Pharma and Biotech Sector in India Key Opportunities for UK Organisations

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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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Thank You