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Multiple Sclerosis-China Drug Forecast and Market Analysis to 2024

Multiple Sclerosis-China Drug Forecast and Market Analysis to 2024


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Executive Summary

Multiple Sclerosis-China 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.

Sales of DMT products in China were estimated to be USD 61.3m in 2014, making it the second smallest MS market behind India. GlobalData anticipates steep growth to occur mid-forecast resulting from the launch of the first oral DMTs in China. Currently only four DMTs are available, with mitoxantrone being used off-label for MS in China. As such, the anticipated approval of two oral agents will not only provide added convenience for patients but will increase the diversity of treatment options, leading to a notable rise in treatment rates.

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

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

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

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 China 32

4.3.1 Forecast 32

4.3.2 Key Events 35

4.3.3 Drivers and Barriers 35

5 Competitive Assessment 36

5.1 Overview 36

5.2 Product Profiles-Major Injectable Brands 38

5.2.1 Betaseron 38

5.2.2 Avonex 43

5.2.3 Rebif 48

5.2.4 Copaxone 52

5.2.5 Tysabri 58

5.2.6 Lemtrada 63

5.2.7 Plegridy 70

5.3 Product Profiles-Major Small Molecule Brands 76

5.3.1 Gilenya 76

5.3.2 Aubagio 82

5.3.3 Tecfidera 87

5.4 Other Disease-Modifying Therapies 93

5.4.1 Overview 93

6 Unmet Need and Opportunity Analysis 95

6.1 Overview 95

6.2 Curative Therapies 96

6.2.1 Unmet Need 96

6.2.2 Gap Analysis 97

6.2.3 Opportunity 98

6.3 The High Cost of MS Drugs 99

6.3.1 Unmet Need 99

6.3.2 Gap Analysis 100

6.3.3 Opportunity 101

6.4 Safety and Tolerability of Therapy 101

6.4.1 Unmet Need 101

6.4.2 Gap Analysis 102

6.4.3 Opportunity 103

6.5 Effective Treatments for Progressive MS 103

6.5.1 Unmet Need 103

6.5.2 Gap Analysis 105

6.5.3 Opportunity 105

6.6 Inconvenient Route of Administration and Frequent Dosing 106

6.6.1 Unmet Need 106

6.6.2 Gap Analysis 107

6.6.3 Opportunity 107

6.7 MS Biomarkers for Early Diagnosis and Treatment Choice 107

6.7.1 Unmet Need 107

6.7.2 Gap Analysis 109

6.7.3 Opportunity 109

7 Pipeline Assessment 111

7.1 Overview 111

7.2 Clinical Trial Mapping 111

7.2.1 Clinical Trials by Country 111

7.3 Promising Drugs in Clinical Development 112

7.3.1 Zinbryta 115

7.3.2 Ocrelizumab 123

7.3.3 Ofatumumab 130

7.3.4 Opicinumab 136

7.3.5 Nerventra 141

7.3.6 Masitinib 148

7.3.7 Siponimod 153

7.3.8 Ozanimod 159

7.3.9 Ponesimod 163

7.4 Late-Stage Therapeutic Vaccines 169

7.4.1 NeuroVax 170

7.4.2 Tcelna 173

7.5 Other Drugs in Development 177

8 Market Outlook 180

8.1 China 180

8.1.1 Forecast 180

8.1.2 Key Events 184

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: Sales for MS in China by Therapy Type, 2014-2024 34

Figure 5: MS Therapeutics-Clinical Trials by Country, 2015 112

Figure 6: Multiple Sclerosis-Phase II-III Pipeline, 2015 114

Figure 7: Competitive Assessment of Late-Stage Pipeline Agents in MS, 2014-2024 115

Figure 8: Multiple Sclerosis-Phase II-III Therapeutic Vaccines, 2015 170

Figure 9: Sales for MS in China by Therapy Type, 2014-2024 183

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: Sales Forecasts (USD m) for MS in the China, 2014-2024 33

