The Top Ten Specialty Pharmaceutical Companies: Positioning, performance and SWOT analyses

The Top Ten Specialty Pharmaceutical Companies
Positioning, performance and SWOT analyses

Specialty pharmaceutical companies focus the majority of their efforts upon one or two therapeutic areas that are served by specialized physicians. Their traditional mode of operation is to acquire under-promoted branded products from Big Pharma companies that are generating lower sales and significantly increase revenues through the application of targeted marketing and promotional activities. However, the dynamics of the industry are changing. Rising costs for in-licensing and acquiring late stage/approved products have driven companies to develop products internally in order to remain competitive.

‘The Top Ten Specialty Pharmaceutical Companies’ is a new report published by Business Insights that explores the global competitive landscape of the specialty pharmaceutical industry. The latest key trends and evolving business models in the specialty pharmaceutical market are identified and the leading companies in this sector are profiled in detail. For each of the top ten specialty pharma companies, this report provides a detailed examination of geographic and therapeutic focus, major currently marketed products and growth strategies in the form of key acquisitions and divestments. The opportunities and threats facing each of these leading players are also assessed.

Discover the key trends and growth drivers of the specialty pharma market, compare the strategies and perfomance of the top ten companies and evaluate their future prospects with this new report...

Some key findings from this report

• The global specialty pharma market reached an overall value of $61.6bn in 2007, an increase of 15.7% from 2006. The ten leading companies represented 36.4% of the total market in 2007.

• Servier currently leads the worldwide specialty pharma industry. The company had a market share of 7.0% in 2007, representing sales of $4.3bn, an increase of 20.3% over 2006.

• Gilead intend to maintain its current dominance in the HIV/AIDS treatment market by accelerating the discovery, development and marketing of antiretroviral drugs and by establishing a foothold in the economies of emerging markets.

• Many drug delivery companies are changing focus to become specialty pharma companies, by using their drug delivery technologies to develop improved formulations of existing molecules. Alza was the first drug delivery company to complete this transition.

• Cephalon has a strong late-stage pipeline and anticipates several product approvals and launches during 2008–10. The company expects four FDA approvals within its oncology and pain management franchises in 2008, in addition to the launch of two new onclogy products before 2010.


Top reasons to order your copy today
• Identify the market dynamics of the global specialty pharma industry over the 2006-07 period, understand the potential benefits of emerging business models and identify the latest industrial trends across the UK, Japan, France, Germany, Italy, Spain and the US.

• Evaluate the performance and strategies of the top 10 players in the global specialty pharma market with this report’s examination of the geographic and therapeutic focus and currently marketed product portfolios of Servier, Gilead, Forest, Shire, Biogen Idec, Cephalon, Sepracor, Lundbeck, Endo Pharma and CSL.

• Assess the future prospects of the top ten specialty pharma companies with this report’s analysis of each firm’s strengths, weaknesses, opportunties and threats, in addition to an examination of growth strategies via product acquistions and divestments.

• Measure the progress of leading specialty pharma companies outside of the top ten by anlaysing the portfolios and therapeutic/geographic focus of Covidien, Allergan, ONO, Genzyme, Gruenenthal, Warner Chilcott, Ferring, Stiefel Labs, Bracco and Leo Pharma.

Key issues examined in this report
• Genericization of specialty products. Specialty pharma products with orphan drug status become vulnerable to genericization once this status has expired. Biogenerics are increasing as a result of favourable EU legislation.

• Cannibalization of product sales. Intense competition has forced specialty pharma companies to reformulate or recombine their products at a high rate. This ‘cannibalization’ has resulted in a shortening of individual product lifecycles.

• Lack of incentives in Europe. Pricing and reimbursement pressures in Europe have created greater boundaries to innovation, leading to fewer undervalued late-stage products. As a result, traditional specialty companies are likely to face future difficulties in this region.

• CNS treatments dominate the specialty sector. CNS is the largest therapeutic area for the leading specialty pharma companies, with half of the top ten companies focused on CNS and neurology treatments.

Your questions answered
• How fast is the global market for specialty pharmaceutical treatments expanding?

• What are the trends in the global specialty pharmaceutical market?

• Who are the top 10 players in the industry and how much of the market do they control?

• Which growth strategies have proven most effective?

• Which business models have been adopted by leading companies to gain competitive advantage and enhance market share?

• What are the strengths, weaknesses, opportunties and threats facing each of the top 10 players?

• Where are the most exciting growth opportunities for leading specialty pharmaceutical companies?

