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Description : This "Indian Pharmaceuticals Industry Report (June 2020)" is a very good presentation on Indian Pharmaceutical industry prepared by India Brand Equity Fund ( IBEF ) which works under Commerce Ministry, Govt of India. A very good effort is made to cover all aspects of Indian pharma.

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JUNE 2017 11 BIOTECHNOLOGY JUNE 2017 (As of 9 June 2017) For updated information, please visit www.ibef.org
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JUNE 2017 22 For updated information, please visit www.ibef.org Executive Summary………….…………..…..3 Advantage India……………….………..…….4 Market Overview and Trends….....................6 Strategies Adopted……………….………….16 Growth Drivers…......................................…20 Opportunities………………………………...33 Success Stories: Major Players…….……..38 Useful Information.......................................42 BIOTECHNOLOGY JUNE 2017
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3 JUNE 2017 For updated information, please visit www.ibef.org Source: Department of Biotechnology, Ministry of Science & Technology , Ministry of External Affairs, Government of India, Make In India, TechSci Research Note: F - Forecast EXECUTIVE SUMMARY BIOTECHNOLOGY By FY25, India’s biotech industry is estimated to increase to USD100 billion from USD7 billion in FY15 & is currently valued at USD11 billion in FY16. The biotech industry is expected to experience significant growth amid favourable business conditions 12th In Five-Year Plan, the government aims to spend USD3.7 billion on biotechnology compared to USD1.1 billion in the 11th Five-Year Plan Increasing government expenditure is likely to augment growth in biotechnology industry. India’s pharmaceuticals market size is USD36.7 billion in 2016 & estimated to reach at USD55 billion in 2020F Growing pharmaceuticals market is estimated to aid growth of the biotech industry Percentage rise in investments 236.36% CAGR: 10.6% CAGR: 30.46% USD Billion 1.1 3.7 Eleventh Five Year Plan Twelfth Five Year Plan USD Billion 7 11 100 FY 15 FY 16 USD Billion FY 25F 36.7 55 FY 16 FY 20F
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ADVANTAGE INDIA BIOTECHNOLOGY
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5 JUNE 2017 ADVANTAGE INDIA Source: CIS India, Ministry OF External Affairs, Government of India, Ministry of Health,, ABLE, TechSci Research; Note: E - Estimate For updated information, please visit www.ibef.org FY16 Market Value: USD11 billion FY25E Market Value: USD100 billion Advantage India BIOTECHNOLOGY RGorbouwsitndgedmeamndand India’s billion-plus population base offers a huge market for biotech products & services Increasing economic prosperity and health consciousness would continue to fuel demand for healthcare services Better accessibility to healthcare services further accelerates the demand Innovation opportunities Public funding is being offered for product innovation and research in the biotech sector The private sector has been aggressively pursuing focused R&D Public-Private partnerships will improve the market with innovative research and development Government of Gujarat aims to create 1 lakh jobs in the state’s biotechnology industry Policy support In FY15, Ministry of Biotechnology adopted the open access policy In FY16, National Intellectual Property Rights Policy 2016 has been released Research Assistance Council has been set up National Rural Healthcare Mission launched to boost healthcare spending Also, in FY16, DBT launched National Biotechnology Development Strategy Increasing investments FDI investment up to 100 per cent is permitted via the automatic route A low cost and skilled labour force is attracting outsourced research activity Launch of Biotechnology Industry Partnership Programme (BIPP) is boosting industry participation In January 2017, 54 MoUs worth USD 767.18 million were signed for projects in biotechnology sector in Gujarat Global Summit-2017
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MARKET OVERVIEW & TRENDS BIOTECHNOLOGY
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JUNE 2017 MAJOR MILESTONES IN INDIAN BIOTECHNOLOGY INDUSTRY Source: EXIM bank of India research, MakeinIndia, Ministry of External Affairs, CII, TechSci Research Note: R&D - Research and Development, DBT – Department of Biotechnology 7 BIOTECHNOLOGY 1978: India’s 1st biotech firm, Biocon, was setup 1981: Centre for Cellular & Molecular Biology setup in Hyderabad 1984: Institute for Microbial Technology, Chandigarh was setup 1986: Department of Biotechnology (DBT) was formed 1987: National Institute of Immunology was setup by DBT 1989: Bangalore Genei commenced operations 1991: National Centre for Biological Sciences pursued R&D in molecular biology 1994: Syngene, India’s 1st Contract Research Organisation (CRO), started R&D services 1997: Centre for Biological Technology (CBT) was established to focus on bioinformatics & genomics 1998: Monsanto Research established an R&D centre for plant genomics 1998: DBT approved Mahyco- Monsanto to grow Bt cotton 2007: National Biotechnology Development Strategy launched 2007: With the joint efforts of Government of UP, Department of Biotechnology & Government of India & Department of Science & Technology, a fully functional biotechnology park was setup in Lucknow 2009: National Biotechnology Regulatory Authority Bill 2008 introduced in the parliament & Biotechnology Industry Partnership Programme was launched 2010: Cadila Healthcare, Serum Institute of India & Bharat Biotech launched 1st H1N1 swine flu vaccine. 1978–90 1990–99 2000-2010 For updated information, please visit www.ibef.org
