Prostate Cancer Therapeutics Market to 2019 - Rising Prevalence and Strong Uptake of Recent Approvals to Drive Robust Growth to 2019

Prostate Cancer Therapeutics Market to 2019 - Rising Prevalence and Strong Uptake of Recent Approvals to Drive Robust Growth to 2019

Summary

GBI Research has released the pharmaceutical report “Prostate Cancer Therapeutics Market to 2019 - Rising Prevalence and Strong Uptake of Recent Approvals to Drive Robust Growth to 2019”. The recent approval of a number of highly effective drugs, including Zytiga and Xtandi, has provided late-stage patients with a number of options and increased survival times by a number of months. These recent approvals are anticipated to generate strong revenues during the forecast following increasing uptake by physicians as the treatment algorithm shifts towards their first-line usage over Taxotere. Additionally, a very large late-stage pipeline is anticipated to produce a number of new market entrants which are superior to existing products. Overall, this is anticipated to drive rapid market growth from $4.1 billion in 2012 to $8.0 billion by 2019 at a CAGR of 10.1%.

Scope

- A brief introduction to prostate cancer, including the disease’s pathogenesis, risk factors, diagnosis, staging and treatment algorithms for each stage.
- In-depth analysis of drugs available for the treatment of prostate cancer, including analyses of their safety, efficacy, treatment patterns and strengths/weaknesses. Includes a heat map comparing the drugs in terms of safety and efficacy.
- Comprehensive review of the pipeline for prostate cancer therapies, including individual analysis of a number of late-stage pipeline drugs that are likely to enter the market in the forecast period. The pipeline is analyzed on the basis of phase distribution, molecule types and molecular targets, program type.
- Additional in-depth analysis of pipeline drug clinical trials by phase, molecule type, trial size, trial duration and program failure rate analyses for each molecule type and mechanism of action.
- Multi-scenario forecast data of the market to 2019, taking into account how it will be affected by the introduction of new drugs, the expiry of key patents on current drugs and the changes in disease epidemiology across the key developed markets including the US, Japan, Germany, the UK, France, Italy and Spain.
- Discussion of the drivers and barriers for market growth.
- Discussion of the licensing and co-development deals landscape in prostate cancer, Includes an analysis of licensing deals by stage of development, molecule type and mechanism of action. Also includes an analysis of both licensing and co-development deals by year and value and network maps of licensing and co-development deals.

Reasons to buy

- Understand the different levels of prostate cancer therapies, from early-stage prostate cacner to metastatic and castrate-resistant prostate cancer.
- Understand the vast scope and diversity of the pipeline, including which molecule types and mechanisms of action are prominent.
- Observe the trends in clinical trial duration and size amongst clinical Phases, between molecule types and mechanisms of action, and use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for prostate cancer therapeutics.
- Assess the potential clinical and commercial impact of current late-stage pipeline molecules on the prostate cancer therapeutics market.

