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

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.

Companies mentioned

AB Science

AbbVie

Advantagene

Amgen

Aptevo Therapeutics

Asana BioSciences

Astellas

AstraZeneca

Bayer

Bristol Myers Squibb

Clovis Oncology

Dendreon

Eli Lilly

Endocyte

ESSA Pharma

Ferring Pharmaceuticals

FUJIFILM Corporation

GlaxoSmithKline

Innocrin

Inovio Pharmaceuticals

Ipsen

J&J

MedImmune

Merck & Co.

Myovant Sciences

Novartis

Pfizer

Roche

Sanofi

Sotio

Takeda

Tolmar

Tracon Pharmaceuticals

Table of Contents

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Prostate Cancer: Executive Summary

2.1 Value of Prostate Cancer Market to Increase Two-Fold By 2026

2.2 Xtandi to Become the Undisputed Leader in the Global Prostate Cancer Market

2.3 Prostate Cancer Treatment Landscape to Undergo Dramatic Change

2.4 Prostate Cancer Pipeline Moving Towards Precision Medicine

2.5 Unmet Need Will Remain for the Identification of New Targets and Biomarkers of Response

2.6 What Do the Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Etiology

4.1.2 Pathophysiology

4.1.3 Biomarkers

4.2 Classification or Staging Systems

4.3 Symptoms

4.4 Prognosis

4.5 Quality of Life

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.3.1 US

5.3.2 5EU

5.3.3 Japan

5.4 Forecast Methodology

5.4.1 Sources Used

5.4.2 Forecast Assumptions and Methods

5.5 Epidemiological Forecast for Prostate Cancer (2016–2026)

5.5.1 Diagnosed Incident Cases of Prostate Cancer

5.5.2 Age-Specific Incident Cases of Prostate Cancer

5.5.3 Incident Cases by Stage at Diagnosis

5.5.4 Incident Cases by Risk of Biochemical Recurrence

5.5.5 10-Year Diagnosed Prevalent Cases of Prostate Cancer

5.5.6 10-Year Prevalent CRPC Cases

5.5.7 10-Year Prevalent Metastatic Prostate Cancer Cases

5.5.8 10-Year Prevalent mCRPC Cases with HRD Mutations

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of Analysis

5.6.3 Strengths of Analysis

6 Disease Management

6.1 Diagnosis Overview

6.2 Treatment Overview

6.2.1 Treatment Guidelines and Leading Prescribed Drugs

6.2.2 Clinical Practice

6.3 US

6.3.1 Diagnosis

6.3.2 Clinical Practice

6.4 France

6.4.1 Diagnosis

6.4.2 Clinical Practice

6.5 Germany

6.5.1 Diagnosis

6.5.2 Clinical Practice

6.6 Italy

6.6.1 Diagnosis

6.6.2 Clinical Practice

6.7 Spain

6.7.1 Diagnosis

6.7.2 Clinical Practice

6.8 UK

6.8.1 Screening and Diagnosis

6.8.2 Clinical Practice

6.9 Japan

6.9.1 Diagnosis

6.9.2 Clinical Practice

7 Competitive Assessment

7.1 Overview

7.2 Second-Generation Hormonal Therapies

7.2.1 Zytiga (Abiraterone Acetate)

7.2.2 Xtandi (Enzalutamide)

7.3 Targeted Therapies

7.3.1 Xofigo (Radium 223 Dichloride)

7.4 Chemotherapies

7.4.1 Jevtana (Cabazitaxel)

7.5 Therapeutic Vaccines

7.5.1 Provenge (Sipuleucel-T)

7.6 First-Generation Hormonal Therapies

7.6.1 Zoladex (Goserelin Acetate)

7.6.2 Lupron Depot (Leuprolide Acetate)

7.6.3 Eligard (Leuprolide Acetate)

7.6.4 Trelstar (Triptorelin Pamoate)

7.6.5 Vantas (Histrelin Acetate)

7.6.6 Firmagon (Degarelix)

7.6.7 Casodex (Bicalutamide)

7.7 Bone Therapies

7.7.1 Zometa (Zoledronic Acid)

7.7.2 Xgeva (Denosumab)

8 Unmet Needs and Opportunity Assessment

8.1 Overview

8.2 Therapies That Provide a Durable Overall Survival Benefit for mCRPC Patients

8.2.1 Unmet Need

8.2.2 Gap Analysis

8.2.3 Opportunity

8.3 Therapeutic Options for Non-Metastatic CRPC

8.3.1 Unmet Need

8.3.2 Gap Analysis

8.3.3 Opportunity

8.4 Identification of Biomarkers to Predict Zytiga and Xtandi Resistance and Agents Able to Overcome Resistance to Available Therapies

