Pipeline Perspectives: Vaccines - Expanding Portfolio Diversity

TABLE OF CONTENTS

CHAPTER 1 EXECUTIVE SUMMARY

• Scope of the analysis
• Datamonitor insight into the vaccine market
• Increasing candidate numbers and heterogeneity in late-stage vaccine development present significant opportunity for key players to expand their portfolios. This wealth of choice will lead to tough investment decisions, which may ultimately affect the dynamics of the whole market.
• Rising competition for a limited number of alliances with larger players will force small biotechnology companies to fund their own Phase III or consider more mid-size partners. Datamonitor believes that a search for appropriate resources and capabilities will intensify and drive industry consolidation. The recent acquisition of PowderJect by Chiron supports this hypothesis.
• Increasing competition to supply vaccines against specific disease targets will highlight the need for greater product differentiation. Investigating and incorporating novel formulations, adjuvants and delivery systems could help to maintain competitive advantage.
• Novel delivery routes may boost efficacy while improving convenience
• Reduced dosage requirements may offer competitive advantage
• Flexible storage may increase geographical access
• Summary
• Key metrics

CHAPTER 2 PATIENT POTENTIAL

• Introduction
• Pediatric population
• Elderly population
• Traveler's population
• Low-risk groups

CHAPTER 3 R&D APPROACH

• Classification of pipeline vaccines
• Vaccine clinical trial design
• Trial endpoint definition
• Immunogenicity
• Pathogen neutralization
• Clinical/disease endpoint
• Comparator trials
• Safety
• Trial size

CHAPTER 4 VACCINE PIPELINE ANALYSIS

• Key success factors
• Delivery
• Improved safety
• Efficacy
• Dosage
• Storage
• Manufacturing and increased availability
• Broader disease coverage
• Combination products
• Late-stage vaccine pipeline by indication
• Key companies involved in the vaccine pipeline
• GSK
• Marketed products
• Pipeline

CHAPTER 5 VACCINE ANALYSIS AND FORECASTS

• Overview of late-stage pipeline vaccines
• Influenza vaccines
• Disease overview
• Target population
• Economic disease burden
• Currently marketed products
• Fluzone
• Fluvirin
• Key success factors
• Efficacy in high-risk groups
• Annual reformulation and availability
• Delivery
• Side effects
• Strain coverage
• FluMist
• Profile
• Drug overview
• Overview of clinical trial data
• Patient potential
• Marketing factors
• Satisfaction of unmet needs
• Market value at maturity
• Vaccines against sexually transmitted diseases (STDs)
• Overcoming the moral dilemma
• Health economics
• HPV vaccine: Merck & Co./CSL
• Disease overview
• Profile
• Clinical trial data
• Patient potential
• Marketing factors
• Satisfaction of unmet needs
• Market value at maturity
• Simplirix: GSK's HSV vaccine
• Disease overview
• Vaccine profile
• Clinical trial data
• Patient potential
• Marketing factors
• Satisfaction of unmet needs
• Market value at maturity
• Meningitis vaccines
• Disease overview
• Current vaccines
• Key success factors
• Aventis Pasteur's Menactra
• Drug overview
• Clinical trial data
• Patient potential
• Marketing factors
• Satisfaction of unmet needs
• MMR-V combinations
• Disease overview
• Measles
• Mumps
• Rubella
• Varicella zoster virus (VZV)
• Current vaccinations
• MMR vaccines
• Varicella vaccine
• Key success factors in MMR and VZV vaccination
• Merck & Co.'s MMR-V
• Profile
• Drug overview
• Clinical trial data
• GSK's MMR-V
• Clinical trial data
• Patient potential for MMR-V
• Marketing factors
• Market value at maturity
• Pneumococcal vaccines
• Disease overview
• Current pneumococcal vaccines
• Prevnar
• Pneumovax
• Key success factors
• Increased strain coverage
• Flexible and efficient manufacturing capability
• GSK's conjugated pneumococcal vaccine
• Drug overview
• Satisfaction of unmet need
• Wyeth's PnCRM9
• Drug overview
• Clinical trial data
• Satisfaction of unmet need
• Pneumococcal patient potential
• Marketing factors
• Market value at maturity
• Respiratory syncitial virus
• Disease overview
• Pierre Fabre's RSV vaccine: BBG2Na
• Drug overview
• Clinical trial data
• Patient potential
• Marketing factors
• Market value at maturity
• Hepatitis B vaccines
• Disease overview
• Current marketed HBV vaccines
• Engerix-B
• Recombivax HB/HB Vax II
• Twinrix
• Comvax
• Key unmet needs
• Fendrix
• Profile
• Vaccine overview
• Clinical trial data
• Patient potential
• Marketing factors
• Bio-Hep-B
• Profile
• Vaccine overview
• Clinical trial data
• Patient potential
• Marketing factors
• Satisfaction of unmet needs
• Market value at maturity
• Staphylococcal vaccines
• Disease overview
• Resistance
• Nabi's StaphVax
• Drug overview
• Clinical trial data
• Patient potential
• Marketing factors
• Market value at maturity

