Vaccine Technologies and Global Markets

Vaccine Technologies and Global Markets

Through the late 1980s, the vaccine market was beset by limited portfolios and profitability. Recent technological breakthroughs in understanding disease mechanisms, probably necessitated by pandemics and vaccine shortages, have provided momentum for research in the past decade or so. This is apparent from the increased research, patent, and regulatory activity in this area. Breakthroughs in molecular biology, immunology, and computing promise a bright future for the treatment of not only infectious diseases but also for treatment of conditions such as chronic infections, cancer, autoimmune diseases, allergies, and even nicotine addiction and high blood pressure using vaccine technologies. Advances are also being made in almost all adjunct areas of vaccine research, such as the mode of delivery, use of combination vaccines, vaccine adjuvants, and vaccine manufacturing.

The market has also witnessed significant strategic alliance activity, changes in centers of manufacture, and an increase in the importance of hitherto small (such as adult vaccines) or nonexistent (therapeutic) segments.

Most of all, international health agencies have recognized the importance of disease prevention and stupendous funding is being channelized into research, purchase, and administration of vaccines.  
 

INTRODUCTION

STUDY GOALS AND OBJECTIVES

REASONS FOR DOING THIS STUDY

SCOPE OF REPORT

INTENDED AUDIENCE

METHODOLOGY

INFORMATION SOURCES

ABOUT THE AUTHOR

RELATED BCC RESEARCH REPORTS

BCC ONLINE SERVICES

DISCLAIMER

SUMMARY

SUMMARY TABLE GLOBAL VACCINE MARKET: REVENUE FORECAST BY TECHNOLOGY SEGMENTS THROUGH 2013 ($ MILLIONS)

SUMMARY FIGURE GLOBAL VACCINE MARKET: REVENUE FORECAST BY TECHNOLOGY SEGMENTS 2003-2013

($ MILLIONS)

OVERVIEW

VACCINE DEFINITION

TABLE 1 EXISTING HUMAN VACCINES IN THE GLOBAL MARKET HISTORY

TABLE 2 HUMAN VACCINES: MORBIDITY AND DEVELOPMENT

TABLE 2 (CONTINUED)

TABLE 2 (CONTINUED)

TABLE 2 (CONTINUED)

CLASSIFICATION OF VACCINES BY IMMUNOGEN

INACTIVATED OR ATTENUATED

TOXOID

LIVE AVIRULENT BACTERIN

SUBUNIT VACCINES

CONJUGATE VACCINES

DNA VACCINES

RECOMBINANT VECTOR VACCINES

CLASSIFICATION OF VACCINES BY APPLICATION

PROPHYLACTIC VACCINES

Polio Vaccines

Funding Scenario

TABLE 3 FUNDING SCENARIO FOR ERADICATING POLIO ($ MILLIONS)

TABLE 4 TYPES OF POLIO VACCINES

Rotavirus Vaccines

Typhoid Vaccine

Oral Typhoid Vaccine (Ty21a)

Varicella Vaccines

Hepatitis B Vaccine

Hib Vaccine

TABLE 5 VARIOUS FORMULATIONS OF HIB VACCINE

TABLE 6 COMBINATIONS OF HEP B AND HIB

Influenza

Cost-Effectiveness of Influenza Vaccination

TABLE 7 LOSS DUE TO HUMAN INFLUENZA MORBIDITY

Influenza Recommendation for China

TABLE 8 CHINESE GOVERNMENT RECOMMENDATION FOR FLU VACCINATION

TABLE 9 DOSE REQUIREMENT IN CHINA—FLU VACCINES, 2002-2006 (MILLION DOSES)

TABLE 10 SEASONAL INFLUENZA VACCINE PRODUCTION ESTIMATES

THERAPEUTIC VACCINES

Cancer Vaccines

Antigen/Adjuvant Vaccines

Whole Cell Tumor Vaccines

Dendritic Cell (DC) Vaccines

Viral Vectors and DNA Vaccines

Idiotype Vaccines

Idiotype Vaccines (Continued)

Quality Control and Release Testing

Sterility Testing

TABLE 11 CANCER VACCINES IN DEVELOPMENT

TABLE 11 (CONTINUED)

TABLE 12 PROTEIN- OR PEPTIDE-BASED CANCER VACCINES IN CLINICAL DEVELOPMENT

TABLE 13 CELL-BASED VACCINES IN DEVELOPMENT

Human Immunodeficiency Virus (HIV)

Human … (Continued)

TABLE 14 VACCINES IN DEVELOPMENT FOR HIV

Malaria Vaccines

Challenges in Developing a Malaria Vaccine

TABLE 15 VACCINES IN DEVELOPMENT FOR MALARIA

TABLE 15 (CONTINUED)

COMBINATION VACCINES

CONCERNS WITH COMBINATION VACCINES

TABLE 16 ADVANTAGES OF COMBINATION VACCINES

ANIMAL VACCINES

ANIMAL VACCINES (CONTINUED)

