(GlobalData) Renal Dialysis Equipment, (May, 2016) (1)

REFERENCE CODE GDME0227MAR | PUBLICATION DATE MAY 2016
RENAL DIALYSIS EQUIPMENT –

GLOBAL ANALYSIS AND MARKET FORECASTS
Executive Summary
Key Metrics in Major Markets Market Dynamics
The table below highlights the key metrics of the With the growth of the elderly population and
global renal dialysis equipment market. patients with diabetes and hypertension, the
prevalence of kidney disease is increasing rapidly,
Renal Dialysis Equipment and Hemodialysis
Products, Key Metrics in the 10MM which leads the rising demand for renal dialysis
(2015) Global Market Value: Renal Dialysis
$14.44bn
equipment. Hemodialysis products dominate over
Equipment
70% of the renal dialysis equipment market, due to
(2015) Global Market Value: Hemodialysis
$10.52bn
Products high familiarity with the hemodialysis procedure
(2015) US Market Value: Renal Dialysis
Equipment
$4.18bn among healthcare providers, the large number of
(2015) 5EU Market Value: Renal Dialysis hemodialysis centers, and favorable
$2.76bn
Equipment
reimbursement. However, because of the
(2015) Asia-Pacific Market Value: Renal Dialysis
$7.13bn
Equipment convenience of home-based procedures,
(2015) Brazil Market Value: Renal Dialysis technological innovation, and the relatively low
$364.50m
Equipment
Forecast cost, peritoneal dialysis has consistently gained
(2022) Global Market Value: Renal Dialysis acceptance. As a result, the peritoneal dialysis
$18.34bn
Equipment
products market is growing robustly. In addition,
(2022) Global Market Value: Hemodialysis
$11.98bn
Products with the rising adoption of continuous renal
(2022) US Market Value: Renal Dialysis replacement therapy (CRRT), the market for CRRT
$5.13bn
Equipment
(2022) 5EU Market Value: Renal Dialysis machines expands rapidly. Furthermore, home
$3.17bn
Equipment
dialysis gives patients control over the frequency,
(2022) Asia-Pacific Market Value: Renal Dialysis
$9.43bn place, and timing of conducting dialysis. The
Equipment
(2022) Brazil Market Value: Renal Dialysis
$603.20m home-based dialysis equipment market urgently
Equipment
Source: GlobalData, primary research interviews with industry
needs more effective and portable devices that
representatives, leading nephrologists, and other demand-side
stakeholders in the 10MM (US, France, Germany, Italy, Spain, UK, feature less water consumption, use-friendly
Japan, Brazil, China, and India)
5EU = France, Germany, Italy, Spain, and the UK; Asia-Pacific =
interfaces, and advanced information technology.
Japan, China, and India
The US is the largest market owing to a large
number of dialysis patients, easy access to
numerous dialysis centers, and availability of
reimbursement. The hemodialysis products market
in the 5EU and Japan is mature, but the growing
demand for home-based care and increasing
awareness of peritoneal dialysis will drive the total
Renal Dialysis Equipment – Global Analysis and Market Forecast

2
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Executive Summary
renal dialysis equipment market to new heights. unfavorable reimbursement scenario and
Emerging economies demonstrate stronger growth downward pricing pressure. Driven by rising
than global averages. China ranks as the fastest- adoption of peritoneal dialysis modality and
growing market, driven by a largely untreated increasing demand in emerging markets, the global
population and recently improved health insurance peritoneal dialysis products market is widening at a
coverage. CAGR of 6.92%.
Key Players in the Global Renal Dialysis What Do Physicians Think?

Equipment Market
Product innovation is the key driver of the renal
The largest and most dynamic companies in the dialysis equipment market:
renal dialysis devices market offer comprehensive
“Any technical innovation that reduces caregiver
portfolios of hemodialysis machines, peritoneal
workload and makes dialysis therapy less
dialysis systems, CRRT machines, and associated
resource-intensive is desired.”
accessories and solutions. Fresenius and Baxter
Key Opinion Leader
became market leaders by offering a variety of
products in different dialysis modalities. Other Home-based dialysis, including the needleless
companies, including B. Braun, Nikkiso, Nipro, procedure peritoneal dialysis and home
Asahi Kasei, Toray, and NxStage, have remained hemodialysis, improves the patients’ quality of life
innovative in order to compete with the larger and will become more popular:
manufacturers.
“I have been focused on home dialysis care for
Global Market Future Outlook several years now…I get the most joy knowing that
a patient is able to go back to their life choices with
Driven by aging populations, growing awareness of
alterations here and there that allow them to
therapeutic modalities, and expanding demand in
maintain their life as they want it.”
emerging countries, the global renal dialysis
market is expanding at a steady compound annual Key Opinion Leader
growth rate (CAGR) of 3.48%. India and China are
Nephrologists want to have greater treatment
the fastest-growing markets, demonstrating
flexibility, with access to innovative treatment
CAGRs of 8.07% and 7.78%, respectively. The US
options that they know may benefit their patients:
market is growing at a CAGR of 2.99%, whereas
the 5EU are expanding at a slower CAGR of
1.97%. The Japanese market, with a negative
CAGR of 0.06%, is shrinking because of an

3
Executive Summary
“I’m very interested in hemodiafiltration, [because] “Patients involved in modality selection are more
it shows better outcomes for dialysis-related satisfied with their treatment. One of my challenges
amyloidosis. It is widely used in Europe and Japan, is how to conduct patient education effectively and
but not the US. I hope I can use it to treat my involve them in the decision-making process. It has
patients.” the potential to enhance individualized patient
care.”
Key Opinion Leader
Key Opinion Leader
Education and training remain an unmet need
since patients are not given sufficient information
about dialysis modalities:

4
GLOBAL ANALYSIS AND MARKET FORECAST
Table of Contents
1 Table of Contents
1 Table of Contents ......................................................................................................................... 5
1.1 List of Tables ...................................................................................................................... 10
1.2 List of Figures ..................................................................................................................... 12
2 Introduction ................................................................................................................................. 16
2.1 Catalyst ............................................................................................................................... 18
2.2 Technology Overview ......................................................................................................... 19
2.2.1 Dialysis Access ............................................................................................................... 19
2.2.2 Hemodialysis .................................................................................................................. 20
2.2.3 Peritoneal Dialysis .......................................................................................................... 20
2.2.4 Continuous Renal Replacement Therapy ....................................................................... 22
2.3 Key Mergers, Acquisitions, and Deals ................................................................................ 22
2.4 Product Recalls................................................................................................................... 24
3 Market Access ............................................................................................................................ 25
3.1 Regulation .......................................................................................................................... 25
3.2 Registries ............................................................................................................................ 26
3.3 Reimbursement .................................................................................................................. 27
4 Unmet Needs .............................................................................................................................. 33
4.1 Research Gaps ................................................................................................................... 33
4.2 Treatment Flexibility............................................................................................................ 33
4.3 Technological Innovation .................................................................................................... 34
4.4 Home-Based Devices ......................................................................................................... 35

5
Table of Contents
4.5 Shortage of Nephrology Specialists.................................................................................... 37
4.6 Patient Education and Training........................................................................................... 37
5 Competitive Assessment ............................................................................................................ 38
5.1 Major Players ...................................................................................................................... 38
5.1.1 Fresenius SE & Co. KGaA .............................................................................................. 38
5.1.2 Baxter International Inc. .................................................................................................. 40
5.1.3 B. Braun Melsungen AG ................................................................................................. 41
5.1.4 Nikkiso Co., Ltd. .............................................................................................................. 43
5.1.5 Nipro Corporation ........................................................................................................... 44
5.1.6 Asahi Kasei Corporation ................................................................................................. 45
5.1.7 NxStage Medical, Inc. ..................................................................................................... 46
5.1.8 Toray Medical Co., Ltd. ................................................................................................... 47
5.2 Emerging Players ............................................................................................................... 49
5.2.1 Medtronic plc .................................................................................................................. 49
5.3 Marketed Products Assessment ......................................................................................... 50
5.3.1 HD Machines .................................................................................................................. 50
5.3.2 PD Machines and Systems ............................................................................................. 52
5.3.3 CRRT Machines.............................................................................................................. 52
5.3.4 PD Solutions ................................................................................................................... 53
5.3.5 Dialyzers ......................................................................................................................... 54
5.4 Pipeline Assessment and Key Clinical Trials ...................................................................... 57
5.4.1 Pipeline Assessment ...................................................................................................... 57
5.4.2 Key Clinical Trials ........................................................................................................... 59

6
Table of Contents
6 Market Outlooks ......................................................................................................................... 62
6.1 Procedure Trends ............................................................................................................... 62
6.1.1 Vascular Access ............................................................................................................. 62
6.1.2 Dialysis Modalities .......................................................................................................... 64
6.1.3 Dialyzer Reuse ............................................................................................................... 69
6.1.4 Hemodiafiltration ............................................................................................................. 69
6.1.5 Home Dialysis ................................................................................................................. 70
6.2 Market Drivers and Barriers ................................................................................................ 72
6.2.1 Driver: Population Expectation........................................................................................ 72
6.2.2 Driver: Increasing Number of Dialysis Centers ............................................................... 73
6.2.3 Driver: Growing Awareness of Diseases and Therapeutic Modalities ............................ 76
6.2.4 Driver: Technological Innovations ................................................................................... 77
6.2.5 Driver: Favorable Government Healthcare Policy and Funding...................................... 77
6.2.6 Barrier: Safety Concerns................................................................................................. 78
6.2.7 Barrier: Restricted Reimbursement................................................................................. 78
6.3 Company Share Analysis ................................................................................................... 79
6.3.1 HD Products ................................................................................................................... 79
6.3.2 HD Machines .................................................................................................................. 82
6.3.3 Dialyzers ......................................................................................................................... 84
6.3.4 PD Products .................................................................................................................... 86
6.4 Market Outlooks by Segment ............................................................................................. 88
6.4.1 Global Overview ............................................................................................................. 88
6.4.2 By Region ....................................................................................................................... 93

7
Table of Contents
6.5 Market Outlooks by Geography ........................................................................................ 101
6.5.1 Global Overview: Renal Dialysis Equipment................................................................. 101
6.5.2 Global Overview: HD Products ..................................................................................... 103
6.5.3 Global Overview: PD Products ..................................................................................... 106
6.5.4 US ................................................................................................................................. 109
6.5.5 France ........................................................................................................................... 112
6.5.6 Germany ....................................................................................................................... 115
6.5.7 Italy ............................................................................................................................... 118
6.5.8 Spain ............................................................................................................................. 121
6.5.9 UK ................................................................................................................................. 123
6.5.10 Japan ............................................................................................................................ 126
6.5.11 Brazil ............................................................................................................................. 129
6.5.12 China ............................................................................................................................ 132
6.5.13 India .............................................................................................................................. 136
7 Appendix ................................................................................................................................... 140
7.1 Bibliography ...................................................................................................................... 140
7.2 Abbreviations .................................................................................................................... 145
7.3 Methodology ..................................................................................................................... 147
7.3.1 Overview ....................................................................................................................... 147
7.3.2 Coverage ...................................................................................................................... 147
7.3.3 Secondary Research .................................................................................................... 147
7.4 Forecasting Methodology ................................................................................................. 148
7.5 Primary Research Efforts.................................................................................................. 148

8
Table of Contents
7.6 About the Authors ............................................................................................................. 150
7.6.1 Tina Deng, MSc, MBS, Analyst, Medical Devices ........................................................ 150
7.6.2 Linda Tian, MSc, Managing Analyst, Medical Devices ................................................. 150
7.6.3 David Brady, Director of Operations – Market Research .............................................. 151
7.6.4 Tyler Fletcher, Global Head of Medical Devices ........................................................... 151
7.7 About GlobalData ............................................................................................................. 152
7.8 Disclaimer ......................................................................................................................... 152

9
Table of Contents
1.1 List of Tables
Table 1: Definition for Renal Dialysis Equipment ................................................................................................ 17
Table 2: Key Mergers and Acquisitions (2013–2016) ......................................................................................... 23
Table 3: Product Recalls (2014–2016) ............................................................................................................... 24
Table 4: Company Profile – Fresenius................................................................................................................ 39
Table 5: Fresenius SWOT Analysis, 2016 .......................................................................................................... 39
Table 6: Company Profile – Baxter ..................................................................................................................... 41
Table 7: Baxter SWOT Analysis, 2016 ............................................................................................................... 41
Table 8: Company Profile – B. Braun ................................................................................................................. 42
Table 9: B. Braun SWOT Analysis, 2016 ............................................................................................................ 43
Table 10: Company Profile – Nikkiso .................................................................................................................. 44
Table 11: Nikkiso SWOT Analysis, 2016 ............................................................................................................ 44
Table 12: Company Profile – Nipro ..................................................................................................................... 45
Table 13: Nipro SWOT Analysis, 2016 ............................................................................................................... 45
Table 14: Company Profile – Asahi Kasei .......................................................................................................... 46
Table 15: Asahi Kasei SWOT Analysis, 2016 ..................................................................................................... 46
Table 16: Company Profile – NxStage Medical .................................................................................................. 47
Table 17: NxStage Medical SWOT Analysis, 2016 ............................................................................................ 47
Table 18: Company Profile – Toray Medical ....................................................................................................... 48
Table 19: Toray Medical SWOT Analysis, 2016 ................................................................................................. 48
Table 20: Company Profile – Medtronic.............................................................................................................. 49
Table 21: Medtronic SWOT Analysis, 2016 ........................................................................................................ 50
Table 22: Key Marketed HD Machines ............................................................................................................... 51
Table 23: Key Marketed PD Machines ............................................................................................................... 52

10
Table of Contents
Table 24: Key Marketed CRRT Machines .......................................................................................................... 53
Table 25: Key Marketed PD Solutions ................................................................................................................ 54
Table 26: Key Marketed Dialyzers ...................................................................................................................... 56
Table 27: Key Pipeline Products ......................................................................................................................... 58
Table 28: Key Clinical Trials................................................................................................................................ 60
Table 29: Global Procedure Volumes for Vascular Access in the 10MM, 2015 ................................................. 63
Table 30: Global Procedure Volumes for Vascular Access in the 10MM, 2022 ................................................. 64
Table 31: Global Procedure Volumes for Dialysis Modalities in the 10MM, 2015 .............................................. 65
Table 32: Global Procedure Volumes for Dialysis Modalities in the 10MM, 2022 .............................................. 66
Table 33: Global Procedure Volumes for Peritoneal Dialysis Modalities in the 10MM, 2015 ............................. 67
Table 34: Global Procedure Volumes for Peritoneal Dialysis Modalities in the 10MM, 2022............................. 68
Table 35: Global Procedure Volumes for Home-Based Dialysis in the 10MM, 2015 and 2022 ......................... 72
Table 36: Global Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022 ............. 90
Table 37: 5EU Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022 ................. 94
Table 38: APAC Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022 .............. 98
Table 39: Global Market Value Forecast by Country for Renal Dialysis Equipment, $m, 2013–2022 ............. 102
Table 40: Global Market Value Forecast by Country for HD Products, $m, 2013–2022 .................................. 104
Table 41: Global Market Value Forecast by Country for PD Products, $m, 2013–2022 .................................. 107
Table 42: US Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022 ................. 110
Table 43: France Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022........... 113
Table 44: Germany Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022 ....... 116
Table 45: Italy Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022 ............... 119
Table 46: Spain Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022............. 122
Table 47: UK Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022 ................. 124

11
Table of Contents
Table 48: Japan Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022 ............ 127
Table 49: Brazil Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022 ............. 130
Table 50: China Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022 ............ 134
Table 51: India Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022 .............. 137
1.2 List of Figures
Figure 1: Global HD Reimbursement in the 10MM, 2015 ................................................................................... 28
Figure 2: Global PD Reimbursement in the 10MM, 2015 ................................................................................... 29
Figure 3: Renal Dialysis Reimbursement in the US, 2015.................................................................................. 30
Figure 4: Global Procedure Trends for Vascular Access in the 10MM, 2015..................................................... 63
Figure 5: Global Procedure Forecasts for Vascular Access in the 10MM, 2022 ................................................ 64
Figure 6: Global Procedure Trends for Dialysis Modalities in the 10MM, 2015.................................................. 65
Figure 7: Global Procedure Forecasts for Dialysis Modalities in the 10MM, 2022 ............................................. 66
Figure 8: Global Procedure Trends for Peritoneal Dialysis Modalities in the 10MM, 2015 ................................ 67
Figure 9: Global Procedure Forecasts for Peritoneal Dialysis Modalities in the 10MM, 2022 ............................ 68
Figure 10: Global Procedure Trends for Dialyzer Reuse in the 10MM, 2015 ..................................................... 69
Figure 11: Global Trends for Home-Based Dialysis in the 10MM, 2015 and 2022 ............................................ 72
Figure 12: Global Dialysis Population in the 10MM, 2015 and 2022 .................................................................. 73
Figure 13: Global Dialysis Market in 2015 .......................................................................................................... 74
Figure 14: Global Trends of Dialysis Centers in the 10MM, 2015 ...................................................................... 75
Figure 15: Global Forecasts of Dialysis Centers in the 10MM, 2022 ................................................................. 76
Figure 16: US and Brazil Company Share for HD Products, 2015 ..................................................................... 80
Figure 17: 5EU Company Share for HD Products, 2015 .................................................................................... 81
Figure 18: APAC Company Share for HD Products, 2015 ................................................................................. 82

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Table of Contents
Figure 19: 5EU Company Share for HD Machines, 2015 ................................................................................... 83
Figure 20: APAC Company Share for HD Machines, 2015 ................................................................................ 83
Figure 21: US and Brazil Company Share for HD Machines, 2015 .................................................................... 84
Figure 22: 5EU Company Share for Dialyzers, 2015 .......................................................................................... 85
Figure 23: APAC Company Share for Dialyzers, 2015 ....................................................................................... 85
Figure 24: US and Brazil Company Share for Dialyzers, 2015........................................................................... 86
Figure 25: 5EU Company Share for PD Products, 2015 .................................................................................... 87
Figure 26: APAC Company Share for PD Products, 2015 ................................................................................. 87
Figure 27: US and Brazil Company Share for PD Products, 2015 ..................................................................... 88
Figure 28: Global Market Value Forecast for Renal Dialysis Equipment, 2013–2022........................................ 89
Figure 29: Global Market Value Forecast by Market Segment for HD Products, 2013–2022 ............................ 91
Figure 30: Global Market Value Forecast by Market Segment for PD Products, 2013–2022 ............................ 92
Figure 31: Global Market Value Forecast by Market Segment for CRRT Machines, 2013–2022 ...................... 93
Figure 32: 5EU Market Value Forecast for Renal Dialysis Equipment, 2013–2022 ........................................... 93
Figure 33: 5EU Market Value Forecast by Market Segment for HD Products, 2013–2022 ............................... 95
Figure 34: 5EU Market Value Forecast by Market Segment for PD Products, 2013–2022 ............................... 96
Figure 35: 5EU Market Value Forecast by Market Segment for CRRT Machines, 2013–2022 ......................... 96
Figure 36: APAC Market Value Forecast for Renal Dialysis Equipment, 2013–2022 ........................................ 97
Figure 37: APAC Market Value Forecast by Market Segment for HD Products, 2013–2022 ............................ 99
Figure 38: APAC Market Value Forecast by Market Segment for PD Products, 2013–2022........................... 100
Figure 39: APAC Market Value Forecast by Market Segment for CRRT Machines, 2013–2022 .................... 100
Figure 40: Global Market Value Forecast by Country for Renal Dialysis Equipment, 2013–2022 ................... 101
Figure 41: Global Renal Dialysis Equipment Market Share Comparison by Country, 2015 and 2022 ............ 103
Figure 42: Global Market Value Forecast by Country for HD Products, 2013–2022 ........................................ 104

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Table of Contents
Figure 43: Global HD Products Market Share Comparison by Country, 2015 and 2022 ................................. 105
Figure 44: Global Market Value Forecast by Country for PD Products, 2013–2022 ........................................ 106
Figure 45: Global PD Products Market Share Comparison by Country, 2015 and 2022 ................................. 108
Figure 46: US Market Value Forecast by Segment for Renal Dialysis Equipment, 2013–2022....................... 109
Figure 47: US Market Value Forecast by Market Segment for HD Products, 2013–2022 ............................... 111
Figure 48: US Market Value Forecast by Market Segment for PD Products, 2013–2022 ............................... 111
Figure 49: France Market Value Forecast by Segment for Renal Dialysis Equipment, 2013–2022 ................ 112
Figure 50: France Market Value Forecast by Market Segment for HD Products, 2013–2022 ......................... 114
Figure 51: France Market Value Forecast by Market Segment for PD Products, 2013–2022 ......................... 115
Figure 52: Germany Market Value Forecast by Segment for Renal Dialysis Equipment, 2013–2022 ............. 116
Figure 53: Germany Market Value Forecast by Market Segment for HD Products, 2013–2022 ..................... 117
Figure 54: Germany Market Value Forecast by Market Segment for PD Products, 2013–2022...................... 118
Figure 55: Italy Market Value Forecast by Segment for Renal Dialysis Equipment, 2013–2022 ..................... 119
Figure 56: Italy Market Value Forecast by Market Segment for HD Products, 2013–2022 .............................. 120
Figure 57: Italy Market Value Forecast by Market Segment for PD Products, 2013–2022 .............................. 121
Figure 58: Spain Market Value Forecast by Segment for Renal Dialysis Equipment, 2013–2022 .................. 121
Figure 59: Spain Market Value Forecast by Market Segment for HD Products, 2013–2022 ........................... 122
Figure 60: Spain Market Value Forecast by Market Segment for PD Products, 2013–2022 ........................... 123
Figure 61: UK Market Value Forecast by Segment for Renal Dialysis Equipment, 2013–2022....................... 124
Figure 62: UK Market Value Forecast by Market Segment for HD Products, 2013–2022 ............................... 125
Figure 63: UK Market Value Forecast by Market Segment for PD Products, 2013–2022 ............................... 125
Figure 64: Japan Market Value Forecast by Segment for Renal Dialysis Equipment, 2013–2022 .................. 126
Figure 65: Japan Market Value Forecast by Market Segment for HD Products, 2013–2022 .......................... 128
Figure 66: Japan Market Value Forecast by Market Segment for PD Products, 2013–2022........................... 129

14
Table of Contents
Figure 67: Brazil Market Value Forecast by Segment for Renal Dialysis Equipment, 2013–2022................... 130
Figure 68: Brazil Market Value Forecast by Market Segment for HD Products, 2013–2022 ........................... 131
Figure 69: Brazil Market Value Forecast by Market Segment for PD Products, 2013–2022 ........................... 132
Figure 70: China Market Value Forecast by Segment for Renal Dialysis Equipment, 2013–2022 .................. 133
Figure 71: China Market Value Forecast by Market Segment for HD Products, 2013–2022 ........................... 135
Figure 72: China Market Value Forecast by Market Segment for PD Products, 2013–2022 ........................... 135
Figure 73: India Market Value Forecast by Segment for Renal Dialysis Equipment, 2013–2022 .................... 136
Figure 74: India Market Value Forecast by Market Segment for HD Products, 2013–2022 ............................ 138
Figure 75: India Market Value Forecast by Market Segment for PD Products, 2013–2022............................. 139
Figure 76: Primary Research Summary for Renal Dialysis Equipment ............................................................ 149

15
Introduction
2 Introduction
Between 8% and 10% of the adult population have some form of kidney damage, and millions die
prematurely due to complications related to kidney disease (World Kidney Day, 2015). When
kidney disease reaches an advanced stage, dangerous levels of fluid, electrolytes, and wastes can
build up in the body. The disease can progress to end-stage renal disease (ESRD), which is fatal More than 450,000
patients in the US
without a kidney transplant or dialysis. Because of the growing lag between the number of kidney and about 1.7
million renal
donors and potential kidney transplant recipients, dialysis remains the primary treatment available patients worldwide
to ESRD patients. More than 450,000 patients in the US and about 1.7 million renal patients receive dialysis
treatment.
worldwide receive dialysis treatment (National Kidney Foundation, 2016).
Renal dialysis equipment is intended to provide an artificial replacement for lost kidney function due
to renal failure. With the development of the equipment, the quality of life (QOL) for patients with
advancing kidney failure has been greatly improved. Based on GlobalData’s primary and
secondary research into kidney failure, key markets for medical device-based dialysis treatments
were identified. The scope of the renal dialysis equipment market covers capital equipment
including hemodialysis (HD) machines, peritoneal dialysis (PD) machines, and continuous renal
replacement therapy (CRRT) machines; accessories including grafts, dialysis catheters,
arteriovenous (AV) vascular needles, blood tubing sets, dialyzers, PD catheters, and PD transfer
sets; and solutions including dialysates and PD solutions (Table 1).

