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The Top 10 Generics Companies: Strategic Insight, Growth Opportunities and Competitive Dynamics in the US and Europe
Business Insights, March 2006, Pages: 178
Executive Summary
The generics market in US and Europe 12
Teva/IVAX 13
Sandoz (incl. Eon Labs and HEXAL) 14
Mylan 15
Ratiopharm 16
Watson Pharmaceuticals Inc. 17
Par Pharmaceuticals, Inc. 18
Merck KGaA 19
Baxter International Inc. 20
STADA 21
Apotex 22
Chapter 1 The generics market in the US and Europe
Summary 24
Introduction 25
Total generics market based on dollar sales 26
Western Europe 31
UK 31
Spain 32
Germany 32
France 33
Italy 34
US 34
Total generics market based on standard unit sales 35
The top 10 players 37
Geographic focus of the top 10 38
US 38
5EU 39
Future geographic trends 40
Generics as a proportion of total sales of the top 10 41
Therapeutic focus of the top 10 42
Central nervous system 43
Cardiovascular system 43
General anti-infectives 43
Alimentary tract and metabolism 44
Key marketed products of the top 10 45
Key M&A activity 46
Sandoz/Eon/HEXAL 46
Teva/IVAX 47
Future outlook 48
Drivers of growth 49
FDA first approvals 49
Major upcoming patent expirations 49
Government influence and legislation 50
Medicare prescription drug plan 51
Resistors to growth 51
Competition between generics 51
Generic market maturity 51
Legislation enforcing generic drug pricing 52
FDA ANDA approval 52
Key strategies for growth 52
Chapter 2 Teva/IVAX
Summary 56
Company overview 57
Teva 57
IVAX 57
Strategic position 58
Strengths 59
Weaknesses 59
Opportunities 60
Threats 60
Geographic focus 61
Marketed products 63
First generic FDA approvals, 2005 65
Therapeutic focus 66
M&A and licensing activity 67
Chapter 3 Sandoz (incl. Eon Labs and HEXAL)
Summary 70
Company overview 71
Strategic analysis 72
Strengths 72
Weaknesses 73
Opportunities 73
Threats 74
Geographic focus 74
Marketed products 76
First generic FDA approvals, 2005 77
Therapeutic focus 78
M&A and licensing activity 79
Chapter 4 Mylan
Summary 82
Company overview 83
Strategic position 84
Strengths 84
Weaknesses 85
Opportunities 85
Threats 86
Geographic focus 86
Marketed products 88
First generic FDA approvals, 2005 89
Therapeutic focus 90
M&A and licensing activity 91
Chapter 5 Ratiopharm
Ratiopharm 94
Company overview 95
Strategic position 96
Strengths 96
Weaknesses 96
Opportunities 97
Threats 98
Geographic focus 99
Marketed products 100
First generic FDA approvals, 2005 102
Therapeutic focus 102
M&A and licensing activity 103
Chapter 6 Watson Pharmaceuticals Inc.
Summary 106
Company overview 107
Strategic position 108
Strengths 108
Weaknesses 109
Opportunities 109
Threats 110
Geographic focus 110
Marketed products 111
First generic FDA approvals, 2005 113
Therapeutic focus 113
M&A and licensing activity 114
Chapter 7 Par Pharmaceuticals, Inc.
Summary 118
Company overview 119
Strategic Position 120
Strengths 120
Weaknesses 121
Opportunities 121
Threats 122
Geographic focus 122
Marketed products 123
First generic FDA approvals, 2005 124
Therapeutic focus 124
M&A and licensing activity 126
Chapter 8 Merck KGaA
Summary 130
Company overview 131
Strategic position 132
Strengths 133
Weaknesses 133
Opportunities 133
Threats 134
Geographic focus 134
Marketed products 135
First generic FDA approvals, 2005 136
Therapeutic focus 137
M&A and licensing activity 138
Chapter 9 Baxter International Inc.
