Stakeholder Perspectives: Influenza Vaccines - Flying back Into Flu

Table of Contents

• ABOUT DATAMONITOR HEALTHCARE
  • About the Infectious Disease pharmaceutical analysis team
• CHAPTER 1 VACCINE MARKET OVERVIEW
  • Towards the $10 billion barrier
    • Vaccines - a good business to be in
      • Differences between IMS Health and company-reported data
  • The US market - strong products and stakeholder commitment
    • Childhood vaccines - more coverage, better tracking
    • Adult vaccines - playing catch-up
      • Vaccine funding - moving to the private sector
    • Prevnar maintains dominance of pneumococcal vaccines
      • A successful year
      • Strong clinical impact
      • Overcoming vaccine shortages
      • International roll-out
      • Future challenges to Prevnar
  • The US market - the strengthening adolescent segment
    • GSK's Boostrix and Sanofi's Adacel
      • Boostrix profile
      • Adacel profile
    • Sanofi's Menactra
      • US recommendations for college students - a long time coming
      • Menactra - a better meningitis vaccine
      • Menactra - an expensive campaign
      • Menactra - next steps
      • Chiron's meningococcal ACWY vaccine
    • HPV vaccines on the way
      • Merck and GSK are developing preventative HPV vaccines
      • Gardasil versus Cervarix
      • Issues associated with STI vaccination
      • HPV vaccine market potential
  • 2005 - unprecedented commercial activity
    • Aggressive GSK leads a growing global market
      • Acquisition of ID Biomedical
    • Novartis acquires weakened Chiron
    • Further consolidation - Crucell moves on Berna
• CHAPTER 2 THE INFLUENZA VACCINE MARKET
  • Influenza is a global killer
    • Influenza is a global burden, affecting mainly the elderly and the very young
    • Influenza A and B cause annual epidemics
      • Antigenic drift versus antigenic shift
    • Seasonal (interpandemic) influenza
    • Pandemic influenza
      • A rare but recurrent event
      • Avian influenza H5N1 - a pandemic strain?
      • Global preparedness planning
  • Despite decades of experience, producing flu vaccines is a difficult business
    • Current flu vaccines are classified into TIV and LAIV
    • Unpredictable demand and commodity pricing
      • Historical fluctuation in number of flu vaccine manufacturers
      • Chiron debacle exposes the fragility of US seasonal vaccine supply
      • Current value and volume estimation of the global seasonal influenza vaccine market
    • The challenge of new product development
      • The pros and cons of LAIV
      • Intranasal administration is not enough to command premium pricing
      • Restricted age indication prevents usage in high-risk groups
      • FluMist requires storage at -15°C and cannot be refrozen following thawing
      • Strategies designed to increase product uptake
• CHAPTER 3 MARKETED AND DEVELOPMENTAL INFLUENZA VACCINES
  • Overview of egg-based systems
    • Producing an egg-based vaccine takes six months
      • Adjuvantation significantly improves vaccine efficacy
    • Fluzone
      • Key facts
      • Vaccine description
      • Event screen
    • Fluvirin
      • Key facts
      • Vaccine description
      • Clinical trial data
      • Event screen
    • Fluarix
      • Key facts
      • Vaccine description
      • Clinical trial data
      • Event screen
    • FluMist
      • Key facts
      • Vaccine description
      • Clinical trial data
      • Event screen
    • Inflexal
      • Key facts
      • Vaccine description
      • Clinical trial data
      • Event screen
    • Fluviral
      • Key facts
      • Vaccine description
      • Ongoing clinical trials
      • Event screen
    • Summary
  • Developmental influenza vaccines
    • Egg-based systems - a time for replacement?
    • Newer egg-based systems
      • Solvay's Invivac is based on virosomal technology
      • MedImmune's CAIV-T - a replacement for FluMist?
    • Cell culture-based systems
      • Vero, MDCK or PER.C6 cells?
      • Solvay's Influvac TC has long been approved but not marketed
      • Baxter's InfluJect (PreFluCel) - an uncertain future
      • Chiron's cell culture influenza vaccine
      • Sanofi-Crucell's inactivated split virus vaccine
      • Nobilon's/BioDiem's LAIV
    • Other technologies
      • FluInsure - a proteosome-based approach
      • FluBlØk - producing hemagglutinin in insect cells
      • PowderMed's plasmid DNA vaccine - is it safe?
      • Acambis's "universal" M2 ion channel-based influenza vaccine
• CHAPTER 4 FUTURE OUTLOOK
  • Several growth drivers fuel significant expansion of the influenza vaccine market
    • Commitments to increased vaccination
      • Strategies aimed at increasing vaccination coverage
      • Over 10 new vaccine launches by 2010
  • The global vaccine market 2010
    • In the seven major markets, 2010 sales might be as high as $3.7 billion
      • Consensus among different forecasts
      • Assumptions
      • Methodology
  • Commercial drivers and resistors to cell culture flu
    • Expensive to establish
    • Expensive to license
    • Who is most committed?
