Pipeline and Commercial Insight: Influenza Vaccines - Pandemic threat revitalizes the sector
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Infectious Diseases Pharmaceutical Analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the influenza vaccine market - page 4
- Key metrics - page 6
- Datamonitor Pipeline Assessment Summary - page 7
- CHAPTER 2 EPIDEMIOLOGY - page 9
- Incidence - page 9
- Risk groups - page 11
- Transmission and symptoms - page 12
- Diagnosis - page 14
- Virus subtypes - page 14
- Prevention and treatment - page 16
- Vaccination prevents influenza infection - page 16
- Antivirals can provide symptom relief and accelerate recovery - page 17
- Antigenic shift and drift - page 17
- Seasonal influenza epidemics - page 19
- Influenza pandemics - page 21
- Recent pandemics - fearsome lessons - page 22
- Current pandemic status - waiting for the wave - page 23
- H5N1 - the next pandemic virus? - page 25
- Pandemic scenario - dramatic outlook for public health and economy - page 29
- Preparing for disaster - national and international pandemic planning - page 30
- CHAPTER 3 MARKET DEFINITION AND OVERVIEW - page 32
- Market size and growth estimates - page 33
- Current vaccine classes - page 35
- Trivalent inactivated vaccines - page 35
- Life-attenuated influenza vaccines - page 35
- Vaccine manufacturing - page 38
- Egg-based manufacturing is lengthy and inflexible - page 40
- Cell-based manufacturing would offer big advantages - page 43
- MDCK (Madin Darby Canine Kidney Cells) - page 45
- Vero cells - page 45
- Per.C6 cells - page 46
- Although highly promising, cell culture-based manufacturing still needs further development - page 47
- Influenza vaccine supply - a yearly gamble - page 48
- The number of vaccine manufacturers is fluctuating - page 49
- Manufacturing capacities are expanding, but still not sufficient to meet global needs - page 51
- Manufacturing problems can have a dramatic impact - the Chiron case - page 54
- Influenza vaccine demand fluctuates considerably and is hard to predict - page 57
- Time shifts between supply and vaccination schedules lead to fading demand as the flu season progresses - page 59
- Changes in recommendations and subjective perception of risk have a significant impact on demand - page 60
- Vaccination coverage rates vary among countries - page 62
- Complex distribution pathways can delay timely vaccine supply - page 67
- Country analysis - page 70
- US - actively encouraging increased vaccination and influenza research - page 70
- Pull - enlarging the national market size - page 71
- Push - supporting the entry of additional products and suppliers - page 75
- EU5 - slowly waking up to the influenza challenge - page 77
- A European Influenza Task Force could improve co-ordination between European countries and the industry - page 78
- Flu vaccines are cheaper in Europe than in the US - page 78
- Reimbursement policies favor risk groups - page 79
- Japan - low awareness and distrust hamper vaccine uptake - page 80
- Japan has a low vaccination coverage due to low awareness and unfavorable reimbursement rates - page 80
- Pandemic preparedness is a central concern of the Japanese government - page 81
- US - actively encouraging increased vaccination and influenza research - page 70
- Unmet needs in influenza vaccines - page 82
- Pandemic vaccines could moderate the impact of a flu pandemic - page 83
- Extending of manufacturing capacities would guarantee sufficient vaccine supply - page 85
- Adjuvants could lead to better efficacy of vaccines in the elderly and reduce the amount of antigen needed for immunization - page 85
- Faster manufacturing techniques would make vaccine production more flexible - page 87
- Universal vaccines could eliminate the need for yearly updates - page 88
- Needle-free administration methods would make vaccination more convenient - page 89
- CHAPTER 4 CURRENT PLAYERS AND THEIR STRATEGIES - page 91
- Overview - page 92
- Sanofi pasteur - expanding market leadership - page 93
- Current position - page 93
- Fluzone (Vaxigrip) - page 93
- Strategic development - page 94
- Cell-culture-based manufacturing - high hopes for Per.C6 - page 95
