Table of Contents
1 Table of Contents 3
1.1 List of Tables 6
1.2 List of Figures 6
2 Introduction 8
2.1 What are Generic Drugs? 8
2.1.1 Generic Drugs by Type 9
2.2 The Global Generic Drugs Market 9
2.2.1 Will the US Continue to Dominate the Global Generic Drugs Market? 9
2.3 Therapy Areas with Highest Levels of Genericization, 2016–2021 10
2.4 Entry Strategies for Generic Drugs 11
3 Generic Drugs Market: Drivers and Restraints 13
3.1 Factors Driving the Global Generic Drugs Market 15
3.1.1 The Patent Cliff is a Key Driver of Growth for Generic Drugs 15
3.1.2 Recent and Upcoming Patent Expiries of Notable Drugs 15
3.1.3 Will Governments Worldwide Continue Promoting Generic Drug Usage? 16
3.1.4 Generic Drug Approvals are Reaching Record Numbers in Key Markets 17
3.1.5 How Will Global Demographic Trends Impact Demand for Generic Drugs 17
3.1.6 Which Emerging Economies are the Most Promising for Generic Drugs Companies? 18
3.2 Factors Restraining Growth in the Global Generic Drugs Market 19
3.2.1 Delayed Launch of Generic Equivalents 20
3.2.2 Are Generic Drugs Still Negatively Perceived? 21
3.2.3 Impact of Supplemental Examination Provision of Patent Reform Act on Generics in the US 22
3.2.4 Pricing Pressures and Rising Costs for Generic Manufacturers 23
4 Generic Drug Pipeline for Top Small Molecule Drugs in the Market 24
4.1 Sensipar/Mimpara (cinacalcet) 24
4.1.1 Key Patent Expiry Dates and Potential Generic Competition 24
4.1.2 Sensipar/Mimpara Sales Forecast, 2011–2021 24
4.2 Tarceva (erlotinib) 25
4.2.1 Key Patent Expiry Dates and Potential Generic Competition 25
4.2.2 Tarceva Sales Forecast, 2011–2021 26
4.3 Lyrica (pregabalin) 26
4.3.1 Key Patent Expiry Dates and Potential Generic Competition 26
4.3.2 Lyrica Sales Forecast, 2011–2011 27
4.4 Vesicare (solifenacin) 28
4.4.1 Key Patent Expiry Dates and Potential Generic Competition 28
4.4.2 Vesicare Sales Forecast, 2011–2021 28
4.5 Viagra (sildenafil) 29
4.5.1 Key Patent Expiry Dates and Potential Generic Competition 29
4.5.2 Viagra Sales Forecast, 2011–2021 30
4.6 Vytorin/Inegy (ezetimibe plus simvastatin) 30
4.6.1 Key Patent Expiry Dates and Potential Generic Competition 30
4.6.2 Vytorin/Inegy Sales Forecast, 2011–2021 31
4.7 Truvada (emtricitabine plus tenofovir) 31
4.7.1 Key Patent Expiry Dates and Potential Generic Competition 32
4.7.2 Truvada Sales Forecast, 2011–2021 32
4.8 Zytiga (abiraterone) 32
4.8.1 Key Patent Expiry Dates and Potential Generic Competition 33
4.8.2 Zytiga Sales Forecast, 2011–2021 33
4.9 Benicar (olmesartan) 33
4.9.1 Key Patent Expiry Dates and Potential Generic Competition 33
4.9.2 Benicar Sales Forecast, 2011–2021 34
4.10 Exjade/Asunra (deferasirox) 34
4.10.1 Key Patent Expiry Dates and Potential Generic Competition 34
4.10.2 Exjade/Asunra Sales Forecast, 2011–2021 35
5 Strategies to Promote Generic Drug Usage by Companies 36
5.1 Authorized Generics 37
5.1.1 Diovan 38
5.1.2 Colcrys 38
5.2 Paragraph IV Certification 39
5.2.1 Baraclude 39
5.2.2 Copaxone 40
5.3 Super Generics 40
5.3.1 Super Generics: Intravail 41
6 Government Policies and Strategies to Promote Generic Drug Usage 42
6.1 Compulsory Licensing 42
6.1.1 Voluntary Licensing 42
6.1.2 Compulsory Licensing in the US 42
6.1.3 Compulsory Licensing in the EU 42
6.1.4 Compulsory Licensing in Asia-Pacific 42
6.1.5 Impact of Compulsory Licensing on Competition 44
6.1.6 Impact of Compulsory Licensing on Innovation 45
6.1.7 Impact of Compulsory Licensing on Pricing and Economies 45
6.1.8 CL Case Study– Nexavar 45
6.2 Generic Substitution 45
6.2.1 Impact of Generic Substitution in the US 45
6.2.2 Generic Substitution in the EU 46
6.2.3 Generic Substitution in Asia-Pacific 46
6.3 Tendering Generic Drugs 47
6.4 Parallel Trade 47
6.5 Impact of the Affordable Care Act on Generic Drugs 48
6.6 Physician Incentives for Prescribing 49
