Vaccines 2012

Kalorama Information
A division of
MarketResearch.com

September 2012

38 East 29th Street

Sixth Floor
New York, New York
10016

www.kaloramainformation.com

212.807.2660 t
800.298.5603 t
212.807.2676 f

CHAPTER ONE: EXECUTIVE SUMMARY ..........................................................1

The Global Vaccines Industry ............................................................................................ 1
Scope and Methodology.................................................................................................... 1
Overview ........................................................................................................................... 2
Pediatric Preventative Vaccines ........................................................................................ 3
The Market .......................................................................................................................... 5
Adult Preventative Vaccines ............................................................................................. 8
The Market ........................................................................................................................ 10
Total Market ...................................................................................................................... 12
Issues and Trends .............................................................................................................. 14

CHAPTER TWO: INTRODUCTION TO VACCINES ........................................19

A Brief History: The Development of Vaccines ............................................................. 20
The Immune Response ...................................................................................................... 21
Mechanism of Action ........................................................................................................ 21
Types of Vaccines .............................................................................................................. 22
Attenuated (Weakened) Live Viruses ............................................................................. 22
Killed (Inactivated) Viruses ............................................................................................ 24
Toxoid Vaccines ............................................................................................................. 25
Genetically Engineered/Modified Vaccines ................................................................... 25
Vaccine Approval Process ................................................................................................ 27

CHAPTER THREE: PEDIATRIC PREVENTIVE VACCINES .........................33

Introduction ....................................................................................................................... 33
Childhood Immunization in the United States ............................................................... 35
Childhood Immunization Rates ...................................................................................... 37
Challenges to the Vaccine Delivery System ................................................................... 37
The Effect of U.S. Healthcare Reform ............................................................................ 38
Recommended Childhood Immunization Schedule ........................................................ 39
State Immunization Recommendations .......................................................................... 47
United Nations Initiatives ............................................................................................... 47
Pediatric Vaccine Products .............................................................................................. 48
BCG ................................................................................................................................ 48
Diphtheria, Tetanus, Pertussis, Hepatitis B and Polio .................................................... 49
Haemophilus Influenzae Type B ..................................................................................... 56
Hepatitis A ...................................................................................................................... 57
Measles, Mumps and Rubella ......................................................................................... 58
Meningococcal Disease................................................................................................... 62
Pneumococcal Conjugate ................................................................................................ 64
Rotavirus ......................................................................................................................... 66
Varicella .......................................................................................................................... 69
Copyright 2012 Kalorama Information, LLC.
Reproduction without prior written permission, in any media now in existence or hereafter developed,
in whole or in any part, is strictly prohibited.

Pediatric Vaccines in Development.................................................................................. 70

Cost of Vaccines in the United States .............................................................................. 70
The World Market for Pediatric Preventive Vaccines ................................................. 73
Total Market Size and Forecast ...................................................................................... 73
Hepatitis Vaccine Market................................................................................................ 79
Haemophilus Influenzae Type B Vaccine Market .......................................................... 81
Measles, Mumps and Rubella Vaccines ......................................................................... 83
Combination Vaccines Market........................................................................................ 86
Pneumococcal Vaccine ................................................................................................... 89
Poliovirus Vaccine .......................................................................................................... 92
Varicella Vaccines .......................................................................................................... 94
Other Vaccines Market ................................................................................................... 96

CHAPTER FOUR: ADULT PREVENTIVE VACCINES ..................................101

Introduction ..................................................................................................................... 101
Adult Vaccine-Preventable Diseases: Facts and Figures ............................................. 102
Global Influenza Surveillance Program ........................................................................ 104
U.S. Surveillance .......................................................................................................... 105
Recommendations for Adult Immunizations ................................................................ 105
Adult Vaccine Products .................................................................................................. 109
Cervical Cancer ............................................................................................................. 112
Cholera .......................................................................................................................... 119
Diphtheria-Tetanus ....................................................................................................... 121
Hepatitis ........................................................................................................................ 122
Influenza ....................................................................................................................... 125
Japanese Encephalitis.................................................................................................... 133
Pneumococcal Disease .................................................................................................. 134
Rabies............................................................................................................................ 135
Shingles ......................................................................................................................... 136
Typhoid Fever ............................................................................................................... 138
Yellow Fever ................................................................................................................. 138
Adult Vaccines in Development ..................................................................................... 139
The World Market for Adult Preventive Vaccines ...................................................... 141
Total Market Size and Forecast .................................................................................... 141
Cervical Cancer Market ................................................................................................ 146
Hepatitis Market............................................................................................................ 148
Influenza Vaccine Market ............................................................................................. 151
Travel, DT, and Miscellaneous Vaccine Market .......................................................... 157