- Capacity - leading the field - page 95
- Adjuvants - falling behind? - page 96
- Pandemic vaccines - first-to-market in the US? - page 96
- Strategic outlook - page 98
- Current position - page 93
- Novartis Vaccines - recovering from Chiron's failure - page 98
- Current position - page 98
- Fluvirin - page 98
- Agrippal S1 - page 99
- Fluad - page 99
- Begrivac - page 100
- Strategic development - page 100
- Expanding reach - acquisition of Chiron provided access to influenza vaccine market - page 100
- Cell-culture-based manufacturing - first-to-market with Optaflu? - page 101
- Capacity - new facilities in the US and Europe set to increase production - page 101
- Adjuvants - MF59, a new paradigm? - page 102
- Pandemic vaccines - Europe as stepping stone - page 103
- Strategic outlook - page 103
- Current position - page 98
- GSK - the lucky third - page 103
- Current position - page 103
- Fluarix - page 104
- FluLaval/Fluviral - page 104
- Strategic development - page 105
- Expanding reach - acquisition of ID Biomedical opens gate to the US market - page 105
- Cell-culture-based manufacturing - lagging behind the competition - page 106
- Capacity - acquisition of Wyeth's Marietta facility set to speed up cell-based manufacturing - page 107
- Adjuvants -acquisition of Corixa provides access to novel technologies - page 107
- Pandemic vaccines - first and second generation candidates show promising prospects - page 107
- Strategic outlook - page 108
- Current position - page 103
- MedImmune - new hope in pediatric treatment - page 108
- Current position - page 108
- FluMist - page 109
- Strategic development - page 110
- Expanding reach - positioning and market penetration as main issues - page 110
- Cell-culture-based manufacturing - catching up with the giants - page 112
- Capacity - fill/finish as critical bottleneck - page 113
- Pandemic vaccines - joining forces with NIAID - page 113
- Strategic outlook - page 114
- Current position - page 108
- CSL - preparing to enter the US market - page 114
- Current position - page 114
- Fluvax - page 114
- Strategic development - page 115
- Expanding reach - US launch likely in the near future - page 115
- Capacity - doubling production for the US market - page 116
- Pandemic vaccines - slim chances to match the competition - page 116
- Strategic outlook - page 117
- Current position - page 114
- Solvay - failing to commercialize on Influvac TC - page 117
- Current position - page 117
- Influvac - page 117
- Invivac/Inflexal V - page 118
- Strategic development - page 118
- Cell-culture-based manufacturing - Influvac TC loses competitive advantage due to manufacturing delay - page 119
- Capacity - it's all about cell-based production - page 119
- Pandemic vaccines - projects still in early stages - page 119
- Strategic outlook - page 120
- Current position - page 117
- CHAPTER 5 PATIENT-BASED FORECAST ANALYSIS - page 121
- Datamonitor's patient-based forecasting model - page 122
- Limitations of the patient-based forecasting model - page 122
- CHAPTER 6 R&D APPROACH - page 124
- Classification of pipeline products - page 124
- Seasonal influenza vaccines - page 124
- Pandemic influenza vaccines - page 124
- Clinical trial design in influenza vaccine studies - page 125
- Classification of pipeline products - page 124
- CHAPTER 7 PIPELINE ANALYSIS SEASONAL INFLUENZA - page 128
- Pipeline overview for seasonal influenza - page 129
- Late-stage pipeline summary - page 130
- Comparative assessment - page 131
- Definition of current comparator therapy - page 133
- Seasonal influenza vaccine gold standard: Fluzone - page 134
- Optaflu (Novartis Vaccines) - page 137
- Drug overview - page 137
- Clinical trial data - page 138
- Phase III trial (EU) - comparison of safety, tolerability and immunogenicity of influenza vaccines in adults and elderly - page 140
- Patient potential - page 141
- Marketing factors - page 142
- Satisfaction of unmet needs - page 142
- Datamonitor drug assessment summary - page 143
- FluBlØk (Protein Sciences/UMN Pharma) - page 144
- Drug overview - page 144
- Clinical trial data - page 145
