Pipeline and Commercial Insight: Influenza Vaccines - Pandemic threat revitalizes the sector : Market Research Report

Pipeline and Commercial Insight: Influenza Vaccines - Pandemic threat revitalizes the sector

Published by: Datamonitor

Published: Apr. 6, 2007 - 245 Pages

ABOUT DATAMONITOR HEALTHCARE: About the Infectious Diseases Pharmaceutical Analysis team
CHAPTER 1 EXECUTIVE SUMMARY: Scope of the analysis; Datamonitor insight into the influenza vaccine market; Key metrics; Datamonitor Pipeline Assessment Summary
CHAPTER 2 EPIDEMIOLOGY: Incidence; Risk groups; Transmission and symptoms; Diagnosis; Virus subtypes; Prevention and treatment; Vaccination prevents influenza infection; Antivirals can provide symptom relief and accelerate recovery; Antigenic shift and drift; Seasonal influenza epidemics; Influenza pandemics; Recent pandemics - fearsome lessons; Current pandemic status - waiting for the wave; H5N1 - the next pandemic virus?; Pandemic scenario - dramatic outlook for public health and economy; Preparing for disaster - national and international pandemic planning
CHAPTER 3 MARKET DEFINITION AND OVERVIEW: Market size and growth estimates; Current vaccine classes; Trivalent inactivated vaccines; Life-attenuated influenza vaccines; Vaccine manufacturing; Egg-based manufacturing is lengthy and inflexible; Cell-based manufacturing would offer big advantages; MDCK (Madin Darby Canine Kidney Cells); Vero cells; Per.C6 cells; Although highly promising, cell culture-based manufacturing still needs further development; Influenza vaccine supply - a yearly gamble; The number of vaccine manufacturers is fluctuating; Manufacturing capacities are expanding, but still not sufficient to meet global needs; Manufacturing problems can have a dramatic impact - the Chiron case; Influenza vaccine demand fluctuates considerably and is hard to predict; Time shifts between supply and vaccination schedules lead to fading demand as the flu season progresses; Changes in recommendations and subjective perception of risk have a significant impact on demand; Vaccination coverage rates vary among countries; Complex distribution pathways can delay timely vaccine supply; Country analysis; US - actively encouraging increased vaccination and influenza research; Pull - enlarging the national market size; Push - supporting the entry of additional products and suppliers; EU5 - slowly waking up to the influenza challenge; A European Influenza Task Force could improve co-ordination between European countries and the industry; Flu vaccines are cheaper in Europe than in the US; Reimbursement policies favor risk groups; Japan - low awareness and distrust hamper vaccine uptake; Japan has a low vaccination coverage due to low awareness and unfavorable reimbursement rates; Pandemic preparedness is a central concern of the Japanese government; Unmet needs in influenza vaccines; Pandemic vaccines could moderate the impact of a flu pandemic; Extending of manufacturing capacities would guarantee sufficient vaccine supply; Adjuvants could lead to better efficacy of vaccines in the elderly and reduce the amount of antigen needed for immunization; Faster manufacturing techniques would make vaccine production more flexible; Universal vaccines could eliminate the need for yearly updates; Needle-free administration methods would make vaccination more convenient
CHAPTER 4 CURRENT PLAYERS AND THEIR STRATEGIES: Overview; Sanofi pasteur - expanding market leadership; Current position; Fluzone (Vaxigrip); Strategic development; Cell-culture-based manufacturing - high hopes for Per.C6; Capacity - leading the field; Adjuvants - falling behind?; Pandemic vaccines - first-to-market in the US?; Strategic outlook; Novartis Vaccines - recovering from Chiron's failure; Current position; Fluvirin; Agrippal S1; Fluad; Begrivac; Strategic development; Expanding reach - acquisition of Chiron provided access to influenza vaccine market; Cell-culture-based manufacturing - first-to-market with Optaflu?; Capacity - new facilities in the US and Europe set to increase production; Adjuvants - MF59, a new paradigm?; Pandemic vaccines - Europe as stepping stone; Strategic outlook; GSK - the lucky third; Current position; Fluarix; FluLaval/Fluviral; Strategic development; Expanding reach - acquisition of ID Biomedical opens gate to the US market; Cell-culture-based manufacturing - lagging behind the competition; Capacity - acquisition of Wyeth's Marietta facility set to speed up cell-based manufacturing; Adjuvants -acquisition of Corixa provides access to novel technologies; Pandemic vaccines - first and second generation candidates show promising prospects; Strategic outlook; MedImmune - new hope in pediatric treatment; Current position; FluMist; Strategic development; Expanding reach - positioning and market penetration as main issues; Cell-culture-based manufacturing - catching up with the giants; Capacity - fill/finish as critical bottleneck; Pandemic vaccines - joining forces with NIAID; Strategic outlook; CSL - preparing to enter the US market; Current position; Fluvax; Strategic development; Expanding reach - US launch likely in the near future; Capacity - doubling production for the US market; Pandemic vaccines - slim chances to match the competition; Strategic outlook; Solvay - failing to commercialize on Influvac TC; Current position; Influvac; Invivac/Inflexal V; Strategic development; Cell-culture-based manufacturing - Influvac TC loses competitive advantage due to manufacturing delay; Capacity - it's all about cell-based production; Pandemic vaccines - projects still in early stages; Strategic outlook
CHAPTER 5 PATIENT-BASED FORECAST ANALYSIS: Datamonitor's patient-based forecasting model; Limitations of the patient-based forecasting model
CHAPTER 6 R&D APPROACH: Classification of pipeline products; Seasonal influenza vaccines; Pandemic influenza vaccines; Clinical trial design in influenza vaccine studies
CHAPTER 7 PIPELINE ANALYSIS SEASONAL INFLUENZA: Pipeline overview for seasonal influenza; Late-stage pipeline summary; Comparative assessment; Definition of current comparator therapy; Seasonal influenza vaccine gold standard: Fluzone; Optaflu (Novartis Vaccines); Drug overview; Clinical trial data; Phase III trial (EU) - comparison of safety, tolerability and immunogenicity of influenza vaccines in adults and elderly; Patient potential; Marketing factors; Satisfaction of unmet needs; Datamonitor drug assessment summary; FluBlØk (Protein Sciences/UMN Pharma); Drug overview; Clinical trial data; Phase II/III - immunogenicity and safety of trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine in healthy adults; Phase IIb - dose-related safety and immunogenicity of a trivalent baculovirus-expressed influenza-virus hemagglutinin vaccine in elderly adults; Patient potential; Marketing factors; Satisfaction of unmet needs; Datamonitor drug assessment summary; Flu Improved (GlaxoSmithKline); Drug overview; Clinical trial data; Phase II trial (EU) - Study to evaluate the immunogenicity and the safety of an adjuvanted influenza vaccine candidate; Patient potential; Marketing factors; Satisfaction of unmet needs; Datamonitor drug assessment summary; Seasonal flu vaccines (Sanofi pasteur); Flu Micro-Injection; Flu Infants; Flu vaccine - new formulation; FluInsure (GlaxoSmithKline); Drug overview; Clinical trial data; Patient potential; Marketing factors; Satisfaction of unmet needs; Datamonitor drug assessment summary; Immunostimulant seasonal influenza vaccine (Iomai); Drug overview; Clinical trial data; Patient potential; Marketing factors; Satisfaction of unmet needs; Datamonitor drug assessment summary; Late-stage pipeline vaccines developed outside the seven major markets; Influsome-Vac (NasVax); LAIV (BioDiem, Nobilon); Early-stage vaccines for prevention of seasonal influenza; DNA vaccines; PowderMed - Pfizer's entry route into the vaccine business; Universal vaccines; Late-stage development compounds recently discontinued; InfluJect (Baxter) - an uncertain future
