PharmaPoint: Prostate Cancer - Global Drug Forecast and Market Analysis to 2026

PharmaPoint: Prostate Cancer - Global Drug Forecast and Market Analysis to 2026

Summary

The prostate cancer market is expected to experience a moderate growth between 2016 and 2026. The main drivers of growth will be the expected label expansion of second-generation hormonal agents into hormone-sensitive disease and non-metastatic castration resistant prostate cancer (nmCRPC), and the launch and uptake of nine new premium-priced therapies.

Until now, the hormone sensitive setting has been dominated by the use of cheap first-generation hormonal agents, with the use of premium-priced second-generation hormonal agents (Xtandi and Zytiga) limited to metastatic CRPC. The prostate cancer competitive landscape is going to experience a substantial change. Given that Zytiga and Xtandi are limited by the insurgence of acquired resistance, physicians will face the critical issue of determining the best treatment sequence for subsequent lines of therapy, most notably in the mCRPC setting. Additionally, companies are now moving toward a more personalized approach in prostate cancer, targeting mCRPC patients with specific genetic signatures, such as PTEN loss and DNA repair abnormalities. GlobalData expects these biomarker-driven drug development strategies to induce further patient stratification and to add complexity to the CRPC treatment algorithm.

Scope

- Overview of prostate cancer, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Annualized prostate cancer therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in seven patient segments, forecast from 2016 to 2026.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the prostate cancer therapeutics market.
- Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for prostate cancer. The most promising candidates in Phase III development are profiled.
- Analysis of the current and future market competition in the global prostate cancer market. 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

The report will enable you to -
- 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 global prostate cancer market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global prostate cancer market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing 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.
 

