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Vaccines 2010: World Market Analysis, Key Players, and Critical Trends in a Fast-
Changing Industry

August 1, 2010

Vaccines have been one of the faster growing areas of the pharmaceutical industry, and
during a troubling series of years, they have been the superstars of many companies'
portfolios. They've also attracted the attention of insurance companies, retail outlets and
the media. The global market for vaccines experienced strong growth through 2009 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 Information has been closely following vaccine markets and since 2006 has
instituted a yearly market research report schedule to keep up with fast-moving
developments. Our latest comprehensive update, Vaccines 2010: World Market
Analysis, Key Players, and Critical Trends in a Fast-Changing Industry, examines the
market for vaccines used in humans for various disease. This state-of-the-industry
report is a must-have for any executive who wants to stay on top of a rapidly changing
market and see what’s expected down the road. You can count on the objectivity and
accuracy of our numbers and analysis—whether you're preparing a strategic
presentation, benchmarking your company's performance against the competition,
preparing a new product launch or seeking out an acquisition or a new partnership.

The report covers only commercialized vaccines and developmental vaccines for
diseases that are already vaccine-preventable; it does not cover emerging vaccines for
diseases that are not currently vaccine-preventable.

Included in this report are current market size and forecast for the following vaccines:

Pediatric Vaccines:
o Combinations
o Hepatitis
o HIB
o MMR
o Pneumococcal
o Poliovirus
 o Varicella
o Other Pediatric

Adult Vaccines:
o Cervical Cancer
o Hepatitis
o Influenza
o Pneumococcal
o Travel; DT; Misc.

Important trends such as vaccine safety, vaccine shortages, preventing pandemics,

vaccines and bioterrorism, DNA vaccination, innovations in vaccine delivery systems
and innovations in vaccine Production are covered in the report. In addition, the reort
profiles key competitors in the vaccine industry. Companies profiled in the report
include:

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

Sales estimates for each market segment represent global revenues and are expressed
in current dollars. Estimates are provided for the historic 2005 to 2009 period and
forecasts are provided through 2014. Historical information for this report was gathered
from a wide variety of published sources including company reports and filings,
government documents, legal filings, trade journals, newspapers and business press,
analysts’ reports and other sources. Interviews with company representatives and other
experts were conducted to capture the perspectives from industry participants’ point of
view and assess trends, and form the basis of the forecasting and competitive analysis.

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY

 The Global Vaccine Industry
o Scope and Methodology
o Overview
o Pediatric Preventative Vaccines
The Market
Adult Preventative Vaccines
The Market
Total Market
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 Subunit Vaccines
o Conjugate Vaccines
o DNA Vaccination
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. Health Care 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 Diphtheria
o Pertussis
o Tetanus
o Hepatitis B
o Poliomyelitis
o Haemophilus Influenzae Type B
 o Hepatitis A
o Measles, Mumps and Rubella
o Measles
o Mumps
o Rubella
o Meningococcal Disease
o Pneumococcal Conjugate
o Rotavirus
o Varicella
Pediatric Vaccines in Development
Cost of Vaccines in the United States The World Market for Pediatric Preventive Vaccines
o Total Market Size and Forecast
o Hepatitis Vaccine Market
 Market Analysis
 Leading Products and Competitors
o Haemophilus Influenzae Type B Vaccine Market
 Market Analysis
 Leading Products and Competitors
o Measles, Mumps and Rubella Vaccines
 Market Analysis
o Combination Vaccines Market
 Market Analysis
 Leading Products and Competitors
o Pneumococcal Vaccine
 Leading Products and Competitors
o Poliovirus Vaccine
 Market Analysi
 Leading Products and Competitors
o Varicella Vaccine
 Market Analysis
 Leading Products and Competitors
o Other Vaccines Market
 Market Analysis
 Leading Products and Competitors

