Meningococcal disease is an acute infection caused by the gram-negative bacterium Neisseria meningitidis. Its rapid onset and severity of symptoms makes prompt and effective diagnosis and treatment nearly impossible. For these reasons the meningococcal disease space is dominated by vaccines. Currently, tetravalent conjugate vaccines, such as Sanofi’s Menactra and Novartis’ Menveo, account for the vast majority of global sales, with the US adolescent market being the key target segment. GlobalData expects growth in the meningococcal vaccines market to be driven by the launch of serotype B vaccines, which address a critical unmet need in the treatment landscape, and an increase in the coverage rates of existing routine vaccination programs. Cost-effectiveness concerns, especially for serogroup B vaccines, will serve as a key barrier to market growth. Vaccines that better protect infants and/or provide a longer duration of immunity also have an opportunity to seize market share during 2012-2022.

Highlights

Key Questions Answered

• How large an impact will serotype B vaccines have on the meningococcal market? What do key opinion leaders think of these vaccines?

 

• What are the key vaccines for each age segment and country?

 

• Which meningococcal vaccines will face adoption challenges in the market? What is the projected uptake of new vaccines, such as Novartis’ Bexsero, over the forecast period?

 

• The developmental pipeline consists of vaccines that address serotype B protection and immunogenicity in infants. Which of these vaccines will attain high sales revenues during 2012-2022 and in which markets?

 

• What governmental and industry developments are likely to affect the vaccination rates in the markets researched? Which is the largest growth market globally?

 

Key Findings

• Country-specific epidemiology and serotype distributions heavily influence immunization recommendations and vaccine usage.

 

• The potential impact of serogroup B vaccines on the marketplace will be determined by their inclusion in routine vaccination programs.

 

• Major players will leverage their R&D, manufacturing, and distribution networks to maintain their stakes in the market.

 

• Government endorsements of new and existing vaccines, in particular serogroup B vaccines, are anticipated to dramatically influence market growth.

 

Scope

• Overview of meningococcal disease, including epidemiology, etiology, general symptoms from infection, and national vaccination recommendations and guidelines.

 

• Annualized meningococcal vaccine market revenue, annual cost of vaccination and treatment usage pattern data from 2012 and forecast for ten years to 2022.

 

• Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the meningococcal vaccine market.

 

• Pipeline analysis: comprehensive data split across different phases and emerging trends, specifically serotype B vaccines and early stage infant and pentavalent vaccines.

 

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

 

Reasons to buy

• Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.

 

• Develop business strategies by understanding the trends shaping and driving the meningococcal vaccine market.

 

• Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global meningococcal vaccine market in future.

 

• Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.

 

• Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

 

• Track drug sales in the global meningococcal vaccine market from 2012-2022.

 

• Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

 

Table of Contents

 

 

1 Table of Contents 8

1.1 List of Tables 15

1.2 List of Figures 19

 

2 Introduction 20

2.1 Catalyst 20

2.2 Related Reports 21

2.3 Upcoming Related Reports 21

 

3 Disease Overview 22

3.1 Etiology and Pathophysiology 23

3.1.1 Etiology 23

3.1.2 Pathophysiology 25

3.2 Symptoms 27

3.3 Prognosis 28

 

4 Epidemiology 29

4.1 Disease Background 29

4.2 Risk Factors and Comorbidities 30

4.2.1 Infants and Young Children are at Greatest Risk for Developing Meningococcal Disease 30

4.2.2 Direct Contact and Overcrowding are the Primary Risk Factors for Infection 31

4.2.3 Exposure is Highest for Those Traveling to the African "Meningitis Belt" 32

4.3 Global Trends 33

4.3.1 US 33

4.3.2 5EU 34

4.3.3 Australia 35

4.3.4 Brazil 36

4.4 Forecast Methodology 37

4.4.1 Sources Used 39

4.4.2 Forecast Assumptions and Methods 44

4.4.3 Sources Not Used 49

4.5 Epidemiology Forecast of Meningococcal Disease (2012-2022) 50

4.5.1 Incident Cases of Meningococcal Disease 50

4.5.2 Age-Specific Incident Cases of Meningococcal Disease 53

4.5.3 Incident Cases of Meningococcal Disease By Serogroup 56

4.6 Discussion 58

4.6.1 Conclusions on Epidemiological Trends 58

4.6.2 Limitations of the Analysis 59

4.6.3 Strengths of the Analysis 60

 

