PharmaPoint: Multiple Sclerosis-Global Drug Forecast and Market Analysis to 2024

PharmaPoint: Multiple Sclerosis-Global Drug Forecast and Market Analysis to 2024


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Executive Summary

Multiple Sclerosis (MS) is an inflammatory autoimmune disease of the central nervous system which leads to neurological disability. The exact underlying cause of the disease is poorly understood; however, it appears to involve a complex combination of genetic susceptibility and a non-genetic trigger. The MS therapeutics market has entered an exciting phase, with an upsurge of available treatment options. Over the forecast period, patients are expected to continue to switch to the oral disease-modifying therapies (DMTs), lessening the stronghold of the established injectable treatments. There are also several promising products in the late-stage pipeline, with a diverse range of mechanisms offering clinical advantages intended to address unmet needs. Both pipeline and marketed DMTs are seeking approval for the treatment of progressive MS, which currently represents a significant unmet need. These factors are expected to increase treatment rates throughout the 10MM resulting, driving market growth. However, this will be largely offset by brand erosion due to the emergence of biosimilars and generic small molecules.

 

Scope

Overview of MS, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

Annualized MS market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024.

Key topics covered include market characterization, unmet needs, R&D and clinical trials assessment, late stage clinical trial analysis and implications for the MS therapeutics market.

Pipeline analysis: focus on nine late-stage pipeline MS drugs, discussing emerging trends as well as an overview of earlier phase drugs and a top-line analysis of therapeutic vaccines.

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.



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2Introduction

2.1Catalyst

2.2Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.2Classification

3.2.1Relapse-Remitting Multiple Sclerosis

3.2.2Secondary Progressive Multiple Sclerosis

3.2.3Primary Progressive Multiple Sclerosis

3.2.4Progressive Relapsing Multiple Sclerosis

3.3Symptoms

3.4Prognosis

3.5Quality of Life

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.2.1Family members of MS patients have a 1–5% risk of developing MS

4.2.2Women are twice as likely to develop MS, but men have a worse prognosis

4.2.3Caucasians have a higher risk of MS than any other race/ethnicity

4.2.4Protective effect of vitamin D on MS may relate to latitude and month of birth

4.2.5Timing of environmental exposures affects MS risk

4.2.6Exposure to smoking may increase MS risk and worsen prognosis

4.2.7Autoimmune Disease Comorbidities of MS

4.2.8Mental comorbidities are found in up to 60% of MS patients and may affect relapse rates

4.3Global Trends

4.3.1North America

4.3.2Europe

4.3.3Asia

4.4Forecast Methodology

4.4.1Sources Used

4.4.2Sources Not Used

4.4.3Forecast Assumptions and Methods

4.5Epidemiological Forecast of Multiple Sclerosis (2014–2024)