16
Introduction
Table 1: Definition for Renal Dialysis Equipment

Category Segment Description
Portable HD Portable HD machines are smaller in size, occupy less space, and are used for ease
HD machines of patient access.
machines Stand-alone HD These are more specialized and comparatively larger-sized machines for performing
machines HD on patients.
PD PD machines, also called cyclers, are used in continuous cycler-assisted peritoneal
NA
machines dialysis (CCPD) to fill and drain the abdomen, usually while a patient sleeps.
CRRT CRRT machines are intended for dialysis treatment that is provided as a continuous
NA
machines 24-hour-a-day therapy.
Grafts are strong artificial tubes inserted by surgeons underneath the skin of a
patient’s forearm, upper arm, or thigh. One end of the tube connects to one of the
Grafts
arteries, and the other end connects to one of the veins (in the same limb). The graft
may be straight or in the shape of a horseshoe.
Dialysis Dialysis catheters are intended for exchanging blood from the patient to and from the
catheters HD machine. These catheters are made of plastic.
AV fistula needles are used to surgically create a direct connection between an
AV fistula artery and a vein, resulting in the formation of a large blood vessel with an increased
needles blood flow, providing access for HD. Arterial and venous fistula needles are included
in this segment.
Dialysis
Blood tubing sets act as the connecting link between the blood vessels and the
accessories Blood tubing
dialysis machine via the AV fistula needles. They are used to carry blood to and from
sets
the body.
Dialyzers are special filters used in HD and CRRT for removing toxic substances and
Dialyzers
an excess of water from the blood.
PD catheters are soft catheters that are used in PD to carry the dialysis solution into
PD catheters and out of the abdomen. The standard catheter for PD is made of soft tubing that has
polyester cuffs.
PD transfer sets are usually attached to the PD catheters at time of insertion in the
PD transfer sets operating room. A PD transfer set attachment to the PD catheter enables a closed
system upon discontinuation/disconnection from PD system.
Dialysates are dialysis fluids that consist of purified water, glucose, and electrolytes.
Dialysates The concentration of electrolytes, besides potassium and the buffer substance,
closely resembles that which occurs naturally in the blood.
PD solutions are intended to use the peritoneal membrane as a natural semi-
Solutions permeable membrane. The dialysis is carried out with the help of a specially
formulated dialysis solution, which is instilled around the membrane to ease the
PD solutions
process. The solution comes in dextrose concentrations ranging from 1.5% to 4.25%.
One unit consists of 3,000ml (fill volume) of peritoneal dialysis solution of any
concentration.
Source: GlobalData

17
Introduction
This report focuses on the renal dialysis equipment market outlook for the dialysis treatment of
kidney disease. It provides a comprehensive review of market trends, unmet needs, mergers and
acquisitions, and other strategic market activities of global companies. The global market is defined
as the 10 countries covered in this report, which are the US, France, Germany, Italy, Spain, the
UK, Japan, Brazil, China, and India, presently and through 2022.
2.1 Catalyst
The demand for dialysis treatment is mainly driven by the increasing number of patients with
ESRD. On average, one in 10 adults has chronic kidney failure in their lifetime (National Kidney
Foundation, 2016). Diabetes and hypertension are the two diseases that often precede the onset of
chronic kidney disease (Jha et al., 2013). The rapid growth of an aging population with diabetes
and/or hypertension leads to the rising number of ESRD patients. In developing countries, over one
million ESRD patients are not treated due to the access and affordability of treatment (National
Kidney Foundation, 2016).
Technical advancement not only accelerates the acceptance of dialysis treatment, but also greatly
improves patients’ QOL. When HD was introduced as an effective workable treatment in 1943
(Kolff et al., 1944), the outlook for patients with ESRD suddenly changed from the expectation of
impending death to indefinite survival. Since then, dialysis has advanced from an intensive bedside
therapy to a more streamlined treatment. It sometimes can be self-administered in a patient’s
home. Modern technology has simplified dialysis treatment by reducing the time and effort required
by patients and caregivers.
Favorable reimbursement scenarios have been a major market growth catalyst in developed
countries. For example, in the US, the Medicare End-Stage Renal Disease Program was
introduced in 1973 as a result of the Social Security Amendments of 1972 (Public Law 92-603,
section 299I), which paid for dialysis for nearly all Americans with ESRD (Eggers, 2000). Prior to
the passing of this legislation, dialysis was limited to a very few patients mainly due to its extremely
high cost. This program created a strong financial incentive for providers to maximize the number
of patients who could receive dialysis treatment.

18
Introduction
2.2 Technology Overview
2.2.1 Dialysis Access
Dialysis access is a dialysis patient’s lifeline. It should be in place weeks or months before the first
dialysis treatment. Surgery needs to be completed to create a stronger blood flow for an HD patient
and a fluid exchange route for a PD patient.
2.2.1.1 Vascular Access for HD
Vascular access is a surgically created vein used to remove and return blood during HD. Vascular
access lets large amounts of blood flow continuously to filter as much as possible per treatment.
Two types of vascular access designed for long-term use are the AV fistula and the AV graft.
According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), an AV
fistula requires two to three months to mature, before the patient can use it for HD. An AV graft can
be used two to three weeks after surgery (NIDDK, 2014a). If renal failure has progressed quickly, a
patient may not have the time for placement of an AV fistula or AV graft before starting HD
treatment. Therefore, a third type of vascular access, the venous catheter, would be placed for
short-term use. If fistula or graft surgery is unsuccessful, then a patient will require a long-term
venous catheter access. The 2015 Kidney Disease Outcomes Quality Initiative Hemodialysis
Adequacy Guideline recommends an AV fistula as the preferred vascular access for HD, because
of its low complication rate and longer lifespan as compared to other available vascular access
options (National Kidney Foundation, 2015).
2.2.1.2 Dialysis Access for PD
In PD, a soft catheter is used to carry the dialysis solution into and out of the abdomen. The
standard catheter for PD is made of elastic tubing that has polyester cuffs. The cuffs merge with
scar tissue to keep the catheter in place. The end of the tubing that is inside the abdomen has
many holes to allow the free flow of solution in and out. As soon as the catheter is in place, a
patient can start to receive the solution through it, although a full schedule of exchanges probably
will not begin for two to three weeks (NIDDK, 2010). This break-in period helps build up scar tissue
that keeps the catheter in place.

19
Introduction
2.2.2 Hemodialysis
HD is the most common method used to treat ESRD worldwide. In HD, a machine filters wastes,
salts, and fluid from blood outside the body. Blood that is allowed to flow through the dialyzer
removes wastes and extra fluids. The clean blood is then returned to the body. Removing harmful
wastes and extra salt and fluids helps control blood pressure and keep the proper balance of
chemicals such as potassium and sodium.
Solute removal with HD is achieved either by convection, diffusion, or a combination of both

methods, called hemodiafiltration. Diffusion most efficiently removes small molecular weight
substances such as urea, creatinine, and potassium. Middle and larger molecular weight
substances are more efficiently removed by using the convection method, called hemofiltration.
During hemofiltration, hydrostatic pressure causes the filtration of plasma across a semi-permeable
membrane. Solutes are dragged across the membrane along with the plasma, resulting in
convective transport of solutes in the same direction as water. Combining diffusive and convective
clearance with hemodiafiltration allows improved clearance of both small and large molecular
weight substances (Jean et al., 2015).
Generally, most people receive HD for three to five hours, three times a week in a dialysis center
(NIDDK, 2014b). The recent guidelines published in 2015 suggest that patients with ESRD be
offered in-center, short, frequent HD as an alternative to conventional in-center three-times-weekly
HD after considering individual patient preferences, the potential QOL and physiological benefits,
and the risks of these therapies (National Kidney Foundation, 2015).
In recent years, more compact and simpler dialysis machines have made home HD increasingly
attractive. The 2015 Clinical Practice Guideline suggests home long HD, which lasts six to eight
hours, three to six nights per week for patients with ESRD who prefer this therapy. But even with
better procedures and equipment, HD is still a complicated and inconvenient therapy that requires
a coordinated effort from a whole healthcare team (USRDS, 2015).
2.2.3 Peritoneal Dialysis
PD uses the peritoneum as a natural permeable membrane to allow waste products and extra fluid
to pass from blood into the dialysis solution. The solution contains dextrose that will pull wastes
and extra fluid into the abdominal cavity. These wastes and fluid then leave the body when the
dialysis solution is drained. The used solution, containing wastes and extra fluid, is then thrown

20
Introduction
away. The exchange takes about 30 to 40 minutes. The period that the dialysis solution is in the
abdomen is called the dwell time. A typical schedule calls for four exchanges a day, each with a
dwell time of four to six hours (NIDDK, 2010). Different types of PD have separate schedules of
daily exchanges (McMillan, 2014).
2.2.3.1 Continuous Ambulatory Peritoneal Dialysis (CAPD)
CAPD doesn’t require a machine. The PD solution fills and empties the abdomen by gravity. A
patient can walk around with the dialysis solution in the abdomen. A typical adult infuses 2–3L of
PD solution four to five times a day. PD solution is allowed to remain for four hours during the day
and eight to 12 hours at night.
2.2.3.2 Continuous Cycler-Assisted Peritoneal Dialysis (CCPD)
CCPD, also known as automated peritoneal dialysis (APD), requires a machine called a cycler to
fill and drain the abdomen, usually while a patient sleeps. It has become the most popular form of
PD in developed countries. Some patients require both CAPD and CCPD to achieve adequate
clearances.
2.2.3.3 Intermittent Peritoneal Dialysis (IPD)
IPD is of use mainly in the treatment of acute kidney injury. In adults, 2–3L of dialysate is infused
over 10 to 15 minutes, allowed to dwell in the peritoneal cavity for 30 to 40 minutes, and drained in
about 10 to 15 minutes. Multiple exchanges may be needed over 12 to 48 hours.
Although HD has dominated the dialysis market, the unique features of PD have it becoming more
and more popular. First, PD is less physiologically stressful than HD, doesn't require as much food
and fluid restriction as HD, and doesn't use needles. Second, PD gives patients more freedom. It
can be a home therapy and does not require the infrastructure of dialysis clinics. Last but not least,
according to the United States Renal Data System (USRDS), PD remains less costly on a per-
patient basis than HD. In the US, the one-year costs per patient using HD and PD were
approximately $80,000 and $60,000, respectively (USRDS, 2015). However, PD requires much
more patient involvement than in-center HD. Maintaining sterile technique is essential. The most
important and common complications are peritonitis and catheter exit-site infection.

21
Introduction
2.2.4 Continuous Renal Replacement Therapy
CRRT is a dialysis modality used to treat critically ill, hospitalized patients in the intensive care unit
who develop acute kidney injury. CRRT is any renal replacement therapy that is intended to be
applied for 24 hours per day in the intensive care unit. The term CRRT describes a variety of blood
purification techniques, which may vary considerably according to the mechanism of solute
transport, the type of membrane, the presence or absence of dialysate solution, and the type of
vascular access. CRRT provides slower solute clearance per unit time, but over 24 hours may
even exceed clearances as compared with intermittent therapies (Pannu and Gibney, 2005).
2.3 Key Mergers, Acquisitions, and Deals
Key mergers, acquisitions, and deals struck between manufacturers can have an important impact
on the state of the renal dialysis equipment market. Table 2 highlights the most influential deals in
the arena recently.
In 2013, Baxter Healthcare Corporation (Baxter) acquired dialysis competitor Gambro AB

(Gambro), trading $3.9 billion for an expanded share of the global renal market. At that time, Baxter
was the world’s second-largest maker of renal dialysis equipment, and Gambro was the third. The
addition of Gambro extended Baxter’s portfolio in the HD segment and made Baxter an
unquestioned leader. On the other hand, because of such a huge consolidation, antitrust concerns
arose from regulatory authorities’ point of view. Baxter had to sell off its CRRT segment to comply
with EU regulation, and then had to discontinue an outsourcing production deal in China with Nipro
Corporation.
Medtronic plc (Medtronic) recently acquired Italian HD treatment solutions company Bellco Societa
unipersonale a r.l. (Bellco). The medical device giant is folding the acquisition into its newly formed
Renal Care Solutions business. Medtronic is now one of the largest providers of dialysis catheters
through its acquisition of Covidien plc., and appears to want a firm foothold in other segments of
the dialysis devices market. The participation of Medtronic makes the competition of the renal
dialysis equipment market even more intense.

22
Introduction
Table 2: Key Mergers and Acquisitions (2013–2016)

Transaction
Company Target Deal Type Deal Value Primary Motivations
Date
Expanding Medtronic’s Renal
February 1, Bellco Societa
Medtronic plc Acquisition $119.5m Care Solutions business with
2016 unipersonale a r.l.
the addition of dialysis portfolio.
DTZ Dialyse Strengthening B. Braun’s
November B. Braun Avitum
Trainings-Zentren Acquisition Undisclosed market share in the dialysis
19, 2015 AG
GmbH provider business.
Enabling Debiotech and
Fresenius
November 3, Fresenius Medical Care to
Medical Care Debiotech S.A. Partnerships Undisclosed
2015 develop home-based PD
AG & Co. KGaA
technologies
Enabling Toray Industries and
Fresenius Fresenius Medical Care to
September Toray Industries,
Medical Care Partnerships Undisclosed distribute acute blood
16, 2015 Inc.
AG & Co. KGaA purification devices in European
countries
Enabling B. Braun Avitum to
Lauer Membran
June 2, B. Braun Avitum strengthen its market position
Wassertechnik Acquisition $45m
2015 AG as a system provider for
GmbH.
dialysis therapy.
Expanding Medtronic’s portfolio
of medical technology products
January 26,
Medtronic plc Covidien plc Acquisition $49.9bn and services, and strengthening
2015
its business in worldwide
healthcare market.
Enabling Rockwell Medical to
expand and accelerate its
Baxter
October 3, Rockwell Medical, hemodialysis concentrate
Healthcare Partnerships $45m
2014 Inc. business; and strengthening
Corporation
Baxter Healthcare’s product
portfolio
Expanding Nikkiso’s presence
January 6, Baxter Asset
Nikkiso Co., Ltd. $38.8m in the acute renal failure
2014 International Inc. Transactions
marketplace.
Extending Baxter’s portfolio in
Baxter
September the HD segment and enhancing
Healthcare Gambro AB Acquisition $3.9bn
6, 2013 its global leadership in renal
Corporation
therapies
Source: GlobalData

23
Introduction
2.4 Product Recalls
Product recalls can negatively impact a medical device manufacturer’s sales revenues, in addition
to hampering a company’s brand image. Recent recalls of renal dialysis devices are not frequent,
but they are all categorized as Class I, which is the most serious type of recall and involves
situations in which there is a reasonable probability that use of these products will cause serious
adverse health consequences or death. Table 3 below highlights some of the more notable recalls
of recent years.
Table 3: Product Recalls (2014–2016)

Recall Recall
Company Product Recall Motivations
Date Class
May 2, Baxter VASCU-GUARD Peripheral May cause blood clots; one report of serious
Class I
2015 Healthcare Vascular Patch injury
April 4, Fresenius NaturaLyte Liquid Halomonas (species 1, 2, 3) contamination;
Class I
2014 Medical Care Bicarbonate Concentrate one report of death and two reports of injury
Source: GlobalData

24
Market Access
3 Market Access
3.1 Regulation
Renal dialysis equipment is highly regulated by governments. In the US, based on the degree of
regulatory control necessary to ensure safety and effectiveness, renal dialysis equipment is
assigned as a Class II device, which require special controls for labeling, guidance, tracking,
design, performance standards, and post-market monitoring. Most require Premarket Notification
510(k). Particularly, implanted blood access devices for HD were preamendment Class III devices,
but were recently reclassified into Class II (special controls) and subject to premarket notification.
In 2016, the FDA published a guidance document that provides recommendations for complying
with special controls issued as part of the change (FDA, 2016).
The design and construction of dialysis equipment must follow precisely documented processes,
and their performance must meet stringent documentation, development testing, production testing,
and field maintenance requirements. In 1991, the FDA published “Quality Assurance Guidelines for
HD Devices” to discuss quality assurance for dialysate delivery equipment, dialyzers, dialyzer
reprocessing and testing equipment, and other equipment associated with the dialysis procedure
(FDA, 1991). Meanwhile, medical device developers must meet the requirements of ISO 13485 for
quality management system and the IEC 60601-1 product safety standard for electrical medical
equipment (FDA, 2015).
The basic regulation within the EU is Council Directive 93/42/EEC from 1993, commonly known as
the Medical Device Directive (European Commission, 2015). This directive defines essential
requirements now used as the basis for the registration, called Conformité Européeanne (CE)-
marking, of medical devices within the EU. Specific European standards for dialysis equipment
include EN 13867:2002+a1:2009 for HD concentrates, EN 60601-2-39:2008 for peritoneal dialysis
equipment, and EN 60601-2-16:1998 for HD, hemodiafiltration, and hemofiltration equipment. The
dialysis equipment is categorized to Class IIb. However, the EU Commission considers peritoneal
dialysis solutions as those that are to be administered parenterally to patients with an identified
medically diagnosed condition and that have a metabolic mode of action; therefore, such solutions
cannot be qualified as medical devices in the EU (European Commission, 2010).

25
Market Access
The Pharmaceuticals and Medical Devices Agency (PMDA) classifies and regulates medical
devices in Japan. The PMDA outlines certification standards for a variety of renal dialysis
equipment, including hemodialysis machines, dialyzers, and accessories (PMDA, 2015). Due to
relatively high risk to the human body, the PMDA categorizes these products as Class III devices,
which are specially controlled medical devices and require certification from a third party and
approval by the Ministry of Health, Labour, and Welfare (MHLW) (PMDA, 2015). The PMDA has
specific and strict regulations for each segment of the renal dialysis equipment, which forms
barriers for foreign companies accessing the Japanese market. Elsewhere in the Asia-Pacific
region (APAC; Japan, China, and India), the China Food and Drug Administration (CFDA)
classifies HD products as Class III medical devices, versus categorizing PD products as Class II
medical device (CFDA, 2016). For Class II and III medical devices approved overseas, the CFDA
requires CE approval, Premarket Notification 510(k), and ISO 13485 certification to register the
dialysis product. In addition, the Chinese authorities conduct technical reviews and product testing.
Following the evaluations, the CFDA delivers a final decision on the pending approval.
Furthermore, dialysis devices must re-register every four years (CFDA, 2016). As a result, these
complex regulations require longer processing time for overseas companies.
3.2 Registries
In the field of ESRD care, registries have been widely established to collect data on patients
undergoing dialysis. Registry data have revealed variability in incidence, prevalence, and treatment
modalities around the world. Data from these registries can help illustrate trends and outcomes
from dialysis, impact healthcare procedures and policy, and eventually lead to improved QOL. For
example, cost data ascertained through the USRDS helped drive a recent shift in healthcare policy
with the End-Stage Renal Disease Prospective Payment System, designed to better manage costs
for ESRD treatment (Collins, 2012). Data from the ESRD Networks in the United States support the
Fistula First Breakthrough Initiative, which was introduced to increase AV fistula placement and
reduce central venous catheter use, to improve patient survival and QOL by providing a number of
incentives for both patients and healthcare providers (End-Stage Renal Disease National
Coordinating Center, 2016).
However, few registries were identified in areas with emerging economies. No national registries
for dialysis patients were identified in APAC countries such as China and India. This results in
information gaps in healthcare and outcomes for large populations of ESRD patients.

26
Market Access
Effective collaborations or partnerships with existing registries or societies could help to develop
renal registries where they currently do not exist, or enhance data collection and dissemination for
currently existing registries. Current examples of this type of initiative include the recently
established EURODOPPS, which is a partnership between the European Renal Association –
European Dialysis and Transplant Association (ERA-EDTA) and Dialysis Outcomes and Practice
Patterns Study (DOPPS) (EURODOPPS, 2013); the Registry of Patient Registries by the US
Agency for Healthcare Research and Quality; and the ERA-EDTA/Sociedad Latinoamericana de
Nefrología e Hipertensión Registries Fellowships (ERA-EDTA, 2015). These programs help expand
knowledge on the epidemiology of ESRD and address scientific and policy questions, and use the
strengths contained in multiple registries to generate new insights into treatments for ESRD
patients.
3.3 Reimbursement
Dialysis treatment is expensive, but governments pay much of the cost in most countries. As
shown in Figure 1 and Figure 2, public insurers paid nearly 80% of all dialysis therapies in 2015
worldwide. The difference between HD and PD modality is insignificant, except for Spain where the Dialysis treatment is
expensive, but
government pays about 87% of HD therapies but almost all of PD. European countries such as governments pay
much of the cost in
Spain, Italy, France, and the UK, pay from 87% to 99% for dialysis, which reimburse more than most countries.
other developed countries in the 10MM. In India, public insurers pay the least amount among the
10MM, 42% for HD and 33% for PD. In the US, federal health insurance plans, including Medicare
and Medicaid, pay usually up to 80%, and private insurance or state programs often pay the rest,
as illustrated in Figure 3. Medicare currently pays for up to three treatments per week, unless there
is medical justification for more than three weekly treatments, regardless of modality.

27
Market Access
Figure 1: Global HD Reimbursement in the 10MM, 2015

100% 1% 2% 2% 1% 1% 1% 2%
10% 9% 7% 12%
12%
90% 16%
20%
27% 27%
80%
70%
47%
60%
50% 99%
89% 91% 87% 90%
40% 83%
79%
73% 72%
30%
20% 42%
10%
0%
US France Germany Italy Spain UK Japan Brazil China India
Public Private None
Source: GlobalData, primary research interviews and surveys with nephrologists (2016)
10MM = US, France, Germany, Italy, Spain, UK, Japan, Brazil, China, and India
Totals may not sum due to rounding.

28
Market Access
Figure 2: Global PD Reimbursement in the 10MM, 2015

100% 1% 1% 2%
6% 4% 6%
8%
90% 16% 19%
19% 22%
29%
80%
70%
62%
60%
50% 98%
94% 96%
91%
40% 84% 82%
80% 78%
71%
30%
20%
33%
10%
0%
Public Private None


29
Market Access
Figure 3: Renal Dialysis Reimbursement in the US, 2015

A) HD
None
Private 1%
16%
Medicaid
13%
Medicare
70%
B) PD
None
1%
Private
19%
Medicaid
13%
Medicare
67%
Reimbursement for dialysis consumes a considerable portion of healthcare costs for a relatively
small proportion of the total population. Despite affecting less than 0.03% of the total population in
developed countries, ESRD consumes 3% of annual healthcare budgets in many countries
(Couser et al., 2011). In the US, ESRD beneficiaries made up 1.1% of the Medicare population, but
Medicare fee for service amounted to $39.9 billion for ESRD patients, which made up 7.1% of the
overall Medicare paid claims cost in 2013 (USRDS, 2015). The expensive technology, intensive
labor in the delivery of the treatment, and complex comorbidity contributes to the high cost.

30
Market Access
Controlling rising costs is the major objective of the reimbursement systems in the developed
countries. In the US, the Centers for Medicare and Medicaid Services (CMS) bundles multiple
costs into a single payment along with other measures. The Comprehensive ESRD Care Model
was launched in 2015 for large dialysis organizations (CMS, 2016a); through this model, CMS will
partner with healthcare providers and suppliers to test the effectiveness of a new payment and
service delivery model in providing beneficiaries with patient-centered, high-quality care. Since
2002, the Japanese government has not only cut overall reimbursement rates but also cut
reimbursement incentives for higher quality of care, for example, with the abolishment of policies
paying for dialysis treatments of longer duration (Fukuhara et al., 2007). The National Health
Service (NHS) in England proposed reimbursement cuts in its National Tariff Payments System in
2015 (NHS, 2015). As a result, the renal dialysis market is coming under pressure from tightening
healthcare budgets.
More incentives in the reimbursement system are introduced to reward more efficient treatment
options. For example, in the US, partnerships with acute care providers will be incentivized for
dialysis centers. Health information technology interoperability is the other key factor. In recent
years, CMS has tried to get providers to put more patients on home dialysis by revising its payment
system, waiving a 90-day waiting period for reimbursement for home-based patients that is
required for in-center patients and increasing payment for training patients to perform home dialysis
from $33 a session to $50 (CMS, 2016b). In addition, the UK has implemented an incentive if
patients use an AV fistula. Similarly, CMS has instituted a quality incentive program for dialysis
providers that rewards high AV fistula prevalence and penalizes high central venous catheters
prevalence (CMS, 2013).
Lack of medical insurance coverage continues to constrain dialysis acceptance in developing

economies. Governments are balancing cost and access and making an effect to improve
insurance coverage for patients with ESRD. For example, in 2009, the Chinese government
announced an ambitious healthcare reform plan and committed to spend an additional $125 billion
over the following three years to provide affordable and equitable basic universal healthcare by
2020 (Meng et al., 2012). There are three programs in the medical insurance system in China: the
urban employee basic medical insurance, the urban resident basic medical insurance, and the new
cooperative medical scheme for residents in rural locations. All three basic medical insurance
systems cover both HD and PD, but the reimbursement rates vary from 50% to 90% across regions
(Liu, 2013). In 2012, the central government included ESRD on the list of major diseases, providing

31
Market Access
an influential policy guarantee and resources to promote the prevalence and quality of dialysis in
China. In 2015, according to GlobalData primary data, the government paid up to 90% of dialysis
therapies in China.

