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Prostate Cancer Market to 2021-Increasing Disease Prevalence to be a Key Driver of Market Growth

Prostate Cancer Market to 2021-Increasing Disease Prevalence to be a Key Driver of Market Growth


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Executive Summary

Prostate Cancer Market to 2021-Increasing Disease Prevalence to be a Key Driver of Market Growth

Prostate Cancer (PC) is a disease predominately of the elderly with 60% of cases diagnosed in men aged 65 or over. Prostate cancer is slow growing, and asymptomatic at its earliest stages. However, with the use of digital rectal examination, the PSA test, and the incidental discovery of tumors following resection of the prostate, the majority of PC cases are diagnosed at an early stage (60%). As PC is slow growing, many patients can leave their disease untreated for extended periods of time with frequent monitoring (watchful waiting or active surveillance), with many patients dying from other causes before treatment is indicated. Surgery and/or radiotherapy is often curative when treatment is indicated for localized disease, with androgen deprivation being the standard of first-line care. However, most patients ultimately develop resistant disease, for whom treatment options have historically been limited, with treatment with docetaxel being standard. The recent approval of Zytiga and Xtandi for docetaxel refractory disease in 2011 and 2012 have improved survival of resistant patients, but there is a clear clinical need to diversify the treatment options for this patient cohort.

The current late-stage drugs in development for PC address this clinical need, however, results so far have been mixed, with none demonstrating clinically transformative efficacy of safety. As a result, the growth in PC prevalence as a result of a global aging population is expected to be the key driver of this market throughout the forecast period.

Scope

Global revenues for the PC market are forecast to rise at a moderate CAGR of 9.5% from USD 7.6bn in 2014 to USD 13.6bn in 2021.

-What factors are driving the market growth?

-How can the factors limiting growth be overcome in the future?

The pipeline addresses clinical need in the market; seven of the nine late-stage pipeline products are being developed as therapies for metastatic castration resistant disease.

-What other gaps in the market are being addressed by the current pipeline dynamics?

The variation in molecule type has shifted away from small molecules (predominately hormonal therapies), the dominance of which has decreased from 91% across marketed products to 50% across the pipeline.

-What are the dynamics of the remaining 50% of the pipeline?

-How does this reflect the need for novel targeted therapies?

There has been a significant shift away from hormonal therapies. Key mechanisms of action across the pipeline include cancer immunotherapies against PSMA, whole cell vaccines and targeted therapies against the PI3K/Akt/mTOR pathway.

-What is the scientific rationale behind these targets?

-How successful have drugs against these targets been? How successful are they expected to be in the future?

Several drugs are expected to be approved during the forecast period: ProstAtak, ODM201, ARN-509, and Tookad. However, their sales are expected to be limited by high costs and a lack of comparative trials.

-Where will these novel therapies fit into the current treatment algorithm for PC?

Reasons To Buy

This report will allow you to

Understand the current clinical and commercial landscape by considering disease pathogenesis, diagnosis, prognosis, and the treatment options available at each stage of diagnosis.

Visualize the composition of the PC market in terms of dominant molecule types and targets, highlighting the current unmet needs and how they can be addressed to allow a competitive understanding of gaps in the current market.

Analyze the PC pipeline and stratify by stage of development, molecule type, and molecular target.

Visualize the clinical safety and efficacy of late-stage pipeline drugs via a detailed heat map, outlining the results across major clinical trial endpoints.

Understand the growth in patient epidemiology, annual therapy costs, and market revenues for the AML market globally and across the US, UK, France, Germany, Italy, Spain, Japan, and Canada.

Identify commercial opportunities in the PC deals landscape by analyzing trends in licensing and co-development deals.

