Market Report Source

Overview

This report provides an overview of the global generics industry, including its size and growth, followed by current trends in the industry that are expected to lead to worldwide growth. It also provides information on the current competitive generic pharmaceuticals industry in the major markets, the US and EU.

Table of Contents

Executive Summary 14
Industry overview 14
Novartis (Sandoz) 15
Teva 16
Mylan 17
Ratiopharm 18
Apotex 18
Pfizer (Greenstone) 19
Sanofi-Aventis (Winthrop) 20
Watson 21
Bayer 22
Stada 23

Chapter 1 Introduction 26
What is this report about? 26
Methodology 26

Chapter 2 Industry overview 28
Summary 28
Introduction 29
Market overview 29
Global generics market: size and growth 29
Market overview for the US/5EU 30

• The US 32


• The UK 34


• France 36


• Germany 37


• Spain 39


• Italy 41

Top trends in the industry 43
Changing paradigms towards emerging markets 43
The generics manufacturing base is shifting to low cost hubs 45
Growing legislative support for ‘follow-on biologics’ 46
Increasing participation of branded Pharma companies in generics industry 47
Consolidation 49
Top ten generic companies 50
Global ranking 50
US/5EU consolidated 50
Therapeutic focus of the top 10 51
Key marketed products of the top 10 53
Geographic focus of the top 10 54

• US ranking 54


• EU ranking 55

Chapter 3 Novartis (Sandoz) 58
Summary 58
Business description 59
Geographic focus 60
Marketed products 61
Major therapeutic focus 62
Growth strategies 63
Focus on difficult-to-make and biosimilar generics 63
Acquisitions and divestments 64
SWOT analysis 65

Strengths 66

• Size and leading generics position 66


• Dynamic launches 66

Weaknesses 67

• Development setbacks 67

Opportunities 67

• Strong pipeline 67

Threats 68

• Legal proceedings 68

Chapter 4 Teva 70
Summary 70
Teva’s acquisition of Barr Pharma 71
Broader product-market focus 71
P&L synergies 71
Current business description 72
Geographic focus 73
Marketed products 74
Major therapeutic focus 75
Growth strategies 77
Acquisitions and divestments 77
SWOT analysis 78

Strengths 79

• Leading generics market position 79


• Global infrastructure 79

Weaknesses 80

• Distribution model 80

Opportunities 80

• Focus on hospitals and institutional channels 81

Threats 81

• Failure to obtain market exclusivity in the US 81

Chapter 5 Mylan 84
Summary 84
Business description 85
Geographic focus 86
Marketed products 87
Major therapeutic focus 88
Growth strategies 89
Acquisitions and divestments 90
SWOT analysis 91

Strengths 91

• Leading market position in Asia Pacific 91


• Growth through strategic acquisitions 92

Weaknesses 92

• Dependence on a few key products 92

Opportunities 93

• Growing generics demand 93

Threats 93

• Merck Generics litigations 93

Chapter 6 Ratiopharm 96
Summary 96
Business description 97
Geographic focus 97
Marketed products 99
Major therapeutic focus 99
Growth strategies 100
Focus on biosimilars 100
Acquisitions and divestments 101
SWOT analysis 102

Strengths 102

• Leading position in Germany 102

Weaknesses 103

• Dependence on European market 103

Opportunities 103

• Biosimilar filgrastim 103


• Launch of generic Plavix 103

Threats 104

• Competition in German generics market 104

Chapter 7 Apotex 106
Summary 106
Business description 107
Geographic focus 107
Marketed products 108
Major therapeutic focus 109
Growth strategies 110
Strategic alliances 110
Investments in R&D 111
Acquisitions and divestments 111
SWOT analysis 112

Strengths 112

• Strong R&D capabilities 112

Weaknesses 113

• Lawsuits relating to patent infringement 113

Opportunities 113

• Expanding global footprint beyond Canada and the US 113


• Successful tender bid for critical healthcare needs in Africa 114

Threats 114

• Extending market exclusivity period in Canada 114


• Growing pseudo (authorized) generics market in Canada 114

Chapter 8 Pfizer (Greenstone) 118
Summary 118
Business description 119
Geographic focus 119
Marketed products 120
Major therapeutic focus 121
Growth strategies 122
Extending generics market share 122
Acquisitions and divestments 123
SWOT analysis 123

