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