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

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Published: December 29, 2017 Report Code: GDHC155PIDR-ST

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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.

Bayer
Biogen
Merck KGaA
Teva
Sanofi
Novartis
Roche
Actelion
Celgene
AbbVie
Alkermes
TG Therapeutics
GeNeuro
Antisense Therapeutics
AB Science
MedDay
Coherus Bioscience
InnoBioscience
MediciNova
Santhera Pharmaceuticals
GSK
Ionis Pharmaceutical

Table of Contents

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 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

Table

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

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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