1 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 39

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 42

3.4.3 Zometa (zoledronic acid)-Novartis 43

4 Pipeline Product Developments 44

4.1 Developmental Pipeline by Phase and Molecular Target 44

4.2 Mechanisms of Action in the Pipeline 46

5 Clinical Trials 50

5.1 Clinical Trial Failure Rate 50

5.2 Clinical Trial Duration 52

5.2.1 Clinical Trial Size 56

5.3 Promising Pipeline Molecules 61

5.3.1 Localized Disease 61

5.3.2 mCRPC-First Line 67

5.3.3 mCRPC-Second Line 79

6 Market Forecasts 83

6.1 Global 83

6.1.1 Treatment Usage Patterns 83

6.1.2 Market Size 85

6.2 North America 85

6.2.1 US 85

6.2.2 Canada 88

6.3 Top Five European Markets 90

6.3.1 Treatment Usage Patterns 90

6.3.2 Annual Cost of Therapy 92

6.3.3 Market Size 93

6.4 Japan 95

6.4.1 Treatment Usage Patterns 95

6.4.2 Annual Cost of Therapy 95

6.4.3 Market Size 97

7 Drivers and Barriers 98

7.1 Market Drivers 98

7.1.1 Major Unmet Treatment Needs of Late-Stage PC Patients 98

7.1.2 Increasing Incidence of PC Driven by Global Aging of Population 98

7.1.3 Continued Uptake of Zytiga and Xtandi 98

7.1.4 Approval of Numerous Premium Products in PC Market 98

7.1.5 High Number of Pipeline Drugs 99

7.2 Market Barriers 99

7.2.1 Recent and Future Patent Expiries 99

7.2.2 Uptake Limited by Premium Price of Several Novel Therapies 99

8 Strategic Consolidation 101

8.1 Co-development Deals 101

8.1.1 Pfizer Enters into Co-Development Agreement with Merck 104

8.1.2 Immatics Enters into R&D Agreement with Roche for Cancer Vaccine 104

8.1.3 Merck & Co Enters into Agreement with ARIAD Pharma 105

8.1.4 Medivation Enters into Co-Development Agreement with Astellas Pharma 105

8.1.5 Aduro Biotech Enters into Agreement with Novartis for Immuno-Oncology Products 105

8.1.6 Bayer Schering Enters into Co-Development Agreement with Micromet 106

8.1.7 Takeda Pharma Enters into Agreement with Cell Genesys 106

8.2 Licensing Deals 106

8.2.1 Astellas Pharma Enters into Licensing Agreement with AVEO Pharma for Tivozanib 109

8.2.2 Algeta Enters into Licensing Agreement with Bayer for Alpharadin 109

8.2.3 Sanofi-Aventis Enters into Licensing Agreement with Oxford BioMedica 110

8.2.4 Ascenta Therapeutics Enters into Licensing Agreement with Sanofi 110

8.2.5 Aduro Biotech Enters into Exclusive Licensing Agreement with Janssen Biotech 110

9 Appendix 111

9.1 All Pipeline Drugs by Phase 111

9.1.1 Discovery 111

9.1.2 Preclinical 115

9.1.3 IND/CTA-Filed 129

9.1.4 Phase I 130

9.1.5 Phase II 136

9.1.6 Phase III 144

9.2 Market Forecasts to 2021 145

9.2.1 Global 145

9.2.2 US 145

9.2.3 Canada 145

9.2.4 UK 146

9.2.5 France 146

9.2.6 Germany 146

9.2.7 Italy 147

9.2.8 Spain 147

9.2.9 Japan 147

9.3 References 148

9.4 Abbreviations 158

9.5 Research Methodology 160

9.5.1 Secondary Research 160

9.5.2 Marketed Product Profiles 161

9.5.3 Late-Stage Pipeline Candidates 161

9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 161

9.5.5 Product Competitiveness Framework 161

9.5.6 Pipeline Analysis 161

9.5.7 Forecasting Model 162

9.5.8 Deals Data Analysis 163

9.6 Contact Us 164

9.7 Disclaimer 164

1.1 List of Tables

Table 1: Prostate Cancer Therapeutics, Commonly Mutated or Overexpressed Genes 12

Table 2: Prostate Cancer Therapeutics, Disease Stage Classification 15

Table 3: Prostate Cancer Therapeutics, Risk Classification for Localized Cancer, D'Amico System 16

Table 4: Prostate Cancer Therapeutics, Common Definitions of High-Risk Prostate Cancer 16

Table 5: Marketed GnRH Agonists and Their Routes of Administration for Prostate Cancer 21

Table 6: Prostate Cancer Therapeutics, Top Five European Markets, Forecast Growth in Prevalence and Treatment Populations, 2014-2021 90