CHAPTER FIVE: VACCINES MARKET SUMMARY .....................................161

Trends Driving the Vaccines Market ............................................................................ 161
Market Size and Forecast ............................................................................................... 164
Vaccine Sales by Region............................................................................................... 168
Vaccine Market Competitors ........................................................................................ 170
Copyright 2012 Kalorama Information, LLC.
Reproduction without prior written permission, in any media now in existence or hereafter developed,
in whole or in any part, is strictly prohibited.

Pediatric Vaccines ......................................................................................................... 173

Adult Vaccines .............................................................................................................. 177

CHAPTER SIX: ISSUES AND TRENDS .............................................................179

Vaccine Safety.................................................................................................................. 179
Refusal to Immunize ..................................................................................................... 179
Obesity .......................................................................................................................... 182
Post-Licensure Surveillance .......................................................................................... 182
The Vaccine Injury Compensation Program ................................................................. 184
World Health Organization ........................................................................................... 185
Other Initiatives ............................................................................................................ 186
The Future of Vaccine Safety ....................................................................................... 187
Vaccine Shortages ........................................................................................................... 187
Preventing Shortages in the Developed Countries ........................................................ 188
Preventing Shortages in Developing Nations ............................................................... 189
Preventing Pandemics ..................................................................................................... 191
U.S. National Vaccine Plan........................................................................................... 191
Vaccines and Bioterrorism ............................................................................................. 192
Overview ....................................................................................................................... 192
Project Bioshield Act .................................................................................................... 192
National Bio and Agro-Defense Facility ...................................................................... 194
Vaccine Treatment and Evaluation Units ..................................................................... 195
Anthrax ......................................................................................................................... 196
Smallpox ....................................................................................................................... 197
DNA Vaccination ............................................................................................................. 199
Innovations in Vaccine Delivery Systems ...................................................................... 200
Mucosal Delivery .......................................................................................................... 201
Intranasal Delivery ........................................................................................................ 202
Vaccine Patches ............................................................................................................ 204
Vaccine Chips and Microneedles .................................................................................. 205
Innovations in Vaccine Production ................................................................................ 205
Plants ............................................................................................................................. 206
Insects ........................................................................................................................... 208
Nanoparticle Systems.................................................................................................... 208
Cloning.......................................................................................................................... 209

CHAPTER SEVEN: COMPANY PROFILES .....................................................211

AlphaVax, Inc. ................................................................................................................. 211
History and Lines of Business ...................................................................................... 211
Strategic Alliances ........................................................................................................ 212
Vaccine Products .......................................................................................................... 213
Financial Information.................................................................................................... 213
Bavarian Nordic A/S ....................................................................................................... 214
History and Lines of Business ...................................................................................... 214
Strategic Alliances ........................................................................................................ 214
Copyright 2012 Kalorama Information, LLC.
Reproduction without prior written permission, in any media now in existence or hereafter developed,
in whole or in any part, is strictly prohibited.

Vaccine Products .......................................................................................................... 215

