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Growth Strategies In Generics: Innovative And Aggressive Strategies And Their Impact On Branded Pharmaceuticals
Business Insights, July 2004, Pages: 172
Executive summary 10
Introduction 10
Market overview 10
Successful US strategies 11
Successful European strategies 12
US legislation and its impact 13
European legislation and its impact 14
US barriers to generics growth 15
European barriers to generics growth 16
Future prospects and conclusions 17
Chapter 1 Market overview 20
Summary 20
Introduction 21
US vs Europe – differences and contradictions 23
Global opportunities – forthcoming patent expiries 27
Underdeveloped markets 29
Expand abroad or stay at home? 32
Multinational R&D companies’ involvement in generics 34
Chapter 2 Successful US strategies 38
Summary 38
Overview of US generic market 39
Leading US generic companies 41
The road to success 42
Distribution of commodity generics 42
Manufacture and distribution of commodity generics 43
Acquisition 44
Patent challenges – Paragraph IV filings and first to file 46
Specialty generics - reducing the competition levels 48
Products with technologically challenging formulations 48
Controlled release generics 49
Products where significant regulatory support is required 49
Products with limited availability of the API 50
Proprietary drugs — branded and generic products together 50
Biogenerics 51
Chapter 3 Successful European strategies 54
Summary 54
Overview of European generic markets 55
Pricing 56
Intellectual property 57
Generic prescribing levels 57
Purchasing decision based on price 58
Pricing based on supply and demand 58
Leading European companies 59
The road to success 61
Distribution of commodity generics 61
Manufacture and distribution of commodity generics 62
Patent challenges 63
Be first to launch 64
Acquisition 65
Specialty generics - reducing the competition levels 66
Proprietary drugs - branded products alongside generics 67
Biogenerics 67
Chapter 4 US legislation and its impact 70
Summary 70
Overview of US generic legislation 71
Hatch-Waxman amendments 72
Benefits to the R&D side 72
Benefits to the generic side 73
Disadvantages of the legislation 75
McCain-Schumer legislation 77
Gregg-Schumer Act 78
The impact of new legislation 80
Single 30 month stay 80
Orange Book listings 81
180-day exclusivity 81
Authorized generics 82
Bioequivalence 82
Chapter 5 European legislation and its impact 86
Summary 86
Overview of European generic legislation 87
Directive 2001/83 89
Directive 2004/27/EC 90
Benefits to the R&D side 90
Benefits to the generic side 93
The impact of new legislation 94
Definition of a generic 94
Bolar clause 95
“Is Marketed” 95
European Reference Product 97
Harmonization of SmPC’s 98
Disadvantages of the legislation – winners and losers 98
Other IP issues 99
Chapter 6 US barriers to generics growth 102
Summary 102
Introduction 103
Threats to the industry 103
Market saturation 103
Increasing wholesaler consolidation 104
Overseas competitors – India 105
Overseas competitors – Europe 107
Gaps in patent expiries 109
Reference prices 110
Parallel imports 111
Individual company strategies 114
Movement away from normal release oral commodity generics 115
Adjustment of product portfolio to include higher margin products 116
Investment in original R&D 117
Acquisitions 119
Expansion into overseas markets 120
Alliances with overseas manufacturers in India or Latin America 122
Biogenerics 122
The role of trade associations 124
Chapter 7 European barriers to generics growth 128
Summary 128
Overview 129
Threats to the industry 130
Market saturation 130
Increasing wholesaler consolidation 131
Overseas competitors – India 131
Overseas competitors – Europe 133
Reference prices 134
Parallel imports 136
Individual company strategies 137
Portfolio adjustment 138
Expand abroad 140
Attack patents – risks and opportunities 143
Form an alliance with multinational 145
Conduct own R&D 146
Biogenerics 147
Add parallel imports to the range 149
Enter OTC market 149
The role of trade associations 150
Lobby for legislative change 150
Lobby against legislative change 150
Chapter 8 Future prospects and conclusions 153
Summary 153
Overview 154
Trends in manufacturing 156
Movement of manufacturing facilities 156
Threats to generics companies 157
Trends in marketing 159
Movement upstream 159
Expansion overseas 161
Target areas for expansion 162
The future of generics in the US 164
US profit margins 164
Future legislative changes 165
The future of generics in Europe 166
Pan-European generics 166
Legislation 167
IP Problems 167
The generics competitive landscape 168
Generic superheroes 168
Consolidation of generic companies 168
Branded pharmaceutical company consolidation 169
Growth prospects for generics 170
Outlook by therapeutic area 172
List of Figures
Figure 1.1: Examples of differences between US and Europe (as at start of 2004) 25
Figure 1.2: Generic penetration in Europe 30
Figure 2.3: Significant factors necessary for the development of a healthy generic market 39
Figure 2.4: Branded sales and sales growth of the leading generics companies, 2000–01 50
Figure 3.5: Factors necessary for the development of a healthy generic market 55
Figure 3.6: European sales of leading generics players, 2001 59
Figure 6.7: The value of major US patent expiries to 2008 110
Figure 6.8: Generics R&D strategies – trade off between risk and competition level 119
Figure 6.9: Drivers and resistors to geographic expansion 121
Figure 7.10: European prices compared against reference price systems 135
Figure 7.11: Pharmaceutical prices and generic penetration in Europe 142
Figure 8.12: Generic penetration rates in Europe, 2003 154
Figure 8.13: Opportunities and saturation in generics markets 155
Figure 8.14: Threats to generics companies 158
Figure 8.15: The evolution of successful generics companies 160
Figure 8.16: Plans for overseas expansion 161
Figure 8.17: Target areas for expansion 162
Figure 8.18: Use of regional offices, subsidiaries, acquisition and local agents 163
Figure 8.19: The impact of recent changes in pharmaceutical law 165
Figure 8.20: Annual growth predictions for generic drugs, 2004, responses by type of company170
Figure 8.21: Annual growth predictions for generic drugs, 2004, responses by location of respondents 171
Figure 8.22: Most attractive therapy areas for generic drugs growth 172
List of Tables
Table 1.1: Size of key generics markets, 2001-02 24
Table 1.2: Best selling pharmaceuticals (2003) and their patent expiry dates 28
Table 2.3: Major generic companies in the US market 2002 41
Table 2.4: Generics players and their subsidiaries (selected list) 45
Table 3.5: Comparison of different national pharmaceutical price levels, 2000 56
Table 3.6: Generics players and their subsidiaries (selected list) 65
Table 4.7: Comparison of major legislative provisions in the US 79
Table 5.8: EU members and their date of accession 87
Table 5.9: Generic substitution by country in Europe (as at February 2004) 88
Table 5.10: EU data exclusivity times as at early 2003 91
Table 6.11: Key US patent expiries, 2001-2006 123
Table 7.12: European price comparisons, 1996-2003 129
Table 7.13: European reference pricing systems in each country, by type 134
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