APPENDIX A

• Additional data
• List of tables
• List of figures
• Bibliography
• Epidemiology
• Clinical trial data
• Other sources

APPENDIX B

• About Datamonitor
• About Datamonitor Healthcare
• Datamonitor Healthcare's research and analysis methodologies
• Datamonitor Healthcare's therapy area capabilities
• About Disease analysis team
• Datamonitor Healthcare's Consulting expertise
• Datamonitor's Therapeutic Consulting expertise
• Key therapy team members
• Simon Hemsworth, Director of Therapy Area Analysis
• John Savopoulos, Lead Analyst, Infectious Diseases
• David Abramson, Therapeutic Lead Consultant
• Disclaimer

List of tables

• Table 1: Historical and forecast population, 0-4 years, across the major markets (000s), 1990-2015
• Table 2: Historical and forecast growth of population aged 65+ (000s), 1990-2015
• Table 3: Workforce across the major pharmaceutical markets (millions), 2002
• Table 4: Estimated EU/US sales for key late-phase vaccines at market maturity
• Table 5: Recommended childhood and adolescent immunization schedule, US, 2003
• Table 6: Historical and forecast population, 0-4 years, across the major markets (000s), 1990-2015
• Table 7: Annual number of vaccinees for key pediatric vaccines (000s)
• Table 8: Historical and forecast growth of population aged 65+ (000s), 1990-2015
• Table 9: Global endemic areas of travelers' infections
• Table 10: International tourist arrivals by region (millions), 1990-2001
• Table 11: US resident travel abroad by region (000s), 1995-2002
• Table 12: Assumptions used to calculate travel vaccine patient potential
• Table 13: Working age population across the major pharmaceutical markets (millions), 1990-2015
• Table 14: Workforce across the major pharmaceutical markets (millions), 2002
• Table 15: Clinical trial information for selected vaccines approved by the FDA since 1996
• Table 16: GSK's marketed vaccine portfolio, 2002
• Table 17: GSK's vaccine R&D pipeline, 2003
• Table 18: Key late-phase vaccines, 2003
• Table 19: US/EU estimated FluMist market value at maturity
• Table 20: Predicted total incidence and mortality of cervical cancer across the seven major markets, 2003
• Table 21: US/EU total HPV vaccine sales at maturity
• Table 22: Simplirix EU/US sales at market maturity
• Table 23: Key meningococcal vaccines, 2003
• Table 24: Comparison of profiles of MMR II and Priorix
• Table 25: Publications related to MMR and autism, 1982-2003
• Table 26: Varivax profile
• Table 27: Estimated US/EU sales of MMR-V at market maturity
• Table 28: Incidence of pneumococcal infection in the under fives (000s)
• Table 29: Prevnar profile
• Table 30: Pneumovax profile
• Table 31: Estimated US/EU conjugated pneumococcal vaccine sales at market maturity
• Table 32: Estimated RSV incidence and hospitalizations in the under-twos across the seven major markets (000s), 2002
• Table 33: Demographic and other characteristics of RSV infection in the US, 1998-2001
• Table 34: In-patient/out-patient resource use comparison for RSV infection in the US, 1998-2001
• Table 35: Estimated US/EU sales of RSV vaccine at market maturity
• Table 36: HBV prevalence in the seven major markets, 2002
• Table 37: Global sales of HBV vaccines, 2001-01
• Table 38: Key indications of Engerix-B
• Table 39: Dose requirements of Recombivax HB in specific populations
• Table 40: Dose requirements of Recombivax HB in specific populations
• Table 41: Hepatitis B seroprotection one month after the first and third injection of Bio-Hep-B or Engerix-B
• Table 42: Estimated sales of two-dose and extra-strength HBV vaccines in the EU/US at market maturity
• Table 43: Number of hospitalized patients associated with Staphylococcus infection across the seven major markets, 2001
• Table 44: Incidence of MRSA in European Countries
• Table 45: Healthcare statistics across the seven major pharmaceutical markets, 2000
• Table 46: Estimated EU/US sales of Staphylococcus vaccines at market maturity
• Table 47: Estimated hospitalized patient potential for pneumonia across seven nations, 2000-01 (000s)
• Table 48: Estimated hospitalized patient potential for UTI across seven nations, 2000-01 (000s)
• Table 49: Estimated number of hospitalizations due to peritonitis, 2000-01
• Table 50: Estimated incidence of osteomyletis across seven nations, 2001
• Table 51: Estimated incidence of serious skin and soft tissue infections across seven nations, 2001
• Table 52: Estimated incidence of infective endocarditis across seven nations, 2001
• Table 53: Incidence of nosocomial infections across seven major nations (millions), 2000
• Table 54: Surgical site infection by category of surgical procedure in English hospitals, 1997-99
• Table 55: Estimated incidence of nosocomial pneumonia (000s), 2001

