Global Human Vaccines Industry

  • March 2012
  • -
  • Global Industry Analysts
  • -
  • 821 pages

This report analyzes the worldwide markets for Prophylatic Human Vaccines in US$ Million by the following Product Segments: Pediatric Prophylactic Vaccines and Adult Prophylactic Vaccines. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Middle East and Latin America. Annual estimates and forecasts are provided for the period 2009 through 2017. Also, a six-year historic analysis is provided for these markets. The report also analyzes the world market for Therapeutic Vaccines for the period 2010 to 2015. The report profiles 162 companies including many key and niche players such as ALK - Abelló A/S, 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, 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 primarily based upon search engine sources in the public domain.

Table Of Contents





I. INTRODUCTION, METHODOLOGY and PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation and Reporting Level I-3
Quantitative Techniques and Analytics I-3
Product Definitions and Scope of Study I-3
Prophylactic Vaccines I-3
Therapeutic Vaccines I-4

II. EXECUTIVE SUMMARY

1. MARKET OVERVIEW and OUTLOOK II-1
Human Vaccines Market Remains Resilient to Recession II-1
Global Human Vaccines Market: A Snapshot II-1
Market Dynamics II-2
Vaccine Pricing: The Developed - Developing Divide II-2
Growth Drivers in a Capsule II-3
Developed World: The Key Markets II-3
Looking Ahead II-3
Emerging Markets: The Future Growth Area II-4
Competitive Scenario II-5
World’s Leading Producers II-5
Table 1: Leading Players in the Worldwide Vaccines Market
(2008): Market Share Breakdown by Value Sales for
GlaxoSmithKline, Sanofi-Aventis, Merck and Co., Novartis,
Wyeth, and Others (includes corresponding Graph/Chart) II-6
ALK- The Global Leader in Allergy Vaccines II-6
Table 2: Leading Players in the Worldwide Allergy Vaccines
Market (2005 and 2006 - A Historic Perspective): Market Share
Breakdown of Value Sales (*) for ALK- Abelló, Stallergenes,
Allergopharma, and Others (includes corresponding
Graph/Chart) II-7

2. PRODUCT OVERVIEW II-8
Introduction to the Concept of Immunity II-8
Role of Vaccines in Strengthening the Immune System II-8
Vaccines and Immunotherapy II-9
Historical Overview of Vaccines II-9
How it Began II-9
So Far So Good II-11
Successful Vaccine Introductions in the Past II-11
Contribution of Animal Research to Vaccine Production II-11
Types of Vaccines II-12
Live, Attenuated Vaccines II-13
Combination Vaccines II-14
Killed or Inactivated Vaccines II-14
DNA and Recombinant DNA Vaccines II-15
Toxoids II-15
Cellular Fractions II-15
Conjugate Vaccines II-15
Subunit Vaccines II-16
Passive Immunization II-16
Prophylactic Vaccines II-16
Prevention Better than Cure II-16
Prophylactic Pediatric Vaccines II-17
Vaccination Over the Years II-17
A Mature Market II-17
Challenges for Pediatric Vaccines Market II-18
BCG Vaccine II-18
Growth Boosting Factors for TB Vaccines II-19
Demand Restraining Factors for TB Vaccines II-19
Major Issues to be Addressed in the TB Vaccine Market II-19
Table 3: Global Historic Review for TB Vaccines Market:
Annual Sales for Years 2000 through 2005 (In US$ Million)
(includes corresponding Graph/Chart) II-20
Hemophilus Influenza Type B Vaccine II-20
Hib and Combination Vaccines by Producer II-20
Table 4: Historic Review for Pediatric Haemophilis
Influenza B Vaccine Market in the US and Europe: Annual
Sales for 2000-2005 (In US$ Million) (includes
corresponding Graph/Chart) II-21

Table 5: Historic Review for Pediatric Haemophilis
Influenza B Vaccine Market in the US: Annual Sales for
2000-2005 (In Million Doses) (includes corresponding
Graph/Chart) II-21
Diphtheria/Tetanus/Pertussis Vaccines II-22
DTP, DTaP, and Combination Vaccines Offered by Major
Producers in US II-22
Table 6: Leading Players in the US DTP and DTaP Vaccines
Market (2003-2005 - A Historic Review): Market Share
Breakdown of Value Sales for Sanofi Pasteur, Wyeth,
GlaxoSmithkline, and others (includes corresponding
Graph/Chart) II-23

Table 7: Historic Review of DTP and DTaP Vaccines Market in
the US: Annual Sales for 2000- 2005 (In US$ Million)
(includes corresponding Graph/Chart) II-23

Table 8: Historic Review of DTP Vaccine Market in Europe:
Annual Sales for 2000-2005 (In US$ Million) (includes
corresponding Graph/Chart) II-24
Hepatitis A Vaccine II-24
Hepatitis B Vaccine II-24
Hepatitis B Epidemiology II-25
Table 9: World Market for Hepatitis B Vaccines: Annual
Sales for Years 2009 through 2017 (In US $ Million)
(includes corresponding Graph/Chart) II-25

Table 10: Historic Review for Hepatitis B Vaccines Market
in US and Europe: Annual Sales for 2000-2005 (In US$
Million) (includes corresponding Graph/Chart) II-26
Measles/Mumps/Rubella Vaccines II-26
Table 11: Historic Review for Measles-Mumps- Rubella (MMR)
Vaccine Market in US and Europe: Annual Sales for 2000-2005
(In US$ Million) (includes corresponding Graph/Chart) II-27

