Biotechnology in India and key people Sector landscape Key statistics Key areas of potential Stem...
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Transcript of Biotechnology in India and key people Sector landscape Key statistics Key areas of potential Stem...
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
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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
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Recent collaborations, Investments and In-
licensing
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
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Key areas of potential
Stem Cells
Bio Informatics
Clinical Research
Agri Biotech
Drug Discovery
Biosimilars
Vaccines
Medical Devices
Oncology
Funding opportunity
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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
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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
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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
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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
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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
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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
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Agri- Bio
1.2 billion people need to eat!
In 2011-12 Agri sector incerased revenue by 23%
Agriculture priority in 2013-2014 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
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Agri Bio Opportunities
Technology platform licensing
Conservation of natural resources
Existing technology and expertise on food crop
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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
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Biosimilars Opportunities
Expertise sharing
Co-development with India with risk-sharing
Regulation and quality support
Platform technologies for manufacture
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Vaccines in India
The largest revenue earner in the biopharma segment
India is the largest vaccine manufacturer
Every 3rd 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
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
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
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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
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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
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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
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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
Oncology in India - continued
Has the highest potential for M&A and also largest demand for in-
licensing 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
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
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
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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
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Way forward
• Get more information –
• Develop an India strategy –
• Look for specific opportunities –
• Warm up contacts –
• Visit the market –
• Follow up –
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