32
Unmet Needs
4 Unmet Needs
4.1 Research Gaps
Research that can improve products and outcomes in dialysis is urgently needed. Although
mortality rates of dialysis patients have declined 30% since 1999, they remain several-fold higher
than those of age-matched individuals in the general population, and patients experience an
average of nearly two hospital admissions per year (O’Hare et al., 2011). Attempts to improve
outcomes include initiating HD at the best timing, increasing dialysis frequency and/or duration,
using newer membranes, and employing supplemental or alternative hemodiafiltration.
“Although improvements have been made in this area, better predictive instruments for determining
when a patient is likely to require dialysis therapy are important, such as timely creation of vascular
access and PD catheter placement.”
Key Opinion Leader
“Additional research is needed to understand whether there is a clinical benefit associated with
hemodiafiltration versus conventional HD.”
Key Opinion Leader
4.2 Treatment Flexibility
Clinicians want to have greater treatment flexibility, with access to innovative treatment options
they know may benefit their patients. For instance, hemodiafiltration is more popular in Europe and
Japan, showing good outcomes in prevention of complications, treatment of dialysis-induced
hypotension and dialysis-related amyloidosis, and improvement of dialysis efficiency. However, few
dialysis centers in the US currently offer this option to patients.
“I’m very interested in hemodiafiltration, [because] it shows better outcomes for dialysis-related
amyloidosis. It is widely used in Europe and Japan, but not the US. I hope I can use it to treat my
patients.”
Key Opinion Leader

33
Unmet Needs
Personalized dialysis care offers renal patients with diabetes or circulatory diseases medical
services that are managed by coordinated specialists. Indeed, patients with one or more chronic
conditions accounted for $8 billion of the total $9 billion in Medicare spending growth for patients
ages 65 and older between 2010 and 2013 (USRDS, 2015).
“They [dialysis patients] usually have diabetes and hypertension as well. It’s ideal to cooperate with
other specialists. If the prescription of peritoneal dialysis solution provides better blood sugar
control, or does it decrease the infection rate? We need to take all these factors into consideration.”
Key Opinion Leader
4.3 Technological Innovation
Technological innovation is the key driver of the medical device industry. One major challenge of
HD machines is to reduce water consumption for home HD, to give dialysis patients more One major
challenge of
independence and mobility with a resource-efficient device. In addition, therapies tailored to the hemodialysis
machines is to
condition of individual patients are on the rise, which requires new design of dialysis machines, reduce water
consumption for
including blood volume monitors, dialysis dose monitors, and other advanced monitoring devices. home hemodialysis
to give dialysis
In the field of dialyzers, a new generation of high-efficiency, lightweight, and environment-friendly patients more
membranes and filters is desired for hemodialysis treatment. In the area of PD, the PD solutions independence and
mobility with a
usually contain high concentrations of glucose, glucose degradation products, and lactate. resource-efficient
device.
However, a large proportion of ESRD patients have diabetes. This drawback of PD solution has
limited the extensive use of PD modality.
“I’m interested in any technology that can save water. A standard hemodialysis machine uses a
large quantity of purified water. Take that into home, you must have a way to use high volume of
water and you have to able to purify the water. So the water access or water usage is a big issue. It
usually includes a water treatment system that involves plumbing and physical changing at home.”
Key Opinion Leader
“I think the biggest challenge related to peritoneal dialysis solution is…the solution, as a choice of
having osmotic effect in it, is glucose. And half of our population are diabetics. That for me is one of
the biggest issues. We haven’t found anything that can work as well as glucose itself and removing
the fluid and working against our patients.”
Key Opinion Leader

34
Unmet Needs
On the other hand, user-friendly technology is in demand. Desirable features include wireless touch
screen, straightforward software, animation to illustrate procedures, and cloud technology to allow
clinicians to access patient information remotely.
“Any technical innovation that reduces caregiver workload and makes dialysis therapy less
resource-intensive is desired.”
Key Opinion Leader
4.4 Home-Based Devices
Home-based dialysis, including needleless procedure PD and home HD, improves patients’ QOL
and will become more popular. Being on dialysis treatment means that patients have to cope with a
drastic change in everyday life. The most important outcomes to patients were the safety of
treatment, satisfaction with care, and health-related QOL (Janssen et al., 2015). Patients want to
have a more active role in their treatment, especially when it is time-consuming and impacts on
their daily activities. In addition, the global population is aging, and the elderly are more likely to live
with chronic diseases that require daily medical care at home. Due to medical advancements,
many individuals with ESRD are living longer but are dependent on home medical care. Finally, an
increasing focus on reducing healthcare costs for patients of all ages has spurred the growth of the
home-based devices market.
“I have been focused on home dialysis care for several years now…I get the most joy knowing that
a patient is able to go back to their life-choices with alterations here and there that allow them to
maintain their life as they want it.”
Key Opinion Leader
“Most people who are in in-center dialysis will tell you that they are usually very much incapacitated
after going in for their treatment. Home dialysis users tend to recover in about 30 minutes.”
Key Opinion Leader
The other targets of home-based dialysis are patients in rural regions. Missing dialysis sessions,
which reduces the dialysis dose delivered and has been associated with increased mortality risk,
occurs often in rural areas. Some patients in the US have to drive more than one hour to arrive the
nearest dialysis center, and they are likely to miss dialysis sessions. According to GlobalData’s
primary research, on average, patients go to hemodialysis center 2.6 times a week in the US,

35
Unmet Needs
which is lower than most of the developed countries. In rural regions, patients usually visit dialysis
centers once a week. More frequent home HD is truly accessible, giving these patients improved
health and greater control over their treatment and their lives.
“The most challenging aspect…is patient not showing up [for their dialysis treatment]. As I said, we
are in a very big state. We have people who have to drive an hour to come to dialysis unit. Home
hemodialysis is a good choice for them.”
Key Opinion Leader
Related to the home-based treatment option, portable or wearable equipment that allows patients
to administer their care in the comfort of their own home or even take with them when they travel is
in demand. Portable devices are usually battery powered, but more importantly they don’t require
an external source of pure water, instead continuously filtering the water that was used and
reintroducing it back into the device. For a wearable machine, the entire package weight can be
made lighter than 10 pounds.
“I believe it [portable dialysis device] would be a future trend. Patients are free to travel, opening
the door to fulfill life experiences, while they continue to receive the renal care they need to stay
healthy.”
Key Opinion Leader
Although home use devices provide great benefits to patients and families, including QOL
improvements and cost savings, they are associated with unique risks that result from interactions
among the user, the environment, and the device, and can greatly affect patient safety. For
example, using dialysis devices outside professional healthcare facilities requires advanced health
information technology that not only ensures data security, but also allow physicians to review the
data and manage treatment remotely.
“Using cloud technology, physicians and nurses can work with those results the day after, and they
can see trends, and reflect on trends and prevent any failure from occurring.”
Key Opinion Leader

36
Unmet Needs
4.5 Shortage of Nephrology Specialists
The shortage of nephrology specialists remains another challenge for the management of patients
with chronic kidney disease in developing countries. In China, the ratio is 1 nephrologist to 15,000
patients with chronic kidney disease (Liu, 2013). The Chinese government is now considering
tasking workers, such as nurses, community health workers, or village doctors, to fill the workforce
gaps, especially in low-income areas. In this case, it may cost dialysis providers more to educate
healthcare practitioners comprehensively.
“We don’t have enough nephrology workforce for the large elderly populations [in China]. There is
not enough exposure to nephrology among medical students and residents. Because of the tense
doctor-patient relationship, trainees decline interests in neurological clinical practice.”
Key Opinion Leader
4.6 Patient Education and Training
Patients are not given sufficient information about dialysis modalities. In a study including 3,867
patients from 36 different European countries, more than half of patients indicated that they could
not freely choose their modality, and information to facilitate selection of alternative modalities
seemed suboptimal, with half of patients not remembering being presented another modality than
their current one (Van Biesen et al., 2014). The study also found that education to support the
management of kidney disease in patients’ daily and professional lives was perceived as
suboptimal. A similar situation happens in the US (Fadem et al., 2011).
“Patients involved in modality selection are more satisfied with their treatment. One of my
challenges is how to conduct patient education effectively and involve them in the decision-making
process. It has the potential to enhance individualized patient care.”
Key Opinion Leader

37
Competitive Assessment
5 Competitive Assessment
5.1 Major Players
5.1.1 Fresenius SE & Co. KGaA
5.1.1.1 Overview
Fresenius SE & Co. KGaA (Fresenius) is a global healthcare group that offers products and
services for dialysis treatment. It provides various dialysis services through its own clinics and sells
its products to other dialysis service providers. Its major manufacturing plants are in the US,
Germany, China, Sweden, and Japan. Fresenius conducts operations in Asia-Pacific, Europe,
Africa, and the Americas.
Unlike other dialysis product providers, Fresenius has transformed from a pure product supplier
into an integrated care company. As a result, sales revenue from renal care services has more
than tripled, from $5.1 billion to $17.7 billion, during the last 10 years. With 3,361 dialysis clinics in
over 45 countries, Fresenius operates the largest and most internationally diversified network of
hospitals (Fresenius, 2015). Combining the running of clinics with the manufacture of dialysis
devices has helped Fresenius dominate both equipment and service markets.
Fresenius recently created its Care Coordination business, which aims to integrate specialists into
coordinated disease management teams for each patient. On average, 10% of adults have
diabetes, and one in three of them also has chronic kidney disease (World Kidney Day, 2015).
Meanwhile, 20% of adults have hypertension, and one in five of them also has chronic kidney
disease. The needs of these patients with more than one chronic disease are largely unmet. This
program intends to offer renal patients with diabetes or circulatory diseases medical services
targeted to their needs and managed by coordinated specialists. In the US, Fresenius acquired
Sound Inpatient Physicians to gain a network of clinical physicians, and National Cardiovascular
Partners to enhance outpatient cardiovascular service. Both acquisitions strengthen Fresenius’
new Care Coordination business, which is expected to bring the company more than $1 billion
revenue (Fresenius, 2015).

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Table 4: Company Profile – Fresenius

Headquarters Bad Homburg, Germany
Website www.fmc-ag.com
Its major products and services include machines for HD, acute dialysis, and PD; solutions for infusion
Focus therapy; dialysis care services; Spectra laboratories; liver support therapy services; and provision
projects and services for hospitals and other healthcare facilities.
November 2015: entered into an exclusive agreement with Debiotech to develop a portfolio of state-of-
the-art PD technologies.
Recent Deals
July 2015: agreed to divest its dialysis services unit in Venezuela.
April 2015: entered into distribution agreement with Sequana Medical
February 2016: reported results for Q4 2015 that net revenue increased slightly, by 1% to $4,348m, as
compared to Q4 2014. Organic revenue growth was 5%.
Recent News February 2016: made an offer of $250m just a day after the bellwether trials for victims of GranuFlo and
NaturaLyte had begun.
November 2015: opened R&D center in Shanghai, China
Source: GlobalData
5.1.1.2 SWOT Analysis
Table 5: Fresenius SWOT Analysis, 2016

Largest integrated provider of products and services in the global dialysis equipment market
Strengths Vertically integrated design-production-distribution model
State-of-the-art manufacturing facilities in all major geographical regions
Product recalls and thousands of adverse events due to product defects and patient safety issues
Weaknesses
Increasing debt burden by 13.2% to $9,531.9m in FY2014
Expanding, fast-growing PD market
Maintaining and expanding strategic alliances relating to product development, distribution, and joint
Opportunities
marketing
Strategic acquisition could help the company strengthen its product portfolio and market presence
Reliance on referrals of patients from physicians and other clinicians
High competition in the renal dialysis equipment market
Threats
The nephrologists’ perception of PD being a relatively infection-prone procedure
Strict regulatory environment with various local, state, federal, and transnational laws and regulations
Source: GlobalData

39
5.1.2 Baxter International Inc.
5.1.2.1 Overview
Baxter International Inc. (Baxter) is a diversified global healthcare company that operates in two
divisions: BioScience and Medical Products. Baxter’s Medical Products business produces
intravenous solutions and other products used in the delivery of fluids and drugs to patients,
inhalation anesthetics, contract manufacturing services, and products to treat ESRD, including
solutions and other products for PD and HD. It has operations in the Americas, Middle East, Africa,
Europe, and Asia-Pacific.
The company maintains a leading position in the global healthcare market through acquisitions,
partnerships, and strategic alliances. In line with this strategy, Baxter acquired Chatham
Therapeutics, LLC; Gambro AB; Synovis Life Technologies, Inc.; Baxa Corporation; and Prism
Pharmaceuticals, Inc. In 2013, Baxter completed acquisition of Gambro for $3.9 billion. The
acquisition broadened Baxter’s dialysis product portfolio, complemented its global home dialysis
offerings, and positioned the company to better meet the needs of the global market. In addition,
Baxter built upon its pipeline of investigational home HD and automated PD systems by adding
Gambro’s novel and next-generation monitors, dialyzers, devices, and dialysis solutions. The
completion of the deal meant the combination of two of the world’s top three makers of dialysis
equipment by revenue. This strengthened Baxter’s hold on the renal dialysis products market and
potentially enabled it to usurp the market leader position of Fresenius Medical.
Baxter's worldwide revenues in 2015 totaled $10 billion and declined 7%. Adjusting for the impact
of foreign exchange and US cyclophosphamide sales, Baxter's revenues increased 3%. Sales
within the US totaled $4 billion, while international sales totaled $6 billion. Baxter's Renal Products
sales totaled $984m, representing a 1% increase on a constant currency basis, and a 9% decline
on a reported basis (Baxter, 2015). Sales growth in Q4 benefited from increased demands for PD
products and CRRT therapies and Baxter’s strong product portfolio. Baxter’s new product lines
include two new CCPD systems, HomeChoice Claria with Sharesource and Amia with
Sharesource. These new systems incorporate advanced technology and additional patient and
provider-centric improvements, enhancing Baxter's PD leadership. The launch of AK-98, Baxter's
new in-center HD system, in several countries in Eastern and Central Europe, Middle East and
Africa, Latin America, and Asia-Pacific, helps Baxter reach new customers and grow its HD
products market.

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Table 6: Company Profile – Baxter

Headquarters Deerfield, Illinois, US
Website www.baxter.com
Development, manufacture, and marketing of medical products that assist healthcare professionals and
Focus their patients in the treatment of hemophilia, immune disorders, infectious diseases, kidney disease,
trauma, and other chronic and acute medical conditions
Recent Deals August 2015: Third Point acquired 7% stake in Baxter International.
February 2016: reported results for Q4 2015 that exceeded the company’s previously issued guidance.
Recent News January 2016: announced it was voluntarily recalling four lots of intravenous (IV) solutions to the
hospital/user level due to the potential for leaking containers and particulate matter.
Source: GlobalData
Table 7: Baxter SWOT Analysis, 2016

Diverse range of products in various therapeutic areas
Rapid expansion strategies in potential international market
Combined chronic and acute portfolio to meet diverse patient needs, creating synergies and broader
Strengths
market opportunities
Strong R&D activities and robust pipeline of innovative products across the entire renal care continuum
Effective inorganic growth strategies
Patent infringement litigations
Weaknesses
Product recalls due to product defects and patient safety issues
Rapid growth of nephrology and urology devices market
Opportunities Strategic restructuring to enhance business operations and existing product line
FDA approval of new renal replacement solutions in CRRT and automated PD systems
Technological changes and new products developed by key competitors
Substantial debt, which stood at $9.3bn in FY2014
Threats
High competition in the renal dialysis market
The nephrologists’ perception of PD being a relatively infection-prone procedure
Source: GlobalData
5.1.3 B. Braun Melsungen AG
5.1.3.1 Overview
B. Braun Melsungen AG (B. Braun) is a global healthcare company that operates in four business
divisions: the Hospital Care division, which supplies hospitals with infusion, injection solutions, and
disposable medical products; the Aesculap division, which supplies products and services for all
the core processes in surgery; the Out Patient Market division, which supplies medical products
outside the hospital for chronically ill and long-term-care patients; and the B. Braun Avitum division,

41
which compiles the products and services concerning extra-corporeal blood treatment. It operates
in Europe, the Americas, Asia-Pacific, Africa, and the Middle East.
The B. Braun Avitum division provides medical systems and services for the treatment of chronic
and acute renal failure and therapeutic apheresis. This division provides services through its
dialysis centers in several countries by leveraging its capabilities to merge modern treatment
systems, consulting services, and training courses across Europe, Asia, and Africa. The B. Braun
Avitum division recorded revenue of €737.9m ($850.9m) in FY2014, reflecting an increase of
20.5% over revenue for FY2013. This segment accounted for 13.6% of the total revenue of the
company for FY2013. The company has identified emerging markets, such as Asia, Latin America,
and Eastern Europe, as an important growth market.
The company implemented certain strategic initiatives that are aimed at enhancing its business
operations and existing product line. In November 2015, the company acquired DTZ Dialyse
Trainings-Zentren GmbH, which operates 14 renal care centers in Germany, three in Austria, and
one in Italy. This acquisition further enhances B. Braun’s presence in Europe. In June 2015, the
company acquired Lauer Membran Wassertechnik GmbH, which offers water treatment systems
for dialysis. This acquisition strengthens B. Braun’s future market position as a system provider for
dialysis therapy.
Table 8: Company Profile – B. Braun

Headquarters Melsungen, Germany
Website www.bbraun.com
The company markets and sells products and services catering to basic healthcare, intensive care
Focus units, anesthesia, and emergency care sectors. The company also provides solutions for extracorporeal
blood treatment and core surgical procedures.
November 2015: acquired DTZ Dialyse Trainings-Zentren GmbH
June 2015: acquired Lauer Membran Wassertechnik GmbH, a manufacturer of water treatment
Recent Deals
systems for dialysis.
April 2015: Proxy Biomedical extended distribution agreement with B. Braun Surgical
December 2015: change in B. Braun management board
Recent News
December 2015: showcased its robust pharmacy portfolio at ASHP
Source: GlobalData

42
Table 9: B. Braun SWOT Analysis, 2016

Strong R&D capabilities, seeking to improve treatment quality and efficiency for HD and acute dialysis
Strengths Strong presence around the world
High sales and operating profit of the Hospital Care franchise
Product safety issues including a few adverse events and product recalls
Weaknesses
Patent infringement litigations with healthcare companies
Strong growth of Braun Avitum
Opportunities Newly approved products in healthcare area
Strategic expansion of the international network of dialysis centers through acquisition
Cost containment pressures from government and other reimbursement providers
Threats Intense competition from both domestic and foreign chemical manufacturers
Strict regulatory environment
Source: GlobalData
5.1.4 Nikkiso Co., Ltd.
5.1.4.1 Overview
Nikkiso Co., Ltd. (Nikkiso) is a diversified company that develops, manufactures, and markets
medical equipment and industrial instruments. Nikkiso classifies its business into three categories:
industrial, aerospace, and medical. The medical division manufactures and sells HD machines,
dialyzers, blood tubing sets, blood glucose controller, powder dialysate for HD treatment, and
CRRT products. The medical division contributed 42% of the company’s net sales in 2015. The
company has operations in Asia, Europe, and North America.
After acquisition of Baxter’s CRRT business, sales in the medical division improved 2.5% to $542m
(Nikkiso, 2015). However, other segments have had a substantial decline. Operating income fell
33.2% to $52m due to the drop in dialysis machine sales, the weaker Japanese currency, and the
temporary jump in depreciation and relocation expenses associated with the restructuring of
Japanese manufacturing bases. Nikkiso focuses on maintaining high market share in its home
market of Japan and continues to market Total System products combining with dialysis monitoring
machines and disposables. Currently, Nikkiso pays particular attention to the online
hemodiafiltration treatment segment. It has developed dialysis equipment that achieves a high level
of water purity and is facilitating the wider use of hemodiafiltration.

43
Table 10: Company Profile – Nikkiso

Headquarters Tokyo, Japan
Website www.nikkiso.com
The major products that the company offers include non-seal pump, ecoflow pump, high-flow and high-
Focus pressure diaphragm pumps, cryogenic submerged motor pump, steam/water sampling, blocker doors,
torque boxes, thrust reversers, and dialysis machines, among others.
January 2014: Nikkiso completed the acquisition of the CRRT business of Baxter International for a
Recent Deals
purchase consideration of JPY3,800m ($38.8m).
December 2015: reported revenues of JPY129,255m ($1,217m) for FY2015, an increase of 6.3% over
Recent News
FY2014.
Source: GlobalData
Table 11: Nikkiso SWOT Analysis, 2016

Strong industrial division, which accounts for 50% of the company’s revenue
Strong medical segment, which accounts for 42% of the company’s revenue
Strengths Effects on R&D, focusing on the development of artificial organs such as kidneys and pancreases, and
electronic apparatuses such as cardiovascular bypass pumps and polymer alloy membranes
Sufficient cash reserves with an increase in the cash and cash equivalents in FY2015
Declining profitability with low operating income and margins, and increasing operating expenses
Weaknesses
Increasing debt burden 23.94% to total JPY70,485m ($663.4m) in FY2015
Growing nephrology and urology devices market
Opportunities Various strategic initiatives to add new products to its portfolio including the acquisition of CRRT
business from Baxter
Threats Strict regulatory environment
Stiff competition in the renal dialysis market
Source: GlobalData
5.1.5 Nipro Corporation
5.1.5.1 Overview
Nipro Corporation (Nipro) is a provider of renal and medical surgical products, and carries out the
manufacturing, development, and sale of medical devices. The products apply to the fields of
cardiology, urology and nephrology, interventional radiology, and anesthesiology. In the field of
dialysis products, sales of hemodiafiltration filters and dialysis monitoring devices largely increased
in its domestic market and overseas in 2015. Nipro distributes its products through direct sales
forces, sales companies in Germany, Turkey, Switzerland, England, Serbia, and South Africa, and

44
through a distribution agent in South Korea. It has manufacturing facilities located in Japan, Brazil,
Spain, and the US.
Table 12: Company Profile – Nipro

Headquarters Osaka, Japan
Website www.nipro-global.com
Renal products, interventional and anesthesiology products, injection and infusion products,
Focus
cardiopulmonary products, diabetic products, and enzymes products, among others.
October 2015: Sinocare acquired Nipro Diagnostics from Nipro for $273m
Recent Deals
September 2015: Nipro entered into a definitive agreement to acquire Infraredx, Inc.
March 2015: reported revenues of JPY325,084m ($3,060m) for FY2015, an increase of 8.1% over
FY2014.
Recent News
November 2014: introduced the first dialyzer in the US without bisphenol A or bis(2-ethylhexyl)
phthalate at the American Society of Nephrology Kidney Week 2014
Source: GlobalData
Table 13: Nipro SWOT Analysis, 2016

Strong performance of medical-related segment
Strengths Increasing profitability with high operating income and margins
Strong R&D capabilities with two R&D facilities in Japan and the US
Product safety issues, which led to two recalls of several glucose monitors and safety scalp vein sets in
Weaknesses 2014
Increasing debt burden in FY2015 by 5.89% over the previous year
Approvals of a few new products including ELISIO-H Hemodialyzer
Opportunities
Strategic expansion initiatives on production capacity
Threats Stringent government regulations
Stiff competition in the renal dialysis market
Source: GlobalData
5.1.6 Asahi Kasei Corporation
5.1.6.1 Overview
Asahi Kasei Corporation (Asahi Kasei), formerly Asahi Chemical Industry Co. Ltd., is a holding
company of Asahi Kasei Group. The products apply to the fields of chemicals and fibers,
electronics, healthcare, and construction. Asahi Kasei markets its products under various brand
names, such as Hebel Haus, Atlas, Pimel, Elcitonin, Hebel Maison, Planova, Eazet, Neoma,

45
Sunfort, and Hipore, through its subsidiaries. The company has operations in various countries
including the UK, Belgium, Thailand, France, Germany, the US, Japan, Italy, Spain, Taiwan,
Indonesia, and Korea. In FY 2014, sales of dialysis products in Japan were affected by decreased
reimbursement prices, but sales in the US and China were firm.
Table 14: Company Profile – Asahi Kasei

Headquarters Chiyoda-ku, Japan
Website www.asahi-kasei.co.jp
The company’s product portfolio includes polymers, acrylonitrile, caustic soda, styrene, diagnostic
Focus
reagents, nutritional products, contact lenses, medical devices, and electronic products.
Recent Deals June 2015: Zoll Medical, a subsidiary of Asahi Kasei, acquires Kyma Medical for $35m
March 2015: reported revenues of JPY1,986,405m ($18,692m) for FY2015, an increase of 4.7% over
Recent News
FY2014.
Source: GlobalData
Table 15: Asahi Kasei SWOT Analysis, 2016

Expertise in R&D with a network of established R&D centers and laboratories
Strengths Broad product portfolio and diverse end markets
Strong presence in its domestic market
Increasing receivables of total JPY324.05bn ($3.05bn) and inventory levels to JPY339.67bn ($3.20bn)
Weaknesses
in FY2015
New products launch including XIAFLEX injection and a new optical polymer AZP
Opportunities Growing nephrology and urology devices market
Strategic expansion initiatives to increase annual production capacity
High raw material price risks
Threats Intense competition from both domestic and foreign players
Source: GlobalData
5.1.7 NxStage Medical, Inc.
5.1.7.1 Overview
NxStage Medical, Inc. (NxStage) is a medical device company that develops, manufactures, and
markets products for the treatment of kidney failure, fluid overload, and related blood treatments
and procedures. Its main product is NxStage System One, which is indicated for the treatment of
acute and chronic renal failure by using hemofiltration, hemodialysis, and ultrafiltration for both

46
clinic and home use. NxStage also develops the Pureflow SL dialysate preparation system, which
is an integrated system that is designed to produce ultra-pure product water from ordinary tap
water. The company has a presence in Germany, the US, Italy, the UK, and Mexico.
Table 16: Company Profile – NxStage Medical

Headquarters Lawrence, Massachusetts, US
Website www.nxstage.com/
Products for the treatment of kidney failure, fluid overload, and related blood treatments and
Focus
procedures.
Recent Deals November 2010: completed a public offering of its common stock, for gross proceeds of $66.1m.
February 2016: presented abstracts highlighting benefits of its Nx2me Connected Health technology as
well as those seen in programs with increased home hemodialysis training volume in 2016 Annual
Recent News Dialysis Conference
January 2016: NxStage Kidney Care, Inc., a subsidiary of NxStage Medical, Inc., announced the
opening of its dialysis center in Germantown, a suburb of Memphis, Tennessee, US.
Source: GlobalData
Table 17: NxStage Medical SWOT Analysis, 2016

Innovations in several product lines, including home HD machines, PD machines, and CRRT machines
Strengths Focusing on product improvement and user experience
Fast growing in the renal dialysis equipment market
Relatively narrow product portfolio
Weaknesses
New player in the renal care area
Opportunities
Approvals of a few new products including System One home hemodialysis machine
Threats High competition in the renal dialysis market
Physicians’ and patients’ acceptance of home-based therapy
Source: GlobalData
5.1.8 Toray Medical Co., Ltd.
5.1.8.1 Overview
Toray Medical Co., Ltd. (Toray Medical), a subsidiary of Toray Industries, Inc., is a medical device
company that provides pharmaceutical products, medical devices, and related services. It offers
machines and equipment for dialysis, such as a reverse osmosis water purification system, multi-
patient dialysate supply system, dialysis machines, and monitors. Along with Filtryzer, Toray

47
Medical launched a dialysis monitor with precise UF volumetric control function. Toray Medical’s
original double-chamber system was adopted in various types of dialysis monitors and single-
patient dialysis machines of following generations. Toray Medical also developed a new series of
Toraysulfone and Toraylight dialyzers made of polysulfone membrane, and hemofilters for CRRT.
The company has manufacturing facilities in Shizuoka, Okazaki, Seta, Shiga, and Mishima.
Table 18: Company Profile – Toray Medical

Headquarters Chuo-ku, Japan
Website www.toray-medical.com
The company’s products include home hemodialysis machines, hemodialyzers, dialysis machines,
blood purification devices for intensive care, balloon catheter for percutaneous trans-mitral
Focus
commissurotomy, indwelling vascular catheter for hepatic arterial infusion chemotherapy, and X-ray
protective eyewear.
June 2011: Toray Industries, Inc. and its subsidiaries Toray Medical Co., Ltd. and Toray Industries
Recent Deals (China) Co., Ltd. formed a joint venture with Qingdao Jifa Group Co., Ltd. for manufacture and sales of
HD machines and artificial kidneys.
January 2012: decided to build a new plant to manufacture artificial kidneys at Toray Medical (Qingdao)
Recent News
Co., Ltd.
Source: GlobalData
Table 19: Toray Medical SWOT Analysis, 2016

Innovations in several product lines
Strengths More than 30 years of sales experience in the APAC market
Expansion strategies in China
Weaknesses Relatively narrow portfolio
Opportunities High demand of renal dialysis products in China
Threats
High competition in the renal dialysis market
Source: GlobalData
APAC = Japan, China, and India

48
5.2 Emerging Players
5.2.1 Medtronic plc
5.2.1.1 Overview
Medtronic, plc (Medtronic), formerly Medtronic, Inc., is a medical technology company that
develops, manufactures, and markets a wide range of medical devices, therapies, and services
used in the treatment of chronic conditions such as heart disease, spinal conditions, neurological
disorders, vascular disease, and diabetes. The company sells its products through its direct sales
force in the US and a combination of direct sales representatives and independent distributors in
markets outside the US. The company serves physicians, patients, and clinicians in Asia-Pacific,
Europe, the Americas, the Middle East, and Africa.
Medtronic recently
Medtronic recently formed its renal care solutions business as part of the Minimally Invasive formed its renal
care solutions
Therapies group's Patient Monitoring & Recovery division. In 2015, Medtronic acquired Covidien, business as part of
the Minimally
the leading provider of the dialysis catheter market. On February 1, 2016, Medtronic announced Invasive Therapies
group's Patient
that it acquired privately held Bellco, an Italian HD treatment solutions company. In addition, Monitoring &
Recovery division.
Medtronic will enter the kidney dialysis business in collaboration with India’s Apollo Hospitals
Enterprise Ltd. Medtronic is developing a low-cost, portable approach for patients in the developing
world, who are less likely to have access to service offered on machines made by Fresenius and
Baxter, and need other options that don’t require as much water and infrastructure.
Table 20: Company Profile – Medtronic

Headquarters Dublin, Ireland
Website www.medtronic.com
Its major products include aortic and peripheral vascular products, cardiac rhythm and heart failure
products, coronary and structural heart products, advanced surgical technologies and general surgical
products, medical supplies, respiratory and monitoring solutions, venous solutions, diabetes services
Focus
and solutions, intensive insulin management solutions, non-intensive diabetes therapies,
neuromodulation and neurovascular devices, orthopedic and spine products, surgical technologies, and
renal care solutions.
February 2016: acquired Bellco S.r.l., a company engaged in HD treatment solutions.
Recent Deals
January 2015: successfully completed the previously announced acquisition of Covidien plc.
March 2016: Medtronic announced financial results for Q3 2016. The Minimally Invasive Therapies
Group (MITG) contains most of the legacy Covidien business that was acquired in late January 2015
Recent News and therefore was not reported as part of legacy Medtronic in Q3 2015. MITG worldwide revenue of
$2.291bn increased 5%, a strong quarter for the group, with Surgical Solutions growing above market
and Patient Monitoring & Recovery growing at market.
Source: GlobalData

49
Table 21: Medtronic SWOT Analysis, 2016

Strong presence in the global medical devices market
Strengths Expertise in developing and acquiring new products
Business combination with Covidien, having a diverse growth profile and wide geographical coverage
New player in the renal dialysis products market
Weaknesses
Dialysis product portfolio that is not comprehensive
Opportunities
Expansion strategies in India
Threats High competition in the renal dialysis market
Source: GlobalData
5.3 Marketed Products Assessment
5.3.1 HD Machines
One key trend for HD machines is to give physicians treatment flexibility. New designs of HD
machines usually include blood volume monitors, dialysis dose monitors, and other advanced
monitoring devices to help physicians analyze dialysis adequacy and tailor personalized therapy to
meet the needs of individual patients. The new HD machines that were made in Japan feature
functions of online hemodiafiltration. HD machines from B. Braun and NxStage are indicated for
both acute and chronic kidney failure. Most HD machines are standalone HD machines, except for
NxStage System One. Notably, it is the only portable hemodialysis system FDA-cleared for home
hemodialysis and home nocturnal hemodialysis.
In addition to basic HD function, most of the current HD machines have features to reduce
caregiver workload. Touch screen interfaces have been used for all new HD machines. Fresenius’
HD machine 2008T introduces advanced information technology to allow clinicians to access
patient information directly.

