PharmaSphere: Global Generics Strategy - Key Drivers, Markets and Trends in 2013



Summary



GlobalData’s "PharmaSphere: Global Generics Strategy - Key Drivers, Markets and Trends in 2013" report, provides strategic analysis of the global generics industry. It discusses key trends, significant M&A deals in 2012, and describes the operations strategy of these companies. Furthermore, it includes a geographical segmentation of the top 30 companies into various markets, including the BRIC countries (Brazil, Russia, India, and China), to identify the top players in each market.

Throughout the report, GlobalData’s analysts provide you with expert insight, expanding on each strategy and factor discussed, with the aim of providing you with the tools needed for making informed business decisions



Scope


- The report identifies the key generic players in various markets, including a special focus on emerging markets such as India, China, Russia, and Brazil.
- Furthermore, it provides detailed analysis of the various generic markets including the US, Europe, APAC, and BRIC.
- The report contains expert insights on the corporate strategies of generic companies seeking competitive advantage in the highly competitive generics industry.



Reasons to buy


- Identify the key generic players in various markets, including the emerging markets such as India, China, Russia, and Brazil
- Analyze and track the strategies that successful generic companies are using to gain share in the increasingly competitive market
- Understand the key drivers and trends in the global generics industry
- Use this information as an independent source for your due diligence and transaction strategy

Table Of Contents

Table of Contents

1 Table of Contents 5
1.1 List of Tables 9
1.2 List of Figures 9
2 Introduction 11
2.1 Report Scope 11
2.2 Upcoming Related Reports 12
2.3 Recently Published Reports 13
3 Generics Industry Dynamics 14
3.1 Generics to the Fore 14
3.1.1 Imminence of the Patent Cliff 14
3.1.2 Rising healthcare expenditures prompts many governments to resort to generics to save costs 19
3.1.3 Focus on emerging markets 20
3.1.4 Generic companies continuously drill holes in Big Pharma’s deep pockets 21
4 Strategic Deals Trends 24
4.1 Big Pharma’s need to plug its revenue gap 26
4.2 Governments cut healthcare spending as financial austerity spreads globally 26
4.3 Low margins in the generics business necessitate scale economies 26
4.4 Highlighted Deals from 2012 27
4.4.1 Watson Closes $5.5 billion Purchase of Actavis 28
4.4.2 Mylan Enters into Generics Partnership with Pfizer 31
4.4.3 Merck and Supera Farma Laboratórios 35
5 Generics in North America 37
5.1 Overview 37
5.2 United States 38
5.2.1 The US Pharmaceutical Industry 38
5.2.2 Key Players 50
5.2.3 Outlook 51
6 Generics in the Asia-Pacific (APAC) 52
6.1 Overview 52
6.2 Australia: Healthcare Policy Reform and the Generics Business 53
6.2.1 Prescription Drug Regulation and Pricing in Australia 53
6.2.2 The Australian Generics Business Environment 58
6.2.3 Key Players 63
6.2.4 Australia’s Healthcare Reform and Impact on the Role of Generics 64
6.3 Japan 67
6.3.1 The Japanese Pharmaceutical Market 67
6.3.2 Perception of Generics in Japan 69
6.3.3 Impact of Pharmacies on Generics Substitution 70
6.3.4 Generics Approval and Market Exclusivity 71
6.3.5 Key Players 72
7 Generics in Europe and Africa 74
7.1 Overview 74
7.2 Europe 75
7.2.1 The Increasing Burden on Healthcare 75
7.2.2 Case Study: Germany 77
7.3 Africa 81
7.3.1 The Need for Local Production 81
7.3.2 Low regulatory compliance and infrastructure result in a weak pharmaceutical industry 82
7.3.3 Low standard of living makes medicines unaffordable, discouraging local players 82
7.3.4 Global organizations and multinationals are standardizing Africa’s pharmaceutical space 83
7.3.5 Pharmaceutical Manufacturing Plan for Africa 84
7.3.6 Case Study: South Africa 84
8 Generics in the BRIC Countries 94
8.1 Overview 94
8.2 Brazil 95
8.2.1 Latin America Market Leader 95
8.2.2 Government industrial policies will aid further development of the pharmaceutical industry 96
8.2.3 Generics in Brazil 97
8.2.4 Key Players 99
8.3 Russia 101
8.3.1 The New Federal Law on Health in the Russian Federation 101
8.3.2 Pharma 2020 will further encourage domestic production in Russia 103
8.3.3 Healthy financial situation places less pressure on the Russian government to reduce healthcare costs 103
8.3.4 Key Player 104
8.4 India 105
8.4.1 Absence of product patents before 2005 triggered the birth of the Indian generics market 105
8.4.2 Quality manufacturing facilities create an ideal environment for generics to thrive 106
8.4.3 Inter-firm competition enables capabilities development 107
8.4.4 Policies and initiatives encourage participation in generics manufacturing by driving demand 107
8.4.5 Increased competition from larger multinationals may stymie the development of smaller domestic players 108
8.4.6 Growing pressures on patent laws could challenge domestic generics manufacturers 109
8.4.7 Key Market Players 110
8.4.8 Outlook 113
8.5 China 115
8.5.1 Parallel demographics presents different scenarios on China’s pharmaceutical industry 115
8.5.2 A dysfunctional healthcare system provides little incentive for generics substitution 116
8.5.3 Soaring healthcare expenditures pressure China’s financial stability 117
8.5.4 Healthcare reform will level the pharmaceutical industry playing field and foster the growth of the generics sector 118
8.5.5 Key Players 119
8.5.6 Market Outlook 120
9 Strategic Outlook 121
9.1 Patent expiries and evolution of the regulatory landscape fuel generics 121
9.1.1 US patent expiry wave presents a unique opportunity for generic manufacturers 121
9.1.2 Government reforms will continue to facilitate generic prescribing 122
9.1.3 Consolidation sweeps through the generics sector 122
9.1.4 India’s generic companies are an emerging force in the global generics market 123
10 Appendix 124
10.1 Bibliography 124
10.2 Abbreviations 132
10.3 Research Methodology 137
10.3.1 Coverage 137
10.3.2 Secondary Research 138
10.3.3 Expert Panel Validation 138
10.4 About the Authors 138
10.4.1 Analyst 138
10.4.2 Director of Healthcare Industry Dynamics 139
10.4.3 Global Head of Healthcare Research and Consulting 139
10.5 About the Industry Dynamics Team 140
10.6 About GlobalData 140
10.7 Contact Us 141
10.8 Disclosure Information 141
10.9 Disclaimer 141