- Phase II/III - immunogenicity and safety of trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine in healthy adults - page 147
- Phase IIb - dose-related safety and immunogenicity of a trivalent baculovirus-expressed influenza-virus hemagglutinin vaccine in elderly adults - page 148
- Patient potential - page 150
- Marketing factors - page 150
- Satisfaction of unmet needs - page 150
- Datamonitor drug assessment summary - page 151
- Flu Improved (GlaxoSmithKline) - page 153
- Drug overview - page 153
- Clinical trial data - page 153
- Phase II trial (EU) - Study to evaluate the immunogenicity and the safety of an adjuvanted influenza vaccine candidate - page 155
- Patient potential - page 155
- Marketing factors - page 155
- Satisfaction of unmet needs - page 156
- Datamonitor drug assessment summary - page 156
- Seasonal flu vaccines (Sanofi pasteur) - page 157
- Flu Micro-Injection - page 157
- Flu Infants - page 157
- Flu vaccine - new formulation - page 158
- FluInsure (GlaxoSmithKline) - page 158
- Drug overview - page 158
- Clinical trial data - page 159
- Patient potential - page 161
- Marketing factors - page 161
- Satisfaction of unmet needs - page 162
- Datamonitor drug assessment summary - page 162
- Immunostimulant seasonal influenza vaccine (Iomai) - page 163
- Drug overview - page 163
- Clinical trial data - page 163
- Patient potential - page 164
- Marketing factors - page 164
- Satisfaction of unmet needs - page 164
- Datamonitor drug assessment summary - page 165
- Late-stage pipeline vaccines developed outside the seven major markets - page 166
- Influsome-Vac (NasVax) - page 166
- LAIV (BioDiem, Nobilon) - page 166
- Early-stage vaccines for prevention of seasonal influenza - page 167
- DNA vaccines - page 168
- PowderMed - Pfizer's entry route into the vaccine business - page 170
- Universal vaccines - page 171
- DNA vaccines - page 168
- Late-stage development compounds recently discontinued - page 172
- InfluJect (Baxter) - an uncertain future - page 173
- Pipeline overview for seasonal influenza - page 129
- CHAPTER 8 PIPELINE ANALYSIS PANDEMIC INFLUENZA - page 175
- Pipeline overview for pandemic influenza - page 175
- Late-stage pipeline summary - page 179
- Comparative assessment - page 180
- Definition of current comparator therapy - page 181
- H5N1 vaccines - page 182
- Sanofi pasteur - page 183
- H5N1 influenza virus vaccine - page 183
- GSK - page 186
- Daronrix - page 186
- H5N1-007 - page 188
- Novartis Vaccines - page 190
- Focetria - page 190
- Baxter - page 193
- H5N1 pandemic vaccine - page 193
- CSL - page 195
- H5N1 Pandemic Vaccine - page 195
- Sanofi pasteur - page 183
- H9N2 vaccines - page 197
- Novartis Vaccines - page 198
- H9N2 pandemic vaccine - page 198
- GSK - page 200
- H9N2 pandemic vaccine - page 200
- Crucell - page 202
- H9N2 pandemic vaccine - page 202
- Novartis Vaccines - page 198
- H2N2 vaccines - page 204
- GSK - page 204
- H2N2 pandemic vaccine - page 204
- GSK - page 204
- Early-stage vaccines for prevention of pandemic influenza - page 206
- Pipeline overview for pandemic influenza - page 175
- APPENDIX A - page 207
- Bibliography - page 207
- APPENDIX B - page 231
- Limitations of IMS data - page 231
- About Datamonitor - page 232
- About Datamonitor Healthcare - page 232
- Datamonitor Healthcare's therapy area capabilities - page 233
- About the Infectious Diseases analysis team - page 234
- Key therapy team members - page 235
- Holger Rovini, Head of Respiratory and Infectious Diseases - page 235
- Hedwig Kresse, Associate Analyst, Infectious Diseases - page 235
- Disclaimer - page 235
- List of Tables
- Table 1: Key influenza parameters for the seven major markets - page 6
- Table 2: Companies developing cell-based manufacturing and US funding for cell culture development - page 44
- Table 3: Current and future production capacity of key influenza vaccine manufacturers - page 53
- Table 4: Influenza vaccination rates in the US, 2004 - page 72
- Table 5: Influenza vaccine catalog prices by manufacturer, US. 2005-06 - page 77
- Table 6: Influenza pandemic contracts announced to date - page 84
