Table of Contents
CHAPTER 1: EXECUTIVE SUMMARY
THE GLOBAL VACCINES INDUSTRY
SCOPE AND METHODOLOGY
MARKET ESTIMATES AND FORECASTS
CHAPTER 2: INTRODUCTION TO VACCINES
INTRODUCTION
Exhibit 2-1: Global Morbidity of Vaccine Preventable Diseases in 1990 vs. 2016 (Diphtheria, Measles, Polio, Tetanus, Whooping Cough, Yellow Fever)
A BRIEF HISTORY: THE DEVELOPMENT OF VACCINES
THE HUMAN IMMUNE SYSTEM
VACCINE MECHANISM OF ACTION
TYPES OF VACCINES
Attenuated (Weakened) Live Viruses
Exhibit 2-2: Attenuated Virus Production
Killed (Inactivated) Viruses
Toxoid Vaccines
Genetically Engineered/Modified Vaccines
VACCINE APPROVAL PROCESS
Exhibit 2-3: VAERS Table of Reportable Events Following Vaccination
CHAPTER 3: PEDIATRIC PREVENTATIVE VACCINES
INTRODUCTION
Exhibit 3-1: Global Child Immunization Rates for Vaccines Recommended by the WHO, 2016 (Haemophilus influenzae type B, Hepatitis B, Measles, Pneumococcal diseases, Polio, Rotaviruses, Rubella, Tetanus)
CHILDHOOD IMMUNIZATION IN THE UNITED STATES
Exhibit 3-2: Immunization Profile of the United States – Population by Age Group, Number of Vaccine-Preventable Diseases Reported by Disease, 1990–2014 (Live Births, Population (< 15 years), Population (< 5 years), Surviving Infants, Total population; Diphtheria, Measles, Mumps, Neonatal tetanus, Polio, Total tetanus, Yellow fever)
Childhood Immunization Rates
Challenges to the Vaccine Delivery System
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
Pneumococcal Conjugate
Rotavirus
Respiratory Syncytial Virus
Varicella
PEDIATRIC VACCINES IN DEVELOPMENT
Exhibit 3-3: Selected Pediatric Vaccines in Development, 2018
THE WORLD MARKET FOR PEDIATRIC PREVENTIVE VACCINES
Total Market Size and Forecast
Exhibit 3-4: World Market for Pediatric Preventive Vaccines by Type (Hep, HiB, MMR, Combinations, Pneumococcal Disease, Polio, Varicella, Others) 2015–2024, in $ Millions
Exhibit 3-5: Growth of World Market for Pediatric Preventative Vaccines by Type (Hep, HiB, MMR, Combinations, Pneumococcal Disease, Polio, Varicella, Others) 2015–2024
Exhibit 3-6: Market Share of Pediatric Preventative Vaccines by Type, 2017 (Hep, HiB, MMR, Combinations, Pneumococcal Disease, Polio, Varicella, Others) (%)
Exhibit 3-7: Market Share of Pediatric Preventative Vaccines by Type, 2024 (Hep, HiB, MMR, Combinations, Pneumococcal Disease, Polio, Varicella, Others) (%)
Exhibit 3-8: World Market for Pediatric Preventative Vaccines by Region (U.S., North America/Caribbean, South America, EU, Japan, India, China, Rest of World) 2015–2024, in $ Millions
Exhibit 3-9: Growth of World Market for Pediatric Preventative Vaccines by Region (U.S., North America/Caribbean, South America, EU, Japan, India, China, Rest of World) 2015–2024
Hepatitis Vaccine Market
Exhibit 3-10: World Pediatric Hepatitis Vaccine Market, 2015 – 2024 ($ Millions)
Haemophilus Influenzae Type B Vaccine Market
Exhibit 3-11: World Hib Vaccine Market, 2015-2024 ($ Millions)
Measles, Mumps and Rubella Vaccines
Exhibit 3-12: World MMR Vaccine Market, 2015-2024 ($ Millions)
Combination Vaccines Market
Exhibit 3-13: World Pediatric Combination Vaccine Market, 2015-2024 ($ Millions)
Pneumococcal Vaccine
Exhibit 3-14: World Pediatric Pneumococcal Vaccine Market, 2015-2024 ($ Millions)
Poliovirus Vaccine
Exhibit 3-15: World Poliovirus Vaccine Market, 2015-2024 ($ Millions)
Varicella Vaccines