Table 7: Prostate Cancer Therapeutics, Top Five European Markets, Annual Cost of Therapy (USD ), 2014-2021 92

Table 8: Prostate Cancer Therapeutics, Top Five European Markets, Market Size (USD m), 2014-2021 94

Table 9: Prostate Cancer Therapeutics, Global, Developmental Pipeline, Discovery, 2015 111

Table 10: Prostate Cancer Therapeutics, Global, Developmental Pipeline, Preclinical, 2015 115

Table 11: Prostate Cancer Therapeutics, Global, Developmental Pipeline, IND/CTA-Filed, 2015 129

Table 12: Prostate Cancer Therapeutics, Global, Developmental Pipeline, Phase I, 2015 130

Table 13: Prostate Cancer Therapeutics, Global, Developmental Pipeline, Phase II, 2015 136

Table 14: Prostate Cancer Therapeutics, Global, Developmental Pipeline, Phase III, 2015 144

Table 15: Prostate Cancer Market, Global, Market Forecasts, 2014-2021 145

Table 16: Prostate Cancer Market, US, Market Forecasts, 2014-2021 145

Table 17: Prostate Cancer Market, Canada, Market Forecasts, 2014-2021 145

Table 18: Prostate Cancer Market, The UK, Market Forecasts, 2014-2021 146

Table 19: Prostate Cancer Market, France, Market Forecasts, 2014-2021 146

Table 20: Prostate Cancer Market, Germany, Market Forecasts, 2014-2021 146

Table 21: Prostate Cancer Market, Italy, Market Forecasts, 2014-2021 147

Table 22: Prostate Cancer Market, Spain, Market Forecasts, 2014-2021 147

Table 23: Prostate Cancer Market, Japan, Market Forecasts, 2014-2021 147

1.2 List of Figures

Figure 1: Prostate Cancer Therapeutics, Treatment, Stages I and II 18

Figure 2: Prostate Cancer Therapeutics, Treatment, Stage III 19

Figure 3: Prostate Cancer Therapeutics, Treatment, Stage IV 27

Figure 4: Prostate Cancer Therapeutics, Efficacy Results for Key Parameters-Marketed Products, Hormone Sensitive Disease 28

Figure 5: Prostate Cancer Therapeutics, Safety Results for Key Parameters-Marketed Products, Hormone Sensitive Disease 29

Figure 6: Prostate Cancer Therapeutics, Efficacy Results for Key Parameters-Marketed Products, First-line Treatment mCRPC 30

Figure 7: Prostate Cancer Therapeutics, Safety Results for Key Parameters-Marketed Products, First-line Treatment mCRPC 31

Figure 8: Prostate Cancer Therapeutics, Efficacy Results for Key Parameters-Marketed Products, Second-line Treatment mCRPC 32

Figure 9: Prostate Cancer Therapeutics, Safety Results for Key Parameters-Marketed Products, Second-line Treatment mCRPC 33

Figure 10: Prostate Cancer Therapeutics, Global, Overview of Pipeline Products 45

Figure 11: Prostate Cancer Therapeutics, Global, Mechanisms of Action 48

Figure 12: Prostate Cancer Therapeutics, Global, Mechanisms of Action 49

Figure 13: Prostate Cancer Therapeutics, Global, Clinical Trial Failure Rate (%), 2006-2015 50

Figure 14: Market Prostate Cancer Therapeutics, Global, Clinical Trial Failure Rate by Molecule Type (%), 2006-2015 51

Figure 15: Prostate Cancer Therapeutics, Global, Clinical Trial Failure Rate by Mechanism of Action (%), 2006-2015 52

Figure 16: Prostate Cancer Therapeutics, Global, Clinical Trial Duration by Molecule Type (months), 2006-2015 53

Figure 17: Prostate Cancer Therapeutics, Global, Clinical Trial Duration by Mechanism of Action (months), 2006-2015 55

Figure 18: Prostate Cancer Therapeutics Market, Global, Clinical Trial Size per Product by Molecule Type (participants), 2006-2015 57

Figure 19: Prostate Cancer Therapeutics, Global, Clinical Trial Size per Product by Mechanism of Action (participants), 2006-2015 58

