Albany, NY -- (SBWIRE) -- 12/08/2016 -- GBI Research, the leading business intelligence provider, has released its latest research, "Multiple Sclerosis Therapeutics to 2019 Treatment Diversification, Increasing Efficacy, and Pipeline Innovation Combine to Drive Growth". Currently there are a number of disease-modifying drugs in the Multiple Sclerosis (MS) market that are indicated for the treatment of relapsing forms of the disease, specifically reducing the frequency of disease relapses. The market is led by Copaxone, which achieved global sales of $4 billion in 2012. Over the forecast period 2012–2019, a variety of new drugs are due to enter the market that will offer a vast improvement in efficacy but also convenience, as many of these drugs are orally administered. Additionally, a high number of monoclonal Antibodies (mAbs) are due to enter the market and diversify it in terms of its portfolio for late stage or aggressive MS. All of these drugs have been shown to offer substantial improvements over current therapies. The price of these new therapies is expected to be high, particularly for the mAbs, but this is unlikely to hinder their uptake. As a result of this, as well as an overall increase in the treated population, GBI Research believes the global market has the potential to grow to a value of $17.9 billion by 2019.

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Scope

A brief introduction to MS, including the disease's history, pathogenesis, risk factors and diagnosis.

In-depth analysis of the eight major disease-modifying drugs for MS, including analyses of their safety, efficacy, treatment patterns and strengths/weaknesses. Includes a heat map comparing the drugs in terms of safety and efficacy.

Comprehensive review of the pipeline for MS therapies, including individual analysis of a number of late-stage pipeline drugs that are likely to enter the market in the forecast period. The pipeline is analyzed on the basis of phase distribution, molecule types and molecular targets, as well as administration routes.

Additional analysis of pipeline drug clinical trials by phase, molecule type, trial size and trial duration.

Multi-scenario forecast model of the market, taking into account how it will be affected by the introduction of new drugs, the expiry of key patents on current drugs and the changes in disease epidemiology.

Discussion of the drivers and barriers for market growth or decay.

Reasons to buy

Understand the different levels of MS therapies, from early-stage/mild MS to late-stage/aggressive MS.

Understand the vast scope of the pipeline, including which molecule types and mechanisms of action are prominent.

Observe the trends in clinical trial duration and size amongst clinical phases and molecule types, and use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for multiple sclerosis therapeutics.

Observe the shift in clinical trial endpoints with clinical phase, and use this data to potentially influence any future developmental programs.

Assess the potential clini

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Table of Contents

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 7

2 Introduction 8
2.1 Disease Overview 8
2.2 Epidemiology 8
2.3 Symptoms 9
2.4 Etiology 9
2.5 Pathophysiology 10
2.5.1 Blood Brain Barrier Degradation 10
2.5.2 Cellular Infiltration of the Central Nervous System 10
2.6 Co-morbidities/Complications 11
2.7 Diagnosis 12
2.7.1 McDonald Criteria 12
2.7.2 Physical Examination 13
2.7.3 MRI Scans 13
2.7.4 Lumbar Puncture 13
2.7.5 Other Diagnostic Tests 13
2.8 Prognosis 14
2.9 Treatment Efficacy 15
2.10 Treatment Options 15
2.10.1 Corticosteroids 16
2.10.2 Anti-neoplastic Drugs 16
2.10.3 Skeletal Muscle Relaxants 16
2.10.4 Pain Management in MS 17
2.11 Treatment Algorithm 17
2.12 Non-pharmacological Therapies 19

3 Therapeutic Landscape 20
3.1 Copaxone (glatiramer acetate) – Teva Pharmaceuticals 20
3.2 Betaseron (interferon beta 1b) – Bayer AG 21
3.3 Avonex (interferon beta 1a IM) – Biogen 22
3.4 Rebif (interferon beta 1a SC) – Merck Serono 23
3.5 Tysabri (natalizumab) – Biogen Idec/Elan Corporation 24
3.6 Gilenya (fingolimod hydrochloride) – Mitsubishi Tanabe and Novartis 25
3.7 Aubagio (Teriflunomide) – Genzyme Corporation and Sanofi-Aventis 26
3.8 Novantrone (mitoxantrone ) – Merck Serono 26
3.9 Conclusion 28
3.10 Unmet Need 28

4 Pipeline for Multiple Sclerosis Therapeutics 29
4.1 Overall Pipeline 29
4.2 Route of Administration 31
4.3 Molecular Targets within the MS Pipeline 32
4.4 Clinical Trials 34
4.4.1 Failure Rate of Developmental Programs 34
4.4.2 Clinical Trial Size 36
4.4.3 Clinical Trial Duration 38
4.5 Promising Pipeline Candidates 40
4.5.1 Lemtrada (alemtuzumab) – Genzyme and Bayer Schering Pharma 40
4.5.2 Tecfidera (dimethyl fumarate) – Biogen Idec 40
4.5.3 Laquinimod (laquinimod sodium) – Teva Pharmaceuticals 41
4.5.4 ocrelizumab – F. Hoffman-La Roche 42
4.5.5 daclizumab – Biogen Idec and Abbot Laboratories 42
4.5.6 firategrast – GlaxoSmithKline 43
4.5.7 Siponimod (BAF-312) – Novartis AG 44
4.6 Conclusion 44

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