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H1N1 Vaccines

This report analyzes the Global market for H1N1 Vaccines in US$ Million. The report provides separate comprehensive analytics for the North America, Europe, Asia-Pacific, and Rest of World. Annual estimates and forecasts are provided for the period 2009 through 2018. The report profiles 29 companies including many key and niche players such as Abbott Laboratories, Baxter International, Inc., CPL Biologicals Pvt. Ltd., CSL Limited, bioCSL, GlaxoSmithKline Plc, MedImmune, LLC, Novartis AG, Sanofi Pasteur, SA, Sinovac Biotech Ltd., and Zydus Cadila. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs.

Table of Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

  • Study Reliability and Reporting Limitations
  • Disclaimers
  • Data Interpretation & Reporting Level
    • Quantitative Techniques & Analytics
  • Product Definitions and Scope of Study

II. EXECUTIVE SUMMARY

1. GLOBAL MARKET OVERVIEW

  • A Prelude
  • Current and Future Analysis
  • Challenges Facing Healthcare Industry in Tackling Pandemics
  • Cumbersome Production Process of Pandemic Vaccines
  • Inefficiencies in Vaccine Distribution: A Cause of Concern
  • Competitive Scenario
  • H1N1 Influenza Vaccines and Manufacturers

2. GROWTH DRIVERS & INHIBITORS

  • Key Growth Drivers
  • Emerging Economies Present Potent Markets for H1N1 Vaccines
  • Consumer Awareness About Influenza Vaccines on the Rise
  • Threat of Antigenic Shift of H1N1 Virus Lingers
  • Influenza A(H1N1) pdm09 Virus Continues to Influence Global Influenza Activity
  • Government Purchases Continue to Propel Sales
    • Table 1: Mortality Rates of Major Influenza Pandemics Over the Last 100 Years (includes corresponding Graph/Chart)
  • Key Growth Inhibitors
  • High Competition Lowers Profit Margins
  • Shorter Lifecycle Of Pandemic Influenza
  • Ongoing Financial Crisis Affects Drug Prices and Manufacturing Cycles
  • Large-Scale Investments Pose Entry Barriers for Smaller Players

3. AN INSIGHT INTO GLOBAL VACCINES MARKET

  • Vaccines Market to Witness Robust Increase in Sales Driven by Robust Demand
  • Pneumococcal and Pediatric Multivalent Vaccines Dominate Sales
    • Table 2: Global Vaccines Market by Category (2012): Percentage Breakdown of Value Sales for Pneumococcal, Pediatric Multivalent, HPV, Influenza, Hepatitis, Rotavirus, Adult Booster, Meningococcal and Shingles (includes corresponding Graph/Chart)
  • Competitive Scenario
    • Table 3: Global Vaccines Market by Leading Manufacturer (2012): Percentage Market Share Breakdown of Value Sales for Sanofi Pasteur, GlaxoSmithKline, Merck & Co, Pfizer, Novartis Vaccines & Diagnostics, Astra Zeneca and Others (includes corresponding Graph/Chart)
  • H1N1 Influenza Diagnostic Tests
    • Table 4: Global Laboratory Rapid Testing by Leading Players (2012): Percentage Market Share Breakdown of Value Sales for Alere, Quidel, Meridian Bioscience, Beckman Coulter/Danaher, OraSure and Others (includes corresponding Graph/Chart)
  • Major Trends
  • Antigenic Shift of Virus Unlocks Possibilities for New Seasonal Influenza Vaccines
  • Quadrivalent Vaccines - A Whole New Generation of Seasonal Influenza Vaccines
  • Innovations in Vaccine Technology to Drive the Effort for a Universal Influenza Vaccine

4. H1N1 PANDEMIC - A HISTORICAL PERSPECTIVE

  • Influenza A (H1N1) 2009: The Global Pandemic
    • Table 5: Global Death Toll from 2009 A H1N1 (2009-2012) (includes corresponding Graph/Chart)

5. ECONOMIC IMPACT OF H1N1 PANDEMIC IN RETROSPECT

  • Pork & Pork Products
  • Airlines, Tourism & Hospitality
  • Hand Sanitizers
    • Table 6: US Market Revenues for Hand-Sanitizers for the Years 2008 through 2012 in US$ Millions (includes corresponding Graph/Chart)
  • Healthcare & Pharmaceuticals

