ScientiaVision Product Pinpoint: The New Vaccines

Publication Date	March 2009
Publisher	Scientia Veritas
Product Type	Report
Pages	215
ISBN Number	not applicable
Product Code	STV00002

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Summary

Vaccines approved in the last five years have not only improved on previous products, but have created entirely new markets addressing patients of all ages. Merck's RotaTeq and GlaxoSmithKline's Rotarix rotavirus vaccines are intended for infants, Merck's Gardasil and GlaxoSmithKline's Cervarix (not yet approved in the United States) human papillomavirus (HPV) vaccines are intended for female patients aged 9 to 26, GlaxoSmithKline's Twinrix provides protection against both hepatitis A and hepatitis B for patients aged 18 and over, and Merck's Zostavax prevents herpes zoster (shingles) in patients aged 60 and over.

Vaccines in new therapeutic areas have created entirely new market segments and expanded the target population for vaccines. Coupled with increased emphasis on immunization worldwide, expensive cancer vaccines on the horizon, and increased immunization in emerging markets, the vaccines market is exploding faster than imagined possible just a few years ago. New blockbuster vaccines have completely changed the face of the market. Leading products and product lines in 2008 totaled US$10.0 billion (€6.9 billion) and included the following:

Prevnar (Wyeth): 2008 sales of US$2.7 billion (€1.9 billion);
Gardasil (Merck): 2008 sales of US$1.4 billion (€959 million), sales estimated at US$2.3 billion (€1.6 billion) when counting Gardasil sales by Merck, Sanofi Pasteur MSD, and CSL;
ProQuad/M-M-R II/Varivax (Merck): 2008 sales of US$1.3 billion (€867 million);
Infanrix/Pediarix (GlaxoSmithKline): 2008 sales of US$1.3 billion (€859 million);
Hepatitis Vaccines (GlaxoSmithKline): 2008 sales of US$1.2 billion (€838 million);
Polio/Whooping Cough/Hib Vaccines (Sanofi Pasteur): 2008 sales of US$1.1 billion (€768 million); and
Influenza Vaccines (Sanofi Pasteur): 2008 sales of US$1.1 billion (€736 million).

The worldwide market for vaccines has more than doubled in three years, from US$11.6 billion (€9.4 billion) in 2005 to US$25.2 billion (€16.5 billion) in 2008, having grown at a compound annual rate of 31.8% (27.6% for Euros). The market has primarily been driven by the billion-dollar products Prevnar; Gardasil; Merck's ProQuad/M-M-R II/Varivax line; Infanrx and Pediarix; GlaxoSmithKline's hepatitis line; Sanofi Pasteur's line of polio/whooping cough/Hib vaccines; and Sanofi Pasteur's line of influenza vaccines.

For the forecast period, SV projects that sales will more than double again to US$50.7 billion (€34.7 billion) in 2013, reflecting compound annual growth of 21.7% (19.2% for Euros). Growth will be driven by the following:

Introduction of improved, high-value vaccines, such as those for pneumococcus and meningococcus;
Continued growth in HPV vaccines as more countries put them on national immunization lists;
Growth in sales of influenza vaccines for seasonal use and pandemic preparedness;
Growth in sales of hepatitis vaccines;
Introduction of improved travel and endemic vaccines;
Increased immunization rates in developing countries;
Increased immunization rates in Japan; and
The introduction of expensive autologous cancer vaccines.

This report breaks the market down by regions, as well as by product categories, with historical, base year, and forecast data for each market segment. Market shares are provided for 2005 through 2008.

Notes on the Data

The base year for this report is 2008. Historical data cover 2005 through 2007, and forecasts cover 2009 through 2013. All data are presented at the level of product sales by manufacturers. All data are presented in both U.S. dollars and Euros. Corporate financial data reported in currencies other than U.S. dollars or Euros have been converted into both U.S. dollars and Euros. Scientia Veritas (SV) used average exchange rates for the year in making conversions. For 2005, US$1 = €0.8045 and €1 = US$1.2430; for 2006, US$1 = €0.7970 and €1 = US$1.2547; for 2007, US$1 = €0.7308 and €1 = US$1.3683; and for 2008, US$1 = €0.6834 and €1 = US$1.4633. For 2009 and forward, the 2008 exchange rates were used. Corporate financial data was obtained from filings with the U.S. Securities and Exchange Commission (SEC; Washington, DC) that included quarterly reports, and 10K and 20F annual filings; annual reports; and press releases. Market estimates were also based on both primary and secondary research.

