This document discusses the development of the biopharmaceuticals industry in India. It provides an overview of the characteristics and growth of the Indian biopharma market, which is valued at over $4 billion and growing 20-25% annually. It also outlines India's advantages for global R&D, including a skilled workforce, lower costs, and efficient clinical trials. The upcoming biosimilars opportunity from patent expiries is highlighted as a major driver. Challenges include financing difficulties and developing human resources excellence. Overall, the biopharma sector is one of India's fastest growing industries.

1. DEVELOPMENT OF
BIOPHARMACEUTICA
LS INDUSTRY IN
INDIA
Dr. Bhaswat S. Chakraborty
Sr. VP & Chair, R&D Core Committee
Cadila Pharmaceuticals Ltd.
Presented at Industrial Research in Development
of Biopharmaceuticals, a DSIR Workshop, AMA
Centre, Ahmadabad, February 24, 2015
1

2. CONTENTS
 Biotech world & Indian Biotech Pharmaceuticals
 Some characteristics of Indian Biopharma
 Favorable environment for Global R&D labs set up in India
 Why India
 Indian Labs & CROs
 MNC R&D Labs
 Opportunities available – upcoming trends
 The patent cliff
 Biosimilars opportunity
 Bottlenecks & Challenges
Various issues
 Conclusions
2

3. TOP 10 PRODUCTS BY SALES IN
2014
3
Rank Product Company Technology
WW
sales($m)
1 Avastin Roche Monoclonal antibody 9,232
2 Humira Abbott + Eisai Monoclonal antibody 9,134
3 Rituxan Roche Monoclonal antibody 7,815
4 Enbrel Wyeth + Amgen + Takeda Recombinant product 6,583
5 Lantus Sanofi-Aventis Recombinant product 6,386
6 Herceptin Roche Monoclonal antibody 5,796
7 Crestor AstraZeneca
Small molecule
chemistry
5,739
8 Spiriva Boehringer Ingelheim
Small molecule
chemistry
5,552
9 Remicade
SGP + J&J + Mitsubishi
Tanabe
Monoclonal antibody 5,220
10 Gleevec/Glivec Novartis
Small molecule
chemistry
5,136

4. INDIAN BIOPHARMA
MARKET
 Pharmaceutical and health
biotechnology is one of India’s fastest
growing sectors
 Biopharmaceuticals account for 64% of
the Indian biotech industry
 Valued at >4 Bn USD
 Growing ~20-25% rate per annum
 Consists of vaccines, bio-similars,
therapeutics, diagnostics, regenerative
medicines and medical technology
 Vaccines and bio-similars constitute
the largest component of the
Indian bio-pharma segment 4

5. INDIA: A MAJOR SUPPLIER OF
VACCINES TO UNICEF
Polio-free India one of the 'most impressive accomplishments'
ever – Bill Gates, January 2015
5

6. CHARACTERISTICS OF
INDIAN BIOPHARMA
INDUSTRY
 Growth in India is primarily export-driven
 Export sales are rising at annual rate of 47%
 Domestic sales have risen only up to 6% per
 Vaccines are the largest and fastest-growing sector
 Currently account for about 43% of India's total
biopharmaceutical sales
 Cf. 16% for diagnostics and 13% for therapeutics
 Industry growth is concentrated in a small number of
companies
 ~30 companies account for majority of sales
 Led by Biocon, Serum Institute, Zydus, Panacea Biotec...
 And India-based subsidiaries of MNCs 6

7. CHARACTERISTICS OF
INDIAN BIOPHARMA
INDUSTRY..
 Indian companies manufacture wide range of
biopharmaceuticals
 Iclude recombinant insulin, EPO, G-CSF, recombinant
hepatitis-B vaccine, streptokinase, interferon α-2b, rituximab,
and anti-EGFR & anti –VEGF MAb products..
 Indian biopharmaceutical R&D is increasing rapidly
 Since 2003, the R&D budgets of the top 10 Indian
pharmaceutical companies have more than doubled
7

8. WHY INDIA
 The presence of a highly skilled, English speaking workforce of
over 8.5m qualified scientists coupled with a large network of
investigators
 A feeder system of 314 medical & a >1000 pharmacy colleges, with
our 35,000 students graduating every year
 Nearly 700,000 hospital beds and the largest number of USFDA
approved facilities outside the US
 Lower set-up costs
 Access to a large and genetically diverse patient pool with
comparatively lower treatment costs than US and Europe
 One of the fastest subject recruitment rates globally (c.3x-4x the
global average), with 40-50% lower screen failure and dropout
rates compared to the global averages
 Favorable government policy to continue to develop a favorable
regulatory environment
8

