PharmaPoint: Meningococcal Vaccines – Global Drug Forecast and Market Analysis to 2025

Neisseria meningitidis is a Gram-negative, encapsulated diplococcal bacterium and is the causative agent for invasive meningococcal disease. Although relatively rare around the globe, invasive meningococcal disease is widely feared because of its high mortality rate even in otherwise healthy individuals. The onset of invasive meningococcal disease typically begins within three to seven days of infection, but can occur as early as one day after infection. If left untreated, meningococcal disease progresses rapidly. Even with appropriate treatment, up to 10% of all cases still result in death within 24 to 48 hours of symptom onset. This rapid onset and progression of the disease emphasizes the need for a prophylactic approach by vaccination.

Pharmaceutical companies have developed vaccines addressing the most urgent medical needs based on clinical efficacy and epidemiology. The resulting vaccines can be divided into three categories, although other and finer segmentations can be made. These three categories include monovalent vaccines targeting serogroup C (MenC vaccines), vaccines protecting against most serogroup B strains (MenB vaccines), and tetravalent vaccines protecting against serogroups A, C, W, and Y (MenACWY vaccines). While the MenB vaccines use recombinant proteins as antigens, all other meningococcal vaccines are based on the polysaccharide capsules of the various serogroups.

Scope

Overview of meningococcal disease, including epidemiology, etiology, pathophysiology, regional serogroup distribution, as well current routine meningococcal vaccine recommendations of all 8MM covered.

Topline meningococcal vaccine market revenue from 2015–2025. Recent acquisitions, approvals and governmental recommendations are included in the forecast model.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, and clinical trial design for the meningococcal vaccine market.

Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and analysis of late-stage pipeline products. An interactive clinical and commercial analyzer tool is available.

Analysis of the current and future market competition in the global meningococcal vaccine marketplace. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Highlights

Based on interviews with key opinion leaders (KOLs), GlobalData has identified key unmet needs in the meningococcal vaccine marketplace.

What will be the effect of recent and upcoming changes in national immunization schedules?

How will the new first-in-class vaccine covering all main serogroups (MenABCWY) be received in the different markets?

What research and development (R&D) strategies will companies leverage to compete in the future meningococcal vaccine marketplace?

Which patient population(s) are most likely to be targeted for vaccines against serogroup B and the pentavalent MenABCWY pipeline vaccine?

Companies mentioned

GlaxoSmithKline

Pfizer

Sanofi Pasteur

GlaxoSmithKline

Pfizer

Sanofi Pasteur

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

2.3Upcoming Related Reports

3Disease Overview

3.1Introduction ...

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

2.3Upcoming Related Reports

3Disease Overview

3.1Introduction

3.2Etiology and Pathophysiology

3.2.1Etiology

3.2.2Pathophysiology

3.3Symptoms

3.4Prognosis

4Epidemiology

4.1Disease Background

4.2Risk Factors and morbidities

4.3Global Trends

4.3.1US

4.3.25EU

4.3.3Japan and Brazil

4.4Forecast Methodology

4.4.1Sources Used Tables

4.4.2Forecast Assumptions and Methods

4.4.3Sources Not Used

4.5Epidemiological Forecast for IMD (2015–2025)

4.5.1All IMD Combined

4.5.2Laboratory-Confirmed Incident Cases of Serogroup B IMD

4.5.3Laboratory-Confirmed Incident Cases of Serogroup C IMD

4.5.4Laboratory-Confirmed Incident Cases of Serogroup Y IMD

4.5.5Laboratory-Confirmed Incident Cases of Other Serogroup IMD

4.5.6Distribution of Serogroups

4.5.7US College Freshmen

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

5Disease Management

5.1Meningococcal Immunization Policy

5.1.1Routine Immunization Recommendations and Most Frequently Administered Meningococcal Vaccines

