去勢抵抗性前立腺がん(CRPC)治療薬の世界市場:インサイト・疫学・市場予測

◆英語タイトル:Castrate-resistant Prostate Cancer (CRPC) - Market Insights, Epidemiology and Market Forecast - 2030
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◆発行日:2020年6月
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【レポートの概要】

DelveInsight’s ‘Castrate-resistant Prostate Cancer (CRPC) -Market Insights, Epidemiology and Market Forecast – 2030’ report delivers an in-depth understanding of the CRPC, historical and forecasted epidemiology as well as the CRPC market trends in the United States, EU5 (Germany, France, Italy, Spain, and United Kingdom), and Japan.

The CRPC market report provides current treatment practices, emerging drugs, CRPC market share of the individual therapies, current and forecasted CRPC market size from 2017 to 2030 segmented by seven major markets. The Report also covers current CRPC treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses underlying potential of the market.

Geography Covered
• The United States

• EU5 (Germany, France, Italy, Spain and the United Kingdom)

• Japan

Study Period: 2017–2030

CRPC: Disease Understanding and Treatment Algorithm
CRPC Overview

Prostate cancer is a type of malignancy that occurs in the prostate gland. It is one of the most common types of cancer found in men. This cancer usually grows slowly and is confined to the prostate gland initially, where it may not cause serious harm.

According to the Cancer Treatment Centres of America (CTCA), more than 99% of prostate cancers are adenocarcinomas, which develop in the gland cells. The exact cause of prostate cancer is unknown. However, several things can increase the risk of developing this condition like age, family history, diet, high testosterone level, genome changes, and race.

In the majority of the cases, the symptoms of prostate cancer are not apparent in the early stages of the disease. The symptoms of prostate cancer may be different for each man, and other conditions may cause some of these symptoms like blood in semen, erectile dysfunction, painful ejaculation, pain in pelvic area, and numbness in legs.

CRPC Diagnosis

Patients undergo regular prostate cancer screening before symptoms appear. Screening may involve one or more of the following tests: prostate-specific antigen (PSA), digital rectal exam (DRE), prostate ultrasound, prostate MRI,prostate Mp-MRI.

CRPC Treatment

Treatment strategies of prostate cancers depend on the stage and progression of cancer. For localized or locally advanced prostate cancer active surveillance, surgery, and radiation therapy is the three major treatment options.

Besides, this other treatment options for prostate cancers include chemotherapy, hormone therapy, and immunotherapy. Hormonal therapy has been a mainstay in the treatment of advanced prostate cancer. However, many prostate cancers ultimately fail to respond to androgen deprivation therapy (ADT) and are termed castrate-resistant prostate cancer (CRPC). If a patient stops responding to hormone treatment, then he is referred to as non-metastatic CRPC (nmCRPC; only found in the prostate gland). For nmCRPC, three agents are approved for the treatment of non-metastatic CRPC, including Erleada (apalutamide; Janssen Biotech), Xtandi (enzalutamide), and Nubeqa (darolutamide). Metastatic CRPC is a stage of cancer, which has spread to other parts of the body, such as lymph nodes or bones and no longer responds to treatment that lowers testosterone. Several drugs such as Provenge, Jevtana, Zytiga, and Xtandi are available for the treatment of mCRPC.

CRPC Epidemiology
The CRPC epidemiology division provides the insights about historical and current CRPC patient pool and forecasted trend for each seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

Key Findings

The total cases of CRPC in the 7MM were found to be 265,891 in 2017 which is expected to grow during the study period, i.e., 2017–2030.

The disease epidemiology covered in the report provides historical as well as forecasted CRPC epidemiology [segmented as Total Prevalent Cases of Prostate Cancer, Total Diagnosed Cases of Prostate Cancer, Age-specific Cases of Prostate Cancer, Total Diagnosed Cases of Prostate Cancer by Clinical Stages, Total Non-metastatic and Metastatic Cases of CRPC, and Total Treated Cases of Non-metastatic and Metastatic CRPC] scenario of CRPC in the 7MM covering United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom), and Japan from 2017 to 2030.

Country Wise- CRPC Epidemiology

Estimates show that the highest cases of CRPC are in the United States, followed by Germany, France, Japan, and Italy in 2017.

CRPC Drug Chapters
Drug chapter segment of the CRPC report encloses the detailed analysis of CRPC marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the CRPC clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

CRPC Marketed Drugs

Erleada (apalutamide): Janssen Pharmaceuticals

Erleada (apalutamide) is a next-generation oral androgen receptor (AR) inhibitor that blocks the androgen signaling pathway in prostate cancer cells. It is indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). It is taken orally, once daily, with or without food. Erleada inhibits the growth of cancer cells in three ways: by preventing the binding of androgen to the AR; by stopping the AR from entering the cancer cells; and by preventing the AR from binding to the DNA of the cancer cell.

