For more information on this report please contact ediz.ibrahim@visiongain.com (+44 (0) 2075499976) or refer to our website: http://www.visiongain.com/Report/1126/World-Vaccines-Market-2013-2023
2. Contents
1. Executive Summary
1.1 Overview of Findings
1.2 Chapters in the Report
1.3 Research and Analysis Methods
1.4 What Are Vaccines?
2. Overview of Vaccines Market, 2013-2023
2.1 Vaccines Market to Continue to Perform Strongly to 2023
2.2 Paediatric Vaccines Remain Central to Market
2.2.1 Adult Vaccination and Therapeutic Vaccines the Major Drivers to 2023
2.3 What Diseases and Technologies Drive the Market in 2013?
2.3.1 Ancillary Technologies
2.4 Pfizer’s Prevnar Leads the Market in 2013
2.5 Top Three Companies Held 52% of Market in 2012
2.5.1 Sanofi Pasteur: Leading Paediatric Portfolio
2.5.2 GlaxoSmithKline: a Strong Presence in Every Segment
2.5.3 Merck: Zostavax Revival Boosts 2012 Performance
2.5.4 Pfizer: A Major Player on the Strength of Prevnar
2.5.5 Novartis: Vaccines Business to be Divested?
2.5.6 Other Players in the Market: A Crowded Second Tier
2.5.6 Other Players in the Market2.8.1 The Vaccines Market
3. Paediatric Vaccines Segment, 2013-2023
3.1 Segment to Lose Market Share, but Still Record Strong Growth
3.2 Combinations Form Basis of Segment Revenues
3.3 Prevnar Franchise Represents a Quarter of the Paediatric Segment’s Total Value in 2012
3.3.1 Prevnar-13: Domination to Continue?
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3.3.1.1 First of the Blockbuster Vaccines
3.3.1.2 Label Extensions for Prevnar Continue
3.3.1.3 Synflorix Competing Strongly in Emerging Markets
3.3.1.4 Big Three Vaccine Manufacturers All Set to Challenge Pfizer in Pneumococcal Disease
Area
3.3.1.5 How Much Room for Growth for Prevnar-13?
3.3.2 Sanofi Pasteur and GlaxoSmithKline Competing in Paediatric Combination Space
3.3.2.1 Hexaxim Boosts Sanofi Portfolio
3.3.2.2 GlaxoSmithKline Combinations Make Gains in US in 2012
3.3.2.3 Inadequacies in Pertussis and Hepatitis B Care
3.3.2.4 Room for Vaccine Competition in Those Disease Areas?
3.3.2.5 Sanofi and GSK Head-to-Head, 2013-2023
3.3.3 Competition Increases in Meningitis Vaccines Space
3.3.3.1 Menveo Label Widened in August 2013
3.3.3.2 Other Competitors for Paediatric A, C, Y and W-135 Serotypes Market
3.3.3.3 Bexsero Still to Convince EU Payers
3.3.4 Four-Disease Combination is Merck’s Leading Paediatric Vaccine
3.3.4.1 Supply Issues Still Restraining ProQuad
3.3.4.2 Varivax Commercial Backbone of Combination
3.3.4.3 Mumps Immunity Waning?
3.3.4.4 Will MMR-II/ProQuad/Varivax Realise its Full Market Potential?
3.3.5 Duel for the Rotavirus Market Continues
3.3.5.1 RotaTeq Leads the Market
3.3.5.2 Rotavirus Immunisation Added to UK Schedules
3.3.5.3 New Chinese and Indian Products Come to Developing World
3.3.5.4 Will RotaTeq Hit the Blockbuster Heights?
3.3.6 Paediatric Vaccines Against Other Diseases, 2013
3.3.6.1 Japanese Encephalitis Vaccine Approved for Children
3.3.6.2 Mosquirix Records Disappointing Phase 3 Data
3.3.6.3 Sanofi Records a First in 50 Years of Dengue Research
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3.3.6.4 Two MedImmune RSV Vaccines in Development
