多発性硬化症（MS）治療薬の世界市場予測および分析...市場調査レポートについてご紹介

1 Table of Contents
1 Table of Contents 10
1.1 List of Tables 17
1.2 List of Figures 23
2 Introduction 25
2.1 Catalyst 25
2.2 Related Reports 26
3 Disease Overview 27
3.1 Etiology and Pathophysiology 27
3.1.1 Etiology 27
3.1.2 Pathophysiology 28
3.2 Classification 29
3.2.1 Relapse-Remitting Multiple Sclerosis 29
3.2.2 Secondary Progressive Multiple Sclerosis 30
3.2.3 Primary Progressive Multiple Sclerosis 30
3.2.4 Progressive Relapsing Multiple Sclerosis 30
3.3 Symptoms 31
3.4 Prognosis 32
3.5 Quality of Life 33
4 Epidemiology 34
4.1 Disease Background 34
4.2 Risk Factors and Comorbidities 35
4.2.1 Family members of MS patients have a 1-5% risk of developing MS 36
4.2.2 Women are twice as likely to develop MS, but men have a worse prognosis 37
4.2.3 Caucasians have a higher risk of MS than any other race/ethnicity 37
4.2.4 Protective effect of vitamin D on MS may relate to latitude and month of birth 37
4.2.5 Timing of environmental exposures affects MS risk 38
4.2.6 Exposure to smoking may increase MS risk and worsen prognosis 38
4.2.7 Autoimmune Disease Comorbidities of MS 39
4.2.8 Mental comorbidities are found in up to 60% of MS patients and may affect relapse rates 39
4.3 Global Trends 40
4.3.1 North America 40
4.3.2 Europe 41
4.3.3 Asia 41
4.4 Forecast Methodology 42
4.4.1 Sources Used 45
4.4.2 Sources Not Used 51
4.4.3 Forecast Assumptions and Methods 51
4.5 Epidemiological Forecast of Multiple Sclerosis (2014-2024) 58
4.5.1 Diagnosed Prevalent Cases of MS 58
4.5.2 Age-Specific Diagnosed Prevalent Cases of MS 60
4.5.3 Sex-Specific Diagnosed Prevalent Cases of MS 62
4.5.4 Diagnosed Incident Cases of MS 64
4.5.5 Age-Specific Diagnosed Incident Cases of MS 66
4.5.6 Sex-Specific Diagnosed Incident Cases of MS 68
4.5.7 MS Subtypes 69
4.6 Discussion 70
4.6.1 Epidemiological Forecast Insight 70
4.6.2 Limitations of the Analysis 71
4.6.3 Strengths of the Analysis 71
5 Disease Management 72
5.1 Diagnosis 72
5.2 Treatment Overview 76
5.2.1 Management of Acute Relapse 78
5.2.2 Treatment with Disease-Modifying Therapies 78
5.2.3 Symptomatic Therapies 83
5.3 US 84
5.3.1 Diagnosis 84
5.3.2 Drug Treatment 85
5.4 France 89
5.4.1 Diagnosis 89
5.4.2 Drug Treatment 90
5.5 Germany 92
5.5.1 Diagnosis 92
5.5.2 Drug Treatment 93
5.6 Italy 95
5.6.1 Diagnosis 95
5.6.2 Drug Treatment 96
5.7 Spain 98
5.7.1 Diagnosis 98
5.7.2 Drug Treatment 99
5.8 UK 101
5.8.1 Diagnosis 101
5.8.2 Drug Treatment 102
5.9 Japan 104
5.9.1 Diagnosis 104
5.9.2 Drug Treatment 105
5.10 Canada 107
5.10.1 Diagnosis 107
5.10.2 Drug Treatment 108
5.11 China 110
5.11.1 Diagnosis 110
5.11.2 Drug Treatment 111
5.12 India 113
5.12.1 Diagnosis 113
5.12.2 Drug Treatment 114
6 Competitive Assessment 116
6.1 Overview 116
6.2 Product Profiles – Major Injectable Brands 118
6.2.1 Betaseron 118
6.2.2 Avonex 123
6.2.3 Rebif 128
6.2.4 Copaxone 132
6.2.5 Tysabri 138
6.2.6 Lemtrada 143
6.2.7 Plegridy 150