In February 2018, Erleada received approval from the United States Food and Drug Administration (US FDA) for the treatment of patients with nmCRPC.

In January 2019, the European Commission (EC) has granted marketing authorization for Erleada next generation oral androgen receptor inhibitor for the treatment of adult patients with nmCRPC who are at high risk of developing metastatic disease.

In March 2019, Janssen obtained the Ministry of Health, Labour and Welfare (MHLW) approval of Erleada (apalutamide) 60mg tablet for the treatment for adults with castration-resistant prostate cancer without distant metastases.

In August 2013, Johnson & Johnson completed acquisition of Aragon Pharmaceuticals, Inc., a privately-held pharmaceutical company focused on drugs to treat hormonally-driven cancers.

Xtandi (Enzalutamide): Astellas Pharma/Pfizer

It is an orally bioavailable, organic, non-steroidal small molecule targeting the androgen receptor with potential antineoplastic activity. Enzalutamide inhibits the activity of prostate cancer cell ARs, which may result in a reduction in prostate cancer cell proliferation and, correspondingly, a reduction in the serum prostate specific antigen (PSA) level. AR over-expression in prostate cancer represents a key mechanism associated with prostate cancer hormone resistance.

In September 2014, the US FDA approved a new indication for the use of Xtandi capsules to treat patients with metastatic CRPC. The FDA initially approved Xtandi, an oral, once daily androgen receptor inhibitor, in August 2012 for use in patients with metastatic CRPC who previously received docetaxel (chemotherapy). In October 2009, Medivation, which is now part of Pfizer and Astellas entered into a global agreement to jointly develop and commercialize enzalutamide.

Nubeqa (Darolutamide/ODM-201): Bayer HealthCare/Orion Corporation

Nubeqa is an androgen receptor inhibitor with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription. Nubeqa is approved for the treatment of patients with nmCRPC. Nubeqa is supplied as film-coated tablets containing 300 mg of darolutamide for oral use. In July 2019, the US FDA approved darolutamide, for nmCRPC. Approval was based on ARAMIS (NCT02200614), a multicenter, double-blind, placebo-controlled clinical trial in 1,509 patients with nmCRPC. Nubeqa is also approved in European Union as well as in Japan.

Jevtana (Cabazitaxel): Sanofi

Jevtana (cabazitaxel) injection is an antineoplastic agent belonging to the taxane class that is for intravenous use. It is prepared by semi-synthesis with a precursor extracted from yew needles. It is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. This product is marketed in US, Europe, Japan as well as, over 75 countries. Jevtana had also received the fast-track designation by the US FDA for metastatic prostate cancer.

Products detail in the report…

CRPC Emerging Drugs

Lynparza (Olaparib): AstraZeneca/ Merck Sharp & Dohme

Lynparza (olaparib) is ¬first and best-in-class oral poly ADP-ribose polymerase (PARP) inhibitor, and the -first targeted treatment to block DDR in tumoursharbouring a de¬ficiency in homologous recombination repair (HRR), such as mutations in BRCA1 and/or BRCA2. Astrazeneca have global strategic oncology collaboration with Merck to co-develop and co-commercialize Lynparza.

Recently in January 2020, the US FDA accepted the supplemental New Drug Application for Lynparza (olaparib) and granted Priority Review in the US for patients with mCRPC and deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutations, which have progressed following prior treatment with a new hormonal agent. A Prescription Drug User Fee Act (PDUFA) date is set for the second quarter of 2020. The priority review is based on the results from the Phase III PROfound trial, which were presented during the Presidential Symposium at the 2019 European Society of Medical Oncology congress.

Currently, it is also in phase III trial in combination with abiraterone for the treatment of patients with first-line therapy in men with mCRPC. It was also evident by AstraZeneca pipeline that the filing of Lynparza was also accepted in Europe and Japan for patients with mCRPC and deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutations, which have progressed following prior treatment with a new hormonal agent.

Rubraca (Rucaparib): Clovis Oncology

Clovis Oncology is investigating one of their lead candidates named Rubraca (Rucaparib) for various cancer indications. It is an oral, small-molecule inhibitor of PARP1, PARP2 and PARP3 being developed in Prostate Cancer, and Ovarian Cancer as well as several additional solid tumor indications.

The US Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for Rubraca and granted priority review status to the application with a Prescription Drug User Fee Act (PDUFA) date of May 15, 2020. Clovis submitted the NDA submission for Rucaparib as monotherapy treatment of adult patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer in November 2019.

Niraparib: Janssen Research & Development

Niraparib is an orally available, highly selective poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, with potent activity against PARP-1 and PARP-2 deoxyribonucleic acid (DNA)-repair polymerases. Niraparib is currently investigated by Janssen Research & Development. However, Niraparib is currently marketed as ZEJULA by TESARO (an oncology-focused business within GSK), devoted to providing transformative therapies to people facing cancer. At present, Niraparib is being evaluated in MAGNITUDE, GALAHAD, and QUEST study.