CLASSIFICATION OF VETERINARY VACCINES

FIGURE 1 TYPES OF ANIMAL VACCINES

Feline Vaccines

TABLE 17 FACTORS DETERMINING CHOICE OF FELINE VACCINE

Routine Feline Vaccines

Canine Core Vaccines

Canine Noncore Vaccines10

POULTRY VACCINES

Live, Attenuated Vaccines

Inactivated Vaccines

TABLE 18 VACCINE ADMINISTRATION METHODS FOR POULTRY

TABLE 19 CLASSIFICATION BASED ON THE ROUTE OF ADMINISTRATION

TABLE 20 COMMERCIAL POULTRY VACCINES

TABLE 20 (CONTINUED)

TABLE 20 (CONTINUED)

TABLE 20 (CONTINUED)

TABLE 20 (CONTINUED)

TABLE 20 (CONTINUED)

TABLE 20 (CONTINUED)

TABLE 20 (CONTINUED)

TABLE 20 (CONTINUED)

AQUACULTURE VACCINES

TABLE 21 VACCINES LICENSED FOR AQUACULTURE WORLDWIDE

TABLE 21 (CONTINUED)

TABLE 22 AQUACULTURE NEEDS — REGION BASED

TABLE 22 (CONTINUED)

VACCINATION SCHEDULE

TABLE 23 EFFECT OF MODIFICATION OF VACINATION SCHEDULES

RISKS OF CHANGES TO SCHEDULES

DESIGNING AN IMMUNIZATION SCHEDULE

ISSUES TO BE CONSIDERED WHILE PLANNING TO INTRODUCE A NEW VACCINE

Disease Burden and Cost

Epidemiology of the Disease and Morbidity and Mortality

TABLE 24 VACCINE DELIVERY: TECHNOLOGY IMPACT THROUGH MODIFICATION OF IMMUNIZATION SERVICES

VACCINE ADVERSE REACTIONS

TABLE 25 COMMON ADVERSE REACTIONS

VACCINE SAFETY DATALINK (VSD) PROJECT

TABLE 26 MANAGED CARE ORGANIZATION (MCO) SITES

TABLE 27 SIGNIFICANT CORRELATIONS BETWEEN VACCINES AND ADVERSE REACTIONS

TABLE 28 CURRENT PRIORITY STUDIES

RAPID CYCLE ANALYSIS (RCA) PROJECT

VACCINE SAFETY RESEARCH

TABLE 29 RESEARCH ACTIVITIES OF THE CDC OFFICE OF SCIENCE COORDINATION AND INNOVATION

REPORTING SIDE EFFECTS

THE VACCINE ADVERSE EVENT REPORTING SYSTEM (VAERS)

TABLE 30 ADVERSE EVENT INFORMATION FROM VAERS

TABLE 30 (CONTINUED)

TABLE 31 ADVERSE EVENTS WITH VACCINES

TABLE 32 COMMON SIDE EFFECTS OF VACCINES

TABLE 33 COMPONENTS AND VACCINES THAT INCREASE IGE LEVELS

TABLE 34 SIDE EFFECTS OF SOME COMPONENTS OF VACCINES

TABLE 34 (CONTINUED)

Aluminum

TABLE 35 SIDE EFFECTS OF ALUMINUM IN VACCINES

VACCINE CONCERNS

Thimerosal (Ethylmercury) as an Additive in Vaccines

Unsubstantiated Link between MMR Vaccine and Autism

VACCINE TECHNOLOGY REVIEW

VACCINE MANUFACTURE — AN OVERVIEW

ESSENTIAL COMPONENTS FOR SUCCESSFUL

DEVELOPMENT OF A LARGE-SCALE

MANUFACTURING PROCESS

CELL CULTURE-BASED VACCINE PRODUCTION

Advantages of Cell Culture Technologies over Egg-based

Manufacturing Methods

REVERSE GENETICS MANUFACTURING

GENETIC REASSORTMENT

PLANT-BASED VACCINE MANUFACTURING

OVERVIEW OF CURRENT GOOD MANUFACTURING

PRACTICES (CGMPS)

TABLE 36 VACCINE MANUFACTURING PROCESSES AND THEIR IMPERATIVES

TABLE 37 TENTATIVE TIMEFRAME OF VACCINE PRODUCTION PROCESS

VACCINE MEDIA

TABLE 38 VACCINE PRODUCTION — CELL CULTURE

Madin-Darby Bovine Kidney (MDBK) Media

M 3553 — Madin-Darby Bovine Kidney Growth Medium

Serum-Free (MDBK-GM-SF)

M 0682 Madin-Darby Bovine Kidney Maintenance

Medium (MDBK-MM-PF)

Madin-Darby Canine Kidney (MDCK) Media

TABLE 39 ADVANTAGES OVER TRADITIONAL SERUM SUPPLEMENTED MEDIA

M 3803 — Madin-Darby Canine Kidney Medium

M 3678 Madin-Darby Canine Kidney Medium

Titerhigh Chick Embryo Fibroblast (CEF) Medium

Titerhigh Chick Embryo Fibroblast (CEF) Medium

VACCINE COMPANION PRODUCTS AND MEDIUM

SUPPLEMENTS

Antioxidant Supplement (1000x)

