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 influenza market 3
Related reports 6
Upcoming related reports 6
CHAPTER 2 MARKET DEFINITION 8
Market definition for this report 8
CHAPTER 3 SEASONAL INFLUENZA VACCINE MARKET OVERVIEW AND FORECAST 10
Seven major markets 10
Current and future market overview 10
Vaccination recommendations 11
Vaccination coverage rates 13
Opportunities and threats 13
Opportunities 13
Threats 19
Forecast to 2018/19 20
US 23
Current market assessment 23
Vaccination recommendations 26
Vaccination coverage rates 27
Opportunities and threats 34
Opportunities 35
Threats 45
Forecast to 2018/19 50
Japan 54
Current and future market assessment 54
Vaccination recommendations 55
Vaccination coverage rates 56
Opportunities and threats 57
Opportunities 58
Threats 60
Forecast to 2018/19 61
Five major European markets (5EU) 64
Current and future market assessment 64
Vaccination recommendations 65
Vaccination coverage rates 69
Opportunities and threats 74
Opportunities 75
Threats 77
Forecast to 2018/19 77
France 79
Current and future market assessment 79
Vaccination recommendations 82
Vaccination coverage rates 84
Forecast to 2018/19 87
Germany 91
Current and future market assessment 91
Vaccination recommendations 95
Vaccination coverage rates 96
Forecast to 2018/19 98
Italy 102
Current and future market assessment 102
Vaccination recommendations 103
Vaccination coverage rates 104
Forecast to 2018/19 105
Spain 109
Current and future market assessment 109
Vaccination recommendations 111
Vaccination coverage rates 113
Forecast to 2018/19 114
UK 117
Current and future market assessment 117
Vaccination recommendations 119
Vaccination coverage rates 121
Forecast to 2018/19 123
Rest of the world snapshot 127
Current market assessment 127
Unmet needs 129
Vaccines with increased efficacy in the elderly constitute the largest unmet need 130
Experts still see a need for novel influenza treatment and prevention strategies 132
Needle-free administration techniques could make vaccination faster and more convenient 133
Faster and more flexible manufacturing technologies are particularly important for pandemic vaccine supply 134
Antigen sparing is a key focus for pandemic vaccination 136
Improved efficacy in children is considered less important by most experts 137
CHAPTER 4 INFLUENZA VACCINES - KEY DEVELOPERS, PRODUCTS AND STRATEGIES 138
Strategic Overview 138
Trends in corporate strategy 139
Improved immunogenicity, particularly in the elderly, is a key development focus 140
Alternative delivery routes could increase convenience and efficacy 141
Manufacturing capacity continues to play an important role for corporate strategies 142
Vaccine manufacturers are looking to expand to additional geographies 144
Pandemic vaccines offer government funding and stockpiling opportunities 145
Sanofi Pasteur - the market leaders 146
Corporate strategy overview 146
Influenza portfolio assessment 149
Seasonal influenza vaccines 149
Pandemic influenza vaccines (excluding influenza A(H1N1)) 153
Manufacturing capacity 155
Adjuvants 156
Strategic outlook 157
Novartis - the innovators 158
Corporate strategy overview 158
Influenza portfolio assessment 159
Seasonal influenza vaccines 159
Fluvirin 161
Agrippal S1 162
Fluad/Adiugrip 162
Begrivac 163
Optaflu 164
Pandemic influenza vaccines (excluding influenza A(H1N1)) 164
Manufacturing capacity 167
Adjuvants 167
Strategic outlook 168
GlaxoSmithKline - the lucky third 170
Corporate strategy overview 170
Influenza portfolio assessment 173
Seasonal influenza vaccines 173
Pandemic influenza vaccines (excluding influenza A(H1N1)) 178
Manufacturing capacity 180
Adjuvants 180
Strategic outlook 181
AstraZeneca/MedImmune - the niche players 182
Corporate strategy 182
Influenza portfolio assessment 184
Seasonal influenza vaccines 184
Pandemic influenza vaccines (excluding influenza A(H1N1)) 189
Manufacturing capacity 190
Adjuvants 191
Strategic outlook 191
CSL - the southern stars 193
Corporate strategy 193
Influenza portfolio assessment 194
Seasonal influenza vaccines 194
Pandemic influenza vaccines (excluding influenza A(H1N1)) 195
Manufacturing capacity 197
Adjuvants 197
Strategic outlook 198
Solvay - looking east 199
Corporate strategy 199
Influenza portfolio assessment 201
Seasonal influenza vaccines 201
Pandemic influenza vaccines (excluding influenza A(H1N1)) 204
Manufacturing capacity 205
Adjuvants 206
Strategic outlook 206
Portfolio assessment of other leading companies 207
Other seasonal vaccines in development 207
Other marketed seasonal influenza vaccines 208
Other pipeline seasonal influenza vaccines 209
Other pandemic vaccines in clinical development (excluding influenza A(H1N1)) 214
CHAPTER 5 INFLUENZA ANTIVIRALS 218
Overview of competitive landscape 218
US 223
Japan 223
5EU 224
Tamiflu (oseltamivir; Roche) 226
Drug profile 226
Commercial perspective 227
SWOT analysis and outlook 230
Relenza (zanamivir; GlaxoSmithKline) 233
Drug profile 233
Commercial perspective 234
SWOT analysis 236
Drivers of brand choice 238
Tamiflu offers a more convenient mode of administration 238
Relenza's better resistance profile could increase the drug's market share 239
Reports linking Tamiflu with neuropsychiatric events are perceived negatively by parts of the medical community 240