Table 12: Historic Review for Measles-Mumps-Rubella (MMR)
Vaccine Market in the US: Annual Sales for 2000-2005 (In
Millions of Doses) (includes corresponding Graph/Chart) II-27
Rotavirus Vaccines II-28
Polio Vaccines II-28
Table 13: Historic Review for Polio Vaccines Market in
Europe: Annual Sales for 2000-2005 (In US$ Million)
(includes corresponding Graph/Chart) II-28

Table 14: Historic Review for Polio Vaccines Market in the
US: Annual Sales for 2000-2005 (In US$ Million) (includes
corresponding Graph/Chart) II-29

Table 15: Historic Review for Polio Vaccine Market for Both
Vaccine Types in the US: Annual Sales for 2000-2005 (In
Million Doses) (includes corresponding Graph/Chart) II-29

Table 16: Historic Review for Polio Vaccine Market for Both
Vaccine Types (OPV and IPV) in the US in Percent of Doses
from 2000-2005 II-30
Varicella Vaccine II-30
Table 17: Historic Review for Varicella Vaccine Market in
the US and Europe: Annual Sales for 2000- 2005 (In US$
Million) (includes corresponding Graph/Chart) II-31

Table 18: Historic Review for Varicella Vaccines Market in
the US: Annual Sales for 2000-2005 (In Million Doses)
(includes corresponding Graph/Chart) II-31
Need for Combination Vaccines II-32
Prophylactic Adult Vaccines II-32
Favorable Market Growth II-32
Hepatitis A Vaccine II-33
Hepatitis B Vaccines II-34
Key Issues Affecting the Adult Hepatitis Vaccines Market II-35
Cholera Vaccine II-35
Hepatitis A/Hepatitis B Vaccine II-35
Japanese Encephalitis Vaccines II-35
Influenza Vaccines II-36
Table 19: Global Flu Vaccines Market by Region (2005):
Percentage Share Breakdown of Value Sales for the US, EU,
and Rest of the World (includes corresponding Graph/Chart) II-37

Table 20: Global Flu Vaccines Market by Leading Players
(2005): Market Share Breakdown by Volume Sales for Sanofi
Pasteur, Chiron, GSK and Others (includes corresponding
Graph/Chart) II-37

Table 21: Rate of Influenza Vaccine Consumption Among Target
Groups (includes corresponding Graph/Chart) II-37

Table 22: Global Historic Review for Adult Influenza
Vaccines: Annual Sales for 2000-2005 (In US$ Million)
(includes corresponding Graph/Chart) II-38
Growth Boosting Factors for Influenza Vaccines Market II-38
Key Issues Affecting Influenza Vaccines Market II-38
Age-Driven Strategies Drive Target Market for Influenza
Vaccines II-39
Healthcare Professionals Increase Target Market for
Influenza Vaccines II-39
Lyme Disease Vaccine II-39
Pneumococcal Disease Vaccines II-39
Meningococcal Vaccines II-40
Rabies Vaccines II-40
Table 23: Global Historic Review for Rabies Vaccines: Annual
Sales for 2000-2005 (In US$ Million) (includes
corresponding Graph/Chart) II-41
Typhoid Vaccine II-42
Yellow Fever Vaccine II-42
Need for Additional Vaccines II-42
Therapeutic Vaccines II-44
DNA Holds the Key II-44
Huge Potential for Protein Based Vaccines II-44
Therapeutic Hepatitis Vaccines II-44
Therapeutic Addiction Vaccines II-45
Cancer Vaccines II-45
Human Papillomavirus (HPV) Vaccine II-45
Breakthroughs in Cancer Vaccine Market II-45
Factors Affecting the Market for Cancer Vaccines II-46
Vaccine for AIDS II-46
What is AIDS? II-46
Global Statistics II-47
Table 24: Worldwide HIV/AIDS - 2007 (includes corresponding
Graph/Chart) II-47

Table 25: Worldwide HIV and AIDS Incidences (2007): A
Regional Breakdown for Living and Newly Infected Cases
(includes corresponding Graph/Chart) II-48

Table 26: Worldwide HIV and AIDS Prevalence Rate in Adults
Aged between 15 and 49 Years for the Year 2007 (includes
corresponding Graph/Chart) II-49
Asia-Pacific II-49
Central Asia and Eastern Europe II-50
Commonwealth of Independent States (CIS) II-50
Latin America (Including the Caribbean Islands) II-50
Sub Saharan Africa II-50
North Africa and the Middle East II-51
Developed Regions and High-Income Countries II-51
United States II-51
Table 27: New HIV Infection Cases among Men in the US
(2006): Percentage Breakdown by Mode of Infection
(includes corresponding Graph/Chart) II-51

Table 28: New HIV Infection Cases in the US (2006):
Percentage Breakdown by Racial/Ethnic Groups (includes
corresponding Graph/Chart) II-52

Table 29: New HIV Infection Cases among Women in the US
(2006): Percentage Breakdown by Mode of Infection
(includes corresponding Graph/Chart) II-52
Development of Treatment Options II-52
Categories of Vaccines for AIDS II-53
HIV Vaccines Under Development II-53
HIV Vaccines (Prophylactic/Therapeutic) Under Development:
As of 2010 II-53
Malaria Vaccine II-54
Therapeutic Vaccines Against Infectious Diseases: The
Challenges II-54
Melanoma: Prospects for Treatment II-54
Melanoma Vaccines under Development: As of 2010 II-54
Autoimmune Diseases II-55
How Do Autoimmune Diseases Occur II-55
Types of Autoimmune Diseases II-55
Need for Developing Autoimmune Therapeutic Vaccines II-55
Travel Vaccines: Opportunities II-55
SARS - A Review II-55
Vaccinations Recommended for Travel to High-Risk Areas II-56
Mechanisms for Vaccine Delivery II-57
Edible Vaccines II-57
Oral Vaccines II-59
Tablet Based Vaccines II-59
Mucosal Delivery II-59
Transdermal Patch Delivery II-59