3.3.6.5 Novartis Targeting Typhoid Opportunity
3.3.6.6 Hand, Foot and Mouth Vaccine: A Chinese Target
3.3.6.7 Anthrax Vaccines for Children?
3.3.6.8 Potential Vaccines for Autism and Diabetes
3.4 Summary: The Biggest Segment, but the Least Dynamic
4. Influenza Vaccines Segment, 2013-2023
4.1 New Pandemics Offer Biggest Growth Opportunities to 2023
4.2 Major Seasonal and Pandemic Vaccine Opportunities Remain
4.3 Abbvie and AstraZeneca Among the Segment’s Big Players
4.3.1 Sanofi has the Largest Influenza Franchise
4.3.1.1 Seasonal Vaccines Dominate the Franchise
4.3.1.2 Quadrivalent Product Will Bolster Steady Growth for the Fluzone-Led Franchise
4.3.1.3 Novartis’ Portfolio Leads the Seasonal Influenza Competition
4.3.1.4 GlaxoSmithKline and AstraZeneca Also Competing
4.3.1.5 Merck to Join the Seasonal Market Leaders?
4.3.2 Differentiating Seasonal Influenza Vaccines
4.3.2.1 CDC Promises Redesign of Influenza Vaccine Coverage
4.3.2.2 FDA Endorses Quadrivalents for the First Time in 2013
4.3.2.3 Cell Culture and Baculovirus-Derived Products Join the Market
4.3.2.4 Significant Scope for Enlarging the Patient Population
4.3.2.5 VLP, VERO and Intranasal Candidates in Pipeline
4.3.3 Threat and Opportunity: the Pandemic Influenza Space
4.3.3.1 H5N1: The Main Target
4.3.3.2 Novavax’s VLP Product Among the Leading H5N1 Candidates
4.3.3.3 H1N1: New Options for Post-Pandemic Strain
4.3.3.4 Pandemic H9N2: A Continuous Background Risk
4.3.3.5 H7N9: New Pandemic Threat in 2013
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4.3.3.6 Response to H7N9 Beyond China and Taiwan
