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

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

Summary


Multiple sclerosis (MS) is an inflammatory autoimmune disease of the central nervous system (CNS) that leads to neurological disability. The MS therapeutics market has entered an exciting phase, with an upsurge of available treatment options and several promising late-stage pipeline products offering diverse mechanisms of action (MOAs). The arrival of novel oral disease-modifying therapies (DMTs) has fulfilled a significant unmet need in the treatment of MS by providing patients with a more convenient route of administration.

With an estimated $14.7B in drug sales, the US dominated the MS market in the 2016 forecast base year, representing around 76.9% of the overall market across the 7MM. We expect the US to remain the leading market throughout the forecast period, generating sales of over $19B in 2026. However, its global market share is expected to decline slightly toabout 76% due to a higher rate of growth in other markets. This dominating position within the 7MM is due to the significantly higher costs of marketed products in the US and the high diagnosed prevalence in the country.

We forecasts that the US will see moderate sales growth over the 10 year forecast period, at a CAGR of around 2.7%, which will be driven by an increase in treatment rates and the introduction of numerous pipeline products offsetting the generic erosion of key brands.

The main drivers of growth in the MS market over the forecast period are -

  • The launch of efficacious pipeline products with convenient oral formulations or less frequent dosing.
  • The continued uptake of oral DMTs, which typically have a higher annual cost of therapy (ACOT) and improved compliance rates.
  • An increase in the number of DMT treatment options that target progressive MS subtypes.
The report PharmaPoint: Multiple Sclerosis - Global Drug Forecast and Market Analysis to 2026 , provide overview of MS: including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.

In depth, this report provides the following -
  • 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.
Companies mentioned in this report: Bayer, Biogen, Merck KGaA, Teva, Sanofi, Novartis.

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.


