Multiple Sclerosis: Global Drug Forecast and Market Analysis to 2028

MS is a primary autoimmune disease with a mechanism involving recurrent inflammatory attacks on the central nervous system (CNS) due to a dysfunctional immune system, leading to neurological disability . The exact underlying cause of the inflammatory autoimmune process remains unknown; however, it is widely believed that MS results from a complex interaction of genetic susceptibility and environmental factors. MS is primarily considered an inflammatory demyelinating disorder of the CNS, and is characterized by lymphocyte and macrophage infiltrates, as well as glial cell activation. The key pathological finding in MS neural tissue is the presence of diffuse inflammatory lesions, also known as plaques, which are primarily found in the spinal cord, optic nerves, brainstem, periventricular white matter, and also extend into the grey matter. Neurologists are in general agreement that MS patients can be grouped into four major categories on the basis of the disease course. These categories are relapse-remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS), primary progressive multiple sclerosis (PPMS), and progressive relapsing multiple sclerosis (PRMS).

The current MS market is highly competitive, with 14 available treatment options, most of which are considered to be immunomodulatory agents. The majority of approved treatments address the inflammatory and systemic origins of the disease, but few possess neuroprotective effects and, as such, have an insufficient impact on the underlying neurologic deterioration caused by MS. The primary goal of treatment with DMTs is to effectively manage disease activity by reducing the frequency of relapses and delaying the accrual of permanent disability.

GlobalData estimates that drug sales for MS in 2018 were approximately $19.8B across the seven major markets covered in this report. Over the 10-year forecast period, the market is expected to grow to $32.9B at a CAGR of 5.2%. This growth will be driven by the launch of eleven late-stage pipeline products.

Key Questions Answered

What are the key MS treatments in 2018?

When will the late stage pipeline products launch, and how will it affect drug sales and the overall MS market in the 7MM?

Which unmet needs will remain unaddressed in the forecast period and what opportunities remain for pharmaceutical companies?

Scope

Overview of Multiple Sclerosis, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.

Annualized Multiple Sclerosis therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in three patient segments (RRMS, SPMS and PPMS) forecast from 2018 to 2028.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the Multiple Sclerosis therapeutics market

Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for Multiple Sclerosis therapy. The most promising candidates in Phase III development are profiled.

Analysis of the current and future market competition in the global Multiple Sclerosis therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Highlights

Significant growth is expected in the MS market from 2018 to 2028

GlobalData’s anticipate that eleven late stage pipeline drugs will launch over the forecast period. These are expected to be the main driver of growth in the MS market across the 7MM.

GlobalData projects that Ocrevus will be one of the highest-selling DMT for MS, generating $7.6B in the 7MM in 2028.

There are no curative therapies for MS, and most existing DMTs only have limited efficacy on slowing neurodegeneration and disease progression. This will remain an unmet need in the 7MM.

Opportunities are expected for pharmaceutical companies to develop drugs which have novel MOAs; which have potential disease modifying properties.

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 Multiple Sclerosis therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global Multiple Sclerosis 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.

Companies mentioned

Teva

Roche

TG Therapeutics

Avadel Pharmaceuticals

GSK

GeNeuro

Biogen

AbbVie

Celgene

Actelion

Jannsen

AB Science

MedDay

MediciNova

Merck Serono

Sanofi

Bayer

Novartis

Table of Contents

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 2018 to 2028

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 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 Relapsing-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

5.5 Epidemiological Forecast for MS (2018–2028)

5.5.1 Diagnosed Incident Cases of MS

5.5.2 Age-Specific Diagnosed Incident Cases of MS

5.5.3 Sex-Specific Diagnosed Incident Cases of MS

5.5.4 Diagnosed Prevalent Cases of MS

5.5.5 Age-Specific Diagnosed Prevalent Cases of MS

5.5.6 Sex-Specific Diagnosed Prevalent Cases of MS

5.5.7 Diagnosed Prevalent Cases of MS by Type

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations 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 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)

7.4.5 Mayzent (siponimod)

7.4.6 Vumerity (diroximel fumarate)

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 Elezanumab

9.5 Promising Drugs in Clinical Development – Oral Therapies

9.5.1 Ozanimod

9.5.2 Ponesimod

9.5.3 Masitinib

9.5.4 MD1003

9.5.5 MN-166

9.5.6 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 – Prescriber Survey

12.7 About the Authors

12.7.1 Analyst

12.7.2 Therapy Area Director

12.7.3 Epidemiologist

12.7.4 Global Director of Therapy Analysis and Epidemiology

12.7.5 Global Head and EVP of Healthcare Operations and Strategy

12.8 About GlobalData

12.9 Contact Us

12.10 Disclaimer

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 Comorbid Conditions Associated with MS