1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 7
1.2 List of Figures 8
2 Introduction 9
2.1 Pathophysiology and Etiology 9
2.2 Epidemiology 11
2.3 Disease Progression 13
2.4 Treatment 15
3 Marketed Products 19
3.1 Hormonal Therapies 19
3.1.1 Zoladex (Goserelin) – AstraZeneca 19
3.1.2 Lupron Depot (Leuprolide acetate) – Abbvie 21
3.1.3 Triptorelin 22
3.1.4 Firmagon (degarelix) – Ferring 22
3.1.5 Casodex (Bicalutamide) 23
3.1.6 Summary 23
3.2 Chemotherapy agents 24
3.2.1 Taxotere (Docetaxel) – Sanofi 24
3.2.2 Jevtana (Cabazitaxel) – Sanofi 25
3.3 Therapeutic Vaccines 26
3.3.1 Provenge (sipuleucel-T) – Dendreon 26
3.4 Targeted therapies (Second Generation Anti-androgens) 27
3.4.1 Zytiga (Abiraterone acetate) – Janssen 27
3.4.2 Xtandi (Enzalutamide) – Astellas/Medivation 27
3.5 Bone Metastasis Treatments 28
3.5.1 Xofigo (Radium 223) – Bayer/Algeta 28
3.5.2 Xgeva (denosumab) – Amgen 29
3.5.3 Zometa (zoledronic acid) – Novartis 29
3.6 Heat Map for Marketed Products 30
4 Prostate Cancer Developmental Pipeline 33
4.1 Overall Pipeline 33
4.2 Mechanisms of Action 35
4.3 Clinical Trials 36
4.3.1 Attrition Rate 36
4.3.2 Enrollment 38
4.3.3 Duration 41
4.4 Key Late-Stage Pipeline Molecules 43
4.4.1 Cometriq (Cabozantinib) – Exelixis 43
4.4.2 OGX-011 (custirsen sodium) – Teva 43
4.4.3 TAK-700 (orteronel) – Takeda 44
4.4.4 ProstAtak (AdvTk+ valcyclovir) – Advantagene 44
4.4.5 ProstVac – Bavarian Nordic 44
4.4.6 Tasquinimod – Active Biotech 45
4.4.7 Yervoy (Ipilimumab) – Bristol-Myers Squibb 46
4.4.8 ARN-509 – Aragon Pharmaceuticals, Johnson and Jonhson 46
5 Market Forecast to 2019 47
5.1 Global 47
5.1.1 Treatment Usage Patterns 47
5.1.2 Market Size 49
5.2 North America 50
5.2.1 US 50
5.2.2 Canada 52
5.3 Five European Markets 54
5.3.1 Treatment Usage Patterns 54
5.3.2 Annual Cost of Therapy 56
5.3.3 Market Size 57
5.4 Japan 58
5.4.1 Treatment Usage Patterns 58
5.4.2 Market Size 59
6 Prostate Cancer Therapeutics: Drivers and Barriers 60
6.1 Drivers 60
6.1.1 Major Unmet Treatment Needs of Late Stage Prostate Cancer Patients 60
6.1.2 Increasing Disease Population 60
6.1.3 New Drugs Entering the Market 60
6.1.4 Rapid and Robust Uptake of Recently Approved High-Cost Therapies 60
6.1.5 Rapid Inflation Rate for Specialty Pharmaceutical Products in the US 60
6.1.6 Market Capture of Previously Untreated Patient Segments 61
6.2 Barriers 61
6.2.1 Uncertain Treatment Algorithm 61
6.2.2 Uptake Limited by High Prices for New Products 61
6.2.3 Patent Expiry of Taxotere 61
6.2.4 Intensifying Competition Acting as a Barrier to Market Capture 61
7 Licensing and Co-development Deals Analysis 62
7.1 Licensing Deals 62
7.1.1 Algeta Enters into Licensing Agreement with Bayer Schering for Xofigo 65
7.1.2 Sanofi-Aventis Enters into a Licensing Agreement with Oxford BioMedica 65
7.1.3 Novacea Enters Into Licensing Agreement With Schering-Plough For Asentar 65
7.1.4 Teva Pharma Enters into a Licensing Agreement with Oncogenex Pharma for OGX-011 65
7.1.5 Hoffman La Roche Enters into a Licensing Agreement with Inovio Pharmaceuticals for Prostate Cancer and Hepatitis B Immunotherapy Products 66
7.1.6 Colby Pharmaceutical Company Enters into a Licensing Agreement with MannKind for Cancer Immunotherapy Products 66
7.1.7 Ipsen Enters into a Licensing Agreement with GTx 66
7.1.8 Protox Therapeutics Enters into a Licensing Agreement with Kissei Pharma 67
7.1.9 AEterna Zentaris Enters Into License And Collaboration Agreement With Nippon Kayaku For Ozarelix 67
7.1.10 Orion Corporation Enters Into Agreement With Indevus Pharmaceuticals 67
7.2 Co-Development Deals 68
7.2.1 Medivation Enters into Co-Development Agreement with Astellas Pharma 69
7.2.2 Takeda Pharma Enters into an Agreement with Cell Genesys 69
7.2.3 Active Biotech Enters into Co-Development Agreement with Ipsen 69
8 Appendix 70
8.1 Market Definitions 70
8.2 Abbreviations 70
8.3 Sources 73
8.4 Sources for Marketed Products Heat Map 78
8.5 Scientific Support 78
8.6 Research Methodology 78
8.6.1 Coverage 79
8.6.2 Secondary Research 79
8.6.3 Therapeutic Landscape 79
8.6.4 Epidemiology-Based Forecasting 80
8.6.5 Market Size by Geography 81
8.6.6 Geographical Landscape 82
8.6.7 Pipeline Analysis 82
8.6.8 Competitive Landscape 82
8.6.9 Expert Panel Validation 82
8.7 All Publicly Announced Pipeline Products, by Phase 83
8.7.1 Discovery 83
8.7.2 Preclinical/IND-Filed 85
8.7.3 Phase I 94
8.7.4 Phase II 97
8.7.5 Phase III/Pre-Registration 101
8.7.6 Undisclosed Stage of Development 103
8.8 Tabular Forecast Data 103
8.8.1 Global 103
8.8.2 US 104
8.8.3 UK 104
8.8.4 France 105
8.8.5 Germany 105
8.8.6 Italy 106
8.8.7 Spain 106
8.8.8 Japan 107
8.8.9 Canada 107
8.9 Disclaimer 107

