Pipeline and Commercial Insight: Pediatric and Adolescent Vaccines
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the Disease pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor's insight into the pediatric and adolescent vaccines market - page 4
- Related reports - page 5
- Key metrics - page 6
- CHAPTER 2 MARKET DEFINITION AND OVERVIEW - page 9
- Summary - page 9
- Market definition for this report - page 9
- Market size and growth - page 10
- Vaccines - a rapidly growing pharmaceutical sector - page 10
- The US dominate global vaccine sales, but main growth opportunities lie in emerging markets - page 11
- Pediatric and adolescent vaccines are at the core of the vaccines industry - page 12
- Market drivers and restrictors - page 15
- Growing awareness among parents and physicians is the main driver of the pediatric and adolescent vaccines market - page 15
- High prices and problems in reaching adolescents could emerge as major restrictors - page 16
- Recent approvals - page 18
- Key players in the childhood and adolescent vaccines market - page 19
- Merck & Co/Sanofi Pasteur - joint domination - page 21
- Sanofi Pasteur - influenza, meningitis and DTP as revenue drivers - page 21
- Sanofi Pasteur MSD - a successful joint venture - page 23
- Merck & Co - leading in novel, innovative segments including HPV and rotavirus - page 24
- GSK Biologicals - expanding beyond Europe - page 27
- Wyeth - it's all about Prevnar - page 30
- Novartis Vaccines - hoping for a meningitis blockbuster vaccine - page 32
- Merck & Co/Sanofi Pasteur - joint domination - page 21
- Recommendations and vaccination coverage across the seven major markets - page 35
- US - page 35
- Vaccination schedules - page 35
- Coverage - page 37
- Japan - page 40
- Vaccination schedules - page 40
- Coverage - page 41
- France - page 42
- Vaccination schedules - page 42
- Coverage - page 44
- Germany - page 46
- Vaccination schedules - page 46
- Coverage - page 47
- Italy - page 50
- Vaccination schedules - page 50
- Coverage - page 51
- Spain - page 54
- Vaccination schedules - page 54
- Coverage - page 54
- UK - page 55
- Vaccination schedules - page 55
- Coverage - page 57
- US - page 35
- R&D approach - clinical trials for vaccines - page 58
- CHAPTER 3 DIPHTHERIA, TETANUS, PERTUSSIS VACCINES - MULTIVALENT COMBINATIONS ON THE RISE - page 62
- Summary - page 62
- Epidemiology - page 63
- Diphtheria - page 63
- Tetanus - page 65
- Pertussis - page 67
- Market opportunity - page 69
- Currently marketed DTP vaccines - page 70
- Case Study: GSK versus Sanofi Pasteur - page 71
- GSK's DTP franchise - Pediarix and Boostrix as main sales drivers - page 71
- Sanofi Pasteur's DTP franchise - lagging behind in combination vaccines - page 77
- Unmet needs - page 80
- DTP vaccine pipeline - page 80
- Globorix - GSK's contribution for developing countries - page 81
- CHAPTER 4 MEASLES, MUMPS, RUBELLA, VARICELLA VACCINES - MMR-V COMBINATIONS GAIN POPULARITY - page 83
- Summary - page 83
- Epidemiology - page 84
- Measles - page 84
- Mumps - page 86
- Rubella - page 88
- Varicella - page 89
- Market opportunity - page 90
- Currently marketed vaccines - page 91
- Case study: GSK versus Sanofi/Merck & Co - page 92
- Merck & Co/Sanofi Pasteur's MMR and Varicella franchise - building on MMR II - page 92
- M-M-R II - page 95
- Varivax - page 96
- ProQuad - page 97
- Franchise summary - page 98
- GSK's MMR and Varicella franchise - a step behind Merck & Co - page 100
- Priorix - page 103
- Varilrix - page 104
- Priorix Tetra - page 104
- Franchise summary - page 104
- Merck & Co/Sanofi Pasteur's MMR and Varicella franchise - building on MMR II - page 92
- Unmet needs - page 106
- MMR and varicella vaccine pipeline - page 106