3. MARKET TRENDS and ISSUES II-60
Newer Vaccines in Pipeline to Cheer Up Pharma Companies II-60
Select Vaccines Currently in Phase III Clinical Trials II-60
Threat of Pandemic Rejuvenates Vaccine Market II-60
Influenza Vaccines On a Growing Spree II-61
H1N1 Vaccines Hit the Market in August 2009 II-61
H1N1 Influenza Vaccines and Manufacturers II-62
Influenza Market Faces Several Challenges II-63
Economic Factors Hamper Optimal Vaccine Development and Delivery II-63
Increasing Need for Vaccine Promotion in the Developing Regions II-63
Changing Vaccine Needs II-63
DNA Vaccines: Engineering Growth II-64
AIDS Vaccine: Long Road Ahead II-65
HIV Vaccines Research Clipped by Lack of Funds II-66
Funding Drops In HIV Vaccine Research Amid Recession II-66
Noninjectable Vaccines: Gain Without Pain II-66
Need for a Human Vaccine for Leishmaniasis II-66
Conjugate Vaccines: A Technological Innovation II-67
Need For a New TB Vaccine II-67
Table 30: Worldwide Prevalence of TB Cases (in ‘000s) by
Region for the Year (2007) (includes corresponding
Graph/Chart) II-67
Companies Involved in TB Vaccine Research: As of 2010 II-68
Religious Concerns Over Immunizing Young Girls Against Human
Papillomavirus II-68
Changing Travel Patterns Increase Demand for Hepatitis B Vaccine II-68
DTaP Vaccines Approved for Booster Vaccination II-69
Advances in Biotechnology Spearheading Vaccines’ Growth II-69
BioWarfare: Threat Perception and Preparedness II-69
Overview of Potential Bio-Terrorist Agents II-70
Smallpox (Variola Major) II-70
Anthrax (Bacillus Anthracis) II-70
Plague (Yersinia Pestis) II-70
Botulism (Clostridium Botulinum) II-71
Tularemia (Francisella Tularensis) II-71
Market Concerns II-71
Safety Factor II-71
Development Delays II-72
Storage Problems II-72
Perfluorocarbons as Alternative to Overcome Storage Problems II-72
Costs II-72
Standards for Vaccine Safety and Quality II-72

4. DISTRIBUTION CHANNELS II-73

5. TECHNOLOGICAL DEVELOPMENTS II-74
Applying Gene Therapy to Develop Therapeutic Solutions II-74
Research and Trials of AIDS Vaccines II-74
Ongoing Clinical Testing for AIDS Vaccines: Status As of 2010 II-74
International AIDS Vaccine Initiative (IAVI) II-75
Cancer II-75
Cancer Type and Area Effected II-75
Immunotherapies for Cancer II-75
Cancer Treatment Drugs II-76
Issues Effecting the Development of Commercially Viable
Cancer Vaccines II-76
Frequency of Vaccination II-77
Growth Boosters in the Cancer Vaccines Market II-77
Available Cancer Treatment Vaccines II-78
Select Cancer Vaccines (Therapeutic and Prophylactic) in
Clinical Trials: As of 2010 II-78
Other Cancer Treatment Vaccines II-79
Application of Botulinum Toxin as Delivery Mechanism for Oral
Vaccines II-79

6. CLINICAL TRIALS IN THE VACCINES MARKET II-80
Vaccinogen Selects Clinipace for Phase 3b Clinical Trial with
OncoVAX II-80
BioSante to Restart Prostate Cancer Vaccine Clinical Testing II-80
University of Oxford to Commence Phase 2b Proof-of- Concept
Clinical Trials with TB Vaccine in Infants II-80
Emergent Begins Phase I/II Clinical Studies of AIG for
Anthrax Treatment II-81

