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Multiple Sclerosis Therapeutics to 2019 - Treatment Diversification, Increasing Efficacy, and Pipeline Innovation Combine to Drive Growth

GBI Research
Published Date » 2013-07-31
No. Of Pages » 93
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.

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 clinical and commercial impact of current late-stage pipeline molecules on the multiple sclerosis therapeutics market.
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

5 Market Forecast to 2019 47
5.1 Geographical Markets 47
5.1.1 Key Developed Markets 47
5.1.2 US 50
5.1.3 Top Five EU Countries 52
5.1.4 Japan 56
5.2 Drivers and Barriers 58
5.2.1 Drivers 58
5.2.2 Barriers 59

6 Deals and Strategic Consolidations 61
6.1 Major Co-development Deals 61
6.1.1 Daiichi Sankyo Enters into an Agreement with Amplimmune 63
6.1.2 Karo Bio Enters into an Agreement with Pfizer 63
6.1.3 Proteostasis Enters into an Agreement with Elan 63
6.1.4 Lycera Enters into an Agreement with Merck 64
6.1.5 Facet Enters into an Agreement with Trubion 64
6.1.6 UCB Enters into an Agreement with Biogen 64
6.2 Major Licensing Deals 65
6.2.1 Addex Extends its Licensing Agreement with Merck 68
6.2.2 Biogen Enters into a Licensing Agreement with Acorda Therapeutics 69
6.2.3 Genzyme Enters into a Licensing Agreement with Bayer Healthcare 69
6.2.4 Novartis Enters into a Licensing Agreement with Peptimmune 69
6.2.5 Merck Serono Enters into a Licensing Agreement with Apitope Technology 69
6.2.6 Antisense Enters into a Licensing Agreement with Teva Pharmaceutical 70
6.2.7 BioMS Medical Corp Enters into a Licensing Agreement with Eli Lilly 70
6.2.8 Biotica Enters into an Agreement with Wyeth 70

7 Appendix 71
7.1 Pipeline Product Tables by Phase 71
7.2 Market Forecasting Data Tables to 2019 81
7.3 Market Definition 85
7.4 Abbreviations 85
7.5 References 86
7.6 Methodology 89
7.7 Secondary Research 90
7.8 Therapeutic Landscape 90
7.9 Epidemiology-Based Forecasting 91
7.10 Market Size by Geography 92
7.11 Pipeline Analysis 93
7.12 Contact Us 93
7.13 Disclaimer 93

List of Tables


Table 1: McDonald Criteria, Multiple Sclerosis, 2013 12
Table 2: Expanded Disability Status Scale, Multiple Sclerosis, 2013 14
Table 3: Multiple Sclerosis, Global, Market Forecast, ($bn), 2012–2019 81
Table 4: Multiple Sclerosis, US, Market Forecast, ($bn), 2012–2019 81
Table 5: Multiple Sclerosis, UK, Market Forecast, ($bn), 2012–2019 82
Table 6: Multiple Sclerosis, France, Market Forecast, ($bn), 2012–2019 82
Table 7: Multiple Sclerosis, Germany, Market Forecast, ($bn), 2012–2019 83
Table 8: Multiple Sclerosis, Italy, Market Forecast, ($bn), 2012–2019 83
Table 9: Multiple Sclerosis, Spain, Market Forecast, ($bn), 2012–2019 84
Table 10: Multiple Sclerosis, Japan, Market Forecast, ($bn), 2012–2019 84

List of Figures


Figure 1: Treatment Algorithm, Global, Multiple Sclerosis, 2013 18
Figure 2: Multiple Sclerosis, Marketed Products Heat Map 27
Figure 3: Overall Pipeline for Multiple Sclerosis 30
Figure 4: Routes of Administration in the Pipeline 31
Figure 5: Molecular Targets of Pipeline Molecules 32
Figure 6: Molecular Targets in MS Pipeline by Phase of Development 33
Figure 7: Failure Rate of MS Clinical Trials, 2006–2013 35
Figure 8: Reasons for Clinical Trial Failure, 2006–2013 36
Figure 9: Clinical Trial Size by Product and Phase, 2006–2013 37
Figure 10: Clinical Trial Duration by Phase and Molecule Type, 2006–2013 39
Figure 11: Multiple Sclerosis, Pipeline Product Heat Map 45
Figure 12: Multiple Sclerosis, Marketed Product Heat Map, 2012–2019 46
Figure 13: Multiple Sclerosis Market, Global, Patient Volumes (‘000) and Market Size ($bn), 2012–2019 49
Figure 14: Multiple Sclerosis Market, US, Patient Volumes (‘000), Annual Cost of Treatment ($) and Market Size ($bn), 2012–2019 51
Figure 15: Multiple Sclerosis Market, EU5, Patient Population (‘000), 2012–2019 53
Figure 16: Multiple Sclerosis Market, EU5, Annual Cost of Treatment ($), 2012–2019 54
Figure 17: Multiple Sclerosis Market, EU5, Market Size ($bn), 2013–2019 55
Figure 18: Multiple Sclerosis Market, Japan, Patient Volume (‘000), Annual Cost of Treatment ($) and Market Size ($bn), 2013–2019 57
Figure 19: Multiple Sclerosis, Co-development Deals by Geography, Value and Year, 2006–2013 61
Figure 20: Multiple Sclerosis, Co-Development Deal Frequency by Phase and Molecule Type 2006–2013 62
Figure 21: Multiple Sclerosis, Licensing Deals by Geography, Value and Year, 2006–2013 66
Figure 22: Multiple Sclerosis, Licensing Deal frequency by Phase and Molecule Type, 2006–2013 67
Figure 23: Multiple Sclerosis, Licensing Deal Value by Molecule Type and Mechanism of Action, 2006–2013 68
Figure 24: Multiple Sclerosis, Global, Pharmaceutical Pipeline (Discovery) 71
Figure 25: Multiple Sclerosis, Global, Pharmaceutical Pipeline (Pre-Clinical)-I 72
Figure 26: Multiple Sclerosis, Global, Pharmaceutical Pipeline (Pre-Clinical)-II 73
Figure 27: Multiple Sclerosis, Global, Pharmaceutical Pipeline (Pre-Clinical)-III 74
Figure 28: Multiple Sclerosis, Global, Pharmaceutical Pipeline (Phase I) -I 75
Figure 29: Multiple Sclerosis, Global, Pharmaceutical Pipeline (Phase I) -II 76
Figure 30: Multiple Sclerosis, Global, Pharmaceutical Pipeline (Phase II) - I 77
Figure 31: Multiple Sclerosis, Global, Pharmaceutical Pipeline (Phase II) - II 78
Figure 32: Multiple Sclerosis, Global, Pharmaceutical Pipeline (Phase III) 79
Figure 33: Multiple Sclerosis, Global, Pharmaceutical Pipeline (Pre-Registration) 79
Figure 34: Multiple Sclerosis, Global, Pharmaceutical Pipeline (Undisclosed) 80
Figure 35: Multiple Sclerosis Market, Global, GBI Research Market Sizing Model 92

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