6.6.1 Legal Issues Regarding Physician Incentives 49
7 Mergers and Acquisitions in the Global Generic Drugs Market 50
7.1 Mergers and Acquisitions to Improve the Value Chain 51
7.1.1 Optimizing R&D 51
7.1.2 Increased Access to Active Pharmaceutical Ingredients and Formulations 52
7.1.3 Enhancing Marketing and Distribution Channels for Generic Drugs 52
7.2 Geographical Expansion Through Mergers and Acquisitions 53
7.3 Strategic Planning 53
7.4 Major Deals in the Global Generic Drugs Market and their Impact 54
8 Top Global Generic Drug Companies 57
8.1 Teva – Leading Generic Drugs Company in the World 57
8.1.1 Overview 57
8.1.2 Main Business Segments and Focus 57
8.1.3 Recent Activity in the Generics Market 58
8.1.4 Teva: SWOT Analysis 58
8.2 Sandoz 58
8.2.1 Recent Activity in the Generic Drugs Market 59
8.2.2 Sandoz: SWOT Analysis 59
8.3 Mylan 59
8.3.1 Recent Activity in the Generic Drugs Market 59
8.3.2 Mylan: SWOT Analysis 60
8.4 Sun Pharma 60
8.4.1 Recent Activity in the Generic Drugs Market 60
8.4.2 Sun Pharma: SWOT Analysis 61
8.5 Aspen 61
8.5.1 Recent Activity in the Generic Drugs Market 61
8.5.2 Aspen Pharmacare, SWOT analysis 62
8.6 Hospira 62
8.6.1 Recent Activity in the Generic Drugs Market 62
8.6.2 Hospira: Drugs SWOT analysis 63
8.7 Fresenius Kabi 63
8.7.1 Recent Activity in the Generic Drugs Market 63
8.7.2 Fresenius Kabi: SWOT analysis 64
8.8 Lupin 64
8.8.1 Recent Activity in the Generic Drugs Market 64
8.8.2 Lupin: SWOT analysis 65
9 Conclusion 66
10 Appendix 67
10.1 Industry Survey Results, Therapy Areas with Highest Levels Of Genericization, 2016–2021 67
10.2 Industry Survey Results, Therapy Areas with Highest Levels of Genericization, R&D Expert Panel vs Commercial Expert Panel, 2016–2021 67
10.3 Industry Survey Results, Most Important Factors Promoting Generic Drugs Usage at a Global Level 68
10.4 Industry Survey Results, Most Important Factors Promoting Generic Drugs Usage at a Global Level, R&D Expert Panel vs Commercial Expert Panel 68
10.5 Industry Survey Results, Most Important Factors Promoting Generic Drugs Usage at a Global Level, European Panel vs North American Panel vs Asia Panel 69
10.6 Industry Survey Results, Leading Emerging Markets for Generic Drug Manufacturers, 2016–2021 69
10.7 Industry Survey Results: Most Important Factors Hindering or Delaying Approval of Generic Drugs Globally 70
10.8 Industry Survey Results: Most Important Factors Hindering or Delaying Approval of Generic Drugs, R&D Expert Panel vs Commercial Expert Panel 70
10.9 Industry Survey Results: Do Physicians in Developed Markets Regard Generic Drugs to be as Safe and Effective as Branded Drugs? 71
10.10 Industry Survey results, Most Popular Strategies or Regulations Leveraged by Companies in Generic Sector 71
10.11 Industry Survey results, Most Popular Strategies or Regulations Leveraged by Companies in Generics Sector, North American Panel vs European Panel vs Asian Panel 72
10.12 Industry Survey Results: The Impact of Compulsory Licensing on Innovator Companies in Emerging Markets 72
10.13 Industry Survey Results: The Impact of Compulsory Licensing on Innovator Companies in Emerging Markets, North American panel vs. European panel vs. Asian panel 73
10.14 Industry Survey results, Most Important Factors Contributing to Surge in M&A Activity in Generic Drugs Market 73
10.15 Industry Survey Results, The Most Important Factors Contributing to the Surge in M&A Activity in the Generic Drugs Market, North American panel vs. European panel vs. Asian panel 74
10.16 Industry Survey Results: Market Dynamics Affected by Continued Consolidation in the Generic Drugs Market 74
10.17 Industry Survey Results, North American Panel vs European Panel vs Asian Panel, Market Dynamics Affected by Continued Consolidation in the Generic Drugs Market 75
10.18 Bibliography 75
10.19 Contact Us 83
10.20 Disclaimer 83