7. RESEARCH BREAKTHROUGHS - A HISTORIC PERSPECTIVE BUILDER II-82
Favrille Announces Phase III Registration Trial Results of
Specifid in Patients with Follicular B-Cell Non-Hodgkin's
Lymphoma II-82
Novartis Announces Phase III Results of Menveo® Vaccine II-82
Emergent Commences Phase II Clinical Study of Typhoid Vaccine II-82
AVANT’s Single-Dose Oral Ty800 Vaccine Meets Key Endpoints II-83
Emergent BioSolutions’ Typhoid Vaccine Completes Final Phase
II Clinical Trial II-83
Antigenics Announces Positive Data on Phase-I Study of ACAM-
FLU-ATM Vaccine II-83
Bavarian Nordic’s IMVAMUNE® Post-Exposure Vaccination
Demonstrates Protection Against Fatal Poxvirus Infection II-84
BSU Scientists to Commence Human West Nile Vaccine
Development Project II-84
Intercell Concludes First Phase Clinical Studies of IC31®
Adjuvanted Influenza Vaccine II-84
Protherics Commences Phase 2 Angiotensin Vaccine Study II-85
Novartis Receives European Approval for Optaflu® Flu Vaccine II-85
CSL Biotherapies Files BLA for Influenza Vaccine II-85
Orchestra Therapeutics Abandons Development of HIV Vaccine II-86
AlphaVax Concludes Phase I Clinical Trial of Flu Vaccine II-86
AVANT Presents Preclinical Data on Enteric Vaccine II-87
Baxter Declares Results of Seasonal Flu Vaccine Candidate Trial II-87
IDM Pharma Announces Interim Data of Phase II Clinical Trials
of Lung Cancer Vaccine II-87
Novavax Announces Developments in Discovery Program II-88
Acambis Pioneers Testing of West Nile Virus Vaccine in Grown Ups II-88
Acambis Initiates Test of single-dose JE vaccine in India II-89
AVAX Technologies Initiates Phase 3 Clinical Trial For M-Vax II-89
LigoCyte Pharmaceuticals Begins Clinical Testing of Norovirus
Vaccine II-89
Alphavax Initiates Clinical Testing for Flu and CMV Vaccines II-89
Sanofi Pasteur Begins Phase 2 Testing of New Influenza Vaccine II-90
Antigenics Reveals the Preliminary Data of Clinical Trial of
Oncophage® II-90
Baxter Reveals Phase I/II Clinical Trial Results of H5N1
Pandemic Vaccine II-91
Crucell and AERAS Initiates Tuberculosis Vaccine Clinical Trial II-91
DOR BioPharma Announces Phase I Results of RiVaxâ„¢ II-91
GlaxoSmithKline Starts Clinical Trials to Test H5N1 Pandemic
Flu Vaccines II-91
MedImmune Initiates Phase I Clinical Trial of Avian H5N1 Vaccine II-91
MedImmune Reveals Results of Phase 3 Study for CAIV-T II-92
MedImmune Initiates Second Phase 1 Study with MEDI-534 II-92
Sanofi Pasteur Initiates First Clinical Trial of Cell Based
H7N1 Vaccine II-92
Therion Biologics Completes Enrollment for Phase III trials
of PANVAC-VF II-92
ViRexx Finishes the Treatment in Phase I Study of Hepa Vaxx B
Vaccine II-93
Antigenics Begins Phase I Clinical Trial of AG-707 II-93
Positive Results in Novavax’s Pandemic Influenza Vaccine Pre
-clinical Trials II-93
Trials Reveal H5N1 Pre-Pandemic Vaccine of Sanofi Pasteur
Effective II-93
PowderMed Reveals Results for Phase 1 Trials for Influenza
Vaccine II-93
Phase II clinical trials of China's hepatitis B vaccine II-93
Findings Prove New Nose-Spray Vaccines Effective II-94
Large Doses of H5N1 Influenza Vaccine Appears Effective II-94
New Vaccine Technology to Prevent TB II-94
HPV Vaccine to Help Prevent Cervical Cancer II-94
Scientists Develop H7N1 Avian Influenza Vaccine II-94
Human H5N1 Vaccine Developed by Central Hygiene and
Epidemiology Institute II-95

8. PRODUCT DEVELOPMENT/LAUNCHES II-96
Vivalis and SAFC Launch Ex-Cell EBx Media II-96

9. PRODUCT DEVELOPMENT/LAUNCHES - A HISTORIC PERSPECTIVE BUILDER II-97
MSD Pharmaceuticals India Launches GARDASIL Vaccine II-97
Sanofi-Aventis Introduces ActHIB Vaccine in Japan II-97
Sinovac Biotech Introduces Anflu® II-97
Nventa Biopharmaceuticals Develops Poly IC-Poly Arginine II-97
Replikins Develops New Synthesized Vaccine II-98
GlaxoSmithKline Biologicals Launches Cervarix II-98
CSL Develops New Vaccine for Prevention of Bird Flu II-98
GlaxoSmithKline to Introduce Five Key Medicines for Oncology II-98
FFF Enterprises Unveils My Flu Vaccine Network II-98
Nabi Biopharmaceuticals to Develop NicVax Vaccine for
Reducing Nicotine Effects II-99
GenPhar Develops Highly Effective Tetravalent Dengue Vaccine II-99
Iomai Commences the Development of Prophylactic Travelerâ„¢s
Diarrhea Vaccine II-99
Biological Immunological to Produce and Sell r-Hepatitis B
Vaccine II-99
Thailand Researchers Commence the Development of Human Bird
Flu Vaccine II-99
USV to Commercialize Typhoid Vaccine II-100
ALK-Abelló Introduces GRAZAX® Anti-Allergy Vaccine II-100
Novartis Unveils Influenza Virus Vaccine Fluvirin® II-100
Wyeth Introduces Latest 7-in-1 Pneumococcal Conjugate Vaccine II-100
Intervet Releases Arnhem, a Prototype of Avian Influenza Vaccine II-100
Shantha Launches ‘Jencevac’ Brain Fever Vaccine II-101
Wockhardt and Zhejiang Introduces New Hepatitis- A Vaccine II-101
GSK Introduces Rotarix(R) Vaccines for Infants II-101
Sinovac Biotech Introduces Biliveâ„¢ II-101

