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PharmaPoint: Multiple Sclerosis - Global Drug Forecast and Market Analysis to 2026

  • Published Date: 01 Dec 2017
  • Number of Pages: 343
  • Category: Pharmaceuticals
  • Country: Global

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PharmaPoint: Multiple Sclerosis - Global Drug Forecast and Market Analysis to 2026

Summary

Multiple Sclerosis (MS) is a chronic, inflammatory neurological disorder characterized pathologically by demyelination, axonal transection, and neurodegeneration within the central nervous system. It is the most common cause of non-traumatic neurological disability in young adults, afflicting at least 2.5 million people worldwide. In most patients, the disease is characterized initially by episodes of reversible neurological deficits, which is often followed by progressive neurological deterioration over time. The precise etiology of MS remains incompletely elucidated, but it is believed to involve a complex interaction between various environmental and genetic factors.

The late-stage candidates include products from both established and emerging players with a wide range of mechanism of action (MOA). Progressive MS is a significant focus for product development, with 8 of the late-stage products targeting this patient group as an initial indication, such as protecting mitochondrial energy sources (idebenone), antioxidants (MD1003), promoting remyelination (opicinumab) and neuroprotection (ibudilast and laquinimod). There is currently a distinct lack of DMT options for patients with progressive MS subtypes, and patients remain significantly underserved. The majority of the Phase III candidates targeting RRMS are based on established MOAs, such as second generation S1P receptor modulators (ozanimod and ponesimod) or anti-CD20 mAbs (ofatumumab and ublituximab).

Scope

- Overview of MS: including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Annualized MS market revenue, cost of therapy per patient, and treatment usage patterns in three patient segments (RRMS, PPMS and SPMS), forecast from 2016 to 2026.
- Key topics covered: strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the MS therapeutics market
- Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for MS therapy. Promising candidates in Phase IIB or above were profiled.
- Analysis of the current and future market competition in the global MS therapeutics market. 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 MS therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global MS therapeutics market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing 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.
 

