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Global Human Vaccines Industry

NEW YORK, May 16, 2012 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

Global Human Vaccines Industry

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 - Abello 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.

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


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


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 & 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 HaemophilisInfluenza B Vaccine Market in the US: Annual Sales for2000-2005 (In Million Doses) (includes correspondingGraph/Chart) II-21Diphtheria/Tetanus/Pertussis Vaccines II-22DTP, DTaP, and Combination Vaccines Offered by MajorProducers in US II-22Table 6: Leading Players in the US DTP and DTaP VaccinesMarket (2003-2005 - A Historic Review): Market ShareBreakdown of Value Sales for Sanofi Pasteur, Wyeth,GlaxoSmithkline, and others (includes correspondingGraph/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) (includescorresponding Graph/Chart) II-24Hepatitis A Vaccine II-24Hepatitis B Vaccine II-24Hepatitis B Epidemiology II-25Table 9: World Market for Hepatitis B Vaccines: AnnualSales 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 (InMillions of Doses) (includes corresponding Graph/Chart) II-27Rotavirus Vaccines II-28Polio Vaccines II-28Table 13: Historic Review for Polio Vaccines Market inEurope: 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 BothVaccine Types in the US: Annual Sales for 2000-2005 (InMillion 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 inthe US: Annual Sales for 2000-2005 (In Million Doses)(includes corresponding Graph/Chart) II-31Need for Combination Vaccines II-32Prophylactic Adult Vaccines II-32Favorable Market Growth II-32Hepatitis A Vaccine II-33Hepatitis B Vaccines II-34Key Issues Affecting the Adult Hepatitis Vaccines Market II-35Cholera Vaccine II-35Hepatitis A/Hepatitis B Vaccine II-35Japanese Encephalitis Vaccines II-35Influenza Vaccines II-36Table 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 TargetGroups (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 & AIDS Incidences (2007): ARegional Breakdown for Living and Newly Infected Cases(includes corresponding Graph/Chart) II-48

Table 26: Worldwide HIV & 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 & 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 & 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 (includescorresponding 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 & ISSUES II-60Newer Vaccines in Pipeline to Cheer Up Pharma Companies II-60Select Vaccines Currently in Phase III Clinical Trials II-60Threat of Pandemic Rejuvenates Vaccine Market II-60Influenza Vaccines On a Growing Spree II-61H1N1 Vaccines Hit the Market in August 2009 II-61H1N1 Influenza Vaccines and Manufacturers II-62Influenza Market Faces Several Challenges II-63Economic Factors Hamper Optimal Vaccine Development and Delivery II-63Increasing Need for Vaccine Promotion in the Developing Regions II-63Changing Vaccine Needs II-63DNA Vaccines: Engineering Growth II-64AIDS Vaccine: Long Road Ahead II-65HIV Vaccines Research Clipped by Lack of Funds II-66Funding Drops In HIV Vaccine Research Amid Recession II-66Noninjectable Vaccines: Gain Without Pain II-66Need for a Human Vaccine for Leishmaniasis II-66Conjugate Vaccines: A Technological Innovation II-67Need For a New TB Vaccine II-67Table 30: Worldwide Prevalence of TB Cases (in '000s) byRegion for the Year (2007) (includes correspondingGraph/Chart) II-67Companies Involved in TB Vaccine Research: As of 2010 II-68Religious Concerns Over Immunizing Young Girls Against HumanPapillomavirus II-68Changing Travel Patterns Increase Demand for Hepatitis B Vaccine II-68DTaP Vaccines Approved for Booster Vaccination II-69Advances in Biotechnology Spearheading Vaccines' Growth II-69BioWarfare: Threat Perception and Preparedness II-69Overview of Potential Bio-Terrorist Agents II-70Smallpox (Variola Major) II-70Anthrax (Bacillus Anthracis) II-70Plague (Yersinia Pestis) II-70Botulism (Clostridium Botulinum) II-71Tularemia (Francisella Tularensis) II-71Market Concerns II-71Safety Factor II-71Development Delays II-72Storage Problems II-72Perfluorocarbons as Alternative to Overcome Storage Problems II-72Costs II-72Standards for Vaccine Safety and Quality II-72