5.2US

5.2.1Immunization Recommendations

5.2.2Clinical Practice

5.3France

5.3.1Immunization Recommendations

5.3.2Clinical Practice

5.4Germany

5.4.1Immunization Recommendations

5.4.2Clinical Practice

5.5Italy

5.5.1Immunization Recommendations

5.5.2Clinical Practice

5.6Spain

5.6.1Immunization Recommendations

5.6.2Clinical Practice

5.7UK

5.7.1Immunization Recommendations

5.7.2Clinical Practice

5.8Japan

5.9Brazil

5.9.1Immunization Recommendations

5.9.2Clinical Practice

6Competitive Assessment

6.1Overview

6.2Product Profiles – MenACWY Vaccines

6.2.1Menactra

6.2.2Menveo

6.2.3Nimenrix

6.3Product Profiles – MenB Vaccines

6.3.1Bexsero

6.3.2Trumenba

6.4Product Profiles – MenC Vaccines

6.4.1NeisVac-C

6.4.2Menjugate

6.4.3Menitorix

6.5Other Meningococcal Vaccines

6.5.1Overview

7Unmet Needs and Opportunities

7.1Overview

7.2A Safe and Effective Universal Meningococcal Vaccine

7.2.1Unmet Need

7.2.2Gap Analysis

7.2.3Opportunity

7.3Long-Term Protection Against Invasive Meningococcal Disease

7.3.1Unmet Need

7.3.2Gap Analysis

7.3.3Opportunity

7.4Improvements in Clinical Trial Design

7.4.1Unmet Need

7.4.2Gap Analysis

7.4.3Opportunity

7.5Improved Vaccine Cost Effectiveness

7.5.1Unmet Need

7.5.2Gap Analysis

7.5.3Opportunity

7.6A Prenatal Meningococcal Vaccine

7.6.1Unmet Need

7.6.2Gap Analysis

7.6.3Opportunity

7.7Reducing Vaccination Frequency in Infants

7.7.1Unmet Need

7.7.2Gap Analysis

7.7.3Opportunity

7.8Enhanced Education and Awareness of the General Population

7.8.1Unmet Need

7.8.2Gap Analysis

7.8.3Opportunity

8Pipeline Assessment

8.1Overview

8.2Clinical Trial Mapping and Future Trends

8.2.1Clinical Trials by Status

8.2.2Clinical Trials by Pipeline Vaccine

8.2.3Future Clinical Trial Design Considerations

8.3Promising Vaccines in Clinical Development

8.3.1MenABCWY

8.3.2Men Quad TT

8.3.3Brazil MenC Vaccine

8.4Promising Early-Stage Pipeline Products

9Current and Future Players

9.1Overview

9.2Trends in Corporate Strategy

9.3Company Profiles

9.3.1GlaxoSmithKline

9.3.2Sanofi

9.3.3Pfizer

10Market Outlook

10.1Global Markets

10.1.1Forecast

10.1.2Drivers and Barriers – Global Issues

10.2United States

10.2.1Forecast

10.2.2Key Events

10.2.3Drivers and Barriers

10.35EU

10.3.15EU

10.3.2France

10.3.3Germany

10.3.4Italy

10.3.5Spain

10.3.6UK

10.4Japan

10.4.1Forecast

10.4.2Key Events

10.4.3Drivers and Barriers

10.5Brazil

10.5.1Forecast

10.5.2Key Events

10.5.3Drivers and Barriers

11Appendix

11.1Bibliography

11.2Abbreviations

11.3Methodology

11.4Forecasting Methodology

11.4.1Vaccine Coverage

11.4.2Vaccine Approval vs. Routine Schedule Inclusion

11.4.3Vaccines Included

11.4.4Key Launch Dates

11.4.5General Pricing Assumptions

11.4.6Individual Vaccine Assumptions

11.4.7Pricing of Pipeline Agents

11.5Primary Research – KOLs Interviewed for this Report

11.6Primary Research – Prescriber Survey

11.7About the Authors

11.7.1Analyst

11.7.2Therapy Area Director

11.7.3Epidemiologist

11.7.4Managing Epidemiologist

11.7.5Global Director of Therapy Analysis and Epidemiology

11.7.6Global Head of Healthcare

11.8About GlobalData

11.9Disclaimer

List of Tables

Table 1: Symptoms of Meningococcal Disease

Table 2: Risk Factors and Comorbidities for IMD

Table 3: 8MM, Sources of Laboratory-Confirmed IMD Incidence

Table 4: 8MM ...