6. H1N1 INFLUENZA - AN OVERVIEW

  • Influenza Virus: A Quick Primer
  • Symptoms and Characteristics
  • Types of Influenza
  • Influenza A Virus
  • Influenza A (H1N1) Virus
  • Different Names, in Different Countries
  • Symptoms and Risk Factors
  • The Pandemic Life-Cycle
  • Seasonal Influenza vis-a-vis H1N1 Flu
  • How H1N1 Is Diagnosed?
  • Prevention and Vaccination Against H1N1
    • Prevention
    • Vaccination
  • Vaccine Virus Selection for the 2012-2013 Influenza Season
    • WHO Recommended Virus Strains for Seasonal Influenza Vaccines for Northern Hemisphere for 2013-2014
    • WHO Recommended Virus Strains for Seasonal Influenza Vaccines for Southern Hemisphere for 2013
  • How H1N1 Vaccine is Prepared?
    • Egg-Based Production Process
    • Cell Culture-Based Technology
    • Recombinant Technology
  • Side Effects of H1N1 Vaccine
  • Primary Targets for Vaccination
  • Adverse Group for Vaccination
  • Treatment for Swine-Flu Infected Individuals
    • Anti-Virals for Pandemic (H1N1) 2009 Infection
    • Recommended Dosage of Anti-Viral
    • Peramivir - An Investigational Antiviral for H1N1

7. REGULATORY APPROVALS

  • GSK Obtains Marketing Authorization for Quadrivalent Influenza Vaccine in the UK and Germany
  • Sanofi Pasteur's Review Application for Quadrivalent Influenza Vaccine Accepted by EU
  • MedImmune Announces FDA Clearance of First Quadrivalent Flu Vaccine
  • Novartis Announces FDA Approval for Cell-Culture Derived Vaccine
  • GlaxoSmithKline Obtains FDA Approval for FLUARIXA® QUADRIVALENT
  • Tianyuan Receives GMP Certification for Influenza and H1N1 Vaccine
  • Kitasato Daiichi Sankyo Vaccine and Daiichi Sankyo Group Obtain Approval from Japanese Government for H1N1 Vaccine Production
  • Baxter Secures rMRP Approval from Austrian Agency for Health and Food Safety
  • AstraZeneca Announces European Commission's Approval of FLUENZ Vaccine

8. REGULATORY APPROVALS IN THE RECENT PAST

  • Serum Institute of India Secures Approval from DCGI for Usage of HIN1 Injectable Vaccine
  • Quest Diagnostics Obtains Approval for Simplexa Influenza A H1N1 Test from FDA
  • Zydus Cadila Obtains Approval from DCGI
  • Intelligent Medical Devices Receives FDA Approval for Usage of H1N1 Influenza Virus Assay
  • CSL Biotherapies Receives TGA Approval for Panvax® H1N1
  • WHO Prequalifies Arepanrix™ H1N1 Vaccine of GlaxoSmithKline
  • CSL Obtains Approval for Extended Use of 2009 HINI Influenza vaccine in Infants
  • Novartis Receives Approval for Celtura®
  • Baxter Obtains Approval for Vero Cell-Based CELVAPAN H1N1 Vaccine in Europe
  • CHMP Recommends Approval of Novartis' Focetria® in Europe
  • Sanofi Pasteur Obtains License from the US FDA for Influenza A (H1N1) 2009 Monovalent Vaccine
  • Sanofi Pasteur Receives Approval for New Vaccine Production Facility
  • US FDA Approves Supplemental BLA of GSK, for Unadjuvanted Influenza A (H1N1) Pandemic Vaccine
  • Health Canada Approves H1N1 Virus Vaccine
  • Sanofi Pasteur Gains Approval of Afssaps for A (H1N1) 2009 Vaccine in France
  • Novartis Obtains Prequalification Status from the WHO for Supply of Influenza A (H1N1) 2009 Vaccines in Developing World
  • Novartis Obtains Swissmedic Approval for Celtura®
  • CSL Biotherapies Receives US FDA Licensure for its Thimerosal-free Pandemic Influenza A (H1N1) 2009 Monovalent Vaccine
  • MedImmune Receives US FDA Approval for Nasal Spray H1N1 Vaccine
  • Sinovac Obtains Revised Approval for PANFLU.1 (H1N1) from State Food and Drug Administration
  • Sinovac Gains Certificate of Approval for Supply of PANFLU.1 in Mexico
  • Jiangsu Yanshen Gains Manufacturing License from SFDA, for H1N1 Flu Vaccine

