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Introduction
With a number of blockbuster drugs getting off patent in the coming years and increasing R&D costs coupled with low R&D productivity, major pharmaceutical companies worldwide are finding it difficult to maintain their bottom lines. They have taken recourse to outsourcing part of their research and manufacturing activities to lower cost countries, thereby saving costs and time, in the process. This has led to the evolution of Contract Research and Manufacturing Services (CRAMS) as a fast emerging business opportunity for Indian companies

Key findings & highlights

• Growth in contract manufacturing is likely to be driven by increasing outsourcing of latestage and off-patent molecules by big pharma companies to compete with generics.
  
  
• The critical success factors of Indian companies engaged in CRAMS include smooth supply chain management, proper research design etc
  
  
• The top Indian pharmaceutical players are demerging their R&D activities into a separate company, focusing more on new chemical entities and new drug delivery system.
  
  
• India, with its inherent competitive advantages, stands as one of the most preferred outsourcing destinations for a range of activities in the coming years.

Reasons to buy

• Increasing outsourcing of latestage and off-patent molecules
  
  
• Understand the market trends and market size for contract research in India
  
  
• Reveals the critical success factors of Indian companies engaged in CRAMS
  
  
• Spot business opportunities

 
 

Executive Summary

Highlights

1. Introduction

1.1 Contract Research (Cr)

1.2 Contract Manufacturing (Cm)

1.2.1 Generics

1.2.2 Patented Drugs

1.2.3 Intermediates For Nces

1.3 Industry Specific Applications

1.3.1 Pharmaceuticals

1.3.2 Biotechnology

1.3.3 Health Care

1.4 Advantages

1.5 Disadvantages

2. Market Overview

2.1 Characteristics Of The Crams Companies Of India

2.2 Areas Of Government Support Critical To The Company

2.3 R&D Strategies Of Companies In Crams

2.4 Research On Local Disease Conditions

2.5 Emerging Business Strategies

2.6 Fda-Approved Manufacturing Plants In India

2.7 Trips Compliance And Impact On Companies

2.8 Emerging Business Model

2.9 Service Providers In Contract Manufacturing

2.10 Current Market

2.10.1 Pharmaceutical Industry: A Major Player

2.10.2 Market Status

2.10.3 Contract Research

2.10.4 Contract Manufacturing

2.10.5 Contract Research Through Clinical Trials

2.11 Historical Development

2.12 Market Players

2.13 Planning Outsourcing Process

2.14 India-China Emerging Players

2.15 R&D Spin-Off

3. Industrial Applications

3.1 Pharmaceuticals

3.2 Biotechnology

3.3 Data Management

4. Crams Outsourcing

4.1 Introduction

4.2 Market Status

4.3 Outsourcing In Clinical Research

4.4 Reasons For Outsourcing To Cros

4.5 Some Important Outsourcing Activities

5. Growth Drivers

5.1 Arising Need In Pharma Value Chain

5.2 Demand For Nces And Inds

5.3 Need For Speedy And Low Cost R&D

5.4 Patenting Requirements

5.5 Manpower development

5.6 MNCs, leveraging on their Indian subsidiaries for global support

6. ISSUES AND CHALLENGES

6.1 Non-Availability of Skilled Manpower

6.2 Growing global competition

6.3 MNCs opening Captive CROs

6.4 Manufacturing units

6.5 Others

6.6 Competition from China

7. MAJOR PLAYERS

7.1 Introduction

7.2 Indian companies

7.3 Multinational Companies

7.4 Major players foraying areas

7.5 Major players and their CRAMS revenues

7.6 M&A in CRAMS

7.7 Some alliances in CRAMS

8. REGULATORY ISSUES

8.1 Government Regulations

8.1.1 FDA

8.2 Patent Regime

8.2.1 Changes in India's patent regime and access to medicine