Cell Freezing Medium—DMSO

Dulbecco’s Phosphate Buffered Saline Modified

Dulbecco’s Phosphate Buffered Saline (D-PBS)

L-Glutamine Solution, 200 Mm

Hank’s Balanced Salt Solution Modified

Polyamine Supplement (1,000x)

Trypsin-EDTA Solution (1x)

Trypsin Inhibitor Solution (1x)

VACCINE PURIFICATION

CHROMATOGRAPHY — VACCINE PURIFICATION

PLASMID PURIFICATION

Disposable Technologies Enhance Plasmid Purification

STEPS FOR CLINICAL STUDIES

PRECLINICAL SAFETY TESTING

Candidate Vaccines: Preclinical Safety Testing

Qualification of Testing Facility: Good Laboratory

Practices (GLP)-Capable Facility

Protocol Design

Protocol … (Continued)

Protocol … (Continued)

Protocol … (Continued)

VACCINE ADJUVANTS

TABLE 40 ADVANTAGES OF ADJUVANTS

TABLE 41 DEFINITIVE IMPACT OF ADJUVANTS

ALUMINIUM ADJUVANTS

TABLE 42 VACCINES WITH ALUMINUM ADJUVANTS

TABLE 43 ADJUVANT TYPES

COLD CHAIN SYSTEMS

TEMPERATURE MONITORING

FIGURE 2 A TYPICAL COLD CHAIN

TABLE 44 EFFECT OF TEMPERATURE ON VACCINES

TABLE 45 VACCINE STORAGE GUIDELINES

TABLE 46 PREVENTIVE MEASURES TO PREVENT MISHAP

TABLE 47 VACCINE INVENTORY CONTROL

VACCINE VIAL MONITORS

ACTIVE AND PASSIVE COLD CHAIN SYSTEMS

Active and Passive Cold … (Continued)

PATENT ANALYSIS

TABLE 48 MAJOR U.S. PATENTS ISSUED FOR VACCINES

TABLE 48 (CONTINUED)

TABLE 48 (CONTINUED)

TABLE 48 (CONTINUED)

TABLE 48 (CONTINUED)

TABLE 48 (CONTINUED)

TABLE 48 (CONTINUED)

TABLE 48 (CONTINUED)

TABLE 48 (CONTINUED)

TABLE 48 (CONTINUED)

TABLE 48 (CONTINUED)

TABLE 48 (CONTINUED)

TABLE 48 (CONTINUED)

FIGURE 3 U.S. PATENT TREND ANALYSIS: HUMAN AND ANIMAL VACCINE PATENTS, 2003-2007

FIGURE 4 EUROPEAN PATENT TREND ANALYSIS: HUMAN AND ANIMAL VACCINE PATENTS, 2003-2007

TABLE 49 USPTO — ANIMAL VACCINES, 2007

TABLE 49 (CONTINUED)

TABLE 50 EUROPEAN PATENTS, 2005-2007

TABLE 50 (CONTINUED)

TABLE 50 (CONTINUED)

TABLE 50 (CONTINUED)

TABLE 50 (CONTINUED)

CLINICAL TRIALS

TABLE 51 COUNTRY ATTRACTIVENESS INDEX FOR CLINCIAL TRIALS, 2007

TABLE 52 PIPELINE CANDIDATES — VACCINES

TUBERCULOSIS

1. Study: T Cell Turnover Following Vaccination with MVA85A

2. Study: Phase I Trial of an Ltk63 Adjuvated Tuberculosis Nasal Subunit Vaccine (Ag85b-Esat6) (Tmuva-01)

3. Study: The Effect of Bacille Calmette Guerin (BCG) Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants.

3. Study: The Effect of … (Continued)

4. Study: The Safety and Immunogenicity of a TB Vaccine; MVA85A in Healthy Volunteers Who Are Infected with HIV

5. Study: Screening of Healthy Volunteers for Clinical Trials of Vaccines to Prevent Infectious Diseases.

HIV

1. Study: Screening HIV-Infected Patients for Vaccine Studies

2. Study: A Study of MVA85A in Asymptomatic Volunteers Infected with TB, HIV, or Both

3. Study: Should Low Birth Weight Infants Be Vaccinated with BCG Vaccine at Birth in Developing Countries?

CANCER

1. Study: Vaccine Maintenance Treatment for Nonsmall Cell Lung Cancer

2. Study: Cancer Vaccine Study for Unresectable Stage III Nonsmall Cell Lung Cancer

3. Study: Safety, Immunogenicity and Preliminary Efficacy Study of Recombinant Human EGFRp64k/Montanide ISA 51 Vaccine for Patients with Nonsmall Cell Lung Cancer (NSCLC) After Receiving Conventional First Line Chemotherapy