Content

1. EXECUTIVE SUMMARY
1.1   Notes on the Data
1.2   The Market by Region

2   INTRODUCTION
2.1   Opportunities
2.1.1   Lack of Generic Competition
2.1.2   Additional Indications and Age Targeting
2.1.3   Adjuvants, Multivalent Vaccines, and Improved Efficacy
2.1.4   Cancer Vaccines
2.1.5   New Delivery Technologies
2.1.6   Acquisitions, Licensing, and Marketing Agreements
2.2   Challenges
2.2.1   Antibodies
2.2.2   Facilities, Time, and Technology
2.2.3   Shortages
2.2.4   Autism and Thimerosal

3   TYPES OF VACCINES
3.1   Conjugate Vaccines
3.2   DNA Vaccines
3.3   Inactivated Vaccines
3.4   Live, Attenuated Vaccines
3.5   Recombinant Vector Vaccines
3.6   Subunit Vaccines
3.7   Toxoid Vaccines
3.8   Vaccines Licensed in the United States
3.8.1   Anthrax
3.8.2   Diphtheria
3.8.3   Haemophilus Influenzae Type B
3.8.4   Hepatitis A
3.8.5   Hepatitis B
3.8.6   Human Papillomavirus
3.8.7   Influenza
3.8.8   Japanese Encephalitis
3.8.9   Measles
3.8.10   Meningococcus
3.8.11   Mumps
3.8.12   Pertussis
3.8.13   Plague
3.8.14   Pneumococcus
3.8.15   Poliovirus
3.8.16   Rabies
3.8.17   Rotavirus
3.8.18   Rubella
3.8.19   Smallpox
3.8.20   Tetanus
3.8.21   Tuberculosis
3.8.22   Typhoid
3.8.23   Varicella
3.8.24   Yellow Fever
3.8.25   Zoster
3.9   Vaccines Prequalified by the World Health Organization

4   THE WORLDWIDE VACCINES MARKET
4.1   Size of the Market
4.2   The Market by Region
4.3   The Market by Supplier
4.3.1   The Market by Vaccine Category
4.3.2   The Market for Cancer Vaccines
4.3.3   The Market for Hepatitis Vaccines
4.3.4   The Market for Influenza Vaccines
4.3.5   The Market for Meningococcus and Pneumococcus Vaccines
4.3.6   The Market for Rotavirus Vaccines
4.3.7   The Market for Travel and Endemic Vaccines
4.3.8   The Market for Other Vaccines
4.4   Market Drivers
4.4.1   Immunization Rates
4.4.2   Population Projections
4.4.3   Pricing
4.4.4   Creation of New Vaccine Markets

5 VACCINES IN DEVELOPMENT

6   COMPETITORS
6.1   Acambis, Inc
6.2   Berna Biotech-See Crucell N.V
6.3   BioPort Corporation-See Emergent BioSolutions Inc
6.4   Crucell N.V
6.5   CSL Biotherapies
6.6   Emergent BioSolutions Inc
6.7   GlaxoSmithKline
6.8   MedImmune Vaccines Inc
6.9   Merck & Company, Inc
6.10   Novartis Vaccines & Diagnostics
6.11   Sanofi Pasteur
6.12   Vaccinogen Inc
6.13   Wyeth Pharmaceuticals, Inc