50
Table 22 below highlights some of the major brands of HD machines marketed by the most
prominent renal dialysis devices companies.
Table 22: Key Marketed HD Machines

Manufacturer Product Name Key Features Territory
Offering a modular design for maximum treatment versatility, introducing vascular access
Fresenius 2008K series US
surveillance with online clearance with access flow, being used in center or at home
Accessing clinical medical information systems directly, reducing risks associated with cross-
Fresenius 2008T US
contamination of dialysis and management information system equipment
5008 VorDiax
A high convective therapy—mixed hemodiafiltration, enabling high-volume hemodiafiltration,
Fresenius & 5008S EU
easy handling, efficient and sustainable
CorDiax
Diascan system and a completely new user interface, flexibility in fluid preparation and saves
Baxter AK96 water, concentrates, and staff effort, a compact lightweight body with smooth-lock wheels, EU
convenient and cost-effective disinfection strategies
Easy-to-use touch screen, quality-assured HD system that helps healthcare professionals reach
EU and
Baxter AK98 treatment targets for patients, improvement in customer efficiency and reduces total cost of
APAC
ownership due to an open system aligned with clinical procedures
Providing high-flux and low-flux HD, hemofiltration, and ultrafiltration, real-time Kt/V monitoring
Baxter Phoenix X36 through the Diascan Monitoring System, compensated blood flow, full-color touch screen, and US
sodium and ultrafiltration profiling
Compact design, user-friendly interface with 12.1-inch color touch screen, good performance
Nikkiso DBB-27 with single pump, single needle, dialysate filter, and network connection, safety monitoring, and Japan
easy maintenance
Simple design, stable performance for HD, hemofiltration, hemodiafiltration, and online
Nikkiso DBB-05 Japan
hemodiafiltration, user-friendly interface, solicitous measures for safety, easy maintenance
Nikkiso DBB-06 Easy-to-read screen for better operations, individually customized background color Japan
Fulfilling the requirements for high-quality therapies, double-dialysate filters for online
Nikkiso DBB-07 Japan
hemodiafiltration with further purification of dialysate
Dialog+ A dialysis system that can be used for patients with acute or chronic kidney failure, a high-
Hemodialysis permeability HD system, obtaining effectiveness information on the patient's HD treatment during
B. Braun US
System with a double-needle procedure by continuously measuring the UV absorption in the spent dialysate
Adimea line, providing the Kt/V calculation to measure of dialysis treatment effectiveness online
Humanized design, convenient operation, safety and reliability of treatment, optional functions of
Toray TQS-88 Japan, EU
online hemodiafiltration
Precise uniform flow control, safe and comfortable dialysis for patients and easy operation for
medical personnel, 5.7-inch liquid-crystal display touch panel and easy-to-handle control panel,
Toray TR-FX the option of automatic blood pressure monitoring, hot water disinfection, concentrate piping, Japan
one-piece type endotoxin cut filter, automatic power backup system, disinfectant bottle and bottle
holder
Asahi Kasei MDS-101 Compact design, operation with touch panel, secured ultrafiltration system, easy maintenance EU
US, EU,
NxStage A highly permeable hemodialyzer intended for the treatment of acute or chronic renal failure, Australia,
NxStage
System One delivering hemofiltration or ultrafiltration at home or in travel. New
Zealand
Source: GlobalData

51
5.3.2 PD Machines and Systems
Table 23 highlights some prominent brands of PD machines. Baxter dominates the PD machines
market with a competitive product portfolio designed for a wide range of the market. Fresenius has
introduced new devices Sleepsafe Harmony and Liberty cycler for PD. Mirroring the trends of HD
machines, new PD machines feature improved user interfaces and expanded therapy options. For
the PD systems used for CAPD, the design places emphasis on preventing contamination and
reducing infection.
Table 23: Key Marketed PD Machines

APD system, guided prescription directly on the device, optimized
France,
Sleepsafe fluid usage and barcode recognition of fluid bags, large touch
Fresenius Germany,
harmony screen with animations, integrated handles, PatientCardPlus with
Spain
more than 12 months patient treatment data
APD system, large color touch screen and graphical user interface,
Fresenius Liberty cycler US
provides options for both time-based and cycle-based programs
CAPD system, replaces the traditional clamping and unclamping
Fresenius Staysafe steps with a simple dial, eliminating the need for patients to mask US, Japan
and wash their hands prior to disconnect
Easy-to-use touch screen with a graphical user interface and voice
Amia with guidance, automatic transfer of data between patient and clinic
Baxter US
Sharesource through Sharesource technology, more compact size and modern
design
HomeChoice & APD system, providing automatic control of dialysate solution
Baxter US
HomeChoice Pro exchange during peritoneal dialysis therapy
APD system, Sharesource is a two-way, web-based remote
HomeChoice
connectivity platform for home therapy that allows physicians to
Baxter Claria with EU, Asia
more readily access their home patients' historical treatment data
Sharesource
and deliver individual treatment settings remotely.
Serena APD APD system, a home-based cycler, BREAKpoint software that
Baxter EU
Cycler provides flexibility to personalize patient's prescription automatically
CAPD system, special design features that enhance flush,
Baxter Ultrabag System decreasing backflow and protecting fluid path from touch US
contamination
Source: GlobalData
5.3.3 CRRT Machines
Table 24 below highlights key players in the CRRT machines market. CRRT is underutilized in
patients with acute kidney injury due to lack of awareness and education. Currently, there are not
many products in the CRRT machines market. The design of CRRT machines usually includes
safety-focused and user-friendly features.

52
Table 24: Key Marketed CRRT Machines

Large and adjustable touch screen, citrate and calcium pumps, clear
separation of fresh and used fluids, hygienic operation, heparin pump,
four rotatable wheels with 2-stage locking system, air-free pressure
Fresenius MultiFiltratePRO Germany
measurement units, blood and fluid pumps with automated insertion
and ejection of all pump segments and clamps for return as well as
access bloodlines.
Automated and integrated anticoagulation through pre-blood pump and
syringe pump, accurate fluid management, streamlined alarm
management to minimize multiple-alarm situations, patented deaeration
Baxter Prismaflex US
chamber, innovative sterile solutions, touch-screen interface, integrated
conveniently with hospital information system, automated pressure
monitoring and calibration, complete system with proven hemofilter sets
Source: GlobalData
5.3.4 PD Solutions
The PD solutions segment leads the PD products market due to high-volume use in every
treatment. However, the use of PD solutions with high concentrations of glucose, glucose
degradation products and lactate, high osmolality, and low pH, is harmful both for the peritoneum
and the patient. Newer PD solutions with alternative buffers, a higher pH, and fewer glucose
degradation products, or ones that contain icodextrin or amino acids as osmotic agents, have been
shown to improve peritoneal membrane health. Icodextrin solution enhances fluid and sodium
removal, and the once-daily use of icodextrin can reduce the harmful effects caused by the
exposure of the peritoneal membrane to glucose. Use of PD therapy, with or without the newer PD
solutions, is associated with an improvement in patient survival that is equivalent to that obtained
with HD. Therefore, the conventional glucose-based solutions continue to have a well-established
role in PD therapy, particularly in the many countries where the newer PD solutions are not easily
available.

53
Table 25: Key Marketed PD Solutions

Product
Manufacturer Key Features Territory
Name
France,
An infusion of 2,000ml solution per exchange four times a day, improved
Fresenius Balance Germany,
biocompatibility; preserved membrane defense; reduced risk of peritonitis
Spain
Being used for CAPD, an infusion of 2,000ml solution per exchange four
Fresenius BicaVera times a day, improved biocompatibility; preserved membrane defense; EU
improved correction of acidosis
Baxter Dianeal Easy to manufacture, low cost US
Containing icodextrin, sustained ultrafiltration; reduced hyperglycemia;
Baxter Extraneal Global
improved metabolic profile and body composition
Containing amino acids, avoiding glucose exposure; peritoneal membrane
Baxter Nutrineal Global
protection; enhanced nutrition
Double chambers, improved biocompatibility; preserved membrane
Baxter Physioneal Global
defense; reduced infusion pain
Source: GlobalData
5.3.5 Dialyzers
Dialyzers play a key role in the HD products market. Currently, there are numerous products
available in the market. Membrane performance, as determined by the effectiveness of solute
clearance and biocompatibility, is the greatest feature to differentiate products. Technological
advances in membrane design, chemical composition, and sterilization methods lead to enhanced
performance and versatility. Table 26 below highlights some of the major brands of dialyzers
marketed by the most prominent renal dialysis devices companies.
Based on different membrane permeability or flux, dialyzers are categorized into high- and low-flux
dialyzers. Generally, high-flux dialyzers should be used preferentially. Patients with diabetes, lower
serum albumin, or longer dialysis vintage should be considered a priority for selection of high-flux
dialyzers. The use of high-flux dialyzers is now widespread worldwide and will increase further as
convective therapies that require use of these filters, including hemodiafiltration and hemofiltration,
become established (Blankestijn et al., 2010). However, factors such as cost should be considered.
The 2015 Kidney Disease Outcomes Quality Initiative Hemodialysis Adequacy Guideline
recommend the use of biocompatible, either high- or low-flux HD membranes for intermittent HD
(National Kidney Foundation, 2015). Further research needs to be done to understand the benefit-
cost ratio of high- versus low-flux membranes.

54
There are disposable and reusable dialyzers. Reuse is considered safe as long as the dialyzer is
cleaned before each use. A recent study shows that minimally reused high-flux filters were
associated with reduction in the hazard ratio for mortality, having a benefit for hypoalbuminemic
patients and possibly for diabetics (Argyropoulos et al., 2015). On the other hand, reuse of
dialyzers is sometimes associated with environmental contamination, allergic reactions, residual
chemical infusion, inadequate concentration of disinfectants, and pyrogen reactions. In the
developed world, reuse of dialyzers is either prohibited by law, in the European Union and Japan,
or not practiced as a result of operational protocols for the majority of the dialysis providers, in the
US. In developing countries and regions, a dialysis center may use the same dialyzer more than
once per patient for socio-economic reasons.

55
Table 26: Key Marketed Dialyzers

Optiflux
A polyethersulfone fiber dialyzer, providing volumetric fluid balancing,
Fresenius F25ONR US
allowing precise water removal, and increasing patient comfort
dialyzer
Including F160, F180, F190, F210, F230 polysulfone dialyzers,
differentiating on the membrane surface area; being used for acute or
Fresenius Optiflux series chronic renal failure; electron beam or EtO sterilization; high, small, and US
middle molecule clearance; good endotoxin barrier; high and low flux
available
Being used for high-volume hemodiafiltration, increased fiber lumen for
EU,
Fresenius FX CorDiax better flow conditions, optimized fiber design for better removal of
Japan
uremic toxins
Xenuium A polyethersulfone fiber dialyzer, high-flux, single-use, sterilization and
Baxter Global
Hemodialyzer priming
Three-layer membrane, sterilization and priming, Baxter’s most popular
Baxter Revaclear US
dialyzer
Baxter Ployflux Designed for reuse, high-flux, steam-sterilized US
Baxter Exeltra High-flux, single-use US
A high-flux polynephron dialyzer, performing therapies such as HD,
ELISIO-H
Nipro hemofiltration, hemoconcentration, and hemodiafiltration, high removal US
Hemodialyzer
of small molecules and low-molecular-weight proteins
A polyethersulfone hollow fiber dialyzer, performing therapies such as
Pureflux-H
Nipro hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration, US
Hemodialyzer
higher clearance of low-molecular-weight protein and less albumin loss
Pureflux-L A polyethersulfone fiber dialyzer, performing therapies such as HD, US and
Nipro
Hemodialyzers hemofiltration, hemoconcentration, and hemodiafiltration EU
Using hydrophobic PEPA membrane, which has characteristic three-
layer structure with endotoxin blocking and adsorbing ability, not
Nikkiso FL series Japan
containing polyvinylpyrrolidone, high biocompatibility, and less
complement activity.
Good antithrombogenicity, suppressing polyvinylpyrrolidone elution
while keeping small-molecule removal capability, good clearance of low-
Nikkiso FD series Japan
molecular-weight protein with minimum loss of albumin, characteristic
feature of endotoxin blocking and adsorbing ability kept in its integrity
Diacap
A sterile, high-permeability dialyzer, composed of polysulfone hollow
Polysulfone
B. Braun fiber capillary membranes in a polycarbonate housing with a US
HiFlo 23
polyurethane potting resin and a silicone O-ring
Hemodialyzer
Consisting of amembris membrane for the filtration of blood, good in
Xevonta High small-molecule clearance, optimal selectivity for maximal ß2m-
B. Braun EU
Flux Dialyzer elimination with simultaneous minimal albumin loss, biocompatibility,
high endotoxin retention, and minimum rinse volume
US, EU,
Polymethylmethacrylate membrane, good biocompatibility and well-
Toray Filtryzer series and
balanced removal capability of small and middle molecular substances
Japan
Toraysulfone US and
Toray Polysulfone membrane, obtaining uniform flow of dialysate
series EU
Leoceed series Lightweight, ecological design, European-made, high and low flux
Asahi Kasei Japan
hemodialyzer available

56
Asahi Kasei APS series High-flux polysulfone dialyzers, the bestseller of Asahi Kasei’s dialyzers EU
Polysulfone dialyzer, good clearance ability for small and middle-sized
Asahi Kasei Rexeed series US
molecules, high and low flux available
Asahi Kasei Vie series Vitamin E-interactive polysulfone membrane, high and low flux available Japan
Asahi Kasei KF-201 series A synthetic low-flux dialyzer with good biocompatibility Japan
Streamline
Express Reducing the amount of labor required for machine set-ups, reducing
Dialyzer With the number of touch point contamination sites, including a single-use,
NxStage US
Pre-attached gamma-sterilized dialyzer, indicating for the Fresenius 2008 and B.
Blood Tubing Braun HD machines
Set
Source: GlobalData
5.4 Pipeline Assessment and Key Clinical Trials
5.4.1 Pipeline Assessment
Table 27 below highlights some of the major pipeline products designed by the most influential
renal dialysis devices companies. The key pipelines in the renal dialysis devices area include home
HD machines, portable HD devices, a new generation of PD and CRRT machines with better
performance and wireless connectivity, and dialyzers with advanced membrane performance.
In addition, innovative projects collaborated between research institutes and start-up companies
are eye-catching and impactful. For example, Nephron+, supported by the EU with nearly €5m
($5.6m), focuses on the developing of the wearable artificial kidney, which uses advanced
nanofiltration technology and does not require large quantities of water (Nephron+, 2014). With this
solution, patients could receive continuous HD wherever they are and stay mobile and active in
social and economic life. The device is currently undergoing pre-clinical trials and will have to pass
several rounds of stringent tests before it is available for the market.

57
Table 27: Key Pipeline Products

Territory
Product and
Description Manufacturer
Name Launch
Date
Portable Artificial Kidney is a Class III device. It is intended for HD to
treat kidney failure. It is designed to remove waste products such as
Portable creatinine, urea, and free water from the blood during renal failure. It is US
Artificial based on Sorbent Technology. The device can be easily dismantled in Fresenius in approval
Kidney to two portable sections that are easy to transport and can be process
assembled without the help of a technician. It needs six liters of
portable tap water for HD treatment.
Artis Dialysis System is an HD machine intended for the treatment of
renal failure. It is designed for continuous therapy adjustments to the
status of the patient for better comfort and more consistent delivery of China
Artis Dialysis
the prescription. It consists of a touch-screen interface, placing the Baxter December,
System
user in control and facilitating the decision-making process. It has a 2017
blood circuit for the extracorporeal blood circulation that significantly
reduces the number of user actions and risks of misuse.
Global
Next Gen Next Gen ICHD Monitor is intended to be used during HD procedures.
Baxter December,
ICHD Monitor It is designed to monitor in-center high-dose HD.
2019
PrismaLung is a membrane gas exchange device intended to be used US
during renal replacement therapy. It is designed to facilitate CO 2
PrismaLung Baxter December,
elimination and pH compensation. It is indicated for hypercapnic,
ventilated, and renal replacement therapy. 2016
PrisMAX is intended to be used for CRRT. It is designed to slow fluid US

removal and support patient recovery. It is a substitute for impaired
PrisMAX Baxter December,
renal function over an extended period. It features a touch screen
and step-by-step automated instructions to enhance ease of use. 2016
Theralite is a protein-permeable membrane intended for the treatment

of myeloma kidney. It is designed to reduce free light chains (FLCs) in
combination with effective dialysis treatment. It is based on High Cut- US
Theralite off Technology. Abnormal levels of FLCs in myeloma patients’ blood Baxter October,
reach the kidneys and enter the distal tubules and form waxy casts 2018
(cast nephropathy) that block the flow of urine and cause interstitial
inflammation, which leads to acute kidney injury.
Theranova 400 Dialyzer is intended to be used for treatment of renal US
Theranova failure. It is designed to sieve the middle molecules such as β2-
Baxter December,
400 Dialyzer microglobulin (β2-m) while restricting the loss of vital albumin during
HD. It contains a membrane with large pore sizes. 2016
VIVIA HD System is a portable home dialysis device intended for

treatment of ESRD. It is designed to deliver more frequent, extended
duration, short daily or nocturnal home dialysis, known as high-dose
HD therapy. It offers better cleansing of the blood of wastes, salt, and
water while the patient is sleeping at night. Its touch screen and
VIVIA graphic user interface displays large, easy-to-comprehend graphics US
Hemodialysis and animations that help guide patients through setup, treatment, and Baxter
System clean-up. It has an Access Disconnect Sensor that causes the system July, 2018
to stop pumping if the needle dislodges. It also has one-button fluid
infusion to help minimize user error and promote additional safety for
the patient. It includes the fully integrated Sharesource wireless
connectivity platform that allows physicians and nurses to
comprehensively monitor home therapy remotely.

58
Next US
Next Generation NxStage System One is an HD machine intended to
Generation
treat renal failure. It is designed to remove waste products from the NxStage December,
NxStage
blood in patients with acute and chronic renal failure. 2016
System One
NxStage US
System One - NxStage System One - Peritoneal Dialysis is a portable dialysis
NxStage December,
Peritoneal system intended for PD to treat chronic renal failure.
Dialysis 2017
Next Generation Critical Care System is a hemodialyzer intended for

CRRT in critical care settings. It is designed to provide HD,
Next US
hemofiltration, or isolated ultrafiltration in acute renal failure patients. It
Generation
has a simplified one-view display that provides real-time treatment NxStage January,
Critical Care
information as well as easy troubleshooting capabilities. It provides 2022
System
therapeutic and practical advantages as well as multiple therapy
options from a single, efficient, portable machine.
APS
Polysulfone- APS Polysulfone-Membrane Artificial Kidney - New Version is a Global
membrane dialysis device intended to treat renal failure. It is designed to replace
Asahi Kasei January,
Artificial the damaged kidney to pump blood and clean wastes from the blood. It
Kidney - New also monitors the blood flow. 2024
Version
Hemodialysis Equipment is a hemodiafiltration machine intended for
dialysis therapy to treat renal failure. It is designed to pump blood and Global
Hemodialysis monitor the blood flow to clean wastes from the blood. It is used to Asahi Kasei
Equipment monitor blood pressure and the rate of fluid removal from the body. It September,
JMS
uses the Qs control function that automatically controls the amount of 2020
replacement fluid to maintain pressure on the filter membrane surface.
Portable Hemodialysis System is an extracorporeal dialysis system
Portable India
intended for renal replacement therapy. It is designed for removal of
Hemodialysis Medtronic
waste products such as creatinine, urea, and free water from the blood July, 2016
System
in hospitalized patients with ESRD.
Source: GlobalData
5.4.2 Key Clinical Trials
Current clinical trials in the area of renal dialysis products focus on the safety and efficacy of
pipeline products. For example, several trials target the equivalency of home-based dialysis
equipment, including Fresenius’ PD machine, Baxter’s HomeChoice and VIVIA Hemodialysis
System, and NxStage’s System One. Some trials in the area of home dialysis are associated with
assessing the frequent, extended-duration, nocturnal home high-dose therapy. One trial aims to
provide preliminary data regarding a portable device, Wearable Artificial Kidney. A number of trials
compare the safety, performance, and hemocompatibility of innovative dialyzers. The key
competitors involve Baxter’s Theranova 400, Fresenius’ Cordiax Fx-800, and Nipro’s ELISIO-15H.
In addition, companies and researchers pay special attention to a new generation of CRRT

59
equipment and its application. Table 27 below shows key clinical trials in the renal dialysis
equipment area recently.
Table 28: Key Clinical Trials

Clinical Trial Sponsor/
Trial Title Trial Status Product Name Territory
Identifier Company
A Randomized, Multicenter,
HomeChoice/Ho
Crossover Study Comparing NCT02525497
Ongoing, not meChoice Pro
the Domestic FM Peritoneal GDME2028454 Baxter China
recruiting Automated
Dialysis Machine with Baxter MD-PD-2014
Personal Cycler
HomeChoice
DSU-D
Benefits of the Nephros Dual Ultrafilter;
Stage Ultrafilter in Chronic DIASAFE plus
Fresenius,
HD Patients: Evidence for GDME2030129 Completed filter; EXELTRA US
Baxter
Improved ESA Dialyzer High-
Responsiveness Flux, Single-Use
Dialyzers
Comparison of the Clinical
Theranova 400
Performance of 2 Theranova
Dialyzer;
400 Dialyzer Prototypes in NCT02377622
CorDiax FX 80
HD with a High-flux Dialyzer GDME2026492 Fresenius Completed Germany
dialyzer;
in HD and a High-flux 1407-001
CorDiax FX 800
Dialyzer in hvHDF: A Pilot
Dialyzer
Study
First 24 Hour Human Trial of
NCT02280005 Ongoing, not Wearable
the Wearable Artificial Fresenius US
GDME2024942 recruiting Artificial Kidney
Kidney
HD With The 2008 Sorbent
NCT01437761
System: A Pilot Evaluation Ongoing, 2008 Sorbent
GDME1006260 Fresenius US
Of Different Treatment recruiting System
150-11
Prescriptions
A Clinical Study Comparing
the Basic Performance and ELISIO 15H PP
Blood Compatabilty Synthetic
NCT02433210 University of
Characteristics of Nipro Hemodialyzer;
GDME2027420 Missouri, Planned US
ELISIO-15H, Gambro Optiflux 160NR;
1214453 Nipro, Baxter
Polyflux Revaclear and Polyflux
Fresenius Optiflux 160 NR Revaclear
Dialyzers
Low Flow CO2 Removal via
a Membrane Gas Exchange
Device (Prismalung) on a University of
NCT02590575
Renal Replacement Platform Erlangen- Ongoing, Prismaflex; Pris
GDME2029374 Germany
(Prismaflex) in Hypercapnic, Nurnberg, recruiting maLung
SZ_G_023.14-II-4
Ventilated Patients Baxter
Requiring Renal
Replacement
DEKA
U.S. Clinical Trial for VIVIA Research and VIVIA
Ongoing,
Investigational Home GDME2030706 Development Hemodialysis US
recruiting
Hemodialysis System Corporation, System
Baxter

60
Clinical Study to Elucidate

the Potential Effect of
Dialyzer Leaching of BPA University of ELISIO 15H PP
NCT02627118 Ongoing,
from the Fresenius Optiflux Connecticut Synthetic
GDME2029808 recruiting by US
160NR When Compared to Health Center, Hemodialyzer;
15-156-3 invitation
a Non-BPA Containing Nipro, Baxter Optiflux 160NR
Dialyzer, the Nipro ELISIO-
15H
Elisio-H
Hemodialyzer; N
Test of the Nipro ELISIO H NCT00735059
EXcorLab ext Generation
Dialyzer in Different Dialysis GDME2016649 Completed Belgium
GmbH, Nipro ELISIO
Treatment Procedures KSEL0702
POLYNEPHRO
N
Comparison of Nocturnal
NxStage System
Hemodialysis (NHD) and NCT00667511
One - Nocturnal
Short Daily Hemodialysis GDME1002189 NxStage Completed US
Home
(DHD) with the NxStage CP0010
Hemodialysis
System One
Source: GlobalData
The GDME numbers describe the codes in the GlobalData database.