1.1 List of Tables 8
1.2 List of Figures 11
2 Prostate Cancer: Executive Summary 13
2.1 Value of Prostate Cancer Market to Increase Two-Fold By 2026 14
2.2 Xtandi to Become the Undisputed Leader in the Global Prostate Cancer Market 16
2.3 Prostate Cancer Treatment Landscape to Undergo Dramatic Change 18
2.4 Prostate Cancer Pipeline Moving Towards Precision Medicine 18
2.5 Unmet Need Will Remain for the Identification of New Targets and Biomarkers of Response 20
2.6 What Do the Physicians Think? 20
3 Introduction 23
3.1 Catalyst 23
3.2 Related Reports 24
3.3 Upcoming Related Reports 24
4 Disease Overview 25
4.1 Etiology and Pathophysiology 25
4.1.1 Etiology 25
4.1.2 Pathophysiology 26
4.1.3 Biomarkers 27
4.2 Classification or Staging Systems 29
4.3 Symptoms 31
4.4 Prognosis 31
4.5 Quality of Life 31
5 Epidemiology 33
5.1 Disease Background 33
5.2 Risk Factors and Comorbidities 33
5.3 Global and Historical Trends 35
5.3.1 US 36
5.3.2 5EU 37
5.3.3 Japan 37
5.4 Forecast Methodology 37
5.4.1 Sources Used 38
5.4.2 Forecast Assumptions and Methods 43
5.5 Epidemiological Forecast for Prostate Cancer (2016-2026) 52
5.5.1 Diagnosed Incident Cases of Prostate Cancer 52
5.5.2 Age-Specific Incident Cases of Prostate Cancer 53
5.5.3 Incident Cases by Stage at Diagnosis 54
5.5.4 Incident Cases by Risk of Biochemical Recurrence 55
5.5.5 10-Year Diagnosed Prevalent Cases of Prostate Cancer 56
5.5.6 10-Year Prevalent CRPC Cases 57
5.5.7 10-Year Prevalent Metastatic Prostate Cancer Cases 58
5.5.8 10-Year Prevalent mCRPC Cases with HRD Mutations 59
5.6 Discussion 60
5.6.1 Epidemiological Forecast Insight 60
5.6.2 Limitations of Analysis 62
5.6.3 Strengths of Analysis 62
6 Disease Management 63
6.1 Diagnosis Overview 63
6.2 Treatment Overview 66
6.2.1 Treatment Guidelines and Leading Prescribed Drugs 66
6.2.2 Clinical Practice 67
6.3 US 90
6.3.1 Diagnosis 90
6.3.2 Clinical Practice 92
6.4 France 94
6.4.1 Diagnosis 95
6.4.2 Clinical Practice 95
6.5 Germany 98
6.5.1 Diagnosis 98
6.5.2 Clinical Practice 99
6.6 Italy 102
6.6.1 Diagnosis 102
6.6.2 Clinical Practice 103
6.7 Spain 105
6.7.1 Diagnosis 105
6.7.2 Clinical Practice 105
6.8 UK 107
6.8.1 Screening and Diagnosis 107
6.8.2 Clinical Practice 108
6.9 Japan 111
6.9.1 Diagnosis 111
6.9.2 Clinical Practice 112
7 Competitive Assessment 115
7.1 Overview 115
7.2 Second-Generation Hormonal Therapies 117
7.2.1 Zytiga (Abiraterone Acetate) 117
7.2.2 Xtandi (Enzalutamide) 127
7.3 Targeted Therapies 139
7.3.1 Xofigo (Radium 223 Dichloride) 139
7.4 Chemotherapies 146
7.4.1 Jevtana (Cabazitaxel) 146
7.5 Therapeutic Vaccines 151
7.5.1 Provenge (Sipuleucel-T) 151
7.6 First-Generation Hormonal Therapies 160
7.6.1 Zoladex (Goserelin Acetate) 160
7.6.2 Lupron Depot (Leuprolide Acetate) 164
7.6.3 Eligard (Leuprolide Acetate) 167
7.6.4 Trelstar (Triptorelin Pamoate) 171
7.6.5 Vantas (Histrelin Acetate) 174
7.6.6 Firmagon (Degarelix) 177
7.6.7 Casodex (Bicalutamide) 182
7.7 Bone Therapies 186
7.7.1 Zometa (Zoledronic Acid) 186
7.7.2 Xgeva (Denosumab) 189
