CHAPTER ONE: EXECUTIVE SUMMARY. The Global Vaccine Industry CHAPTER TWO: INTRODUCTION TO VACCINES

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1 CHAPTER ONE: EXECUTIVE SUMMARY The Global Vaccine Industry o Scope and Methodology o Overview o Pediatric Preventative Vaccines o The Market o Adult Preventative Vaccines o The Market o Total Market o Issues and Trends CHAPTER TWO: INTRODUCTION TO VACCINES A Brief History: The Development of Vaccines The Immune Response Mechanism of Action Types of Vaccines o Attenuated (Weakened) Live Viruses o Killed (Inactivated) Viruses o Toxoid Vaccines o Genetically Engineered/Modified Vaccines o Vaccine Approval Process CHAPTER THREE: PEDIATRIC PREVENTIVE VACCINES Introduction Childhood Immunization in the United States o Childhood Immunization Rates o Challenges to the Vaccine Delivery System o The Effect of U.S. Healthcare Reform o Recommended Childhood Immunization Schedule o State Immunization Recommendations o United Nations Initiatives Pediatric Vaccine Products o BCG o Diphtheria, Tetanus, Pertussis, Hepatitis B and Polio o Haemophilus Influenzae Type B o Hepatitis A o Measles, Mumps and Rubella o Meningococcal Disease o Pneumococcal Conjugate o Rotavirus o Varicella Pediatric Vaccines in Development Cost of Vaccines in the United States

2 The World Market for Pediatric Preventive Vaccines o Total Market Size and Forecast o Hepatitis Vaccine Market o Haemophilus Influenzae Type B Vaccine Market o Measles, Mumps and Rubella Vaccines o Combination Vaccines Market o Pneumococcal Vaccine o Poliovirus Vaccine o Varicella Vaccines o Other Vaccines Market CHAPTER FOUR: ADULT PREVENTIVE VACCINES Introduction Adult Vaccine-Preventable Diseases: Facts and Figures Global Influenza Surveillance Program o U.S. Surveillance o Recommendations for Adult Immunizations o WHO International Health Regulations Adult Vaccine Products o Cervical Cancer o Cholera o Diphtheria-Tetanus o Hepatitis o Influenza o Japanese Encephalitis o Pneumococcal Disease o Rabies o Shingles o Typhoid Fever o Yellow Fever Adult Vaccines in Development The World Market for Adult Preventive Vaccines o Total Market Size and Forecast o Cervical Cancer Market o Hepatitis Market o 1Influenza Vaccine Market o Travel, DT, and Miscellaneous Vaccine Market CHAPTER FIVE: VACCINES MARKET SUMMARY Trends Driving the Vaccines Market Market Size and Forecast

3 Vaccine Sales by Region Vaccine Market Competitors Pediatric Vaccines Adult Vaccines CHAPTER SIX: ISSUES AND TRENDS Vaccine Safety Refusal to Immunize Obesity Post-Licensure Surveillance The Vaccine Injury Compensation Program World Health Organization Other Initiatives The Future of Vaccine Safety Vaccine Shortages Preventing Shortages in the Developed Countries Preventing Shortages in Developing Nations Preventing Pandemics U.S. National Vaccine Plan Vaccines and Bioterrorism Overview Project Bioshield Act National Bio and Agro-Defense Facility Vaccine Treatment and Evaluation Units Anthrax Smallpox DNA Vaccination Innovations in Vaccine Delivery Systems Mucosal Delivery Intranasal Delivery Vaccine Patches Vaccine Chips and Microneedles Innovations in Vaccine Production Plants Insects Nanoparticle Systems Cloning CHAPTER SEVEN: COMPANY PROFILES AlphaVax, Inc.