- CHAPTER 5 PNEUMOCOCCAL VACCINES - PREVNAR CONTINUES TO DOMINATE THE FIELD - page 107
- Summary - page 107
- Epidemiology - page 108
- Market opportunity - page 109
- Currently marketed vaccines - page 110
- Case study: Prevnar, the first vaccine blockbuster - page 111
- Vaccine profile - page 111
- Future opportunities and risks - page 116
- Prevnar has an acceptable cost-benefit profile and is targeting a growing market - page 116
- Serotype shift in pneumococcal infections is emerging as a new challenge - page 117
- Commercial forecast for Prevnar - page 119
- Unmet needs - page 120
- S. pneumoniae late-stage pipeline analysis and forecasts - page 121
- Pipeline summary - page 121
- 13vPnC (Wyeth) - page 122
- Product overview - page 122
- Clinical trial data - page 123
- Marketing factors - page 127
- Satisfaction of unmet needs - page 128
- Forecasts to 2016 - page 128
- Datamonitor vaccine assessment summary - page 129
- Synflorix/Streptorix - page 130
- Product overview - page 130
- Clinical trial data - page 131
- Marketing factors - page 135
- Satisfaction of unmet needs - page 136
- Forecasts to 2016 - page 136
- Datamonitor vaccine assessment - page 137
- Comparative forecasts - page 138
- CHAPTER 6 MENINGOCOCCAL VACCINES - MENACTRA'S MONOPOLY UNDER THREAT - page 140
- Summary - page 140
- Epidemiology - page 141
- Market opportunity - page 143
- Men ACWY - a large untouched childhood market - page 143
- Men B - huge potential for a universal vaccine - page 145
- Currently marketed vaccines - page 146
- N. meningitidis ACWY - page 146
- N. meningitidis B - page 147
- Case study: Menactra - page 149
- Product profile - page 149
- Clinical data - association with Guillain-Barré syndrome as a hurdle? - page 150
- Expanding the franchise - Menactra for all age groups - page 151
- Future opportunities and risks - market leadership under threat - page 152
- Commercial forecast for Menactra - page 154
- Unmet needs - page 155
- Conjugate vaccines against N. meningitidis ACWY for pediatric use are urgently required - page 155
- Broad-acting vaccines against N. meningitidis B represent a crucial unmet need - page 155
- N. meningitidis ACWY late-stage pipeline analysis and forecast - page 156
- Pipeline summary - page 156
- Men ACWY vaccine (Novartis) - page 157
- Product overview - page 157
- Clinical trial data - page 157
- Marketing factors - page 164
- Satisfaction of unmet needs - page 164
- Forecasts to 2016 - page 164
- Datamonitor vaccine assessment - page 165
- GSK-134612 - page 167
- Product overview - page 167
- Clinical trial data - page 167
- Marketing factors - page 176
- Satisfaction of unmet needs - page 176
- Forecasts to 2016 - page 176
- Datamonitor vaccine assessment - page 177
- Comparative forecasts for Men ACWY vaccines - page 178
- Hib-MenCY-TT (GSK) - page 180
- Product overview - page 180
- Clinical trial data - page 180
- Marketing factors - page 186
- Satisfaction of unmet needs - page 186
- Datamonitor vaccine assessment - page 187
- MemVac A, C, Y, & W-135 (Transgene Biotek) - page 188
- Product overview - page 188
- Clinical trial data - page 189
- Marketing factors - page 189
- Satisfaction of unmet needs - page 189
- Datamonitor vaccine assessment - page 190
- N. meningitidis B late-stage pipeline analysis and forecast - page 191
- Pipeline summary - page 191
- Recombinant meningococcal B vaccine (Novartis) - page 192
- Product overview - page 192
- Clinical trial data - page 192
- Marketing factors - page 195
- Satisfaction of unmet needs - page 195
- Forecasts to 2016 - page 196
- Meningococcal B vaccine (Wyeth) - page 196
- Product overview - page 196
- Clinical trial data - page 196
- Marketing factors - page 199
- Satisfaction of unmet needs - page 199
- Forecasts to 2016 - page 199