Outlook - balancing of stockpiles likely 241
US formulary tier status for leading brands 242
Trends in marketing strategies 243
Marketing strategy for leading influenza antivirals 243
Tamiflu 244
Relenza 245
Promotional spend 245
Unmet needs 247
Pipeline influenza antivirals 249
Peramivir (Biocryst, Shionogi, Green Cross) 249
Drug profile 250
Development overview 251
Product positioning 253
SWOT analysis 253
CS-8958 (Biota, Daiichi Sankyo) 254
Drug profile 255
Development overview 256
Product positioning 259
SWOT analysis 259
Favipiravir/T-705 (Toyama) 260
Drug profile 261
Innovative early stage compounds 263
CHAPTER 6 THE 2009 INFLUENZA A(H1N1) PANDEMIC 265
Background and timeline 265
Over the last century, three influenza A pandemics have occurred 265
The current influenza A(H1N1) pandemic continues to spread rapidly across the globe 266
Antivirals 270
Key challenges for antiviral therapy of influenza A(H1N1) 270
The emergence of resistances against antivirals, including Tamiflu, is a major risk 270
Supply shortages are likely if influenza antivirals are used without sufficient consideration 270
Compulsory licensing for influenza antivirals could become a threat in emerging and developing countries 272
Vaccination against influenza A(H1N1) 272
Key challenges for vaccine development and administration against influenza A(H1N1) 273
Lack of manufacturing capacity is likely to result in undersupply of pandemic vaccine 273
Timely production and administration of a vaccine will be crucial 276
The organization of a seamless supply chain will be the greatest challenge in pandemic management 279
Costs will be an issue for developing countries 281
Key needs with regards to influenza A(H1N1) vaccine development and production 282
Safety and reactogenicity are the most important requirements for an influenza A(H1N1) vaccine 283
Fast manufacturing technologies remain a key need 284
Established influenza vaccine and treatment providers will draw the largest commercial benefit out of the current influenza(H1N1) pandemic 285
Novartis - indirect benefits for adjuvant technology expected 289
GlaxoSmithKline - the allrounders 290
Roche - relying on ongoing need for Tamiflu 292
Baxter - outpacing the competition in manufacturing 292
Sanofi Pasteur - set to gain from capacity lead 293
MedImmune - focusing on the US 294
CSL - Australia and beyond 295
There is room and need for other strategies such as universal vaccines or influenza antibodies 296
Success in universal influenza vaccine development has been limited so far 297
Influenza antibodies could provide a useful tool for the treatment of severe cases of influenza 300
BIBLIOGRAPHY 302
Literature 302
APPENDIX A - MARKET ASSUMPTIONS 322
Data definitions, limitations and assumptions 322
Standard units 322
Forecast methodology 322
Datamonitor forecast methodology 322
Datamonitor's patient-based forecasting model 323
Limitations of the patient-based forecasting model 325
APPENDIX B 326
Contributing experts 326
Conferences attended 326
Report methodology 326
About Datamonitor 327
About Datamonitor Healthcare 327
About the Infectious Diseases analysis team 328
Key therapy team members 329
Holger Rovini, Head of Respiratory and Infectious Diseases 329
Hedwig Kresse, Senior Analyst, Infectious Diseases 329
Disclaimer 330
List of Tables
Table 1: Influenza vaccine recommendations, seven major markets, 2009 12
Table 2: Summary of opportunities and threats in the influenza market, seven major markets, 2009 13
Table 3: Seven major markets - seasonal influenza vaccine market forecast; 2005/06-2018/19 21
Table 4: Seasonal influenza vaccine recommendations in key target groups, US, 2009 27
Table 5: Summary of opportunities and threats in the inflammatory bowel disease market in the US, 2009 35
Table 6: Estimated influenza vaccination rates, US, 2009 43
Table 7: US - seasonal influenza vaccine market forecast; 2005/06-2018/19 51
Table 8: US - seasonal influenza vaccine coverage forecast; 2005/06-2018/19 53
Table 9: Currently marketed seasonal influenza vaccines, Japan, 2009 54
Table 10: Seasonal influenza vaccine recommendations for key target groups, Japan, 2009 56
Table 11: Summary of opportunities and threats in the influenza market, Japan, 2009 58
Table 12: Japan - seasonal influenza vaccine market forecast; 2005/06-2018/19 62
Table 13: Japan - seasonal influenza vaccine coverage forecast; 2005/06-2018/19 64
Table 14: National influenza vaccine recommendations for individuals suffering from underlying medical conditions (without regard to age); 5EU, 2009 67
Table 15: Summary of opportunities and threats in the influenza market, 5EU, 2009 75
Table 16: 5EU - seasonal influenza vaccine market forecast; 2005/06-2018/19 79
Table 17: Currently marketed seasonal influenza vaccines, France, 2009 80
Table 18: Influenza vaccine prices per dose, France, 2005-2008 81
Table 19: Seasonal influenza vaccine recommendations, France, 2009 83
Table 20: France - seasonal influenza vaccine market forecast; 2005/06-2018/19 89
Table 21: France - seasonal influenza vaccine coverage forecast; 2005/06-2018/19 91
Table 22: Currently approved and marketed seasonal influenza vaccines, Germany, 2009 93
Table 23: Influenza vaccine prices per dose, Germany, 2005-2008 94