8.3 Customs Duty

8.4 GATT/TRIPS/WTO

8.5 Unsafe Drugs

8.6 Industry's Growing Influence over Research

8.7 Academia and Industry - Eroding boundaries

8.8 Regulatory System in India: Government policies

8.8.1 Exemption of Customs Duty

8.8.2 Tax benefit

8.8.3 Role of IACUC

8.9 Regulation of Ethical Issues

8.9.1 Animal-to-Human Transplants: Ethics of Xeno-transplantation

8.9.2 Human Tissue: Ethical and Legal Issues

8.9.3 Clinical Trials without Ethical Review

8.10 Indian Government’s Stand

8.11 Research and Development Regulations

8.12 Government policies

8.12.1 Infrastructural support

8.12.2 Incentives

8.12.3 Single window clearance

9. CRITICAL SUCCESS FACTORS

9.1 Manufacturing/Production

9.1.1 Supply Chain Management

9.1.2 New Product development

9.1.3 Application of E-sourcing

9.2. Research

9.2.1 Infrastructure

9.2.2 Research design

9.2.3 Professionally Trained Manpower

9.2.4 Government Procedures/Sanctions

9.2.5 Data Management

10. FUTURE OUTLOOK

10.1 High expectations, lot of promises

10.2 Manufacturing and Licensing Opportunities

10.3 Mergers and Acquisitions

10.4 Licensed Production

10.5 Marketing Tie-ups

10.6 Budding Research base

10.7 Increasing R&D investment of global pharma companies

10.8 Conclusion

ANNEXURE 1

BIBLIOGRAPHY

ANNEXURE 2

ANNEXURE 3

ANNEXURE 4

AVRA Laboratories Pvt. Ltd.

BioArc Research Solutions

Biocon

Cadila Healthcare

Chembiotek Research International

Dishman Pharmaceuticals and Chemicals Ltd.

Divis Lab

Ind-Swift Laboratories Ltd.

Intas Biopharmaceuticals Ltd

Ipca Laboratories Limited

JB Chemicals and Pharmaceuticals Ltd.

Jubilant Organosys Ltd.

Matrix Laboratories Ltd.

Nicholas Piramal

Orchid Pharmaceuticals

Reliance Research and Development Services

Sai Life Sciences Ltd.

Shashun Chemicals & Drugs Ltd.

Suven Life Sciences Ltd.

Vimta Labs Limited

Wockhardt Ltd

List of Tables

Table 1: Major Business Motives to Outsource

Table 2: CRAMS Areas of Operation

Table 3: Areas of government support

Table 4: Drawbacks in TRIPS compliance

Table 5: Contract Manufacturing deals in India

Table 6: A comparison between India and China

Table 7:R&D spending for Top companies

Table 8: Outsourcing industry partnership analysis

Table 9: Patent expiry dates of some major molecules

Table 10: List of drugs withdrawn from commercial activities

Table 11: Suggestive operational model

List of Figures

Figure 1: Dynamics of Pharmaceutical industry

Figure 2: New molecular entities (NMEs) and biologic license applications approved by the US FDA, 2001-2007

Figure 3: Future estimated R&D cost

Figure 4: Trends in Pharma Industry

Figure 5: Need for CRAMS in Pharma industry

Figure 6: Sourcing opportunity evaluation by pharma companies

Figure 7: Post-2005 R&D strategies of Indian CRAM companies

Figure 8: Research on local disease conditions

Figure 9: Business strategies of Indian companies in CRAM

Figure 10: Number of FDA approved manufacturing units in 2006

Figure 11: Emerging business model

Figure 12: Global Pharmaceutical Outsourcing Industry

Figure 13: Indian Pharmaceutical Outsourcing Market

Figure 14: Segment of Indian Pharma outsourcing market (2006)

Figure 15: Indian CRO market (2006)

Figure 16: Indian CMO market segment (2006)

Figure 17: Big pharma partnering with Indian pharma

Figure 18: Reasons for outsourcing

Figure 19: Global R&D expenditure, development times, global pharmaceutical sales and new molecular entity output 1996-2006

Figure 20: Annual Sales Value for Products Losing Exclusivity

Figure 21: Different aspects of patenting requirements

Figure 22: DMF's Fillings (January 2000-June2007)

Figure 23: Future Market Outlook