NEW YORK, Feb. 16 Reportlinker.com announces that a new market research report is available in its catalogue:
Commercial prospects for dengue vaccines
Advertisement
http://www.reportlinker.com/p0177162/Commercial-prospects-for-dengue-vaccines.html
Dengue vaccines have reached the late-phase clinical trials stage. Beremans has undertaken a robustly independent and realistic assessment of the commercial prospects of these vaccines. Beremans is not linked to or affiliated with any organisation with any interest in promoting dengue vaccines, whether commercial or not-for-profit; there were no conflicts of interest which could have affected our findings. The report includes an examination of the clinical need for a vaccine (nature of disease, independent estimation of global incidence, identification and quantification of at-risk populations worldwide), an outline of the scientific / technological background (including key issues in dengue vaccine development), an assessment of the competitive environment, quantification and 2020 projections of total potential end-users of a dengue vaccine (namely, travellers from all developed economies to all regions of dengue transmission; private sector users in dengue transmission regions; and public sector users in dengue transmission regions), and 2020 revenue projections for a dengue vaccine, broken down by private sector sales in the developed world, private sector sales in the developing world, and public sector sales in the developing world.
Advertisement
Companies mentioned
GSK, SanofiPasteur, Acambis, Inovio, VGX, Shantha, Hawaii Biotech, Inviragen, Novartis, Biological E, Panacea Biotec, Alphavax
SYNOPSIS ..... 8
1. Executive summary ....... 9
2. Clinical need ................. 13
2.1 Overview ................ 13
2.2 The disease ............. 13
2.2.1 Causative agents - dengue viruses ....................13
2.2.2 Disease symptoms ................ 13
2.2.3 Disease pathophysiology ...... 14
2.3 Incidence ................ 19
2.3.1 Reported incidence ............... 19
2.3.2 Estimates of actual incidence .......20
2.4 Transmission ........... 22
2.4.1 Transmission mechanism ...... 22
2.4.2 Aedes aegypti ... 22
2.4.3 Aedes albopictus ................... 23
2.5 Populations currently at risk ........ 24
2.5.1 Relevant populations ............ 24
2.5.2 Global dengue transmission activity ..................25
2.5.3 Risk factors for endemic populations ................28
2.5.4 Endemic countries ................ 29
2.5.5 Possibly endemic countries ... 30
2.5.6 At-risk countries .................... 30
2.5.7 Global distribution of endemic, possibly endemic and at-risk countries .......31
2.5.8 At-risk travellers .................... 32
2.5.9 Risk factors for travellers ...... 32
2.6 Current treatment and prevention options ..............33
2.6.1 Current treatment ................. 33
2.6.2 Current prevention ............... 33
2.7 Current clinical need .................... 35
2.8 Summary ................ 37
3. Scientific / technology background .. 39
3.1 Overview ................ 39
3.2 Virus factors ........... 39
3.2.1 Humoral immunity to viral components ............39
3.2.2 Cellular immunity to viral components ..............40
3.2.3 Genetic variation in dengue viruses ...................40
3.2.4 Invasion of host cells by virus .......41
3.2.5 Modulation of host immune response ..............41
3.3 Host factors ............ 42
3.4 Key issues in dengue vaccine development ..............43
3.4.1 Surrogate markers of safety and efficacy ..........44
3.4.2 Viral interference and immunodominance effects ..................45
3.4.3 Clinical considerations .......... 45
3.5 Early stage approaches to dengue vaccine development ..............46
3.5.1 DNA vaccines ... 46
3.5.2 Vaccines with attenuating mutations ................46
3.5.3 Subunit vaccines ................... 46
3.5.4 Prime boost approaches ....... 46
3.5.5 Other approaches ................. 47
3.6 Summary ................ 48
4. Dengue vaccine market: general features .50
4.1 Overview ................ 50
