World Vaccines Market 2013-2023

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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 Pfizers 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 Segments 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 Mercks 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 Segments 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 Novavaxs 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 Gardasils Prospects Depend on its Successor 5.3.2 GlaxoSmithKline Continues to Dominate Hepatitis Vaccine Space 5.3.2.1 Few Competitors Beside Mercks Recombivax 5.3.2.2 China Market Key for GlaxoSmithKlines Hepatitis Vaccines 5.3.2.3 FDA Rejects Dynavaxs 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 Sanofis 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 Zostavaxs Revival Continue?

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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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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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8.4 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 BiondVaxs 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 BiondVaxs 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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10.8 Concluding Remarks

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List of Tables
Table 1.1 Currency Exchange Rates Table 2.1 Vaccines Market: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 2.2 Vaccines Market: Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 2.3 Vaccines Market Breakdown by Segment: Revenues ($m), Market Share (%), 2012 Table 2.4 Vaccines Market by Segment: Revenues ($m), AGR (%), CAGR (%), Market Shares (%), 2012-2017 Table 2.5 Vaccines Market Breakdown by Segment: Revenues ($m), Market Share (%), 2017 Table 2.6 Vaccines Market by Segment: Revenues ($m), AGR (%), CAGR (%), Market Shares (%), 2018-2023 Table 2.7 Vaccines Market Breakdown by Segment: Revenues ($m), Market Share (%), 2023 Table 2.8 Vaccine-Preventable Diseases and their Statistics Table 2.9 Types of Vaccine, 2013 Table 2.10 Leading Vaccine Products: Revenues ($m), Market Shares (%), 2012 Table 2.11 Leading Vaccine Products: Revenues ($m), AGR (%), CAGR (%), Market Shares (%), 2012-2017 Table 2.12 Leading Vaccine Products: Revenues ($m), AGR (%), CAGR (%), Market Shares (%), 2018-2023 Table 2.13 Leading Vaccine Manufacturers: Revenues ($m), Market Share (%), 2012 Table 3.1 Paediatric Vaccines Segment: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 3.2 Paediatric Vaccines Segment: Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 3.3 Leading Paediatric Vaccine Products: Revenues ($m), Segment Market Share (%), 2012 Table 3.4 Selected Pipeline Products in Paediatric Vaccines Segment, 2013 Table 3.5 Paediatric Pneumococcal Vaccines Pipeline, 2013 Table 3.6 Prevnar Revenue Breakdown by Segment (Paediatric and Adult Prophylactic): Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 3.7 Prevnar Revenue Breakdown by Segment (Paediatric and Adult Prophylactic): Revenues ($m), AGR (%), CAGR (%), 2018-2023

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Table 3.8 Pentacel/Pediacel/Pentaxim/Others; Infanrix/Pediarix/Others: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 3.9 Pentacel/Pediacel/Pentaxim/Others; Infanrix/Pediarix/Others: Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 3.10 ProQuad/ MMR-II/ Varivax: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 3.11 ProQuad/ MMR-II/ Varivax: Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 3.12 RotaTeq: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 3.13 RotaTeq: Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 4.1 Influenza Vaccines Segment: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 4.2 Influenza Vaccines Segment: Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 4.3 Leading Influenza Vaccine Products: Revenues ($m), Segment Market Share (%), 2012 Table 4.4 Selected Pipeline Products in Influenza Vaccines Segment, 2013 Table 4.5 Fluzone/Panenza/Humenza/Intanza/IDflu/Emerflu/Others: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 4.6 Fluzone/Panenza/Humenza/Intanza/IDflu/Emerflu/Others: Revenues ($m), AGR (%), CAGR (%), 2018-2023 Table 4.7 Selected Pipeline Seasonal Influenza Vaccine Products, 2013 Table 4.8 Selected Pipeline H5N1 Pandemic Vaccine Products, 2013 Table 4.9 Selected Pipeline H1N1 Pandemic Vaccine Products, 2013 Table 4.10 Selected Pipeline H9N2 Pandemic Vaccine Products, 2013 Table 4.11 Selected Pipeline Universal Influenza Vaccine Products, 2013 Table 5.1 Adult Prophylactic Vaccines Segment: Revenues ($m), AGR (%), CAGR (%), 20122017 Table 5.2 Adult Prophylactic Vaccines Segment: Revenues ($m), AGR (%), CAGR (%), 20182023 Table 5.3 Leading Adult Prophylactic Vaccine Products: Revenues ($m), Segment Market Share (%), 2012 Table 5.4 Selected Pipeline Products in Adult Prophylactic Vaccines Segment, 2013 Table 5.5 Gardasil: Revenues ($m), AGR (%), CAGR (%), 2012-2017 Table 5.6 Gardasil: Revenues ($m), AGR (%), CAGR (%), 2018-2023

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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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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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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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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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Abbott Laboratories 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

Organisations Mentioned in Report

Aaron Diamond AIDS Research Center

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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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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 Cubas 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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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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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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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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UMN Pharma UNICEF United Biomedical Universidad de Chile Universit Laval University of Cape Town University of Guelph University of London University of Minnesota's Centre for Infectious Disease Research and Policy University of Queensland University of Toronto US National Biodefence Science Board US Naval Medical Research Center Utrecht University Vaccine Research Center (NIAID) Vaccine Technologies Vaccinogen Vakzine Projekt Management Valneva Vanderbilt University Vaxart Vaxin VaxInnate VaxOnco Vical Vivalis Vodafone Walter Reed Army Institute World Health Organisation (WHO) Xcellerex

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Zhejiang Tianyuan Zuellig Pharma

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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 Mercks 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 Gardasils Prospects Depend on its Successor

Although Gardasils 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. Visiongains 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 Gardasils 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)
Source: visiongain 2013

2013 1755 -7

2014 1823 4

2015 1875 3

2016 1581 -16

2017 1429 -10 -5

1895

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Table 5.6 Gardasil: Revenues ($m), AGR (%), CAGR (%), 2018-2023
2018 Revenues ($m ) AGR (%) CAGR (%, 2018-2023) CAGR (%, 2012-2023)
Source: visiongain 2013

2019 1101 -14

2020 929 -16

2021 725 -22

2022 680 -6

2023 650 -4 -13 -9

1276 -11

Figure 5.4 Gardasil: Revenues ($m), 2012-2023

2000 1800 1600 Revenues ($m) 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

GlaxoSmithKlines hepatitis vaccines account for ~85% of the hepatitis vaccines market. As noted, hepatitis B is widely included in paediatric combinations. Of GlaxoSmithKlines 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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