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

Summary

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.

Highlights

Key Questions Answered

- 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?

Key Findings

- GlobalData projects the meningococcal vaccine market in the US, 5EU, Japan, and Brazil to grow from approximately $1.1bn in 2015 to $1.8bn in 2025, at a compound annual growth rate (CAGR) of 5.4%. This growth across the 8MM will primarily be driven by the introduction of additional meningococcal vaccines into the national routine infant and adolescent vaccination schedules in some 5EU countries. Further growth will be the result of the launch of a pentavalent MenABCWY vaccine during the forecast period while the commercial meningococcal vaccine markets in Brazil and Japan will experience a decline at a negative CAGR of 1.8% and 0.9% respectively.
- With most countries in the 8MM using serogroup B vaccines only for individuals at high risk of contracting meningococcal disease, the routine application of these protein-based vaccines is seen as the major unmet need to be addressed in the oncoming years.
- GlobalData anticipates that opportunities will center on the improvement of vaccine long-term efficacy whilst addressing the cost effectiveness concerns voiced by various governmental institutions.

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.

Reasons to buy

The report will enable you to -
- 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 global meningococcal vaccine market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the meningococcal vaccine market in the 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.
- 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

PharmaPoint: Meningococcal Vaccines - Global Drug Forecast and Market Analysis to 2025
1 Table of Contents
1 Table of Contents 11


