6 20.4 33.1 10.1%
Total 59.0
59.0 64.8 71.2 114.4 9.9%
CVVHDF. This market is projected to reach USD 42.4 million by 2022 from USD 27.4 million in 2015, at a
CAGR of 9.1% from 2017 to 2022.
9.4 CONTINUOUS VENOVENOUS HEMODIALYSIS (CVVHD)

This technique removes solutes by diffusion using dialysates; replacement fluids are not required in this
therapy. In CVVHD, the dialysate runs countercurrent to blood flow (similar to IHD) but at a slower rate of
1L to 1.2L/hour. This therapy is more effective in removing small to medium-sized molecules as compared
to other CRRT modalities. This process is usually performed continuously until renal functions are
recovered, which may take between two to three days and two to three weeks. In this technique, blood is
passed through a dialyzer, and the dialysate is circulated on the other side of the semi-permeable
membrane. The concentration of small substances tends to equilibrate by diffusion on this membrane. In
this modality, the fluid gathered in the effluent bag is equal to the sum of the amount of fluid removed
from the patient and the dialysate.
Market growth can be attributed to the effectiveness of this modality in removing small and medium-sized
molecules. CVVHD is mostly used in patients suffering from acute renal failure and lactic acidosis. Slow
extended daily dialysis (SLEDD) is a viable alternative to CVVHD. However, SLEDD is less expensive than
CVVHD; this factor has reduced the adoption of CVVHD among AKI patients in budget-constrained
hospitals. CVVHD is also not sufficient for clearance of medium to larger molecules and does not provide
support for reducing the effect of systemic inflammatory response syndrome in AKI patients, which could
restrain its adoption and thereby limit the market growth to a certain extent.
87
TABLE 26 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR CVVHD, BY REGION,

CAGR
Region 2015 2016 2017-e 2022-p
(2017–2022)
Europe 41.0 42.8 44.6 55.4 4.4%
North America 35.2 37.2 39.3 52.3 5.9%
Asia-Pacific 23.8 25.6 27.6 40.4 7.9%
RoW 12.3 13.2 14.1 19.7 7.0%
Total 112.3
112.3 118.8 125.6 167.8 6.0%
CVVHD. This regional segment is projected to reach USD 55.4 million by 2022 from USD 44.6 million in
TABLE 27 EUROPE: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR CVVHD,

CAGR
(2017–2022)
Germany 14.3 14.9 15.5 19.1 4.2%
France 9.5 10.0 10.5 13.8 5.5%
U.K. 8.8 9.2 9.6 12.0 4.7%
RoE 8.4 8.7 9.0 10.5 3.1%
Total 41.0 42.8 44.6 55.4 4.4%
CVVHD. This market is projected to reach USD 19.1 million by 2022 from USD 15.5 million in 2017, at a
CAGR of 4.2% from 2017 to 2022.
TABLE 28 NORTH AMERICA: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR CVVHD,
CAGR
Country 2015 2016 2017-e 2022-p
(2017–2022)
U.S. 32.3 34.1 36.0 47.7 5.8%
Canada 2.9 3.1 3.3 4.5 6.5%
Total 35.2 37.2 39.3 52.3 5.9%
88
In 2017, the U.S. is estimated to account for the largest share of 91.6% of the global CRRT market for
CAGR of 5.8% from 2017 to 2022.
TABLE 29 ASIA-PACIFIC: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR CVVHD,

CAGR
Country 2015 2016 2017-e 2022-p
(2017–2022)
Japan 8.7 9.4 10.0 14.1 7.0%
China 5.5 6.0 6.6 10.1 9.0%
India 2.8 3.0 3.2 4.6 7.5%
RoAPAC 6.7 7.3 7.9 11.7 8.2%
Total 23.8
23.8 25.6 27.6 40.4 7.9%
Interviews,, and MarketsandMarkets Analysis
y
CAGR of 7.0% from 2017 to 2022.
9.5 SLOW CONTINUOUS ULTRAFILTRATION (SCUF)

SCUF primarily removes water from the bloodstream through ultrafiltration. This process removes excess
water at a very slow ultrafiltration rate. SCUF is usually performed from 4–24 hours until the targeted water
level is reached within the patient. This therapy is a low-intensity nursing procedure as compared to other
CRRT modalities. In this therapy, blood is passed through a hemofilter that filters water along with some
other substances. However, this modality does not allow the removal of solutes due to the slow
ultrafiltration rate. Additionally, in SCUF, there is no compensation for the filtration of undesired losses of
other substances. The amount of fluid collected in the effluent bag is equal to the amount removed from
the patient’s body.
The small market share of this segment is mainly due to its very low adoption owing to insufficiencies in
waste clearance considering the severity of patients.
However, SCUF does not use dialysates or replacement fluids for the removal of excess fluid from the
bloodstream; thus, fluid overload without uremia is the main indication for the application of SCUF. It also
reduces pressure on the body (particularly on the heart). Its increasing use in resolving fluid overloads,
pulmonary edemas, and congestive heart failure is the key factor driving the growth of the global SCUF
market. Furthermore, the ultrafiltrate utilized in SCUF is typically low, which helps in maintaining the
stability of a patient’s vital signs and does not have any major side effects.
89
TABLE 30 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR SCUF, BY REGION,

CAGR
Region 2015 2016 2017-e 2022-p
(2017–2022)
Europe 20.0 20.5 20.9 23.1 2.0%
North America 15.5 16.0 16.4 18.8 2.7%
Asia-Pacific 11.0 11.6 12.1 14.9 4.3%
RoW 5.8 6.0 6.2 7.5 3.6%
Total 52.3
52.3 54.0 55.7 64.4 2.9%
SCUF. This regional segment is projected to reach USD 23.1 million by 2022 from USD 20.9 million in
TABLE 31 EUROPE: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR SCUF, BY COUNTRY,
CAGR
(2017–2022)
Germany 7.1 7.2 7.4 8.1 1.8%
France 4.7 4.8 5.0 5.8 3.1%
U.K. 4.3 4.4 4.5 5.0 2.3%
RoE 4.0 4.0 4.1 4.2 0.7%
Total 20.0 20.5 20.9 23.1 2.0%
SCUF. This market is projected to reach USD 8.1 million by 2022 from USD 7.4 million in 2017, at a CAGR
of 1.8% from 2017 to 2022.
TABLE 32 NORTH AMERICA: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR SCUF,
CAGR
Country 2015 2016 2017-e 2022-p
(2017–2022)
U.S. 14.0 14.5 14.9 17.0 2.7%
Canada 1.5 1.5 1.6 1.8 3.2%
Total 15.5 16.0 16.4 18.8 2.7%
90
In 2017, U.S. is estimated to account for the largest share of 90.5% of the North American CRRT market
for SCUF. This market is projected to reach USD 17.0 million by 2022 from USD 14.9 million in 2017, at
a CAGR of 2.7% from 2017 to 2022.
TABLE 33 ASIA-PACIFIC: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR SCUF,

CAGR
(2017–2022)
Japan 4.2 4.4 4.6 5.5 3.7%
China 2.4 2.6 2.7 3.5 5.2%
India 1.2 1.3 1.3 1.6 4.1%
RoAPAC 3.2 3.3 3.5 4.4 4.4%
Total 11.0
11.0 11.6 12.1 14.9 4.3%
SCUF. This market is projected to reach USD 5.5 million by 2022 from USD 4.6 million in 2017, at a CAGR
of 3.7% from 2017 to 2022.
91

BY REGION
KEY FINDINGS
The European CRRT market is estimated to command the largest share of 37.7% of the global
CRRT market in 2017.
The high share of this regional segment can largely be attributed to factors such as the
increasing incidence of AKI due to the rapidly growing aging population, high utilization rate of
CRRT, and the increasing number of approvals for CRRT systems for multiple applications in this
region.
The Asia-Pacific CRRT market, on the other hand, is estimated to grow at the highest CAGR of
9.4% from 2017 to 2022 to reach USD 371.0 million by 2022.
Growth in the Asia-Pacific region is mainly due to the large AKI and ESRD patient population,
high utilization of CRRT in Australia and Japan, and improving healthcare infrastructure across
the Asian countries.
In 2017, North America is expected to account for the second-largest share of the global CRRT
market; it is projected to reach USD 443.3 million by 2022, at a CAGR of 6.7% during the
forecast period.
92
10.1 INTRODUCTION
In this report, the global CRRT market is divided into four major regions, namely, North America, Europe,
Asia-Pacific, and the Rest of the World (RoW), with each region studied further at the country level.
In 2017, Europe is estimated to account for the largest share of 37.7% of the global CRRT market, followed
by North America with a share of 29.3%. The large share of the European market can be attributed to the
increasing cases of acute kidney injury (AKI) and widespread use of CRRT in the region.
Asia-Pacific is expected to account for the third-largest share of 21.6% of the global CRRT market in 2017.
The demand for CRRT products in the APAC is growing primarily due to the high use of CRRT in Australia
and Japan and the rising number of AKI and ESRD patients in APAC countries. The Asian and Latin
American countries represent the fastest-growing regional markets for CRRT.
PERIOD
600
Market Size (USD Million)
500
400
300
200
100
0
Europe North America Asia-Pacific RoW
2017 411.6 320.5 236.5 123.9
2022 535.9 443.3 371.0 182.0
CAGR 5.4% 6.7% 9.4% 8.0%
Source: Acute Kidney Injury Network (AKIN), American Society of Nephrology (ASN), Asian Renal Association, Canadian Society of
Nephrology (CSN), ClinicalTrial.gov, Centers for Medicare and Medicaid Services (CMS), European Societies of Nephrology [ERA-
EDTA], FDA, National Kidney Foundation, The United States Renal Data System (USRDS), Annual Reports, SEC Filings, Press
TABLE 34 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY REGION,

CAGR
Region 2015 2016 2017-e 2022-p
(2017–2022)
Europe 371.2 390.9 411.6 535.9 5.4%
North America 282.6 300.9 320.5 443.3 6.7%
Asia-Pacific 197.4 216.1 236.5 371.0 9.4%
RoW 106.6 115.0 123.9 182.0 8.0%
Total 957.8 1,022.9 1,092.5 1,532.3 7.0%
Europe is estimated to account for the largest share of 37.7% of the global CRRT market in 2017. This
regional segment is projected to reach USD 535.9 million by 2022 from USD 411.6 million in 2017, at a
CAGR of 5.4% from 2017 to 2022.
93
10.2 EUROPE
In this report, the European market is segmented into Germany, France, the U.K., and the Rest of Europe. A
number of factors, such as the increasing cases of AKI in this region, growth in aging population, approvals
for CRRT machines as well as anticoagulating agents for multiple applications, and wide use of CRRT
products in Europe are driving market growth.
FIGURE 35 EUROPE: CRRT MARKET SNAPSHOT
EUROPE
EUROPE: CRRT MARKET, BY PRODUCT,
Europe is expected to The European CRRT 2017 (USD MILLION)
account for 37.7% of the market is expected to
global CRRT market in grow at a CAGR of 5.4% 199.3
2017 (2017–2022) 147.8
64.5
Germany accounts for the largest share

Dialysates and Disposables Systems
of ~35.9% of the European CRRT market Replacement Fluids
EUROPE: CRRT MARKET, BY COUNTRY, EUROPE: CRRT MARKET, BY PRODUCT,

2022 (USD MILLION)
2017 (USD MILLION)
257.8
COUNTRY/REGION MARKET SIZE
200.9
Germany 147.8
77.2
France 96.0

U.K. 87.4 Replacement Fluids
RoE 80.4
EUROPE: CRRT MARKET,
BY MODALITY, 2017 (USD MILLION)
FACTORS SUPPORTING THE GROWTH OF THE
CRRT MARKET IN EUROPE
CVVH CVVHDF
High adoption of CRRT for AKI treatment
Approval of CRRT for multiple applications 210.1 135.9
across European countries
Rising awareness about AKI in this region CVVHD SCUF
Growing number of clinical studies to establish
the efficacy and safety profile of CRRT 44.6 20.9
94
10.2.1 APPROVAL OF CRRT MAC HINES FOR MULTIPLE APPLICATIONS

A number of CRRT machines have been CE-Marked for multiple applications in Europe, as opposed to
North America where the same products have been approved only for a single application. Due to this,
CRRT machines see greater use across a wider range of applications in Europe than in North America. The
Prisma System is approved for a complete range of CRRT modalities as well as therapeutic plasma
exchange (TPE) in Europe; in North America, it has been approved only for AKI treatment in acute settings.
European regulatory policies are less stringent as compared to their North American counterparts; this has
expedited the launch of CRRT devices in Europe. The Prisma System, which was launched in Europe in
1995, was released in the U.S. two years later (Offered by Baxter International, Inc, U.S.). The Prismaflex
System, a next-generation CRRT system, was introduced in 2004 in Europe and 2005 in the U.S.
10.2.2 INTENSIVIST PREFERENCE FOR CRRT FOR AKI TREATMENT

In Europe, ICU patients for AKI treatment are treated under the guidance of intensivists who generally
prefer CRRT, as dialysis requires coordination with nephrologists and dialysis nurses. CRRT also enables
better hemodynamic stability and therapeutic effect (resulting from cytokine removal) and easier fluid
balance control.
As per an online survey conducted by Matthieu et al. on members of the European Society of Intensive
Care Medicine in January 2013, of a total of 272 intensivists (218 from Europe, 54 from other continents),
50% preferred using both intermittent hemodialysis and CRRT, but 88% preferred using CRRT (Source:
Haymarket Media, Inc.). Additionally, the rate of switching from CRRT to IHD is lowest in Europe and
Australia, due to the high preference for CRRT, favorable reimbursement scenario, and the presence of
trained ICU nurses for the procedure. This has ensured a steady and growing demand for CRRT in Europe.
10.2.3 PLAYERS FOCUS ON LEVERAGING GROWTH OPPORTUNITIES IN

EUROPE
Many of the key players in the market are increasingly focusing on developing technologically advanced
CRRT products in Europe, which will further drive the demand for advanced CRRT products in this region.
To leverage growth opportunities in the European market, leading players adopt organic and inorganic
growth strategies. For instance, in February 2013, NxStage obtained the CE Mark for its new high-flow
capabilities with the NxStage System One system. In May 2012, Bellco (Italy) launched three new devices—
FLEXYA, AMPLYA, and CARPE DIEM (Cardio Pediatric Emergency Dialysis Machine) for the treatment of
renal patients.
Many domestic and international manufacturers are also focusing on building their distribution channels
for CRRT products in Europe. In September 2014, Toray Industries, Inc. (Japan) entered into an agreement
with Fresenius Medical Care to exclusively distribute its acute blood purification devices (such as
TORAYMYXIN) and CRRT devices (such as PMMA hemofilter) in eight European countries.
However, the systemic anticoagulation complications remain a major challenge to the wider application of
CRRT, as this complication exposes the critically ill to the risk of active bleeding episodes.
95
TABLE 35 EUROPE: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY COUNTRY,

CAGR
(2017–2022)
Germany 133.9 140.7 147.8 190.3 5.2%
France 84.6 90.2 96.0 132.2 6.6%
U.K. 78.2 82.6 87.4 116.1 5.8%
RoE 74.6 77.5 80.4 97.3 3.9%
Total 371.2 390.9 411.6 535.9 5%
Germany is estimated to account for the largest share of 35.9% of the European CRRT products market in
CAGR of 5.2% from 2017 to 2022.
TABLE 36 EUROPE: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,

CAGR
Product 2015 2016 2017-e 2022-p
(2017–2022)
Dialysates & Replacement Fluids 180.1 189.5 199.3 257.8 5.3%
Disposables 131.0 139.2 147.8 200.9 6.3%
Systems 60.1 62.3 64.5 77.2 3.7%
Total 371.2
371.2 390.9 411.6 535.9 5.4%
the European CRRT market in 2017. This segment is projected to reach USD 257.8 million by 2022 from
USD 199.3 million in 2017, at a CAGR of 5.3% during the forecast period.
TABLE 37 EUROPE: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,

CAGR
Modality 2015 2016 2017-e 2022-p
(2017–2022)
CVVH 190.3 200.0 210.1 270.4 5.2%
CVVHDF 119.9 127.7 135.9 187.0 6.6%
CVVHD 41.0 42.8 44.6 55.4 4.4%
SCUF 20.0 20.5 20.9 23.1 2.0%
Total 371.2 390.9 411.6 535.9 5.4%
96
The CVVH segment is estimated to account for the largest share of 51.1% of the European CRRT market in
10.2.4 GERMANY
Germany is estimated to account for the largest share of 35.9% of the European CRRT market in 2017. Its
large share can be attributed to the growing number of AKI cases in the country, growth in the aging
population and life expectancy, the increasing demand for dialysis services, favorable reimbursement
scenario, and the development and commercialization of advanced CRRT products by leading players in
Germany.
10.2.4.1 Rising focus of players on the German CRRT market

The rising focus of CRRT manufacturers on the development and commercialization of technologically
advanced CRRT products in Germany will contribute to the growth of this market in the coming years. This
can be illustrated with the introduction of multiFiltratePRO (in May 2015) by Fresenius Medical Care
(Germany) for the treatment of AKI in critically ill patients in ICUs. This system provides nephrologists and
intensivists with advanced features such as an ergonomic design, easy application of CRRT, and
comprehensive integrated Ci-Ca anticoagulation for acute dialysis.
Likewise, in May 2012, Gambro (now a part of Baxter) entered into a partnership with Novalung GmbH
(Germany) to launch a new therapy to address the unmet medical needs in the field of CO 2 removal in
ICUs. The partnership enabled the integration of Novalung’s unique membrane gas exchange technology
into Gambro’s Prismaflex platform. This enabled Baxter to add a CO2 removal technique to its CRRT
platform.
Moreover, leading players are increasingly focusing on expanding their CRRT offerings as well as
production capacities in Germany, for which they have adopted various organic and inorganic growth
strategies. In May 2012, Asahi Kasei Medical and NxStage concluded an agreement that helped both
companies to expand their production capacity for dialyzers in Germany, by combining the polysulfone
hollow-fiber membranes of Asahi Kasei Medical and the assembly technology of NxStage. This agreement
enabled both companies to expand their strategic alliance further and build on their well-established
partnership in the renal care (including CRRT) market.
10.2.4.2 Favorable reimbursement for CRRT

As compared to other European countries, Germany has a well-established medical reimbursement
system. More than 90% of its population has mandatory health insurance coverage, which covers
reimbursement for new technologies for AKI treatment. The reimbursement for AKI treatment is provided
under the G-DRG codes L71Z and L60. Hospitals receive a fixed DRG fee that covers the total treatment
cost, including hospital stay. The reimbursement for AKI treatment ranges between EUR 3,000 to EUR
11,000 in Germany, as compared to EUR 1,727 to EUR 6,978 in France and EURO 3,700 in Italy.
The presence of favorable reimbursement policies has served to accelerate the adoption of CRRT over
alternative modalities. Subsequently, this can be expected to drive the growth of the German CRRT market
in the coming years.
97
TABLE 38 GERMANY: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,

2013-2020 (USD MILLION)
CAGR
Product 2015 2016 2017-e 2022-p
(2017–2022)
65.7 69.0 72.5 93.3 5.2%
Fluids
Disposables 47.0 49.7 52.6 70.3 6.0%
Systems 21.2 21.9 22.6 26.7 3.3%
Total 133.9
133.9 140.7 147.8 190.3 5.2%
In 2017, the dialysates and replacement fluids segment is estimated to account for the largest share of
49.1% of the CRRT market in Germany. This segment is projected to reach USD 93.3 million by 2022 from
TABLE 39 GERMANY: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,

CAGR
Modality 2015 2016 2017-e 2022-p
(2017–2022)
CVVH 69.2 72.6 76.1 96.9 4.9%
CVVHDF 43.3 46.0 48.8 66.3 6.3%
CVVHD 14.3 14.9 15.5 19.1 4.2%
SCUF 7.1 7.2 7.4 8.1 1.8%
Total 133.9 140.7 147.8 190.3 5.2%
In 2017, the CVVH segment is estimated to account for the largest share of 51.5% of the CRRT market in
Germany. This segment is projected to reach USD 96.9 million by 2022 from USD 76.1 million in 2017, at
a CAGR of 4.9% during the forecast period.
10.2.5 U.K.
The U.K. is estimated to account for 21.2% of the European CRRT market in 2017. It is projected to grow at
a CAGR of 5.8% in the forecast period. This can be attributed to the increasing incidence of AKI cases and
growing adoption of CRRT for the treatment of AKI in the country.
The U.K. is a relatively lucrative market for CRRT product manufacturers as even smaller companies can
easily penetrate this market. This is because only 72 NHS trusts coordinate kidney care in the U.K.; this
allows manufacturers to cover the entire country with a smaller sales force efficiently. The country also has
favorable reimbursement policies for the treatment of AKI.
To leverage growth opportunities in the U.K., many of the key players in the CRRT market are adopting
organic strategies for growth, such as the establishment of strong marketing and distribution channels.
NxStage, for instance, established a direct sales model in the U.K. that helped it market its System One
and other related products directly through its subsidiary, NxStage Medical UK, Ltd., in the country.
98
10.2.5.1 Rising awareness about AKI in the U.K.