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JUNE 2017 MAJOR MILESTONES IN INDIAN BIOTECHNOLOGY INDUSTRY Source: EXIM bank of India research, MakeinIndia, Ministry of External Affairs, CII, TechSci Research Note: R&D - Research and Development DBT – Department of Biotechnology 8 BIOTECHNOLOGY 2011: Government approved setting up the Biotechnology Industry Research Assistance Council (BIRAC) 2012: India ranked 12th in the world in biotech & 3rd largest in Asia-Pacific, after Japan & Korea 2013: India became the biggest producer of Hepatitis B vaccine recombinant 2015: DBT allocated USD0.735 million to University of Agricultural Sciences to support a national multi-institutional project. 2015: DBT launched “The National Biotechnology Development Strategy 2015- 2020 programme” to turn India into biotechnology hub. 2010-15 2016: 8th Biotechnology Industry Research Assistance Council (BIRAC) announced 8th call for proposals related to inventions & ideas under Biotechnology Ignition Grant (BIG) Scheme. 2016: The Regional Centre for Biotechnology Bill, 2016 was passed by Lok Sabha to impart training & education under guidance of United Nations Educational, Scientific & Cultural Organization (UNESCO). 2016: India's National Intellectual Property Rights policy was launched. 2017: Ministry of Health, Malaysia, awarded, Biocon, a contract worth US$68.43 million to supply recombinant human insulin formulations for a duration of 3 years 2017: Syngene, the contract research arm of Biocon, has decided to invest USD200 million in capital expenditure till fiscal 2019. Post 2015 For updated information, please visit www.ibef.org
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KEY SEGMENTS IN THE INDIAN BIOTECHNOLOGY INDUSTRY Source: ABLE - Biospectrum Industry Survey, June 2013; TechSci Research BIOTECHNOLOGY Bio-pharmaceutical are or products therapeutic preventative medicines that are from naturally derived materials present in organisms, recombinant living using DNA (rDNA) technology Bio-services mainly include clinical research & CRO along with custom manufacturing Bio-agriculture is segmented into hybrid seeds, transgenic crops, bio- pesticides & bio- fertilisers Bio-industrial predominantly comprises enzyme manufacturing & marketing companies Bio-informatics deals with the creation & maintenance of extensive electronic databases on various biological systems; industry Bio-pharma Bio-services Bio-agri Bio-industrial Bio-informatics Biotechnology JUNE 2017 9 For updated information, please visit www.ibef.org
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MAJOR PRODUCTS/SERVICES OF THE INDIAN BIOTECHNOLOGY INDUSTRY Source: ABLE - Biospectrum Industry Survey, Ministry of External Affairs, TechSci Research BIOTECHNOLOGY Biotechnology Bio-pharma Bio-services Bio-agri Bio-industrial Bio-informatics Vaccines Diagnostic Therapeutic Custom Manufacturing Contract Research Organisation Hybrid seeds Bio-fertilisers Bio-pesticides Industrial enzymes Database services Integrated research app software Biotech software services Clinical Trials JUNE 2017 10 For updated information, please visit www.ibef.org
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Market size (USD billion) Source: ABLE - Biospectrum Industry Survey, Makeinindia, Ministry of External Affairs, TechSci Research Global Industry Analysts Report (GIA) Notes: CAGR - Compound Annual Growth Rate FY16: As of April 2016. Note: F-Forecast previous years, the Indian biotech industry witnessed YoY growth of 57.14 per cent in FY16; the total industry size stood at USD11 billion by FY16 & is estimated to reach USD11.6 billion by FY17 Fast-paced growth is likely to continue; the industry is expected to increase in size to USD11.6 billion by 2017, driven by a range of factors such as growing demand, intensive R&D activities & strong government initiatives The Indian biotech industry comprising about 800 companies is currently valued at USD11 billion. In order to achieve market size of USD100 billion by 2025, the Government of India needs to initiate research activities & develop infrastructure & human capital, with an investment of US$ 5 billion. Fast-developing clinical capabilities with the country becoming a popular destination for clinical trials, contract research & manufacturing activities India biotech start-ups attracted investments worth US$ 2.8 billion between 2012 & February 2017. Recent studies have revealed that India has about 7.6 per cent of total mammal species, 12.6 per cent of bird species, 11 per cent of fish & approximately 6 per cent of the total flowering plants of the world. The country’s large population base is a huge contributor to the continuing growth of the industry. BIOTECHNOLOGY ROBUST GROWTH IN BIOTECH INDUSTRY Growing at a faster pace, in comparison with the CAGR: 20.33% 1.1 1.5 1.9 2.6 2.6 3 3.8 4.3 4.3 5 7 11 11.6 JUNE 2017 11 For updated information, please visit www.ibef.org
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Market break-up by revenues (FY16) Source: ASSOCHAM, Makeinindia, TechSci Research The bio-pharmaceutical segment accounted for largest revenue share of 64 per cent in India biotech industry, during FY16. India is becoming a leading destination for clinical trials, contract research & manufacturing activities which is leading to the growth of bio services sector In FY16, the bio-services & bio-agri segments accounted for 18 per cent & 14 per cent of the biotech industry, respectively Serum Institute of India is the largest BioPharma company in the country & accounts for approximately 22 per cent of BioPharma market In May 2017, the Department of Biotechnology held a strategy meet in Delhi to discuss the future scenario of the Biotechnology industry in the country. The meet highlighted the aim of reaching US$100 billion mark by 2025, research and development of cutting edge technologies and other important aspects. BIO-PHARMA ACCOUNTS FOR MAJORITY MARKET SHARE AND WITNESSES FASTEST GROWTH IN FY16 BIOTECHNOLOGY 64% 18% 14% 3% 1% Bio-pharma Bio-services Bio-agri Bio-industry Bio- informatics JUNE 2017 12 For updated information, please visit www.ibef.org
