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Multiple Sclerosis-Japan Drug Forecast and Market Analysis to 2024

Multiple Sclerosis-Japan Drug Forecast and Market Analysis to 2024


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Executive Summary

Multiple Sclerosis-Japan 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 Japan reached USD 109.6m during 2014, which is considerably smaller than the Western markets covered in this report. GlobalData anticipates that the market growth will be steady between 2014 and 2018, as treatment rates increase supported by the launches of Tysabri, Copaxone, and Tecfidera. However, slower growth rates are expected between 2018 and 2021, as these novel agents become established within the Japanese market.

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

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

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

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 Japan 32

4.3.1 Diagnosis 32

4.3.2 Drug Treatment 33

5 Competitive Assessment 35

5.1 Overview 35

5.2 Product Profiles-Major Injectable Brands 37

5.2.1 Betaseron 37

5.2.2 Avonex 42

5.2.3 Rebif 47

5.2.4 Copaxone 51

5.2.5 Tysabri 57

5.2.6 Lemtrada 62

5.2.7 Plegridy 69

5.3 Product Profiles-Major Small Molecule Brands 75

5.3.1 Gilenya 75

5.3.2 Aubagio 81

5.3.3 Tecfidera 86

5.4 Other Disease-Modifying Therapies 92

5.4.1 Overview 92

6 Unmet Need and Opportunity Analysis 94

6.1 Overview 94

6.2 Curative Therapies 95

6.2.1 Unmet Need 95

6.2.2 Gap Analysis 96

6.2.3 Opportunity 97

6.3 The High Cost of MS Drugs 98

6.3.1 Unmet Need 98

6.3.2 Gap Analysis 99

6.3.3 Opportunity 100

6.4 Safety and Tolerability of Therapy 100

6.4.1 Unmet Need 100

6.4.2 Gap Analysis 101

6.4.3 Opportunity 102

6.5 Effective Treatments for Progressive MS 102

6.5.1 Unmet Need 102

6.5.2 Gap Analysis 104

6.5.3 Opportunity 104

6.6 Inconvenient Route of Administration and Frequent Dosing 105

6.6.1 Unmet Need 105

6.6.2 Gap Analysis 106

6.6.3 Opportunity 106

6.7 MS Biomarkers for Early Diagnosis and Treatment Choice 106

6.7.1 Unmet Need 106

6.7.2 Gap Analysis 108

6.7.3 Opportunity 108

7 Pipeline Assessment 110

7.1 Overview 110

7.2 Clinical Trial Mapping 110

7.2.1 Clinical Trials by Country 110

7.3 Promising Drugs in Clinical Development 111

7.3.1 Zinbryta 114

7.3.2 Ocrelizumab 122

7.3.3 Ofatumumab 129

7.3.4 Opicinumab 135

7.3.5 Nerventra 140

7.3.6 Masitinib 147

7.3.7 Siponimod 152

7.3.8 Ozanimod 158

7.3.9 Ponesimod 162

7.4 Late-Stage Therapeutic Vaccines 168

7.4.1 NeuroVax 169

7.4.2 Tcelna 172

7.5 Other Drugs in Development 176

8 Market Outlook 179

8.1 Japan 179

8.1.1 Forecast 179

8.1.2 Key Events 183

8.1.3 Drivers and Barriers 184

9 Appendix 185

9.1 Bibliography 185

9.2 Abbreviations 207

9.3 Methodology 212

9.4 Forecasting Methodology 212

9.4.1 Diagnosed MS Patients 212

9.4.2 Percent Drug-Treated Patients 212

9.4.3 Launch and Patent Expiry Dates 213

9.4.4 General Pricing Assumptions 214

9.4.5 Individual Drug Assumptions 215

9.4.6 Generic Erosion 221

9.4.7 Pricing of Pipeline Agents 221

9.5 Primary Research-KOLs Interviewed for this Report 223

9.6 Primary Research-Prescriber Survey 226

9.7 About the Authors 227

9.7.1 Analyst 227

9.7.2 Therapy Area Director 227

9.7.3 Epidemiologist 228

9.7.4 Global Director of Therapy Research and Analysis 228

9.8 About GlobalData 229

9.9 Disclaimer 229

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 111

Figure 5: Multiple Sclerosis-Phase II-III Pipeline, 2015 113

Figure 6: Competitive Assessment of Late-Stage Pipeline Agents in MS, 2014-2024 114

Figure 7: Multiple Sclerosis-Phase II-III Therapeutic Vaccines, 2015 169

Figure 8: Sales for MS in Japan by Therapy Type, 2014-2024 182

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: Japan-MS Diagnosis Metrics 32