Publisher Name : GlobalData


1.1 List of Tables 8
1.2 List of Figures 11
2 Executive Summary 12
2.1 Moderate Growth Expected in the MS Market from 2016 to 2026 13
2.2 R&D and Corporate Strategies within the MS Market 14
2.3 Current Treatments Leave a High Level of Unmet Need in the MS Market 16
2.4 Opportunities Remain for Products that Will Fulfill Significant Unmet Needs in the MS Market 17
2.5 Late-Stage Pipeline Drugs Entering the MS Market Will Be a Key Driver of Growth 18
2.6 What Do the Physicians Think? 19
3 Introduction 23
3.1 Catalyst 23
3.2 Related Reports 24
4 Disease Overview 25
4.1 Etiology and Pathophysiology 25
4.1.1 Etiology 25
4.1.2 Pathophysiology 26
4.2 Classification 27
4.2.1 Relapse-Remitting MS 27
4.2.2 Secondary Progressive MS 27
4.2.3 Primary Progressive MS 28
4.2.4 Progressive Relapsing MS 28
4.3 Symptoms 29
4.4 Prognosis 30
4.5 Quality of Life 31
5 Epidemiology 32
5.1 Disease Background 32
5.2 Risk Factors and Comorbidities 32
5.3 Global and Historical Trends 33
5.4 Forecast Methodology 35
5.4.1 Sources 35
5.4.2 Forecast Assumptions and Methods 38
5.4.3 Diagnosed Prevalent Cases of MS 38
5.4.4 Diagnosed Prevalent Cases of MS by Types 42
5.4.5 Diagnosed Incident Cases of MS 44
5.5 Epidemiological Forecast for MS (2016-2026) 47
5.5.1 Diagnosed Prevalent Cases of MS 47
5.5.2 Age-Specific Diagnosed Prevalent Cases of MS 48
5.5.3 Sex-Specific Diagnosed Prevalent Cases of MS 48
5.5.4 Diagnosed Prevalent Cases of MS by Types 49
5.5.5 Diagnosed Incident Cases of MS 50
5.5.6 Age-Specific Diagnosed Incident Cases of MS 51
5.5.7 Sex-Specific Diagnosed Incident Cases of MS 52
5.6 Discussion 53
5.6.1 Epidemiological Forecast Insight 53
5.6.2 Limitation of Analysis 54
5.6.3 Strengths of Analysis 55
6 Disease Management 56
6.1 Diagnosis Overview 56
6.2 Treatment Overview 59
6.2.1 Management of Acute Relapse 60
6.2.2 Treatment with Disease-Modifying Therapies 61
6.2.3 Challenges in Drug Selection as More DMTs Enter the MS Market 61
6.2.4 Shifting MS Treatment Paradigms Unfolding as New DMTs and New Data Become Available 63
6.2.5 Symptomatic Therapies 65
6.3 US 66
6.3.1 Diagnosis 66
6.3.2 Drug Treatment 67
6.4 France 71
6.4.1 Diagnosis 71
6.4.2 Drug Treatment 72
6.5 Germany 74
6.5.1 Diagnosis 74
6.5.2 Drug Treatment 75
6.6 Italy 77
6.6.1 Diagnosis 77
6.6.2 Drug Treatment 77
6.7 Spain 79
6.7.1 Diagnosis 79
6.7.2 Drug Treatment 80
6.8 UK 82
6.8.1 Diagnosis 82
6.8.2 Drug Treatment 83
6.9 Japan 85
6.9.1 Diagnosis 85
6.9.2 Drug Treatment 86
7 Competitive Assessment 89
7.1 Overview 89
7.2 Product Profiles - Non-Monoclonal Antibody Injectable Therapies 91
7.2.1 Betaseron (interferon beta-1b) 91
7.2.2 Avonex (interferon beta-1a) 96
7.2.3 Rebif (interferon beta-1a) 100
7.2.4 Plegridy (pegylated interferon beta-1a) 104
7.2.5 Copaxone (glatiramer acetate) 110
7.3 Product Profiles - Monoclonal Antibody Injectable Therapies 114
7.3.1 Tysabri (natalizumab) 114
7.3.2 Lemtrada (alemtuzumab) 120
7.3.3 Zinbryta (daclizumab) 125
7.3.4 Ocrevus (ocrelizumab) 131
7.4 Product Profiles - Oral Therapies 138
7.4.1 Gilenya (fingolimod) 138
7.4.2 Aubagio (teriflunomide) 143
7.4.3 Tecfidera (dimethyl fumarate) 148
7.4.4 Mavenclad (cladribine) 153
7.5 Other Disease-Modifying Therapies 159
7.5.1 Overview 159
8 Unmet Needs and Opportunity Assessment 160
8.1 Overview 160
8.2 Curative Therapies 161
8.2.1 Unmet Need 161
8.2.2 Gap Analysis 162
8.2.3 Opportunity 163
8.3 Effective Treatments for Progressive MS 163
8.3.1 Unmet Need 163
8.3.2 Gap Analysis 165
8.3.3 Opportunity 166
8.4 The High Cost of MS Drugs 166
8.4.1 Unmet Need 166
8.4.2 Gap Analysis 168
8.4.3 Opportunity 168
8.5 Safety and Tolerability of Therapy 169
8.5.1 Unmet Need 169
8.5.2 Gap Analysis 169
8.5.3 Opportunity 171
8.6 MS Biomarkers for Early Diagnosis and Treatment Choice 171
8.6.1 Unmet Need 171
8.6.2 Gap Analysis 172
8.6.3 Opportunity 172
9 Pipeline Assessment 174
9.1 Overview 174
9.2 Clinical Trial Mapping 175
9.2.1 Clinical Trials by Country 175
9.3 Promising Drugs in Clinical Development - Overview 176
9.4 Promising Drugs in Clinical Development - Injectable Therapies 179
9.4.1 Ofatumumab 179
9.4.2 Ublituximab 186
9.4.3 GnbAC-1 189
9.4.4 Opicinumab 193
9.4.5 ATL-1102 199
9.5 Promising Drugs in Clinical Development - Oral Therapies 203
9.5.1 Siponimod 203
9.5.2 Ozanimod 210
9.5.3 Ponesimod 215
9.5.4 Masitinib 220
9.5.5 ALKS 8700 225
9.5.6 MD1003 229
9.5.7 CHS-131 234
9.5.8 IB-MS 238
9.5.9 Ibudilast 242
9.5.10 Laquinimod 247
9.5.11 Idebenone 254
9.5.12 Evobrutinib 257
9.6 Other Drugs in Development 260
10 Current and Future Players 263
10.1 Overview 263
10.2 Trends in Corporate Strategy 265
10.3 Company Profiles 266
10.3.1 Biogen 266
10.3.2 Teva 269
10.3.3 Merck Serono (EMD Serono) 271
10.3.4 Sanofi (Genzyme) 272
10.3.5 Bayer 274
10.3.6 Novartis 276
10.3.7 Roche 278
11 Market Outlook 280
11.1 Global Markets 280
11.1.1 Forecast 280
11.1.2 Drivers and Barriers - Global Issues 285
11.2 US 286
11.2.1 Forecast 286
11.2.2 Key Events 289
11.2.3 Drivers and Barriers 290
11.3 5EU 290
11.3.1 Forecast 290
11.3.2 Key Events 294
11.3.3 Drivers and Barriers 295
11.4 Japan 295
11.4.1 Forecast 295
11.4.2 Key Events 298
11.4.3 Drivers and Barriers 299
12 Appendix 300
12.1 Bibliography 300
12.2 Abbreviations 319
12.3 Methodology 325
12.4 Forecasting Methodology 325
12.4.1 Diagnosed MS Patients 325
12.4.2 Percent Drug-Treated Patients 326
12.4.3 Launch and Patent Expiry Dates 326
12.4.4 General Pricing Assumptions 327
12.4.5 Individual Drug Assumptions 328
12.4.6 Generic Erosion 334
12.4.7 Pricing of Pipeline Agents 334
12.5 Primary Research - KOLs Interviewed for This Report 336
12.6 Primary Research - Payers Interviewed for This Report 338
12.7 Primary Research - Prescriber Survey 338
12.8 About the Authors 339
12.8.1 Analyst 339
12.8.2 Therapy Area Director 339
12.8.3 Epidemiologist 340
12.8.4 Global Director of Therapy Analysis and Epidemiology 340
12.8.5 Global Head and EVP of Healthcare Operations and Strategy 341
12.9 About GlobalData 342
12.10 Contact Us 342
12.11 Disclaimer 343
 



