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Multiple Sclerosis-US Drug Forecast and Market Analysis to 2024

Multiple Sclerosis-US Drug Forecast and Market Analysis to 2024


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Executive Summary

Multiple Sclerosis-US Drug Forecast and Market Analysis to 2024

Summary

Multiple Sclerosis (MS) is an inflammatory autoimmune disease of the central nervous system which leads to neurological disability. The exact underlying cause of the disease is poorly understood; however, it appears to involve a complex combination of genetic susceptibility and a non-genetic trigger. The MS therapeutics market has entered an exciting phase, with an upsurge of available treatment options. Over the forecast period, patients are expected to continue to switch to the oral disease-modifying therapies (DMTs), lessening the stronghold of the established injectable treatments. There are also several promising products in the late-stage pipeline, with a diverse range of mechanisms offering clinical advantages intended to address unmet needs. Both pipeline and marketed DMTs are seeking approval for the treatment of progressive MS, which currently represents a significant unmet need. These factors are expected to increase treatment rates throughout the 10MM resulting, driving market growth. However, this will be largely offset by brand erosion due to the emergence of biosimilars and generic small molecules.

GlobalData estimates that drug sales for MS in the US reached USD 11.9 billion during 2014, making this the largest market within the 10MM. Slow growth is expected to occur between 2014 and 2018, attributed to the continued uptake of products with high ACOTs. This will be followed by a two-year decline due to the generic erosion of key brands, namely Teva's Copaxone and Novartis' Gilenya. However, growth will return from 2020 onwards as generic erosion is offset by sales of novel pipeline agents.

*This is an on-demand report and will be delivered within 24 hrs. (excluding weekends) of the purchase.

Scope

Overview of MS 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 MScription, safety and efficacy profiles as well as a SWOT analysis.

Sales forecast for the top drugs in the US from 2014-2024.

Analysis of the impact of key events as well the drivers and restraints affecting the US MS 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 MS.

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 2014-2024 in the US.