Opdivo (nivolumab): Bristol-Myers Squibb

Opdivo (Nivolumab) by Bristol-Myers Squibb is a human immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor PD-1, with immune checkpoint inhibitory and antineoplastic activities. BMS is working on assessing the clinical activity seen with Opdivo in combination with docetaxel in male patients with metastatic castration-resistant prostate cancer. This drug is currently in phase III trial in combination with docetaxel for patients with metastatic castration resistant prostate cancer who have progressed after second-generation hormonal manipulation. Apart from this it is also in phase II trial in combination with Yervoy for patients with metastatic castration-resistant prostate cancer who have progressed after prior Docetaxel-containing regimen.

Products detail in the report…

CRPC Market Outlook
Key Findings

The CRPC market size in the 7MM is expected to change during the study period 2017–2030.The therapeutic market of CRPC in seven major markets was USD 6,160 million in 2017 which is expected to increase during study period (2017–2030).

The United States Market Outlook

In 2017, the total market size of CRPC therapies was USD 3,653 million in the United States which is expected to increase in the study period (2017–2030).

EU-5 Countries: Market Outlook

In 2017, the total market size of CRPC therapies was USD 1,911 million in the EU-5 countries which is expected to increase in the study period (2017–2030).

Japan Market Outlook

The total market size of CRPC therapies in Japan was USD 596 million in 2017.

CRPC Pipeline Development Activities
The drugs which are in pipeline include:

1. Lynparza (AstraZeneca/ Merck Sharp & Dohme): Pre-registration

2. Rucaparib (Clovis Oncology): Pre-registration

3. Opdivo (Bristol-Myers Squibb): Phase III

4. Niraparib(Janssen Research & Development): Phase III

5. Ipatasertib (Hoffmann-La Roche): Phase III

6. HC-1119 (Hinova Pharmaceuticals): Phase III

7. 177Lu-PSMA-617 (Novartis): Phase III

8. Seviteronel (Innocrin Pharmaceutical): Phase II

9. Capivasertib (AstraZeneca): Phase II

Product details and complete list of emerging products will be provided in the full report…

CRPC Drugs Uptake
Lynparza which have already shown better efficacy compared to abiraterone or enzalutamide is expected to garner the maximum sales during the forecast period. On the other hand, in non-metastatic CRPC, Erleada with better clinical profile and early mover advantage is expected to generate maximum revenue in this setting.

Access and Reimbursement Scenario in CRPC Therapies
In mCRPC setting, most of the therapies can secure the positive recommendation given the high unmet need in this particular setting. And for emerging therapies targeting this setting benchmark for comparison would be Xtandi and Zytiga.
In nmCRPC setting, access and reimbursement path for newer and as well approved therapies will not a cake walk and similar findings seen in case of Xtandi rejection by NICE for treating hormone-relapsed non-metastatic prostate cancer or nmCRPC.
KOL-Views
To keep up with current market trends, we take KOLs and SME’s opinion working in CRPC domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or CRPC market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis
We perform Competitive and Market Intelligence analysis of the CRPC Market by using various Competitive Intelligence tools that includes – SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report
The report covers the descriptive overview of CRPC, explaining its causes, signs and symptoms, pathophysiology, and currently available therapies.
Comprehensive insight has been provided into the CRPC epidemiology and treatment in the 7MM.
Additionally, an all-inclusive account of both the current and emerging therapies for CRPC is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
A detailed review of CRPC market; historical and forecasted is included in the report, covering drug outreach in the 7MM.
The report provides an edge while developing business strategies, by understanding trends shaping and driving the global CRPC market.
Report Highlights
In the coming years, CRPC market is set to change due to the rising awareness of the disease and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
The companies and academics are working to assess challenges and seek opportunities that could influence CRPC R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
Major players are involved in developing therapies for CRPC. Launch of emerging therapies, will significantly impact the CRPC market.
A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for CRPC.
Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.
CRPC Report Insights
Patient Population
Therapeutic Approaches
CRPC Pipeline Analysis
CRPC Market Size and Trends
Market Opportunities
Impact of upcoming Therapies
CRPC Report Key Strengths
11 Years Forecast
7MM Coverage
CRPC Epidemiology Segmentation
Key Cross Competition
Highly Analyzed Market
Drugs Uptake
CRPC Report Assessment
SWOT Analysis
Current Treatment Practices
Unmet Needs
Pipeline Product Profiles
Conjoint Analysis
Market Attractiveness
Market Drivers and Barriers
Key Questions
Market Insights:

What was the CRPC Market share (%) distribution in 2017 and how it would look like in 2030?
What would be the CRPC total market Size as well as market size by therapies across the 7MM during the study period (2017–2030)?
What are the key findings pertaining to the market across the 7MM and which country will have the largest CRPC market size during the study period (2017–2030)?
At what CAGR, the CRPC market is expected to grow in 7MM during the study period (2017–2030)?
What would be the CRPC market outlook across the 7MM during the study period (2017–2030)?
What would be the CRPC market growth till 2030 and what will be the resultant market size in the year 2030?
How would the market drivers, barriers and future opportunities affect the market dynamics and a subsequent analysis of the associated trends?
CRPC patient types/ pool where unmet need is more and whether emerging therapies will be able to address the residual unmet need?
How emerging therapies are performing on the parameters like efficacy, safety, route of administration (RoA), treatment duration and frequencies on the basis of their clinical trial results?
Among the emerging therapies, what are the potential therapies which are expected to disrupt the CRPC market?

