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Generic Growth Strategies - Market Driven by Impending Patent Cliff, Declining R&D Productivity and Government Initiatives to Reduce Healthcare Costs

  • Published: Dec-2012
  • Report Code: GBIHC263MR
  • Report Format: pdf

Description

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Generic Growth Strategies: Executive Summary

2.1 Leading Generic Companies Resort to Multiple Strategies for Growth

2.2 Difficult-to-Reproduce Generics Being Developed to Beat Competition

2.3 Opportunities Worth More than $100 billion in Generics and Biosimilars

2.4 Significant Increase in ANDA Applications and Approvals

2.5 Government Initiatives for Generics Strengthen as Healthcare Costs Increase

3 Generic Growth Strategies: Introduction

3.1 GBI Research Report Guidance

4 Generic Growth Strategies: Market Overview

4.1 Overview of the Generics Market

4.1.1 Leading Generics Companies

4.1.2 Generics Market Share

4.2 Drivers and Restraints

4.2.1 Drivers

4.2.2 Restraints

5 Generic Growth Strategies: Regulatory Landscape

5.1 The US

5.1.1 Hatch-Waxman Act and ANDA

5.1.2 Shortening Market Exclusivity of Biopharmaceuticals and Impact on Generics

5.1.3 ‘Pay-For-Delay’ Ban to be Detrimental to Innovators as Well as Generics

5.1.4 Cost-sharing of Generic Drugs

5.1.5 Impact of Supplemental Examination Provision of Patent Reform Act on Generics

5.1.6 Biologics Price Competition and Innovation Act Falls Short

5.2 Europe

5.2.1 Generic Penetration

5.2.2 Generic Substitution

5.2.3 Pricing and Reimbursement

5.2.4 Marketing Authorization for Generics

5.2.5 Generic Landscape in Leading European Markets

5.2.6 Common European Union Patent System

5.2.7 Tendering

5.2.8 Regulatory Landscape for Biosimilars

5.2.9 The Future of Biosimilars is Advancing Along a Path Smoothened by European Groundwork

5.3 Japan

5.3.1 Generics

5.3.2 Biosimilar

6 Generic Growth Strategies: Major Strategies

6.1 Authorized Generics

6.1.1 Case Study

6.2 Mergers and Acquisitions

6.2.1 Vertical Integration

6.2.2 Therapeutic Expansion – Biosimilars

6.3 Outsourcing

6.3.1 Outsourcing Opportunities in Biosimilars

6.3.2 Outsourcing is Also a Source of Income for Generics Companies

6.4 Marketing Partnership

6.4.1 Case Studies

6.5 Paragraph IV Certifications

6.5.1 Case Studies

6.5.2 Example of a Paragraph IV Challenge That Did Not Work Out for a Generic

6.6 R&D Strategies Employed by Key Players in the Generics Market

6.6.1 Super Generics

6.6.2 Biosimilars

6.7 Increasing Awareness and Acceptance

7 Generic Growth Strategies: Competitive Landscape

7.1 Teva Pharmaceutical Industries Limited

7.1.1 Overview

7.1.2 Revenue Analysis

7.1.3 Therapeutic Focus

7.1.4 Geographic Focus

7.1.5 Generic Growth Strategies

7.1.6 SWOT

7.2 Sandoz

7.2.1 Overview

7.2.2 Revenue Analysis

7.2.3 Therapeutic Focus

7.2.4 Geographic Focus

7.2.5 Generic Growth Strategies

7.2.6 SWOT

7.3 Mylan

7.3.1 Overview

7.3.2 Revenue Analysis

7.3.3 Therapeutic Focus

7.3.4 Geographic Focus

7.3.5 Generic Growth Strategies

7.3.6 SWOT

7.4 Watson

7.4.1 Overview

7.4.2 Revenue Analysis

7.4.3 Therapeutic Focus

7.4.4 Geographic Focus

7.4.5 Generic Growth Strategies

7.4.6 SWOT

7.5 Actavis

7.5.1 Overview

7.5.2 Revenue Analysis

7.5.3 Therapeutic Focus

7.5.4 Geographic Focus

7.5.5 Generic Growth Strategies

7.5.6 SWOT

7.6 Hospira

7.6.1 Overview

7.6.2 Revenue Analysis

7.6.3 Therapeutic Focus

7.6.4 Geographic Focus

7.6.5 Generic Growth Strategies

7.6.6 SWOT

7.7 Sanofi

7.7.1 Overview

7.7.2 Revenue Analysis

7.7.3 Geographic Focus

7.7.4 Generic Growth Strategies

7.7.5 SWOT

7.8 Daiichi Sankyo

7.8.1 Overview

7.8.2 Revenue Analysis

7.8.3 Geographic Focus

7.8.4 Generic Growth Strategies

7.8.5 SWOT

7.9 Aspen

7.9.1 Overview

7.9.2 Revenue Analysis

7.9.3 Geographic Focus

7.9.4 Generic Growth Strategies

7.9.5 SWOT

7.10 STADA

7.10.1 Overview

7.10.2 Revenue Analysis

7.10.3 Therapeutic Focus

7.10.4 Geographic Focus

7.10.5 Generic Growth Strategies

7.10.6 SWOT

8 Generic Growth Strategies: Conclusion

9 Generic Growth Strategies: Appendix

9.1 Market Definitions

9.2 Abbreviations

9.3 Bibliography

9.4 Research Methodology

9.4.1 Coverage

9.4.2 Secondary Research

9.4.3 Primary Research

9.4.4 Expert Panel Validation

9.5 Contact Us

9.6 Disclaimer

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