61
Market Outlooks
6 Market Outlooks
6.1 Procedure Trends
6.1.1 Vascular Access
Instead of an AV graft and a catheter, clinical practice guidelines recommend an AV fistula as the
preferred vascular access due to its low complication rate and longer lifespan. Despite the
emphasis on improving AV fistula success rates, at the time of initial dialysis 80% of patients in the
US are using a catheter; at 90 days after initiation of dialysis, 68.3% of HD patients were still using
a catheter; eventually, approximately 62.5% of prevalent dialysis patients were using an AV fistula
(USRDS, 2016). With improvements in pre-dialysis care during the critical transition period to
ESRD, this suboptimal practice pattern will be improved. A national campaign called “Fistula First,
Catheter Last,” encourages facilities to reach the target rate of 68% of patients on fistulas (National
Kidney Foundation, 2015).
As illustrated in Figure 4, nearly 60% of HD patients were using an AV fistula only, and about a
third of patients used a catheter in 2015 in the 10MM. Because of an advanced dialysis healthcare
system, Japan had the highest AV fistula usage rate of 82% and the lowest catheter usage rate of
5%. In contrast, about half of Indian patients used catheters, which was the highest rate among the
countries covered by this report. Table 29 shows procedure volumes for vascular access in the
10MM in 2015.

62
Market Outlooks
Figure 4: Global Procedure Trends for Vascular Access in the 10MM, 2015
100%
5%
90% 22% 25% 13% 24%
29% 29% 27%
80% 36% 37%
47%
70% 11% 7%
20% 6% 11%
14% 5%
60% 4%
50% 6%
40% 82%
65% 64% 69%
30% 58% 57% 59% 62% 59%
47%
20%
10%
0%
Spain
Japan
China
India
France
US
UK
Italy
Brazil
Germany
Fistula Graf t Catheter
Source: GlobalData
Table 29: Global Procedure Volumes for Vascular Access in the 10MM, 2015
Country US France Germany Italy Spain UK Japan Brazil China India Total
Fistula 266,896 26,871 52,204 42,304 14,588 15,499 259,577 91,587 205,463 22,032 997,019
Graft 104,731 6,293 9,433 6,518 1,585 3,025 42,743 9,384 25,136 3,305 212,153
Catheter 93,962 12,131 17,641 17,742 8,343 6,307 15,912 44,071 65,573 17,111 298,794
Source: GlobalData
Figure 5 and Table 30 show global procedure trends and volumes for vascular access in 2022.
Based on the primary survey and interviews with nephrologists, GlobalData forecasts the use of
catheters will decrease by 6% globally by 2022. With significant declines of 14% and 15%,
physicians in Brazil and India will greatly reduce the use of catheters and improve the quality of
vascular access procedures.

63
Market Outlooks
Figure 5: Global Procedure Forecasts for Vascular Access in the 10MM, 2022
100%
7%
90% 16% 19%
27% 23% 14% 23%
34% 32% 32% 32%
80%
18% 5% 11%
70% 12%
13% 5% 7% 9%
60% 14%
50%
40% 79%
73% 70%
30% 65% 61% 63% 62% 66%
60%
53%
20%
10%
0%
Spain
Japan
India
France
US
UK
Italy
Brazil
China
Germany
Fistula Graf t Catheter

Source: GlobalData
Table 30: Global Procedure Volumes for Vascular Access in the 10MM, 2022
Fistula 335,366 31,516 48,510 56,214 16,226 18,648 274,786 155,985 321,518 40,603 1,299,372
Graft 100,346 8,652 11,002 4,709 2,016 3,547 51,885 13,725 59,848 6,085 261,814
Catheter 78,500 17,303 19,004 24,145 7,936 6,180 22,529 42,288 83,874 18,429 320,190
Source: GlobalData
6.1.2 Dialysis Modalities
The choice of modality depends on several factors, including availability, cost, physician expertise,
hemodynamic stability, and the primary purpose of the procedure. On average, PD patients were
younger than those receiving HD, and fewer of them had a history of congestive heart failure
(Berger et al., 2009). The use of HD is a mainstream treatment for patients with ESRD. Large
numbers of operational HD centers, high familiarity with the HD procedure among healthcare
providers, accessibility of reimbursement, and a broad therapeutic portfolio contribute to the

64
Market Outlooks
dominance of HD. However, because of the convenience of home-based and needleless

procedures, and the relatively low cost, the adoption rate of PD treatment continuously increases.
The growing demand for home-based care, increasing awareness of PD, the rising cost of HD at
dialysis centers, and the development of protocols are expected to drive the PD market to new
heights.
As shown in Figure 6, 86% of total renal dialysis patients were treated through HD, while 14% of
patients were using PD in 2015. The percentage of HD patients went up to 96% and PD patients
only account for 4% in Japan. As a result of the relatively cheap price of PD and national education
programs, China had the highest acceptance of PD, reaching 29% of dialysis patients. Table 31
outlines procedure volumes for dialysis modalities in the 10MM in 2015.
Figure 6: Global Procedure Trends for Dialysis Modalities in the 10MM, 2015
100% 4%
10% 13% 10% 8% 12%
90% 15% 15% 18%
29%
80%
70%
60%
50% 96%
90% 87% 90% 92% 88%
40% 85% 85% 82%
72%
30%
20%
10%
0%
Spain
Japan
China
India
France
US
UK
Italy
Brazil
Germany
Hemodialysis Peritoneal Dialysis

Source: GlobalData
Table 31: Global Procedure Volumes for Dialysis Modalities in the 10MM, 2015
Hemodialysis 422,303 41,403 72,006 60,348 23,303 23,448 311,991 118,789 273,222 36,719 1,383,533
Peritoneal
74,524 4,652 10,950 6,705 4,145 5,043 12,324 9,910 108,907 4,818 241,977
Dialysis
Source: GlobalData

65
Market Outlooks
According to GlobalData’s primary research, HD will keep dominating the dialysis care area and
PD procedures will increase by 6% in 2022, as illustrated in Figure 7. Except for the developing
countries, EU countries, including Italy and Spain, will be expected to have higher growth rates of
PD treatment. About 35% of patients will choose PD as their primary dialysis care in China. Table
32 highlights procedure volumes for dialysis modalities in the 10MM in 2022.
Figure 7: Global Procedure Forecasts for Dialysis Modalities in the 10MM, 2022
100% 5%
15% 16% 16% 11% 16%
90% 20% 18%
25%
80% 35%
70%
60%
50% 95%
85% 84% 84% 89% 84%
40% 80% 83%
75%
30% 65%
20%
10%
0%
Spain
Japan
China
India
France
US
UK
Italy
Brazil
Germany
Hemodialysis Peritoneal Dialysis

Source: GlobalData
Table 32: Global Procedure Volumes for Dialysis Modalities in the 10MM, 2022
Hemodialysis 480,123 51,497 71,444 74,752 25,195 26,870 341,349 185,476 436,845 58,505 1,752,057
Peritoneal
123,047 8,946 13,608 14,133 8,398 5,700 17,966 22,924 235,224 11,310 461,255
Dialysis
Source: GlobalData

66
Market Outlooks
For better understanding of PD modality and its growth, the use of different types of PD was
compared. As shown in Figure 8 and Table 33, CAPD was the most common type of PD worldwide
in 2015. Because it does not require a machine, this modality was extremely popular in developing
countries including India and China. In developed countries, more patients were likely to use
CCPD. In the US and UK, the percentage of CCPD patients was around 70%. IPD is usually done
in the hospital, and was the least common modality in PD treatment.
Figure 8: Global Procedure Trends for Peritoneal Dialysis Modalities in the 10MM, 2015
100% 4% 3% 1%
6% 8% 8%
12% 12% 17%
90%
22% 27% 29%
80%
43%
70%
44% 44% 58%
60% 59% 43%
50% 84%
40% 62%
73% 70%
30% 56%
20% 44% 43% 41%
33% 38%
10%
9% 8%
0%
Spain
Japan
India
France
US
UK
Italy
Brazil
China
Germany
CCPD CAPD IPD

Source: GlobalData
Table 33: Global Procedure Volumes for Peritoneal Dialysis Modalities in the 10MM, 2015
CCPD 54,216 2,047 3,603 2,897 1,554 3,530 5,053 5,559 10,019 371 88,849
CAPD 16,209 2,047 6,461 2,984 2,408 1,357 5,238 4,251 67,631 4,062 112,647
IPD 4,099 558 887 831 182 156 2,033 99 31,256 385 40,488
Source: GlobalData

67
Market Outlooks
Figure 9 and Table 34 below show GlobalData’s forecasts for different types of PD modalities. In
2022, both CAPD and CCPD will be popular forms of PD. Nearly half of PD patients will deploy
CAPD, while 41% of them will choose CCPD. GlobalData expects a growth of 8% with CCPD
modality by 2022. With 78% of their patients employing CCPD, the US and UK are the largest
markets of CCPD. Meanwhile, CCPD patients will increase by over 10% in European countries
including France, Italy, and Spain. China and India have great potential in development of CCPD
as well.
Figure 9: Global Procedure Forecasts for Peritoneal Dialysis Modalities in the 10MM, 2022
100% 5% 5% 2% 4% 4%
11% 7%
14% 16%
90% 20%
18% 28%
80%
38% 41%
70% 32% 34% 48%
60% 49%
79%
50%
52%
40% 78% 78%
30% 55%
55% 55% 55%
48%
20% 36%
10% 19% 16%
0%
Spain
Japan
India
France
US
UK
Italy
Brazil
China
Germany
CCPD CAPD IPD

Source: GlobalData
Table 34: Global Procedure Volumes for Peritoneal Dialysis Modalities in the 10MM, 2022
CCPD 95,730 4,875 4,899 7,745 3,998 4,446 9,881 12,631 45,634 1,855 191,693
CAPD 21,779 2,863 6,600 4,777 4,006 1,129 6,881 9,491 123,258 8,969 189,751
IPD 5,537 1,208 2,109 1,611 386 125 1,204 802 66,333 486 79,802
Source: GlobalData

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Market Outlooks
6.1.3 Dialyzer Reuse
Dialyzer reuse is a necessary component for environmental, financial, or resource constraint

reasons. Some physicians believe that reused high-flux dialyzers may realize the same benefits
over non-reused low-flux dialyzers (Argyropoulos et al., 2015). As shown in Figure 10, approximate
20% of dialysis patients employ reprocessed dialyzers, most of which are in the developing
economies like India and Brazil. GlobalData expects the dialyzer reuse rate will drop as a result of
economic growth in the developing countries.
Figure 10: Global Procedure Trends for Dialyzer Reuse in the 10MM, 2015
100% 92%
90%
80%
80%
70%
60%
50%
40%
30%
20% 13%
10% 10%
10% 7% 5%
3%
0% 0%
0%
Spain
Japan
India
France
US
UK
Italy
Brazil
China
Germany
Source: GlobalData
6.1.4 Hemodiafiltration
Particularly in the developed countries, the methods for dialysis have become more diverse and
sophisticated. Among treatment methods, hemodiafiltration has a high degree of clinical
effectiveness compared with other HD methods, and it is drawing attention as a more advanced
therapy. The main reasons for selecting hemodiafiltration include prevention of complications,
treatment of dialysis-induced hypotension and dialysis-related amyloidosis, and improvement of
dialysis efficiency. Online hemodiafiltration in the predilution mode is mainly selected to prevent
complications, whereas that in the postdilution mode is selected to treat dialysis-related
amyloidosis and dialysis-induced hypotension.

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Market Outlooks
With favorable government healthcare policies, the number of hemodiafiltration treatments is

With favorable
expected to grow dramatically. In April 2012, the use of online hemodiafiltration was officially government
included in the setting of additional points in the health insurance system in Japan. The number of healthcare policies,
the number of
patients who underwent online hemodiafiltration increased by nearly 10,000 by the end of 2012, hemodiafiltration
treatment is
from 1.7% to 7.9% of total dialysis patients (Janssen et al., 2015). GlobalData forecasts that, with expected to grow
dramatically.
its success in the EU and Japan, hemodiafiltration will become popular in the US and help the
traditional HD market hit new heights.
“I’m very interested in hemodiafiltration, [because] it shows better outcomes for dialysis-related
amyloidosis. It is widely used in Europe and Japan, but not the US. I hope I can use it to treat my
patients.”
Key Opinion Leader
6.1.5 Home Dialysis
The advantages of home dialysis, including both home-based PD and HD, are clear. Research
shows that patients who have more frequent dialysis, during the day or overnight, have better
health outcomes than those who visit an outpatient center three times a week (National Kidney
Foundation, 2015). Meanwhile, home dialysis also gives patients opportunities to control the place
and timing of conducting dialysis. Home dialysis makes itself even more appealing to patients in
rural regions who try to avoid long commutes to dialysis centers.
However, patient demographics, reimbursement policies, cost issues, and physician comfort levels
have restricted broader use of home dialysis. Because of the complicated procedure, home dialysis
is only appropriate for a small number of usually younger patients. Older dialysis patients often
suffer from more than one chronic disease, which makes it difficult to perform dialysis at home. In
addition, patients must have enough room for treatment and a dialysis assistant for home HD. In
most countries like the US, insurance for home dialysis is not sufficient to cover the costs, which
includes the visits of home health nurses.
“Most programs that train nephrologists don't have enough people who are on home dialysis. As a
result, the nephrologists are not comfortable offering home hemodialysis, which in turn it feeds into
the cycle of it not being offered enough.”
Key Opinion Leader

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Market Outlooks
Despite all the challenges, the progress of increasing home dialysis therapy options is steady. The
Despite all the
good news is that CMS has tried to improve acceptance of home dialysis by revising its payment challenges, the
progress of
system. CMS not only waived a 90-day waiting period for reimbursement for home dialysis increasing home
patients, but also increased the rate for training patients to perform home dialysis by 50% (CMS, dialysis therapy
options is steady.
2016b). According to USRDS, the use of home dialysis has increased appreciably in recent years
(USRDS, 2015). In the US in 2013, there were a total of 53,765 home-based patients, an increase
of 9% from 2012. Being used by 45,258 patients, home-based PD was the clear leader, but home
HD took a jump of almost 700 patients from 2012, to 8,507 patients. Among all home dialysis
cases, the proportion using home HD was over three-fold higher in 2013 than in 2001, from 5.2% to
15.8% (USRDS, 2015).
According to the primary survey and interviews with nephrologists, all countries covered by this
report will be expected to have an increase of home dialysis modality. GlobalData forecasts a 6%
growth in home dialysis therapy among all dialysis modalities by 2022 in the 10MM. As illustrated in
Figure 11, the US and UK will enjoy the largest growth of 9%, whereas Japan will have the smallest
increase of 3%. In addition, because of the largely untreated dialysis population, use of home
dialysis among incident ESRD patients in emerging economies will increase notably in the next
seven years. Considering the rapidly increasing number of ESRD patients, the procedure volume
of home-based dialysis will rise dramatically, as shown in Table 35.

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Market Outlooks
Figure 11: Global Trends for Home-Based Dialysis in the 10MM, 2015 and 2022
25%
20%
20% 19%
15% 14%
14%
11%
10% 10% 10% 10%
10% 9%
7%
5% 6%
4% 4%
5% 3%
2% 2%
1%
0%
0%
Spain
Japan
India
France
US
UK
Italy
Brazil
China
Germany
2015 2022
Source: GlobalData
Table 35: Global Procedure Volumes for Home-Based Dialysis in the 10MM, 2015 and 2022
2015 44,218 2,395 2,572 6,907 1,125 2,735 4,192 2,059 382 872 67,456
2022 107,666 8,160 5,869 12,711 2,990 6,058 15,451 20,423 38,308 6,772 224,406
Source: GlobalData
6.2 Market Drivers and Barriers
6.2.1 Driver: Population Expectation

Approximate 60% of
patient growths will
Based on the growth of the elderly population and patients with diabetes, the prevalence of ESRD be driven by the
emerging markets
is increasing rapidly. Lifestyle changes, obesity, and sedentary habits in aging populations of China, Brazil, and
India over the next
contribute to a high incidence of diabetes, hypertension, and vascular disease, which are seven years; by
2022, these markets
responsible for a rise in ESRD. Global incidence rates for treated ESRD range from 45 to 458 per will account for
million population (USRDS, 2015), with an increase of 6% to 7% annually, notably outpacing the more than 43% of
the dialysis
annual population growth rate of 1.2% (Grassmann et al., 2006). Approximately 60% of patient population.
growth will be driven by the emerging markets of China, Brazil, and India over the next seven

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Market Outlooks
years; by 2022, these markets will account for more than 43% of the dialysis population, as
illustrated in Figure 12.
Figure 12: Global Dialysis Population in the 10MM, 2015 and 2022
2015 2022
Brazil Brazil
India 8% India
10%
3% US
US 3%
27%
31%
China
23%
China
30%
Japan
16%
5EU Japan
15% 20% 5EU
14%
Source: GlobalData
5EU = France, Germany, Italy, Spain, and the UK; 10MM = US, 5EU, Japan, Brazil, China, and India
6.2.2 Driver: Increasing Number of Dialysis Centers
A high number of dialysis centers is driving the growth of the renal dialysis market. Data from
Japan and US renal registries showed a positive correlation between the number of dialysis
patients and dialysis centers (Masakane et al., 2015; USRDS, 2015). The more dialysis centers
were opened, the more patients were treated, and the more products are consumed. In developing
countries, if government healthcare policy allows, an increasing number of private and publicly
owned dialysis centers contributes to market expansion.
Combining the manufacture of machines with the running of clinics has helped a large dialysis
organization dominate both markets. What industry admires about Fresenius is its one-stop
shopping model. Although a clinic run by Fresenius does not necessarily purchase all dialysis
products manufactured by Fresenius, the pendulum will swing to its own company when the choice
needs to be made among homogeneous products with the same cost. In addition, the company
can pursue a consolidation strategy that allows it to negotiate a better deal and spread fixed costs
over a great number of centers.

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Market Outlooks
According to key opinion leaders in the dialysis industry, the dialysis service or care market,
including running dialysis clinics and administering drugs, accounts for around 82% of the total According to key
opinion leaders in
dialysis market, as shown in Figure 13. the dialysis industry,
dialysis service or
care market,
Figure 13: Global Dialysis Market in 2015 including running
dialysis clinics and
Dialysis administering drugs,
Devices accounts for around
18% 82% of the total
dialysis market.
Dialysis
Service
82%
Source: GlobalData
The providers of dialysis centers include publicly operated hospitals or clinics, private companies
like Fresenius, and private individuals or nephrologists. Figure 14 outlines global trends of different
dialysis centers in 2015. Publicly operated hospitals performed 56% of dialysis treatment in the
10MM. In China, Japan, and most of the European countries the percentages were higher, up to
87%. Private companies treated 22% of dialysis patients in the 10MM, and private individuals
occupied the remaining 22% of the dialysis service market.

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Market Outlooks
Figure 14: Global Trends of Dialysis Centers in the 10MM, 2015
100% 3% 4%
12% 15% 14% 9%
90% 22% 19%
37% 34%
80% 41%
25% 51% 23%
70% 53%
22%
60% 2%
22%
50% 74% 19%
87%
40% 23% 81%
30% 56% 61% 64% 61%
20% 44% 40% 44%
10% 27%
14%
0%
Spain
Japan
India
France
US
UK
10MM
Italy
Brazil
China
Germany
Publicly operated hospitals/clinics Private companies (e.g. Fresenius)

Private individuals/nephrologists
Source: GlobalData
Notably, private companies treated the majority of American dialysis patients. The dialysis service
market in the US is highly consolidated. Particularly during the last two decades, there has been
continued growth in large, for-profit dialysis companies. The two biggest operators of dialysis clinics
in the US are Fresenius and DaVita HealthCare Partners (DaVita), which bought Gambro's
American clinics in 2004. Each of them runs almost a third of America's dialysis clinics, controlling
more than 64% of the market (USRDS, 2015). In contrast, there has been little to no growth in the
small dialysis organizations, or not-for-profit organizations like Dialysis Clinics, Inc., or hospital-
based dialysis facilities. U.S. Renal Care became the third largest dialysis provider through a
merger with DSI Renal in January 2015, although their number of patients only accounts for less
10% of Fresenius’ or DaVita’s (U.S. Renal Care, 2016).
Figure 15 shows that the percentage of dialysis centers operated by private companies will
increase by 10% in the next seven years. The faster-growing areas include Germany, Spain, the
UK, China, India, and Brazil. With the largest and most international network of dialysis clinics,
Fresenius will keep growing in both the renal dialysis service and devices market.

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Market Outlooks
Figure 15: Global Forecasts of Dialysis Centers in the 10MM, 2022

100% 1% 1%
10% 9%
90% 19% 15% 15%
23%
32% 32% 33%
80% 43% 22%
70% 29% 63%
32% 36%
60% 32%
4%
50% 80% 31%
43%
40%
67% 70%
30% 56%
49% 49% 53%
20% 46%
36% 36%
10% 26%
10%
0%
Spain
Japan
India
France
US
UK
10MM
Italy
Brazil
China
Germany
Publicly operated hospitals/clinics Private companies (e.g. Fresenius)

Private individuals/nephrologists
Source: GlobalData
6.2.3 Driver: Growing Awareness of Diseases and Therapeutic Modalities
The growing health consciousness and awareness of ESRD increase the demand for renal care
and dialysis treatment. Dialysis education has consistently been shown to increase the likelihood of
patients choosing a certain modality for dialysis care. PD is one of the fastest-growing modalities,
as a result of numerous education programs that have largely increased nephrologists’ and
patients’ awareness.
“Our company has very robust education department. We provide global education on therapy—
not just use our product, [for example,] how to place a catheter, how to prescribe and optimal
dialysis and minimizing glucose in dialysis patients from dialysis solutions. We have many doctors.
Not only doctors, we have our clinical educators, nurses. They speak at conferences and provide
information, so that’s a big key factor that I feel is important. Along with that, we do have clinical
educators that provide support to the clinic….Our PD rates have gone up significantly in the last
two years. When I first saw it, it was 10–15%, it went up to 20% and now it’s up around 40%.”
Key Opinion Leader

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Market Outlooks
6.2.4 Driver: Technological Innovations
Strong demand for innovative products and therapies is one of the main growth factors in the renal
dialysis market. New technology drives updates of dialysis devices and improves outcomes of
dialysis treatment. Technological advances in membrane design, chemical composition, and
sterilization methods have led to enhanced performance and versatility to the extent that dialyzer
choice may reduce morbidity and prolong survival. New HD machines equipped with blood volume
monitors and dialysis dose monitors help clinicians access the condition of individual patients and
personalize the dialysis treatment. Newer PD solutions with fewer glucose degradation products
have been shown to improve peritoneal membrane health and viability.
Information technology has changed people’s perception of medical devices and will further impact
the choice of dialysis modality. For example, an advanced mobile application allows ESRD patients
using a home HD system to have their treatment data sent wirelessly to the clinician’s portal. The
portal is accessible to the patient’s healthcare providers, including nephrologists, nurses,
technicians, and surgeons, and enables them to access patient information remotely. By having
sufficient assistance from healthcare teams, home-based dialysis patients will have more freedom
and confidence in the self-administered treatment.
6.2.5 Driver: Favorable Government Healthcare Policy and Funding
Because of the high cost of the dialysis treatment, country economic and government support is
extremely critical in the renal dialysis business. A country’s percentage of patients receiving
dialysis therapy is positively correlated with gross domestic product (GDP), especially in countries
with a GDP below $3,000 per capita (Luño, 2007). Other factors, like percentage of GDP spent on
healthcare, dialysis reimbursement rate, and the private for-profit share of dialysis provision, may
contribute to faster growth rates in developing countries, compared with developed countries where
increases are driven more by ESRD incidence than access to treatment.
In developing countries, to make dialysis affordable to the majority of patients with ESRD,
governments are improving coverage for dialysis treatment. The initiatives are reforming the
healthcare system and providing an opportunity to increase the prevalence of dialysis and improve
long-term outcomes for patients with ESRD. For example, the Chinese central government
included ESRD on the list of major diseases in 2012, providing an important policy guarantee and
resources to promote the prevalence and quality of dialysis in China (Liu, 2013). In addition, the
government is planning to adjust reimbursement policies and introduce new insurance systems in

77
Market Outlooks
rural areas. Furthermore, the government has encouraged community-based care and the
development of Community Health Centres, as well as the training of general practitioners,
especially in rural areas.
6.2.6 Barrier: Safety Concerns
Products safety issues affect a medical device manufacturer’s sales revenues and hamper a
company’s brand image. Although recalls of renal dialysis devices are few, they are usually the
most serious type of recall and associated with serious adverse health consequences or death. In
August 2001, authorities in Spain reported that 10 patients had died while or shortly after
undergoing dialysis using a Baxter dialyzer. Two months later, 21 dialysis patients died in Croatia
over the span of one week. As a result, Baxter issued a recall of its A, AF, and AX series dialyzers.
An FDA investigation into the dialysis filters revealed that a chemical used in the manufacturing
process did not evaporate from the dialyzer and found its way into the bloodstream of the patients,
where it subsequently inhibited blood flow (Davis, 2006).
6.2.7 Barrier: Restricted Reimbursement
In the developed economies, controlling increasing costs is the main challenge of reimbursement
In the developed
systems. Case management and global budget-related approaches are being widely introduced. economies,
controlling
By bundling multiple costs into a single payment along with other measures, CMS has been increasing costs is
the main challenge
moving to cut dialysis costs in the US. The Comprehensive ESRD Care Model was introduced and of reimbursement
systems.
CMS will partner with healthcare providers and suppliers to test the effectiveness of the new
payment and service delivery model in providing patients with high-quality care. For dialysis
providers to realize savings and survive, they can either pursue a consolidation strategy that allows
them to spread their fixed costs over a greater number of centers, or find ways to offer the same
service more cheaply, which means choosing the most cost-effective devices.
Reimbursement policies also impact modality selection, and ultimately allocation of future dialysis-
related resources. Although the 2015 Kidney Disease Outcomes Quality Initiative Hemodialysis
Adequacy Guideline shows that in-center short-frequent HD resulted in statistically significant
improvements in health-related QOL and several surrogate outcomes, CMS typically covers three
HD treatments every week. As a result, patients usually have to pay more out of pocket for more-
frequent HD. In addition, in-center HD depends on fixed resources; however, home-based options
depend on variable resources, which is not covered thoroughly by the current reimbursement
system.

