多発性硬化症：世界市場（医薬品市場予測及び分析～2022）...市場調査レポートについてご紹介

1 Table of Contents
1 Table of Contents 8
1.1 List of Tables 15
1.2 List of Figures 19
2 Introduction 21
2.1 Catalyst 21
2.2 Upcoming Related Reports 22
3 Disease Overview 23
3.1 Etiology and Pathophysiology 23
3.1.1 Etiology 23
3.1.2 Pathophysiology 24
3.1.3 Classification of Multiple Sclerosis 25
3.2 Symptoms 27
3.2.1 Prognosis 28
3.2.2 Quality of Life 29
4 Epidemiology 30
4.1 Risk Factors 30
4.1.1 Family members of MS patients have a 1-5% risk of developing MS 30
4.1.2 Women are twice as likely to develop MS, but men have a worse prognosis 30
4.1.3 Caucasians have a higher risk of MS than any other race/ethnicity 31
4.1.4 Protective effect of vitamin D on MS may relate to latitude and month of birth 31
4.1.5 Timing of environmental exposures affects MS risk 32
4.1.6 Exposure to smoking may increase MS risk and worsen prognosis 32
4.2 Comorbidities 33
4.2.1 Autoimmune diseases may be comorbidities of MS 33
4.2.2 Mental comorbidities are found in up to 60% of MS patients and may affect relapse rates 34
4.3 Global Trends 35
4.3.1 North America 35
4.3.2 Europe 36
4.3.3 Asia 36
4.4 Forecast Methodology 37
4.4.1 Sources Used 39
4.4.2 Forecast Assumptions and Methods 45
4.4.3 Sources Not Used 54
4.5 Epidemiology Forecast for Multiple Sclerosis 55
4.5.1 Total Prevalent Cases of Multiple Sclerosis 55
4.5.2 Age-Specific Prevalent Cases of Multiple Sclerosis 57
4.5.3 Gender-Specific Prevalent Cases of Multiple Sclerosis 59
4.5.4 Total Incident Cases of Multiple Sclerosis 61
4.5.5 Age-Specific Incident Cases of Multiple Sclerosis 63
4.5.6 Gender-Specific Incident Cases of Multiple Sclerosis 65
4.5.7 Multiple Sclerosis Subtypes 67
4.6 Discussion 68
4.6.1 Conclusions on Epidemiological Trends 68
4.6.2 Limitations of the Analysis 69
4.6.3 Strengths of the Analysis 69
5 Disease Management 70
5.1 Diagnosis 70
5.2 Treatment Overview 73
5.2.1 Management of Acute Relapse 74
5.2.2 Treatment with Disease-Modifying Therapies 74
5.2.3 Symptomatic Therapies 77
5.3 US 78
5.3.1 Diagnosis 78
5.3.2 Clinical Practice 78
5.4 France 80
5.4.1 Diagnosis 80
5.4.2 Clinical Practice 80
5.5 Germany 82
5.5.1 Diagnosis 82
5.5.2 Clinical Practice 82
5.6 Italy 84
5.6.1 Diagnosis 84
5.6.2 Clinical Practice 84
5.7 Spain 85
5.7.1 Diagnosis 85
5.7.2 Clinical Practice 85
5.8 UK 87
5.8.1 Diagnosis 87
5.8.2 Clinical Practice 87
5.9 Japan 89
5.9.1 Diagnosis 89
5.9.2 Clinical Practice 89
5.10 Canada 90
5.10.1 Diagnosis 90
5.10.2 Clinical Practice 90
5.11 China 91
5.11.1 Diagnosis 91
5.11.2 Clinical Practice 91
5.12 India 92
5.12.1 Diagnosis 92
5.12.2 Clinical Practice 92
6 Competitive Assessment 94
6.1 Overview 94
6.2 Strategic Competitor Assessment 95
6.3 Product Profiles – Major Brands 97
6.3.1 Betaseron/Betaferon (interferon beta-1b) 97
6.3.2 Avonex (interferon beta-1a) 103
6.3.3 Rebif (interferon beta-1a) 109
6.3.4 Copaxone (glatiramer acetate; copolymer-1) 114
6.3.5 Tysabri (natalizumab) 120
6.3.6 Gilenya/Imusera (fingolimod; FTY720) 126
6.3.7 Aubagio (teriflunomide) 132
6.3.8 Other Disease-Modifying Therapies 138
7 Opportunity and Unmet Need 139
7.1 Overview 139
7.2 Unmet Needs 140
7.2.1 Currently Available MS Drugs Only Provide Partial Benefits 140
