Infectious Diseases Vaccine Market Overview: Key Companies & Strategies - In times of crisis, Big Pharma turns to vaccines

Long being regarded as an unattractive market, vaccines have re-emerged as successful growth driver for Big Pharma. The launch and rapid uptake of novel, high-price products such as Wyeth's Prevnar or Merck & Co's Gardasil, along with the emergence of novel vaccine technologies and favourable legislation have brought vaccines back into the main focus of pharmaceutical and biotech companies.

Report Highlights
With the exception of influenza, only two to three vaccine manufacturers compete for each disease. This lack of competition combined with public health requirements to guarantee a stable supply of vaccines has resulted in a recent upward shift of vaccine prices for specialty vaccines.

The most significant threat to the oligopoly of the Big 5 in the vaccines market comes from companies from emerging markets, which have large manufacturing capacities for biologics and are able to produce even complex substances like vaccines at low costs.

While vaccine sales have grown at a CAGR of 32% between 2004 and 2007 and shown an annual growth rate of 46% between 2006 and 2007, overall pharmaceutical sales have grown much more slowly, with both the 2004-2007 CAGR as well as the growth rate between 2006 and 2007 only reaching 8%.
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ABOUT DATAMONITOR HEALTHCARE 2
About the Infectious diseases pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Strategic scoping and focus 3
Datamonitor insight into the disease market 3
Related reports 8
CHAPTER 2 MARKET DEFINITION 10
Market definition for this report 10
CHAPTER 3 MARKET OVERVIEW 12
Summary 12
Vaccines have emerged as key revenue drivers for Big Pharma 13
The emergence of new technologies has increased the possibilities for vaccine development 13
The success stories of Prevnar and Gardasil fuel hopes for further vaccine blockbusters 15
New legislation in the US has decreased the risks of litigation for vaccine manufacturers 18
The high entry hurdles for generics manufacturers make vaccines an attractive sector in times of the decline of the traditional blockbuster model 20
Upholding the strong growth of the vaccine sector as a whole will be the key challenge in the coming decade 23
Current market assessment 24
Five big companies dominate the vaccines market 24
The global vaccine market is growing very fast and the importance of vaccines for pharmaceutical portfolios is increasing 25
Over the last four years, approvals of novel vaccines as well as consolidation have shaped the global vaccine market 28
The US remain the main market for vaccines in 2007 29
Wyeth's Prevnar and Merck & Co's Gardasil have both reached blockbuster status 30
Snapshot of other important vaccines players 31
AstraZeneca: holding on to MedImmune's heritage? 33
Bavarian Nordic: niche player in biodefense 33
Baxter - strong manufacturing capacity as key opportunity 33
CSL: controlling the Australian vaccines market 34
Crucell: attractive dual business model 35
Emergent BioSolutions: focusing on biodefense 35
Intercell: the multi-partner company 36
Pfizer: building on DNA vaccines and adjuvants 37
Solvay: influenza as key focus 37
Opportunities and threats 38
Opportunities 39
Development of vaccines for novel indications 39
Development of new technologies 41
Expansion to emerging and developing markets 41
Increasing awareness and ""disease marketing"" 43
Threats 44
Cost containment 44
Regulatory requirement for increasingly large trials increases upfront investments and development times 45
