Generic Growth Strategies - Market Driven by Impending Patent Cliff, Declining R&D Productivity and Government Initiatives to Reduce Healthcare Costs
Publisher Name » GBI Research
Published Date » 2012-12-14
No. Of Pages » 78
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.
The report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Researchs 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 20132020, 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.
Scope
- 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.
Reasons to buy
- Build understanding of the key generic growth strategies in place and the trends in the market.
- Align your product portfolio to the markets with high growth potential.
- Develop market-entry and market expansion strategies by identifying the potential region and therapeutics market segments poised for strong growth.
- Create a more tailored country strategy through the understanding of key drivers and barriers in the global generics market.
- Optimize your R&D pipeline through the identification and understanding of the key strategy for your drug.
- Identify the key players best positioned to capitalize on their products through the 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.
Table of Contents
4 Generic Growth Strategies - Regulatory Landscape 23
4.1 The US 23
4.1.1 Hatch-Waxman Act and ANDA 23
4.1.2 Shortening Market Exclusivity of Biopharmaceuticals and Impact on Generics 25
4.1.3 Pay-For-Delay Ban to be Detrimental to Innovators as Well as Generics 25
4.1.4 Cost-sharing of Generic Drugs 25
4.1.5 Impact of Supplemental Examination Provision of Patent Reform Act on Generics 26
4.1.6 Biologics Price Competition and Innovation Act Falls Short 26
4.2 Europe 28
4.2.1 Generic Penetration 28
4.2.2 Generic Substitution 29
4.2.3 Pricing and Reimbursement 29
4.2.4 Marketing Authorization for Generics 29
4.2.5 Generic Landscape in Leading European Markets 29
4.2.6 Common European Union Patent System 31
4.2.7 Tendering 32
4.2.8 Regulatory Landscape for Biosimilars 32
4.2.9 The Future of Biosimilars is Advancing Along a Path Smoothened by European Groundwork 32
4.3 Japan 33
4.3.1 Generics 33
4.3.2 Biosimilar 34
5 Generic Growth Strategies - Major Strategies 35
5.1 Authorized Generics 35
5.1.1 Case Study 37
5.2 Mergers and Acquisitions 37
5.2.1 Vertical Integration 39
5.2.2 Therapeutic Expansion - Biosimilars 39
5.3 Outsourcing 40
5.3.1 Outsourcing Opportunities in Biosimilars 40
5.3.2 Outsourcing is Also a Source of Income for Generics Companies 40
5.4 Marketing Partnership 41
5.4.1 Case Studies 41
5.5 Paragraph IV Certifications 42
5.5.1 Case Studies 42
5.5.2 Example of a Paragraph IV Challenge That Did Not Work Out for a Generic 42
5.6 R&D Strategies Employed by Key Players in the Generics Market 43
5.6.1 Super Generics 43
5.6.2 Biosimilars 44
5.7 Increasing Awareness and Acceptance 46
6 Generic Growth Strategies - Competitive Landscape 47
6.1 Teva Pharmaceutical Industries Limited 47
6.1.1 Overview 47
6.1.2 Revenue Analysis 47
6.1.3 Therapeutic Focus 48
6.1.4 Geographic Focus 48
6.1.5 Generic Growth Strategies 48
6.1.6 SWOT 51
6.2 Sandoz 52
6.2.1 Overview 52
6.2.2 Revenue Analysis 52
6.2.3 Therapeutic Focus 52
6.2.4 Geographic Focus 52
6.2.5 Generic Growth Strategies 53
6.2.6 SWOT 54
6.3 Mylan 55
6.3.1 Overview 55
6.3.2 Revenue Analysis 55
6.3.3 Therapeutic Focus 55
6.3.4 Geographic Focus 55
6.3.5 Generic Growth Strategies 57
6.3.6 SWOT 58
6.4 Watson 59
6.4.1 Overview 59