4.3.4 Universal Influenza Vaccines: A Distant Dream?
4.3.4.1 Universal Candidates Reach Phase 2
4.4 Overview: High Innovation, Low Market-Entry Barriers, High Volumes of Product Needed
5. Adult Prophylactic Vaccines Segment, 2013-2023
5.1 Prevnar Approval to Boost the Segment to 2023
5.2 Routine Adult Vaccination to Become a Reality by 2023?
5.3 Gardasil Represented Nearly a Fifth of Segment Revenues in 2012
5.3.1 Gardasil Dominating HPV Disease Area
5.3.1.1 Cervarix Declines as Japan Catches Up in 2012
5.3.1.2 New Markets for Gardasil
5.3.1.3 Is There a Need for V503?
5.3.1.4 GlaxoSmithKline and Merck to Continue Dominating this Space
5.3.1.5 Gardasil’s Prospects Depend on its Successor
5.3.2 GlaxoSmithKline Continues to Dominate Hepatitis Vaccine Space
5.3.2.1 Few Competitors Beside Merck’s Recombivax
5.3.2.2 China Market Key for GlaxoSmithKline’s Hepatitis Vaccines
5.3.2.3 FDA Rejects Dynavax’s Heplisav Citing Safety Concerns
5.3.2.4 Hepatitis C A Major Pipeline Target
5.3.2.5 Engerix and Other GlaxoSmithKline Products to Continue Growing Through 2017
5.3.3 Reimmunisation against Pneumococcal, Meningococcal Disease
5.3.3.1 Menveo and Nimenrix Sanofi’s Main Challengers
5.3.3.2 Pfizer and JN-International Have Pipeline Candidates
5.3.3.3 How Big is the Adult Pneumonia Potential Market?
5.3.3.4 Sanofi Leads Booster Vaccination Space
5.3.3.5 Pertussis and TB Major Unaddressed Needs
5.3.4 Shingles Market Remains Relatively Untapped
5.3.4.1 Will Zostavax’s Revival Continue?
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6. Contents
5.3.4.2 Two New Late-Stage Shingles Candidates
5.3.4.3 Other Herpesvirus R&D in Vaccines
5.3.4.4 Need for Cytomegalovirus Vaccine?
5.3.5 Other Unmet Needs in the Adult Segment
5.3.5.1 Dengue Fever the Next Target
5.3.5.2 Anthrax and Other Bio-Terror Vaccines
5.3.5.3 HIV Vaccine: 30-Year Hunt Continues After HVTN 505
5.3.5.4 Developers’ Interest in Malaria
5.3.5.5 Anti-Staphyloccocal Vaccines Form an Important Need
5.3.5.6 Other New Antibacterial Vaccines in Development
5.3.5.7 Important New Antiviral Vaccine Targets
5.3.5.8 Protozoans and Other Vaccine Targets
5.4 Overview: Extensive Pipeline, but Adult Immunisation Still Needs to Become More Widely
Established
6. Therapeutic Vaccines Segment, 2013-2023
6.1 The Fastest-Growing Segment to 2023
6.2 The Future for Vaccines R&D?
6.3 Anti-Allergy Vaccines Make Up Bulk of Segment in 2012
6.3.1 Provenge: Troubled Segment Leader
6.3.1.1 Competition and Patient Doubt Undermine Provenge
6.3.1.2 Future Sales Growth for Dendreon?
6.3.1.3 Two Phase 3 Allogeneic Vaccines to Provide Competition
6.3.1.4 NorthWest Biotherapeutics Following Oxford BioMedica Out of the Race?
6.3.1.5 Products in Development in Ten Areas of Oncology
6.3.2 Novarx Heads Lung Cancer Hunt After Failure of Stimuvax
6.3.2.1 Lucanix Leads the Way
6.3.2.2 MAGE-A3 Also in Late-Stage Trials
6.3.2.3 Stiff Competition for MAGE-A3 in Melanoma Pipeline
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7. Contents
6.3.2.4 Agenus In Late-Stage Trials in Melanoma and Renal Cancer
6.3.3 Other Major Solid Tumour Targets
6.3.3.1 Breast Cancer One of the Most-Crowded Areas of Therapeutic Vaccines Pipeline
6.3.3.2 Pancreatic Cancer: Major Unmet Need, Slender Pipeline
6.3.3.3 Still Several Ovarian Cancer Candidates After Abagovamab Disappointment
6.3.3.4 Several Candidates Against Glioblastoma
6.3.3.5 Other Cancer Vaccines in Development
6.3.4 Other Chronic Diseases: Vaccine Treatments for RA and Diabetes?
6.3.4.1 New Options in Chronic Neurodegenerative Diseases Pipeline
6.3.4.2 HIV: Major Therapeutic Vaccines Target
6.3.4.3 Other Chronic Viral Infections Pipeline
6.3.4.4 Cat Allergies and Other New Allergy Targets for Vaccine R&D
6.3.4.5 Addictions and Other Therapeutic Vaccine Targets
6.4 Overview: Huge Potential, but Little Market Success to Date