4.5.1Diagnosed Prevalent Cases of MS

4.5.2Age-Specific Diagnosed Prevalent Cases of MS

4.5.3Sex-Specific Diagnosed Prevalent Cases of MS

4.5.4Diagnosed Incident Cases of MS

4.5.5Age-Specific Diagnosed Incident Cases of MS

4.5.6Sex-Specific Diagnosed Incident Cases of MS

4.5.7MS Subtypes

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

5Disease Management

5.1Diagnosis

5.2Treatment Overview

5.2.1Management of Acute Relapse

5.2.2Treatment with Disease-Modifying Therapies

5.2.3Symptomatic Therapies

5.3US

5.3.1Diagnosis

5.3.2Drug Treatment

5.4France

5.4.1Diagnosis

5.4.2Drug Treatment

5.5Germany

5.5.1Diagnosis

5.5.2Drug Treatment

5.6Italy

5.6.1Diagnosis

5.6.2Drug Treatment

5.7Spain

5.7.1Diagnosis

5.7.2Drug Treatment

5.8UK

5.8.1Diagnosis

5.8.2Drug Treatment

5.9Japan

5.9.1Diagnosis

5.9.2Drug Treatment

5.10Canada

5.10.1Diagnosis

5.10.2Drug Treatment

5.11China

5.11.1Diagnosis

5.11.2Drug Treatment

5.12India

5.12.1Diagnosis

5.12.2Drug Treatment

6Competitive Assessment

6.1Overview

6.2Product Profiles – Major Injectable Brands

6.2.1Betaseron

6.2.2Avonex

6.2.3Rebif

6.2.4Copaxone

6.2.5Tysabri

6.2.6Lemtrada

6.2.7Plegridy

6.3Product Profiles – Major Small Molecule Brands

6.3.1Gilenya

6.3.2Aubagio

6.3.3Tecfidera

6.4Other Disease-Modifying Therapies

6.4.1Overview

7Unmet Need and Opportunity

7.1Overview

7.2Curative Therapies

7.2.1Unmet Need

7.2.2Gap Analysis

7.2.3Opportunity

7.3The High Cost of MS Drugs

7.3.1Unmet Need

7.3.2Gap Analysis

7.3.3Opportunity

7.4Safety and Tolerability of Therapy

7.4.1Unmet Need

7.4.2Gap Analysis

7.4.3Opportunity

7.5Effective Treatments for Progressive MS

7.5.1Unmet Need

7.5.2Gap Analysis

7.5.3Opportunity

7.6Inconvenient Route of Administration and Frequent Dosing

7.6.1Unmet Need

7.6.2Gap Analysis

7.6.3Opportunity

7.7MS Biomarkers for Early Diagnosis and Treatment Choice

7.7.1Unmet Need

7.7.2Gap Analysis

7.7.3Opportunity

8Pipeline Assessment

8.1Overview

8.2Clinical Trial Mapping

8.2.1Clinical Trials by Country

8.3Promising Drugs in Clinical Development

8.3.1Zinbryta

8.3.2Ocrelizumab

8.3.3Ofatumumab

8.3.4Opicinumab

8.3.5Nerventra

8.3.6Masitinib

8.3.7Siponimod

8.3.8Ozanimod

8.3.9Ponesimod

8.4Late-Stage Therapeutic Vaccines

8.4.1NeuroVax

8.4.2Tcelna

8.5Other Drugs in Development

9Current and Future Players

9.1Overview

9.2Trends in Corporate Strategy

9.3Company Profiles

9.3.1Biogen

9.3.2Teva

9.3.3Merck Serono (EMD Serono)

9.3.4Sanofi (Genzyme)

9.3.5Bayer

9.3.6Novartis

9.3.7Roche

10Market Outlook

10.1Global Markets

10.1.1Forecast

10.1.2Drivers and Barriers — Global Issues

10.2United States

10.2.1Forecast

10.2.2Key Events

10.2.3Drivers and Barriers

10.35EU

10.3.1Forecast

10.3.2Key Events

10.3.3Drivers and Barriers

10.4Japan

10.4.1Forecast

10.4.2Key Events

10.4.3Drivers and Barriers

10.5Canada

10.5.1Forecast

10.5.2Key Events

10.5.3Drivers and Barriers

10.6China

10.6.1Forecast

10.6.2Key Events

10.6.3Drivers and Barriers

10.7India

10.7.1Forecast

10.7.2Key Events

10.7.3Drivers and Barriers

11Appendix

11.1Bibliography

11.2Abbreviations

11.3Methodology

11.4Forecasting Methodology

11.4.1Diagnosed MS Patients

11.4.2Percent Drug-Treated Patients

11.4.3Launch and Patent Expiry Dates

11.4.4General Pricing Assumptions

11.4.5Individual Drug Assumptions

11.4.6Generic Erosion

11.4.7Pricing of Pipeline Agents

11.5Primary Research — KOLs Interviewed for this Report

11.6Primary Research — Prescriber Survey

11.7About the Authors

11.7.1Analyst

11.7.2Therapy Area Director

11.7.3Epidemiologist

11.7.4Global Director of Therapy Research and Analysis

11.8About GlobalData

11.9Contact Us

11.10Disclaimer

Figure 1: Accrual of Disability in the Four Subtypes of MS

Figure 2: 10MM, Diagnosed Prevalent Cases of MS, Ages =20 Years, Men and Women, N, Select Years, 2014–2024