Exhibit 3-16: World Pediatric Varicella Vaccine Market, 2015-2024 ($ Millions)
Other Pediatric Vaccines
Exhibit 3-17: World Other Pediatric Vaccine Market, 2015-2024 ($ Millions)
CHAPTER 4: ADULT PREVENTATIVE VACCINES
INTRODUCTION
GLOBAL INFLUENZA SURVEILLANCE PROGRAM
U.S. Surveillance
RECOMMENDED ADULT IMMUNIZATIONS
Exhibit 4-1: U.S. Influenza Vaccine Effectiveness, 2004 – 2018 (%)
WHO International Health Regulations
ADULT VACCINE PRODUCTS
BCG
Cervical Cancer
Exhibit 4-2: Initiatives to Require HPV Vaccination by U.S. State, 2018
Cholera
Diphtheria-Tetanus
Ebola
Hepatitis
Influenza
Exhibit 4-3: U.S. Flu Season Severity from 2008 to 2018
Exhibit 4-4: WHO Pandemic Classification Schedule
Japanese Encephalitis
Nosocomial Infections
Pneumococcal Disease
Rabies
Shingles
Typhoid Fever
Yellow Fever
ADULT VACCINES IN DEVELOPMENT
Exhibit 4-5: Selected Adult Vaccines in Development, 2018
THE WORLD MARKET FOR ADULT PREVENTIVE VACCINES
Total Market Size and Forecast
Exhibit 4-6: World Market Adult Preventive Vaccines by Type (Hepatitis, Influenza, Pneumococcal, Travel/Other) 2015–2024, in $ Millions
Exhibit 4-7: Growth of World Market for Adult Preventive Vaccines by Type (Cervical Cancer, Hepatitis, Influenza, Pneumococcal, Travel/Other) 2015–2024 ($ Millions)
Exhibit 4-8: Market Share of Adult Preventative Vaccines by Type, 2017 (%) (Cervical Cancer, Hepatitis, Influenza, Pneumococcal, Travel/Other)
Exhibit 4-9: Market Share of Adult Preventative by Type, 2024 (%) (Cervical Cancer, Hepatitis, Influenza, Pneumococcal, Travel/Other)
Exhibit 4-10: World Market for Adult Preventative Vaccines by Region (U.S., North America/Caribbean, South America, EU, Japan, India, China, Rest of World) 2015–2024, in $ Millions
Exhibit 4-11: Growth of World Market for Adult Preventative Vaccines by Region (U.S., North America/Caribbean, South America, EU, Japan, India, China, Rest of World) 2015–2024 ($ Millions)
Cervical Cancer Market
Exhibit 4-12: World Cervical Cancer Vaccine Market, 2015-2024 ($ Millions)
Hepatitis Market
Exhibit 4-13: World Adult Hepatitis Preventative Vaccine Market, 2015-2024 ($ Millions)
Influenza Vaccine Market
Exhibit 4-14: World Adult Influenza Preventative Vaccine Market, 2015-2024 ($ Millions)
Exhibit 4-15: Estimated World Population by Region and Selected Age Group, 2018, in Millions (Africa, Asia, Europe, North America, Oceania, South America, World; 40-54, 55-64, 65+, Total)
Pneumococcal Vaccine Market
Exhibit 4-16: World Adult Pneumococcal Preventative Vaccine Market, 2015-2024 ($ Millions)
Exhibit 4-17: U.S. Seasonal Influenza Vaccination by Age Group and Season, 2009-2016 (Children [6 months-17 years], Adults [≥18 years])
Travel and Other Vaccine Market
Exhibit 4-18: World Adult Travel and Other Preventative Vaccine Market, 2015-2024 ($ Millions)
CHAPTER 5: TOTAL VACCINES MARKET
TRENDS DRIVING THE VACCINES MARKET
Exhibit 5-1: Sales Growth of Vaccines vs. Pharmaceuticals, 2015-2024
MARKET SIZE AND FORECAST
Exhibit 5-2: Total World Market for Preventive Vaccines by Type, 2015–2024, in $ Millions (Pediatric Total: Combinations, Hepatitis, HIB, MMR, Pneumococcal, Poliovirus, Varicella, Others; Adult Total: Cervical, Hepatitis, Influenza, Pneumococcal, Travel & Other; Total)
Exhibit 5-3: Total World Market for Vaccines by Type, 2015-2024 (Pediatric, Adult) ($ Millions)
Exhibit 5-4: World Market for Vaccines Share by Type, 2015 (Pediatric, Adult) (%)