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


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-82Favrille Announces Phase III Registration Trial Results ofSpecifid in Patients with Follicular B-Cell Non-Hodgkin'sLymphoma II-82Novartis Announces Phase III Results of Menveo® Vaccine II-82Emergent Commences Phase II Clinical Study of Typhoid Vaccine II-82AVANT's Single-Dose Oral Ty800 Vaccine Meets Key Endpoints II-83Emergent BioSolutions' Typhoid Vaccine Completes Final PhaseII Clinical Trial II-83Antigenics Announces Positive Data on Phase-I Study of ACAM-FLU-ATM Vaccine II-83Bavarian Nordic's IMVAMUNE® Post-Exposure VaccinationDemonstrates Protection Against Fatal Poxvirus Infection II-84BSU Scientists to Commence Human West Nile VaccineDevelopment Project II-84Intercell Concludes First Phase Clinical Studies of IC31®Adjuvanted Influenza Vaccine II-84Protherics Commences Phase 2 Angiotensin Vaccine Study II-85Novartis Receives European Approval for Optaflu® Flu Vaccine II-85CSL Biotherapies Files BLA for Influenza Vaccine II-85Orchestra Therapeutics Abandons Development of HIV Vaccine II-86AlphaVax Concludes Phase I Clinical Trial of Flu Vaccine II-86AVANT Presents Preclinical Data on Enteric Vaccine II-87Baxter Declares Results of Seasonal Flu Vaccine Candidate Trial II-87IDM Pharma Announces Interim Data of Phase II Clinical Trialsof Lung Cancer Vaccine II-87Novavax Announces Developments in Discovery Program II-88Acambis Pioneers Testing of West Nile Virus Vaccine in Grown Ups II-88Acambis Initiates Test of single-dose JE vaccine in India II-89AVAX Technologies Initiates Phase 3 Clinical Trial For M-Vax II-89LigoCyte Pharmaceuticals Begins Clinical Testing of NorovirusVaccine II-89Alphavax Initiates Clinical Testing for Flu and CMV Vaccines II-89Sanofi Pasteur Begins Phase 2 Testing of New Influenza Vaccine II-90Antigenics Reveals the Preliminary Data of Clinical Trial ofOncophage® II-90Baxter Reveals Phase I/II Clinical Trial Results of H5N1Pandemic Vaccine II-91Crucell and AERAS Initiates Tuberculosis Vaccine Clinical Trial II-91DOR BioPharma Announces Phase I Results of RiVax™ II-91GlaxoSmithKline Starts Clinical Trials to Test H5N1 PandemicFlu Vaccines II-91MedImmune Initiates Phase I Clinical Trial of Avian H5N1 Vaccine II-91MedImmune Reveals Results of Phase 3 Study for CAIV-T II-92MedImmune Initiates Second Phase 1 Study with MEDI-534 II-92Sanofi Pasteur Initiates First Clinical Trial of Cell BasedH7N1 Vaccine II-92Therion Biologics Completes Enrollment for Phase III trialsof PANVAC-VF II-92ViRexx Finishes the Treatment in Phase I Study of Hepa Vaxx BVaccine II-93Antigenics Begins Phase I Clinical Trial of AG-707 II-93Positive Results in Novavax's Pandemic Influenza Vaccine Pre-clinical Trials II-93Trials Reveal H5N1 Pre-Pandemic Vaccine of Sanofi PasteurEffective II-93PowderMed Reveals Results for Phase 1 Trials for InfluenzaVaccine II-93Phase II clinical trials of China's hepatitis B vaccine II-93Findings Prove New Nose-Spray Vaccines Effective II-94Large Doses of H5N1 Influenza Vaccine Appears Effective II-94New Vaccine Technology to Prevent TB II-94HPV Vaccine to Help Prevent Cervical Cancer II-94Scientists Develop H7N1 Avian Influenza Vaccine II-94Human H5N1 Vaccine Developed by Central Hygiene andEpidemiology Institute II-95


Vivalis and SAFC Launch Ex-Cell EBx Media II-96

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


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


ALK - Abello 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 & Company, Inc. (USA) II-160

Novartis Vaccines & 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-168Table 31: World Recent Past, Current & Future Analysis forHuman Vaccines (Prophylactic) by Geographic Region - US,Canada, Japan, Europe, Asia-Pacific (excluding Japan), LatinAmerica and Rest of World Markets Independently Analyzed withAnnual Sales Figures in US$ Million for Years 2009 through2017 (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 ofDollar Sales for US, Canada, Japan, Europe, Asia-Pacific(excluding Japan), Latin America and Rest of World Markets forYears 2003, 2011 & 2017 (includes corresponding Graph/Chart) II-170

Table 34: World Recent Past, Current & 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 AdultMarkets Independently Analyzed with Annual Sales Figures inUS$ Million for Years 2003 through 2008 (includescorresponding 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 & 2017 (includes corresponding Graph/Chart) II-173

Table 37: World Recent Past, Current & Future Analysis forPediatric Prophylactic Vaccines by Geographic Region - US,Canada, Japan, Europe, Asia-Pacific (excluding Japan), LatinAmerica and Rest of World Markets Independently Analyzed withAnnual Sales Figures in US$ Million for Years 2009 through2017 (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 ProphylacticVaccines by Geographic Region - Percentage Breakdown of DollarSales for US, Canada, Japan, Europe, Asia-Pacific (excludingJapan), Latin America and Rest of World Markets for Years2003, 2011 & 2017 (includes corresponding Graph/Chart) II-176

Table 40: 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 2009 through 2017