2 Introduction 26
2.1 Catalyst 26
2.2 Related Reports 27
2.3 Upcoming Related Reports 27
3 Disease Overview 28
3.1 Introduction 28
3.2 Etiology and Pathophysiology 29
3.2.1 Etiology 29
3.2.2 Pathophysiology 35
3.3 Symptoms 37
3.4 Prognosis 38
4 Epidemiology 39
4.1 Disease Background 39
4.2 Risk Factors and morbidities 40
4.3 Global Trends 42
4.3.1 US 43
4.3.2 5EU 44
4.3.3 Japan and Brazil 46
4.4 Forecast Methodology 47
4.4.1 Sources Used Tables 48
4.4.2 Forecast Assumptions and Methods 55
4.4.3 Sources Not Used 69
4.5 Epidemiological Forecast for IMD (2015-2025) 70
4.5.1 All IMD Combined 70
4.5.2 Laboratory-Confirmed Incident Cases of Serogroup B IMD 79
4.5.3 Laboratory-Confirmed Incident Cases of Serogroup C IMD 82
4.5.4 Laboratory-Confirmed Incident Cases of Serogroup Y IMD 84
4.5.5 Laboratory-Confirmed Incident Cases of Other Serogroup IMD 86
4.5.6 Distribution of Serogroups 88
4.5.7 US College Freshmen 90
4.6 Discussion 91
4.6.1 Epidemiological Forecast Insight 91
4.6.2 Limitations of the Analysis 93
4.6.3 Strengths of the Analysis 94
5 Disease Management 95
5.1 Meningococcal Immunization Policy 95
5.1.1 Routine Immunization Recommendations and Most Frequently Administered Meningococcal Vaccines 98
5.2 US 101
5.2.1 Immunization Recommendations 103
5.2.2 Clinical Practice 107
5.3 France 109
5.3.1 Immunization Recommendations 110
5.3.2 Clinical Practice 113
5.4 Germany 115
5.4.1 Immunization Recommendations 115
5.4.2 Clinical Practice 118
5.5 Italy 119
5.5.1 Immunization Recommendations 120
5.5.2 Clinical Practice 122
5.6 Spain 122
5.6.1 Immunization Recommendations 123
5.6.2 Clinical Practice 126
5.7 UK 127
5.7.1 Immunization Recommendations 128
5.7.2 Clinical Practice 131
5.8 Japan 132
5.9 Brazil 134
5.9.1 Immunization Recommendations 135
5.9.2 Clinical Practice 137
6 Competitive Assessment 138
6.1 Overview 138
6.2 Product Profiles - MenACWY Vaccines 140
6.2.1 Menactra 140
6.2.2 Menveo 147
6.2.3 Nimenrix 154
6.3 Product Profiles - MenB Vaccines 160
6.3.1 Bexsero 160
6.3.2 Trumenba 169
6.4 Product Profiles - MenC Vaccines 177
6.4.1 NeisVac-C 177
6.4.2 Menjugate 182
6.4.3 Menitorix 188
6.5 Other Meningococcal Vaccines 192
6.5.1 Overview 192
7 Unmet Needs and Opportunities 197
7.1 Overview 197
7.2 A Safe and Effective Universal Meningococcal Vaccine 199
7.2.1 Unmet Need 199
7.2.2 Gap Analysis 200
7.2.3 Opportunity 201
7.3 Long-Term Protection Against Invasive Meningococcal Disease 203
7.3.1 Unmet Need 203
7.3.2 Gap Analysis 203
7.3.3 Opportunity 204
7.4 Improvements in Clinical Trial Design 205
7.4.1 Unmet Need 205
7.4.2 Gap Analysis 207
7.4.3 Opportunity 208
7.5 Improved Vaccine Cost Effectiveness 209
7.5.1 Unmet Need 209
7.5.2 Gap Analysis 210
7.5.3 Opportunity 210
7.6 A Prenatal Meningococcal Vaccine 212
7.6.1 Unmet Need 212
7.6.2 Gap Analysis 212
7.6.3 Opportunity 213
7.7 Reducing Vaccination Frequency in Infants 214
7.7.1 Unmet Need 214
7.7.2 Gap Analysis 215
7.7.3 Opportunity 215
7.8 Enhanced Education and Awareness of the General Population 217
7.8.1 Unmet Need 217
7.8.2 Gap Analysis 218
7.8.3 Opportunity 219
8 Pipeline Assessment 221
8.1 Overview 221
8.2 Clinical Trial Mapping and Future Trends 223
8.2.1 Clinical Trials by Status 223
8.2.2 Clinical Trials by Pipeline Vaccine 224
8.2.3 Future Clinical Trial Design Considerations 225
8.3 Promising Vaccines in Clinical Development 229
8.3.1 MenABCWY 231
8.3.2 Men Quad TT 242
8.3.3 Brazil MenC Vaccine 248
8.4 Promising Early-Stage Pipeline Products 252
9 Current and Future Players 255
9.1 Overview 255
9.2 Trends in Corporate Strategy 261
9.3 Company Profiles 264
9.3.1 GlaxoSmithKline 264
9.3.2 Sanofi 271
9.3.3 Pfizer 275
10 Market Outlook 281
10.1 Global Markets 281
10.1.1 Forecast 281
10.1.2 Drivers and Barriers - Global Issues 288
10.2 United States 296
10.2.1 Forecast 296
10.2.2 Key Events 303
10.2.3 Drivers and Barriers 303
10.3 5EU 309
10.3.1 5EU 309
10.3.2 France 323
10.3.3 Germany 327
10.3.4 Italy 331
10.3.5 Spain 335
10.3.6 UK 340
10.4 Japan 345
10.4.1 Forecast 345
10.4.2 Key Events 348
10.4.3 Drivers and Barriers 349
10.5 Brazil 351
10.5.1 Forecast 351
10.5.2 Key Events 354
10.5.3 Drivers and Barriers 354
11 Appendix 356
11.1 Bibliography 356
11.2 Abbreviations 398
11.3 Methodology 404
11.4 Forecasting Methodology 404
11.4.1 Vaccine Coverage 405
11.4.2 Vaccine Approval vs. Routine Schedule Inclusion 405
11.4.3 Vaccines Included 405
11.4.4 Key Launch Dates 406
11.4.5 General Pricing Assumptions 407
11.4.6 Individual Vaccine Assumptions 408
11.4.7 Pricing of Pipeline Agents 413
11.5 Primary Research - KOLs Interviewed for this Report 414
11.6 Primary Research - Prescriber Survey 419
11.7 About the Authors 420
11.7.1 Analyst 420
11.7.2 Therapy Area Director 420
11.7.3 Epidemiologist 421
11.7.4 Managing Epidemiologist 421
11.7.5 Global Director of Therapy Analysis and Epidemiology 422
11.7.6 Global Head of Healthcare 422
11.8 About GlobalData 423
11.9 Disclaimer 423