Awareness about AKI and its treatment has risen in the country mainly due to a number of public and
private initiatives. The National Confidential Enquiry into Patient Outcomes and Death (NCEPOD) has
helped raise awareness about AKI in the U.K. by publishing a report which highlights the high mortality rate
related to AKI. This report drew attention towards the process of care practiced in ICU settings in the
country. The U.K. government has also established an AKI delivery board that provides guidelines for AKI
treatment through the National Institute for Health and Clinical Excellence (NICE). These initiatives may
enable the government to target educational resources appropriately based on the identified knowledge
gaps. To achieve this, the government has developed and introduced electronic educational resources and
e-learning packages.
However, a shortage of quality and efficient renal services restricts market growth to a certain extent
(Source: Perit Dial Int 2011 vol. 31 no. Supplement 2 S63-S72). In addition to this, regional variations in
the allocation of medical resources are hampering the growth of the CRRT market in the U.K.
TABLE 40 U.K.: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,

CAGR
Product 2015 2016 2017-e 2022-p
(2017–2022)
37.2 39.3 41.4 54.7 5.7%
Fluids
Disposables 28.2 30.2 32.2 45.0 6.9%
Systems 12.7 13.2 13.7 16.4 3.7%
Total 78.2 82.6 87.4 116.1 5.8%
47.4% of the CRRT market in the U.K. This segment is projected to reach USD 54.7 million by 2022 from
TABLE 41 U.K.: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,

CAGR
Modality 2015 2016 2017-e 2022-p
(2017–2022)
CVVH 39.5 41.7 44.0 58.1 5.7%
CVVHDF 25.6 27.4 29.2 40.9 6.9%
CVVHD 8.8 9.2 9.6 12.0 4.7%
SCUF 4.3 4.4 4.5 5.0 2.3%
Total 78.2 82.6 87.4 116.1 5.8%
the U.K. This segment is projected to reach USD 58.1 million by 2022 from USD 44.0 million in 2017, at a
99
10.2.6 FRANCE
France is estimated to account for 21.2% of the European CRRT market in 2017. The growth of the market
in France is mainly driven by the increase in the AKI patient population and aging population and the
presence of a large number of critical care units in the country. In 2012, there were more than 70,000
ESRD patients in France, including ~37,000 patients on dialysis (Source: ERA-EDTA, Issue 3/May 26,
2012).
10.2.6.1 Significant number of ongoing clinical studies

The large number of clinical trials to establish the safety and efficacy profile of CRRT undertaken by key
players in collaboration with universities and hospitals in France will contribute to the growth of the CRRT
market in the country. In December 2016, Hopital Louis Pradel (France) initiated a clinical trial, “Diagnosis
Accuracy of Hemoconcentration to Detect Hypovolemia During CRRT.” This study intended to analyze blood
protein concentration variations during CRRT therapy for the prediction of rates of hypovolemia in ICUs. In
May 2013, Hospices Civils de Lyon (France) initiated a clinical trial, “Citrate Versus Heparin
Anticoagulation: Effect on Molecules Clearances (RCA-SHA).” This study aimed to compare middle-
molecular-weight molecules and cytokine clearances in super-high flux continuous venovenous
hemodialysis using regional citrate anticoagulation versus systemic heparin anticoagulation in septic
patients with AKI (Source: ClinicalTrials.gov).
Additionally, in France, the government pays the entire treatment cost of dialysis, which increases the
affordability of treatment, thus driving the growth of the CRRT market in the country. However, the growth
of the CRRT market in France is limited due to variations in reimbursement policies (the reimbursement of
kidney treatment in France is dependent on provider type, location, and treatment mode).
TABLE 42 FRANCE: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,

CAGR
Product 2015 2016 2017-e 2022-p
(2017–2022)
40.5 43.0 45.6 61.9 6.3%
Fluids
Disposables 30.2 32.5 35.0 50.8 7.7%
Systems 13.9 14.6 15.4 19.5 4.9%
Total 84.6
8 4.6 90.2 96.0 132.2 6.6%
47.5% of the CRRT market in France. This segment is projected to reach USD 61.9 million by 2022 from
100
TABLE 43 FRANCE: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,

CAGR
Modality 2015 2016 2017-e 2022-p
(2017–2022)
CVVH 43.0 45.8 48.7 66.6 6.5%
CVVHDF 27.5 29.6 31.8 46.1 7.7%
CVVHD 9.5 10.0 10.5 13.8 5.5%
SCUF 4.7 4.8 5.0 5.8 3.1%
Total 84.6
84.6 90.2 96.0 132.2 6.6%
France. This segment is projected to reach USD 66.6 million by 2022 from USD 48.7 million in 2017, at a
10.2.7 REST OF EUROPE

The RoE comprises Italy, Spain, Belgium, the Netherlands, Nordic countries, Russia, and others, which form
a significantly smaller portion of the European CRRT market. The RoE is estimated to account for 19.5% of
the European CRRT market in 2017 and is expected to grow at a CAGR of 3.9% during the forecast period.
Factors such as the growing demand for CRRT and the rising prevalence of sepsis, diabetes, and
hypertension (the cause of kidney failure) will contribute to the growth of the CRRT market in this region.
Spain’s favorable reimbursement policies are a key factor driving the growth of this regional market.
Spain’s National Health System provides insurance coverage for up to 95% of its population. Additionally,
there is no cost to patients for the treatment of renal diseases in the country (Source: J Nephrol 2011;
24(04): 438-445).
A number of research projects and clinical trials to understand the efficacy of CRRT products are currently
underway in the countries mentioned above. In May 2013, Hospital Universitari de Bellvitge (Spain)
initiated a clinical trial to understand the impact of a continuous dialysis technique associated with
increased adsorption membranes in severe septic patients with AKI. Likewise, in February 2010, University
Hospital, Ghent initiated a research study—The Influence of Fluid Removal Using Continuous Venovenous
Hemofiltration (CVVH) on Intra-abdominal Pressure and Kidney Function. It aims at performing a feasibility
check to use CVVH for fluid removal in patients with IAH, fluid overload, and AKI. It also intends to ascertain
whether the use of CVVH for fluid removal will have a beneficial effect on organ dysfunction as compared
to CVVH without fluid removal.
In Eastern Europe, the number of AKI patients is growing at a high rate. This is mainly due to the ongoing
economic recovery in the region, huge patient population base, increasing awareness among healthcare
providers, rising geriatric population, and growing focus of global players on this market. However, despite
impressive recent progress, much remains to be done in such countries in terms of healthcare
infrastructure development and reimbursement provision for the full utilization of CRRT modalities.
Moreover, the shortage of proper healthcare for acute settings, the high procedural cost of CRRT as
compared to IHD, and poor reimbursement systems in some RoE countries such as Poland and Hungary
are restraining the growth of the CRRT market in this region. An acute shortage of adequate dialysis
facilities to address the huge patient base is the main factor restraining the growth of the Russian CRRT
market. There were only two dialysis centers per 1 million people in Russia in 2011, around three times
101
less than the average in Western Europe and nearly eight times less than the average in the U.S. (Source:
The Government of Ulyanovsk).
TABLE 44 ROE: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET SIZE, BY PRODUCT,

CAGR
Product 2015 2016 2017-e 2022-p
(2017–2022)
36.8 38.2 39.7 48.0 3.9%
Fluids
Disposables 25.6 26.8 27.9 34.8 4.5%
Systems 12.2 12.5 12.8 14.6 2.6%
Total 74.6
74.6 77.5 80.4 97.3 3.9%
the RoE CRRT market in 2017. This segment is projected to reach USD 48.0 million by 2022 from USD
39.7 million in 2017, at a CAGR of 3.9% during the forecast period.
TABLE 45 ROE: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET SIZE, BY MODALITY,
CAGR
Modality 2015 2016 2017-e 2022-p
(2017–2022)
CVVH 38.6 39.9 41.3 48.9 3.4%
CVVHDF 23.6 24.8 26.1 33.8 5.3%
CVVHD 8.4 8.7 9.0 10.5 3.1%
SCUF 4.0 4.0 4.1 4.2 0.7%
Total 74.6 77.5 80.4 97.3 3.9%
The CVVH segment is estimated to account for the largest share of 51.4% of the RoE CRRT market in
102
10.3 NORTH AMERICA

North America, comprising the U.S. and Canada, is estimated to account for a significant share of the
global CRRT market in 2017. This is mainly due to the increasing number of AKI patients in the region,
growing aging population, increasing focus of global players on the North American CRRT market, and the
use of CRRT as a preferred option in hemodynamically unstable patients.
AKI prevalence in North America increased from ~0.2% to ~2.4% from 1999 to 2011. However, the
number of AKI patients undergoing dialysis in the region decreased from ~6.1% to 1.8% during the same
time period (Source: United State Renal Data System, USRDS). Additionally, it is estimated that there are
over 200,000 cases of acute kidney failure in the U.S. each year (Source: NxStage Annual Report, 2013).
Thus, the growing number of AKI cases, coupled with the increasing use of CRRT (due to decreasing use of
other dialysis modalities) for AKI treatment is fueling the growth of the North American CRRT market.
Sepsis is the primary cause for AKI in North America. It is estimated that more than 1,000,000 cases of
sepsis are registered among hospitalized patients each year in the U.S. (Source: Expert Rev Anti Infect
Ther., author manuscript). According to the National Surviving Sepsis Campaign, sepsis causes 210,000
fatalities every year in this region.
North America is also notable for its rapid adoption of technologically advanced products. This has
stimulated the influx and introduction of new instruments in the North American CRRT market, as key
manufacturers focus on capitalizing on the opportunities offered by this high demand. In addition, a
number of training programs have been carried out by both private and public bodies in the region. For
example, in September 2015, the Wisconsin Nurses Association organized a CRRT course at the University
of Wisconsin Hospital and Clinics to prepare ICU nurses and clinicians to take care of patients receiving
CRRT. Additionally, in June 2014, Gambro organized a training course (CRRT Review and Refresh) in Los
Angeles (U.S.) to discuss basic CRRT principles, describe evidence-based practice, support research, and
explain the safety management features of CRRT machines to medical personnel. Such programs help
create awareness about CRRT instruments and technologies in the region.
10.3.1 HIGH PREFERENCE F OR OTHER DIALYSIS MODALITIES

Compared to Europe, Australia, and Japan, the use of CRRT for the treatment of AKI patients is very low in
North America. This is mainly because nephrologists in North America are more inclined to use other
dialysis modalities (such as IHD and SLEDD) as compared to CRRT. This is due to the high procedural cost
of CRRT as compared to SLEDD and IHD, lack of clinical trial evidence in favor of the safety and efficacy of
CRRT, and the stringent regulatory policies in the region.
The high cost of CRRT, as compared to IHD and SLEDD, hinders its adoption in North American ICUs. For
instance, the average daily cost for SLEDD is ~USD 240, as compared to ~USD 440 for CRRT. Additionally,
the cost of CRRT can range between ~USD 2,676/week and ~USD 3,924/week (CAD 3,486/week and
CAD 5,117/week), whereas the cost of IRRT is estimated to be ~USD 1,029/week (CAD 1,342/week)
(Source: Srisawat et al. Critical Care 2010, 14:R46).
In North America, CRRT is usually prescribed by nephrologists as opposed to intensivists in other countries
such as Germany, Australia, and Japan where CRRT is prescribed by intensivists in ~85% of AKI cases as
compared to 25% in the U.S. (Source: Blood Purif 2016;42:224-237).
10.3.2 REGULATORY POLICIES, A KEY HINDRANCE TO MARKET GROWTH

Stringent and time-consuming regulatory policies for the approval of new products form a key hindrance to
the growth of the CRRT market. The current multilayered regulations of the U.S. FDA have led to delays in
the launch of products that have already been approved outside North America. Additionally, no CRRT
machines have been approved for the treatment of multiple indications, which is not the case in Europe.
Moreover, the FDA has not approved any anticoagulating agent, unlike Europe. This is negatively affecting
the use of various CRRT products in North America.
103
FIGURE 36 NORTH AMERICA: CRRT MARKET SNAPSHOT
NORTH AMERICA
NORTH AMERICA: CRRT MARKET, BY PRODUCT,
2017 (USD MILLION)
North America is expected This regional segment is 153.3

to account for 29.3% of the expected to grow at a
global CRRT market in CAGR of 6.7%
116.2
2017 (2017–2022) 51.0

Replacement
The U.S. accounts for the largest share of ~91.0% of the Fluids
North American CRRT market
NORTH AMERICA: CRRT MARKET, BY PRODUCT,
2022 (USD MILLION)
210.4
NORTH AMERICA: CRRT MARKET, BY COUNTRY,
2017 (USD MILLION)
168.9
63.9
COUNTRY MARKET SIZE

U.S. 291.6 Replacement
Fluids
Canada 28.8
NORTH AMERICA: CRRT MARKET,

BY MODALITY, 2017 (USD MILLION)
FACTORS SUPPORTING THE GROWTH OF THE CRRT
MARKET IN NORTH AMERICA
CVVH CVVHDF
Growing incidence of AKI
164.9 99.8
Increasing focus of global players on the North
American market
Development and commercialization of technologically CVVHD SCUF
advanced CRRT products
Rising aging population coupled with kidney disorders 39.3 16.4
104
TABLE 46 NORTH AMERICA: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY COUNTRY,

CAGR
Country 2015 2016 2017-e 2022-p
(2017–2022)
U.S. 257.5 274.0 291.6 402.1 6.6%
Canada 25.1 26.9 28.8 41.2 7.4%
Total 282.6
282.6 300.9 320.5 443.3 6.7%
The U.S. is estimated to account for the largest share of 91.0% of the North American CRRT market in
CAGR of 6.6% from 2017 to 2022.
TABLE 47 NORTH AMERICA: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,

CAGR
Product 2015 2016 2017-e 2022-p
(2017–2022)
135.6 144.2 153.3 210.4 6.5%
Fluids
Disposables 100.3 108.0 116.2 168.9 7.8%
Systems 46.6 48.8 51.0 63.9 4.6%
Total 282.6 300.9 320.5 443.3 6.7%
the North American CRRT market in 2017. This segment is projected to reach USD 210.4 million by 2022
TABLE 48 NORTH AMERICA: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,

CAGR
Modality 2015 2016 2017-e 2022-p
(2017–2022)
CVVH 145.8 155.1 164.9 226.5 6.6%
CVVHDF 86.1 92.7 99.8 145.7 7.9%
CVVHD 35.2 37.2 39.3 52.3 5.9%
SCUF 15.5 16.0 16.4 18.8 2.7%
Total 282.6 300.9 320.5 443.3 6.7%
105
The CVVH segment is estimated to account for the largest share of 51.5% of the North American market in
10.3.3 U.S.
The U.S. is estimated to account for the largest share (~91.0%) of the North American CRRT market in
2017. Market growth in the U.S. is primarily driven by the growing prevalence of AKI and rising aging
population in the country.
The National Institutes of Health (NIH) spent approximately USD 430 million on research on kidney
disorders, including AKI, in FY 2015 (Source: United States Government). In September 2013, the National
Institute of Diabetes and Digestive and Kidney Diseases renewed a grant shared by the University of
California and the University of Alabama at the Birmingham School of Medicine (U.S.) to expand its
research into AKI. Favorable government support for AKI treatment and research is expected to support the
growth of this market in the coming years.
A new payment structure announced by the U.S. CMS is also expected to help drive the use of CRRT. It
provides reimbursement on a per-treatment basis irrespective of the modality or place of treatment used
by AKI patients. Given that ESRD facilities were authorized to treat AKI patients (as of January 2017), this
is expected to increase access to AKI treatments for patients—including CRRT.
10.3.3.1 Growth in AKI prevalence

It is estimated that the number of people aged 65 years and above in the U.S. will increase by ~63%, from
~44.4 million in 2013 to 72.8 million by 2030 (Source: U.S. Census Bureau and Population Reference
Bureau, Vol. 66, No. 1). In 2013, the incidence of AKI among Medicare patients in the 66–69 age group
was 14.9 per 1,000 patients in the U.S. This increased to 18.8, 26.4, 35.9, and 49.6, respectively, for ages
70–74, 75–79, 80–84, and 85 and older (Source: USRDS).
According to an editorial published in JAMA (Journal of the American Medical Association) in June 2012,
the incidence rate of AKI was 2.1 per 1,000 population in the U.S. It is estimated that over 200,000 cases
of AKI are reported in the U.S. each year (Source: NxStage Annual Report, 2013). The Kidney Health
Initiative (KHI) also reported that the AKI patient population has doubled in the last decade in the U.S.
Further increases in the prevalence of AKI, coupled with the growth of the U.S. geriatric population, will
boost the use of CRRT and thereby help market growth.
10.3.3.2 New product development to boost the demand for CRRT products
Continuous technological advancements in CRRT products by domestic market players and the high
adoption of new technologies in the U.S. market are other factors stimulating the growth of the CRRT
market. For instance, in January 2015, Baxter obtained FDA approval for its Phoxillum solution for
electrolyte management during CRRT. Hypophosphatemia is a common electrolyte disturbance that occurs
in patients undergoing CRRT and Phoxillum is the only FDA-approved pre-mixed solution comprising
phosphate. Phoxillum is designed to facilitate electrolyte management during CRRT by allowing the use of
a single type of solution across a wide clinical spectrum of AKI patients. Similarly, in April 2013, the FDA
cleared NxStage’s System One machine that eliminates the need for effluent collection.
106
10.3.3.3 Ongoing clinical trials to prove the safety and efficacy of CRRT
products
The positive outcomes of a large number of ongoing research projects and clinical trials to establish the
safety and efficacy profile of CRRT will drive the adoption of CRRT products in the U.S. These ongoing
projects are focusing on a broad range of kidney-relevant topics, ranging from pharmacokinetics in patients
receiving CRRT to vascular access and lupus nephritis.
Collaborative approaches for research on the advancements in treatment therapies for AKI patients will
also contribute to the growth of CRRT demand. For instance, in September 2012, the American Society of
Nephrology (ASN) and the U.S. FDA established a public-private partnership called the Kidney Health
Initiative (KHI) to ensure high-quality care and patient safety as well as promote innovation in the
treatment of kidney diseases. Currently, KHI is running five projects through a collaborative partnership
with the kidney community (including the FDA, research institutes, pharma and biotech companies
(including dialysis organizations), and organizations of healthcare professionals and patients) (Source:
American Society of Nephrology).
Recent clinical studies initiated in the U.S. include:
Safety and TDM of Continuous Infusion Vancomycin through Continuous Renal Replacement
Therapy Solution was initiated in January 2017 to evaluate the safety of delivering continuous
infusion vancomycin in pediatric patients during CRRT.
Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal
Replacement Therapy (CRRT) was initiated in September 2016 by Baxter Healthcare
Corporation (U.S.). This study aimed to determine the efficacy of new investigational CRRT
solutions, namely Prismocitrate 18, in terms of lengthening the extracorporeal circuit life in AKI
patients receiving CRRT.
10.3.3.4 Shortage of registered nurses in ICU settings