8.4.1 Unmet Need

8.4.2 Gap Analysis

8.4.3 Opportunity

8.5 Identification of New Targets and Positive Predictive Biomarkers of Response

8.5.1 Unmet Need

8.5.2 Gap Analysis

8.5.3 Opportunity

9 Pipeline Assessment

9.1 Overview

9.2 Promising Drugs in Clinical Development

9.3 Immunotherapies

9.3.1 ProstAtak (Aglatimagene Besadenovec)

9.3.2 Stapuldencel-t (DCVAC/PCa)

9.3.3 ITK-1

9.3.4 Tecentriq (Atezolizumab)

9.4 Second-Generation Hormonal Therapies

9.4.1 Apalutamide (ARN-509)

9.4.2 Darolutamide (ODM-201)

9.5 Targeted Therapies

9.5.1 Masitinib (AB1010)

9.5.2 Lynparza (Olaparib)

9.5.3 Rubraca (Rucaparib Camsylate)

9.5.4 Ipatasertib (GDC-0068)

9.6 First-Generation Hormonal Therapies

9.6.1 Relugolix (TAK-385)

9.7 Promising Drugs in Early-Stage Development

9.7.1 Targeting the P13K/AKT/mTOR Pathway

9.7.2 Immunotherapies

9.7.3 Prostate-Specific Membrane Antigen-Targeted Therapies

9.7.4 Hormonal Therapies

9.8 Other Drugs in Development

10 Current and Future Players

10.1 Overview

10.2 Trends in Corporate Strategy

10.3 Company Profiles

10.3.1 Astellas

10.3.2 AstraZeneca

10.3.3 Bayer

10.3.4 Clovis Oncology

10.3.5 Johnson & Johnson

10.3.6 Pfizer

10.3.7 Roche

10.3.8 Sanofi

11 Market Outlook

11.1 Global Markets

11.1.1 Forecast

11.1.2 Drivers and Barriers – Global Issues

11.2 US

11.2.1 Forecast

11.2.2 Key Events

11.2.3 Drivers and Barriers

11.3 5EU

11.3.1 Forecast

11.3.2 Key Events

11.3.3 Drivers and Barriers

11.4 Japan

11.4.1 Forecast

11.4.2 Key Events

11.4.3 Drivers and Barriers

12 Appendix

12.1 Bibliography

12.2 Abbreviations

12.3 Methodology

12.3.1 Forecasting Methodology

12.3.2 Diagnosed Prostate Cancer Patients

12.3.3 Percent Drug-Treated Patients

12.3.4 Drugs Included in Each Therapeutic Class

12.3.5 Launch and Patent Expiry Dates

12.3.6 General Pricing Assumptions

12.3.7 Individual Drug Assumptions

12.3.8 Generic Erosion

12.4 Primary Research – KOLs Interviewed for This Report

12.5 Primary Research – Prescriber Survey

12.6 About the Authors

12.6.1 Analyst

12.6.2 Therapy Area Director

12.6.3 Epidemiologist

12.6.4 Epidemiology Reviewers

12.6.5 Global Director of Therapy Analysis and Epidemiology

12.6.6 Global Head and EVP of Healthcare Operations and Strategy

12.7 About GlobalData

12.8 Contact Us

12.9 Disclaimer

List of Tables

Table 1: Prostate Cancer: Key Metrics in Seven Major Pharmaceutical Markets

Table 2: Stage Definitions for PCa

Table 3: NCCN Risk-Category Classification System for PCa

Table 4: Risk Factors and Comorbidities for Prostate Cancer

Table 5: AJCC Staging of Prostate Cancer

Table 6: Risk Category Definitions

Table 7: 7MM, Diagnosed Incident Cases of Prostate Cancer, Men, Ages ≥35 Years, Select Years, 2016–2026