Report Highlights

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The top ten specialty pharmaceutical companies Executive Summary 14
Industry overview 14
Servier 15
Forest 15
Gilead 16
Shire 17
Biogen Idec 17
Cephalon 18
Sepracor 19
Lundbeck 19
Endo Pharmaceuticals 20
CSL 21
Chapter 1 Introduction 24
Scope of the report 24
Methodology 24
Chapter 2 Industry overview 28
Summary 28
Introduction 29
Different models of the specialty pharmaceutical industry 29
Product licensing players 30
Niche therapeutic area concentrators 30
De-prioritized product adopters 31
Drug delivery experts going up the value chain 31
Branded genericization experts 32
Market size and growth rate 33
Global positioning of the top 10 specialty pharmaceutical companies 34
Therapeutic focus of the top 10 34
Geographic focus of the top 10 36
Trends in the specialty pharmaceutical industry 38
Product life extension through label expansion 38
Genericization of specialty pharmaceutical products 39
Evolving specialty pharmaceutical industry in Japan and China 40
Japanese market 41
Chinese market 41
Drug delivery companies transitioning to specialty pharma companies 42
Chapter 3 Servier 44
Summary 44
Company overview 45
Geographic focus 46
Marketed products 47
Major therapeutic focus 48
Growth strategies 49
Investment in R&D capabilities 49
Acquisitions and divestments 49
SWOT analysis 50
Strengths 50
Strong in-house R&D capabilities 50
Dominant market position in Russia 51
Weaknesses 51
Dependence on low growth therapy areas 51
Opportunities 51
Boosting R&D efforts through collaboration 51
Threats 52
Tough operating conditions in France 52
Chapter 4 Forest 54
Summary 54
Company overview 55
Geographic focus 55
Marketed products 56
Major therapeutic focus 57
Growth strategies 57
Product acquisitions 57
Acquisitions/divestments 58
SWOT analysis 59
Strengths 59
Strong balance sheet 59
Strong selling and marketing capabilities 60
Weaknesses 60
Highly dependent on one blockbuster drug-Lexapro 60
Opportunities 60
Growing hospital-acquired infections (HAI) drug market 60
Threats 61
Sluggish antidepressant market 61
Chapter 5 Gilead 64
Summary 64
Company overview 65
Geographic focus 66
Marketed products 67
Major therapeutic focus 67
Growth strategies 67
Maintaining leadership position in the HIV/AIDS treatment 67
Expanding product portfolio in new therapy areas 68
Gaining traction in developing economies 69
Acquisitions and divestments 69
SWOT analysis 70
Strengths 70
Strong customer base for antiretroviral therapy 70
Strong presence in antiviral market 71
Weaknesses 71
Dependence on limited number of wholesalers in the US 71
Opportunities 72
Expanding treatments for chronic hepatitis 72
Agreement with Navitas Assets for Pulmonary Arterial
Hypertension (PAH) 72
Robust product pipeline in Phase II and Phase III clinical trials 72
Threats 73
Intense competition in crowded market segments 73
New product launches may cannibalize existing product sales 73
Chapter 6 Shire 76
Summary 76
Company overview 77
Geographic focus 78
Marketed products 79
Major therapeutic focus 80
Growth strategies 80
Focus outside the US 80
Focus on R&D in core therapeutic areas 81
Acquisitions and divestments 81
SWOT analysis 82
Strengths 82
Strong position in the US ADHD market 82
Weaknesses 83
Increase in SG&A expenses 83
Opportunities 83
Strong development pipeline 83
Expansion into Europe 84
Ability to Capitalize on the emerging adult ADHD market 84
Threats 84
Declining royalties with increasing competition 84
Chapter 7 Biogen Idec 88
Summary 88
Company overview 89
Geographic focus 90
Marketed products 91
Major therapeutic focus 91
Growth strategies 91
Expanding footprint in markets outside the US 91
Acquisitions and divestments 92
SWOT analysis 93
Strengths 93
Significant presence in immune system and oncology therapeutic
areas 93
Weaknesses 94
Substantial dependence on Avonex revenues 94
Opportunities 94
Robust product development pipeline 94
Threats 94
Increasing threat to Avonex in MS market 94
Arbitration with partner Genentech over Rituxan 95
Chapter 8 Cephalon 98
Summary 98
Company overview 99
Geographic focus 100
Marketed products 101
Major therapeutic focus 102
Growth strategies 102
Focus on growing oncology business and expanding beyond Europe 102