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 6

1.2 List of Figures 10

2 Introduction 11

2.1 Catalyst 11

2.2 Related Reports 12

3 Disease Overview 13

3.1 Etiology and Pathophysiology 13

3.1.1 Etiology 13

3.1.2 Pathophysiology 14

3.2 Classification 15

3.2.1 Relapse-Remitting Multiple Sclerosis 15

3.2.2 Secondary Progressive Multiple Sclerosis 16

3.2.3 Primary Progressive Multiple Sclerosis 16

3.2.4 Progressive Relapsing Multiple Sclerosis 16

3.3 Symptoms 17

3.4 Prognosis 18

3.5 Quality of Life 19

4 Disease Management 20

4.1 Diagnosis 20

4.2 Treatment Overview 24

4.2.1 Management of Acute Relapse 26

4.2.2 Treatment with Disease-Modifying Therapies 26

4.2.3 Symptomatic Therapies 31

4.3 US 32

4.3.1 Diagnosis 32

4.3.2 Drug Treatment 33

5 Competitive Assessment 38

5.1 Overview 38

5.2 Product Profiles-Major Injectable Brands 40

5.2.1 Betaseron 40

5.2.2 Avonex 45

5.2.3 Rebif 50

5.2.4 Copaxone 54

5.2.5 Tysabri 60

5.2.6 Lemtrada 65

5.2.7 Plegridy 72

5.3 Product Profiles-Major Small Molecule Brands 78

5.3.1 Gilenya 78

5.3.2 Aubagio 84

5.3.3 Tecfidera 89

5.4 Other Disease-Modifying Therapies 95

5.4.1 Overview 95

6 Unmet Need and Opportunity Analysis 97

6.1 Overview 97

6.2 Curative Therapies 98

6.2.1 Unmet Need 98

6.2.2 Gap Analysis 99

6.2.3 Opportunity 100

6.3 The High Cost of MS Drugs 101

6.3.1 Unmet Need 101

6.3.2 Gap Analysis 102

6.3.3 Opportunity 103

6.4 Safety and Tolerability of Therapy 103

6.4.1 Unmet Need 103

6.4.2 Gap Analysis 104

6.4.3 Opportunity 105

6.5 Effective Treatments for Progressive MS 105

6.5.1 Unmet Need 105

6.5.2 Gap Analysis 107

6.5.3 Opportunity 107

6.6 Inconvenient Route of Administration and Frequent Dosing 108

6.6.1 Unmet Need 108

6.6.2 Gap Analysis 109

6.6.3 Opportunity 109

6.7 MS Biomarkers for Early Diagnosis and Treatment Choice 109

6.7.1 Unmet Need 109

6.7.2 Gap Analysis 111

6.7.3 Opportunity 111

7 Pipeline Assessment 113

7.1 Overview 113

7.2 Clinical Trial Mapping 113

7.2.1 Clinical Trials by Country 113

7.3 Promising Drugs in Clinical Development 114

7.3.1 Zinbryta 117

7.3.2 Ocrelizumab 125

7.3.3 Ofatumumab 132

7.3.4 Opicinumab 138

7.3.5 Nerventra 143

7.3.6 Masitinib 150

7.3.7 Siponimod 155

7.3.8 Ozanimod 161

7.3.9 Ponesimod 165

7.4 Late-Stage Therapeutic Vaccines 171

7.4.1 NeuroVax 172

7.4.2 Tcelna 175

7.5 Other Drugs in Development 179

8 Market Outlook 182

8.1 United States 182

8.1.1 Forecast 182

8.1.2 Key Events 186

8.1.3 Drivers and Barriers 187

9 Appendix 188

9.1 Bibliography 188

9.2 Abbreviations 210

9.3 Methodology 215

9.4 Forecasting Methodology 215

9.4.1 Diagnosed MS Patients 215

9.4.2 Percent Drug-Treated Patients 215

9.4.3 Launch and Patent Expiry Dates 216

9.4.4 General Pricing Assumptions 217

9.4.5 Individual Drug Assumptions 218

9.4.6 Generic Erosion 224

9.4.7 Pricing of Pipeline Agents 224

9.5 Primary Research-KOLs Interviewed for this Report 226

9.6 Primary Research-Prescriber Survey 229

9.7 About the Authors 230

9.7.1 Analyst 230

9.7.2 Therapy Area Director 230

9.7.3 Epidemiologist 231

9.7.4 Global Director of Therapy Research and Analysis 231

9.8 About GlobalData 232

9.9 Disclaimer 232

1.2 List of Figures

Figure 1: Accrual of Disability in the Four Subtypes of MS 17

Figure 2: Expanded Disability Status Scale (EDSS) 24

Figure 3: Algorithm for the Treatment of MS with Disease-Modifying Therapies 30

Figure 4: MS Therapeutics-Clinical Trials by Country, 2015 114

Figure 5: Multiple Sclerosis-Phase II-III Pipeline, 2015 116

Figure 6: Competitive Assessment of Late-Stage Pipeline Agents in MS, 2014-2024 117

Figure 7: Multiple Sclerosis-Phase II-III Therapeutic Vaccines, 2015 172

Figure 8: Sales for MS in the United States by Therapy Type, 2014-2024 185

1.1 List of Tables

Table 1: Common Presenting Symptoms of MS 18

Table 2: Factors That Can Affect Prognosis in MS 19

Table 3: Revised 2010 McDonald Criteria for the Diagnosis of MS 23

Table 4: Treatment Guidelines for MS 25

Table 5: Top Three Disease-Modifying Therapies Prescribed for MS by Market 29

Table 6: Pharmacotherapy for Common MS Symptoms 31

Table 7: US-MS Diagnosis Metrics 33

Table 8: US-MS Treatment Metrics 37

Table 9: Leading Disease-Modifying Drugs for the Treatment of MS, 2015 40

Table 10: Product Profile-Betaseron 42

Table 11: Betaseron SWOT Analysis, 2015 44

Table 12: Global Sales Forecasts (USD m) for Betaseron, 2014-2024 45

Table 13: Product Profile-Avonex 46

Table 14: Avonex SWOT Analysis, 2015 48

Table 15: Global Sales Forecasts (USD m) for Avonex, 2014-2024 49

Table 16: Product Profile-Rebif 51

Table 17: Rebif SWOT Analysis, 2014 53

Table 18: Global Sales Forecasts (USD m) for Rebif, 2014-2024 54

Table 19: Product Profile-Copaxone 56

Table 20: Copaxone SWOT Analysis, 2015 58

Table 21: Global Sales Forecasts (USD m) for Copaxone, 2014-2024 59

Table 22: Product Profile-Tysabri 62

Table 23: Tysabri SWOT Analysis, 2015 64

Table 24: Global Sales Forecasts (USD m) for Tysabri, 2014-2024 65

Table 25: Product Profile-Lemtrada 68

Table 26: Lemtrada SWOT Analysis, 2015 71

Table 27: Global Sales Forecasts (USD m) for Lemtrada, 2014-2024 72

Table 28: Product Profile-Plegridy 73

Table 29: Clinical and MRI Endpoints at Year 1 from a Phase III Trial of Plegridy in MS 74