Table 1: Symptoms of Meningococcal Disease

Table 2: Risk Factors and Comorbidities for IMD

Table 3: 8MM, Sources of Laboratory-Confirmed IMD Incidence

Table 4: 8MM, Sources of Laboratory-Confirmed Serogroup B IMD Incidence

Table 5: 8MM, Sources of Laboratory-Confirmed Serogroup C IMD Incidence

Table 6: 8MM, Sources of Laboratory-Confirmed Serogroup Y IMD Incidence

Table 7: 8MM, Sources of Laboratory-Confirmed Other Serogroup IMD Incidence (Includes Serogroups A, W, X, and All Others)

Table 8: 5EU, Japan, and Brazil Sources of Laboratory-Confirmed Serogroup W IMD Incidence

Table 9: Germany, Italy, and Brazil, Sources of Laboratory-Confirmed Serogroup A IMD Incidence

Table 10: College Freshmen Residing in Campus Accommodation

Table 11: 8MM, Laboratory-Confirmed Incident Cases of All IMD, All Ages, Both Sexes, N, Selected Years 2015–2025

Table 12: 8MM and Japan, Age-specific Laboratory-Confirmed Incident Cases of IMD, Both Sexes, N (Row %), 2015

Table 13: 7MM, Age-Specific Laboratory-Confirmed Incident Cases of IMD, Both Sexes, N (Row %), 2015

Table 14: 8MM, Laboratory-Confirmed Incident Cases of All IMD, All Ages, Both Sexes, N (Row %), 2015

Table 15: 8MM, Laboratory-Confirmed Incident Cases of Serogroup B IMD, All Ages, Both Sexes, N, Selected Years 2015–2025

Table 16: 8MM, Laboratory-Confirmed Incident Cases of Serogroup C IMD, All Ages, Both Sexes, N, Selected Years, 2015–2025

Table 17: 8MM, Laboratory-Confirmed Incident Cases of Serogroup Y IMD, All Ages, Both Sexes, N, Selected Years, 2015–2025

Table 18: 8MM, Laboratory-Confirmed Incident Cases of Other Serogroup IMD, All Ages, Both Sexes, N, Selected Years, 2015–2025

Table 19: College Freshmen in the US, All Ages, Both Sexes, N, Selected Years, 2015–2025

Table 20: National Immunization Recommendation Agencies, 2016

Table 21: National Immunization Recommendations for Meningococcal Vaccines, 2016

Table 22: Most Frequently Administered Meningococcal Vaccines in the Global Markets, 2015

Table 23: Country Profile – US

Table 24: Country Profile – France

Table 25: Country Profile – Germany

Table 26: Country Profile – Italy

Table 27: Country Profile – Spain

Table 28: Country Profile – UK

Table 29: Country Profile – Japan

Table 30: Country Profile – Brazil

Table 31: Leading Vaccines Against Meningococcal Disease, 2015

Table 32: Product Profile – Menactra

Table 33: Efficacy of Menactra for Individuals Receiving Either One- or Two-Dose Regimens

