World Human Vaccines Market

World Human Vaccines Market

This report analyzes the worldwide markets for Human Vaccines in Millions of US$. The major product segments analyzed are Prophylactic Vaccines (Pediatric Prophylactic Vaccines, & Adult Prophylactic Vaccines), and Therapeutic Vaccines. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Middle East and Latin America. Annual forecasts are provided for each region for the period of 2001 through 2015. A ten-year historic analysis is also provided for these markets with annual market analytics. The report profiles 164 companies including many key and niche players worldwide such as ALK – Abelló A/S, Acambis PLC, Bavarian Nordic A/S, Crucell N.V., CSL Ltd., GlaxoSmithKline PLC, GlaxoSmithKline Biologicals S.A, Medimmune, Inc, Merck & Company, Inc., Novartis Vaccines & Diagnostics, Inc., Sanofi-Aventis S A, Sanofi-Pasteur SA, Sanofi Pasteur, Inc., Shanta Biotechnics Ltd., Vaxin, Inc., and Wyeth. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.

HUMAN VACCINES MCP-1176
A GLOBAL STRATEGIC BUSINESS REPORT


CONTENTS


I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-2
Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3
Prophylactic Vaccines I-3
Therapeutic Vaccines I-3


II. EXECUTIVE SUMMARY

1. Market Overview & Outlook II-1
Market Dynamics II-1
Global Human Vaccine Market: A Snapshot II-2
Vaccine Pricing: The Developed - Developing Divide II-2
Overview in the Recent Context II-2
Historical Perspective II-3
Successful Vaccine Introductions in the Past II-3
Looking Ahead II-3
Key Markets II-4
Competitive Scenario II-4
World’s Leading Producers II-4
Table 1: Leading Players in the Worldwide Human Vaccines
Market (2005): Percentage Breakdown by Value Sales for
Sanofi-Aventis, GlaxoSmithKline, Wyeth, Merck, and Others
(includes corresponding Graph/Chart) II-5
ALK- The Global Leader in Allergy Vaccines II-5
Table 2: Leading Players in the Worldwide Allergy Vaccines
Market (2005 & 2006): Percentage Breakdown by Value Sales
for ALK-Abelló, Stallergenes, Allergopharma, and Others
(includes corresponding Graph/Chart) II-5

2. Product Overview II-6
Introduction to the Concept of Immunity II-6
Role of Vaccines in Strengthening the Immune System II-6
Vaccines and Immunotherapy II-7
Historical Overview of Vaccines II-7
How it Began II-7
So Far So Good II-8
Contribution of Animal Research to Vaccine Production II-8
Types of Vaccines II-9
Live, Attenuated Vaccines II-10
Combination Vaccines II-11
Killed or Inactivated Vaccines II-11
DNA & Recombinant DNA Vaccines II-11
Toxoids II-12
Cellular Fractions II-12
Conjugate Vaccines II-12
Subunit Vaccines II-13
Passive Immunization II-13
Prophylactic Vaccines II-13
Prevention Better than Cure II-13
Prophylactic Pediatric Vaccines II-13
Vaccination Over the Years II-14
A Mature Market II-14
Challenges for Pediatric Vaccines Market II-15
BCG Vaccine II-15
Growth Boosting Factors for TB Vaccines II-16
Demand Restraining Factors for TB Vaccines II-16
Major Issues to be addressed in the TB Vaccine Market II-16
Table 3: TB Vaccines Market Worldwide: Annual Sales for
2000-2005 (In US$ Million) (includes corresponding
Graph/Chart) II-17
Hemophilus Influenza Type B Vaccine II-17
Hib and Combination Vaccines by Producer II-17
Table 4: Pediatric Haemophilis Influenza B Vaccine Market in
the US and Europe: Annual Sales for 2000-2005 (In US$
Million) (includes corresponding Graph/Chart) II-18

Table 5: Pediatric Haemophilis Influenza B Vaccine Market in
the US: Annual Sales for 2000-2005 (In Million Doses)
(includes corresponding Graph/Chart) II-18
Diphtheria/Tetanus/Pertussis Vaccines II-18
DTP, DTaP, and Combination Vaccines Offered by Major
Producers in US II-19
Table 6: Leading Players in the US DTP and DTaP Vaccines
Market (2003-2005): Percentage Breakdown by Value Sales for
Sanofi Pasteur, Wyeth, GlaxoSmithkline, and Others (includes
corresponding Graph/Chart) II-19

Table 7: DTP and DTaP Vaccines Market in the US: Annual
Sales for 2000-2005 (In US$ Million) (includes corresponding
Graph/Chart) II-20

Table 8: DTP Vaccine Market in Europe: Annual Sales for
2000-2005 (In US$ Million) (includes corresponding
Graph/Chart) II-20
Hepatitis A Vaccine II-20
Hepatitis B Vaccine II-20
Hepatitis B Epidemiology II-21
Table 9: Hepatitis B Vaccines Market in US and Europe:
Annual Sales for 2000-2005 (In US$ Million) (includes
corresponding Graph/Chart) II-21
Measles/Mumps/Rubella Vaccines II-21
Table 10: Measles-Mumps-Rubella (MMR) Vaccine in US and
Europe: Annual Sales for 2000-2005 (In US$ Million)
(includes corresponding Graph/Chart) II-22

Table 11: Measles-Mumps-Rubella (MMR) Vaccine Market in the
US: Annual Sales for 2000-2005 (In Millions of Doses)
(includes corresponding Graph/Chart) II-22
Rotavirus Vaccines II-23
Polio Vaccines II-23
Table 12: Polio Vaccine Market in Europe: Annual Sales for
2000-2005 (In US$ Million) (includes corresponding
Graph/Chart) II-23

