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

NEW YORK, May 16, 2013 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

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

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

Summary GlobalData has released its new Country report, "PharmaPoint: Multiple Sclerosis - United Kingdom 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.

Market growth will be driven by the launch of new DMTs, including several oral therapies that will increase overall treatment rates, and novel DMTs, such as siponimod, that specifically target the large population of MS patients in the UK who have a progressive MS subtype. However, a high rate of generic substitution once key branded products go off patent is an important barrier that limits the market size.


- 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 UK including product description, safety and efficacy profiles as well as a SWOT analysis.- Sales forecast for the top drugs in the UK from 2012-2022.- Analysis of the impact of key events as well the drivers and restraints affecting the UK 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 UK1 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 United Kingdom 284.3.1 Diagnosis 284.3.2 Clinical Practice 285 Competitive Assessment 305.1 Overview 305.2 Strategic Competitor Assessment 315.3 Product Profiles – Major Brands 335.3.1 Betaseron/Betaferon (interferon beta-1b) 335.3.2 Avonex (interferon beta-1a) 385.3.3 Rebif (interferon beta-1a) 435.3.4 Copaxone (glatiramer acetate; copolymer-1) 475.3.5 Tysabri (natalizumab) 515.3.6 Gilenya/Imusera (fingolimod; FTY720) 565.3.7 Aubagio (teriflunomide) 615.3.8 Other Disease–Modifying Therapies 666 Opportunity and Unmet Need 676.1 Overview 676.2 Unmet Needs 686.2.1 Currently Available MS Drugs Only Provide Partial Benefits 686.2.2 The High Cost of MS Drugs Could Continue to Price out Patients 696.2.3 Safety and Tolerability of Therapy is Undermined by Side Effects 706.2.4 Effective Treatments for Progressive MS Are Still Elusive 716.2.5 Inconvenient Route of Administration and Frequent Dosing Limits Compliance 726.2.6 The Lack of Predictive Biomarkers Delays MS Diagnosis 736.3 Unmet Needs Gap Analysis 746.4 Opportunities 756.4.1 Treatments for Progressive MS 756.4.2 Targeting Patients with Clinically Isolated Syndrome 757 Pipeline Assessment 767.1 Overview 767.2 Promising Drugs in Clinical Development 787.2.1 BG-12 (dimethyl fumarate; BG00012) 807.2.2 Lemtrada (alemtuzumab) 857.2.3 Laquinimod (ABR-215062) 917.2.4 Daclizumab High-Yield Process (HYP) 967.2.5 Ocrelizumab (RG1594) 1017.2.6 Siponimod (BAF-312) 1067.2.7 NU-100 (interferon beta-1b) 1107.2.8 Masitinib (AB-1010) 1147.2.9 Tcelna (imilecleucel-T) 1188 Market Outlook 1228.1 United Kingdom 1228.1.1 Forecast 1228.1.2 Key Events 1268.1.3 Drivers and Barriers 1279 Appendix 1299.1 Bibliography 1299.2 Abbreviations 1409.3 Methodology 1449.4 Forecasting Methodology 1449.4.1 Diagnosed MS patients 1449.4.2 Percent Drug-Treated Patients 1459.4.3 Drugs Included in Each Therapeutic Class 1459.4.4 Launch and Patent Expiry Dates 1469.4.5 General Pricing Assumptions 1479.4.6 Individual Drug Assumptions 1489.4.7 Generic Erosion 1529.4.8 Pricing of Pipeline agents 1529.5 Physicians and Specialists Included in This Report 1539.6 Primary Research – Prescriber Survey 1549.7 About the Authors 1559.7.1 Analysts 1559.7.2 Global Head of Healthcare 1569.8 About GlobalData 1579.9 Contact Us 1579.10 Disclaimer 157

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 32Table 8: Product Profile – Betaseron 34Table 9: Betaseron/Betaferon SWOT Analysis, 2012 37Table 10: Product Profile – Avonex 39Table 11: Avonex SWOT Analysis, 2012 42Table 12: Product Profile – Rebif 44Table 13: Rebif SWOT Analysis, 2012 46Table 14: Product Profile – Copaxone 48Table 15: Copaxone SWOT Analysis, 2012 50Table 16: Product Profile – Tysabri 52Table 17: Tysabri SWOT Analysis, 2012 55Table 18: Product Profile – Gilenya 57Table 19: Gilenya SWOT Analysis, 2012 60Table 20: Product Profile – Aubagio 62Table 21: Aubagio SWOT Analysis, 2012 65Table 22: Summary of Alternative MS DMTs, 2012 66Table 23: Overall Unmet Needs – Current Level of Attainment 67Table 24: Clinical Unmet Needs – Gap Analysis, 2012 74Table 25: Multiple Sclerosis – Phase Pipeline, 2012 78Table 26: Comparison of Therapeutic Classes in Development for Multiple Sclerosis, 2012 79Table 27: Product Profile – BG-12 81Table 28: BG-12 SWOT Analysis, 2012 84Table 29: Product Profile – Lemtrada 86Table 30: Lemtrada SWOT Analysis, 2012 90Table 31: Product Profile – Laquinimod 92Table 32: Laquinimod SWOT Analysis, 2012 95Table 33: Product Profile – Daclizumab High-Yield Process 96Table 34: Daclizumab SWOT Analysis, 2012 100Table 35: Product Profile – Ocrelizumab 102Table 36: Ocrelizumab SWOT Analysis, 2012 105Table 37: Product Profile – Siponimod 106Table 38: Siponimod SWOT Analysis, 2012 109Table 39: Product Profile – NU-100 111Table 40: NU-100 SWOT Analysis, 2012 113Table 41: Product Profile – Masitinib 114Table 42: Masitinib SWOT Analysis, 2012 117Table 43: Product Profile – Tcelna 119Table 44: Tcelna SWOT Analysis, 2012 121Table 45: Sales Forecasts ($m) for Multiple Sclerosis in the United Kingdom, 2012–2022 124Table 46: Key Events Impacting Sales for Multiple Sclerosis in the United Kingdom, 2012 126Table 47: Multiple Sclerosis Market in the United Kingdom – Drivers and Barriers, 2012 127Table 48: Key Launch Dates 146Table 49: Key Patent Expiries 146Table 50: Physicians Surveyed, By Country 154

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 78Figure 5: Sales for Multiple Sclerosis in the United Kingdom by Drug Class, 2012-2022 125

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