T A B L E O F C O N T E N T S
CHAPTER ONE: EXECUTIVE SUMMARY................................................................1
The Global Vaccines Industry ..................................................................................................1
Scope And Methodology .........................................................................................................1
Overview ................................................................................................................................1
Pediatric Preventative Vaccines...............................................................................................3
The Market................................................................................................................................6
Adult Preventative Vaccines....................................................................................................8
The Market..............................................................................................................................11
Total Market............................................................................................................................14
Issues and Trends.....................................................................................................................15
A “Gardasil Effect” in R&D? .................................................................................................17
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 ....................................................................................................................24
Genetically Engineered/Modified Vaccines ..........................................................................24
Subunit Vaccines ...................................................................................................24
Conjugate Vaccines ...............................................................................................25
DNA Vaccination...................................................................................................25
Vaccine Approval Process .......................................................................................................27
CHAPTER THREE: PEDIATRIC VACCINES ..........................................................29
Introduction.............................................................................................................................29
Childhood Immunization in the United States ......................................................................31
Childhood Immunization Rates .............................................................................................31
Challenges to the Vaccine Delivery System..........................................................................32
Recommended Childhood Immunization Schedule...............................................................33
State Immunization Recommendations .................................................................................36
Pediatric Vaccine Products .....................................................................................................39
BCG Vaccines .......................................................................................................................39
Diphtheria, Tetanus, Pertussis, Hepatitis B and Polio Vaccines............................................39
Diphtheria ..............................................................................................................41
Pertussis .................................................................................................................41
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Tetanus...................................................................................................................42
Hepatitis B .............................................................................................................42
Poliomyelitis ..........................................................................................................43
Haemophilus Influenzae Type B Vaccines............................................................................44
Hepatitis A Vaccines .............................................................................................................45
Measles, Mumps and Rubella Vaccines ................................................................................46
Measles ..................................................................................................................47
Mumps ...................................................................................................................48
Rubella ...................................................................................................................49
Pneumococcal Conjugate Vaccine.........................................................................................49
Rotavirus Vaccines ................................................................................................................50
Varicella Vaccines .................................................................................................................52
Meningococcal Vaccines .......................................................................................................53
Cost of Vaccines in the United States .....................................................................................54
Pediatric Vaccines in Development ........................................................................................55
Global Initiatives for Vaccine Research ................................................................................55
Enterotoxigenic Escherichia coli ...........................................................................58
Parainfluenza Virus Type 3 ...................................................................................60
Pneumococcal Vaccines.........................................................................................61
Respiratory Syncytial Virus...................................................................................61
The World Market for Pediatric Preventive Vaccines ........................................................63
Total Market Size and Forecast .............................................................................................63
DTP and DTaP Vaccine Market ............................................................................................67
Market Analysis .....................................................................................................68
Leading Products and Competitors........................................................................68
Hepatitis Vaccine Market ......................................................................................................69
Market Analysis .....................................................................................................70
Leading Products and Competitors........................................................................70
Haemophilus Influenzae Type B Vaccine Market .................................................................71
Market Analysis .....................................................................................................71
Leading Products and Competitors........................................................................72
Measles, Mumps and Rubella Vaccines ................................................................................72
Market Analysis .....................................................................................................72
Combination Vaccines Market ..............................................................................................74
Market Analysis .....................................................................................................75
Leading Products and Competitors........................................................................75
Pneumococcal Vaccine..........................................................................................................76
Leading Products and Competitors........................................................................77
Poliovirus Vaccine.................................................................................................................78
Market Analysis .....................................................................................................78
Leading Products and Competitors........................................................................79
Varicella Vaccines .................................................................................................................79
Market Analysis .....................................................................................................80
Leading Products and Competitors........................................................................81
Other Vaccines Market ..........................................................................................................81
Market Analysis .....................................................................................................81