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Market Outlooks
“Most patients do not have access to home dialysis because either their insurance, mostly
Medicare, is not going to pay enough to cover the costs, or [the patients] lack sufficient socio-
economic resources to be on it.”
Key Opinion Leader
6.3 Company Share Analysis
Based on the primary survey and interviews with both demand- and supply-side stakeholders in the
renal dialysis equipment market, GlobalData has estimated company dominance in specific regions
and markets. Company shares are presented as approximate percentages.
6.3.1 HD Products
Figure 16, Figure 17, and Figure 18 below illustrate the key stakeholders in the HD products
Driven by operating
market in the 10MM. Fresenius leads the pack with 53% of the total market share. Driven by
numerous dialysis
operating numerous dialysis centers worldwide and offering a diverse product portfolio, Fresenius centers worldwide
and offering a
is a dominant player in the global HD products market. Baxter, with its acquisition of Grambo, diverse product
portfolio, Fresenius
enjoys approximately 28% of the market, whereas Japan-based Nikkiso occupies about 10% of the is a dominant player
in the global
global HD products space. Other important players, including B. Braun, Nipro, and Toray, control hemodialysis
products market.
the remaining 9% of the market.
Due to different strengths of each company and specialties of each district, company share for HD
products varies from country to country. In the US, Fresenius dominates the market with 79% of
the market share, followed by Baxter with 20%, as shown in Figure 16. Fresenius leads the
Brazilian market with over half of the market share.

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Market Outlooks
Figure 16: US and Brazil Company Share for HD Products, 2015
100% 2%
9% 10%
90% 20% 0%
10%
80%
70% 37%
28%
60%
50%
40% 79%
30%
53% 53%
20%
10%
0%
10MM US Brazil
Fresenius Medical Care Baxter Nikkiso Other
Source: GlobalData
Figure 17 outlines the company share for HD products in the 5EU. Mirroring global trends, the EU
market features Fresenius and Baxter in the top two leading positions. B. Braun enjoys 14% of the
German market. Medtronic, through its acquisition of Italy-based Bellco, holds around 5% of the
HD products market in Italy and Spain.

80
Market Outlooks
Figure 17: 5EU Company Share for HD Products, 2015
100%
9% 6% 9% 7% 5%
14% 2% 3%
90%
10% 12%
80% 13% 34%
70% 40% 37%
28% 16%
60% 42%
50%
40%
30% 58% 61%
53% 53% 53%
20% 38%
10%
0%
10MM Germany UK France Italy Spain
Source: GlobalData
Driven by a high volume of sales in its home market of Japan, Nikkiso achieves the leading position
in the region with 60% of the Japanese market share, as illustrated in Figure 18. About 94% of the
Japanese market is made up of local manufacturers. Toray and Nipro enjoy 15% and 13% of the
market, respectively. Global giant Fresenius and Baxter each only occupy 3% of the Japanese
market. In developing countries, Fresenius occupies more than half of the market, followed by
Baxter. B. Braun controls approximately 7% of the market in China. Local manufacturers do not
have a notable market share in the HD products space in China or India.

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Market Outlooks
Figure 18: APAC Company Share for HD Products, 2015

100% 1%
1%
9% 7%
90% 4% 13%
10%
80% 34%
70% 37%
28%
60%
50%
40% 85%
60%
30%
53% 53%
20%
10% 3%
0% 3%
10MM Japan China India
Source: GlobalData
10MM = US, France, Germany, Italy, Spain, UK, Japan, Brazil, China, and India; APAC = Japan, China, and India
6.3.2 HD Machines
Figure 19, Figure 20, and Figure 21 below outline the HD machines space. Mirroring HD products,
Fresenius, Baxter, and Nikkiso are the top three players in the HD capital equipment market, which
indicates that HD products sales are driven by capital equipment. Once dialysis centers purchase
HD machines from one company, they are likely to buy accessories from the same company. Other
key players include B. Braun and Nipro, which occupy approximately 10% of the market.
Differences among districts are observed. In the US, Fresenius leads the HD machines market with
more than 90% of the market share. In the 5EU, Fresenius and Baxter remain the top two players.
Germany-based B. Braun occupies 10% and 13% of the HD machines space in Spain and
Germany, respectively. Nikkiso dominates its home market of Japan, while Nipro, Asahi Kasei, and
Toray occupy 25% of the space. In developing countries including China and Brazil, Fresenius
achieves the leading position, but Baxter is close behind with a third of the HD machines market. In
India, Fresenius maintains the largest share of nearly 90% in the HD machines business.

82
Market Outlooks
Figure 19: 5EU Company Share for HD Machines, 2015

100%
10% 7% 8% 7%
13% 3% 3% 14%
90% 6%
10%
80% 11%
31%
70% 25% 15% 46% 33%
41%
60%
50%
40%
30% 61% 59%
55% 53%
20% 45% 46%
10%
0%
Source: GlobalData
Figure 20: APAC Company Share for HD Machines, 2015
100% 2%
10% 8% 1%
90% 25% 8% 8%
10%
80%
70% 25% 37%
60%
50%
64% 90%
40%
30% 55%
47%
20%
10% 7%
0% 5%
Source: GlobalData

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Market Outlooks
Figure 21: US and Brazil Company Share for HD Machines, 2015
100% 3%
10% 2%
90% 5% 14%
10%
80%
70% 30%
25%
60%
50%
91%
40%
30% 55% 56%
20%
10%
0%
10MM US Brazil
Source: GlobalData
6.3.3 Dialyzers
As Figure 22, Figure 23, and Figure 24 below illustrate, Fresenius and Baxter remain the top two
players in the dialyzers market. However, Nipro, instead of Nikkiso, becomes the third player with
14% of the market space. Fresenius enjoys over 86% of market share in the US. In the 5EU, other
than the three major players, B. Braun controls 15% of the German market and nearly 10% of
Spain’s market. The Japanese dialyzer market is dominated by local manufacturers with intense
competition. Nipro achieves the leading position, and Asahi Kasei, Toray, and Nikkiso occupy 18%,
15%, and 10% of the space, respectively. B. Braun enjoys the remaining 10% of the dialyzers
market in China. Fresenius keeps dominating the Indian dialyzers market with 85% of the market
share.

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Market Outlooks
Figure 22: 5EU Company Share for Dialyzers, 2015
100% 2% 6%
12% 15% 15% 14%
90% 8%
80% 14% 35% 11%
18% 18%
70% 30%
22% 19%
60% 19%
50% 32%
40%
30% 63%
53% 55% 56%
49%
20% 36%
10%
0%
Fresenius Medical Care Baxter Nipro Other

Source: GlobalData
Figure 23: APAC Company Share for Dialyzers, 2015
100% 3%
12% 10% 6%
90% 8%
11%
80% 14%
48%
70%
22% 25%
60%
50%
40% 85%
30% 42%
53% 54%
20%
10%
5%
0% 5%
Source: GlobalData

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Market Outlooks
Figure 24: US and Brazil Company Share for Dialyzers, 2015
100% 5%
12% 2%
90% 24%
7%
80% 14%
70%
22%
60% 36%
50%
86%
40%
30%
53%
20% 40%
10%
0%
10MM US Brazil
Source: GlobalData
6.3.4 PD Products
Compared with the HD products market, fewer players are involved in the PD products market and
the competition is relatively less intense. As pictured below in Figure 25, Figure 26, and Figure 27,
US-based Baxter is already well-situated in the global PD market, enjoying a market share of 65%
in the 10MM. In China and India, Baxter dominates approximately 90% of the PD products market
due to its rapid expansion strategies and massive education programs in developing countries. By
expanding the fast-growing PD market, Fresenius achieves 31% of the PD products market in the
10MM and performs better than Baxter in the US and EU countries including Germany and Spain.
Nikkiso enjoys 13% in its home market of Japan and 2% globally.

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Market Outlooks
Figure 25: 5EU Company Share for PD Products, 2015
100% 2%
2% 5%
2%
90%
80%
47% 48%
70% 57%
52%
65%
60%
89%
50%
40%
30%
52% 52%
20% 44% 43%
31%
10%
11%
0%

Source: GlobalData
Figure 26: APAC Company Share for PD Products, 2015
100% 2%
2% 11% 9%
90% 1%
80% 13%
70%
65%
60%
50% 97%
89%
40% 71%
30%
20%
31%
10%
5% 4% 1%
0%
Source: GlobalData

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Market Outlooks
Figure 27: US and Brazil Company Share for PD Products, 2015

100% 2%
2%
90%
80%
46%
53%
70%
65%
60%
50%
40%
30%
54%
47%
20%
31%
10%
0%
10MM US Brazil
Source: GlobalData
6.4 Market Outlooks by Segment
6.4.1 Global Overview
Figure 28 below outlines the growth of the global renal dialysis equipment market. GlobalData
valued the overall space at $14.44 billion in 2015. The total market will grow at a steady compound
annual growth rate (CAGR) of 3.48% to reach $18.34 billion by 2022.

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Market Outlooks
Figure 28: Global Market Value Forecast for Renal Dialysis Equipment, 2013–2022
20,000
18,000
16,000
Revenue ($m)
14,000
12,000
10,000
8,000
6,000
4,000
2,000
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Hemodialysis Products
Peritoneal Dialysis Products
Continuous Renal Replacement Therapy Machines
Source: GlobalData
As shown in Table 36, capital equipment, including HD machines, PD machines, and CRRT
machines, makes up approximately 23% of the total market. Other devices, including accessories
and solutions, occupy the majority of the market. Depending on the lifespan of capital equipment,
dialysis centers may not replace capital equipment or buy additional units in a given year, but they
continuously purchase disposables to meet the demands of high-volume procedures.

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Market Outlooks
Table 36: Global Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022
Segment 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 CAGR
HD Machines 2,489.0 2,424.2 2,464.6 2,499.6 2,536.5 2,563.3 2,594.9 2,639.9 2,681.2 2,721.5 1.43%
PD Machines 159.7 159.7 164.3 168.8 171.4 174.3 179.0 182.8 186.4 190.1 2.10%
CRRT
653.4 691.7 758.6 784.9 851.7 925.5 1,007.9 1,098.4 1,198.7 1,309.7 8.11%
Machines
Fistula
415.7 419.6 423.8 428.0 432.4 437.1 442.1 447.4 453.1 459.2 1.16%
Needles
Blood Tubing
1,742.1 1,790.7 1,841.2 1,893.2 1,947.3 2,003.5 2,062.1 2,123.2 2,186.9 2,253.5 2.93%
Sets
Dialyzers 3,342.4 3,397.0 3,454.6 3,514.0 3,577.1 3,644.2 3,715.6 3,791.8 3,873.1 3,960.1 1.97%
Grafts 279.9 283.0 286.5 289.9 293.9 298.4 303.5 309.3 315.9 323.4 1.74%
Dialysis
88.1 87.8 87.6 87.2 86.9 86.7 86.5 86.4 86.4 86.5 –0.18%
Catheters
Dialysates 1,904.1 1,932.4 1,961.1 1,990.0 2,019.5 2,049.5 2,080.1 2,111.5 2,143.7 2,176.9 1.50%
PD Catheters 33.6 36.4 39.4 42.5 45.8 49.4 53.4 57.6 62.3 67.3 7.96%
PD Transfer
4.6 4.9 5.3 5.7 6.1 6.5 7.0 7.5 8.1 8.7 7.39%
Sets
PD Solutions 2,563.3 2,750.0 2,950.8 3,158.4 3,381.4 3,621.3 3,879.5 4,157.7 4,457.6 4,781.2 7.14%
Total 13,675.9 13,977.4 14,437.7 14,862.1 15,349.9 15,859.7 16,411.6 17,013.7 17,653.6 18,338.1 3.48%
Source: GlobalData
CAGR calculated from 2015 to 2022
The HD products section of the total market will expand from $10.5 billion in 2015 to $12.0 billion in
2022, at a CAGR of 1.88%. As illustrated by Figure 29, dialyzers are the largest segment within the
HD products market, because of frequent replacements and higher pricing than other disposables.
HD machines are the second largest division within the HD products market and they drive the
sales of other HD disposables.

90
Market Outlooks
Figure 29: Global Market Value Forecast by Market Segment for HD Products, 2013–2022
14,000
12,000
10,000
Revenue ($m)
8,000
6,000
4,000
2,000
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Hemodialysis Machines Fistula Needles Blood Tubing Sets
Dialyzers Graf ts Dialysis Catheters
Dialysates
Source: GlobalData
The global market value of PD products is thriving at a higher CAGR of 6.92%. The market is
forecast to reach $5.0 billion by 2022, driven by improvements in PD technology and increasing
awareness of the procedure. PD solutions represent the largest segment within the PD products
market since high volumes of PD solutions are used in each PD treatment. Figure 30 below
outlines these trends.

91
Market Outlooks
Figure 30: Global Market Value Forecast by Market Segment for PD Products, 2013–2022
6,000
5,000
4,000
Revenue ($m)
3,000
2,000
1,000
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Peritoneal Dialysis Machines Peritoneal Dialysis Catheters
Peritoneal Dialysis Transf er Sets Peritoneal Dialysis Solutions
Source: GlobalData
Figure 31 below illustrates trends of the CRRT machines section of the total market. The CRRT
machines market will increase from $758.6m in 2015 to $1.3 billion in 2022. The market is forecast
to grow at a CAGR of 8.11% due to rising awareness of the therapy. Through education and
innovation, the CRRT products market will keep growing rapidly.

92
Market Outlooks
Figure 31: Global Market Value Forecast by Market Segment for CRRT Machines, 2013–2022
1,400
1,200
1,000
Revenue ($m)
800
600
400
200
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022

Source: GlobalData
6.4.2 By Region
6.4.2.1 5EU
Figure 32: 5EU Market Value Forecast for Renal Dialysis Equipment, 2013–2022
3,500
3,000
Revenue ($m)
2,500
2,000
1,500
1,000
500
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData
5EU = France, Germany, Italy, Spain, and the UK

93
Market Outlooks
Figure 32 above and Table 37 below summarize the 5EU renal dialysis equipment markets. The
overall space, valued at about $2.76 billion in 2015, is expanding at a CAGR of 1.97%, slower than
the global average. The HD products market, valued at $2.07 billion in 2015, is growing at a CAGR
of 0.77%, whereas the PD products market, valued at $0.64 billion in 2015, is expanding at a
CAGR of 4.93%. The CRRT machines market has the highest CAGR of 7.78%.
Table 37: 5EU Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022
Segment 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 CAGR
HD
227.7 232.7 233.9 235.0 236.1 237.3 238.5 239.7 241.0 241.5 0.46%
Machines
PD
54.3 54.8 55.0 55.2 55.5 55.5 55.6 55.8 56.0 56.3 0.32%
Machines
CRRT
43.5 47.9 52.1 54.4 59.0 63.9 69.1 74.8 81.1 88.0 7.78%
Machines
Fistula
88.7 88.8 89.0 89.0 89.1 89.2 89.2 89.3 89.3 89.3 0.05%
Needles
Blood
Tubing 422.3 425.0 427.8 430.4 433.0 435.7 438.3 441.0 443.7 446.4 0.61%
Sets
Dialyzers 774.6 782.8 791.1 799.2 807.3 815.5 823.7 831.9 840.2 848.5 1.01%
Grafts 32.2 32.1 32.1 32.0 32.0 32.0 32.1 32.2 32.4 32.6 0.21%
Dialysis
21.5 21.6 21.7 21.9 22.1 22.3 22.6 22.9 23.3 23.7 1.24%
Catheters
Dialysates 470.4 474.3 478.2 482.0 485.9 489.9 493.9 497.9 501.9 506.0 0.81%
PD
6.0 6.4 6.8 7.3 7.7 8.3 8.8 9.4 10.0 10.7 6.66%
Catheters
PD
Transfer 0.8 0.8 0.8 0.9 0.9 1.0 1.0 1.1 1.2 1.2 5.73%
Sets
PD
517.0 543.8 572.5 601.8 633.0 666.1 701.3 738.9 778.8 821.5 5.29%
Solutions
Total 2,658.9 2,710.9 2,761.0 2,809.1 2,861.7 2,916.6 2,974.2 3,034.8 3,098.9 3,165.7 1.97%
Source: GlobalData
The 5EU HD products market features dialyzers as the leading segment, as seen in Figure 33
below. Blood tubing sets and dialysates have comparable revenue generation. Grafts and dialysis
catheters have the smallest revenue generation because of lower volumes of the vascular access
procedures.

94
Market Outlooks
Figure 33: 5EU Market Value Forecast by Market Segment for HD Products, 2013–2022
2,500
2,000
Revenue ($m)
1,500
1,000
500
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Hemodialysis Machine Fistula Needles Blood Tubing Sets

Dialysates
Source: GlobalData
The PD products market will expand from $0.64 billion in 2015 to $0.87 billion in 2022, at a CAGR
of 4.93%. As shown in Figure 34 below, PD solutions, generating strong revenue relative to their
share of sales volume, are growing steadily at a CAGR of 5.29%.

95
Market Outlooks
Figure 34: 5EU Market Value Forecast by Market Segment for PD Products, 2013–2022
1,000
900
800
Revenue ($m)
700
600
500
400
300
200
100
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022

Source: GlobalData
Figure 35 below shows the expansion of the CRRT machines space in the 5EU.
Figure 35: 5EU Market Value Forecast by Market Segment for CRRT Machines, 2013–2022
100
90
80
70
Revenue ($m)
60
50
40
30
20
10
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022

Source: GlobalData

96
Market Outlooks
6.4.2.2 APAC
Figure 36: APAC Market Value Forecast for Renal Dialysis Equipment, 2013–2022
10,000
9,000
8,000
7,000
Revenue ($m)
6,000
5,000
4,000
3,000
2,000
1,000
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData
As illustrated by Figure 36 above and summarized in Table 38 below, the APAC renal dialysis
equipment space, valued at $7.13 billion, is growing at a CAGR of 4.07%. The regional market,
consisting of Japan, China, and India, is larger than the US and the 5EU countries in terms of total
revenue.

97
Market Outlooks
Table 38: APAC Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022
Segment 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 CAGR
HD
1,653.3 1,600.4 1,630.8 1,649.4 1,670.4 1,694.0 1,720.2 1,749.3 1,781.6 1,816.0 1.55%
Machines
PD
22.7 22.4 23.0 23.4 24.0 24.5 25.1 25.7 26.4 27.1 2.40%
Machines
CRRT
530.3 557.5 610.2 628.1 680.2 737.7 801.4 871.9 950.4 1,037.5 7.88%
Machines
Fistula
212.8 214.7 216.9 219.2 221.8 224.8 228.1 231.8 235.8 240.3 1.48%
Needles
Blood
Tubing 793.2 815.4 838.9 863.7 889.9 917.8 947.3 978.7 1,012.1 1,047.7 3.23%
Sets
Dialyzers 1,730.6 1,765.4 1,803.7 1,844.9 1,890.2 1,940.0 1,994.6 2,054.3 2,119.5 2,190.7 2.82%
Grafts 98.7 101.5 104.7 108.0 111.7 115.9 120.6 125.9 131.9 138.5 4.09%
Dialysis
19.9 20.3 20.7 21.1 21.5 21.9 22.4 22.9 23.4 23.9 2.08%
Catheters
Dialysates 893.8 908.3 923.3 938.8 954.9 971.6 989.0 1,007.2 1,026.2 1,046.1 1.80%
PD
16.3 17.9 19.7 21.5 23.5 25.7 28.1 30.8 33.7 36.9 9.40%
Catheters
PD
Transfer 1.7 1.8 2.0 2.2 2.4 2.7 2.9 3.2 3.5 3.9 9.69%
Sets
PD
774.3 853.3 940.3 1,033.1 1,135.2 1,247.8 1,371.9 1,508.7 1,659.5 1,825.8 9.94%
Solutions
Total 6,747.6 6,878.9 7,134.3 7,353.4 7,625.8 7,924.4 8,251.7 8,610.5 9,004.2 9,434.6 4.07%
Source: GlobalData,
Like most geographies, the APAC countries feature dialyzers as the leading HD products segment.
As seen in Figure 37 below, HD machines also enjoy sizable revenues due to their relatively high
prices and wider use in clinical settings. The CAGR of HD products market is higher than in the
5EU, because of a large proportion of untreated populations in China and India.

98
Market Outlooks
Figure 37: APAC Market Value Forecast by Market Segment for HD Products, 2013–2022
7,000
6,000
Revenue ($m)
5,000
4,000
3,000
2,000
1,000
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Hemodialysis Machine Fistula Needles Blood Tubing Sets

Dialysates
Source: GlobalData
Due to the rapid growth in China and India, the APAC PD products market is expanding at a higher
CAGR of 9.79%. Mirroring the global PD products space, PD solutions, leading the PD products
market, are growing at a speedy rate with a CAGR of 9.94%, as shown in Figure 38 below.

99
Market Outlooks
Figure 38: APAC Market Value Forecast by Market Segment for PD Products, 2013–2022
2,000
1,800
1,600
1,400
Revenue ($m)
1,200
1,000
800
600
400
200
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData
Figure 39 below highlights the rapid growth of the CRRT machines market in the APAC.
Figure 39: APAC Market Value Forecast by Market Segment for CRRT Machines, 2013–2022
1,200
1,000
800
Revenue ($m)
600
400
200
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022

Source: GlobalData

100
Market Outlooks
6.5 Market Outlooks by Geography
6.5.1 Global Overview: Renal Dialysis Equipment
As illustrated in Figure 40 and Table 39 below, the US led the pack by generating $4.18 billion in
revenue in 2015. With the higher prevalence of dialysis patients and an advanced healthcare
system, Japan was the second largest market worldwide. Other developed countries, including
Germany, France, and Italy, play an important role by occupying significant portions of the global
total renal dialysis equipment market. Emerging economies such as China, India, and Brazil are
demonstrating stronger growth than global averages.
Figure 40: Global Market Value Forecast by Country for Renal Dialysis Equipment, 2013–2022
20,000
18,000
16,000
Revenue ($m)
14,000
12,000
10,000
8,000
6,000
4,000
2,000
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData

101
Market Outlooks
Table 39: Global Market Value Forecast by Country for Renal Dialysis Equipment, $m, 2013–2022
Country 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 CAGR
US 3,951.7 4,047.9 4,178.0 4,309.0 4,443.3 4,568.5 4,701.9 4,848.0 4,990.4 5,134.7 2.99%
France 456.2 467.4 480.6 493.3 507.0 521.3 536.3 551.9 568.3 585.4 2.86%
Germany 855.6 867.8 872.3 876.1 881.0 886.2 891.7 897.7 904.4 910.8 0.62%
Italy 790.1 809.1 829.9 850.2 871.7 894.1 917.5 942.0 967.6 994.6 2.62%
Spain 249.2 256.3 264.4 272.4 281.0 290.2 300.0 310.5 321.7 333.7 2.84%
UK 307.9 310.2 313.8 317.2 321.0 324.8 328.7 332.7 336.9 341.1 1.20%
Japan 3,963.1 3,899.9 3,918.9 3,891.7 3,888.6 3,887.3 3,887.9 3,890.6 3,896.1 3,902.6 –0.06%
Brazil 317.8 339.7 364.5 390.6 419.2 450.2 483.9 520.4 560.0 603.2 7.46%
China 2,670.8 2,857.7 3,084.7 3,321.6 3,586.4 3,874.7 4,188.6 4,530.8 4,904.0 5,311.4 8.07%
India 113.6 121.4 130.6 140.1 150.8 162.5 175.2 189.1 204.2 220.6 7.78%
Total 13,675.9 13,977.4 14,437.7 14,862.1 15,349.9 15,859.7 16,411.6 17,013.7 17,653.6 18,338.1 3.48%
Source: GlobalData
Figure 41 below shows the global shares of the renal dialysis equipment space for each of the
10MM in 2015 and in 2022. As of 2015, the US occupies nearly 29% of the global market.
GlobalData expects this share to be constant in the forecast years. Notably, the Chinese market
will have a noticeably higher stake of 29% on the global stage in 2022 due to reforms of its
healthcare system. In addition, the Japanese share of the global space will shrink because of tepid
growth and the restrained reimbursement policy.

102
Market Outlooks
Figure 41: Global Renal Dialysis Equipment Market Share Comparison by Country, 2015 and 2022
2015
1%
21%
29%
3% US
France
3%
6% Germany
27%
6% Italy
2% 2%
Spain
2022
UK
1%
Japan
28%
29%
Brazil
China
3% India
3%
5%
6%
21% 2%
2%
Source: GlobalData
6.5.2 Global Overview: HD Products
HD products dominate the renal dialysis devices market. GlobalData estimates the market value for
HD products to be approximately $10.52 billion in 2015 in the 10MM. The overall space is
expanding at a CAGR of 1.88%. The market for accessories and solutions is much greater than the
capital equipment market.