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Source: Department of Biotechnology, Government Of India, TechSci Research In FY16, 2,621 projects have been received by Department of Biotechnology which are categorised as ongoing number of biotechnology projects in India. Delhi accounted for the largest share of 13.93 per cent of the total number of projects received in biotechnology sector, followed by Tamil Nadu, which accounted for a share of 10.95 per cent In FY16, a total of 365 biotechnology projects were allocated to Delhi at an approved project cost of USD11.87 million. As of November 2016, Odisha released the draft of its 1st Biotechnology policy. The state aims to become one of the top 5 bio-tech hubs in the country. The state government has proposed to set up a fund with investment of USD3.73 million & provide land on priority for setting up of biotechnology projects In September 2016, Department of Biotechnology, Government Of India, decided to set up marine biotech institute and laboratory in Goa. BIOTECHNOLOGY State wise share for Ongoing Number Of Biotech Projects FY16 STATE WISE SHARE FOR ONGOING NUMBER OF BIOTECH PROJECTS FY16 13.93% 10.95% 9.92% 8.32% 6.64% 6.64% 5.80% 3.43% 34.38% Delhi Tamil Nadu Karnataka Maharashtra Telangana Uttar Pradesh West Bengal Haryana Others JUNE 2017 13 For updated information, please visit www.ibef.org
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JUNE 2017 Remarkable global positioning India is among the top 12 biotech destinations in the world India ranks 2nd in Asia, after China India is the world’s largest producer of recombinant Hepatitis B vaccine Pharma companies focusing on biotech Ranbaxy, Cadila Healthcare, Lupin, Wockhardt & Dr Reddy’s are among the major Indian pharmaceutical companies operating in the bio-pharma segment. NOTABLE TRENDS IN THE INDIAN BIOTECH SECTOR BIOTECHNOLOGY Global companies setting up base US based DiabetOmics Inc., medical diagnostic company has raised USD4 million from Ventureast & USD1 million from KI Varaprasad Reddy for driving manufacturing & commercialisation activities in India. Biosimilars and molecular diagnostic remain strongholds Growth in the sector is anticipated to come from the country's strong position in biosimilars & molecular diagnostics as well as personalised medicine (where export & domestic trends look promising). In 2016, development of biosimilars has been speeding up via Glycosylation Control Technology. Source: Ministry of External Affairs, TechSci Research, Indian Law Offices Bt: For updated information, please visit www.ibef.org 14 Growth in Genetically Modified crops According to International Service for the Acquisition of Agri-Biotech Applications, India has the 4th largest area covered under genetically modified crops. In India, 11.57 million hectares of area is covered under genetically modified crops which is majorly dominated by Bt cotton. After Bt cotton, Bt brinjal, covering an area of 7.6 million hectares, is potentially benefitting farmers as well as consumers.
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STRATEGIES ADOPTED BIOTECHNOLOGY
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STRATEGIES ADOPTED BIOTECHNOLOGY Strand Life Sciences recently collaborated with US-based El Camino Hospital to establish a genomics & pharmacogenomics centre in San Francisco, BIRAC in 2016 collaborated with Department of Electronics & Information Technology (DeitY) & announced a proposal under Industry Innovation Programme on Medical Electronics (IIPME) to promote innovative technologies in Medical Electronics sector. India’s 1st public-private-partnership agreement was announced between Sun Pharma & Indian Council of Medical Research (ICMR), Govt. of India, Ministry of Health & Family Welfare (MOHFW), Govt. of Madhya Pradesh. Department of Biotechnology, Department of Science & Technology, Government of India, recently collaborated with Australian government & announced 4 new research projects in biotechnology under the Indo Australia Biotechnology Fund. In 2015, Dr. Reddy’s Laboratories acquired UCB (India) for USD131.02 million. The acquisition has been done for established brands of UCB in India, Nepal, Sri Lanka & Maldives As of October 2016, Advanced Enzyme Technologies, a biotech based firm in Mumbai signed an agreement with JC Biotech - Active Pharmaceutical Ingredient (API) maker in Hyderabad, to acquire 70 per cent stake in the company. Tata Trusts along with Lockheed, an aerospace major brand has collaborated with Department of science & technology under the 2nd edition of the India innovation growth programme (IIGP 2.0), to improve and utilise the science & technology infrastructure in the country. Strategic collaborations with niche players and government bodies Mergers & Acquisitions JUNE 2017 16 For updated information, please visit www.ibef.org Source: Ministry of External Affairs, RBI; Note: Govt. - Government
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STRATEGIES ADOPTED BIOTECHNOLOGY Pharma companies, including Avesthagen, TCG Life Sciences, Advinus Therapeutics & Jubilant Biosys have stepped up investments in personalised medicine. The idea is to eliminate the unpredictable nature of drug development through personalized medicine. For instance, Xcode Life Sciences uses InDNA technology to provide personalised solutions for lifestyle-related diseases, such as coronary, diabetes & obesity, using saliva samples. Action Biotech provides genetic tests to predict response from chemotherapy drugs. Geneombio Technologies offer gene-based prediction to assess genetic susceptibility towards major lifestyle diseases. Acton Biotech, OncQuest Laboratories, etc. are few of the other notable players operating in the field of personalized medicine in India. Companies are evolving their product mix to reflect growing repertoire in Biologics, Branded Formulations & Research Services In June 2017, vaccine manufacturer Bharat Biotech announced the commencement of phase-1 first-in-human clinical trials of the in-house developed chikungunya vaccine. Stepped up investment in personalised medicine For ramping up service offerings JUNE 2017 17 For updated information, please visit www.ibef.org Source: Ministry of External Affairs, RBI