Financial Information.................................................................................................... 215
Baxter Healthcare ........................................................................................................... 216
History and Lines of Business ...................................................................................... 216
Strategic Alliances ........................................................................................................ 216
Vaccine Products .......................................................................................................... 217
Financial Information.................................................................................................... 217
Bharat Biotech ................................................................................................................. 218
History and Lines of Business ...................................................................................... 218
Strategic Alliances ........................................................................................................ 218
Vaccine Products .......................................................................................................... 218
Financial Information.................................................................................................... 219
Crucell /Johnson & Johnson .......................................................................................... 220
History and Lines of Business ...................................................................................... 220
Strategic Alliances ........................................................................................................ 221
Vaccine Products .......................................................................................................... 221
Financial Information.................................................................................................... 222
Emergent Biosolutions .................................................................................................... 223
History and Lines of Business ...................................................................................... 223
Strategic Alliances ........................................................................................................ 224
Vaccine Products .......................................................................................................... 225
Financial ........................................................................................................................ 225
GlaxoSmithKline ............................................................................................................. 226
History and Lines of Business ...................................................................................... 226
Strategic Alliances ........................................................................................................ 226
Vaccine Products .......................................................................................................... 228
Financial Information.................................................................................................... 229
Medimmune ..................................................................................................................... 230
History and Lines of Business ...................................................................................... 230
Strategic Alliances ........................................................................................................ 230
Vaccine Products .......................................................................................................... 231
Financial Information.................................................................................................... 231
Merck & Co. Inc .............................................................................................................. 232
History and Lines of Business ...................................................................................... 232
Strategic Alliances ........................................................................................................ 232
Vaccine Products .......................................................................................................... 233
Financial Information.................................................................................................... 234
Novartis ............................................................................................................................ 235
History and Lines of Business ...................................................................................... 235
Strategic Alliances ........................................................................................................ 235
Vaccine Products .......................................................................................................... 236
Financial Information.................................................................................................... 237
History and Lines of Business ...................................................................................... 239
Strategic Alliances ........................................................................................................ 239
Vaccine Products .......................................................................................................... 239
Financial Information.................................................................................................... 240
Copyright 2012 Kalorama Information, LLC.
Reproduction without prior written permission, in any media now in existence or hereafter developed,
in whole or in any part, is strictly prohibited.

Sanofi Pasteur .................................................................................................................. 241

History and Lines of Business ...................................................................................... 241
Strategic Alliances ........................................................................................................ 241
Vaccine Products .......................................................................................................... 243
Financial Information.................................................................................................... 245

COMPANY DIRECTORY .....................................................................................246

Copyright 2012 Kalorama Information, LLC.

Reproduction without prior written permission, in any media now in existence or hereafter developed,
in whole or in any part, is strictly prohibited.

CHAPTER ONE: EXECUTIVE SUMMARY

Figure 1-1: World Market for Pediatric Vaccines 2007-2016 Revenues (in millions) ................... 6
Figure 1-2: World Market for Adult Vaccines 2007-2016 Revenues (in millions) ....................... 11

CHAPTER TWO: INTRODUCTION TO VACCINES

Table 2-1: Impact of Vaccines in the 20th Century Annual Morbidity in the 20th
Century vs 2011 ................................................................................................................................. 20
Figure 2-1: Attenuated Virus Production ........................................................................................ 23
Table 2-2: Vaccine-Preventable Diseases, August 2012................................................................... 24
Table 2-3: VAERS Table of Reportable Events Following Vaccination ........................................ 30

CHAPTER THREE: PEDIATRIC PREVENTIVE VACCINES

Table 3-1: Global Immunization Rates by Vaccine Type 2010....................................................... 34
Table 3-2: Immunization Profile of the United States: Population by Age Group,
Number of Vaccine-Preventable Diseases Reported by Disease 1990 - 2010 ............................... 36
Table 3-3: U.S. Recommended Immunization Schedule for Children Ages 0 Through
6 Years, 2012 ...................................................................................................................................... 40
Table 3-4: U.S. Recommended Immunization Schedule for Adolescents Ages
7 to 18 Years, 2012............................................................................................................................ 44
Table 3-5: Selected Pediatric Vaccines in Development, August 2012 ........................................... 72
Table 3-6: World Market for Pediatric Vaccines by Type (DTaP/DTP, Hep,
HiB, MMR, Combinations, Pneumococcal, Polio, Varicella, Others) 2007-2016
Revenues (in millions) ..................................................................................................................... 75
Figure 3-1: Market Share of Pediatric Vaccines by Type 2011 ...................................................... 76
Figure 3-2: Market Share of Pediatric Vaccines, by Type 2016 ..................................................... 77
Table 3-7: World Market for Pediatric Vaccines by Region (U.S., North America,
South America, EU, Japan, India, China, Rest of World) 2006-2015 Revenues ........................ 78
Table 3-8: World Pediatric Hepatitis Vaccine Market 2007-2016 ................................................. 79
Table 3-9: World Hib Vaccine Market, 2007-2016 .......................................................................... 82
Copyright 2012 Kalorama Information, LLC.
Reproduction without prior written permission, in any media now in existence or hereafter developed,
in whole or in any part, is strictly prohibited.