Table 13: Polio Vaccines Market in the US: Annual Sales for
2000-2005 (In US$ Million) (includes corresponding
Graph/Chart) II-24

Table 14: Polio Vaccine Market for Both Vaccine Types in the
US: Annual Sales for 2000-2005 (In Million Doses) (includes
correspondingGraph/Chart) II-24

Table 15: Polio Vaccine Market for Both Vaccine Types (OPV
and IPV) in the US in Percent of Doses from 2000-2005
(includes corresponding Graph/Chart) II-24
Varicella Vaccine II-25
Table 16: Varicella Vaccine Market in the US and Europe:
Annual Sales for 2000-2005 (In US$ Million) (includes
corresponding Graph/Chart) II-25

Table 17: Varicella Vaccines Market in the US: Annual Sales
for 2000-2005 (In Million Doses) (includes corresponding
Graph/Chart) II-26
Need for Combination Vaccines II-26
Prophylactic Adult Vaccines II-27
Favorable Market Growth II-27
Hepatitis A Vaccine II-27
Hepatitis B Vaccines II-28
Key Issues Affecting the Adult Hepatitis Vaccines Market II-29
Cholera Vaccine II-29
Hepatitis A/Hepatitis B Vaccine II-29
Japanese Encephalitis Vaccines II-30
Influenza Vaccines II-30
Table 18: Global Flu Vaccines Market (2005): Percentage
Breakdown by Value Sales for the US, EU, and Rest of the
World (includes corresponding Graph/Chart) II-31

Table 19: Global Flu Vaccines Market (2005): Percentage
Breakdown by Volume Sales for Sanofi Pasteur, Chiron, GSK
and Others (includes corresponding Graph/Chart) II-31

Table 20: Rate of Influenza Vaccine Consumption Among Target
Groups (includes corresponding Graph/Chart) II-31

Table 21: Adult Influenza Vaccines Market Worldwide: Annual
Sales for 2000-2005 (In US$ Million) (includes corresponding
Graph/Chart) II-32
Growth Boosting Factors for Influenza Vaccines Market II-32
Key Issues Affecting Influenza Vaccines Market II-32
Age-Driven Strategies Drive Target Market for Influenza
Vaccines II-32
Healthcare Professionals Increase Target Market for
Influenza Vaccines II-33
Lyme Disease Vaccine II-33
Pneumococcal Disease Vaccines II-33
Meningococcal Vaccines II-34
Rabies Vaccines II-34
Table 22: Rabies Vaccine Market Worldwide: Annual Sales for
2000-2005 (In US$ Million) (includes corresponding
Graph/Chart) II-35
Typhoid Vaccine II-35
Yellow Fever Vaccine II-35
Need for Additional Vaccines II-35
Therapeutic Vaccines II-37
DNA Holds the Key II-37
Huge Potential for Protein Based Vaccines II-38
Cancer Vaccines II-38
Human Papillomavirus (HPV) Vaccine II-38
Breakthroughs in Cancer Vaccine Market II-38
Factors Affecting the Market for Cancer Vaccines II-39
Vaccine for AIDS II-39
What is AIDS? II-39
Global Statistics II-39
Table 23: Worldwide HIV/AIDS Estimates - 2007 (includes
corresponding Graph/Chart) II-40
Table 24: Worldwide HIV & AIDS Incidences (2007): A
Regional Breakdown for Living and Newly Infected Cases
(includes corresponding Graph/Chart) II-40

Table 25: Worldwide HIV & AIDS Prevalence Rate in Adults
Aged between 15 and 49 Years for the Year 2007 (includes
corresponding Graph/Chart) II-41
Asia-Pacific II-41
Central Asia & Eastern Europe II-42
Commonwealth of Independent States (CIS) II-42
Latin America (Including the Caribbean Islands) II-42
Sub Saharan Africa II-42
North Africa & the Middle East II-43
Developed Regions and High Income Countries II-43
United States II-43
Table 26: New HIV Infection Cases among Men in the US
(2006): Percentage Breakdown by Mode of Infection
(includes corresponding Graph/Chart) II-43

Table 27: New HIV Infection Cases in the US (2006):
Percentage Breakdown by Racial/Ethnic Groups (includes
corresponding Graph/Chart) II-44

Table 28: New HIV Infection Cases among Women in the US
(2006): Percentage Breakdown by Mode of Infection
(includes corresponding Graph/Chart) II-44
Development of Treatment Options II-44
Categories of Vaccines for AIDS II-44
HIV Vaccines in Development II-45
HIV Vaccines (Prophylactic/Therapeutic) Under Development
(2007) by Key Manufacturers II-45
Malaria Vaccine II-45
Therapeutic Vaccines Against Infectious Diseases: The
Challenges II-46
Melanoma: Prospects for Treatment II-46
Vaccines for Melanoma in Development II-46
Autoimmune Diseases II-46
How Do Autoimmune Diseases Occur II-46
Types of Autoimmune Diseases II-46
Need for Developing Autoimmune Therapeutic Vaccines II-46
Travel Vaccines: Opportunities II-47
SARS - Need for Urgent Solutions II-47
Vaccinations Recommended for Travel to High-Risk Areas II-48
Mechanisms for Vaccine Delivery II-48
Edible Vaccines II-49
Oral Vaccines II-50
Tablet Based Vaccines II-50
Mucosal Delivery II-50
Transdermal Patch Delivery II-50