Figure 3: 10MM, Diagnosed Prevalent Cases of MS, by Age, Men and Women, N, 2014

Figure 4: 10MM, Diagnosed Prevalent Cases of MS, Ages =20 Years, by Sex, N, 2014

Figure 5: 10MM, Diagnosed Incident Cases of MS, Ages =20 Years, Men and Women, N, Select Years, 2014–2024

Figure 6: 10MM, Diagnosed Incident Cases of MS, by Age, Men and Women, N, 2014

Figure 7: 10MM, Diagnosed Incident Cases of MS, by Sex, N, 2014

Figure 8: 10MM, MS Subtype Distributions, %*, 2014

Figure 9: Expanded Disability Status Scale (EDSS)

Figure 10: Algorithm for the Treatment of MS with Disease-Modifying Therapies

Figure 11: MS Therapeutics — Clinical Trials by Country, 2015

Figure 12: Multiple Sclerosis — Phase II–III Pipeline, 2015

Figure 13: Competitive Assessment of Late-Stage Pipeline Agents in MS, 2014–2024

Figure 14: Multiple Sclerosis — Phase II–III Therapeutic Vaccines, 2015

Figure 15: Company Portfolio Gap Analysis in MS, 2014–2024

Figure 16: Global Sales for MS by Region, 2014–2024

Figure 17: Global Sales for MS by Therapy Type, 2014–2024

Figure 18: Sales for MS in the United States by Therapy Type, 2014–2024

Figure 19: Sales for MS in the 5EU by Therapy Type, 2014–2024

Figure 20: Sales for MS in Japan by Therapy Type, 2014–2024

Figure 21: Sales for MS in Canada by Therapy Type, 2014–2024

Figure 22: Sales for MS in China by Therapy Type, 2014–2024

Figure 23: Sales for MS in India by Drug Class, 2014–2024

Table 1: Common Presenting Symptoms of MS

Table 2: Factors That Can Affect Prognosis in MS

Table 3: Risk Factors and Comorbidities for MS

Table 4: Sources of MS Diagnosed Prevalence and Diagnosed Incidence Data Used in the Epidemiology Forecast

Table 5: 10MM, Diagnosed Prevalent Cases of MS, Ages =20 Years, Men and Women, N, Select Years, 2014–2024

Table 6: 10MM, Diagnosed Prevalent Cases of MS, by Age, Men and Women, N (Row %), 2014

Table 7: 10MM, Diagnosed Prevalent Cases of MS, Ages =20 Years, by Sex, N (Row %), 2014

Table 8: 10MM, Diagnosed Incident Cases of MS, Ages =20 Years, Men and Women, N, Select Years, 2014–2024

Table 9: 10MM, Diagnosed Incident Cases of MS, by Age, Men and Women, N (Row %), 2014

