Industry Insight - Indian Biopharma

Transcription

1 Brochure More information from Industry Insight - Indian Biopharma Description: Biopharmaceuticals are complex macromolecules (Large molecules) created through the genetic manipulation of living organisms using gene cloning, recombinant DNA (gene splicing), or cell fusion technologies. The total Biopharma industry grew by 12% over FY to Rs88.28 billion in The total bio-pharma industry, consisting of therapeutics, vaccines, diagnostics, and other products such as statins, and continues to be largest contributor to the overall biotech market in the country. The good performance of the bio-pharma sector is attributed to the strongly growing vaccine business which accounted for about 51% of the total bio-pharma business in fiscal year Interestingly, India is one of the largest producers of traditional vaccines in the world. The life science sector is emerging as a key industrial segment in the national economy. India is counted among the top 12 global biotech hotspots and is the 3rd largest in Asia Pacific (in terms of number of biotech companies). The Regulatory framework in Biotechnology is undergoing a huge revamp and hence the Biopharma sector is also expected to be affected by it. Though there are no specifically separate Regulations and Policies for the Biopharma sector all the aspects of the upcoming Biotech Policy which will affect the sector are discussed in the report. The emerging positive trends in India offer a potential solution to some of these problems. There are seven key broad areas to leverage the advantages that India offers to the established pharma and biotech industries. These include contract research, R&D alliances, clinical trials, R&D for neglected diseases, in-licensing of preclinical as well as early clinical drug candidates, IT applications and data management and herbal heritage. The above background initiated need for a comprehensive Industry Insight on Indian Biopharma. Overview of The Indian Biopharma in India with a brief preamble of Industry Overview is discussed in the beginning along with its Segmental analysis of biopharma industry according to its Vaccines, Diagnostics and Therapeutics. application of growth drivers, issues and challenges, core technologies, major players, regulatory environment, Critical success factors, emerging trends and opportunities in india is discussed in total 10 chapters. Contents: EXECUTIVE SUMMARY HIGHLIGHTS 1. INDUSTRY OVERVIEW 1.1 The Industry Industry Structure Industry Size Industry Segments Segment Performance Exports Vs Domestic Business 1.2 Introduction to Biopharma What is Biopharma? Industry Classification 1.3 Biopharma Market Size 1.4 Biopharma Industry Segments Vaccines Diagnostics Therapeutics 1.5 Contribution of Biopharma sector to domestic & exports sales of Biotechnology 2. SEGMENT ANALYSIS - BIOPHARMA 2.1 Segment Analysis: Vaccines An introduction to vaccines and vaccine trials Indian Vaccine Market Scenario Major Players Major Vaccines Available Challenges before the Vaccine Industry 2.2 Segment Analysis: Diagnostics

2 2.2.1 Diagnostics market Segmentation Current Market Scenario Demand Scenario Market is Import Driven Key Segments Major Players Emerging areas for diagnostic market Major Diagnostics India as a preferred destination for outsourcing clinical trials Challenges before the Indian Diagnostics Industry 2.3 Segment Analysis: Therapeutics Current Market Scenario Major Therapeutic Segments Segment Analysis: Antibiotics Segment Demand for Recombinant Biotech Drugs in India Government Support for Recombinant Therapeutics Major Players Recombinant Therapeutic Products in India 3. GROWTH DRIVERS 3.1 Growing population and improving incomes 3.2 Emerging lifestyle diseases 3.3 Increasing Investment in Infrastructure and R&D 3.4 Increasing Bio-partnering Activities 3.5 Increasing Outsourcing Opportunities 3.6 Emerging Contract Research Market 4. ISSUES & CHALLENGES 4.1 Increasing Productivity & Profitability 4.2 Lack of Skilled manpower in the area of bio-pharma 4.3 Daunting regulatory system 4.4 A Confusing Patent Law for India 4.5 Ethical Issues 4.6 FDA Regulations 4.7. Environmental Factors 4.8 Bioequivalence issue in Bio-generics 4.9 Comparative Low R&D Expenditures Result in Price Wars 4.10 Sub-Critical Resource Allocation by Public Companies 4.11 High Duties on Imported Products Restrains Volume Growth 4.12 Having Tailor-Made Drugs Could Result in Loss of Potential Revenues 4.13 Small Biotech Start Ups Find Marketing of Products Difficult 4.14 Access to capital 4.15 Reducing Time to Market 5. CORE TECHNOLOGIES IN BIOPHARMA 5.1 Antisense Technology 5.2 Immobilization of enzymes and cells 5.3 Cell culture 5.4 Monoclonal Antibodies 5.5 Protein engineering 5.6 Biosensors 5.7 Microarrays 5.8 Enzyme engineering and Technology 6. MAJOR PLAYERS 6.1 Biocon Ltd 6.2. Serum Institute of India Ltd 6.3 Panacea Biotech Ltd 6.4 Reliance Life Sciences 6.5 Novo Nordisk 6.6 Shantha Biotechnics 6.7 Indian Immunologicals Ltd 6.8 Bharat Biotech 6.9 Eli Lilly 6.10 Bharat Serums and Vaccines Ltd 7. REGULATORY ENVIRONMENT IN BIOPHARMA 7.1 Government of India Policy on Biotechnology