Strengths 123

• Strong market position 123

Weaknesses 124

• Geographic concentration in the US 124

Opportunities 124

• Growth opportunities in emerging markets 124

Threats 125

• Competition in the US generics market 125

Chapter 9 Sanofi-Aventis (Winthrop) 128
Summary 128
Business description 129
Geographic focus 129
Marketed products 130
Major therapeutic focus 131
Growth strategies 133
Regionalization strategy 133
Acquisitions and divestments 133
SWOT analysis 134

Strengths 134

• Strong presence in emerging economies 134

Weaknesses 135

• Lack of presence in the US 135

Opportunities 135

• Biosimilar generics in the field of low molecular weight heparin 135

Threats 135

• Low penetration of generics in France 135

Chapter 10 Watson 138
Summary 138
Business description 139
Geographic focus 139
Marketed products 140
Major therapeutic focus 140
Growth strategies 142
Growing offshore presence 142
Acquisitions and divestments 142
SWOT analysis 143

Strengths 143

• Global centers of excellence 143

Weaknesses 144

• Dependence on third-party manufacturers 144

Opportunities 144

• Expansion in India 144?

Threats 145

• Loss of revenues from Ferrlecit 145

Chapter 11 Bayer 148
Summary 148
Business description 149
Geographic focus 149
Marketed products 151
Major therapeutic focus 152
Growth strategies 152
Building on government initiatives to promote generics 152
Acquisitions and divestments 153
SWOT analysis 153

Strengths 154

• Strong R&D capabilities 154

Weaknesses 154

• Lack of presence in the US and the UK 154

Opportunities 154

• Focus on emerging economies 154

Threats 155

• Regulatory pressure on generic pricing in Germany 155

Chapter 12 Stada 158
Summary 158
Business description 159
Geographic focus 159
Marketed products 161
Major therapeutic focus 162
Growth strategies 163
Cost optimization 163
Continuous portfolio expansion 163
Acquisitions and divestments 164
SWOT analysis 165

Strengths 165

• Low-price cost structure of ALIUD Pharma 165


• Strong local sales infrastructure 166

Weaknesses 166

• Dependence on third-party suppliers and manufacturers 166

Opportunities 166

• Launch of biosimilar Erythropoietin-zeta 166


• Expanding footprint in Eastern Europe 167

Threats 167

• Regulatory pressure on generics pricing in Germany 167

Chapter 13 Conclusion 170
Introduction 170
Generics outperforming the ethical pharmaceutical industry 170
Reassessing growth strategies 170
Generics competition within the biotech sector 171
Stripping-off the pricing advantage 171
Outlook 172