Table 34: Safety of Menactra for Individuals Receiving One Dose of Menactra

Table 35: Menactra SWOT Analysis, 2016

Table 36: Global Sales Forecast ($m) for Menactra, 2015–2025

Table 37: Product Profile – Menveo

Table 38: Efficacy of Menveo

Table 39: Safety of Menveo

Table 40: Menveo SWOT Analysis, 2016

Table 41: Global Sales Forecasts ($m) for Menveo, 2015–2025

Table 42: Product Profile – Nimenrix

Table 43: Efficacy of Nimenrix

Table 44: Safety of Nimenrix

Table 45: Nimenrix SWOT Analysis, 2016

Table 46: Global Sales Forecast ($m) for Nimenrix, 2015–2025

Table 47: Product Profile – Bexsero

Table 48: Efficacy of Bexsero

Table 49: Safety of Bexsero

Table 50: Bexsero SWOT Analysis, 2016

Table 51: Global Sales Forecasts ($m) for Bexsero, 2015-2025

Table 52: Product Profile – Trumenba

Table 53: Efficacy of Trumenba

Table 54: Safety of Trumenba

Table 55: Trumenba SWOT Analysis, 2016

Table 56: Global Sales Forecasts ($m) for Trumenba, 2015–2025

Table 57: Product Profile – NeisVac-C

Table 58: Efficacy of NeisVac-C

Table 59: Safety of NeisVac-C

Table 60: NeisVac-C SWOT Analysis, 2016

Table 61: Global Sales Forecasts ($m) for NeisVac-C, 2015–2025

Table 62: Product Profile – Menjugate

Table 63: Efficacy of Menjugate

Table 64: Safety of Menjugate

Table 65: Menjugate SWOT Analysis, 2016

Table 66: Global Sales Forecasts ($m) for Menjugate, 2015–2025

Table 67: Product Profile – Menitorix

Table 68: Efficacy of Menitorix

Table 69: Safety of Menitorix

Table 70: Menitorix SWOT Analysis, 2016

Table 71: Global Sales Forecasts ($m) for Menitorix, 2015–2025

Table 72: Other Meningococcal Vaccines

Table 73: Unmet Needs and Opportunities for Meningococcal Vaccines

Table 74: Product Profile – MenABCWY

Table 75: Immunogenicity of MenABCWY

Table 76: MenABCWY SWOT Analysis, 2016

Table 77: Global Sales Forecast ($m) for MenABCWY, 2015–2025

Table 78: Product Profile – Men Quad TT

Table 79: Men Quad TT SWOT Analysis, 2016

Table 80: Global Sales Forecasts ($m) for Men Quad TT, 2015–2025

Table 81: Product Profile – Brazil’s MenC

Table 82: Brazil MenC SWOT Analysis, 2016

Table 83: Global Sales Forecast ($m) for Brazil’s MenC, 2015-2025

Table 84: Important Meningococcal Vaccines in Development, 2016

Table 85: Key Companies in the Meningococcal Vaccine Market in the 8MM, 2016

Table 86: GSK’s Meningococcal Vaccines Portfolio Assessment, 2016

Table 87: GSK SWOT Analysis in Meningococcal Vaccines, 2016

Table 88: Sanofi’s Meningococcal Vaccines Portfolio Assessment, 2016

Table 89: Sanofi SWOT Analysis in Meningococcal Vaccines, 2016

Table 90: Pfizer’s Meningococcal Vaccines Portfolio Assessment, 2016

Table 91: Pfizer SWOT Analysis in Meningococcal Vaccines, 2016

Table 92: Global Sales Forecasts ($m) for Meningococcal Vaccines, 2015–2025

Table 93: 8MM Meningococcal Vaccines Market – Drivers and Barriers, 2015–2025

Table 94: US Sales Forecast ($m) for Meningococcal Vaccines, 2015?2025

Table 95: Key Events Impacting Sales for Meningococcal Disease in the US, 2015?2025

Table 96: US Meningococcal Vaccines Market – Drivers and Barriers, 2015?2025

Table 97: 5EU Sales Forecasts ($m) for Meningococcal Vaccines, 2015?2025

Table 98: 5EU Meningococcal Vaccines Market – Drivers and Barriers, 2015?2025

Table 99: France Sales Forecast ($m) for Meningococcal Vaccines, 2015?2025

Table 100: Key Events Impacting Sales for Meningococcal Vaccines in France, 2015?2025

Table 101: France Meningococcal Vaccines Market – Drivers and Barriers, 2015?2025

Table 102: Sales Forecast ($m) for Meningococcal Vaccines in Germany, 2015?2025

Table 103: Key Events Impacting Sales for Meningococcal Disease in Germany, 2015?2025

Table 104: Germany Meningococcal Vaccines market – Drivers and Barriers, 2015?2025

Table 105: Italy Sales Forecasts ($m) for Meningococcal Vaccines, 2015?2025

Table 106: Key Events Impacting Sales for Meningococcal Disease in Italy, 2015?2025

Table 107: Italy Meningococcal Vaccines Market – Drivers and Barriers, 2015?2025

Table 108: Spain Sales Forecast ($m) for Meningococcal Vaccines, 2015?2025

Table 109: Key Events Impacting Sales for Meningococcal Vaccines in Spain, 2015?2025

Table 110: Spain Meningococcal Vaccines Market – Drivers and Barriers, 2015?2025

Table 111: UK Sales Forecast ($m) for Meningococcal Vaccines, 2015?2025

Table 112: Key Events Impacting Sales for Meningococcal Disease in the UK, 2015?2025

Table 113: UK Meningococcal Vaccines market – Drivers and Barriers, 2015?2025

Table 114: Japan Sales Forecasts ($m) for Meningococcal Vaccines, 2015?2025

Table 115: Key Events Impacting Sales for Meningococcal Vaccines in Japan, 2015?2025

Table 116: Japan Meningococcal Vaccines Market – Drivers and Barriers, 2015?2025

Table 117: Brazil Sales Forecasts ($m) for Meningococcal Vaccines, 2015?2025

Table 118: Key Events Impacting Sales for Meningococcal Disease in Brazil, 2015?2025

Table 119: Brazil Meningococcal Vaccines Market – Drivers and Barriers, 2015?2025

Table 120: Key Launch Dates

Table 121: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Membrane Structure of N. meningitidis

Figure 2: Genetic Clusters for Polysaccharide Capsules

Figure 3: Laboratory-Confirmed Incidence of IMD in the EU, All Ages ...

