Pharma and Biotech Sector in India

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1 Pharma and Biotech Sector in India Key Opportunities for UK Organisations

2 Overview Structure and key people Sector landscape Key statistics Key areas of potential Stem Cells Bio Informatics Clinical Research Agri Biotech Biosimilars Vaccines Medical Devices Funding opportunity IP and India Oncology in India Key challenges Events you should look out for UKTI and your journey in India

3 Sector landscape Biotech sector is the sunrise sector with dedicated Government, research and industry focus on development of novel molecules and diagnostics and delivery of healthcare There are over 300 companies in India doing research, trials, services, agri and informatics Bangalore key cluster for R&D in India. Hyderabad, Pune and Mumbai all key areas of focus The DBT is the nodal point for R&D, infrastructure, bio safety guidelines for biotech Biotech Industry Research Assistance Council (BIRAC) is a new company set up by DBT to help/incubate emerging companies and ideas. 5 biotech parks set up under this across India Rise in investments into India through M&A activity and through collaborations in the recent past. Eg: Abbott Nutrition collaborated with Syngene, GSK with Biological E, MSD (Merck India), Astra Zeneca in TB

4 Recent collaborations, Investments and Inlicensing BMS-Biocon DRL and Merck Serono Abbott and Syngene Merck in India through MSD in vaccine GSK with Biological E vaccine AZ in TB research Piramal life sciences Mylan with Strides Arcolab Wellcome Trust DBT Alliance Ranbaxy with Daichi Pfizer investments in India Intas, Alembic and Glenmark all have co-development deals

5 Key areas of potential Stem Cells Bio Informatics Clinical Research Agri Biotech Drug Discovery Biosimilars Vaccines Medical Devices Oncology Funding opportunity

6 Stem Cells and Regenerative Medicine $ 350 Mn market now bound to grow India key player in stem cells among the developing world Focus both on therapies and services (banking) allogenic mesenchymal, embryonic, adipose tissue, limbal No embryonic stem cells Regulation not in place. Guidelines influenced by the UK Largely based in Bangalore Private players (Stempeutics, ANSA Research, Reliance Life Sciences) and Research institutes (InStem, NCBS, IISc, AIIMS, CMC) Clinical trials in the area ongoing by Stempeutics, DBT, Reliance Over 20 trials registered in India Therapeutic indications: Parkinson s Musculo skeletal disorders, Oncology, Cardiac

7 Opportunities in Stem Cells and Regen Med Disease Models hard to get in India for specific areas Collaborations with Researchers Clinical Trials can be done in the UK partnering here Joint Research in critical areas like brain tumors, oncology, retinal, neuro-degenerative Regulation Cell lines supply to India

8 BioInformatics With IT capital BioInformatics a natural fit Work on drug development, disease modeling, clinical data management, genome sequencing, molecular marker studies, e- Healthcare Key companies: Strand Life Sciences, Cellworks, Occimum, Connexios, Mazumdar Shaw Cancer Centre

9 BioInformatics Opportunity Direct supply of data analysis tools for better data management in trials Licensing of technology platforms for drug discovery, development and manufacture Partnering in drug development Gene Sequencing Modeling studies Molecular marker studies Pathway analysis and predictive biology Imaging and image reading

10 Clinical Research India targets to be the Clinical Trials hub for the world Services is a key sector for India, major outsourcing destination Close to 5% of trials are being done in India Large expertise available Gene Pool very diverse, huge population and treatment naïve Cost effectiveness very high Ist in Man studies not possible in India for molecules not developed in India Regulatory framework exists and will be more robust and quick in the next few months Key companies: Semler Research, Advinus, Aurigene, Syngene, Jubilant, GVK, Quintiles, Manipal Acunova Over 30 CROs in BA/BE studies and 50 at Phase I to IV Key therapeutic areas are Oncology, diabetes, anti-infective, psychiatry, endocrinology, CNS, CVD

11 Clinical Research Opportunities Opportunity to work with India s leading Pharma companies in clinical research, proof of concept and animal studies Bringing new life to de-prioritised products Translational science Early clinical development strength in UK Collaborate with large Indian CROs to provide competitive services to global players Co-development on risk-sharing model

12 Agri- Bio 1.2 billion people need to eat! In Agri sector incerased revenue by 23% Agriculture priority in for Government Total land under Bt Cotton is over 10 million hectare and about 80% of the revenue from the sector Over 95% of all cotton grown in India is Bt cotton Bt Brinjal will be the first food crop to be commercialised and others Bt Rice, Bt Maize, Bt Tomato and Bt Cauliflower Key companies work on increased produce, better efficiency of resource and pest control Key companies are Metahelix, Nuziveedu Seeds, Rasi Seeds, Monsanto Minimal VC funding in the sector

