Influenza Vaccines
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Infectious Disease pharmaceutical analysis team - page 2
- CHAPTER 1 VACCINE MARKET OVERVIEW - page 10
- Towards the $10 billion barrier - page 10
- Vaccines - a good business to be in - page 10
- Differences between IMS Health and company-reported data - page 11
- Vaccines - a good business to be in - page 10
- The US market - strong products and stakeholder commitment - page 14
- Childhood vaccines - more coverage, better tracking - page 15
- Adult vaccines - playing catch-up - page 19
- Vaccine funding - moving to the private sector - page 21
- Prevnar maintains dominance of pneumococcal vaccines - page 22
- A successful year - page 22
- Strong clinical impact - page 23
- Overcoming vaccine shortages - page 24
- International roll-out - page 25
- Future challenges to Prevnar - page 27
- The US market - the strengthening adolescent segment - page 28
- GSK's Boostrix and Sanofi's Adacel - page 29
- Boostrix profile - page 30
- Adacel profile - page 31
- Sanofi's Menactra - page 31
- US recommendations for college students - a long time coming - page 33
- Menactra - a better meningitis vaccine - page 34
- Menactra - an expensive campaign - page 35
- Menactra - next steps - page 36
- Chiron's meningococcal ACWY vaccine - page 37
- HPV vaccines on the way - page 37
- Merck and GSK are developing preventative HPV vaccines - page 37
- Gardasil versus Cervarix - page 40
- Issues associated with STI vaccination - page 41
- HPV vaccine market potential - page 44
- GSK's Boostrix and Sanofi's Adacel - page 29
- 2005 - unprecedented commercial activity - page 46
- Aggressive GSK leads a growing global market - page 46
- Acquisition of ID Biomedical - page 48
- Novartis acquires weakened Chiron - page 49
- Further consolidation - Crucell moves on Berna - page 51
- Aggressive GSK leads a growing global market - page 46
- Towards the $10 billion barrier - page 10
- CHAPTER 2 THE INFLUENZA VACCINE MARKET - page 53
- Influenza is a global killer - page 53
- Influenza is a global burden, affecting mainly the elderly and the very young - page 53
- Influenza A and B cause annual epidemics - page 54
- Antigenic drift versus antigenic shift - page 55
- Seasonal (interpandemic) influenza - page 56
- Pandemic influenza - page 58
- A rare but recurrent event - page 59
- Avian influenza H5N1 - a pandemic strain? - page 60
- Global preparedness planning - page 62
- Despite decades of experience, producing flu vaccines is a difficult business - page 64
- Current flu vaccines are classified into TIV and LAIV - page 64
- Unpredictable demand and commodity pricing - page 66
- Historical fluctuation in number of flu vaccine manufacturers - page 66
- Chiron debacle exposes the fragility of US seasonal vaccine supply - page 67
- Current value and volume estimation of the global seasonal influenza vaccine market - page 71
- The challenge of new product development - page 73
- The pros and cons of LAIV - page 74
- Intranasal administration is not enough to command premium pricing - page 75
- Restricted age indication prevents usage in high-risk groups - page 75
- FluMist requires storage at -15°C and cannot be refrozen following thawing - page 76
- Strategies designed to increase product uptake - page 76
- Influenza is a global killer - page 53
- CHAPTER 3 MARKETED AND DEVELOPMENTAL INFLUENZA VACCINES - page 78
- Overview of egg-based systems - page 78
- Producing an egg-based vaccine takes six months - page 78
- Adjuvantation significantly improves vaccine efficacy - page 80
- Fluzone - page 81
- Key facts - page 81
- Vaccine description - page 81
- Event screen - page 82
- Fluvirin - page 83
- Key facts - page 83
- Vaccine description - page 83
- Clinical trial data - page 84
- Event screen - page 84
- Fluarix - page 87
- Key facts - page 87
- Vaccine description - page 88
- Clinical trial data - page 88
- Event screen - page 88
- FluMist - page 90
- Key facts - page 90
- Vaccine description - page 90
- Clinical trial data - page 91
- Event screen - page 91
- Inflexal - page 93
- Key facts - page 93
- Vaccine description - page 93
- Clinical trial data - page 93
- Event screen - page 94
- Fluviral - page 95
- Key facts - page 95
- Vaccine description - page 96
- Ongoing clinical trials - page 96