6.4.2 Revenue Analysis 59
6.4.3 Therapeutic Focus 59
6.4.4 Geographic Focus 59
6.4.5 Generic Growth Strategies 60
6.4.6 SWOT 61
6.5 Actavis 62
6.5.1 Overview 62
6.5.2 Revenue Analysis 62
6.5.3 Therapeutic Focus 62
6.5.4 Geographic Focus 62
6.5.5 Generic Growth Strategies 62
6.5.6 SWOT 63
6.6 Hospira 64
6.6.1 Overview 64
6.6.2 Revenue Analysis 64
6.6.3 Therapeutic Focus 64
6.6.4 Geographic Focus 64
6.6.5 Generic Growth Strategies 65
6.6.6 SWOT 66
6.7 Sanofi 67
6.7.1 Overview 67
6.7.2 Revenue Analysis 67
6.7.3 Geographic Focus 67
6.7.4 Generic Growth Strategies 67
6.7.5 SWOT 68
6.8 Daiichi Sankyo 68
6.8.1 Overview 68
6.8.2 Revenue Analysis 68
6.8.3 Geographic Focus 68
6.8.4 Generic Growth Strategies 68
6.8.5 SWOT 69
6.9 Aspen 69
6.9.1 Overview 69
6.9.2 Revenue Analysis 69
6.9.3 Geographic Focus 69
6.9.4 Generic Growth Strategies 70
6.9.5 SWOT 70
6.10 STADA 71
6.10.1 Overview 71
6.10.2 Revenue Analysis 71
6.10.3 Therapeutic Focus 71
6.10.4 Geographic Focus 71
6.10.5 Generic Growth Strategies 72
6.10.6 SWOT 72
Table 1: Generic Growth Strategies, Global, Revenues of Leading Generic Companies ($bn), 2010-2011 13
Table 2: Generic Growth Strategies, Global, Revenues of Major Drugs Due for Patent Expiry ($m), 2013-2020 17
Table 3: Generic Growth Strategies, Number of Generic ANDA Filed and Approvals, 2006-2011 18
Table 4: Generic Growth Strategies, ANDA Approvals by Month, The US, 2011-2012 19
Table 5: Generic Growth Strategies, Number of EMA Authorized Generics, Europe, 2007-2012 20
Table 6: Generic Growth Strategies, Number of Biosimilars Authorized by the EMA, Europe, 2006-2012 22
Table 7: Generic Growth Strategies, The US, Generic Drug Cost-Sharing (%), 2011-2020 26
Table 8: Generic Growth Strategies, Notable Authorized Generics Entry, The US, 2010-2012 35
Table 9: Generic Growth Strategies, Generic Products Launched, Teva, The US, 2011 49
Table 10: Generic Growth Strategies, Top Five Generic Active Ingredients, STADA Group, Revenue ($m), 2011 71
Figure 1: Generic Growth Strategies, Global, Revenues of Leading Generic Companies ($bn), 2010-2011 13
Figure 2: Generic Growth Strategies, Generic Market Share in Selected Countries, 2010 14
Figure 3: Generic Growth Strategies, Drivers and Restraints, 2012 15
Figure 4: Generic Growth Strategies, Global, Revenues of Top 10 Drugs Due for Patent Expiry ($m), 2013-2020 16
Figure 5: Generic Growth Strategies, Number of Generic ANDA Filed and Approvals, 2006-2011 18
Figure 6: Generic Growth Strategies, ANDA Approvals by Month, The US, 2011-2012 19
Figure 7: Generic Growth Strategies, Number of EMA Authorized Generics, Europe, 2007-2012 20
Figure 8: Generic Growth Strategies, Number of Biosimilars Authorized by the EMA, Europe, 2006-2012 22
Figure 9: Generic Growth Strategies, The US, Generic Drug Cost-Sharing (%), 2011-2020 25
Figure 10: Generic Growth Strategies, SWOT Analysis, Teva, 2012 51
Figure 11: Generic Growth Strategies, SWOT Analysis, Sandoz, 2012 54
Figure 12: Generic Growth Strategies, SWOT Analysis, Mylan, 2012 58
Figure 13: Generic Growth Strategies, SWOT Analysis, Watson, 2012 61
Figure 14: Generic Growth Strategies, SWOT Analysis, Actavis, 2012 63
Figure 15: Generic Growth Strategies, SWOT Analysis, Hospira, 2012 66
Figure 16: Generic Growth Strategies, SWOT Analysis, Sanofi, 2012 68
Figure 17: Generic Growth Strategies, SWOT Analysis, Daiichi Sankyo, 2012 69
Figure 18: Generic Growth Strategies, SWOT Analysis, Aspen, 2012 70
Figure 19: Generic Growth Strategies, SWOT Analysis, STADA Arzneimittel AG, 2012 72