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GROWTH DRIVERS BIOTECHNOLOGY
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JUNE 2017 For updated information, please visit www.ibef.org 19 Source: Makeinindia, TechSci Research SECTOR BENEFITS FROM RISING INCOME AND POPULATION BIOTECHNOLOGY Inviting GrGorwowiningg ddeemmanadnd Increasing investments Policy support India’s large population, a huge market for biotech products & services Higher healthcare expenditure & an increase in Bio-agri products Strong growth in export demand & a rise in medical tourism Adoption of Open Access Policy in FY15 R&D focus; Indian government has been funding institutes for biotech research Rising investments from domestic & foreign players 100 per cent FDI permitted through automatic route for manufacturers of drugs & pharmaceuticals Low cost and skilled labour force attracting outsourced research activity Increase in budgetary allocations to the Biotech & Healthcare sectors in 5 year plans Resulting in
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JUNE 2017 For updated information, please visit www.ibef.org 20 Source: MHRD, National Biotechnology Development Strategy, DBT, TechSci Research HIGHER HEALTHCARE EXPENDITURE DRIVING DOMESTIC DEMAND BIOTECHNOLOGY Exponential growth in government funding Government spending on healthcare, as a percentage of GDP, for the 12th Five-Year Plan is around 2.5 per cent & to at least 3 per cent of GDP by 2022. Government has announced to allocate USD5.43 billion to its healthcare department. Medical tourism in India has reached USD3.6 billion in FY2015 & is estimated to reach USD6 billion by 2018. During the 11th Five-Year Plan, the Department of Biotechnology utilised 94.49 per cent of the allocated resources In 2016, government plans to establish 17 new All India Institute of Medical Sciences & 20 cancer institutes, across the country. Specialised treatment The number of lifestyle-related diseases being reported is rising; this has led to demand for various kinds of specialised treatments Ailments such as cancer & diabetes have led to a higher demand for biological products Bugworks Research India has made the world’s largest Google traffic map for oncology pathways which is being used by global medical professionals across the globe for customize treatment for cancer patients. Preventive healthcare Around 1.2 billion ailments are reported annually & this number is expected to rise at a CAGR of 30 per cent to 15 billion cases by 2015 on account of better access to healthcare facilities & rising lifestyle diseases Population growth has elevated the vaccine demand for the geriatric & paediatric population In April 2017, scientists from IIT Chennai discovered that Aspirin can cure cancer 129.4 302.1 1,354.2 Healthcare Funds Availability (USD million) 3,726.4 Ninth FYP Tenth FYP Eleventh FYP Twelfth FYP Source: WHO Statistics 2012 Note: FYP – Five Year Plan
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Source: Fortis Healthcare Limited 2008–09, McKinsey Quarterly, NCAER, TechSci Research RISING INCOME AND INCIDENCE OF CHRONIC LIFESTYLE DISEASES BIOTECHNOLOGY Notes: Greater distributional efficiencies and increasing demand (especially from rural areas) due to rising disposable incomes have created new markets for products within the country, F - Forecast Million household, 100% Income segment 209.10 266.50 304.80 Notes: Income distribution is calculated in constant 2015 dollars; $1=65. Because of rounding, not all percentages add up to 100. F - Forecast 1.5% 2.0% 5.0% 11.0% 8.0% 3.0% 20.0% 42.0% 46.0% 44.0% 18.0% 2016 2025F Affluent(15400-30800) Next billion(2300-7700) 2005 Elite(>30800) Aspirers(7700-15400) Strugglers(<2300) JUNE 2017 21 For updated information, please visit www.ibef.org
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STRONG POLICY SUPPORT CRUCIAL TO THE SECTOR’S DEVELOPMENT BIOTECHNOLOGY Source: “Biotechnology facilities,” Department of Biotechnology, TechSci Research, Note: BIRAC - Biotechnology Industry Research Assistance Council Programme for SC/ST and Rural Population Training & demonstration programme in various biotechnology based activities were undertaken to empower the population, resulting in socioeconomic upliftment Single-window clearance NBDS has made a proposal to set up the National Biotechnology Regulatory Authority to provide a single-window clearance mechanism for all bio-safety products to create efficiencies & streamline the drug approval process Biotechnology Industry Research Assistance Council BIRAC has been established to promote research & innovation capabilities in India’s biotech industry. The council will provide funding to biotech companies for technology & product development. BIRAC under Small Business Innovation Research Initiative scheme supports innovations in biotechnology. Biotechnology Based Programme for Women Programme on application of biotechnology for women being conducted to provide employment, skill development, awareness generation, health improvement & socio-economic upliftment. State Policy Support JUNE 2017 22 For updated information, please visit www.ibef.org The Andhra Pradesh government in 2015 formulated a new policy which covers the benefits for the following categories: Incubation Centres, Biotech manufacturing industries, Life Science Park, Life Science Knowledge Centre, Research & Development Centres. The Tamil Nadu government announced a biotech policy in 2014 which aims to encourage new companies to operate in Tamil Nadu & increasing the R&D & manufacturing activities. The Biotechnology Policy of Gujarat established in 2015, promises to provide financial incentives up to USD3.81 million & capital assistance up to USD7.63 million would be given to biotechnology parks & companies.