Table 8: 7MM, 10-Year Diagnosed Prevalent Cases of Prostate Cancer, Men, Ages ≥35 Years, Select Years, 2016–2026

Table 9: Treatment Guidelines for Prostate Cancer

Table 10: Most-Prescribed Drugs for Prostate Cancer by Drug Class in the Global Markets in 2016

Table 11: Country Profile – US

Table 12: Country Profile – France

Table 13: Country Profile – Germany

Table 14: Country Profile – Italy

Table 15: Country Profile – Spain

Table 16: Country Profile – UK

Table 17: Country Profile – Japan

Table 18: Leading Branded Treatment for PCa, 2017

Table 19: Product Profile – Zytiga

Table 20: Efficacy of Zytiga in Chemotherapy-Naïve mCRPC

Table 21: Efficacy of Zytiga in Chemotherapy-Resistant mCRPC

Table 22: Results of the LATITUDE Trial of Zytiga

Table 23: Zytiga SWOT Analysis, 2017

Table 24: Product Profile – Xtandi

Table 25: Efficacy of Xtandi in Chemotherapy-Naïve mCRPC

Table 26: Efficacy of Xtandi in Chemotherapy-Resistant mCRPC

Table 27: Xtandi SWOT Analysis, 2017

Table 28: Product Profile – Xofigo

Table 29: Efficacy of Xofigo in mCRPC

Table 30: Xofigo SWOT Analysis, 2017

Table 31: Product Profile – Jevtana

Table 32: Efficacy of Jevtana as Second-Line Treatment Post-Docetaxel Failure in mCRPC

Table 33: Jevtana SWOT Analysis, 2017

Table 34: Product Profile – Provenge

Table 35: Efficacy of Provenge in mCRPC

Table 36: Provenge SWOT Analysis, 2017

Table 37: Product Profile – Zoladex

Table 38: Efficacy of Zoladex in mCRPC

Table 39: Efficacy of Zoladex as Neoadjuvant/Adjuvant Treatment

Table 40: Zoladex SWOT Analysis, 2017

Table 41: Product Profile – Lupron Depot

Table 42: Lupron Depot SWOT Analysis, 2017

Table 43: Product Profile – Eligard

Table 44: Efficacy of Eligard in Advanced PCa

Table 45: Eligard SWOT Analysis, 2017

Table 46: Product Profile – Trelstar

Table 47: Efficacy of Trelstar in Advanced PCa

Table 48: Trelstar SWOT Analysis, 2017

Table 49: Product Profile – Vantas

Table 50: Vantas SWOT Analysis, 2017

Table 51: Product Profile – Firmagon

Table 52: Efficacy of Firmagon in Advanced PCa

Table 53: Firmagon SWOT Analysis, 2017

Table 54: Product Profile – Casodex

Table 55: Casodex SWOT Analysis, 2017

Table 56: Product Profile – Zometa

Table 57: Efficacy of Zometa in Advanced PCa

Table 58: Zometa SWOT Analysis, 2017

Table 59: Product Profile – Xgeva

Table 60: Efficacy of Xgeva in Advanced mCRPC

Table 61: Xgeva SWOT Analysis, 2017

Table 62: Product Profile – ProstAtak

Table 63: Efficacy of ProstAtak as Adjuvant Treatment in Combination with Radiotherapy in Localized PCa