3. Market Trends & Issues II-51
Newer Vaccines in Pipeline to Cheer Up Pharma Companies II-51
Threat of Pandemic Rejuvenates Vaccine Market II-51
Influenza Vaccines On a Growing Spree II-51
Influenza Market Faces Several Challenges II-51
Economic Factors Hamper Optimal Vaccine Development and Delivery II-52
Increasing Need for Vaccine Promotion in the Developing Regions II-52
Changing Vaccine Needs II-52
DNA Vaccines: Engineering Growth II-53
AIDS Vaccine: Long Road Ahead II-54
Noninjectable Vaccines: Gain Without Pain II-54
Need for a Human Vaccine for Leishmaniasis II-55
Conjugate Vaccines: A Technological Innovation II-55
Need For a New TB Vaccine II-55
Companies Involved in TB Vaccine Research II-56
Religious Concerns Over Immunizing Young Girls II-56
Changing Travel Patterns Increase Demand for Hepatitis B Vaccine II-56
DTaP Vaccines Approved for Booster Vaccination II-56
Advances in Biotechnology Spearheading Vaccines’ Growth II-56
BioWarfare: Threat Perception and Preparedness II-57
Overview of Potential Bio-Terrorist Agents II-57
Smallpox (Variola Major) II-57
Anthrax (Bacillus Anthracis) II-58
Plague (Yersinia Pestis) II-58
Botulism (Clostridium Botulinum) II-58
Tularemia (Francisella Tularensis) II-58
Market Concerns II-58
Safety Factor II-58
Development Delays II-59
Storage Problems II-59
Perfluorocarbons as Alternative to Overcome Storage Problems II-59
Costs II-59
Standards for Vaccine Safety and Quality II-60

4. Distribution Channels II-61

5. Technological Developments II-62
Applying Gene Therapy to Develop Therapeutic Solutions II-62
Research and Trials of AIDS Vaccines II-62
Ongoing R&D for AIDS Vaccines II-62
International AIDS Vaccine Initiative (IAVI) II-62
Cancer II-63
Cancer Type and Area Effected II-63
Immunotherapies for Cancer II-63
Drugs for Cancer II-63
Issues Effecting the Development of Commercially Viable
Cancer Vaccines II-64
Frequency of Vaccination II-64
Growth Boosters in the Cancer Vaccines Market II-64
Cancer Vaccines Available II-65
Select Cancer Vaccines in Trial Stage II-65
Other Vaccines for Cancer II-66
Application of Botulinum Toxin as Delivery Mechanism for Oral
Vaccines II-66

6. Clinical Trials II-67
AVANT’s Single-Dose Oral Ty800 Vaccine Meets Key Endpoints II-67
Emergent BioSolutions’ Typhoid Vaccine Completes Final Phase
II Clinical Trial II-67
Antigenics Announces Positive Data on Phase-I Study of ACAM-
FLU-ATM Vaccine II-67
Bavarian Nordic’s IMVAMUNE® Post-Exposure Vaccination
Demonstrates Protection Against Fatal Poxvirus Infection II-68
BSU Scientists to Commence Human West Nile Vaccine Development
Project II-68
Intercell Concludes First Phase Clinical Studies of IC31®
Adjuvanted Influenza Vaccine II-68
Protherics Commences Phase 2 Angiotensin Vaccine Study II-69
CSL Biotherapies Files BLA for Influenza Vaccine II-69
Orchestra Therapeutics Abandons Development of HIV Vaccine II-69
AlphaVax Concludes Phase I Clinical Trial of Flu Vaccine II-70
AVANT Presents Preclinical Data on Enteric Vaccine II-70
Baxter Declares Results of Seasonal Flu Vaccine Candidate Trial II-70
IDM Pharma Announces Interim Data of Phase II Clinical Trials
of Lung Cancer Vaccine II-71
Novavax Announces Developments in Discovery Program II-71
Acambis Pioneers Testing of West Nile Virus Vaccine in Grown Ups II-72
Acambis Initiates Test of single-dose JE vaccine in India II-72
AVAX Technologies Initiates Phase 3 Clinical Trial For M-Vax II-72
LigoCyte Pharmaceuticals Begins Clinical Testing of Norovirus
Vaccine II-72
Alphavax Initiates Clinical Testing for Flu and CMV Vaccines II-73
Sanofi Pasteur Begins Phase 2 Testing of New Influenza Vaccine II-73
Antigenics Reveals the Preliminary Data of Clinical Trial of
Oncophage® II-74
Baxter Reveals Phase I/II Clinical Trial Results of H5N1
Pandemic Vaccine II-74
Crucell and AERAS Initiates Tuberculosis Vaccine Clinical Trial II-74
DOR BioPharma Announces Phase I Results of RiVax™ II-74
GlaxoSmithKline Starts Clinical Trials to Test H5N1 Pandemic
Flu Vaccines II-74
MedImmune Initiates Phase I Clinical Trial of Avian H5N1 Vaccine II-75
MedImmune Reveals Results of Phase 3 Study for CAIV-T II-75
MedImmune Initiates Second Phase 1 Study with MEDI-534 II-75
Sanofi Pasteur Initiates First Clinical Trial of Cell Based
H7N1 Vaccine II-75
Therion Biologics Completes Enrollment for Phase III trials of
PANVAC-VF II-75
ViRexx Finishes the Treatment in Phase I Study of HepaVaxx B
Vaccine II-76
Antigenics Begins Phase I Clinical Trial of AG-707 II-76
Positive Results in Novavax’s Pandemic Influenza Vaccine Pre-
clinical Trials II-76
Trials Reveal H5N1 Pre-Pandemic Vaccine of Sanofi Pasteur
Effective II-76
PowderMed Reveals Reveals for Phase 1 Trials for Influenza
Vaccine II-76
Phase II clinical trials of China's hepatitis B vaccine II-76