CHAPTER 8 PIPELINE ANALYSIS PANDEMIC INFLUENZA: Pipeline overview for pandemic influenza; Late-stage pipeline summary; Comparative assessment; Definition of current comparator therapy; H5N1 vaccines; Sanofi pasteur; H5N1 influenza virus vaccine; GSK; Daronrix; H5N1-007; Novartis Vaccines; Focetria; Baxter; H5N1 pandemic vaccine; CSL; H5N1 Pandemic Vaccine; H9N2 vaccines; Novartis Vaccines; H9N2 pandemic vaccine; GSK; H9N2 pandemic vaccine; Crucell; H9N2 pandemic vaccine; H2N2 vaccines; GSK; H2N2 pandemic vaccine; Early-stage vaccines for prevention of pandemic influenza
APPENDIX A - BIBLIOGRAPHY
APPENDIX B: Limitations of IMS data; 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 influenza parameters for the seven major markets; Table 2: Companies developing cell-based manufacturing and US funding for cell culture development; Table 3: Current and future production capacity of key influenza vaccine manufacturers; Table 4: Influenza vaccination rates in the US, 2004; Table 5: Influenza vaccine catalog prices by manufacturer, US. 2005-06; Table 6: Influenza pandemic contracts announced to date; Table 7: Key needle-free influenza vaccine administration methods in development, 2007; Table 8: Acquisitions in the influenza vaccine space, 2005-06; Table 9: Fluzone dosages; Table 10: Fluvax dosages by age group; Table 11: Late-stage pipeline seasonal influenza, February 2007; Table 12: Datamonitor drug assessment parameters; Table 13: Fluzone (Sanofi pasteur) - product profile; Table 14: Fluzone formulations, 2006-07; Table 15: Fluzone - efficacy in children aged 6-24 months; Table 16: Optaflu (Novartis) - product profile; Table 17: Optaflu - clinical trial summary; Table 18: FluBlØk (Protein Sciences) - product profile; Table 19: FluBlØk - clinical trial summary; Table 20: Flu Improved (GSK) - product profile; Table 21: Flu Improved - clinical trial summary; Table 22: FluInsure (GSK) - product profile; Table 23: FluInsure - clinical trial summary; Table 24: Immunostimulant seasonal influenza vaccine (Iomai) - product profile; Table 25: Early-stage seasonal and universal influenza vaccines, February 2007; Table 26: Key DNA flu vaccines in development; Table 27: Recently discontinued late-stage influenza vaccines; Table 28: Pandemic influenza - late-stage pipeline overview; Table 29: H5N1 influenza virus vaccine (Sanofi pasteur) - product profile; Table 30: Daronrix (GSK) - product profile; Table 31: H5N1-007 (GSK) - product profile; Table 32: Focetria (Novartis) - product profile; Table 33: H5N1 pandemic vaccine (Baxter) - product profile; Table 34: H5N1 pandemic vaccine (CSL) - product profile; Table 35: H9N2 pandemic vaccine (Novartis) - product profile; Table 36: H9N2 pandemic vaccine (GSK) - product profile; Table 37: H9N2 pandemic vaccine (Crucell) - product profile; Table 38: H2N2 pandemic vaccine (GSK) - product profile; Table 39: Early stage pipeline pandemic influenza vaccines, February 2007
List of Figures: Figure 1: Drivers and restrictors in the influenza vaccine market; Figure 2: Influenza vaccine market size forecast (7MM), 2006-16; Figure 3: Datamonitor pipeline assessment summary - seasonal influenza vaccines; Figure 4: Datamonitor pipeline assessment summary - pandemic influenza vaccines; Figure 5: Global annual influenza disease burden; Figure 6: Population at high risk of influenza infection or influenza-associated complications; Figure 7: Influenza A virus: structure and electron micrograph; Figure 8: Antigenic drift versus antigenic shift; Figure 9: Recommended vaccination schedule and months of peak influenza activity, US 1976-2006; Figure 10: Development of a pandemic influenza virus; Figure 11: Overview over influenza pandemics in the 20th century; Figure 12: WHO and CDC classification systems for pandemic threat; Figure 13: Emergence of new Influenza A subtypes, 1977-2006; Figure 14: Cumulative number of confirmed human cases of avian Influenza A/(H5N1); Figure 15: Spread of H5N1 in poultry, wild birds and humans, 1996-2006; Figure 16: Current spread of H5N1 in poultry and wild birds, January 2007; Figure 17: Geographical spread of influenza vaccine sales, 2006; Figure 18: Growth drivers of the flu vaccine market; Figure 19: TIV and LAIV - key common and differentiating factors; Figure 20: Steps of the influenza vaccine manufacturing process and