Acquisitions and divestments 103
SWOT analysis 104
Strengths 104
Strong presence in CNS with Provigil leading in the forefront 104
Strong pain management franchise 105
Weaknesses 105
Positioned in low growth therapeutic area 105
Opportunities 106
Strong late-stage product pipeline 106
Threats 106
Heavy focus on the US market 106
Chapter 9 Sepracor 110
Summary 110
Company overview 111
Geographic focus 111
Marketed products 112
Major therapeutic focus 113
Growth strategies 113
Realignment and expansion of sales force to enhance traction in target
markets 113
Expansion beyond the US market 114
Acquisitions and divestments 114
SWOT analysis 115
Strengths 115
Strong presence in insomnia drug market 115
Focused promotion in insomnia drug market 116
Weaknesses 116
Presence in low growth therapy areas 116
Opportunities 116
Successful licensing agreements 116
Threats 117
Single-isomers susceptible to patent challenges 117
Chapter 10 Lundbeck 120
Summary 120
Company overview 121
Geographic focus 122
Marketed products 123
Major therapeutic focus 123
Growth strategies 123
Establish commercial presence in Japan and the US 123
Acquisitions and divestments 124
SWOT analysis 125
Strengths 125
Strong position in the CNS market 125
Weaknesses 126
No commercial presence in the world’s largest pharmaceutical
markets 126
Opportunities 126
Broad product pipeline 126
Threats 127
R&D setbacks 127
Chapter 11 Endo Pharmaceuticals 130
Summary 130
Company overview 131
Geographic focus 131
Marketed products 132
Major therapeutic focus 132
Growth strategies 132
Focused marketing and promotional efforts for established brands 132
Enhancing product line through in-licensing complementary products,
compounds and technologies 133
Acquisitions and divestments 133
SWOT analysis 134
Strengths 134
Robust portfolio of branded products 134
Weaknesses 135
Over reliance on two key customers 135
Opportunities 135
Expansion of product portfolio through licensing agreement 135
Threats 136
Generic competition 136
Chapter 12 CSL 138
Summary 138
Company overview 139
Geographic focus 140
Marketed products 141
Major therapeutic focus 142
Growth strategies 142
Invest in new product development 142
Acquisitions and divestments 143
SWOT analysis 144
Strengths 144
Strong market position in plasma therapeutics 144
Weaknesses 145
Product recalls 145
Opportunities 145
Proposed acquisition of Talecris 145
Threats 145
Impact of AUSFTA 145
Chapter 13 11 to 20 Companies 148
Covidien 148
Company overview 148
Geographic focus 149
Marketed products 150
Major therapeutic focus 151
Allergan 152
Company overview 152
Geographic focus 153
Marketed products 154
Major therapeutic focus 155
ONO 156
Company overview 156
Marketed products 157
Major therapeutic focus 158
Genzyme 159
Company overview 159
Geographic focus 160
Marketed products 161
Major therapeutic focus 162
Gruenenthal 163
Company overview 163
Geographic focus 163
Marketed products 165
Major therapeutic focus 166
Warner Chilcott 167
Company overview 167
Geographic focus 167
Marketed products 168
Major therapeutic focus 169
Ferring 170
Company overview 170
Geographic focus 171
Marketed products 172
Major therapeutic focus 173
Stiefel Labs 174
Company overview 174
Geographic focus 175
Marketed products 176
Major therapeutic focus 177
Bracco 178
Company overview 178
Geographic focus 179
Marketed products 180
Major therapeutic focus 181
Leo Pharma 182
Company overview 182
Geographic focus 183
Marketed products 184
Major therapeutic focus 185
Chapter 14 Appendix 188
Glossary 188
Index 189
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Table 2.1: Largest therapy areas for the top 10 companies ($m), 2007 35
Table 2.2: Top 10 specialty pharmaceutical companies’ sales in the US/5EU ($m), 2007 37
Table 2.3: Orphan biologics blockbuster with expired market exclusivity in the US 40
Table 3.4: Servier snapshot 45
Table 3.5: Servier’s top marketed products global sales ($m), 2007 47
Table 4.6: Forest snapshot 55
Table 4.7: Forest’s top marketed products global sales ($m), 2007 56
Table 5.8: Gilead snapshot 65
Table 5.9: Gilead’s top marketed products global sales ($m), 2007 67
Table 6.10: Shire snapshot 77
Table 6.11: Shire’s top marketed products global sales ($m), 2007 79
Table 7.12: Biogen Idec snapshot 89