5 Disease Management 61

5.1 Meningococcal Immunization Policy 62

5.2 US 65

5.2.1 Meningococcal Immunization Recommendations and Policies 65

5.2.2 Clinical Practice 68

5.3 France 70

5.3.1 Meningococcal Immunization Recommendations and Policies 70

5.3.2 Clinical Practice 72

5.4 Germany 74

5.4.1 Meningococcal Immunization Recommendations and Policies 74

5.4.2 Clinical Practice 75

5.5 Italy 76

5.5.1 Meningococcal Immunization Recommendations and Policies 76

5.5.2 Clinical Practice 77

5.6 Spain 78

5.6.1 Meningococcal Immunization Recommendations and Policies 78

5.6.2 Clinical Practice 79

5.7 UK 81

5.7.1 Meningococcal Immunization Recommendations and Policies 81

5.7.2 Clinical Practice 83

5.8 Japan 85

5.8.1 Meningococcal Immunization Recommendations and Policies 85

5.8.2 Clinical Practice 85

5.9 Australia 86

5.9.1 Meningococcal Immunization Recommendations and Policies 86

5.9.2 Clinical Practice 88

5.10 Brazil 90

5.10.1 Meningococcal Immunization Recommendations and Policies 90

5.10.2 Clinical Practice 91

 

6 Competitive Assessment 93

6.1 Overview 93

6.2 Strategic Competitor Assessment 93

6.3 Product Profiles - Major Brands 95

6.3.1 Menactra 95

6.3.2 Menveo 102

6.3.3 Nimenrix 107

6.3.4 MenHibrix 111

6.3.5 Menitorix 116

6.3.6 Meningitec 120

6.3.7 Menjugate 124

6.3.8 NeisVac-C 128

6.3.9 Menomune 132

6.3.10 Bexsero 136

 

7 Opportunity and Unmet Need 141

7.1 Overview 141

7.2 Unmet Needs 142

7.2.1 Unmet Need: Protection Against Serogroup B Disease 142

7.2.2 Unmet Need: A Pentavalent (MenABCWY) Vaccine 143

7.2.3 Unmet Need: More Cost-Effective Vaccines 144

7.2.4 Unmet Need: Improved Duration of Immunity in Children and Adolescents 145

7.2.5 Unmet Need: Immunogenic Infant Vaccines 147

7.2.6 Unmet Need: Improved Vaccination Coverage Rates 148

7.2.7 Unmet Need: Increased Patient Awareness and Education 149

7.3 Unmet Needs Gap Analysis 150

7.4 Opportunities 151

7.4.1 Opportunity: Broadening Serogroup Protection with New and Existing Antigen Combinations 151

7.4.2 Opportunity: Improving Immune Response Duration with Adjuvants 152

7.4.3 Opportunity: Developing More Cost-Effective Vaccines by Partnering with Manufacturers in Emerging Markets 153

 

8 Pipeline Assessment 154

8.1 Overview 154

8.2 Clinical Trial Mapping 155

8.2.1 Clinical Trials by Country 155

8.3 Clinical Trials by Phase and Trial Status 157

8.4 Promising Vaccines in Clinical Development 159

8.4.1 MnB rLP2086 162

8.5 Promising Vaccines in Early Clinical Development 169

8.5.1 Meninge ACYW conj. 170

8.5.2 MenABCWY 174

8.5.3 MenC conjugate 177

8.5.4 Heptavalent DTP-Hib-HepB-IPV-MenC 180

 

