Indian Pharmaceuticals Industry Report

Summary

Cygnus estimates that Indian pharmaceutical industry reached at US$10.88 billion in 2008-09 and it is likely to double its value to US$20.95 billion in 2014. Global recession could not impact Indian Pharma industry and Pharma companies are bullish about demand generated from the overseas market along with stronger growth in internal demand in the near future.

SCOPE OF THE REPORT

• Global Pharmaceutical Market – A snap-shot
• Overview of Indian Pharma industry – its structure, segmentation,

Major Therapeutic segments, M&A, demand & supply, FDI

• Foreign trade
• Profiles of 20 leading Pharma Companies
• Growth Drivers and Issues & challenges
• Outsourcing & Generic opportunities for the Industry.
• Regulatory Issues
• Critical Success Factors
• Future Outlook

MAJOR POINTS DISCUSSED

• Leading Therapeutic segment analysis
• Trends in pharmaceutical industry -2009
• Analysis of FDI in Pharma sector country wise & sector wise
• Exports and import in trends (country wise export)
• Analysis of Top products
• Major players (therapeutic wise analysis for top five companies)
• Outsourcing investments trends
• Future Outlook – Projections upto 2014 and the brighter sides of the industry.

REASONS TO BUY

• Comprehensive report while entering the new year
• Providing an overall view of the industry Global as well as Indian.
• Useful to understand the business opportunities in Indian Market
• Useful to understand the business opportunities in overseas market.
• An analytical report with trends, charts & graphs to help you in taking informed decision

FOR WHOM
This report will immensely help a wide cross section of the Customers including like Pharma Companies, Industry Researchers, Independent Consultants and Students & faculty of various Pharma institutions

Contents

Executive summary

Highlights

1. Industry Overview - Global and Domestic
1.1 Global Pharmaceutical Market
1.1.1 Leading Therapeutic Classes
1.1.2 Major Markets
1.1.3 Trends in Pharmaceutical Industry in 2009
1.1.4 Global M&A
1.1.5 Major Global Players
1.2 Indian Pharmaceutical Industry
1.2.1 Introduction
1.2.2 Pharmaceutical Industry Structure
1.2.3 Segmentation of the Indian Pharmaceutical Industry
1.2.4 Pharmaceutical Market structure and Size
1.2.5 Major Therapeutic Segments
1.2.6 Merger & Acquisition
1.2.7 Demand-Supply Analysis
1.2.8 Foreign Direct Investments in Indian Pharma

2. Foreign Trade in Pharmaceutical Industry
2.1 Exports
2.1.1 Country Wise Exports
2.1.2 Exports Trends
2.2 Imports
2.2.1 Bulk Drugs Imports
2.3 Future Outlook

3. Growth Drivers
3.1 Global Growth Drivers
The global growth drivers of the pharmaceutical industry are given below:
3.1.1 Innovation in Biotechnology
3.1.2 Demographic Transition
3.1.3 Rising Real Incomes
3.1.4 Medical Technology
3.1.5 Generic and Niche
3.1.6 Unmet Medical Needs
3.2 Indian Pharma Drivers
3.2.1 Ageing Population
3.2.2 Lifestyle Drugs
3.2.3 Healthcare Expenditure
3.2.4 Upgradation of Medical Services, Devices & Equipment
3.2.5 Exports
3.2.6 Generic Drugs
3.2.7 Research & Development
3.2.8 Contract Manufacturing Opportunitiies
3.2.9 Middle Class, Rural Market to Fuel Pharma Growth
3.2.10 Pharma Firms Betting Big on Nutraceuticals

4. Issues & Challenges
4.1 Sustaining Exports
4.2 IPR Issues
4.2.1 Pricing
4.2.2 Data protection
4.3 R&D Focus
4.3.1 Looming shortage of trained human resources
4.3.2 Animal trials
4.3.3 Regulatory infrastructure
4.3.4 Managing productivity
4.4 Exploiting Generic Opportunities requires Huge Investment
4.5 Price Control
4.6 Infrastructure
4.6.1 R&D infrastructure
4.6.2 Quality of marketing infrastructure
4.7 Spurious Drugs