4. Study: Vaccine Therapy in Treating Patients with Stage III, Stage IV, or Relapsed Nonsmall Cell Lung Cancer Treated with First Line Chemotherapy

5. Study: DNP-Modified Autologous Tumor Cell Vaccine for Resectable Nonsmall Cell Lung Cancer

6. Study: Vaccine Therapy in Treating Patients with Stage IIIB or Stage IV Nonsmall Cell Lung Cancer Who Have Finished First Line Chemotherapy

7. Study: Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Stage IB, Stage II, or Stage IIIA Nonsmall Cell Lung Cancer

8. Study: Vaccine Therapy in Treating Patients with Advanced Refractory or Recurrent Nonsmall Cell Lung Cancer

9. Study: Vaccine Therapy and GM-CSF in Treating Patients with Acute Myeloid Leukemia, Myelodysplastic Syndromes, Nonsmall Cell Lung Cancer, or Mesothelioma

RECENT TECHNOLOGICAL BREAKTHROUGHS

DNA VACCINES

DNA Vaccines (Continued)

DNA Vaccines (Continued)

Challenge Studies in Primates

TABLE 53 NEW AGE VACCINES FOR SPECIFIC DISEASES

MARKER VACCINES

Minimum Demands to Vaccination

Demands on the Companion Discriminatory Test

Marker Vaccines in Disease Control

Criterion for Use of Marker Vaccines

TABLE 54 ADVANTAGES OF THE USE OF MARKER VACCINES

TABLE 55 DISADVANTAGES OF THE USE OF MARKER VACCINES

Use of Marker Vaccines — Economical Considerations

TABLE 56 SIGNIFICANT RESEARCH WORK ON MARKER VACCINES

PROTEINS AS VACCINES IN THE FUTURE

REGULATORY OVERVIEW

TABLE 57 NATIONAL REGULATORY AUTHORITIES (NRAS) AND NATIONAL CONTROL LABORATORIES (NCLS) IN COUNTRIES PRODUCING VACCINES PREQUALIFIED FOR PURCHASE BY UNITED NATIONS AGENCIES

TABLE 57 (CONTINUED)

TABLE 57 (CONTINUED)

TABLE 58 SOME GUIDELINES AND REQUIREMENTS RELEVANT TO EVALUATION OF VACCINES AND THEIR PUBLISHING AUTHORITIES

TABLE 58 (CONTINUED)

TABLE 58 (CONTINUED)

TABLE 58 (CONTINUED)

REGULATIONS GOVERNING HUMAN VACCINES IN THE UNITED STATES

FIGURE 5 OVRR — ORGANIZATION CHART

FIGURE 6 REGULATORY ISSUES UNDER OVRR’S AMBIT

FIGURE 7 STAGES OF REVIEW AND REGULATION

CMC DEVELOPMENT

CMC Development (Continued)

FIGURE 8 CMC DEVELOPMENT PROCESS

CURRENT GOOD MANUFACTURING PRACTICES (CGMPS)

REGULATION FOR PANDEMIC VACCINES

FIGURE 9 FDA ROLE THROUGHOUT PANDEMIC VACCINE DEVELOPMENT, EVALUATION, AND AVAILABILITY

TABLE 59 REGULATORY ISSUES IN VACCINE DEVELOPMENT IN THE U.S.

REGULATIONS GOVERNING VETERINARY VACCINES IN THE UNITED STATES

REGULATIONS GOVERNING VACCINES IN THE EUROPEAN

UNION

PREPAREDNESS FOR PANDEMICS AND SPEEDING UP

REGULATIONS

Highlights of European Preparedness for Pandemics or

Other Emergencies

Highlights of U.S. Preparedness for Pandemics or Other

Emergencies

OPPORTUNITIES TO OPTIMIZE THE REGULATORY PROCESS

FOR VACCINES

OPPORTUNITIES TO OPTIMIZE…(CONTINUED)