List of Tables

Table 1: First-Time Generic Drug Approvals, 2012 15
Table 2: Health Expenditures of OECD Countries as a Percentage of GDP, 2001-2010 19
Table 3: Recent and Upcoming US Patent Expirations, with FY2011 and FY2012 Sales Data 22
Table 4: Overview of the Collaboration and MandA Deals in this Report, 2012 27
Table 5: Watson Acquires Actavis in $5.5 Billion Deal 30
Table 6: Pfizer’s Collaboration with Mylan Pharmaceuticals 34
Table 7: Merck’s JV with Supera Farma Laboratórios 36
Table 8: Generics-Focused Deals by Major Drug Companies, 2008-2012 62
Table 9: Initial Phase of Price Reductions through Disclosure Agreements, 2009 66
Table 10: Top 10 Pharmaceutical Companies in Brazil, 1998 and 2007 96
Table 11: China: Urban and Rural Pharmaceutical Market Size, 2012 115



List of Figures

Figure 1: NME Approvals by the FDA, 1996-2012 14
Figure 2: Trend in Deals in the Generics Industry, 2008-2012 25
Figure 3: Pfizer: Emerging Markets Revenues as a Percentage of Annual Revenues, 2006-2012 32
Figure 4: Merck: Market focus1, 2007-2011 35
Figure 5: North American Generics Market Landscape - FY2012 Corporate Revenue Growth vs. North American Revenue Growth 37
Figure 6: Domestic Exports of Pharmaceutical Products from the US, 2000-2011 39
Figure 7: RandD Spending by PhRMA Members, 2004-2011 40
Figure 8: US Healthcare Expenditures and GDP, 2002-2011 43
Figure 9: US per Capita Healthcare Expenditures and GDP, 2001-2010 44
Figure 10: FDA Generic Drug Review Process 46
Figure 11: Generic Drug Approvals in the US, 2008-2012 47
Figure 12: APAC Generics Market Landscape - FY2012 Corporate Revenue Growth vs. APAC Revenue Growth 52
Figure 13: Australia: Trends in Prescription Volume and Government Costs, 2000-2011 59
Figure 14: Australian Government’s and Patients’ Contributions to PBS Costs, 2005-2011 60
Figure 15: Average Birth Life Expectancies1 in the APAC Region, 2012 68
Figure 16: EMEA Generics Market Landscape - FY2012 Corporate Revenue Growth vs. EMEA Revenue Growth 74
Figure 17: Birth Life Expectancies in Europe, 2010 vs. 2003 75
Figure 18: Public-Debt and Budget-Deficit-to-GDP Ratios in the Eurozone, 2012 76
Figure 19: Generics vs. Branded Products Split in South Africa, 2002-2006 87
Figure 20: Generics vs. Branded Products Split in South Africa, 2008-2012 88
Figure 21: Generics Utilization in South Africa, 2012-2020 92
Figure 22: BRIC Generics Market Landscape - FY2012 Corporate Revenue Growth vs. BRIC Revenue Growth 94
Figure 23: Russia, Percentage of Total Healthcare Expenditures by Revenue Source, 2009 102
Figure 24: Value of Pharmaceutical Exports from India, 2002-2011 106
Figure 25: Indian Generics Market Landscape - FY2012 Corporate Revenue Growth vs. India Revenue Growth 110
Figure 26: Total and Government Healthcare Expenditures* in China, 2001-2011 117

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