- Table 7: Key needle-free influenza vaccine administration methods in development, 2007 - page 90
- Table 8: Acquisitions in the influenza vaccine space, 2005-06 - page 93
- Table 9: Fluzone dosages - page 94
- Table 10: Fluvax dosages by age group - page 115
- Table 11: Late-stage pipeline seasonal influenza, February 2007 - page 131
- Table 12: Datamonitor drug assessment parameters - page 132
- Table 13: Fluzone (Sanofi pasteur) - product profile - page 134
- Table 14: Fluzone formulations, 2006-07 - page 134
- Table 15: Fluzone - efficacy in children aged 6-24 months - page 135
- Table 16: Optaflu (Novartis) - product profile - page 137
- Table 17: Optaflu - clinical trial summary - page 139
- Table 18: FluBlØk (Protein Sciences) - product profile - page 144
- Table 19: FluBlØk - clinical trial summary - page 146
- Table 20: Flu Improved (GSK) - product profile - page 153
- Table 21: Flu Improved - clinical trial summary - page 154
- Table 22: FluInsure (GSK) - product profile - page 158
- Table 23: FluInsure - clinical trial summary - page 160
- Table 24: Immunostimulant seasonal influenza vaccine (Iomai) - product profile - page 163
- Table 25: Early-stage seasonal and universal influenza vaccines, February 2007 - page 168
- Table 26: Key DNA flu vaccines in development - page 170
- Table 27: Recently discontinued late-stage influenza vaccines - page 173
- Table 28: Pandemic influenza - late-stage pipeline overview - page 180
- Table 29: H5N1 influenza virus vaccine (Sanofi pasteur) - product profile - page 183
- Table 30: Daronrix (GSK) - product profile - page 186
- Table 31: H5N1-007 (GSK) - product profile - page 188
- Table 32: Focetria (Novartis) - product profile - page 190
- Table 33: H5N1 pandemic vaccine (Baxter) - product profile - page 193
- Table 34: H5N1 pandemic vaccine (CSL) - product profile - page 195
- Table 35: H9N2 pandemic vaccine (Novartis) - product profile - page 198
- Table 36: H9N2 pandemic vaccine (GSK) - product profile - page 200
- Table 37: H9N2 pandemic vaccine (Crucell) - product profile - page 202
- Table 38: H2N2 pandemic vaccine (GSK) - product profile - page 204
- Table 39: Early stage pipeline pandemic influenza vaccines, February 2007 - page 206
- List of Figures
- Figure 1: Drivers and restrictors in the influenza vaccine market - page 5
- Figure 2: Influenza vaccine market size forecast (7MM), 2006-16 - page 6
- Figure 3: Datamonitor pipeline assessment summary - seasonal influenza vaccines - page 7
- Figure 4: Datamonitor pipeline assessment summary - pandemic influenza vaccines - page 7
- Figure 5: Global annual influenza disease burden - page 10
- Figure 6: Population at high risk of influenza infection or influenza-associated complications - page 12
- Figure 7: Influenza A virus: structure and electron micrograph - page 15
- Figure 8: Antigenic drift versus antigenic shift - page 19
- Figure 9: Recommended vaccination schedule and months of peak influenza activity, US 1976-2006 - page 20
- Figure 10: Development of a pandemic influenza virus - page 21
- Figure 11: Overview over influenza pandemics in the 20th century - page 22
- Figure 12: WHO and CDC classification systems for pandemic threat - page 24
- Figure 13: Emergence of new Influenza A subtypes, 1977-2006 - page 25
- Figure 14: Cumulative number of confirmed human cases of avian Influenza A/(H5N1) - page 26
- Figure 15: Spread of H5N1 in poultry, wild birds and humans, 1996-2006 - page 27
- Figure 16: Current spread of H5N1 in poultry and wild birds, January 2007 - page 28
- Figure 17: Geographical spread of influenza vaccine sales, 2006 - page 33
- Figure 18: Growth drivers of the flu vaccine market - page 34
- Figure 19: TIV and LAIV - key common and differentiating factors - page 37
- Figure 20: Steps of the influenza vaccine manufacturing process and involved stakeholders - page 39
- Figure 21: Egg-based vaccine manufacturing - page 40
- Figure 22: Comparative analysis of MDCK, Vero and Per.C6 cells - page 44
- Figure 23: Vaccine providers for the US market, 2000-06 - page 50
- Figure 24: Vaccine manufacturers in the seven major markets, 2006 - page 51
- Figure 25: Global influenza vaccine manufacturing capacity, 1994-2006 - page 52