Low-cost manufacturers from emerging markets could shake up the sector and undercut prices 46
Negative publicity and public scares through anti-vaccination activists 48
CHAPTER 4 MERCK & CO - THE INNOVATOR 51
Summary 51
Strategic overview 52
History of vaccines division 52
Sales performance 55
Geographic spread 56
Seasonality 57
Role of vaccines in overall company portfolio 58
Portfolio analysis 60
Gardasil 61
RotaTeq 64
Zostavax 66
Hepatitis franchise 68
Other viral vaccines 70
Other vaccines 71
Pipeline analysis 73
Heplisav 76
V710 78
V503 79
V419 79
V950 80
Deals and alliances 80
Product deals 81
In-licensing of Heplisav from Dynavax Technologies 83
Collaboration with Intercell regarding staphylococcal vaccines 83
In-licensing of Gardasil from CSL 84
Development collaborations with PATH and the Indian Council of Medical Research 84
M&A, distribution and marketing agreements 85
Technology deals 85
In-licensing of Idera's TLR7, 8, 9 adjuvant candidates for use in vaccines against oncology, infectious diseases and Alzheimer's disease 86
Research collaboration with Iomai regarding Iomai's transdermal patch delivery technology 87
Grants and government contracts 87
Strategic outlook 88
Strengths: Merck & Co's strong portfolio of novel, high-price vaccines will continue to provide large vaccine revenues 89
Weaknesses: late-stage failures have thinned Merck & Co's vaccine pipeline 89
Opportunities: further geographic expansion of Merck & Co's novel vaccines portfolio could result in substantial revenue increases 91
Threats: competition for RotaTeq and Gardasil is emerging 92
CHAPTER 5 SANOFI PASTEUR - THE CUSTOMIZER 93
Summary 93
Strategic overview 94
History of vaccines division 94
Sales performance 98
Seasonality 99
Role of vaccines in overall company portfolio 99
Portfolio analysis 101
Influenza vaccine franchise 102
Pediatric combination franchise 105
Adult/adolescent booster franchise 109
Meningitis/pneumonia franchise 111
Travel, endemic, MMR vaccine franchise 114
Other vaccines 116
Pipeline analysis 118
Influenza 123
Pediatric and adolescent combination vaccines 124
Meningitis/pneumonia 125
Travelers and endemic vaccines 126
Other vaccines 128
Deals and alliances 130
Product deals 130
Licensing agreement with Crucell regarding cell-based influenza vaccines and related technical services agreement with Lonza 133
Manufacturing and supply agreement with M.P. Chumakov Institute of Poliomyelitis and Virus Encephalitides regarding polio vaccine for Russia 133
Research and license agreement with Statens Serum Institut regarding tuberculosis vaccine candidate 133
M&A, distribution and marketing agreements 134
Acquisition of Acambis 135
Joint venture with Daiichi Sankyo for the Japanese market 136
Technology deals 136
Licensing of Becton-Dickinson's micro-delivery technology 139
Grants and government contracts 139
Strategic outlook 141
Strengths: ongoing leadership in important flu and pediatric combination sectors 142
Weaknesses: focus on follow-on has resulted in lack of innovation 143
Opportunities: hidden pipeline gems with blockbuster potential 144
Threats: Menactra's monopoly expected to fall 144
CHAPTER 6 GLAXOSMITHKLINE - THE ALL-ROUNDER 146
Summary 146
Strategic overview 147
History of vaccine division 147
Sales performance 150
Geographic spread 151
Seasonality 152
Role of vaccines in overall company portfolio 153
Portfolio analysis 155
Infanrix franchise 156
Hepatitis franchise 159
Influenza franchise 160
Cervarix 163
Rotarix 165
Other vaccines 166
Pipeline analysis 167
Meningitis 170
Pneumococcal disease 171
Influenza 171
Travel vaccines and tuberculosis 172
Cancer 172
Deals and alliances 173
Product deals 173
In-licensing of two Alzheimer vaccine candidates from Affiris 175
