Generic Growth Strategies - Manufacturers to Increase Focus on Super Generics and Biosimilars to Dr

Scope

The scope of this report includes - - Detailed study of generic growth strategies with special emphasis on strategies which help in combating intensive competition. - Analysis of the major strategies adopted by companies looking to expand geographical reach. - Case studies of successful generic growth strategies. - Competitive profiling of leading companies. The key companies studied in this report are Teva, Sandoz, Hospira, Watson, Mylan, Perrigo, STADA, DRL, Par, Apotex and Actavis.

Reasons to buy

The report will enhance your decision making capability. It will allow you to - - Build understanding of the key generic growth strategies in place and the trends in the market - Optimize your R&D pipeline through identification and understanding of the key strategy for your drug. - Identify the key players best positioned to capitalize on their products through effective management of their patented products. - Develop effective business strategies related to generic drugs through the analytical insight gained from case studies covering different strategies in the market. Companies Mentioned

Teva Sandoz Hospira Watson Mylan Perrigo STADA DRL Par Pharma Apotex Lupin Actavis

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

1.1 List of Tables Table 1: Generic Growth Strategies , Notable Patent Expiries Due by 2014 11 Table 2: Generic Growth Strategies, Market Rules for Use of Generic Drugs Across Certain EU Markets 18 Table 3: Generic Growth Strategies, Market Incentives for Use of Generic Drugs Across Certain EU Markets 18 Table 4: Generic Growth Strategies, Notable Authorized Generics by 2010 32 Table 5: Generic Growth Strategies, Strengthening Backward Integration 34 Table 6: Generic Growth Strategies, Biosimilars Approval Pathways in the US and Europe, Patent Expiry for Major Biologic Drugs, 2010-2016 51 Table 7: Generic Growth Strategies, Top Generics Manufacturers by Sales, 2004 and 2009 53

1.2 List of Figures Figure 1: Generic Growth Strategies, Global, Revenues of Top Generic Companies ($m), 2008-2009 6 Figure 2: Generic Growth Strategies, Global, Revenues of Top 10 Drugs due for Patent Expiry ($m), 2010-2014 9 Figure 3: Generic Growth Strategies, Global, Total Value of the Drugs to Lose Patent Protection by 2014, by Therapeutic Segment ($bn) 10 Figure 4: Generic Growth Strategies, ANDA Filings, 2001–2009 12 Figure 5: Generic Growth Strategies, ANDA Approvals, 2005–2010 13 Figure 6: Generic Growth Strategies, Generic Market Share in Selected Countries in Off-patent Drugs Market, 2009 14 Figure 7: Generic Growth Strategies, Top Six Biopharmaceuticals of 2009 – High Biosimilars Market Potential 15 Figure 8: Generic Growth Strategies, Patent Applications by Top 10 Pharmaceutical Patent Applicants at US Patent Office, 1995–2008 16 Figure 9: Generic Growth Strategies, Market Share of Leading Generic Companies, 2009 19 Figure 10: Generic Growth Strategies, Revenue of Top Generic Companies ($m), 2008-2009 20 Figure 11: Generic Growth Strategies, Generic Drug Review Process 21 Figure 12: Generic Growth Strategies, ANDA Patent Certification Types and FDA Approval Processes 22 Figure 13: Generic Growth Strategies, Proportion of LCM Projects in the Late-stage Development Pipeline by Therapeutic Area, 2010 23 Figure 14: Generic Growth Strategies, Comparison of CAGR of R&D Expenditure and Growth of Sales Over the Last Five Years for the Top Five Companies, 2003–2008 25 Figure 15: Generic Growth Strategies, the US, Impact Analysis of Changing Regulatory Landscape, 27 Figure 16: Generic Growth Strategies, Acquisitions by Matrix Labs 35 Figure 17: Generic Growth Strategies, Benefits of Marketing Partnership to Watson and Moksha8 40 Figure 18: Generic Growth Strategies, Contribution to Growth, 2009-2014 43 Figure 19: Generic Growth Strategies, Percentage of Out-of-Pocket Healthcare Financing by Country 44 Figure 20: Generic Growth Strategies, Top Strategies to Expand in Pharmerging Markets 46 Figure 21: Generics Growth Strategies, SWOT Analysis for Teva 54 Figure 22: Generics Growth Strategies, SWOT Analysis for Sandoz 55 Figure 23: Generics Growth Strategies, SWOT Analysis for Hospira 56 Figure 24: Generics Growth Strategies, SWOT Analysis for Watson 57 Figure 25: Generics Growth Strategies, SWOT Analysis for Mylan 58 Figure 26: Generics Growth Strategies, SWOT Analysis for Perrigo 59 Figure 27: Generics Growth Strategies, SWOT Analysis for STADA 60 Figure 28: Generics Growth Strategies, SWOT Analysis for PAR 62 Figure 29: Generics Growth Strategies, SWOT Analysis for Apotex 63 Figure 30: Generics Growth Strategies, SWOT Analysis for Lupin 64 Figure 31: Generics Growth Strategies, SWOT Analysis for Actavis 65 For more information kindly visit : http://www.bharatbook.com/detail.asp?id=192775&rt=Generic-Growth-Strategies-Manufacturers-to-Increase-Focus-on-Super-Generics-and-Biosimilars-to-Drive-Revenues.html

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