KEY TRENDS — GROWTH DRIVERS AND INHIBITORS

GROWTH DRIVERS

“OMICS” TECHNOLOGIES DRIVE THE VACCINE

INDUSTRY

DEVELOPMENT OF TECHNOLOGIES THROUGHOUT

VACCINE VALUE CHAIN

GREATER NUMBER OF VACCINES IN THE NEAR FUTURE

OFFSHORING AND LICENSING OPPORTUNITIES

STRATEGIC ENTRY AND CONTRIBUTION OF LOCAL, REGIONAL PLAYERS

RECOGNITION OF DISEASE PREVENTION BY KEY

INTERNATIONAL STAKEHOLDERS

ERADICATION, ELIMINATION, AND RESURGENCE OF DISEASE RELATED TO VACCINATION

INCREASE IN PUBLIC-PRIVATE PARTNERSHIPS

FUELLING GROWTH OF THE INDUSTRY

RECOGNITION OF VACCINE INITIATIVES IN AUXILLIARY

SYSTEMS

ANIMAL VACCINES STUDIES AID HUMAN VACCINE

DEVELOPMENT

VACCINATION AS A BETTER ALTERNATIVE TO LIVESTOCK SLAUGHTER

GROWTH INHIBITORS

TECHNICAL BARRIERS

REGULATORY BARRIERS

PATENT EXPIRY ISSUES

COMPLEXITY OF VACCINE DISTRIBUTION

GEOGRAPHICAL DIFFERENCES

NEED FOR SKILLED PERSONNEL AND/OR TRAINING

LACK OF INVOLVEMENT FROM PUBLIC AND LOCAL

ADMINISTRATION

RELIGIOUS AND CULTURAL BARRIERS TO VACCINATION

ECONOMIC BARRIERS: AFFORDABILITY AND PERCEPTIONS OF COST

LACK OF AWARENESS AMONG POTENTIAL VACCINEES

Lack of Awareness…(Continued)

VACCINE MARKET

SUPPLY SIDE

SUPPLY SIDE (CONTINUED)

PUBLIC VACCINE SUPPLY

VACCINE SHORTAGES

TABLE 60 CAUSES OF VACCINE SHORTAGE

DEMAND SIDE

FIRST ADVANCE MARKET COMMITMENT (AMC) IN FEBRUARY 2007

TABLE 61 SAVINGS FROM DISEASE ERADICATION ($ BILLIONS)

PUBLIC FUNDING GAP

MARKET METRICS

TABLE 62 FORECAST FOR GLOBAL VACCINE REVENUE BY MAJOR

SEGMENTS THROUGH 2013 ($ MILLIONS)

FIGURE 10 ANNUAL SPENDING FOR IMMUNIZATION PROGRAMS IN 72 LOW-INCOME COUNTRIES, 2000-2013 ($ BILLIONS)

FIGURE 11 FORECAST FOR GLOBAL VACCINE REVENUES BY MAJOR SEGMENT, 2003-2013 ($ MILLIONS)

TABLE 63 FORECAST FOR GLOBAL HUMAN VACCINE REVENUE, THROUGH 2013 ($ MILLIONS)

FIGURE 12 HUMAN VACCINES: MARKET POTENTIAL UNTILL 2013

TABLE 64 GLOBAL PROJECTIONS FOR MINOR HUMAN VACCINE REVENUE THROUGH 2013 ($ MILLIONS)

TABLE 64 (CONTINUED)

TABLE 65 PROJECTIONS FOR GLOBAL CANCER VACCINES REVENUE, THROUGH 2013 ($ MILLIONS)

FIGURE 13 PROJECTIONS FOR GLOBAL CANCER VACCINES REVENUE, 2003-2013 ($ MILLIONS)

VETERINARY VACINES

FIGURE 14 VETERINARY VACCINES: REGIONAL REVENUE CONTRIBUTION (%)

TABLE 66 GLOBAL ANIMAL HEALTH REVENUES, 2006 ($ MILLIONS)

FIGURE 15 GLOBAL ANIMAL HEALTH MARKET SHARES, 2006 (%)

INDUSTRY PARTICIPANT PROFILES

MANUFACTURERS

ACAMBIS

BHARAT BIOTECH

TABLE 67 RESEARCH GRANTS FOR BHARAT BIOTECH

TABLE 68 PRODUCT PORTFOLIO — BHARAT BIOTECH

INTERNATIONAL

CHOONGANG VACCINE LABORATORY

CRUCELL

EUROCINE VACCINES AB

GLAXOSMITHKLINE

TABLE 69 PORTFOLIO OF VACCINES: GLAXOSMITHKLINE

GREEN CROSS

KOREA VACCINE CO, LTD.

TABLE 70 VACCINE PORTFOLIO OF KOREA VACCINE

MERCK & CO., INC

TABLE 71 MERCK — VACCINE PORTFOLIO

NOVARTIS AG

PANACEA BIOTEC, LTD

TABLE 72 PRODUCT PORTFOLIO — PANACEA BIOTEC

SANOFI PASTEUR

TABLE 73 VACCINE PORTFOLIO: SANOFI PASTEUR

SCHERING-PLOUGH CORPORATION

TABLE 74 SCHERING-PLOUGH — PORTFOLIO OF LIVESTOCK

VACCINES

TABLE 74 (CONTINUED)

TABLE 74 (CONTINUED)

TABLE 74 (CONTINUED)

TABLE 74 (CONTINUED)

TABLE 74 (CONTINUED)

SHANTHA BIOTECHNICS

WYETH

TABLE 75 PORTFOLIO OF VACCINES: WYETH PHARMACEUTICALS

ADDITIONAL MARKET PLAYERS

ADVAXIC, INC

AERAS GLOBAL TB VACCINE FOUNDATION, USA

AGRILABS, INC

ALPHARMA INC.

BAYER ANIMAL HEALTH

BENCHMARK BIOLABS, INC.