Table 8: Key Events Impacting Sales for MS in China, 2014-2024 35

Table 9: MS Market in China-Drivers and Barriers, 2014-2024 35

Table 10: Leading Disease-Modifying Drugs for the Treatment of MS, 2015 38

Table 11: Product Profile-Betaseron 40

Table 12: Betaseron SWOT Analysis, 2015 42

Table 13: Global Sales Forecasts (USD m) for Betaseron, 2014-2024 43

Table 14: Product Profile-Avonex 44

Table 15: Avonex SWOT Analysis, 2015 46

Table 16: Global Sales Forecasts (USD m) for Avonex, 2014-2024 47

Table 17: Product Profile-Rebif 49

Table 18: Rebif SWOT Analysis, 2014 51

Table 19: Global Sales Forecasts (USD m) for Rebif, 2014-2024 52

Table 20: Product Profile-Copaxone 54

Table 21: Copaxone SWOT Analysis, 2015 56

Table 22: Global Sales Forecasts (USD m) for Copaxone, 2014-2024 57

Table 23: Product Profile-Tysabri 60

Table 24: Tysabri SWOT Analysis, 2015 62

Table 25: Global Sales Forecasts (USD m) for Tysabri, 2014-2024 63

Table 26: Product Profile-Lemtrada 66

Table 27: Lemtrada SWOT Analysis, 2015 69

Table 28: Global Sales Forecasts (USD m) for Lemtrada, 2014-2024 70

Table 29: Product Profile-Plegridy 71

Table 30: Clinical and MRI Endpoints at Year 1 from a Phase III Trial of Plegridy in MS 72

Table 31: Clinical and MRI Endpoints at Year 2 from a Phase III Trial of Plegridy in MS 73

Table 32: Adverse Events During Year 1 of a Phase III Trial of Plegridy in MS 74

Table 33: Plegridy SWOT Analysis, 2015 75

Table 34: Global Sales Forecasts (USD m) for Plegridy, 2014-2024 76

Table 35: Product Profile-Gilenya 78

Table 36: Gilenya SWOT Analysis, 2015 80

Table 37: Global Sales Forecasts (USD m) for Gilenya, 2014-2024 81

Table 38: Product Profile-Aubagio 83

Table 39: Aubagio SWOT Analysis, 2015 86

Table 40: Global Sales Forecasts (USD m) for Aubagio, 2014-2024 87

Table 41: Product Profile-Tecfidera 89

Table 42: Tecfidera SWOT Analysis, 2015 91

Table 43: Global Sales Forecasts (USD m) for Tecfidera, 2014-2024 93

Table 44: Summary of Alternative MS DMTs, 2014 94

Table 45: Unmet Need and Opportunity in MS 96

Table 46: Product Profile-Zinbryta High-Yield Process 117

Table 47: Adverse Events during Year 1 of a Phase III trial of Zinbryta in MS 119

Table 48: Zinbryta SWOT Analysis, 2015 122

Table 49: Global Sales Forecasts (USD m) for Zinbryta, 2014-2024 123

Table 50: Product Profile-Ocrelizumab 125

Table 51: Ocrelizumab SWOT Analysis, 2015 129

Table 52: Global Sales Forecasts (USD m) for ocrelizumab, 2014-2024 130

Table 53: Product Profile-Ofatumumab 131

Table 54: Ofatumumab SWOT Analysis, 2015 135

Table 55: Global Sales Forecasts (USD m) for Ofatumumab, 2014-2024 136

Table 56: Product Profile-Opicinumab 137

Table 57: Opicinumab SWOT Analysis, 2015 140

Table 58: Product Profile-Nerventra 143

Table 59: Nerventra SWOT Analysis, 2015 147

Table 60: Global Sales Forecasts (USD m) for Nerventra, 2014-2024 148

Table 61: Product Profile-Masitinib 149

Table 62: Masitinib SWOT Analysis, 2015 152

Table 63: Global Sales Forecasts (USD m) for Masitinib, 2014-2024 153

Table 64: Product Profile-Siponimod 154

Table 65: Siponimod SWOT Analysis, 2015 157

Table 66: Global Sales Forecasts (USD m) for siponimod, 2014-2024 158

Table 67: Product Profile-Ozanimod 160

Table 68: Ozanimod SWOT Analysis, 2015 162

Table 69: Global Sales Forecasts (USD m) for Ozanimod, 2014-2024 163

Table 70: Product Profile-Ponesimod 164

Table 71: Efficacy Results for Ponesimod in a Phase IIb MS Trial 165

Table 72: Ponesimod SWOT Analysis, 2015 168

Table 73: Global Sales Forecasts (USD m) for Ponesimod, 2014-2024 169

Table 74: Product Profile-NeuroVax 171

Table 75: NeuroVax SWOT Analysis, 2015 173

Table 76: Product Profile-Tcelna 175

Table 77: Tcelna SWOT Analysis, 2015 177

Table 78: Drugs in Development, 2015 178

Table 79: Sales Forecasts (USD m) for MS in the China, 2014-2024 182

Table 80: Key Events Impacting Sales for MS in China, 2014-2024 184

Table 81: MS Market in China-Drivers and Barriers, 2014-2024 184

Table 82: Key Launch Dates 213

Table 83: Key Patent Expiries 213

Table 84: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 226

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