Epidemiology Insights:

What is the disease risk, burden and unmet needs of the CRPC?
What is the historical CRPC patient pool in seven major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan?
What would be the forecasted patient pool of CRPC in 7 major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan?
What will be the growth opportunities in the 7MM with respect to the patient population pertaining to CRPC?
Out of all the 7MM countries, which country would have the highest prevalent population of CRPC during the study period (2017–2030)?
At what CAGR the population is expected to grow in the 7MM during the study period (2017–2030)?
What are the various recent and upcoming events which are expected to improve the diagnosis of CRPC?
Current Treatment Scenario, Marketed Drugs and Emerging Therapies:
What are the current options for the treatment of CRPC along with the approved therapy?
What are the current treatment guidelines for the treatment of CRPC in the US, Europe and Japan?
What are the CRPC marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
How many companies are developing therapies for the treatment of CRPC?
How many therapies are developed by each company for the treatment of CRPC?
How many emerging therapies are in mid stage, and late stage of development for the treatment of CRPC?
What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the CRPC therapies?
What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
What are the clinical studies going on for CRPC and their status?
What are the key designations that have been granted for the emerging therapies for CRPC?
What is the global historical and forecasted market of CRPC?
Reasons to buy
The report will help in developing business strategies by understanding trends shaping and driving the CRPC market.
To understand the future market competition in the CRPC market and Insightful review of the key market drivers and barriers.
Organize sales and marketing efforts by identifying the best opportunities for CRPC in the US, Europe (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
Identification of strong upcoming players in market will help in devising strategies that will help in getting ahead of competitors.
Organize sales and marketing efforts by identifying the best opportunities for CRPC market.
To understand the future market competition in the CRPC market.