Table 30: Clinical and MRI Endpoints at Year 2 from a Phase III Trial of Plegridy in MS 75

Table 31: Adverse Events During Year 1 of a Phase III Trial of Plegridy in MS 76

Table 32: Plegridy SWOT Analysis, 2015 77

Table 33: Global Sales Forecasts (USD m) for Plegridy, 2014-2024 78

Table 34: Product Profile-Gilenya 80

Table 35: Gilenya SWOT Analysis, 2015 82

Table 36: Global Sales Forecasts (USD m) for Gilenya, 2014-2024 83

Table 37: Product Profile-Aubagio 85

Table 38: Aubagio SWOT Analysis, 2015 88

Table 39: Global Sales Forecasts (USD m) for Aubagio, 2014-2024 89

Table 40: Product Profile-Tecfidera 91

Table 41: Tecfidera SWOT Analysis, 2015 93

Table 42: Global Sales Forecasts (USD m) for Tecfidera, 2014-2024 95

Table 43: Summary of Alternative MS DMTs, 2014 96

Table 44: Unmet Need and Opportunity in MS 98

Table 45: Product Profile-Zinbryta High-Yield Process 119

Table 46: Adverse Events during Year 1 of a Phase III trial of Zinbryta in MS 121

Table 47: Zinbryta SWOT Analysis, 2015 124

Table 48: Global Sales Forecasts (USD m) for Zinbryta, 2014-2024 125

Table 49: Product Profile-Ocrelizumab 127

Table 50: Ocrelizumab SWOT Analysis, 2015 131

Table 51: Global Sales Forecasts (USD m) for ocrelizumab, 2014-2024 132

Table 52: Product Profile-Ofatumumab 133

Table 53: Ofatumumab SWOT Analysis, 2015 137

Table 54: Global Sales Forecasts (USD m) for Ofatumumab, 2014-2024 138

Table 55: Product Profile-Opicinumab 139

Table 56: Opicinumab SWOT Analysis, 2015 142

Table 57: Product Profile-Nerventra 145

Table 58: Nerventra SWOT Analysis, 2015 149

Table 59: Global Sales Forecasts (USD m) for Nerventra, 2014-2024 150

Table 60: Product Profile-Masitinib 151

Table 61: Masitinib SWOT Analysis, 2015 154

Table 62: Global Sales Forecasts (USD m) for Masitinib, 2014-2024 155

Table 63: Product Profile-Siponimod 156

Table 64: Siponimod SWOT Analysis, 2015 159

Table 65: Global Sales Forecasts (USD m) for siponimod, 2014-2024 160

Table 66: Product Profile-Ozanimod 162

Table 67: Ozanimod SWOT Analysis, 2015 164

Table 68: Global Sales Forecasts (USD m) for Ozanimod, 2014-2024 165

Table 69: Product Profile-Ponesimod 166

Table 70: Efficacy Results for Ponesimod in a Phase IIb MS Trial 167

Table 71: Ponesimod SWOT Analysis, 2015 170

Table 72: Global Sales Forecasts (USD m) for Ponesimod, 2014-2024 171

Table 73: Product Profile-NeuroVax 173

Table 74: NeuroVax SWOT Analysis, 2015 175

Table 75: Product Profile-Tcelna 177

Table 76: Tcelna SWOT Analysis, 2015 179

Table 77: Drugs in Development, 2015 180

Table 78: Sales Forecast (USD m) for MS in the United States, 2014-2024 184

Table 79: Key Events Impacting Sales for MS in the US, 2014-2024 186

Table 80: MS Market in the US-Drivers and Barriers, 2014-2024 187

Table 81: Key Launch Dates 216

Table 82: Key Patent Expiries 216

Table 83: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 229

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