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Multiple Sclerosis-5EU Drug Forecast and Market Analysis to 2024

Multiple Sclerosis-5EU Drug Forecast and Market Analysis to 2024


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Executive Summary

Multiple Sclerosis-5EU 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 believes market growth will be steady between 2014 and 2021, driven by an increase in treatment rates as pipeline agents enter the market. Following this, growth is expected to slow as Gilenya faces patent expiry in this market. The impact of generic competition will be significant, as Gilenya is anticipated to be the highest-selling DMT in the 5EU prior to its patent expiry. Market growth driven by the continued uptake of the pipeline agents will be largely offset by Gilenya's generic erosion, and the availability of generic fingolimod will limit the uptake of the novel S1P receptor modulators.

*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 5EU including product MScription, safety and efficacy profiles as well as a SWOT analysis.

Sales forecast for the top drugs in 5EU from 2014-2024.

Analysis of the impact of key events as well the drivers and restraints affecting 5EU 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 5EU.

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 7

1.2 List of Figures 11

2 Introduction 12

2.1 Catalyst 12

2.2 Related Reports 13

3 Disease Overview 14

3.1 Etiology and Pathophysiology 14

3.1.1 Etiology 14

3.1.2 Pathophysiology 15

3.2 Classification 16

3.2.1 Relapse-Remitting Multiple Sclerosis 16

3.2.2 Secondary Progressive Multiple Sclerosis 17

3.2.3 Primary Progressive Multiple Sclerosis 17

3.2.4 Progressive Relapsing Multiple Sclerosis 17

3.3 Symptoms 18

3.4 Prognosis 19

3.5 Quality of Life 20

4 Disease Management 21

4.1 Diagnosis 21

4.2 Treatment Overview 25

4.2.1 Management of Acute Relapse 27

4.2.2 Treatment with Disease-Modifying Therapies 27

4.2.3 Symptomatic Therapies 32

4.3 France 33

4.3.1 Diagnosis 33

4.3.2 Drug Treatment 33

4.4 Germany 36

4.4.1 Diagnosis 36

4.4.2 Drug Treatment 37

4.5 Italy 39

4.5.1 Diagnosis 39

4.5.2 Drug Treatment 40

4.6 Spain 42

4.6.1 Diagnosis 42

4.6.2 Drug Treatment 43

4.7 UK 45

4.7.1 Diagnosis 45

4.7.2 Drug Treatment 46

5 Competitive Assessment 49

5.1 Overview 49

5.2 Product Profiles-Major Injectable Brands 51

5.2.1 Betaseron 51

5.2.2 Avonex 56

5.2.3 Rebif 61

5.2.4 Copaxone 65

5.2.5 Tysabri 71

5.2.6 Lemtrada 76

5.2.7 Plegridy 83

5.3 Product Profiles-Major Small Molecule Brands 89

5.3.1 Gilenya 89

5.3.2 Aubagio 95

5.3.3 Tecfidera 100

5.4 Other Disease-Modifying Therapies 106

5.4.1 Overview 106

6 Unmet Need and Opportunity Analysis 108

6.1 Overview 108

6.2 Curative Therapies 109

6.2.1 Unmet Need 109

6.2.2 Gap Analysis 110

6.2.3 Opportunity 111

6.3 The High Cost of MS Drugs 112

6.3.1 Unmet Need 112

6.3.2 Gap Analysis 113

6.3.3 Opportunity 114

6.4 Safety and Tolerability of Therapy 114

6.4.1 Unmet Need 114

6.4.2 Gap Analysis 115

6.4.3 Opportunity 116

6.5 Effective Treatments for Progressive MS 116

6.5.1 Unmet Need 116

6.5.2 Gap Analysis 118

6.5.3 Opportunity 118

6.6 Inconvenient Route of Administration and Frequent Dosing 119

6.6.1 Unmet Need 119

6.6.2 Gap Analysis 120

6.6.3 Opportunity 120

6.7 MS Biomarkers for Early Diagnosis and Treatment Choice 120

6.7.1 Unmet Need 120

6.7.2 Gap Analysis 122

6.7.3 Opportunity 122

7 Pipeline Assessment 124

7.1 Overview 124

7.2 Clinical Trial Mapping 124

7.2.1 Clinical Trials by Country 124