10. RECENT INDUSTRY ACTIVITY II-102
‘Sanofi-Aventis’ Name Turns Simpler, Now Known as Just ‘Sanofi’ II-102
Antigenics Changes Name to Agenus, Provides Pipeline Details II-102
AltraVax Acquires Vaccine Development Technology Package from
Maxygen II-102
Pfizer Integrates RandD operations of Wyeth II-103
Dendreon Receives FDA Approval for PROVENGE® Vaccine to Treat
Men with Advanced Prostate Cancer II-103
SVA and Parenteral Biotech Enter into a Partnership to
Distribute and Supply Vaccines II-103
Novartis Obtains FDA Approval for Menveo® Vaccine II-103
Pfizer to Supply Vaccine for Pneumococcal Disease II-104
Torii Enters into Partnership with Riken II-104
Sanofi-Aventis Acquires Shantha Biotechnics II-104
Affitech AS Merges with Pharmexa A/S II-104
Takeda Acquires IDM Pharma II-105
Pfizer Concludes Wyeth’s Acquisition II-105
Sanofi Pasteur and Syntiron Sign Agreement to Develop and
Market Prophylactic Vaccine II-105
Cell Genesys Merges with BioSante Pharmaceuticals II-105
Simcere Pharmaceutical Acquires Controlling Stake in ChinaVax II-106
Novartis to Acquire 85% Stake in Zhejiang Tianyuan II-106
FDA Approves Merck’s Gardasil for Males under 9 to 26 Years Age II-106
Merck Sign Agreement with CSL Biotherapies II-106
Sinovac Forms JV with Dalian to Develop and Market Human-Use
Vaccines II-106
CPL Enters Into JV with Novavax II-107
Nobilon Ties-up with WHO II-107
GeoVax Labs to Relocate Operations II-107
SingVax and Inviragen Merge II-107
Sanofi-aventis and Mexican Authorities Enter into Agreement II-108
Kitasato Institute and Daiichi Sankyo Ink Agreement II-108
ACVD to Enter into Alliance with Emory Vaccine Center II-108
Emory University to Set Up Emory Institute for Drug Discovery II-108
ImmunoVaccine Technologies Enters into Partnership with FIT
Biotech II-108
VGX Pharmaceuticals Merges with Inovio Biomedical II-109
Sanofi Pasteur Obtains EC Approval for INTANZA®/IDflu® II-109
European Commission Grants Marketing Authorization to Ixiaro®
Vaccine II-109
US FDA Approves Ixiaro® Vaccine II-109
Emergent BioSolutions Purchases Protein Sciences II-109
Vaccine Technologies Signs Agreement with Celldex Therapeutics II-110
Oxford-Emergent Tuberculosis Consortium and ProBio Gen Ink
Agreement II-110
JN-International to Acquire Biocor’s Vaccine Research and
Manufacturing Plant II-110
Mymetics to Acquire Bestewil Holding BV II-111
Eureka Genomics and Nanobac Pharmaceuticals to Merge II-111
Immunovaccine Enters into Agreement with National Cancer
Institute II-111
GSK Forms Joint Venture with Walvax II-111