7. Research Breakthroughs II-77
Findings Prove New Nose-Spray Vaccines Effective II-77
Large Doses of H5N1 Influenza Vaccine Appears Effective II-77
New Vaccine Technology to Prevent TB II-77
HPV Vaccine to Help Prevent Cervical Cancer II-77
Scientists Develop H7N1 Avian Influenza Vaccine II-77
Human H5N1 Vaccine Developed by Central Hygiene and
Epidemiology Institute II-78

8. Product Development II-79
Nabi Biopharmaceuticals to Develop NicVax Vaccine for Reducing
Nicotine Effects II-79
GenPhar Develops Highly Effective Tetravalent Dengue Vaccine II-79
Iomai Commences the Development of Prophylactic Traveler™s
Diarrhea Vaccine II-79
Biological Immunological to Produce and Sell r-Hepatitis B
Vaccine II-79
Thailand Researchers Commence the Development of Human Bird
Flu Vaccine II-79
USV to Commercialize Typhoid Vaccine II-79

9. Product Launches II-80
GlaxoSmithKline to Introduce Five Key Medicines for Oncology II-80
FFF Enterprises Unveils My Flu Vaccine Network II-80
ALK-Abelló Introduces GRAZAX® Anti-Allergy Vaccine II-80
Novartis Unveils Influenza Virus Vaccine Fluvirin® II-81
Wyeth Introduces Latest 7-in-1 Pneumococcal Conjugate Vaccine II-81
Intervet Releases Arnhem, a Prototype of Avian Influenza Vaccine II-81
Shantha Launches ‘Jencevac’ Brain Fever Vaccine II-81
Wockhardt and Zhejiang Introduces New Hepatitis-A Vaccine II-81
GSK Introduces Rotarix(R) Vaccines for Infants II-82
Sinovac Biotech Introduces Bilive™ II-82

