Prostate Cancer - Canada Drug Forecast and Market Analysis to 2023

Prostate Cancer - Canada Drug Forecast and Market Analysis to 2023


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Executive Summary

Prostate Cancer - Canada Drug Forecast and Market Analysis to 2023

Summary

Prostate cancer is the second most common cancer in men worldwide, after skin cancer. It accounts for 15% of all the cancers diagnosed in men, and thus represents a huge burden on healthcare systems. While patients diagnosed with early-stage, localized prostate cancer can be cured, patients who are diagnosed with or progress to castration-resistant prostate cancer (CRPC) have no curative options. This report focuses on the current treatment landscape, unmet needs, pipeline assessment and market outlook for prostate cancer. . Since 2010, five new drugs have been approved for the treatment of CRPC: Dendreon's Provenge, Sanofi's Jevtana, Johnson & Johnson's Zytiga, Medivation/Astellas' Xtandi, and Bayer's Xofigo. During the forecast period from 2013-2023, GlobalData expects that nine new late-stage pipeline agents will launch, eight of which will be for the treatment of CRPC. As a result of this unprecedented level of clinical development, GlobalData predicts there will be massive changes in the CRPC treatment paradigm. In addition, due to the influx of new therapies, the size of the prostate cancer market across the nine major pharmaceutical markets (9MM) (US, France, Germany, Italy, Spain, UK, Japan, Brazil, and Canada) will increase three-fold.

In 2013, GlobalData estimated that the sales of branded prostate cancer therapies in Canada were USD41m. This strong growth will be a result of the increasing incidence of prostate cancer as the population ages, increased sales resulting from the launch of eight new premium-priced pipeline products during the forecast period, and the label extension of Xtandi into the nmCRPC and hormone-sensitive prostate cancer patient populations.

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Scope

Overview of Prostate Cancer 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 description, safety and efficacy profiles as well as a SWOT analysis.

Sales forecast for the top drugs in Canada from 2013-2023.

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

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 2013-2023 in Canada.



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1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 6