Table 64: ProstAtak SWOT Analysis, 2017

Table 65: Product Profile – Stapuldencel-t

Table 66: Efficacy of Stapuldencel-t in mCRPC

Table 67: Results from the Randomized Phase II Study of Stapuldencel-t in mCRPC

Table 68: Stapuldencel-t SWOT Analysis, 2017

Table 69: Product Profile – ITK-1

Table 70: Efficacy Results from the Phase II Study of ITK-1 in mCRPC

Table 71: ITK-1 SWOT Analysis, 2017

Table 72: Product Profile – Tecentriq

Table 73: Tecentriq SWOT Analysis, 2017

Table 74: Product Profile – Apalutamide

Table 75: Efficacy of Apalutamide in nmCRPC

Table 76: Efficacy of Apalutamide in mCRPC

Table 77: Apalutamide SWOT Analysis, 2017

Table 78: Product Profile – Darolutamide

Table 79: Efficacy of Darolutamide in nmCRPC

Table 80: Darolutamide SWOT Analysis, 2017

Table 81: Product Profile – Masitinib

Table 82: Masitinib SWOT Analysis, 2017

Table 83: Product Profile – Lynparza

Table 84: Efficacy of Lynparza in mCRPC

Table 85: Lynparza SWOT Analysis, 2017

Table 86: Product Profile – Rubraca

Table 87: Rubraca SWOT Analysis, 2017

Table 88: Product Profile – Ipatasertib

Table 89: Efficacy of Ipatasertib in mCRPC

Table 90: Efficacy of Ipatasertib in mCRPC According to PTEN Status

Table 91: Ipatasertib SWOT Analysis, 2017

Table 92: Product Profile – Relugolix

Table 93: Efficacy of Relugolix in HNPC

Table 94: Relugolix SWOT Analysis, 2017

Table 95: Early-Stage Agents Targeting the P13K/AKT/mTOR Pathway

Table 96: Immune Checkpoint Inhibitors in Early-Stage Development for mCRPC

Table 97: PSMA-Targeted Therapeutics in Early-Stage Development for mCRPC

Table 98: Hormonal Therapies in Early-Stage Development for mCRPC

Table 99: Drugs in Development for PCa, 2017, Part 1

Table 100: Drugs in Development for PCa, 2017, Part 2

Table 101: Drugs in Development for PCa, 2017, Part 3

Table 102: Key Companies in the PCa Market in the 7MM, 2016–2026

Table 103: Astellas’ PCa Portfolio Assessment, 2017

Table 104: AstraZeneca’s PCa Portfolio Assessment, 2017

Table 105: Bayer’s PCa Portfolio Assessment, 2017

Table 106: Clovis Oncology’s PCa Portfolio Assessment, 2017

Table 107: J&J’s PCa Portfolio Assessment, 2017

Table 108: Pfizer’s PCa Portfolio Assessment, 2017

Table 109: Roche’s PCa Portfolio Assessment, 2017

Table 110: Sanofi’s PCa Portfolio Assessment, 2017

Table 111: Prostate Cancer Market – Global Drivers and Barriers, 2016–2026

Table 112: Key Events Impacting Sales for Prostate Cancer in the US, 2016–2026

Table 113: Prostate Cancer Market – Global Drivers and Barriers in the US, 2016–2026

Table 114: Key Events Impacting Sales for Prostate Cancer in the 5EU, 2016–2026

Table 115: Prostate Cancer Market – Global Drivers and Barriers in the 5EU, 2016–2026

Table 116: Prostate Cancer Market in the 5EU – Country-Specific Barriers in the 5EU, 2016–2026

Table 117: Key Events Impacting Sales for Prostate Cancer in Japan, 2016–2026

Table 118: Prostate Cancer Market – Global Drivers and Barriers in Japan, 2016–2026

Table 119: Key Historical and Projected Launch Dates for Prostate Cancer

Table 120: Key Historical and Projected Patent Expiry Dates for Prostate Cancer

Table 121: Average Body Weight Across the 7MM

Table 122: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Global Sales Forecast by Country for Prostate Cancer in 2016 and 2026

Figure 2: Analysis of the Company Portfolio Gap in Prostate Cancer During the Forecast Period, 2016–2026

Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents in Prostate Cancer, 2016–2026

Figure 4: 7MM, Age-Standardized Diagnosed Incidence of Prostate Cancer, Men, Ages ≥35 Years, 2006–2026

Figure 5: Sources Used and Not Used for Calculations of Incident Cases

Figure 6: Sources Used and Not Used for Calculations of 10-Year Diagnosed Prevalent Cases