1.1 List of Tables
Table 1: Prostate Cancer Therapeutics, Prostate Cancer Risk Factors 10
Table 2: Prostate Cancer Therapeutics, Prostate Cancer Staging 13
Table 3: Prostate Cancer Therapeutics, Abbreviations 70
Table 4: Prostate Cancer Therapeutics, Sources for Heat Map 78
Table 5: Prostate Cancer Therapeutics, Global, All Pipeline Products (Discovery), 2013 83
Table 6: Prostate Cancer Therapeutics, Global, All Pipeline Products (Preclinical/IND Filed), 2013 85
Table 7: Prostate Cancer Therapeutics, Global, All Pipeline Products (Phase I), 2013 94
Table 8: Prostate Cancer Therapeutics, Global, All Pipeline Products (Phase II), 2013 97
Table 9: Prostate Cancer Therapeutics, Global, All Pipeline Products (Phase III/Pre-Registration), 2013 101
Table 10: Prostate Cancer Therapeutics, Global, All Pipeline Products (Undisclosed Stage of Development), 2013 103
Table 11: Prostate Cancer, Leading Eight Markets, Market Forecast, 2012–2019 103
Table 12: Prostate Cancer, US, Market Forecast, 2012–2019 104
Table 13: Prostate Cancer, UK, Market Forecast, 2012–2019 104
Table 14: Prostate Cancer, France, Market Forecast, 2012–2019 105
Table 15: Prostate Cancer, Germany, Market Forecast, 2012–2019 105
Table 16: Prostate Cancer, Italy, Market Forecast, 2012–2019 106
Table 17: Prostate Cancer, Spain, Market Forecast, 2012–2019 106
Table 18: Prostate Cancer, Japan, Market Forecast, 2012–2019 107
Table 19: Prostate Cancer, Canada, Market Forecast, 2012–2019 107

1.2 List of Figures
Figure 1: Prostate Cancer Therapeutics: Percentage of Men Diagnosed with Prostate Cancer in the US, by Age, 2005–2009 11
Figure 2: Prostate Cancer Therapeutics: Average Number of New Cases and Age-Specific Incidence Rates per 100,000 Population, UK, 2008–2010 12
Figure 3: Prostate Cancer Therapeutics: Prostate Cancer Treatment Algorithm (Stages I and II) 15
Figure 4: Prostate Cancer Therapeutics: Prostate Cancer Treatment Algorithm (Stage III) 15
Figure 5: Prostate Cancer Therapeutics: Prostate Cancer Treatment Algorithm (Stage IV) 16
Figure 6: Prostate Cancer Therapeutics, Sales of Zoladex ($m), 2000–2012 20
Figure 7: Prostate Cancer Therapeutics, Sales of Lupron Depot ($m), 2009–2012 21
Figure 8: Prostate Cancer Therapeutics, Sales of Taxotere ($bn), 2004–2012 24
Figure 9: Prostate Cancer Therapeutics: Heat Map (mCRPC) 31
Figure 10: Market for Prostate Cancer, Global, Pipeline Overview, 2013 34
Figure 11: Market for Prostate Cancer, Global, Mechanisms of Action, 2013 35
Figure 12: Market for Prostate Cancer, Global, Clinical Trial Failure Rates, 2006–2013 36
Figure 13: Market for Prostate Cancer, Global, Clinical Trial Failure Rates (Molecule Type), 2006–2013 37
Figure 14: Market for Prostate Cancer, Global, Clinical Trial Failure Rates (Mechanism of Action), 2006–2013 38
Figure 15: Market for Prostate Cancer, Global, Clinical Trial Enrollment by Product (Molecule Type), 2006–2013 39
Figure 16: Market for Prostate Cancer, Global, Clinical Trial Enrollment by Product (Mechanism of Action), 2006–2013 40
Figure 17: Market for Prostate Cancer, Global, Clinical Trial Duration (Molecule Type), 2006–2013 41
Figure 18: Market for Prostate Cancer, Global, Clinical Trial Duration (Mechanism of Action), 2006–2013 42
Figure 19: Prostate Cancer Therapeutics: Top Eight Major Markets, Prevalence Populations, 2012–2019 48
Figure 20: Prostate Cancer Therapeutics: Top Eight Major Markets, Market Forecast ($bn), 2012–2019 49
Figure 21: Prostate Cancer Therapeutics, US, Treatment Usage Patterns, 2012–2019 50
Figure 22: Prostate Cancer Therapeutics: US, Market Forecast ($m), 2012–2019 51
Figure 23: Market for Prostate Cancer Therapeutics to 2019, Canada, Treatment Usage Patterns, 2012–2019 52
Figure 24: Prostate Cancer Therapeutics: Canada, Market Size ($m), 2012–2019 53
Figure 25: Prostate Cancer Therapeutics: Leading Five European Markets, Treatment Usage Patterns, 2012–2019 55
Figure 26: Prostate Cancer Therapeutics: Leading Five European Markets, Annual Cost of Therapy, 2012–2019 56
Figure 27: Prostate Cancer Therapeutics: Leading Five European Countries, Market Size ($m), 2012–2019 57
Figure 28: Prostate Cancer Therapeutics: Japan, Treatment Usage Patterns, 2012–2019 58
Figure 29: Prostate Cancer Therapeutics: Japan, Market Size ($m), 2012 – 2019 59
Figure 30: Market for Prostate Cancer, Global, Licensing Deals, 2006–2012 62
Figure 31: Market for Prostate Cancer, Global, Licensing Deals, 2006–2012 63
Figure 32: Market for Prostate Cancer, Global, Licensing Deals, 2006–2012 64
Figure 33: Market for Prostate Cancer, Global, Co-Development Deals, 2006–2012 68
Figure 34: Market for Prostate Cancer, Global, Co-Development Deals, 2006–2012 68
Figure 35: GBI Research Market Forecasting Model 81