1.2 List of Figures 9

2 Introduction 11

2.1 Catalyst 11

2.2 Related Reports 11

2.3 Upcoming Related Reports 12

3 Disease Overview 13

3.1 Etiology and Pathophysiology 13

3.1.1 Etiology 13

3.1.2 Pathophysiology 13

3.2 Staging 14

3.3 Symptoms 18

3.4 Prognosis 18

3.5 Quality of Life 19

4 Disease Management 20

4.1 Diagnosis and Treatment Overview 20

4.1.1 Screening and Diagnosis 20

4.1.2 Treatment Guidelines and the Leading Prescribed Drugs 22

4.1.3 Clinical Practice 24

4.2 Canada 34

5 Competitive Assessment 35

5.1 Overview 35

5.2 Product Profiles - Major Brands, Targeted Therapies 36

5.2.1 Zytiga (abiraterone acetate) 36

5.2.2 Xtandi (enzalutamide) 42

5.2.3 Xofigo (radium 223 dichloride) 47

5.3 Product Profiles - Major Brands, Chemotherapies 53

5.3.1 Jevtana (cabazitaxel) 53

5.4 Product Profiles - Major Brands, Therapeutic Vaccines 57

5.4.1 Provenge (sipuleucel-T) 57

5.5 Product Profiles - Major Brands, Hormone Therapies 61

5.5.1 Zoladex (goserelin acetate) 61

5.5.2 Lupron Depot (leuprolide acetate) 64

5.5.3 Eligard (leuprolide acetate) 67

5.5.4 Trelstar (triptorelin acetate) 69

5.5.5 Firmagon (degarelix) 71

5.5.6 Casodex (bicalutamide) 74

5.6 Product Profiles - Major Brands, Bone Therapies 77

5.6.1 Zometa (zoledronic acid) 77

5.6.2 Xgeva (denosumab) 79

6 Unmet Need and Opportunity 83

6.1 Overview 83

6.2 Therapies That Provide a Durable Overall Survival Benefit for mCRPC Patients 84

6.2.1 Unmet Need 84

6.2.2 Gap Analysis 85

6.2.3 Opportunity 86

6.3 Therapeutic Options for nmCRPC Patients 86

6.3.1 Unmet Need 86

6.3.2 Gap Analysis 87

6.3.3 Opportunity 87

6.4 Identification of Biomarkers to Predict Zytiga and Xtandi Resistance 88

6.4.1 Unmet Need 88

6.4.2 Gap Analysis 89

6.4.3 Opportunity 90

6.5 Defining the Best Sequence of Drugs to Manage mCRPC 90

6.5.1 Unmet Need 90

6.5.2 Gap Analysis 91

6.5.3 Opportunity 92

7 Pipeline Assessment 93

7.1 Overview 93

7.2 Product Profiles ? Immunotherapies 96

7.2.1 Yervoy (ipilimumab) 96

7.2.2 ProstVac 102

7.2.3 ProstAtak 107

7.2.4 DCVAC/PCa 112

7.2.5 ITK1 117

7.3 Product Profiles - Targeted Therapies 122

7.3.1 Custirsen Sodium 122

7.3.2 Tasquinimod 127

7.3.3 ARN-509 132

7.3.4 ODM-201 136

8 Market Outlook 142

8.1 Canada 142

8.1.1 Forecast 142

8.1.2 Key Events 145

8.1.3 Drivers and Barriers 146

9 Appendix 147

9.1 Bibliography 147

9.2 Abbreviations 166

9.3 Methodology 171

9.4 Forecasting Methodology 171

9.4.1 Diagnosed Prostate Cancer Patients 171

9.4.2 Percentage Drug-Treated Patients 172

9.4.3 Drugs Included in Each Therapeutic Class 172

9.4.4 Launch and Patent Expiry Dates 173

9.4.5 General Pricing Assumptions 174

9.4.6 Individual Drug Assumptions 175

9.4.7 Pricing of Pipeline Agents 178

9.5 Primary Research - KOLs Interviewed for This Report 180

9.6 Primary Research - Prescriber Survey 182

9.7 About the Authors 183

9.7.1 Analyst 183

9.7.2 Director of Oncology 183

9.7.3 Epidemiologist 184

9.7.4 Global Head of Healthcare 184

9.8 About GlobalData 185

9.9 Disclaimer 185

1.2 List of Figures

Figure 1: Disease Management Flowchart for Prostate Cancer 25

Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in Prostate Cancer, 2013-2023 96

Figure 3: Yervoy's Clinical Development 98

Figure 4: Potential Clinical and Commercial Positioning of Yervoy 100

Figure 5: ProstVac's Clinical Development 104

Figure 6: Potential Clinical and Commercial Positioning of ProstVac 105

Figure 7: ProstAtak's Clinical Development 109

Figure 8: Potential Clinical and Commercial Positioning of ProstAtak 110

Figure 9: DCVAC/PCa's Clinical Development 113

Figure 10: Potential Clinical and Commercial Positioning of DCVAC/PCa 115

Figure 11: ITK1's Clinical Development 118

Figure 12: Potential Clinical and Commercial Positioning of ITK1 120

Figure 13: Custirsen Sodium's Clinical Development 124

Figure 14: Potential Clinical and Commercial Positioning of Custirsen Sodium 125

Figure 15: Tasquinimod's Clinical Development 129

Figure 16: Potential Clinical and Commercial Positioning of Tasquinimod 130

Figure 17: ARN-509's Clinical Development 134

Figure 18: Potential Clinical and Commercial Positioning of ARN-509 135

Figure 19: ODM-201's Clinical Development 138

Figure 20: Potential Clinical and Commercial Positioning of ODM-201 139

Figure 21: Sales for Prostate Cancer in Canada by Drug Class, 2013-2023 144

1.1 List of Tables

Table 1: TNM Classification of Prostate Cancer 16

Table 2: Prostate Cancer Staging 17

Table 3: Risk-Group Classifications Used in Prostate Cancer 18

Table 4: Most Commonly Used Treatment Guidelines for Prostate Cancer, 2014 22

Table 5: Most Commonly Prescribed Hormonal Therapies for Prostate Cancer, 2014 23

Table 6: Most Commonly Prescribed Chemotherapeutic, Drug, and Bone Therapies for CRPC, 2014 24

