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PharmaPoint: Prostate Cancer-Global Drug Forecast Market Analysis to 2023

PharmaPoint: Prostate Cancer-Global Drug Forecast Market Analysis to 2023


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Executive Summary

PharmaPoint: Prostate Cancer-Global Drug Forecast and Market Analysis to 2023

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.

Highlights

Key Questions Answered

How will prostate cancer disease management change as new agents enter the market?

Which prostate cancer patients have the greatest unmet needs and how well will these needs be addressed by the new agents?

What are the most dominant players in the prostate cancer space and what corporate strategies are pursued by these companies?

What are the most promising late-stage pipeline agents for prostate cancer? How do they compare to currently marketed products?

What opportunities will remain for future players following the launch of these pipeline agents?

Key Findings

The prostate cancer market, in the 9MM is forecasted to rapidly increase from USD 2.6bn in 2013 to USD 8.3bn in 2023, at a CAGR of 12.4%. This growth will be driven by the label extensions of currently marketed drugs as well as the launch of nine new premium-priced therapies for the treatment of prostate cancer.

GlobalData expects Medivation and Astellas' Xtandi will become the market leader in prostate cancer. Xtandi is currently approved for pre- and post-chemotherapy metastatic castration-resistant prostate cancer (CRPC). Over the course of the forecast period, GlobalData anticipates it will receive label extensions in non-metastatic CRPC and hormone-sensitive prostate cancer, making it available to virtually all prostate cancer patients segments, with the exception of those with localized disease.

The prostate cancer pipeline is robust with nine drugs in late-stage development. While androgen biosynthesis is still a major target, many of the pipeline candidates have diverse mechanisms of action and target proteins and pathways that are not targeted by the currently marketed prostate cancer treatments. Among these new candidates are a checkpoint inhibitor, a clusterin inhibitor, and an anti-angiogenic agent. There are also several vaccines, both autologous and off-the-shelf, that have a significant presence in this pipeline.

Scope

Overview of prostate cancer, including epidemiology, etiology, pathophysiology, clinical staging, symptoms, prognosis, quality of life, and disease management.

Annualized prostate cancer therapeutics market revenue from 2013-2023. Annual cost of therapy, and major marketed and pipeline drug sales in this forecast period are included.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, and implications for the prostate cancer therapeutics market.

Pipeline analysis: The prostate cancer pipeline is robust with many late-stage candidates set to launch in the forecast period. Comprehensive analysis of the nine most promising candidates in Phase III development are highlighted and profiled.

Analysis of the current and future market competition in the global prostate cancer therapeutics market, including insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons To Buy

Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.

Develop business strategies by understanding the trends shaping and driving the 9MM prostate cancer market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the 9MM prostate cancer therapeutics market in the future.

Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.

Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

1 Table of Contents

1 Table of Contents 9

1.1 List of Tables 15

1.2 List of Figures 20

2 Introduction 22

2.1 Catalyst 22

2.2 Related Reports 22

2.3 Upcoming Related Reports 23

3 Disease Overview 24

3.1 Etiology and Pathophysiology 24

3.1.1 Etiology 24

3.1.2 Pathophysiology 24

3.2 Staging 25

3.3 Symptoms 29

3.4 Prognosis 29

3.5 Quality of Life 30

4 Epidemiology 31

4.1 Disease Background 31

4.2 Risk Factors and Comorbidities 31

4.3 Global Trends 34

4.3.1 US 35

4.3.2 5EU 36

4.3.3 Japan, Brazil, and Canada 36

4.4 Forecast Methodology 37

4.4.1 Sources Used 38

4.4.2 Sources Not Used 44

4.4.3 Forecast Assumptions and Methods 45

4.5 Epidemiological Forecast for Prostate Cancer (2013-2023) 48

4.5.1 Diagnosed Incident Cases of Prostate Cancer 48

4.5.2 Age-Specific Diagnosed Incident Cases of Prostate Cancer 50

4.5.3 Age-Standardized Diagnosed Incidence of Prostate Cancer 52

4.5.4 Clinical Stage at Diagnosis 54

4.5.5 Diagnosed Five-Year Prevalent Cases of Prostate Cancer 55

4.5.6 Diagnosed Five-Year Prevalent Cases of CRPC 56

4.5.7 Diagnosed Five-Year Prevalent Cases of Bone Metastases Among CRPC Patients 58

4.6 Discussion 60

4.6.1 Epidemiological Forecast Insight 60

4.6.2 Limitations of the Analysis 61

4.6.3 Strengths of the Analysis 62

5 Disease Management 63

5.1 Diagnosis and Treatment Overview 63

5.1.1 Screening and Diagnosis 63

5.1.2 Treatment Guidelines and the Leading Prescribed Drugs 65

5.1.3 Clinical Practice 67

5.2 US 77

5.3 France 78

5.4 Germany 79

5.5 Italy 80

5.6 Spain 81

5.7 UK 82

5.8 Japan 83

5.9 Brazil 84

5.10 Canada 85

6 Competitive Assessment 86

6.1 Overview 86

6.2 Product Profiles-Major Brands, Targeted Therapies 87

6.2.1 Zytiga (abiraterone acetate) 87

6.2.2 Xtandi (enzalutamide) 93

6.2.3 Xofigo (radium 223 dichloride) 98

6.3 Product Profiles-Major Brands, Chemotherapies 104

6.3.1 Jevtana (cabazitaxel) 104

6.4 Product Profiles-Major Brands, Therapeutic Vaccines 108

6.4.1 Provenge (sipuleucel-T) 108

6.5 Product Profiles-Major Brands, Hormone Therapies 112

6.5.1 Zoladex (goserelin acetate) 112

6.5.2 Lupron Depot (leuprolide acetate) 115

6.5.3 Eligard (leuprolide acetate) 118

6.5.4 Trelstar (triptorelin acetate) 120

6.5.5 Firmagon (degarelix) 122

6.5.6 Casodex (bicalutamide) 125

6.6 Product Profiles-Major Brands, Bone Therapies 128

6.6.1 Zometa (zoledronic acid) 128

6.6.2 Xgeva (denosumab) 130

7 Unmet Need and Opportunity 134

7.1 Overview 134

7.2 Therapies That Provide a Durable Overall Survival Benefit for mCRPC Patients 135

7.2.1 Unmet Need 135

7.2.2 Gap Analysis 136

7.2.3 Opportunity 137

7.3 Therapeutic Options for nmCRPC Patients 137

7.3.1 Unmet Need 137

7.3.2 Gap Analysis 138

7.3.3 Opportunity 138

7.4 Identification of Biomarkers to Predict Zytiga and Xtandi Resistance 139

7.4.1 Unmet Need 139

7.4.2 Gap Analysis 140

7.4.3 Opportunity 141

7.5 Defining the Best Sequence of Drugs to Manage mCRPC 141

7.5.1 Unmet Need 141

7.5.2 Gap Analysis 142

7.5.3 Opportunity 143

8 Pipeline Assessment 144

8.1 Overview 144

8.2 Product Profiles ? Immunotherapies 147

8.2.1 Yervoy (ipilimumab) 147

8.2.2 ProstVac 153

8.2.3 ProstAtak 158

8.2.4 DCVAC/PCa 163

8.2.5 ITK1 168

8.3 Product Profiles-Targeted Therapies 173

8.3.1 Custirsen Sodium 173

8.3.2 Tasquinimod 178

8.3.3 ARN-509 183

8.3.4 ODM-201 187

9 Current and Future Players 193

9.1 Overview 193

9.2 Trends in Corporate Strategy 195

9.3 Company Profiles 196

9.3.1 Astellas 196

9.3.2 Johnson & Johnson 198

9.3.3 Bayer 200

10 Market Outlook 202

10.1 Global Markets 202

10.1.1 Forecast 202

10.1.2 Drivers and Barriers-Global Issues 206

10.2 US 206

10.2.1 Forecast 206

10.2.2 Key Events 210

10.2.3 Drivers and Barriers 211

10.3 5EU 211

10.3.1 Forecast 211

10.3.2 Key Events 215

10.3.3 Drivers and Barriers 216

10.4 Japan 216

10.4.1 Forecast 216

10.4.2 Key Events 220

10.4.3 Drivers and Barriers 221