7.2.2 The High Cost of MS Drugs Could Continue to Price out Patients 141
7.2.3 Safety and Tolerability of Therapy is Undermined by Side Effects 142
7.2.4 Effective Treatments for Progressive MS Are Still Elusive 143
7.2.5 Inconvenient Route of Administration and Frequent Dosing Limits Compliance 144
7.2.6 The Lack of Predictive Biomarkers Delays MS Diagnosis 145
7.3 Unmet Needs Gap Analysis 146
7.4 Opportunities 148
7.4.1 Treatments for Progressive MS 148
7.4.2 Targeting Patients with Clinically Isolated Syndrome 148
8 Pipeline Assessment 149
8.1 Overview 149
8.2 Clinical Trial Mapping 151
8.2.1 Clinical Trials by Country 151
8.3 Clinical Trials by Phase and Trial Status 152
8.4 Promising Drugs in Clinical Development 153
8.4.1 Tecfidera (dimethyl fumarate) 155
8.4.2 Lemtrada (alemtuzumab) 161
8.4.3 Laquinimod (ABR-215062) 168
8.4.4 Daclizumab High-Yield Process (HYP) 175
8.4.5 Ocrelizumab (RG1594) 181
8.4.6 Siponimod (BAF-312) 187
8.4.7 NU-100 (interferon beta-1b) 193
8.4.8 Masitinib (AB-1010) 198
8.4.9 Tcelna (imilecleucel-T) 203
9 Current and Future Players 208
9.1 Overview 208
9.2 Trends in Corporate Strategy 210
9.3 Company Profiles 212
9.3.1 Biogen Idec 212
9.3.2 Teva Pharmaceutical Industries 215
9.3.3 Merck Serono (EMD Serono) 218
9.3.4 Sanofi 221
9.3.5 Bayer HealthCare Pharmaceuticals 224
9.3.6 Novartis International 226
9.3.7 Hoffmann-La Roche 229
9.3.8 GlaxoSmithKline 231
10 Market Outlook 233
10.1 Global Markets 233
10.1.1 Forecast 233
10.1.2 Drivers and Barriers – Global Issues 236
10.2 United States 240
10.2.1 Forecast 240
10.2.2 Key Events 244
10.2.3 Drivers and Barriers 244
10.3 France 247
10.3.1 Forecast 247
10.3.2 Key Events 251
10.3.3 Drivers and Barriers 251
10.4 Germany 254
10.4.1 Forecast 254
10.4.2 Key Events 258
10.4.3 Drivers and Barriers 258
10.5 Italy 261
10.5.1 Forecast 261
10.5.2 Key Events 264
10.5.3 Drivers and Barriers 264
10.6 Spain 267
10.6.1 Forecast 267
10.6.2 Key Events 271
10.6.3 Drivers and Barriers 271
10.7 United Kingdom 273
10.7.1 Forecast 273
10.7.2 Key Events 277
10.7.3 Drivers and Barriers 277
10.8 Japan 280
10.8.1 Forecast 280
10.8.2 Key Events 283
10.8.3 Drivers and Barriers 283
10.9 Canada 285
10.9.1 Forecast 285
10.9.2 Key Events 289
10.9.3 Drivers and Barriers 289
10.10 China 291
10.10.1 Forecast 291
10.10.2 Key Events 294
10.10.3 Drivers and Barriers 295
10.11 India 297
10.11.1 Forecast 297
10.11.2 Key Events 299
10.11.3 Drivers and Barriers 300
11 Appendix 302
11.1 Bibliography 302
11.2 Abbreviations 320
11.3 Methodology 324
11.4 Forecasting Methodology 324
11.4.1 Diagnosed MS patients 324
11.4.2 Percent Drug-Treated Patients 325
11.4.3 Drugs Included in Each Therapeutic Class 325
11.4.4 Launch and Patent Expiry Dates 326
11.4.5 General Pricing Assumptions 327
11.4.6 Individual Drug Assumptions 328
11.4.7 Generic Erosion 332
11.4.8 Pricing of Pipeline agents 332
11.5 Physicians and Specialists Included in This Report 334
11.6 Primary Research – Prescriber Survey 335
11.7 About the Authors 336
11.7.1 Analysts 336
11.7.2 Epidemiologists 337
11.7.3 Global Head of Healthcare 337
11.8 About GlobalData 338
11.9 Contact Us 338
11.10 Disclaimer 338