4 Bavarian Nordic A/S Baxter Healthcare Bharat Biotech Crucell /Johnson & Johnson Emergent biosolutions o Financial GlaxoSmithKline Medimmune Merck & Co. Inc Novartis

5 Sanofi Pasteur APPENDIX: COMPANY DIRECTORY CHAPTER ONE: EXECUTIVE SUMMARY LIST OF EXHIBITS Figure 1-1: World Market for Pediatric Vaccines Revenues (in millions) Figure 1-2: World Market for Adult Vaccines Revenues (in millions) CHAPTER TWO: INTRODUCTION TO VACCINES Table 2-1: Impact of Vaccines in the 20th Century Annual Morbidity in the 20th Century vs 2011 Exhibit 2-1: Attenuated Virus Production Table 2-2: Vaccine-Preventable Diseases, August 2012 Table 2-3: VAERS Table of Reportable Events Following Vaccination CHAPTER THREE: PEDIATRIC PREVENTIVE VACCINES Table 3-1: Global Immunization Rates by Vaccine Type 2010 Table 3-2: Immunization Profile of the United States: Population by Age Group, Number of Vaccine-Preventable Diseases Reported by Disease Table 3-3: U.S. Recommended Immunization Schedule for Children Ages 0 Through 6 Years, 2012 Table 3-4: U.S. Recommended Immunization Schedule for Adolescents Age 7 to 18 Years, 2012 Table 3-5: Selected Pediatric Vaccines in Development, August 2012 Table 3-6: World Market for Pediatric Vaccines by Type (DTaP/DTP, Hep, HiB, MMR, Combinations, Pneumococcal, Polio, Varicella, Others) Revenues (in millions) Figure 3-1: Market Share of Pediatric Vaccines by Type 2011 Figure 3-2: Market Share of Pediatric Vaccines, by Type 2016 Table 3-7: World Market for Pediatric Vaccines by Region (U.S., North America, South America, EU, Japan, India, China, Rest of World) Revenues Table 3-8: World Pediatric Hepatitis Vaccine Market Table 3-9: World Hib Vaccine Market,

6 Table 3-10: World MMR Vaccines Market Table 3-11: World Combination Vaccines Market Table 3-12: World Pediatric Pneumococcal Vaccine Market Table 3-13: World Poliovirus Vaccine Market Table 3-14: World Varicella Vaccine Market Table 3-15: World Pediatric Other Vaccines Market CHAPTER FOUR: ADULT PREVENTIVE VACCINES Table 4-1: Universal Adult Immunization Schedule 2012 Table 4-2: Summary of Recommendations for Adult Immunization Table 4-3: Initiatives to Require HPV Vaccination by U.S. State, 2012 Figure 4-1: U.S. Flu Season Severity from 2002 to 2012 Table 4-4: WHO Pandemic Classification Schedule Table 4-5: Selected Adult Preventive Vaccines in Development, 2012 Table 4-6: World Market for Adult Preventive Vaccines by Type (Hepatitis, Influenza, Pneumococcal, Travel/DT/Misc.), Revenues Figure 4-1: Market Share of Adult Vaccines, by Type, 2011 Figure 4-2: Market Share of Adult Vaccines, by Type, 2016 Table 4-7: World Market for Adult Vaccines by Region (U.S., North America, South America, EU, Japan, India, China, Rest of World) Revenues Table 4-8: World Cervical CancerVaccine Market Table 4-9: World Hepatitis Vaccine Market Table 4-10: World Influenza Vaccine Market Table 4-11: 2011 Estimated Population by Region and Selected Age Group Table 4-12: World Pneumococcal Vaccine Market Table 4-13: World Travel; Diphtheria-Tetanus; Miscellaneous Vaccines Market CHAPTER FIVE: VACCINES MARKET SUMMARY Figure 5-1: Sales Growth of Vaccines vs. Pharmaceuticals Table 5-1: The World Vaccines Market by Vaccine Type Revenues Figure 5-2: World Market for Vaccines Share by Type, 2007, 2011 and 2016 Table 5-2: The World Vaccines Market by Region (U.S., North America, SouthAmerica, EU, Japan, India, China, ROW) Revenues Table 5-3: Major Manufacturers Shares of the World Vaccine Market, 2011 Figure 5-3: 2011 World Vaccines Market Share, by Leading Competitors Table 5-4: Major Manufacturer s Shares of the World Pediatric Vaccine Market 2011 Figure 5-5: Market Share of Pediatric Vaccines Market, 2011 Table 5-5: Major Manufacturer s Shares of the World Adult Vaccine Market 2011 Figure 5-6: Market Share of Adult Vaccines Market 2011 CHAPTER SIX: ISSUES AND TRENDS Table 6-1: Selected Companies/Laboratories Developing Biodefense Vaccines