7   COMPANY ADDRESSES

LIST OF EXHIBITS

EXHIBIT 1:   THE WORLDWIDE MARKET FOR VACCINES, BY REGION, IN U.S. DOLLARS, 2005, 2008, AND 2013
EXHIBIT 2:   THE WORLDWIDE MARKET FOR VACCINES, BY REGION, IN EUROS, 2005-2013
EXHIBIT 3:   THE WORLDWIDE MARKET FOR VACCINES, BY REGION, PERCENT DISTRIBUTION, 2008 (PIE CHART)
EXHIBIT 4:   VACCINES APPROVED IN THE UNITED STATES, BY COMPANY
EXHIBIT 5:   VACCINES APPROVED IN THE UNITED STATES, BY PROTECTION PROVIDED
EXHIBIT 6:   VACCINES LICENSED AND AVAILABLE IN THE UNITED STATES, BY TYPE AND TARGET POPULATION
EXHIBIT 7:   WORLD HEALTH ORGANIZATION'S LIST OF VACCINES PREQUALIFIED FOR PURCHASE BY UNITED NATIONS AGENCIES AS OF FEBRUARY 2009
EXHIBIT 8:   THE WORLDWIDE MARKET FOR VACCINES, BY REGION, IN U.S. DOLLARS, 2005-2013
EXHIBIT 9:   THE WORLDWIDE MARKET FOR VACCINES, BY REGION, IN EUROS, 2005-2013
EXHIBIT 10:   THE WORLDWIDE MARKET FOR VACCINES, BY REGION, PERCENT DISTRIBUTION, 2005-2013
EXHIBIT 11:   THE WORLDWIDE MARKET FOR VACCINES, BY REGION, PERCENT DISTRIBUTION, 2005 (PIE CHART)
EXHIBIT 12:   THE WORLDWIDE MARKET FOR VACCINES, BY REGION, PERCENT DISTRIBUTION, 2008 (PIE CHART)
EXHIBIT 13:   THE WORLDWIDE MARKET FOR VACCINES, BY REGION, PERCENT DISTRIBUTION, 2013 (PIE CHART)
EXHIBIT 14:   THE WORLDWIDE MARKET FOR VACCINES, BY LEADING COMPANIES, IN U.S. DOLLARS, 2005-2008
EXHIBIT 15:   THE WORLDWIDE MARKET FOR VACCINES, BY LEADING COMPANIES, IN EUROS, 2005-2008
EXHIBIT 16:   THE WORLDWIDE MARKET FOR VACCINES, BY LEADING COMPANIES, 2005 (PIE CHART)
EXHIBIT 17:   THE WORLDWIDE MARKET FOR VACCINES, BY LEADING COMPANIES, 2008 (PIE CHART)
EXHIBIT 18:   THE WORLDWIDE MARKET FOR VACCINES, BY CATEGORY, 2005-2013, IN U.S. DOLLARS
EXHIBIT 19:   THE WORLDWIDE MARKET FOR VACCINES, BY CATEGORY, 2005-2013, IN EUROS
EXHIBIT 20:   THE WORLDWIDE MARKET FOR VACCINES, BY CATEGORY, PERCENT DISTRIBUTION, 2005-2013
EXHIBIT 21:   THE WORLDWIDE MARKET FOR VACCINES, BY CATEGORY, 2005 (PIE CHART)
EXHIBIT 22:   THE WORLDWIDE MARKET FOR VACCINES, BY CATEGORY, 2008 (PIE CHART)
EXHIBIT 23:   THE WORLDWIDE MARKET FOR VACCINES, BY CATEGORY, 2013 (PIE CHART)
EXHIBIT 24:   THE WORLDWIDE MARKET FOR CANCER VACCINES, IN U.S. DOLLARS AND EUROS, 2005 TO 2013
EXHIBIT 25:   THE WORLDWIDE MARKET FOR CANCER VACCINES, MARKET SHARE BY SUPPLIER, IN U.S. DOLLARS AND EUROS, 2005 TO 2008
EXHIBIT 26:   THE WORLDWIDE MARKET FOR CANCER VACCINES, MARKET SHARE BY SUPPLIER, 2008 (PIE CHART)
EXHIBIT 27:   THE WORLDWIDE MARKET FOR HEPATITIS VACCINES, IN U.S. DOLLARS AND EUROS, 2005 TO 2013