- Comparative assessment - page 200
- CHAPTER 7 HUMAN PAPILLOMAVIRUS VACCINES - A PROMISING NEW MARKET - page 202
- Summary - page 202
- Epidemiology - page 203
- Market opportunity - page 204
- Currently marketed vaccines - page 205
- Case study: Gardasil versus Cervarix - page 206
- Gardasil - first-to-market vaccine for prevention of cervical cancer and genital warts - page 206
- Product profile - page 206
- Future challenges and risks - page 207
- Cervarix - GSK's runner-up - page 210
- Product profile - page 210
- Future challenges and risks - page 211
- Comparison: Gardasil offers a broader therapeutic spectrum - page 213
- Commercial forecasts - page 217
- Gardasil - first-to-market vaccine for prevention of cervical cancer and genital warts - page 206
- Unmet needs - page 219
- HPV vaccine pipeline - page 221
- CHAPTER 8 ROTAVIRUS VACCINES - ROTATEQ AND ROTARIX HEAD-TO-HEAD - page 222
- Summary - page 222
- Epidemiology - page 223
- Market opportunity - page 224
- Currently marketed vaccines - page 227
- Case study: RotaTeq versus Rotarix - page 228
- New solutions are needed following the withdrawal of Wyeth's RotaShield - page 228
- RotaTeq - first-to-market in the US - page 230
- Rotarix - catching up from Europe - page 232
- Comparison - page 235
- Commercial forecasts - page 236
- Unmet needs - page 236
- Rotavirus vaccine pipeline - page 237
- BIBLIOGRAPHY - page 238
- Literature - page 238
- APPENDIX - page 255
- Methodology - page 255
- Datamonitor forecast methodology - page 255
- Datamonitor's patient-based forecasting model - page 256
- Limitations of the patient-based forecasting model - page 258
- Datamonitor drug assessment summary - page 258
- Datamonitor forecast methodology - page 255
- Contributing experts - page 260
- About Datamonitor - page 261
- About Datamonitor Healthcare - page 261
- Datamonitor Healthcare's therapy area capabilities - page 262
- About the Infectious Diseases analysis team - page 262
- Key therapy team members - page 264
- Holger Rovini, Head of Respiratory and Infectious Diseases - page 264
- Hedwig Kresse, Associate Analyst, Infectious Diseases - page 264
- Disclaimer - page 264
- Methodology - page 255
- List of Tables
- Table 1: Key parameters of the pediatric and adolescent vaccines market for the seven major markets, 2006-2016 - page 6
- Table 2: Forecast key products in pediatric and adolescent vaccines ($m), 2006-2016 - page 7
- Table 3: Key players in the pediatric and adolescent vaccines market, 2007 - page 20
- Table 4: Merck & Co/ Sanofi Pasteur: Childhood and adolescent vaccine portfolio - page 26
- Table 5: GSK: childhood and adolescent vaccines portfolio, 2007 - page 29
- Table 6: Wyeth: childhood and adolescent vaccines portfolio, 2007 - page 32
- Table 7: Novartis: childhood and adolescent vaccines portfolio, 2007 - page 33
- Table 8: Major DTP vaccines - page 71
- Table 9: GSK's DTP franchise: components, 2007 - page 72
- Table 10: Sanofi's DTP franchise: components, 2007 - page 78
- Table 11: DTP vaccine pipeline, June 2007 - page 81
- Table 12: Major MMR and varicella vaccines, 2007 - page 92
- Table 13: Merck & Co's MMR/Varicella franchise: overview, 2007 - page 93
- Table 14: M-M-R II: Key components - page 95
- Table 15: TypeTableTitleHere - page 101
- Table 16: Priorix: key components - page 103
- Table 17: MMR and varicella pipeline, June 2007 - page 106
- Table 18: Major pneumococcal vaccines, 2007 - page 111
- Table 19: Prevnar: product profile - page 112
- Table 20: Prevnar: recent events - page 115
- Table 21: Late-stage pipeline for S. pneumoniae infection, May 2007 - page 121
- Table 22: 13vPnC - Vaccine overview - page 122
- Table 23: 13vPnC - Clinical trial overview - page 124
- Table 24: Synflorix/Streptorix: vaccine overview, 2007 - page 130