7. Leading National Vaccines Markets, 2013-2023
7.1 US and EU5 Represent Over 70% of Market
7.2 The US Remains the Foundation of the Global Market in 2013
7.3 Strong Pro-Immunisation Stance in US
7.4 EU5: Medical Need Vies with Austerity Economics
7.5 Japan: Low Existing Coverage Means High Market Potential
7.6 BRIC Nations: To Overtake EU5 in Market Share by 2023
7.7 Rest of the World: Unmet Needs Remain
8. Qualitative Industry Analysis, 2013
8.1 Vaccines Expand in Importance for Pharmaceutical Industry
8.2 Weaknesses: Many Challenges in this Sector
8.3 Opportunities: MRSA, HIV, and Other Unmet Needs Remain
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8. Contents
8.4 Threats: Cost-Effectiveness a Harder Sell for Governments
8.5 Social Concerns: One of the Most Emotive Areas of Healthcare
8.6 Technological Developments: New Delivery Systems, New Adjuvants, 2D Barcoding and
Other Innovations
8.7 Health Economics: 2700% Increase in Cost of Vaccinating a Child
8.8 Political Issues: From Bio-Defence to Polio Eradication, Governments Hold the Key to the
Market
9. Research Interviews, 2013
9.1 Interview with Dr. Louis J. Picker, Oregon Health and Science University
9.1.1 Challenges of DNA/Ad Vector Vaccines
9.1.2 Broadly Neutralising Antibodies for HIV
9.1.3 A Third Way? The T-Cell Vaccine Approach
9.1.4 Combinations and Other Strategies for HIV
9.1.5 Getting to the Clinic with Therapeutic and Prophylactic HIV Vaccines
9.2 Interview with Tamar Ben-Yedidia, PhD, Chief Scientific Officer, and Tanya Gottlieb, PhD,
Business Development, BiondVax Pharmaceuticals
9.2.1 Progress of BiondVax’s Candidate Vaccine
9.2.2 Trialling the Vaccine as a Primer
9.2.3 Assays for Universal Vaccine Effectiveness
9.2.4 Key Differentiators for BiondVax’s Candidate
10. Conclusions
10.1 Vaccines Market Remains on Course for Steady Growth to 201
10.2 Sales Growth to Be Sustained 2018-2023
10.3 Adult Segment to Grow Twice as Fast as Paediatric Segment
10.4 Therapeutic Vaccines to Gain Importance from 2018-2023
10.5 Market Remains Heavily Consolidated
10.6 Blockbuster Products Lead the Way; Scope in Developing World
10.7 Rich Pipeline, Particularly in Therapeutic Vaccines
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12. Contents
Table 5.7 Engerix/ Fendrix/ Havrix/ Twinrix/ Ambirix: Revenues ($m), AGR (%), CAGR (%), 20122017
Table 5.8 Engerix/ Fendrix/ Havrix/ Twinrix/ Ambirix: Revenues ($m), AGR (%), CAGR (%), 20182023
Table 5.9 Menactra and Other Meningitis/Pneumonia Vaccines: Revenues ($m), AGR (%), CAGR
(%), 2012-2017
Table 5.10 Menactra and Other Meningitis/Pneumonia Vaccines: Revenues ($m), AGR (%),
CAGR (%), 2018-2023
Table 5.11 Selected Pipeline Meningitis Vaccines, 2013
Table 5.12 Selected Pipeline Pneumonia Vaccines, 2013
Table 5.13 Selected Pipeline TB, Diphtheria, Pertussis, Tetanus and Rotavirus Adult Vaccines,
2013
Table 5.14 Zostavax: Revenues ($m), AGR (%), CAGR (%), 2012-2017
Table 5.15 Zostavax: Revenues ($m), AGR (%), CAGR (%), 2018-2023
Table 5.16 Selected Pipeline for Herpesvirus Vaccines, 2013
Table 5.17 Selected Pipeline for New Adult Vaccines for Currently Vaccine-Preventable Diseases,
2013
Table 5.18 Selected Pipeline for Dengue Virus Vaccines, 2013
Table 5.19 Selected Pipeline for Anthrax and Other Potential Bio-Terrorism Agents Vaccines,
2013
Table 5.20 Selected Pipeline for HIV Vaccines, 2013
Table 5.21 Selected Pipeline for Malaria Vaccines, 2013
Table 5.22 Selected Pipeline for New Antibacterial Vaccines, 2013
Table 5.23 Selected Pipeline for New Antiviral Vaccines, 2013
Table 5.24 Selected Pipeline for Other New Adult Prophylactic Vaccines, 2013
Table 6.1 Therapeutic Vaccines Segment: Revenues ($m), AGR (%), CAGR (%), 2012-2017
Table 6.2 Therapeutic Vaccines Segment: Revenues ($m), AGR (%), CAGR (%), 2018-2023