The U.S. is currently facing a shortage of registered ICU nurses. According to the Bureau of Labor Statistics,
1.2 million new vacancies of government-certified nurses are expected to arise by 2022. This shortage will
more than double in the U.S. by 2025. Since CRRT requires extensive nursing care, this shortage of trained
ICU nurses in the U.S. is expected to limit market growth in the country.
Other factors limiting the growth of the U.S. market include reductions in healthcare spending, the
stringent regulatory scenario, time-consuming approval process, and the high procedural costs of CRRT in
the U.S. as compared to SLEDD and IHD.
TABLE 49 U.S.: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,

CAGR
Product 2015 2016 2017-e 2022-p
(2017–2022)
123.3 131.0 139.2 190.4 6.5%
Fluids
Disposables 91.5 98.4 105.8 153.4 7.7%
Systems 42.7 44.6 46.6 58.3 4.6%
Total 257.5
2 57.5 274.0 291.6 402.1 6.6%
107
47.7% of the CRRT market in the U.S. This segment is projected to reach USD 190.4 million by 2022 from
TABLE 50 U.S.: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,

CAGR
Modality 2015 2016 2017-e 2022-p
(2017–2022)
CVVH 132.5 140.8 149.6 204.6 6.5%
CVVHDF 78.6 84.7 91.1 132.7 7.8%
CVVHD 32.3 34.1 36.0 47.7 5.8%
SCUF 14.0 14.5 14.9 17.0 2.7%
Total 257.5
257.5 274.0 291.6 402.1 6.6%
the U.S. This segment is projected to reach USD 204.6 million by 2022 from USD 149.6 million in 2017, at
a CAGR of 6.5% during the forecast period.
10.3.4 CANADA
Canada is estimated to account for 9.0% of the North American CRRT market in 2017. This market will be
driven by the growing number of AKI and ESRD cases and high utilization rate of CRRT products. CRRT is
also cheaper in Canada than in the U.S. because the average nursing cost in Canada is less (~USD
15/hour). The payment for a particular CRRT procedure is made by the government depending on the type
of treatment, irrespective of duration. The low cost of treatment in Canada is a key factor driving the growth
of the country’s CRRT market.
Also, some organizations in Canada are actively raising awareness on AKI and its treatment among both
patients and doctors. The Kidney Foundation of Canada, for example, provides training and research
programs for AKI researchers through its KRESCENT program.
However, the fragmented nature of the Canadian market and the long sales cycles to hospitals make it
difficult for manufacturers to set up distribution networks for CRRT products. The distribution of medical
equipment in Canada is dominated by large distributors and international countries with strong sales
forces and marketing budgets. Due to this, a majority of Canadian manufacturers focus on exports to the
U.S.; products are mainly distributed through large and wholesale retail organizations in the country.
108
10.3.4.1 Rising AKI prevalence

The incidence of AKI and ESRD is increasing in Canada. This is partly because of the aging population and
increasing prevalence of diabetes, cardiovascular disease, and chronic kidney disease. The use of drugs
toxic to the kidneys (including nonsteroidal anti-inflammatories) and contrast media in diagnostic imaging
procedures is also contributing to the increasing incidence of AKI in the country. The growing number of
AKI and ESRD patients in Canada is thus fueling the growth of the CRRT market.
The incidence of AKI in Canada is ~1.8 to 5.2 per 1,000 populations, which is very close to the incidence of
myocardial infarction in the country (The Kidney Foundation of Canada). Critically ill ESRD patients who
cannot tolerate traditional dialysis due to their hemodynamic instability opt for CRRT. In 2011, there were
~40,385 individuals living with ESRD in Canada, which was more than triple the number recorded in 1992
(Source: Canadian Institute for Health Information). Additionally, a study conducted by Health Canada at
five Canadian hospitals (including 603 patients) during a 30-day period found that 26.7% of ICU patients
developed AKI. This indicates that an increase in admissions to the ICU would also help the CRRT market
grow. More than 100,000 patients are cared for in Canadian ICUs each year, according to the Canadian
Intensive Care Foundation.
Ongoing research related to ascertaining the safety and efficacy profile of CRRT as compared to other
dialysis techniques in Canada is currently underway. The completion of these clinical studies with positive
results will further contribute to the adoption of CRRT products in Canada. In March 2012, the University of
Alberta (Canada) initiated a clinical trial study on “Intra-Operative Continuous Renal Replacement Therapy
in Liver Transplantation: A Phase II Randomized Controlled Trial (INCEPTION).” This study aimed to
compare the use of CRRT during surgery with standard supportive care in patients with liver failure waiting
for liver transplantation.
10.3.4.2 High cost of CRRT as compared to IHD

The current approach to the management of ARF in critically ill patients in Canada is inconsistent and
depends on the following factors—availability of equipment; costs; physician specialties, expertise,
preference, or management philosophy; indication for renal replacement (fluid removal versus solute
clearance); availability of trained nursing staff; and beliefs about the benefits of each therapy.
The lack of a consistent, evidence-informed approach to the treatment of acute renal failure is problematic
because of the high cost of providing critical care. The provision of care to critically ill patients consumes a
disproportionate amount of healthcare resources. In the absence of evidence demonstrating the clinical
superiority of one modality compared with another, the choice between IHD and CRRT should be made on
the basis of cost-effectiveness rather than provider preference, convenience, or perceptions about the
benefits of each therapy.
The average cost (per hospitalization) of IHD and CRRT is ~USD 2,103 and ~USD 5,757, respectively, in
Canada. Given current CRRT usage rates of 26% to 68%, selectively funding IHD when either technology is
appropriate would save USD 2.1 million to USD 6.1 million in annual acute care costs across Canada.
Additionally, the benefit from CRRT is yet to be proven, in comparison to IHD. Therefore, the high costs of
CRRT as compared to IHD are negatively impacting the growth of the market.
109
TABLE 51 CANADA: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,

CAGR
Product 2015 2016 2017-e 2022-p
(2017–2022)
12.3 13.2 14.1 20.0 7.2%
Fluids
Disposables 8.8 9.5 10.3 15.5 8.5%
Systems 4.0 4.2 4.4 5.7 5.2%
Total 25.1
25.1 26.9 28.8 41.2 7.4%
The dialysates and replacement fluids segment is estimated to account for a share of 48.9% of the
Canadian CRRT market in 2017. This segment is projected to reach USD 20.0 million by 2022 from USD
TABLE 52 CANADA: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,

CAGR
Modality 2015 2016 2017-e 2022-p
(2017–2022)
CVVH 13.3 14.2 15.3 21.9 7.4%
CVVHDF 7.4 8.0 8.7 13.0 8.4%
CVVHD 2.9 3.1 3.3 4.5 6.5%
SCUF 1.5 1.5 1.6 1.8 3.2%
Total 25.1 26.9 28.8 41.2 7.4%
The CVVH segment is estimated to account for a share of 53.0% of the Canadian CRRT market in 2017.
This segment is projected to reach USD 21.9 million by 2022 from USD 15.3 million in 2017, at a CAGR of
7.4% during the forecast period.
110
10.4 ASIA-PACIFIC
In this report, the Asia-Pacific region is segmented into Japan, China, India, and the Rest of Asia-Pacific
(RoAPAC). This region is estimated to account for 21.6% of the global CRRT market and is expected to grow
at the highest CAGR of 9.4% from 2017 to 2022 to reach USD 371.0 million by 2022. This high growth
rate is mainly due to the rapidly increasing patient population, rising sepsis incidence, increasing
prevalence of hypertension and diabetes (which are the major causes of AKI), high use of CRRT in Australia
and Japan, improving healthcare expenditure on renal diseases, and increasing accessibility to CRRT for
AKI treatment.
The demand for CRRT products is growing in Asian countries at a higher pace due to rising awareness
about advanced medical treatment including CRRT and improving healthcare infrastructures. This has led
to the expansion of existing facilities and establishment of new ones in emerging Asia-Pacific countries.
The emerging nations including China, Brazil, and India will drive 45% of the ESRD patient growth over the
next five years. These nations are estimated to account for 33% of the dialysis population by 2020, which
highlights the need for governments to invest in ensuring accessibility and affordability of CRRT products in
this region.
10.4.1 INCREASING NUMBER OF SEPSIS CASES IN INDIA

Over the last two decades, the number of deaths from sepsis annually has increased in India owing to the
growing number of elderly individuals in the country, rising number of organ transplants and surgical
procedures requiring the suppression of a patient’s immune system, and excessive use of antibiotics in the
treatment of infectious diseases resulting in the development of drug-resistant bacteria. It is claimed that
more than 90,000 individuals are at risk of sepsis every year in India. Patients with severe sepsis have a
mortality rate of ~40% to 60%, with the highest mortality shown in the elderly population. Currently, India
addresses 750,000 sepsis cases every year, with an overall mortality rate of 12.08% and 59.26% in ICU
patients and severe-stage sepsis patients, respectively (Source: Innersense: Newsletter of SRL, November
2014, Voice 161 on SepsiScreen: NextGen Platform for Diagnosis of Sepsis).
High use of CRRT in Australia and Japan

In Australia and other Asian countries, intensivists are responsible for managing patients with CRRT. Thus,
the adoption of CRRT products in these countries is high, which further adds to the growth of the CRRT
market in this region. The high adoption of CRRT in these countries is mainly due to the perceived
advantages of CRRT over IHD such as increased hemodynamic stability, reduced vasopressor requirement
during fluid removal, and continuous control of fluid balance. Japan shows the highest adoption of CRRT
among all Asian countries for the treatment of AKI. In Australia, the rate of switching from CRRT to IHD is
the lowest owing to the high preference for CRRT and the presence of trained ICU nurses.
111
FIGURE 37 ASIA-PACIFIC: CRRT MARKET SNAPSHOT
ASIA-PACIFIC
APAC: CRRT MARKET, BY PRODUCT,
Asia-Pacific is expected The Asia-Pacific CRRT 2017 (USD MILLION)
to account for 21.6% of market is expected to
the global CRRT market grow at a CAGR of 9.4%
in 2017 (2017–2022) 118.6
84.1
33.8
Japan accounts for the largest share

of ~38.0% of the Asia-Pacific CRRT market Replacement Fluids
APAC: CRRT MARKET, BY PRODUCT,

APAC: CRRT MARKET, BY COUNTRY, 2022 (USD MILLION)
2017 (USD MILLION)
COUNTRY/REGION MARKET SIZE 186.2

135.7
Japan 89.9
49.1
China 53.2
India 25.1 Replacement Fluids
RoAPAC 68.3
APAC: CRRT MARKET,

FACTORS SUPPORTING THE GROWTH OF THE BY MODALITY, 2017 (USD MILLION)
CRRT MARKET IN APAC
Rising incidence of AKI and ESRD in Asia-Pacific CVVH CVVHDF

Ongoing clinical trials to establish clinical
125.5 71.2
evidence of the efficacy of CRRT and its superior
therapeutic outcomes
High utilization of CRRT in Australia and Japan CVVHD SCUF
Improving healthcare infrastructure and growing
economies 27.6 12.1
112
10.4.2 STUDIES AND CLINICAL TRIALS TO ESTABLISH THE SAFETY AND

EFFICACY PROFILE OF CRRT
A large number of research studies and clinical trials are conducted in Asia-Pacific countries due to the
lower operational costs, the large population base, limited regulatory barriers, and effective compliance
with regulatory guidelines. Listed below are a few examples of research studies and clinical trials for CRRT:
The Hospital of Guangzhou Medical University (China) is planning to initiate a new clinical
study—“The Timing of Continuous Renal Replacement Therapy Initiation in Sepsis-associated
Acute Kidney Injury in the Intensive Care Unit” in January 2018. This study aims to observe the
impact of CRRT initiation timings on the therapeutic outcomes of the treatment modality.
In July 2012, Ruijin Hospital (China) initiated a clinical research, “Continuous Blood Purification
for the Regulation of Early Inflammatory Response In Severe Acute Pancreatitis” to evaluate the
effects of three treatment protocols (CVVH 6h, CVVHDF 6h, and CVVH 10h) for the first three
days in severe acute pancreatitis (SAP) patients.
In October 2009, a research study titled “Randomized Evaluation of Normal versus Augmented
Level of renal replacement (RENAL)” was published in the New England Journal of Medicine. It
showed significant improvements in the survival rate for AKI patients when treated with CRRT in
ICUs. This study was conducted among 1,508 critically ill AKI patients through a multi-center,
randomized controlled trial across Australia and New Zealand. CRRT was adopted as the initial
therapy for AKI patients in the RENAL study. A lower-intensity group (CRRT dose of 25 mL/kg/hr)
or a higher-intensity group (CRRT dose of 40 mL/kg/hr) was randomly assigned to these
patients. The study showed that there were no significant differences between the lower-
intensity and higher-intensity CRRT groups, with respect to either renal recovery or mortality.
10.4.3 UNFAVORABLE REIMBURSEMENT SCENARIO

Reimbursement for CRRT is the key determinant for its adoption over IHD, due to its higher procedural
cost. However, most Asia-Pacific countries (except Japan and the Pacific countries) do not provide
government reimbursements for this procedure. Universally reimbursed and equitable CRRT programs are
rare in Asia (except Japan). Therefore, dialysis facilities in these countries are largely dependent on private
"for-profit" reimbursement providers. Only a few of the emerging economies have government-funded
reimbursement schemes. A substantial population segment in these countries lives in rural and remote
areas, where even fundamental medical care is scarce. This is a major challenge to the adoption of CRRT
products in this region.
g
TABLE 53 ASIA-PACIFIC: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY COUNTRY,

CAGR
(2017–2022)
Japan 76.8 83.1 89.9 132.6 8.1%
China 42.7 47.7 53.2 91.4 11.4%
India 21.1 23.0 25.1 38.5 8.9%
RoAPAC 56.8 62.3 68.3 108.5 9.7%
Total 197.4
197.4 216.1 236.5 371.0 9.4%
113
Japan is estimated to account for the largest share of 38.0% of the Asia-Pacific CRRT modalities market in
CAGR of 8.1% from 2017 to 2022.
TABLE 54 ASIA-PACIFIC: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,

CAGR
Product 2015 2016 2017-e 2022-p
(2017–2022)
99.0 108.4 118.6 186.2 9.4%
Fluids
Disposables 69.5 76.4 84.1 135.7 10.1%
Systems 29.0 31.3 33.8 49.1 7.8%
Total 197.4
197.4 216.1 236.5 371.0 9.4%
the Asia-Pacific CRRT market in 2017. This segment is projected to reach USD 186.2 million by 2022 from
USD 118.6 million in 2017, at a CAGR of 9.4% during the forecast period
TABLE 55 ASIA-PACIFIC: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,

CAGR
Modality 2015 2016 2017-e 2022-p
(2017–2022)
CVVH 103.7 114.1 125.5 201.2 9.9%
CVVHDF 59.0 64.8 71.2 114.4 9.9%
CVVHD 23.8 25.6 27.6 40.4 7.9%
SCUF 11.0 11.6 12.1 14.9 4.3%
Total 197.4 216.1 236.5 371.0 9.4%
The CVVH segment is estimated to account for the largest share of 53.1% of the Asia-Pacific CRRT market
in 2017. This segment is projected to reach USD 201.2 million by 2022 from USD 125.5 million in 2017,
at a CAGR of 9.9% during the forecast period.
114
10.4.4 JAPAN
The CRRT market in Japan is fully protected and dominated by local CRRT manufacturers, which makes it
difficult for foreign players to enter this market.
Japan is estimated to account for 38.0% of the Asia-Pacific CRRT market in 2017. This is primarily due to
the high preference for CRRT over other renal replacement modalities in the country due to its clinical
benefits in AKI patients and the availability of a 100% reimbursement by the Japanese government to
acute renal patients, irrespective of modality.
In Japan, the incidence of severe sepsis is increasing due to the growing elderly population (over the age of
60) as this age group has the highest risk of developing sepsis. The incidence of severe sepsis or septic
shock in the country is estimated to be around 380,000 cases annually (Source: Press Release of Eisai
Co., Ltd, January 25, 2011). In Japanese PICUs (pediatric intensive care units), the mortality rate was
~19% due to severe sepsis or septic shock (Source: National Pediatric Intensive Care Registry in Japan,
Volume 38, Issue 7/July, 2012). The high incidence of severe sepsis, coupled with the growing aging
population in Japan, will drive the CRRT market in the country.
10.4.4.1 Increasing use of CRRT for non -renal indications

Japan is highly focused on establishing definite evidence for the use of CRRT for purposes other than renal
support. Leading players, in collaboration with hospitals and universities in Japan, are conducting active
research to prove the use of CRRT for purposes other than renal support (non-renal indications for CRRT).
Several research attempts have been made to use different blood purification methods for removing
inflammatory mediators (for instance, cytokines) in severe sepsis patients. These research studies have
helped establish the efficacy for CHDF (continuous hemodiafiltration) by utilizing PMMA membrane
hemofilters, which can adsorb and remove different cytokines, online CHDF, and plasma diafiltration.
Moreover, a cytokine-adsorbing column is currently under clinical evaluation to establish the efficacy of
CRRT for non-renal indications.
In November 2014, Spectral Diagnostics Inc. (Spectral, Canada) announced that the analysis of the largest
Japanese registry data exhibited a remarkable reduction in the mortality rate of septic patients treated with
Toraymyxin (PMX). The outcomes and analysis were presented at the American Society of Nephrology,
which supported Spectral’s EUPHRATES trial design. This study was conducted by the University of Tokyo
(Japan) in support of the Japanese government. This research study evaluated the Japanese Diagnosis
Procedure Combination Database. It compared 1,116 patients with septic shock and treated with both
PMX and CRRT to 1,115 patients with septic shock treated with only CRRT. This showed that the PMX
treatment resulted in a significant reduction of ~25% in the mortality rate of septic patients.
10.4.4.2 Well-established healthcare system

As CRRT procedures are expensive, the well-established reimbursement system for this treatment modality
in Japan eliminates the cost concerns related to CRRT treatment and results in a very low switching rate
among AKI patients. Thus, the well-established medical infrastructure in the country is expected to drive
the demand for CRRT in the next five years.
10.4.4.3 Large number of domestic manufacturers —a barrier to the entry

of major players
The presence of a large number of local market players (such as Nikkiso Co., Ltd.; Toray Medical Co., Ltd.;
and Asahi Kasei Corporation) poses a key challenge to global manufacturers seeking to expand their
presence in Japan. The Japanese CRRT market is very non-conducive for the entry of foreign dialysis
providers. This is due to government policies, legal restrictions, and low market openness. Moreover, the
approval process for CRRT products in Japan is stringent, expensive, and time-consuming. This further
limits the growth of the CRRT market in Japan.
115
TABLE 56 JAPAN: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,

CAGR
Product 2015 2016 2017-e 2022-p
(2017–2022)
38.5 41.8 45.3 67.7 8.4%
Fluids
Disposables 27.0 29.3 31.8 47.6 8.4%
Systems 11.2 12.0 12.8 17.4 6.4%
Total 76.8
76.8 83.1 89.9 132.6 8.1%
50.4% of the CRRT market in Japan. This segment is projected to reach USD 67.7 million by 2022 from
TABLE 57 JAPAN: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,

