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An Overview of the Life Sciences

and Outsourcing Landscape in India:

Spotlight on Bangalore

A CanBiotech Report

CanBiotech, 2007

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Executive Summary:

Countries that can offer lower costs during research and development

while ensuring adequate protection of intellectual property and adherenceto global regulatory standards are well positioned to attract the attention of

large biopharmaceutical companies looking to outsource drug discovery

and/or development.

India is poised to make big contributions to the global healthcare industry.

The country is emerging as a competitive base for several segments of the

R&D value chain, especially in late discovery, preclinical, and clinicaldevelopment.

Major multinationals have established subsidiaries in India. U.S. andEuropean companies are collaborating with Indian firms to develop new

drugs and vaccines, to conduct clinical trials and toxicity studies, to

perform molecular modeling and lead optimization, to provide computer

services such as bioinformatics, and to develop industrial production

processes for new drug ingredients. Similarly, venture capitalists from theU.S. and Singapore are helping to fund start-up biotechnology companies

in India.

Indian companies are also set to tap into the global biopharmaceutical

outsourcing market. These companies are increasingly moving into thedeveloped market and transitioning from bulk drugs to formulation

exports. Indian companies are also expected to produce many of the top

drop drugs that are scheduled to lose patent protection over the next fewyears. India will not only be accessing the generics market, but the

research focus of many large companies has shifted toward the discovery

of new chemicals-providing the skill set necessary for upstream

outsourcing.

Bangalore is fast becoming one of major hubs of the biotechnology

industry in India. With Bangalore firmly established as the country'spremier IT and biotech hub, it comes as no surprise that the city is home to

India's largest biocluster. Approximately 158 of the 320 biotech

companies are based there, with total revenues of Rs 1,400 crore. Further,

An Overview of the Life Sciences

and Outsourcing Landscape in India:

Spotlight on Bangalore

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fifty-five per cent of India's biotechnology companies are located in

Karnataka. The Government of Karnataka is committed to establishing abiotechnology corridor for the development of the biotechnology industry

in Karnataka.

Contract Research Organizations have great potential to function as exportoriented units and are comparable in their activity to the software

development activities in the IT sector. Software services were outsourced

by large overseas IT companies, starting initially with the sub-contractingsoftware development of small modules of complex software and a decade

later, the Indian IT sector is now capable of handling the entire software

development process-the primary reason for the prolific growth in the ITsector. Contract research in biotechnology offers the same growth

potential and the Government of Karnataka is firmly committed to

supporting these organizations.

Through the use of brief case studies we provide an overview of theactivities of several multinational companies located in Bangalore as wellas the current state of affair of contract research outsourcing in Bangalore.

Contact information is provided for these companies including key

executive names.

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Executive Summary

The Drug Discovery and DevelopmentLife Cycle

The Innovation ProcessThe Drive toward Outsourcing

Contract Research

Early Drug DiscoveryContract Manufacturing

Regulation

Outsourcing Opportunities in India

The Life Sciences Industry in India

Trends across the Life CycleAdvantages of Outsourcing to India

Enabling Life Sciences and

Outsourcing in Bangalore

Government Policy

Infrastructure Development

Academic Support

Limitations to Overcome

Intellectual Property

RegulationLanguage and Culture

Business Models Operating in India

Focus on Drug Discovery

Preclinical Research and Business

ModelsFocus on Clinical Research

Clinical Research Business Models

Managing the Outsourcing

RelationshipSelection Process

Development of the Partnership

Case Studies: Biotechnology and

Pharmaceutical Companies in

Bangalore

Advinus TherapeuticsAstraZeneca India

Aurigene Discovery Technologies Ltd.Bangalore Genei Pvt. Ltd.

CytoGenomics Pvt. Ltd.

GlaxoSmithKline Pharmaceuticals Ltd.Jubilant BiosysMetahelix Life Sciences Pvt. Ltd.

Molecular Connections

Pharmed MedicareSartorius

Siri Technologies Pvt. Ltd.Strand Life SciencesStrides ArcolabTriesta SciencesXCyton DiagnosticXP Biotek Pvt. Ltd.

Case Studies: Contract Research

Organizations in Bangalore

Biocon India GroupSyngene

ClinigeneClinTec InternationalManipal AcunovaQuintiles IndiaRallis R&D CenterReaMetrix India Pvt. Ltd.Sanmar Specialty Chemicals LimitedSynchron Research Services Pvt. Ltd.

Table of Contents

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List of Figures:

Outsourced Segments and Activities of the R&D Value Chain Biotechnology Performance across Asia-Pacific, Europe, and the United States Trends across the Indian R&D Value Chain Business Models Operating across the Early Discovery and Clinical Value Chain

List of Tables:

R&D Budget Break-Down Indias Current and Projected Share of the Preclinical and Clinical Services

Markets

Finding Preclinical and Clinical Service Providers Companies in Bangalore-Drug Discovery and Development Focus Contract Research Organizations in Bangalore-Services Offered