List Of Tables

1.1 List of Tables
Table 1: Multiple Sclerosis: Key Metrics in the Seven Major Pharmaceutical Markets 12
Table 2: Common Presenting Symptoms of MS 30
Table 3: Factors That Can Affect Prognosis in MS 31
Table 4: Risk Factors and Comorbidities for MS 33
Table 5: 7MM, Diagnosed Prevalent Cases of MS, Both Sexes, All Ages, Selected Years 2016-2026 47
Table 6: Revised 2010 McDonald Criteria for the Diagnosis of MS 58
Table 7: Treatment Guidelines for MS 60
Table 8: Top Three Disease-Modifying Therapies Prescribed for MS by Market 64
Table 9: Pharmacotherapy for Common MS Symptoms 66
Table 10: US - MS Diagnosis Metrics 67
Table 11: US - MS Treatment Metrics 71
Table 12: France - MS Diagnosis Metrics 72
Table 13: France - MS Treatment Metrics 74
Table 14: Germany - MS Diagnosis Metrics 75
Table 15: Germany - MS Treatment Metrics 76
Table 16: Italy - MS Diagnosis Metrics 77
Table 17: Italy - MS Treatment Metrics 79
Table 18: Spain - MS Diagnosis Metrics 80
Table 19: Spain - MS Treatment Metrics 82
Table 20: UK - MS Diagnosis Metrics 83
Table 21: UK - MS Treatment Metrics 85
Table 22: Japan - MS Diagnosis Metrics 86
Table 23: Japan - MS Treatment Metrics 88
Table 24: Leading Disease-Modifying Drugs for the Treatment of MS, 2017 91
Table 25: Product Profile - Betaseron 93
Table 26: Efficacy Results for Betaseron in a Phase III (IFNBMS) Trial 94
Table 27: Betaseron SWOT Analysis, 2015 95
Table 28: Product Profile - Avonex 97
Table 29: Efficacy Results for Avonex in a Phase III Trial 98
Table 30: Avonex SWOT Analysis, 2017 99
Table 31: Product Profile - Rebif 101
Table 32: Rebif SWOT Analysis, 2017 103
Table 33: Product Profile - Plegridy 105
Table 34: Clinical and MRI Endpoints at Year 1 from a Phase III Trial of Plegridy in MS 106
Table 35: Clinical and MRI Endpoints at Year 2 from a Phase III Trial of Plegridy in MS 107
Table 36: AEs During Year 1 of a Phase III Trial of Plegridy in MS 108
Table 37: Plegridy SWOT Analysis, 2017 109
Table 38: Product Profile - Copaxone 111
Table 39: Copaxone SWOT Analysis, 2017 113
Table 40: Product Profile - Tysabri 116
Table 41: Efficacy Results for Zinbryta in a Phase III (DECIDE) Trial 117
Table 42: Tysabri SWOT Analysis, 2017 119
Table 43: Product Profile - Lemtrada 121
Table 44: Efficacy Results for Lemtrada in a CARE II Extension Trial 123
Table 45: Lemtrada SWOT Analysis, 2017 124
Table 46: Product Profile - Zinbryta High-Yield Process 127
Table 47: Efficacy Results for Zinbryta in a Phase III (DECIDE) Trial 128
Table 48: Summary Safety Data for Zinbryta in a Phase III (DECIDE) Trial 129
Table 49: Zinbryta SWOT Analysis, 2017 130
Table 50: Product Profile - Ocrevus 133
Table 51: Efficacy Results for Ocrevus in a Phase III (OPERA I and OPERA II) MS Trial 134
Table 52: Efficacy Results for Ocrevus in Phase III (OPERA I and OPERA II) MS Trials 134
Table 53: Safety Results for Ocrevus in Phase III (OPERA I and OPERA II) MS Trials 136
Table 54: Safety Results for Ocrevus in Phase III (ORATARIO) MS Trials 136
Table 55: Ocrevus SWOT Analysis, 2017 137
Table 56: Product Profile - Gilenya 140
Table 57: Gilenya SWOT Analysis, 2017 142
Table 58: Product Profile - Aubagio 144
Table 59: Aubagio SWOT Analysis, 2017 147
Table 60: Product Profile - Tecfidera 150
Table 61: Tecfidera SWOT Analysis, 2015 152
Table 62: Product Profile - Mavenclad 155
Table 63: Efficacy Results for Mavenclad in a Phase III (CLARITY and CLARITY EXTENSION) MS Trial 156
Table 64: Safety Results for Mavenclad in a Phase III (CLARITY) MS Trial 157