10. Recent Industry Activity II-83
Emergent BioSolutions Acquires Group of Anthrax Monoclonal
Antibodies from AVANIR II-83
China Biopharma and BKXPC Enter into Agreement II-83
Encorium Signs Contract with Protherics for Phase 2 Trial of
ATV for Hypertension II-83
GenPhar to Establish Vaccine Production Plant in South Carolina II-84
Intercell Partners SSI and Sanofi Pasteur to Further Develop
TB Vaccine II-84
Intercell and PATH Malaria Vaccine Initiative Form New
Partnership for Malaria Vaccine II-84
Intercell Receives Manufacturer's License for Production of JE
Vaccine II-84
GSK Receives US FDA Approval for ROTARIX® Rotavirus Vaccine II-85
Dynavax and Merck & Co Announce Clinical Hold of HEPLISAV
Vaccine Trial II-85
Pharmexa and Ichor Enter into Co-Development Agreement for
Multiple DNA Vaccines II-86
Crucell Enters into Exclusive Development Agreement with Wyeth
Pharmaceuticals II-86
Crucell and Sanofi Ink an Agreement for Advanced Anti-Rabies
Biologicals II-86
FDA Confers Priority Designation for Supplemental Application
for GARDASIL ® II-87
Sanofi Submits a European Marketing Approval Application for
First Influenza Vaccine II-87
IVT Signs an MoU to Take Over Immunotope II-88
Oxford BioMedica Takes Over Oxxon Therapeutics II-88
DND Issues RFP for acquisition of MVA-based smallpox vaccine II-88
GlaxoSmithKline Acquires Reliant Pharmaceuticals II-88
GSK Acquires Praecis Pharmaceuticals II-89
Berna Biotech Divests Stake in Pevion Biotech II-89
GeoVax Signs a Private Placement Agreement with Pure Capital II-89
Crucell Inks a Research License Agreement with ISU ABXIS of Korea II-89
China Biopharma Concludes Capital Funding to ZT Biotech II-89
Crucell and Acambis Ink a Licensing Agreement for PER. C6 ®
Technology II-90
Novartis and Intercell Join Hands to Advance Vaccine Programs II-90
Serum Institute and Akorn Ink MoU for Vaccine
Commercialization in US Market II-90
Merck Plans to Establish a Human Vaccine Facility in Ireland II-91
Schering-Plough Acquires Organon Bio Sciences II-91
Intas Biopharmaceuticals Enters into Collaboration Agreement
with Virionics II-91
Oxxon Therapeutics Starts U.S. Operation II-91
GenPhar and ImmuneRegen Enter into Research Partnership II-92
Intercell Submits BLA for JE Vaccine to US FDA II-92
AVANT and Select Vaccines Enter into R&D Partnership II-92
AVAX Enters into Agreement with Cancer Treatment Centers of
America II-93
CSC’s DVC and Baxter Receive Contract Modification from U.S. HHS II-93
DOR BioPharma Enters into CRADA with Walter Reed Army Institute II-94
Dynavax and Merck to Enter into Partnership to Develop
Hepatitis B Vaccine II-94
Emergent BioSolutions Commences Delivery of BioThrax® to US
Health Department II-94
Maxygen and Sanofi Pasteur sign License Agreement II-95
Beijing Public Health Bureau Enters into Purchase Agreement
with Sinovac II-95
Novartis Wins US Government Contract for Developing Antigen
Technology II-95
MedImmune Announces Licensing of Reverse Genetics Technology
to GlaxoSmithKline II-96
MedImmune Wins US Government Contract II-96
MedImmune and Human Genome Sciences Sign Lease Agreement II-97
Acambis Announces Signing of Collaboration Agreement with
Sanofi Pasteur II-97
Acambis Announces JE Partnership Agreement with Sanofi Pasteur II-97
Crucell Procures Major Patent for Influenza Vaccine Production II-98
CSL Receives FDA Approval for Influenza Virus Vaccine II-98
GlaxoSmithKline Inks Contract with UK Government II-98
Merck & Co., Inc. and Dynavax to Jointly Develop Hepatitis B
Vaccine II-99
Sanofi Pasteur Wins Contract to Design, Retrofit and Maintain
Influenza Vaccine Unit II-99
Sanofi Pasteur Completes Construction of Influenza Vaccine
Production Unit II-99
Amgen Acquires Abgenix II-100
Pfizer Acquires PowderMed II-100
CancerVax and Micromet Merge to Establish Micromet, Inc. II-100
Novartis Acquires Chiron II-100
Dynavax Takes Over Rhein Biotech II-100
AnGes and Vical Ink Collaborative Agreement II-101
GeoVax Merges with Dauphin II-101
Hawaii Biotech and Avantogen Merge to Form New Entity II-101
CytoDyn Acquires Advanced Influenza Technologies II-101
Emergent BioSolutions Acquires VIVACS II-101
Acambis Divests Berna Business to Crucell II-101
Novavax Inks an Agreement with Bharat Biotech to Develop Avian
Flu Vaccine II-101
Aeras Receives License for Developing and Distributing
Tuberculosis Vaccine II-102
Acambis to Supply Smallpox Vaccine to CDCP II-102
AlphaVax and Wyeth Enhance Existing Licensing Agreement II-102
Baxter Enters into a Contract to Supply Pandemic Influenza
Vaccine II-102
Sanofi Pasteur Signs Stockpile Contract with the US Government II-102
Crucell Licenses PER.C6® Technology to ADImmune Corporation II-103
Baxter Wins Stockpile Production Contract for H5N1 from the NHS II-103
Crucell Earns NIH Contract to Develop HIV Vaccine II-103
Novartis Secures Stockpile Supply Contract from the US Government II-103
Novartis Signs Distribution Agreement with Intercell II-103
GSK Receives Stockpile Supply Contract for Fly Pandemic from
the HHS II-104
GSK Signs H5N1 Antigen Influenza Vaccine Contract with
Switzerland II-104
DOR BioPharma Forms Alliance to Develop Ricin Vaccine II-104
Nobilon and NVI to Jointly Develop RSV Vaccine II-105
SciGen and OctoPlus Join Forces to Develop Hepatitis B Vaccine
Delivery II-105
AlphaVax Receives Patent for Alphavaccines Manufacturing Process II-105
IVI Receives Funds for Cholera Vaccine Development Program II-105
Novavax Forms Strategic Alliance with US-based, PacificGMP II-105
Sanofi Pasteur Enters into Partnership with PDVI II-106
MedImmune Inks a Cooperative R&D Agreement with NIAID II-106
MedImmune Bags a Five-Year HHS Contract II-106
Novavax Enters into a Cooperative Research Agreement with CDC II-106
GlaxoSmithKline Establishes New Vaccine Manufacturing Facility II-107
GenPhar Extends R&D Contract with NMRC II-107
Medlmmune Files for INDA with FDA for a New Influenza Vaccine II-107
Rotarix™ Vaccines Receives European Approval II-107
Merck’s GARDASIL® Receives FDA Approval II-108
CDC Adds Merck’s GARDASIL® Under its VFC Category in the US II-108
Medlmmune Submits sBLA to the FDA Refrigerator-Stable
Influenza Vaccine II-108
Medlmmune Submits sBLA to the FDA for Expanded Label for CAIV-T II-108
Medlmmune Receives FDA Approval for the Use of Reverse
Genetics Technology II-108
Vivalis Starts a New Plant in France to Produce Viral Vaccines II-108
Fiocruz Provides Yellow-Fever Vaccine to Peruvian Government II-109
Merck Receives FDA Approval for Zostavax Vaccine II-109
The US Health and Human Services Department Awards Grant to
Pharma Companies II-109
GlaxoSmithKline Expands License and Supply Agreement with
Antigenics II-109
GlaxoSmithKline Applies for Approval for Cervical Cancer Vaccine II-109
Omnia Biologics Signs Deal with Aeras Global TB Vaccine
Foundation II-109
Aeras Alliances with Dutch Scientific Organizations to Develop
Latest TB Vaccines II-110
Embrex, Shenzhen, and P.R. China Team Up for Manufacturing
Influenza Vaccine II-110
Health Canada Grants Approval to Merck’s RotaTeq II-110
HepaLife Technologies Receives License for Technology from MSU II-110
Hindustan Latex Ties-up with Bharat Biotech for Marketing
Vaccines II-110
Emergent BioSolutions and Sanofi Pasteur Sign Agreement II-110
USV and BCIL Enter into Agreement II-111
GenVec Receives Fifth-Year Extension of Contract from NIAID II-111
Inovio Joins Hands with Tripep to Develop Hepatitis C Vaccine II-111
Novavax and Bharat Biotech Form Alliance to Develop Pandemic
Flu Vaccine II-111
Panacea Biotech Joins Hands with NVI to Create Polio Vaccine II-112
Immune Response Ties Up with Accelsiors for Trial of NeuroVax
Vaccine II-112
Nordic Vaccine Joins Forces with Ace BioSciences to Develop
Efficient Vaccines II-112
Eisai Partners with DNAVEC to Develop New Vaccine II-112
ViRexx Partners with DRDC to Develop Biodefence Vaccines II-112
Biovirx Teams Up with IDT to Reintroduce Vaccine for Infants II-113
LG Life Sciences Enters into Agreement with Sinovac II-113
MediGene Awards Licenses to Virionics for CVLP Vaccine Program II-113
FluLaval Influenza Vaccine Receives FDA Approval II-113
Merck Applies for Approval to Market Gardasil in China II-114
Bio-Bridge Establishes New Vaccine Facility in China II-114
SIIL Established the First-ever Biotech SEZ in India II-114
Aeras Foundation Establishes New Laboratory for TB Vaccine II-114
China Biopharma Distributes Flu Vaccine in China II-114
ViroPro Founds New Subsidiary for Developing Medicinal Vaccines II-114
Glaxosmithkline Acquires Corixa Corporation II-115
GSK Acquires ID Biomedical II-115
Pharmexa Acquires GemVax II-115