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Leading Products and Competitors........................................................................83
CHAPTER FOUR: ADULT PREVENTIVE VACCINES ..........................................85
Introduction.............................................................................................................................85
Adult Vaccine-Preventable Diseases: Facts and Figures......................................................86
Global Virological Surveillance Program..............................................................................87
Recommendations for Adult Immunizations.........................................................................88
WHO International Health Regulations.................................................................................99
Adult Vaccine Products...........................................................................................................99
BCG Vaccines .......................................................................................................................99
Cervical Cancer Vaccines....................................................................................................100
Cholera Vaccines .................................................................................................................104
Diphtheria-Tetanus Vaccines...............................................................................................104
Hepatitis Vaccines ...............................................................................................................105
Hepatitis A ...........................................................................................................105
Hepatitis B ...........................................................................................................106
Influenza Vaccines...............................................................................................................107
Japanese Encephalitis Vaccines...........................................................................................110
Pneumococcal Disease Vaccines .........................................................................................110
Rabies Vaccines...................................................................................................................111
Shingles Vaccine .................................................................................................................112
Typhoid Vaccines ................................................................................................................113
Yellow Fever Vaccines........................................................................................................114
Adult Vaccines in Development ............................................................................................115
Global Initiatives for Vaccine Research...............................................................................115
Cancer.................................................................................................................................115
Cholera................................................................................................................................118
HIV/AIDS...........................................................................................................................120
Helicobacter Pylori ..............................................................................................................122
Hepatitis..............................................................................................................................123
Hepatitis B ...........................................................................................................123
Hepatitis C ...........................................................................................................123
Hepatitis E............................................................................................................124
Herpesvirus ..........................................................................................................................124
Influenza ..............................................................................................................................125
Leishmaniasis ......................................................................................................................127
Malaria................................................................................................................................127
Rabies .................................................................................................................................128
Tuberculosis........................................................................................................................128
Typhoid Fever......................................................................................................................129
West Nile Virus ...................................................................................................................129
The World Market for Adult Preventive Vaccines.............................................................130
Total Market Size and Forecast ...........................................................................................130
Cervical Cancer Market .......................................................................................................134
Market Analysis ...................................................................................................135
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Leading Products and Competitors......................................................................136
Hepatitis Market ..................................................................................................................136
Market Analysis ...................................................................................................137
Leading Products and Competitors......................................................................138
Influenza Vaccine Market....................................................................................................138
Market Analysis ...................................................................................................139
Leading Products and Competitors......................................................................141
Market Analysis ...................................................................................................143
Leading Products and Competitors......................................................................145
Travel, DT, and Miscellaneous Vaccine Market .................................................................145
Market Analysis ...................................................................................................146
Leading Products and Competitors......................................................................148
CHAPTER FIVE: VACCINES MARKET SUMMARY...........................................149
Trends Driving the Vaccines Market ...................................................................................149
Market Size and Forecast......................................................................................................150
Vaccine Market Competitors...............................................................................................154
Pediatric Vaccines ...............................................................................................................155
Major Manufacturer’s Market Share ...................................................................156
Adult Vaccines.....................................................................................................................158
Major Manufacturer’s Market Share ...................................................................158
CHAPTER SIX: ISSUES AND TRENDS ...................................................................161
Ressistance to Immunization.................................................................................................161
Vaccine Safety ........................................................................................................................162
Vaccine Adverse Event Reporting System..........................................................163
The Vaccine Safety Datalink Project...................................................................164
The Vaccine Injury Compensation Program .......................................................................164
Increasing US Vaccine Availability ......................................................................................165
Vaccine Shortages ..................................................................................................................166
Preventing Shortages in the Developed Countries...............................................................166
A ‘Gardasil Effect’ in R&D?.................................................................................................167
Vaccines and Bioterrorism....................................................................................................169