7.3 Promising Drugs in Clinical Development 125

7.3.1 Zinbryta 128

7.3.2 Ocrelizumab 136

7.3.3 Ofatumumab 143

7.3.4 Opicinumab 149

7.3.5 Nerventra 154

7.3.6 Masitinib 161

7.3.7 Siponimod 166

7.3.8 Ozanimod 172

7.3.9 Ponesimod 176

7.4 Late-Stage Therapeutic Vaccines 182

7.4.1 NeuroVax 183

7.4.2 Tcelna 186

7.5 Other Drugs in Development 190

8 Market Outlook 193

8.1 5EU 193

8.1.1 Forecast 193

8.1.2 Key Events 199

8.1.3 Drivers and Barriers 200

9 Appendix 201

9.1 Bibliography 201

9.2 Abbreviations 223

9.3 Methodology 228

9.4 Forecasting Methodology 228

9.4.1 Diagnosed MS Patients 228

9.4.2 Percent Drug-Treated Patients 228

9.4.3 Launch and Patent Expiry Dates 229

9.4.4 General Pricing Assumptions 230

9.4.5 Individual Drug Assumptions 231

9.4.6 Generic Erosion 237

9.4.7 Pricing of Pipeline Agents 237

9.5 Primary Research-KOLs Interviewed for this Report 239

9.6 Primary Research-Prescriber Survey 242

9.7 About the Authors 243

9.7.1 Analyst 243

9.7.2 Therapy Area Director 243

9.7.3 Epidemiologist 244

9.7.4 Global Director of Therapy Research and Analysis 244

9.8 About GlobalData 245

9.9 Disclaimer 245

1.2 List of Figures

Figure 1: Accrual of Disability in the Four Subtypes of MS 18

Figure 2: Expanded Disability Status Scale (EDSS) 25

Figure 3: Algorithm for the Treatment of MS with Disease-Modifying Therapies 31

Figure 4: MS Therapeutics-Clinical Trials by Country, 2015 125

Figure 5: Multiple Sclerosis-Phase II-III Pipeline, 2015 127

Figure 6: Competitive Assessment of Late-Stage Pipeline Agents in MS, 2014-2024 128

Figure 7: Multiple Sclerosis-Phase II-III Therapeutic Vaccines, 2015 183

Figure 8: Sales for MS in the 5EU by Therapy Type, 2014-2024 198

1.1 List of Tables

Table 1: Common Presenting Symptoms of MS 19

Table 2: Factors That Can Affect Prognosis in MS 20

Table 3: Revised 2010 McDonald Criteria for the Diagnosis of MS 24

Table 4: Treatment Guidelines for MS 26

Table 5: Top Three Disease-Modifying Therapies Prescribed for MS by Market 30

Table 6: Pharmacotherapy for Common MS Symptoms 32

Table 7: France-MS Diagnosis Metrics 33

Table 8: France-MS Treatment Metrics 36

Table 9: Germany-MS Diagnosis Metrics 37

Table 10: Germany-MS Treatment Metrics 39

Table 11: Italy-MS Diagnosis Metrics 40

Table 12: Italy-MS Treatment Metrics 41

Table 13: Spain-MS Diagnosis Metrics 42

Table 14: Spain-MS Treatment Metrics 45

Table 15: UK-MS Diagnosis Metrics 46

Table 16: UK-MS Treatment Metrics 48

Table 17: Leading Disease-Modifying Drugs for the Treatment of MS, 2015 51

Table 18: Product Profile-Betaseron 53

Table 19: Betaseron SWOT Analysis, 2015 55

Table 20: Global Sales Forecasts (USD m) for Betaseron, 2014-2024 56

Table 21: Product Profile-Avonex 57

Table 22: Avonex SWOT Analysis, 2015 59

Table 23: Global Sales Forecasts (USD m) for Avonex, 2014-2024 60

Table 24: Product Profile-Rebif 62

Table 25: Rebif SWOT Analysis, 2014 64

Table 26: Global Sales Forecasts (USD m) for Rebif, 2014-2024 65

Table 27: Product Profile-Copaxone 67

Table 28: Copaxone SWOT Analysis, 2015 69

Table 29: Global Sales Forecasts (USD m) for Copaxone, 2014-2024 70

Table 30: Product Profile-Tysabri 73

Table 31: Tysabri SWOT Analysis, 2015 75

Table 32: Global Sales Forecasts (USD m) for Tysabri, 2014-2024 76

Table 33: Product Profile-Lemtrada 79

Table 34: Lemtrada SWOT Analysis, 2015 82

Table 35: Global Sales Forecasts (USD m) for Lemtrada, 2014-2024 83

Table 36: Product Profile-Plegridy 84

Table 37: Clinical and MRI Endpoints at Year 1 from a Phase III Trial of Plegridy in MS 85