1.1 List of Tables
Table 1: Symptoms of Meningococcal Disease 38
Table 2: Risk Factors and Comorbidities for IMD 41
Table 3: 8MM, Sources of Laboratory-Confirmed IMD Incidence 48
Table 4: 8MM, Sources of Laboratory-Confirmed Serogroup B IMD Incidence 49
Table 5: 8MM, Sources of Laboratory-Confirmed Serogroup C IMD Incidence 50
Table 6: 8MM, Sources of Laboratory-Confirmed Serogroup Y IMD Incidence 51
Table 7: 8MM, Sources of Laboratory-Confirmed Other Serogroup IMD Incidence (Includes Serogroups A, W, X, and All Others) 52
Table 8: 5EU, Japan, and Brazil Sources of Laboratory-Confirmed Serogroup W IMD Incidence 53
Table 9: Germany, Italy, and Brazil, Sources of Laboratory-Confirmed Serogroup A IMD Incidence 54
Table 10: College Freshmen Residing in Campus Accommodation 54
Table 11: 8MM, Laboratory-Confirmed Incident Cases of All IMD, All Ages, Both Sexes, N, Selected Years 2015-2025 71
Table 12: 8MM and Japan, Age-specific Laboratory-Confirmed Incident Cases of IMD, Both Sexes, N (Row %), 2015 73
Table 13: 7MM, Age-Specific Laboratory-Confirmed Incident Cases of IMD, Both Sexes, N (Row %), 2015 74
Table 14: 8MM, Laboratory-Confirmed Incident Cases of All IMD, All Ages, Both Sexes, N (Row %), 2015 76
Table 15: 8MM, Laboratory-Confirmed Incident Cases of Serogroup B IMD, All Ages, Both Sexes, N, Selected Years 2015-2025 81
Table 16: 8MM, Laboratory-Confirmed Incident Cases of Serogroup C IMD, All Ages, Both Sexes, N, Selected Years, 2015-2025 83
Table 17: 8MM, Laboratory-Confirmed Incident Cases of Serogroup Y IMD, All Ages, Both Sexes, N, Selected Years, 2015-2025 85
Table 18: 8MM, Laboratory-Confirmed Incident Cases of Other Serogroup IMD, All Ages, Both Sexes, N, Selected Years, 2015-2025 87
Table 19: College Freshmen in the US, All Ages, Both Sexes, N, Selected Years, 2015-2025 91
Table 20: National Immunization Recommendation Agencies, 2016 98
Table 21: National Immunization Recommendations for Meningococcal Vaccines, 2016 100
Table 22: Most Frequently Administered Meningococcal Vaccines in the Global Markets, 2015 101
Table 23: Country Profile - US 103
Table 24: Country Profile - France 110
Table 25: Country Profile - Germany 115
Table 26: Country Profile - Italy 120
Table 27: Country Profile - Spain 123
Table 28: Country Profile - UK 128
Table 29: Country Profile - Japan 134
Table 30: Country Profile - Brazil 135
Table 31: Leading Vaccines Against Meningococcal Disease, 2015 140
Table 32: Product Profile - Menactra 142
Table 33: Efficacy of Menactra for Individuals Receiving Either One- or Two-Dose Regimens 144
Table 34: Safety of Menactra for Individuals Receiving One Dose of Menactra 145
Table 35: Menactra SWOT Analysis, 2016 145
Table 36: Global Sales Forecast ($m) for Menactra, 2015-2025 147
Table 37: Product Profile - Menveo 149
Table 38: Efficacy of Menveo 150
Table 39: Safety of Menveo 151
Table 40: Menveo SWOT Analysis, 2016 152
Table 41: Global Sales Forecasts ($m) for Menveo, 2015-2025 154
Table 42: Product Profile - Nimenrix 156
Table 43: Efficacy of Nimenrix 157
Table 44: Safety of Nimenrix 158
Table 45: Nimenrix SWOT Analysis, 2016 159
Table 46: Global Sales Forecast ($m) for Nimenrix, 2015-2025 160
Table 47: Product Profile - Bexsero 162
Table 48: Efficacy of Bexsero 165
Table 49: Safety of Bexsero 166
Table 50: Bexsero SWOT Analysis, 2016 167
Table 51: Global Sales Forecasts ($m) for Bexsero, 2015-2025 169
Table 52: Product Profile - Trumenba 171
Table 53: Efficacy of Trumenba 173
Table 54: Safety of Trumenba 174
Table 55: Trumenba SWOT Analysis, 2016 175
Table 56: Global Sales Forecasts ($m) for Trumenba, 2015-2025 177
Table 57: Product Profile - NeisVac-C 178
Table 58: Efficacy of NeisVac-C 179
Table 59: Safety of NeisVac-C 180
Table 60: NeisVac-C SWOT Analysis, 2016 181
Table 61: Global Sales Forecasts ($m) for NeisVac-C, 2015-2025 182
Table 62: Product Profile - Menjugate 183
Table 63: Efficacy of Menjugate 184
Table 64: Safety of Menjugate 185