EXHIBIT 28:   THE WORLDWIDE MARKET FOR HEPATITIS VACCINES, MARKET SHARE BY SUPPLIER, IN U.S. DOLLARS AND EUROS, 2005 TO 2008
EXHIBIT 29:   THE WORLDWIDE MARKET FOR HEPATITIS VACCINES, MARKET SHARE BY SUPPLIER, 2005 (PIE CHART)
EXHIBIT 30:   THE WORLDWIDE MARKET FOR HEPATITIS VACCINES, MARKET SHARE BY SUPPLIER, 2008 (PIE CHART)
EXHIBIT 31:   THE WORLDWIDE MARKET FOR INFLUENZA VACCINES, IN U.S. DOLLARS AND EUROS, 2005 TO 2013
EXHIBIT 32:   THE WORLDWIDE MARKET FOR INFLUENZA VACCINES, MARKET SHARE BY SUPPLIER, IN U.S. DOLLARS AND EUROS, 2005 TO 2008
EXHIBIT 33:   THE WORLDWIDE MARKET FOR INFLUENZA VACCINES, MARKET SHARE BY SUPPLIER, 2005 (PIE CHART)
EXHIBIT 34:   THE WORLDWIDE MARKET FOR INFLUENZA VACCINES, MARKET SHARE BY SUPPLIER, 2008 (PIE CHART)
EXHIBIT 35:   THE WORLDWIDE MARKET FOR MENINGOCOCCUS AND PNEUMOCOCCUS VACCINES, IN U.S. DOLLARS AND EUROS, 2005 TO 2013
EXHIBIT 36:   THE WORLDWIDE MARKET FOR MENINGOCOCCUS AND PNEUMOCOCCUS VACCINES, MARKET SHARE BY SUPPLIER, IN U.S. DOLLARS AND EUROS, 2005 TO 2008
EXHIBIT 37:   THE WORLDWIDE MARKET FOR MENINGOCOCCUS AND PNEUMOCOCCUS VACCINES, MARKET SHARE BY SUPPLIER, 2005 (PIE CHART)
EXHIBIT 38:   THE WORLDWIDE MARKET FOR MENINGOCOCCUS AND PNEUMOCOCCUS VACCINES, MARKET SHARE BY SUPPLIER, 2008 (PIE CHART)
EXHIBIT 39:   THE WORLDWIDE MARKET FOR ROTAVIRUS VACCINES, IN U.S. DOLLARS AND EUROS, 2005 TO 2013
EXHIBIT 40:   THE WORLDWIDE MARKET FOR ROTAVIRUS VACCINES, MARKET SHARE BY SUPPLIER, IN U.S. DOLLARS AND EUROS, 2005 TO 2008
EXHIBIT 41:   THE WORLDWIDE MARKET FOR ROTAVIRUS VACCINES, MARKET SHARE BY SUPPLIER, 2008 (PIE CHART)
EXHIBIT 42:   THE WORLDWIDE MARKET FOR TRAVEL AND ENDEMIC VACCINES, IN U.S. DOLLARS AND EUROS, 2005 TO 2013
EXHIBIT 43:   THE WORLDWIDE MARKET FOR TRAVEL AND ENDEMIC VACCINES, MARKET SHARE BY SUPPLIER, IN U.S. DOLLARS AND EUROS, 2005 TO 2008
EXHIBIT 44:   THE WORLDWIDE MARKET FOR TRAVEL AND ENDEMIC VACCINES, MARKET SHARE BY SUPPLIER, 2005 (PIE CHART)
EXHIBIT 45:   THE WORLDWIDE MARKET FOR TRAVEL AND ENDEMIC VACCINES, MARKET SHARE BY SUPPLIER, 2008 (PIE CHART)
EXHIBIT 46:   THE WORLDWIDE MARKET FOR OTHER VACCINES, IN U.S. DOLLARS AND EUROS, 2005 TO 2013
EXHIBIT 47:   THE WORLDWIDE MARKET FOR OTHER VACCINES, MARKET SHARE BY SUPPLIER, IN U.S. DOLLARS AND EUROS, 2005 TO 2008
EXHIBIT 48:   THE WORLDWIDE MARKET FOR OTHER VACCINES, MARKET SHARE BY SUPPLIER, 2005 (PIE CHART)
EXHIBIT 49:   THE WORLDWIDE MARKET FOR OTHER VACCINES, MARKET SHARE BY SUPPLIER, 2008 (PIE CHART)
EXHIBIT 50:   THE WORLDWIDE MARKET FOR OTHER VACCINES, BY SEGMENT, VALUE AND PERCENT DISTRIBUTION, 2005-2013, IN U.S. DOLLARS