103
Market Outlooks
Figure 42 below shows the trends for the global HD products market in the 10MM.
Figure 42: Global Market Value Forecast by Country for HD Products, 2013–2022
14,000
12,000
10,000
Revenue ($m)
8,000
6,000
4,000
2,000
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData
Table 40 below outlines the market sizes for HD products in the 10MM.
Table 40: Global Market Value Forecast by Country for HD Products, $m, 2013–2022
Country 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 CAGR
US 2,594.2 2,612.8 2,655.3 2,702.7 2,748.7 2,781.3 2,815.4 2,859.3 2,895.8 2,929.3 1.41%
France 372.2 378.5 385.3 391.9 398.6 405.4 412.2 419.1 426.1 433.2 1.69%
Germany 594.8 596.0 591.4 586.7 582.1 577.5 573.1 568.6 564.2 559.2 –0.80%
Italy 694.8 706.1 718.1 729.9 741.7 753.6 765.6 777.6 789.7 802.0 1.59%
Spain 171.9 172.2 172.7 173.2 173.6 173.9 174.2 174.3 174.5 174.5 0.15%
UK 203.6 204.4 206.1 207.8 209.6 211.4 213.3 215.2 217.2 219.2 0.88%
Japan 3,443.8 3,363.7 3,344.8 3,310.4 3,276.2 3,242.2 3,208.4 3,174.8 3,141.9 3,108.2 –1.04%
Brazil 227.5 238.7 251.4 264.7 278.7 293.5 309.0 325.3 342.4 360.5 5.28%
China 1,883.3 1,983.6 2,111.3 2,247.1 2,391.8 2,546.2 2,710.9 2,886.6 3,074.1 3,274.1 6.47%
India 75.2 78.6 83.0 87.5 92.4 97.5 102.9 108.7 114.7 121.0 5.54%
Total 10,261.3 10,334.8 10,519.4 10,702.0 10,893.5 11,082.7 11,284.9 11,509.6 11,740.5 11,981.2 1.88%
Source: GlobalData

104
Market Outlooks
Figure 43 below shows the market share by country for 2015 and 2022. In 2015, Japan occupied a
third of the HD products market. The US and China were also sizable markets, maintaining 25%
and 20% shares, respectively. The 5EU will more or less maintain their relative shares, whereas
the Chinese stake in the global space will expand to 27% by 2022.
Figure 43: Global HD Products Market Share Comparison by Country, 2015 and 2022
2015
1%
20%
25%
2%
US
4%
France
5%
Germany
32% 7%
2% Italy
2%
Spain
2022
UK
1%
24% Japan
27%
Brazil
China
4%
3% India
5%
7%
1%
26% 2%
Source: GlobalData

105
Market Outlooks
6.5.3 Global Overview: PD Products
Figure 44: Global Market Value Forecast by Country for PD Products, 2013–2022
6,000
5,000
4,000
Revenue ($m)
3,000
2,000
1,000
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022

Source: GlobalData
As adoption of PD therapy grows, PD cyclers and solutions become indispensable in dialysis

centers worldwide. Figure 44 above and Table 41 below outline the global PD devices market. The
US is the leading country, whereas Japan is a comparatively smaller market due to device adoption
rates. The developing economies are forecast to have double-digital CAGRs because of the rising
awareness of the PD modality and large untreated ESRD population.

106
Market Outlooks
Table 41: Global Market Value Forecast by Country for PD Products, $m, 2013–2022
Country 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 CAGR
US 1,284.5 1,356.1 1,434.7 1,513.0 1,592.2 1,674.7 1,762.1 1,851.5 1,943.9 2,039.6 5.15%
France 73.3 77.8 83.1 88.5 94.4 100.6 107.3 114.4 122.1 130.3 6.63%
Germany 245.1 253.5 261.3 269.2 277.3 285.4 293.9 302.8 311.9 321.3 3.00%
Italy 84.2 91.0 98.5 106.3 114.7 123.8 133.7 144.4 156.0 168.7 7.99%
Spain 74.8 81.4 88.7 96.1 104.1 112.7 121.9 131.9 142.7 154.3 8.22%
UK 100.6 102.0 103.6 105.1 106.7 108.4 110.0 111.7 113.4 115.1 1.51%
Japan 105.6 111.6 118.4 123.1 128.1 133.2 138.5 144.1 149.9 155.9 4.01%
Brazil 83.7 93.6 104.7 116.8 130.3 145.3 162.0 180.5 201.2 224.2 11.49%
China 676.3 747.2 826.0 912.3 1,007.6 1,112.8 1,229.1 1,357.6 1,499.6 1,656.4 10.45%
India 33.2 36.7 40.6 44.9 49.5 54.7 60.4 66.7 73.7 81.4 10.44%
Total 2,761.2 2,951.0 3,159.7 3,375.3 3,604.7 3,851.5 4,118.8 4,405.6 4,714.3 5,047.3 6.92%
Source: GlobalData

107
Market Outlooks
Figure 45 below highlights the relative shares of 10MM in the PD products market. GlobalData
expects shares of the US and China to expand during the forecast years.
Figure 45: Global PD Products Market Share Comparison by Country, 2015 and 2022
2015
1%
26%
US
46% France
3% Germany
4%
Italy
3%
3%
3% Spain
8% 3%
UK
2022
2% Japan
40% Brazil
33%
China
India
5%
3%
2% 3%
3% 3% 6%
Source: GlobalData

108
Market Outlooks
6.5.4 US
Figure 46 and Table 42 below show the US renal dialysis devices market, the largest in the world,
growing at a steady CAGR of 2.99%.
Figure 46: US Market Value Forecast by Segment for Renal Dialysis Equipment, 2013–2022
6,000
5,000
Revenue ($m)
4,000
3,000
2,000
1,000
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData

109
Market Outlooks
Table 42: US Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022
Segment 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 CAGR
HD Machines 571.1 553.5 560.5 574.2 587.2 587.5 589.7 602.4 608.0 611.3 1.25%
PD Machines 80.9 80.6 84.3 88.0 89.9 92.0 96.0 98.9 101.4 104.1 3.05%
CRRT
73.0 78.9 87.9 93.3 102.3 112.4 124.5 137.1 150.7 165.7 9.47%
Machines
Fistula
99.0 99.8 100.5 101.0 101.5 101.8 102.1 102.2 102.3 102.3 0.25%
Needles
Blood Tubing
472.2 492.8 513.9 535.1 556.7 578.7 601.2 624.0 647.3 671.1 3.89%
Sets
Dialyzers 808.8 818.6 827.7 835.9 843.4 850.4 856.7 862.5 867.7 872.4 0.75%
Grafts 134.1 133.8 133.6 133.1 132.6 132.1 131.6 131.2 130.7 130.2 –0.37%
Dialysis
40.9 40.2 39.5 38.7 37.9 37.0 36.2 35.4 34.6 33.8 –2.19%
Catheters
Dialysates 468.1 474.0 479.6 484.7 489.5 493.9 497.9 501.7 505.1 508.2 0.83%
PD Catheters 10.0 10.6 11.2 11.8 12.4 13.1 13.8 14.5 15.3 16.0 5.28%
PD Transfer
2.0 2.1 2.2 2.4 2.5 2.6 2.8 2.9 3.1 3.2 5.28%
Sets
PD Solutions 1,191.7 1,262.8 1,337.0 1,410.8 1,487.4 1,567.0 1,649.5 1,735.2 1,824.1 1,916.4 5.28%
Total 3,951.7 4,047.9 4,178.0 4,309.0 4,443.3 4,568.5 4,701.9 4,848.0 4,990.4 5,134.7 2.99%
Source: GlobalData
Figure 47 below shows the expansion of the US HD products market. The sale of HD products,
expanding at a CAGR of 1.41%, is the largest segment of the total renal dialysis devices market, as
in-center HD treatment is used by the majority of dialysis patients in the US. Dialyzers makes up
the largest market, whereas HD machines, blood tubing sets, and dialysates occupy a slightly
smaller market. Sales of dialysis catheters will shrink due to the clinical guideline recommendation
of reducing catheter use.

110
Market Outlooks
Figure 47: US Market Value Forecast by Market Segment for HD Products, 2013–2022
3,500
3,000
2,500
Revenue ($m)
2,000
1,500
1,000
500
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Dialysates
Source: GlobalData
The US is the largest market of PD products in the world by a wide margin, growing at a stable
CAGR of 5.15%. The US PD products market, illustrated in Figure 48 below, is dominated by PD
solutions.
Figure 48: US Market Value Forecast by Market Segment for PD Products, 2013–2022
2,500
2,000
Revenue ($m)
1,500
1,000
500
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData

111
Market Outlooks
6.5.5 France
The French renal dialysis equipment market, outlined in Figure 49 and Table 43 below, was valued
at $480.6m in 2015 and is growing at a CAGR of 2.86%.
Figure 49: France Market Value Forecast by Segment for Renal Dialysis Equipment, 2013–2022
700
600
Revenue ($m)
500
400
300
200
100
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData

112
Market Outlooks
Table 43: France Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022
Segment 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 CAGR
HD Machines 52.0 52.2 52.7 53.3 53.8 54.3 54.9 55.5 56.0 56.5 1.00%
PD Machines 14.3 14.0 14.1 14.3 14.4 14.6 14.7 14.9 15.0 15.1 0.98%
CRRT Machines 10.6 11.1 12.2 12.9 14.1 15.4 16.8 18.4 20.1 21.9 8.77%
Fistula Needles 13.2 13.3 13.5 13.6 13.7 13.8 13.9 14.0 14.1 14.1 0.72%
Blood Tubing Sets 56.8 57.5 58.2 58.9 59.6 60.2 60.9 61.6 62.2 62.9 1.10%
Dialyzers 166.9 170.2 173.6 177.0 180.4 183.8 187.3 190.8 194.3 197.8 1.88%
Grafts 8.2 8.4 8.6 8.8 9.1 9.3 9.5 9.8 10.0 10.3 2.56%
Dialysis Catheters 4.4 4.6 4.7 4.8 5.0 5.1 5.3 5.5 5.6 5.8 3.10%
Dialysates 70.7 72.3 73.9 75.5 77.1 78.8 80.5 82.2 83.9 85.7 2.13%
PD Catheters 1.2 1.3 1.4 1.5 1.6 1.8 1.9 2.0 2.2 2.4 7.60%
PD Transfer Sets 0.1 0.1 0.1 0.1 0.1 0.2 0.2 0.2 0.2 0.2 7.60%
PD Solutions 57.7 62.4 67.4 72.6 78.1 84.1 90.5 97.3 104.7 112.6 7.60%
Total 456.2 467.4 480.6 493.3 507.0 521.3 536.3 551.9 568.3 585.4 2.86%
Source: GlobalData
Figure 50 below highlights the HD products market in France. Reflecting global scenarios, dialyzers
dominate the French market. HD machines, blood tubing sets, and dialysates drew modest
revenue by comparison, but are expanding nonetheless.

113
Market Outlooks
Figure 50: France Market Value Forecast by Market Segment for HD Products, 2013–2022
500
450
400
Revenue ($m)
350
300
250
200
150
100
50
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022

Dialysates
Source: GlobalData
The French PD products market was valued at $83.1m and is growing at a steady CAGR of 6.63%.
As seen in Figure 51 below, the French PD product space features the PD solutions segment as
the clear market leader.

114
Market Outlooks
Figure 51: France Market Value Forecast by Market Segment for PD Products, 2013–2022
140
120
100
Revenue ($m)
80
60
40
20
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022

Source: GlobalData
6.5.6 Germany
Figure 52 and Table 44 below summarize the German renal dialysis equipment space, which is the
largest in the 5EU. The market was valued at $872.3m in 2015 and is expected to reach $910.8m
by 2022, at a meager CAGR of 0.62% due to market saturation.

115
Market Outlooks
Figure 52: Germany Market Value Forecast by Segment for Renal Dialysis Equipment, 2013–2022
1,000
900
800
Revenue ($m)
700
600
500
400
300
200
100
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData
Table 44: Germany Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022
Segment 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 CAGR
HD Machines 50.0 55.9 56.0 56.0 56.0 56.1 56.2 56.2 56.3 55.7 –0.07%
PD Machines 12.2 13.2 13.2 13.2 13.2 13.1 12.9 13.0 13.0 13.0 –0.23%
CRRT Machines 15.8 18.2 19.6 20.2 21.7 23.3 24.7 26.4 28.3 30.3 6.41%
Fistula Needles 30.7 30.2 29.8 29.4 28.9 28.5 28.1 27.7 27.2 26.8 –1.49%
Blood Tubing Sets 117.5 116.2 114.9 113.6 112.4 111.1 109.9 108.7 107.5 106.3 –1.11%
Dialyzers 222.4 221.0 219.6 218.2 216.8 215.4 214.0 212.6 211.2 209.8 –0.65%
Grafts 10.6 10.7 10.8 11.0 11.1 11.2 11.4 11.5 11.6 11.8 1.20%
Dialysates 156.6 154.9 153.2 151.5 149.8 148.2 146.5 144.9 143.3 141.7 –1.11%
PD Catheters 1.7 1.8 1.8 1.9 1.9 2.0 2.0 2.1 2.2 2.2 3.15%
PD Transfer Sets 0.3 0.3 0.4 0.4 0.4 0.4 0.4 0.4 0.4 0.4 3.15%
PD Solutions 230.8 238.3 246.0 253.7 261.7 270.0 278.5 287.3 296.3 305.7 3.15%
Total 855.6 867.8 872.3 876.1 881.0 886.2 891.7 897.7 904.4 910.8 0.62%
Source: GlobalData

116
Market Outlooks
Figure 53 illustrates the HD products space in Germany. Although the total volume of HD devices
is growing, the market value is shrinking as slowing demand and intense competition reduces
prices. As in other countries, dialyzers are the largest segment within the German HD products
market.
Figure 53: Germany Market Value Forecast by Market Segment for HD Products, 2013–2022
700
600
500
Revenue ($m)
400
300
200
100
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Dialysates
Source: GlobalData
Figure 54 highlights the German PD products market. The market is growing at a steady CAGR of
3.00% due to increasing adoption of PD treatment. As expected, PD solutions lead the PD
products market.

117
Market Outlooks
Figure 54: Germany Market Value Forecast by Market Segment for PD Products, 2013–2022
350
300
Revenue ($m)
250
200
150
100
50
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData
6.5.7 Italy
Figure 55 and Table 45 below outline the Italian renal dialysis equipment market. The overall space
in Italy is expected to expand at a CAGR of 2.62%, reaching $994.6m by 2022. Italy is the second
largest market in the 5EU because of the relatively large dialysis population.

118
Market Outlooks
Figure 55: Italy Market Value Forecast by Segment for Renal Dialysis Equipment, 2013–2022
1,200
1,000
Revenue ($m)
800
600
400
200
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData
Table 45: Italy Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022
Segment 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 CAGR
HD Machines 82.1 82.2 83.1 83.9 84.8 85.6 86.5 87.4 88.2 89.1 1.00%
PD Machines 15.1 15.1 15.3 15.4 15.6 15.7 15.9 16.0 16.2 16.4 1.01%
CRRT Machines 11.1 12.1 13.3 14.0 15.3 16.7 18.3 20.0 21.9 23.9 8.77%
Fistula Needles 27.4 27.8 28.2 28.5 28.9 29.2 29.6 29.9 30.2 30.5 1.15%
Dialyzers 251.0 256.7 262.3 267.9 273.5 279.1 284.8 290.4 296.1 301.9 2.03%
Grafts 7.4 6.9 6.5 6.1 5.7 5.3 5.0 4.6 4.4 4.1 –6.45%
Dialysates 146.6 149.9 153.3 156.6 159.9 163.3 166.7 170.1 173.5 176.9 2.07%
PD Catheters 1.8 2.0 2.2 2.4 2.6 2.8 3.1 3.3 3.6 4.0 9.01%
PD Transfer Sets 0.1 0.2 0.2 0.2 0.2 0.2 0.2 0.3 0.3 0.3 9.01%
PD Solutions 67.2 73.7 80.9 88.3 96.3 105.0 114.5 124.7 135.9 148.0 9.01%
Total 790.1 809.1 829.9 850.2 871.7 894.1 917.5 942.0 967.6 994.6 2.62%
Source: GlobalData

119
Market Outlooks
Figure 56 below outlines the HD products market for Italy, which was valued at $718.1m in 2015.
Figure 56: Italy Market Value Forecast by Market Segment for HD Products, 2013–2022
900
800
700
Revenue ($m)
600
500
400
300
200
100
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022

Dialysates
Source: GlobalData
The Italian PD products market is growing at a notable CAGR of 7.99%. As shown in Figure 57, the
Italian PD solutions space, like most other countries, dominates the PD products market.

120
Market Outlooks
Figure 57: Italy Market Value Forecast by Market Segment for PD Products, 2013–2022
180
160
140
Revenue ($m)
120
100
80
60
40
20
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData
6.5.8 Spain
Figure 58 and Table 46 below outline the renal dialysis devices market in Spain. The Spanish
market is relatively small in the 5EU. GlobalData valued the total space at $264.4m in 2015.
Figure 58: Spain Market Value Forecast by Segment for Renal Dialysis Equipment, 2013–2022
400
350
300
Revenue ($m)
250
200
150
100
50
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData

121
Market Outlooks
Table 46: Spain Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022
Segment 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 CAGR
HD Machines 12.2 12.1 12.2 12.2 12.2 12.2 12.2 12.2 12.3 12.3 0.13%
PD Machines 2.4 2.4 2.4 2.4 2.4 2.4 2.4 2.4 2.4 2.4 0.13%
CRRT Machines 2.4 2.7 2.9 3.0 3.3 3.6 3.9 4.2 4.5 4.9 7.87%
Fistula Needles 7.1 7.1 7.1 7.1 7.1 7.1 7.1 7.0 7.0 7.0 –0.28%
Blood Tubing Sets 40.6 40.3 40.0 39.7 39.4 39.0 38.7 38.3 37.9 37.5 –0.90%
Dialyzers 63.1 63.7 64.4 65.1 65.7 66.3 66.9 67.4 67.9 68.4 0.87%
Grafts 2.1 2.1 2.2 2.2 2.2 2.2 2.3 2.3 2.3 2.4 1.43%
Dialysis Catheters 1.9 1.9 1.8 1.8 1.7 1.7 1.6 1.6 1.6 1.5 –2.70%
Dialysates 44.9 45.0 45.1 45.2 45.3 45.4 45.4 45.5 45.5 45.5 0.11%
PD Catheters 0.7 0.8 0.8 0.9 1.0 1.0 1.1 1.2 1.3 1.4 8.40%
PD Transfer Sets 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.2 0.2 0.2 8.40%
PD Solutions 71.7 78.2 85.4 92.7 100.6 109.1 118.3 128.1 138.8 150.2 8.40%
Total 249.2 256.3 264.4 272.4 281.0 290.2 300.0 310.5 321.7 333.7 3.38%
Source: GlobalData
Figure 59 shows the breakdown of the Spanish HD products market, which is led by dialyzers.
Blood tubing sets and dialysates still generate sizable revenue in this space.
Figure 59: Spain Market Value Forecast by Market Segment for HD Products, 2013–2022
200
180
160
Revenue ($m)
140
120
100
80
60
40
20
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Dialysates
Source: GlobalData

122
Market Outlooks
GlobalData forecasts the value of the Spanish PD market will reach to $154.3m, at a CAGR of
8.22%. PD solutions lead the PD products market in Spain, as illustrated in Figure 60 below.
Figure 60: Spain Market Value Forecast by Market Segment for PD Products, 2013–2022
180
160
140
Revenue ($m)
120
100
80
60
40
20
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData
6.5.9 UK
In 2015, GlobalData valued the UK renal dialysis equipment market, outlined by Figure 61 and
Table 47 below, at $313.8m.

123
Market Outlooks
Figure 61: UK Market Value Forecast by Segment for Renal Dialysis Equipment, 2013–2022
400
350
300
Revenue ($m)
250
200
150
100
50
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData
Table 47: UK Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022
Segment 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 CAGR
HD Machines 31.4 30.2 29.9 29.6 29.3 29.0 28.7 28.5 28.2 27.9 –1.01%
PD Machines 10.3 10.1 10.0 9.9 9.8 9.7 9.6 9.5 9.4 9.3 –1.01%
CRRT Machines 3.6 3.8 4.1 4.3 4.6 5.0 5.4 5.9 6.4 6.9 7.66%
Fistula Needles 10.3 10.3 10.4 10.5 10.5 10.6 10.7 10.7 10.8 10.8 0.56%
Dialyzers 71.2 71.1 71.1 71.1 71.0 70.9 70.9 70.8 70.7 70.6 –0.11%
Grafts 3.9 3.9 3.9 3.9 4.0 4.0 4.0 4.0 4.0 4.0 0.25%
Dialysates 51.6 52.2 52.7 53.2 53.7 54.2 54.7 55.2 55.8 56.3 0.95%
PD Catheters 0.6 0.6 0.6 0.6 0.6 0.6 0.6 0.7 0.7 0.7 1.76%
PD Transfer Sets 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 1.76%
PD Solutions 89.6 91.2 92.8 94.5 96.2 97.9 99.6 101.4 103.1 104.9 1.76%
Total 307.9 310.2 313.8 317.2 321.0 324.8 328.7 332.7 336.9 341.1 1.20%
Source: GlobalData
As shown in Figure 62, dialyzers draw the largest share of the HD devices revenue. Blood tubing
sets and dialysates perform comparably well in the UK market by demonstrating steady growth.

124
Market Outlooks
Figure 62: UK Market Value Forecast by Market Segment for HD Products, 2013–2022
250
200
Revenue ($m)
150
100
50
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Dialysates
Source: GlobalData
The UK PD products market, highlighted in Figure 63 below, was valued at $103.6m in 2015.
Because of low adoption rate, the CAGR of PD products space is 1.51%, which is the lowest of the
10MM. PD solutions are the leading segment in the PD products market.
Figure 63: UK Market Value Forecast by Market Segment for PD Products, 2013–2022
140
120
100
Revenue ($m)
80
60
40
20
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData

125
Market Outlooks
6.5.10 Japan
Driven by an advanced healthcare system and the presence of numerous local companies, the
Japanese market is an important one on the global stage. As summarized by Figure 44 and Table
48 below, the Japanese renal dialysis devices market was valued at $3.92 billion in 2015. The
Japanese healthcare system tends to support resource-intense treatments because of its fee-for-
service approach. It rewards the use of expensive services like HD. However, the overall market
value is shrinking because of reimbursement cuts and price reduction.
Figure 64: Japan Market Value Forecast by Segment for Renal Dialysis Equipment, 2013–2022
4,500
4,000
3,500
Revenue ($m)
3,000
2,500
2,000
1,500
1,000
500
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData

126
Market Outlooks
Table 48: Japan Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022
Segment 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 CAGR
HD Machines 963.4 895.4 888.8 868.4 848.5 828.9 809.8 791.1 773.2 754.8 –2.31%
PD Machines 10.4 9.9 9.7 9.5 9.3 9.1 8.9 8.7 8.5 8.3 –2.31%
CRRT Machines 413.8 424.6 455.8 458.2 484.3 511.8 541.0 571.7 604.3 638.5 4.93%
Fistula Needles 146.4 144.0 141.5 138.9 136.3 133.7 131.2 128.6 126.1 123.5 –1.92%
Blood Tubing
502.2 504.3 506.2 507.9 509.6 511.1 512.5 513.8 515.1 516.2 0.28%
Sets
Dialyzers 1,057.0 1,042.5 1,028.0 1,012.5 997.1 981.6 966.2 950.8 935.5 920.2 –1.57%
Grafts 74.5 74.4 74.3 74.2 74.0 73.8 73.6 73.4 73.1 72.9 –0.28%
Dialysis
4.9 5.0 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.9 1.94%
Catheters
Dialysates 695.4 698.2 700.9 703.3 705.6 707.7 709.6 711.5 713.2 714.7 0.28%
PD Catheters 3.7 3.9 4.2 4.4 4.6 4.8 5.0 5.2 5.5 5.7 4.48%
PD Transfer
0.3 0.3 0.3 0.3 0.4 0.4 0.4 0.4 0.4 0.4 4.48%
Sets
PD Solutions 91.2 97.5 104.2 108.9 113.8 118.9 124.3 129.8 135.6 141.5 4.48%
Total 3,963.1 3,899.9 3,918.9 3,891.7 3,888.6 3,887.3 3,887.9 3,890.6 3,896.1 3,902.6 –0.06%
Source: GlobalData
The HD products market in Japan is saturated. Due to intensive competition by Japanese local
manufacturers and restrained reimbursement, the reduced pricing affects the HD products market
value. Figure 65 below shows the dialyzers market enjoying more success in the Japanese market
than other HD products segments.

127
Market Outlooks
Figure 65: Japan Market Value Forecast by Market Segment for HD Products, 2013–2022
4,000
3,500
3,000
Revenue ($m)
2,500
2,000
1,500
1,000
500
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022

Dialysates
Source: GlobalData
Because reimbursement incentives will support more efficient treatment options to reduce the
strain on Japan’s healthcare system budget, prevalence of PD treatment will increase. GlobalData
expects the Japanese PD market will expand to $155.9m, at a steady CAGR of 4.01%. PD
solutions represent the largest segment within the PD products market, as shown in Figure 66
below.

128
Market Outlooks
Figure 66: Japan Market Value Forecast by Market Segment for PD Products, 2013–2022
180
160
140
Revenue ($m)
120
100
80
60
40
20
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData
6.5.11 Brazil
Figure 67 and Table 49 outline the Brazilian renal dialysis equipment market, the largest one in
South America. The overall space, while valued at $364.5m in 2015, is expanding at a slightly
slower CAGR than markets in other emerging economies, such as India and China.

129
Market Outlooks
Figure 67: Brazil Market Value Forecast by Segment for Renal Dialysis Equipment, 2013–2022
700
600
500
Revenue ($m)
400
300
200
100
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData
Table 49: Brazil Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022
Segment 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 CAGR
HD Machines 37.0 37.7 39.3 41.0 42.7 44.6 46.5 48.5 50.6 52.8 4.30%
PD Machines 1.8 1.9 2.0 2.0 2.1 2.2 2.3 2.4 2.5 2.6 4.28%
CRRT Machines 6.6 7.4 8.4 9.0 10.2 11.5 12.9 14.6 16.4 18.5 11.96%
Fistula Needles 15.2 16.3 17.5 18.7 20.0 21.3 22.7 24.2 25.7 27.4 6.62%
Dialyzers 28.5 30.2 32.1 34.0 36.1 38.3 40.6 43.1 45.7 48.4 6.06%
Grafts 14.9 15.5 16.2 16.8 17.6 18.3 19.2 20.1 21.0 22.1 4.53%
Dialysates 71.7 75.8 80.1 84.5 89.2 94.1 99.3 104.8 110.5 116.5 5.51%
PD Catheters 1.3 1.5 1.7 1.9 2.1 2.4 2.6 2.9 3.3 3.7 11.60%
PD Transfer Sets 0.1 0.1 0.2 0.2 0.2 0.2 0.2 0.3 0.3 0.3 11.60%
PD Solutions 80.4 90.1 100.9 112.7 125.8 140.5 156.8 174.9 195.1 217.6 11.60%
Total 317.8 339.7 364.5 390.6 419.2 450.2 483.9 520.4 560.0 603.2 7.46%
Source: GlobalData

130
Market Outlooks
The Brazilian HD products market is growing at a steady CAGR above 5%. As shown in Figure 68
below, dialyzers do not generate as much proportional revenue as they do in other emerging
markets, due to more frequent use of reprocessed dialyzers in Brazil.
Figure 68: Brazil Market Value Forecast by Market Segment for HD Products, 2013–2022
400
350
Revenue ($m)
300
250
200
150
100
50
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Dialysates
Source: GlobalData
Figure 69 below outlines the Brazilian PD devices market, which was valued at $104.7m in 2015
and will expand to $224.2m with a vigorous CAGR of 11.49%. Because of the high volume, PD
solutions dominate the PD products market.

