ワクチンの世界市場の動向と予測

Abstract

Vaccination is the single most cost effective health intervention in all countries. The historical market for vaccine products has been relatively small when compared to the growth of therapeutic products to treat disease. Vaccine production is capital-intensive, utilizes outdated technology and currently produces vaccines only for relatively few diseases.

Emerging and new technologies based on advances in immunology, genetics and molecular biology will address a whole new range of infectious disease and cancer targets. Future vaccine technologies will provide a highly cost-effective alternative to conventional treatment, while at the same time creating a higher profit potential for vaccine products.

Sales of preventive vaccines, once considered a commodity market, are now on the increase. The vaccine market grew by double-digits between 2000 and 2001, exceeding the pharmaceutical sector as a whole, which grew only 8.6% in the same period. The vaccine market has exhibited strong growth since 1999, mainly driven by new product introductions and the expansion of immunization programs.

Interest in vaccine production is spurred by increased demand for flu vaccinations, vaccine use by tourists visiting tropical countries, fears of bioterrorism, and vaccines to combat ongoing sources of widespread epidemics or pandemics, including malaria, herpes, hepatitis C, and HIV. In addition, opportunities for vaccine manufacturers are opening in the prevention and treatment of emerging diseases such as West Nile Virus, ebola, and SARS.

The vaccine R&D pipeline is an indicator of how the breadth of indications covered and the scope of patient groups targeted is likely to increase over the next eight to ten years. For example, more than 80 prophylactic products are in development targeting at least twenty diseases, for which there are currently no marketed vaccines. Volume sales and an associated demand for production capacity will also increase. This will drive companies to increase capacity and improve the efficiency of their manufacturing processes.

Scope and Methodology

This report covers pediatric and adult preventive vaccine products and provides an analysis of therapeutic vaccines for cancer treatment.. In assessing the market for vaccine products, Kalorama Information provides sales data for the 2001-2003 historical years, the 2004 base year, and the 2001 through 2010 forecast years. Revenues are expressed in terms of manufacturers annual sales and in current U.S. dollars.

The information for this report was gathered using both primary and secondary research including comprehensive research of secondary sources such as company literature, databases, investment reports, and medical and business journals. Telephone interviews and email correspondence were the primary method of gathering information. For the purpose of this study, Kalorama Information conducted interviews with key industry officials, consultants, health care providers, and government personnel. These sources were the primary basis in gathering information specifically relating to revenue and market share data presented in this report. Specific interviews with pharmaceutical company representatives included marketing directors, division managers, and product representatives.

Pediatric vaccines include the following:

• Combination vaccines
• Diphtheria-tetanus-pertussis (DTP) and diphtheria-tetanus-acellular pertussis (DTaP)
• Hepatits A; Hepatitis B
• Measles-mumps-rubella (MMR)
• Pneumococcal
• Poliovirus
• Varicella
• Others

Adult vaccines include the following:

• Hepatitis A; Hepatitis B
• Influenza
• Pneunomoccal
• Travel; DT; others

Table of Contents

Chapter One: Executive Summary

Scope and Methodology

Size and Growth of the Market

Market Trends

Industry Structure and Leading Competitors

Chapter 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 Whole Vaccines
• Toxoid Vaccines
• Genetically Engineered/Modified Vaccines
• Subunit Vaccines
• Conjugate Vaccines
• Vaccine Approval Process

DNA Vaccines

• Mechanism of Action of DNA Vaccines
• Advantages of DNA Vaccines

Therapeutic Vaccines to Treat Cancer

Chapter Three: Pediatric Preventive Vaccines

Overview

Childhood Immunization in the United States

• Childhood Immunization Rates
• Challenges to the Vaccine Delivery System
• Recommended Childhood Immunization Schedule

Pediatric Vaccine Products

• BCG Vaccines
• Diphtheria, Tetanus, Pertussis, Hepatitis B and Polio Vaccines
• Diphtheria
• Pertussis
• Tetanus
• Hepatitis B
• Poliomyelitis
• Haemophilus Influenzae Type B Vaccines
• Hepatitis A Vaccines
• Measles, Mumps and Rubella Vaccines
  • Measles
  • Mumps
  • Rubella
• Pneumococcal Conjugate Vaccine
• Rotavirus Vaccines
• Varicella Vaccines