BIMEDA

BIOCOR ANIMAL HEALTH

BIONICHE ANIMAL HEALTH

BIOPURE

BORYUNG BIOPHARMA

CEVA SANTE ANIMALE

COBRA BIOMANUFACTURING, PLC

CYTO DYN, INC.

DAINIPPON PHARMACEUTICAL CO, LTD.

DMS LABS, INC

DURVET, INC. USA

ELANCO ANIMAL HEALTH

HARTZ

HESKA CORPORATION

ICHOR MEDICAL SYSTEMS, INC.

IDEXX LABORATORIES, INC.

IMMUCELL, INC

IVY ANIMAL HEALTH

LAH INTERNATIONAL (GERMAN)

MALAYSIAN VACCINES AND PHARMACEUTICALS

MONSANTO COMPANY

MWI VETERINARY SUPPLY CO.

NUTRAMAX LABORATORIES, INC.

OMAHA VACCINE

ROYER BIOMEDICAL, INC.

SK CHEMICAL

SOLVAY HEALTHCARE

SYNBIOTICS CORPORATION

VAXINE PTY, LTD.

VCA ANTECH

VEDCO, INC.

VIRBAC SA

XCELLEREX CORPORATE HEADQUARTERS

NONGOVERNMENT STAKEHOLDERS

DEPARTMENT OF IMMUNIZATION, VACCINES, AND BIOLOGICALS (IVB)

Initiative for Vaccine Research (IVR)

THE HIV VACCINE TRIALS NETWORK

TABLE 76 HVTN OPERATIONAL CENTERS

PROTECTING THE WORLD FROM EMERGING AND REEMERGING

DISEASES ASSOCIATED WITH

GLOBALIZATION

TABLE 77 MAJOR INFECTIOUS DISEASE CATEGORIES AND LEADING SPONSORS

GAVI

IAVI

THE WORLD ORGANIZATION FOR ANIMAL HEALTH (OIE)

REGULATORY ORGANIZATIONS CONCERNED WITH

VETERINARY VACCINES

CENTERS FOR EPIDEMIOLOGY AND ANIMAL HEALTH

CENTER FOR VETERINARY BIOLOGICS

IFAH-EUROPE

INSTITUTE FOR INTERNATIONAL COOPERATION IN ANIMAL BIOLOGICS

INTERNATIONAL STANDARDS TEAM

NATIONAL VETERINARY SERVICES LABORATORIES

NATIONAL VETERINARY SERVICES LABORATORIES

UNITED STATES ANIMAL HEALTH ASSOCIATION

USDA NATIONAL ANIMAL HEALTH

RECENT INTERNATIONAL MARKET DEVELOPMENTS

GSK SEEKS APPROVAL FOR NEW MENINGITIS VACCINE

VACCINE FOR KEEPING THE BLOOD PRESSURE UNDER

CHECK

VACCINE FOR NICOTINE ADDICTION

SCIENTISTS REPORT A NEW METHOD TO SPEED BIRD FLU

VACCINE PRODUCTION

BIODEGRADABLE MICROSPHERES DELIVER TIME RELEASE

VACCINES, STIMULATE DIFFERENT IMMUNE RESPONSE

NASAL SPRAY FLU VACCINE RECEIVES NOD FOR 2-YEAR-OLDS

IN UNITED STATES

ONCOPHAGE FAILS TRIALS

NEW PRODUCTION FACILITY OF NOVARTIS’ — CELL

CULTURED-BASED FACILITY FOR INFLUENZA VACCINE

PRODUCTION

XCELLEREX GETS TWO CONTRACTS TO DEVELOP

TECHNOLOGY TO ACCELERATE PROTEIN AND VACCINE

MANUFACTURING

DISPOSABLE TECHNOLOGIES — A BETTER PROSPECT

NEEDLE-FREE TECHNOLOGIES FOR VACCINE DELIVERY

FACTORY ZONE FOR ANIMAL VACCINE DEVELOPMENT AND PRODUCTION

CERUS CORPORATION AWARDED GRANTS FOR ITS LISTERIABASED

VACCINE PLATFORMS

VACCINE MANUFACTURERS GET FUNDING TO DEVELOP

CELL-BASED INFLUENZA VACCINES

CRUCELL GRANTED $5 MILLION TO FURTHER DEVELOP TB VACCINE

INTERNATIONAL ORGANIZATIONS COLLABORATE FOR A MENINGITIS VACCINE

THE ROLE OF THE U.S. FDA

FUTURE DIRECTIONS

EFFICIENT VACCINE MANUFACTURING: TREATMENT FOR MENINGOCOCCAL DISEASE IN AFRICA

PORTAL TO OFFER INFORMATION TO COMPILE INFORMATION

ON INFECTIOUS DISEASES RESEARCH

TABLE 78 STRATEGIC ALLIANCES IN THE VACCINE INDUSTRY

TABLE 78 (CONTINUED)

TABLE 78 (CONTINUED)

TABLE 78 (CONTINUED)

TABLE 78 (CONTINUED)