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12th Five-Year Plan expenditure (USD billion) Source: Deptt. of Science and Technology, TechSci Research pace of research, innovation & development. The main objective is to advance biotechnology as strategic area by taking India’s strengths in foundational sciences to globally competitive levels. In addition, emphasis is on expanding the application of biotechnologies for overall growth of bio- economy within the framework of inclusive development 12th The Five-Year Plan aims to accelerate the pace of research, innovation & development to improve biotechnology in India. The government plans to strengthen regulatory science & infrastructure, which involves setting up the Biotechnology Regulatory Authority of India (BRAI) & a central agency for regulatory testing & certification of laboratories The plan also entails expanding & commissioning new bioclusters at Faridabad, Mohali Kalyani & Hyderabad It aims to encourage & increase the pool of research scholars & scientists by three-fivefold in biological & interdisciplinary space across levels (PhD, PDFs, young faculty) Central Government approved development of 6 new IT & Bio- Tech SEZs, from 4 developers for across 3 states. As of 31st March 2016, Special Economic Zones attracted investments worth USD57439 million. BIOTECH IN FOCUS IN 12TH FIVE-YEAR PLAN The overall strategy of 12th Five-Year Plan is to accelerate the BIOTECHNOLOGY 1.1 3.7 Eleventh Five Year Plan Twelfth Five Year Plan 12th Five-Year Plan fund allocation (USD billion) 26% 22% 17% 14% 21% Medical biotech Agri biotech Basic bio & emerging areas Biodiversity, bioresources & Environment Capacity building JUNE 2017 23 For updated information, please visit www.ibef.org
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Joint Venture fund In February 2015, Aurobindo Pharma announced a Joint Venture with Tergene Biotech company for cost effective development of the Pneumococcal Conjugate Vaccine (PCV). Infrastructure development India’s central government & state governments, in collaboration with private players, continue to develop new infrastructure facilities, especially at biotechnology parks The government is developing 3 major biotech clusters at Mohali in Punjab, Faridabad in Haryana & Bengaluru in Karnataka. It plans to set up an agri-biotech cluster in Pune (Maharashtra) & Kolkata (West Bengal) GOVERNMENT FUNDING CRUCIAL FOR THE BIOTECH INDUSTRY BIOTECHNOLOGY International collaborations India has partnered with countries such as the UK, Russia, Italy, the US and France to enable knowledge transition. In 2015, the UK Medical Research Council (MRC) and the Government of India Department for Biotechnology (DBT) formed an alliance to fund three major global research centers In 2016, the European Molecular Biology Organization (EMBO) signed an agreement with the Government of India to enhance collaborative research activities between India and Europe. Clinical Establishments Bill In a move to standardise procedures, the Indian Parliament passed the Clinical Establishments Bill 2010, which would make registration of clinical trials as well as clinical research organisations mandatory in the country The Bill also includes standard operating procedures for various trial related tasks Government plans to fast track the approval process for clinical trials while ensuring that CROs involved comply with stricter quality and compliance checks. Source: Ernst & Young, TechSci Research; Note: DST-Department of science and Technology, DBT-Department of Biotechnology Research Funding Agency JUNE 2017 24 For updated information, please visit www.ibef.org The DST has consistently enabled transformational changes through appropriate responses & non- participative roles. In 2015, DBT & Tekes (Finland) joined to form an alliance to fund international standard joint projects to address Indian & global needs
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CENTRE AND STATE GOVERNMENT INITIATIVES PROVIDE BIG BOOST TO BIOTECH INDUSTRY BIOTECHNOLOGY JUNE 2017 25 For updated information, please visit www.ibef.org Source: Ernst & Young, TechSci Research Notes: BIPP - Biotechnology Industry Partnership Programmes, SBIRI - Small Business Innovation Research Industry, BIRAC - Biotechnology Industry Research Assistance Council, IP – Intellectual Property
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REGULATORY FRAMEWORK OF THE INDIAN BIOTECH SECTOR BIOTECHNOLOGY Source: Policy and rules, Department of Biotechnology website, TechSci Research Government of India Ministry of Science & Technology Ministry of Environment & Forests Department of Biotechnology Department of Environment, Forests & Wildlife Recombinant DNA Advisory Committee (RDAC) Regulatory Committee on Genetic Manipulation (RCGM) Institutional Biosafety Committee (IBSC) Genetic Engineering Approval Committee (GEAC) JUNE 2017 26 For updated information, please visit www.ibef.org
