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Stakeholder Perspectives: Influenza Vaccines - Flying back Into FluPublished by: Datamonitor Published: Dec. 26, 2005 - 166 Pages Table of ContentsTABLE OF CONTENTS CHAPTER 1 VACCINE MARKET OVERVIEW 10 Towards the $10 billion barrier 10 Vaccines - a good business to be in 10 Differences between IMS Health and company-reported data 11 The US market - strong products and stakeholder commitment 14 Childhood vaccines - more coverage, better tracking 15 Adult vaccines - playing catch-up 19 Vaccine funding - moving to the private sector 21 Prevnar maintains dominance of pneumococcal vaccines 22 A successful year 22 Strong clinical impact 23 Overcoming vaccine shortages 24 International roll-out 25 Future challenges to Prevnar 27 The US market - the strengthening adolescent segment 28 GSK’s Boostrix and Sanofi’s Adacel 29 Boostrix profile 30 Adacel profile 31 Sanofi’s Menactra 31 US recommendations for college students - a long time coming 33 Menactra - a better meningitis vaccine 34 Menactra - an expensive campaign 35 Menactra - next steps 36 Chiron’s meningococcal ACWY vaccine 37 HPV vaccines on the way 37 Merck and GSK are developing preventative HPV vaccines 37 Gardasil versus Cervarix 40 Issues associated with STI vaccination 41 HPV vaccine market potential 44 2005 - unprecedented commercial activity 46 Aggressive GSK leads a growing global market 46 Acquisition of ID Biomedical 48 Novartis acquires weakened Chiron 49 Further consolidation - Crucell moves on Berna 51 CHAPTER 2 THE INFLUENZA VACCINE MARKET 53 Influenza is a global killer 53 Influenza is a global burden, affecting mainly the elderly and the very young 53 Influenza A and B cause annual epidemics 54 Antigenic drift versus antigenic shift 55 Seasonal (interpandemic) influenza 56 Pandemic influenza 58 A rare but recurrent event 59 Avian influenza H5N1 - a pandemic strain? 60 Global preparedness planning 62 Despite decades of experience, producing flu vaccines is a difficult business 64 Current flu vaccines are classified into TIV and LAIV 64 Unpredictable demand and commodity pricing 66 Historical fluctuation in number of flu vaccine manufacturers 66 Chiron debacle exposes the fragility of US seasonal vaccine supply 67 Current value and volume estimation of the global seasonal influenza vaccine market 71 The challenge of new product development 73 The pros and cons of LAIV 74 Intranasal administration is not enough to command premium pricing 75 Restricted age indication prevents usage in high-risk groups 75 FluMist requires storage at -15°C and cannot be refrozen following thawing 76 Strategies designed to increase product uptake 76 CHAPTER 3 MARKETED AND DEVELOPMENTAL INFLUENZA VACCINES 78 Overview of egg-based systems 78 Producing an egg-based vaccine takes six months 78 Adjuvantation significantly improves vaccine efficacy 80 Fluzone 81 Key facts 81 Vaccine description 81 Event screen 82 Fluvirin 83 Key facts 83 Vaccine description 83 Clinical trial data 84 Event screen 84 Fluarix 87 Key facts 87 Vaccine description 88 Clinical trial data 88 Event screen 88 FluMist 90 Key facts 90 Vaccine description 90 Clinical trial data 91 Event screen 91 Inflexal 93 Key facts 93 Vaccine description 93 Clinical trial data 93 Event screen 94 Fluviral 95 Key facts 95 Vaccine description 96 Ongoing clinical trials 96 Event screen 96 Summary 98 Developmental influenza vaccines 98 Egg-based systems - a time for replacement? 98 Newer egg-based systems 101 Solvay’s Invivac is based on virosomal technology 101 MedImmune’s CAIV-T - a replacement for FluMist? 102 Cell culture-based systems 103 Vero, MDCK or PER.C6 cells? 105 Solvay’s Influvac TC has long been approved but not marketed 109 Baxter’s InfluJect (PreFluCel) - an uncertain future 109 Chiron’s cell culture influenza vaccine 110 Sanofi-Crucell’s inactivated split virus vaccine 110 Nobilon’s/BioDiem’s LAIV 111 Other technologies 111 FluInsure - a proteosome-based approach 112 FluBlØk - producing hemagglutinin in insect cells 112 PowderMed’s plasmid DNA vaccine - is it safe? 114 Acambis’s “universal” M2 ion channel-based influenza vaccine 116 CHAPTER 4 FUTURE OUTLOOK 117 Several growth drivers fuel significant expansion of the influenza vaccine market 117 Commitments to increased vaccination 117 Strategies aimed at increasing vaccination coverage 119 Over 10 new vaccine launches by 2010 120 The global vaccine market 2010 121 In the seven major markets, 2010 sales might be as high as $3.7 billion 121 Consensus among different forecasts 122 Assumptions 123 Methodology 127 Commercial drivers and resistors to cell culture flu 128 Expensive to establish 129 Expensive to license 130 Who is most committed? 134 The role of vaccination in a pandemic 136 H5N1 prototype pandemic vaccines 138 Sanofi Pasteur’s alum adjuvanted vaccine 138 Chiron’s MF59 adjuvanted vaccine 139 GSK’s pandemic vaccine 139 Others 140 Vaccines versus antivirals 140 Roche and the renaissance of Tamiflu 144 APPENDIX A 148 Segmenting the vaccine market 148 Sales channels and limitations of IMS data 148 Bibliography 152 Journals 152 Datamonitor reports 154 Miscellaneous 155 Press releases 157 Other press releases (not sourced in the text) 160 Websites 165 AbstractIntroductionInfluenza is a highly infectious disease which globally infects 10-20% of the population every year causing up to 500,000 deaths. Although all persons are at risk, the elderly and the young are the most vulnerable. For decades, trivalent prophylactic vaccines produced in chicken eggs have been used to reduce the burden of influenza with approximately 300 million doses produced globally. Scope Evaluation of total 2004 global vaccine market value, historical growth since 1999 and major company market share Overview of major influenza vaccine products, producers and new product development Expert led discussion of drivers and resistors to cell culture flu systems in seasonal/pandemic scenarios Forecast value and demand (doses) for influenza vaccines in 2010 with launch predictions Highlights Despite the Chiron debacle, collective sales of influenza vaccines from Western producers surpassed the $1 billion level in 2004 with 10% growth over the previous year. Expanding recommendations for vaccination continue to fuel global demand. Datamonitor forecasts that in the seven major markets demand for influenza vaccines will expand to 370 million doses and a market value of $3.7 billion by 2010. Global capacity will expand appropriately to meet this goal but competition will intensify with 11 predicted new product launches. Cell culture flu could amount to 15% of US doses supplied in 2010 if the FDA can overcome safety concerns with the MDCK line. Although heralded as a much needed solution, cell culture flu still requires substantial capital investment. Reasons to Purchase Review an up to date expert discussion of major dynamics within the global vaccine market Gain insight into how the market for influenza vaccines is now an attractive growth option Understand commercial drivers and resistors for cell culture flu systems Get Full Details About This Report >> |
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