Table 6.3 Leading Therapeutic Vaccine Products: Revenues ($m), Segment Market Share (%),
2012
Table 6.4 Selected Therapeutic Vaccines, 2013
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13. Contents
Table 6.5 Selected Pipeline Prostate Cancer Therapeutic Vaccines, 2013
Table 6.6 Selected Pipeline Lung Cancer Therapeutic Vaccines, 2013
Table 6.7 Selected Pipeline Melanoma Therapeutic Vaccines, 2013
Table 6.8 Selected Pipeline Renal Cancer Therapeutic Vaccines, 2013
Table 6.9 Selected Pipeline Colorectal Cancer Therapeutic Vaccines, 2013
Table 6.10 Selected Pipeline Haematological Cancer Therapeutic Vaccines, 2013
Table 6.11 Selected Pipeline Breast Cancer Therapeutic Vaccines, 2013
Table 6.12 Selected Pipeline Pancreatic Cancer Therapeutic Vaccines, 2013
Table 6.13 Selected Pipeline Ovarian Cancer Therapeutic Vaccines, 2013
Table 6.14 Selected Pipeline Brain Cancer Therapeutic Vaccines, 2013
Table 6.15 Selected Other Cancer Therapeutic Vaccines, 2013
Table 6.16 Selected RA and Diabetes Therapeutic Vaccines, 2013
Table 6.17 Selected AD and MS Therapeutic Vaccines, 2013
Table 6.18 Selected HIV Therapeutic Vaccines, 2013
Table 6.19 Selected Other Chronic Viral Infections Therapeutic Vaccines, 2013
Table 6.20 Selected Anti-Allergy Therapeutic Vaccines, 2013
Table 6.21 Selected Other Therapeutic Vaccines, 2013
Table 7.1 Vaccines Market Breakdown by Region: Revenues ($m), Market Share (%), 2012
Table 7.2 Vaccines Market by Region: Revenues ($m), AGR (%), CAGR (%), Market Shares (%),
2012-2017
Table 7.3 Vaccines Market Breakdown by Region: Revenues ($m), Market Share (%), 2017
Table 7.4 Vaccines Market by Region: Revenues ($m), AGR (%), CAGR (%), Market Shares (%),
2018-2023
Table 7.5 Vaccines Market Breakdown by Region: Revenues ($m), Market Share (%), 2023
Table 8.1 World Vaccines Market: Strengths and Weaknesses, 2013
Table 8.2 World Vaccines Market: Opportunities and Threats, 2013
Table 8.3 World Vaccines Market: STEP Analysis, 2013-2023
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14. Contents
List of Figures
Figure 2.1 Vaccines Market: Revenues ($m), 2012-2023
Figure 2.2 Vaccines Market Breakdown by Segment: Revenues ($m), Market Share (%), 2012
Figure 2.3 Vaccines Market Breakdown by Segment: Revenues ($m), Market Share (%), 2017
Figure 2.4 Vaccines Market Breakdown by Segment: Revenues ($m), Market Share (%), 2023
Figure 2.5 Vaccines Market Breakdown by Segment: Revenues ($m), 2012-2023
Figure 2.6 Vaccines Market Breakdown by Segment: Revenues ($m), 2012, 2017, 2023
Figure 2.7 Leading Vaccine Products: Revenues ($m), Market Share (%), 2012
Figure 2.8 Leading Vaccine Products: Revenues ($m), 2012-2023
Figure 2.9 Leading Vaccine Manufacturers: Revenues ($m), Market Share (%), 2012
Figure 3.1 Paediatric Vaccines Segment: Revenues ($m), 2012-2023
Figure 3.2 Global Mortality Due to VPDs in Children Under Five, Breakdown by Disease (%),
2008
Figure 3.3 Leading Paediatric Vaccine Products: Revenues ($m), Segment Market Share (%),
2012
Figure 3.4 Leading Paediatric Pneumococcal Vaccine Products: Market Share (%), 2012
Figure 3.5 Prevnar Revenue Breakdown by Segment (Paediatric and Adult Prophylactic):
Revenues ($m), 2012-2023
Figure 3.6 Pentacel/Pediacel/Pentaxim/Others; Infanrix/Pediarix/Others: Revenues ($m), 20122023
Figure 3.7 ProQuad/ MMR-II/ Varivax: Revenues ($m), 2012-2023
Figure 3.8 Division of Rotavirus Vaccine Market (%), 2012
Figure 3.9 RotaTeq: Revenues ($m), 2012-2023
Figure 3.10 Drivers and Restraints for Paediatric Vaccines, 2013
Figure 4.1 Influenza Vaccines Segment: Revenues ($m), 2012-2023
Figure 4.2 Leading Influenza Vaccine Products: Revenues ($m), Segment Market Share (%),
2012
Figure 4.3Fluzone/Panenza/Humenza/Intanza/ IDflu/Emerflu/Others: Breakdown by Seasonal and
Pandemic Revenues ($m), 2010-2012
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15. Contents