In-licensing of MAGE-A3 and other tumor antigens from the Ludwig Institute of Cancer Research 175
In-licensing of meningitis antigens and IP from Imclone 175
In-licensing of Rotarix from AVANT Immunotherapeutics 176
Strategic alliance with MedImmune for the development of Cervarix 176
M&A, public-private partnerships, distribution and marketing agreements 176
Acquisition of ID Biomedical 179
Acquisition of Corixa Corporation 180
Promotion Service Agreement with Sinovac Biotech and establishment of an exclusive cooperation agreement with Shenzhen Neptunus Interlong Bio-Technique Co. Ltd. (NIBT) 180
Technology deals 181
Licensing of MedImmune's reverse genetics technology for influenza 183
Grants and government contracts 183
Strategic outlook 184
Strengths: commercializing on a continuing strong portfolio 186
Weaknesses: suboptimal US penetration constitutes major revenue limitation 186
Opportunities: strong pipeline to drive future revenues 187
Threats: FDA's attitude towards novel adjuvants unlikely to change soon 188
CHAPTER 7 WYETH - THE ONE HIT WONDER 190
Summary 190
Strategic overview 191
History of vaccines division 191
Sales performance 193
Geographic spread 194
Seasonality 195
Role of vaccines in overall company portfolio 196
Portfolio analysis 198
Prevnar 199
Pipeline analysis 201
Prevnar 13 203
ACC-001 204
MnB rLP2086 204
Deals and alliances 205
Product deals 205
License agreement with RIVM for meningitis B vaccine 206
Alliance with Elan for development of new drugs to treat Alzheimer's disease 206
M&A, public-private partnerships 207
Equity Investment in Alphavax 208
Technology deals 208
In-licensing of Inhibitex's MSCRAMM (Microbial Surface Components Recognizing Adhesive Matrix Molecules) protein technology 210
Inlicensing of Inovio's DNA delivery technology 210
Grants and government contracts 210
Strategic outlook 211
Strengths: Wyeth will continue to dominate the pneumococcal vaccine market 212
Weaknesses: strong reliance on Prevnar franchise as sole revenue generator 213
Opportunities: strong focus on new geographies and target groups 214
Threats: emerging competitors in key revenue sectors 214
CHAPTER 8 NOVARTIS - THE NEWCOMER 216
Summary 216
Strategic overview 217
History of vaccines division 217
Sales performance 220
Geographic spread 221
Seasonality 222
Role of vaccines in overall company portfolio 223
Portfolio analysis 224
Influenza vaccine franchise 225
Travel vaccine franchise 227
Meningitis vaccines 228
Pediatric/adult DTP/polio/Hib vaccines 229
Pipeline analysis 230
Meningitis 234
Influenza 235
Novel therapeutic vaccines 236
CAD106 (Alzheimer's disease, Phase II) 236
Nic002 (nicotine dependence, Phase II) 236
Others 237
Deals and alliances 238
Product deals 238
Strategic partnership with Intercell 241
Marketing and distribution agreement for Intercell's Ixiaro 241
In-licensing of CAD106 and Nic002 from Cytos Biotechnology 242
M&A, distribution and marketing agreements 242
Acquisition of Chiron 244
Acquisition of PowderJect and Spin-off of PowderMed by Chiron 245
Divestment of SBL Vaccin AB 246
Technology deals 246
Grants and government contracts 247
Strategic outlook 249
Strengths: Novartis has a strong influenza portfolio and excellent science 250
Weaknesses: two years after the acquisition of Chiron, Novartis's vaccine division is still fragmented 251
Opportunities: Menveo and Men B as potential blockbusters 251
Threats: competition in the meningitis space is fierce 252
BIBLIOGRAPHY 253
Company financial reports 253
Merck & Co 253
Sanofi Pasteur 253
GlaxoSmithKline 253
Wyeth 254
Novartis 254
Further literature 254
APPENDIX 263
Contributing experts 263