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Source: Press Information Bureau, TechSci Research Biotechnology infrastructure is witnessing a shift from traditional clusters to specialised industrial infrastructure such as biotech or science parks Karnataka, Andhra Pradesh, Maharashtra, Tamil Nadu & Kerala have been early movers in establishing world-class biotech parks and clusters. biotechnology industry planned to establish a seed plant in Buldhana district of Maharashtra. Science & Technology Department has acquired 10 acres of land in Jammu & Kashmir to set up 1st biotechnology park in the state. Life sciences & advanced biotechnology committee, economic development board & the Government of Andhra Pradesh, is planning to develop a biotechnology research park to develop the state as a biotech hub. According to the Association of Biotechnology Led Enterprises (ABLE), over 3,000 entrepreneurs have established 1,022 biotechnology start-ups across the country between 2012 and 2016. SOLID INDUSTRY INFRASTRUCTURE WOULD DRIVE GROWTH The 12th Five Year Plan (2012–17) aims to set up 3–5 bio- clusters with technology incubators, technology parks, innovation centres & entrepreneurship development units BIOTECHNOLOGY Chandigarh JUNE 2017 27 For updated information, please visit www.ibef.org Jodhpur Gandhinagar Sohna Jaipur Anand Jamnagar In 2016, Monsanto, a leading player in global Baroda Midnapore Jogindernagar Shimla Pantnagar Alwar Bhubaneshwar Konark Aurangabad Pune Hyderabad Visakhapatnam Kochi Karwar Bengaluru Chennai Madurai Puducherry Operational biotech parks
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Research parks Communities generating innovation, technology and knowledge Knowledge of existing firms commercialisation of intellectual property Creation of new companies Research partners Flow of talent Exchange of ideas Access to laboratories and specialised equipment Universities Govt. research laboratories Other R&D institutions Private firms Job and income generation Source: Research and Information System CONCEPT OF BIOTECH PARK BIOTECHNOLOGY The flow of job and income generation in biotechnology, through involvement of public & private initiatives with proper utilisation of available resources, is explained in the following diagram: for Developing Countries (RIS), TechSci Research JUNE 2017 28 For updated information, please visit www.ibef.org
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Fellowships rose from 100 to 250 per year for PhD students, in addition to 100 postdoctoral & 50 biotechnology overseas associateships Government provided grant-in-aid to the industry for R&D in certain diseases such as malaria & leishmaniasis or kala-azar HIGH-END RESEARCH INFRASTRUCTURE CREATES SCOPE FOR INNOVATION BIOTECHNOLOGY Source: Research and Information System for Developing Countries (RIS), TechSci Research, "Mid-term appraisal“ 29 For updated information, please visit www.ibef.org JUNE 2017
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Department of Biotechnology supports various biotech facilities in the nation, which is driving the biotechnology industry by providing advanced research infrastructure. Various biotech facilities have been established by Department of Biotechnology under “Task Force on Research Resources, Service Facilities and Platforms”. HIGH-END RESEARCH INFRASTRUCTURE CREATES SCOPE FOR INNOVATION BIOTECHNOLOGY Source: Research and Information System for Developing Countries (RIS), TechSci Research, "Mid-term appraisal“ 30 For updated information, please visit www.ibef.org JUNE 2017
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JUNE 2017 For updated information, please visit www.ibef.org 31 STRONG INFLOW OF FOREIGN INVESTMENT BIOTECHNOLOGY Source: Thomson One Banker, TechSci Research
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OPPORTUNITIES BIOTECHNOLOGY
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Vaccines Vaccines & recombinant therapeutics are the sectors driving the biotechnology industry’s growth in India Newer prominent therapies such as monoclonal antibodies products, stem cell therapies are expected to pick up pace in the foreseeing future In 2015, Bharat Biotech launched ‘Rotavac’ vaccine in India, three doses of the vaccine can prevent the Rotavirus diarrhea in infants. Indian pharmaceutical firms supply 80 per cent of the anti retroviral drugs to fight AIDS globally As on October 2016, Sun Pharmaceutical Industries Ltd & International Centre for Genetic Engineering & Biotechnology (ICGEB) signed a pact to develop vaccine for all four serotypes of dengue virus. HUGE OPPORTUNITIES FOR INNOVATION IN AGRICULTURE/HEALTHCARE BIOTECHNOLOGY Bioactive therapeutic proteins Protein & antibody production & fabrication of diagnostic protein chips are promising areas for investment Stem cell research, cell engineering & cell-based therapeutics are other areas, where India can cash its expertise Agriculture sector Hybrid seeds, including GM seeds, represent new business opportunities in India based on yield improvement Growing at an annual growth rate of 10-15 per cent, the Indian hybrid seed industry is estimated at USD1.93 billion in FY16, wherein Bt cotton is leading the market accounting for 45 per cent share India hybrid seed industry. Source: India Law Offices, TechSci Research Intellectual Property JUNE 2017 33 For updated information, please visit www.ibef.org Using the patent system as a mechanism to control drug pricing forestalls making the difficult decisions about necessary investment in the healthcare system, but does not deal with the underlying issues.