Cost of Vaccines in the United States

Pediatric Vaccines in Development

• Global Initiatives for Vaccine Research
• Diarrhea-Related Diseases
• Rotavirus
• Rotavirus Vaccines
• Rotavirus Vaccines in Clinical Trials
• Enterotoxigenic Escherichia coli
• ETEC Vaccines in Clinical Trials
• Acute Respiratory Infections
• Streptococcus Pneumoniae
• Pneumococcal Vaccines
• Respiratory Syncytial Virus
• RSV Vaccines in Clinical Trials
• Parainfluenza Virus Type 3
• PIV-3 Vaccines in Clinical Trials
• The World Market for Pediatric Preventive Vaccines

• Total Market Size and Forecast
• DTP and DTaP Vaccine Market
• Market Analysis
• Leading Products and Competitors
• Hepatitis Vaccine Market
• Market Analysis
• Leading Products and Competitors
• Haemophilus Influenzae Type B Vaccine Market
• Market Analysis
• Leading Products and Competitors
• Measles, Mumps and Rubella Vaccines
• Market Analysis
• Leading Products and Competitors
• Combination Vaccines Market
• Market Analysis
• Leading Products and Competitors
• Pneumococcal Vaccine
• Market Analysis
• Poliovirus Vaccine
• Market Analysis
• Leading Products and Competitors
• Varicella Vaccines
• Market Analysis
• Leading Products and Competitors
• Other Vaccines Market
• Market Analysis
• Leading Products and Competitors

Chapter Four: Adult Preventive Vaccines

Introduction

Adult Vaccine-Preventable Diseases: Facts and Figures

Global Virological Surveillance Program

Recommendations for Adult Immunizations

• Vaccine Recommendations for International Travel
• CDCs Revised Recommendations for Influenza Vaccination for 2004-05 Flu Season
• Priority Groups for Influenza Vaccination
• Other Vaccination Recommendations
• Vaccination of Persons in Nonpriority Groups
• Persons Who Should Not Receive Influenza Vaccine
• CDCs Recommendations for Yellow Fever Vaccination
• WHO International Health Regulations

Adult Vaccine Products

• BCG Vaccines
• Cholera Vaccines
• Diphtheria-Tetanus Vaccines
• Hepatitis Vaccines
• Hepatitis A
• Hepatitis B
• Influenza Vaccines
• Japanese Encephalitis Vaccine
• Pneumococcal Disease Vaccines
• Rabies Vaccine
• Typhoid Vaccines
• Yellow Fever Vaccines

Adult Vaccines in Development

Global Initiatives for Vaccine Research

• Cholera Vaccines
• Dengue Fever Vaccines
• Epstein-Barr Virus Vaccines
• HIV/AIDS
• AIDS Vaccines
• Helicobacter Pylori Vaccines
• Hepatitis Vaccines
• Hepatitis C
• Hepatitis E
• Herpesvirus Vaccines
• Leishmaniasis
• Severe Acute Respiratory Syndrome
• Shigella Vaccine
• West Nile Virus

The World Market for Adult Preventive Vaccines

• Total Market Size and Forecast
• Hepatitis Market
• Market Analysis
• Leading Products and Competitors
• Influenza Vaccine Market
• Market Analysis
• Leading Products and Competitors
• Pneumococcal Vaccine Market
• Market Analysis
• Leading Products and Competitors
• Travel; DT; Miscellaneous Market
• Market Analysis
• Leading Products and Competitors

Chapter Five: Preventive Vaccines Market Summary

Trends Driving the Preventive Vaccines Market

Market Size and Forecast

• Vaccine Market Competitors
• Pediatric Vaccines
• Major Manufacturers Market Share
• Adult Vaccines
• Major Manufacturers Market Share

Chapter Six: Therapeutic Cancer Vaccines

Cancer Vaccine Technology

Cancer Statistics

Available Cancer Vaccines

• Bladder Cancer

Colorectal Cancer

• Melanoma

Types of Cancers Susceptible to Vaccines

• Breast Cancer
• Cervical Cancer
• Colorectal Cancer
• Gastrointestinal Cancer
• Stomach
• Liver
• Pancreas
• Kidney
• Leukemia
• Lung Cancer
• Lymphoma
• Melanoma
• Multiple Myeloma
• Neuroblastoma
• Ovarian Cancer
• Prostate Cancer
• Sarcoma

