PharmaPoint: Multiple Sclerosis - US Drug Forecast and Market Analysis to 2022

NEW YORK, May 13, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

PharmaPoint: Multiple Sclerosis - US Drug Forecast and Market Analysis to 2022
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PharmaPoint: Multiple Sclerosis - US Drug Forecast and Market Analysis to 2022

Summary

GlobalData has released its new Country report, "PharmaPoint: Multiple Sclerosis - US Drug Forecast and Market Analysis to 2022". Multiple sclerosis (MS) is a chronic, inflammatory neurological disorder characterized pathologically by demyelination, axonal transection and neurodegeneration within the central nervous system. With curative therapy still elusive, current disease management is dependent on life-long pharmacotherapy with disease-modifying therapies (DMT). The dominance of first-line injectable DMTs, including the interferon beta (IFNß) agents: Bayer's Betaseron/Betaferon (IFNß-1b), Biogen's Avonex (IFNß-1a) and Merck's Rebif (IFNß-1a), and Teva's Copaxone (glatiramer acetate), has been a salient feature of the MS therapeutics market. However, the competitive landscape is undergoing significant change with the emergence of oral therapies, several pipeline products with notable efficacies, and looming generics/biosimilars following the patent expiries of key branded products during the forecast period. In addition, the entry of new companies such as Sanofi/Genzyme and F. Hoffmann-La-Roche/Genentech will challenge the position of the established players in the MS marketplace.

The US is the largest MS market due to the high prevalence of the disease and comparatively high MS drug prices.During the forecast period, the major driver for market growth is an increase in the diagnosis rate following adoption of the revised 2010 McDonald criteria, which greatly reduced the time to diagnosis, and the push by physicians for the earlier initiation of treatment in patients. Other important drivers include the launch of several pipeline DMTs that provide improved efficacy and convenient administration, as well as increased accessibility to treatment due to US healthcare reform, which will both result in higher treatment rates. Furthermore, the launch of novel DMTs that specifically target progressive MS, such as masitinib and siponimod, will also increase treatment uptake by patients with PPMS or SPMS. With several key patent expiries of leading branded products occurring throughout the forecast period, generic erosion will be the biggest barrier to market growth.

Note: This is upcoming report and will be delivered within 24 hrs of the purchase (excluding weekends).

Scope

- Overview of the Multiple Sclerosis 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 description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the US from 2012-2022.
- Analysis of the impact of key events as well the drivers and restraints affecting the US Multiple Sclerosis 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 Multiple Sclerosis
- 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 2012-2022 in the US

Table of Contents

1 Table of Contents 4
1.1 List of Tables 8
1.2 List of Figures 10
2 Introduction 11
2.1 Catalyst 11
2.2 Related Reports 12
2.3 Upcoming Related Reports 13
3 Disease Overview 14
3.1 Etiology and Pathophysiology 14
3.1.1 Etiology 14
3.1.2 Pathophysiology 15
3.1.3 Classification of Multiple Sclerosis 16
3.2 Symptoms 18
3.2.1 Prognosis 19
3.2.2 Quality of Life 20
4 Disease Management 21
4.1 Diagnosis 21
4.2 Treatment Overview 23
4.2.1 Management of Acute Relapse 24
4.2.2 Treatment with Disease-Modifying Therapies 25
4.2.3 Symptomatic Therapies 26
4.3 US 27
4.3.1 Diagnosis 27
4.3.2 Clinical Practice 27
5 Competitive Assessment 30
5.1 Overview 30
5.2 Strategic Competitor Assessment 30
5.3 Product Profiles – Major Brands 31
5.3.1 Betaseron/Betaferon (interferon beta-1b) 31
5.3.2 Avonex (interferon beta-1a) 36
5.3.3 Rebif (interferon beta-1a) 40
5.3.4 Copaxone (glatiramer acetate; copolymer-1) 44
5.3.5 Tysabri (natalizumab) 48
5.3.6 Gilenya/Imusera (fingolimod; FTY720) 52
5.3.7 Aubagio (teriflunomide) 56
5.3.8 Other Disease–Modifying Therapies 61
6 Opportunity and Unmet Need 62
6.1 Overview 62
6.2 Unmet Needs 63
6.2.1 Currently Available MS Drugs Only Provide Partial Benefits 63
6.2.2 The High Cost of MS Drugs Could Continue to Price out Patients 64
6.2.3 Safety and Tolerability of Therapy is Undermined by Side Effects 65
6.2.4 Effective Treatments for Progressive MS Are Still Elusive 65
6.2.5 Inconvenient Route of Administration and Frequent Dosing Limits Compliance 66
6.2.6 The Lack of Predictive Biomarkers Delays MS Diagnosis 67
6.3 Unmet Needs Gap Analysis 67
6.4 Opportunities 69
6.4.1 Treatments for Progressive MS 69
6.4.2 Targeting Patients with Clinically Isolated Syndrome 69
7 Pipeline Assessment 70
7.1 Overview 70
7.2 Promising Drugs in Clinical Development 71
7.2.1 BG-12 (dimethyl fumarate; BG00012) 74
7.2.2 Lemtrada (alemtuzumab) 78
7.2.3 Laquinimod (ABR-215062) 83
7.2.4 Daclizumab High-Yield Process (HYP) 88
7.2.5 Ocrelizumab (RG1594) 92
7.2.6 Siponimod (BAF-312) 96
7.2.7 NU-100 (interferon beta-1b) 100
7.2.8 Masitinib (AB-1010) 103
7.2.9 Tcelna (imilecleucel-T) 106
8 Market Outlook 111
8.1 United States 111
8.1.1 Forecast 111
8.1.2 Key Events 115
8.1.3 Drivers and Barriers 115
9 Appendix 118
9.1 Bibliography 118
9.2 Abbreviations 129
9.3 Methodology 133
9.4 Forecasting Methodology 133
9.4.1 Diagnosed MS patients 133
9.4.2 Percent Drug-Treated Patients 134
9.4.3 Drugs Included in Each Therapeutic Class 134
9.4.4 Launch and Patent Expiry Dates 134
9.4.5 General Pricing Assumptions 135
9.4.6 Individual Drug Assumptions 136
9.4.7 Generic Erosion 140
9.4.8 Pricing of Pipeline agents 140
9.5 Physicians and Specialists Included in This Report 141
9.6 Primary Research – Prescriber Survey 142
9.7 About the Authors 143
9.7.1 Analysts 143
9.7.2 Global Head of Healthcare 144
9.8 About GlobalData 145
9.9 Contact Us 145
9.10 Disclaimer 145