10.5 Brazil 221

10.5.1 Forecast 221

10.5.2 Key Events 225

10.5.3 Drivers and Barriers 226

10.6 Canada 226

10.6.1 Forecast 226

10.6.2 Key Events 230

10.6.3 Drivers and Barriers 231

11 Appendix 232

11.1 Bibliography 232

11.2 Abbreviations 251

11.3 Methodology 256

11.4 Forecasting Methodology 256

11.4.1 Diagnosed Prostate Cancer Patients 256

11.4.2 Percentage Drug-Treated Patients 257

11.4.3 Drugs Included in Each Therapeutic Class 257

11.4.4 Launch and Patent Expiry Dates 258

11.4.5 General Pricing Assumptions 259

11.4.6 Individual Drug Assumptions 260

11.4.7 Pricing of Pipeline Agents 263

11.5 Primary Research-KOLs Interviewed for This Report 265

11.6 Primary Research-Prescriber Survey 267

11.7 About the Authors 268

11.7.1 Analyst 268

11.7.2 Director of Oncology 268

11.7.3 Epidemiologist 269

11.7.4 Global Head of Healthcare 269

11.8 About GlobalData 270

11.9 Disclaimer 270

1.2 List of Figures

Figure 1: 9MM, Historical Age-Standardized Prostate Cancer Diagnosed Incidence (Cases per 100,000 Population), 1998-2007 35

Figure 2: 9MM, Diagnosed Incident Cases of Prostate Cancer, Ages ?40 Years, N, 2013-2023 50

Figure 3: 9MM, Age-Specific Diagnosed Incident Cases of Prostate Cancer, N, 2013 52

Figure 4: 9MM, Age-Standardized Diagnosed Incidence of Prostate Cancer, Ages ?40 Years, 2013 53

Figure 5: 9MM, Percentage Distribution of Incident Cases of Prostate Cancer By Clinical Stage at Diagnosis, Ages ?40 Years 54

Figure 6: 9MM, Diagnosed Five-Year Prevalent Cases of Prostate Cancer, Ages ?40 Years, 2013-2023 56

Figure 7: 9MM, Diagnosed Five-Year Prevalent Cases of CRPC, Ages ?40 Years, 2013-2023 58

Figure 8: 9MM, Diagnosed Five-Year Prevalent Cases of Bone Metastases Among CRPC Patients, Ages ?40 Years, 2013-2023 59

Figure 9: Disease Management Flowchart for Prostate Cancer 68

Figure 10: Competitive Assessment of Late-Stage Pipeline Agents in Prostate Cancer, 2013-2023 147

Figure 11: Yervoy's Clinical Development 149

Figure 12: Potential Clinical and Commercial Positioning of Yervoy 151

Figure 13: ProstVac's Clinical Development 155

Figure 14: Potential Clinical and Commercial Positioning of ProstVac 156

Figure 15: ProstAtak's Clinical Development 160

Figure 16: Potential Clinical and Commercial Positioning of ProstAtak 161

Figure 17: DCVAC/PCa's Clinical Development 164

Figure 18: Potential Clinical and Commercial Positioning of DCVAC/PCa 166

Figure 19: ITK1's Clinical Development 169

Figure 20: Potential Clinical and Commercial Positioning of ITK1 171

Figure 21: Custirsen Sodium's Clinical Development 175

Figure 22: Potential Clinical and Commercial Positioning of Custirsen Sodium 176

Figure 23: Tasquinimod's Clinical Development 180

Figure 24: Potential Clinical and Commercial Positioning of Tasquinimod 181

Figure 25: ARN-509's Clinical Development 185

Figure 26: Potential Clinical and Commercial Positioning of ARN-509 186

Figure 27: ODM-201's Clinical Development 189

Figure 28: Potential Clinical and Commercial Positioning of ODM-201 190

Figure 29: Company Portfolio Gap Analysis in Prostate Cancer, 2013-2023 195

Figure 30: Global Sales for Prostate Cancer by Region, 2013-2023 205

Figure 31: Sales for Prostate Cancer in the US by Drug Class, 2013?2023 209

Figure 32: Sales for Prostate Cancer in the 5EU by Drug Class, 2013-2023 214

Figure 33: Sales for Prostate Cancer in Japan by Drug Class, 2023 219

Figure 34: Sales for Prostate Cancer in Brazil by Drug Class, 2013-2023 224

Figure 35: Sales for Prostate Cancer in Canada by Drug Class, 2013-2023 229

1.1 List of Tables

Table 1: TNM Classification of Prostate Cancer 27

Table 2: Prostate Cancer Staging 28

Table 3: Risk-Group Classifications Used in Prostate Cancer 29

Table 4: Risk Factors and Comorbidities for Prostate Cancer 33

Table 5: 9MM, Sources of Prostate Cancer Diagnosed Incidence Data 38

Table 6: 9MM, Sources of Data for the Clinical Stage of Prostate Cancer at Diagnosis 39

