Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 7
2 Introduction 10
2.1 Disease Introduction 10
2.2 Symptoms and Risk Factors 10
2.3 Etiology and Pathophysiology 11
2.4 Diagnosis 13
2.4.1 Digital Rectal Examination 13
2.4.2 Imaging 13
2.4.3 Biopsy 13
2.4.4 Tumor Markers 14
2.5 Disease Staging and Risk Assessment 15
2.6 Treatment Algorithm 17
2.6.1 Localized or Locally Advanced Prostate Cancer 17
2.6.2 Hormone Sensitive Metastatic Prostate Cancer 19
2.6.3 Metastatic Castration Resistant Prostate Cancer 23
2.6.4 Heat Map – Marketed Products Overview 27
3 Marketed Products 34
3.1 Hormonal Therapies 34
3.1.1 First Generation 35
3.1.2 Second Generation 38
3.2 Chemotherapy Agents 39
3.2.1 Taxotere (docetaxel) – Sanofi 40
3.2.2 Jevtana (cabazitaxel) – Sanofi 40
3.3 Therapeutic Vaccines 41
3.3.1 Provenge (sipuleucel-t) – Dendreon 41
3.4 Bone Metastasis Treatments 42
3.4.1 Xofigo (radium 223) – Bayer/Algeta 42
3.4.2 Xgeva (denosumab) – Amgen 43
3.4.3 Zometa (zoledronic acid) – Novartis 43
4 Pipeline Product Developments 45
4.1 Developmental Pipeline by Phase and Molecular Target 45
4.2 Mechanisms of Action in the Pipeline 47
5 Clinical Trials 51
5.1 Clinical Trial Failure Rate 51
5.2 Clinical Trial Duration 53
5.2.1 Clinical Trial Size 57
5.3 Promising Pipeline Molecules 62
5.3.1 Localized Disease 62
5.3.2 mCRPC – First Line 68
5.3.3 mCRPC – Second Line 80
6 Market Forecasts 84
6.1 Global 84
6.1.1 Treatment Usage Patterns 84
6.1.2 Market Size 86
6.2 North America 86
6.2.1 US 86
6.2.2 Canada 89
6.3 Top Five European Markets 91
6.3.1 Treatment Usage Patterns 91
6.3.2 Annual Cost of Therapy 93
6.3.3 Market Size 94
6.4 Japan 96
6.4.1 Treatment Usage Patterns 96
6.4.2 Annual Cost of Therapy 96
6.4.3 Market Size 98
7 Drivers and Barriers 99
7.1 Market Drivers 99
7.1.1 Major Unmet Treatment Needs of Late-Stage PC Patients 99
7.1.2 Increasing Incidence of PC Driven by Global Aging of Population 99
7.1.3 Continued Uptake of Zytiga and Xtandi 99
7.1.4 Approval of Numerous Premium Products in PC Market 99
7.1.5 High Number of Pipeline Drugs 100
7.2 Market Barriers 100
7.2.1 Recent and Future Patent Expiries 100
7.2.2 Uptake Limited by Premium Price of Several Novel Therapies 100
8 Strategic Consolidation 102
8.1 Co-development Deals 102
8.1.1 Pfizer Enters into Co-Development Agreement with Merck 105
8.1.2 Immatics Enters into R&D Agreement with Roche for Cancer Vaccine 105
8.1.3 Merck & Co Enters into Agreement with ARIAD Pharma 106
8.1.4 Medivation Enters into Co-Development Agreement with Astellas Pharma 106
8.1.5 Aduro Biotech Enters into Agreement with Novartis for Immuno-Oncology Products 106
8.1.6 Bayer Schering Enters into Co-Development Agreement with Micromet 107
8.1.7 Takeda Pharma Enters into Agreement with Cell Genesys 107
8.2 Licensing Deals 107
8.2.1 Astellas Pharma Enters into Licensing Agreement with AVEO Pharma for Tivozanib 110
8.2.2 Algeta Enters into Licensing Agreement with Bayer for Alpharadin 110
8.2.3 Sanofi-Aventis Enters into Licensing Agreement with Oxford BioMedica 111
8.2.4 Ascenta Therapeutics Enters into Licensing Agreement with Sanofi 111
8.2.5 Aduro Biotech Enters into Exclusive Licensing Agreement with Janssen Biotech 111
9 Appendix 112
9.1 All Pipeline Drugs by Phase 112
9.1.1 Discovery 112
9.1.2 Preclinical 116
9.1.3 IND/CTA-Filed 131
9.1.4 Phase I 131
9.1.5 Phase II 137
9.1.6 Phase III 145
9.2 Market Forecasts to 2021 146
9.2.1 Global 146
9.2.2 US 146
9.2.3 Canada 146
9.2.4 UK 147
9.2.5 France 147
9.2.6 Germany 147
9.2.7 Italy 148
9.2.8 Spain 148
9.2.9 Japan 148
9.3 References 149
9.4 Abbreviations 159
9.5 Research Methodology 161
9.5.1 Secondary Research 161
9.5.2 Marketed Product Profiles 162
9.5.3 Late-Stage Pipeline Candidates 162
9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 162
9.5.5 Product Competitiveness Framework 162
9.5.6 Pipeline Analysis 163
9.5.7 Forecasting Model 164
9.5.8 Deals Data Analysis 165
9.6 Contact Us 165
9.7 Disclaimer 165