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Bio services Sector Beyond biothereapeutics, the bioservices sector is poised to grow because of its skilled labour force, attractive costs & access to major markets in Asia. In FY16, Bio services was the 2nd largest sector in India’s biotechnology industry with 18 per cent market share & accounted for market size of US$1.98 billion. India’s bioservices sector includes global contract research organisations, such as Quintiles, as well as Indian companies including GVK Bio, Jubilant Biosys & Advinus. HUGE OPPORTUNITIES FOR INNOVATION IN AGRICULTURE/HEALTHCARE BIOTECHNOLOGY Bio Pharmaceutical Industry As the cost of bringing new molecules from discovery to market continues to rise, the global biopharmaceutical industry is seeking ways to improve efficiency. The Department of Pharmaceuticals, Government of India planned to introduce venture capital fund of US$146.72 million to fasten growth in biotech & pharmaceutical industry. In May 2017, the government approved a programme for the development of the bio pharmaceuticals through industry-institution tie-ups. The government has decided to invest US$223.14 million towards this mission over the next five years. Manufacturing India has the opportunity to replicate in biologics the same type of success it has had with small molecule drugs. Indian Immunologicals Ltd (IIL) plans to set up a new vaccine manufacturing facility in Pondicherry with an investment of US$47.99 million Source: India Law Offices, TechSci Research, Ministry of External Affairs Bioinformatics JUNE 2017 34 For updated information, please visit www.ibef.org The convergence of the life sciences with information technology is creating a particular opportunity for India. The advent of low-cost, whole genome sequencing & the growing role of molecular diagnostics in both precision & preventive medicine, and proliferation of data has created a significant demand for bioinformatics.
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Contract research The R&D sector has huge potential; many opportunities have been created with a number of foreign companies investing in this sector Indian pharmaceutical companies possess competitive skills in chemical synthesis & process engineering; OUTSOURCING OPENS UP FURTHER AVENUES FOR GROWTH OF BIOTECH BIOTECHNOLOGY Clinical trials India offers a suitable population for clinical trials because of its diverse gene pools, which cover a large number of diseases Cost effectiveness, competition & increased confidence on capabilities and skill sets have propelled many global pharmaceutical companies to increase their clinical research investment in the nation International collaboration Memorandum of Understanding (MOU) have been signed with Denmark & Finland & joint call for proposals have been issued Joint projects have also been funded with the Biotechnology & Biological Sciences Research Council (BBSRC), UK New agreements on vision research with National Institutes of Health (NIH), USA & an amendment to the agreement with Contraceptive Research and Development Programme (CONRAD) In 2015, DBT announced Indo-Australian Gold Fellowships to support researches to undertake collaborative research project in Australia for 24 months. Source: India Law Offices, Deptt. of Biotechnology, TechSci Research Others JUNE 2017 35 For updated information, please visit www.ibef.org Other potential areas of development include medicinal, aromatic plants, animal biotechnology, aquaculture, marine biotechnology, seri biotechnology, stem cell biology, environmental biotechnology, biofuels, biopesticides, human genetics & genome analysis Revised India-Cyprus tax treaty includes the plan for developing hi-tech sector in Cyprus, which will lead to the future cooperation among the two countries in the field of Biotechnology.
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Market size (USD million) Source: Deptt. of Biotechnology, Marketresearch, ABLE, TechSci Research Note: E - Estimates 1st India was the country in the world to establish a Biotechnology Information System (BTIS) network in 1987. This facilitated development of bioinformatics that has provided support to the biotechnology sector Bioinformatics research is poised to become one of the fastest emerging markets in India Bioinformatics is estimated to rise at a CAGR of 34.92 per cent to USD2.7 billion during FY12–25 India currently has close to 10 per cent of the global professional and skilled bioinformaticians With 10 per cent of the global professional & skilled bioinformaticians, Indian bioinformatics companies can play a significant role in critical areas such as data mining, mapping and DNA sequencing There is also opportunity in functional genomics, proteomics & molecule design simulation In July 2016, government allowed setting up of bioinformatics units in residential areas BIOINFORMATICS TO GROW CONSIDERABLY BIOTECHNOLOGY CAGR: 34.92% 55 JUNE 2017 36 For updated information, please visit www.ibef.org 140 2,700 FY12 FY15 FY25E
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SUCCESS STORIES BIOTECHNOLOGY
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38 JUNE 2017 For updated information, please visit www.ibef.org BIOCON: AN EARLY MOVER IN THE GLOBAL BIOTECH MARKET Biocon’s position in the Indian market during FY15–16 Biocon received an award Greentech Environment Gold Award for Excellence in Environment Management Pharmexcil Gold Patent Award Golden Peacock Award for CSR Biocon Foundation is recognized for Outstanding Contribution to Public Health by WHO India Revenue and net profit (USD million) Source: Biocon Company Website BIOTECHNOLOGY Incorporated in 1978 at Bengaluru, India IPO offering in 2004 (BSE, NSE India) Among the producers of statins & immunosuppr essants 2011: Launched INSUPen®, a convenient & affordable reusable insulin delivery device Market cap of USD3.39 billion in FY16 world’s largest • Revenue in FY17 stood at USD606.72 million while net profit totaled USD91.03 million Initiated trials for IN-105 (oral insulin program) in the US Tied-up with Quark Pharmaceuticals to develop novel siRNA-based therapeutics Partnered with Advaxis to develop a novel cancer immunotherapy 2016: Biocon’s biosimilar Insulin Glargine was granted regulatory approval in Japan & is estimated to be launched in Q1 FY17. 2016: 1st generic formulation, Rosuvastatin Tablets was granted European approval & is estimated to be launched in FY17 with company benefitting from an expected revenue of USD1.2 billion. 260 315 408 448 467.3 486.6 514.7 545.4 606.72 50.9 56.9 74.6 70.6 93.3 68.8 81.5 136.6 91.03 FY09 FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY17 Revenue Net Profit