Table 7.13: Biogen Idec’s top marketed products global sales ($m), 2007 91
Table 8.14: Cephalon snapshot 99
Table 8.15: Cephalon’s top marketed products global sales ($m), 2007 101
Table 9.16: Sepracor snapshot 111
Table 9.17: Sepracor’s top marketed products global sales ($m), 2007 112
Table 10.18: Lundbeck snapshot 121
Table 10.19: Lundbeck’s top marketed products global sales ($m), 2007 123
Table 11.20: Endo Pharmaceuticals snapshot 131
Table 11.21: Endo Pharmaceuticals top marketed products global sales ($m), 2007 132
Table 12.22: CSL snapshot 139
Table 12.23: CSL’s top marketed products global sales ($m), 2007 141
Table 13.24: Covidien snapshot 148
Table 13.25: Covidien’s top marketed products global sales ($m), 2007 150
Table 13.26: Allergan snapshot 152
Table 13.27: Allergan’s top marketed products global sales ($m), 2007 154
Table 13.28: ONO snapshot 156
Table 13.29: ONO’s top marketed products global sales ($m), 2007 157
Table 13.30: Genzyme snapshot 159
Table 13.31: Genzyme’s top marketed products global sales ($m), 2007 161
Table 13.32: Gruenenthal snapshot 163
Table 13.33: Gruenenthal’s top marketed products global sales ($m), 2007 165
Table 13.34: Warner Chilcott snapshot 167
Table 13.35: Warner Chilcott’s top marketed products global sales ($m), 2007 168
Table 13.36: Ferring snapshot 170
Table 13.37: Ferring’s top marketed products global sales ($m), 2007 172
Table 13.38: Stiefel Labs snapshot 174
Table 13.39: Stiefel Labs’ top marketed products global sales ($m), 2007 176
Table 13.40: Bracco snapshot 178
Table 13.41: Bracco’s top marketed products global sales ($m), 2007 180
Table 13.42: Leo Pharma snapshot 182
Table 13.43: Leo Pharma’s top marketed products global sales ($m), 2007 184
Figure 2.1: Niche therapeutic area concentrators’ business model 30
Figure 2.2: De-prioritized product adopters’ business model 31
Figure 2.3: Drug delivery experts’ business model 32
Figure 2.4: Branded genericization experts’ business model 32
Figure 2.5: Top 10 specialty pharmaceutical companies global market share (%), 2007 34
Figure 2.6: Geographic focus of the top 10 companies in the US/5EU, 2007 36
Figure 2.7: Trends in the specialty pharmaceuticals industry 38
Figure 3.8: Servier’s geographic focus, 2006–07 46
Figure 3.9: Servier’s therapeutic focus, 2007 48
Figure 3.10: Servier SWOT analysis 50
Figure 4.11: Forest’s therapeutic focus, 2007 57
Figure 4.12: Forest SWOT analysis 59
Figure 5.13: Gilead’s geographic focus, 2006–07 66
Figure 5.14: Gilead SWOT analysis 70
Figure 6.15: Shire’s geographic focus, 2006–07 78
Figure 6.16: Shire’s therapeutic focus, 2007 80
Figure 6.17: Shire SWOT analysis 82
Figure 7.18: Biogen Idec’s geographic focus, 2006–07 90
Figure 7.19: Biogen Idec SWOT analysis 93
Figure 8.20: Cephalon’s geographic focus, 2006–07 100
Figure 8.21: Cephalon’s therapeutic focus, 2007 102
Figure 8.22: Cephalon SWOT analysis 104
Figure 9.23: Sepracor’s therapeutic focus, 2007 113
Figure 9.24: Sepracor SWOT analysis 115
Figure 10.25: Lundbeck’s geographic focus, 2006–07 122
Figure 10.26: Lundbeck SWOT analysis 125
Figure 11.27: Endo Pharm SWOT analysis 134
Figure 12.28: CSL’s geographic focus, 2006–07 140
Figure 12.29: CSL’s therapeutic focus, 2007 142
Figure 12.30: CSL SWOT analysis 144
Figure 13.31: Covidien’s geographic focus, 2006–07 149
Figure 13.32: Covidien’s therapeutic focus, 2007 151
Figure 13.33: Allergan’s geographic focus, 2006–07 153
Figure 13.34: Allergan’s therapeutic focus, 2007 155
Figure 13.35: ONO’s therapeutic focus, 2007 158
Figure 13.36: Genzyme’s geographic focus, 2006–07 160
Figure 13.37: Genzyme’s therapeutic focus, 2007 162
Figure 13.38: Gruenenthal’s geographic focus, 2006–07 164
Figure 13.39: Gruenenthal’s therapeutic focus, 2007 166
Figure 13.40: Warner Chilcott’s therapeutic focus, 2007 169
Figure 13.41: Ferring’s geographic focus, 2006–07 171
Figure 13.42: Ferring’s therapeutic focus, 2007 173
Figure 13.43: Stiefel Labs’ geographic focus, 2006–07 175
Figure 13.44: Stiefel Labs’ therapeutic focus, 2007 177
Figure 13.45: Bracco’s geographic focus, 2006–07 179
Figure 13.46: Bracco’s therapeutic focus, 2007 181
Figure 13.47: Leo Pharma’s geographic focus, 2006–07 183
Figure 13.48: Leo Pharma’s therapeutic focus, 2007 185
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