Table 10: 10MM, Diagnosed Incident Cases of MS, by Sex, N (Row %), 2014

Table 11: Revised 2010 McDonald Criteria for the Diagnosis of MS

Table 12: Treatment Guidelines for MS

Table 13: Top Three Disease-Modifying Therapies Prescribed for MS by Market

Table 14: Pharmacotherapy for Common MS Symptoms

Table 15: US – MS Diagnosis Metrics

Table 16: US – MS Treatment Metrics

Table 17: France – MS Diagnosis Metrics

Table 18: France – MS Treatment Metrics

Table 19: Germany – MS Diagnosis Metrics

Table 20: Germany – MS Treatment Metrics

Table 21: Italy – MS Diagnosis Metrics

Table 22: Italy – MS Treatment Metrics

Table 23: Spain – MS Diagnosis Metrics

Table 24: Spain – MS Treatment Metrics

Table 25: UK – MS Diagnosis Metrics

Table 26: UK – MS Treatment Metrics

Table 27: Japan – MS Diagnosis Metrics

Table 28: Japan – MS Treatment Metrics

Table 29: Canada – MS Diagnosis Metrics

Table 30: Canada – MS Treatment Metrics

Table 31: China – MS Diagnosis Metrics

Table 32: China – MS Treatment Metrics

Table 33: India – MS Diagnosis Metrics

Table 34: India – MS Treatment Metrics

Table 35: Leading Disease-Modifying Drugs for the Treatment of MS, 2015

Table 36: Product Profile — Betaseron

Table 37: Betaseron SWOT Analysis, 2015

Table 38: Global Sales Forecasts ($m) for Betaseron, 2014–2024

Table 39: Product Profile — Avonex

Table 40: Avonex SWOT Analysis, 2015

Table 41: Global Sales Forecasts ($m) for Avonex, 2014–2024

Table 42: Product Profile — Rebif

Table 43: Rebif SWOT Analysis, 2014

Table 44: Global Sales Forecasts ($m) for Rebif, 2014–2024

Table 45: Product Profile — Copaxone

Table 46: Copaxone SWOT Analysis, 2015

Table 47: Global Sales Forecasts ($m) for Copaxone, 2014–2024

Table 48: Product Profile — Tysabri

Table 49: Tysabri SWOT Analysis, 2015

Table 50: Global Sales Forecasts ($m) for Tysabri, 2014–2024

Table 51: Product Profile — Lemtrada

Table 52: Lemtrada SWOT Analysis, 2015

Table 53: Global Sales Forecasts ($m) for Lemtrada, 2014–2024

Table 54: Product Profile — Plegridy

Table 55: Clinical and MRI Endpoints at Year 1 from a Phase III Trial of Plegridy in MS

Table 56: Clinical and MRI Endpoints at Year 2 from a Phase III Trial of Plegridy in MS

