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World Vaccines Market 2013-2023

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Contents

1.1 Overview of Findings

1.2 Chapters in the Report

1.3 Research and Analysis Methods

1.4 What Are Vaccines?

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

3.1 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?

1. Executive Summary

2. Overview of Vaccines Market, 2013-2023

3. Paediatric Vaccines Segment, 2013-2023

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Contents 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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Contents 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

4.1 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

4. Influenza Vaccines Segment, 2013-2023

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Contents 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

5.1 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?

5. Adult Prophylactic Vaccines Segment, 2013-2023

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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

6.1 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

6. Therapeutic Vaccines Segment, 2013-2023

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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

7.1 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

8.1 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

7. Leading National Vaccines Markets, 2013-2023

8. Qualitative Industry Analysis, 2013

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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

9.1 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

10.1 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

9. Research Interviews, 2013

10. Conclusions

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Contents 10.8 Concluding Remarks

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Contents

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

List of Tables

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Contents 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 (%), 2012-

2017

Table 5.2 Adult Prophylactic Vaccines Segment: Revenues ($m), AGR (%), CAGR (%), 2018-

2023

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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Contents Table 5.7 Engerix/ Fendrix/ Havrix/ Twinrix/ Ambirix: Revenues ($m), AGR (%), CAGR (%), 2012-

2017

Table 5.8 Engerix/ Fendrix/ Havrix/ Twinrix/ Ambirix: Revenues ($m), AGR (%), CAGR (%), 2018-

2023

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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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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Contents

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), 2012-

2023

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

List of Figures

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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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Contents

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

Organisations Mentioned in Report

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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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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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Contents 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

www.visiongain.com

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

www.visiongain.com

Contents 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

www.visiongain.com

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

www.visiongain.com

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

www.visiongain.com

Contents UMN Pharma

UNICEF

United Biomedical

Universidad de Chile

Université 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

www.visiongain.com

Contents 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 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 2013 2014 2015 2016 2017

Revenues ($m) 1895 1755 1823 1875 1581 1429

AGR (%) -7 4 3 -16 -10

CAGR (%,2012-2017) -5

Source: visiongain 2013

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World Vaccines Market 2013-2023

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).

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

0

200

400

600

800

1000

1200

1400

1600

1800

2000

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Rev

enue

s ($

m)

Year

Source: visiongain 2013