Figure 7: Sources Used and Not Used for Calculations of Diagnosed Incident Cases by Stage at Diagnosis and Metastases

Figure 8: Sources Used and Not Used for Calculations of 10-Year Diagnosed Prevalent Cases of CRPC

Figure 9: Sources Used and Not Used for Calculations of 10-Year Diagnosed Prevalent Cases with HRD Mutations

Figure 10: 7MM, Age-Specific Diagnosed Incident Cases of Prostate Cancer, Men, Ages ≥35 Years, 2016

Figure 11: 7MM, Diagnosed Incident Cases of Prostate Cancer by Stage at Diagnosis, Men, Ages ≥35 Years, 2016

Figure 12: 7MM, Diagnosed Incident Cases of Prostate Cancer by Risk of Biochemical Recurrence, Men, Ages ≥35 Years, 2016

Figure 13: 7MM, 10-Year Prevalent Cases of CRPC, Men, Ages ≥35 Years, 2016

Figure 14: 7MM, 10-Year Prevalent Cases of Prostate Cancer by Metastases, Men, Ages ≥35 Years, 2016

Figure 15: 7MM, 10-Year Prevalent Cases of Prostate Cancer with HRD Mutations, Men, Ages ≥35 Years, 2016

Figure 16: Treatment Algorithm for Localized Prostate Cancer

Figure 17: Treatment Algorithm for Progressive and Advanced Prostate Cancer

Figure 18: Zytiga’s Clinical Development in PCa

Figure 19: Xtandi’s Clinical Development in PCa

Figure 20: Xofigo’s Clinical Development in PCa

Figure 21: Provenge’s Clinical Development in PCa

Figure 22: Firmagon’s Clinical Development in PCa

Figure 23: Overview of the Unmet Need and Opportunity in Prostate Cancer, 2017

Figure 24: Overview of the Development Pipeline in PCa

Figure 25: Pivotal Phase II/III Trials for the Promising Pipeline Agents, Part 1

Figure 26: Pivotal Phase II/III Trials for the Promising Pipeline Agents, Part 2

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

Figure 28: ProstAtak Clinical Development in PCa

Figure 29: Clinical and Commercial Positioning of ProstAtak

Figure 30: Stapuldencel-t Clinical Development in PCa

Figure 31: Clinical and Commercial Positioning of Stapuldencel-t

Figure 32: ITK-1 Clinical Development in PCa

Figure 33: Clinical and Commercial Positioning of ITK-1

Figure 34: Tecentriq Clinical Development in PCa

Figure 35: Clinical and Commercial Positioning of Tecentriq

Figure 36: Apalutamide Clinical Development in PCa

Figure 37: Clinical and Commercial Positioning of Apalutamide

Figure 38: Darolutamide Clinical Development in PCa

Figure 39: Clinical and Commercial Positioning of Darolutamide

Figure 40: Masitinib Clinical Development in PCa

Figure 41: Clinical and Commercial Positioning of Masitinib

Figure 42: Lynparza Clinical Development in PCa

Figure 43: Clinical and Commercial Positioning of Lynparza

Figure 44: Rubraca Clinical Development in PCa

Figure 45: Clinical and Commercial Positioning of Rubraca

Figure 46: Ipatasertib Clinical Development in PCa

Figure 47: Clinical and Commercial Positioning of Ipatasertib

Figure 48: Relugolix Clinical Development in PCa

Figure 49: Clinical and Commercial Positioning of Relugolix

Figure 50: Global Sales of Branded Products for PCa by Company in 2016–2026

Figure 51: Analysis of the Company Portfolio Gap in PCa During the Forecast Period

Figure 52: Global (7MM) Sales Forecast by Country for Prostate Cancer in 2016 and 2026

Figure 53: Global (7MM) Sales Forecast by Drug Class for Prostate Cancer in 2016 and 2026

Figure 54: Sales Forecast by Class for Prostate Cancer in the US in 2016 and 2026

Figure 55: Sales Forecast by Class for Prostate Cancer in the 5EU in 2016 and 2026

Figure 56: Sales Forecast by Class for Prostate Cancer in Japan in 2016 and 2026

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