Overview .............................................................................................................................169
Project Bioshield Act of 2004..............................................................................................169
National Bio and Agro-Defense Facility .............................................................................172
Vaccine Treatment and Evaluation Units ............................................................................173
Anthrax ...............................................................................................................................174
Smallpox.............................................................................................................................175
Plague .................................................................................................................................176
Botulism..............................................................................................................................177
Tularemia............................................................................................................................178
Viral Hemorrhagic Fevers ...................................................................................................179
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DNA Vaccination ...................................................................................................................179
Innovations in Vaccine Delivery Systems ............................................................................181
Edible Vaccines ...................................................................................................................182
Mucosal Delivery.................................................................................................................182
Intranasal Delivery...............................................................................................................183
Oral Vaccines.......................................................................................................................185
Vaccine Patches ...................................................................................................................185
CHAPTER SEVEN: COMPANY PROFILES ...........................................................187
Acambis plc............................................................................................................................187
History and Lines of Business .............................................................................................187
Strategic Alliances ...............................................................................................................188
Vaccine Products .................................................................................................................188
Financial Information ..........................................................................................................189
AlphaVax, Inc.........................................................................................................................190
History and Lines of Business .............................................................................................190
Strategic Alliances ...............................................................................................................190
Vaccine Products .................................................................................................................191
Avant Immunotherapeutics ..................................................................................................193
History and Lines of Business .............................................................................................193
Strategic Alliances ...............................................................................................................193
Vaccine Products .................................................................................................................194
Financial Information ..........................................................................................................195
Bavarian Nordic A/S..............................................................................................................196
History and Lines of Business .............................................................................................196
Strategic Alliances ...............................................................................................................196
Vaccine Products .................................................................................................................197
Financial Information ..........................................................................................................197
Baxter Healthcare ..................................................................................................................198
History and Lines of Business .............................................................................................198
Strategic Alliances ...............................................................................................................198
Vaccine Products .................................................................................................................199
Financial Information ..........................................................................................................199
Crucell....................................................................................................................................200
History and Lines of Business .............................................................................................200
Strategic Alliances ...............................................................................................................200
Vaccine Products .................................................................................................................202
Financial Information ..........................................................................................................202
Emergent biosolutions ...........................................................................................................203
History and Lines of Business .............................................................................................203
Strategic Acquisition and Alliance ......................................................................................203
Vaccine Products .................................................................................................................204
Financial ..............................................................................................................................204
GlaxoSmithKline...................................................................................................................205
History and Lines of Business .............................................................................................205
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Strategic Alliances ...............................................................................................................205
Vaccine Products .................................................................................................................206
Financial Information ..........................................................................................................207
Medimmune...........................................................................................................................208
History and Lines of Business .............................................................................................208
Strategic Alliances ...............................................................................................................208
Vaccine Products .................................................................................................................209
Financial Information ..........................................................................................................209
Merck & Co. Inc ....................................................................................................................210
History and Lines of Business .............................................................................................210
Strategic Alliances ...............................................................................................................210
Vaccine Products .................................................................................................................210
Financial Information ..........................................................................................................212
Nabi Biopharmaceuticals ......................................................................................................213
History and Lines of Business .............................................................................................213
Strategic Alliance.................................................................................................................213
Vaccine Products .................................................................................................................214
