Multiple Sclerosis – US Drug Forecast and Market Analysis to 2024

Pages: 234 Published: September 01, 2015 Report Code: GDHC327CFR

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 estimates that drug sales for MS in the US reached $11.9 billion during 2014, making this the largest market within the 10MM. Slow growth is expected to occur between 2014 and 2018, attributed to the continued uptake of products with high ACOTs. This will be followed by a two-year decline due to the generic erosion of key brands, namely Teva’s Copaxone and Novartis’ Gilenya. However, growth will return from 2020 onwards as generic erosion is offset by sales of novel pipeline agents. *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 the US including product MScription, safety and efficacy profiles as well as a SWOT analysis.

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

Analysis of the impact of key events as well the drivers and restraints affecting the US 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 the US.

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

4.3US

4.3.1Diagnosis

4.3.2Drug 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

8.1United States

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: US – MS Diagnosis Metrics

Table 8: US – MS Treatment Metrics

Table 9: Leading Disease-Modifying Drugs for the Treatment of MS, 2015

Table 10: Product Profile — Betaseron

Table 11: Betaseron SWOT Analysis, 2015

Table 12: Global Sales Forecasts ($m) for Betaseron, 2014–2024

Table 13: Product Profile — Avonex

Table 14: Avonex SWOT Analysis, 2015

Table 15: Global Sales Forecasts ($m) for Avonex, 2014–2024

Table 16: Product Profile — Rebif

Table 17: Rebif SWOT Analysis, 2014

Table 18: Global Sales Forecasts ($m) for Rebif, 2014–2024

Table 19: Product Profile — Copaxone

Table 20: Copaxone SWOT Analysis, 2015

Table 21: Global Sales Forecasts ($m) for Copaxone, 2014–2024

Table 22: Product Profile — Tysabri

Table 23: Tysabri SWOT Analysis, 2015

Table 24: Global Sales Forecasts ($m) for Tysabri, 2014–2024

Table 25: Product Profile — Lemtrada

Table 26: Lemtrada SWOT Analysis, 2015

Table 27: Global Sales Forecasts ($m) for Lemtrada, 2014–2024

Table 28: Product Profile — Plegridy

Table 29: Clinical and MRI Endpoints at Year 1 from a Phase III Trial of Plegridy in MS

Table 30: Clinical and MRI Endpoints at Year 2 from a Phase III Trial of Plegridy in MS

Table 31: Adverse Events During Year 1 of a Phase III Trial of Plegridy in MS

Table 32: Plegridy SWOT Analysis, 2015

Table 33: Global Sales Forecasts ($m) for Plegridy, 2014–2024

Table 34: Product Profile — Gilenya

Table 35: Gilenya SWOT Analysis, 2015

Table 36: Global Sales Forecasts ($m) for Gilenya, 2014–2024

Table 37: Product Profile — Aubagio

Table 38: Aubagio SWOT Analysis, 2015

Table 39: Global Sales Forecasts ($m) for Aubagio, 2014–2024

Table 40: Product Profile — Tecfidera

Table 41: Tecfidera SWOT Analysis, 2015

Table 42: Global Sales Forecasts ($m) for Tecfidera, 2014–2024

Table 43: Summary of Alternative MS DMTs, 2014

Table 44: Unmet Need and Opportunity in MS

Table 45: Product Profile — Zinbryta High-Yield Process

Table 46: Adverse Events during Year 1 of a Phase III trial of Zinbryta in MS

Table 47: Zinbryta SWOT Analysis, 2015

Table 48: Global Sales Forecasts ($m) for Zinbryta, 2014–2024

Table 49: Product Profile — Ocrelizumab

Table 50: Ocrelizumab SWOT Analysis, 2015

Table 51: Global Sales Forecasts ($m) for ocrelizumab, 2014–2024

Table 52: Product Profile — Ofatumumab

Table 53: Ofatumumab SWOT Analysis, 2015

Table 54: Global Sales Forecasts ($m) for Ofatumumab, 2014–2024

Table 55: Product Profile — Opicinumab

Table 56: Opicinumab SWOT Analysis, 2015

Table 57: Product Profile — Nerventra

Table 58: Nerventra SWOT Analysis, 2015

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

Table 60: Product Profile – Masitinib

Table 61: Masitinib SWOT Analysis, 2015

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

Table 63: Product Profile — Siponimod

Table 64: Siponimod SWOT Analysis, 2015

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

Table 66: Product Profile — Ozanimod

Table 67: Ozanimod SWOT Analysis, 2015

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

Table 69: Product Profile — Ponesimod

Table 70: Efficacy Results for Ponesimod in a Phase IIb MS Trial

Table 71: Ponesimod SWOT Analysis, 2015

Table 72: Global Sales Forecasts ($m) for Ponesimod, 2014–2024

Table 73: Product Profile — NeuroVax

Table 74: NeuroVax SWOT Analysis, 2015

Table 75: Product Profile — Tcelna

Table 76: Tcelna SWOT Analysis, 2015

Table 77: Drugs in Development, 2015

Table 78: Sales Forecast ($m) for MS in the United States, 2014–2024

Table 79: Key Events Impacting Sales for MS in the US, 2014–2024

Table 80: MS Market in the US — Drivers and Barriers, 2014–2024

Table 81: Key Launch Dates

Table 82: Key Patent Expiries

Table 83: 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 United States by Therapy Type, 2014–2024

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