The global market for human vaccines experienced strong growth through 2013 with the introduction of new vaccines. These new products and other trends are well-covered in Vaccines: The World Market. The Kalorama information report examines the global market for vaccines, covering specifically commercialized vaccines and developmental vaccines for diseases that are already vaccine-preventable.

Vaccination protects not only individuals, but also entire communities from diseases spread by person-to-person transmission. The high growth rates and successful launch of several recent products have kept interest in the global vaccine market high. This report investigates the changes vaccine manufacturers have undergone in the past year, providing world market analysis, identifying the key players, and outlining critical trends in this fast-changing industry.

Included in this report are current market size and forecasts to 2020 for the following vaccines:

Pediatric Vaccines:

• Pneumococcal
• Combinations
• Varicella
• MMR
• Poliovirus
• Hepatitis
• HIB
• Other Pediatric

Adult Vaccines:

• Influenza
• Cervical Cancer
• Hepatitis
• Pneumococcal
• Travel; DT; Misc.

The global market for vaccines experienced strong growth in many categories through 2013, declines in others, and this is expected to continue through the forecast period. Growth is being fueled by new product introductions and rising usage in all regions. Kalorama provides a global perspective in this report, including estimates of vaccine sales (pediatric and adult segments) in the following regions:

• U.S.
• Rest of North Amer.
• South America
• Europe
• Japan
• India
• China
• Rest of World

Despite ongoing improvements in pediatric vaccination, it is estimated that at least two million children die each year from diseases that could have been prevented by already existing vaccines. This problem is most significant in low income countries, with the health disparity between rich and poor countries resulting in average life spans of about 77 and 52 years, respectively. In addition to this high death toll, millions more suffer disability and illness because they have not been immunized.

Adult immunization is an important, but frequently overlooked, part of patient care. Though vaccination programs typically focus on children, adults in industrialized countries are more likely to die as a result of vaccine-preventable diseases than are children. For example, vaccination can prevent about 50% of deaths from pneumococcal disease and 80% of deaths from influenza-related complications in the elderly. Pharmacoeconomic studies have demonstrated the value of influenza and pneumococcal vaccines; however, immunization rates for these diseases continue to be low in the elderly populations.

Key issues in the global vaccine market today include product safety, refusal to immunize, supply shortages, the use of vaccines to prevent pandemics and address bioterrorism, and innovations in vaccine delivery systems. The following issues are discussed in this report.

• Vaccine Safety
• Refusal to Immunize
• Obesity
• Post-Licensure Surveillance
• The Future of Vaccine Safety
• Vaccine Shortages
• Preventing Pandemics
• Project Bioshield Act
• National Bio and Agro-Defense Facility
• DNA Vaccination
• Mucosal Delivery
• Intranasal Delivery
• Vaccine Patches
• Vaccine Chips and Microneedles
• Innovations in Vaccine Production
• Nanoparticle Systems
• Cloning

This report includes profiles of the key players in vaccines, including:

• AlphaVax, Inc.
• Bavarian Nordic A/S
• Baxter Healthcare
• Bharat Biotech
• Crucell /Johnson & Johnson
• Emergent biosolutions
• GlaxoSmithKline
• Medimmune
• Merck & Co. Inc
• Novartis
• Sanofi Pasteur
• Pfizer

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
Recommended Childhood Immunization Schedule
State Immunization Recommendations
United Nations Initiatives
Pediatric Vaccine Products
BCG
Diphtheria, Tetanus, Pertussis, Hepatitis B and Polio
Haemophilus Influenzae Type B
Hepatitis A
Measles, Mumps and Rubella
Meningococcal Disease
Pneumococcal Conjugate
Rotavirus
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 Market
Combination Vaccines Market
Pneumococcal Vaccine Market
Poliovirus Vaccine Market
Varicella Vaccines Market
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
Cervical Cancer
Cholera
Diphtheria-Tetanus
Hepatitis
Influenza
Japanese Encephalitis
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
Travel, DT, and Miscellaneous Vaccine Market

Five: Vaccines Market Summary
Trends Driving the Vaccines Market
Market Size and Forecast
United States
North America
South America
Europe
Japan
India
China
Rest of World
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
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

Seven: Company Profiles
AlphaVax, Inc.
History and Lines of Business
Strategic Alliances
Vaccine Products
Financial Information
Bavarian Nordic A/S
History and Lines of Business
Strategic Alliances
Vaccine Products
Financial Information
Baxter Healthcare
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
Emergent biosolutions
History and Lines of Business
Strategic Alliances
Vaccine Products
Financial
GlaxoSmithKline
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
Novartis
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

