Multiple Sclerosis – 5EU Drug Forecast and Market Analysis to 2024

Pages: 246 Published: September 01, 2015 Report Code: GDHC331CFR

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. GlobalData believes market growth will be steady between 2014 and 2021, driven by an increase in treatment rates as pipeline agents enter the market. Following this, growth is expected to slow as Gilenya faces patent expiry in this market. The impact of generic competition will be significant, as Gilenya is anticipated to be the highest-selling DMT in the 5EU prior to its patent expiry. Market growth driven by the continued uptake of the pipeline agents will be largely offset by Gilenya’s generic erosion, and the availability of generic fingolimod will limit the uptake of the novel S1P receptor modulators. *This is an on-demand report and will be delivered within 24 hrs. (excluding weekends) of the purchase.

Scope

Overview of MS including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.

Detailed information on the key drugs in 5EU including product MScription, safety and efficacy profiles as well as a SWOT analysis.

Sales forecast for the top drugs in 5EU from 2014-2024.

Analysis of the impact of key events as well the drivers and restraints affecting 5EU MS market.

Reasons to Buy

Understand and capitalize by identifying products that are most likely to ensure a robust return

Stay ahead of the competition by understanding the changing competitive landscape for MS.

Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential

Make more informed business decisions from insightful and in-depth analysis of drug performance

Obtain sales forecast for drugs from 2014-2024 in 5EU.