1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Executive Summary
2.1 Moderate Growth Expected in the MS Market from 2016 to 2026
2.2 R&D and Corporate Strategies within the MS Market
2.3 Current Treatments Leave a High Level of Unmet Need in the MS Market
2.4 Opportunities Remain for Products that Will Fulfill Significant Unmet Needs in the MS Market
2.5 Late-Stage Pipeline Drugs Entering the MS Market Will Be a Key Driver of Growth
2.6 What Do the Physicians Think?
3 Introduction
3.1 Catalyst
3.2 Related Reports
4 Disease Overview
4.1 Etiology and Pathophysiology
4.1.1 Etiology
4.1.2 Pathophysiology
4.2 Classification
4.2.1 Relapse-Remitting MS
4.2.2 Secondary Progressive MS
4.2.3 Primary Progressive MS
4.2.4 Progressive Relapsing MS
4.3 Symptoms
4.4 Prognosis
4.5 Quality of Life
5 Epidemiology
5.1 Disease Background
5.2 Risk Factors and Comorbidities
5.3 Global and Historical Trends
5.4 Forecast Methodology
5.4.1 Sources
5.4.2 Forecast Assumptions and Methods
5.4.3 Diagnosed Prevalent Cases of MS
5.4.4 Diagnosed Prevalent Cases of MS by Types
5.4.5 Diagnosed Incident Cases of MS
5.5 Epidemiological Forecast for MS (2016-2026)
5.5.1 Diagnosed Prevalent Cases of MS
5.5.2 Age-Specific Diagnosed Prevalent Cases of MS
5.5.3 Sex-Specific Diagnosed Prevalent Cases of MS
5.5.4 Diagnosed Prevalent Cases of MS by Types
5.5.5 Diagnosed Incident Cases of MS
5.5.6 Age-Specific Diagnosed Incident Cases of MS
5.5.7 Sex-Specific Diagnosed Incident Cases of MS
5.6 Discussion
5.6.1 Epidemiological Forecast Insight
5.6.2 Limitation of Analysis
5.6.3 Strengths of Analysis
6 Disease Management
6.1 Diagnosis Overview
6.2 Treatment Overview
6.2.1 Management of Acute Relapse
6.2.2 Treatment with Disease-Modifying Therapies
6.2.3 Challenges in Drug Selection as More DMTs Enter the MS Market
6.2.4 Shifting MS Treatment Paradigms Unfolding as New DMTs and New Data Become Available
6.2.5 Symptomatic Therapies
6.3 US
6.3.1 Diagnosis
6.3.2 Drug Treatment
6.4 France
6.4.1 Diagnosis
6.4.2 Drug Treatment
6.5 Germany
6.5.1 Diagnosis
6.5.2 Drug Treatment
6.6 Italy
6.6.1 Diagnosis
6.6.2 Drug Treatment
6.7 Spain
6.7.1 Diagnosis
6.7.2 Drug Treatment
6.8 UK
6.8.1 Diagnosis
6.8.2 Drug Treatment
6.9 Japan
6.9.1 Diagnosis
6.9.2 Drug Treatment
7 Competitive Assessment
7.1 Overview
7.2 Product Profiles - Non-Monoclonal Antibody Injectable Therapies
7.2.1 Betaseron (interferon beta-1b)
7.2.2 Avonex (interferon beta-1a)
7.2.3 Rebif (interferon beta-1a)
7.2.4 Plegridy (pegylated interferon beta-1a)
7.2.5 Copaxone (glatiramer acetate)
7.3 Product Profiles - Monoclonal Antibody Injectable Therapies
7.3.1 Tysabri (natalizumab)
7.3.2 Lemtrada (alemtuzumab)
7.3.3 Zinbryta (daclizumab)
7.3.4 Ocrevus (ocrelizumab)
7.4 Product Profiles - Oral Therapies
7.4.1 Gilenya (fingolimod)
7.4.2 Aubagio (teriflunomide)
7.4.3 Tecfidera (dimethyl fumarate)
7.4.4 Mavenclad (cladribine)
7.5 Other Disease-Modifying Therapies
7.5.1 Overview
8 Unmet Needs and Opportunity Assessment
8.1 Overview
8.2 Curative Therapies
8.2.1 Unmet Need
8.2.2 Gap Analysis
8.2.3 Opportunity
8.3 Effective Treatments for Progressive MS
8.3.1 Unmet Need
8.3.2 Gap Analysis
8.3.3 Opportunity
8.4 The High Cost of MS Drugs
8.4.1 Unmet Need
8.4.2 Gap Analysis
8.4.3 Opportunity
8.5 Safety and Tolerability of Therapy
8.5.1 Unmet Need
8.5.2 Gap Analysis
8.5.3 Opportunity
8.6 MS Biomarkers for Early Diagnosis and Treatment Choice
8.6.1 Unmet Need
8.6.2 Gap Analysis