【レポートの目次】

1. Key Insights

2. Executive Summary of CRPC

3. SWOT Analysis of CRPC

4. CRPC: Market Overview at a Glance

5. CRPC: Disease Background and Overview

5.1. Introduction

5.1.1. Signs and Symptoms of Prostate Cancer

5.1.2. Risk Factors and Causes of Prostate Cancer

5.1.3. Pathophysiology of Prostate Cancer

5.1.4. Prostate Neoplasia

5.1.5. Genetics of Prostate Cancer

6. Diagnosis of Prostate Cancer

6.1. Screening Tests for Prostate Cancer

6.2. Tests to Diagnose Prostate Cancer

6.3. Stages and Grades of Prostate Cancer

7. Epidemiology and Patient Population

7.1. Key Findings

7.2. Assumptions and Rationale: 7MM

7.3. Epidemiology Scenario: 7MM

7.3.1. Total Prevalent Cases of Prostate Cancer in the 7MM

7.3.2. Total Diagnosed Cases of Prostate Cancer by Clinical Stages in the 7MM

7.3.3. Total Non-metastatic and Metastatic Cases of CRPC in the 7MM

7.3.4. Total Treated cases of Non-metastatic CRPC Patients in the 7MM

7.3.5. Total Treated Cases of Metastatic CRPC Patients in the 7MM

7.4. The United States Epidemiology

7.4.1. Total Diagnosed Cases of Prostate Cancer in the United States

7.4.2. Age-specific Cases of Prostate Cancer in the United States

7.4.3. Total Diagnosed Cases of Prostate Cancer by Clinical Stages in the United States

7.4.4. Total Non-metastatic and Metastatic Cases of CRPC in the United States

7.4.5. Total Treated cases of Non-metastatic CRPC Patients in the United States

7.4.6. Total Treated Cases of Metastatic CRPC Patients in the United States

8. EU-5 Country-wise Epidemiology

8.1. Germany

8.1.1. Total Diagnosed Prevalent cases of Prostate Cancer in Germany

8.1.2. Age-specific Diagnosed Prevalent cases of Prostate Cancer in Germany

8.1.3. Total Diagnosed Prevalent cases of Prostate Cancer by Clinical Stages in Germany

8.1.4. Total Non-metastatic and Metastatic Cases of CRPC in Germany

8.1.5. Total Treated cases of Non-metastatic CRPC Patients in Germany

8.1.6. Total Treated Cases of Metastatic CRPC Patients in Germany

8.2. France

8.2.1. Total Diagnosed Prevalent cases of Prostate Cancer in France

8.2.2. Age-specific Diagnosed Prevalent cases of Prostate Cancer in France

8.2.3. Total Diagnosed Prevalent cases of Prostate Cancer by Clinical Stages in France

8.2.4. Total Non-metastatic and Metastatic Cases of CRPC in France

8.2.5. Total Treated cases of Non-metastatic CRPC Patients in France

8.2.6. Total Treated Cases of Metastatic CRPC Patients in France

8.3. Italy

8.3.1. Total Diagnosed Prevalent cases of Prostate Cancer in Italy

8.3.2. Age-specific Diagnosed Prevalent cases of Prostate Cancer in Italy

8.3.3. Total Diagnosed Prevalent cases of Prostate Cancer by Clinical Stages in Italy

8.3.4. Total Non-metastatic and Metastatic Cases of CRPC in Italy

8.3.5. Total Treated cases of Non-metastatic CRPC Patients in Italy

8.3.6. Total Treated Cases of Metastatic CRPC Patients in Italy

8.4. Spain

8.4.1. Total Diagnosed Prevalent cases of Prostate Cancer in Spain

8.4.2. Age-specific Diagnosed Prevalent cases of Prostate Cancer in Spain

8.4.3. Total Diagnosed Prevalent cases of Prostate Cancer by Clinical Stages in Spain

8.4.4. Total Non-metastatic and Metastatic Cases of CRPC in Spain

8.4.5. Total Treated cases of Non-metastatic CRPC Patients in Spain

8.4.6. Total Treated Cases of Metastatic CRPC Patients in Spain

8.5. United Kingdom

8.5.1. Total Diagnosed Prevalent cases of Prostate Cancer in the United Kingdom

8.5.2. Age-specific Diagnosed Prevalent cases of Prostate Cancer in the United Kingdom

8.5.3. Total Diagnosed Prevalent cases of Prostate Cancer by Clinical Stages in the United Kingdom

8.5.4. Total Non-metastatic and Metastatic Cases of CRPC in the United Kingdom

8.5.5. Total Treated cases of Non-metastatic CRPC Patients in the United Kingdom

8.5.6. Total Treated Cases of Metastatic CRPC Patients in the United Kingdom

8.6. Japan

8.6.1. Total Diagnosed Prevalent cases of Prostate Cancer in Japan

8.6.2. Age-specific Diagnosed Prevalent cases of Prostate Cancer in Japan

8.6.3. Total Diagnosed Prevalent cases of Prostate Cancer by Clinical Stages in Japan

8.6.4. Total Non-metastatic and Metastatic Cases of CRPC in Japan

8.6.5. Total Treated cases of Non-metastatic CRPC Patients in Japan

8.6.6. Total Treated Cases of Metastatic CRPC Patients in Japan

9. Current Treatment Practices: Prostate Cancer

9.1. Treatment Algorithm of Prostate Cancer

9.2. Observation or Active Surveillance

9.3. Surgery

9.3.1. Open or Laparoscopic Radical Prostatectomy

9.3.2. Risks of Prostate Surgery

9.4. Radiation Therapy

9.4.1. Types of Radiation Therapy

9.5. Hormone Therapy

9.5.1. Types of Hormone Therapy

9.6. Immunotherapy

9.6.1. Vaccine

9.6.2. Immune checkpoint inhibitors

9.7. Chemotherapy

10. Guideline of Prostate Cancer

10.1. The European Association of Urology (EAU) Guideline for Management of Prostate Cancer: 2020

10.2. The National Comprehensive Cancer Network (NCCN) Guidelines for Prostate Cancer: 2019

10.2.1. Screening Guidelines

10.2.2. Genetic Testing