EXHIBIT 51:   THE WORLDWIDE MARKET FOR OTHER VACCINES, BY SEGMENT, VALUE AND PERCENT DISTRIBUTION, 2005-2013, IN EUROS
EXHIBIT 52:   THE WORLDWIDE MARKET FOR OTHER VACCINES, BY SEGMENT, 2005 (PIE CHART)
EXHIBIT 53:   THE WORLDWIDE MARKET FOR OTHER VACCINES, BY SEGMENT, 2008 (PIE CHART)
EXHIBIT 54:   THE WORLDWIDE MARKET FOR OTHER VACCINES, BY SEGMENT, 2013 (PIE CHART)
EXHIBIT 55:   REGIONAL AND GLOBAL SUMMARIES OF IMMUNIZATION WITH THE THIRD DOSE OF POLIO VACCINE AMONG CHILDREN UNDER ONE YEAR OF AGE, 1980, 1990, 2000, AND 2006
EXHIBIT 56:   REGIONAL AND GLOBAL SUMMARIES OF IMMUNIZATION WITH THE THIRD DOSE OF DIPHTHERIA-TETANUS-PERTUSSIS VACCINE AMONG CHILDREN UNDER ONE YEAR OF AGE, 1980, 1990, 2000, AND 2006
EXHIBIT 57:   REGIONAL AND GLOBAL SUMMARIES OF IMMUNIZATION WITH SECOND AND SUBSEQUENT DOSES OF TETANUS VACCINE AMONG PREGNANT WOMEN, 1980, 1990, 2000, AND 2006
EXHIBIT 58:   REGIONAL AND GLOBAL SUMMARIES OF IMMUNIZATION WITH MEASLES-CONTAINING VACCINE AMONG CHILDREN UNDER ONE YEAR OF AGE, 1980, 1990, 2000, AND 2006
EXHIBIT 59:   REGIONAL AND GLOBAL SUMMARIES OF IMMUNIZATION WITH THE THIRD DOSE OF HEPATITIS B VACCINE AMONG CHILDREN UNDER ONE YEAR OF AGE, 1980, 1990, 2000, AND 2006
EXHIBIT 60:   REGIONAL AND GLOBAL SUMMARIES OF IMMUNIZATION WITH THE THIRD DOSE OF HAEMOPHILUS INFLUENZA TYPE B VACCINE AMONG CHILDREN UNDER ONE YEAR OF AGE, 1980, 1990, 2000, AND 2006
EXHIBIT 61:   REGIONAL AND GLOBAL SUMMARIES OF YELLOW FEVER VACCINATION AMONG CHILDREN UNDER ONE YEAR OF AGE, 1980, 1990, 2000, AND 2006
EXHIBIT 62:   REGIONAL AND GLOBAL SUMMARIES OF BCG VACCINATION AMONG CHILDREN UNDER ONE YEAR OF AGE, 1980, 1990, 2000, AND 2006
EXHIBIT 63:   WORLD POPULATION, BY AGE GROUPS, 1998, 2003, 2008, 2010, AND 2015
EXHIBIT 64:   POPULATION OF AFRICA, BY AGE GROUPS, 1998, 2003, 2008, 2010, AND 2015
EXHIBIT 65:   POPULATION OF NORTH AMERICA, BY AGE GROUPS, 1998, 2003, 2008, 2010, AND 2015
EXHIBIT 66:   POPULATION OF SOUTH AMERICA, BY AGE GROUPS, 1998, 2003, 2008, 2010, AND 2015
EXHIBIT 67:   POPULATION OF ASIA, BY AGE GROUPS, 1998, 2003, 2008, 2010, AND 2015
EXHIBIT 68:   POPULATION OF EUROPE, BY AGE GROUPS, 1998, 2003, 2008, 2010, AND 2015
EXHIBIT 69:   POPULATION OF OCEANIA, BY AGE GROUPS, 1998, 2003, 2008, 2010, AND 2015
EXHIBIT 70:   PEDIATRIC/VACCINES FOR CHILDREN PROGRAM PRICE LIST
EXHIBIT 71:   ADULT VACCINE PRICE LIST
EXHIBIT 72:   INFLUENZA VACCINE PRICE LIST
EXHIBIT 73:   SELECTED VACCINES IN DEVELOPMENT, BY COMPANY
EXHIBIT 74:   SELECTED VACCINES IN DEVELOPMENT, BY PROTECTION PROVIDED
EXHIBIT 75:   SELECTED VACCINES IN DEVELOPMENT, BY DEVELOPMENT STAGE