Pipeline and Commercial Insight: Pediatric and Adolescent Vaccines

Table of Contents

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