Cancer Vaccine Pipeline

• Vaccine Candidates in Phase III
• Vaccine Candidates in Phase II
• Vaccine Candidates in Phase I

The Emerging Cancer Vaccine Market

• Total Market Size and Forecast
• Competitor Analysis

Chapter Seven: Issues and Trends

Vaccine Safety

• Pre-licensure Evaluation
• Post-Licensure Surveillance
• Vaccine Adverse Event Reporting System
• The Vaccine Safety Datalink Project
• The Vaccine Injury Compensation Program
• The Future of Vaccine Safety

Vaccine Shortages

• Preventing Future Shortages in the U.S.
• Financial incentives
• Equitable pricing
• Utilizing vaccine stockpiles

Impact of Product Divergence on Vaccine Supply in Developing Countries

Vaccines and Bioterrorism

• Overview
• Project Bioshield Act of 2004
• Anthrax
• Smallpox
• Plague
• Botulism
• Tularemia
• Viral Hemorrhagic Fevers

Innovations in Vaccine Delivery Systems

• Edible Vaccines
• Mucosal Delivery
• Intranasal Delivery
• Oral Vaccines
• Vaccine Patches

Chapter Eight: Company Profiles

Acambis plc

• History and Lines of Business
• Strategic Alliances
• Vaccine Products
• Financial Information

AlphaVax, Inc.

• History and Lines of Business
• Strategic Alliances
• Vaccine Products

Avant Immunotherapeutics

• History and Lines of Business
• Strategic Alliances
• Vaccine Products

Aventis Pasteur

• 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

Berna Biotech AG

• History and Lines of Business
• Strategic Alliances
• Vaccine Products
• Financial Information
• BioPort Corporation

• History and Lines of Business
• Strategic Acquisition and Alliance
• Vaccine Products

Chiron Corporation

• History and Lines of Business
• Strategic Alliances
• Vaccine Products
• Financial Information
• Corixa Corporation

• History and Lines of Business
• Strategic Alliances
• Vaccine Products

Epimmune, Inc.

• History and Development
• Corporate Contract with NIH
• Vaccine Products

GlaxoSmithKline

• History and Lines of Business
• Strategic Alliances
• Vaccine Products
• Financial Information
• ID Biomedical Corporation

• History and Lines of Business
• Vaccine Products

MedImmune, Inc.

• 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

Nabi Biopharmaceuticals

• History and Lines of Business
• Strategic Alliance
• Vaccine Products
• Financial Information

Vical Incorporated

• History and Lines of Business
• Strategic Alliances
• Technology Platform
• Therapeutic Cancer Vaccine Products in Clinical Trials
• Financial Information

Wyeth

• History and Lines of Business
• Vaccine Products
• Financial Information

Appendix A: Vaccine Products

Appendix B: Company Directory

list of exhibits

Chapter One: Executive Summary

Table 1-1: Impact of Vaccines in the 20th Century Table 1-2: The World Vaccines Market by Vaccine Target 2001-2005 Figure 1-1: World Market for Vaccines, by Type, 2001-2010 Figure 1-2: World Market for Vaccines, by Type, 2001, 2005 and 2010= Table 1-3: Major Manufacturers Shares of the World Vaccine Market 2003 Figure 1-3: World Vaccines Market Share by Leading Competitors 2003

Chapter Two: Introduction to Vaccines

• Table 2-1: Impact of Vaccines in the 20th Century
• Table 2-2: Vaccine-Preventable Diseases