9. ADVANTAGE INDIA
 Cost advantage
 Manufacturing capabilities
 Enhancement of vaccine portfolios
 Biosimilars
 CROs & clinical trial expertise
 Recruitment efficiency
 Regulatory efficiency
 Reliable contract research and mfg.
9

10. ALREADY EXISTING
CAPABILITIES
 About 20 companies in India are already developing
bio-similars.
 ~25 recombinant therapeutics available in India and
15 of them are manufactured within the country.
 ~50 brands are commercialized in the country by
leading companies such as Biocon, Shantha, Reliance
Life Sciences, Wockhardt and Intas .. includes MNCs
like Novo Nordisk, GSK, Eli Lilly ,,,
 Approximately 72 recombinant drugs are currently
undergoing different stages of clinical trials 10

11. SOME SPECIFIC
ADVANTAGES IN INDIA
11

12. INDIAN CROS
 India has >70 active CROs engaged in BE & Clinical trials
 Mostly Phase II-IV trials including stats & rep[ort writing,
pre- and post approval services
 Top Players
 Quintiles, PPD, Paraxel
 Siro Clinpharm, GVK Bio, Lamda Therapeutics, Inverika
 Excellent reputation in protecting clients’ IPR (unlike many
other countries)
 Follow international standards in professionalism, accuracy,
precision in output through regulatory and institutional bodies
 Indian CROs are good in developing activity metrics
 market evolution, market analysis, develop relations with decision
makers to get comprehensive and reliable predictions etc.
 Still highly cost attractive
12

13. INDIA’S SHARE OF GLOBAL
CLINICAL TRIALS
13

14. BA/BE STUDY COST COMPARISON
14

15. OTHER RESEARCH COST
COMPARISON
15

16. MNCS BILATERAL R&D WITH
INDIAN COS.
 Merck established discovery sourcing deals
 with Advinus in 2006 for metabolic-disorder drugs
 with Nicholas Piramal in 2007 for oncology drugs
 with and Orchid in 2008 for antibacterial compounds
 Eli Lilly has had similar agreements for collaborative
approach across several therapeutic areas
 with Nicholas Piramal in 2007
 with Suven Life Sciences in 2008
 with and Zydus Cadila in 2009
 with Jubilant in 2008
 GlaxoSmithKline with Dr. Reddy’s for cardiovascular,
diabetes, oncology, gastroenterology and pain management
therapeutics 16

17. STRUCTURING RELATIONSHIPS FOR
VALUE CREATION BY INDIAN
COMPANIES
 Build
 Nothing like it
 Strategic acquisitions
 Acquisition of assets in a strategy to increase capabilities
and drive scale.
 Joint ventures
 Accompanied by strategic stakes with nascent and sub-
scale companies
 Customer-supplier relationships
 To secure capacity, test delivery capabilities and consider
acquisition or joint venturing
17

18. UPCOMING TRENDS: THE PATENT
CLIFF
 A major driver of Indian Biopharma Industry
 Many companies are planning to diversify into
biosimilars and get into joint ventures for mfg
etc.
 Indian biotech can offer all areas of strength
especially in collaborative efforts
 Discovery, research and development, support
activities, marketing, and lobbying are other
opportunities
 The humanitarian value is huge
 The returns are huge as well 18

19. EVOLUTION OF GLOBAL SALES OF
TOP TEN BRANDED BIOLOGICS
FROM 2004-11
19

20. 20

21. The 2012–2019 patent cliff is highlighted in yellow
FOR THE TOP TEN SELLING
BIOLOGICS
21
Calo-Fern´andez B et al (2012) Pharmaceuticals 2012, 5, 1393-1408

22. A GENERAL STRATEGY DIAGRAM FOR A
SUCCESSFUL ENTRANCE INTO
BIOSIMILARS MARKET
22
Calo-Fern´andez B et al (2012) Pharmaceuticals 2012, 5, 1393-1408
The requirement for key capabilities varies
with the market maturity: from brand-driven in
short term to price-driven in long term

23. Inserted subfigures are Pfizer’s biosimilar capabilities
before the acquisition of Wyeth and the contributions of this
deal
ESTABLISHING THE STRATEGIC
DEALS
23