Table 65: Mavenclad SWOT Analysis, 2017 158
Table 66: Summary of Alternative MS DMTs, 2016 159
Table 67: Product Profile - Ofatumumab 181
Table 68: Efficacy Results for Ofatumumab in a Phase IIB (MIRROR) MS Trial 182
Table 69: Safety Results for Ofatumumab in a Phase IIB (MIRROR) MS Trial 183
Table 70: Ofatumumab SWOT Analysis, 2017 185
Table 71: Product Profile - Ublituximab (TG-1101) 187
Table 72: TG-1101 SWOT Analysis, 2017 188
Table 73: Product Profile - GnbAC-1 190
Table 74: GnbAC-1 SWOT Analysis, 2017 192
Table 75: Product Profile - Opicinumab 195
Table 76: Efficacy Results for Opicinumab in a Phase IIb (SYNERGY) MS Trial 196
Table 77: Opicinumab SWOT Analysis, 2017 199
Table 78: Product Profile - ATL-1102 200
Table 79: Summary of the Efficacy Results of the Phase IIA trial of ALT-1102 201
Table 80: Safety Results of the Phase IIA trial of ALT-1102 202
Table 81: ATL-1102 SWOT Analysis, 2017 203
Table 82: Product Profile - Siponimod 205
Table 83: Safety of Siponimod 207
Table 84: Siponimod SWOT Analysis, 2017 209
Table 85: Product Profile - Ozanimod 211
Table 86: Ozanimod SWOT Analysis, 2017 214
Table 87: Product Profile - Ponesimod 216
Table 88: Efficacy Results for Ponesimod in a Phase IIb MS Trial 217
Table 89: Ponesimod SWOT Analysis, 2015 219
Table 90: Product Profile - Masitinib 221
Table 91: Masitinib SWOT Analysis, 2017 224
Table 92: Product Profile - ALKS 8700 226
Table 93: ALKS 8700 SWOT Analysis, 2017 228
Table 94: Product Profile - MD1003 230
Table 95: Efficacy Results for MD1003 in a Phase III MS-SPI Trial 231
Table 96: MD1003 SWOT Analysis, 2017 233
Table 97: Product Profile - CHS-131 235
Table 98: Efficacy Data from Phase II Study for CHS-131 236
Table 99: Efficacy Data from Phase II Study for CHS-131 236
Table 100: CHS-131 SWOT Analysis, 2017 237
Table 101: Product Profile - IB-MS 239
Table 102: Interim Efficacy Results of IB-MS in SPMS and PPMS Patients 240
Table 103: IB-MS SWOT Analysis, 2016 241
Table 104: Product Profile - Ibudilast 244
Table 105: Efficacy Data from Phase II Study for Ibudilast 245
Table 106: Safety Data from Phase II Study for Ibudilast 245
Table 107: Ibudilast SWOT Analysis, 2017 247
Table 108: Product Profile - Laquinimod 250
Table 109: Laquinimod SWOT Analysis, 2017 253
Table 110: Product Profile - Idebenone 255
Table 111: Idebenone SWOT Analysis, 2017 257
Table 112: Product Profile - Evobrutinib 258
Table 113: Evobrutinib SWOT Analysis, 2017 260
Table 114: Drugs in Development, 2017 261
Table 115: Key Companies in the MS Market, 2016 264
Table 116: Biogen’s MS Portfolio Assessment, 2017 268
Table 117: Teva’s MS Portfolio Assessment, 2017 270
Table 118: Merck’s MS Portfolio Assessment, 2015 272
Table 119: Sanofi’s MS Portfolio Assessment, 2017 274
Table 120: Bayer’s MS Portfolio Assessment, 2015 276
Table 121: Novartis’ MS Portfolio Assessment, 2017 278
Table 122: Roche’s MS Portfolio Assessment, 2017 279
Table 123: Global MS Market - Drivers and Barriers, 2016-2026 285
Table 124 Key Events Impacting Sales for MS in the US, 2016-2026 289
Table 125: MS Market in the US - Drivers and Barriers, 2016-2026 290
Table 126: Key Events Impacting Sales for MS in the 5EU, 2016-2026 294
Table 127: MS Market in the 5EU - Drivers and Barriers, 2016-2026 295
Table 128: Key Events Impacting Sales for MS in Japan, 2016-2026 298
Table 129: MS Market in Japan - Drivers and Barriers, 2016-2026 299
Table 130: Key Launch Dates 326
Table 131: Key Patent Expiries 327
Table 132: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 338
 