6.3 Product Profiles – Major Small Molecule Brands 156
6.3.1 Gilenya 156
6.3.2 Aubagio 162
6.3.3 Tecfidera 167
6.4 Other Disease-Modifying Therapies 173
6.4.1 Overview 173
7 Unmet Need and Opportunity 175
7.1 Overview 175
7.2 Curative Therapies 176
7.2.1 Unmet Need 176
7.2.2 Gap Analysis 177
7.2.3 Opportunity 178
7.3 The High Cost of MS Drugs 179
7.3.1 Unmet Need 179
7.3.2 Gap Analysis 180
7.3.3 Opportunity 181
7.4 Safety and Tolerability of Therapy 181
7.4.1 Unmet Need 181
7.4.2 Gap Analysis 182
7.4.3 Opportunity 183
7.5 Effective Treatments for Progressive MS 183
7.5.1 Unmet Need 183
7.5.2 Gap Analysis 185
7.5.3 Opportunity 185
7.6 Inconvenient Route of Administration and Frequent Dosing 186
7.6.1 Unmet Need 186
7.6.2 Gap Analysis 187
7.6.3 Opportunity 187
7.7 MS Biomarkers for Early Diagnosis and Treatment Choice 187
7.7.1 Unmet Need 187
7.7.2 Gap Analysis 189
7.7.3 Opportunity 189
8 Pipeline Assessment 191
8.1 Overview 191
8.2 Clinical Trial Mapping 191
8.2.1 Clinical Trials by Country 191
8.3 Promising Drugs in Clinical Development 192
8.3.1 Zinbryta 195
8.3.2 Ocrelizumab 203
8.3.3 Ofatumumab 210
8.3.4 Opicinumab 216
8.3.5 Nerventra 221
8.3.6 Masitinib 228
8.3.7 Siponimod 233
8.3.8 Ozanimod 239
8.3.9 Ponesimod 243
8.4 Late-Stage Therapeutic Vaccines 249
8.4.1 NeuroVax 250
8.4.2 Tcelna 253
8.5 Other Drugs in Development 257
9 Current and Future Players 260
9.1 Overview 260
9.2 Trends in Corporate Strategy 262
9.3 Company Profiles 263
9.3.1 Biogen 263
9.3.2 Teva 266
9.3.3 Merck Serono (EMD Serono) 269
9.3.4 Sanofi (Genzyme) 271
9.3.5 Bayer 274
9.3.6 Novartis 277
9.3.7 Roche 280
10 Market Outlook 283
10.1 Global Markets 283
10.1.1 Forecast 283
10.1.2 Drivers and Barriers — Global Issues 289
10.2 United States 290
10.2.1 Forecast 290
10.2.2 Key Events 294
10.2.3 Drivers and Barriers 295
10.3 5EU 295
10.3.1 Forecast 295
10.3.2 Key Events 301
10.3.3 Drivers and Barriers 302
10.4 Japan 302
10.4.1 Forecast 302
10.4.2 Key Events 306
10.4.3 Drivers and Barriers 307
10.5 Canada 307
10.5.1 Forecast 307
10.5.2 Key Events 312
10.5.3 Drivers and Barriers 313
10.6 China 313
10.6.1 Forecast 313
10.6.2 Key Events 317
10.6.3 Drivers and Barriers 317
10.7 India 318
10.7.1 Forecast 318
10.7.2 Key Events 321
10.7.3 Drivers and Barriers 321
11 Appendix 322
11.1 Bibliography 322
11.2 Abbreviations 344
11.3 Methodology 349
11.4 Forecasting Methodology 349
11.4.1 Diagnosed MS Patients 349
11.4.2 Percent Drug-Treated Patients 349
11.4.3 Launch and Patent Expiry Dates 350
11.4.4 General Pricing Assumptions 351
11.4.5 Individual Drug Assumptions 352
11.4.6 Generic Erosion 358
11.4.7 Pricing of Pipeline Agents 358
11.5 Primary Research — KOLs Interviewed for this Report 360
11.6 Primary Research — Prescriber Survey 363
11.7 About the Authors 364
11.7.1 Analyst 364
11.7.2 Therapy Area Director 364
11.7.3 Epidemiologist 365
11.7.4 Global Director of Therapy Research and Analysis 365
11.8 About GlobalData 366
11.9 Disclaimer 366