Prostate Cancer - Japan Drug Forecast and Market Analysis to 2023

Prostate Cancer - Japan Drug Forecast and Market Analysis to 2023


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Executive Summary

Prostate Cancer - Japan 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.

The Japanese market for prostate cancer will grow significantly over the forecast period. As none of the branded prostate cancer therapies for CRPC were available in Japan in 2013, GlobalData expects there will be rapid uptake of Xtandi, Jevtana and Zytiga, which all launched in Japan in 2014.

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

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

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



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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 Japan 35

5 Competitive Assessment 36

5.1 Overview 36

5.2 Product Profiles - Major Brands, Targeted Therapies 37

5.2.1 Zytiga (abiraterone acetate) 37

5.2.2 Xtandi (enzalutamide) 43

5.2.3 Xofigo (radium 223 dichloride) 48

5.3 Product Profiles - Major Brands, Chemotherapies 54

5.3.1 Jevtana (cabazitaxel) 54

5.4 Product Profiles - Major Brands, Therapeutic Vaccines 58

5.4.1 Provenge (sipuleucel-T) 58

5.5 Product Profiles - Major Brands, Hormone Therapies 62

5.5.1 Zoladex (goserelin acetate) 62

5.5.2 Lupron Depot (leuprolide acetate) 65

5.5.3 Eligard (leuprolide acetate) 68

5.5.4 Trelstar (triptorelin acetate) 70

5.5.5 Firmagon (degarelix) 72

5.5.6 Casodex (bicalutamide) 75

5.6 Product Profiles - Major Brands, Bone Therapies 78

5.6.1 Zometa (zoledronic acid) 78

5.6.2 Xgeva (denosumab) 80

6 Unmet Need and Opportunity 84

6.1 Overview 84

6.2 Therapies That Provide a Durable Overall Survival Benefit for mCRPC Patients 85

6.2.1 Unmet Need 85

6.2.2 Gap Analysis 86

6.2.3 Opportunity 87

6.3 Therapeutic Options for nmCRPC Patients 87

6.3.1 Unmet Need 87

6.3.2 Gap Analysis 88

6.3.3 Opportunity 88

6.4 Identification of Biomarkers to Predict Zytiga and Xtandi Resistance 89

6.4.1 Unmet Need 89

6.4.2 Gap Analysis 90

6.4.3 Opportunity 91

6.5 Defining the Best Sequence of Drugs to Manage mCRPC 91

6.5.1 Unmet Need 91

6.5.2 Gap Analysis 92

6.5.3 Opportunity 93

7 Pipeline Assessment 94

7.1 Overview 94

7.2 Product Profiles ? Immunotherapies 97

7.2.1 Yervoy (ipilimumab) 97

7.2.2 ProstVac 103

7.2.3 ProstAtak 108

7.2.4 DCVAC/PCa 113

7.2.5 ITK1 118

7.3 Product Profiles - Targeted Therapies 123

7.3.1 Custirsen Sodium 123

7.3.2 Tasquinimod 128

7.3.3 ARN-509 133

7.3.4 ODM-201 137

8 Market Outlook 143

8.1 Japan 143

8.1.1 Forecast 143

8.1.2 Key Events 146

8.1.3 Drivers and Barriers 147

9 Appendix 148

9.1 Bibliography 148

9.2 Abbreviations 167

9.3 Methodology 172

9.4 Forecasting Methodology 172

9.4.1 Diagnosed Prostate Cancer Patients 172

9.4.2 Percentage Drug-Treated Patients 173

9.4.3 Drugs Included in Each Therapeutic Class 173

9.4.4 Launch and Patent Expiry Dates 174

9.4.5 General Pricing Assumptions 175

9.4.6 Individual Drug Assumptions 176

9.4.7 Pricing of Pipeline Agents 179

9.5 Primary Research - KOLs Interviewed for This Report 181

9.6 Primary Research - Prescriber Survey 183

9.7 About the Authors 184

9.7.1 Analyst 184

9.7.2 Director of Oncology 184

9.7.3 Epidemiologist 185

9.7.4 Global Head of Healthcare 185

9.8 About GlobalData 186

9.9 Disclaimer 186

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 97

Figure 3: Yervoy's Clinical Development 99

Figure 4: Potential Clinical and Commercial Positioning of Yervoy 101

Figure 5: ProstVac's Clinical Development 105

Figure 6: Potential Clinical and Commercial Positioning of ProstVac 106

Figure 7: ProstAtak's Clinical Development 110

Figure 8: Potential Clinical and Commercial Positioning of ProstAtak 111

Figure 9: DCVAC/PCa's Clinical Development 114

Figure 10: Potential Clinical and Commercial Positioning of DCVAC/PCa 116

Figure 11: ITK1's Clinical Development 119

Figure 12: Potential Clinical and Commercial Positioning of ITK1 121

Figure 13: Custirsen Sodium's Clinical Development 125