Table 38: Clinical and MRI Endpoints at Year 2 from a Phase III Trial of Plegridy in MS 86

Table 39: Adverse Events During Year 1 of a Phase III Trial of Plegridy in MS 87

Table 40: Plegridy SWOT Analysis, 2015 88

Table 41: Global Sales Forecasts (USD m) for Plegridy, 2014-2024 89

Table 42: Product Profile-Gilenya 91

Table 43: Gilenya SWOT Analysis, 2015 93

Table 44: Global Sales Forecasts (USD m) for Gilenya, 2014-2024 94

Table 45: Product Profile-Aubagio 96

Table 46: Aubagio SWOT Analysis, 2015 99

Table 47: Global Sales Forecasts (USD m) for Aubagio, 2014-2024 100

Table 48: Product Profile-Tecfidera 102

Table 49: Tecfidera SWOT Analysis, 2015 104

Table 50: Global Sales Forecasts (USD m) for Tecfidera, 2014-2024 106

Table 51: Summary of Alternative MS DMTs, 2014 107

Table 52: Unmet Need and Opportunity in MS 109

Table 53: Product Profile-Zinbryta High-Yield Process 130

Table 54: Adverse Events during Year 1 of a Phase III trial of Zinbryta in MS 132

Table 55: Zinbryta SWOT Analysis, 2015 135

Table 56: Global Sales Forecasts (USD m) for Zinbryta, 2014-2024 136

Table 57: Product Profile-Ocrelizumab 138

Table 58: Ocrelizumab SWOT Analysis, 2015 142

Table 59: Global Sales Forecasts (USD m) for ocrelizumab, 2014-2024 143

Table 60: Product Profile-Ofatumumab 144

Table 61: Ofatumumab SWOT Analysis, 2015 148

Table 62: Global Sales Forecasts (USD m) for Ofatumumab, 2014-2024 149

Table 63: Product Profile-Opicinumab 150

Table 64: Opicinumab SWOT Analysis, 2015 153

Table 65: Product Profile-Nerventra 156

Table 66: Nerventra SWOT Analysis, 2015 160

Table 67: Global Sales Forecasts (USD m) for Nerventra, 2014-2024 161

Table 68: Product Profile-Masitinib 162

Table 69: Masitinib SWOT Analysis, 2015 165

Table 70: Global Sales Forecasts (USD m) for Masitinib, 2014-2024 166

Table 71: Product Profile-Siponimod 167

Table 72: Siponimod SWOT Analysis, 2015 170

Table 73: Global Sales Forecasts (USD m) for siponimod, 2014-2024 171

Table 74: Product Profile-Ozanimod 173

Table 75: Ozanimod SWOT Analysis, 2015 175

Table 76: Global Sales Forecasts (USD m) for Ozanimod, 2014-2024 176

Table 77: Product Profile-Ponesimod 177

Table 78: Efficacy Results for Ponesimod in a Phase IIb MS Trial 178

Table 79: Ponesimod SWOT Analysis, 2015 181

Table 80: Global Sales Forecasts (USD m) for Ponesimod, 2014-2024 182

Table 81: Product Profile-NeuroVax 184

Table 82: NeuroVax SWOT Analysis, 2015 186

Table 83: Product Profile-Tcelna 188

Table 84: Tcelna SWOT Analysis, 2015 190

Table 85: Drugs in Development, 2015 191

Table 86: Sales Forecasts (USD m) for MS in the 5EU, 2014-2024 197

Table 87: Key Events Impacting Sales for MS in the 5EU, 2014-2024 199

Table 88: MS Market in the 5EU-Drivers and Barriers, 2014-2024 200

Table 89: Key Launch Dates 229

Table 90: Key Patent Expiries 229

Table 91: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 242

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