CAGR
Modality 2015 2016 2017-e 2022-p
(2017–2022)
CVVH 41.0 44.4 47.9 70.7 8.1%
CVVHDF 22.9 25.0 27.4 42.4 9.1%
CVVHD 8.7 9.4 10.0 14.1 7.0%
SCUF 4.2 4.4 4.6 5.5 3.7%
Total 76.8 83.1 89.9 132.6 8.1%
Japan. This segment is projected to reach USD 70.7 million by 2022 from USD 47.9 million in 2017, at a
116
10.4.5 CHINA
China is the biggest user of CRRT products in the Asia-Pacific region, accounting for a share of 22.5% of
the Asia-Pacific CRRT market in 2017. The increasing prevalence of AKI, coupled with the increasing
elderly population, large number of clinical research projects, and rising focus of key players on the market
are key factors driving market growth in China. Improving healthcare infrastructure in China further
supports market growth.
However, the Chinese CRRT market has a significant entry barrier—its cost-intensive and time-consuming
entry processes. The reimbursement scenario for CRRT is not well established in China—reimbursement
rates for RRT vary from 50% to 90% across regions with different socioeconomic statuses. Moreover, AKI
patients in the country opt for IHD instead of CRRT, owing to its lower procedural cost.
10.4.5.1 Rising incidence of AKI and ESRD in China

AKI is relatively widespread in China and is associated with severe morbidity and mortality. The overall
incidence rate of AKI in China is ~11.6%, of which around 40% were drug-related and 16% induced by
Chinese traditional medicines or remedies. On the other hand, the in-hospital mortality of AKI was 8.8%
(source: Clin J Am Soc Nephrol. 2015 Sep 4). Moreover, in China, the number of ESRD patients was
1,300,000 in 2013; this number is estimated to reach 3,000,000 by 2021 (Source: Flexdialysis
presentation, 2013). The growing prevalence of diabetes and hypertension is a key factor contributing to
the high prevalence of AKI in China. For instance, the number of diabetic patients in China was 109 million
in 2015, with a prevalence rate of 10.6 among adults (aged 20 to 79 years) (Source: International
Diabetes Federation, 2016). Similarly, the number of hypertensive patients in China was less than 100
million in 1991, which reached 260 million in 2012 (Source: China Daily, April 2013).
10.4.5.2 Ongoing research studies

Hospitals and universities are conducting a large number of clinical research studies to establish the safety
and efficacy of CRRT in China. In February 2015, Peking University First Hospital (China) initiated a clinical
study “Efficacy and Safety of Heparin-coated Surface-treated Polyacrylonitrile Membrane Hemofilter in
Critical Ill CRRT Patients”. Likewise, in March 2011, Wei Shi, Guangdong General Hospital (China)
conducted a clinical trial to understand the effects of the intensity of CRRT in patients with AKI. In October
2008, Ai Peng (People’s hospital in Shanghai, China) started a research study to evaluate the role of CVVH
in patients with acute paraquat poisoning (PQ).
TABLE 58 CHINA: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,

CAGR
Product 2015 2016 2017-e 2022-p
(2017–2022)
21.3 23.7 26.3 44.6 11.1%
Fluids
CRRT Disposables 15.2 17.1 19.3 34.6 12.4%
CRRT Systems 6.3 6.9 7.6 12.2 9.9%
Total 42.7
42.7 47.7 53.2 91.4 11.4%
In 2017, the dialysates and replacement fluids segment is estimated to account for a share of 49.5% of
the CRRT market in China. This segment is projected to reach USD 44.6 million by 2022 from USD 26.3
117
TABLE 59 CHINA: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,

CAGR
Modality 2015 2016 2017-e 2022-p
(2017–2022)
CVVH 21.5 24.4 27.7 50.2 12.6%
CVVHDF 13.2 14.7 16.2 27.6 11.3%
CVVHD 5.5 6.0 6.6 10.1 9.0%
SCUF 2.4 2.6 2.7 3.5 5.2%
Total 42.7
42.7 47.7 53.2 91.4 11.4%
In 2017, the CVVH segment is estimated to account for a share of 51.2% of the CRRT market in China. This
segment is projected to reach USD 50.2 million by 2022 from USD 27.7 million in 2017, at a CAGR of
12.6% during the forecast period.
10.4.6 INDIA
India is expected to account for 10.6% of the Asia-Pacific CRRT market in 2017, owing to its large patient
population, increasing number of AKI cases, rising elderly population, growing number of patients admitted
to ICUs, and increasing number of dialysis centers in the country.
10.4.6.1 Rising sepsis cases in India

Sepsis is the major cause of AKI in India. A number of risk factors (such as the need for immune system
suppression in organ transplants and surgical procedures and overuse of antibiotics in the treatment of
infectious diseases, which leads to the development of drug-resistant bacteria) are responsible for the
increased number of sepsis-related deaths. In India, patients with severe sepsis have a death rate of
around 40%–60%, with the elderly age group (above 60 years) showing the highest death rate. The country
addresses 750,000 sepsis cases every year, with an overall death rate of ~12% and ~59% in ICU patients
and severe-stage sepsis patients, respectively (Source: Innersense: Newsletter of SRL, November 2014,
Voice 161 on SepsiScreen: NextGen Platform for Diagnosis of Sepsis). Likewise, in a research study, a total
of 92 (60 male and 32 female) patients underwent 525 hemodialysis sessions. The average age of these
patients was 56.5±16 years. This study found that the cause of AKI was sepsis in 64 cases (Source:
Research Article Published on “Outcomes and Characteristics of Intermittent Hemodialysis for AKI in ICU”
in Indian Journal of Nephrology: 2013- Volume: 23, Issue: 1, Page: 30-33). Thus, the high incidence of
sepsis is expected to drive market growth.
118
10.4.6.2 Increase in the number of dialysis patients

According to the Indian Society of Nephrology, the number of people undergoing dialysis at hospitals is
increasing by almost 30% annually. It is estimated that India will have the maximum number of dialysis
patients in the coming 25 years. This rapid increase in the number of dialysis patients is due to the
increasing prevalence of diabetes and hypertension (major causes for ESRD) in the country. Moreover, the
incidence of AKI in India is 17.3 cases per 100 individuals every year (Indian Journal of Nephrology, Vol.
24, No. 5, September-October, 2014, pp. 280-285). Thus, the rising prevalence of ESRD/AKI cases in India
will drive the growth of the CRRT market in the country.
10.4.6.3 Rising number of patients admitted to ICUs

The number of patients admitted to ICUs for the treatment of critical conditions is also growing in India. An
estimated 14.3 million patients are admitted to ICUs in India each year (source: LIFE). As AKI occurs in
5.7%–24% of ICU patients, the rising number of ICU patients will further aid the growth of the market.
10.4.6.4 Unfavorable reimbursement scenario

The reimbursement scenario in India is not well established for the full reimbursement and insurance
coverage of CRRT. A significant percentage of patients in the country are not covered by insurance or any
other reimbursement modality. This is a key challenge to market growth.
10.4.6.5 Lack of randomized trials and dearth of technical expertise

In India, a paucity of randomized trials comparing the outcomes of modified techniques of HD and CRRT
has led to a lack of clinical evidence in favor of CRRT over IHD. Additionally, lack of funds and technical
expertise required to operate CRRT machines and the labor-intensive and expensive nature of this modality
form major limitations to utilizing CRRT.
10.4.6.6 Dearth of indigenous manufacturers for CRRT products in India

Currently, the Indian CRRT market is dominated by foreign players and is mostly import-based. This is
because there are few local manufacturers in India with the ability to make sophisticated CRRT equipment.
Local manufacturers often make medical equipment like catheters, blood tubing sets, and needles.
However, these companies are yet to expand their product lines into CRRT machines. It will likely take
years for locally produced equipment to reach the performance and quality standards of imported medical
devices, due to the lack of technologically advanced manufacturing facilities.
119
TABLE 60 INDIA: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,

CAGR
Product 2015 2016 2017-e 2022-p
(2017–2022)
10.8 11.7 12.8 19.8 9.1%
Fluids
Disposables 7.4 8.1 8.8 13.8 9.3%
Systems 3.0 3.2 3.4 4.9 7.3%
Total 21.1
21.1 23.0 25.1 38.5 8.9%
In 2017, the dialysates and replacement fluids segment is estimated to account for a share of 51.1% of
the CRRT market in India. This segment is projected to reach USD 19.8 million by 2022 from USD 12.8
TABLE 61 INDIA: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,

CAGR
Modality 2015 2016 2017-e 2022-p
(2017–2022)
CVVH 11.2 12.3 13.4 21.0 9.4%
CVVHDF 6.0 6.5 7.2 11.3 9.5%
CVVHD 2.8 3.0 3.2 4.6 7.5%
SCUF 1.2 1.3 1.3 1.6 4.1%
Total 21.1 23.0 25.1 38.5 8.9%
India. This segment is projected to reach USD 21.0 million by 2022 from USD 13.4 million in 2017, at a
120
10.4.7 REST OF ASIA-PACIFIC

This section comprises Australia, Taiwan, and South Korea, which form a significantly smaller portion of the
Asia-Pacific CRRT market. The high prevalence of AKI and ESRD is a major market driver in this region. In
Australia, the incident rate for treated ESRD is projected to increase from 11 per 100,000 people in 2009
to 19 per 100,000 people in 2020, owing to increasing diabetes prevalence and the aging population
(Source: A Model for Home Dialysis, Australia – 2012).
In the last decade, the prevalence of sepsis has increased by 8% to 13% in Australia. The elderly show
higher susceptibility to sepsis. In Australia, around 17,000 cases of sepsis are reported each year, and
~50% of sepsis patients are aged 65 years or above. As the high incidence of sepsis in elderly patients
results in AKI, this will drive the growth of the CRRT market.
The increasing focus of leading players on expanding their CRRT business in Australia due to the high
utilization of CRRT products in the country is driving the growth of the CRRT market. Australia accounts for
the highest utilization of CRRT products primarily due to the perceived advantages of CRRT over IHD in
treating critical illnesses, such as increased hemodynamic stability and decreased vasopressor
requirement during fluid removal. Additionally, in Australia, the rate of switching from CRRT to IHD is the
lowest due to the high preference for CRRT by nephrologists and intensivists.
However, poor and inequitable health insurance rebates for renal dialysis provided by Australian insurance
providers is hampering the development of private dialysis services in Australia. Additionally, a dearth of
trained ICU nurses poses a key challenge to the growth of the CRRT market in Australia—the country
currently faces a shortage of ~600 critical care nurses (Source: The Australian Health Ministers Advisory
Council).
The large number of clinical trials undertaken by hospitals in this region (mainly in South Korea, due to the
low costs of conducting clinical trials in the region) for the development of safety and efficacy profiles of
CRRT products also aids in market growth. Yonsei University (South Korea) completed a clinical trial study,
‘The Predictors for Continuous Renal Replacement Therapy in Liver Transplant Patients’ in February 2013.
This study was focused on identifying perioperative factors that would identify patients at risk of AKI after
liver transplantation (Source: ClinicalTrials.gov). Likewise, in August 2015, Seoul National University
Hospital (Korea) completed a clinical study aimed at understanding the effects of high-volume CRRT in
patients with septic AKI.
The growth of the Korean market can be attributed to the availability of government reimbursements—90%
of the total cost of dialysis is reimbursed, irrespective of modality. Players are also focusing on the growth
opportunities in the region. Singapore also accounts for a significant share of the RoAPAC CRRT market.
This is due to the large number of ongoing research activities and the growing number of AKI patients.
Moreover, initiatives taken by the National Kidney Foundation to encourage adoption of CRRT for the
treatment of AKI are also contributing to the growth of the CRRT market in Singapore.
However, the high cost of CRRT treatment, poor reimbursement scenario across the region, and a dearth of
accessibility towards CRRT in most underdeveloped countries due to poor healthcare infrastructure are the
key factors hindering the growth of the CRRT market in these countries.
121
10.4.7.1 Taiwan, a lucrative market for CRRT players

Taiwan is a major CRRT market in this section, mainly because of the high incidence and prevalence of AKI
and sepsis in this country. The incidence of severe sepsis is 69 per 1,000 surgical ICU admissions (Source:
An article published by Wolters Kluwer Health, Inc., U.S.). The rising incidence of diabetes is also
responsible for the higher incidence rate of AKI and sepsis in the country. In 2013, more than 70,000
people underwent dialysis in Taiwan, of which 45% had diabetes.
The growing focus of global players on the CRRT market in Taiwan is also propelling market growth.
Moreover, National Health Insurance (NHI) provides coverage for all expenses related to dialysis and
transplants. However, factors such as the high cost of CRRT and increasing medical expenses are the key
hindrances to the growth of the CRRT market in Taiwan.
TABLE 62 ROAPAC: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,

CAGR
Product 2015 2016 2017-e 2022-p
(2017–2022)
28.4 31.2 34.2 54.1 9.6%
Fluids
Disposables 19.9 21.9 24.2 39.8 10.4%
Systems 8.5 9.2 10.0 14.7 8.1%
Total 56.8
56.8 62.3 68.3 108.5 9.7%
the RoAPAC CRRT market in 2017. This segment is projected to reach USD 54.1 million by 2022 from USD
TABLE 63 ROAPAC: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,

CAGR
Modality 2015 2016 2017-e 2022-p
(2017–2022)
CVVH 30.0 33.1 36.5 59.4 10.2%
CVVHDF 16.9 18.6 20.4 33.1 10.1%
CVVHD 6.7 7.3 7.9 11.7 8.2%
SCUF 3.2 3.3 3.5 4.4 4.4%
Total 56.8 62.3 68.3 108.5 9.7%
The CVVH segment is estimated to account for the largest share of 53.4% of the RoAPAC CRRT market in
122
10.5 REST OF THE WORLD (ROW)

The RoW market includes Latin America (Brazil, Chile, Mexico, and Colombia) and the Middle East (Saudi
Arabia, the UAE, Lebanon, and Kuwait). While significantly smaller than other markets, this is the second-
fastest-growing segment of the CRRT market.
10.5.1 LATIN AMERICA AND THE MIDDLE EAST

Latin America is estimated to account for the largest share of the RoW CRRT market in 2017. The rising
incidence of AKI, coupled with the growing elderly population in several countries in this region, is one of
the major factors driving market growth. In Brazil, Noronha et al. reported an incidence of 7.9 AKI cases
per 1,000 hospital admissions annually (Source: CJASN May 2008 vol. 3 no. 3 881-886). Also, the
increasing incidence of diabetes and hypertension, which are root causes of kidney failure, also supports
the growth of the CRRT market in this region. However, the reuse of bloodline sets and dialyzers, high cost
of treatment, shortage of indigenous/domestic manufacturers, and variations in reimbursement policies
are restraining the growth of the CRRT market in Latin America.
The reimbursement scenario for CRRT products varies from country to country in Latin America and the
Middle East, which is another major factor restraining the growth of the CRRT market in these regions. In
Latin America, reimbursements for RRT vary extensively. Only a few countries offer universal coverage
based on a public (Brazil, Chile, and Uruguay) or private healthcare system (Argentina). Some still have
major restrictions in terms of offering access to RRT (Bolivia, Ecuador, and Peru). Most countries offer a
mixed system for dialysis reimbursement, with different shares attributed to private and public systems. In
Argentina, access to RRT is universal, and all patients have a healthcare provider. A majority of the patients
are covered by PAMI (Argentina's state-funded medical care system); less than 5% are in the public system
(source: Perit Dial Int February 2009 vol. 29 no. Supplement 2 S222-S226). In Brazil, CRRT is paid in a fee-
for-service structure. About 90% of RRT patients are universally covered by the public health system in
Brazil. However, in the UAE and other countries in the Middle East, only a few renal patients are
reimbursed by private insurance companies. This is due to the low healthcare expenditure and poor
socioeconomic status in these countries.
To leverage growth opportunities in this region, leading players are continuously focused on driving growth
through both organic and inorganic growth strategies. For instance, Baxter is highly focused on expanding
its CRRT business in Latin America and Asia-Pacific. This can be illustrated with its recent acquisition of
Gambro AB (Sweden) in December 2012. Through this acquisition, the company intends to expand
Gambro’s reach to the high-growth regions of Latin America.
Manufacturers are also conducting clinical trials in collaboration with universities and hospitals in this
region. In March 2012, the Royal Alexandra Hospital (Saudi Arabia) sponsored a clinical research study (in
collaboration with the University of Alberta and Gambro Renal Products, Inc.) to understand whether NAC
and continuous venovenous hemodiafiltration can be used early for the treatment of rhabdomyolysis to
reduce the chance of developing acute kidney failure.
However, the preference for IHD is greater in Latin America due to the high cost of CRRT, lack of awareness
regarding the benefits of CRRT over IHD, and the dearth of trained healthcare providers in this region. This
is expected to limit market growth to a certain extent.
123
FIGURE 38 ROW: CRRT MARKET SNAPSHOT
FULL PAGE INFOGRAPHIC

REST OF THE WORLD
RoW is expected to The RoW CRRT market RoW: CRRT MARKET, BY PRODUCT,
account for 11.4% of the is expected to grow at 2017 (USD MILLION)
global CRRT market in a CAGR of 8.0%
63.0
2017 (2017–2022) 43.0
17.9
The CRRT market in RoW is expected to reach Dialysates and Disposables Systems
USD 182.0 million by 2022 Replacement Fluids
RoW: CRRT MARKET, BY PRODUCT,

2022 (USD MILLION)
ROW : CRRT MARKET, BY MODALITY
91.8
66.0
MARKET SIZE (USD CAGR
MODALITY 24.2
MILLION) (2017) (2017–2022)
CVVH 66.5 8.1% Dialysates and Disposables Systems

Replacement Fluids
CVVHDF 37.2 8.9%
CVVHD 14.1 7.0%

RoW: CRRT MARKET,
SCUF 6.2 3.6% BY MODALITY, 2017 (USD MILLION)
FACTORS SUPPORTING THE GROWTH OF

THE CRRT MARKET IN ROW CVVH CVVHDF
66.5 37.2
Growing AKI patient population
Improving regulatory system in Latin American
countries CVVHD SCUF
Growing awareness about CRRT among the
healthcare providers 14.1 6.2
124
10.5.2 NEW AMENDMENTS OPEN BRAZILIAN HEALTHCARE INDUSTRY TO

FOREIGN INVESTMENT
In January 2015, the Brazilian government passed a new legislation to remove restrictions on the direct
and indirect involvement of foreign capital in private hospitals and clinics across the country. This strategic
move was aimed to improve its national healthcare system. This decreases the entry barriers for foreign
players in the Brazilian market. With this law, foreign dialysis companies who are already well positioned in
the market are also allowed to invest directly and even fully acquire control in their investments. As a
result, international service providers are increasingly focusing on entering the Brazilian kidney care
market.
However, owing to a lack of defined standards, awareness, and high cost, technicians in Brazil reuse
bloodline sets about ten times, which is limiting the growth of this market. Furthermore, the high cost of
CRRT and stringent regulatory policies are also hindering the growth of the CRRT market in Brazil.
TABLE 64 ROW: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT,

CAGR
Product 2015 2016 2017-e 2022-p
(2017–2022)
Dialysates & Replacement Fluids 54.4 58.6 63.0 91.8 7.8%
Disposables 36.3 39.5 43.0 66.0 8.9%
Systems 15.8 16.8 17.9 24.2 6.3%
Total 106.6
106.6 115.0 123.9 182.0 8.0%
the RoW CRRT products market in 2017. This segment is projected to reach USD 91.8 million by 2022
TABLE 65 ROW: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY,