Figure 14: Potential Clinical and Commercial Positioning of Custirsen Sodium 126

Figure 15: Tasquinimod's Clinical Development 130

Figure 16: Potential Clinical and Commercial Positioning of Tasquinimod 131

Figure 17: ARN-509's Clinical Development 135

Figure 18: Potential Clinical and Commercial Positioning of ARN-509 136

Figure 19: ODM-201's Clinical Development 139

Figure 20: Potential Clinical and Commercial Positioning of ODM-201 140

Figure 21: Sales for Prostate Cancer in Japan by Drug Class, 2023 145

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 - Japan 35

Table 8: Leading Branded Drugs Used to Treat Prostate Cancer, 2014 37

Table 9: Product Profile - Zytiga 39

Table 10: Zytiga SWOT Analysis, 2014 41

Table 11: Global Sales Forecasts (USDm) for Zytiga, 2013?2023 42

Table 12: Product Profile - Xtandi 45

Table 13: Xtandi SWOT Analysis, 2014 47

Table 14: Global Sales Forecasts (USDm) for Xtandi, 2013?2023 48

Table 15: Product Profile - Xofigo 51

Table 16: Xofigo SWOT Analysis, 2014 52

Table 17: Global Sales Forecasts (USDm) for Xofigo, 2013?2023 53

Table 18: Product Profile - Jevtana 55

Table 19: Jevtana SWOT Analysis, 2014 56

Table 20: Global Sales Forecasts (USDm) for Jevtana, 2013?2023 57

Table 21: Product Profile - Provenge 60

Table 22: Provenge SWOT Analysis, 2014 61

Table 23: Global Sales Forecasts (USDm) for Provenge, 2013?2023 62

Table 24: Product Profile - Zoladex 63

Table 25: Zoladex SWOT Analysis, 2014 65

Table 26: Product Profile - Lupron 66

Table 27: Lupron SWOT Analysis, 2014 67

Table 28: Product Profile - Eligard 69

Table 29: Eligard SWOT Analysis, 2014 70

Table 30: Product Profile - Trelstar 71

Table 31: Trelstar SWOT Analysis, 2014 72

Table 32: Product Profile - Firmagon 73

Table 33: Firmagon SWOT Analysis, 2014 75

Table 34: Product Profile - Casodex 76

Table 35: Casodex SWOT Analysis, 2014 78

Table 36: Product Profile - Zometa 79

Table 37: Zometa SWOT Analysis, 2014 80

Table 38: Product Profile - Xgeva 82

Table 39: Xgeva SWOT Analysis, 2014 83

Table 40: Unmet Need and Opportunity in Prostate Cancer 85

Table 41: Drugs in Phase III Clinical Trials for Prostate Cancer 96

Table 42: Product Profile - Yervoy 99

Table 43: Yervoy SWOT Analysis, 2014 102

Table 44: Global Sales Forecasts (USDm) for Yervoy, 2013?2023 103

Table 45: Product Profile - ProstVac 104

Table 46: ProstVac SWOT Analysis, 2014 107

Table 47: Global Sales Forecasts (USDm) for ProstVac, 2013?2023 108

Table 48: Product Profile - ProstAtak 109

Table 49: ProstAtak SWOT Analysis, 2014 112

Table 50: Global Sales Forecasts (USDm) for ProstAtak, 2013?2023 113

Table 51: Product Profile - DCVAC/PCa 114

Table 52: DCVAC/PCa SWOT Analysis, 2014 117

Table 53: Global Sales Forecasts (USDm) for DCVAC, 2013?2023 118

Table 54: Product Profile - ITK1 119

Table 55: ITK1 SWOT Analysis, 2014 121

Table 56: Global Sales Forecasts (USDm) for ITK1, 2013?2023 122

Table 57: Product Profile - Custirsen Sodium 124

Table 58: Custirsen Sodium SWOT Analysis, 2014 127

Table 59: Global Sales Forecasts (USDm) for Custirsen Sodium, 2013?2023 128

Table 60: Product Profile - Tasquinimod 129

Table 61: Tasquinimod SWOT Analysis, 2014 132

Table 62: Global Sales Forecasts (USDm) for Tasquinimod, 2013?2023 133

Table 63: Product Profile - ARN-509 134

Table 64: ARN-509 SWOT Analysis, 2014 136

Table 65: Global Sales Forecasts (USDm) for ARN-509, 2013?2023 137

Table 66: Product Profile - ODM-201 138

Table 67: ODM-201 SWOT Analysis, 2014 141

Table 68: Global Sales Forecasts (USDm) for ODM-201, 2013-2023 142

Table 69: Sales Forecasts (USDm) for Prostate Cancer in Japan, 2013?2023 144

Table 70: Key Events Impacting Sales for Prostate Cancer in Japan, 2013-2023 146

Table 71: Japan Prostate Cancer Market - Drivers and Barriers, 2013?2023 147

Table 72: Key Launch Dates, Marketed and Pipeline Prostate Cancer Drugs 174

Table 73: Key Patent Expiration or Loss of Market Exclusivity Dates, Marketed Prostate Cancer Drugs 174

Table 74: Average Body Weight and Surface Area Across the 9MM 176

Table 75: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 183

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