Project: Establishment of International Standard Contract Research Organization (CRO) in

Bangladesh (Biofiber International Limited)

Investment: BDT 160 Crore or USD 15 Million for 5 Years

Investment 5 Years Project Overview: Contract Research Organizations (CROs) are organizations,
Period which provide clinical trial and other research support services (Bioequivalence
studies (BE), Diagnostics and others) mainly for the pharmaceutical,
biotechnology, medical device industries and Government and Non-Government
Institutes including Research Institutes and Universities. However, in
Bangladesh, there isn’t a single international standard CRO existing till date
despite a minimum of USD 200 Million market annually.

Net Profit after BDT 4000.00 Crore
10 Years USD 400.00 Million
Market Cap BDT 60,000 Crore
after 10 Years /USD 6.00 Billion
Current Management Portfolio
A Management Team consisting of
Scientists, Physicians, Pharmacists,
Microbiologists & CA’s
More than 120 Years of Combined
Team Experiences of relevant field in
home and abroad
• Globally, the CRO annual revenue has risen from US$ 21 billion in 2011 to
US$ 35 billion in 2015, and to an estimated US$ 61 billion in 2020
• In Bangladesh, parallel to the phenomenal growth of the pharma industry, the
estimated CRO potential has grown from US$ 100 million in 2016 to US$ 200
million in 2020. Moreover, the requirement of CRO services in Bangladesh will
have an even sharper rise after 2032, with the expiry of the TRIPS (Trade-
Related Aspects of International Property Rights) exemption
• Bangladesh is exporting medicines to about 147 out of 182 countries and the
pharmaceutical market size will see a growth of 114% and will reach more than
USD 6 Billion per annum by the year 2025 and USD 10 Billion by 2030 and
the export market will reach to at least USD 1.5 Billion by 2030
• At present, Bangladeshi Top Pharmaceuticals Industries are out-sourcing their
CRO activities (Bioequivalence studies, and Clinical Trials) from India,
Malaysia, Jordan & Singapore etc.
• Bangladesh is transferring USD 200 Million yearly to other countries for CRO
related activities and the neighbouring India, got a yearly CRO-Revenue of
USD 2 Billion

Establishment Biofiber International Limited (BFI) have already been registered in the RJSC in 2020 in Bangladesh
of BFI and shall be established as the first Bangladeshi CRO to operate according to international standards,
with skills and expertise in drug-related research and validation processes. In addition to high-standard
clinical trial units for Phase I Clinical Trials and BE studies, the other components of BFI would be, Phase
2 to Phase 4 Clinical Trials, diagnostic lab facilities, and a training institutes of international standards.
BFI is highly expected to emerge as a premier CRO in Bangladesh, with international standard
contributions to both local as well as global pharma, biotech and related industries.
Time required BFI has already completed the following major tasks over the last couple of years like,
for the full • RJSC Registration in March, 2020,
swing • Around 50 essential Standard Operating Procedures (SOPs) have been Completed, (most
operation of critical and intellectual part of the industry),
the BFI • Completed GCP Certification of Management Staffs,
• About 250 Essential Collaborations with Scientists and Professors in home (150) and abroad
(100) have been completed,
• Website Hosting (https://biofiberinternational.com/our-leadership/ is under construction and
• The Lab and Corporate office which will include Voluntary Clinical Trial Units, Archival Facility,
Cold Room Facility, MOUs with Diagnostics and Hospitals during specific trial (Phase 2-4)
completion, Diagnostic Lab shall be established after getting foreign investment of USD 15.00
Million which has already been in process in-exchange of 20% of its share with potential
Client/Institute and whom would also represent the Board of the Company. The
Investor/Investment Company should get a ROI of at least USD 300-400 Million after 5
years and USD 700-800 Million after 10 years for their 20% holdings of BFI share,
• This in-flow of USD 15.00 Million (BDT 160.00 Crore) shall be confirmed and transferred to BFI
accounts by the last quarter of 2023 and eventually BFI shall be in-operation in full swing by
the 3rd Quarter of 2024 and start its activities with Local BE Studies and Clinical Trials for the
Pharmaceuticals Industries of Bangladesh and other countries

Strictly Private & Confidential Founder: Mohd. Shamim Iqbal, MSc, MSc, PhD 1
Branding and BFI shall be an international standard CRO in Bangladesh embodied with all sorts of infrastructural and
Making BFI regulatory compliances. In the fourth years of its operation (In the 1st quarter of 2027), BFI shall seek
Multinational international collaboration mutually exclusive partnerships with any top-tier CROs of the world. BFI will
Company sale 15% of its existing share to any of those top tier CROs considering the company asset, net profit,
(MNC) intellectual property values and good will with a win-win basis deal (Approximately USD 25-30 Million
or higher) based on the bargain and mutually exclusive terms and conditions with the Top CROs of the
world.

