Table of Contents
1 Table of Contents 3
1.1 List of Tables 5
1.2 List of Figures 5
2 Generic Growth Strategies: Introduction 6
2.1 GBI Research Report Guidance 7
3 Generic Growth Strategies: Market Overview 8
3.1 Overview of the Generics Market 8
3.2 Patent Expiries – Peak Years 8
3.3 Patent Expiration of Blockbuster Drugs, By Therapeutic Area 10
3.4 Upcoming Patent Expiries 11
3.5 Trends and Issues 11
3.5.1 ANDA Filings and Approvals are on the Rise 11
3.5.2 European Market for Small Molecule Generic Drugs versus Biosimilars 13
3.5.3 Untapped Generics Market in Certain European Countries 14
3.5.4 Biosimilars Focus – Innovators as Well as Generics Companies 15
3.5.5 Drop in Patent Applications by Top Innovator Companies a Cause of Worry for Generics 16
3.5.6 Evergreening Strategies Pose an Issue 17
3.5.7 Market Forces in the European Union 17
4 Generic Growth Strategies: Current Generic Landscape 19
4.1 Generic Industry Structure 19
4.2 Generic Drug Industry Evolution – Changes in the Last 30 Years 20
4.2.1 Stronger Patent Protection 20
4.2.2 Need to Differentiate is Important for Generics Now More Than Ever 20
4.2.3 Hatch-Waxman Act and ANDA 21
4.3 Challenges Facing Generics Industry 23
4.3.1 LCM Strategy Adopted by Innovators to Stay Competitive Poses Challenge to Generics 23
4.3.2 R&D Productivity at a Low for Innovator Companies – Likely to Affect Generics in the Long Run 24
4.4 Reasons to Implement Generic Growth Strategies 26
5 Generic Growth Strategies: Regulatory Landscape with Impact Analysis 27
5.1 The US 27
5.1.1 Shortening Market Exclusivity of Biopharmaceuticals and Impact on Generics 27
5.1.2 ‘Pay-For-Delay’ Ban to be Detrimental to Innovators as Well as Generics 27
5.1.3 Impact of Supplemental Examination Provision of Patent Reform Act on Generics 28
5.1.4 Biologics Price Competition and Innovation Act Falls Short 28
5.2 Europe 29
5.2.1 Common European Union Patent System 29
5.2.2 Tendering 30
5.2.3 Future of Biosimilars Is Advancing Along a Path Smoothened By European Groundwork 30
5.3 Japan 31
6 Generic Growth Strategies: Major Strategies 32
6.1 Authorized Generics 32
6.1.1 Case Study 33
6.2 Mergers and Acquisitions 34
6.2.1 Vertical Integration 34
6.2.2 Therapeutic Expansion – Biosimilars 36
6.2.3 Patent Challenge Access 36
6.2.4 Geographic Expansion and Diversification 37
6.3 Outsourcing 37
6.3.1 Outsourcing Opportunities in Biosimilars 37
6.3.2 Outsourcing is Also a Source of Income to Generic Companies 38
6.3.3 Contract Sales Organizations: Strategic Partnership 39
6.4 Marketing Partnership 40
6.4.1 Case Study 40
6.5 Paragraph IV Certifications 41
6.5.1 Case Study 41
6.5.2 Example of Paragraph IV Challenge That Did Not Work Out for a Generic 42
6.6 Expansion to Pharmerging Markets – Opportunities in BRIC Countries 43
6.6.1 Emerging Markets Pose an Attractive Option for Innovators Going Generic 44
6.6.2 Generic Companies and Innovators Synergize Capabilities to Explore New Territories 45
6.6.3 Case Study 46
6.7 R&D Strategies Employed by Key Players in the Generics Market 47
6.7.1 Super Generics 47
6.7.2 Biosimilars 48
6.7.3 Case Study 52
7 Generic Growth Strategies: Company Portfolio and Strategic Analysis of Leading Generics Players 53
7.1.1 Teva 53
7.1.2 Sandoz 55
7.1.3 Hospira 56
7.1.4 Watson 57
7.1.5 Mylan 58
7.1.6 Perrigo 59
7.1.7 STADA 60
7.1.8 DRL 61
7.1.9 Par Pharma 61
7.1.10 Apotex 63
7.1.11 Lupin 64
7.1.12 Actavis 65
8 Generic Growth Strategies: Appendix 66
8.1 Market Definitions 66
8.2 List of Abbreviations 66
8.3 Research Methodology 67
8.3.1 Coverage 67
8.3.2 Secondary Research 67
8.3.3 Primary Research 68
8.3.4 Expert Panel Validation 68
8.4 Contact Us 68
8.5 Disclaimer 69
8.6 Sources 69