- Table 25: Synflorix: efficacy and safety trials - page 132
- Table 26: Synflorix: booster trials - page 133
- Table 27: Synflorix: combination trials - page 134
- Table 28: Major meningitis vaccines, 2007 - page 147
- Table 29: Menactra: product profile - page 149
- Table 30: N. meningitidis ACWY: pipeline overview, 2007 - page 156
- Table 31: Men ACWY: product profile - page 157
- Table 32: Meningococcal ACWY Vaccine (Novartis): clinical trials - page 159
- Table 33: GSK-134612: product profile - page 167
- Table 34: GSK-134612: clinical trial overview - page 168
- Table 35: Hib-MenCY-TT: product profile - page 180
- Table 36: Hib-MenCY-TT (GSK): clinical trial overview - page 181
- Table 37: MemVac A, C, Y, & W-135: product profile - page 188
- Table 38: Clinical pipeline N. meningitidis B infection, May 2007 - page 191
- Table 39: Recombinant meningococcal B vaccine (Novartis): clinical trial overview - page 193
- Table 40: Meningococcal B vaccine (Wyeth): Clinical trial overview - page 198
- Table 41: Major HPV vaccines, 2007 - page 206
- Table 42: HPV vaccines pipeline, June 2007 - page 221
- Table 43: Major rotavirus vaccines, 2007 - page 227
- Table 44: RotaShield: table of events - page 229
- Table 45: RotaTeq: recent key events - page 232
- Table 46: Rotarix: recent key events - page 234
- Table 47: Rotavirus vaccine pipeline, June 2007 - page 237
- Table 48: Datamonitor drug assessment parameters - page 259
- List of Figures
- Figure 1: Key players in the overall vaccine market , 2004-06 - page 11
- Figure 2: Geographical spread of vaccine sales, 2005 - page 12
- Figure 3: Childhood and adolescent vaccines market growth ($ billion), 2004-2010 - page 13
- Figure 4: Datamonitor's combined sales forecast by company for the pneumococcal, Men ACWY, Men B, HPV and rotavirus vaccines market; 2003-2016, 7 major markets - page 14
- Figure 5: Market drivers and restrictors for pediatric and adolescent vaccines, 2007 - page 15
- Figure 6: Product approvals in the pediatric/adolescent vaccines sector, 2001-06 - page 19
- Figure 7: Sanofi Pasteur: total vaccine sales ($m), 2002-06 - page 21
- Figure 8: Sanofi Pasteur: class spread of total 2006 vaccine sales and relative growth on 2005 - page 22
- Figure 9: Sanofi Pasteur MSD: total vaccine sales ($m) 2001--06 - page 24
- Figure 10: Merck & Co: total vaccine sales ($m), 2004-06 - page 24
- Figure 11: GSK: total vaccine sales ($m), 1999-2006 - page 27
- Figure 12: GSK: geographical spread of total 2006 vaccine sales and growth on 2005 - page 28
- Figure 13: Wyeth - additional launches planned for Prevnar - page 31
- Figure 14: Sales volume by franchise of total Novartis vaccine sales, 2006 - page 33
- Figure 15: Geographical presence of Novartis Vaccines, 2007 - page 34
- Figure 16: Recommended childhood immunization schedule - US, 2007 - page 35
- Figure 17: Childhood vaccination coverage rates - US, 2005/06 - page 38
- Figure 18: Childhood vaccination coverage timeline - US 2000-06 - page 39
- Figure 19: Recommended childhood immunization schedule - Japan, 2005 - page 40
- Figure 20: Distribution of Japanese encephalitis in Asia, 1970-1998 - page 41
- Figure 21: National vaccination coverage rates - Japan, 2005 - page 42
- Figure 22: Recommended childhood immunization schedule - France, 2006 - page 43
- Figure 23: Childhood vaccination coverage rates - France, 2001-04 - page 44
- Figure 24: Recommended childhood immunization schedule - Germany, 2007 - page 46
- Figure 25: Childhood vaccination coverage rates - Germany, 2005 - page 48
- Figure 26: Germany: coverage rates in school entrants, 1996-2005 - page 49
- Figure 27: Recommended childhood immunization schedule - Italy, 2007 - page 51
- Figure 28: Childhood vaccination coverage rates - Italy, 2003 - page 52