(includes corresponding Graph/Chart) II-177

Table 41: World Historic Review for Adult ProphylacticVaccines by Geographic Region - US, Canada, Japan, Europe,Asia-Pacific (excluding Japan), Latin America and Rest ofWorld Markets Independently Analyzed with Annual SalesFigures in US$ Million for Years 2003 through 2008 (includescorresponding 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 & 2017 (includes corresponding Graph/Chart) II-179

Table 43: World Recent Past, Current & Future Analysis forHuman Vaccines (Therapeutic) - Independently Analyzed withAnnual Sales Figures in US$ Million for Years 2009 through2017 (includes corresponding Graph/Chart) II-180III. MARKET


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 ofPercent of Doses: 2000-2005 (includes correspondingGraph/Chart) III-4'Bright' Outlook for Therapeutic Vaccines III-4Select Cancer Vaccines in Pipeline in the US: As of 2010 III-5Market Share of Key Players in North America III-5Table 46: Leading Players in the North American HumanVaccines Market (2005 - A Recent Past Review): MarketShare Breakdown of Value Sales for Merck, Sanofi-Aventis,Wyeth, Glaxo SmithKline and Others (includescorresponding Graph/Chart) III-5The US Influenza Vaccine Market III-5Table 47: The US Influenza Vaccine Market: Production andDistribution of Influenza Vaccine (In Millions) for thePeriod 2000-2001 to 2007- 2008 (includes correspondingGraph/Chart) III-6US DHHS Allocates US$1 Billion for Developing H1N1 Vaccinein 2009 III-72007-2008 Influenza Vaccine Season III-7Table 48: Influenza Vaccine Producers for the InfluenzaSeason (2007-2008): Market Share Breakdown in ProductionTerms for Sanofi Pasteur, Novartis, GlaxoSmithKline,MedImmune, and CSL (includes corresponding Graph/Chart) III-72005-2006 Influenza Vaccine Season III-7Table 49: Funds Forwarded by HHS for Influenza VaccineProduction (2005-2006) to Key Vaccine Manufacturers (In USDollars) (includes corresponding Graph/Chart III-8Influenza Vaccine Producers for the 2006-2007 InfluenzaSeason III-8Problems Effecting Timely Supply of Influenza Vaccine III-8Table 50: Influenza Vaccines Market in the US (2005 - AHistoric Review): Percentage Breakdown of Value Sales forSanofi Aventis, Chiron , GSK, and Medimmune (includescorresponding Graph/Chart) III-9Key Statistics III-9Table 51: Number of Children (In Millions) Under 5 Yearsof Age in the US: 2000-2005 (includes correspondingGraph/Chart) III-9Vaccines and Intended User Group III-10Need for Immunization Schedule for Adults III-10Adult Population: To Drive Future Growth of PertussisVaccines Market III-11Table 52: Pertussis Cases (In Millions) for Years 2000through 2008 (includes corresponding Graph/Chart) III-11Federal Research & Grants III-11National Cancer Institute III-11National Institutes of Health (NIH) III-11NIH Scientists Showcase Potential West Nile Virus Vaccine III-12NIH Doles Out Grants to Biotech Companies III-12Development Funds for HIV Vaccines- Recent Past Data III-12Development Funds for Biodefense-Related Vaccines-RecentPast Data III-12The National Institute of Allergy and Infectious Diseases(NIAID) III-13Intramural Research III-13Extramural Divisions III-13Vaccine Pricing in the US III-13Table 53: Vaccine Prices (In US$ per Dose) in the US:2002-2005 (includes corresponding Graph/Chart) III-14Regulatory Environment III-14Review Process Make Vaccines Safer III-14Imports-Exports Scenario: A Historic Perspective III-14Exports of Human Vaccines for 2004 III-14Table 54: US Domestic Exports of Vaccines for HumanMedicine for the Year 2004 (Value in '000 US Dollars)(includes corresponding Graph/Chart) III-15Imports of Human Vaccines for 2004 III-15Table 55: US Imports of Vaccines for Human Medicine forthe Year 2004 (Value in '000 US Dollars) (includescorresponding Graph/Chart) III-15Select Players III-16Alphavax, Inc. III-16Agenus Inc. (Formerly Antigenics, Inc.) (USA) III-16Antigenics, Inc. III-16Avax Technologies, Inc. III-16Baxter International, Inc. III-17Celldex Therapeutics, Inc. III-17Dendreon Corporation III-18Dynavax Technologies Corp. III-18Emergent BioSolutions Inc. III-19GenPhar, Inc. III-19Ligocyte Pharmaceuticals, Inc III-20Maxygen, Inc. III-20Micromet, Inc. III-21Novavax, Inc. III-21Progenics Pharmaceuticals, Inc. III-21Soligenix, Inc. III-22B.Market Analytics III-23Table 56: US Recent Past, Current & Future Analysis forHuman Vaccines (Prophylactic) by Product Group/ Segment -Pediatric Prophylactic Vaccines and Adult ProphylacticVaccines Independently Analyzed with Annual Sales Figures inUS$ Million for Years 2009 through 2017 (includescorresponding Graph/Chart) III-23

Table 57: US Historic Re

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