CHAPTER FOUR: ADULT PREVENTIVE VACCINES

Introduction
Adult Vaccine-Preventable Diseases: Facts and Figures
Global Influenza Surveillance Program
Recommendations for Adult Immunizations
o WHO International Health Regulations
Adult Vaccine Products
o BCG
o Cervical Cancer
o Cholera
 o Diphtheria-Tetanus
o Hepatitis
 Hepatitis A
 Hepatitis B
o Influenza
o Japanese Encephalitis
o Pneumococcal Disease
o Rabies
o Shingles
o Typhoid Fever
o Yellow Fever
Adult Vaccines in Development
Total Market Size and Forecast
o Cervical Cancer Market
o Market Analysis
o Leading Products and Competitors
o Hepatitis Market
o Market Analysis
o Leading Products and Competitors
o Influenza Vaccine Market
o Market Analysis
o Leading Products and Competitors
o Market Analysis
o Leading Products and Competitors
o Travel, DT, and Miscellaneous Vaccine Market
o Market Analysis
o Leading Products and Competitors

CHAPTER FIVE: VACCINES MARKET SUMMARY

Trends Driving the Vaccines Market

Market Size and Forecast
Vaccine Sales by Region
Vaccine Market Competitors
Pediatric Vaccines
Major Manufacturer’s Market Share
Adult Vaccines
Major Manufacturer’s Market Share

CHAPTER SIX: ISSUES AND TRENDS

Vaccine Safety
Refusal to Immunize
Obesity
Post-Licensure Surveillance
Vaccine Adverse Event Reporting System
 The Vaccine Safety Datalink Project
Phase IV studies
The Vaccine Injury Compensation Program
Countermeasures Injury Compensation Program
World Health Organization
Other Initiatives
The Future of Vaccine Safety
o Vaccine Shortages
o Preventing Shortages in the Developed Countries
o Financial incentives
o Equitable pricing
o Vaccine stockpiles
o Preventing Shortages in Developing Nations
o Vaccine bonds
o Preventing Pandemics
o 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
Tularemia
Viral Hemorrhagic Fevers
DNA Vaccination
Innovations in Vaccine Delivery Systems
o Edible Vaccines
o Mucosal Delivery
o Intranasal Delivery
o Vaccine Patches
o Vaccine Chips
Innovations in Vaccine Production
o Tobacco Plants
o Insects
o Nanoparticle Systems

CHAPTER SEVEN: COMPANY PROFILES

AlphaVax, Inc.
o History and Lines of Business
o Strategic Alliances
o Vaccine Products
o Financial Information
Bavarian Nordic A/S
o History and Lines of Business
 o Strategic Alliances
o Vaccine Products
o Financial Information
Baxter Healthcare
o History and Lines of Business
o Strategic Alliances
o Vaccine Products
o Financial Information
Bharat Biotech
o History and Lines of Business
o Strategic Alliances
o Vaccine Products
o Financial Information
Celldex Therapeutics
o History and Lines of Business
o Strategic Alliances
o Vaccine Products
o Financial Information
Crucell
o History and Lines of Business
o Strategic Alliances
o Vaccine Products
o Financial Information
Emergent Biosolutions
o History and Lines of Business
o Strategic Acquisition and Alliance
o Vaccine Products
o Financial
GlaxoSmithKline
o History and Lines of Business
o Strategic Alliances
o Vaccine Products
o Financial Information
Medimmune
o History and Lines of Business
o Strategic Alliances
o Vaccine Products
o Financial Information
Merck & Co. Inc
o History and Lines of Business
o Strategic Alliances
o Vaccine Products
o Financial Information
Nabi Biopharmaceuticals
o History and Lines of Business
o Strategic Alliance
 o Vaccine Products
o Financial Information
Novartis
o History and Lines of Business
o Strategic Alliances
o Vaccine Products
o Financial Information
Pfizer
o History and Lines of Business
o Strategic alliances
o Vaccine Products
o Financial Information
Sanofi Pasteur
o History and Lines of Business
o Strategic Alliances
o Vaccine Products
o Financial Information

APPENDIX: COMPANY DIRECTORY

LIST OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

Figure 1-1: World Market for Pediatric Vaccines 2005-2014 Revenues (in millions)
Figure 1-2: World Market for Adult Vaccines 2005-2014 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 2009
Table 2-2: Vaccine-Preventable Diseases, June 2010
Table 2-3: VAERS Table of Reportable Events Following Vaccination