- Figure 29: Coverage for diphtheria, polio, tetanus and Hepatitis B in Italy, 1998 versus 2003 - page 53
- Figure 30: Recommended childhood immunization schedule - Spain, 2007 - page 54
- Figure 31: Childhood vaccination coverage rates - Spain, 1992-2005 - page 55
- Figure 32: Recommended childhood immunization schedule - UK, 2007 - page 56
- Figure 33: Childhood vaccination coverage rates - UK 1995/96-2005/06 - page 57
- Figure 34: Overview of vaccine approval process - US - page 59
- Figure 35: DTP vaccines market: overview, 2007 - page 63
- Figure 36: Diphtheria cases in the US, 1940-2004 - page 64
- Figure 37: Diphtheria: global annual reported incidence and DTP vaccination coverage, 1980-2004 - page 65
- Figure 38: Tetanus cases in the US, 1947-2004 - page 66
- Figure 39: Tetanus: global annual reported incidence and DTP vaccination coverage, 1980-2004 - page 67
- Figure 40: Pertussis cases in the US, 1940-2004 - page 68
- Figure 41: Pertussis: global annual reported incidence and DTP vaccination coverage, 1980-2004 - page 68
- Figure 42: Datamonitor's forecast for the DTP vaccines market across the seven major markets, 2003-2016 - page 70
- Figure 43: GSK's DTP franchise: geographical spread - page 73
- Figure 44: GSK's DTP franchise: sales development, 1999-2006 - page 74
- Figure 45: GSK's DTP vaccine franchise: SWOT analysis - page 76
- Figure 46: US opportunity for Infanrix Polio - page 77
- Figure 47: Sanofi's DTP franchise: SWOT analysis - page 79
- Figure 48: MMR-V vaccines market: overview, 2007 - page 84
- Figure 49: Measles cases in the US, 1950-2004 - page 85
- Figure 50: Measles: global annual reported incidence and measles vaccination coverage, 1980-2004 - page 86
- Figure 51: Mumps cases in the US, 1968-2004 - page 87
- Figure 52: Mumps global annual reported incidence, 1999-2005 - page 87
- Figure 53: Rubella and CRS incidence in the US, 1966-2002 - page 88
- Figure 54: Rubella: global annual reported incidence, 1999-2005 - page 89
- Figure 55: Datamonitor's commercial sales forecast for the MMR-V vaccines market in the US and EU5, 2003-2016 - page 91
- Figure 56: MMR vaccination coverage - UK 1995/96-2005/06 - page 96
- Figure 57: Merck & Co's MMR-V franchise: SWOT analysis - page 99
- Figure 58 : GSK's MMR-V franchise: SWOT analysis - page 105
- Figure 59: Pneumococcal vaccines market: overview, 2007 - page 108
- Figure 60: Datamonitor's forecast for the pneumococcal vaccines market across the seven major markets, 2003-2016 - page 110
- Figure 61: Prevnar: sales, 2000-06 - page 114
- Figure 62: Prevnar: geographical spread of sales, H1 2006 - page 115
- Figure 63: Prevnar: SWOT analysis - page 116
- Figure 64: Incidence of infections with S. pneumoniae subtype 19A in the US, 1999-2004 - page 117
- Figure 65: Prevnar: commercial sales forecast for the annual infant cohort across the seven major markets, 2003-2016 - page 120
- Figure 66: S. pneumoniae subtype coverage of pipeline vaccines, 2007 - page 122
- Figure 67: Comparison of immunogenicity of Prevnar and 13vPnC in a Phase II infant trial, 2006 - page 126
- Figure 68: 13vPnC: commercial sales forecast for the annual infant cohort across the seven major markets, 2003-2016 - page 128
- Figure 69: 13vPnC - SWOT analysis - page 129
- Figure 70: Incremental serotype coverage of Synflorix versus Prevnar - page 131
- Figure 71: Synflorix: commercial sales forecast for the annual infant cohort across the seven major markets, 2003-2016 - page 136
- Figure 72: Synflorix: SWOT analysis - page 137
- Figure 73: Datamonitor pipeline assessment: pneumococcal vaccines - page 139
- Figure 74: Sales forecast pneumococcal vaccines by product across the seven major markets, 2003-2016 - page 139
