The ABLE Decade 2003-2012 Vijay Chandru Strand Life Sciences Association of Biotech Led Enterprises High Panel Science & Technology at UNESCO
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
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 EventsBIO India Partnering High Level Policy Conclave India Pavilion atKnowledge Partner BIO USABangalore INDIA BIO BIOInvest Feb 2012 Dec 2011
4500 40004000 There are over 300 companies that are into the biotech business3500 across the country 31553000 26972500 22832000 1898 14491500 10541000 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
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 20Bioservices 721 586 23Bioagri 551 430 28Bioindustrial 140 125 12Bioinformatics 58 52 11 TOTAL 3835 3155 *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 & 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 Bhttp://www.sciencephoto.com/media/211911/enlarge& Serum Website
Biopharma India .. continuedBiosimilars & TherapeuticsIndian 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 IndiaKey players Intas, Reliance Lifesciences, Biocon, Avesthagen, Lupin, Glenmark , Dr. Reddy’s, Cipla are setting up manufacturing facilities for therapeutics in India.
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
Medical Devices & DiagnosticsGrowth of the healthcare sector. Access issues (telemedicine),preventive and personalized medicine will fuel the growth ofdevices and diagnosticsPlayers Transasia Bio Medicals, Tulip Diagnostics, SpanDiagnostics, Accurex, Bhat Biotech, Bigtec, Achira Labs, Perfint,Ranbaxy Diagnostics, Xcyton, GE Healthcare, Siemens, Abbott,Phillips
Medical Devices & Diagnostics...continuedLow 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.
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
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 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. 200Major companies: 100Metahelix, Nuziveedu Seeds, RasiSeeds, Mahyco, Ankur Seeds, 0 2008-2009 2009-2010 2010-2011Monsanto, J KAgrigenetics, BayerCropsciences, Krishidhan Revenue in USD mil. Seeds Source: Biospectrum ABLE Survey 2011
Bioindustrial India The industrial enzyme consumptionin India is mainly in the detergentmarket, 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
Bioinformatics & Systems Biology IndiaIndian 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 The AVADIS ® Platform Connexios Diabetes 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 fewinstances in which a single branch of technologyhas the potential to address multiple pressingneeds of society.Biotechnology has that potential today with itsability to address Food Security Health Security Energy Security Environmental Remediation