TAIWAN — ANIMAL VACCINES INDUSTRY

TABLE 79 R&D FOCUS

TAIWAN — INVESTING OPPORTUNITIES

Strength

Weakness

Opportunity

Threat

CHINA

BIOTECHNOLOGY AND ITS SISTER TECHNOLOGIES LIGHT UP THE VACCINE FUTURE

INDIA

EDIBLE VACCINES

LIST OF TABLES

SUMMARY TABLE GLOBAL VACCINE MARKET: REVENUE FORECAST BY TECHNOLOGY SEGMENTS THROUGH 2013 ($ MILLIONS)

TABLE 1 EXISTING HUMAN VACCINES IN THE GLOBAL MARKET

TABLE 2 HUMAN VACCINES: MORBIDITY AND DEVELOPMENT

TABLE 3 FUNDING SCENARIO FOR ERADICATING POLIO ($ MILLIONS)

TABLE 4 TYPES OF POLIO VACCINES

TABLE 5 VARIOUS FORMULATIONS OF HIB VACCINE

TABLE 6 COMBINATIONS OF HEP B AND HIB

TABLE 7 LOSS DUE TO HUMAN INFLUENZA MORBIDITY

TABLE 8 CHINESE GOVERNMENT RECOMMENDATION FOR FLU VACCINATION

TABLE 9 DOSE REQUIREMENT IN CHINA—FLU VACCINES, 2002-2006 (MILLION DOSES)