10.2.3. Bone Scan for Diagnosis of Metastatic Disease

10.2.4. Castration-Resistant Prostate Cancer (CRPC)

10.3. Japanese Urological Association Clinical Practice Guideline for Prostate Cancer

11. Unmet Needs of CRPC

12. Marketed Therapies

12.1. Key Cross

12.2. Xofigo (radium Ra 223 dichloride): Bayer Health Care

12.2.1. Product Description

12.2.2. Regulatory Milestones

12.2.3. Other Developmental Activities

12.2.4. Pivotal Clinical Trial

12.2.5. Ongoing Current Pipeline Activity

12.3. Xtandi (Enzalutamide): Astellas Pharma

12.3.1. Product Description

12.3.2. Regulatory Milestones

12.3.3. Other Developmental Activities

12.3.4. Pivotal Clinical Trial

12.3.5. Ongoing Current Pipeline Activity

12.4. Erleada (apalutamide): Janssen Pharmaceutical

12.4.1. Product Description

12.4.2. Regulatory Milestones

12.4.3. Other Developmental Activities

12.4.4. Pivotal Clinical Trials

12.4.5. Ongoing Current Pipeline Activity

12.5. Jevtana (Cabazitaxel): Sanofi

12.5.1. Product Description

12.5.2. Regulatory Milestones

12.5.3. Other Developmental Activities

12.5.4. Pivotal Clinical Trials

12.5.5. Ongoing Current Pipeline Activity

12.6. Nubeqa (Darolutamide/ODM-201): Bayer HealthCare/Orion Corporation

12.6.1. Product Description

12.6.2. Regulatory Milestones

12.6.3. Other Developmental Activities

12.6.4. Pivotal Clinical Trials

12.6.5. Ongoing Current Pipeline Activity

13. Emerging Therapies

13.1. Lynparza (Olaparib): AstraZeneca/ Merck Sharp & Dohme

13.1.1. Product Description

13.1.2. Clinical Development

13.1.3. Safety and Efficacy

13.2. Opdivo (nivolumab): Bristol-Myers Squibb

13.2.1. Product Description

13.2.2. Clinical Development

13.2.3. Safety and Efficacy

13.3. 177Lu-PSMA-617: Novartis

13.3.1. Product Description

13.3.2. Clinical Development

13.3.3. Safety and Efficacy

13.4. HC-1119: Hinova Pharmaceuticals

13.4.1. Product Description

13.4.2. Clinical Development

13.4.3. Safety and Efficacy

13.5. Seviteronel (VT-464): Innocrin Pharmaceutical

13.5.1. Product Description

13.5.2. Clinical Development

13.5.3. Safety and Efficacy

13.6. ODM-208: Orion Pharma

13.6.1. Product Description

13.6.2. Clinical Development

13.6.3. Safety and Efficacy

13.7. Sacituzumab Govitecan (IMMU-132): Immunomedics

13.7.1. Product Description

13.7.2. Clinical Development

13.8. Keytruda (Pembrolizumab/MK-3475): Merck Sharp & Dohme

13.8.1. Product Description

13.8.2. Clinical Development

13.8.3. Safety and Efficacy

13.9. Ipatasertib (RG7440): Hoffmann-La Roche

13.9.1. Product Description

13.9.2. Clinical Development

13.9.3. Safety and Efficacy

13.10. Talazoparib: Pfizer/Astellas Pharma

13.10.1. Product Description

13.10.2. Clinical Development

13.10.3. Safety and Efficacy

13.11. Capivasertib (AZD5363): AstraZeneca

13.11.1. Product Description

13.11.2. Clinical Development

13.11.3. Safety and Efficacy

13.12. AZD4635: AstraZeneca

13.12.1. Product Description

13.12.2. Clinical Development

13.13. Pamiparib (BGB-290): BeiGene

13.13.1. Product Description

13.13.2. Clinical Development

13.14. Rubraca (Rucaparib): Clovis Oncology

13.14.1. Product Description

13.14.2. Clinical Development

13.14.3. Safety and Efficacy

13.15. Niraparib: Janssen Research & Development

13.15.1. Product Description

13.15.2. Clinical Development

13.15.3. Safety and Efficacy

13.16. Proxalutamide (GT0918): Suzhou Kintor Pharmaceutical

13.16.1. Product Description

13.16.2. Clinical Development

13.16.3. Safety and Efficacy

13.17. Abemaciclib (LY2835219): Eli Lilly and Company

13.17.1. Product Description

13.17.2. Clinical Development

13.18. Tomivosertib (eFT508): eFFECTOR Therapeutics

13.18.1. Product Description

13.18.2. Clinical Development

13.19. Onvansertib: Trovagene

13.19.1. Product Description

13.19.2. Clinical Development

13.19.3. Safety and Efficacy

14. CRPC: Seven Major Market Analysis

14.1. Key Findings

14.2. Market Outlook: 7MM

15. 7MM Market Size

15.1. Total Market Size of CRPC in the 7MM

15.2. Total Market size of CRPC by Therapies in the 7MM

15.3. United States Market Size

15.3.1. Total Market size of CRPC in the United States

15.3.2. Total Market size of CRPC by Therapies in the United States

15.4. EU-5 Market Size

15.4.1. Germany Market Size

15.4.2. France Market Size

15.4.3. Italy Market Size

15.4.4. Spain Market Size

15.4.5. United Kingdom Market Size

15.5. Japan Market Size

15.5.1. Total Market size of CRPC in Japan

15.5.2. Total Market size of CRPC by Therapies in Japan

16. Market Access and Reimbursement of CRPC

17. Market Drivers of CRPC

18. Market Barriers of CRPC

19. Appendix

19.1. Bibliography

19.2. Report Methodology

20. DelveInsight Capabilities

21. Disclaimer

22. About DelveInsight

Table 1 Summary of CRPC Market, Epidemiology, and Key Events (2017–2030)

Table 2 Genetic Changes Associated with Prostate Cancer Tumorigenesis

Table 3 Total Prevalent Cases of Prostate Cancer in the 7MM (2017–2030)

Table 4 Total Diagnosed Cases of Prostate Cancer by Clinical Stages in the 7MM (2017–2030)