Table 3-10: World MMR Vaccines Market 2007-2016 ................................................................... 85

Table 3-11: World Combination Vaccines Market 2007-2016 ....................................................... 87
Table 3-12: World Pediatric Pneumococcal Vaccine Market 2007-2016....................................... 91
Table 3-13: World Poliovirus Vaccine Market 2007-2016 .............................................................. 93
Table 3-14: World Varicella Vaccine Market 2007-2016 ................................................................ 95
Table 3-15: World Pediatric Other Vaccines Market 2007-2016 ................................................... 97

CHAPTER FOUR: ADULT PREVENTIVE VACCINES

Table 4-1: Universal Adult Immunization Schedule 2012............................................................. 106
Table 4-2: Summary of Recommendations for Adult Immunization........................................... 107
Table 4-3: Initiatives to Require HPV Vaccination by U.S. State, 2012 ...................................... 115
Figure 4-1: U.S. Flu Season Severity from 2002 to 2012 ............................................................... 127
Table 4-4: WHO Pandemic Classification Schedule ...................................................................... 132
Table 4-5: Selected Adult Preventive Vaccines in Development, 2012......................................... 140
Table 4-6: World Market for Adult Preventive Vaccines by Type (Hepatitis,
Influenza, Pneumococcal, Travel/DT/Misc.), 2007-2016 Revenues ............................................ 142
Figure 4-1: Market Share of Adult Vaccines, by Type, 2011 ........................................................ 143
Figure 4-2: Market Share of Adult Vaccines, by Type, 2016 ........................................................ 144
Table 4-7: World Market for Adult Vaccines by Region (U.S., North America,
South America, EU, Japan, India, China, Rest of World) 2007-2016 Revenues ...................... 145
Table 4-8: World Cervical CancerVaccine Market 2007-2016..................................................... 147
Table 4-9: World Hepatitis Vaccine Market 2007-2016 ................................................................ 149
Table 4-10: World Influenza Vaccine Market 2007-2016 ............................................................. 152
Table 4-11: 2011 Estimated Population by Region and Selected Age Group .............................. 154
Table 4-12: World Pneumococcal Vaccine Market 2007-2016 ..................................................... 155
Table 4-13: World Travel; Diphtheria-Tetanus; Miscellaneous Vaccines
Market 2007-2016 ........................................................................................................................... 158

CHAPTER FIVE: VACCINES MARKET SUMMARY

Figure 5-1: Sales Growth of Vaccines vs. Pharmaceuticals

2007-2016 .................................. 163

Figure 5-2: The World Vaccines Market by Vaccine Type 2007-2016 Revenues ...................... 165
Figure 5-3 World Market for Vaccines Share by Type, 2007, 2011 and 2016 ............................. 167
Copyright 2012 Kalorama Information, LLC.
Reproduction without prior written permission, in any media now in existence or hereafter developed,
in whole or in any part, is strictly prohibited.

Table 5-1: The World Vaccines Market by Region (U.S., North America, South
America, EU, Japan, India, China, ROW) 2007-2016 Revenues ................................................. 171
Table 5-2: Major Manufacturers Shares of the World Vaccine Market, 2011 .......................... 170
Figure 5-4: 2011 World Vaccines Market Share, by Leading Competitors ................................ 171
Table 5-3: Major Manufacturers Shares of the World Pediatric
Vaccine Market 2011...................................................................................................................... 173
Figure 5-5: Market Share of Pediatric Vaccines Market, 2011 .................................................... 176
Table 5-4: Major Manufacturers Shares of the World Adult
Vaccine Market 2011...................................................................................................................... 178
Figure 5-6: Market Share of Adult Vaccines Market 2011 ........................................................... 178

CHAPTER SIX: ISSUES AND TRENDS

Table 6-1: Selected Companies/Laboratories Developing Biodefense Vaccines ......................... 193

Copyright 2012 Kalorama Information, LLC.

Reproduction without prior written permission, in any media now in existence or hereafter developed,
in whole or in any part, is strictly prohibited.