8 Unmet Needs and Opportunity Assessment 193
8.1 Overview 193
8.2 Therapies That Provide a Durable Overall Survival Benefit for mCRPC Patients 195
8.2.1 Unmet Need 195
8.2.2 Gap Analysis 195
8.2.3 Opportunity 197
8.3 Therapeutic Options for Non-Metastatic CRPC 198
8.3.1 Unmet Need 198
8.3.2 Gap Analysis 198
8.3.3 Opportunity 199
8.4 Identification of Biomarkers to Predict Zytiga and Xtandi Resistance and Agents Able to Overcome Resistanceto Available Therapies 200
8.4.1 Unmet Need 200
8.4.2 Gap Analysis 201
8.4.3 Opportunity 202
8.5 Identification of New Targets and Positive Predictive Biomarkers of Response 203
8.5.1 Unmet Need 203
8.5.2 Gap Analysis 204
8.5.3 Opportunity 205
9 Pipeline Assessment 207
9.1 Overview 207
9.2 Promising Drugs in Clinical Development 213
9.3 Immunotherapies 216
9.3.1 ProstAtak (Aglatimagene Besadenovec) 216
9.3.2 Stapuldencel-t (DCVAC/PCa) 223
9.3.3 ITK-1 229
9.3.4 Tecentriq (Atezolizumab) 234
9.4 Second-Generation Hormonal Therapies 239
9.4.1 Apalutamide (ARN-509) 239
9.4.2 Darolutamide (ODM-201) 248
9.5 Targeted Therapies 256
9.5.1 Masitinib (AB1010) 256
9.5.2 Lynparza (Olaparib) 260
9.5.3 Rubraca (Rucaparib Camsylate) 268
9.5.4 Ipatasertib (GDC-0068) 274
9.6 First-Generation Hormonal Therapies 281
9.6.1 Relugolix (TAK-385) 281
9.7 Promising Drugs in Early-Stage Development 287
9.7.1 Targeting the P13K/AKT/mTOR Pathway 287
9.7.2 Immunotherapies 288
9.7.3 Prostate-Specific Membrane Antigen-Targeted Therapies 293
9.7.4 Hormonal Therapies 297
9.8 Other Drugs in Development 300
10 Current and Future Players 303
10.1 Overview 303
10.2 Trends in Corporate Strategy 307
10.3 Company Profiles 310
10.3.1 Astellas 310
10.3.2 AstraZeneca 312
10.3.3 Bayer 314
10.3.4 Clovis Oncology 316
10.3.5 Johnson & Johnson 318
10.3.6 Pfizer 321
10.3.7 Roche 323
10.3.8 Sanofi 325
11 Market Outlook 326
11.1 Global Markets 326
11.1.1 Forecast 326
11.1.2 Drivers and Barriers - Global Issues 330
11.2 US 331
11.2.1 Forecast 331
11.2.2 Key Events 333
11.2.3 Drivers and Barriers 334
11.3 5EU 335
11.3.1 Forecast 335
11.3.2 Key Events 337
11.3.3 Drivers and Barriers 338
11.4 Japan 340
11.4.1 Forecast 340
11.4.2 Key Events 342
11.4.3 Drivers and Barriers 343
12 Appendix 344
12.1 Bibliography 344
12.2 Abbreviations 379
12.3 Methodology 386
12.3.1 Forecasting Methodology 386
12.3.2 Diagnosed Prostate Cancer Patients 386
12.3.3 Percent Drug-Treated Patients 387
12.3.4 Drugs Included in Each Therapeutic Class 387
12.3.5 Launch and Patent Expiry Dates 387
12.3.6 General Pricing Assumptions 389
12.3.7 Individual Drug Assumptions 391
12.3.8 Generic Erosion 402
12.4 Primary Research - KOLs Interviewed for This Report 403
12.5 Primary Research - Prescriber Survey 407
12.6 About the Authors 408
12.6.1 Analyst 408
12.6.2 Therapy Area Director 408
12.6.3 Epidemiologist 409
12.6.4 Epidemiology Reviewers 409
12.6.5 Global Director of Therapy Analysis and Epidemiology 410
12.6.6 Global Head and EVP of Healthcare Operations and Strategy 411
12.7 About GlobalData 412
12.8 Contact Us 412
12.9 Disclaimer 413
 

