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Abstract 54 Pages Executive Summary: Countries that can offer lower costs during research and development while ensuring adequate protection of intellectual property and adherence to 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 clinical development. Major multinationals have established subsidiaries in India. U.S. and European 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 the U.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 the developed 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 few years. 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's premier 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, fifty-five per cent of India's biotechnology companies are located in Karnataka. The Government of Karnataka is committed to establishing a biotechnology corridor for the development of the biotechnology industry in Karnataka. Contract Research Organizations have great potential to function as export oriented 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-contracting software 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 IT sector. 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 the activities of several multinational companies located in Bangalore as well as the current state of affair of contract research outsourcing in Bangalore. Contact information is provided for these companies including key executive names. Table of Contents The Drug Discovery and Development Life Cycle The Innovation Process The Drive toward Outsourcing Contract Research Early Drug Discovery Contract Manufacturing Regulation Outsourcing Opportunities in India The Life Sciences Industry in India Trends across the Life Cycle Advantages of Outsourcing to India Enabling Life Sciences and Outsourcing in Bangalore Government Policy Infrastructure Development Academic Support Limitations to Overcome Intellectual Property Regulation Language and Culture Business Models Operating in India Focus on Drug Discovery Preclinical Research and Business Models Focus on Clinical Research Clinical Research Business Models Managing the Outsourcing Relationship Selection Process Development of the Partnership Case Studies: Biotechnology and Pharmaceutical Companies in Bangalore Advinus Therapeutics AstraZeneca India Aurigene Discovery Technologies Ltd. Bangalore Genei Pvt. Ltd. CytoGenomics Pvt. Ltd. GlaxoSmithKline Pharmaceuticals Ltd. Jubilant Biosys Metahelix Life Sciences Pvt. Ltd. Molecular Connections Pharmed Medicare Sartorius Siri Technologies Pvt. Ltd. Strand Life Sciences Strides Arcolab Triesta Sciences XCyton Diagnostic XP Biotek Pvt. Ltd. Case Studies: Contract Research Organizations in Bangalore Biocon India Group Syngene Clinigene ClinTec International Manipal Acunova Quintiles India Rallis R&D Center ReaMetrix India Pvt. Ltd. Sanmar Specialty Chemicals Limited Synchron Research Services Pvt. Ltd. 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 • India’s 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 | |||
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