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

NEW YORK, May 14, 2013 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

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

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.


- 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 US1 Table of Contents1 Table of Contents 41.1 List of Tables 71.2 List of Figures 92 Introduction 102.1 Catalyst 102.2 Related Reports 113 Disease Overview 133.1 Etiology and Pathophysiology 133.1.1 Etiology 133.1.2 Pathophysiology 143.1.3 Classification of Multiple Sclerosis 153.2 Symptoms 173.2.1 Prognosis 183.2.2 Quality of Life 194 Disease Management 204.1 Diagnosis 204.2 Treatment Overview 234.2.1 Management of Acute Relapse 244.2.2 Treatment with Disease-Modifying Therapies 244.2.3 Symptomatic Therapies 274.3 US 284.3.1 Diagnosis 284.3.2 Clinical Practice 295 Competitive Assessment 315.1 Overview 315.2 Strategic Competitor Assessment 325.3 Product Profiles – Major Brands 345.3.1 Betaseron/Betaferon (interferon beta-1b) 345.3.2 Avonex (interferon beta-1a) 395.3.3 Rebif (interferon beta-1a) 445.3.4 Copaxone (glatiramer acetate; copolymer-1) 485.3.5 Tysabri (natalizumab) 525.3.6 Gilenya/Imusera (fingolimod; FTY720) 575.3.7 Aubagio (teriflunomide) 625.3.8 Other Disease–Modifying Therapies 676 Opportunity and Unmet Need 686.1 Overview 686.2 Unmet Needs 696.2.1 Currently Available MS Drugs Only Provide Partial Benefits 696.2.2 The High Cost of MS Drugs Could Continue to Price out Patients 706.2.3 Safety and Tolerability of Therapy is Undermined by Side Effects 716.2.4 Effective Treatments for Progressive MS Are Still Elusive 726.2.5 Inconvenient Route of Administration and Frequent Dosing Limits Compliance 736.2.6 The Lack of Predictive Biomarkers Delays MS Diagnosis 746.3 Unmet Needs Gap Analysis 756.4 Opportunities 766.4.1 Treatments for Progressive MS 766.4.2 Targeting Patients with Clinically Isolated Syndrome 767 Pipeline Assessment 777.1 Overview 777.2 Promising Drugs in Clinical Development 787.2.1 BG-12 (dimethyl fumarate; BG00012) 817.2.2 Lemtrada (alemtuzumab) 867.2.3 Laquinimod (ABR-215062) 927.2.4 Daclizumab High-Yield Process (HYP) 977.2.5 Ocrelizumab (RG1594) 1027.2.6 Siponimod (BAF-312) 1077.2.7 NU-100 (interferon beta-1b) 1117.2.8 Masitinib (AB-1010) 1157.2.9 Tcelna (imilecleucel-T) 1198 Market Outlook 1238.1 United States 1238.1.1 Forecast 1238.1.2 Key Events 1278.1.3 Drivers and Barriers 1289 Appendix 1309.1 Bibliography 1309.2 Abbreviations 1419.3 Methodology 1459.4 Forecasting Methodology 1459.4.1 Diagnosed MS patients 1459.4.2 Percent Drug-Treated Patients 1469.4.3 Drugs Included in Each Therapeutic Class 1469.4.4 Launch and Patent Expiry Dates 1479.4.5 General Pricing Assumptions 1489.4.6 Individual Drug Assumptions 1499.4.7 Generic Erosion 1539.4.8 Pricing of Pipeline agents 1539.5 Physicians and Specialists Included in This Report 1549.6 Primary Research – Prescriber Survey 1559.7 About the Authors 1569.7.1 Analysts 1569.7.2 Global Head of Healthcare 1579.8 About GlobalData 1589.9 Contact Us 1589.10 Disclaimer 158

List of Tables

Table 1: Common Presenting Symptoms of Multiple Sclerosis 17Table 2: Factors That Can Affect Prognosis in Multiple Sclerosis 18Table 3: Revised 2010 McDonald Criteria for the Diagnosis of Multiple Sclerosis 21Table 4: Treatment Guidelines for Multiple Sclerosis 23Table 5: Top Three Disease-Modifying Therapies Prescribed for Multiple Sclerosis by Market 25Table 6: Pharmacotherapy for Common Multiple Sclerosis Symptoms 27Table 7: Disease-Modifying Drugs for the Treatment of Multiple Sclerosis, 2012 33Table 8: Product Profile – Betaseron 35Table 9: Betaseron/Betaferon SWOT Analysis, 2012 38Table 10: Product Profile – Avonex 40Table 11: Avonex SWOT Analysis, 2012 43Table 12: Product Profile – Rebif 45Table 13: Rebif SWOT Analysis, 2012 47Table 14: Product Profile – Copaxone 49Table 15: Copaxone SWOT Analysis, 2012 51Table 16: Product Profile – Tysabri 53Table 17: Tysabri SWOT Analysis, 2012 56Table 18: Product Profile – Gilenya 58Table 19: Gilenya SWOT Analysis, 2012 61Table 20: Product Profile – Aubagio 63Table 21: Aubagio SWOT Analysis, 2012 66Table 22: Summary of Alternative MS DMTs, 2012 67Table 23: Overall Unmet Needs – Current Level of Attainment 68Table 24: Clinical Unmet Needs – Gap Analysis, 2012 75Table 25: Multiple Sclerosis – Phase Pipeline, 2012 78Table 26: Comparison of Therapeutic Classes in Development for Multiple Sclerosis, 2012 80Table 27: Product Profile – BG-12 82Table 28: BG-12 SWOT Analysis, 2012 85Table 29: Product Profile – Lemtrada 87Table 30: Lemtrada SWOT Analysis, 2012 91Table 31: Product Profile – Laquinimod 93Table 32: Laquinimod SWOT Analysis, 2012 96Table 33: Product Profile – Daclizumab High-Yield Process 97Table 34: Daclizumab SWOT Analysis, 2012 101Table 35: Product Profile – Ocrelizumab 103Table 36: Ocrelizumab SWOT Analysis, 2012 106Table 37: Product Profile – Siponimod 107Table 38: Siponimod SWOT Analysis, 2012 110Table 39: Product Profile – NU-100 112Table 40: NU-100 SWOT Analysis, 2012 114Table 41: Product Profile – Masitinib 115Table 42: Masitinib SWOT Analysis, 2012 118Table 43: Product Profile – Tcelna 120Table 44: Tcelna SWOT Analysis, 2012 122Table 45: Sales Forecasts ($m) for Multiple Sclerosis in the United States, 2012-2022 125Table 46: Key Events Impacting Sales for Multiple Sclerosis the United States, 2012 127Table 47: Multiple Sclerosis Market in the United States – Drivers and Barriers, 2012 128Table 48: Key Launch Dates 147Table 49: Key Patent Expiries 147Table 50: Physicians Surveyed, By Country 155

List of Figures

Figure 1: Accrual of Disability in the Four Subtypes of Multiple Sclerosis 16Figure 2: Expanded Disability Status Scale (EDSS) 22Figure 3: Current Algorithm for the Treatment of MS with Disease-Modifying Therapies 26Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in Multiple Sclerosis, 2012–2022 79Figure 5: Sales for Multiple Sclerosis in the United States by Drug Class, 2012–2022 126

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