List of figures

• Figure 1: The high level of corporate diversity will ultimately change the dynamics of this sector
• Figure 2: Classification of target populations for vaccines
• Figure 3: Historical and forecast global population, 0-4 years, 1990-2015
• Figure 4: Historical and forecast population, 0-4 years, across the major markets, 1990-2015
• Figure 5: Annual number of vaccinees for key pediatric vaccines (000s)
• Figure 6: Global vaccine market by volume and revenue, 2000
• Figure 7: Historical and forecast growth of population aged 65+, 1990-2015
• Figure 8: Influenza vaccine coverage in key groups across the US, 1988-2001
• Figure 9: Pneumococcal vaccine coverage in US citizens aged 65+, 1992-99
• Figure 10: US resident travel abroad by region, 1989-2002
• Figure 11: Estimated travel vaccine patient potential in the US (000s), 2002
• Figure 12: Working age (16-65) population across the major pharmaceutical markets, 1990-2015
• Figure 13: Population of 5-14 year olds across the major pharmaceutical markets, 1990-2015
• Figure 14: Key market dynamics and success factors for vaccine classes
• Figure 15: Key unmet needs in the vaccine market, 2003
• Figure 16: Late-stage vaccine pipeline by type of pathogen, 2003
• Figure 17: Late-stage pipeline by disease indication, 2003
• Figure 18: Late-stage vaccine pipeline by company, 2003
• Figure 19: Late-stage vaccine pipeline by company type, 2003
• Figure 20: Key unmet needs in influenza vaccination, 2003
• Figure 21: Clinical trial design for FluMist in children aged one to six years
• Figure 22: Estimated HSV patient population breakdown in the US
• Figure 23: Merck & Co.'s MMR-V vaccine
• Figure 24: Clinical trial design of GSK's MMR-V vaccine
• Figure 25: Seroconversion rates for GSK's MMR-V vs. Priorix and Varilrix administered separately
• Figure 26: Quarterly global sales of key pneumococcal vaccines, 2001-02
• Figure 27: Clinical trial design for Wyeth's nonavalent pneumococcal vaccine
• Figure 28: Treatment route for RSV patients in the US
• Figure 29: Mean cost of RSV CAP per episode in the US, 1999
• Figure 30: Mean length of hospital stay for RSV CAP in the US, 1999
• Figure 31: Key unmet needs in hepatitis B vaccination, 2003
• Figure 32: GSK's extra-strength hepatitis B vaccine reduced dosage clinical trial design
• Figure 33: GSK's extra-strength hepatitis B vaccine pilot clinical trial design
• Figure 34: GSK's extra-strength hepatitis B vaccine clinical trial design in non-responders
• Figure 35: Seroprotection in non-responder patients following vaccination with Engerix-B and GSK's extra-strength vaccine
• Figure 36: Mean HBs titer in non-responder patients following vaccination with Engerix-B and GSK's extra-strength vaccine
• Figure 37: Comparative immunogenecity of Bio-Hep-B and Engerix-B
• Figure 38: Comparative immunogenecity of Bio-Hep-B and Engerix-B
• Figure 39: Fendrix and Bio-Hep-B satisfaction of unmet need
• Figure 40: Progression of methicillin-resistant Staphylococcus aureus, US
• Figure 41: Incidence of nosocomial infections by site
• Figure 42: Percentage of infections at particular site caused by Staphylococcus aureus, US
• Figure 43: Etiology of surgical site infections, 1997-99
• Figure 44: Percentage of bloodstream infections caused by particular bacteria, US and EU
• Figure 45: Datamonitor's Healthcare Consultancy
• Figure 46: Datamonitor Healthcare's Therapeutic Consulting capabilities