131
Market Outlooks
Figure 69: Brazil Market Value Forecast by Market Segment for PD Products, 2013–2022
250
200
Revenue ($m)
150
100
50
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData
6.5.12 China
The Chinese renal dialysis market space, as seen in Figure 70 and Table 50 below, is the largest The Chinese
government’s
one in the APAC region. The Chinese government’s reforms aim to have universal health reforms aim to have
insurance coverage by 2020, which will greatly improve patients’ access to dialysis treatment. universal health
insurance coverage
GlobalData valued the total space at $3.08 billion in 2015. It is projected to expand at a brisk by 2020, which will
greatly improve the
CAGR of 8.07%. patients’ access to
dialysis treatment.

132
Market Outlooks
Figure 70: China Market Value Forecast by Segment for Renal Dialysis Equipment, 2013–2022
6,000
5,000
Revenue ($m)
4,000
3,000
2,000
1,000
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData

133
Market Outlooks
Table 50: China Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022
Segment 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 CAGR
HD Machines 657.0 671.2 706.6 743.8 783.0 824.3 867.7 913.4 961.6 1,012.3 5.27%
PD Machines 10.4 10.6 11.2 11.8 12.4 13.1 13.7 14.5 15.2 16.0 5.27%
CRRT
111.3 126.9 147.4 162.2 187.0 215.6 248.5 286.5 330.3 380.8 14.52%
Machines
Fistula
63.5 67.6 71.9 76.6 81.5 86.7 92.2 98.1 104.3 110.9 6.38%
Needles
Blood Tubing
286.9 306.9 328.2 351.0 375.3 401.3 429.1 458.9 490.7 524.7 6.93%
Sets
Dialyzers 659.9 708.3 760.2 815.8 875.5 939.5 1,008.3 1,082.0 1,161.2 1,246.1 7.32%
Grafts 21.4 24.0 27.0 30.3 33.9 38.0 42.6 47.7 53.5 60.0 12.06%
Dialysis
12.2 12.5 12.8 13.1 13.4 13.7 14.0 14.4 14.8 15.2 2.54%
Catheters
Dialysates 182.4 193.2 204.6 216.6 229.3 242.7 257.0 272.0 288.0 304.9 5.86%
PD Catheters 12.0 13.3 14.7 16.2 18.0 19.8 21.9 24.2 26.8 29.6 10.51%
PD Transfer
1.3 1.5 1.6 1.8 2.0 2.2 2.4 2.7 3.0 3.3 10.51%
Sets
PD Solutions 652.5 721.8 798.5 882.4 975.2 1,077.7 1,191.0 1,316.2 1,454.6 1,607.5 10.51%
Total 2,670.8 2,857.7 3,084.7 3,321.6 3,586.4 3,874.7 4,188.6 4,530.8 4,904.0 5,311.4 8.07%
Source: GlobalData
As Figure 71 below shows, the Chinese HD products market is expanding robustly, at a CAGR of
6.47%. Dialyzers make up a key segment of the market, experiencing the fastest growth within the
overall sector.

134
Market Outlooks
Figure 71: China Market Value Forecast by Market Segment for HD Products, 2013–2022
3,500
3,000
Revenue ($m)
2,500
2,000
1,500
1,000
500
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Dialysates
Source: GlobalData
The Chinese PD products space, illustrated in Figure 72 below, features all key segments
expanding strongly at CAGRs exceeding 10%. PD solutions lead the pack, but PD machines play a
key role in the PD products market.
Figure 72: China Market Value Forecast by Market Segment for PD Products, 2013–2022
1,800
1,600
1,400
Revenue ($m)
1,200
1,000
800
600
400
200
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData

135
Market Outlooks
6.5.13 India
India, summarized by Figure 73 and Table 51 below, is the second fastest growing market in the
APAC region. GlobalData expects the total space to reach $220.6m by 2022 with a rapid CAGR of
7.78%.
Figure 73: India Market Value Forecast by Segment for Renal Dialysis Equipment, 2013–2022
250
200
Revenue ($m)
150
100
50
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData

136
Market Outlooks
Table 51: India Market Value Forecast by Segment for Renal Dialysis Equipment, $m, 2013–2022
Segment 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 CAGR
HD Machines 32.9 33.8 35.5 37.1 38.9 40.8 42.7 44.8 46.8 49.0 4.72%
PD Machines 1.9 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 4.67%
CRRT Machines 5.3 6.0 7.0 7.7 8.9 10.3 11.9 13.7 15.8 18.2 14.64%
Fistula Needles 2.9 3.2 3.4 3.7 4.0 4.4 4.7 5.1 5.5 5.9 8.03%
Dialyzers 13.7 14.6 15.6 16.6 17.7 18.9 20.1 21.4 22.9 24.4 6.62%
Grafts 2.9 3.1 3.3 3.6 3.8 4.1 4.5 4.8 5.2 5.7 8.02%
Dialysates 16.0 16.9 17.9 18.9 20.0 21.2 22.4 23.7 25.1 26.5 5.81%
PD Catheters 0.7 0.7 0.8 0.9 1.0 1.1 1.2 1.3 1.5 1.6 10.70%
PD Transfer Sets 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.1 0.2 10.70%
PD Solutions 30.6 33.9 37.7 41.7 46.2 51.1 56.6 62.7 69.4 76.8 10.70%
Total 113.6 121.4 130.6 140.1 150.8 162.5 175.2 189.1 204.2 220.6 7.78%
Source: GlobalData
Unlike most of the rest of the 10MM, HD machines draw the most revenue in India. The disposable
products space, outlined in Figure 74 below, also features modest gains made by dialyzers and
dialysates sales.

137
Market Outlooks
Figure 74: India Market Value Forecast by Market Segment for HD Products, 2013–2022
140
120
Revenue ($m)
100
80
60
40
20
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Dialysates
Source: GlobalData
Figure 75 below highlights the Indian PD devices market, which mirrors China. Driven by
increasing dialysis centers and improving health insurance coverage, all sectors of PD products
demonstrate vigorous expansion.

138
Market Outlooks
Figure 75: India Market Value Forecast by Market Segment for PD Products, 2013–2022
90
80
70
Revenue ($m)
60
50
40
30
20
10
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: GlobalData

139
Appendix
7 Appendix
7.1 Bibliography
• Argyropoulos C, et al. (2015). Dialyzer reuse and outcomes of high flux dialysis. PLoS
One 10.6: e0129575.
• Baxter (2015). 2015 Investor Conference: Renal Overview. Available from:

http://investor.baxter.com/phoenix.zhtml?c=86121&p=irol-calendar. [Accessed February 15,
2016].
• Berger A, et al. (2009). Cost comparison of peritoneal dialysis versus hemodialysis in end-
stage renal disease. The American Journal of Managed Care; 15(8): 509–518.
• Blankestijn PJ, et al. (2010). Hemodiafiltration: clinical evidence and remaining questions.
Kidney International; 77: 581–587.
• China Food and Drug Administration (CFDA) (2016). Regulatory Guide. Available from:
http://eng.cfda.gov.cn/WS03/CL0770/. [Accessed February 1, 2016].
• CMS (2013). End-Stage Renal Disease (ESRD) Quality Initiative. Available from:
https://www.cms.gov/Medicare/End-Stage-Renal-Disease/ESRDQualityImproveInit/. [Accessed
February 15, 2016].
• CMS (2016a). Comprehensive ESRD Care Model. Available from:

https://innovation.cms.gov/initiatives/comprehensive-esrd-care/. [Accessed February 15, 2016].
• CMS (2016b). Medicare Benefit Policy Manual Chapter 11 - End Stage Renal Disease.
Available from: https://www.cms.gov/Regulations-and-
Guidance/Guidance/Manuals/downloads/bp102c11.pdf. [Accessed February 15, 2016].
• Collins AJ (2012). ESRD payment policy changes: the new “bundled” dialysis prospective
payment system (PPS) in the United States. Available from: http://www.usrds.org/2012/pres/
USDialysisBundle_impact_NKFCM2012.pdf. [Accessed February 10, 2016].
• Couser WG et al. (2011). The contribution of chronic kidney disease to the global burden of
major noncommunicable diseases. Kidney International; 80(12): 1258–1270.
• Davis JA and May S, eds (2006). Case studies in organizational communication: Ethical
perspectives and practices. SAGE Publishing, Thousand Oaks, CA.

140
Appendix
• Eggers PW (2000). Medicare’s end stage renal disease program. Health Care Financing
Review. 22(1): 55–60.
• End Stage Renal Disease National Coordinating Center (2016). Fistula First Catheter Last –
Professionals. Available from: http://fistulafirst.org/. [Accessed March 1, 2016].
• ERA-EDTA (2015). The European Renal Association-The European Dialysis and Transplant
Association: ERA EDTA/SLANH Registries Fellowships. Available from: http://www.era-edta.
org/page-22-126-184-184-eraedtaoslanhregistriesfellowships.html. [Accessed March 1, 2016].
• EURODOPPS (2013). EURODOPPS, a joint venture of ERA-EDTA and Arbor Research, is

born! Available from: http://www.era-edta-reg.org/files/pressrelease/EURODOPPS%20flyer.
pdf. [Accessed March 1, 2016].
• European Commission (2010). Manual on borderline and classification in the community

regulatory framework for medical devices. Available from:
http://ec.europa.eu/consumers/sectors/medical-
devices/files/wg_minutes_member_lists/version1_7_borderline_manual_en.pdf [Accessed
March 1, 2016].
• European Commission (2015). Medical devices. Available from:

http://ec.europa.eu/growth/sectors/medical-devices/index_en.htm. [Accessed March 1, 2016].
• Fadem SZ, et al. (2011). Satisfaction with renal replacement therapy and education: the
American Association of Kidney Patients survey. Clinical Journal of the American Society of
Nephrology; 6(3): 605–612.
• FDA (1991). Quality Assurance Guidelines for Hemodialysis Devices. Available from:
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocume
nts/ucm073435.pdf. [Accessed March 1, 2016].
• FDA (2015). Overview of Medical Devices and Their Regulatory Pathways. Available from:
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CD
RHTransparency/ucm203018.htm. [Accessed March 1, 2016].

141
Appendix
• FDA (2016). Implanted Blood Access Devices for Hemodialysis: Guidance for Industry and
Food and Drug Administration Staff. Available from:
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocume
nts/ucm308598.pdf. [Accessed March 1, 2016].
• Fresenius (2015). Annual Report 2015. Available from:

https://www.fresenius.com/media_library/Fresenius_GB_US_GAAP_2015_englisch.pdf.
[Accessed March 10, 2016].
• Fukuhara S, et al. (2007). The organization and financing of end-stage renal disease treatment
in Japan. International Journal of Health Care Finance and Economics; 7(2-3): 217–231.
• Grassmann A, et al. (2006). End-stage renal disease: global demographics in 2005 and
observed trends. Artificial Organs; 30(12): 895–897.
• Janssen IM, et al. (2015). Preferences of patients undergoing hemodialysis – results from a
questionnaire-based study with 4,518 patients. Patient Preference and Adherence; 9: 847–855.
• Jean G, et al. (2015). Online-haemodiafiltration vs. conventional haemodialysis: a cross-over

study. BMC Nephrology; 16: 70.
• Jha V, et al. (2013). Chronic kidney disease: global dimension and perspectives. Lancet; 382:
260–272.
• Kolff W, et al. (1944). The artificial kidney, a dialyzer with a great area. Acta Medica
Scandinavica; 117: 121–128.
• Liu ZH (2013). Nephrology in China. Nature Reviews Nephrology; 9: 523–528
• Luño J (2007). The organization and financing of end-stage renal disease in

Spain. International Journal of Health Care Finance and Economics; 7(4): 253–267.
• Masakane I, et al. (2015). An overview of regular dialysis treatment in Japan (as of 31

December 2013). Therapeutic Apheresis and Dialysis; 19(6): 540–574.
• McMillan JI (2014). Peritoneal Dialysis. Merck Manual. Available from:

https://www.merckmanuals.com/professional/genitourinary-disorders/renal-replacement-
therapy/peritoneal-dialysis. [Accessed February 15, 2016].

142
Appendix
• Meng Q, et al. (2012). Trends in access to health services and financial protection in China
between 2003 and 2011: a cross-sectional study. Lancet; 379: 805–814.
• National Health Service (NHS) (2015). National tariff payment system 2015/16: a consultation
notice. Available from: https://www.gov.uk/government/consultations/national-tariff-payment-
system-201516-a-consultation-notice. [Accessed February 15, 2016].
• National Kidney Foundation (2015). KDOQI Clinical Practice Guideline for Hemodialysis
Adequacy: 2015 Update. Available from: http://www.ajkd.org/article/S0272-6386(15)01019-
7/fulltext. [Accessed February 1, 2016].
• National Kidney Foundation (2016). Global facts: about kidney disease. Available from:
https://www.kidney.org/kidneydisease/global-facts-about-kidney-disease. [Accessed February
1, 2016].
• Nephron+ (2014). About the Project. Available from: http://www.nephronplus.eu. [Accessed

March 1, 2016].
• NIDDK (2010). Peritoneal Dialysis Dose and Adequacy. Available from:

http://www.niddk.nih.gov/health-information/health-topics/kidney-disease/peritoneal-dialysis-
dose-and-adequacy/Pages/facts.aspx. [Accessed February 15, 2016].
• NIDDK (2014a). Vascular Access for Hemodialysis. Available from:

http://www.niddk.nih.gov/health-information/health-topics/kidney-disease/vascular-access-for-
hemodialysis/Pages/index.aspx. [Accessed February 15, 2016].
• NIDDK (2014b). Hemodialysis Dose and Adequacy. Available from:

http://www.niddk.nih.gov/health-information/health-topics/kidney-disease/hemodialysis-dose-
and-adequacy/Pages/facts.aspx. [Accessed February 15, 2016].
• Nikkiso (2015). Annual Report 2015. Available from:

http://www.nikkiso.com/ir/annualreport.html. [Accessed February 15, 2016].
• O’Hare AM, et al. (2011). Trends in timing of initiation of chronic dialysis in the United States.
Archives of Internal Medicine; 171(18): 1663–1669.
• Pannu N and Gibney RN (2005). Renal replacement therapy in the intensive care unit.
Therapeutics and Clinical Risk Management; 1(2): 141–150.

143
Appendix
• U.S. Renal Care (2016). About Us. Available from: http://www.usrenalcare.com/about.

[Accessed March 20, 2016].
• USRDS (2015). 2015 USRDS Annual Data Report. Available from:

http://www.usrds.org/2015/view/Default.aspx. [Accessed February 20, 2016].
• Van Biesen W, et al. (2014). Patients’ perceptions of information and education for renal
replacement therapy: an independent survey by the European Kidney Patients’ Federation on
information and support on renal replacement therapy. PLoS ONE; 9(7): e103914.
• World Kidney Day (2015). Chronic Kidney Disease. Available from:

http://www.worldkidneyday.org/faqs/chronic-kidney-disease/. [Accessed February 1, 2016].

144
Appendix
7.2 Abbreviations
5EU 5 major European markets (France, Germany, Italy, Spain, and the UK)
10MM 10 major markets (US, France, Germany, Italy, Spain, the UK, Japan, Brazil,
China, and India)
APAC Asia-Pacific (Japan, India, and China)
APD automated peritoneal dialysis
AV arteriovenous
CAGR compound annual growth rate
CAPD continuous ambulatory peritoneal dialysis
CCPD continuous cycler-assisted peritoneal dialysis
CFDA China Food and Drug Administration
CRRT continuous renal replacement therapy
CMS Centers for Medicare and Medicaid Services
ERA-EDTA European Renal Association – European Dialysis and Transplant Association
EURODOPPS European Dialysis and Transplant Association and Dialysis Outcomes and
Practice Patterns Study
ESRD end-stage renal disease
HD hemodialysis
IPD intermittent peritoneal dialysis
KOL key opinion leader
NHS National Health Service
NIDDK National Institute of Diabetes and Digestive and Kidney Diseases
PD peritoneal dialysis

145
Appendix
PMDA Pharmaceuticals and Medical Devices Agency
QOL quality of life
USRDS United States Renal Data System

146
Appendix
7.3 Methodology
7.3.1 Overview
GlobalData’s dedicated research and analysis teams consist of experienced professionals with
extensive experience in marketing and market research, consulting backgrounds in the medical
device industry, and advanced statistical expertise.
GlobalData adheres to the Codes of Practice of the Market Research Society (www.mrs.org.uk)
and the Strategic and Competitive Intelligence Professionals (www.scip.org). All GlobalData
databases are continuously updated and revised. The following research methodology is followed
for all databases and reports.
7.3.2 Coverage
GlobalData’s coverage is designed to ensure that it represents the most up-to-date vision of the
industry possible. Changes to industry taxonomy are based on extensive research of companies,
associations, and competitors. Company coverage is based on three key factors: revenues,
products, and media attention/innovation/market potential.
• The estimated revenues of all major companies, including private and governmental, are
gathered and used to prioritize coverage.
• Companies that are making the news, or that are of particular interest due to their innovative
approach, are prioritized.
GlobalData aims to provide coverage on all major news events and deals in the medical device
industry, updated on a daily basis. The coverage is further streamlined and strengthened with
additional input from GlobalData’s panel of experts (see below).
7.3.3 Secondary Research
The research process begins with exhaustive secondary research into internal and external
sources to gather qualitative and quantitative information relating to each market.
The secondary research sources that are typically referred to include, but are not limited to:
• Reports and databases published by national and international agencies, such as the FDA and
the World Health Organization (WHO).

147
Appendix
• National government documents and databases from the Centers for Disease Control and
Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS).
• Scientific journals, such as Surgical Endoscopy, Cardiovascular and Thoracic Surgery, and
International Journal of Surgery, as well as other technical literature.
• Company websites, annual reports, financial reports, investor presentations, and US Securities
and Exchange Commission (SEC) filings.
• Procedure registries and costs using the Agency for Healthcare Research and Quality (AHRQ).
• Relevant regulatory and device approval databases, such as the FDA 510(k) and PMA
databases.
• News articles, press releases, and webcasts relating to companies operating in the market.
7.4 Forecasting Methodology
GlobalData used a combined capital equipment-based and patient-based forecasting model to

determine the market size for different renal dialysis devices segments. Estimates are based on a
number of sources, including primary research—KOL interviews and physician surveys—and
secondary research, such as company reports, press releases, published articles, proprietary
databases, and general news media.
7.5 Primary Research Efforts
Figure 76 below illustrates the primary research summary for the 10MM. GlobalData interviewed
119 demand- and supply-side stakeholders in the renal dialysis equipment markets. Demand-side
participants included nephrologists and nurses. Supply-side experts included marketing managers,
sales personnel, and other industry professionals.

148
Appendix
Figure 76: Primary Research Summary for Renal Dialysis Equipment
8% US
20%
9% France
Germany
9% Italy
9% Spain
UK
9%
9% Japan
Brazil
9%
9% China
9%
India
Source: GlobalData

149
Appendix
7.6 About the Authors
7.6.1 Tina Deng, MSc, MBS, Analyst, Medical Devices
Tina Deng is a Medical Devices Analyst at GlobalData Healthcare in Toronto. Prior to working at
GlobalData, she was a consultant at Livingston Market Consultants and performed qualitative and
quantitative market research studies in China. Tina also has 3 years’ experience in medical device
industry in China and Canada, which greatly enhanced her understanding of healthcare marketing
from global and regional perspectives. Tina received a B.Eng in Bioengineering and two Masters,
one in Molecular Biology from East China University of Science and Technology and the other in
Biomedical Science from the University of Guelph.
7.6.2 Linda Tian, MSc, Managing Analyst, Medical Devices
Linda Tian is a Managing Analyst covering medical devices at GlobalData Healthcare in Singapore.
She has authored MediPoint reports on a variety of orthopedic markets, including large joint
replacement, extremities, power tools, and craniomaxillofacial and bone graft substitutes. Prior to
working at GlobalData, she was involved in a research project investigating medical engineering
solutions in osteoarthritis in the Department of Bioengineering at Imperial College London. During
the project, she worked extensively with leading scientists in mechanobiology and focused on the
study of the effects of physical stimulations on human knee cartilage cells. Linda also had a
marketing role at Beike Biotechnology (China), where she was involved in client management and
in developing marketing campaigns.
Linda received a BSc in Biotechnology and an MSc (Distinction) in Biomedical Engineering with a
focus on Biomaterials from Imperial College London.

150
Appendix
7.6.3 David Brady, Director of Operations – Market Research
David Brady is the Director of Operations – Market Research for GlobalData’s medical devices
sector. David currently leads a team of analysts working in Singapore, London, Boston, and
Toronto in the development of syndicated and custom medical device products for clients around
the globe. As a Certified Marketing Research Professional with over 25 years of experience
utilizing market research, consumer insights and business analytics to address core challenges,
David has the expertise to address a wide variety of business issues. Prior to joining GlobalData,
David was the Associate Director, Consumer Insights for Mead Johnson Nutrition (a global infant
nutrition manufacturer). He has also held a variety of other senior roles ranging from managing
market research functions in both the private and public sector to operating his own market
research company.
7.6.4 Tyler Fletcher, Global Head of Medical Devices
Tyler Fletcher is the Global Head of Medical Devices at GlobalData Healthcare. He has worked
extensively with market research studies and has conducted competitive intelligence research
across many medical device markets for the last 10 years at GlobalData, Decision Resources
Group, and Millennium Research Group.
Prior to GlobalData, he worked in several Analyst positions at Millennium Research Group before
starting the Consulting division and leading it for 3 years. After that role, he moved to Decision
Resources Group where he was responsible for the strategy for the Medical Devices group. Over
the last several years he has worked in the Strategy and Operations departments at Decision
Resources Group, with a view into M&A work as well.

151
Appendix
7.7 About GlobalData
GlobalData is a leading global provider of business intelligence in the Healthcare industry.

GlobalData provides its clients with up-to-date information and analysis on the latest developments
in drug research, disease analysis, and clinical research and development. Our integrated business
intelligence solutions include a range of interactive online databases, analytical tools, reports and
forecasts. Our analysis is supported by a 24/7 client support and analyst team.
GlobalData has offices in New York, San Francisco, Boston, London, India, Korea, Japan,
Singapore, and Australia.
7.8 Disclaimer
All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any
form by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior
permission of the publisher, GlobalData.
The facts of this report are believed to be correct at the time of publication, but cannot be
guaranteed. Please note that the findings, conclusions, and recommendations that GlobalData
delivers will be based on information gathered in good faith from both primary and secondary
sources, whose accuracy we are not always in a position to guarantee. As such, GlobalData can
accept no liability whatsoever for actions taken based on any information that may subsequently
prove to be incorrect.

152
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REFERENCE CODE GDME0227MAR | PUBLICATION DATE MAY 2016

RENAL DIALYSIS EQUIPMENT –

Key Metrics in Major Markets Market Dynamics

Renal Dialysis Equipment – Global Analysis and Market Forecast

Key Players in the Global Renal Dialysis What Do Physicians Think?

Renal Dialysis Equipment – Global Analysis and Market Forecast

Renal Dialysis Equipment – Global Analysis and Market Forecast

1.1 List of Tables ...................................................................................................................... 10

1.2 List of Figures ..................................................................................................................... 12

2.1 Catalyst ............................................................................................................................... 18

2.2 Technology Overview ......................................................................................................... 19

2.2.1 Dialysis Access ............................................................................................................... 19

2.2.2 Hemodialysis .................................................................................................................. 20

2.2.3 Peritoneal Dialysis .......................................................................................................... 20

2.2.4 Continuous Renal Replacement Therapy ....................................................................... 22

2.3 Key Mergers, Acquisitions, and Deals ................................................................................ 22

2.4 Product Recalls................................................................................................................... 24

3 Market Access ............................................................................................................................ 25

3.1 Regulation .......................................................................................................................... 25

3.2 Registries ............................................................................................................................ 26

3.3 Reimbursement .................................................................................................................. 27

4 Unmet Needs .............................................................................................................................. 33

4.1 Research Gaps ................................................................................................................... 33

4.2 Treatment Flexibility............................................................................................................ 33

4.3 Technological Innovation .................................................................................................... 34

4.4 Home-Based Devices ......................................................................................................... 35

Renal Dialysis Equipment – Global Analysis and Market Forecast

4.5 Shortage of Nephrology Specialists.................................................................................... 37

4.6 Patient Education and Training........................................................................................... 37

5 Competitive Assessment ............................................................................................................ 38

5.1 Major Players ...................................................................................................................... 38

5.1.1 Fresenius SE & Co. KGaA .............................................................................................. 38

5.1.2 Baxter International Inc. .................................................................................................. 40

5.1.3 B. Braun Melsungen AG ................................................................................................. 41

5.1.4 Nikkiso Co., Ltd. .............................................................................................................. 43

5.1.5 Nipro Corporation ........................................................................................................... 44

5.1.6 Asahi Kasei Corporation ................................................................................................. 45

5.1.7 NxStage Medical, Inc. ..................................................................................................... 46

5.1.8 Toray Medical Co., Ltd. ................................................................................................... 47

5.2 Emerging Players ............................................................................................................... 49

5.2.1 Medtronic plc .................................................................................................................. 49

5.3 Marketed Products Assessment ......................................................................................... 50

5.3.1 HD Machines .................................................................................................................. 50

5.3.2 PD Machines and Systems ............................................................................................. 52

5.3.3 CRRT Machines.............................................................................................................. 52

5.3.4 PD Solutions ................................................................................................................... 53

5.3.5 Dialyzers ......................................................................................................................... 54

5.4 Pipeline Assessment and Key Clinical Trials ...................................................................... 57

5.4.1 Pipeline Assessment ...................................................................................................... 57

5.4.2 Key Clinical Trials ........................................................................................................... 59

Renal Dialysis Equipment – Global Analysis and Market Forecast

6 Market Outlooks ......................................................................................................................... 62

6.1 Procedure Trends ............................................................................................................... 62

6.1.1 Vascular Access ............................................................................................................. 62

6.1.2 Dialysis Modalities .......................................................................................................... 64

6.1.3 Dialyzer Reuse ............................................................................................................... 69

6.1.4 Hemodiafiltration ............................................................................................................. 69

6.1.5 Home Dialysis ................................................................................................................. 70

6.2 Market Drivers and Barriers ................................................................................................ 72