CHAPTER THREE PEDIATRIC PREVENTIVE VACCINES

Table 3-1: Global Immunization Rates by Vaccine Type 2008

Table 3-2: Immunization Profile of the United States: Population by Age Group, Number of Vaccine-
Preventable Diseases Reported by Disease 2002-2008
Table 3-3 : U.S. Recommended Immunization Schedule for Children Ages 0 Through 6 Years, 2010
Table 3-4: U.S. Recommended Immunization Schedule for Adolescents Ages 7 to 18 Years, 2010
Table 3-5: Selected Pediatric Vaccines in Development, June 2010
Table 3-6 : World Market for Pediatric Vaccines by Type (DTaP/DTP, Hep, HiB, MMR, Combinations,
Pneumococcal, Polio, Varicella, Others) 2005-2014 Revenues (in millions)
Figure 3-1: Market Share of Pediatric Vaccines by Type 2009
Figure 3-2: Market Share of Pediatric Vaccines, by Type 2014
Table 3-7 : World Market for Pediatric Vaccines by Region (U.S., North America, South America, EU, Japan,
 India, China, Rest of World) 2005-2014 Revenues (in millions)
Table 3-8: World Pediatric Hepatitis Vaccine Market 2005-2014 World Hib Vaccine Market, 2005-2014
Table 3-10: World MMR Vaccines Market 2005-2014
Table 3-11 World Combination Vaccines Market 2005-2014
Table 3-12 World Pediatric Pneumococcal Vaccine Market 2005-2014
Table 3-13 World Poliovirus Vaccine Market 2005-2014
Table 3-14 World Varicella Vaccine Market 2005-2014
Table 3-15 World Pediatric Other Vaccines Market 2005-2014

CHAPTER FOUR ADULT PREVENTIVE VACCINES

Table 4-1 Universal Adult Immunization Schedule 2010

Table 4-2 Adult Immunization Schedule for Populations with Special Medical Conditions, 2010
Table 4-3 Initiatives to Require HPV Vaccination by U.S. State, 2010
Table 4-4 WHO Pandemic Classification Schedule Selected Adult Preventive Vaccines in Development, 2010
Table 4-6 World Market for Adult Preventive Vaccines by Type (Hepatitis, Influenza, Pneumococcal,
Travel/DT/Misc.), 2005-2014 Revenues (in millions)
Figure 4-1 Market Share of Adult Vaccines, by Type, 2009
Figure 4-2 Market Share of Adult Vaccines, by Type, 2014
Table 4-7 World Market for Adult Vaccines by Region (U.S., North America, South America, EU, Japan, India,
China, Rest of World) 2005-2014 Revenues (in millions)
Table 4-8 World Cervical CancerVaccine Market 2005-2014
Table 4-9 World Hepatitis Vaccine Market 2005-2014 World Influenza Vaccine Market 2005-2014
Table 4-11 CDC Goal to Double Flu Immunization by 2010 Group and Estimated Immunization Rate (2000 vs
2010)
Table 4-12 2009 Estimated Population by Region and Selected Age Group (in millions)
Table 4-13 World Pneumococcal Vaccine Market 2005-2014 World Travel; Diphtheria-Tetanus;
Miscellaneous Vaccines Market 2005-2014 160

CHAPTER FIVE VACCINES MARKET SUMMARY

Figure 5-1 Sales Growth of Vaccines vs. Pharmaceuticals 2005-2014

Figure 5-2 World Market for Vaccines by Type 2005-2014
Table 5-1 The World Vaccines Market by Vaccine Type 2005-2014 Revenues (in millions
Figure 5-3 World Market for Vaccines Share by Type, 2005, 2009 and 2014
Table 5-2 The World Vaccines Market by Region 2005-2014 Revenues (in millions)
Table 5-3 Major Manufacturers’ Shares of the World Vaccine Market, 2009
Figure 5-3 2009 World Vaccines Market Share, by Leading Competitors
Table 5-4 Major Manufacturer’s Shares of the World Pediatric Vaccine Market 2009
Figure 5-5 Market Share of Pediatric Vaccines Market, 2009
Table 5-5 Major Manufacturer’s Shares of the World Adult Vaccine Market 2009
Figure 5-6: Market Share of Adult Vaccines Market 2009

CHAPTER SIX ISSUES AND TRENDS

Table 6-1: Selected Companies/Laboratories Developing Biodefense Vaccines

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