8.6.3 Opportunity
9 Pipeline Assessment
9.1 Overview
9.2 Clinical Trial Mapping
9.2.1 Clinical Trials by Country
9.3 Promising Drugs in Clinical Development - Overview
9.4 Promising Drugs in Clinical Development - Injectable Therapies
9.4.1 Ofatumumab
9.4.2 Ublituximab
9.4.3 GnbAC-1
9.4.4 Opicinumab
9.4.5 ATL-1102
9.5 Promising Drugs in Clinical Development - Oral Therapies
9.5.1 Siponimod
9.5.2 Ozanimod
9.5.3 Ponesimod
9.5.4 Masitinib
9.5.5 ALKS 8700
9.5.6 MD1003
9.5.7 CHS-131
9.5.8 IB-MS
9.5.9 Ibudilast
9.5.10 Laquinimod
9.5.11 Idebenone
9.5.12 Evobrutinib
9.6 Other Drugs in Development
10 Current and Future Players
10.1 Overview
10.2 Trends in Corporate Strategy
10.3 Company Profiles
10.3.1 Biogen
10.3.2 Teva
10.3.3 Merck Serono (EMD Serono)
10.3.4 Sanofi (Genzyme)
10.3.5 Bayer
10.3.6 Novartis
10.3.7 Roche
11 Market Outlook
11.1 Global Markets
11.1.1 Forecast
11.1.2 Drivers and Barriers - Global Issues
11.2 US
11.2.1 Forecast
11.2.2 Key Events
11.2.3 Drivers and Barriers
11.3 5EU
11.3.1 Forecast
11.3.2 Key Events
11.3.3 Drivers and Barriers
11.4 Japan
11.4.1 Forecast
11.4.2 Key Events
11.4.3 Drivers and Barriers
12 Appendix
12.1 Bibliography
12.2 Abbreviations
12.3 Methodology
12.4 Forecasting Methodology
12.4.1 Diagnosed MS Patients
12.4.2 Percent Drug-Treated Patients
12.4.3 Launch and Patent Expiry Dates
12.4.4 General Pricing Assumptions
12.4.5 Individual Drug Assumptions
12.4.6 Generic Erosion
12.4.7 Pricing of Pipeline Agents
12.5 Primary Research - KOLs Interviewed for This Report
12.6 Primary Research - Payers Interviewed for This Report
12.7 Primary Research - Prescriber Survey
12.8 About the Authors
12.8.1 Analyst
12.8.2 Therapy Area Director
12.8.3 Epidemiologist
12.8.4 Global Director of Therapy Analysis and Epidemiology
12.8.5 Global Head and EVP of Healthcare Operations and Strategy
12.9 About GlobalData
12.10 Contact Us
12.11 Disclaimer
1.1 List of Tables
Table 1: Multiple Sclerosis: Key Metrics in the Seven Major Pharmaceutical Markets
Table 2: Common Presenting Symptoms of MS
Table 3: Factors That Can Affect Prognosis in MS
Table 4: Risk Factors and Comorbidities for MS
Table 5: 7MM, Diagnosed Prevalent Cases of MS, Both Sexes, All Ages, Selected Years 2016-2026
Table 6: Revised 2010 McDonald Criteria for the Diagnosis of MS
Table 7: Treatment Guidelines for MS
Table 8: Top Three Disease-Modifying Therapies Prescribed for MS by Market
Table 9: Pharmacotherapy for Common MS Symptoms
Table 10: US - MS Diagnosis Metrics
Table 11: US - MS Treatment Metrics
Table 12: France - MS Diagnosis Metrics
Table 13: France - MS Treatment Metrics
Table 14: Germany - MS Diagnosis Metrics
Table 15: Germany - MS Treatment Metrics
Table 16: Italy - MS Diagnosis Metrics
Table 17: Italy - MS Treatment Metrics
Table 18: Spain - MS Diagnosis Metrics
Table 19: Spain - MS Treatment Metrics
Table 20: UK - MS Diagnosis Metrics
Table 21: UK - MS Treatment Metrics
Table 22: Japan - MS Diagnosis Metrics
Table 23: Japan - MS Treatment Metrics
Table 24: Leading Disease-Modifying Drugs for the Treatment of MS, 2017
Table 25: Product Profile - Betaseron
Table 26: Efficacy Results for Betaseron in a Phase III (IFNBMS) Trial
Table 27: Betaseron SWOT Analysis, 2015
Table 28: Product Profile - Avonex
Table 29: Efficacy Results for Avonex in a Phase III Trial
Table 30: Avonex SWOT Analysis, 2017
Table 31: Product Profile - Rebif
Table 32: Rebif SWOT Analysis, 2017
Table 33: Product Profile - Plegridy