List Of Tables

1.1 List of Tables
Table 1: Prostate Cancer: Key Metrics in Seven Major Pharmaceutical Markets 13
Table 2: Stage Definitions for PCa 29
Table 3: NCCN Risk-Category Classification System for PCa 30
Table 4: Risk Factors and Comorbidities for Prostate Cancer 34
Table 5: AJCC Staging of Prostate Cancer 38
Table 6: Risk Category Definitions 44
Table 7: 7MM, Diagnosed Incident Cases of Prostate Cancer, Men, Ages ≥35 Years, Select Years, 2016-2026 53
Table 8: 7MM, 10-Year Diagnosed Prevalent Cases of Prostate Cancer, Men, Ages ≥35 Years, Select Years, 2016-2026 57
Table 9: Treatment Guidelines for Prostate Cancer 66
Table 10: Most-Prescribed Drugs for Prostate Cancer by Drug Class in the Global Markets in 2016 67
Table 11: Country Profile - US 90
Table 12: Country Profile - France 94
Table 13: Country Profile - Germany 98
Table 14: Country Profile - Italy 102
Table 15: Country Profile - Spain 105
Table 16: Country Profile - UK 107
Table 17: Country Profile - Japan 111
Table 18: Leading Branded Treatment for PCa, 2017 116
Table 19: Product Profile - Zytiga 118
Table 20: Efficacy of Zytiga in Chemotherapy-Naïve mCRPC 123
Table 21: Efficacy of Zytiga in Chemotherapy-Resistant mCRPC 123
Table 22: Results of the LATITUDE Trial of Zytiga 124
Table 23: Zytiga SWOT Analysis, 2017 126
Table 24: Product Profile - Xtandi 127
Table 25: Efficacy of Xtandi in Chemotherapy-Naïve mCRPC 134
Table 26: Efficacy of Xtandi in Chemotherapy-Resistant mCRPC 135
Table 27: Xtandi SWOT Analysis, 2017 137
Table 28: Product Profile - Xofigo 139
Table 29: Efficacy of Xofigo in mCRPC 144
Table 30: Xofigo SWOT Analysis, 2017 145
Table 31: Product Profile - Jevtana 146
Table 32: Efficacy of Jevtana as Second-Line Treatment Post-Docetaxel Failure in mCRPC 148
Table 33: Jevtana SWOT Analysis, 2017 150
Table 34: Product Profile - Provenge 151
Table 35:Efficacy of Provenge in mCRPC 156
Table 36: Provenge SWOT Analysis, 2017 158
Table 37: Product Profile - Zoladex 160
Table 38:Efficacy of Zoladex in mCRPC 162
Table 39:Efficacy of Zoladex as Neoadjuvant/Adjuvant Treatment 162
Table 40: Zoladex SWOT Analysis, 2017 163
Table 41: Product Profile - Lupron Depot 164
Table 42: Lupron Depot SWOT Analysis, 2017 166
Table 43: Product Profile - Eligard 167
Table 44:Efficacy of Eligard in Advanced PCa 169
Table 45: Eligard SWOT Analysis, 2017 170
Table 46: Product Profile - Trelstar 171
Table 47:Efficacy of Trelstar in Advanced PCa 172
Table 48: Trelstar SWOT Analysis, 2017 173
Table 49: Product Profile - Vantas 174
Table 50: Vantas SWOT Analysis, 2017 176
Table 51: Product Profile - Firmagon 177
Table 52:Efficacy of Firmagon in Advanced PCa 180
Table 53: Firmagon SWOT Analysis, 2017 181
Table 54: Product Profile - Casodex 182
Table 55: Casodex SWOT Analysis, 2017 184
Table 56: Product Profile - Zometa 186
Table 57:Efficacy of Zometa in Advanced PCa 187
Table 58: Zometa SWOT Analysis, 2017 188
Table 59: Product Profile - Xgeva 189
Table 60:Efficacy of Xgeva in Advanced mCRPC 191
Table 61: Xgeva SWOT Analysis, 2017 192
Table 62: Product Profile - ProstAtak 216
Table 63:Efficacy of ProstAtak as Adjuvant Treatment in Combination with Radiotherapy in Localized PCa 219
Table 64: ProstAtak SWOT Analysis, 2017 221
Table 65: Product Profile - Stapuldencel-t 223
Table 66:Efficacy of Stapuldencel-t in mCRPC 225
