the able decade 2003 2012
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The ABLE Decade 2003-2012
Vijay ChandruStrand Life Sciences
Association of Biotech Led EnterprisesHigh Panel Science & Technology at UNESCO
Association of Biotech Led Enterpriseswww.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
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
Flagship Events
High Level Policy ConclaveBIO India Partnering
Knowledge Partner Bangalore INDIA BIO
Feb 2012BIOInvestDec 2011
India Pavilion atBIO USA
The Biotech Industry Landscape in India
2002-03 2003-04 2004-05 2005-06 2006-07 2007-08 2008-09 2009-10 2010-110
500
1000
1500
2000
2500
3000
3500
4000
4500
521
772
1054
1449
1898
2283
2697
3155
4000
Revenue in USD millions
Indian Biotech- growth over the years
*Biospectrum-ABLE survey 2010-11
There are over 300 companies that are into the biotech business across the country
Biotech Industry total revenue
Segment2010-11 2009-10
% changeTotal Revenue
(USD mil.)Total Revenue
(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
Indian Biotech Market Segments
*Biospectrum-ABLE survey 2010-11
Biopharma IndiaVaccines
- 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 & affordableSerum 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
http://www.sciencephoto.com/media/211911/enlarge& Serum Website
Shanvac B
Biosimilars & Therapeutics
Indian Market: Revenue- USD 445 million for FY 2010 and Growth of 35%.ProductsThere are 20 recombinant therapeutic products in India. 15 firms are active in
biosimilarsKey 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 playersIntas, Reliance Lifesciences, Biocon, Avesthagen, Lupin, Glenmark , Dr. Reddy’s, Cipla are setting up manufacturing facilities for therapeutics in India.
Biopharma India .. continued
• 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.
Stem Cells
NCBS Campus
Medical Devices & DiagnosticsGrowth 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
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.
Medical Devices & Diagnostics...continued
• India is a major outsourcing destination for contract research in biotechnology fuelled by multinationals’ requirements as well as domestic firms outsourcing part of their discovery chain
- Advinus, Aurigene, Syngene, Jubilant, GVK Biosciences SiroClinpharm, Veeda , Vimta, Suven
• India is a major hub for clinical trials- Quintiles, Omnicare, Manipal Acunova/Ecron
Acunova, Siro Clinpharm Huge patient population and ‘treatment naïve’ There are around 30 CROs conducting BA/BE trials,
50 CROs looking at phase I-IV trials Key therapeutic areas oncology, neurology,
respiratory, diabetes, anti-infective, psychiatry, endocrinology, central nervous system, cardiovascular system.
Bio-Services India
2008-2009 2009-2010 2010-20110
100
200
300
400
500
600
700
800
458
586
721
Revenue in USD mil.
Biospectrum, Jun 2011
Bioagri IndiaKey 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 cotton grown in India is Bt-cotton
Bt-Brinjal set to be the first food crop to be commercialized. Other crops include Bt Rice (enter market by 2012), Bt Maize, Bt Tomato and Bt Cauliflower.
Major companies: Metahelix, Nuziveedu Seeds, Rasi Seeds, Mahyco, Ankur Seeds,Monsanto, J KAgrigenetics, BayerCropsciences,
Krishidhan Seeds
2008-2009 2009-2010 2010-20110
100
200
300
400
500
600
332
430
551
Revenue in USD mil.
Source: Biospectrum ABLE Survey 2011
Bioindustrial India The industrial enzyme consumption in India is mainly in the detergentmarket, starch market, rest (food &feed, textile, leather, paper & pulp.)
Biofuels -Increasing energy usage as India grows at 8-9%.
Renewable energy is a major focus. Several Biofuel initiatives involving: Jatropha, Algae, Biomass.
Firms:Novozymes, Praj, Reliance Lifesciences Advanced Enzymes, Rossari Biotech, Richcore, Sea6, ABAN
Bioremediation - TERI, NEERI Nagpur, BARC Mumbai,
2008-2009 2009-2010 2010-20110
20
40
60
80
100
120
140
160
106
125
139
Revenue in USD mil.
Source: Biospectrum ABLE Survey 2011
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 systemsVirtual 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
Bioinformatics & Systems Biology India
The
AVADIS ®
PlatformConnexios Diabetes Platform
Strand Life Sciences AVADIS Platform
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
Nation is Facing a Regulatory Crisis
• Multiplicity of regulatory agencies• Transgenics and Environment• Ethics and Clinical Trials • Bureacratic Delays• Lack of skilled regulators• …
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.
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 SecurityHealth SecurityEnergy SecurityEnvironmental Remediation