- Event screen - page 96
- Summary - page 98
- Producing an egg-based vaccine takes six months - page 78
- Developmental influenza vaccines - page 98
- Egg-based systems - a time for replacement? - page 98
- Newer egg-based systems - page 101
- Solvay's Invivac is based on virosomal technology - page 101
- MedImmune's CAIV-T - a replacement for FluMist? - page 102
- Cell culture-based systems - page 103
- Vero, MDCK or PER.C6 cells? - page 105
- Solvay's Influvac TC has long been approved but not marketed - page 109
- Baxter's InfluJect (PreFluCel) - an uncertain future - page 109
- Chiron's cell culture influenza vaccine - page 110
- Sanofi-Crucell's inactivated split virus vaccine - page 110
- Nobilon's/BioDiem's LAIV - page 111
- Other technologies - page 111
- FluInsure - a proteosome-based approach - page 112
- FluBlØk - producing hemagglutinin in insect cells - page 112
- PowderMed's plasmid DNA vaccine - is it safe? - page 114
- Acambis's "universal" M2 ion channel-based influenza vaccine - page 116
- Overview of egg-based systems - page 78
- CHAPTER 4 FUTURE OUTLOOK - page 117
- Several growth drivers fuel significant expansion of the influenza vaccine market - page 117
- Commitments to increased vaccination - page 117
- Strategies aimed at increasing vaccination coverage - page 119
- Over 10 new vaccine launches by 2010 - page 120
- Commitments to increased vaccination - page 117
- The global vaccine market 2010 - page 121
- In the seven major markets, 2010 sales might be as high as $3.7 billion - page 121
- Consensus among different forecasts - page 122
- Assumptions - page 123
- Methodology - page 127
- In the seven major markets, 2010 sales might be as high as $3.7 billion - page 121
- Commercial drivers and resistors to cell culture flu - page 128
- Expensive to establish - page 129
- Expensive to license - page 130
- Who is most committed? - page 134
- The role of vaccination in a pandemic - page 136
- H5N1 prototype pandemic vaccines - page 138
- Sanofi Pasteur's alum adjuvanted vaccine - page 138
- Chiron's MF59 adjuvanted vaccine - page 139
- GSK's pandemic vaccine - page 139
- Others - page 140
- H5N1 prototype pandemic vaccines - page 138
- Vaccines versus antivirals - page 140
- Roche and the renaissance of Tamiflu - page 144
- Several growth drivers fuel significant expansion of the influenza vaccine market - page 117
- APPENDIX A - page 148
- Segmenting the vaccine market - page 148
- Sales channels and limitations of IMS data - page 148
- Bibliography - page 152
- Journals - page 152
- Datamonitor reports - page 154
- Miscellaneous - page 155
- Press releases - page 157
- Other press releases (not sourced in the text) - page 160
- Websites - page 165
- Segmenting the vaccine market - page 148
- List of Tables
- Table 1: Classification of global vaccines businesses - page 11
- Table 2: Major company reported vaccines sales, 1999-2005 - page 13
- Table 3: Coverage estimates for school entry vaccinations, 2004-05 school year - page 16
- Table 4: Pediatric/VFC Vaccine Price List, December 2005 - page 18
- Table 5: Adult vaccine price list, December 2005 - page 22
- Table 6: Booster responses to the Tetanus, Diphteria and Pertussis antigens following Boostrix in individual aged 10-18 years - page 31
- Table 7: Scenarios measuring cost effectiveness of meningitis vaccination - page 36
- Table 8: Estimated prophylactic HPV vaccine peak sales - page 46
- Table 9: TIV versus LAIV vaccines: key common and differentiating factors - page 65
- Table 10: Unfolding of events at Chiron's Liverpool plant - page 69
- Table 11: Global influenza vaccine sales for key Western manufacturers, 2003-04 - page 72
- Table 12: FluMist, a LAIV vaccine, is up to 77.5% more expensive than Fluzone, a TIV vaccine - page 75
- Table 13: Fluzone: key facts - page 81
- Table 14: Fluzone dosing by age group - page 81
- Table 15: Key Fluzone events, 2004-05 - page 82
- Table 16: Fluvirin: key facts - page 83
- Table 17: Key Fluvirin events, 2004-05 - page 84
- Table 18: Fluarix: key facts - page 87
- Table 19: Key Fluarix events, 2004-05 - page 88
- Table 20: FluMist: key facts - page 90
- Table 21: Key FluMist events, 2004-05 - page 91
- Table 22: Inflexal V: key facts - page 93
- Table 23: Inflexal clinical trial results - page 94
- Table 24: Key Inflexal V events, 2004-05 - page 94
