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Indian Biopharmaceuticals

Published by: Cygnus Business Consulting and Research

Published: Jan. 1, 2008 - 211 Pages


Table of Contents


EXECUTIVE SUMMARY HIGHLIGHTS

1. INDUSTRY OVERVIEW

1.1 The Industry

1.1.1 Industry Structure

1.1.2 Industry Size

1.1.3 Industry Segments

1.1.4 Segment Performance

1.1.5 Exports Vs Domestic Business

1.2 Introduction to Biopharma

1.2.1 What is Biopharma?

1.2.2 Industry Classification

1.3 Biopharma Market Size

1.4 Biopharma Industry Segments

1.4.1 Vaccines

1.4.2 Diagnostics

1.4.3 Therapeutics

1.5 Contribution of Biopharma sector to domestic & exports sales of Biotechnology

2. SEGMENT ANALYSIS - BIOPHARMA

2.1 Segment Analysis: Vaccines

2.1.1 An introduction to vaccines and vaccine trials

2.1.2 Indian Vaccine Market Scenario

2.1.3 Major Players

2.1.4 Major Vaccines Available

2.1.5 Challenges before the Vaccine Industry

2.2 Segment Analysis: Diagnostics

2.2.1 Diagnostics market Segmentation

2.2.2 Current Market Scenario

2.2.3 Demand Scenario

2.2.4 Market is Import Driven

2.2.5 Key Segments

2.2.6 Major Players

2.2.7 Emerging areas for diagnostic market

2.2.8 Major Diagnostics

2.2.9 India as a preferred destination for outsourcing clinical trials

2.2.10 Challenges before the Indian Diagnostics Industry

2.3 Segment Analysis: Therapeutics

2.3.1 Current Market Scenario

2.3.2 Major Therapeutic Segments

2.3.3 Segment Analysis: Antibiotics Segment

2.3.4 Demand for Recombinant Biotech Drugs in India

2.3.5 Government Support for Recombinant Therapeutics

2.3.6 Major Players

2.3.7 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

3.5 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


6.1. Serum Institute of India Ltd.

6.2 Biocon Ltd.

6.3 Panacea Biotech Ltd

6.4 Venkateshwara Hatcheries Private Ltd.

6.5 Novo Nordisk 6.6 Aventis Pharma Limited

6.7 Indian Immunologicals Ltd.

6.8 Glaxo SmithKline Pharmaceuticals Ltd.

6.9 Shantha Biotechnics

6.10 Bharat Serums and Vaccines Ltd

7. REGULATORY ENVIRONMENT IN BIOPHARMA

7.1 Government of India Policy on Biotechnology

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 - 2005

7.9 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

8.5 Research & Development

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 Major Players in Indian Bio Pharma Sector

Table 1.1: Export Vs Domestic Business in 2006-07

Table 1.2: Segmental Revenue in Biopharma Sector, 2006-07

Table 2.1: Product Segments in the Vaccine Market

Table 2.2: Top Ten Players in Indian Vaccine Segment, 2006-07

Table 2.3: Major Vaccines

Table 2.4: Major Players in the Indian Diagnostic Industry, 2006-07

Table 2.5: Major Diagnostics

Table 2.6: Major segments in the Antibiotics Category

Table 2.7: Major Players in the Therapeutics Segment, 2006-07

Table 2.8: Branded Biodrugs in India

Table 2.9: Therapeutics-Commercialised Technology

Table 2.10: Some Examples of Lifestyle Diseases

Table 6.1: Top ten players in Indian Biopharma Sector, 2006-07

Table 7.1: Some Biopiracy Patents Based on Indigeneous Knowledge of India

Table 9.1: Big R&D Spenders in India

List of Charts

Chart 1.1: Indian Biotech Industry

Chart 1.2: Segment Contribution (%) in biotech industry, 2006-07

Chart 1.3: Segmentwise Biotech Export Market share, 2006-07

Chart 1.4: Segmentwise Biotech Domestic Market share, 2006-07

Chart 1.5: Biopharma Sales in India

Chart 1.6: Biopharma- Share of Exports and Domestic Sales, 2006-07

Chart 1.7: Segmentwise Biopharma Sales Contribution, 2005-06

Chart 1.8: Segmentwise Biopharma Sales Contribution, 2006-07

Chart 1.9: % Share of Biopharma to Biotechnology Domestic Sales, 2006-07

Chart 1.10: % Share of Biopharma to Biotechnology Exports, 2006-07

Chart 2.1: Indian Vaccine Market FY2004- FY2007

Chart 2.2: Segment Wise Contribution in the Animal Vaccine Market

Chart 2.3: Major Players in the Indian Poultry Vaccine Market, 2006-07

Chart 2.4: Indian Diagnostic Market, FY2004-FY2007

Chart 2.5: Indian Therapeutics Market, FY2004-FY2007

Chart 2.6: Highest Growing Segments in Indian Therapeutics Market

Chart 3.1: Global Outsourcing Market, 2006

Chart 11.1: Indian Biopharmaceutical Market Forecast

Abstract

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 global biotech industry size is currently USD73.12 billion, whereas the Indian biotech industry just crossed the USD2 billion (INR 85.41 billion) mark in 2006-07. Bio Pharma remained the largest contributor with a value contribution of INR59.73 billion accounting for a 69.73% contribution.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, comprising of vaccines, therapeutics, other products like statins, and diagnostics registered 26.9% growth in 2006-07 and the segment still is the single largest contributor to the Indian biotech industry.

The report aims at recent trend in biopharma, global market and its trend, estimates of the future market, growth drivers, critical success factors, issues and challenges, core technologies in biopharma,regulatory environment, profiles of major players and their products offering in biopharma.

The report on biopharma provides a segment analysis with reference to vaccines,diagnostics,therapeutics.At the end report provides future outlook of biopharma industry.

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