Table 5: Revised 2017 McDonald Criteria for the Diagnosis of MS

Table 6: Treatment Guidelines for MS

Table 7: Top Three Disease-Modifying Therapies Prescribed for MS, by Market, 2018

Table 8: Pharmacotherapy for Common MS Symptoms

Table 9: US – MS Diagnosis Metrics

Table 10: US – MS Treatment Metrics

Table 11: France – MS Diagnosis Metrics

Table 12: France – MS Treatment Metrics

Table 13: Germany – MS Diagnosis Metrics

Table 14: Germany – MS Treatment Metrics

Table 15: Italy – MS Diagnosis Metrics

Table 16: Italy – MS Treatment Metrics

Table 17: Spain – MS Diagnosis Metrics

Table 18: Spain – MS Treatment Metrics

Table 19: UK – MS Diagnosis Metrics

Table 20: UK – MS Treatment Metrics

Table 21: Japan – MS Diagnosis Metrics

Table 22: Japan – MS Treatment Metrics

Table 23: Leading Disease-Modifying Drugs for the Treatment of MS, 2019

Table 24: Product Profile – Betaseron

Table 25: Efficacy Results for Betaseron in a Phase III (IFNBMS) Trial

Table 26: Betaseron SWOT Analysis, 2019

Table 27: Product Profile – Avonex

Table 28: Efficacy Results for Avonex in a Phase III Trial

Table 29: Avonex SWOT Analysis, 2019

Table 30: Product Profile – Rebif

Table 31: Rebif SWOT Analysis, 2019

Table 32: Product Profile – Plegridy

Table 33: Clinical and MRI Endpoints at Year 1 from a Phase III Trial of Plegridy in MS

Table 34: Clinical and MRI Endpoints at Year 2 from a Phase III Trial of Plegridy in MS

Table 35: AEs During Year 1 of a Phase III Trial of Plegridy in MS

Table 36: Plegridy SWOT Analysis, 2019

Table 37: Product Profile – Copaxone

Table 38: Copaxone SWOT Analysis, 2019

Table 39: Product Profile – Tysabri

Table 40: Efficacy Results for Tysabri in a Phase III (DECIDE) Trial

Table 41: Tysabri SWOT Analysis, 2019

Table 42: Product Profile – Lemtrada

Table 43: Efficacy Results for Lemtrada in a CARE II Extension Trial

Table 44: Lemtrada SWOT Analysis, 2019

Table 45: Product Profile – Ocrevus

Table 46: Efficacy Results for Ocrevus in a Phase III (OPERA I and OPERA II) MS Trial

Table 47: Efficacy Results for Ocrevus in Phase III (OPERA I and OPERA II) MS Trials

Table 48: Efficacy Results for Ocrevus in Phase III (OPERA OLE) MS Trials

Table 49: Efficacy Results for Ocrevus in Phase III (ORATORIO OLE) MS Trials

Table 50: Safety Results for Ocrevus in Phase III (OPERA I and OPERA II) MS Trials

Table 51: Safety Results for Ocrevus in Phase III (ORATARIO) MS Trials

Table 52: Ocrevus SWOT Analysis, 2019

Table 53: Product Profile – Gilenya

Table 54: Gilenya SWOT Analysis, 2019

Table 55: Product Profile – Aubagio

Table 56: Aubagio SWOT Analysis, 2019

Table 57: Product Profile – Tecfidera

Table 58: Tecfidera SWOT Analysis, 2019

Table 59: Product Profile – Mavenclad

Table 60: Efficacy Results for Mavenclad in a Phase III (CLARITY and CLARITY EXTENSION) MS Trial

Table 61: Safety Results for Mavenclad in a Phase III (CLARITY) MS Trial

Table 62: Mavenclad SWOT Analysis, 2019

Table 63: Product Profile – Mazyent

Table 64: Safety of Mazyent

Table 65: Mayzent SWOT Analysis, 2019

Table 66: Product Profile – Vumerity

Table 67: Vumerity SWOT Analysis, 2019

Table 68: Summary of Alternative MS DMTs, 2019

Table 69: Product Profile – Ofatumumab

Table 70: Efficacy Results for Ofatumumab in a Phase III ASCLEPIOS I and II MS Trial

Table 71: Efficacy Results for Ofatumumab in a Phase IIB (MIRROR) MS Trial

Table 72: Safety Results for Ofatumumab in a Phase IIB (MIRROR) MS Trial

Table 73: Ofatumumab SWOT Analysis, 2019

Table 74: Product Profile – Ublituximab (TG-1101)