11. Focus on Select Global Players II-116
ALK - Abelló A/S (Denmark) II-116
Acambis PLC (UK) II-116
Bavarian Nordic A/S (Denmark) II-116
Crucell N.V. (The Netherlands) II-117
CSL Ltd. (Australia) II-118
GlaxoSmithKline PLC (UK) II-118
GlaxoSmithKline Biologicals S.A (Belgium) II-120
Medimmune, Inc. (USA) II-120
Merck & Company, Inc. (USA) II-120
Novartis Vaccines & Diagnostics, Inc. (USA) II-121
Sanofi-Aventis S A (France) II-121
Sanofi-Pasteur SA (France) II-122
Sanofi Pasteur Inc. (USA) II-122
Shantha Biotechnics Ltd. (India) II-123
Vaxin, Inc. (USA) II-123
Wyeth (USA) II-124

12. Global Market Perspective II-125
Table 29: World Recent Past, Current & Future Analysis for
Human Vaccines by Geographic Region - US, Canada, Japan,
Europe, Asia-Pacific (excluding Japan), Latin America and Rest
of World Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2001 through 2010 (includes
corresponding Graph/Chart) II-125

Table 30: World Long-term Projections for Human Vaccines by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), Latin America and Rest of World Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2011 through 2015 (includes corresponding
Graph/Chart) II-126

Table 31: World Historic Market Review for Human Vaccines by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), Latin America and Rest of World Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 1991 through 2000 (includes corresponding
Graph/Chart) II-127

Table 32: World 10-Year Perspective for Human Vaccines by
Geographic Region - Percentage Breakdown of Dollar Sales for
US, Canada, Japan, Europe, Asia-Pacific (excluding Japan),
Latin America and Rest of World Markets for Years 2003, 2008 &
2012 (includes corresponding Graph/Chart) II-128

Table 33: World Recent Past, Current & Future Analysis for
Prophylactic Vaccines by Geographic Region - US, Canada,
Japan, Europe, Asia-Pacific (excluding Japan), Latin America
and Rest of World Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2001 through 2010
(includes corresponding Graph/Chart) II-129

Table 34: World Long-term Projections for Prophylactic
Vaccines by Geographic Region - US, Canada, Japan, Europe,
Asia-Pacific (excluding Japan), Latin America and Rest of
World Markets Independently Analyzed with Annual Sales Figures
in US$ Million for Years 2011 through 2015 (includes
corresponding Graph/Chart) II-130

Table 35: World 10-Year Perspective for Prophylactic Vaccines
by Geographic Region - Percentage Breakdown of Dollar Sales
for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan),
Latin America and Rest of World Markets for Years 2003, 2008 &
2012 (includes corresponding Graph/Chart) II-131

Table 36: World Recent Past, Current & Future Analysis for
Prophylactic Vaccines by Product Segment - Pediatric
Prophylactic Vaccines and Adult Prophylactic Vaccines Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2001 through 2010 (includes corresponding
Graph/Chart) II-132

Table 37: World Long-term Projections for Prophylactic
Vaccines by Product Segment - Pediatric Prophylactic Vaccines
and Adult Prophylactic Vaccines Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2011
through 2015 (includes corresponding Graph/Chart) II-133

Table 38: World 10-Year Perspective for Prophylactic Vaccines
by Product Segment - Percentage Breakdown of Dollar Sales for
Pediatric Prophylactic Vaccines and Adult Prophylactic
Vaccines Markets for Years 2003, 2008 & 2012 II-133

Table 39: World Recent Past, Current & Future Analysis for
Pediatric Prophylactic Vaccines by Geographic Region - US,
Canada, Japan, Europe, Asia-Pacific (excluding Japan), Latin
America and Rest of World Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2001 through
2010 (includes corresponding Graph/Chart) II-134

Table 40: World Long-term Projections for Pediatric
Prophylactic Vaccines by Geographic Region - US, Canada,
Japan, Europe, Asia-Pacific (excluding Japan), Latin America
and Rest of World Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2011 through 2015
(includes corresponding Graph/Chart) II-135

Table 41: World 10-Year Perspective for Pediatric Prophylactic
Vaccines by Geographic Region - Percentage Breakdown of Dollar
Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding
Japan), Latin America and Rest of World Markets for Years
2003, 2008 & 2012 (includes corresponding Graph/Chart) II-136

Table 42: World Recent Past, Current & Future Analysis for
Adult Prophylactic Vaccines by Geographic Region - US, Canada,
Japan, Europe, Asia-Pacific (excluding Japan), Latin America
and Rest of World Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2001 through 2010
(includes corresponding Graph/Chart) II-137