TABLE 10 SEASONAL INFLUENZA VACCINE PRODUCTION ESTIMATES

TABLE 11 CANCER VACCINES IN DEVELOPMENT

TABLE 12 PROTEIN- OR PEPTIDE-BASED CANCER VACCINES IN CLINICAL DEVELOPMENT

TABLE 13 CELL-BASED VACCINES IN DEVELOPMENT

TABLE 14 VACCINES IN DEVELOPMENT FOR HIV

TABLE 15 VACCINES IN DEVELOPMENT FOR MALARIA

TABLE 16 ADVANTAGES OF COMBINATION VACCINES

TABLE 17 FACTORS DETERMINING CHOICE OF FELINE VACCINE

TABLE 18 VACCINE ADMINISTRATION METHODS FOR POULTRY

TABLE 19 CLASSIFICATION BASED ON THE ROUTE OF ADMINISTRATION

TABLE 20 COMMERCIAL POULTRY VACCINES

TABLE 21 VACCINES LICENSED FOR AQUACULTURE WORLDWIDE

TABLE 22 AQUACULTURE NEEDS — REGION BASED

TABLE 23 EFFECT OF MODIFICATION OF VACINATION SCHEDULES

TABLE 24 VACCINE DELIVERY: TECHNOLOGY IMPACT THROUGH MODIFICATION OF IMMUNIZATION SERVICES

TABLE 25 COMMON ADVERSE REACTIONS

TABLE 26 MANAGED CARE ORGANIZATION (MCO) SITES

TABLE 27 SIGNIFICANT CORRELATIONS BETWEEN VACCINES AND ADVERSE REACTIONS

TABLE 28 CURRENT PRIORITY STUDIES

TABLE 29 RESEARCH ACTIVITIES OF THE CDC OFFICE OF SCIENCE COORDINATION AND INNOVATION

TABLE 30 ADVERSE EVENT INFORMATION FROM VAERS

TABLE 31 ADVERSE EVENTS WITH VACCINES

TABLE 32 COMMON SIDE EFFECTS OF VACCINES

TABLE 33 COMPONENTS AND VACCINES THAT INCREASE IGE LEVELS

TABLE 34 SIDE EFFECTS OF SOME COMPONENTS OF VACCINES

TABLE 35 SIDE EFFECTS OF ALUMINUM IN VACCINES

TABLE 36 VACCINE MANUFACTURING PROCESSES AND THEIR IMPERATIVES

TABLE 37 TENTATIVE TIMEFRAME OF VACCINE PRODUCTION PROCESS

TABLE 38 VACCINE PRODUCTION — CELL CULTURE

TABLE 39 ADVANTAGES OVER TRADITIONAL SERUM SUPPLEMENTED MEDIA

TABLE 40 ADVANTAGES OF ADJUVANTS

TABLE 41 DEFINITIVE IMPACT OF ADJUVANTS

TABLE 42 VACCINES WITH ALUMINUM ADJUVANTS

TABLE 43 ADJUVANT TYPES

TABLE 44 EFFECT OF TEMPERATURE ON VACCINES

TABLE 45 VACCINE STORAGE GUIDELINES

TABLE 46 PREVENTIVE MEASURES TO PREVENT MISHAP

TABLE 47 VACCINE INVENTORY CONTROL

TABLE 48 MAJOR U.S. PATENTS ISSUED FOR VACCINES

TABLE 49 USPTO — ANIMAL VACCINES, 2007

TABLE 50 EUROPEAN PATENTS, 2005-2007

TABLE 51 COUNTRY ATTRACTIVENESS INDEX FOR CLINCIAL TRIALS, 2007

TABLE 52 PIPELINE CANDIDATES — VACCINES

TABLE 53 NEW AGE VACCINES FOR SPECIFIC DISEASES

TABLE 54 ADVANTAGES OF THE USE OF MARKER VACCINES

TABLE 55 DISADVANTAGES OF THE USE OF MARKER VACCINES

TABLE 56 SIGNIFICANT RESEARCH WORK ON MARKER VACCINES

TABLE 57 NATIONAL REGULATORY AUTHORITIES (NRAS) AND NATIONAL CONTROL LABORATORIES (NCLS) IN COUNTRIES PRODUCING VACCINES PREQUALIFIED FOR PURCHASE BY UNITED NATIONS AGENCIES

TABLE 58 SOME GUIDELINES AND REQUIREMENTS RELEVANT TO EVALUATION OF VACCINES AND THEIR PUBLISHING AUTHORITIES

TABLE 59 REGULATORY ISSUES IN VACCINE DEVELOPMENT IN THE U.S

TABLE 60 CAUSES OF VACCINE SHORTAGE

TABLE 61 SAVINGS FROM DISEASE ERADICATION ($ BILLIONS)

TABLE 62 FORECAST FOR GLOBAL VACCINE REVENUE BY MAJOR SEGMENTS THROUGH 2013 ($ MILLIONS)

TABLE 63 FORECAST FOR GLOBAL HUMAN VACCINE REVENUE, THROUGH 2013 ($ MILLIONS)

TABLE 64 GLOBAL PROJECTIONS FOR MINOR HUMAN VACCINE REVENUE THROUGH 2013 ($ MILLIONS)

TABLE 65 PROJECTIONS FOR GLOBAL CANCER VACCINES REVENUE, THROUGH 2013 ($ MILLIONS)

TABLE 66 GLOBAL ANIMAL HEALTH REVENUES, 2006 ($ MILLIONS)

TABLE 67 RESEARCH GRANTS FOR BHARAT BIOTECH

TABLE 68 PRODUCT PORTFOLIO — BHARAT BIOTECH INTERNATIONAL

TABLE 69 PORTFOLIO OF VACCINES: GLAXOSMITHKLINE

TABLE 70 VACCINE PORTFOLIO OF KOREA VACCINE

TABLE 71 MERCK — VACCINE PORTFOLIO

TABLE 72 PRODUCT PORTFOLIO — PANACEA BIOTEC

TABLE 73 VACCINE PORTFOLIO: SANOFI PASTEUR

TABLE 74 SCHERING-PLOUGH — PORTFOLIO OF LIVESTOCK VACCINES

TABLE 75 PORTFOLIO OF VACCINES: WYETH PHARMACEUTICALS

TABLE 76 HVTN OPERATIONAL CENTERS

TABLE 77 MAJOR INFECTIOUS DISEASE CATEGORIES AND LEADING SPONSORS

TABLE 78 STRATEGIC ALLIANCES IN THE VACCINE INDUSTRY

TABLE 79 R&D FOCUS

LIST OF FIGURES

SUMMARY FIGURE GLOBAL VACCINE MARKET: REVENUE FORECAST BY TECHNOLOGY SEGMENTS 2003-2013 ($ MILLIONS)

FIGURE 1 TYPES OF ANIMAL VACCINES

FIGURE 2 A TYPICAL COLD CHAIN

FIGURE 3 U.S. PATENT TREND ANALYSIS: HUMAN AND ANIMAL VACCINE PATENTS, 2003-2007

FIGURE 4 EUROPEAN PATENT TREND ANALYSIS: HUMAN AND ANIMAL VACCINE PATENTS, 2003-2007

FIGURE 5 OVRR — ORGANIZATION CHART

FIGURE 6 REGULATORY ISSUES UNDER OVRR’S AMBIT

FIGURE 7 STAGES OF REVIEW AND REGULATION

FIGURE 8 CMC DEVELOPMENT PROCESS

FIGURE 9 FDA ROLE THROUGHOUT PANDEMIC VACCINE DEVELOPMENT, EVALUATION, AND AVAILABILITY

FIGURE 10 ANNUAL SPENDING FOR IMMUNIZATION PROGRAMS IN 72 LOW-INCOME COUNTRIES, 2000-2015 ($ BILLIONS)

FIGURE 11 FORECAST FOR GLOBAL VACCINE REVENUES BY MAJOR SEGMENT, 2003-2013 ($ MILLIONS)

FIGURE 12 HUMAN VACCINES: MARKET POTENTIAL TILL 2013

FIGURE 13 PROJECTIONS FOR GLOBAL CANCER VACCINES REVENUE, 2003-2013 ($ MILLIONS)

FIGURE 14 VETERINARY VACCINES: REGIONAL REVENUE CONTRIBUTION (%)

FIGURE 15 GLOBAL ANIMAL HEALTH MARKET SHARES, 2006 (%)