Table 67:Results from the Randomized Phase II Study of Stapuldencel-t in mCRPC 226
Table 68: Stapuldencel-t SWOT Analysis, 2017 228
Table 69: Product Profile - ITK-1 229
Table 70:Efficacy Results from the Phase II Study of ITK-1 in mCRPC 231
Table 71: ITK-1 SWOT Analysis, 2017 233
Table 72: Product Profile - Tecentriq 234
Table 73: Tecentriq SWOT Analysis, 2017 238
Table 74: Product Profile - Apalutamide 239
Table 75:Efficacy of Apalutamide in nmCRPC 243
Table 76:Efficacy of Apalutamide in mCRPC 244
Table 77: Apalutamide SWOT Analysis, 2017 246
Table 78: Product Profile - Darolutamide 248
Table 79:Efficacy of Darolutamide in nmCRPC 252
Table 80: Darolutamide SWOT Analysis, 2017 254
Table 81: Product Profile - Masitinib 256
Table 82: Masitinib SWOT Analysis, 2017 259
Table 83: Product Profile - Lynparza 260
Table 84:Efficacy of Lynparza in mCRPC 264
Table 85: Lynparza SWOT Analysis, 2017 266
Table 86: Product Profile - Rubraca 268
Table 87: Rubraca SWOT Analysis, 2017 273
Table 88: Product Profile - Ipatasertib 274
Table 89:Efficacy of Ipatasertib in mCRPC 278
Table 90: Efficacy of Ipatasertib in mCRPC According to PTEN Status 278
Table 91: Ipatasertib SWOT Analysis, 2017 280
Table 92: Product Profile - Relugolix 281
Table 93:Efficacy of Relugolix in HNPC 284
Table 94: Relugolix SWOT Analysis, 2017 286
Table 95: Early-Stage Agents Targeting the P13K/AKT/mTOR Pathway 287
Table 96: Immune Checkpoint Inhibitors in Early-Stage Development for mCRPC 290
Table 97: PSMA-Targeted Therapeutics in Early-Stage Development for mCRPC 293
Table 98: Hormonal Therapies in Early-Stage Development for mCRPC 297
Table 99: Drugs in Development for PCa, 2017, Part 1 300
Table 100: Drugs in Development for PCa, 2017, Part 2 301
Table 101: Drugs in Development for PCa, 2017, Part 3 302
Table 102: Key Companies in the PCa Market in the 7MM, 2016-2026 305
Table 103: Astellas’ PCa Portfolio Assessment, 2017 311
Table 104: AstraZeneca’s PCa Portfolio Assessment, 2017 313
Table 105: Bayer’s PCa Portfolio Assessment, 2017 315
Table 106: Clovis Oncology’s PCa Portfolio Assessment, 2017 317
Table 107: J&J’s PCa Portfolio Assessment, 2017 320
Table 108: Pfizer’s PCa Portfolio Assessment, 2017 322
Table 109: Roche’s PCa Portfolio Assessment, 2017 324
Table 110: Sanofi’s PCa Portfolio Assessment, 2017 325
Table 111: Prostate Cancer Market - Global Drivers and Barriers, 2016-2026 330
Table 112: Key Events Impacting Sales for Prostate Cancer in the US, 2016-2026 333
Table 113: Prostate Cancer Market - Global Drivers and Barriers in the US, 2016-2026 334
Table 114: Key Events Impacting Sales for Prostate Cancer in the 5EU, 2016-2026 337
Table 115: Prostate Cancer Market - Global Drivers and Barriers in the 5EU, 2016-2026 338
Table 116: Prostate Cancer Market in the 5EU - Country-Specific Barriers in the 5EU, 2016-2026 339
Table 117: Key Events Impacting Sales for Prostate Cancer in Japan, 2016-2026 342
Table 118: Prostate Cancer Market - Global Drivers and Barriers in Japan, 2016-2026 343
Table 119: Key Historical and Projected Launch Dates for Prostate Cancer 388
Table 120: Key Historical and Projected Patent Expiry Dates for Prostate Cancer 389
Table 121: Average Body Weight Across the 7MM 390
Table 122: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 407
 