11. STRATEGIC CORPORATE DEVELOPMENTS - A HISTORIC PERSPECTIVE
BUILDER II-112
AVANT Adopts New Identity as Celldex Therapeutics II-112
Eli Lilly Takes Over ImClone Systems II-112
Sanofi Pasteur Acquires Acambis II-112
Novartis to Acquire Protez II-112
Novartis Inks Agreement with AlphaVax II-113
Vacsera Signs Agreement with Omninvest II-113
GeoVax Sign LOI with Vivalis II-113
GlaxoSmithKline Receives EC Approval for Prepandrix Vaccine II-114
ShigaMedix SAS and Avesthagen Sign Agreement II-114
Shenzhen Neptunus Inks Agreement with Glaxo SmithKline II-114
Sanofi Pasteur Establishes Vaccine Manufacturing Facility II-114
Emergent BioSolutions Forges Joint Venture with the
University of Oxford II-114
Crucell Bags Contract from NIAID and NIH II-115
PharmAthene Takes Over Business of Avecia II-115
Crucell and Wyeth Pharmaceuticals Sign Agreement II-115
Cytos Biotechnology and Pfizer Vaccines Sign Agreement II-115
Intercell Acquires Iomai II-116
Emergent BioSolutions to Acquire Recombinant Flu Vaccine,
FluBlok® II-116
Encorium Group Signs Contract with Protherics II-116
Beijing Keyuan Xinhai Pharmaceutical Signs Agreement with
China Biopharma II-117
Callisto Merges with Celldex II-117
Mymetics Corp. Buys Preventive Malaria Vaccine of Pevion
Biotech AG II-117
Dynavax Inks Agreement with Novartis II-117
NasVax to Buy Protea Vaccine Technologies II-118
Paladin Labs Buys ViRexx Medical Corp II-118
Emergent BioSolutions Acquires Group of Anthrax Monoclonal
Antibodies from AVANIR II-118
China Biopharma and BKXPC Enter into Agreement II-119
Encorium Signs Contract with Protherics for Phase 2 Trial of
ATV for Hypertension II-119
GenPhar to Establish Vaccine Production Plant in South Carolina II-119
Intercell Partners SSI and Sanofi Pasteur to Further Develop
TB Vaccine II-119
Intercell and PATH Malaria Vaccine Initiative Form New
Partnership for Malaria Vaccine II-120
Intercell Receives Manufacturer's License for Production of
JE Vaccine II-120
GSK Receives US FDA Approval for ROTARIX® Rotavirus Vaccine II-120
Dynavax and Merck and Co Announce Clinical Hold of HEPLISAV
Vaccine Trial II-121
Pharmexa and Ichor Enter into Co-Development Agreement for
Multiple DNA Vaccines II-121
Crucell Enters into Exclusive Development Agreement with
Wyeth Pharmaceuticals II-122
Crucell and Sanofi Ink an Agreement for Advanced Anti-Rabies
Biologicals II-122
FDA Confers Priority Designation for Supplemental Application
for GARDASIL ® II-123
Sanofi Submits a European Marketing Approval Application for
First Influenza Vaccine II-123
Lonza Consolidates Micobial Biopharma Operations II-123
Novartis Acquires Rights Over a Novel Therapeutic Vaccine
Candidate II-124
AstraZeneca Purchases MedImmune II-124
Nobilon Purchases EBxâ„¢ Cell Lines Rights from Vivalis II-124
NasVax Inks Partnership Agreement with SciGen II-124
GSK Inks Co-Promotion Agreement with Sinovac Biotech for Anflu II-125
Pfizer Buys Coley Pharmaceutical Group II-125
FDA Selects sanofi’s H5N1 Vaccine II-125
Novartis Starts Construction of a Cell-Culture Based Vaccine
Production Facility II-125
IVT Signs an MoU to Take Over Immunotope II-125
Oxford BioMedica Takes Over Oxxon Therapeutics II-126
DND Issues RFP for acquisition of MVA-based smallpox vaccine II-126
GlaxoSmithKline Acquires Reliant Pharmaceuticals II-126
GSK Acquires Praecis Pharmaceuticals II-127
Berna Biotech Divests Stake in Pevion Biotech II-127
GeoVax Signs a Private Placement Agreement with Pure Capital II-127
Crucell Inks a Research License Agreement with ISU ABXIS of
Korea II-127
China Biopharma Concludes Capital Funding to ZT Biotech II-127
Crucell and Acambis Ink a Licensing Agreement for PER. C6 ®
Technology II-128
Novartis and Intercell Join Hands to Advance Vaccine Programs II-128
Serum Institute and Akorn Ink MoU for Vaccine
Commercialization in US Market II-128
Merck Plans to Establish a Human Vaccine Facility in Ireland II-129
Schering-Plough Acquires Organon Bio Sciences II-129
Intas Biopharmaceuticals Enters into Collaboration Agreement
with Virionics II-129
Oxxon Therapeutics Starts U.S. Operation II-130
GenPhar and ImmuneRegen Enter into Research Partnership II-130
Intercell Submits BLA for JE Vaccine to US FDA II-130
AVANT and Select Vaccines Enter into RandD Partnership II-130
AVAX Enters into Agreement with Cancer Treatment Centers of
America II-131
CSC’s DVC and Baxter Receive Contract Modification from U.S. HHS II-131
DOR BioPharma Enters into CRADA with Walter Reed Army Institute II-132
Dynavax and Merck to Enter into Partnership to Develop
Hepatitis B Vaccine II-132
Emergent BioSolutions Commences Delivery of Bio Thrax® to US
Health Department II-133
Maxygen and Sanofi Pasteur sign License Agreement II-133
Beijing Public Health Bureau Enters into Purchase Agreement
with Sinovac II-134
Novartis Wins US Government Contract for Developing Antigen
Technology II-134
MedImmune Announces Licensing of Reverse Genetics Technology
to GlaxoSmithKline II-135
MedImmune Wins US Government Contract II-135
MedImmune and Human Genome Sciences Sign Lease Agreement II-135
Acambis Announces Signing of Collaboration Agreement with
Sanofi Pasteur II-136
Acambis Announces JE Partnership Agreement with Sanofi Pasteur II-136
Crucell Procures Major Patent for Influenza Vaccine Production II-136
CSL Receives FDA Approval for Influenza Virus Vaccine II-136
GlaxoSmithKline Inks Contract with UK Government II-137
Merck and Co., Inc. and Dynavax to Jointly Develop Hepatitis B
Vaccine II-137
Sanofi Pasteur Wins Contract to Design, Retrofit and Maintain
Influenza Vaccine Unit II-138
Sanofi Pasteur Completes Construction of Influenza Vaccine
Production Unit II-138
Amgen Acquires Abgenix II-138
Pfizer Acquires PowderMed II-139
CancerVax and Micromet Merge to Establish Micromet, Inc. II-139
Novartis Acquires Chiron II-139
Dynavax Takes Over Rhein Biotech II-139
AnGes and Vical Ink Collaborative Agreement II-139
GeoVax Merges with Dauphin II-139
Hawaii Biotech and Avantogen Merge to Form New Entity II-140
CytoDyn Acquires Advanced Influenza Technologies II-140
Emergent BioSolutions Acquires VIVACS II-140
Acambis Divests Berna Business to Crucell II-140
Novavax Inks an Agreement with Bharat Biotech to Develop
Avian Flu Vaccine II-140
Aeras Receives License for Developing and Distributing
Tuberculosis Vaccine II-140
Acambis to Supply Smallpox Vaccine to CDCP II-141
AlphaVax and Wyeth Enhance Existing Licensing Agreement II-141
Baxter Enters into a Contract to Supply Pandemic Influenza
Vaccine II-141
Sanofi Pasteur Signs Stockpile Contract with the US Government II-141
Crucell Licenses PER.C6® Technology to ADImmune Corporation II-142
Baxter Wins Stockpile Production Contract for H5N1 from the NHS II-142
Crucell Earns NIH Contract to Develop HIV Vaccine II-142
Novartis Secures Stockpile Supply Contract from the US
Government II-142
Novartis Signs Distribution Agreement with Intercell II-142
GSK Receives Stockpile Supply Contract for Fly Pandemic from
the HHS II-143
GSK Signs H5N1 Antigen Influenza Vaccine Contract with
Switzerland II-143
DOR BioPharma Forms Alliance to Develop Ricin Vaccine II-143
Nobilon and NVI to Jointly Develop RSV Vaccine II-144
SciGen and OctoPlus Join Forces to Develop Hepatitis B
Vaccine Delivery II-144
AlphaVax Receives Patent for Alphavaccines Manufacturing Process II-144
IVI Receives Funds for Cholera Vaccine Development Program II-144
Novavax Forms Strategic Alliance with US-based, PacificGMP II-144
Sanofi Pasteur Enters into Partnership with PDVI II-145
MedImmune Inks a Cooperative RandD Agreement with NIAID II-145
MedImmune Bags a Five-Year HHS Contract II-145
Novavax Enters into a Cooperative Research Agreement with CDC II-146
GlaxoSmithKline Establishes New Vaccine Manufacturing Facility II-146
GenPhar Extends RandD Contract with NMRC II-146
Medlmmune Files for INDA with FDA for a New Influenza Vaccine II-146
Rotarixâ„¢ Vaccines Receives European Approval II-147
Merck’s GARDASIL® Receives FDA Approval II-147
CDC Adds Merck’s GARDASIL® Under its VFC Category in the US II-147
Medlmmune Submits sBLA to the FDA Refrigerator-Stable
Influenza Vaccine II-147
Medlmmune Submits sBLA to the FDA for Expanded Label for CAIV-T II-148
Medlmmune Receives FDA Approval for the Use of Reverse
Genetics Technology II-148
Vivalis Starts a New Plant in France to Produce Viral Vaccines II-148
Fiocruz Provides Yellow-Fever Vaccine to Peruvian Government II-148
Merck Receives FDA Approval for Zostavax Vaccine II-148
The US Health and Human Services Department Awards Grant to
Pharma Companies II-148
GlaxoSmithKline Expands License and Supply Agreement with
Antigenics II-149
GlaxoSmithKline Applies for Approval for Cervical Cancer Vaccine II-149
Omnia Biologics Signs Deal with Aeras Global TB Vaccine
Foundation II-149
Aeras Alliances with Dutch Scientific Organizations to
Develop Latest TB Vaccines II-149
Embrex, Shenzhen, and P.R. China Team Up for Manufacturing
Influenza Vaccine II-150
Health Canada Grants Approval to Merck’s RotaTeq II-150
HepaLife Technologies Receives License for Technology from MSU II-150
Hindustan Latex Ties-up with Bharat Biotech for Marketing
Vaccines II-150
Emergent BioSolutions and Sanofi Pasteur Sign Agreement II-150
USV and BCIL Enter into Agreement II-151
GenVec Receives Fifth-Year Extension of Contract from NIAID II-151
Inovio Joins Hands with Tripep to Develop Hepatitis C Vaccine II-151
Novavax and Bharat Biotech Form Alliance to Develop Pandemic
Flu Vaccine II-151
Panacea Biotech Joins Hands with NVI to Create Polio Vaccine II-151
Immune Response Ties Up with Accelsiors for Trial of NeuroVax
Vaccine II-152
Nordic Vaccine Joins Forces with Ace BioSciences to Develop
Efficient Vaccines II-152
Eisai Partners with DNAVEC to Develop New Vaccine II-152
ViRexx Partners with DRDC to Develop Biodefence Vaccines II-152
Biovirx Teams Up with IDT to Reintroduce Vaccine for Infants II-153
LG Life Sciences Enters into Agreement with Sinovac II-153
MediGene Awards Licenses to Virionics for CVLP Vaccine Program II-153
FluLaval Influenza Vaccine Receives FDA Approval II-153
Merck Applies for Approval to Market Gardasil in China II-154
Bio-Bridge Establishes New Vaccine Facility in China II-154
SIIL Established the First-ever Biotech SEZ in India II-154
Aeras Foundation Establishes New Laboratory for TB Vaccine II-154
China Biopharma Distributes Flu Vaccine in China II-155
ViroPro Founds New Subsidiary for Developing Medicinal Vaccines II-155