Table 65: Menjugate SWOT Analysis, 2016 186
Table 66: Global Sales Forecasts ($m) for Menjugate, 2015-2025 187
Table 67: Product Profile - Menitorix 189
Table 68: Efficacy of Menitorix 190
Table 69: Safety of Menitorix 190
Table 70: Menitorix SWOT Analysis, 2016 191
Table 71: Global Sales Forecasts ($m) for Menitorix, 2015-2025 192
Table 72: Other Meningococcal Vaccines 193
Table 73: Unmet Needs and Opportunities for Meningococcal Vaccines 198
Table 74: Product Profile - MenABCWY 234
Table 75: Immunogenicity of MenABCWY 236
Table 76: MenABCWY SWOT Analysis, 2016 240
Table 77: Global Sales Forecast ($m) for MenABCWY, 2015-2025 242
Table 78: Product Profile - Men Quad TT 243
Table 79: Men Quad TT SWOT Analysis, 2016 247
Table 80: Global Sales Forecasts ($m) for Men Quad TT, 2015-2025 248
Table 81: Product Profile - Brazil's MenC 249
Table 82: Brazil MenC SWOT Analysis, 2016 251
Table 83: Global Sales Forecast ($m) for Brazil's MenC, 2015-2025 252
Table 84: Important Meningococcal Vaccines in Development, 2016 254
Table 85: Key Companies in the Meningococcal Vaccine Market in the 8MM, 2016 259
Table 86: GSK's Meningococcal Vaccines Portfolio Assessment, 2016 269
Table 87: GSK SWOT Analysis in Meningococcal Vaccines, 2016 270
Table 88: Sanofi's Meningococcal Vaccines Portfolio Assessment, 2016 274
Table 89: Sanofi SWOT Analysis in Meningococcal Vaccines, 2016 275
Table 90: Pfizer's Meningococcal Vaccines Portfolio Assessment, 2016 279
Table 91: Pfizer SWOT Analysis in Meningococcal Vaccines, 2016 280
Table 92: Global Sales Forecasts ($m) for Meningococcal Vaccines, 2015-2025 285
Table 93: 8MM Meningococcal Vaccines Market - Drivers and Barriers, 2015-2025 288
Table 94: US Sales Forecast ($m) for Meningococcal Vaccines, 2015?2025 301
Table 95: Key Events Impacting Sales for Meningococcal Disease in the US, 2015?2025 303
Table 96: US Meningococcal Vaccines Market - Drivers and Barriers, 2015?2025 303
Table 97: 5EU Sales Forecasts ($m) for Meningococcal Vaccines, 2015?2025 315
Table 98: 5EU Meningococcal Vaccines Market - Drivers and Barriers, 2015?2025 317
Table 99: France Sales Forecast ($m) for Meningococcal Vaccines, 2015?2025 324
Table 100: Key Events Impacting Sales for Meningococcal Vaccines in France, 2015?2025 326
Table 101: France Meningococcal Vaccines Market - Drivers and Barriers, 2015?2025 326
Table 102: Sales Forecast ($m) for Meningococcal Vaccines in Germany, 2015?2025 328
Table 103: Key Events Impacting Sales for Meningococcal Disease in Germany, 2015?2025 330
Table 104: Germany Meningococcal Vaccines market - Drivers and Barriers, 2015?2025 330
Table 105: Italy Sales Forecasts ($m) for Meningococcal Vaccines, 2015?2025 332
Table 106: Key Events Impacting Sales for Meningococcal Disease in Italy, 2015?2025 334
Table 107: Italy Meningococcal Vaccines Market - Drivers and Barriers, 2015?2025 334
Table 108: Spain Sales Forecast ($m) for Meningococcal Vaccines, 2015?2025 337
Table 109: Key Events Impacting Sales for Meningococcal Vaccines in Spain, 2015?2025 339
Table 110: Spain Meningococcal Vaccines Market - Drivers and Barriers, 2015?2025 339
Table 111: UK Sales Forecast ($m) for Meningococcal Vaccines, 2015?2025 342
Table 112: Key Events Impacting Sales for Meningococcal Disease in the UK, 2015?2025 344
Table 113: UK Meningococcal Vaccines market - Drivers and Barriers, 2015?2025 344
Table 114: Japan Sales Forecasts ($m) for Meningococcal Vaccines, 2015?2025 347
Table 115: Key Events Impacting Sales for Meningococcal Vaccines in Japan, 2015?2025 348
Table 116: Japan Meningococcal Vaccines Market - Drivers and Barriers, 2015?2025 349
Table 117: Brazil Sales Forecasts ($m) for Meningococcal Vaccines, 2015?2025 352
Table 118: Key Events Impacting Sales for Meningococcal Disease in Brazil, 2015?2025 354
Table 119: Brazil Meningococcal Vaccines Market - Drivers and Barriers, 2015?2025 354
Table 120: Key Launch Dates 406
Table 121: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 419