- Figure 75: Meningococcal vaccines market: overview, 2007 - page 141
- Figure 76: Meningitis: subtype split - page 142
- Figure 77: Global incidence of meningococcal infections by age, 2007 - page 143
- Figure 78: Datamonitor's forecast for Men ACWY vaccines market across the six major markets (excluding Japan), 2003-2016 - page 145
- Figure 79: Datamonitor's forecast for Men B vaccines market (annual cohort and catch up) across the six major markets (excluding Japan), 2003-2016 - page 146
- Figure 80: Menactra: efficacy profile - page 150
- Figure 81: Menactra: development stage of franchise, 2007 - page 151
- Figure 82: Menactra: SWOT analysis - page 152
- Figure 83: Datamonitor's commercial sales forecast for Menactra for the annual cohort across the six major markets (excluding Japan), 2003-2016 - page 154
- Figure 84: Men ACWY: Phase II efficacy data - page 163
- Figure 85: Datamonitor's commercial sales forecast for Men ACWY (Novartis) for the annual cohort across the six major markets (excluding Japan), 2003-2016 - page 165
- Figure 86: Men ACWY: SWOT analysis, 2007 - page 166
- Figure 87: Datamonitor's commercial sales forecast for GSK-134612 (GSK) for the annual cohort across the six major markets (excluding Japan), 2003-2016 - page 177
- Figure 88: GSK-134612: SWOT analysis - page 177
- Figure 89: N. meningitidis ACWY pipeline: comparative assessment, 2007 - page 179
- Figure 90: Datamonitor's commercial sales forecast for Men ACWY vaccines by product across the six major markets (excluding Japan), 2003-2016 - page 179
- Figure 91: Hib-MenCY-TT: SWOT analysis - page 187
- Figure 92: MemVac A,C,Y&W-135: SWOT analysis - page 190
- Figure 93: Datamonitor's commercial sales forecast for Men B (Novartis) across the six major markets (excluding Japan), 2003-2016 - page 196
- Figure 94: Datamonitor's commercial sales forecast for Men B (Wyeth) across the six major markets (excluding Japan), 2003-2016 - page 200
- Figure 95: Comparison of Wyeth's and Novartis' Men B vaccine candidates, 2007 - page 201
- Figure 96: Datamonitor's commercial sales forecast for Men B vaccines by product across the six major markets (excluding Japan), 2003-2016 - page 201
- Figure 97: HPV vaccines market: overview, 2007 - page 203
- Figure 98: HPV: prevalence in women in the US 2003/04 - page 204
- Figure 99: Datamonitor's forecast for HPV vaccines market across the seven major markets, 2003-2016 - page 205
- Figure 100: Gardasil: SWOT analysis - page 207
- Figure 101: Gardasil: recent key events - page 210
- Figure 102: Cervarix: SWOT analysis - page 212
- Figure 103: Cervarix: recent key events - page 213
- Figure 104: Gardasil versus Cervarix: key characteristics - page 214
- Figure 105: Gardasil versus Cervarix: potential positioning - page 218
- Figure 106: Datamonitor's commercial sales forecast for Gardasil and Cervarix for annual cohort and catch-up vaccination across the seven major markets, 2003-2016 - page 219
- Figure 107: Rotavirus vaccines market: overview, 2007 - page 223
- Figure 108: Rotavirus serotype prevalence in the US, 1996-99 - page 224
- Figure 109: Datamonitor's commercial sales forecast for the rotavirus vaccines market across the seven major markets, 2003-2016 - page 225
- Figure 110: Estimated global distribution of annual deaths due to rotavirus diarrhea, 2007 - page 226
- Figure 111: RotaTeq: SWOT analysis - page 230
- Figure 112: Rotarix: SWOT analysis - page 233
- Figure 113: RotaTeq versus Rotarix: key characteristics - page 235
- Figure 114: Datamonitor's commercial sales forecast for RotaTeq and Rotarix across the seven major markets, 2003-2016 - page 236
- Figure 115: Datamonitor's patient-based vaccine forecasting model - influence factors - page 256
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