12. FOCUS ON SELECT GLOBAL PLAYERS II-156
ALK - Abelló A/S (Denmark) II-156
Bavarian Nordic A/S (Denmark) II-156
Crucell N.V. (The Netherlands) II-157
CSL Ltd. (Australia) II-157
GlaxoSmithKline PLC (UK) II-158
GlaxoSmithKline Biologicals S.A (Belgium) II-160
Medimmune, Inc. (USA) II-160
Merck and Company, Inc. (USA) II-160
Novartis Vaccines and Diagnostics, Inc. (USA) II-161
Sanofi (Formerly Sanofi-Aventis SA) (France) II-162
Sanofi Pasteur, SA (France) II-164
Sanofi Pasteur Inc. (USA) II-166
Shantha Biotechnics Ltd. (India) II-166
Vaxin, Inc. (USA) II-167
Wyeth (USA) II-167

13. GLOBAL MARKET PERSPECTIVE II-168
Table 31: World Recent Past, Current and Future Analysis for
Human Vaccines (Prophylactic) 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 2009 through
2017 (includes corresponding Graph/Chart) II-168

Table 32: World Historic Review for Human Vaccines
(Prophylactic) 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 2003 through 2008 (includes
corresponding Graph/Chart) II-169

Table 33: World 15-Year Perspective for Human Vaccines
(Prophylactic) 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, 2011 and 2017 (includes corresponding Graph/Chart) II-170

Table 34: World Recent Past, Current and Future Analysis for
Human Vaccines (Prophylactic) by Product Segment - Pediatric
and Adult Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2009 through 2017 (includes
corresponding Graph/Chart) II-171

Table 35: World Historic Review for Human Vaccines
(Prophylactic) by Product Segment - Pediatric and Adult
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2003 through 2008 (includes
corresponding Graph/Chart) II-172

Table 36: World 15-Year Perspective for Human Vaccines
(Prophylactic) by Product Segment - Percentage Breakdown of
Dollar Sales for Pediatric and Adult Markets for Years 2003,
2011 and 2017 (includes corresponding Graph/Chart) II-173

Table 37: World Recent Past, Current and 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 2009 through
2017 (includes corresponding Graph/Chart) II-174

Table 38: World Historic Review 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 2003 through 2008 (includes
corresponding Graph/Chart) II-175

Table 39: World 15-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, 2011 and 2017 (includes corresponding Graph/Chart) II-176

Table 40: World Recent Past, Current and 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 2009 through 2017
(includes corresponding Graph/Chart) II-177