  • The role of vaccination in a pandemic
    • H5N1 prototype pandemic vaccines
      • Sanofi Pasteur's alum adjuvanted vaccine
      • Chiron's MF59 adjuvanted vaccine
      • GSK's pandemic vaccine
      • Others
  • Vaccines versus antivirals
    • Roche and the renaissance of Tamiflu
• APPENDIX A
  • Segmenting the vaccine market
    • Sales channels and limitations of IMS data
  • Bibliography
    • Journals
    • Datamonitor reports
    • Miscellaneous
    • Press releases
      • Other press releases (not sourced in the text)
    • Websites
  • List of Tables
    • Table 1: Classification of global vaccines businesses
    • Table 2: Major company reported vaccines sales, 1999-2005
    • Table 3: Coverage estimates for school entry vaccinations, 2004-05 school year
    • Table 4: Pediatric/VFC Vaccine Price List, December 2005
    • Table 5: Adult vaccine price list, December 2005
    • Table 6: Booster responses to the Tetanus, Diphteria and Pertussis antigens following Boostrix in individual aged 10-18 years
    • Table 7: Scenarios measuring cost effectiveness of meningitis vaccination
    • Table 8: Estimated prophylactic HPV vaccine peak sales
    • Table 9: TIV versus LAIV vaccines: key common and differentiating factors
    • Table 10: Unfolding of events at Chiron's Liverpool plant
    • Table 11: Global influenza vaccine sales for key Western manufacturers, 2003-04
    • Table 12: FluMist, a LAIV vaccine, is up to 77.5% more expensive than Fluzone, a TIV vaccine
    • Table 13: Fluzone: key facts
    • Table 14: Fluzone dosing by age group
    • Table 15: Key Fluzone events, 2004-05
    • Table 16: Fluvirin: key facts
    • Table 17: Key Fluvirin events, 2004-05
    • Table 18: Fluarix: key facts
    • Table 19: Key Fluarix events, 2004-05
    • Table 20: FluMist: key facts
    • Table 21: Key FluMist events, 2004-05
    • Table 22: Inflexal V: key facts
    • Table 23: Inflexal clinical trial results
    • Table 24: Key Inflexal V events, 2004-05
    • Table 25: Fluviral: key facts
    • Table 26: Key Fluviral events, 2004-05
    • Table 27: Influenza vaccines comparator table
    • Table 28: Key developmental influenza vaccines
    • Table 29: Protection rates of Invivac versus Influvac
    • Table 30: Comparative analysis of Vero, MDCK and PER.C6 cell lines
    • Table 31: Estimated US 2003/04 and 2004/05 season influenza vaccine coverage, and 2010 healthy people goal
    • Table 32: Census data, 2003 and 2010, seven major markets
    • Table 33: Estimated populations for targeted influenza vaccination, 2003/04 influenza season
    • Table 34: Actual and estimated influenza vaccination coverage rates, 2003-04 and 2010
    • Table 35: Seasonal influenza vaccine market: 2003-04 estimation and 2010 forecast
    • Table 36: Key GSK influenza vaccine-related events, 2004-05
    • Table 37: Developmental H5N1 pandemic vaccines
    • Table 38: Marketed influenza antivirals
  • List of Figures
    • Figure 1: Evaluating global vaccine market value and contribution, 2004
    • Figure 2: Contribution of vaccine companies outside the top 10, 2004
    • Figure 3: Market segmentation by region, 2004
    • Figure 4: US Recommended and Childhood and Adolescent Immunization Schedule, 2005
    • Figure 5: Extent of individuals receiving influenza vaccination by state, 2004
    • Figure 6: Recommended Adult Immunization Schedule, 2005-06
    • Figure 7: Global market segmentation by vaccine type, 2004
    • Figure 8: Number of reported pertussis cases per year, 1922-2000
    • Figure 9: Meningitis outbreaks by serogroups and community settings, 1994-2002
    • Figure 10: Overview of Gardasil Phase III study presented at the Infectious Diseases Society of America (IDSA) annual meeting 2005
    • Figure 11: Comparison of Merck's and GSK's candidate HPV preventative vaccines
    • Figure 12: Potential positioning of developmental prophylactic HPV vaccines
    • Figure 13: Global market share of major vaccines companies, 2004
    • Figure 14: The acquisition of ID Biomedical increases GSK's manufacturing capacity and exposure to the US market
    • Figure 15: Overview of GSK's flu vaccine strategy
    • Figure 16: Global influenza disease burden
    • Figure 17: Population at high risk of influenza infection or influenza-associated complications
    • Figure 18: Influenza virus: structure and electron micrograph
    • Figure 19: Antigenic drift versus antigenic shift
    • Figure 20: Months of peak influenza activity per season and recommended vaccinations season
    • Figure 21: Incidence and mortality caused by H5N1 between December 2003 and December 2005
    • Figure 22: The six phases of pandemic preparedness
    • Figure 23: US Influenza vaccine demand fluctuates between seasons
    • Figure 24: Breakdown of high-risk individuals in whom flu vaccination was recommended in the 2004-05 influenza season
    • Figure 25: Expected and delivered influenza vaccine for the US 2004/05 season
    • Figure 26: Projected supplies for the 2005-06 influenza season
    • Figure 27: Approved age groups for influenza vaccines expected to supply the 2005-06 US market
    • Figure 28: Strategies to increase FluMist penetration in the short and the long term
    • Figure 29: Strategies for the increase of influenza vaccination coverage
    • Figure 30: Estimated US launches of developmental influenza vaccines
    • Figure 31: The influenza vaccine market is expected to expand to over $3.7 billion by 2010 in the seven major markets
    • Figure 32: Forecasting methodology
    • Figure 33: Commercial and regulatory resistors against cell culture flu
    • Figure 34: Tamiflu versus Relenza sales, seven major markets, 2000-04
    • Figure 35: Global Tamiflu sales, 2000-H1 2005
    • Figure 36: Global pandemic versus non-pandemic Tamiflu sales, Q1-Q3 2005
    • Figure 37: Simplified schematic demonstrating vaccine supply channels to patients