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