Appendix: Company Directory

List of Exhibits

Two: Introduction To Vaccines
Table 2-1: Impact of Vaccines in the 20th Century Annual Morbidity in the 20th Century vs 2012
Figure 2-1: Attenuated Virus Production
Table 2-2: Vaccine-Preventable Diseases, March 2014
Table 2-3: VAERS Table of Reportable Events Following Vaccination
Three: Pediatric Preventive Vaccines
Table 3-1: Total Number of Children Who Died from Diseases Preventable by Vaccines Recommended by the WHO 2012
Table 3-2: Immunization Profile of the United States: Population by Age Group, Number of Vaccine-Preventable Diseases Reported by
Disease 1990 - 2012
Table 3-3: Marketplace Enrollment as a Share of the Eligible Population,December 2013
Table 3-4: U.S. Recommended Immunization Schedule for Children
Ages 0 Through 18 Years, 2013
Table 3-5: Selected Pediatric Vaccines in Development, March 2014
Table 3-6: World Market for Pediatric Vaccines by Type (Hep, HiB, MMR,Combinations, Pneumococcal, Polio, Varicella, Others) 2011-2020
Figure 3-1: Market Share of Pediatric Vaccines by Type 2013
Figure 3-2: Market Share of Pediatric Vaccines, by Type 2020
Table 3-7: World Market for Pediatric Vaccines by Region (U.S., North America, South America, EU, Japan, India, China, Rest of World) 2011-2020
Table 3-8: World Pediatric Hepatitis Vaccine Market 2011-2020
Table 3-9: World Hib Vaccine Market, 2011-2020
Table 3-10: World MMR Vaccines Market 2011-2020
Table 3-11: World Combination Vaccines Market 2011-2020
Table 3-12: World Pediatric Pneumococcal Vaccine Market 2011-2020
Table 3-13: World Poliovirus Vaccine Market 2011-2020
Table 3-14: World Varicella Vaccine Market 2011-2020
Table 3-15: World Pediatric Other Vaccines Market 2011-2020
Four: Adult Preventive Vaccines
Table 4-1: Universal Adult Immunization Schedule 2013
Table 4-2: Summary of Recommendations for Adult Immunization
Table 4-3: Initiatives to Require HPV Vaccination by U.S. State, 2014
Figure 4-1: U.S. Flu Season Severity from 2002 to 2013
Table 4-4: WHO Pandemic Classification Schedule
Table 4-5: Selected Adult Preventive Vaccines in Development, 2014
Table 4-6: World Market for Adult Preventive Vaccines by Type (Hepatitis,Influenza, Pneumococcal, Travel/DT/Misc.), 2011-2020
Figure 4-2: Market Share of Adult Vaccines, by Type, 2013
Figure 4-3: Market Share of Adult Vaccines, by Type, 2020
Table 4-7: World Market for Adult Vaccines by Region (U.S., North America,South America, EU, Japan, India, China, Rest of World) 2011-2020
Table 4-8: World Cervical CancerVaccine Market 2011-2020
Table 4-9: World Hepatitis Vaccine Market 2011-2020
Table 4-10: World Influenza Vaccine Market 2011-2020
Table 4-11: 2013 Estimated Population by Region and Selected Age Group
Table 4-12: World Pneumococcal Vaccine Market 2011-2020
Table 4-13: World Travel; Diphtheria-Tetanus; Miscellaneous Vaccines Market 2011-2020
Five: Vaccines Market Summary
Figure 5-1: Sales Growth of Vaccines vs. Pharmaceuticals 2011-2020
Figure 5-2: World Market for Vaccines by Type 2011-2020
Table 5-1: The World Vaccines Market by Vaccine Type 2011-2020
Figure 5-3: World Market for Vaccines Share by Type, 2011
Figure 5-4: World Market for Vaccines Share by Type, 2015 and 2020
Table 5-2: The World Vaccines Market by Region 2011-2020
Table 5-3: Major Manufacturers’ Shares of the World Vaccine Market, 2013
Figure 5-5: 2013 World Vaccines Market Share, by Leading Competitors
Table 5-4: Major Manufacturer’s Shares of the World Pediatric Vaccine Market 2013
Figure 5-6: Market Share of Pediatric Vaccines Market, 2013
Table 5-5: Major Manufacturer’s Shares of the World Adult Vaccine Market 2013
Figure 5-7: Market Share of Adult Vaccines Market 2013
Seven: Company Profiles
Figure 7-1: AlphaVax Product Pipeline, March 2014
Figure 7-2: Bharat Biotech’s Product Pipeline, March 2014
Figure 7-3: Crucell’s Product Pipeline, March 2014
Figure 7-4: Emergent Bioslutions’ Product Pipeline, March 2014
Figure 7-5: Sanofi Pasteur’s Product Pipeline, March 2014