Table 75: TG-1101 SWOT Analysis, 2019

Table 76: Product Profile – GnbAC-1

Table 77: GnbAC-1 SWOT Analysis, 2019

Table 78: Product Profile – Opicinumab

Table 79: Efficacy Results for Opicinumab in a Phase IIb (SYNERGY) MS Trial

Table 80: Opicinumab SWOT Analysis, 2019

Table 81: Product Profile – Elezanumab

Table 82: Elezanumab SWOT Analysis, 2019

Table 83: Product Profile – Ozanimod

Table 84: Ozanimod SWOT Analysis, 2019

Table 85: Product Profile – Ponesimod

Table 86: Efficacy Results for Ponesimod in a Phase IIb MS Trial

Table 87: Ponesimod SWOT Analysis, 2019

Table 88: Product Profile – Masitinib

Table 89: Masitinib SWOT Analysis, 2019

Table 90: Product Profile – MD1003

Table 91: Efficacy Results for MD1003 in a Phase III MS-SPI Trial

Table 92: MD1003 SWOT Analysis, 2019

Table 93: Product Profile – MN-166

Table 94: Efficacy Data from Phase II Study for MN-166

Table 95: Results of Subgroup Analysis from the SPRINT-MS Phase IIB trial for MN-166

Table 96: Safety Data from Phase II Study for MN-166

Table 97: MN-166 SWOT Analysis, 2019

Table 98: Product Profile – Evobrutinib

Table 99: Evobrutinib SWOT Analysis, 2019

Table 100: Drugs in Development, 2019

Table 101: Key Companies in the MS Market, 2019

Table 102: Biogen’s MS Portfolio Assessment, 2019

Table 103: Teva’s MS Portfolio Assessment, 2019

Table 104: Merck’s MS Portfolio Assessment, 2019

Table 105: Sanofi’s MS Portfolio Assessment, 2019

Table 106: Bayer’s MS Portfolio Assessment, 2019

Table 107: Novartis’ MS Portfolio Assessment, 2019

Table 108: Roche’s MS Portfolio Assessment, 2019

Table 109: Global MS Market – Drivers and Barriers, 2018–2028

Table 110 Key Events Impacting Sales for MS in the US, 2018–2028

Table 111: MS Market in the US – Drivers and Barriers, 2018–2028

Table 112: Key Events Impacting Sales for MS in the 5EU, 2018–2028

Table 113: MS Market in the 5EU – Drivers and Barriers, 2018–2028

Table 114: Key Events Impacting Sales for MS in Japan, 2018–2028

Table 115: MS Market in Japan – Drivers and Barriers, 2018–2028

Table 116: Key Launch Dates

Table 117: Key Patent Expiries

Table 118: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Sales for MS by Region, 2018–2028

Figure 2: Company Portfolio Gap Analysis in MS, 2018–2028

Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in MS, 2018–2028

Figure 4: Accrual of Disability in the Four Subtypes of MS

Figure 5: 7MM, Diagnosed Incidence of MS (Cases per 100,000 Population), Men and Women, All Ages, 2018

Figure 6: 7MM, Diagnosed Prevalence of MS (%), Men and Women, All Ages, 2018

Figure 7: 7MM, Sources Used and Not Used to Forecast the Diagnosed Incident Cases of MS

Figure 8: 7MM, Sources Used and Not Used to Forecast the Diagnosed Prevalent Cases of MS

Figure 9: 7MM, Sources Used and Not Used to Forecast the Diagnosed Prevalent Cases of MS by Type

Figure 10: 7MM, Diagnosed Incident Cases of MS, N, Both Sexes, All Ages, 2018

Figure 11: 7MM, Age-Specific Diagnosed Incident Cases of MS, N, Both Sexes, All Ages, 2018

Figure 12: 7MM, Sex-Specific Diagnosed Incident Cases of MS, N, All Ages, 2018

Figure 13: 7MM, Diagnosed Prevalent Cases of MS, N, Both Sexes, All Ages, 2018

Figure 14: 7MM, Age-Specific Diagnosed Prevalent Cases of MS, N, Both Sexes, All Ages, 2018

Figure 15: 7MM, Sex-Specific Diagnosed Prevalent Cases of MS, N, All Ages, 2018

Figure 16: 7MM, Diagnosed Prevalent Cases of MS by Type, N, Both Sexes, All Ages, 2018

Figure 17: EDSS

Figure 18: Algorithm for the Treatment of MS with DMTs

Figure 19: Overview of the Unmet Needs in MS

Figure 20: Overview of the Development Pipeline in MS

Figure 21: MS Therapeutics – Clinical Trials by Country, 2019

Figure 22: MS – Phase II–III Pipeline, 2019

Figure 23: Competitive Assessment of Late-Stage Pipeline Agents in MS, 2018–2028

Figure 24: Company Portfolio Gap Analysis in MS, 2018–2028

Figure 25: Global Sales for MS by Region, 2018–2028

Figure 26: Global Sales for MS by Therapy Type, 2018–2028

Figure 27: Sales for MS in the US by Therapy Type, 2018–2028

Figure 28: Sales for MS in the 5EU by Therapy Type, 2018–2028

Figure 29: Sales for MS in Japan by Therapy Type, 2018–2028

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