Exhibit 5-5: World Market for Vaccines Share by Type, 2024 (Pediatric, Adult) (%)
Vaccine Sales by Region
Exhibit 5-6: World Market for Preventative Vaccines by Region (U.S., North America/Caribbean, South America, EU, Japan, India, China, Rest of World) 2015–2024, in $ Millions
Vaccine Market Competitors
Exhibit 5-7: Major Manufacturers’ Shares of the World Vaccine Market, 2017 (%, $ Millions)
Exhibit 5-8: 2017 World Vaccines Market Share, by Leading Competitors (%)
Pediatric Vaccines
Exhibit 5-9: Major Manufacturers’ Shares of the World Pediatric Preventative Vaccine Market, 2017 (%, $ Millions)
Exhibit 5-10: 2017 World Pediatric Preventative Vaccines Market Share, by Leading Competitors (%)
Adult Vaccines
Exhibit 5-11: Major Manufacturers’ Shares of the World Adult Preventative Vaccine Market, 2017 (%, $ Millions)
Exhibit 5-12: 2017 World Adult Preventative Vaccines Market Share, by Leading Competitors (%)
CHAPTER 6: ISSUES AND TRENDS
OVERVIEW
RISING LIFE EXPECTANCY
INCREASING OBESITY
ADDICTION EPIDEMIC
GROWING OUT OF POCKET SPENDING ON HEALTHCARE
HEALTH INSURANCE CHANGES IN THE U.S.
Affordable Care Act Changes
Reimbursement Changes and Value-Based Care
DECENTRALIZATION OF HEALTHCARE SERVICES
Urgent Care Centers
Retail Clinics
AUSTERITY PROGRAMS IN EUROPE
UK
Other Nations
GLOBAL HEALTHCARE MERGERS AND ACQUISITIONS
Exhibit 6-1: Total U.S. Healthcare M&A Deal Value, 2009–2017, in $ Billions
VACCINE SAFETY
Data
Refusal to Immunize
Exhibit 6-2: Refusal to Vaccinate Form [part 1]
Exhibit 6-2: Refusal to Vaccinate Form [part 2]
Exhibit 6-2: Refusal to Vaccinate Form [part 3]
Post-Licensure Surveillance
The Vaccine Injury Compensation Program
World Health Organization
Other Initiatives
PRICING PRESSURE
Cost of Vaccines in the United States
VACCINE SHORTAGES
Preventing Shortages in the Developed Countries
Preventing Shortages in Developing Nations
Exhibit 6-3: R&D on Major Developing Nations Vaccine-Preventable Pathogens, 2018
Exhibit 6-4: Access to Vaccines Index, 2017
U.S. NATIONAL VACCINE PLAN
VACCINES AND BIOTERRORISM
Project Bioshield Act
Exhibit 6-5: Selected Companies/Laboratories Developing Biodefense Vaccines, 2018
National Bio and Agro-Defense Facility
Vaccine Treatment and Evaluation Units
Anthrax
Smallpox
NEW DISEASE THREATS
Exhibit 6-6: Vaccine-Preventable Diseases, August 2018
STIMULATING VACCINE DEVELOPMENT
Global Health Vaccine Center of Innovation
Human Vaccines Project
INNOVATIONS IN VACCINE DELIVERY SYSTEMS
Mucosal Delivery
Intranasal Delivery
Microneedles
CHAPTER 7: 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
DAIICHI SANKYO CO. LTD.
History and Lines of Business
Strategic Alliances
Vaccine Products
Financial Information
EMERGENT BIOSOLUTIONS
History and Lines of Business
Strategic Alliances
Vaccine Products
Financial Information
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
PAXVAX
History and Lines of Business
Strategic Alliances
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
SERUM INSTITUTE OF INDIA PVT. LTD.
History and Lines of Business
Strategic Alliances
Vaccine Products
Financial Information
SOLIGENIX
History and Lines of Business
Strategic Alliances
Vaccine Products
Financial Information
TAKEDA PHARMACEUTICAL CO. LTD.
History and Lines of Business
Strategic Alliances
Vaccine Products
Financial Information
VALNEVA
History and Lines of Business
Strategic Alliances
Vaccine Products
Financial Information