1. The ABLE Decade 2003-2012
Vijay Chandru
Strand Life Sciences
Association of Biotech Led Enterprises
High Panel Science & Technology at UNESCO

2. Association of Biotech Led Enterprises
www.ableindia.org enABLE Biospectrum
 ABLE is the nodal pan-Indian biotechnology industry organisation
 Established in 2003 in Bangalore, it has now over 220 members from all
across India
 Members are from all segments of Indian biotechnology: bio-pharma, agri,
informatics, diagnostics & devices, and public institutions

3. Mission
 To advocate to the government what the sector would consider
appropriate policies for
 Regulatory environment that promotes innovation in Indian
biotechnology
 Investment and tax regimes for the sector to remain viable
 Human resource development for growth and improvement
 Be a platform for initiating synergistic collaborations in the biotech
arena
 Among domestic players,
 Between domestic and international firms
 Showcase strengths of Indian biotechnology to the global audience
 Catalyse opportunities for biotech start-ups and SMEs by linking
them with investors
 Foster biotechnology entrepreneurship in the research community
 Promote Industry-academia linkages

4. Flagship Events
BIO India Partnering High Level Policy Conclave
India Pavilion at
Knowledge Partner BIO USA
Bangalore INDIA BIO BIOInvest
Feb 2012 Dec 2011

5. The Biotech Industry Landscape in India

6. 4500
4000
4000
There are over 300 companies that are into the biotech business
3500
across the country
3155
3000
2697
2500 2283
2000 1898
1449
1500
1054
1000 772
521
500
0
2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09 2009-10 2010-11
Revenue in USD millions
*Biospectrum-ABLE survey 2010-11

7. Indian Biotech Market Segments
Biotech Industry total revenue
2010-11 2009-10
Segment % change
Total Revenue Total Revenue
(USD mil.) (USD mil.)
Biopharma 2,365 1962 20
Bioservices 721 586 23
Bioagri 551 430 28
Bioindustrial 140 125 12
Bioinformatics 58 52 11
TOTAL 3835 3155
*Biospectrum-ABLE survey 2010-11

8. Biopharma India
Vaccines
- Strong players in vaccines: Serum Institute, Shantha (now part of Sanofi),
Bharat Biotech, Panacea Biotec
- Globally India exports to 150 countries
- Serum Institute is the world’s 5th largest vaccine producer and supplies almost
50% of all vaccines to UNICEF/WHO
- Innovative & affordable
Serum Institute of India launched Nasovac in 2010 at INR 160 (approx $3.5/dose)
which is 50% cheaper than current prevailing prices).
- Sales of human vaccines to grow by 10-15% in the next 5 years
Shanvac B
http://www.sciencephoto.com/media/211911/enlarge
& Serum Website

9. Biopharma India .. continued
Biosimilars & Therapeutics
Indian Market: Revenue- USD 445 million for FY 2010 and Growth of
35%.
Products
There are 20 recombinant therapeutic products in India. 15 firms are
active in biosimilars
Key products are Human insulin, Erythropoeitin, Human Growth
Hormone, GCS-F and Streptokinase.
There are 72 recombinant therapeutic products in various stages of
development in India
Key players
Intas, Reliance Lifesciences, Biocon, Avesthagen, Lupin, Glenmark ,
Dr. Reddy’s, Cipla are setting up manufacturing facilities for
therapeutics in India.

10. Stem Cells
• Growing numbers of players in Stem cell: both therapies and
services (such as banking)
• Private Players: Stempeutics, Reliance Lifesciences, LV Prasad
Eye Institute, Shankar Netralaya, LifeCells
• Public institutions are involved in research as well as therapies:
Delhi: AIIMS, Bangalore: NCBS, InSTEM, IISc, NIMHANS, JNCASR,
Hyderabad: CCMB, CDFD, Vellore: CMC, Mumbai/Pune: KEM
Hospital, NCCS.
NCBS Campus

11. Medical Devices & Diagnostics
Growth of the healthcare sector. Access issues (telemedicine),
preventive and personalized medicine will fuel the growth of
devices and diagnostics
Players
Transasia Bio Medicals, Tulip Diagnostics, Span
Diagnostics, Accurex, Bhat Biotech, Bigtec, Achira Labs, Perfint,
Ranbaxy Diagnostics, Xcyton, GE Healthcare, Siemens, Abbott,
Phillips

12. Medical Devices & Diagnostics...continued
Low cost but innovative:
 Aravind Eye Hospitals (AEH) produces low-cost ($7) intraocular lenses and other
ophthalmic supplies
 Remidio: new generations of opthalamoscopes that are portable & easy to use
 GE India developed a handheld ECG Machine (Mac400) that was conceptualized,
developed and manufactured in India (recently got FDA approval)
 Bigtec microfluidic “lab on chip” is based on a MEMS platform is being used to detect
pathogens: HIV, Chikungunya & Hepatitis B
 Embrace: 1.2 million deaths because of pre-mature births not being able to get
accessible incubators ($20,000). Embrace has developed an innovative warmer for
post-natal children without the use of electricity
 Perfint has developed an computer tomography machine that can position the
needle accurately. Is being used by leading hospitals in India such as AIIMS.