1 Table of Contents
1 Table of Contents 7
1.1 List of Tables 10
1.2 List of Figures 10
1 Table of Contents 7
1.1 List of Tables 10
1.2 List of Figures 10
2 Generic Growth Strategies - Introduction 11
3 Generic Growth Strategies - Market Overview 12
3.1 Overview of the Generics Market 12
3.1.1 Leading Generics Companies 12
3.1.2 Generics Market Share 14
3.2 Drivers and Restraints 15
3.2.1 Drivers 16
3.2.2 Restraints 21
3.1 Overview of the Generics Market 12
3.1.1 Leading Generics Companies 12
3.1.2 Generics Market Share 14
3.2 Drivers and Restraints 15
3.2.1 Drivers 16
3.2.2 Restraints 21
4 Generic Growth Strategies - Regulatory Landscape 23
4.1 The US 23
4.1.1 Hatch-Waxman Act and ANDA 23
4.1.2 Shortening Market Exclusivity of Biopharmaceuticals and Impact on Generics 25
4.1.3 Pay-For-Delay Ban to be Detrimental to Innovators as Well as Generics 25
4.1.4 Cost-sharing of Generic Drugs 25
4.1.5 Impact of Supplemental Examination Provision of Patent Reform Act on Generics 26
4.1.6 Biologics Price Competition and Innovation Act Falls Short 26
4.2 Europe 28
4.2.1 Generic Penetration 28
4.2.2 Generic Substitution 29
4.2.3 Pricing and Reimbursement 29
4.2.4 Marketing Authorization for Generics 29
4.2.5 Generic Landscape in Leading European Markets 29
4.2.6 Common European Union Patent System 31
4.2.7 Tendering 32
4.2.8 Regulatory Landscape for Biosimilars 32
4.2.9 The Future of Biosimilars is Advancing Along a Path Smoothened by European Groundwork 32
4.3 Japan 33
4.3.1 Generics 33
4.3.2 Biosimilar 34
5 Generic Growth Strategies - Major Strategies 35
5.1 Authorized Generics 35
5.1.1 Case Study 37
5.2 Mergers and Acquisitions 37
5.2.1 Vertical Integration 39
5.2.2 Therapeutic Expansion - Biosimilars 39
5.3 Outsourcing 40
5.3.1 Outsourcing Opportunities in Biosimilars 40
5.3.2 Outsourcing is Also a Source of Income for Generics Companies 40
5.4 Marketing Partnership 41
5.4.1 Case Studies 41
5.5 Paragraph IV Certifications 42
5.5.1 Case Studies 42
5.5.2 Example of a Paragraph IV Challenge That Did Not Work Out for a Generic 42
5.6 R&D Strategies Employed by Key Players in the Generics Market 43
5.6.1 Super Generics 43
5.6.2 Biosimilars 44
5.7 Increasing Awareness and Acceptance 46
6 Generic Growth Strategies - Competitive Landscape 47
6.1 Teva Pharmaceutical Industries Limited 47
6.1.1 Overview 47
6.1.2 Revenue Analysis 47
6.1.3 Therapeutic Focus 48
6.1.4 Geographic Focus 48
6.1.5 Generic Growth Strategies 48
6.1.6 SWOT 51
6.2 Sandoz 52
6.2.1 Overview 52
6.2.2 Revenue Analysis 52
6.2.3 Therapeutic Focus 52
6.2.4 Geographic Focus 52
6.2.5 Generic Growth Strategies 53
6.2.6 SWOT 54
6.3 Mylan 55
6.3.1 Overview 55
6.3.2 Revenue Analysis 55
6.3.3 Therapeutic Focus 55
6.3.4 Geographic Focus 55
6.3.5 Generic Growth Strategies 57
6.3.6 SWOT 58
6.4 Watson 59
6.4.1 Overview 59
6.4.2 Revenue Analysis 59
6.4.3 Therapeutic Focus 59
6.4.4 Geographic Focus 59
6.4.5 Generic Growth Strategies 60
6.4.6 SWOT 61
6.5 Actavis 62
6.5.1 Overview 62
6.5.2 Revenue Analysis 62
6.5.3 Therapeutic Focus 62
6.5.4 Geographic Focus 62
6.5.5 Generic Growth Strategies 62
6.5.6 SWOT 63
6.6 Hospira 64
6.6.1 Overview 64
6.6.2 Revenue Analysis 64
6.6.3 Therapeutic Focus 64
6.6.4 Geographic Focus 64
6.6.5 Generic Growth Strategies 65
6.6.6 SWOT 66
6.7 Sanofi 67
6.7.1 Overview 67
6.7.2 Revenue Analysis 67
6.7.3 Geographic Focus 67
6.7.4 Generic Growth Strategies 67
6.7.5 SWOT 68
6.8 Daiichi Sankyo 68
6.8.1 Overview 68
6.8.2 Revenue Analysis 68
6.8.3 Geographic Focus 68