CAGR
Modality 2015 2016 2017-e 2022-p
(2017–2022)
CVVH 57.1 61.6 66.5 97.9 8.1%
CVVHDF 31.4 34.2 37.2 57.0 8.9%
SCUF 12.3 13.2 14.1 19.7 7.0%
CVVHD 5.8 6.0 6.2 7.5 3.6%
Total 106.6 115.0 123.9 182.0 8.0%
The CVVH segment is estimated to account for the largest share of 53.6% of the RoW CRRT market in
125
11 COMPETITIVE LANDSCAPE
11.1 INTRODUCTION
The competitive landscape provides information on the major players offering CRRT products and outlines
the findings and analysis on how well each vendor performs within our criteria. The vendor evaluations are
based on two broad categories—the strength of their product portfolio and business strategy. Each category
carries various criteria, based on which the vendors have been evaluated. The evaluation criteria
considered under product offering includes the breadth of offering (by the type of products offered by the
company), product development and innovations, coverage of treatment modalities, and training and
support services. The evaluation criteria considered under the business strategy includes the companies
geographic reach (on the basis of market and their geographic presence), financial robustness (on the
basis of revenue generated from CRRT products), branding and marketing strategies, and inorganic growth
(on the basis of partnerships, collaborations, mergers, acquisitions, and expansions).
11.1.1 VISIONARY LEADERS

Vendors who fall into this category receive high scores for most evaluation criteria. They have strong and
established product portfolio and have a very strong market presence. They provide innovative CRRT
products. They also have strong business strategies. The companies fall under this category include
Fresenius Medical Care AG & Co. KGaA (Germany), Baxter International Inc. (U.S.), NIKKISO CO., LTD.
(Japan), B. Braun Melsungen AG (Germany), and Bellco S.r.l. (Italy)
11.1.2 INNOVATORS
The companies that have been considered as Innovators have demonstrated substantial product
innovations as compared to their competitors. They have a focused product portfolio. However, they do not
have very strong business strategies for their overall business. NxStage Medical, Inc. (U.S.), Asahi Kasei
Corporation (Japan), Infomed SA (Switzerland), and Medica S.p.A. (Italy) fall under the Innovators category.
11.1.3 DYNAMIC DIFFERENTIAT ORS

The players considered as Dynamic Differentiators are established vendors with very strong business
strategies. However, they provide limited offerings and are less innovative in this market. They focus on a
specific type of technology related to the product. Toray Medical Co., Ltd. (Japan) and Medtronic plc
(Ireland) are recognized as Dynamic Differentiators in the market.
11.1.4 EMERGING COMPANIES

They are vendors with a niche product offering and are starting to gain their position in the market. They do
not have strong business strategies as compared to other established vendors. They might be new
entrants in the market and require some more time before getting significant traction in the market.
Medical Components, Inc. (U.S.), Medites Pharma spol. s.r.o. (Czech Republic), SWS Hemodialysis Care Co.,
Ltd. (China), Ningbo Tianyi Medical Devices Co., Ltd. (China), CytoSorbents Corporation (U.S.), BIOMEDICA
spol. s r.o. (Czech Republic), Anjue Medical Equipment Co., Ltd. (China), Jiangxi Sanxin Medtec Co., Ltd.
(China), Proxima Medicare (India), Nipro Corporation (Japan), CytoPherx, Inc. (U.S.), Dialysis Solutions Inc.
(U.S.), Kimal Electronics Ltd (U.K.), and BL Lifesciences (India) fall under the Emerging Companies
category.
126
FIGURE 39 COMPETITIVE LEADERSHIP MAPPING
INNOVATORS VISIONARY LEADERS
Baxter International Inc.
Fresenius Medical Care AG

& Co. KGaA
B. Braun Melsungen AG
Asahi Kasei Corporation

Medica S.p.A.
Bellco S.r.l. NIKKISO CO., LTD.
Infomed SA
NxStage Medical, Inc.
SWS Hemodialysis Care Cytosorbents Corporation

Co., Ltd. Toray Medical Co., Ltd.
Anjue Medical Equipment
Co., Ltd.
Medical Components, Inc.
CytoPherx, Inc. Kimal Electronics Ltd
Ningbo Tianyi Medical Medites Pharma spol. Medtronic plc

Devices Co., Ltd
Nipro s.r.o.
Corporation
BIOMEDICA spol. s r.o.
Proxima Medicare
Strength of Product Portfolio
Jiangxi Sanxin Medtec Co.,

BL Lifesciences Ltd.
Dialysis Solutions Inc.
EMERGING COMPANIES DYNAMIC DIFFERENTIATORS

Business Strategy Excellence
Source: Press Releases, Investor Presentations, Expert Interviews, and MarketsandMarkets Analysis
FIGURE 40 GLOBAL CRRT MARKET SHARE, BY KEY PLAYERS (2016)
Baxter International Inc. (U.S.),

17.6%
Fresenius Medical Care AG & Co. KGaA (Germany)
6.8% Nikkiso Co., Ltd (Japan)

46.4%
7.2% B. Braun Melsungen AG (Germany)
NxStage Medical, Inc. (U.S.)

9.2%
12.8% Others
127
11.2 STRENGTH OF PRODUCT PORTFOLIO

STRENGTH OF PRODUCT PORTFOLIO
Product Innovation Coverage of Treatment Training and Support
Companies Breadth of Offerings
and Development Modalities Services
(U.S.)
zzzzz zzzzz zzzzz zzzzz
Fresenius Medical Care

AG & Co. KGaA zzzzz zzzzz zzzzz zzzzz
(Germany)

(U.S.)
NIKKISO CO., LTD.

(Japan)
(Germany)

(Japan)
Bellco S.r.l. (Italy) zzzzz zzzzz zzzzz zzzzz

Toray Medical Co., Ltd.
(Japan)
Infomed SA
(Switzerland)
Medica S.p.A. (Italy) zzzzz zzzzz zzzzz zzzzz

Medical Components,
Inc. (U.S.)
Medites Pharma spol.

s.r.o. (Czech Republic)
Medtronic plc (Ireland) zzzzz zzzzz zzzzz zzzzz

SWS Hemodialysis Care
Co., Ltd. (China)
Ningbo Tianyi Medical

Devices Co., Ltd (China)
CytoSorbents
Corporation (U.S.)

(Czech Republic)
Anjue Medical
Equipment Co., Ltd. zzzzz zzzzz zzzzz zzzzz
(China)
Jiangxi Sanxin Medtec
Co., Ltd. (China)
Proxima Medicare
(India)
Nipro Corporation
(Japan)
CytoPherx, Inc. (U.S.) zzzzz zzzzz zzzzz zzzzz

(U.S.)
Kimal Electronics Ltd

(U.K.)
BL Lifesciences (India) zzzzz zzzzz zzzzz zzzzz
zzzzz zzzzz zzzzz zzzzz zzzzz

= EXCELLENT = VERY GOOD = GOOD = AVERAGE = POOR
128
11.3 BUSINESS STRATEGY EXCELLENCE

BUSINESS STRATEGY EXCELLENCE
Inorganic Growth Branding & Marketing
Companies Geographic Reach Financial Robustness
Strategies Initiatives
(U.S.)
Fresenius Medical Care AG

& Co. KGaA (Germany)
NxStage Medical, Inc. (U.S.) zzzzz zzzzz zzzzz zzzzz

NIKKISO CO., LTD. (Japan) zzzzz zzzzz zzzzz zzzzz
(Germany)

(Japan)
Bellco S.r.l. (Italy) zzzzz zzzzz zzzzz zzzzz

Toray Medical Co., Ltd.
(Japan)
Infomed SA (Italy) zzzzz zzzzz zzzzz zzzzz

Medica S.p.A. (Italy) zzzzz zzzzz zzzzz zzzzz
(U.S.)
Medites Pharma spol. s.r.o.

(Czech Republic)
Medtronic plc (Ireland) zzzzz zzzzz zzzzz zzzzz

SWS Hemodialysis Care
Co., Ltd. (China)
Ningbo Tianyi Medical

Devices Co., Ltd. (China)
CytoSorbents Corporation
(U.S.)

(Czech Republic)
Anjue Medical Equipment

Co., Ltd. (China)
Jiangxi Sanxin Medtec Co.,

Ltd. (China)
Proxima Medicare (India) zzzzz zzzzz zzzzz zzzzz
Nipro Corporation (Japan) zzzzz zzzzz zzzzz zzzzz
CytoPherx, Inc. (U.S.) zzzzz zzzzz zzzzz zzzzz

(U.S.)
Kimal Electronics Ltd (U.K.) zzzzz zzzzz zzzzz zzzzz
BL Lifesciences (India) zzzzz zzzzz zzzzz zzzzz
129
11.4 COMPETITIVE INTENSITY

For competitive intensity mapping, each Tier I company (Baxter International, Inc.; NxStage Medical, Inc.; B.
Braun Melsungen AG; and Fresenius Medical Care AG & Co. KGaA) was evaluated on the following seven
parameters to arrive at the competitive intensity score.
11.4.1 EVALUATION PARAMETERS AND SCORES

Subclassification
Sr. No. Evaluation Parameter Explanation Weightage (Score on a Scale of 2 to 10)
2 - Lowest, 10 - Highest
CRRT >$26 K (2); $24 K–$26 K (4); $22

Machines: K–$24 K (6); $20 K–$22 K (8); <$20
10% K (10)
1
CRRT
>$140 (2); $120–$140 (4); $100–
Includes average selling price (in USD) for Bloodline Sets:
*Pricing $120 (6); $80–$100 (8); <$80 (10)
CRRT products 11%
CRRT
Dialysate >$80 (2); $60–$80 (4); $40–$60
Bags/Cases: (6); $25–$40 (8); <$25 (10)
13%
The number and variety of CRRT products Very Weak (2); Weak (4); Average (6);
2 Product Portfolio 13%
offered is considered Strong (8); Very Strong (10)
Includes the presence of advanced (in terms

Very Weak (2); Weak (4); Average (6);
3 *Product Advancements of safety and efficacy) and user-friendly CRRT 12%
Strong (8); Very Strong (10)
products in a company’s product portfolio
Availability of CRRT products across Very Weak (2); Weak (4); Average (6);
4 Geographic Presence 13%
geographies Strong (8); Very Strong (10)
Strategies used by companies to promote

their products to customers
*Promotional/Marketing Very Low (2); Low (4); Average (6);
5 (nephrologists/intensivists, nurses, renal 9%
Activities High (8); Very High (10)
educators, distributors, wholesalers, and
hospitals)
*M&As, Partnerships,
Includes various organic and inorganic growth
6 Collaborations, Agreements, 10% 1 (2); 2 (4); 3 (6); 4 (8); >=5 (10)
strategies adopted by the companies
and Expansions
Includes research and development

Research and Development Very Weak (2); Weak (4); Average (6);
7 capabilities of the company with regard to 9%
Capabilities Strong (8); Very Strong (10)
CRRT products
Note: K= thousand; $=USD

*The period considered is 2014 to 2017.
130
11.4.2 SCORING METHODOLOGY

FIGURE 41 SCORING METHODOLOGY
Rating of Weightages of all

Weightage (%) of Weighted Score of Competitive Intensity
*Parameter X of a Particular the Parameters
Parameter X Parameter X Score
Company
11.4.3 COMPETITIVE INTENSITY SCORE, BY COMPANY

11.4.3.1 Baxter International Inc.
Weightage* Parameter Rating

Sr. No. Evaluation Parameter Explanation Weightage Parameter Rating
(A)
CRRT Machines:
4 0.4
10%
The cost of the company’s CRRT
CRRT Bloodline Sets:
1 *Pricing products is higher compared to 4 0.44
11%
other companies
CRRT Dialysate
4 0.52
Bags/Cases: 13%
The company’s product portfolio

includes a complete range of CRRT
2 Product Portfolio 13% 10 1.3
products (monitors, disposables,
and dialysate bags)
The company focuses on the

*Product
3 development of advanced and user- 12% 9 1.08
Advancements
friendly CRRT products
Availability of CRRT products across

4 Geographic Presence 14% 10 1.4
geographies
The company focuses on

*Promotional/Marketin
5 promotional/marketing activities 9% 9 0.81
g Activities
related to CRRT and AKI
*M&As, Partnerships, Baxter focuses heavily on M&As,

Collaborations, divestments, and agreements to
6 10% 9 0.9
Agreements, and increase its profitability in the CRRT
Expansions market
Baxter significantly invests in R&D

activities to develop breakthrough
Research and
7 technologies. The company is 8% 8 0.64
Development Activities
expected to launch a new advanced
CRRT machine—Prismax—in 2017
Sum of A = 7.49
131
11.4.3.2 Fresenius Medical Care AG & Co. KGaA

Sr. No. Evaluation Parameters Explanation Weightage Parameter Rating
(A)
CRRT Machines: 10% 8 0.8
The cost of the company’s CRRT CRRT Bloodline Sets:

1 *Pricing machine is lower compared to other 8 0.88
11%
competitors
CRRT Dialysate
8 1.04
Bags/Case: 13%
The company’s CRRT product

2 Product Portfolio portfolio includes a complete range 13% 6 0.78
of CRRT products
The company has taken a strategic

*Product move with regard to advancements
3 12% 6 0.72
Advancements in its CRRT products and new
product launches
Besides North America, the

company has a strong presence in
the CRRT market across all
geographies
The company is more focused on

promotional/marketing activities
*Promotional/
5 related to its dialysis (HD and PD) 9% 6 0.54
Marketing Activities
business and less focused on its
CRRT business
No significant deal was witnessed
Collaborations,
6 by the company with regard to CRRT 10% 5 0.5
Agreements, and
in the past three years
Expansions
Research and The company has strong R&D

7 Development capabilities for the development of 8% 4 0.32
Capabilities novel CRRT products
Sum of A = 6.98
132
11.4.3.3 Nikkiso Co., Ltd.

(A)

1 *Pricing machine is lower as compared to 8 0.88
11%
other competitors
CRRT Dialysate
8 1.04
Bags/Cases: 13%

of CRRT products
The company has not taken any

move with regard to advancements
*Product
3 in its CRRT products. Its CRRT 12% 2 0.24
Advancements
system is more complex to use as
compared to other CRRT systems
The company has a strong

geographic presence in the CRRT
market due to its widespread sales
network
The company is less focused on

*Promotional/
Collaborations,
Agreements, and
Expansions

Sum of A = 5.78
133
11.4.3.4 B. Braun Melsungen AG

(A)

1 *Pricing machine is lower as compared to 6 0.66
11%
other competitors
CRRT Dialysate
6 0.78
Bags/Cases: 13%

of CRRT products
The company has not taken any

move with regard to advancements
*Product
3 in its CRRT products. Its CRRT 12% 7 0.84
Advancements
system is more complex to use as
compared to other CRRT systems
The company has a strong

geographic presence in the CRRT
market due to its widespread sales
network
The company is less focused on

*Promotional/
Collaborations,
Agreements, and
Expansions

Sum of A = 5.40
134
11.4.3.5 NxStage Medical, Inc.

(A)

1 *Pricing products is lower as compared to 6 0.66
11%
those of Baxter
CRRT Dialysate
6 0.78
Bags/Cases: 13%

portfolio includes System One and
2 Product Portfolio 13% 2 0.26
PureFlow SL Dialysate Preparation
Systems
The growing acceptability of

*Product NxStage’s CRRT machine is
3 12% 2 0.24
Advancements primarily due to its advanced and
user-friendly features
The company’s CRRT business is

primarily focused in the U.S.
The company focuses on

*Promotional/ promotional/marketing activities
5 9% 4 0.36
Marketing Activities related to CRRT and AKI through
training programs and campaigns
Collaborations,
Agreements, and
Expansions
Research and NxStage has strong R&D

Sum of A = 4.06
135
11.4.4 COMPETITIVE INTENSITY – MAPPING OF BAXTER INTERNATIONAL

INC., FRESENIUS MEDICAL CA RE AG & CO. KGAA, NIKKISO CO.,
LTD., B. BRAUN MELSUNGEN AG, AND NXSTAGE MEDICAL, INC.
FIGURE 42 COMPARISON OF COMPETITIVE INTENSITY SCORES
8.0
Competitive Intensity Score
7.0
6.0
5.0
4.0
3.0
2.0
1.0
0.0
Baxter International Fresenius Medical Nikkiso Co., Ltd. B. Braun Melsungen NxStage Medical, Inc.
Inc. Care AG & Co. KGaA AG
Source: Company Websites, Annual Reports, Press Releases, and MarketsandMarkets Analysis
FIGURE 43 RELATIVE POSITIONING OF COMPANIES BASED ON COMPETITIVE INTENSITY

SCORE AND CRRT FOCUS
10 8.0
7.5 Baxter
7.0 Fresenius
6.5
6.0
Nikkiso
5.5
B. Braun
Competitive Intensity Score
5.0
4.5
4.0 NxStage
3.5
3.0
2.5
2.0
1.5
1.0
0.5
0.0
0 Low
High
CRRT Focus
Source: Company Websites, Annual Reports, Press Releases, and MarketsandMarkets Analysis
136
CRRT focus takes into account the revenue earned by a company from its CRRT business and the level of
engagement of a company (efforts taken by a company) for the growth of its CRRT business compared to
other business segments.
Key Findings
Baxter’s position in the matrix indicates that it has a high CI score and high CRRT focus. Its high
CI score is driven by the acquisition of Gambro, leading to a broad portfolio of CRRT products,
FDA approvals for these CRRT products, strong geographic presence, and high production
capacity.
The CI score and CRRT focus of B. Braun and Fresenius is a little below average, justified by B.
Braun’s limited and Fresenius’ lack of presence in the North American CRRT market and the
complex features of their products leading to low adoption.
NxStage’s CI score is less than that of Fresenius; however, it has a stronger focus on CRRT. This
can be attributed to the rising acceptability of its CRRT system (System One) and the significant
contribution by its acute care business to the total revenue.
137
12 COMPANY PROFILES
12.1 BAXTER INTERNATIONAL INC.
12.1.1 OVERVIEW
Founded in 1931 and headquartered in Illinois, U.S., Baxter International Inc. is a diversified healthcare
company engaged in the development, manufacturing, and marketing of innovative products that save and
sustain the lives patients with infectious diseases, trauma, hemophilia, immune disorders, kidney
diseases, and cancer. Baxter operates through two segments—Renal and Hospital Products. The Renal
business segment provides products and services for the treatment of end-stage renal disease, irreversible
kidney failure, and acute kidney injuries. The company offers a comprehensive portfolio of dialysis products
including products for peritoneal dialysis (PD), in-center hemodialysis (HD), home HD (HHD), continuous
renal replacement therapy (CRRT), and additional dialysis services.
Baxter manufactures products in over 20 countries and serves patients and clinicians in about 100
countries. The company has a strong presence in North America, with diverse manufacturing facilities in
the U.S. and commercial and compounding pharmacy operations and a manufacturing facility in Canada. It
has manufacturing and research facilities across Europe, the Middle East, and Africa. Additionally, the
company has manufacturing and distribution sites as well as renal care facilities in several countries
throughout Latin America. Baxter also has a significant presence in the emerging markets of Asia-Pacific.
The company operates through major subsidiaries such as Baxter Colorado Holding Inc. (U.S.), Baxter
Export Corporation (U.S.), Baxter Argentina S.A., Baxter Healthcare Pty Ltd. (Australia), Baxter R and D
Europe S.C.R.L. (Belgium), Baxter Healthcare (Shanghai) Company Ltd. (China), Gambro Industries SAS
(France), Baxter Manufacturing S.p.A. (Italy), and Baxter Healthcare Limited (New Zealand).
FIGURE 44 BAXTER INTERNATIONAL INC.: COMPANY SNAPSHOT (2016)

COMPANY AT A GLANCE RECENT FINANCIALS
12.00 6.4% 7.0%

6.0%
5.7%
Annual Revenue (USD Billion)
Founded: 1931 10.00 6.0%
R&D Expenditure (%)

Headquarters: Illinois, U.S. 5.0%
8.00
Employees: ~48,000 (As of December 2016) 4.0%
6.00
Annual Revenue: USD 10.16 Billion 3.0%
4.00
R&D Expenditure: USD 0.65 Billion 2.0%
2.00 1.0%
Ownership: Public 10.72 9.97 10.16
0.00 0.0%
2014 2015 2016
GEOGRAPHIC REVENUE MIX BUSINESS REVENUE MIX
11.6% U.S.
Europe Hospital Products

