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

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

  • Published: December 2012
  • Region: Global
  • 78 Pages
  • GBI Research

FEATURED COMPANIES

  • Actavis
  • Aspen
  • Daiichi Sankyo
  • Hospira
  • Mylan
  • Sandoz
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Generic Growth Strategies - Market Driven by Impending Patent Cliff, Declining R&D Productivity and Government Initiatives to Reduce Healthcare Costs

Summary

GBI Research, the leading business intelligence provider, has released its latest research, “Generic Growth Strategies - Market Driven by Impending Patent Cliff, Declining R&D Productivity and Government Initiatives to Reduce Healthcare Costs”. The report provides a comprehensive overview of the generic drugs market in the US, the top five countries in the European Union (EU, covering the UK, France, Germany, Spain and Italy) and Japan. The report focuses on the detailed analysis of major strategies implemented by the top 10 generic companies in the generic drugs market along with company portfolios and strategic analysis. The report gives detail on the current landscape and changes that have structured the generic drugs market. The report also contains an impact analysis of the regulatory landscape in the major geographies pertaining to the generic drugs market. The report also provides in-depth analysis of the unmet needs, drivers and barriers that affect the global generics market.

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1 Table of Contents
1 Table of Contents
1.1 List of Tables
1.2 List of Figures

2 Generic Growth Strategies - Introduction

3 Generic Growth Strategies - Market Overview
3.1 Overview of the Generics Market
3.1.1 Leading Generics Companies
3.1.2 Generics Market Share
3.2 Drivers and Restraints
3.2.1 Drivers
3.2.2 Restraints

4 Generic Growth Strategies - Regulatory Landscape
4.1 The US
4.1.1 Hatch-Waxman Act and ANDA
4.1.2 Shortening Market Exclusivity of Biopharmaceuticals and Impact on Generics
4.1.3 ‘Pay-For-Delay' Ban to be Detrimental to Innovators as Well as Generics
4.1.4 Cost-sharing of Generic Drugs
4.1.5 Impact of Supplemental Examination Provision of Patent Reform Act on Generics
4.1.6 Biologics Price Competition and Innovation Act Falls Short
4.2 Europe
4.2.1 Generic Penetration
4.2.2 Generic Substitution
4.2.3 Pricing and Reimbursement
4.2.4 Marketing Authorization for Generics
4.2.5 Generic Landscape in Leading European Markets
4.2.6 Common European Union Patent System
4.2.7 Tendering
4.2.8 Regulatory Landscape for Biosimilars
4.2.9 The Future of Biosimilars is Advancing Along a Path Smoothened by European Groundwork
4.3 Japan
4.3.1 Generics
4.3.2 Biosimilar

5 Generic Growth Strategies - Major Strategies
5.1 Authorized Generics
5.1.1 Case Study
5.2 Mergers and Acquisitions
5.2.1 Vertical Integration
5.2.2 Therapeutic Expansion - Biosimilars
5.3 Outsourcing
5.3.1 Outsourcing Opportunities in Biosimilars
5.3.2 Outsourcing is Also a Source of Income for Generics Companies
5.4 Marketing Partnership
5.4.1 Case Studies
5.5 Paragraph IV Certifications
5.5.1 Case Studies
5.5.2 Example of a Paragraph IV Challenge That Did Not Work Out for a Generic
5.6 R&D Strategies Employed by Key Players in the Generics Market
5.6.1 Super Generics
5.6.2 Biosimilars
5.7 Increasing Awareness and Acceptance

6 Generic Growth Strategies - Competitive Landscape
6.1 Teva Pharmaceutical Industries Limited
6.1.1 Overview
6.1.2 Revenue Analysis
6.1.3 Therapeutic Focus
6.1.4 Geographic Focus
6.1.5 Generic Growth Strategies
6.1.6 SWOT
6.2 Sandoz
6.2.1 Overview
6.2.2 Revenue Analysis
6.2.3 Therapeutic Focus
6.2.4 Geographic Focus
6.2.5 Generic Growth Strategies
6.2.6 SWOT
6.3 Mylan
6.3.1 Overview
6.3.2 Revenue Analysis
6.3.3 Therapeutic Focus
6.3.4 Geographic Focus
6.3.5 Generic Growth Strategies
6.3.6 SWOT
6.4 Watson
6.4.1 Overview
6.4.2 Revenue Analysis
6.4.3 Therapeutic Focus
6.4.4 Geographic Focus
6.4.5 Generic Growth Strategies
6.4.6 SWOT
6.5 Actavis
6.5.1 Overview
6.5.2 Revenue Analysis
6.5.3 Therapeutic Focus
6.5.4 Geographic Focus
6.5.5 Generic Growth Strategies
6.5.6 SWOT
6.6 Hospira
6.6.1 Overview
6.6.2 Revenue Analysis
6.6.3 Therapeutic Focus
6.6.4 Geographic Focus
6.6.5 Generic Growth Strategies
6.6.6 SWOT
6.7 Sanofi
6.7.1 Overview
6.7.2 Revenue Analysis
6.7.3 Geographic Focus
6.7.4 Generic Growth Strategies
6.7.5 SWOT
6.8 Daiichi Sankyo
6.8.1 Overview
6.8.2 Revenue Analysis
6.8.3 Geographic Focus
6.8.4 Generic Growth Strategies
6.8.5 SWOT
6.9 Aspen
6.9.1 Overview
6.9.2 Revenue Analysis
6.9.3 Geographic Focus
6.9.4 Generic Growth Strategies
6.9.5 SWOT
6.10 STADA
6.10.1 Overview
6.10.2 Revenue Analysis
6.10.3 Therapeutic Focus
6.10.4 Geographic Focus
6.10.5 Generic Growth Strategies
6.10.6 SWOT