4.2 Main stakeholders in vaccine development and procurement ......50
4.2.1 National governments .......... 50
4.2.2 Non-governmental organisations .51
4.2.3 Commercial /academic entities involved in vaccine development ................54
4.2.4 Health care providers and healthcare professionals ...............55
4.2.5 End-users - vaccinees ........... 56
4.3 Vaccine purchase and procurement ....56
4.3.1 Public sector vaccine purchase: developed world ...................56
4.3.2 Public sector vaccine purchase: developing world ..................56
4.3.3 Private sector vaccine purchase: developed world .................58
4.3.4 Private sector vaccine purchase: developing world ................58
4.4 Legal, regulatory and manufacturing issues .............59
4.4.1 Legal ................ 59
4.4.2 Regulatory ........ 59
4.4.3 Manufacturing . 61
4.4 Summary ................ 62
5. Dengue vaccine market: competitive environment .......64
5.1 Overview ................ 64
5.2 Current dengue vaccine candidates and vaccine sponsors ............64
5.2.1 Outline of main candidate dengue vaccines ......64
5.2.2 Outline of main commercial interests ...............67
5.3 Stage of development of main candidate dengue vaccines ...........71
5.3.1 NIH / NIAID vaccine ............... 71
5.3.2 GSK/WRAIR vaccine .............. 74
5.3.3 Hawaii Biotech vaccine ......... 76
5.3.4 Inviragen (Shantha)/CDC vaccine ..76
5.3.5 SanofiPasteur / Acambis vaccine ..77
5.3.6 Inovio / VGX vaccine ............. 78
5.3.7 USAOSG / WRAIR vaccine ..... 79
5.4 Anticipated market entry of a dengue vaccine .........79
5.5 Target market ......... 81
5.6 Non-vaccine competition ............. 83
5.6.1 Dengue therapies .................. 83
5.6.2 Vector control strategies ...... 83
5.6 Summary ................ 85
6. Dengue vaccine market: potential end-user numbers ...87
6.1 Overview ................ 87
6.2 Potential end-user numbers: public vaccine ............87
6.3 Potential end-user numbers: private vaccine ...........90
6.3.1 Travellers from developed economies to endemic countries .90
6.3.2 Private sector purchase within endemic / possibly endemic countries .........93
6.4 Future growth in potential end-user numbers .........94
6.4.1 2020 public sector projections ......94
6.4.2 2020 private sector projections: endemic / possibly endemic countries .......96
6.4.3 2020 private sector projections: relevant travellers ................96
6.5 Summary ................ 98
7. Market penetration and revenue projections ..............100
7.1 Overview .............. 100
7.2 Market penetration: public sector vaccine .............100
7.2.1 Countries wishing to introduce a public sector dengue vaccine ..................101
7.2.2 Countries able to introduce a public sector dengue vaccine .101
7.2.3 Appropriate population segments for a public sector dengue vaccine ........102
7.2.4 Coverage estimates .............103
7.2.5 Timing ............ 103
7.2.6 Public sector market penetration - conclusions ....................107
7.3 Market penetration: private sector vaccine ...........107
7.3.1 Private sector vaccine: market penetration in endemic / possibly endemic countries ....107
7.3.2 Private sector vaccine: market penetration in developed countries ............109
7.4 Vaccine pricing ........ 111
7.4.1 Burden of disease studies ...111
7.4.2 Price benchmarking ............113
7.4.3 Conclusions - dengue vaccine pricing in the public and private sectors .......114
7.5 Revenue projections .................... 115
7.5.1 Key assumptions ................. 115
7.5.2 Dengue vaccine revenue projections to 2020: private sector, developed world..............116
7.5.3 Dengue vaccine revenue projections to 2020: private sector, developing world .............117
7.5.4 Dengue vaccine revenue projections to 2020: public sector, developing world...............118
7.5.5 Beremans estimate of total 2020 market size for dengue vaccines .............119
7.5.6 Third-party estimates of market size for dengue vaccines ....120
7.5.7 Effect of competition ..........121