5. Major Players
5.1 Daiichi Sankyo
5.1.1 Business Profile
5.1.2 Strategies
5.1.3 Financial Profile
5.1.4 SWOT Analysis
5.1.5 Outlook
5.2 Dr Reddy's Laboratories Ltd
5.2.1 Business Profile
5.2.2 Strategies
5.2.3 Financial profile
5.2.4 SWOT Analysis
5.2.5 Outlook
5.3 Cipla Ltd
5.3.1 Business Profile
5.3.2 Strategies
5.3.3 Financial Profile
5.3.4 SWOT Analysis
5.3.5 Outlook
5.4 Sun Pharmaceutical Industries Ltd
5.4.1 Business Profile
5.4.2 Strategies
5.4.3 Financial Profile
5.4.4 SWOT Analysis
5.4.5 Outlook
5.5 Piramal Healthcare Ltd
5.5.1 Business Profile
5.5.3 Financial Profile
5.5.4 SWOT Analysis
5.5.5 Outlook
5.6 Lupin Ltd
5.6.1 Business Profile
5.6.2 Strategies133
5.6.3 Financial profile
5.6.4 SWOT Analysis
5.6.5 Outlook
5.7 Wockhardt Ltd
5.7.1 Business Profile
5.7.2 Strategies
5.7.3 Financial profile
5.7.4 SWOT Analysis140
5.7.5 Outlook
5.8 Jubilant Organosys
5.8.1 Business Profile
5.8.2 Strategies
5.8.3 Financial profile
5.8.4 SWOT Analysis
5.8.5 Outlook
5.9 Aurobindo Pharma Ltd
5.9.1 Business Profile
5.9.2 Strategies
5.9.3 Financial profile
5.9.4 SWOT Analysis
5.9.5 Outlook
5.10 Cadila Healthcare Ltd
5.10.1 Business Profile
5.10.2 Strategies
5.10.3 Financial Profile
5.10.4 SWOT Analysis
5.10.5 Outlook
5.11 Glenmark Pharmaceuticals Ltd162
5.11.1 Business Profile162
5.11.2 Strategies
5.11.3 Financial Profile165
5.11.4 SWOT Analysis
5.11.5 Outlook
5.12 Matrix Laboratories
5.12.1 Business Profile
5.12.2 Strategies
5.12.3 Financial Profile
5.12.4 SWOT Analysis
5.12.5 Outlook
5.13. GlaxoSmithKline Pharmaceuticals Ltd
5.13.1 Business Profile
5.13.2 Strategies
5.13.3 Financial Profile
5.13.4 SWOT Analysis
5.13.5 Outlook
5.14 Torrent Pharmaceuticals
5.14.1 Business Profile
5.14.2 Strategies
5.14.3 Financial Profile
5.14.4 SWOT Analysis
5.14.5 Outlook
5.15 Orchid Chemicals and Pharmaceuticals Ltd
5.15.1 Business Profile
5.15.2 Strategies
5.15.3 Financial Profile
5.15.4 SWOT Analysis
5.15.5 Outlook
5.16 Ipca Laboratories Ltd
5.16.1 Business Profile
5.16.2 Strategies
5.16.3 Financial Profile
5.16.4 SWOT Analysis
5.16.5 Outlook
5.17 Biocon Limited
5.17.1 Business Profile
5.17.2 Strategies
5.17.3 Financial Profile
5.17.4 SWOT Analysis
5.17.5 Outlook
5.18 Divis laboratories
5.18.1 Business profile
5.18.2 Strategies
5.18.3 Financial Profile
5.18.4 SWOT Analysis
5.18.5 Outlook
5.19 Alembic Ltd
5.19.1 Business Profile
5.19.2 Strategies
5.19.3 Financial Profile
5.19.4 SWOT Analysis
5.19.5 Outlook
5.20 Aventis Pharma Ltd
5.20.1 Business Profile
5.20.2 Strategies
5.20.3 Financial Profile
5.20.4 SWOT Analysis
5.20.5 Outlook

6. Outsourcing Opportunities
6.1 Factors Driving Outsourcing
6.1.1 Value Chain Optimisation
6.1.2 FDA-approved Manufacturing Plants in India
6.1.3 Weaker Pipelines and Rising Approval Times
6.1.4 Pressure to Cut Prices
6.1.5 Declining Market Exclusivity Period
6.1.6 Need to Improve Marketing Productivity
6.2 Outsourcing Market
6.2.1 Indian Market
6.2.2 Opportunities for Indian Pharma Companies
6.2.3 Contract Manufacturing
6.2.4 Contract Research225

7. Generic Opportunities
7.1 Generics Market Overview
7.2 Factors Driving Generics Market in India
7.2.1 Cost advantage
7.2.2 Drugs going off patent
7.2.3 Rising healthcare expenditure
7.2.4 Growing population
7.2.5 Emerging lifestyle diseases
7.2.6 Drug Master Filing submission on the Rise