22

Vaccines: The World Market

Vaccines are currently available that prevent both viral and bacterial infections.
Viruses transplant their own deoxyribonucleic acid (DNA) or ribonucleric acid (RNA)
into host cells. Once inside the cell, viral DNA assumes control of the cell, instructing it
to produce specific types of proteins. Vaccines are produced by culturing bacteria or
viruses under conditions that lead to a loss of virulence, but not the ability to provoke an
antigenic response. Other vaccines are created from specially treated toxins or dead
bacteria that are still antigenic.
It typically takes several days for the immune system to mount a sufficiently
strong response to conquer invading organisms; sometimes, this latent period is enough
time for the virus or bacteria to cause disease. If, however, the immune system has been
previously presented with low doses of the antigen, such as the subvirulent doses
introduced by vaccines, the response is much faster and stronger. When the more potent,
virulent version of the organism subsequently invades, the immune system conquers the
disease before it takes hold.
Vaccines cause long-lasting effects (months or even years) against viral diseases
by stimulating the immune response to form antibodies against the disease. They
typically require 2 to 10 days for full protection to be achieved, but the immune response
may be stimulated by repeated doses of antigen (booster shots) delivered after an initial
inoculation.

TYPES OF VACCINES
There are more than two dozen vaccine-preventable diseases for which vaccines
have been formulated. Of these vaccines, four different types are currently available:

Attenuated (weakened) live viruses,

Killed (inactivated) viruses or bacteria,

Toxoid vaccines contain a toxin produced by the bacterium,

Genetically engineered/modified vaccines.

Attenuated (Weakened) Live Viruses

Attenuated viruses consist of live micro-organisms that have been cultivated

under conditions which disable their virulent properties. They typically provoke more
durable immunological responses and are therefore the preferred type of vaccine for
Copyright 2012 Kalorama Information, LLC.
Reproduction without prior written permission, in any media now in existence or hereafter developed,
in whole or in any part, is strictly prohibited.

Chapter Three: Pediatric Vaccines

47

recommended for children aged 11 to 18. Two key reasons were cited for the ACIP
decision: current supply and pipeline products. Only one company, Sanofi Pasteur, had a
licensed meningococcal meningitis immunization for the U.S. market at that time and the
company indicated that it may not be able to supply sufficient quantities of vaccine for 2
to 10-year-olds.
State Immunization Recommendations
In addition to the country-wide inoculation requirements put forth by the U.S. and
other nations, many individual states and provinces promulgate their own rules for
vaccinations to address diseases they deem to be a particular threat to their residents.
These recommendations are often put forth by state bureaus of immunization, which
monitor federal immunization recommendations but also consider specific conditions
affecting their own residents. As of mid 2012, all U.S. states required that children be
immunized before attending school; however, in addition to medical exemptions offered
in each state, 48 states (excluding Mississippi and West Virginia) allow for religious
exemptions and 20 states allow personal belief exemptions for daycare and school.
State requirements continue to be updated. In 2009, for example, a new
immunization law took effect in New Jersey despite widespread protests from many
parents. New Jersey became the first U.S. state to require flu shots for children between 6
months and 5 years who are attending licensed day care and preschool programs;
lawmakers stated that preschoolers developing immune systems and likelihood of
spreading germs make them as vulnerable to complications as the elderly. At the same
time, New Jersey also required preschoolers to get a pneumococcal vaccine and sixthgraders to get vaccines against meningitis and a booster shot against whooping cough.
Other areas of continued state attention include HPV vaccination, which was first
introduced in 2006 with the FDA approval of Mercks Gardasil. As of June 2012, 8 states
have proposed HPV related legislation for the 2011-2012 sessions that would require
adolescent immunization.
United Nations Initiatives
Vaccines have long played a central role in programs supported by international
organizations such as the WHO and the United Nations. Each year, these groups embark
on various programs and campaigns to increase vaccination rates, particularly in the
developing countries. In March 2012, for example, the United Nations announced a
Copyright 2012 Kalorama Information, LLC.
Reproduction without prior written permission, in any media now in existence or hereafter developed,
in whole or in any part, is strictly prohibited.

142

The World Market for Vaccines

Table 4-6
World Market for Adult Preventive Vaccines by Type
(Hepatitis, Influenza, Pneumococcal, Travel/DT/Misc.), 2007-2016
Revenues (in millions)

Year
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016

Cervical
Cancer

Hepatitis

Influenza

Pneumococcal

Travel;
DT; Misc.

Total

Percent
Change

Compound Annual Growth Rate

Period
2007-2011
2011-2016
2007-2016

Cervical
Cancer

Hepatitis

Influenza

Pneumococcal

Travel;
DT; Misc.

DT=diphtheria-Tetanus
Source: Kalorama Information

Copyright 2012 Kalorama Information, LLC.

Reproduction without prior written permission, in any media now in existence or hereafter developed,
in whole or in any part, is strictly prohibited.

Total