Table 5 Total Non-metastatic Cases of CRPC in the 7MM (2017–2030)

Table 6 Total Metastatic Cases of CRPC in the 7MM (2017–2030)

Table 7 Total Treated Cases of nmCRPC by Line of Therapies in the 7MM (2017–2030)

Table 8 Total Treated Cases of mCRPC by Line of Therapies in the 7MM (2017–2030)

Table 9 Total Diagnosed Cases of Prostate Cancer in the United States (2017–2030)

Table 10 Age-specific Cases of Prostate Cancer in the United States (2017–2030)

Table 11 Total Diagnosed Cases of Prostate Cancer by Clinical Stages in the United States (2017–2030)

Table 12 Total Non-metastatic Cases of CRPC in the United States (2017–2030)

Table 13 Total Metastatic Cases of CRPC in the United States (2017–2030)

Table 14 Total Treated Cases of nmCRPC by Line of Therapies in the United States (2017–2030)

Table 15 Total Treated Cases of mCRPC by Line of Therapies in the United States (2017–2030)

Table 16 Total Diagnosed Prevalent cases of Prostate Cancer in Germany (2017–2030)

Table 17 Age-specific Diagnosed Prevalent cases of Prostate Cancer in Germany (2017–2030)

Table 18 Total Diagnosed Prevalent cases of Prostate Cancer by Clinical Stages in Germany (2017–2030)

Table 19 Total Non-metastatic Cases of CRPC in Germany (2017–2030)

Table 20 Total Metastatic Cases of CRPC in Germany (2017–2030)

Table 21 Total Treated Cases of nmCRPC by Line of Therapies in Germany (2017–2030)

Table 22 Total Treated Cases of mCRPC by Line of Therapies in Germany (2017–2030)

Table 23 Total Diagnosed Prevalent cases of Prostate Cancer in France (2017–2030)

Table 24 Age-specific Diagnosed Prevalent cases of Prostate Cancer in France (2017–2030)

Table 25 Total Diagnosed Prevalent cases of Prostate Cancer by Clinical Stages in France (2017–2030)

Table 26 Total Non-metastatic Cases of CRPC in France (2017–2030)

Table 27 Total Metastatic Cases of CRPC in France (2017–2030)

Table 28 Total Treated Cases of nmCRPC by Line of Therapies in France (2017–2030)

Table 29 Total Treated Cases of mCRPC by Line of Therapies in France (2017–2030)

Table 30 Total Diagnosed Prevalent cases of Prostate Cancer in Italy (2017–2030)

Table 31 Age-specific Diagnosed Prevalent cases of Prostate Cancer in Italy (2017–2030)

Table 32 Total Diagnosed Prevalent cases of Prostate Cancer by Clinical Stages in Italy (2017–2030)

Table 33 Total Non-metastatic Cases of CRPC in Italy (2017–2030)

Table 34 Total Metastatic Cases of CRPC in Italy (2017–2030)

Table 35 Total Treated Cases of nmCRPC by Line of Therapies in Italy (2017–2030)

Table 36 Total Treated Cases of mCRPC by Line of Therapies in Italy (2017–2030)

Table 37 Total Diagnosed Prevalent cases of Prostate Cancer in Spain (2017–2030)

Table 38 Age-specific Diagnosed Prevalent cases of Prostate Cancer in Spain (2017–2030)

Table 39 Total Diagnosed Prevalent cases of Prostate Cancer by Clinical Stages in Spain (2017–2030)

Table 40 Total Non-metastatic Cases of CRPC in Spain (2017–2030)

Table 41 Total Metastatic Cases of CRPC in Spain (2017–2030)

Table 42 Total Treated Cases of nmCRPC by Line of Therapies in Spain (2017–2030)

Table 43 Total Treated Cases of mCRPC by Line of Therapies in Spain (2017–2030)

Table 44 Total Diagnosed Prevalent cases of Prostate Cancer in the United Kingdom (2017–2030)

Table 45 Age-specific Diagnosed Prevalent cases of Prostate Cancer in the United Kingdom (2017–2030)

Table 46 Total Diagnosed Prevalent cases of Prostate Cancer by Clinical Stages in the United Kingdom (2017–2030)

Table 47 Total Non-metastatic Cases of CRPC in the United Kingdom (2017–2030)

Table 48 Total Metastatic Cases of CRPC in the United Kingdom (2017–2030)

Table 49 Total Treated Cases of nmCRPC by Line of Therapies in the United Kingdom (2017–2030)

Table 50 Total Treated Cases of mCRPC by Line of Therapies in the United Kingdom (2017–2030)

Table 51 Total Diagnosed Prevalent cases of Prostate Cancer in Japan (2017–2030)

Table 52 Age-specific Diagnosed Prevalent cases of Prostate Cancer in Japan (2017–2030)

Table 53 Total Diagnosed Prevalent cases of Prostate Cancer by Clinical Stages in Japan (2017–2030)

