Table of Contents
ONE: EXECUTIVE SUMMARY
The Global Vaccines Industry
Scope and Methodology
Overview
Pediatric Preventative Vaccines
Adult Preventative Vaccines
The Market
Issues and Trends
TWO: INTRODUCTION TO VACCINES
A Brief History: The Development of Vaccines
The Immune Response
Mechanism of Action
Types of Vaccines
Attenuated (Weakened) Live Viruses
Killed (Inactivated) Viruses
Toxoid Vaccines
Genetically Engineered/Modified Vaccines
Vaccine Approval Process
THREE: PEDIATRIC PREVENTIVE VACCINES
Introduction
Childhood Immunization in the United States
Childhood Immunization Rates
Challenges to the Vaccine Delivery System
The Effect of U.S. Healthcare Reform
The Effect of Addiction
Recommended Childhood Immunization Schedule
State Immunization Recommendations
United Nations Initiatives
Pediatric Vaccine Products
Addiction
BCG
Dengue Fever
Diphtheria, Tetanus, Pertussis, Hepatitis B and Polio
Haemophilus Influenzae Type B
Hand, Foot & Mouth Disease
Hepatitis A
Influenza
Measles, Mumps and Rubella
Meningococcal Disease
Parainfluenza Virus Type 3
Pneumococcal Conjugate
Rotavirus
Respiratory Syncytial Virus
Varicella
Pediatric Vaccines in Development
Cost of Vaccines in the United States
The World Market for Pediatric Preventive Vaccines
Total Market Size and Forecast
Hepatitis Vaccine Market
Haemophilus Influenzae Type B Vaccine Market
Measles, Mumps and Rubella Vaccines
Combination Vaccines Market
Pneumococcal Vaccine
Poliovirus Vaccine
Varicella Vaccines
Other Vaccines Market
FOUR: ADULT PREVENTIVE VACCINES
Introduction
Adult Vaccine-Preventable Diseases: Facts and Figures
Global Influenza Surveillance Program
U.S. Surveillance
Recommendations for Adult Immunizations
WHO International Health Regulations
Adult Vaccine Products
BCG
Cervical Cancer
Cholera
Diphtheria-Tetanus
Ebola
Hepatitis
Influenza
Japanese Encephalitis
Nosocomial Infections
Pneumococcal Disease
Rabies
Shingles
Typhoid Fever
Yellow Fever
Adult Vaccines in Development
The World Market for Adult Preventive Vaccines
Total Market Size and Forecast
Cervical Cancer Market
Hepatitis Market
Influenza Vaccine Market
Pneumococcal Vaccine Market
Travel, DT, and Miscellaneous Vaccine Market
FIVE: VACCINES MARKET SUMMARY
Trends Driving the Vaccines Market
Market Size and Forecast
Vaccine Sales by Region
Vaccine Market Competitors
Pediatric Vaccines
Adult Vaccines
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
Pricing Pressure
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
Stimulating Vaccine Development
Global Health Vaccine Center of Innovation
Human Vaccines Project
Innovations in Vaccine Delivery Systems
Mucosal Delivery
Intranasal Delivery
Vaccine Patches
Vaccine Chips and Microneedles
Innovations in Vaccine Production
Plants
Insects
Nanoparticle Systems
Cloning
SEVEN: COMPANY PROFILES
Bavarian Nordic A/S
History and Lines of Business
Strategic Alliances
Vaccine Products
Financial Information
Bharat Biotech
History and Lines of Business
Strategic Alliances
Vaccine Products
Financial Information
Crucell /Johnson & Johnson
History and Lines of Business
Strategic Alliances
Vaccine Products
Financial Information
CSL Limited
History and Lines of Business
Strategic Alliances
Vaccine Products
Financial Information
Emergent Biosolutions
History and Lines of Business
Strategic Alliances
Vaccine Products
Financial
GlaxoSmithKline
History and Lines of Business
Strategic Alliances
Vaccine Products
Financial Information
Hawaii Biotech
History and Lines of Business
Strategic Alliances
Vaccine Products
Financial Information
MedImmune
History and Lines of Business
Strategic Alliances
Vaccine Products
Financial Information
Merck & Co., Inc
History and Lines of Business
Strategic Alliances
Vaccine Products
Financial Information
Mymetics
History and Lines of Business
Strategic Alliances
Vaccine Products
Financial Information
Opexa Therapeutics
History and Lines of Business
Vaccine Products
Financial Information
Pfizer
History and Lines of Business
Strategic Alliances
Vaccine Products
Financial Information
Sanofi Pasteur
History and Lines of Business
Strategic Alliances
Vaccine Products
Financial Information
APPENDIX: COMPANY DIRECTORY
LIST OF EXHIBITS
TWO: INTRODUCTION TO VACCINES
Table 2-1: Global Morbidity of Vaccine Preventable Diseases in 1990 vs 2014
Figure 2-1: Attenuated Virus Production
Table 2-2: Vaccine-Preventable Diseases, March 2016
Table 2-3: VAERS Table of Reportable Events Following Vaccination