Summary 140
Company overview 141
Strategic Position 142
Strengths 142
Weaknesses 143
Opportunities 143
Threats 143
Geographic focus 144
Marketed products 145
First generic FDA approvals, 2005 147
Therapeutic focus 147
M&A and licensing activity 148
Chapter 10 STADA
Summary 152
Company overview 153
Strategic position 154
Strengths 154
Weaknesses 155
Opportunities 155
Threats 156
Geographic focus 156
Marketed products 157
First generic FDA approvals, 2005 159
Therapeutic focus 159
M&A and licensing activity 160
Chapter 11 Apotex
Summary 164
Company overview 165
Strategic position 166
Strengths 167
Weaknesses 167
Opportunities 168
Threats 168
Geographic focus 168
Marketed products 169
FDA first generic approvals, 2005 171
Therapeutic focus 171
M&A and licensing activity 172
Chapter 12 Appendix
IMS data 176
Index 177
List of Figures
Figure 1.1: Market share of the total generics market, 2004 28
Figure 1.2: Geographic focus of the top 10, 2004 38
Figure 1.3: Proportion of generic sales of the top 10, 2004 42
Figure 1.4: Market share of therapy areas in the US and major European generics pharmaceutical market, 2003-4 44
Figure 1.5: Key drivers and resistors to sales growth in the US/5EU generic drug market 48
Figure 2.6: SWOT analysis for Teva/IVAX 58
Figure 2.7: Teva/IVAX's geographic focus, 2003-4 61
Figure 2.8: Teva/IVAX's therapeutic focus, 2004 66
Figure 3.9: SWOT analysis for Sandoz 72
Figure 3.10: Sandoz’s geographic focus, 2003-4 75
Figure 3.11: Sandoz’s therapeutic focus, 2004 78
Figure 4.12: SWOT analysis for Mylan 84
Figure 4.13: Mylan’s geographic focus, 2003-4 87
Figure 4.14: Mylan’s therapeutic focus, 2004 90
Figure 5.15: SWOT analysis for Ratiopharm 97
Figure 5.16: Ratiopharm’s geographic focus, 2003-4 99
Figure 5.17: Ratiopharm’s therapeutic focus, 2004 102
Figure 6.18: SWOT analysis for Watson 108
Figure 6.19: Watson’s geographic focus, 2003-4 111
Figure 6.20: Watson’s therapeutic focus, 2004 113
Figure 7.21: SWOT analysis for Par 120
Figure 7.22: Par’s geographic focus, 2003-4 122
Figure 7.23: Par’s therapeutic focus, 2004 125
Figure 8.24: SWOT analysis for Merck KGaA 132
Figure 8.25: Merck KGaA’s geographic focus, 2003-4 135
Figure 8.26: Merck KGaA’s therapeutic focus, 2004 137
Figure 9.27: SWOT analysis for Baxter 142
Figure 9.28: Baxter’s geographic focus, 2003-4 144
Figure 9.29: Baxter’s therapeutic focus, 2004 147
Figure 10.30: SWOT analysis for STADA 154
Figure 10.31: STADA’s geographic focus, 2003-4 157
Figure 10.32: STADA’s therapeutic focus, 2004 159
Figure 11.33: SWOT analysis for Apotex 166
Figure 11.34: Apotex’s geographic focus, 2003-4 169
Figure 11.35: Apotex’s therapeutic focus, 2004 171
List of Tables
Table 1.1: Total generic sales in the US and 5EU, 2000-2004 27
Table 1.2: Total generic sales in the US and 5EU (standard units), 2000-2004 35
Table 1.3: Top 10 generics company sales in the US and 5EU, 2003-4 37
Table 1.4: Top 10 generics company sales in the US, 2003-4 39
Table 1.5: Top 10 generics company sales in the 5EU, 2003-4 40
Table 1.6: Largest therapy area based on 2004 sales ($m) 43
Table 1.7: Top 10 generics of the US and 5EU, 2004 45
Table 1.8: Patent expiration dates for the top selling generic drugs, US 46
Table 1.9: FDA first generic approvals, 2001-2005 49
Table 1.10: US patent expirations, 2006-7 50
Table 2.11: Teva/IVAX's top 10 marketed products, 2004 63
Table 2.12: Teva/IVAX's FDA first generic approvals, 2005 65
Table 2.13: Teva/IVAX's key licensing and alliance activity, 2004-5 67
Table 3.14: Sandoz’s top 10 marketed products, 2004 76
Table 3.15: Sandoz's FDA first generic approvals, 2005 77
Table 3.16: Sandoz’s key licensing and alliance activity, 2004-5 80
Table 4.17: Mylan’s top 10 marketed products, 2004 88
Table 4.18: Mylan's FDA first generic approvals, 2005 89
Table 4.19: Mylan’s key licensing and alliance activity, 2004-5 92
Table 5.20: Ratiopharm’s top 10 marketed products, 2004 101
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