Table 43: World Long-term Projections for Adult Prophylactic
Vaccines by Geographic Region - US, Canada, Japan, Europe,
Asia-Pacific (excluding Japan), Latin America and Rest of
World Markets Independently Analyzed with Annual Sales Figures
in US$ Million for Years 2011 through 2015 (includes
corresponding Graph/Chart) II-138

Table 44: World 10-Year Perspective for Adult Prophylactic
Vaccines by Geographic Region - Percentage Breakdown of Dollar
Sales for US, Canada, Japan, Europe, Asia-Pacific (excluding
Japan), Latin America and Rest of World Markets for Years
2003, 2008 & 2012 (includes corresponding Graph/Chart) II-139

Table 45: World, Recent Past, Current & Future Analysis for
Therapeutic Vaccines by Geographic Region - US, Canada, Japan,
Europe, Asia-Pacific (excluding Japan), Latin America and Rest
of World Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2001 through 2010 (includes
corresponding Graph/Chart) II-140

Table 46: World Long-term Projections for Therapeutic Vaccines
by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), Latin America and Rest of World Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2011 through 2015 (includes corresponding
Graph/Chart) II-141

Table 47: World 10-Year Perspective for Therapeutic Vaccines
by Geographic Region - Percentage Breakdown of Dollar Sales
for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan),
Latin America and Rest of World Markets for Years 2003, 2008 &
2012 (includes corresponding Graph/Chart) II-142


III. MARKET

1. The United States III-1
A.Market Analysis III-1
Outlook III-1
Current & Future Analysis III-1
Market Constraints III-1
Supply Shortages III-2
Pediatric Vaccines Market III-2
Market Focus Shifting From Pediatric Vaccines III-2
Growth Boosting Factors for US Pediatric Vaccines Market III-2
Demand Restraining factors for US Pediatric Vaccines Market III-3
Table 48: Pediatric Vaccine Market in the US: Annual
Sales for 2000-2005 (In Millions of Doses) (includes
corresponding Graph/Chart) III-3

Table 49: US Pediatric Vaccine Market: Percent of Doses
by Vaccine Type - 2000 through 2005 (includes
corresponding Graph/Chart) III-4
‘Bright’ Outlook for Therapeutic Vaccines III-4
Select Cancer Vaccines in Pipeline in the US III-4
Market Share of Key Players in North America III-5
Table 50: Leading Players in the North American Human
Vaccines Market (2005): Percentage Breakdown by Value
Sales for Merck, Sanofi-Aventis, Wyeth, GlaxoSmithKline,
and Others (includes corresponding Graph/Chart) III-5
The US Influenza Vaccine Market III-5
Table 51: The US Seasonal Influenza Vaccine Market -
Production and Distribution of Influenza Vaccine in Million
Units (includes corresponding Graph/Chart) III-5

Table 52: Funds Forwarded by HHS for Influenza Vaccine
Production (2005-2006) to Key Vaccine Manufacturers (In US
Dollars) (includes corresponding Graph/Chart) III-6
Influenza Vaccine Producers for the 2006-2007 Influenza Season III-6
Problems Effecting Timely Supply of Influenza Vaccine III-6
Table 53: Influenza Vaccines Market in the US (2005):
Percentage Breakdown of Value Sales for Sanofi Aventis,
Chiron, GSK, and Medimmune (includes corresponding
Graph/Chart) III-7
Key Statistics III-7
Table 54: Number of Children Under 5 Years of Age in the US
(In Millions) (includes corresponding Graph/Chart) III-7
Vaccines and Intended User Group III-8
Need for Immunization Schedule for Adults III-8
Federal Research and Grants III-9
National Cancer Institute III-9
National Institutes of Health (NIH) III-9
NIH Scientists Showcase Potential West Nile Virus Vaccine III-9
NIH Doles Out Grants to Biotech Companies III-9
Development Funds for HIV Vaccines III-10
Development Funds for Biodefense-Related Vaccines III-10
The National Institute of Allergy and Infectious Diseases
(NIAID) III-10
Intramural Research III-10
Extramural Divisions III-10
Vaccine Pricing in the US III-11
Table 55: The US Vaccine Market: Vaccine Prices in US$ Per
Dose (2002-2005) (includes corresponding Graph/Chart) III-11
Regulatory Environment III-11
Review Process Make Vaccines Safer III-11
Imports-Exports Scenario in the Recent Past III-12
Exports of Human Vaccines for 2004 III-12
Table 56: US Domestic Exports of Vaccines for Human
Medicine for the Year 2004 (Value in ‘000 US Dollars)
(includes corresponding Graph/Chart) III-12
Imports of Human Vaccines for 2004 III-12
Table 57: US Imports of Vaccines for Human Medicine for
the Year 2004 (Value in ‘000 US Dollars) (includes
corresponding Graph/Chart) III-12
Clinical Trials III-13
Product Developments III-20
Strategic Corporate Developments III-21
Select Players III-39
Alphavax Inc. III-39
Antigenics Inc. III-39
Avax Technologies, Inc. III-39
Avant Immunotherapeutics, Inc. III-40
Baxter International Inc. III-41
Cell Genesys Inc. III-41
Dendreon Corporation III-42
DOR Biopharma Inc. III-42
Dynavax Technologies Corp. III-43
Emergent BioSolutions Inc. III-43
GenPhar, Inc. III-44
IDM Pharma, Inc III-44
ImClone Systems, Inc. III-45
Ligocyte Pharmaceuticals, Inc III-45
Maxygen, Inc. III-45
MedImmune, Inc III-46
Merck & Company, Inc III-46
Micromet, Inc. III-47
Novartis Vaccines & Diagnostics, Inc. III-47
Novavax, Inc. III-47
Orchestra Therapeutics, Inc. III-48
Progenics Pharmaceuticals Inc. . III-48
Sanofi Pasteur Inc. III-49
Vaxin, Inc. III-49
Wyeth III-50
B.Market Analytics III-51
Table 58: US Recent Past, Current & Future Analysis for
Human Vaccines by Product Group/Segment - Prophylactic
Vaccines (Pediatric Prophylactic Vaccines and Adult
Prophylactic Vaccines) and Therapeutic Vaccines Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2001 through 2010 (includes corresponding
Graph/Chart) III-51