13. Bio-Services India
800
721
• India is a major outsourcing destination for contract 700
research in biotechnology fuelled by multinationals’ 586
600
requirements as well as domestic firms outsourcing
part of their discovery chain 500 458
- Advinus, Aurigene, Syngene, Jubilant, GVK Biosciences
400
SiroClinpharm, Veeda , Vimta, Suven
• India is a major hub for clinical trials 300
- Quintiles, Omnicare, Manipal Acunova/Ecron 200
Acunova, Siro Clinpharm
100
Huge patient population and ‘treatment naïve’
 There are around 30 CROs conducting BA/BE trials, 0
50 CROs looking at phase I-IV trials 2008-2009 2009-2010 2010-2011
 Key therapeutic areas oncology, neurology, Revenue in USD mil.
respiratory, diabetes, anti-infective, psychiatry,
endocrinology, central nervous system,
cardiovascular system.
Biospectrum, Jun 2011

14. Bioagri India
Key Features:
 The total land area under Bt-cotton in 2010-11
was 9.4 million hectare and it constitutes approx.
77% of the revenue of the sector. >90% of all 600
551
cotton grown in India is Bt-cotton
500
430
 Bt-Brinjal set to be the first food crop to be 400
commercialized. Other crops include Bt Rice (enter 332
market by 2012), Bt Maize, Bt Tomato and Bt 300
Cauliflower.
200
Major companies: 100
Metahelix, Nuziveedu Seeds, Rasi
Seeds, Mahyco, Ankur Seeds, 0
2008-2009 2009-2010 2010-2011
Monsanto, J
KAgrigenetics, BayerCropsciences, Krishidhan Revenue in USD mil.
Seeds
Source: Biospectrum ABLE Survey 2011

15. Bioindustrial India
 The industrial enzyme consumption
in India is mainly in the detergent
market, starch market, rest (food &
feed, textile, leather, paper & pulp.) 160
139
140
 Biofuels 125
120
-Increasing energy usage as India grows at 8-9%. 106
Renewable energy is a major focus. Several Biofuel 100
initiatives involving: 80
Jatropha, Algae, Biomass.
60
40
Firms:
Novozymes, Praj, Reliance Lifesciences Advanced 20
Enzymes, Rossari Biotech, Richcore, Sea6, ABAN 0
2008-2009 2009-2010 2010-2011
 Bioremediation
- TERI, NEERI Nagpur, BARC Mumbai, Revenue in USD mil.
Source: Biospectrum ABLE Survey 2011

16. Bioinformatics & Systems Biology India
Indian Firms: Ocimum, Strand Lifesciences, Connexios, Cell
Works, Xcelris, Molecular Connections, Persistent, Genotypic.
Strand’s Avadis Platform (in partnership with Agilent) has 25% global market
share in informatics of “Integrated Systems Biology”
- Virtual Modelling of disease and organ systems
Virtual Liver project (Strand Life Sciences). Virtual Diabetes platform of
Connexios, Virtual Cell Models used as a predictive platform for efficacy &
Toxicity by Cell Works Inc.
-Molecular Marker studies: Mazumdar-Shaw Cancer Centre; Tata Memorial
Centre; Ganit Labs, NIBMG
The
AVADIS ®
Platform
Connexios Diabetes Platform

17. Players
• Multiplicity of Agencies
– Ministries
• Science & Technology (DST,DBT,CSIR)
• Health & Family Welfare (ICMR, DCGI)
• Environment & Forests (GEAC, Biodiversity)
• Chemicals & Fertilizers (DoP)
• Communications & IT (DIT – BioIT)
– Industry Organizations
• ABLE, CII, FICCI, IPA, OPPI, ACRP/ISCR/ACRO

18. Nation is Facing a Regulatory Crisis
• Multiplicity of regulatory agencies
• Transgenics and Environment
• Ethics and Clinical Trials
• Bureacratic Delays
• Lack of skilled regulators
• …

19. National Biotech Regulatory Authority of India
• Pending Legislation (Draft Bill – 2008)
• Authority to
– regulate the research, manufacture, importation and
use of genetically engineered organisms and products
derived thereof
• Three regulatory branches, namely
(a) Agriculture, Forest and Fisheries Branch,
(b) Human and Animal Health Branch,
(c) Industrial and Environmental Applications Branch
• The Authority shall be responsible for enforcement of
this Act.

20. In the history of technology there have been few
instances in which a single branch of technology
has the potential to address multiple pressing
needs of society.
Biotechnology has that potential today with its
ability to address
Food Security
Health Security
Energy Security
Environmental Remediation