兒童及青少年疫苗

Abstract

Overview

Introduction

The pediatric and adolescent vaccines market encompasses many different classes. DTP and MMR combinations continue to form the mainstay of childhood immunization; however, their growth potential is limited. The key opportunities lie in novel, innovative additions to established schedules, particularly pneumococcal (Prevnar), conjugated meningococcal (Menactra) and HPV (Gardasil) vaccines.

Scope

• Strategic analysis of the pediatric and adolescent vaccines market across the seven major markets and of key companies in the sector
• Thorough assessment of underlying commercial and clinical influencers shaping the pediatric and adolescent vaccines market
• Patient-based forecasts for key vaccine classes and products according to recommended vaccination groups and coverage rates in the seven major markets
• In-depth discussion of novel vaccine pipeline candidates and discussion of their future potential

Highlights

Driven by the launch of novel, high-price vaccines such as Gardasil or RotaTeq, the pediatric and adolescent vaccines market is experiencing a rapid growth. Wyeth' s Prevnar has emerged as the first blockbuster vaccine, demonstrating that innovative vaccines can command high prices and yield high revenues in the pediatric vaccines market.

The main future opportunities lie in the pneumococcal, meningococcal and HPV vaccine sectors, where there is a large medical need. Particularly a vaccine against infections with N. meningitidis B would have a potentially huge commercial.

Key challenges include the reluctance of healthcare providers to pay for increasingly expensive vaccines and the lack of widespread organized vaccination programs for school children and teenagers. With an increasing focus on adolescent vaccines such as Gardasil or Menactra, better ways to reach adolescents for vaccination will have to be found.

Reasons to Purchase

• Review clinical and commercial factors driving new product decisions and the strategies of key players in the pediatric and adolescent vaccines market
• Gain insight through a patient-based forecast and a thorough analysis of marketed and pipeline products as well as case studies in key vaccine classes
• Understand concerns, unmet needs and future opportunities by learning about the views of key pediatric and adolescent vaccine opinion leaders

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