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

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

4Disease Management

4.1Diagnosis

4.2Treatment Overview

4.2.1Management of Acute Relapse

4.2.2Treatment with Disease-Modifying Therapies

4.2.3Symptomatic Therapies

4.3France

4.3.1Diagnosis

4.3.2Drug Treatment

4.4Germany

4.4.1Diagnosis

4.4.2Drug Treatment

4.5Italy

4.5.1Diagnosis

4.5.2Drug Treatment

4.6Spain

4.6.1Diagnosis

4.6.2Drug Treatment

4.7UK

4.7.1Diagnosis

4.7.2Drug Treatment

5Competitive Assessment

5.1Overview

5.2Product Profiles – Major Injectable Brands

5.2.1Betaseron

5.2.2Avonex

5.2.3Rebif

5.2.4Copaxone

5.2.5Tysabri

5.2.6Lemtrada

5.2.7Plegridy

5.3Product Profiles – Major Small Molecule Brands

5.3.1Gilenya

5.3.2Aubagio

5.3.3Tecfidera

5.4Other Disease-Modifying Therapies

5.4.1Overview

6Unmet Need and Opportunity Analysis

6.1Overview

6.2Curative Therapies

6.2.1Unmet Need

6.2.2Gap Analysis

6.2.3Opportunity

6.3The High Cost of MS Drugs

6.3.1Unmet Need

6.3.2Gap Analysis

6.3.3Opportunity

6.4Safety and Tolerability of Therapy

6.4.1Unmet Need

6.4.2Gap Analysis

6.4.3Opportunity

6.5Effective Treatments for Progressive MS

6.5.1Unmet Need

6.5.2Gap Analysis

6.5.3Opportunity

6.6Inconvenient Route of Administration and Frequent Dosing

6.6.1Unmet Need

6.6.2Gap Analysis

6.6.3Opportunity

6.7MS Biomarkers for Early Diagnosis and Treatment Choice

6.7.1Unmet Need

6.7.2Gap Analysis

6.7.3Opportunity

7Pipeline Assessment

7.1Overview

7.2Clinical Trial Mapping

7.2.1Clinical Trials by Country

7.3Promising Drugs in Clinical Development

7.3.1Zinbryta

7.3.2Ocrelizumab

7.3.3Ofatumumab

7.3.4Opicinumab

7.3.5Nerventra

7.3.6Masitinib

7.3.7Siponimod

7.3.8Ozanimod

7.3.9Ponesimod

7.4Late-Stage Therapeutic Vaccines

7.4.1NeuroVax

7.4.2Tcelna

7.5Other Drugs in Development

8Market Outlook

8.15EU

8.1.1Forecast

8.1.2Key Events

8.1.3Drivers and Barriers

9Appendix

9.1Bibliography

9.2Abbreviations

9.3Methodology

9.4Forecasting Methodology

9.4.1Diagnosed MS Patients

9.4.2Percent Drug-Treated Patients

9.4.3Launch and Patent Expiry Dates

9.4.4General Pricing Assumptions

9.4.5Individual Drug Assumptions

9.4.6Generic Erosion

9.4.7Pricing of Pipeline Agents

9.5Primary Research — KOLs Interviewed for this Report

9.6Primary Research — Prescriber Survey

9.7About the Authors

9.7.1Analyst

9.7.2Therapy Area Director

9.7.3Epidemiologist

9.7.4Global Director of Therapy Research and Analysis

9.8About GlobalData

9.9Disclaimer

List of Tables

Table 1: Common Presenting Symptoms of MS

Table 2: Factors That Can Affect Prognosis in MS

Table 3: Revised 2010 McDonald Criteria for the Diagnosis of MS

Table 4: Treatment Guidelines for MS

Table 5: Top Three Disease-Modifying Therapies Prescribed for MS by Market

Table 6: Pharmacotherapy for Common MS Symptoms

Table 7: France – MS Diagnosis Metrics

Table 8: France – MS Treatment Metrics

Table 9: Germany – MS Diagnosis Metrics

Table 10: Germany – MS Treatment Metrics

Table 11: Italy – MS Diagnosis Metrics

Table 12: Italy – MS Treatment Metrics

Table 13: Spain – MS Diagnosis Metrics

Table 14: Spain – MS Treatment Metrics

Table 15: UK – MS Diagnosis Metrics

Table 16: UK – MS Treatment Metrics

Table 17: Leading Disease-Modifying Drugs for the Treatment of MS, 2015

Table 18: Product Profile — Betaseron

Table 19: Betaseron SWOT Analysis, 2015

Table 20: Global Sales Forecasts ($m) for Betaseron, 2014–2024

Table 21: Product Profile — Avonex

Table 22: Avonex SWOT Analysis, 2015

Table 23: Global Sales Forecasts ($m) for Avonex, 2014–2024

Table 24: Product Profile — Rebif

Table 25: Rebif SWOT Analysis, 2014

Table 26: Global Sales Forecasts ($m) for Rebif, 2014–2024

Table 27: Product Profile — Copaxone

Table 28: Copaxone SWOT Analysis, 2015

Table 29: Global Sales Forecasts ($m) for Copaxone, 2014–2024

Table 30: Product Profile — Tysabri

Table 31: Tysabri SWOT Analysis, 2015

Table 32: Global Sales Forecasts ($m) for Tysabri, 2014–2024

Table 33: Product Profile — Lemtrada

Table 34: Lemtrada SWOT Analysis, 2015

Table 35: Global Sales Forecasts ($m) for Lemtrada, 2014–2024

Table 36: Product Profile — Plegridy

Table 37: Clinical and MRI Endpoints at Year 1 from a Phase III Trial of Plegridy in MS

Table 38: Clinical and MRI Endpoints at Year 2 from a Phase III Trial of Plegridy in MS

Table 39: Adverse Events During Year 1 of a Phase III Trial of Plegridy in MS

Table 40: Plegridy SWOT Analysis, 2015

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

Table 42: Product Profile — Gilenya

Table 43: Gilenya SWOT Analysis, 2015

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

Table 45: Product Profile — Aubagio

Table 46: Aubagio SWOT Analysis, 2015

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

Table 48: Product Profile — Tecfidera

Table 49: Tecfidera SWOT Analysis, 2015

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

Table 51: Summary of Alternative MS DMTs, 2014

Table 52: Unmet Need and Opportunity in MS

Table 53: Product Profile — Zinbryta High-Yield Process

Table 54: Adverse Events during Year 1 of a Phase III trial of Zinbryta in MS

Table 55: Zinbryta SWOT Analysis, 2015

Table 56: Global Sales Forecasts ($m) for Zinbryta, 2014–2024

Table 57: Product Profile — Ocrelizumab

Table 58: Ocrelizumab SWOT Analysis, 2015

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

Table 60: Product Profile — Ofatumumab

Table 61: Ofatumumab SWOT Analysis, 2015

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

Table 63: Product Profile — Opicinumab

Table 64: Opicinumab SWOT Analysis, 2015

Table 65: Product Profile — Nerventra

Table 66: Nerventra SWOT Analysis, 2015

Table 67: Global Sales Forecasts ($m) for Nerventra, 2014–2024

Table 68: Product Profile – Masitinib

Table 69: Masitinib SWOT Analysis, 2015

Table 70: Global Sales Forecasts ($m) for Masitinib, 2014–2024

Table 71: Product Profile — Siponimod

Table 72: Siponimod SWOT Analysis, 2015

Table 73: Global Sales Forecasts ($m) for siponimod, 2014–2024

Table 74: Product Profile — Ozanimod

Table 75: Ozanimod SWOT Analysis, 2015

Table 76: Global Sales Forecasts ($m) for Ozanimod, 2014–2024

Table 77: Product Profile — Ponesimod

Table 78: Efficacy Results for Ponesimod in a Phase IIb MS Trial

Table 79: Ponesimod SWOT Analysis, 2015

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

Table 81: Product Profile — NeuroVax

Table 82: NeuroVax SWOT Analysis, 2015

Table 83: Product Profile — Tcelna

Table 84: Tcelna SWOT Analysis, 2015

Table 85: Drugs in Development, 2015

Table 86: Sales Forecasts ($m) for MS in the 5EU, 2014–2024

Table 87: Key Events Impacting Sales for MS in the 5EU, 2014–2024

Table 88: MS Market in the 5EU — Drivers and Barriers, 2014–2024

Table 89: Key Launch Dates

Table 90: Key Patent Expiries

Table 91: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country

List of Figures

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

Figure 2: Expanded Disability Status Scale (EDSS)

Figure 3: Algorithm for the Treatment of MS with Disease-Modifying Therapies

Figure 4: MS Therapeutics — Clinical Trials by Country, 2015

Figure 5: Multiple Sclerosis — Phase II–III Pipeline, 2015

Figure 6: Competitive Assessment of Late-Stage Pipeline Agents in MS, 2014–2024

Figure 7: Multiple Sclerosis — Phase II–III Therapeutic Vaccines, 2015

Figure 8: Sales for MS in the 5EU by Therapy Type, 2014–2024

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