41.9% 37.9%
20.0%
Asia-Pacifc
62.1%
Renal
Latin America and
26.5% Canada
Financial Period: January to December

Source: Company Website, Annual Reports, and SEC Filings
138
12.1.2 PRODUCTS OFFERED

Category Product
x Acute Therapy Systems
Prismaflex System
Prismaflex eXeed System
Prismaflex eXeed II System
Aquadex FlexFlow
MARS System
x Dialysate and Replacement Solutions
PrismaSol
PrismaSATE
Phoxillum
Prism0cal B22
PrismOcal
x Hemofilter Sets
M60/M100/M150
ST60/ST100/ST150
HF20
HF1000/HF1400
oXiris
septeX
x Plasmafiltration Sets
TPE 1000/TPE 2000 Set
Acute Renal Dialysis x MARS Treatment Kit
Type 1116/1 – XMARS
Type 1115/1 – PrisMARS
Type 1112/1
Type 1412/1
x Hemoperfusion Kits
PrismafleX HP & Adsorba C Cartridges
à PrismafleX Adsorba 150 Kit
à PrismafleX Adsorba 300 Kit
x Fluids
x Accessories
Effluent Bags
Warmers
à Prismacomfort Blood Warmer
à Prismaflo II
à SP 420
Prismatherm II Blood Warmer

x Adapters / extensions
x Catheter
GamCath
GamCath accessories
139
12.1.3 PRODUCT OFFERING SCORECARD

Baxter International Inc. holds a significant position in the CRRT market with a broad range of
product offerings and widespread geographic reach.
The company offers a compressive portfolio of CRRT products including acute therapy systems,
hemofilter sets, dialysate solutions, replacement solutions, and disposable accessories (such
as blood warmer, effluent bags, and catheters).
The company’s market share in the global CRRT market may affect with the divesture of its
legacy CRRT business (which includes renal therapy products—the Aquarius System, Aqualine
and Aquaset tubing sets, Aquamax hemofilters, and Accusol solutions) in January 2014.
Particulars Rating
Breadth of Offerings zzzzz

Product Innovation and Development zzzzz
Coverage of Treatment Modalities zzzzz
Training and Support Services zzzzz
Penetration Rating : zzzzz zzzzz zzzzz zzzzz zzzzz
12.1.4 BUSINESS STRATEGY SCORECARD

Baxter International Inc. has a strong foothold in the global CRRT market.
The company’s key strengths are its significant geographic presence, a broad range of CRRT
product offerings, solid R&D capabilities, and strong sales & distribution networks across major
markets.
The company mainly focuses on organic growth strategy (such as new product development and
launches) to sustain its leading position in the global CRRT market.
The company is focusing on expanding its CRRT products offering through acquisitions. For
instance, Baxter acquired Sweden-based Gambro AB (which offers products for CRRT) in
September 2013.
140
Particulars Rating
Geographic Outreach zzzzz

Inorganic Growth Strategies zzzzz
Financial Robustness zzzzz
Branding & Marketing Initiatives zzzzz
12.1.5 RECENT DEVELOPMENTS (2014-2017)

Approvals
Year Segment Product
Received U.S. FDA approval for its Phoxillum Renal

2015 therapiesAcAcute Renal Products
Replacement Solutions
Source: Press Releases
Agreements
Year Nature of Agreement Company 1 Company 2 Synergy Deal Size
Baxter
Satellite To offer dialysis services
2017 Agreement International Inc. NA
Healthcare (U.S.) (including CRRT)
(U.S.)
Expansions
Year Location
Established new state-of-the-art manufacturing facility in Opelika, Alabama,

2014 U.S.
to address the growing global demand for dialysis products including CRRT
Other Developments
Year Type Description

Baxter’s legacy CRRT business (which includes renal therapy products—the
2014 Divesture Aquarius System, Aqualine and Aquaset tubing sets, Aquamax hemofilters,
and Accusol solutions) was acquired by Nikkiso America, Inc. (U.S.).
141
12.2 FRESENIUS MEDICAL CARE AG & CO. KGAA
12.2.1 OVERVIEW
Founded in 1996 and headquartered in Bad Homburg vor der Höhe, Germany, Fresenius Medical Care AG
& Co. KGaA is one of the largest providers of products and services for patients with renal diseases
worldwide. It offers products and services across the entire value chain from a single source. The company
operates through two business divisions—Health Care and Dialysis Products. The Health Care division
mainly provides dialysis care services (such as ESRD-related treatments, ESRD-related laboratory testing
services, and acute dialysis services) and care coordination services (such as vascular, cardiovascular, and
endovascular specialty services; non-dialysis laboratory testing services; pharmacy; physician practice
services; hospitalist and intensivist; health plan; and urgent care services). The Dialysis Products division
includes major product groups such as hemodialysis machines & peritoneal dialysis cyclers; dialyzers;
peritoneal dialysis solutions; hemodialysis concentrates, solutions, & granulates; bloodlines; renal
pharmaceuticals; acute therapies products (CRRT products); and other equipment & medical devices.
As of December 2016, Fresenius Medical Care has provided dialysis treatment to ~308,471 patients
through its global network of 3,624 dialysis clinics. The company develops and manufactures dialysis
products through 37 production sites on all continents, and markets these products in more than 120
countries. The company operates in more than 50 countries across four major geographies— North
America, Europe, Asia-Pacific, and Latin America. The major subsidiaries of the company include FMC
Deutschland GmbH, Bad Homburg v.d.H. (Germany), FMC France S.A.S., FMC Holdings Inc. (U.S.), FMC
Colombia S.A., FMC Ltda. (Brazil), FMC Australia PTY Ltd., FMC Japan K.K., FMC (Shanghai) Co. Ltd. (China),
and FMC India Private Ltd.
FIGURE 45 FRESENIUS MEDICAL CARE AG & CO. KGAA: COMPANY SNAPSHOT (2016)
20.00 0.9% 1.0%

0.8%
18.00 0.8% 0.9%
Founded: 1996 16.00 0.8%
R&D Expenditure (%)

Headquarters: Bad Homburg, Germany 14.00 0.7%
12.00 0.6%
Employees: 109,319 (As of December 2016) 10.00 0.5%
Annual Revenue: USD 17.91 Billion 8.00 0.4%
6.00 0.3%
R&D Expenditure: USD 0.16 Billion
4.00 0.2%
Ownership: Public 2.00 15.83 16.74 17.91 0.1%
0.00 0.0%
2014 2015 2016

4.0%
North America
9.1%
18.9%
Europe, Middle East, and Health Care
14.9% Africa
Asia-Pacifc
72.0% Dialysis Products
81.1%
Latin America

Source: Company Website and Annual Reports
142

Category Product
x Acute Therapy Systems
Machines multiFiltratePRO
multiFiltrate
x For Ci-Ca Citrate and Heparin Anticoagulation
Ultraflux EMiC2
CRRT and Plasma Filters
Ultraflux AV Filter: AV paed, AV 400S, AV 600S, and AV 1000S
plasmaFlux - P1dry/P2dry
x Solutions for Cleaning the Blood
Bicarbonate-buffered Hemofiltration Solution

Lactate-buffered Hemofiltration Solution
CRRT Fluids
Ci-Ca Dialysate
Ci-Ca Dialysate Plus
multiPlus
x proVencare Single-lumen Catheter Set
x proVencare Double-lumen Catheter Set
Vascular Access x proVencare High-flow Double-lumen Catheter Set

x proVencare Pediatric Double-lumen Catheter Set
x proVencare Triple-lumen Catheter Set

Fresenius Medical Care is one of the leading players in the CRRT products market.
The company offers acute therapy systems, plasma filters, fluids, and vascular access products
for CRRT.
It has a strong R&D team and widespread geographic reach with presence in 120 countries
across the globe.
Although, the stringent regulatory policies in North America could affect the company’s revenue
growth in the CRRT market.
Particulars Rating

143

Fresenius Medical Care is leading player in the global CRRT market with its broad product
portfolio and noteworthy geographic presence across the globe.
The company mainly focuses on agreements and partnership with competitive players to
enlarge its product offerings in the global CRRT market.
For instance, in last three years, the company has established partnership agreements with
CytoSorbents Corporation (U.S.) and Toray Medical Co. Ltd. (Japan) to market and sell their
CRRT products in European countries.
Particulars Rating


Product Launches

Launched multiFiltratePRO, a therapy system for
2015 Acute therapiesAcAcute Therapies
continuous renal replacement therapy (CRRT)
Expansions
Year Location
Opened new research and production site in Schweinfurt for the

2016 Germany
development and production of dialysis equipment
Established a new research and development center—China
2015 China
Design Center, in Shanghai
144
Agreements
Nature of
Year Company 1 Company 2 Synergy Deal Size
Agreement
Extended its partnership
Fresenius Medical CytoSorbents agreement with CytoSorbents
2017 Agreement Care AG & Co. KGaA Corporation Corporation and added an
NA
(Germany) (U.S.) expansive co-marketing
agreement for the distribution
of CytoSorb
For the distribution of CytoSorb
Fresenius Medical CytoSorbents (an extracorporeal cytokine
2016 Agreement Care AG & Co. KGaA Corporation adsorber used in CRRT) in NA
(Germany) (U.S.)
France, Poland, Sweden,
Denmark, Finland, and Norway
To market and sell Toray’s
Fresenius Medical TORAYMYXIN (an acute blood
Toray Medical
2014 Agreement Care AG & Co. KGaA purification device) and PMMA NA
Co. Ltd. (Japan)
(Germany)
hemofilters in eight European
countries
145
12.3 NIKKISO CO., LTD.
12.3.1 OVERVIEW
Established in 1953 and headquartered in Tokyo, Japan, NIKKISO CO., LTD. manufactures and markets
pumps, sampling and chemical feed systems, equipment for electronic components, aerospace composite
products, and medical equipment. The company operates through three business segments, namely,
Industrial, Aerospace, and Medical Divisions. The Medical Business segment manufactures and markets
hemodialysis machines, dialyzers, blood tubing sets, blood glucose controllers, and powder dialysates. The
company offers CRRT products through its subsidiary—Nikkiso Acute Blood Purification which has
operations in Australia, Brazil, China, Columbia, the Czech Republic, Denmark, France, Germany, Ireland,
Italy, Malaysia, Poland, Spain, Switzerland, Thailand, the U.K., and the U.S.
NIKKISO has its presence in Asia, North America, and Europe. In June 2013, the company merged with its
fully owned subsidiaries, Nikkiso Ryuki Techno Co. Ltd. (Japan), Nikkiso Technica Co. Ltd. (Japan), and
Nikkiso Tohoka Medical Co. Ltd. (Japan) to form a single unit—NIKKISO CO., LTD. Some of its major
subsidiaries are Nikkiso Eiko Co. Ltd. (Japan), BEL Japan, Inc., Nikkiso-Therm Co. Ltd. (Japan), Nikkiso
America, Inc., LEWA-Nikkiso America, Inc., Nikkiso Cryo, Inc. (U.S.), Microtrac, Inc. (U.S.), LEWA GmbH
(Germany), Geveke B.V. (Netherland), Nikkiso-KSB GmbH (Germany), NIKKISO Europe GmbH (Germany),
Shanghai Nikkiso Non-Seal Pump Co. Ltd. (China), Nikkiso Pumps Korea Ltd. (South Korea), and Nikkiso
Vietnam, Inc.
FIGURE 46 NIKKISO CO., LTD.: COMPANY SNAPSHOT (2015)
1.40 2.0%
1.6% 1.5%
Established: 1953 1.20

1.4%
R&D Expenditure (%)

1.00 1.5%
Headquarters: Tokyo, Japan
Employees: 6,558 (As of December 2015) 0.80
1.0%
Annual Revenue: USD 0.91 Billion 0.60
R&D Expenditure: USD 0.01 Billion 0.40 0.5%

Ownership: Public 0.20
1.25 1.21 0.91
0.00 0.0%
2013 2014 2015

3.9%
Japan
9.6%
13.6%
Asia Industrial
35.0%
Europe
23.4% 52.6% Medical
37.8%
North America
Aerospace
24.1% Others
Financial Period: April to March

*Note: For the year 2013 and 2014, the consolidated fiscal year was April to March. From the December 2015, the company has
moved its consolidated fiscal year to January to December. Hence, the Annual revenue for the 2015 year demonstrates revenue
earned between March 2015 and December 2015
Source: Annual Reports and Company Website
146
EXCHANGE RATE: (YEN TO USD)
2013 2014 2015
0.0121 0.0100 0.0083
Source: X-Rates 2017.

Category Product
x Aquarius System
x Aqualine Tubing Set
x Aquamax Hemofilters
Acute Blood Purification Products
x Aqualine Sets
x Accusol Solution
x Renaflo II Hemofilter
12.3.3 PRODUCT OFFERINGS SCO RECARD

NIKKISO holds a significant position in the global CRRT products market with a robust product
portfolio and strong geographic presence.
The company offers automated fluid balance systems for CRRT therapies, hemofilters, tubing
sets, and dialysate solutions.
It has a wide distribution network spread across Australia, Brazil, China, Columbia, the Czech
Republic, Denmark, France, Germany, Ireland, Italy, Malaysia, Poland, Spain, Switzerland,
Thailand, the U.K., and the U.S. for CRRT products.
However, the company lacks in developing new advanced and innovative CRRT products which
could negatively affect its growth in the coming years.
Particulars Rating

147
12.3.4 BUSINESS STRATEGY SC ORECARD

NIKKISO is one of the leading providers of CRRT products.
The company’s wide range of CRRT products and strong geographic network are responsible for
its noteworthy share in the global market.
The company focuses on acquisitions to expand its business in high-growth economies. For
instance, in January 2014, the company acquired Baxter’s (U.S.) legacy CRRT business.
Particulars Rating


Acquisitions
Nature of
Agreement
Acquired Baxter’s legacy CRRT
Baxter business (which includes renal
NIKKISO CO., International, therapy products—the Aquarius
2014 Acquisition NA
LTD. Inc. (CRRT
System, Aqualine and Aquaset
Business) (U.S.)
tubing sets, Aquamax hemofilters,
and Accusol solutions).
148
12.4 NXSTAGE MEDICAL, INC.
12.4.1 OVERVIEW
Founded in 1998 and headquartered in Massachusetts, U.S., NxStage Medical, Inc. is a medical device
company engaged in the development, manufacturing, and marketing of innovative products for the
treatment of kidney failure, fluid overloads, and related blood treatments. The company is also involved in
the sales of needles and blood tubing sets used in dialysis systems for the treatment of end-stage renal
disease. NxStage operates through three reporting segments—System One, In-Center, and Services.
System One is the primary product of NxStage Medical, Inc. and is engaged in the sales and rental of
NxStage System One with NxView and PureFlow SL equipment along with the sales of disposable and
critical care products for CRRT.
NxStage Medical has a strong presence in the U.S. and distribution network (through an international
network of affiliates and distribution partners) in more than 21 countries worldwide. The company has its
manufacturing facilities in Mexico, Germany, and Italy. Some major subsidiaries of the company include
EIR Medical, Inc. (U.S.), MediMexico S. de R.L. de C.V. (Mexico), NxStage Medical UK, LTD., NxStage Tech
GmbH (Germany), NxStage Verwaltungs—GmbH (Germany), Medisystems Europe S.p.A (Italy), and
Medisystems Corporation (U.S.).
FIGURE 47 NXSTAGE MEDICAL, INC.: COMPANY SNAPSHOT (2016)
400 8.5% 10.0%

7.8% 9.0%
Annual Revenue (USD Million)
Founded: 1998 350 7.5%

8.0%
R&D Expenditure (%)

300
Headquarters: Massachusetts, U.S. 7.0%
250 6.0%
Employees: ~3,400 (As of December 2016) 200 5.0%
Annual Revenue: USD 366.4 Million 150 4.0%
3.0%
R&D Expenditure: USD 31.0 Million 100
2.0%
Ownership: Public 50 1.0%
301.5 336.1 366.4
0 0.0%
2014 2015 2016
BUSINESS REVENUE MIX*
4.0% 3.2%
System One
16.9%
In-Center
Services
75.9%
Others
*Note: Business revenue mix includes elimination of intersegment revenues

Source: Annual Reports, Company Website, and SEC Filings
149

Category Product
x The NxStage System One S with NxView
x PureFlow B Solution
Acute Renal Care
x Cartridges
x Blood Tubing Sets
12.4.3 PRODUCT OFFERINGS SCO RECARD

NxStage Medical, Inc. is one of the prominent manufacturers of CRRT products.
The company provides blood tubing sets, pre-attached blood tubing sets, tubing connectors,
cartridges, machines, and other disposables for CRRT.
The high adoption of its CRRT products among end user is the key factor responsible for its
significant position in the U.S. market.
The company has a limited product portfolio in the CRRT market which may hinder its growth in
the coming years.
Particulars Rating


NxStage Medical, Inc. is one of the leading players in the U.S. CRRT market.
To gain greater traction in the market, the company focuses on its R&D capabilities. For
instance, the company increased its R&D expenditure from USD 26.2 million in 2015 to USD
31.0 million in 2016.
150
Particulars Rating


Other Developments
Year Approach Description

NxStage Kidney Care, Inc. launched the NxStage Kidney Care RV
2015 Education and Training
Tour to educate patients on kidney treatment modalities
151
12.5 B. BRAUN MELSUNGEN AG
12.5.1 OVERVIEW
Founded in 1839 and headquartered in Melsungen, Germany, B. Braun Melsungen AG is one of the
world’s leading healthcare suppliers. B. Braun manufactures and markets a wide range of healthcare
products and services for anesthesia & emergency care, ICUs, extracorporeal blood treatment, and surgical
core procedures. The company operates through four segments—Hospital Care, Aesculap, Out Patient
Market, and B. Braun Avitum. The company offers CRRT products through its B. Braun Avitum business
segment.
B. Braun has manufacturing facilities in Germany, Brazil, China, France, India, Malaysia, Poland,
Switzerland, Spain, Hungary, the U.S., and Vietnam, among others. The company distributes more than
5,000 products in over 64 countries, through a network of 262 fully consolidated companies and 22
holding companies. Some of its major subsidiaries include AESCULAP AG (Germany), B. Braun Austria Ges.
m.b.H. (Austria), B. Braun Avitum France S.A.S., B. Braun Avitum Italy S.p.A., B. Braun Avitum Poland
Sp.zo.o., B. Braun Avitum UK Ltd., B. Braun Medical A/ S (Norway), B. Braun Medical LLC (Russia), B. Braun
AESCULAP JAPAN CO. LTD., and B. Braun Medical (India) Pvt. Ltd.
FIGURE 48 B. BRAUN MELSUNGEN AG: COMPANY SNAPSHOT (2016)
8.00 6.0%
Founded: 1839 7.00 4.5%

4.2% 4.3% 5.0%
R&D Expenditure (%)

6.00
Headquarters: Melsungen, Germany 4.0%
5.00
Employees: 58,037 (As of December 2016) 4.00 3.0%
Annual Revenue: USD 7.16 Billion 3.00
2.0%
R&D Expenditure: USD 0.29 Billion 2.00
1.0%
Ownership: Public 1.00
7.22 6.80 7.16
0.00 0.0%
2014 2015 2016
6.2% 3.2% 0.4%

Europe (Excluding
Germany)
12.1% Hospital Care
North America
32.0% Aesculap
16.9% Asia-Pacifc 14.6% 46.2%
B.Braun Avitum
Germany
18.0% OPM (Out Patient Market)
Latin America 26.7%
23.7% Other Sales
Africa and Middle East