Report methodology 263
About Datamonitor 264
About Datamonitor Healthcare 264
About the Infectious Diseases analysis team 265
Key therapy team members 266
Holger Rovini, Head of Respiratory and Infectious Diseases 266
Hedwig Kresse, Senior Analyst, Infectious Diseases 266
Disclaimer 267
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Table 1: Vaccine sales and growth rates of the top five vaccine manufacturers, 2004-9M2008 26
Table 2: Sales breakdown of the four best-selling vaccines, 2004-9M 2008 31
Table 3: Recent key mergers and acquisitions in the vaccines industry, December 2008 32
Table 4: Summary of opportunities and threats in the vaccines market, 2008 39
Table 5: Merck & Co - vaccine portfolio overview, December 2008 61
Table 6: Merck & Co - Gardasil product overview 62
Table 7: Merck & Co - RotaTeq product overview 64
Table 8: Merck & Co - Zostavax product overview 66
Table 9: Merck & Co - hepatitis franchise product overview 68
Table 10: Merck & Co - other viral vaccines product overview 70
Table 11: Merck & Co - other vaccines product overview 72
Table 12: Merck & Co - vaccine pipeline overview, December 2008 74
Table 13: Merck & Co - key vaccine product deals, December 2008 82
Table 14: Merck & Co - Vaccine joint venture with Sanofi Pasteur 85
Table 15: Merck & Co - key vaccine technology deals, December 2008 86
Table 16: Merck & Co vaccines - SWOT analysis, December 2008 88
Table 17: Sanofi Pasteur - vaccine portfolio overview, December 2008 102
Table 18: Sanofi Pasteur - influenza vaccine franchise product overview 103
Table 19: Sanofi Pasteur - pediatric combination vaccine franchise key product overview 107
Table 20: Sanofi Pasteur - booster vaccine franchise product overview 110
Table 21: Sanofi Pasteur - meningitis/pneumonia vaccine franchise product overview 112
Table 22: Sanofi Pasteur - traveler/endemic vaccine franchise product overview 115
Table 23: Sanofi Pasteur - vaccine pipeline overview, December 2008 119
Table 24: Sanofi Pasteur - Key vaccine product deals (1); December 2008 131
Table 25: Sanofi Pasteur - Key vaccine product deals (2); December 2008 132
Table 26: Sanofi Pasteur - key vaccine M&A, public-private partnerships, distribution/marketing agreements, December 2008 135
Table 27: Sanofi Pasteur - key vaccine technology deals, December 2008 138
Table 28: Sanofi Pasteur - key grants and government contracts for vaccines, December 2008 140
Table 29: Sanofi Pasteur - SWOT analysis, December 2008 142
Table 30: GlaxoSmithKline - vaccine portfolio overview, December 2008 156
Table 31: GlaxoSmithKline - Infanrix franchise product overview 157
Table 32: GlaxoSmithKline - DTP adolescent booster product overview 157
Table 33: GlaxoSmithKline - hepatitis franchise product overview 159
Table 34: GlaxoSmithKline - influenza vaccine franchise product overview 162
Table 35: GlaxoSmithKline - other vaccines, overview 167
Table 36: GlaxoSmithKline - vaccine pipeline overview, December 2008 168
Table 37: GlaxoSmithKline - key vaccine product deals; December 2008 174
Table 38: GlaxoSmithKline - key vaccine M&A, public-private partnerships, distribution/marketing agreements, December 2008 178
Table 39: GlaxoSmithKline - key vaccine technology deals, December 2008 182
Table 40: GlaxoSmithKline - key grants and government contracts for vaccines, December 2008 184
Table 41: GlaxoSmithKline vaccines - SWOT analysis, December 2008 185
Table 42: Wyeth - vaccines pipeline, December 2008 202
Table 43: Wyeth - key vaccine product deals, December 2008 206
Table 44: Wyeth - key vaccine M&A, public-private partnerships, distribution/marketing agreements, December 2008 208
Table 45: Wyeth - key vaccine technology deals, December 2008 209