Table 59: US Long-term Projections for Human Vaccines by
Product Group/Segment - Prophylactic Vaccines (Pediatric
Prophylactic Vaccines and Adult Prophylactic Vaccines) and
Therapeutic Vaccines Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2011 through
2015 (includes corresponding Graph/Chart) III-51

Table 60: US Historic Review for Human Vaccines - Annual
Sales Figures in US$ Million for Years 1991 through 2000
(includes corresponding Graph/Chart) III-52

Table 61: US 10-Year Perspective for Human Vaccines by
Product Group/Segment - Percentage Breakdown of Dollar Sales
for Prophylactic Vaccines (Pediatric Prophylactic Vaccines
and Adult Prophylactic Vaccines) and Therapeutic Vaccines
Markets for 2003, 2008 & 2012 (includes corresponding
Graph/Chart) III-52

2. Canada III-53
A.Market Analysis III-53
Clinical Trial III-53
Strategic Corporate Developments III-53
B.Market Analytics III-55
Table 62: Canadian Recent Past, Current & Future Analysis
for Human Vaccines by Product Group / Segment - Prophylactic
Vaccines (Pediatric Prophylactic Vaccines and Adult
Prophylactic Vaccines) and Therapeutic Vaccines Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2001 through 2010 (includes corresponding
Graph/Chart) III-55

Table 63: Canadian Long-term Projections for Human Vaccines
by Product Group/Segment - Prophylactic Vaccines (Pediatric
Prophylactic Vaccines and Adult Prophylactic Vaccines) and
Therapeutic Vaccines Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2011 through
2015 (includes corresponding Graph/Chart) III-56

Table 64: Canadian Historic Review for Human Vaccines -
Annual Sales Figures in US$$ Million for Years 1991 through
2000 (includes corresponding Graph/Chart) III-56

Table 65: Canadian 10-Year Perspective for Human Vaccines by
Product Group/Segment - Percentage Breakdown of Dollar Sales
for Prophylactic Vaccines (Pediatric Prophylactic Vaccines
and Adult Prophylactic Vaccines) and Therapeutic Vaccines
Markets for 2003, 2008 & 2012 (includes corresponding
Graph/Chart) III-57

3. Japan III-58
A.Market Analysis III-58
Strategic Corporate Development III-58
B.Market Analytics III-59
Table 66: Japanese Recent Past, Current & Future Analysis
for Human Vaccines by Product Group/ Segment - Prophylactic
Vaccines (Pediatric Prophylactic Vaccines and Adult
Prophylactic Vaccines) and Therapeutic Vaccines Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2001 through 2010 (includes corresponding
Graph/Chart) III-59

Table 67: Japanese Long-term Projections for Human Vaccines
by Product Group/Segment - Prophylactic Vaccines (Pediatric
Prophylactic Vaccines and Adult Prophylactic Vaccines) and
Therapeutic Vaccines Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2011 through
2015 (includes corresponding Graph/Chart) III-60

Table 68: Japanese Historic Review for Human Vaccines -
Annual Sales Figures in US$$ Million for Years 1991 through
2000 (includes corresponding Graph/Chart) III-60

Table 69: Japanese 10-Year Perspective for Human Vaccines by
Product Group/Segment - Percentage Breakdown of Dollar Sales
for Prophylactic Vaccines (Pediatric Prophylactic Vaccines
and Adult Prophylactic Vaccines) and Therapeutic Vaccines
Markets for 2003, 2008 & 2012 (includes corresponding
Graph/Chart) III-61

4. Europe III-62
A.Market Analysis III-62
Vaccine Pricing in Europe III-62
Major Drawbacks III-62
Current & Future Analysis III-62
Regulatory Mechanism for Vaccines in Europe III-62
Select Players III-63
Table 70: Leading Players in the European Human Vaccines
Market (2005): Percentage Breakdown by Value Sales for
GlaxoSmithKline & Sanofi Pasteur, Wyeth, and Others
(includes corresponding Graph/Chart) III-63

Table 71: Influenza Vaccines Market in Europe (2005 &
2006): Percentage Breakdown of Value Sales for Sanofi
Pasteur, GSK, Novartis Vaccines, and Others in US$ Million
(includes corresponding Graph/Chart) III-63
Strategic Corporate Developments III-63
B.Market Analytics III-65
Table 72: European Recent Past, Current & Future Analysis
for Human Vaccines by Geographic Region - France, Germany,
Italy, UK, Spain, Russia, and Rest of Europe Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2001 through 2010 (includes corresponding
Graph/Chart) III-65

Table 73: European Long-term Projections for Human Vaccines
by Geographic Region - France, Germany, Italy, UK, Spain,
Russia, and Rest of Europe Markets Independently Analyzed
with Annual Sales Figu