List Of Figures

1.2 List of Figures
Figure 1: Sales for MS by Region, 2016-2026 14
Figure 2: Company Portfolio Gap Analysis in MS, 2016-2026 16
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in MS, 2016-2026 19
Figure 4: Accrual of Disability in the Four Subtypes of MS 29
Figure 5: 7MM, Age-Standardized Diagnosed Prevalence of MS (%), Both Sexes, All Ages, 2016 34
Figure 6: 7MM, Age-Standardized Diagnosed Incidence of MS (Cases per 100,000 Population), Both Sexes, All Ages, 2016 35
Figure 7: 7MM, Sources Used and Not Used, Diagnosed Prevalent Cases of MS 36
Figure 8: 7MM, Sources Used and Not Used, Diagnosed Incident Cases of MS 37
Figure 9: 7MM, Sources Used and Not Used for the Diagnosed Prevalent Cases of MS by Types 38
Figure 10: 7MM, Age-Specific Diagnosed Prevalent Cases of MS, Both Sexes, All Ages, 2016 48
Figure 11: 7MM, Sex-Specific Diagnosed Prevalent Cases of MS, Both Sexes, All Ages, 2016 49
Figure 12: 7MM, Diagnosed Prevalent Cases of MS by Types, Both Sexes, All Ages, 2016 50
Figure 13: 7MM, Age-Specific Diagnosed Incident Cases of MS, Both Sexes, All Ages, 2016 52
Figure 14: 7MM, Sex-Specific Diagnosed Incident Cases of MS, Both Sexes, All Ages, 2016 53
Figure 15: EDSS 59
Figure 16: Algorithm for the Treatment of MS with DMTs 65
Figure 17: Overview of the Unmet Needs in MS 161
Figure 18: Overview of the Development Pipeline in MS 174
Figure 19: MS Therapeutics - Clinical Trials by Country, 2017 175
Figure 20: MS - Phase II-III Pipeline, 2017 178
Figure 21: Competitive Assessment of Late-Stage Pipeline Agents in MS, 2016-2026 179
Figure 22: Company Portfolio Gap Analysis in MS, 2016-2026 265
Figure 23: Global Sales for MS by Region, 2016-2026 283
Figure 24: Global Sales for MS by Therapy Type, 2016-2026 284
Figure 25: Sales for MS in the US by Therapy Type, 2016-2026 288
Figure 26: Sales for MS in the 5EU by Therapy Type, 2016-2026 293
Figure 27: Sales for MS in Japan by Therapy Type, 2016-2026 297
 



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