9 Current and Future Players 183

9.1 Overview 183

9.2 Trends in Corporate Strategy 187

9.3 Company Profiles 189

9.3.1 Sanofi 189

9.3.2 Novartis 193

9.3.3 GlaxoSmithKline 197

9.3.4 Baxter 200

9.3.5 Nuron Biotech 202

9.3.6 Pfizer 204

 

10 Market Outlook 206

10.1 Global Markets 206

10.1.1 Forecast 206

10.1.2 Drivers and Barriers - Global Issues 210

10.2 United States 214

10.2.1 Forecast 214

10.2.2 Key Events 218

10.2.3 Drivers and Barriers 219

10.3 France 223

10.3.1 Forecast 223

10.3.2 Key Events 227

10.3.3 Drivers and Barriers 228

10.4 Germany 230

10.4.1 Forecast 230

10.4.2 Key Events 233

10.4.3 Drivers and Barriers 234

10.5 Italy 236

10.5.1 Forecast 236

10.5.2 Key Events 239

10.5.3 Drivers and Barriers 240

10.6 Spain 242

10.6.1 Forecast 242

10.6.2 Key Events 245

10.6.3 Drivers and Barriers 246

10.7 United Kingdom 248

10.7.1 Forecast 248

10.7.2 Key Events 252

10.7.3 Drivers and Barriers 253

10.8 Japan 255

10.8.1 Drivers and Barriers 255

10.9 Australia 257

10.9.1 Forecast 257

10.9.2 Key Events 261

10.9.3 Drivers and Barriers 262

10.10 Brazil 264

10.10.1 Forecast 264

10.10.2 Key Events 267

10.10.3 Drivers and Barriers 268

 

11 Appendix 270

11.1 Bibliography 270

11.2 Abbreviations 292

11.3 Methodology 295

11.4 Forecasting Methodology 295

11.4.1 Vaccine Coverage 296

11.4.2 Vaccine Approval vs. Routine Schedule Inclusion 296

11.4.3 Vaccines Included 297

11.4.4 Key Launch Dates 298

11.4.5 General Pricing Assumptions 299

11.4.6 Individual Vaccine Assumptions 300

11.4.7 Pricing of Pipeline agents 307

11.5 Physicians and Specialists Included in this Study 308

11.6 About the Authors 312

11.6.1 Authors 312

11.6.2 Reviewers 312

11.6.3 Epidemiologists 313

11.6.4 Global Head of Healthcare 314

11.7 About GlobalData 315

11.8 Disclaimer 315

 

List of Tables

 

Table 1: Symptoms of Meningococcal Disease 27

Table 2: Risk Factors for Meningococcal Disease 30

Table 3: Sources of Incidence Data Used in the Epidemiology Forecast 38

Table 4: 8MM, Incident Cases of Meningococcal Disease, N, Select Years, 2012-2022 51

Table 5: 8MM, Incident Cases of Meningococcal Disease, By Age, N (Row %), 2012 54

Table 6: 8MM, Incident Cases of Meningococcal Disease, By Serogroup, N (Row %), 2012 56

Table 7: Meningococcal Immunization Recommendation Agencies by Country 63

Table 8: Recommended Routine Coverage and Most Administered Meningococcal Vaccines by Country in the Global Markets, 2012 64