152
EXCHANGE RATE: (EURO TO USD)
2014 2015 2016
1.329 1.110 1.107
Source: Company Annual Report

Category Product
x Machines
Diapact CRRT
x Hemofilter
Diacap Acute
Haemoselect L 0,5 m2 Plasmafilter
Acute Blood Purification x Bloodline Systems
Diapact CRRT Kits

x Vascular Access
Haemocat Signo
x Solutions
Duosol

B. Braun Melsungen AG offers a wide range of CRRT products including machines, hemofilters,
bloodline systems, vascular access products, and dialysate solutions.
The company’s key strength is its wide geographic network (across Germany, Brazil, China,
France, Malaysia, Poland, Switzerland, Spain, the U.S., and Vietnam).
Although, the stringent regulatory approval process in developed countries is the biggest
challenge for the company, which could affect its growth in the global CRRT market.
Particulars Rating

153

B. Braun Melsungen AG is among the key manufacturers of CRRT products
The company focuses on strengthening its product portfolio by increasing its manufacturing &
R&D capabilities for the development of advanced CRRT products.
For instance, the company introduced its CRRT system—OMNI which provides improved user
interface, diminishes downtime, and optimizes renal dose delivery.
Particulars Rating


Product Launches
2016 Acute Blood Purification OMNI
154
12.6 ASAHI KASEI MEDICAL CO., LTD. (A SUBSIDIARY OF ASAHI KASEI

CORPORATION)
12.6.1 OVERVIEW
Asahi Kasei Corporation is a diversified manufacturer with operations in four business sectors—Chemicals
& Fibers, Homes & Construction Materials, Electronics, and Health Care. The Health Care segment
manufactures and markets pharmaceuticals and medical products. Asahi Kasei Medical Co., Ltd. (Asahi
Kasei Medical) is one of the major subsidiaries operating in the Health Care segment of Asahi Kasei and
offers a wide range of CRRT products.
Founded in 1974 and headquartered in Tokyo, Japan, Asahi Kasei Medical develops, manufactures, and
markets medical devices such as dialyzers (artificial kidneys) and related products, therapeutic apheresis
products, leukocyte reduction filters, and virus removal filters. The company operates through four
business domains—Dialysis, Therapeutic Apheresis, Blood Transfusion, and Bioprocesses.
Some of the major subsidiaries of Asahi Kasei Medical include Asahi Kasei Medical Europe GmbH
(Germany), Asahi Kasei Medical America Inc., Asahi Kasei Medical (Hangzhou) Co., Ltd. (China), Asahi
Kasei Medical Trading (Taiwan) Co., Ltd., Asahi Kasei Medical Trading (Korea) Co., Ltd., N.V. Asahi Kasei
Bioprocess Europe S.A. (Belgium), Asahi Kasei Bioprocess America, Inc., Asahi Kasei Bioprocess Singapore
Pte. Ltd., Asahi Kasei Medical MT Corp. (Japan), and Med-Tech Inc. (Japan).
FIGURE 49 ASAHI KASEI CORPORATION: COMPANY SNAPSHOT (2015)

4.2%
20.00 4.5%
3.7% 3.8%
18.00 4.0%
Founded: 1922 16.00 3.5%
R&D Expenditure (%)

Headquarters: Tokyo, Japan 14.00 3.0%
12.00
Employees: 32,821 (As of March 2016) 2.5%
10.00
2.0%
Revenue: USD 17.23 Billion 8.00
6.00 1.5%
R&D Expenditure: USD 0.72 Billion 1.0%
4.00
Ownership: Public 2.00 18.45 16.53 17.23 0.5%
0.00 0.0%
2013 2014 2015
0.7%
Chemicals and Fibers
9.0%
25.5% Japan
Homes & Construction
14.7% 43.0% Materials
China Health Care
9.5%
65.0% Electronics
Other Regions 32.6%
Others*

*Note: Others include plant engineering & environmental engineering, research & analysis, and employment agency/staffing
operations.
155
EXCHANGE RATE: (YEN TO USD)
2013 2014 2015
0.0097 0.0083 0.0089
Source: Company Annual Report

Category Product
Filters x CUREFLO/Asahi Polysulfone Hemofilter
x Plasauto
Equipment
x Plasauto-CP Pump
12.6.3 PRODUCT OFFERINGS SCORECARD

Asahi Kasei Medical Co., Ltd. offers machines and filters in the CRRT market.
The company focused on strengthening its R&D capabilities by increasing its R&D investment.
For instance, the company increased its R&D expenditure from USD 628.7 million in 2015 to
USD 720.3 million in 2016.
Particulars Rating


Asahi Kasei Medical Co., Ltd. is one of the leading players in the Asia-Pacific CRRT products
market.
The company primarily focuses on the inorganic strategies such as agreements, partnerships,
and collaborations to expand its product offerings in the global market.
For instance, in April 2014, the company signed an agreement with JMS Co., Ltd. (Japan) to
form a business alliance in the field of hemodiafiltration (HDF).
156
Particulars Rating


Agreements
Nature of
Agreement
Asahi Kasei
JMS Co., Ltd. To form a business alliance in the
2014 Agreement Medical Co., Ltd. NA
(Japan)
(Japan) field of hemodiafiltration (HDF)
157
12.7 BELLCO S.R.L. (A PART OF MEDTRONIC PLC)
12.7.1 OVERVIEW
Founded in 1972 and headquartered in Mirandola, Italy, Bellco S.r.l. is involved in the development of
therapies and systems for the treatment of renal failure, multiple organ failure, and congestive heart
failure. The company offers CRRT systems for adult and pediatric AKI patients.
Bellco S.r.l has a direct sales and distribution network in Italy and markets its products in Belgium, Brazil,
China, France, Spain, and Canada. The company has manufacturing sites at Mirandola (Italy) and Tolosa
(France). Bellco do Brasil Ltda, Bellco Canada Inc., and Bellco Hoxen Medical (Shanghai) Co. Ltd (China)
are some of the major subsidiaries of Bellco S.r.l.
Note: Bellco S.r.l. is a privately held company and detailed financial information is not available in the public domain. Hence, financial
details are not added in this section.
12.7.2 PRODUCT OFFERED

Category Productt
x AMPLYA
Equipment x Lynda
x CARPEDIEM
x Abylcath
Catheters
x Abylflow

Bellco S.r.l. is one of the leading providers of pediatric CRRT products.
The company mainly offers CARPEDIEM (a miniaturized Cardio-Renal Pediatric CRRT equipment), AMPLYA
(a CRRT system), and catheters in the CRRT market.
Particulars Rating

158

The company extensively focuses on branding and promotion activities to increase awareness
about its CRRT products and thereby to increase the customer base in the global market.
For instance, in last three year, the company has showcased its CRRT products at various
conferences and symposium across European countries and the U.S.
Particulars Rating


Acquisitions
Nature of
Agreement
Medtronic Medtronic acquired Bellco S.r.l. to

2016 Acquisition Bellco S.r.l (Italy) expand its CRRT product offerings NA
plc (Ireland)
in the global market
Partnerships
Nature of
Agreement
Bellco To increase healthcare access
2015 Partnership Kenyan Government NA
S.R.L (Italy)
for 46 million Kenya citizens
159
Other Developments

Showcased its dialysis portfolio including CRRT products at the SIN 2016-57
2016 Product Showcase
National Congress of the Italian Society of Nephrology (Milan, Italy)
Demonstrated its AMPLYA (CRRT equipment) at the 2016 European Society of
Intensive Care Medicine (Milan, Italy)
Presented AMPLYA and CARPEDIEM (CRRT products) at the IPNA 2016 - 17th
Congress of the International Pediatric Nephrology Association (Brazil)
Demonstrated its CARPEDIEM (a pediatric CRRT system) at the 2016
International Symposium on AKI in Children (U.S.)
2016 Product Showcase Showcased its CRRT product portfolio at EXPOSANITÀ in Bologna (Italy)
Demonstrated CARPEDIEM & AMPLYA (CRRT products) at SMART 2016-27
(Smart Meeting Anesthesia Intensive Care Resuscitation) (Italy)
Product Heart Chievo (Italy) provided Bellco’s CARPEDIEM to the Borgo Roma Hospital’
2016
Deployment (Italy)
Demonstrated its AMPLYA (CRRT system) at the 7th edition of the course,
namely, "Skills and nursing practices for proper CRRT" (Italy)
Demonstrated AMPLYA and CARPEDIEM (CRRT products) at the 36th
International Symposium on Intensive Care and Emergency Medicine (Belgium)
Showcased AMPLYA and CARPEDIEM at the Arab Health 2016 (Dubai, United
Arab Emirates)
Showcased AMPLYA and CARPEDIEM at the SIAARTI 2015-69 National Congress
of the Society of Anesthesia, Analgesia, Resuscitation and Intensive (Italy)
Presented AMPLYA at the 2015 Mediterranean Meeting Anesthesiology
Resuscitation Emergency (Italy)
Demonstrated its CARPEDIEM at the 48th Annual Scientific Meeting of the
European Society of Pediatric Nephrology 2015 (Belgium)
Showcased CARPEDIEM at the 8th International Conference on Pediatric
Continuous Renal Replacement Therapy (pCRRT, U.K.)
Presented AMPLYA and CARPEDIEM at the 33rd Vicenza Course on Critical Care
Nephrology (Italy)
2015 Product Showcase Demonstrated CARPEDIEM at the XXIII National Course Update 2015 (Italy)
Showcased AMPLYA CARPEDIEM at the sixth edition of the course "Skills and
nursing practices for proper CRRT (Italy)
Showcased AMPLYA and CARPEDIEM at the SEN (XLIV Congreso de la Sociedad
Espanola de Nephrology) (Italy)
Demonstrated CARPEDIEM at the International Course "32nd Vicenza HD – PD
(Italy)
Demonstrated CARPEDIEM at the ninth international conference of Moscow
(Russia)
Showcased AMPLYA and CARPEDIEM at the 51st ERA-EDTA Congress Amsterdam
(Netherlands)
Demonstrated CARPEDIEM at the International Symposium on “The
Extracorporeal Treatment Beyond” (Italy)
160
12.8 TORAY MEDICAL CO., LTD.
12.8.1 OVERVIEW
Established in 1980 and headquartered in Tokyo, Japan, Toray Medical Co., Ltd. is the member company
of the Toray Group which develops high-quality pharmaceuticals and medical devices. Toray Medical
provides a wide range of products such as dialyzers, machines, and tubing sets for dialysis procedures and
CRRT.
Toray Group has a wide range of business segments, including Fibers & Textiles, Plastics & Chemicals, IT-
related Products, Carbon Fiber Composite Materials, Environment & Engineering, and Life Science. Toray
Industries, Inc. (Toray) is the core company of the group. The Life Science segment manufactures and
markets advanced medical devices and pharmaceutical products, globally. Toray Group operates its
business in 26 countries across three major regions, namely, Asia, Europe, and the Americas. Some of the
company’s major subsidiaries are Toray International U.K. Ltd., Toray Carbon Fibers Europe S.A. (France),
Toray Industries (China) Co., Ltd., Penfabric Sdn. Berhad (Malaysia), Toray International Singapore Pte. Ltd.,
Toray Fine Chemicals Co., Ltd. (Japan), P.T. Acryl Textile Mills (Indonesia), and Luckytex (Thailand) Public
Co., Ltd.
Toray Medical Co., Ltd. has a strong presence in Japan and significant sales and distribution network
across the Europe, Middle East, Africa, Latin America, Asia, and North America. The company employs
approximately 525 people as of March 2016.
FIGURE 50 TORAY INDUSTRIES, INC.: COMPANY SNAPSHOT (2016)
20.00 3.0% 3.0%

18.00 2.8%
3.0%
Established: 1926 16.00
R&D Expenditure (%)

14.00 2.5%
Headquarters: Tokyo, Japan
12.00 2.0%
No. of Employees: 45,839 (As of March 2016) 10.00
1.5%
Revenue: USD 18.62 Billion 8.00
6.00 1.0%
R&D Expenditure: USD 0.52 Billion
4.00
0.5%
Ownership: Public 2.00 17.84 16.76 18.62
0.00 0.0%
2014 2015 2016
GEOGRAPHIC REVENUE MIX BUSINESS REVENUE MIX*

2.7% 0.7%
Fibers & Textiles
Japan
18.4% 8.7% Plastics & Chemicals
North America, Europe 8.8% IT related Products

47.3% and other areas 42.4%
16.8% 11.9% Carbon Fiber Composite
China Materials
Environment & Engineering
17.5% Others 24.8% Life Science
Others

161

Category Productt
x Toraymyxin (an Extracorporeal hemoperfusion cartridge)
Emergency and Critical Care x Hemofeel SH polysulfone membrane hemofilter

Medicine Business x Hemofeel SX PMMA membrane hemofilter
x Hemofeel SX PMMA membrane hemofilter

Toray Medical Co. Ltd. offers Toraymyxin (an extracorporeal hemoperfusion cartridge) and a
range of hemofilters in the CRRT market.
The company focuses on launching new and innovative products in the market to enhance its
global presence.
For instance, in March 2017, the company launched its third module of Toraymyxin (an
extracorporeal hemoperfusion cartridge used in CRRT) for patients with endotoxemic septic
shock.
Particulars Rating


The company primarily adopts inorganic growth strategies to increase its sales distribution
network across the globe and also to increase its customer base for CRRT products.
In regard with this, in last three years, the company has signed distribution agreements with
Spectral Medical Inc. (Canada) in 2015 and Fresenius Medical Care AG & Co. KGaA (Germany)
in 2014.
162
Particulars Rating


Approvals
Received U.S. FDA 510(k) clearance for third module of Toraymyxin

Emergency and Critical Care
2017 (an extracorporeal hemoperfusion cartridge used in CRRT) for
Medicine Business
patients with endotoxemic septic shock
Agreements
Nature of
Agreement
To distribute Spectral’s rapid test for
Toray the assessment of endotoxin activity
Spectral Medical
2015 Agreement Medical Co. in conjugation with its Toraymyxin (an NA
Inc. (Canada)
Ltd. (Japan)
extracorporeal hemoperfusion
cartridge) in 15 countries across Asia
Fresenius
Toray To market and sell Toraymyxin and
Medical Care AG
2014 Agreement Medical Co. PMMA hemofilters in eight European NA
& Co. KGaA
Ltd. (Japan)
(Germany) countries
163
12.9 INFOMED SA
12.9.1 OVERVIEW
Established in 1997 and headquartered in Geneva, Switzerland, Infomed SA develops, manufactures, and
markets blood purification devices such as CRRT machines, tubing sets, filters, and sorbents that are used
in CRRT as well as plasma therapies. It offers products for fluid overload or renal diseases, blood viscosity
syndromes, and immune disorders.
The company sells and distributes its products in over 300 hospitals across three major regions, namely,
Europe, Asia, and the Middle East.
Note: Infomed SA is a privately held company, and detailed financial information is not available in the public domain. Hence,
financial details are not added in this section.
12.9.2 PRODUCT OFFERED

Category Productt
x HF440
CRRT x CF200: Simple Filtration

x CF100: Cascade Filtration Monitor

Infomed SA offers machines for all the type of CRRT modalities.
The high adoption of its CRRT machines (due multifunction capabilities) is responsible for its
position in the global CRRT market.
The company is highly dependent on the German market and lacks significant presence across
international countries which could limit its growth in the global CRRT market.
Particulars Rating

164

The company mainly focuses on branding and marketing strategies to promote its CRRT
products among healthcare professionals.
For instance, in last few years, the company has participated in various conferences and
symposiums on CRRT across the U.K., Belgium, and France.
Particulars Rating

Note: No significant developments were undertaken by Infomed in the CRRT market during 2014 to 2017.
165
12.10 MEDICA S.P.A.
12.10.1 OVERVIEW
Founded in 1985 and headquartered in Mirandola, Italy; Medica S.p.A. is involved in the development,
manufacturing, and marketing of a range of polysulfone membranes, hemofilters, dialysis filters, dialysis
bloodlines, infusion lines, and water filters for microbiological purification. The company markets these
products to different medical departments such as ICUs, oncology, and cardiology.
Medica S.p.A. has five business divisions, namely, Blood Purification, Water, Fiber Spinning, Menfis
Division, and Technoideal. The Blood Purification division is further divided into five subsegments, namely,
Dialysis, Care for Children, Critical Care, Cardiology, and Bioregenerative Medicine. The acute dialysis
segment provides a wide range of products and offers a range of seven hemofilters for proper CRRT
management in both children and adults. Its products have received CE mark certifications and comply
with standards of ISO 9001 and ISO 13485.
The company’s manufacturing units are located in Italy and Tunisia. Medica distributes its products in
other countries through indirect sales and distribution channels. Some of its subsidiaries include Medica
Méditerranée s.a.r.l (Tunisia), Technoideal s.r.l (Italy), SAR-MED s.r.l (Italy), and Medica France SARL.
Medica S.p.A. is a privately held company, and detailed financial information is not available in the public domain. Hence, financial
details have not been added in this section.

Category Product
CRRT x EQUAsmart CRRT System
CO2 Removal x DECAPsmart
x EQUAsmart Tubing Sets

Tubing Sets
x DECAPsmart Tubing Sets
x MEDISULFONE
Hemofilters
x PUREMA
Plasmafilters x PLASMART

Medica S.p.A. offers a strong range of products for CRRT such as machines, tubing sets,
hemofilters, and other disposables.
The wide adoption of EQUAsmart CRRT System (owing to the multifunction capabilities which
cover all the types of CRRT modalities) is the key strength of the company.
Medica’s revenue generation is highly depended upon the Italian market; which could limit its
growth in global CRRT market.
166
Particulars Rating


The company primarily focuses on the inorganic growth strategies to increase its presence in international
countries outside of Italy.
Particulars Rating

Note: Medica S.p.A. is a privately held company, and its news and developments are not available in the public domain.
167
12.11 MEDICAL COMPONENTS, INC.
12.11.1 OVERVIEW
Founded in 1978 and headquartered in Pennsylvania, U.S., Medical Components, Inc. is involved in the
development, manufacturing, and marketing of vascular access devices and accessories in the field of
interventional medicine and dialysis. It offers a wide range of catheters for dialysis and related treatment
modalities. The company is one of the largest manufacturers of dialysis catheters globally. Currently, the
company has more than 70 product lines in the sphere of healthcare.
Medical Components, Inc. is a privately held company, and detailed financial information is not available in the public domain.
Hence, financial details have not been added in this section.

Category Product
x Duo-Split
x Hemo-Cath ST
x 400XL
x Free Flow ST
x Duo-Flow
x Soft-Line
Short Term Hemodialysis Catheter
x T-3
x Tri-Flow
x Femoral
x Subclavian
x Continuous
x SLX

Medical Components, Inc. offers a wide range of catheter for CRRT
The company is considered to be one of the largest global manufacturers of dialysis catheters
Particulars Rating

Penetration Rating :
168

The company primarily focuses on strengthening its R&D capabilities through development of new
innovative venous catheters for CRRT
Particulars Rating

Medical Components, Inc. is a privately held company, and its news and developments are not available in the public domain.
169
12.12 MEDITES PHARMA SPOL. S.R.O.
12.12.1 OVERVIEW
Founded in 1992 and headquartered in Roznov pod Radhostem, Czech Republic, Medites Pharma spol.
s.r.o. is engaged in the manufacturing of dialysate solution for acute renal failure treatments. The company
offers 30 types of acetate and bicarbonate concentrates for a different type of dialysis treatment
modalities. The company markets its CRRT dialysate fluid solutions under CITRASOL 4%, MEDISOL, and
MEXSOL brand names.
The company’s products meet the requirements of CSN EN ISO 9001:2009, CSN EN ISO 13485:2003
standards and regulatory standards of the European Union.
Note: Medites Pharma spol. s.r.o. is a privately held company and detailed financial information is not available in the public domain.
Hence, financial details have not been added in this section.

