Impact of Patent Expiry on Global Generic Drugs Market - Trends, Opportunities and Challenges Post 2011
- Published: January 2012
- Region: Global
Generic Growth Strategies - Market Driven by Impending Patent Cliff, Declining R&D Productivity and Government Initiatives to Reduce Healthcare Costs
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.
The 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.
The global generics market generated revenues of approximately $162 billion with a growth of 9.3% in 2011, representing about 19% of generic market share in the international pharmaceutical market. The generic pharmaceutical industry is significantly fragmented; the top 10 pharmaceutical companies accounted for 26% of global generics sales by value in 2011. The US has very high levels of generic utilization, with nearly 80% of prescriptions dispensed being generics.
The pharmaceutical industry will experience major patent expiries during 2013–2020, of which 2014 to 2017 are expected to be peak years, with the loss of patents for drugs whose sales were worth more than $76 billion during 2011. By 2015, branded products with sales of up to $135 billion will go off-patent, giving generic pharmaceutical companies immense opportunities to capitalize on the market. Along with generic drugs, pharmaceutical companies will also have the opportunity to develop biosimilars, as biologics with 2011 sales of approximately $64 billion will go off-patent over the next five years.
- 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.
- Analysis of the generic pharmaceutical market in the leading geographies of the world, which includes the US, the UK, Germany, France, Italy, Spain, and Japan.
- Key drivers and barriers that have a significant impact on the market.
- Competitive benchmarking of leading companies. Key companies studied in this report are Teva, Sandoz, Mylan, Watson, Actavis, Hospira, Sanofi, Daiichi Sankyo, Aspen and STADA.
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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
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
4.2.1 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
4.2.8 Regulatory Landscape for Biosimilars
4.2.9 The Future of Biosimilars is Advancing Along a Path Smoothened by European Groundwork
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
5.3.1 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
5.7 Increasing Awareness and Acceptance
6 Generic Growth Strategies - Competitive Landscape
6.1 Teva Pharmaceutical Industries Limited
6.1.2 Revenue Analysis
6.1.3 Therapeutic Focus
6.1.4 Geographic Focus
6.1.5 Generic Growth Strategies
6.2.2 Revenue Analysis
6.2.3 Therapeutic Focus
6.2.4 Geographic Focus
6.2.5 Generic Growth Strategies
6.3.2 Revenue Analysis
6.3.3 Therapeutic Focus
6.3.4 Geographic Focus
6.3.5 Generic Growth Strategies
6.4.2 Revenue Analysis
6.4.3 Therapeutic Focus
6.4.4 Geographic Focus
6.4.5 Generic Growth Strategies
6.5.2 Revenue Analysis
6.5.3 Therapeutic Focus
6.5.4 Geographic Focus
6.5.5 Generic Growth Strategies
6.6.2 Revenue Analysis
6.6.3 Therapeutic Focus
6.6.4 Geographic Focus
6.6.5 Generic Growth Strategies
6.7.2 Revenue Analysis
6.7.3 Geographic Focus
6.7.4 Generic Growth Strategies
6.8 Daiichi Sankyo
6.8.2 Revenue Analysis
6.8.3 Geographic Focus
6.8.4 Generic Growth Strategies
6.9.2 Revenue Analysis
6.9.3 Geographic Focus
6.9.4 Generic Growth Strategies
6.10.2 Revenue Analysis
6.10.3 Therapeutic Focus
6.10.4 Geographic Focus
6.10.5 Generic Growth Strategies
7 Generic Growth Strategies - Conclusion
8 Generic Growth Strategies - Appendix
8.1 Market Definitions
8.4 Research Methodology
8.4.2 Secondary Research
8.4.3 Primary Research
8.4.4 Expert Panel Validation
8.5 Contact Us
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
- Daiichi Sankyo