Table 34: Clinical and MRI Endpoints at Year 1 from a Phase III Trial of Plegridy in MS
Table 35: Clinical and MRI Endpoints at Year 2 from a Phase III Trial of Plegridy in MS
Table 36: AEs During Year 1 of a Phase III Trial of Plegridy in MS
Table 37: Plegridy SWOT Analysis, 2017
Table 38: Product Profile - Copaxone
Table 39: Copaxone SWOT Analysis, 2017
Table 40: Product Profile - Tysabri
Table 41: Efficacy Results for Zinbryta in a Phase III (DECIDE) Trial
Table 42: Tysabri SWOT Analysis, 2017
Table 43: Product Profile - Lemtrada
Table 44: Efficacy Results for Lemtrada in a CARE II Extension Trial
Table 45: Lemtrada SWOT Analysis, 2017
Table 46: Product Profile - Zinbryta High-Yield Process
Table 47: Efficacy Results for Zinbryta in a Phase III (DECIDE) Trial
Table 48: Summary Safety Data for Zinbryta in a Phase III (DECIDE) Trial
Table 49: Zinbryta SWOT Analysis, 2017
Table 50: Product Profile - Ocrevus
Table 51: Efficacy Results for Ocrevus in a Phase III (OPERA I and OPERA II) MS Trial
Table 52: Efficacy Results for Ocrevus in Phase III (OPERA I and OPERA II) MS Trials
Table 53: Safety Results for Ocrevus in Phase III (OPERA I and OPERA II) MS Trials
Table 54: Safety Results for Ocrevus in Phase III (ORATARIO) MS Trials
Table 55: Ocrevus SWOT Analysis, 2017
Table 56: Product Profile - Gilenya
Table 57: Gilenya SWOT Analysis, 2017
Table 58: Product Profile - Aubagio
Table 59: Aubagio SWOT Analysis, 2017
Table 60: Product Profile - Tecfidera
Table 61: Tecfidera SWOT Analysis, 2015
Table 62: Product Profile - Mavenclad
Table 63: Efficacy Results for Mavenclad in a Phase III (CLARITY and CLARITY EXTENSION) MS Trial
Table 64: Safety Results for Mavenclad in a Phase III (CLARITY) MS Trial
Table 65: Mavenclad SWOT Analysis, 2017
Table 66: Summary of Alternative MS DMTs, 2016
Table 67: Product Profile - Ofatumumab
Table 68: Efficacy Results for Ofatumumab in a Phase IIB (MIRROR) MS Trial
Table 69: Safety Results for Ofatumumab in a Phase IIB (MIRROR) MS Trial
Table 70: Ofatumumab SWOT Analysis, 2017
Table 71: Product Profile - Ublituximab (TG-1101)
Table 72: TG-1101 SWOT Analysis, 2017
Table 73: Product Profile - GnbAC-1
Table 74: GnbAC-1 SWOT Analysis, 2017
Table 75: Product Profile - Opicinumab
Table 76: Efficacy Results for Opicinumab in a Phase IIb (SYNERGY) MS Trial
Table 77: Opicinumab SWOT Analysis, 2017
Table 78: Product Profile - ATL-1102
Table 79: Summary of the Efficacy Results of the Phase IIA trial of ALT-1102
Table 80: Safety Results of the Phase IIA trial of ALT-1102
Table 81: ATL-1102 SWOT Analysis, 2017
Table 82: Product Profile - Siponimod
Table 83: Safety of Siponimod
Table 84: Siponimod SWOT Analysis, 2017
Table 85: Product Profile - Ozanimod
Table 86: Ozanimod SWOT Analysis, 2017
Table 87: Product Profile - Ponesimod
Table 88: Efficacy Results for Ponesimod in a Phase IIb MS Trial
Table 89: Ponesimod SWOT Analysis, 2015
Table 90: Product Profile - Masitinib
Table 91: Masitinib SWOT Analysis, 2017
Table 92: Product Profile - ALKS 8700
Table 93: ALKS 8700 SWOT Analysis, 2017
Table 94: Product Profile - MD1003
Table 95: Efficacy Results for MD1003 in a Phase III MS-SPI Trial
Table 96: MD1003 SWOT Analysis, 2017
Table 97: Product Profile - CHS-131
Table 98: Efficacy Data from Phase II Study for CHS-131
Table 99: Efficacy Data from Phase II Study for CHS-131
Table 100: CHS-131 SWOT Analysis, 2017
Table 101: Product Profile - IB-MS