Table 57: Adverse Events During Year 1 of a Phase III Trial of Plegridy in MS

Table 58: Plegridy SWOT Analysis, 2015

Table 59: Global Sales Forecasts ($m) for Plegridy, 2014–2024

Table 60: Product Profile — Gilenya

Table 61: Gilenya SWOT Analysis, 2015

Table 62: Global Sales Forecasts ($m) for Gilenya, 2014–2024

Table 63: Product Profile — Aubagio

Table 64: Aubagio SWOT Analysis, 2015

Table 65: Global Sales Forecasts ($m) for Aubagio, 2014–2024

Table 66: Product Profile — Tecfidera

Table 67: Tecfidera SWOT Analysis, 2015

Table 68: Global Sales Forecasts ($m) for Tecfidera, 2014–2024

Table 69: Summary of Alternative MS DMTs, 2014

Table 70: Unmet Need and Opportunity in MS

Table 71: Product Profile — Zinbryta High-Yield Process

Table 72: Adverse Events during Year 1 of a Phase III trial of Zinbryta in MS

Table 73: Zinbryta SWOT Analysis, 2015

Table 74: Global Sales Forecasts ($m) for Zinbryta, 2014–2024

Table 75: Product Profile — Ocrelizumab

Table 76: Ocrelizumab SWOT Analysis, 2015

Table 77: Global Sales Forecasts ($m) for ocrelizumab, 2014–2024

Table 78: Product Profile — Ofatumumab

Table 79: Ofatumumab SWOT Analysis, 2015

Table 80: Global Sales Forecasts ($m) for Ofatumumab, 2014–2024

Table 81: Product Profile — Opicinumab

Table 82: Opicinumab SWOT Analysis, 2015

Table 83: Product Profile — Nerventra

Table 84: Nerventra SWOT Analysis, 2015

Table 85: Global Sales Forecasts ($m) for Nerventra, 2014–2024

Table 86: Product Profile – Masitinib

Table 87: Masitinib SWOT Analysis, 2015

Table 88: Global Sales Forecasts ($m) for Masitinib, 2014–2024

Table 89: Product Profile — Siponimod

Table 90: Siponimod SWOT Analysis, 2015

Table 91: Global Sales Forecasts ($m) for siponimod, 2014–2024

Table 92: Product Profile — Ozanimod

Table 93: Ozanimod SWOT Analysis, 2015

Table 94: Global Sales Forecasts ($m) for Ozanimod, 2014–2024

Table 95: Product Profile — Ponesimod

Table 96: Efficacy Results for Ponesimod in a Phase IIb MS Trial

Table 97: Ponesimod SWOT Analysis, 2015

Table 98: Global Sales Forecasts ($m) for Ponesimod, 2014–2024

Table 99: Product Profile — NeuroVax

Table 100: NeuroVax SWOT Analysis, 2015

Table 101: Product Profile — Tcelna

Table 102: Tcelna SWOT Analysis, 2015

Table 103: Drugs in Development, 2015

Table 104: Key Companies in the MS Market, 2015

Table 105: Biogen’s Multiple Sclerosis Portfolio Assessment, 2015

Table 106:Biogen SWOT Analysis, 2015

Table 107: Teva’s MS Portfolio Assessment, 2015

Table 108: Teva SWOT Analysis, 2015

Table 109: Merck’s Multiple Sclerosis Portfolio Assessment, 2015

Table 110: Merck SWOT Analysis, 2015

Table 111: Sanofi’s Multiple Sclerosis Portfolio Assessment, 2015

Table 112: Sanofi SWOT Analysis, 2015

Table 113: Bayer’s MS Portfolio Assessment, 2015

Table 114: Bayer SWOT Analysis, 2015

Table 115: Novartis’ MS Portfolio Assessment, 2015

Table 116: Novartis SWOT Analysis, 2015

Table 117: Roche’s Multiple Sclerosis Portfolio Assessment, 2015

Table 118: Roche SWOT Analysis, 2015

Table 119: Global Sales Forecast ($m) for MS, 2014–2024

Table 120: Global MS Market — Drivers and Barriers, 2014–2024

Table 121: Sales Forecast ($m) for MS in the United States, 2014–2024

Table 122: Key Events Impacting Sales for MS in the US, 2014–2024

Table 123: MS Market in the US — Drivers and Barriers, 2014–2024

Table 124: Sales Forecasts ($m) for MS in the 5EU, 2014–2024

Table 125: Key Events Impacting Sales for MS in the 5EU, 2014–2024

Table 126: MS Market in the 5EU — Drivers and Barriers, 2014–2024

Table 127: Sales Forecasts ($m) for MS in the Japan, 2014–2024

Table 128: Key Events Impacting Sales for MS in Japan, 2014–2024

Table 129: MS Market in Japan — Drivers and Barriers, 2014–2024

Table 130: Sales Forecasts ($m) for MS in the Canada, 2014–2024

Table 131: Key Events Impacting Sales for MS in Canada, 2014–2024

Table 132: MS Market in Canada — Drivers and Barriers, 2014–2024

Table 133: Sales Forecasts ($m) for MS in the China, 2014–2024

Table 134: Key Events Impacting Sales for MS in China, 2014–2024

Table 135: MS Market in China — Drivers and Barriers, 2014–2024

Table 136: Sales Forecasts ($m) for MS in the India, 2014–2024

Table 137: Key Events Impacting Sales for MS in India, 2014–2024

Table 138: MS Market in India — Drivers and Barriers, 2014–2024

Table 139: Key Launch Dates

Table 140: Key Patent Expiries

Table 141: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country

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