List Of Figures

1.2 List of Figures
Figure 1: Global Sales Forecast by Country for Prostate Cancer in 2016 and 2026 16
Figure 2: Analysis of the Company Portfolio Gap in Prostate Cancer During the Forecast Period, 2016-2026 17
Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents in Prostate Cancer, 2016-2026 20
Figure 4: 7MM, Age-Standardized Diagnosed Incidence of Prostate Cancer, Men, Ages ≥35 Years, 2006-2026 37
Figure 5: Sources Used and Not Used for Calculations of Incident Cases 40
Figure 6: Sources Used and Not Used for Calculations of 10-Year Diagnosed Prevalent Cases 41
Figure 7: Sources Used and Not Used for Calculations of Diagnosed Incident Cases by Stage at Diagnosis and Metastases 42
Figure 8: Sources Used and Not Used for Calculations of 10-Year Diagnosed Prevalent Cases of CRPC 43
Figure 9: Sources Used and Not Used for Calculations of 10-Year Diagnosed Prevalent Cases with HRD Mutations 44
Figure 10: 7MM, Age-Specific Diagnosed Incident Cases of Prostate Cancer, Men, Ages ≥35 Years, 2016 55
Figure 11: 7MM, Diagnosed Incident Cases of Prostate Cancer by Stage at Diagnosis, Men, Ages ≥35 Years, 2016 56
Figure 12: 7MM, Diagnosed Incident Cases of Prostate Cancer by Risk of Biochemical Recurrence, Men, Ages ≥35 Years, 2016 57
Figure 13: 7MM, 10-Year Prevalent Cases of CRPC, Men, Ages ≥35 Years, 2016 59
Figure 14: 7MM, 10-Year Prevalent Cases of Prostate Cancer by Metastases, Men, Ages ≥35 Years, 2016 60
Figure 15: 7MM, 10-Year Prevalent Cases of Prostate Cancer with HRD Mutations, Men, Ages ≥35 Years, 2016 61
Figure 16: Treatment Algorithm for Localized Prostate Cancer 76
Figure 17: Treatment Algorithm for Progressive and Advanced Prostate Cancer 90
Figure 18: Zytiga’s Clinical Development in PCa 123
Figure 19: Xtandi’s Clinical Development in PCa 134
Figure 20: Xofigo’s Clinical Development in PCa 144
Figure 21: Provenge’s Clinical Development in PCa 157
Figure 22: Firmagon’s Clinical Development in PCa 180
Figure 23: Overview of the Unmet Need and Opportunity in Prostate Cancer, 2017 195
Figure 24: Overview of the Development Pipeline in PCa 213
Figure 25: Pivotal Phase II/III Trials for the Promising Pipeline Agents, Part 1 214
Figure 26: Pivotal Phase II/III Trials for the Promising Pipeline Agents, Part 2 215
Figure 27: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of PCa During the Forecast Period 216
Figure 28: ProstAtak Clinical Development in PCa 220
Figure 29: Clinical and Commercial Positioning of ProstAtak 221
Figure 30: Stapuldencel-t Clinical Development in PCa 226
Figure 31: Clinical and Commercial Positioning of Stapuldencel-t 228
Figure 32: ITK-1 Clinical Development in PCa 231
Figure 33: Clinical and Commercial Positioning of ITK-1 233
Figure 34: Tecentriq Clinical Development in PCa 237
Figure 35: Clinical and Commercial Positioning of Tecentriq 238
Figure 36: Apalutamide Clinical Development in PCa 243
Figure 37: Clinical and Commercial Positioning of Apalutamide 246
Figure 38: Darolutamide Clinical Development in PCa 252
Figure 39: Clinical and Commercial Positioning of Darolutamide 254
Figure 40: Masitinib Clinical Development in PCa 258
Figure 41: Clinical and Commercial Positioning of Masitinib 259
Figure 42: Lynparza Clinical Development in PCa 264
Figure 43: Clinical and Commercial Positioning of Lynparza 266
Figure 44: Rubraca Clinical Development in PCa 271
Figure 45: Clinical and Commercial Positioning of Rubraca 273
Figure 46: Ipatasertib Clinical Development in PCa 278
Figure 47: Clinical and Commercial Positioning of Ipatasertib 280
Figure 48: Relugolix Clinical Development in PCa 284
Figure 49: Clinical and Commercial Positioning of Relugolix 286
Figure 50: Global Sales of Branded Products for PCa by Company in 2016-2026 307
Figure 51: Analysis of the Company Portfolio Gap in PCa During the Forecast Period 308
Figure 52: Global (7MM) Sales Forecast by Country for Prostate Cancer in 2016 and 2026 329
Figure 53: Global (7MM) Sales Forecast by Drug Class for Prostate Cancer in 2016 and 2026 330
Figure 54: Sales Forecast by Class for Prostate Cancer in the US in 2016 and 2026 333
Figure 55: Sales Forecast by Class for Prostate Cancer in the 5EU in 2016 and 2026 337
Figure 56: Sales Forecast by Class for Prostate Cancer in Japan in 2016 and 2026 342
 

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