Table 7: 9MM, Sources of Prostate Cancer Diagnosed Five-Year Prevalent Cases Data 40

Table 8: 9MM, Sources of CRPC Diagnosed Five-Year Prevalent Cases Data 41

Table 9: 9MM, Diagnosed Incident Cases of Prostate Cancer, Ages ?40 Years, N, 2013-2023 49

Table 10: 9MM, Age-Specific Diagnosed Incident Cases of Prostate Cancer, N, Row (%), 2013 51

Table 11: 9MM, Diagnosed Five-Year Prevalent Cases of Prostate Cancer, Ages ?40 Years, 2013-2023 55

Table 12: 9MM, Diagnosed Five-Year Prevalent Cases of CRPC, Ages ?40 Years, 2013-2023 57

Table 13: 9MM, Diagnosed Five-Year Prevalent Cases of Bone Metastases Among CRPC Patients, Ages ?40 Years, 2013-2023 59

Table 14: Most Commonly Used Treatment Guidelines for Prostate Cancer, 2014 65

Table 15: Most Commonly Prescribed Hormonal Therapies for Prostate Cancer, 2014 66

Table 16: Most Commonly Prescribed Chemotherapeutic, Drug, and Bone Therapies for CRPC, 2014 67

Table 17: Diagnosis and Treatment of Prostate Cancer, Country Profile-US 77

Table 18: Diagnosis and Treatment of Prostate Cancer, Country Profile-France 78

Table 19: Diagnosis and Treatment of Prostate Cancer, Country Profile-Germany 79

Table 20: Diagnosis and Treatment of Prostate Cancer, Country Profile-Italy 80

Table 21: Diagnosis and Treatment of Prostate Cancer, Country Profile-Spain 81

Table 22: Diagnosis and Treatment of Prostate Cancer, Country Profile-UK 82

Table 23: Diagnosis and Treatment of Prostate Cancer Country Profile-Japan 83

Table 24: Diagnosis and Treatment of Prostate Cancer, Country Profile-Brazil 84

Table 25: Diagnosis and Treatment of Prostate Cancer, Country Profile-Canada 85

Table 26: Leading Branded Drugs Used to Treat Prostate Cancer, 2014 87

Table 27: Product Profile-Zytiga 89

Table 28: Zytiga SWOT Analysis, 2014 91

Table 29: Global Sales Forecasts (USD m) for Zytiga, 2013?2023 92

Table 30: Product Profile-Xtandi 95

Table 31: Xtandi SWOT Analysis, 2014 97

Table 32: Global Sales Forecasts (USD m) for Xtandi, 2013?2023 98

Table 33: Product Profile-Xofigo 101

Table 34: Xofigo SWOT Analysis, 2014 102

Table 35: Global Sales Forecasts (USD m) for Xofigo, 2013?2023 103

Table 36: Product Profile-Jevtana 105

Table 37: Jevtana SWOT Analysis, 2014 106

Table 38: Global Sales Forecasts (USD m) for Jevtana, 2013?2023 107

Table 39: Product Profile-Provenge 110

Table 40: Provenge SWOT Analysis, 2014 111

Table 41: Global Sales Forecasts (USD m) for Provenge, 2013?2023 112

Table 42: Product Profile-Zoladex 113

Table 43: Zoladex SWOT Analysis, 2014 115

Table 44: Product Profile-Lupron 116

Table 45: Lupron SWOT Analysis, 2014 117

Table 46: Product Profile-Eligard 119

Table 47: Eligard SWOT Analysis, 2014 120

Table 48: Product Profile-Trelstar 121

Table 49: Trelstar SWOT Analysis, 2014 122

Table 50: Product Profile-Firmagon 123

Table 51: Firmagon SWOT Analysis, 2014 125

Table 52: Product Profile-Casodex 126

Table 53: Casodex SWOT Analysis, 2014 128

Table 54: Product Profile-Zometa 129

Table 55: Zometa SWOT Analysis, 2014 130

Table 56: Product Profile-Xgeva 132

Table 57: Xgeva SWOT Analysis, 2014 133

Table 58: Unmet Need and Opportunity in Prostate Cancer 135

Table 59: Drugs in Phase III Clinical Trials for Prostate Cancer 146

Table 60: Product Profile-Yervoy 149

Table 61: Yervoy SWOT Analysis, 2014 152