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JUNE 2017 For updated information, please visit www.ibef.org 39 SERUM INSTITUTE OF INDIA: GAINING GLOBAL GROUND Source: Company website, ABLE, TechSci Research BIOTECHNOLOGY Strong presence in Bio Pharma space Company sells products in 140 countries worldwide Serum Institute sold around 1.3 billion vaccines doses in 2015 Generated revenue of USD600 million in FY16 Started operations with manufacturing of Tetanus Antitoxin, followed by Tetanus Toxoid Commenced export of vaccines to UN agencies; export crosses over a 100 countries Focused on gaining R&D edge, global market reach and wide product portfolio Focus on R&D Launched India's first MMR Vaccine Tresivac children in the world vaccinated by Serum Institute’s vaccine Recognised as India's number one bio-tech company for 2 consecutive years 1967 1994–2000 2005–16 Launched the world's only adsorbed liquid HDC Rabies vaccine Serum Institute has bought selling rights from Biotech Visterra VIS513 antibody for dengue Serum Institute to distribute BCG-based TB vaccine in India, originally developed in Germany 2016 Serum Institute recognised as the world's largest producer of vaccines for Measles & DTP One out of every two
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JUNE 2017 For updated information, please visit www.ibef.org 40 BIOTECHNOLOGY India’s 3rd largest Biotech company. Present in >35 countries worldwide >1,510 patent applications filed globally; of this, 415 have been granted FY10–11 revenues up by 32% to USD203.7 million Generated revenue of USD99.77 million in FY16 Established plant for vaccine production at New Delhi under the name Radicura Pharma Merged Panacea Drugs & Radicura Pharma to form Panacea Biotec Ltd & launched IPO in 1995 Strategic alliance with Kremers Urban for entry into generics Approval for development & commercialisation of Anthrax vaccine 1988 1994–2000 Forayed into Healthcare Delivery; entered into a collaboration to set up 220- bed multi-super specialty hospital & a R&D centre in Delhi 2005–16 Source: Company website, TechSci Research Selected by WHO for developing the sabin based injectable polio vaccine Started drug delivery R&D centre at Lalru Licensing agreement with National Institute of Health, US, for hair growth hormone 2004 Started new state-of- the-art Oncology centre at Baddi Launched anti- diabetic drug “Tenepan” 2016 PANACEA BIOTECH: FOCUS ON INNOVATION AND R&D Launched “CABAPAN” for treatment of mCRPC 2016 Note: mCRPC stands for metastatic Castration Resistant Prostrate Cancer
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USEFUL INFORMATION BIOTECHNOLOGY
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INDUSTRY ASSOCIATIONS JUNE 2017 42 For updated information, please visit www.ibef.org BIOTECHNOLOGY Association of Biotechnology Led Enterprises (ABLE) # 123/C, 16th Main Road, 5th Cross, 4th Block Near Sony World Showroom/Headstart School Koramangala, Bengaluru – 560034 Phone: 91 80 41636853 25633853 E-mail: info@ableindia.org Website: www.ableindia.org All India Biotech Association (AIBA) "VIPPS Center" 2. Local Shopping Centre Block EFGH, Masjid Moth, Greater Kailash-II, New Delhi-110048 Tel: 91 11 29211487 (Direct), 29220546/547 Fax: 91 11 29223089, 29229166 Email: unmalik@aibaonline.com Website: www.aibaonline.com
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GLOSSARY Bt: Bacillus thuringiensis CAGR: Compound Annual Growth Rate CRO: Contract Research Organisation DNA: Deoxyribonucleic acid FYP: Five Year Plan GCP: Good Clinical Practice INR: Indian Rupee NBTB: National Biotechnology Board OAD: Oral Anti-diabetic Drugs R&D: Research And Development FY: Indian Financial Year (April to AUGUST) So FY10 implies April 2009 to AUGUST 2010 USD: US Dollar Wherever applicable, numbers have been rounded off to the nearest whole number JUNE 2017 43 For updated information, please visit www.ibef.org BIOTECHNOLOGY
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Exchange rates (Fiscal Year) JUNE 2017 44 For updated information, please visit www.ibef.org EXCHANGE RATES Exchange rates (Calendar Year) BIOTECHNOLOGY Source: Reserve bank of India, Average for the year
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India Brand Equity Foundation (“IBEF”) engaged TechSci to prepare this presentation and the same has been prepared by TechSci in consultation with IBEF. All rights reserved. All copyright in this presentation and related works is solely and exclusively owned by IBEF. The same may not be reproduced, wholly or in part in any material form (including photocopying or storing it in any medium by electronic means and whether or not transiently or incidentally to some other use of this presentation), modified or in any manner communicated to any third party except with the written approval of IBEF. This presentation is for information purposes only. While due care has been taken during the compilation of this presentation to ensure that the information is accurate to the best of TechSci and IBEF’s knowledge and belief, the content is not to be construed in any manner whatsoever as a substitute for professional advice. TechSci and IBEF neither recommend nor endorse any specific products or services that may have been mentioned in this presentation and nor do they assume any liability or responsibility for the outcome of decisions taken as a result of any reliance placed on this presentation. Neither TechSci nor IBEF shall be liable for any direct or indirect damages that may arise due to any act or omission on the part of the user due to any reliance placed or guidance taken from any portion of this presentation. DISCLAIMER BIOTECHNOLOGY JUNE 2017 45 For updated information, please visit www.ibef.org

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