Figure 1: Membrane Structure of N. meningitidis

Figure 2: Genetic Clusters for Polysaccharide Capsules

Figure 3: Laboratory-Confirmed Incidence of IMD in the EU, All Ages, Both Sexes, 2000–2014

Figure 4: 8MM, Laboratory-Confirmed Incident Cases of all IMD, All Ages, Both Sexes, N, Selected Years 2015–2025

Figure 5: 7MM, Age-Specific Laboratory-Confirmed Incident Cases of IMD, Both Sexes, 2015

Figure 6: 8MM, Laboratory-Confirmed Incident Cases of All IMD, All Ages, Both Sexes, N, 2015

Figure 7: 8MM, Age-Standardized Laboratory-Confirmed Incidence (Cases per 100,000 Population) of IMD, All Ages, by Sex, 2015

Figure 8: 8MM, Laboratory-Confirmed Incident Cases of Serogroup B IMD, All Ages, Both Sexes, N, Selected Years 2015–2025

Figure 9: 8MM, Laboratory-Confirmed Incident Cases of Serogroup C IMD, All Ages, Both Sexes, N, Selected Years, 2015–2025

Figure 10: 8MM, Laboratory-Confirmed Incident Cases of Serogroup Y IMD, All Ages, Both Sexes, N, Selected Years, 2015–2025

Figure 11: 8MM, Laboratory-Confirmed Incident Cases of Other Serogroup IMD, All Ages, Both Sexes, N, Selected Years, 2015–2025

Figure 12: 8MM, Serogroup Distribution of Laboratory-Confirmed Incident IMD Cases, %, 2015

Figure 13: 8MM, Serogroup Distribution of Laboratory-Confirmed Incident IMD Cases, %, 2025

Figure 14: College Freshmen Living in Campus Accommodation in the US, All Ages, Both Sexes, N, Selected Years, 2015–2025

Figure 15: National Immunization Schedule for Meningococcal Vaccines across the 8MM

Figure 16: Meningococcal Vaccines – Key Clinical Trial Landscape, 2016

Figure 17: Meningococcal Vaccines – Phase II/III Pipeline, 2016

Figure 18: Competitive Assessment of Late-Stage Pipeline Meningococcal Vaccines, 2015–2025

Figure 19: Clinical and Commercial Positioning of MenABCWY

Figure 20: Clinical and Commercial Positioning of Men Quad TT

Figure 21: Clinical and Commercial Positioning of Brazil’s MenC

Figure 22: Global Sales of Branded Vaccines for Meningococcal Disease by Company, 2015–2025

Figure 23: Company Portfolio Gap Analysis in Meningococcal Vaccines, 2015–2025

Figure 24: Annual Sales of Meningococcal Vaccines by Type of Vaccine in 2015 and 2025

Figure 25: Global Sales for Meningococcal Vaccines by Region, 2015 and 2025

Figure 26: US Sales of Meningococcal Vaccines by Type of Vaccine in 2015 and 2025

Figure 27: Sales of Meningococcal Vaccines by Type of Vaccine in the 5EU in 2015 and 2025

Figure 28: France Sales of Meningococcal Vaccines by Type of Vaccine in 2015 and 2025

Figure 29: Germany Sales of Meningococcal Vaccines by Type of Vaccine in 2015 and 2025

Figure 30: Italy Sales of Meningococcal Vaccines by Type of Vaccine in 2015 and 2025

Figure 31: Spain Sales of Meningococcal Vaccines by Type of Vaccine in 2015 and 2025

Figure 32: UK Sales of Meningococcal Vaccines by Type of Vaccine in 2015 and 2025

Figure 33: Japan Sales of Meningococcal Vaccines by Type of Vaccine in 2015 and 2025

Figure 34: Brazil Sales of Meningococcal Vaccines by Type of Vaccine in 2015 and 2025

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