Figure 4.4 Fluzone/Panenza/Humenza/Intanza/IDflu/Emerflu/Others: Revenues ($m), 2012-2023
Figure 4.5 Drivers and Restraints for Influenza Vaccines, 2013
Figure 5.1 Adult Prophylactic Vaccines Segment: Revenues ($m), 2012-2023
Figure 5.2 Leading Adult Prophylactic Vaccine Products: Revenues ($m), Segment Market Share
(%), 2012
Figure 5.3 Division of HPV Vaccine Market (%), 2012
Figure 5.4 Gardasil: Revenues ($m), 2012-2023
Figure 5.5 Engerix/ Fendrix/ Havrix/ Twinrix/ Ambirix: Revenues ($m), 2012-2023
Figure 5.6 Menactra and Other Meningitis/Pneumonia Vaccines: Revenues ($m), 2012-2023
Figure 5.7 Zostavax: Revenues ($m), 2012-2023
Figure 5.8 Drivers and Restraints for Adult Prophylactic Vaccines, 2013
Figure 6.1 Therapeutic Vaccines Segment: Revenues ($m), 2012-2023
Figure 6.2 Leading Therapeutic Vaccine Products: Revenues ($m), Segment Market Shares (%),
2012
Figure 6.3 Drivers and Restraints for Therapeutic Vaccines, 2013
Figure 7.1 Vaccines Market Breakdown by Region: Revenues ($m), Market Share (%), 2012
Figure 7.2 Vaccines Market Breakdown by Region: Revenues ($m), Market Share (%), 2017
Figure 7.3 Vaccines Market Breakdown by Region: Revenues ($m), Market Share (%), 2023
Figure 7.4 Vaccines Market Breakdown by Region: Revenues ($m), 2012-2023
Figure 7.5 Vaccines Market Breakdown by Regional Bloc: Revenues ($m), 2012-2023
Figure 7.6 Vaccines Market Breakdown by Region: Revenues ($m), 2012, 2017, 2023
Figure 7.7 US Vaccines Market: Revenues ($m), 2012-2023
Figure 7.8 EU5 Vaccines Market: Revenues ($m), 2012-2023
Figure 7.9 Japanese Vaccines Market: Revenues ($m), 2012-2023
Figure 7.10 BRIC Nations Vaccines Market: Revenues ($m), 2012-2023
Figure 7.11 Rest of the World Vaccines Market: Revenues ($m), 2012-2023
Figure 10.1 World Vaccines Market: Revenues ($m), 2012-2017
Figure 10.2 World Vaccines Market: Revenues ($m), 2018-2023
Figure 10.3 World Vaccines Market, Breakdown by Segment: Revenues ($m), 2012-2017
Figure 10.4 World Vaccines Market, Breakdown by Segment: Revenues ($m), 2018-2023
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16. Contents
Organisations Mentioned in Report
Abbott Laboratories
Aaron Diamond AIDS Research Center
Abbott Laboratories
AbbVie
Acambis
ACE Biosciences
Activartis Biotech
Adamis Pharmaceuticals
Aduro BioTech
Advaxis
Aeras
Aeras Global TB Vaccine Foundation
Affiris
Agency for Science, Technology and Research (Singapore)
Agenus
Akela Pharma
ALK Abello
Allergy Therapeutics
Allertein Therapeutics
Alnylam
AlphaVax
Altravax
American Academy of Pediatrics
Amgen
Antigen Discovery
Antigen Express
Antigenics
Argos Therapeutics
Astellas Pharma
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17. Contents
AstraZeneca
Augmenta Biologicals
AuRx
AVAX Technologies
Baxter Healthcare
Bayer HealthCare
Bayhill Therapeutics
Beijing Key Yuan Xinhai Pharmaceutical
Beijing Vigoo Biological
Bellicum Pharmaceuticals
Bharat Biotech
Biken Japan
Bill & Melinda Gates Foundation
Bio-Manguinhos
BiondVax
Bionor Pharma
BioNTech
BioSante Pharmaceuticals
Biotech Synergy
Biovest International
BN ImmunoTherapeutics (Bavarian Nordic)
Boston Children's Hospital
BravoBio
Butantan
Cadila Pharma
Cancer Advances
Celldex Therapeutics
CEL-SCI
Celtic Pharma
Center of Molecular Immunology (Cuba)
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18. Contents
Centers for Disease Control (CDC)
CG Therapeutics
Chemo-Sero-Therapeutic Research Institute
Chengdu Institute
China National Biotech Group (CNBG)
China NT Pharma Group
Chinese Centre for Disease Control
Chinese State Food and Drug Administration (SFDA)
Chiron
Circassia
Colby Pharmaceutical
Columbia University
Cosmo Pharmaceuticals
Crucell
CSL Biotherapies
Cuba’s Center of Molecular Immunology
CureVac
Cytokine PharmaSciences
Cytos Biotechnology
Daiichi Sankyo
DBV Technologies
Dendreon
Denka Seiken Company