Chapter 14 Appendix 176

Glossary 176

Index 178

List of Figures

Figure 2.1: Global generics market size, 2004–2007 ($m) 30
Figure 2.2: Market position of the global top 10 generics companies, 2007 32
Figure 2.3: Generics drivers and resistors – the US 33
Figure 2.4: Generics drivers and resistors – the UK 35
Figure 2.5: Generics drivers and resistors – France 37
Figure 2.6: Generics drivers and resistors – Germany 38
Figure 2.7: Generics drivers and resistors – Spain 40
Figure 2.8: Generics drivers and resistors – Italy 42
Figure 2.9: Emerging markets generic sales, 2003–2007 ($m) 44
Figure 2.10: Pharmaceutical companies and their generic divisions 48
Figure 2.11: Top 10 generic companies global market share, 2007 50
Figure 2.12: Geographic focus of the top 10 in US/5EU, 2007 54
Figure 3.13: Novartis’ (Sandoz) geographic focus, 2006–2007 60
Figure 3.14: Novartis’ (Sandoz) therapeutic focus, 2007 63
Figure 3.15: Novartis (Sandoz) SWOT analysis 65
Figure 4.16: Teva’s geographic focus, 2006–2007 74
Figure 4.17: Teva’s therapeutic focus, 2007 76
Figure 4.18: Teva SWOT analysis 78
Figure 5.19: Mylan’s geographic focus, 2006–2007 87
Figure 5.20: Mylan’s therapeutic focus, 2007 89
Figure 5.21: Mylan SWOT analysis 91
Figure 6.22: Ratiopharm’s geographic focus, 2006–2007 98
Figure 6.23: Ratiopharm’s therapeutic focus, 2007 100
Figure 6.24: Ratiopharm SWOT analysis 102
Figure 7.25: Apotex’s geographic focus, 2006–2007 108
Figure 7.26: Apotex’s therapeutic focus, 2007 110
Figure 7.27: Apotex SWOT analysis 112
Figure 8.28: Pfizer’s (Greenstone) geographic focus, 2006–2007 120
Figure 8.29: Pfizer’s (Greenstone) therapeutic focus, 2007 122
Figure 8.30: Pfizer (Greenstone) SWOT analysis 123
Figure 9.31: Sanofi-Aventis’ (Winthrop) geographic focus, 2006–2007 130
Figure 9.32: Sanofi-Aventis’ (Winthrop) therapeutic focus, 2007 132
Figure 9.33: Sanofi-Aventis (Winthrop) SWOT analysis 134
Figure 10.34: Watson’s therapeutic focus, 2007 141
Figure 10.35: Watson SWOT analysis 143
Figure 11.36: Bayer’s geographic focus, 2006–2007 150
Figure 11.37: Bayer’s therapeutic focus, 2007 152
Figure 11.38: Bayer SWOT analysis 153
Figure 12.39: Stada’s geographic focus, 2006–2007 160
Figure 12.40: Stada’s therapeutic focus, 2007 162
Figure 12.41: Stada SWOT analysis 165
Figure 13.42: Comparative analysis of top 10 generic companies 172

List of Tables

Table 2.1: Total generic sales in the US/5EU, 2003–2007 ($m) 31
Table 2.2: Generic sales by volume in the US/5EU, 2003–2007 (Standard units m) 31
Table 2.3: Biologics going off patent in the US, 2008–2011 47
Table 2.4: Top 10 generic companies’ sales in the US/5EU, 2003–2007 ($m) 51
Table 2.5: Largest therapy areas for generics for the top 10, 2007 ($m) 52
Table 2.6: Market share by therapy area in the US/5EU generics market, 2006–2007 52
Table 2.7: Top 10 generics by sales value in the US/5EU, 2007 ($m) 53
Table 2.8: Top 10 generic companies in the US, 2003–2007 ($m) 55
Table 2.9: Top 10 generics companies in 5EU, 2003–2007 ($m) 56
Table 3.10: Novartis (Sandoz) snapshot 59
Table 3.11: Novartis’ (Sandoz) top 10 marketed products sales, 2006–2007 ($m) 61
Table 4.12: Teva snapshot 71
Table 4.13: Teva’s top 10 marketed products sales, 2006–2007 ($m) 75
Table 5.14: Mylan snapshot 85
Table 5.15: Mylan’s top 10 marketed products sales, 2006–2007 ($m) 88
Table 6.16: Ratiopharm snapshot 97
Table 6.17: Ratiopharm’s top 10 marketed products sales, 2006–2007 ($m) 99
Table 7.18: Apotex snapshot 107
Table 7.19: Apotex’ top 10 marketed products sales, 2006–2007 ($m) 109
Table 8.20: Pfizer (Greenstone) snapshot 119
Table 8.21: Pfizer’s (Greenstone) top 10 marketed products sales, 2006–2007 ($m) 121
Table 9.22: Sanofi-Aventis (Winthrop) snapshot 129
Table 9.23: Sanofi-Aventis’ (Winthrop) top 10 marketed products sales, 2006–2007 ($m) 131
Table 10.24: Watson snapshot 139
Table 10.25: Watson’s top 10 marketed products sales, 2006–2007 ($m) 140
Table 11.26: Bayer snapshot 149
Table 11.27: Bayer’s top 10 marketed products sales, 2006–2007 ($m) 151
Table 12.28: Stada snapshot 159
Table 12.29: Stada’s top 10 marketed products sales, 2006–2007 ($m) 161