Market Report Source

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 of this report

• 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

Research and analysis 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.

Key reasons to read this report

• 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 Disease 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
  • USA
  • Japan
  • France
  • Germany
  • Italy
  • Spain
  • UK
• 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-Barre 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
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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