6.8.4 Generic Growth Strategies 68
6.8.5 SWOT 69
6.9 Aspen 69
6.9.1 Overview 69
6.9.2 Revenue Analysis 69
6.9.3 Geographic Focus 69
6.9.4 Generic Growth Strategies 70
6.9.5 SWOT 70
6.10 STADA 71
6.10.1 Overview 71
6.10.2 Revenue Analysis 71
6.10.3 Therapeutic Focus 71
6.10.4 Geographic Focus 71
6.10.5 Generic Growth Strategies 72
6.10.6 SWOT 72
7 Generic Growth Strategies - Conclusion 73
8 Generic Growth Strategies - Appendix 74
8.1 Market Definitions 74
8.2 Abbreviations 74
8.3 Bibliography 75
8.4 Research Methodology 77
8.4.1 Coverage 77
8.4.2 Secondary Research 77
8.4.3 Primary Research 78
8.4.4 Expert Panel Validation 78
8.5 Contact Us 78
8.6 Disclaimer 78
8.1 Market Definitions 74
8.2 Abbreviations 74
8.3 Bibliography 75
8.4 Research Methodology 77
8.4.1 Coverage 77
8.4.2 Secondary Research 77
8.4.3 Primary Research 78
8.4.4 Expert Panel Validation 78
8.5 Contact Us 78
8.6 Disclaimer 78
List of Tables
Table 1: Generic Growth Strategies, Global, Revenues of Leading Generic Companies ($bn), 2010-2011 13
Table 2: Generic Growth Strategies, Global, Revenues of Major Drugs Due for Patent Expiry ($m), 2013-2020 17
Table 3: Generic Growth Strategies, Number of Generic ANDA Filed and Approvals, 2006-2011 18
Table 4: Generic Growth Strategies, ANDA Approvals by Month, The US, 2011-2012 19
Table 5: Generic Growth Strategies, Number of EMA Authorized Generics, Europe, 2007-2012 20
Table 6: Generic Growth Strategies, Number of Biosimilars Authorized by the EMA, Europe, 2006-2012 22
Table 7: Generic Growth Strategies, The US, Generic Drug Cost-Sharing (%), 2011-2020 26
Table 8: Generic Growth Strategies, Notable Authorized Generics Entry, The US, 2010-2012 35
Table 9: Generic Growth Strategies, Generic Products Launched, Teva, The US, 2011 49
Table 10: Generic Growth Strategies, Top Five Generic Active Ingredients, STADA Group, Revenue ($m), 2011 71
List of Figures
Figure 1: Generic Growth Strategies, Global, Revenues of Leading Generic Companies ($bn), 2010-2011 13
Figure 2: Generic Growth Strategies, Generic Market Share in Selected Countries, 2010 14
Figure 3: Generic Growth Strategies, Drivers and Restraints, 2012 15
Figure 4: Generic Growth Strategies, Global, Revenues of Top 10 Drugs Due for Patent Expiry ($m), 2013-2020 16
Figure 5: Generic Growth Strategies, Number of Generic ANDA Filed and Approvals, 2006-2011 18
Figure 6: Generic Growth Strategies, ANDA Approvals by Month, The US, 2011-2012 19
Figure 7: Generic Growth Strategies, Number of EMA Authorized Generics, Europe, 2007-2012 20
Figure 8: Generic Growth Strategies, Number of Biosimilars Authorized by the EMA, Europe, 2006-2012 22
Figure 9: Generic Growth Strategies, The US, Generic Drug Cost-Sharing (%), 2011-2020 25
Figure 10: Generic Growth Strategies, SWOT Analysis, Teva, 2012 51
Figure 11: Generic Growth Strategies, SWOT Analysis, Sandoz, 2012 54
Figure 12: Generic Growth Strategies, SWOT Analysis, Mylan, 2012 58
Figure 13: Generic Growth Strategies, SWOT Analysis, Watson, 2012 61
Figure 14: Generic Growth Strategies, SWOT Analysis, Actavis, 2012 63
Figure 15: Generic Growth Strategies, SWOT Analysis, Hospira, 2012 66
Figure 16: Generic Growth Strategies, SWOT Analysis, Sanofi, 2012 68
Figure 17: Generic Growth Strategies, SWOT Analysis, Daiichi Sankyo, 2012 69
Figure 18: Generic Growth Strategies, SWOT Analysis, Aspen, 2012 70
Figure 19: Generic Growth Strategies, SWOT Analysis, STADA Arzneimittel AG, 2012 72
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