Category Productt
x CITRASOL 4%
CRRT x MEDISOL
x MEXSOL

Medites Pharma spol. s.r.o. offers a comprehensive portfolio for dialysate fluid for CRRT
The company is the only Czech manufacturer of hemodialysis concentrates and largest
manufacturer of solutions for CRRT in the country.
Particulars Rating

170

The company primarily focuses maintaining standard manufacturing process and quality; which enables
the company to establish its brand image in terms of quality of its products in global market.
Particulars Rating

Note: Medites Pharma spol. s.r.o. is a privately held company and its news and developments are not available in the public domain.
171
12.13 MEDTRONIC PLC
12.13.1 OVERVIEW
Medtronic plc develops, manufactures, and markets medical devices, therapies, and services for the
treatment of a broad range of medical conditions, including cardiovascular diseases, spinal conditions,
neurological disorders, and diabetes. The company’s business is divided into four segments—Cardiac And
Vascular Group, Minimally Invasive Therapies Group, Restorative Therapies Group, and Diabetes Group.
The Minimally Invasive Therapies Group provides advanced renal patient care by offering dialysis catheters
through Covidien Ltd. (Ireland).
Medtronic Inc. was incorporated as Medtronic plc after its acquisition of Covidien plc (Ireland) in January
2015 at a value of USD 42.9 billion. It operates in 160 countries across the globe. Its key subsidiaries
include Covidien Ltd. (Ireland), Medtronic AG (Switzerland), Medtronic China, Ltd., and Medtronic Ablation
Frontiers LLC (U.S.).
FIGURE 51 MEDTRONIC PLC.: COMPANY SNAPSHOT (2016)
35.00 19.0%
Annual Revenue (USD Billion) 30.00 17.0%
Founded: 1949
15.0%
R&D Expenditure (%)

Headquarters: Dublin, Ireland 25.00
13.0%
No. of Employees: 98,017 (As of April 2016) 20.00 8.7% 11.0%
8.1% 7.7%
15.00 9.0%
Revenue: USD 28.83 Billion
7.0%
R&D Expenditure: USD 2.22 Billion 10.00
5.0%
Ownership: Public 5.00 3.0%
17.01 20.26 28.83
0.00 1.0%
2014 2015 2016

5.2% 6.5%
Americas Cardiac and Vascular Group
10.6%
EMEA (Europe, Middle 25.0% 35.3% Minimally Invasive Therapies
East, and Africa) Group
23.2%
61.0% Asia Pacific Restorative Therapies Group
Greater China 33.2% Diabetes Group

172

Category Productt
CRRT Acute Haemodialysis Catheters

Medtronic plc offers a wide range of catheters for CRRT
A strong geographic presence and robust R&D capabilities are the key strengths of the
company.
Particulars Rating

12.13.4 BUSINESS SCORECARD

The company is mainly focused on inorganic growth strategies (such as acquisitions and
mergers) to expand its footprints in global CRRT market.
For instance, in last three years, the company acquired two companies namely, Bellco S.R.L.
(Italy) and Covidien (Ireland) to expand its CRRT product offerings in the global market.
Particulars Rating

173
12.13.5 RECENT DEVELOPMENTS ( 2014-2017)

Acquisitions
Nature of
Agreement
Medtronic Plc Bellco S.R.L. Acquired Bellco S.R.L. to expand

2016 Acquisition its CRRT product offerings in the NA
(Ireland) (Italy)
global market.
Acquired Covidien, a leading
Medtronic Inc. Covidien plc surgical devices company, to $42.9
2015 Acquisition strengthen its product portfolio of
(U.S.) (Ireland) billion
surgical devices market including
CRRT products.
174
12.14 SWS HEMODIALYSIS CARE CO. LTD.
12.14.1 OVERVIEW
Established in 2001, and headquartered at Chongqing, China; SWS Hemodialysis Care Co., Ltd. is engaged
in the development, manufacturing, and distribution of specialized in blood purification machines. The
company offers hemoperfusion devices, CRRT equipment, and hemodialysis equipment.
SWS Hemodialysis Care Co., Ltd. has a strong presence in China, and it also distributes its products in
international markets across Southern Asia, West Asia, and Latin America. The company has a largest
national blood purification research center in China.
Note: SWS Hemodialysis Care Co., Ltd. is a privately held company, and detailed financial information is not available in the public
domain. Hence, financial details have not been added in this section.

Category Productt
CRRT Equipment SWS-3000A CRRT Equipment

SWS Hemodialysis Care Co., Ltd. offers its SWS-3000A CRRT Equipment which is capable of performing
SCUF and CVVH.
Particulars Rating

175

The company primarily focuses on the development of innovative CRRT products through investing in its
national research center.
Particulars Rating

Note: SWS Hemodialysis Care Co., Ltd. is a privately held company, and its news and developments are not available in the public
domain.
176
12.15 NINGBO TIANYI MEDICAL APPLIANCE CO., LTD.
12.15.1 OVERVIEW
Founded in 1998 and headquartered in Ningbo, China, Ningbo Tianyi Medical Devices Co., Ltd. is involved
in the development, manufacturing, and distribution of medical supplies. It specializes in the
manufacturing of disposable medical polymer appliances. The company offers products under seven
categories, namely, Extracorporeal Blood Treatment Devices; Feeding Devices & Catheters; Puncture
Injection Equipment; Physical Therapy & Rehabilitation Equipment; Medical Polymer Materials & High-
Quality Products; Medical Hygienic & Surgical Dressing Materials; and Ward Nursing Equipment &
Apparatus. The company provides extracorporeal blood circuits for CRRT.
Ningbo Tianyi Medical Devices Co., Ltd. has a strong presence in China with more than 1,000 dealers in
the country. The company also distributes products in other overseas markets.
Note: Ningbo Tianyi Medical Devices Co., Ltd. is a privately held company, and detailed financial information is not available in the
public domain. Hence, financial details are not added in this section.

Category Productt
CRRT Extracorporeal Blood Circuit

Ningbo Tianyi Medical Devices Co., Ltd. offers extracorporeal blood circuit for CRRT
Particulars Rating

177

The company mainly focuses on branding and marketing strategies to increase awareness about its CRRT
products.
Particulars Rating


Other Developments

Showcased extracorporeal blood circuit for CRRT at the Kidney
Week (Chicago, U.S.)
Source: Press release
178
13 APPENDIX
13.1 INSIGHTS OF INDUSTRY EXPERTS
“The global CRRT market was valued at ~USD 1,000 million in 2016, and is projected
to grow at a CAGR of ~7% to 8% in the next five years. This growth is primarily due to
the increasing number of AKI cases, growing number of ICU patients, and rising
adoption of CRRT for the treatment of renal patients.”
“Europe accounted for the largest share of ~35% to 40% of the overall CRRT market
in 2016. This is mainly due to the approval of CRRT systems for multiple applications
and the treatment of AKI patients under the guidance of intensivists who generally
prefer CRRT.”
“The CRRT market scenario is very different in Japan as compared to that of the U.S.
and Germany. The market in Japan is fully protected and highly dominated by
domestic CRRT manufacturers. This restricts the entry of international players in the
market in Japan.”
“There is no market for CRRT products in South Africa due to treatment lags for AKI
patients stemming from a lack of accessibility and affordability of CRRT products.”
179
13.2 DISCUSSION GUIDE
Q. 1. Provide your views on the growth prospects of the global CRRT market. What is the current scenario and what
growth trajectory is expected in the future?
Your Viewpoint: ________________________________________________________________
Q. 2. Provide the global and regional size of the CRRT market in 2016 as well as their expected CAGRs over the next five
years.
CAGR%
Region Market Size (USD Million)/Market Share (%), 2016
(2017–2022)
Global
North America
Europe
Asia-Pacific
Rest of the World (RoW 1)
Total
RoW comprises of Latin America, the Middle East, and Africa.
Your Viewpoint: _________________________________________________________________
Q. 3. Provide market shares as well as projected growth rates of the following product segments in the global CRRT
market. What are the key factors that will drive the fastest-growing segments of the market in the next five years?
(Kindly validate the market segmentation and let me know if I am missing anything or if there is any
overlapping between these segments.)
CAGR
Product Market Share (%), 2016
(2017–2022)
Systems
Disposables
Dialysates and Replacement Fluids

Total
Your Viewpoint: _________________________________________________________________
180
Q. 4. Provide market shares as well as projected growth rates of the following subsegments of the CRRT disposables
market. What are the key factors that will drive the fastest-growing segments of the market in the next five years?
(Kindly validate the market segmentation and let me know if I am missing anything or if there is any
overlapping between these segments.)
CAGR
Type Market Share (%), 2016
(2017–2022)
Bloodline Sets
Hemofilters
Other Disposables
Total
Your Viewpoint: _________________________________________________________________
Q. 5. Provide market shares as well as projected growth rates of the following modality segments in the global CRRT
market.
(Kindly validate the market segmentation and let me know if I have missed any segment, or whether there
is any overlapping between these segments.)
CAGR
Modality Market Share (%), 2016
(2017–2022)
SCUF
CVVH
CVVHD
CVVHDF
Total
Your Viewpoint: _________________________________________________________________
Q. 6. Provide market shares of the following key players in the global CRRT market. Also, validate the key players and let
us know if we are missing any major players.
Company Name Market Share (%), 2016

Baxter International, Inc.
Fresenius Medical Care AG & Co. KGaA
Bellco S.r.l.
Infomed SA
Medica S.p.A
Nikkiso Co., Ltd.
Toray Medical Company Limited
Others
Your Viewpoint: _________________________________________________________________
181
Q. 7. Kindly validate the drivers, restraints, opportunities, and challenges for the global CRRT market. Please suggest if
there are any other factors that are affecting (positively or negatively) the market.
Parameter Factor
Increasing global incidence of AKI

Growing number of ICU patients
Clinical advantages of CRRT over intermittent blood purification techniques
Drivers Technological advancements and new product launches
Growing prevalence of diabetes and hypertension

Any other
High procedural cost of CRRT
Complications associated with CRRT

Restraints
Stringent regulatory guidelines for CRRT in North America
Any other
Emerging markets
Increasing applications of CRRT
Ongoing research to establish the safety and efficacy profile of CRRT
Opportunities
Development of a CRRT system for pediatric patients
Untapped market growth opportunities in North America
Any other
High complexity of therapy
Shortage of trained ICU nurses in developed countries
Challenges Poor reimbursement scenario in developing countries
Lack of awareness about the benefits of CRRT

Any other
Your Viewpoint: _________________________________________________________________
Q. 8. What are the upcoming technologies/product areas that will have a significant impact on this market in the
future?
Your Viewpoint: _________________________________________________________________
Q. 9. What will be the revenue pockets for this market in the next five years?
Your Viewpoint: _________________________________________________________________
Q. 10. How do you see your company’s position in this market in the next five years?
Your Viewpoint: _________________________________________________________________
182
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to all of the published titles and any new ones added over the course of the subscription period. You can
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MarketsandMarkets Knowledge Store Snapshot
183
MarketsandMarkets Knowledge Store: Healthcare Industry Snapshot
184
13.4 INTRODUCING RT: REAL-TIME MARKET INTELLIGENCE

Revenue Tree (RT) is an interactive platform that systematically helps users enhance their revenues by
identifying high-potential growth markets and tracking the same on a real-time basis, at a competitive,
customer-centric, and ecosystem level.
The in-built intelligence of the tool auto-identifies competitors, allied markets, market values, and
customers, and helps users identify the tangible hotspots of revenue growth, both in existing and new
markets. The unique feature of the RT is the Ecosystem, which is linked across a wide range of industries
and markets.
Features and Benefits of RT:

Visual presentation of market data
Real-time information on market trends and developments
Information specific to an application, type, or region
Competitive intelligence (by tracking developments of major players)
Forward integration in value chain to find potential clients
Comparison of two or more markets
185
13.5 AVAILABLE CUSTOMIZATIONS

With the given market data, MarketsandMarkets offers customizations as per the company’s specific
needs. The following customization options are available for the report:
Product Analysis
Product matrix, which gives a detailed comparison of the product portfolios of each company
Geographic Analysis
Further breakdown of the Rest of Asia-Pacific CRRT market into South Korea, Australia, New
Zealand, and others
Further breakdown of the Latin American CRRT market into Brazil, Argentina, and the Rest of
Latin America
Company Information
Detailed analysis and profiling of additional market players (up to 5)
186
13.6 RELATED REPORTS

Sr. No Report Title Published Date
Hemodialysis and Peritoneal Dialysis Market

By Products (Machines, Dialyzer, AV Fistula, AV Graft, Bloodlines, Catheters, Transfer
Sets, CAPD, APD) & Services, Modality (Conventional, Nocturnal), End User (In-center,
1 February 2017
Hospital, Home) - Global Forecast to 2021
http://www.marketsandmarkets.com/Market-Reports/dialysis-market-1279.html
Apheresis Market
By Product (Plasma & Component Separator, Hemoperfusion, Disposable), Procedure
(Therapeutic, Photopheresis, Donor), Application (Plasmapheresis, Plateletpheresis),
2 February 2017
Technology (Centrifuge, Membrane Separation) - Global Forecast to 2021
http://www.marketsandmarkets.com/Market-Reports/apheresis-market-950.html
187
13.7 AUTHOR DETAILS
Rajiv Kalia Over 10 years of experience in market research and consulting in Pharmaceuticals
Associate Director
/Biotechnology, Medical Devices and Healthcare IT.
Healthcare Extensive experience in market estimations, primary & secondary research techniques,
strategic & competitive assessment of companies, Investment opportunity analysis &
product opportunity evaluation. He endeavors to constantly track and analyze
healthcare market developments and research areas for the team.
Prior to joining Markets and Markets, he has worked with WNS Global Services and
Smartanalyst India Private Limited in similar areas.
Rajiv holds a Master’s degree in Pharmaceuticals with a major in Pharmacology from
Manipal University and also has a post graduate diploma in Financial Management.
Dr. Anita Joshi Dr. Anita Joshi is a biotechnologist with 10 years of Research & Academics experience
Senior Consultant
from National Institute of Virology, Pune and Pune University, followed by 16+ years’
experience in assignments for reputed organizations primarily in the Pharma-
Healthcare
Healthcare Industry. The assignments handled by her were primarily in the areas of
Marketing, QA-QC and R&D. She has worked with companies including Thermo Fisher
Scientific, Merck Millipore, Lonza India, Span Diagnostics Ltd, Advanced Enzyme
Technologies, AC Nielsen, and others prior to joining Markets and Markets. She has
also undertaken various projects for Govt. Institutions such as NIV, ARI and Haffkine
Institute, Mumbai.
Asmita Ranbhise Asmita has over five years of experience in market research and consulting in
Associate Manager
Healthcare industry.
Healthcare She has extensively worked on building market estimation and forecasting models for
commercialized and pipeline products in pharma and medical device industry in
several consulting and market research projects. She has worked on assignments
dealing with market assessment, epidemiology assessment, pricing & reimbursement
analysis, pipeline analysis, competitive intelligence, business analytic frameworks for
multiple geographies, and recommendations for market entry. In addition, for pharma
projects she has also worked on analogue and attribute analysis, patient based and
sales based forecasting, demand and capacity planning, and perceptual mapping.
She is Gold medalist in MBA (Biotechnology, Marketing) from University of Pune, India
and is college topper throughout her academic career.
Shailendra Gaikwad Shailendra has 3 years of experience in market research and consulting in Healthcare
Senior Research Analyst
industry.
Healthcare He has extensively worked on building market estimation and forecasting models for
commercialized and pipeline products in pharma and medical device industry in
several consulting and market research projects. He has worked on assignments
dealing with market assessment, epidemiology assessment, pricing & reimbursement
analysis, pipeline analysis, competitive intelligence, business analytic frameworks for
multiple geographies, and recommendations for market entry.
188
Shailendra holds a Master’s degree in Biotechnology, Marketing from Department of

Management Sciences (PUMBA), Savitribai Phule Pune University, India.
Gayatri Baregoda Gayatri has over 2 years of experience in market research and consulting space in
Research Analyst
healthcare domain. She holds B. Pharma degree from Gujarat Technological University
along with PGDM in Pharmaceutical Management from MITCON Institute of
Healthcare
Management (Pune).
Has worked on several consulting and syndicated market research reports. She has
worked on various Medical Devices & Healthcare IT markets (Spinal Implants and
Spinal Devices, Smoke Evacuation Systems, eClinical Solutions, Breast Imaging
Technologies, Hemodialysis and Peritoneal Dialysis, and Orthopedic Braces and
Supports).
189
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acknowledge, when ordering, that MarketsandMarkets’ strategic analysis services are for their internal use
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based on interviews, and is therefore subject to fluctuations.
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CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) MARKET - FORECAST TO 2022

Copyright © 2017 MarketsandMarkets

2 RESEARCH METHODOLOGY ...................................................................................... 20

3 EXECUTIVE SUMMARY .............................................................................................. 33

4 PREMIUM INSIGHTS ................................................................................................ 36

5.2.1.4 Technological advancements and new product launches .................................... 43

6 INDUSTRY INSIGHTS ................................................................................................ 51

6.4 PORTER’S FIVE FORCES ANALYSIS ................................................................................................60

7 ADOPTION OF CONTINUOUS RENAL REPLACEMENT THERAPY, BY REGION ................. 65

8 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY PRODUCT ...................... 69

9 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY ..................... 80

10 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY REGION ......................... 92

10.2.5 U.K. ............................................................................................................................... 98

11 COMPETITIVE LANDSCAPE ..................................................................................... 126

12 COMPANY PROFILES .............................................................................................. 138

12.4 NXSTAGE MEDICAL, INC. ............................................................................................................149

12.11 MEDICAL COMPONENTS, INC. ....................................................................................................168

13 APPENDIX .............................................................................................................. 179

TABLE 26 CONTINUOUS RENAL REPLACEMENT THERAPY MARKET FOR CVVHD, BY REGION,

TABLE 52 CANADA: CONTINUOUS RENAL REPLACEMENT THERAPY MARKET,

FIGURE 1 GLOBAL CONTINUOUS RENAL REPLACEMENT THERAPY MARKET: RESEARCH

FIGURE 33 GLOBAL CONTINUOUS RENAL REPLACEMENT THERAPY MARKET, BY MODALITY

ABBREVIATION FULL FORM

AAKP The American Association of Kidney Patients

AKIN Acute Kidney Injury Network

ARF Acute Kidney Failure

ASP Average Selling Price

BGMP Brazil Good Manufacturing Practice

CSN Canadian Society of Nephrology

FOA Funding Opportunity Announcement

IRRT Intermittent Renal Replacement Therapy

ISN International Society of Nephrology

MOH Ministry of Health

ABBREVIATION FULL FORM

MOST Multi-Organ Support Therapy

PICUs Pediatric Intensive Care Units

PMA Premarket Approval

PMDL Pharmaceutical and Medical Device Law

RCA Regional Citrate Anticoagulation

RCCSA Indian Society of Nephrology, Renal Care Society of South Africa

RoW Rest of the World

SMEs Subject-Matter Experts

TKDC The Kidney Dialysis Centre

U.K. United Kingdom

USRDS The United States Renal Data System

1.1 OBJECTIVES OF THE STUDY

1.2 MARKET DEFINITION

1.3 MARKET SCOPE

1.3.1 MARKETS COVERED

1.3.2 GEOGRAPHIC SCOPE

REST OF THE WORLD

1.3.3 YEARS CONSIDERED FOR THE STUDY

HISTORICAL YEAR BASE YEAR ESTIMATED YEAR PROJECTED YEAR

Some companies in the CRRT market are privately held;

A limited positive response was received from primaries in

2.1 RESEARCH APPROACH

FIGURE 1 GLOBAL CONTINUOUS RENAL REPLACEMENT THERAPY MARKET: RESEARCH

Classification of the overall CRRT market

CRRT products market segmentation Market

The global market size for 2017 Global CRRT market

Dialysates and replacement fluids,