- Figure 26: Influenza vaccine manufacturing facilities, 2006 - page 52
- Figure 27: High-risk individuals recommended for flu vaccination, US. 2004-05 - page 55
- Figure 28: Chiron - share price in response to events, Aug 2004- May 2005 - page 56
- Figure 29: Expected, delivered and demanded influenza vaccine supply for the US, 2004-05 season - page 57
- Figure 30: Influenza vaccine supply versus demand in the US, 1980-2006 - page 58
- Figure 31: Flu vaccine supply and demand in relation to population recommended for vaccination, US 2003-06 - page 58
- Figure 32: Supply versus demand in a typical flu season - page 59
- Figure 33: Global influenza vaccination coverage, 2002-03 season - page 65
- Figure 34: Drivers and restrictors for influenza vaccination - page 66
- Figure 35: US influenza vaccine distribution network - page 68
- Figure 36: Use of different providers for influenza vaccination, US, 2005-06 - page 70
- Figure 37: US government strategies to foster growth of the national flu vaccine market - page 71
- Figure 38: US average prices per dose in multi-dose vials, TIVs, 2002-06 - page 76
- Figure 39: Unmet needs in influenza vaccines - page 83
- Figure 40: Leading players in the influenza vaccine market, US and EU5, 2005 - page 92
- Figure 41: Sanofi pasteur - influenza vaccine strategy - page 94
- Figure 42: Novartis Vaccines - influenza vaccine strategy - page 100
- Figure 43: GSK - influenza vaccine strategy - page 105
- Figure 44: MedImmune - influenza vaccine strategy - page 110
- Figure 45: CSL - influenza vaccine strategy - page 115
- Figure 46: Solvay - influenza vaccine strategy - page 118
- Figure 47: Influenza vaccine clinical trial process - page 126
- Figure 48: Datamonitor's assessment of seasonal influenza pipeline vaccines - page 133
- Figure 49: Fluzone - strengths and weaknesses - page 136
- Figure 50: Comparison of seroprotection rates between Optaflu and Agrippal in EU Phase III trial, 2006 - page 141
- Figure 51: Optaflu - Datamonitor's competitive positioning analysis for seasonal influenza, 2007 - page 143
- Figure 52: FluBlØk: - efficacy results of Phase IIb trial - page 149
- Figure 53: FluBlØk - Datamonitor's competitive positioning analysis for seasonal influenza, 2007 - page 152
- Figure 54: Flu Improved - Datamonitor's competitive positioning analysis for seasonal influenza, 2007 - page 156
- Figure 55: FluInsure - Datamonitor's competitive positioning analysis for seasonal influenza, 2007 - page 162
- Figure 56: Iomai's immunostimulant seasonal influenza vaccine - Datamonitor's competitive positioning analysis for seasonal influenza, 2007 - page 165
- Figure 57: Pandemic versus pre-pandemic vaccination strategy - page 178
- Figure 58: Datamonitor drug assessment summary - pandemic influenza pipeline vaccines - page 181
- Figure 59: Datamonitor's competitive positioning analysis of H5N1 influenza virus vaccine (Sanofi pasteur) for pandemic influenza, 2007 - page 184
- Figure 60: Datamonitor's competitive positioning analysis of Daronrix (GSK) for pandemic influenza, 2007 - page 187
- Figure 61: Datamonitor's competitive positioning analysis of H5N1-007 (GSK) for pandemic influenza, 2007 - page 189
- Figure 62: Datamonitor's competitive positioning analysis of Focetria (Novartis) for pandemic influenza, 2007 - page 191
- Figure 63: Datamonitor's competitive positioning analysis of H5N1 pandemic vaccine (Baxter) for pandemic influenza, 2007 - page 194
- Figure 64: Datamonitor's competitive positioning analysis of H5N1 pandemic vaccine (CSL) for pandemic influenza, 2007 - page 196
- Figure 65: Datamonitor's competitive positioning analysis of H9N2 pandemic vaccine (Novartis) for pandemic influenza, 2007 - page 199
- Figure 66: Datamonitor's competitive positioning analysis of H9N2 pandemic vaccine (GSK) for pandemic influenza, 2007 - page 201
- Figure 67: Datamonitor's competitive positioning analysis of H9N2 pandemic vaccine (Crucell) for pandemic influenza, 2007 - page 203
- Figure 68: Datamonitor's competitive positioning analysis of H2N2 pandemic vaccine (GSK) for pandemic influenza, 2007 - page 205
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