involved stakeholders; Figure 21: Egg-based vaccine manufacturing; Figure 22: Comparative analysis of MDCK, Vero and Per.C6 cells; Figure 23: Vaccine providers for the US market, 2000-06; Figure 24: Vaccine manufacturers in the seven major markets, 2006; Figure 25: Global influenza vaccine manufacturing capacity, 1994-2006; Figure 26: Influenza vaccine manufacturing facilities, 2006; Figure 27: High-risk individuals recommended for flu vaccination, US. 2004-05; Figure 28: Chiron - share price in response to events, Aug 2004- May 2005; Figure 29: Expected, delivered and demanded influenza vaccine supply for the US, 2004-05 season; Figure 30: Influenza vaccine supply versus demand in the US, 1980-2006; Figure 31: Flu vaccine supply and demand in relation to population recommended for vaccination, US 2003-06; Figure 32: Supply versus demand in a typical flu season; Figure 33: Global influenza vaccination coverage, 2002-03 season; Figure 34: Drivers and restrictors for influenza vaccination; Figure 35: US influenza vaccine distribution network; Figure 36: Use of different providers for influenza vaccination, US, 2005-06; Figure 37: US government strategies to foster growth of the national flu vaccine market; Figure 38: US average prices per dose in multi-dose vials, TIVs, 2002-06; Figure 39: Unmet needs in influenza vaccines; Figure 40: Leading players in the influenza vaccine market, US and EU5, 2005; Figure 41: Sanofi pasteur - influenza vaccine strategy; Figure 42: Novartis Vaccines - influenza vaccine strategy; Figure 43: GSK - influenza vaccine strategy; Figure 44: MedImmune - influenza vaccine strategy; Figure 45: CSL - influenza vaccine strategy; Figure 46: Solvay - influenza vaccine strategy; Figure 47: Influenza vaccine clinical trial process; Figure 48: Datamonitor's assessment of seasonal influenza pipeline vaccines; Figure 49: Fluzone - strengths and weaknesses; Figure 50: Comparison of seroprotection rates between Optaflu and Agrippal in EU Phase III trial, 2006; Figure 51: Optaflu - Datamonitor's competitive positioning analysis for seasonal influenza, 2007; Figure 52: FluBlØk: - efficacy results of Phase IIb trial; Figure 53: FluBlØk - Datamonitor's competitive positioning analysis for seasonal influenza, 2007; Figure 54: Flu Improved - Datamonitor's competitive positioning analysis for seasonal influenza, 2007; Figure 55: FluInsure - Datamonitor's competitive positioning analysis for seasonal influenza, 2007; Figure 56: Iomai's immunostimulant seasonal influenza vaccine - Datamonitor's competitive positioning analysis for seasonal influenza, 2007; Figure 57: Pandemic versus pre-pandemic vaccination strategy; Figure 58: Datamonitor drug assessment summary - pandemic influenza pipeline vaccines; Figure 59: Datamonitor's competitive positioning analysis of H5N1 influenza virus vaccine (Sanofi pasteur) for pandemic influenza, 2007; Figure 60: Datamonitor's competitive positioning analysis of Daronrix (GSK) for pandemic influenza, 2007; Figure 61: Datamonitor's competitive positioning analysis of H5N1-007 (GSK) for pandemic influenza, 2007; Figure 62: Datamonitor's competitive positioning analysis of Focetria (Novartis) for pandemic influenza, 2007; Figure 63: Datamonitor's competitive positioning analysis of H5N1 pandemic vaccine (Baxter) for pandemic influenza, 2007; Figure 64: Datamonitor's competitive positioning analysis of H5N1 pandemic vaccine (CSL) for pandemic influenza, 2007; Figure 65: Datamonitor's competitive positioning analysis of H9N2 pandemic vaccine (Novartis) for pandemic influenza, 2007; Figure 66: Datamonitor's competitive positioning analysis of H9N2 pandemic vaccine (GSK) for pandemic influenza, 2007; Figure 67: Datamonitor's competitive positioning analysis of H9N2 pandemic vaccine (Crucell) for pandemic influenza, 2007; Figure 68: Datamonitor's competitive positioning analysis of H2N2 pandemic vaccine (GSK) for pandemic influenza, 2007

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Pipeline and Commercial Insight: Influenza Vaccines - Pandemic threat revitalizes the sector

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