Table 46: Wyeth - key grants and government contracts for vaccines, December 2008 211
Table 47: Wyeth vaccines - SWOT analysis, December 2008 212
Table 48: Novartis - vaccine portfolio overview; December 2008 225
Table 49: Novartis - Influenza vaccine franchise product overview 226
Table 50: Novartis - travel vaccine franchise key product overview 227
Table 51: Novartis - meningococcal vaccine franchise product overview 228
Table 52: Novartis - clinical vaccine pipeline overview, December 2008 231
Table 53: Novartis - key vaccine product deals, December 2008 240
Table 54: Novartis - key vaccine M&A, public-private partnerships, distribution/marketing agreements, December 2008 244
Table 55: Novartis - key vaccine technology deals, December 2008 247
Table 56: Novartis - key grants and government contracts for vaccines, December 2008 248
Table 57: Novartis - SWOT analysis, December 2008 249
Figure 1: Comparison of IMS-reported versus company-reported global sales data for vaccines, 2007 10
Figure 2: Prevnar: global sales 2001-9M2008 16
Figure 3: Gardasil: sales 2004-9M2008 17
Figure 4: National Vaccine Injury Compensation Program - petition and award statistics, 1990-2008 20
Figure 5: Comparison of lifecycles of pharmaceuticals and vaccines 22
Figure 6: Market growth cycle for vaccines 23
Figure 7: Market shares of the five key vaccine players in total vaccine sales, 2004 versus 2007 24
Figure 8: Combined vaccine sales of the top five vaccine manufacturers, 2004-9M2008 25
Figure 9: Vaccines versus overall pharmaceutical sales, 2007 27
Figure 10: Vaccine sales as share of overall company pharmaceutical sales, 2004-9M2008 28
Figure 11: Key events impacting the vaccines market, 2004-08 29
Figure 12: 2007 vaccine sales of Merck & Co, GlaxoSmithKline, Wyeth, Novartis and Sanofi Pasteur MSD by geography 30
Figure 13: Share of leading vaccines on a product basis, 2004-2007 31
Figure 14: Birth cohort sizes - seven major markets versus BRIC countries 42
Figure 15: Possible strategies for penetration of emerging markets 43
Figure 16: Public sector costs of routine childhood immunization per child, US, 1975-2008 44
Figure 17: Number of enrolled patients in Phase III trials for selected vaccines 46
Figure 18: Presence of local/regional vaccine manufacturers in emerging geographies 47
Figure 19: Reported measles cases and MMR vaccination coverage in England, 1996--2007 49
Figure 20: Merck & Co - vaccines pedigree, 2008 54
Figure 21: Merck & Co - total vaccine sales, 2004-2008; Q1-Q3 56
Figure 22: Merck & Co vaccine sales - geographic spread, 2004-9M2008 57
Figure 23: Merck & Co - total vaccine sales, by quarter, 2006-9M2008 58
Figure 24: Merck & Co - vaccine sales as share of overall company pharmaceutical sales, 2004-9M2008 59
Figure 25: Merck & Co - vaccines versus overall pharmaceutical sales, 2007 60
Figure 26: Merck & Co - Gardasil sales by geography, 2004-9M2008 62
Figure 27: Merck & Co - RotaTeq sales by geography, 2004-9M2008 65
Figure 28: Merck & Co - Zostavax sales by geography, 2004-9M2008 67
Figure 29: Merck & Co - hepatitis franchise sales by geography, 2004-9M2008 69
Figure 30: Merck & Co - other viral vaccines sales by geography, 2004-9M2008 71
Figure 31: Merck & Co - other vaccines sales by geography, 2004-9M2008 73
Figure 32: Merck & Co - overlap between marketed vaccines portfolio and pipeline vaccines, December 2008 75
Figure 33: Merck & Co - clinical vaccines pipeline depth, December 2008 76
Figure 34: Sanofi Pasteur - history of vaccines division 96
Figure 35: Sanofi Pasteur - vaccines pedigree, 2008 97
Figure 36: Sanofi Pasteur - total vaccine sales, 2004-9M 2008 98