3 7.2 Existing Regulatory Framework 7.3 IPR Issues in Biotechnology 7.4 Funding Agencies in Biotech Research 7.5 Budgetary Allocation 7.6 Venture Capital Funding 7.7 Foreign Direct Investments 7.8 National Biotech Development Strategy Sectoral Road Map from DBT on Biopharma 7.10 Biopiracy 7.11 Biosafety 8. CRITICAL SUCCESS FACTORS 8.1 Human Resources 8.2 New Product Development 8.3 Networking: Strategic Alliances & Partnering Activities 8.4 Co-development 8.5 Economies in R&D 8.6 Therapeutic Segment Coverage 8.7 Meeting the Global Demand 8.8 World-class Practices 9. EMERGING TRENDS 9.1 Big Pharmaceutical Companies Are Scouting For Biopharma Partners 9.2 Increasing Demand for Biogenerics 9.3 Companies Specialising In Specific Therapeutic or Disease Areas 9.4 R&D Spend On the Rise 9.5 Global Biotech R&D Productivity on the Rise 9.6 Increasing Outsourcing by Pharmaceutical Companies 9.7 Immunogenicity 10. OPPORTUNITIES IN INDIA 10.1 Increasing Pharma R&D opportunities in India 10.2 Opportunities in Clinical Research 10.3 Increasing Opportunities in Contract Manufacturing 11. OUTLOOK BIBLIOGRAPHY GLOSSARY ANNEXURE I List of Tables Table 1.1: Export Vs Domestic Business in Table 1.2: Segmental Revenue in Biopharma Sector, Table 2.1: Product Segments in the Vaccine Market in Table 2.2: Major Players in Vaccines, Table 2.3; Major Vaccines, Table 2.4: Major Diagnostics, Table 2.5: Major segments in the antibiotic category Table 2.6: Major Players in the Therapeutic Segment, Table 2.7: 50 Branded Biodrugs in India Table 2.8: Therapeutics Commercialised Technology Table 3.1: Some Examples of Lifestyle Diseases Table 6.1: Top Ten Players in Indian Biopharma Sector Table 7.1: Some Biopiracy Patents Based on Indigenous Knowledge of India Table 9.1: Big R&D Spenders in India List of Charts Chart 1.1: Indian Biotech Industry, FY04- FY Chart 1.2: Segment Contribution (%) in biotech industry, Chart 1.3: Segmentwise Biotech Export Market share, Chart 1.4: Segmentwise Biotech Domestic Market share, Chart 1.5: Biopharma Sales in India Chart 1.6: Segment-wise Biopharma Sales Contribution in Chart 1.7: %Share of Biopharma to Biotechnology Domestic sales Chart 1.8: %Share of Biopharma to Biotechnology Exports Chart 2.1: Indian Vaccine Market FY2006- FY2 Chart 2.2: Segment Wise Contribution in the Animal Vaccine Market

4 Chart 2.3: Indian Diagnostic Market, FY2006-FY2 Chart 2.4: Indian Therapeutics Market, FY2007-FY2 Chart 2.5: Highest Growing Segments in Indian Therapeutics Market Chart 11.1: Indian Biopharmaceutical Market Forecast Ordering: Order Online - Order by Fax - using the form below Order by Post - print the order form below and send to Research and Markets, Guinness Centre, Taylors Lane, Dublin 8, Ireland.

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