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Development of Biopharmaceuticals Industry in India
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
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
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
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
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
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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