9. PRODUCT LAUNCHES

  • FGBU Federal Center Develops H1N1 Swine Flu Inactivated Vaccine
  • Biolab Launches New Diagnostic Test for Swine Flu
  • VABIOTECH Develops Vaccines for A/H1N1 and A/H5N1 Viruses
  • Focus Diagnostics and 3M Unveil Simplexa™ Test on 3M™ Integrated Cycler
  • Bharat Biotech Introduces HNVAC H1N1 Swine Flu Vaccine
  • Serum Institute Unveils Nasovac Nasal Vaccine
  • Zydus Cadila Rolls Out Vaxiflu-S H1N1 Vaccine
  • The Scientific Research Institute Introduces New A/H1N1 Flu Vaccine

10. RECENT INDUSTRY ACTIVITY

  • bioCSL Restarts Manufacture of Influenza Vaccine
  • bioCSL Obtains Government Contracts for Vaccine Distribution
  • InGen Biosciences Inks Exclusive Dual Partnership Agreements
  • Vical and U.S. Naval Medical Research Center Extend Collaboration
  • Seegene and H1N1 Cross-Agencies Task Force Sign Research Agreement

11. INDUSTRY ACTIVITIES IN THE RECENT PAST

  • Vical and GenomIdea Ink Evaluation and Supply Agreement
  • Sinovac Biotech Signs Exclusive Distribution and Supply Licensing Agreement with Parenteral Biotech
  • Biological E Obtains License from VaxInnate for H1N1 Pandemic Swine Flu Vaccine
  • Fraunhofer USA Initiates Human Trial of H1N1 Influenza Vaccine
  • Novavax Announces Positive Results of A/H1N1 Pandemic Influenza Vaccine
  • Sinovac Biotech Clinches Fifth Consecutive Supply Order from MIIT for Panflu.1 H1N1 Vaccine
  • Zydus Cadila Completes Phase I Clinical Trial With its H1N1 Vaccine
  • Cadila Pharmaceuticals and Novavax Launch CPL Biologicals Pvt. Ltd.
  • Novartis Delivers 7.5 Million Doses of Influenza A (H1N1) Vaccine to HHS
  • Novartis Opens New Production Facility for Cell Culture-Based Influenza Vaccines Production in the United States
  • Novartis to Takeover Majority Interest in Chinese H1N1 Vaccine Maker
  • PhageVax Launches DNA Vaccine Platform
  • NIH to Initiate 2009 H1N1 Influenza Vaccine Trial in Persons with Asthma
  • Inovio Teams Up with Canadian Health Agency Pennsylvanian University on Swine Flu Vaccine
  • Simcere to Acquire Majority Interest in ChinaVax
  • Sanofi Pasteur Clinches Additional Order from HHS Department of the US
  • Sanofi Pasteur Bags Order from French Health Ministry, for Influenza A (H1N1) Vaccine
  • Sanofi Pasteur Inks Deal with Butantan Institute for Supply of Influenza A (H1N1) Virus Vaccine
  • McKesson Extends Partnership Deal with CDC
  • BD Receives Order from the Department of HHS
  • GSK Receives Order from the Department of HHS
  • MedImmune Recalls 4.7 Million Courses of Nasal H1N1 Flu Vaccine
  • Novavax and Xcellerex Enter into a Partnership

12. FOCUS ON SELECT GLOBAL PLAYERS

  • Abbott Laboratories (US)
  • Baxter International, Inc. (US)
  • CPL Biologicals Pvt. Ltd (India)
  • CSL Limited (Australia)
  • bioCSL (Australia)
  • GlaxoSmithKline Plc. (UK)
  • MedImmune, LLC. (USA)
  • Novartis AG (Switzerland)
  • Sanofi Pasteur, SA (France)
  • Sinovac Biotech Ltd. (China)
  • Zydus Cadila (India)