THREE: PEDIATRIC PREVENTIVE VACCINES
Table 3-1: Global Child Immunization Rates for Vaccines Recommended by the WHO, 2015
Table 3-2: Immunization Profile of the United States: Population by Age Group,Number of Vaccine-Preventable Diseases Reported by Disease, 1990 – 2014
Figure 3-1: National Overdose Death Rates, Number of Deaths from Prescription Drugs, 2001 – 2014
Figure 3-2: National Overdose Death Rates, Number of Deaths from Heroin, 2001 – 2014
Table 3-3: Marketplace Enrollment as a Share of the Eligible Population, September 2015
Table 3-4: U.S. Recommended Immunization Schedule for Children Ages Through 18 Years, 2016
Figure 3-3: FluMist Flu Hero
Table 3-5: Selected Pediatric Vaccines in Development, March 2016
Table 3-6: World Market for Pediatric Vaccines by Type (Hep, HiB, MMR,Combinations, Pneumococcal, Polio, Varicella, Others), 2013-2022 Revenues
Figure 3-4: Market Share of Pediatric Vaccines by Type, 2015 (Hep, HiB, MMR,Combos, Pneumococcal, Polio, Varicella, Others)
Figure 3-5: Market Share of Pediatric Vaccines, by Type, 2022 (Hep, HiB, MMR,Combos, Pneumococcal, Polio, Varicella, Others)
Table 3-7: World Market for Pediatric Vaccines by Region (U.S., North America,South America, EU, Japan, India, China, Rest of World), 2013-2022 Revenues
Table 3-8: World Pediatric Hepatitis Vaccine Market, 2013-2022
Table 3-9: World Hib Vaccine Market, 2013-2022
Table 3-10: World MMR Vaccines Market, 2013-2022
Table 3-11: World Combination Vaccines Market, 2013-2022
Table 3-12: World Pediatric Pneumococcal Vaccine Market, 2013-2022
Table 3-13: World Poliovirus Vaccine Market, 2013-2022
Table 3-14: World Varicella Vaccine Market, 2013-2022
Table 3-15: World Pediatric Other Vaccines Market, 2013-2022
FOUR: ADULT PREVENTIVE VACCINES
Table 4-1: Universal Adult Immunization Schedule, 2016
Table 4-2: Summary of Recommendations for Adult Immunization
Table 4-3: Initiatives to Require HPV Vaccination by U.S. State, 2016
Figure 4-1: U.S. Flu Season Severity from 2002 to 2015
Table 4-4: WHO Pandemic Classification Schedule
Table 4-5: Selected Adult Preventive Vaccines in Development, 2016
Table 4-6: World Market for Adult Preventive Vaccines by Type (Hepatitis,Influenza, Pneumococcal, Travel/DT/Misc.), 2013-2022 Revenues
Figure 4-2: Market Share of Adult Vaccines, by Type, 2015 (Cervical Cancer;Hepatitis; Influenza; Pneumococcal; Travel, DT, Misc.)
Figure 4-3: Market Share of Adult Vaccines, by Type, 2022 (Cervical Cancer;Hepatitis; Influenza; Pneumococcal; Travel, DT, Misc.)
Table 4-7: World Market for Adult Vaccines by Region (U.S., North America,South America, EU, Japan, India, China, Rest of World), 2013-2022 Revenues
Table 4-8: World Cervical CancerVaccine Market, 2013-2022
Table 4-9: World Hepatitis Vaccine Market, 2013-2022
Table 4-10: World Influenza Vaccine Market, 2013-2022
Table 4-11: 2015 Estimated Population by Region and Selected Age Group(Africa,Asia, Europe, North America, Oceania, South America, World)
Table 4-12: World Pneumococcal Vaccine Market, 2013-2022
Table 4-13: World Travel; Diphtheria-Tetanus; Miscellaneous Vaccines Market,2013-2022
FIVE: VACCINES MARKET SUMMARY
Figure 5-1: Sales Growth of Vaccines vs. Pharmaceuticals, 2013-2022
Figure 5-2: World Market for Vaccines by Type, 2013-2022 (Pediatric,Adult)
Table 5-1: The World Vaccines Market by Vaccine Type, 2013-2022(Pediatric:
Combinations, Hepatitis, HIB, MMR, Pneumococcal, Poliovirus, Varicella, Others;
Adult: Cervical Cancer, Hepatitis, Influenza, Pneumococcal, Travel – DT – Misc.,Total)
Figure 5-3: World Market for Vaccines Share by Type, 2013 and 2022 (Pediatric,Adult)
Table 5-2: The World Vaccines Market by Region, 2013-2022 (U.S., North America /Caribbean, South America, EU, Japan, India, China, ROW, Total)
Table 5-3: Major Manufacturers’ Shares of the World Vaccine Market, 2015
Figure 5-4: 2015 World Vaccines Market Share, by Leading Competitors
Table 5-4: Major Manufacturer’s Shares of the World Pediatric Vaccine Market,2015
Figure 5-5: Market Share of Pediatric Vaccines Market, 2015
Table 5-5: Major Manufacturers’ Shares of the World Adult Vaccine Market,2015
Figure 5-6: Market Share of Adult Vaccines Market, 2015
SIX: ISSUES AND TRENDS
Figure 6-1: Refusal to Vacinate Form
Table 6-1: Selected Companies/Laboratories Developing Biodefense Vaccines
SEVEN: COMPANY PROFILES
Figure 7-1: Bharat Biotech’s Product Pipeline, March 2016
Figure 7-2: Sanofi Pasteur’s Product Pipeline, March 2016