Desmond Tutu TB Centre
Diabetes UK
Diamyd
Dynavax
DynPort Vaccine Company
Eisai
Elea Laboratories
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EMD Serono
Emergent BioSolutions
Endocyte
Epeius Biotechnologies
Erasmus Medical Centre
Etubics
European Medicines Agency (EMA)
Evans Medical
Food and Drug Administration (US FDA)
Galena Biopharma
GAVI Alliance
GE Healthcare
GeneCure Biotechnologies
Genetic Immunity
Genocea Biosciences
GenPhar
GenVec
GeoVax Labs
Geron
GlaxoSmithKline (GSK)
Glide Pharma
Gliknik
Global Health Innovative Technology Fund (GHIT Fund)
GlobeImmune
Gradalis
Greer Laboratories
Hawaii Biotech
Health Protection Agency (HPA)
Heat Biologics
Helmholtz Centre for Infection Research
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20. Contents
iBio
Ichor Medical Systems
immatics biotechnologies
Immune Response Biopharma
Immune Targeting Systems
Immunitor
ImmunoCellular Therapeutics
Immunocore
ImmunoFrontier
Immunomic Therapeutics
Immunotope
Immunovaccine
Immunovative Therapies
ImmusanT
Infectious Diseases Research Institute
Inovio Pharmaceuticals
Intercell
Intercell USA
International AIDS Vaccine Initiative (IAVI)
International Federation of Pharma Manufacturers and Associations (IFPMA)
International Medica Foundation
Inviragen
J. Craig Venter Institute
Janssen Alzheimer Immunotherapy
JN-International Medical
Johnson & Johnson
Joint Committee on Vaccination and Immunisation (JCVI, UK)
KAEL-GemVax
Karolinska Institute
Kitasato Institute
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Korean Ministry of Health and Welfare
La Jolla Institute for Allergy & Immunology
Life Technologies
LigoCyte Pharmaceuticals
Liquidia Technologies
London School of Hygiene and Tropical Medicine
MabVax Therapeutics
Max Planck Society
MaxCyte
Medecins Sans Frontieres (MSF)
Medicago
MedImmune
Memgen
Menarini
Merck & Co.
Merck Serono
Meridian Biosciences
Mitsubishi Tanabe Pharma
Momotaro-Gene
Nabi Biopharmaceuticals
NanoBio
Nanotherapeutics
National Administration of Medicines, Food and Medical Technology (ANMAT, Argentina)
Natrix Separations
NewLink Genetics
Northwest Biotherapeutics
Novadigm Therapeutics
Novartis
NovaRx
Novavax
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22. Contents
Novo Energies
Nuron Biotech
NuVax Therapeutics
Nypro Healthcare
Okairos
OncoPep
Oncothyreon
Opal Therapeutics
Opexa Therapeutics
Opko Health
Optimer Pharmaceuticals
Orban Biotech
Oregon Health and Science University, Vaccine and Gene Therapy Institute
Oxford BioMedica
PaxVax
Petrovax
Pfizer
PharmAthene
Pique Therapeutics
Polynoma
Prima Biomed
Profectus Biosciences
Progenics Pharmaceuticals
Protein Sciences
PsiOxus Therapeutics
Quantum Immunologics
Quest PharmaTech
Sanaria
Sanofi
Sanofi Pasteur
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23. Contents
Sarepta
SciVac
Scripps Research Institute
Selecta Biosciences
Serum Institute of India
Shanghai BravoBio
Shanghai Pharma
Shantha Biotech
Shionogi
Sinopharm Group
Sinovac Biotech
Soligenix
South African Tuberculosis Vaccine Initiative (SATVI)
Stallergenes
Stemline Therapeutics
Sumagen
Sunovion Pharmaceuticals
Takeda
TapImmune
TD Vaccines
Tekmira
Tesco
Tetragenetics
Teva Pharmaceutical industries
Theraclone Sciences
Thymon
Topaz Pharmaceuticals
Transgene
TVAX Biomedical
UK Joint Committee on Vaccination and Immunisation
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26. World Vaccines Market 2013-2023
phase 3 studies on the candidate, the largest of which is a head-to-head comparison of Gardasil
and V 503 in 14,000 women. Merck announced in 2013 it is extending the clinical trials of V503
since too few patients in the Gardasil arm of the trial have developed HPV infections. This implies
that there is no medical need to vaccinate against additional subtypes of HPV; Gardasil alone
appears to offer adequate protection.