Table 7: Diagnosis and Treatment of Prostate Cancer, Country Profile - Canada 34

Table 8: Leading Branded Drugs Used to Treat Prostate Cancer, 2014 36

Table 9: Product Profile - Zytiga 38

Table 10: Zytiga SWOT Analysis, 2014 40

Table 11: Global Sales Forecasts (USDm) for Zytiga, 2013?2023 41

Table 12: Product Profile - Xtandi 44

Table 13: Xtandi SWOT Analysis, 2014 46

Table 14: Global Sales Forecasts (USDm) for Xtandi, 2013?2023 47

Table 15: Product Profile - Xofigo 50

Table 16: Xofigo SWOT Analysis, 2014 51

Table 17: Global Sales Forecasts (USDm) for Xofigo, 2013?2023 52

Table 18: Product Profile - Jevtana 54

Table 19: Jevtana SWOT Analysis, 2014 55

Table 20: Global Sales Forecasts (USDm) for Jevtana, 2013?2023 56

Table 21: Product Profile - Provenge 59

Table 22: Provenge SWOT Analysis, 2014 60

Table 23: Global Sales Forecasts (USDm) for Provenge, 2013?2023 61

Table 24: Product Profile - Zoladex 62

Table 25: Zoladex SWOT Analysis, 2014 64

Table 26: Product Profile - Lupron 65

Table 27: Lupron SWOT Analysis, 2014 66

Table 28: Product Profile - Eligard 68

Table 29: Eligard SWOT Analysis, 2014 69

Table 30: Product Profile - Trelstar 70

Table 31: Trelstar SWOT Analysis, 2014 71

Table 32: Product Profile - Firmagon 72

Table 33: Firmagon SWOT Analysis, 2014 74

Table 34: Product Profile - Casodex 75

Table 35: Casodex SWOT Analysis, 2014 77

Table 36: Product Profile - Zometa 78

Table 37: Zometa SWOT Analysis, 2014 79

Table 38: Product Profile - Xgeva 81

Table 39: Xgeva SWOT Analysis, 2014 82

Table 40: Unmet Need and Opportunity in Prostate Cancer 84

Table 41: Drugs in Phase III Clinical Trials for Prostate Cancer 95

Table 42: Product Profile - Yervoy 98

Table 43: Yervoy SWOT Analysis, 2014 101

Table 44: Global Sales Forecasts (USDm) for Yervoy, 2013?2023 102

Table 45: Product Profile - ProstVac 103

Table 46: ProstVac SWOT Analysis, 2014 106

Table 47: Global Sales Forecasts (USDm) for ProstVac, 2013?2023 107

Table 48: Product Profile - ProstAtak 108

Table 49: ProstAtak SWOT Analysis, 2014 111

Table 50: Global Sales Forecasts (USDm) for ProstAtak, 2013?2023 112

Table 51: Product Profile - DCVAC/PCa 113

Table 52: DCVAC/PCa SWOT Analysis, 2014 116

Table 53: Global Sales Forecasts (USDm) for DCVAC, 2013?2023 117

Table 54: Product Profile - ITK1 118

Table 55: ITK1 SWOT Analysis, 2014 120

Table 56: Global Sales Forecasts (USDm) for ITK1, 2013?2023 121

Table 57: Product Profile - Custirsen Sodium 123

Table 58: Custirsen Sodium SWOT Analysis, 2014 126

Table 59: Global Sales Forecasts (USDm) for Custirsen Sodium, 2013?2023 127

Table 60: Product Profile - Tasquinimod 128

Table 61: Tasquinimod SWOT Analysis, 2014 131

Table 62: Global Sales Forecasts (USDm) for Tasquinimod, 2013?2023 132

Table 63: Product Profile - ARN-509 133

Table 64: ARN-509 SWOT Analysis, 2014 135

Table 65: Global Sales Forecasts (USDm) for ARN-509, 2013?2023 136

Table 66: Product Profile - ODM-201 137

Table 67: ODM-201 SWOT Analysis, 2014 140

Table 68: Global Sales Forecasts (USDm) for ODM-201, 2013-2023 141

Table 69: Sales Forecasts (USDm) for Prostate Cancer in Canada, 2013?2023 143

Table 70: Key Events Impacting Sales for Prostate Cancer in Canada, 2013-2013 145

Table 71: Canada Prostate Cancer Market - Drivers and Barriers, 2013-2023 146

Table 72: Key Launch Dates, Marketed and Pipeline Prostate Cancer Drugs 173

Table 73: Key Patent Expiration or Loss of Market Exclusivity Dates, Marketed Prostate Cancer Drugs 173

Table 74: Average Body Weight and Surface Area Across the 9MM 175

Table 75: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 182

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