Financial Information ..........................................................................................................214
Novartis..................................................................................................................................215
History and Lines of Business .............................................................................................215
Strategic Alliances ...............................................................................................................215
Vaccine Products .................................................................................................................216
Pfizer ......................................................................................................................................217
History and Lines of Business .............................................................................................217
Strategic alliances ................................................................................................................217
Vaccine products .................................................................................................................218
Financial Information ..........................................................................................................218
Pharmexa...............................................................................................................................219
History and Lines of Business .............................................................................................219
Strategic alliances ................................................................................................................219
Vaccine Products .................................................................................................................220
Financial Information ..........................................................................................................220
Sanofi Pasteur........................................................................................................................221
History and Lines of Business .............................................................................................221
Strategic Alliances ...............................................................................................................221
Vaccine Products .................................................................................................................222
Financial Information ..........................................................................................................223
Wyeth .....................................................................................................................................224
History and Lines of Business .............................................................................................224
Vaccine Products .................................................................................................................224
Financial Information ..........................................................................................................225
APPENDIX: COMPANY DIRECTORY....................................................................227
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T A B L E O F E X H I B I T S
CHAPTER ONE: EXECUTIVE SUMMARY
Figure 1-1: World Market for Pediatric Vaccines 2004-2013 Revenues ........................................7
Figure 1-2: World Market for Adult Vaccines 2004-2013 Revenues ............................................13
CHAPTER TWO: INTRODUCTION TO VACCINES
Table 2-1: Impact of Vaccines in the 20th Century Annual Morbidity in
the 20th Century vs 2006..................................................................................................................21
Table 2-2: Vaccine-Preventable Diseases, April 2008 .....................................................................23
CHAPTER THREE: PEDIATRIC PREVENTIVE VACCINES
Table 3-1: Global Immunization Rates by Vaccine Type 2006 ......................................................30
Table 3-2: Immunization Profile of the United States: Population by Age
Group, Number of Vaccine-Preventable Diseases Reported by Disease 2000-2006..................32
Table 3-3: U.S. Recommended Childhood Immunization Schedule, 2008 ....................................34
Table 3-4: U.S. Recommended Adolescent Immunization Schedule, 2008 ...................................37
Table 3-5: Selected Pediatric Vaccines in Development, April 2008..............................................56
Table 3-6: World Market for Pediatric Vaccines by Type (DTaP/DTP, Hep,
HiB, MMR, Combos, Pneumococcal, Polio, Varicella, Others) 2004-2013 ..............................64
Figure 3-1: Market Share of Pediatric Vaccines by Type 2007......................................................65
Figure 3-2: Market Share of Pediatric Vaccines, by Type 2013.....................................................66
Table 3-7: World DTP and DTaP Vaccine Market 2004-2013.......................................................67
Table 3-8: World Pediatric Hepatitis Vaccine Market 2004-2013 .................................................69
Table 3-9: World Hib Vaccine Market, 2004-2013..........................................................................71
Table 3-10: World MMR Vaccines Market 2004-2013 ...................................................................73
Table 3-11: World Combination Vaccines Market 2004-2013 .......................................................74
Table 3-12: World Pediatric Pneumococcal Vaccine Market 2004-2013 ......................................77
Table 3-13: World Poliovirus Vaccine Market 2004-2013..............................................................79
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Table 3-14: World Varicella Vaccine Market 2004-2013................................................................80
Table 3-15: Other Vaccines Market 2004-2013 ...............................................................................82
CHAPTER FOUR: ADULT PREVENTIVE VACCINES
Table 4-1: Universal Adult Immunization Schedule 2008 ..............................................................89
Table 4-2: Adult Immunization Schedule for Populations with Special Medical
Conditions, 2008 ..............................................................................................................................90
Table 4-3: Initiatives to Require HPV Vaccination by U.S. State, 2008 ......................................103
Table 4-4: Selected Adult Preventive Vaccines in Development, 2008 ........................................116
Table 4-5: World Market for Adult Preventive Vaccines by Type
(Hepatitis, Influenza, Pneumococcal, Travel/DT/Misc.), 2004-2013.........................................132
Figure 4-1: Market Share of Adult Vaccines, by Type, 2007 (Cervical Cancer, Hepatitis,
Influenza, Pneumococcal, Travel)................................................................................................133
Figure 4-2: Market Share of Adult Vaccines, by Type, 2013........................................................134
Table 4-6: World Cervical CancerVaccine Market 2004-2013 ....................................................135
Table 4-7: World Hepatitis Vaccine Market 2004-2014................................................................137
Table 4-8: World Influenza Vaccine Market 2004-2013...............................................................139
Table 4-9: CDC Goal to Double Flu Immunization by 2010 Group and
Estimated Immunization Rate (2000 vs 2010) ...........................................................................140
Table 4-10: 2007 Estimated Population by Region and Selected Age Group..............................141
Table 4-11: World Pneumococcal Vaccine Market 2004-2013.....................................................143
Table 4-12: World Travel; Diphtheria-Tetanus; Miscellaneous Vaccines
Market 2004-2013..........................................................................................................................146
CHAPTER FIVE: VACCINES MARKET SUMMARY
Table 5-1: The World Vaccines Market by Vaccine Type 2004-2013 .........................................151
Figure 5-1: World Market for Vaccines by Type 2004-2013 ........................................................152
Figure 5-2: World Market for Vaccines Share by Type, 2004, 2007 and 2013 ...........................153
Table 5-2: Major Manufacturers’ Shares of the World Vaccine Market, 2007 .........................154
Figure 5-3: 2007 World Vaccines Market Share, by Leading Competitors ................................155
Table 5-3: Major Manufacturer’s Shares of the World Pediatric
Vaccine Market 2007.....................................................................................................................157
Figure 5-5: Market Share of Pediatric Vaccines Market, 2007....................................................157
Table 5-4: Major Manufacturer’s Shares of the World Adult Vaccine Market 2007...............159
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