5.3.1.4 GlaxoSmithKline and Merck to Continue Dominating this Space
In addition to V503, Merck has an octavalent candidate VLP-based candidate, V502. This product
completed phase 1 studies, with a phase 2 trial being withdrawn prior to enrolment in 2012,
presumably because Merck’s R&D focus is on the more-advanced V503 candidate. Genticel is
developing a therapeutic vaccine, ProCervix, for high-risk HPV patients; Inovio also has a
therapeutic DNA vaccine candidate, VGX-3100, in development. These therapeutic vaccines are
dealt with in the following chapter. In terms of preventive vaccines, GlaxoSmithKline seems set to
remain the only challenger to Merck in the HPV space.
5.3.1.5 Gardasil’s Prospects Depend on its Successor
Although Gardasil’s revenues will fluctuate, visiongain anticipates that the product broadly faces a
decline based on its relative maturity and the likelihood of competition from the V-503 follow-on. If
further clinical data shows no rationale for transitioning patients to the nine-valent franchise
extension, Gardasil may continue to enjoy market dominance. Visiongain’s prediction here is
based on the likelihood that clinical data will ultimately justify the transition to V-503, with
consequent cannibalisation of Gardasil revenues. By 2017, visiongain estimates these revenues
will decline to $1429m. By 2023, general substitution of V-503 will see Gardasil’s revenues fall to
$650m, visiongain believes. See Table 5.5, Table 5.6, and Figure 5.4.
Table 5.5 Gardasil: Revenues ($m), AGR (%), CAGR (%), 2012-2017
2012
Revenues ($m )
AGR (%)
CAGR (%,2012-2017)
2013
2014
2015
2016
2017
1895
1755
1823
1875
1581
1429
-7
4
3
-16
-10
-5
Source: visiongain 2013
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27. World Vaccines Market 2013-2023
Table 5.6 Gardasil: Revenues ($m), AGR (%), CAGR (%), 2018-2023
2018
2019
2020
2021
2022
2023
Revenues ($m )
1276
1101
929
725
680
650
AGR (%)
-11
-14
-16
-22
-6
-4
CAGR (%, 2018-2023)
-13
CAGR (%, 2012-2023)
-9
Source: visiongain 2013
Figure 5.4 Gardasil: Revenues ($m), 2012-2023
2000
1800
Revenues ($m)
1600
1400
1200
1000
800
600
400
200
0
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023
Year
Source: visiongain 2013
5.3.2 GlaxoSmithKline Continues to Dominate Hepatitis Vaccine Space
GlaxoSmithKline’s hepatitis vaccines account for ~85% of the hepatitis vaccines market. As noted,
hepatitis B is widely included in paediatric combinations. Of GlaxoSmithKline’s other vaccines,
Twinrix offers inoculation against hepatitis A and hepatitis B to patients 18 years of age or over,
and comes in preservative-free liquid form for intramuscular injection. GlaxoSmithKline also
markets separate vaccines for hepatitis A (Havrix) and hepatitis B (Engerix-B, a recombinant
subunit vaccine supplied in refrigerated, preservative-free liquid form or in pre-filled syringes, and
its reformulation Fendrix for patients aged 15 years or over).
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