Enlistment of BFI shall be enlisted in the Dhaka Stock Exchange (DSE) & Chittagong Stock Exchange (CSE) in the
BFI in the DSE last quarter of the 4th years of operation after the completion of the Joint-Venture (JV) in 2027.
& CSE & NYSE Moreover, BFI shall also be enlisted in the New York Stock Exchange (NYSE) in the 8th years of
operation in 2030. In the meantime, BFI will extend its capacity by establishing or acquisitions of world
class Hospitals, Research Institutes, Biotech Companies etc. in Bangladesh and around the Globe.

BFI Revenue Basically, with our highly experienced scientists, management and advisory team mostly from icddr,b
Generating (www.icddrb.org) and aboard and with a huge number of national and international collaborators; BFI is
Sources sure to run the business with an international standard with a projected gross profit of around 20 Million
USD by the 5th year and 395 Million USD by the 10th year from conducting Clinical Trials Only, (Table
1) from the inception and initiation of the CRO. However, the CRO will cross operational breakeven in
the 3rd year and shall be in profit from the last quarter of 3rd years of the operation during the projected
time period. Moreover, the total gross profit of BFI would be much higher and would include the following
sectors:
Revenue Sources Gross Profit in 5- Gross Profit in10-
Years Period Years Period
(2024-2028) (2024-2033)

A. Clinical Trials (Phase 1 to Phase 4; (Globally) USD 25 Million USD 350 Million

B. BE Studies (Local & International) USD 20 Million USD 150 Million

C. Diagnostics (Mostly Local) USD 5 Million USD 20 Million

D. CRO Intellectual Property USD 250 Million USD 500 Million

Value in 2027 and 2030 respectively

E. MNC Conversion by Selling 15% BFI Share to USD 30 Million

a Top International CRO (Within World Top 10)

F. Enlistment in the DSE & CSE in 2027 (offering USD 10 Million

2 Million (20.00 lac) general share out of its 50
Million (5.00 Crore) share through IPO with a (Through IPO; BDT
minimum price of BDT 500.00/Share or USD 500/Share or USD
5.00/Share) 5.00/Share)

G. Enlistment of BFI in the NYSE in 2030 (offering USD 500 Million

20% of general share (20 Million) out of 100 (Through IPO; USD
Million shares with a price of USD 25.00 25/Share)

H. Market Capital USD 2.00 Billion in USD 4.50 Billion in

DSE CSE/BDT NYSE/
20,000 Crore
BDT 45,000 Crore

I. Net Asset Value (NAV)/Share BDT 2000/Share USD 615/Share

(DSE & CSE) (NYSE)
A. Net Profit after 25% Tax, and others USD 50 Million USD 340 Million

B. Earning Per Share (EPS) BDT100.00/Share USD 3.40/Share

Strictly Private & Confidential Founder: Mohd. Shamim Iqbal, MSc, MSc, PhD 2
 Table 1: Investment, Profit & Loss of CRO for 5-Years & 10-Years Period (Excluding JV Revenue)
Budget Lines Year Year Year Year Year 5 Years Year Yea Year Year Year 10 Years
1 2 3 4 5 Total 6 r 8 9 10 Total
7
CAPEX Total 60 15 75 10 10 20 115
Variable Total 21 16 17 18 20 91 22 24 26 28 31 221
SubTotal CAPEX & Variable (in 81 31 17 18 20 166 32 34 46 28 31 336
crore)
SubTotal (in million) US$ 8 3 2 2 2 17 40
Revenue (in crore) - 17 60 128 213 417 298 425 680 850 1,020 3,689
Revenue (in million) US$ - 2 6 13 22 43 30 42 68 85 100 325
Gross Profit/Loss (in crore) (81) (14) 43 109 193 251 266 476 719 822 904 3,438
Gros sProfit/Loss (in million) (8) (1.5) 4.5 11 20 26 27 48 72 82 91 346
US$

Strictly Private & Confidential Founder: Mohd. Shamim Iqbal, MSc, MSc, PhD 3
 Global Costing of Clinical Trials and Bioequivalence (BE) Studies:

Average Clinical Trials Costs and Timeline:

Types of Duration Average Premises

Clinical Trial Costs/Trial
Phase I 3 months to 1 Year USD 3.36 Million BFI Clinical Trial Unit
Phase 2 6 months to 2 Years USD 13.5 Million Specialized Hospitals
Phase 3 18 months to 3 Years USD 21.8 Million Specialized Hospitals
Phase 4 Several Years USD 26.2 Million Post Marketing Surveillance
BE Studies 2-3 Weeks USD 0.10 Million BFI Clinical Trial Unit

BE Studies Costs and Timeline: A typical bioequivalence (BE) study costs

approximately $250,000 including costs for packaging, clinical facilities, data internalization,
bioanalytical analysis, pharmacokinetic and statistical analysis, and report generation. 9 days
(approximately) including the wash-out period of 48 hours and the time between last blood
sampling in the last period to the final examination tests. In Bangladesh, the annual market of
CRO is as minimum as USD 200 Million and the cost of a single BE is USD 150,000, USD 75,000
and USD 50,000 while exporting medicines to 1st World Countries, 2nd World Countries and 3rd
World Countries respectively. And an approximate time required for a single BE Study is about 2-
3 Weeks with an involvement of 6-12 voluntary participants for each study.
N.B.  Phase 2 Clinical Trials and BE Studies shall be the major sources of revenue for BFI.

Strictly Private & Confidential Founder: Mohd. Shamim Iqbal, MSc, MSc, PhD 4
 Overall Pharmaceutical Market and CRO Scenario by 2030 in Bangladesh

Obligations
Provide means for filing patents

TRIPS
Protect patents and exclusive marketing rights
Provide minimum 20 years protection for patents

TRIPS Cannot copy and

Advantage sell patented
drugs

Must import at
high price

Exemption from TRIPS obligations until 2032

TRIPS Council decision, 6 November 2015, IP/C/73
Reference: https://www.un.org/ldcportal/trips-agreement-transitional-period-for-pharmaceutical-products/

Top-10 CROs 2017 Revenue

1. Laboratory Corporation of America Holdings (USA) $10.44bn
2. IQVIA (USA) $ 9.74bn
3. Syneos Health (USA) $ 2.67bn
4. Parexel International Corporation (USA) $ 2.44bn
5. PRA Health Sciences (USA) $ 2.26bn
6. Pharmaceutical Product Development (USA) $ 1.90bn
7. Charles River Laboratories (USA) $ 1.84bn
8. Icon (Ireland) $ 1.76bn
9. WuXi Apptec (China) $ 1.01bn
10. Medpace Holdings (USA) $ 0.44bn
Partnership with international CRO: We will try to build partnership with other international CROs
(With any of the top 10s or 20s of the world). We will approach first the numbers: 1, 3, 5, 8, 9 and 10.

TRIPS & Opportunities of CROs in Bangladesh

TRIPS allowed Bangladeshi pharma companies to produce and export products inexpensively. However, validation
processes necessary to export pharma products to the regulated market (Developed Countries) requires
Bioequivalence (BE) studies. A competent international-standard Bangladeshi CRO can conduct BE studies in a
significantly more cost-effective and time-saving manner. The local CRO will also be able to offer it’s expertise and
services to international pharmaceuticals with a substantial cost benefit.

After expiry of TRIPS: Options for Bangladeshi Pharma Companies will require
1. Developing new-molecules
2. Manufacturing APIs through reverse-engineering
3. Collaboration/Merger/Acquisition by International Pharma Companies
4. Manufacturing of drug through purchasing patent/paying royalty

A Bangladeshi CRO can make huge contribution for options 1 & 2 (and to some extent also to option 3) in making
the products highly competitive in both the local and global markets. Moreover, the local production of USD 10 Billion
products and USD 1.5 Billion export by 2030, shall exclusively requires BE studies results to be strictly attached
with each and every single product with dosages forms to those approximately 150 exported countries of the
world thus rendering a huge revenue sources for BFI by 2030.

Strictly Private & Confidential Founder: Mohd. Shamim Iqbal, MSc, MSc, PhD 5
 Clients for the BFI:

1. Pharmaceuticals Industries, Agrovet Industries, Nutraceuticals and Herbal

Industries (Local & International)
2. Government and Private Universities (Local & International)
3. Government and Private Research Institutes (Local & International)
4. Government and Private Biotech Industries (Local & International)
5. Government and Private Medical Device Industries (Local & International)
6. Government Regulatory Institutes (Local & International)

Existing Collaborators for the BFI:

1. National >150,
2. International >100

Some of our Top Current International Collaborators for BFI (N=20):