List of Tables

Table 1: Common Presenting Symptoms of Multiple Sclerosis 18
Table 2: Factors That Can Affect Prognosis in Multiple Sclerosis 19
Table 3: Revised 2010 McDonald Criteria for the Diagnosis of Multiple Sclerosis 22
Table 4: Treatment Guidelines for Multiple Sclerosis 24
Table 5: Top Three Disease-Modifying Therapies Prescribed for Multiple Sclerosis by Market 25
Table 6: Pharmacotherapy for Common Multiple Sclerosis Symptoms 27
Table 7: Disease-Modifying Drugs for the Treatment of Multiple Sclerosis, 2012 31
Table 8: Product Profile – Betaseron 33
Table 9: Betaseron/Betaferon SWOT Analysis, 2012 36
Table 10: Product Profile – Avonex 37
Table 11: Avonex SWOT Analysis, 2012 40
Table 12: Product Profile – Rebif 41
Table 13: Rebif SWOT Analysis, 2012 44
Table 14: Product Profile – Copaxone 45
Table 15: Copaxone SWOT Analysis, 2012 47
Table 16: Product Profile – Tysabri 49
Table 17: Tysabri SWOT Analysis, 2012 52
Table 18: Product Profile – Gilenya 53
Table 19: Gilenya SWOT Analysis, 2012 56
Table 20: Product Profile – Aubagio 58
Table 21: Aubagio SWOT Analysis, 2012 60
Table 22: Summary of Alternative MS DMTs, 2012 61
Table 23: Overall Unmet Needs – Current Level of Attainment 62
Table 24: Clinical Unmet Needs – Gap Analysis, 2012 68
Table 25: Multiple Sclerosis – Phase Pipeline, 2012 71
Table 26: Comparison of Therapeutic Classes in Development for Multiple Sclerosis, 2012 73
Table 27: Product Profile – BG-12 75
Table 28: BG-12 SWOT Analysis, 2012 78
Table 29: Product Profile – Lemtrada 80
Table 30: Lemtrada SWOT Analysis, 2012 83
Table 31: Product Profile – Laquinimod 85
Table 32: Laquinimod SWOT Analysis, 2012 88
Table 33: Product Profile – Daclizumab High-Yield Process 89
Table 34: Daclizumab SWOT Analysis, 2012 92
Table 35: Product Profile – Ocrelizumab 93
Table 36: Ocrelizumab SWOT Analysis, 2012 96
Table 37: Product Profile – Siponimod 97
Table 38: Siponimod SWOT Analysis, 2012 100
Table 39: Product Profile – NU-100 101
Table 40: NU-100 SWOT Analysis, 2012 103
Table 41: Product Profile – Masitinib 104
Table 42: Masitinib SWOT Analysis, 2012 106
Table 43: Product Profile – Tcelna 107
Table 44: Tcelna SWOT Analysis, 2012 110
Table 45: Sales Forecasts ($m) for Multiple Sclerosis in the United States, 2012-2022 113
Table 46: Key Events Impacting Sales for Multiple Sclerosis the United States, 2012 115
Table 47: Multiple Sclerosis Market in the United States – Drivers and Barriers, 2012 115
Table 48: Key Launch Dates 135
Table 49: Key Patent Expiries 135
Table 50: Physicians Surveyed, By Country 142

List of Figures

Figure 1: Accrual of Disability in the Four Subtypes of Multiple Sclerosis 17
Figure 2: Expanded Disability Status Scale (EDSS) 23
Figure 3: Current Algorithm for the Treatment of MS with Disease-Modifying Therapies 26
Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in Multiple Sclerosis, 2012–2022 72
Figure 5: Sales for Multiple Sclerosis in the United States by Drug Class, 2012–2022 114

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Pathology Industry: PharmaPoint: Multiple Sclerosis - US Drug Forecast and Market Analysis to 2022

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