Figure 37: Sanofi Pasteur - total vaccine sales, by quarter, 2006-9M2008 99
Figure 38: Sanofi Aventis - vaccine sales as share of overall company pharmaceutical sales, 2004-9M2008 100
Figure 39: Sanofi Aventis - vaccines versus overall pharmaceutical sales, 2007 101
Figure 40: Sanofi Pasteur - influenza vaccine franchise sales, 2004-9M2008 104
Figure 41: Sanofi Pasteur - pediatric combination vaccine franchise sales, 2004-9M2008 108
Figure 42: Sanofi Pasteur - booster vaccine franchise sales, 2004-9M2008 110
Figure 43: Sanofi Pasteur - meningitis/pneumonia vaccine franchise sales, 2004-9M2008 113
Figure 44: Sanofi Pasteur - traveler/endemic vaccine franchise sales, 2004-9M2008 116
Figure 45: Sanofi Pasteur - other vaccine sales, 2004-9M2008 117
Figure 46: Sanofi Pasteur - share of Sanofi Pasteur MSD joint venture sales by vaccine class, 2004-9M2008 118
Figure 47: Sanofi Pasteur - clinical vaccines pipeline depth and breadth, December 2008 121
Figure 48: Sanofi Pasteur - overlap between marketed vaccines portfolio and pipeline vaccines, December 2008 122
Figure 49: GlaxoSmithKline - history of vaccines division 148
Figure 50: GlaxoSmithKline - vaccines pedigree, 2008 149
Figure 51: GlaxoSmithKline - total vaccine sales, 2004-9M2008 151
Figure 52: GlaxoSmithKline vaccine sales - geographic spread, 2004-9M2008 152
Figure 53: GlaxoSmithKline - total vaccine sales, by quarter, 2006-9M2008 153
Figure 54: GlaxoSmithKline - vaccine sales as share of overall company pharmaceutical sales, 2004-9M2008 154
Figure 55: GlaxoSmithKline - vaccines versus overall pharmaceutical sales, 2007 155
Figure 56: GlaxoSmithKline - Infanrix and Boostrix franchise sales by geography, 2004-9M2008 158
Figure 57: GlaxoSmithKline - hepatitis vaccine franchise sales by geography, 2004-9M2008 160
Figure 58: GlaxoSmithKline - influenza vaccine franchise sales by geography, 2004-9M2008 163
Figure 59: GlaxoSmithKline - Cervarix sales by geography, 2004-9M2008 164
Figure 60: GlaxoSmithKline - Rotarix sales by geography, 2004-9M2008 166
Figure 61: GlaxoSmithKline - overlap between marketed vaccines portfolio and pipeline vaccines, December 2008 169
Figure 62: GlaxoSmithKline - clinical vaccines pipeline depth and breadth, December 2008 170
Figure 63: GlaxoSmithKline vaccines pipeline - adjuvanted versus non-adjuvanted candidates, December 2008 188
Figure 64: Wyeth - vaccines pedigree, 2008 192
Figure 65: Wyeth - total vaccine sales (Prevnar), 2004-9M2008 193
Figure 66: Wyeth vaccine sales (Prevnar) - geographic spread, 2004-9M2008 195
Figure 67: Wyeth - total vaccine sales (Prevnar), by quarter, 2006-9M2008 196
Figure 68: Wyeth - vaccine sales (Prevnar) as share of overall company pharmaceutical sales, 2004-9M2008 197
Figure 69: Wyeth - vaccines (Prevnar) versus overall pharmaceutical sales, 2007 198
Figure 70: Wyeth - Prevnar sales by geography, 2004-9M2008 200
Figure 71: Wyeth - overlap between marketed vaccines portfolio and pipeline vaccines, December 2008 202
Figure 72: Novartis - history of vaccines division 218
Figure 73: Novartis - vaccines pedigree, 2008 219
Figure 74: Novartis- total vaccine sales, 2004-9M2008 221
Figure 75: Novartis vaccines and diagnostics sales - geographic spread, 2004-9M2008 222
Figure 76: Novartis - total vaccine and diagnostics sales, by quarter, 2006-9M2008 223
Figure 77: Novartis - vaccines and diagnostics sales as share of overall company pharmaceutical sales (excluding consumer health), 2004-9M2008 224
Figure 78: Novartis - overlap between marketed vaccines portfolio and pipeline vaccines 232
Figure 79: Novartis - clinical vaccines pipeline depth and breadth, December 2008 233
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