Chapter Three: Pediatric Preventive Vaccines

• Table 3-1: Global Immunization Score Card: Percentage of Countries and Population Left to Reach by WHO Objective
• Table 3-2: Immunization Profile of the United States
• Table 3-3: U.S. Recommended Childhood Immunization Schedule, July through December 2004
• Table 3-4: Cost of Vaccines: Private Sector Versus Public Sector: Prices Last Reviewed/Updated, August 2004
• Table 3-5: Selected Pediatric Vaccines in Development
• Table 3-6: World Market for Pediatric Vaccines by Type 2001-2010
• Figure 3-1: Market Share of Pediatric Vaccines by Type 2004
• Figure 3-2: Market Share of Pediatric Vaccines by Type 2010
• Table 3-7: World DTP and DTaP Vaccine Market 2001-2010
• Table 3-8: World Pediatric Hepatitis Vaccine Market 2001-2010
• Table 3-9: World Hib Vaccine Market, 2001-2010
• Table 3-10: World MMR Vaccines Market 2001-2010
• Table 3-11: World Combination Vaccines Market 2001-2010
• Table 3-12: World Pediatric Pneumococcal Vaccine Market 2001-2010
• Table 3-13: World Poliovirus Vaccine Market 2001-2010
• Table 3-14: World Varicella Vaccine Market 2001-2010
• Table 3-15: World Travel & Other Vaccines Market 2001-2010

Chapter Four: Adult Preventive Vaccines

• Table 4-1: Low Adult Vaccination: A Costly Heath care Burden Number of Vaccine-Preventable Deaths in the United States vs Five Other Causes
• Table 4-2: Universal Adult Immunization Schedule 2004
• Table 4-3: Adult Immunization Schedule for Populations with Special Medical Conditions, 2004
• Table 4-4: Selected Adult Preventive Vaccines in Development, 2004
• Table 4-5: World Market for Adult Preventive Vaccines, 2001-2010
• Figure 4-1: Market Share of Adult Vaccines, by Type, 2004
• Figure 4-2: Market Share of Adult Vaccines, by Type, 2010
• Table 4-6: World Hepatitis Vaccine Market 2001-2010
• Table 4-8: World Influenza Vaccine Market 2001-2010
• Figure 4-3: Immunization Rates of Persons Receiving Influenza Vaccine in 2002 by Age Group
• Table 4-8: CDC Goal to Double Flu Immunization by 2010
• Table 4-9: 2003 Estimated Population by Region and Selected Age Group
• Table 4-10: World Pneumococcal Vaccine Market 2001-2010
• Figure 4-5: European 65+ Population: Percent by Country
• Table 4-11: World Travel; Diphtheria-Tetanus; Miscellaneous Vaccines Market 2001-2010

Chapter Five: Preventive Vaccines Market Summary

• Table 5-1: The World Vaccines Market by Vaccine Type 2001-2010
• Figure 5-1: World Market for Vaccines by Type 2001-2010
• Figure 5-2: World Market for Vaccines Share by Type, 2001, 2005 and 2010
• Table 5-2: Major Manufacturers Shares of the World Vaccine Market, 2003
• Figure 5-3: 2003 World Vaccines Market Share, by Leading Competitors
• Figure 5-4: Global Market Share of Leading Competitors by Region, 2003
• Table 5-3: Major Manufacturers Shares of the World Pediatric Vaccine Market 2003
• Figure 5-5: Market Share of Pediatric Vaccines Market, 2003
• Table 5-4: Major Manufacturers Shares of the World Adult Vaccine Market 2003. 145
• Figure 5-6: Market Share of Adult Vaccines Market 2003

Chapter Six: Therapeutic Cancer Vaccines

• Table 6-1: Estimated and Projected World Cancer Incidence by Common Type of Cancer, 2003 and 2020
• Figure 6-1: Estimated and Projected World Cancer Incidence by Common Type of Cancer, 2003 and 2020
• Table 6-2: Estimated and Projected World Cancer Mortality by Common Type of Cancer, 2003 and 2020
• Figure 6-2: Estimated and Projected World Cancer Mortality by Common Type of Cancer, 2003 and 2020152
• Table 6-3: Cancer Vaccines in the Pipeline
• Table 6-4: World Market Cancer Vaccines by Current and Emerging Markets 2001-2008
• Figure 6-3: Cancer Vaccines by Current and Emerging Market Revenues and Percent Distribution, 2001-2008

Chapter Seven: Issues and Trends

• Table 7-1: Impact of Vaccines in the 20th Century
• Table 7-2: Tailored Products: Divergence of Vaccine Products Between Industrialized and Developing Countries
• Table 7-3: Selected Companies/Laboratories Developing Biodefense Vaccines

Appendix A: Vaccine Products

Table A-1: Selected Vaccines Currently Available Worldwide Table A-2: Vaccines Licensed for Immunizations and Distributed in the United States as of January 2004