- Table 25: Fluviral: key facts - page 95
- Table 26: Key Fluviral events, 2004-05 - page 97
- Table 27: Influenza vaccines comparator table - page 98
- Table 28: Key developmental influenza vaccines - page 100
- Table 29: Protection rates of Invivac versus Influvac - page 101
- Table 30: Comparative analysis of Vero, MDCK and PER.C6 cell lines - page 105
- Table 31: Estimated US 2003/04 and 2004/05 season influenza vaccine coverage, and 2010 healthy people goal - page 118
- Table 32: Census data, 2003 and 2010, seven major markets - page 123
- Table 33: Estimated populations for targeted influenza vaccination, 2003/04 influenza season - page 125
- Table 34: Actual and estimated influenza vaccination coverage rates, 2003-04 and 2010 - page 126
- Table 35: Seasonal influenza vaccine market: 2003-04 estimation and 2010 forecast - page 127
- Table 36: Key GSK influenza vaccine-related events, 2004-05 - page 136
- Table 37: Developmental H5N1 pandemic vaccines - page 140
- Table 38: Marketed influenza antivirals - page 141
- List of Figures
- Figure 1: Evaluating global vaccine market value and contribution, 2004 - page 12
- Figure 2: Contribution of vaccine companies outside the top 10, 2004 - page 14
- Figure 3: Market segmentation by region, 2004 - page 15
- Figure 4: US Recommended and Childhood and Adolescent Immunization Schedule, 2005 - page 17
- Figure 5: Extent of individuals receiving influenza vaccination by state, 2004 - page 20
- Figure 6: Recommended Adult Immunization Schedule, 2005-06 - page 21
- Figure 7: Global market segmentation by vaccine type, 2004 - page 26
- Figure 8: Number of reported pertussis cases per year, 1922-2000 - page 30
- Figure 9: Meningitis outbreaks by serogroups and community settings, 1994-2002 - page 33
- Figure 10: Overview of Gardasil Phase III study presented at the Infectious Diseases Society of America (IDSA) annual meeting 2005 - page 39
- Figure 11: Comparison of Merck's and GSK's candidate HPV preventative vaccines - page 40
- Figure 12: Potential positioning of developmental prophylactic HPV vaccines - page 43
- Figure 13: Global market share of major vaccines companies, 2004 - page 47
- Figure 14: The acquisition of ID Biomedical increases GSK's manufacturing capacity and exposure to the US market - page 48
- Figure 15: Overview of GSK's flu vaccine strategy - page 49
- Figure 16: Global influenza disease burden - page 53
- Figure 17: Population at high risk of influenza infection or influenza-associated complications - page 54
- Figure 18: Influenza virus: structure and electron micrograph - page 55
- Figure 19: Antigenic drift versus antigenic shift - page 56
- Figure 20: Months of peak influenza activity per season and recommended vaccinations season - page 57
- Figure 21: Incidence and mortality caused by H5N1 between December 2003 and December 2005 - page 61
- Figure 22: The six phases of pandemic preparedness - page 63
- Figure 23: US Influenza vaccine demand fluctuates between seasons - page 67
- Figure 24: Breakdown of high-risk individuals in whom flu vaccination was recommended in the 2004-05 influenza season - page 68
- Figure 25: Expected and delivered influenza vaccine for the US 2004/05 season - page 70
- Figure 26: Projected supplies for the 2005-06 influenza season - page 73
- Figure 27: Approved age groups for influenza vaccines expected to supply the 2005-06 US market - page 74
- Figure 28: Strategies to increase FluMist penetration in the short and the long term - page 76
- Figure 29: Strategies for the increase of influenza vaccination coverage - page 120
- Figure 30: Estimated US launches of developmental influenza vaccines - page 121
- Figure 31: The influenza vaccine market is expected to expand to over $3.7 billion by 2010 in the seven major markets - page 122
- Figure 32: Forecasting methodology - page 128
- Figure 33: Commercial and regulatory resistors against cell culture flu - page 128
- Figure 34: Tamiflu versus Relenza sales, seven major markets, 2000-04 - page 143
- Figure 35: Global Tamiflu sales, 2000-H1 2005 - page 145
- Figure 36: Global pandemic versus non-pandemic Tamiflu sales, Q1-Q3 2005 - page 146
- Figure 37: Simplified schematic demonstrating vaccine supply channels to patients - page 150
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