Table 9: Leading Vaccines for Meningococcal Disease, 2012 94

Table 10: Product Profile - Menactra 96

Table 11: Menactra SWOT Analysis, 2012 99

Table 12: Global Sales Forecasts ($m) for Menactra, 2012-2022 101

Table 13: Product Profile - Menveo 103

Table 14: Menveo SWOT Analysis, 2012 105

Table 15: Global Sales Forecasts ($m) for Menveo, 2012-2022 106

Table 16: Product Profile - Nimenrix 108

Table 17: Nimenrix SWOT Analysis, 2012 109

Table 18: Global Sales Forecasts ($m) for Nimenrix, 2012-2022 110

Table 19: Product Profile - MenHibrix 112

Table 20: MenHibrix SWOT Analysis, 2012 114

Table 21: Global Sales Forecasts ($m) for MenHibrix, 2012-2022 115

Table 22: Product Profile - Menitorix 117

Table 23: Menitorix SWOT Analysis, 2012 118

Table 24: Global Sales Forecasts ($m) for Menitorix, 2012-2022 119

Table 25: Product Profile - Meningitec 121

Table 26: Meningitec SWOT Analysis, 2012 122

Table 27: Global Sales Forecasts ($m) for Meningitec, 2012-2022 123

Table 28: Product Profile - Menjugate 125

Table 29: Menjugate SWOT Analysis, 2012 126

Table 30: Global Sales Forecasts ($m) for Menjugate, 2012-2022 127

Table 31: Product Profile - NeisVac-C 129

Table 32: NeisVac-C SWOT Analysis, 2012 130

Table 33: Global Sales Forecasts ($m) for NeisVac-C, 2012-2022 131

Table 34: Product Profile - Menomune 133

Table 35: Menomune SWOT Analysis, 2012 134

Table 36: Global Sales Forecasts ($m) for Menomune, 2012-2022 135

Table 37: Product Profile - Bexsero 137

Table 38: Bexsero SWOT Analysis, 2012 138

Table 39: Global Sales Forecasts ($m) for Bexsero, 2012-2022 140

Table 40: Overall Unmet Needs - Current Level of Attainment 141

Table 41: Clinical Unmet Needs - Gap Analysis, 2012 150

Table 42: Meningococcal Vaccines - Clinical Trials by Phase and Status, 2012 158

Table 43: Meningococcal Vaccines - Phase Pipeline, 2012 160

Table 44: Comparison of Vaccines in Development for Meningococcal Disease, 2012 161

Table 45: Product Profile - MnB rLP2086 163

Table 46: MnB rLP2086 SWOT Analysis, 2012 166

Table 47: Global Sales Forecasts ($m) for MnB rLP2086, 2012-2022 168

Table 48: Product Profile - Meninge ACYW conj. 170

Table 49: Meninge ACYW conj. SWOT Analysis, 2012 173

Table 50: Product Profile - MenABCWY 175

Table 51: MenABCWY SWOT Analysis, 2012 176

Table 52: Product Profile - MenC conjugate 178

Table 53: MenC conjugate SWOT Analysis, 2012 179

Table 54: Product Profile - Heptavalent DTP-Hib-HepB-IPV-MenC 180

Table 55: Heptavalent DTP-Hib-HepB-IPV-MenC SWOT Analysis, 2012 182

Table 56: Key Companies in the Meningococcal Vaccines Market, 2012 186

Table 57: Sanofi's Meningococcal Vaccines Portfolio Assessment, 2012 191

Table 58: Sanofi SWOT Analysis, 2012 192

Table 59: Novartis' Meningococcal Vaccines Portfolio Assessment, 2012 195

Table 60: Novartis SWOT Analysis, 2012 196

Table 61: GSK's Meningococcal Vaccines Portfolio Assessment, 2012 198

Table 62: GSK SWOT Analysis, 2012 199

Table 63: Baxter's Meningococcal Vaccines Portfolio Assessment, 2012 201

Table 64: Baxter SWOT Analysis, 2012 201

Table 65: Nuron Biotech's Meningococcal Vaccines Portfolio Assessment, 2012 203

Table 66: Nuron Biotech SWOT Analysis, 2012 203

Table 67: Pfizer's Meningococcal Vaccines Portfolio Assessment, 2012 205

Table 68: Pfizer SWOT Analysis, 2012 205

Table 69: Global Sales Forecasts ($m) for Meningococcal Vaccines, 2012-2022 208

Table 70: Global Meningococcal Vaccines Market - Drivers and Barriers, 2012-2022 210

Table 71: Sales Forecasts ($m) for Meningococcal Vaccines in the United States, 2012-2022 216

Table 72: Key Events Impacting Sales for Meningococcal Vaccines in US, 2012 219

Table 73: United States Meningococcal Vaccines Market - Drivers and Barriers, 2012-2022 219

Table 74: Sales Forecasts ($m) for Meningococcal Vaccines in France, 2012-2022 225