13 Agri Bio Opportunities Technology platform licensing Conservation of natural resources Existing technology and expertise on food crop

14 Biosimilars 48 products off-patent in next few years huge opportunity in India Inherent strength in reverse engineering Over 25 biosimilars already in India 20 companies active in this area Key products are Human Insulin, Erythropoeitin, Human Growth Hormone, GCS-F and Streptokinase Costs are up to 80% lower in India Key players are Glenmark, Biocon, Intas, Reliance Life Sciences, Avesthagen, Lupin, DRL, Cipla, Novo Nordisk

15 Biosimilars Opportunities Expertise sharing Co-development with India with risk-sharing Regulation and quality support Platform technologies for manufacture

16 Vaccines in India The largest revenue earner in the biopharma segment India is the largest vaccine manufacturer Every 3 rd vaccine for DPT is from Serum Institute in India 70% of vaccines manufactured are exported 80% of the vaccine purchased by UN agencies are from India Estimated value ranges from $ 260 Mn to $ 500 Mn (McKinsey report) Key companies: Serum, Panacea, Shantha, Bharat Biotech, Indian Immunologicals, Ranbaxy, GSK, Biological E Key clusters are in Pune, Mumbai and Hyderabad

17 Vaccine Opportunity Absence of single-window clearance Quick permissions for trials to be conducted in India R&D partnerships similar to GSK-Biological E Technology platform interventions Collaborations to plug into supply chain and storage of vaccines

18 Medical Devices and Diagnostics Focus is on preventive and personalised medicine Cost arbitrage is 70% for manufacturing devices and diagnostic kits Advanced IT sector helps in high-end equipment Key players: Transasia Bio, Tulip Diagnostics, Span Diagnostics, Bhat Biotech, Xcyton, GE Healthcare

19 Medical Devices/Diagnostics Opportunities Healthcare a huge focus and demand devices is a high demand (NRHM) Collaborations with Diagnostics companies in India for incremental innovation Devices and Diagnostics for large public and private healthcare providers

20 Funding in India Funding amount available : GBP 3 Billion 30% of budget in PPP Interest rates for funding range 0 to 6% and approval up to 12 weeks Tax incentives like weighted deduction of 200% R&D expenses Early stage funding through BIRAP, BIPP, SIBRI and Ignition Grant Scheme CSIR has New Millennium Indian Technology Leadership Initiatives DBT-Wellcome Trust Programmes and GBP 20 Mn towards Crop Production Research UK provides largest grants in India Bill & Mellinda Gates Foundation Grand Challenge Programme

21 Intellectual Property and India Registration can be done through National filing and International filing Apply through Indian attorney Could take 4 to 5 years Costs 50 excluding legal fees Enforcement is for 20 years from date of application Compulsory licensing is a challenge (Bayer and Natco) also possible (Herceptin, Ixabepilone and Dasatinib) Glivec of Novartis shows India s stand against evergreening of patents

22 Oncology in India India is the world s third largest market for Oncology Second largest (8%) cause of death in India so huge demand for cancer products in India new cases growth at 7% yoy Fragmented market with several MNCs and Indian companies Indian Government focusses on PPP models and reducing prices of essential drugs Key areas breast cancer, colorectal cancer, lung cancer, NHL and prostrate cancer CAGR of 6.5% expected to grow to $ 250 million

23 Oncology in India - continued Has the highest potential for M&A and also largest demand for inlicensing for India Key companies in India: BMS, Pfizer, Roche, Sanofi-Aventis, GSK, SP Corporation, Fresenius Kabi, Natco Pharma, Sun Pharma, DRL and Biocon Over 30 companies in India market cancer products Major driver now is increasing patient population and combination therapy is fast becoming standard therapy

24 Limitations in Oncology Unclear patent laws (Novartis-Gleveec) Restrictive pricing and reimbursement policies Lack of quality infrastructure Insufficient Government support Low patient affordability and lack of insurance support from Government Insufficient academia-industry collaborations

25 Key Challenges for India Stringency and quick processes in Regulation is an immediate need. Regulators working on this IP clarity and marketing the India IP story in the right light is critical Better and more PPP models to be encouraged More Industry-Academia collaborations to be encouraged Support through an existing eco-system Cambridge, Nottingham, Manchester type clusters Good political environment and strong pricing system

26 Events you should not miss! The UK-India Oncology Summit September 2013 The CPhI India December 2013 Bangalore India Bio February 2014 ISCR Clinical Research January 2014

27 Way forward Get more information Develop an India strategy Look for specific opportunities Warm up contacts Visit the market Follow up

28 Thank You