13. GLOBAL MARKET PERSPECTIVE

    • Table 7: World Recent Past, Current & Future Analysis for H1N1 Vaccines by Geographic Region - North America, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed by Annual Sales Figures in US$ Million for the Years 2009 through 2018 (includes corresponding Graph/Chart)
    • Table 8: World 10-year Analysis for H1N1 Vaccines by Geographic Region - Percentage Breakdown of Dollar Sales for North America, Europe, Asia-Pacific, and Rest of World Markets for the Years 2009, 2013 and 2018 (includes corresponding Graph/Chart)

III. MARKET

1. NORTH AMERICA

  • A. Market Analysis
    • Medicare and Medicaid Services for Influenza in the US
    • Table 9: CDC Price List for Pediatric Influenza Vaccines in Basic Package: 2013-2014
    • Table 10: CDC Price List for Adult Influenza Vaccines in Basic Package: 2013-2014
    • Rapid Spread of the H1N1 Pandemic Pegged to Delay in Vaccine Administration
    • Swine Flu Pandemic Undermines US Pork Exports Considerably
      • Restrictions Imposed on Various Pork Products in Russia and China during Pandemic A H1N1Outbreak
    • Table 11: US Pork Exports by Destination Country (2008 & 2013E): Percentage Breakdown of Export Value for Japan, Mexico, China & Hong Kong, Canada, Russia, and Others (includes corresponding Graph/Chart)
    • A Historical Perspective on the H1N1 Pandemic in North America
      • First Case of H1N1 Infection Reported in Mexico
      • Swine Flu Spreads to the United States
      • Canadian Government Launches H1N1 Mass Vaccination Campaign
    • Major H1N1 Vaccines Available in North American Marketplace
      • US FDA-Approved Influenza Vaccines with 2009 H1N1 Virus Strain Indicated for 2013-2014 Flu Season
      • US FDA-Approved Quadrivalent Vaccines Incorporating H1N1 Strain for Influenza Type A and B (2013)
      • Preparations Authorized by Health Canada for Influenza, including H1N1, in Canada (2013)
    • Product Approvals & Launches
    • Strategic Corporate Developments
    • Select Key Players
  • B. Market Analytics
    • Table 12: North American Recent Past, Current & Future Analysis for H1N1 Vaccines Analyzed by Annual Sales Figures in US$ Million for the Years 2009 through 2018 (includes corresponding Graph/Chart)

2. EUROPE

  • A. Market Analysis
    • Insights into European Influenza Vaccination Scenario
      • Cell-based Vaccine Production Remains Nascent
      • Major Influenza Vaccines Available in European Union Member Countries
      • Major H1N1 Flu Vaccines Available in Select East European Markets
      • ECDC Proposes New Influenza Vaccination Strategy
      • Immunization of High-Risk Demographics
      • Protecting Children, Adolescents, and Young Adults
      • Stemming the Spread of Infection in Public Centers
      • EMA approval for Quadrivalent LAIVs Pending
      • Anticipated Enhancements in Influenza Vaccine Products
    • Historical Perspective on the H1N1 Pandemic in Europe
    • Product Approvals & Launches
    • Strategic Corporate Developments
    • Select Key Players
  • B. Market Analytics
    • Table 13: European Recent Past, Current & Future Analysis for H1N1 Vaccines Analyzed by Annual Sales Figures in US$ Million for the Years 2009 through 2018 (includes corresponding Graph/Chart)

3. ASIA-PACIFIC

  • A. Market Analysis
    • Leading Influenza H1N1 Vaccine Brands Available in Select Asia-Pacific Markets
    • Historical Perspective on the Outbreak of H1N1 Pandemic in 2009 in Select Regions
      • Japan
      • South Korea
      • Taiwan
      • Malaysia
      • Philippines
      • New Zealand
      • India
      • China
      • Hong Kong
      • Singapore
      • Australia
    • Product Approvals & Launches
    • Strategic Corporate Developments
    • Select Players
  • B. Market Analytics
    • Table 14: Asia-Pacific Recent Past, Current & Future Analysis for H1N1 Vaccines by Geographic Region Analyzed by Annual Sales Figures in US$ Million for the Years 2009 through 2018 (includes corresponding Graph/Chart)

4. REST OF THE WORLD

  • A. Market Analysis
    • Product Approvals & Launches
  • B. Market Analytics
    • Table 15: Rest of the World Recent Past, Current & Future Analysis for H1N1 Vaccines by Geographic Region Analyzed by Annual Sales Figures in US$ Million for the Years 2009 through 2018 (includes corresponding Graph/Chart)
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