7.5.8 Other revenue sources ........122
7.6 Summary .............. 123
8. Expert interviews ...... 126
8.1 Overview .............. 126
8.2 Interviewee responses ............... 126
8.2.1 Is a significant burden of disease likely to follow any spread of albopictus into the
developed world? ... 126
8.2.2 Are those regions of the developed world that are somewhat at risk of dengue likely to
adopt a public sector dengue vaccine, were one to become available? ...............126
8.2.3 What is the right immune correlate to measure in assessments of vaccine safety and
efficacy? ................. 126
8.2.4 Could vaccine-induced ADE be a problem for the current generation of dengue vaccine
candidates? ............ 126
8.2.5 When can we expect to see a Phase 3 trial of a candidate dengue vaccine?....................127
8.2.6 When can we expect to see an approved dengue vaccine? ..127
8.2.7 Are the Sanofi and GSK vaccines likely to be aimed at different segments of the paediatric
population? ............ 127
8.2.8 Will any of the current candidate dengue vaccines be applicable to the majority of short notice
travelers? ..... 127
8.2.9 How will endemic countries fund the introduction of a public sector dengue vaccine? ..127
8.2.10 Which of the endemic countries are most likely to add a dengue vaccine to the public
sector immunisation schedule? ...127
8.2.11 What current developments seem most likely to lead to a step change in dengue
prevention or management? ....... 128
8.2.12 What will the year 2020 look like with regard to dengue incidence, vaccine approval, and
vaccine uptake? ...... 128
8.3 Summary .............. 129
9. References ................ 130
APPENDICES ................. 146
Appendix 1: Quantitative incidence data by country, 2004-2008 ..........147
Appendix 2: Reported dengue activity by country, 2004-2008 ..............151
Appendix 3: Methodology behind population estimates / projections .155
Appendix 4: Interview transcripts ........157
A4.1: Prof. Duane Gubler ................. 157
A4.2: Lt-Col. Dr. Stephen Thomas ....161
A4.3 Prof. Annelise Wilder-Smith ....167
Appendix 5: Dengue vaccine clinical trials ...171
Appendix 6: International travel data: correction and adjustment methodology ........177
Appendix 7: Spread of endemicity / at-risk status to new countries .....188
A7.1 Historical patterns of increased incidence, severity and distribution ...............188
A7.2 Overview of factors driving the rise in dengue incidence, severity and distribution.............189
A7.3 Key factors that drive increases in dengue incidence, severity and distribution ...................190
A7.3.1 Population growth / urbanisation .................190
A7.3.2 International travel and trade: impact on vector distribution ...................191
A7.3.3 International travel and trade: impact on virus distribution .191
A7.3.4 Climate: impact on dengue transmission ......192
A7.3.5 Climate: impact on vector distribution ..........192
A7.4 Projected patterns of dengue incidence and geographic spread .193
A7.5 Summary ............ 196
Appendix 8: Dengue in travellers .........197
A8.1 Overview ............ 197
A8.2 Reports of travel-associated dengue ....................197
A8.2.1 Dengue in travellers from developed economies ...............197
A8.2.2 Dengue in travellers from emerging economies .................198
A8.3 Trends in travel-associated dengue .198
A8.3.1 Trends in incidence of travel-associated dengue ................198
A8.3.2 Trends in severity of travel-associated dengue ...................199
A8.4 Conclusions - dengue risk in travellers ................200
Appendix 9: DTP3 coverage rates for likely adopters of dengue vaccine .202
Appendix 10: Terms and conditions under which this report has been purchased ......203
To order this report:
Pharmaceutical Industry: Commercial prospects for dengue vaccines
More Market Research Report
Check our Company Profile, SWOT and Revenue Analysis!
Nicolas Bombourg Reportlinker Email: [email protected] US: (805)652-2626 Intl: +1 805-652-2626
SOURCE Reportlinker