Table 8: Japan-MS Treatment Metrics 34

Table 9: Leading Disease-Modifying Drugs for the Treatment of MS, 2015 37

Table 10: Product Profile-Betaseron 39

Table 11: Betaseron SWOT Analysis, 2015 41

Table 12: Global Sales Forecasts (USD m) for Betaseron, 2014-2024 42

Table 13: Product Profile-Avonex 43

Table 14: Avonex SWOT Analysis, 2015 45

Table 15: Global Sales Forecasts (USD m) for Avonex, 2014-2024 46

Table 16: Product Profile-Rebif 48

Table 17: Rebif SWOT Analysis, 2014 50

Table 18: Global Sales Forecasts (USD m) for Rebif, 2014-2024 51

Table 19: Product Profile-Copaxone 53

Table 20: Copaxone SWOT Analysis, 2015 55

Table 21: Global Sales Forecasts (USD m) for Copaxone, 2014-2024 56

Table 22: Product Profile-Tysabri 59

Table 23: Tysabri SWOT Analysis, 2015 61

Table 24: Global Sales Forecasts (USD m) for Tysabri, 2014-2024 62

Table 25: Product Profile-Lemtrada 65

Table 26: Lemtrada SWOT Analysis, 2015 68

Table 27: Global Sales Forecasts (USD m) for Lemtrada, 2014-2024 69

Table 28: Product Profile-Plegridy 70

Table 29: Clinical and MRI Endpoints at Year 1 from a Phase III Trial of Plegridy in MS 71

Table 30: Clinical and MRI Endpoints at Year 2 from a Phase III Trial of Plegridy in MS 72

Table 31: Adverse Events During Year 1 of a Phase III Trial of Plegridy in MS 73

Table 32: Plegridy SWOT Analysis, 2015 74

Table 33: Global Sales Forecasts (USD m) for Plegridy, 2014-2024 75

Table 34: Product Profile-Gilenya 77

Table 35: Gilenya SWOT Analysis, 2015 79

Table 36: Global Sales Forecasts (USD m) for Gilenya, 2014-2024 80

Table 37: Product Profile-Aubagio 82

Table 38: Aubagio SWOT Analysis, 2015 85

Table 39: Global Sales Forecasts (USD m) for Aubagio, 2014-2024 86

Table 40: Product Profile-Tecfidera 88

Table 41: Tecfidera SWOT Analysis, 2015 90

Table 42: Global Sales Forecasts (USD m) for Tecfidera, 2014-2024 92

Table 43: Summary of Alternative MS DMTs, 2014 93

Table 44: Unmet Need and Opportunity in MS 95

Table 45: Product Profile-Zinbryta High-Yield Process 116

Table 46: Adverse Events during Year 1 of a Phase III trial of Zinbryta in MS 118

Table 47: Zinbryta SWOT Analysis, 2015 121

Table 48: Global Sales Forecasts (USD m) for Zinbryta, 2014-2024 122

Table 49: Product Profile-Ocrelizumab 124

Table 50: Ocrelizumab SWOT Analysis, 2015 128

Table 51: Global Sales Forecasts (USD m) for ocrelizumab, 2014-2024 129

Table 52: Product Profile-Ofatumumab 130

Table 53: Ofatumumab SWOT Analysis, 2015 134

Table 54: Global Sales Forecasts (USD m) for Ofatumumab, 2014-2024 135

Table 55: Product Profile-Opicinumab 136

Table 56: Opicinumab SWOT Analysis, 2015 139

Table 57: Product Profile-Nerventra 142

Table 58: Nerventra SWOT Analysis, 2015 146

Table 59: Global Sales Forecasts (USD m) for Nerventra, 2014-2024 147

Table 60: Product Profile-Masitinib 148

Table 61: Masitinib SWOT Analysis, 2015 151

Table 62: Global Sales Forecasts (USD m) for Masitinib, 2014-2024 152

Table 63: Product Profile-Siponimod 153

Table 64: Siponimod SWOT Analysis, 2015 156

Table 65: Global Sales Forecasts (USD m) for siponimod, 2014-2024 157

Table 66: Product Profile-Ozanimod 159

Table 67: Ozanimod SWOT Analysis, 2015 161

Table 68: Global Sales Forecasts (USD m) for Ozanimod, 2014-2024 162

Table 69: Product Profile-Ponesimod 163

Table 70: Efficacy Results for Ponesimod in a Phase IIb MS Trial 164

Table 71: Ponesimod SWOT Analysis, 2015 167

Table 72: Global Sales Forecasts (USD m) for Ponesimod, 2014-2024 168

Table 73: Product Profile-NeuroVax 170

Table 74: NeuroVax SWOT Analysis, 2015 172

Table 75: Product Profile-Tcelna 174

Table 76: Tcelna SWOT Analysis, 2015 176

Table 77: Drugs in Development, 2015 177

Table 78: Sales Forecasts (USD m) for MS in the Japan, 2014-2024 181

Table 79: Key Events Impacting Sales for MS in Japan, 2014-2024 183

Table 80: MS Market in Japan-Drivers and Barriers, 2014-2024 184

Table 81: Key Launch Dates 213

Table 82: Key Patent Expiries 213

Table 83: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 226

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