1.2 List of Figures
Figure 1: Membrane Structure of N. meningitidis 30
Figure 2: Genetic Clusters for Polysaccharide Capsules 32
Figure 3: Laboratory-Confirmed Incidence of IMD in the EU, All Ages, Both Sexes, 2000-2014 44
Figure 4: 8MM, Laboratory-Confirmed Incident Cases of all IMD, All Ages, Both Sexes, N, Selected Years 2015-2025 72
Figure 5: 7MM, Age-Specific Laboratory-Confirmed Incident Cases of IMD, Both Sexes, 2015 75
Figure 6: 8MM, Laboratory-Confirmed Incident Cases of All IMD, All Ages, Both Sexes, N, 2015 77
Figure 7: 8MM, Age-Standardized Laboratory-Confirmed Incidence (Cases per 100,000 Population) of IMD, All Ages, by Sex, 2015 79
Figure 8: 8MM, Laboratory-Confirmed Incident Cases of Serogroup B IMD, All Ages, Both Sexes, N, Selected Years 2015-2025 82
Figure 9: 8MM, Laboratory-Confirmed Incident Cases of Serogroup C IMD, All Ages, Both Sexes, N, Selected Years, 2015-2025 84
Figure 10: 8MM, Laboratory-Confirmed Incident Cases of Serogroup Y IMD, All Ages, Both Sexes, N, Selected Years, 2015-2025 86
Figure 11: 8MM, Laboratory-Confirmed Incident Cases of Other Serogroup IMD, All Ages, Both Sexes, N, Selected Years, 2015-2025 88
Figure 12: 8MM, Serogroup Distribution of Laboratory-Confirmed Incident IMD Cases, %, 2015 89
Figure 13: 8MM, Serogroup Distribution of Laboratory-Confirmed Incident IMD Cases, %, 2025 90
Figure 14: College Freshmen Living in Campus Accommodation in the US, All Ages, Both Sexes, N, Selected Years, 2015-2025 91
Figure 15: National Immunization Schedule for Meningococcal Vaccines across the 8MM 99
Figure 16: Meningococcal Vaccines - Key Clinical Trial Landscape, 2016 224
Figure 17: Meningococcal Vaccines - Phase II/III Pipeline, 2016 230
Figure 18: Competitive Assessment of Late-Stage Pipeline Meningococcal Vaccines, 2015-2025 231
Figure 19: Clinical and Commercial Positioning of MenABCWY 239
Figure 20: Clinical and Commercial Positioning of Men Quad TT 246
Figure 21: Clinical and Commercial Positioning of Brazil's MenC 250
Figure 22: Global Sales of Branded Vaccines for Meningococcal Disease by Company, 2015-2025 260
Figure 23: Company Portfolio Gap Analysis in Meningococcal Vaccines, 2015-2025 261
Figure 24: Annual Sales of Meningococcal Vaccines by Type of Vaccine in 2015 and 2025 286
Figure 25: Global Sales for Meningococcal Vaccines by Region, 2015 and 2025 287
Figure 26: US Sales of Meningococcal Vaccines by Type of Vaccine in 2015 and 2025 302
Figure 27: Sales of Meningococcal Vaccines by Type of Vaccine in the 5EU in 2015 and 2025 316
Figure 28: France Sales of Meningococcal Vaccines by Type of Vaccine in 2015 and 2025 325
Figure 29: Germany Sales of Meningococcal Vaccines by Type of Vaccine in 2015 and 2025 329
Figure 30: Italy Sales of Meningococcal Vaccines by Type of Vaccine in 2015 and 2025 333
Figure 31: Spain Sales of Meningococcal Vaccines by Type of Vaccine in 2015 and 2025 338
Figure 32: UK Sales of Meningococcal Vaccines by Type of Vaccine in 2015 and 2025 343
Figure 33: Japan Sales of Meningococcal Vaccines by Type of Vaccine in 2015 and 2025 348
Figure 34: Brazil Sales of Meningococcal Vaccines by Type of Vaccine in 2015 and 2025 353

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