24. Konde V. (2009) Journal of Commercial Biotechnology Vol. 15, 3, 215–226
INDIAN BIOTECH
COMPANIES
24

25. Company Products/technologies/services in the market
Business
model
Main sector
Advinus Theraputics,
Bangalore and Pune
Metabolic disorders, inflammatory diseases, neglected
diseases
Hybrid
Avestha, Bangalore
Agbiotech and transgenics, biosimilars Vertical
Bharat Biotech International,
Hyderabad Recombinant drugs, cardiovascular diseases, vaccines Product
Bhat Bio-Tech India,
Bangalore
Recombinant proteins, diagnostic markers Hybrid
Bharat Serums and Vaccines,
Mumbai Plasma derivatives, monoclonals, hormones, serums.. Product
Biocon, Bangalore Industrial enzymes, recombinant protein therapeutic
products and human growth hormone
Vertical
Biological E., Hyderabad Diagnostics, combination vaccines, antitetanus and
antisnake venom sera
Vertical
Dr Reddy's Laboratories,
Hyderabad
Infectious and parasitic diseases, oncology, immune
disorders, endocrine, nutritional and metabolic
diseases, ..
Vertical
Gennova Biopharmaceuticals,
Pune
Hi-tech molecules in nephrology, oncology and
cardiology segment
Product
Indian Immunologicals,
Hyderabad
Pediatric and childhood vaccines, DNA-based vaccines,
animal- and human-health products
Product
Indian biotechnology database (http://www.indianbiotech.com/in/db/index.php).
25

26. UNDERSTANDING THE
BIOTECH & LIFE SCIENCES
BUSINESS MODEL
26

27. 27

28. MANUFACTURING PROCESS FOR
BIOLOGICS
28

29. GENERAL CHALLENGES &
BOTTLENECKS IN INDIA
 Highly competitive environment with multiple small sized CROs
 Perceived data quality issues in the light of recent blacklisting of
certain principal investigators for fraudulent data
 With a positive of overall track record, this perception is likely
to diminish
 Decreasing quality of infrastructure, as the tier-one cities in India
become saturated with CROs
 There is a need to consider tier-two cities that remain
untapped and also offer a greater pool of treatment naïve
patients
 Regulatory challenges in gaining approval for clinical trials
 The Indian Government has initiated a multi-billion dollar
process to streamline the regulatory environment
 Excellence in human resources is still a challenge
29

30. FINANCING FOR INDIAN
BIOTECH
 Some banks help
 e.g. Yes Bank: “is philosophically committed to support the
growth of the Indian Biotechnology Sector (so far ~ $1 billion)”
 But, in general, money for biotechnology is not easy to come by
 Don’t have many venture capital funds in this sector,
 largely because it is knowledge intensive and because the
regulatory pathway is not very clear to the common investor
 Location helps
 Biotech in India is clustered in Bangalore and Hyderabad
(~39% of the total revenue)
 Like the San Francisco & Boston in US, they have some of
India’s best research institutions and universities
30

31. LOOKING FORWARD: NATIONAL
BIOTECH DEVELOPMENT
STRATEGY
 With DBT's budget to >$300 mn USD annually, this
program is promoting following areas:
The establishment of more university-linked
research centers, with facilities and teaching
standards of international quality.
The rapid expansion of biotech-related PhD and
postdoctoral programs.
Incentives for the repatriation of Indian-born
scientists currently working abroad.
Support for academic laboratory and private
biotech partnerships 31

32. CONCLUDING REMARKS
 Health/pharmaceutical biotechnology is one of India’s fastest
growing sectors
 India has innovative as well as biosimilar biotech capabilities
 Indian biotech companies are growing at ~20-25% rate per
annum
 Biologics patent cliff offers Indian companies a huge opportunity
 Capability-benchmarking is the key for any company planning to
generate value from the biologics patent cliff
 Entering biosimilars market is facilitated by acquiring or
developing R&D, manufacturing, supporting activities, marketing
or lobbying
 India has >70 active CROs engaged in BE & Clinical trials which
are cost effective, professional, IPR-sensitive and offer high
quality services
 Steep competition among CROs, quality of data, financing, and
excellence in human resources are major challenges
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33. THANK YOU VERY
MUCH
Acknowledgement: Ms. Raji Nair
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