7 Generic Growth Strategies - Conclusion

8 Generic Growth Strategies - Appendix
8.1 Market Definitions
8.2 Abbreviations
8.3 Bibliography
8.4 Research Methodology
8.4.1 Coverage
8.4.2 Secondary Research
8.4.3 Primary Research
8.4.4 Expert Panel Validation
8.5 Contact Us
8.6 Disclaimer

1.1 List of Tables

Table 1: Generic Growth Strategies, Global, Revenues of Leading Generic Companies ($bn), 2010-2011
Table 2: Generic Growth Strategies, Global, Revenues of Major Drugs Due for Patent Expiry ($m), 2013-2020
Table 3: Generic Growth Strategies, Number of Generic ANDA Filed and Approvals, 2006-2011
Table 4: Generic Growth Strategies, ANDA Approvals by Month, The US, 2011-2012
Table 5: Generic Growth Strategies, Number of EMA Authorized Generics, Europe, 2007-2012
Table 6: Generic Growth Strategies, Number of Biosimilars Authorized by the EMA, Europe, 2006-2012
Table 7: Generic Growth Strategies, The US, Generic Drug Cost-Sharing (%), 2011-2020
Table 8: Generic Growth Strategies, Notable Authorized Generics Entry, The US, 2010-2012
Table 9: Generic Growth Strategies, Generic Products Launched, Teva, The US, 2011
Table 10: Generic Growth Strategies, Top Five Generic Active Ingredients, STADA Group, Revenue ($m), 2011

1.2 List of Figures

Figure 1: Generic Growth Strategies, Global, Revenues of Leading Generic Companies ($bn), 2010-2011
Figure 2: Generic Growth Strategies, Generic Market Share in Selected Countries, 2010
Figure 3: Generic Growth Strategies, Drivers and Restraints, 2012
Figure 4: Generic Growth Strategies, Global, Revenues of Top 10 Drugs Due for Patent Expiry ($m), 2013-2020
Figure 5: Generic Growth Strategies, Number of Generic ANDA Filed and Approvals, 2006-2011
Figure 6: Generic Growth Strategies, ANDA Approvals by Month, The US, 2011-2012
Figure 7: Generic Growth Strategies, Number of EMA Authorized Generics, Europe, 2007-2012
Figure 8: Generic Growth Strategies, Number of Biosimilars Authorized by the EMA, Europe, 2006-2012
Figure 9: Generic Growth Strategies, The US, Generic Drug Cost-Sharing (%), 2011-2020
Figure 10: Generic Growth Strategies, SWOT Analysis, Teva, 2012
Figure 11: Generic Growth Strategies, SWOT Analysis, Sandoz, 2012
Figure 12: Generic Growth Strategies, SWOT Analysis, Mylan, 2012
Figure 13: Generic Growth Strategies, SWOT Analysis, Watson, 2012
Figure 14: Generic Growth Strategies, SWOT Analysis, Actavis, 2012
Figure 15: Generic Growth Strategies, SWOT Analysis, Hospira, 2012
Figure 16: Generic Growth Strategies, SWOT Analysis, Sanofi, 2012
Figure 17: Generic Growth Strategies, SWOT Analysis, Daiichi Sankyo, 2012
Figure 18: Generic Growth Strategies, SWOT Analysis, Aspen, 2012
Figure 19: Generic Growth Strategies, SWOT Analysis, STADA Arzneimittel AG, 2012

Generic Giants Strategize to Exploit Massive Patent Cliff Potential

Huge rewards and strong competition are prompting generic drug manufacturers to closely examine the best way to maximize market share as the industry patent cliff approaches its peak, states a new report from business intelligence analysts GBI Research.

According to the firm’s latest report*, the revenues of drugs subject to patent expiration between 2013 and 2020 are valued at over US$100 billion, offering producers of generics and biosimilars a fantastic opportunity to substantially bolster their own sales.

However, while the next few years hold great promise for these companies, fierce competition exists not only from rival generics manufacturers, but also from major pharmaceutical players looking to maintain market dominance with ‘Authorized Generics’ (AG). In response, generics firms are re-evaluating their approach to the market.

GBI Research states that companies such as Hospira are reaching out to new locales in order to build a global presence, while targeting governments looking to bring down healthcare costs. Exploiting pharmaceutically underdeveloped economies may allow generics firms to launch products first, challenging the intellectual property of proprietary pharmaceutical majors.

Generics producers also hope to capitalize on expiring patents by manufacturing complex generics that are difficult to reproduce. These “super generics” have high barriers to entry, a greater price than most other generics and incur greater Research and Development (R&D) costs; however, there is significant potential for super generics within specific therapeutic areas, such as cancer and conditions involving the central nervous system.

GBI Research expects demand for high-quality generics to increase in the future, as key drugs lose patent protection and governments are offered opportunities to provide vital treatments at significantly reduced costs.

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

This report provides a comprehensive overview of the generic drugs market in the US, the top five countries in the European Union (EU, covering the UK, France, Germany, Spain and Italy) and Japan.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research’s team of industry experts.

- Teva Pharmaceutical Industries Limited
- Sandoz
- Mylan
- Watson
- Actavis
- Hospira
- Sanofi
- Daiichi Sankyo
- Aspen
- STADA

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