Harold Eliot Varmus: American Oncologist, Nobel Laurette in 1989 for Physiology and
Medicine, Co-Chair, Scientific Advisory Council of President Barack Obama, USA
Sir Peter David Gluckman: New Zealand Pediatrician & Scientist and Chief Science
Advisor to the New Zealand Prime Minister from 2009 to 2018.
Prof. Dr. Graham A Hitman, Queen Mary University of London. UK
Dr. Amanda Palmer, JPUPH, USA

Dr. D. Mahalanabis, Institute of Applied Studies, India

Prof Henry Binder, Yale University, USA
Prof George Fuchs, USA
Prof. M Santosham, USA
Prof. Dr. Zuo-Feng Zhang, University of California Los Angeles (UCLA), USA
Prof. Beate Ritz UCLA, USA
Dr. Freddie Bray, IARC, France
Prof. Carlo La Vecchia, University of Milan, Italy

Prof. Klaus Gyr, Basel University, Switzerland

Dr. P. Chaturvedi, Indus Pharma, USA
Prof C. Beglinger, Basel University, Switzerland
Charles B. Stephensen, Ph.D., Research Leader, USDA ARS WHNRC, Adjunct
Professor, University of California, Davis. USA
Marjorie J. Haskell, Ph.D., Associate Research Nutritionist, University of California,
Davis. USA
Professor Georg Lietz, Ph.D., Institute of Cellular Medicine, Newcastle University, UK
Professor Mark C Steinhoff, MD, Division of Infectious Diseases, Cincinnati Children's
Hospital, Medical Center. Ohio USA

Strictly Private & Confidential Founder: Mohd. Shamim Iqbal, MSc, MSc, PhD 6
 Future of CRO in the Lens of Open Artificial Intelligence (AI), Chat GPT
1. What would be the business growth for Contract Research Organization in
the next decade?
AI Answer: The business growth for Contract Research Organizations (CROs) can be
expected to significantly increase in the next decade. This is predominantly due to the
continued rise in biopharmaceutical research and development spending, which is now
estimated to reach $199.7 billion globally by 2026. The growing prevalence of chronic
diseases, such as cancer, and a general rise in spending on healthcare, is likely to further
drive the industry. Additionally, it is expected that CROS will expand their engagements and
services to encompass more sophisticated service offerings such as regulatory consulting and
biostatistics. As technology evolves, CROs are expected to develop new technologies and
techniques to meet the needs of their clients. These factors, when taken together, suggest
that the CRO industry is likely to see strong growth over the next 10 years.

2. What would be the expected CAGR for Contract Research Organization in the
next decade?
AI Answer: The CAGR for Contract Research Organizations (CROS) over the next decade is
expected to be around 10%. This is due to the increasing demand for CRO services from the
pharmaceutical, biotechnology and medical device industries, driven by the need for faster
product development and regulatory approvals. Additionally, the growing prevalence of
personalized medicine and the emergence of new therapeutic areas are expected to expand
the market for CROS over the upcoming decade.

3. What are the advantages of Contract Research Organizations in Bangladesh

after the expiry of TRIPS in 2032?
AI Answer: A. Cost-Effective Solution: The contract research organizations (CROs) in
Bangladesh will provide a cost-effective solution for the research and development (R&D)
requirements of the local industry, with lower overheads and specialized knowledge.
B. Technological Support: CROS will provide the necessary technological and scientific
expertise to speed up the process of developing products in Bangladesh.
C. Risk Reduction: CROS will reduce the risk of failure in the R&D process by providing
timely and comprehensive services.
D. Access to Global Markets: Bangladesh's CROS can easily provide access to markets in
other countries within the region and beyond, which will be beneficial for domestic industries.
E. Networking Opportunities: The presence of robust CROS in the country will create
economic linkages between companies within and beyond the region, which will be beneficial
for the country's overall economic growth.
F. Intellectual Property Protection: CROS can also provide necessary support and guidance
on protecting intellectual property rights of local companies. This would be beneficial for the
local industry and help them commercialize their products in other countries.

4. What would be the revenue of Contract Research Organization in Asia Pacific

compared to the USA and Europe in the next decade?
AI Answer: It is difficult to predict the exact revenue growth for Contract Research
Organizations in the Asia Pacific region for the next decade. However, it is expected that the
CRO market in the region will grow at a faster rate than in the United States and Europe due
to the presence of a large population, rapid economic growth and increased government
support for the sector. According to a Frost & Sullivan report, the Asia Pacific CRO market is
projected to grow at a compound annual growth rate of 11.9% in the next five years and to
reach a market size worth US$6.7 billion by 2022. This is compared to a projected compound
annual growth of 7.9% for the US and 7.1% for Europe.

Strictly Private & Confidential Founder: Mohd. Shamim Iqbal, MSc, MSc, PhD 7