Table 102: Interim Efficacy Results of IB-MS in SPMS and PPMS Patients
Table 103: IB-MS SWOT Analysis, 2016
Table 104: Product Profile - Ibudilast
Table 105: Efficacy Data from Phase II Study for Ibudilast
Table 106: Safety Data from Phase II Study for Ibudilast
Table 107: Ibudilast SWOT Analysis, 2017
Table 108: Product Profile - Laquinimod
Table 109: Laquinimod SWOT Analysis, 2017
Table 110: Product Profile - Idebenone
Table 111: Idebenone SWOT Analysis, 2017
Table 112: Product Profile - Evobrutinib
Table 113: Evobrutinib SWOT Analysis, 2017
Table 114: Drugs in Development, 2017
Table 115: Key Companies in the MS Market, 2016
Table 116: Biogen’s MS Portfolio Assessment, 2017
Table 117: Teva’s MS Portfolio Assessment, 2017
Table 118: Merck’s MS Portfolio Assessment, 2015
Table 119: Sanofi’s MS Portfolio Assessment, 2017
Table 120: Bayer’s MS Portfolio Assessment, 2015
Table 121: Novartis’ MS Portfolio Assessment, 2017
Table 122: Roche’s MS Portfolio Assessment, 2017
Table 123: Global MS Market - Drivers and Barriers, 2016-2026
Table 124 Key Events Impacting Sales for MS in the US, 2016-2026
Table 125: MS Market in the US - Drivers and Barriers, 2016-2026
Table 126: Key Events Impacting Sales for MS in the 5EU, 2016-2026
Table 127: MS Market in the 5EU - Drivers and Barriers, 2016-2026
Table 128: Key Events Impacting Sales for MS in Japan, 2016-2026
Table 129: MS Market in Japan - Drivers and Barriers, 2016-2026
Table 130: Key Launch Dates
Table 131: Key Patent Expiries
Table 132: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country
1.2 List of Figures
Figure 1: Sales for MS by Region, 2016-2026
Figure 2: Company Portfolio Gap Analysis in MS, 2016-2026
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in MS, 2016-2026
Figure 4: Accrual of Disability in the Four Subtypes of MS
Figure 5: 7MM, Age-Standardized Diagnosed Prevalence of MS (%), Both Sexes, All Ages, 2016
Figure 6: 7MM, Age-Standardized Diagnosed Incidence of MS (Cases per 100,000 Population), Both Sexes, All Ages, 2016
Figure 7: 7MM, Sources Used and Not Used, Diagnosed Prevalent Cases of MS
Figure 8: 7MM, Sources Used and Not Used, Diagnosed Incident Cases of MS
Figure 9: 7MM, Sources Used and Not Used for the Diagnosed Prevalent Cases of MS by Types
Figure 10: 7MM, Age-Specific Diagnosed Prevalent Cases of MS, Both Sexes, All Ages, 2016
Figure 11: 7MM, Sex-Specific Diagnosed Prevalent Cases of MS, Both Sexes, All Ages, 2016
Figure 12: 7MM, Diagnosed Prevalent Cases of MS by Types, Both Sexes, All Ages, 2016
Figure 13: 7MM, Age-Specific Diagnosed Incident Cases of MS, Both Sexes, All Ages, 2016
Figure 14: 7MM, Sex-Specific Diagnosed Incident Cases of MS, Both Sexes, All Ages, 2016
Figure 15: EDSS
Figure 16: Algorithm for the Treatment of MS with DMTs
Figure 17: Overview of the Unmet Needs in MS
Figure 18: Overview of the Development Pipeline in MS
Figure 19: MS Therapeutics - Clinical Trials by Country, 2017
Figure 20: MS - Phase II-III Pipeline, 2017
Figure 21: Competitive Assessment of Late-Stage Pipeline Agents in MS, 2016-2026
Figure 22: Company Portfolio Gap Analysis in MS, 2016-2026
Figure 23: Global Sales for MS by Region, 2016-2026
Figure 24: Global Sales for MS by Therapy Type, 2016-2026
Figure 25: Sales for MS in the US by Therapy Type, 2016-2026
Figure 26: Sales for MS in the 5EU by Therapy Type, 2016-2026
Figure 27: Sales for MS in Japan by Therapy Type, 2016-2026

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