Figure 20: Prostate Cancer Therapeutics, Global, Clinical Trial Size per Individual Trial by Molecule Type (participants), 2006-2015 59

Figure 21: Prostate Cancer Therapeutics, Global, Clinical Trial Size of Products by Mechanism of Action (participants), 2006-2015 60

Figure 22: Prostate Cancer Therapeutics, Global, Tookad Revenue Forecast (USD m), 2018-2021 63

Figure 23: Prostate Cancer Therapeutics, Global, ProstAtak Revenue Forecast (USD m), 2019-2021 65

Figure 24: Prostate Cancer Therapeutics, Efficacy Results for Key Parameters-Pipeline Products, Localized Disease 66

Figure 25: Prostate Cancer Therapeutics, Safety Results for Key Parameters-Pipeline Products, Localized Disease 67

Figure 26: Prostate Cancer Therapeutics, Global, ODM-201 Forecast Revenue (USD m), 2018-2021 69

Figure 27: Prostate Cancer Therapeutics, Global, Prostvac Revenue Forecast (USD m), 2017-2021 71

Figure 28: Prostate Cancer Therapeutics, Global, ARN-509 Revenue Forecast (USD m), 2020-2021 73

Figure 29: Prostate Cancer Therapeutics, Global, Custirsen Sodium Revenue Forecast (USD m), 2017-2021 76

Figure 30: Prostate Cancer Therapeutics, Efficacy Results for Key Parameters-Marketed (Highlighted in Blue) and Pipeline Products, mCRPC-First Line 77

Figure 31: Prostate Cancer Therapeutics, Safety Results for Key Parameters-Marketed (Highlighted in Blue) and Pipeline Products, mCRPC-First Line 78

Figure 32: Prostate Cancer Therapeutics, Global, DCVAC Revenue Forecast (USD m), 2019-2021 80

Figure 33: Prostate Cancer Therapeutics, Efficacy Results for Key Parameters-Marketed (Highlighted in Blue) and Pipeline Products, mCRPC-Second Line 82

Figure 34: Prostate Cancer Therapeutics, Global, Treatment Usage Patterns ('000), 2014-2021 84

Figure 35: Prostate Cancer Therapeutics, Global, Market Size (USD bn), 2014-2021 85

Figure 36: Prostate Cancer Therapeutics, US, Treatment Usage Patterns ('000) and Annual Cost of Therapy (USD ), 2014-2021 86

Figure 37: Prostate Cancer Therapeutics, US, Market Revenue (USD m), 2014-2021 87

Figure 38: Prostate Cancer Therapeutics, Canada, Treatment Usage Patterns and ACoT ('000; USD ), 2014-2021 89

Figure 39: Prostate Cancer Therapeutics, Canada, Market Revenue (USD m), 2014-2021 90

Figure 40: Prostate Cancer Therapeutics, Top Five European Markets, Treatment Usage Patterns ('000), 2014-2021 91

Figure 41: Prostate Cancer Therapeutics, Top Five European Markets, Annual Cost of Therapy (USD ), 2014-2021 93

Figure 42: Prostate Cancer Therapeutics, Top Five European Markets, Market Revenue (USD m), 2014-2021 94

Figure 43: Prostate Cancer Therapeutics, Japan, Treatment Usage Patterns and Annual Cost of Therapy ('000; USD ), 2014-2021 96

Figure 44: Prostate Cancer Therapeutics, Japan, Market Revenue (USD m), 2014-2021 97

Figure 45: Prostate Cancer Therapeutics, Global, Co-Development Deals by Region, Value and Year, 2006-2014 102

Figure 46: Prostate Cancer Therapeutics, Global, Co-Development Deals by Molecule Type, 2006-2014 103

Figure 47: Prostate Cancer Therapeutics, Global, Co-Development Deals by Molecule Type, 2006-2014 104

Figure 48: Prostate Cancer Therapeutics, Global, Licensing Deals by Value and Year, 2006-2014 107

Figure 49: Prostate Cancer Therapeutics, Global, Licensing Deals by Phase and Molecule Type, 2006-2014 108

Figure 50: Prostate Cancer Therapeutics, Global, Licensing Deals by Mechanism of Action, 2006-2014 109

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