8. Regulatory Issues
8.1 Overview
8.2 Regulatory Environment
8.2.1 General regulations
8.3 Entry Strategies
8.3.1 Importing pharmaceuticals
8.3.2 Manufacturing under license
8.3.3 Entry through joint venture/subsidiary
8.3.4 Approvals for foreign companies with prior Indian exposure
8.3.5 Additional options
8.4 Key Legislations247
8.4.1 The Drugs and Cosmetics Act, 1940247
8.4.2 The Medicinal & Toilet Preparations Act, 1955 with Rules, 1956
8.4.3 The Drug Policy, 1986249
8.4.4 The Essential Commodities Act, 1955
8.4.5 Indian Patents Act, 1970249
8.4.6 The Drugs Price Control Order, 1995
8.4.7 Good Manufacturing Practices
8.4.8 The Pharmacy Act, 1948
8.5 Regulatory Bodies
8.5.1 The Drugs Controller of India
8.5.2 State Food and Drug Administration251
8.5.3 National Pharmaceutical Pricing Authority
8.5.4 Department of Chemicals and Petrochemicals
8.5.5 Foreign Investment promotion board
8.5.6 Central Drugs Standard Control Organisation253
8.5.7 Central Drug Authority
8.6 Price Controls255
8.6.1 Pricing of Scheduled Bulk Drugs
8.6.2 Pricing of Scheduled Formulations Imported into India
8.6.3 Pricing Regulations
8.7 Intellectual Property Rights
8.7.1 Legal Procedure
8.7.2 Compulsory Licensing and Revocation of EMR260
8.7.3 Permission for residents to apply for patents outside India
8.7.4 Trademarks
8.8 Manufacturing
8.8.1 Industrial Licensing
8.8.2 Additional Approvals/Registration
8.9 Imports
8.9.1 Imports of Capital Goods and Raw Materials
8.9.2 Pharmaceutical Imports
8.10 New Drug Approval Process
8.10.1 Drug Approval Procedure
8.11 Product Standards
8.11.1 Labelling
8.12 Tariff Structure
8.12.1 Local Manufacturing Duty
8.12.2 Sales Tax
8.13 Marketing and Distribution
8.13.1 Licensing of sales outlets and stock holding
8.13.2 Prescription Drugs
8.13.3 Advertisement and Promotion
8.13.4 Regulations of Advertising
8.13.5 Packing and Labelling
8.13.6 Distribution
8.13.7 Brands
8.13.8 Restrictive Trade Practices
8.13.9 Consumer Protection

9. Critical Success Factors
9.1 Research & Development
9.2 New Product Development
9.3 Therapeutic Coverage
9.4 Marketing
9.5 Exports
9.6 Critical Mass
9.7 Low-cost Production
9.8 World-class Practices

10. Future Outlook

LIST OF CHARTS
Figure 1.1: Global pharmaceutical market value (2003-2008)
Figure 1.2: Percentage share of global therapeutic segment (2004-08)
Figure 1.3: Global therapeutic segments percentage market share variation (2004-08)
Figure1.4: Pharmaceutical Industry Structure
Figure 1.5: Therapeutic Segmentation
Figure 1.6: Chronic Segment
Figure 1.7: Acute Segment
Figure 1.8: Indian Bulk Drugs Market (2005-09)
Figure 1.9: Indian Pharmaceutical Market Structure
Figure 1.10: Revenue flow in the Pharmaceutical Market
Figure 1.11: Indian Pharmaceutical Market (2004-2009)
Figure 1.12: Major Therapeutic Segments Contribution Percentage
Figure 1.13: FDI in India Cumulative from Apr'00 to June
Figure 1.14: FDI in Indian Pharma
Figure 1.15: FDI in India by different countries (FY07-FY10)
Figure2.1: Indian Pharmaceutical Exports (FY05-09)
Figure2.2:Region-wise Export data (FY03-08)
Figure3.1: Percentage of population above 65 years
Figure 3.2: Value of products going off patent 2009-12
Figure 3.3: Age-wise Population Distribution
Figure 3.4: Pattern of healthcare expenditure
Figure 6.1: R&D value chain
Figure 6.2: Broad categories in R&D value chain
Figure 6.3: Average time taken for drug discovery
Figure 6.4: FDA-approved manufacturing units in countries other than the US, 2006
Figure 6.5: Global Pharmaceutical Outsourcing Industry
Figure 6.6: Indian Pharmaceutical Outsourcing Market
Figure 6.7: Indian CMO Market by Segment (2008)
Figure 6.8: Indian CRO Market (2008)
Figure 7.1: Global generic market (2004-09)
Figure 7.2: Patent expires by value (2008-12)
Industry Insight - Indian Pharmaceuticals
Figure 7.3: DMF fillings (Global VS India)
Figure 7.4: Country wise DMF filings (2000-08)
Figure 7.5: India ANDA Approvals as % of total approvals (2001-08)
Figure 7.6 ANDA approvals received by Indian players (2001-08)
Figure 8.1: Organisational Chart of Department of Chemical and Petrochemicals
Figure 10.1: Future outlook (FY10-14)