Table 62: Global Sales Forecasts (USD m) for Yervoy, 2013?2023 153

Table 63: Product Profile-ProstVac 154

Table 64: ProstVac SWOT Analysis, 2014 157

Table 65: Global Sales Forecasts (USD m) for ProstVac, 2013?2023 158

Table 66: Product Profile-ProstAtak 159

Table 67: ProstAtak SWOT Analysis, 2014 162

Table 68: Global Sales Forecasts (USD m) for ProstAtak, 2013?2023 163

Table 69: Product Profile-DCVAC/PCa 164

Table 70: DCVAC/PCa SWOT Analysis, 2014 167

Table 71: Global Sales Forecasts (USD m) for DCVAC, 2013?2023 168

Table 72: Product Profile-ITK1 169

Table 73: ITK1 SWOT Analysis, 2014 171

Table 74: Global Sales Forecasts (USD m) for ITK1, 2013?2023 172

Table 75: Product Profile-Custirsen Sodium 174

Table 76: Custirsen Sodium SWOT Analysis, 2014 177

Table 77: Global Sales Forecasts (USD m) for Custirsen Sodium, 2013?2023 178

Table 78: Product Profile-Tasquinimod 179

Table 79: Tasquinimod SWOT Analysis, 2014 182

Table 80: Global Sales Forecasts (USD m) for Tasquinimod, 2013?2023 183

Table 81: Product Profile-ARN-509 184

Table 82: ARN-509 SWOT Analysis, 2014 186

Table 83: Global Sales Forecasts (USD m) for ARN-509, 2013?2023 187

Table 84: Product Profile-ODM-201 188

Table 85: ODM-201 SWOT Analysis, 2014 191

Table 86: Global Sales Forecasts (USD m) for ODM-201, 2013-2023 192

Table 87: Key Companies in the Prostate Cancer Market in the 9MM, 2014 194

Table 88: Astellas' Prostate Cancer Portfolio Assessment, 2014 198

Table 89: J&J's Prostate Cancer Portfolio Assessment, 2014 200

Table 90: Bayer's Prostate Cancer Portfolio Assessment, 2014 201

Table 91: Global Sales Forecasts (USD m) for Prostate Cancer, 2013-2023 204

Table 92: Global Prostate Cancer Market-Drivers and Barriers, 2013-2023 206

Table 93: Sales Forecasts (USD m) for Prostate Cancer in the US, 2013-2023 208

Table 94: Key Events Impacting Sales for Prostate Cancer in the US, 2013-2023 210

Table 95: US Prostate Cancer Market-Drivers and Barriers, 2013?2023 211

Table 96: Sales Forecasts (USD m) for Prostate Cancer in the 5EU, 2013-2023 213

Table 97: Key Events Impacting Sales for Prostate Cancer in the 5EU, 2013-2023 215

Table 98: 5EU Prostate Cancer Market-Drivers and Barriers, 2013?2023 216

Table 99: Sales Forecasts (USD m) for Prostate Cancer in Japan, 2013?2023 218

Table 100: Key Events Impacting Sales for Prostate Cancer in Japan, 2013-2023 220

Table 101: Japan Prostate Cancer Market-Drivers and Barriers, 2013?2023 221

Table 102: Sales Forecasts (USD m) for Prostate Cancer in Brazil, 2013?2023 223

Table 103: Key Events Impacting Sales for Prostate Cancer in Brazil, 2013-2023 225

Table 104: Brazil Prostate Cancer Market-Drivers and Barriers, 2013?2023 226

Table 105: Sales Forecasts (USD m) for Prostate Cancer in Canada, 2013?2023 228

Table 106: Key Events Impacting Sales for Prostate Cancer in Canada, 2013-2013 230

Table 107: Canada Prostate Cancer Market-Drivers and Barriers, 2013-2023 231

Table 108: Key Launch Dates, Marketed and Pipeline Prostate Cancer Drugs 258

Table 109: Key Patent Expiration or Loss of Market Exclusivity Dates, Marketed Prostate Cancer Drugs 258

Table 110: Average Body Weight and Surface Area Across the 9MM 260

Table 111: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 267

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