Generic Growth Strategies - Manufacturers to Increase Focus on Super Generics and Biosimilars to Drive Revenues
GBI Research has released its research “Generic Growth Strategies - Manufacturers to Increase Focus on Super Generics and Biosimilars to Drive Revenues”.Source: Generic Growth Strategies MarketIt provides a comprehensive overview of the generic drugs market, analysis of upcoming noteworthy patent expirations, and trends and issues facing the generics market. The report delves into much detail on the current landscape; changes that have structured the generic drugs market in the last 30 years; and the reason behind the players’ urgency in developing and implementing generic growth strategies. The report also contains impact analysis of the regulatory landscape in the major geographies pertaining to the generic drugs market. Major strategies adopted by the leading companies in the generic drugs market have been analyzed in much detail, along with an elaborate company portfolio and strategic analysis of leading generic players. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts. GBI Research has found that the pharmaceutical industry in general and the generics sector in particular have turned out to be highly competitive of late. There is rampant consolidation; novel business models are developing, such as hybrid models between generic and innovator companies; and generics companies partnering with third-party sales teams to increase growth. The benefits from these partnerships are wide ranging for the generics companies, from higher access to research and development capabilities and innovator drugs’ access to wider penetration in new markets.
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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.
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.
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
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