Table 41: World Historic Review 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 2003 through 2008 (includes
corresponding Graph/Chart) II-178

Table 42: World 15-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, 2011 and 2017 (includes corresponding Graph/Chart) II-179

Table 43: World Recent Past, Current and Future Analysis for
Human Vaccines (Therapeutic) - Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2009 through
2017 (includes corresponding Graph/Chart) II-180


III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Outlook III-1
Growth Drivers III-1
Market Constraints III-1
Supply Shortages Mar Vaccines Market in Early Part of the
Decade III-2
Pediatric Vaccines Market III-2
Market Focus Shifting From Pediatric Vaccines III-2
Growth Drivers for US Pediatric Vaccines Market III-2
Demand Restraining factors for US Pediatric Vaccines Market III-3
Table 44: US Historic Review for Pediatric Vaccines:
Annual Sales (In Millions of Doses) for Years 2000
through 2005 (includes corresponding Graph/Chart) III-3

Table 45: US Pediatric Vaccines by Type in terms of
Percent of Doses: 2000-2005 (includes corresponding
Graph/Chart) III-4
‘Bright’ Outlook for Therapeutic Vaccines III-4
Select Cancer Vaccines in Pipeline in the US: As of 2010 III-5
Market Share of Key Players in North America III-5
Table 46: Leading Players in the North American Human
Vaccines Market (2005 - A Recent Past Review): Market
Share Breakdown of Value Sales for Merck, Sanofi-Aventis,
Wyeth, Glaxo SmithKline and Others (includes
corresponding Graph/Chart) III-5
The US Influenza Vaccine Market III-5
Table 47: The US Influenza Vaccine Market: Production and
Distribution of Influenza Vaccine (In Millions) for the
Period 2000-2001 to 2007- 2008 (includes corresponding
Graph/Chart) III-6
US DHHS Allocates US$1 Billion for Developing H1N1 Vaccine
in 2009 III-7
2007-2008 Influenza Vaccine Season III-7
Table 48: Influenza Vaccine Producers for the Influenza
Season (2007-2008): Market Share Breakdown in Production
Terms for Sanofi Pasteur, Novartis, GlaxoSmithKline,
MedImmune, and CSL (includes corresponding Graph/Chart) III-7
2005-2006 Influenza Vaccine Season III-7
Table 49: Funds Forwarded by HHS for Influenza Vaccine
Production (2005-2006) to Key Vaccine Manufacturers (In US
Dollars) (includes corresponding Graph/Chart III-8
Influenza Vaccine Producers for the 2006-2007 Influenza
Season III-8
Problems Effecting Timely Supply of Influenza Vaccine III-8
Table 50: Influenza Vaccines Market in the US (2005 - A
Historic Review): Percentage Breakdown of Value Sales for
Sanofi Aventis, Chiron , GSK, and Medimmune (includes
corresponding Graph/Chart) III-9
Key Statistics III-9
Table 51: Number of Children (In Millions) Under 5 Years
of Age in the US: 2000-2005 (includes corresponding
Graph/Chart) III-9
Vaccines and Intended User Group III-10
Need for Immunization Schedule for Adults III-10
Adult Population: To Drive Future Growth of Pertussis
Vaccines Market III-11
Table 52: Pertussis Cases (In Millions) for Years 2000
through 2008 (includes corresponding Graph/Chart) III-11
Federal Research and Grants III-11
National Cancer Institute III-11
National Institutes of Health (NIH) III-11
NIH Scientists Showcase Potential West Nile Virus Vaccine III-12
NIH Doles Out Grants to Biotech Companies III-12
Development Funds for HIV Vaccines- Recent Past Data III-12
Development Funds for Biodefense-Related Vaccines-Recent
Past Data III-12
The National Institute of Allergy and Infectious Diseases
(NIAID) III-13
Intramural Research III-13
Extramural Divisions III-13
Vaccine Pricing in the US III-13
Table 53: Vaccine Prices (In US$ per Dose) in the US:
2002-2005 (includes corresponding Graph/Chart) III-14
Regulatory Environment III-14
Review Process Make Vaccines Safer III-14
Imports-Exports Scenario: A Historic Perspective III-14
Exports of Human Vaccines for 2004 III-14
Table 54: US Domestic Exports of Vaccines for Human
Medicine for the Year 2004 (Value in ‘000 US Dollars)
(includes corresponding Graph/Chart) III-15
Imports of Human Vaccines for 2004 III-15
Table 55: US Imports of Vaccines for Human Medicine for
the Year 2004 (Value in ‘000 US Dollars) (includes
corresponding Graph/Chart) III-15
Select Players III-16
Alphavax, Inc. III-16
Agenus Inc. (Formerly Antigenics, Inc.) (USA) III-16
Antigenics, Inc. III-16
Avax Technologies, Inc. III-16
Baxter International, Inc. III-17
Celldex Therapeutics, Inc. III-17
Dendreon Corporation III-18
Dynavax Technologies Corp. III-18
Emergent BioSolutions Inc. III-19
GenPhar, Inc. III-19
Ligocyte Pharmaceuticals, Inc III-20
Maxygen, Inc. III-20
Micromet, Inc. III-21
Novavax, Inc. III-21
Progenics Pharmaceuticals, Inc. III-21
Soligenix, Inc. III-22
B.Market Analytics III-23
Table 56: US Recent Past, Current and Future Analysis for
Human Vaccines (Prophylactic) by Product Group/ Segment -
Pediatric Prophylactic Vaccines and Adult Prophylactic
Vaccines Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2009 through 2017 (includes
corresponding Graph/Chart) III-23

Table 57: US Historic Re

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