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Multiple Sclerosis-Canada Drug Forecast and Market Analysis to 2024

Multiple Sclerosis-Canada Drug Forecast and Market Analysis to 2024


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Executive Summary

Multiple Sclerosis-Canada 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.

Canada was the third-largest MS market in the 10MM in 2014, with DMT sales totaling USD 1.2 billion. Steady growth is anticipated to occur between 2014 and 2020 as a result of novel pipeline agents with improved clinical profiles entering the market and the continued uptake of products with a high ACOT. The market is then expected to plateau until 2024 as generic erosion of key brands, including Tecfidera, Aubagio, and Gilenya, offsets potential growth driven by pipeline drug uptake.

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

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

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

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 Canada 32

4.3.1 Diagnosis 32

4.3.2 Drug Treatment 33

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 Canada 180

8.1.1 Forecast 180

8.1.2 Key Events 184

8.1.3 Drivers and Barriers 185

9 Appendix 186

9.1 Bibliography 186

9.2 Abbreviations 208

9.3 Methodology 213

9.4 Forecasting Methodology 213

9.4.1 Diagnosed MS Patients 213

9.4.2 Percent Drug-Treated Patients 213

9.4.3 Launch and Patent Expiry Dates 214

9.4.4 General Pricing Assumptions 215

9.4.5 Individual Drug Assumptions 216

9.4.6 Generic Erosion 222

9.4.7 Pricing of Pipeline Agents 222

9.5 Primary Research-KOLs Interviewed for this Report 224

9.6 Primary Research-Prescriber Survey 227

9.7 About the Authors 228

9.7.1 Analyst 228

9.7.2 Therapy Area Director 228

9.7.3 Epidemiologist 229

9.7.4 Global Director of Therapy Research and Analysis 229

9.8 About GlobalData 230

9.9 Disclaimer 230

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 112

Figure 5: Multiple Sclerosis-Phase II-III Pipeline, 2015 114

Figure 6: Competitive Assessment of Late-Stage Pipeline Agents in MS, 2014-2024 115

Figure 7: Multiple Sclerosis-Phase II-III Therapeutic Vaccines, 2015 170

Figure 8: Sales for MS in Canada 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: Canada-MS Diagnosis Metrics 33

Table 8: Canada-MS Treatment Metrics 35

Table 9: Leading Disease-Modifying Drugs for the Treatment of MS, 2015 38

Table 10: Product Profile-Betaseron 40

Table 11: Betaseron SWOT Analysis, 2015 42

Table 12: Global Sales Forecasts (USD m) for Betaseron, 2014-2024 43

Table 13: Product Profile-Avonex 44

Table 14: Avonex SWOT Analysis, 2015 46

Table 15: Global Sales Forecasts (USD m) for Avonex, 2014-2024 47

Table 16: Product Profile-Rebif 49

Table 17: Rebif SWOT Analysis, 2014 51

Table 18: Global Sales Forecasts (USD m) for Rebif, 2014-2024 52

Table 19: Product Profile-Copaxone 54

Table 20: Copaxone SWOT Analysis, 2015 56

Table 21: Global Sales Forecasts (USD m) for Copaxone, 2014-2024 57

Table 22: Product Profile-Tysabri 60

Table 23: Tysabri SWOT Analysis, 2015 62

Table 24: Global Sales Forecasts (USD m) for Tysabri, 2014-2024 63

Table 25: Product Profile-Lemtrada 66

Table 26: Lemtrada SWOT Analysis, 2015 69

Table 27: Global Sales Forecasts (USD m) for Lemtrada, 2014-2024 70

Table 28: Product Profile-Plegridy 71

Table 29: Clinical and MRI Endpoints at Year 1 from a Phase III Trial of Plegridy in MS 72

Table 30: Clinical and MRI Endpoints at Year 2 from a Phase III Trial of Plegridy in MS 73

Table 31: Adverse Events During Year 1 of a Phase III Trial of Plegridy in MS 74

Table 32: Plegridy SWOT Analysis, 2015 75

Table 33: Global Sales Forecasts (USD m) for Plegridy, 2014-2024 76

Table 34: Product Profile-Gilenya 78

Table 35: Gilenya SWOT Analysis, 2015 80

Table 36: Global Sales Forecasts (USD m) for Gilenya, 2014-2024 81

Table 37: Product Profile-Aubagio 83

Table 38: Aubagio SWOT Analysis, 2015 86

Table 39: Global Sales Forecasts (USD m) for Aubagio, 2014-2024 87

Table 40: Product Profile-Tecfidera 89

Table 41: Tecfidera SWOT Analysis, 2015 91

Table 42: Global Sales Forecasts (USD m) for Tecfidera, 2014-2024 93

Table 43: Summary of Alternative MS DMTs, 2014 94

Table 44: Unmet Need and Opportunity in MS 96

Table 45: Product Profile-Zinbryta High-Yield Process 117

Table 46: Adverse Events during Year 1 of a Phase III trial of Zinbryta in MS 119

Table 47: Zinbryta SWOT Analysis, 2015 122

Table 48: Global Sales Forecasts (USD m) for Zinbryta, 2014-2024 123

Table 49: Product Profile-Ocrelizumab 125

Table 50: Ocrelizumab SWOT Analysis, 2015 129

Table 51: Global Sales Forecasts (USD m) for ocrelizumab, 2014-2024 130

Table 52: Product Profile-Ofatumumab 131

Table 53: Ofatumumab SWOT Analysis, 2015 135

Table 54: Global Sales Forecasts (USD m) for Ofatumumab, 2014-2024 136

Table 55: Product Profile-Opicinumab 137

Table 56: Opicinumab SWOT Analysis, 2015 140

Table 57: Product Profile-Nerventra 143

Table 58: Nerventra SWOT Analysis, 2015 147

Table 59: Global Sales Forecasts (USD m) for Nerventra, 2014-2024 148

Table 60: Product Profile-Masitinib 149

Table 61: Masitinib SWOT Analysis, 2015 152

Table 62: Global Sales Forecasts (USD m) for Masitinib, 2014-2024 153

Table 63: Product Profile-Siponimod 154

Table 64: Siponimod SWOT Analysis, 2015 157

Table 65: Global Sales Forecasts (USD m) for siponimod, 2014-2024 158

Table 66: Product Profile-Ozanimod 160

Table 67: Ozanimod SWOT Analysis, 2015 162

Table 68: Global Sales Forecasts (USD m) for Ozanimod, 2014-2024 163

Table 69: Product Profile-Ponesimod 164

Table 70: Efficacy Results for Ponesimod in a Phase IIb MS Trial 165

Table 71: Ponesimod SWOT Analysis, 2015 168

Table 72: Global Sales Forecasts (USD m) for Ponesimod, 2014-2024 169

Table 73: Product Profile-NeuroVax 171

Table 74: NeuroVax SWOT Analysis, 2015 173

Table 75: Product Profile-Tcelna 175

Table 76: Tcelna SWOT Analysis, 2015 177

Table 77: Drugs in Development, 2015 178

Table 78: Sales Forecasts (USD m) for MS in the Canada, 2014-2024 182

Table 79: Key Events Impacting Sales for MS in Canada, 2014-2024 184

Table 80: MS Market in Canada-Drivers and Barriers, 2014-2024 185

Table 81: Key Launch Dates 214

Table 82: Key Patent Expiries 214

Table 83: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 227

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