Table 75: Key Events Impacting Sales for Meningococcal Vaccines in France, 2012-2022 227

Table 76: France Meningococcal Vaccines Market - Drivers and Barriers, 2012-2022 228

Table 77: Sales Forecasts ($m) for Meningococcal Vaccines in Germany, 2012-2022 231

Table 78: Key Events Impacting Sales for Meningococcal Vaccines in Germany, 2012-2022 233

Table 79: Germany Meningococcal Vaccines Market - Drivers and Barriers, 2012-2022 234

Table 80: Sales Forecasts ($m) for Meningococcal Vaccines in Italy, 2012--2022 237

Table 81: Key Events Impacting Sales for Meningococcal Vaccines in Italy, 2012-2022 239

Table 82: Italy Meningococcal Vaccines Market - Drivers and Barriers, 2012-2022 240

Table 83: Sales Forecasts ($m) for Meningococcal Vaccines in Spain, 2012-2022 243

Table 84: Key Events Impacting Sales for Meningococcal Vaccines in Spain, 2012-2022 245

Table 85: Spain Meningococcal Vaccines Market - Drivers and Barriers, 2012-2022 246

Table 86: Sales Forecasts ($m) for Meningococcal Vaccines in the United Kingdom, 2012-2022 250

Table 87: Key Events Impacting Sales for Meningococcal Vaccines in UK, 2012-2022 252

Table 88: United Kingdom Meningococcal Vaccines Market - Drivers and Barriers, 2012-2022 253

Table 89: Japan Meningococcal Vaccines Market - Drivers and Barriers, 2012-2022 255

Table 90: Sales Forecasts ($m) for Meningococcal Vaccines in Australia, 2012-2022 259

Table 91: Key Events Impacting Sales for Meningococcal Vaccines in Australia, 2012-2022 261

Table 92: Australia Meningococcal Vaccines Market - Drivers and Barriers, 2012-2022 262

Table 93: Sales Forecasts ($m) for Meningococcal Vaccines in Brazil, 2012-2022 265

Table 94: Key Events Impacting Sales for Meningococcal Vaccines in Brazil, 2012-2022 267

Table 95: Brazil Meningococcal Vaccines Market - Drivers and Barriers, 2012-2022 268

Table 96: Key Launch Dates 298

Table 97: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 311

 

List of Figures

 

Figure 1: Membrane Structure of N. meningitidis 24

Figure 2: 8MM, Incident Cases of Meningococcal Disease, N, Select Years, 2012-2022 52

Figure 3: 8MM, Incident Cases of Meningococcal Disease, By Age, N, 2012 55

Figure 4: 8MM, Incident Cases of Meningococcal Disease, By Serogroup, %, 2012 57

Figure 5: Meningococcal Vaccines - Clinical Trials by Country, 2012 155

Figure 6: Competitive Assessment of Late-Stage Pipeline Agents in Meningococcal Vaccines, 2012-2022 160

Figure 7: Company Portfolio Gap Analysis in Meningococcal Vaccines, 2012-2022 186

Figure 8: Global Sales for Meningococcal Vaccines by Region, 2012-2022 209

Figure 9: Sales for Meningococcal Vaccines in the United States by Vaccine Class, 2012-2022 217

Figure 10: Sales for Meningococcal Vaccines in France by Vaccine Class, 2012-2022 226

Figure 11: Sales for Meningococcal Vaccines in Germany by Vaccine Class, 2012-2022 232

Figure 12: Sales for Meningococcal Vaccines in Italy by Vaccine Class, 2012-2022 238

Figure 13: Sales for Meningococcal Vaccines in Spain by Vaccine Class, 2012-2022 244

Figure 14: Sales for Meningococcal Vaccines in the United Kingdom by Vaccine Class, 2012-2022 251

Figure 15: Sales for Meningococcal Vaccines in Australia by Vaccine Class, 2012-2022 260

Figure 16: Sales for Meningococcal Vaccines in Brazil by Vaccine Class, 2012-2022 266