Table 54 Total Non-metastatic Cases of CRPC in Japan (2017–2030)

Table 55 Total Metastatic Cases of CRPC in Japan (2017–2030)

Table 56 Total Treated Cases of nmCRPC by Line of Therapies in Japan (2017–2030)

Table 57 Total Treated Cases of mCRPC by Line of Therapies in Japan (2017–2030)

Table 58 Marketed Key Cross of Prostate Cancer

Table 59 Xofigo (radium Ra 223 dichloride), Clinical Trial Description, 2020

Table 60 Xtandi (Enzalutamide), Clinical Trial Description, 2020

Table 61 Erleada (apalutamide), Clinical Trial Description, 2020

Table 62 Jevtana (cabazitaxel), Clinical Trial Description, 2020

Table 63 Nubeqa (darolutamide), Clinical Trial Description, 2020

Table 64 Lynparza (olaparib), Clinical Trial Description, 2020

Table 65 Opdivo (nivolumab), Clinical Trial Description, 2020

Table 66 177Lu-PSMA-617, Clinical Trial Description, 2020

Table 67 HC-1119, Clinical Trial Description, 2020

Table 68 Seviteronel (VT-464), Clinical Trial Description, 2020

Table 69 ODM-208, Clinical Trial Description, 2020

Table 70 IMMU-132 (Sacituzumab govitecan), Clinical Trial Description, 2020

Table 71 Keytruda (Pembrolizumab/MK-3475), Clinical Trial Description, 2020

Table 72 Ipatasertib (RG7440), Clinical Trial Description, 2020

Table 73 Talazoparib, Clinical Trial Description, 2020

Table 74 Capivasertib (AZD5363), Clinical Trial Description, 2020

Table 75 AZD4635, Clinical Trial Description, 2020

Table 76 Pamiparib (BGB-290), Clinical Trial Description, 2020

Table 77 Rubraca (Rucaparib), Clinical Trial Description, 2020

Table 78 Niraparib, Clinical Trial Description, 2020

Table 79 Proxalutamide (GT0918), Clinical Trial Description, 2020

Table 80 Abemaciclib (LY2835219), Clinical Trial Description, 2020

Table 81 Tomivosertib (eFT508), Clinical Trial Description, 2020

Table 82 Onvansertib, Clinical Trial Description, 2020

Table 83 7MM Market Size of Prostate Cancer in USD Million (2017–2030)

Table 84 7MM Market Size of Prostate Cancer by Types, in USD Million (2017–2030)

Table 85 7MM Market Size of CRPC by Therapies, in USD Million (2017–2030)

Table 86 United States Market Size of Prostate Cancer by Types, in USD Million (2017–2030)

Table 87 United States Market Size of CRPC by Therapies, in USD Million (2017–2030)

Table 88 Germany, Market Size of Prostate Cancer, in USD Million (2017–2030)

Table 89 France, Market Size of Prostate Cancer, in USD Million (2017–2030)

Table 90 France Market Size of CRPC by Therapies, in USD Million (2017–2030)

Table 91 Italy, Market Size of Prostate Cancer, in USD Million (2017–2030)

Table 92 Italy Market Size of CRPC by Therapies, in USD Million (2017–2030)

Table 93 Spain, Market Size of Prostate Cancer, in USD Million (2017–2030)

Table 94 Spain Market Size of CRPC by Therapies, in USD Million (2017–2030)

Table 95 United Kingdom, Market Size of Prostate Cancer, in USD Million (2017–2030)

Table 96 United Kingdom Market Size of CRPC by Therapies, in USD Million (2017–2030)

Table 97 Japan, Market Size of Prostate Cancer, in USD Million (2017–2030)

Table 98 Japan Market Size of CRPC by Therapies, in USD Million (2017–2030)

Table 99 National Institute for Health and Care Excellence (NICE) Decisions for CRPC Therapies

Table 100 Haute Autorité de santé (HAS) Decisions for CRPC Therapies

Table 101 IQWiG Decisions for CRPC Therapies



List of Figures:

Figure 1 CRPC SWOT Analysis

Figure 2 Prostate Cancer

Figure 3 Sign and Symptoms of Prostate Cancer

Figure 4 Risks Factors of Prostate Cancer

Figure 5 Pathophysiology of Prostate Cancer

Figure 6 Progression of Prostate Cancer and the Development of mCRPC

Figure 7 Diagnosis of Prostate Cancer

Figure 8 Gleason Score of Prostate Cancer

Figure 9 Global Heat Map of Prostate Cancer

Figure 10 Total Prevalent Cases of Prostate Cancer in the 7MM (2017–2030)

Figure 11 Total Diagnosed Cases of Prostate Cancer by Clinical Stages in the 7MM (2017–2030)

Figure 12 Total Non-metastatic Cases of CRPC in the 7MM (2017–2030)

Figure 13 Total Metastatic Cases of CRPC in the 7MM (2017–2030)

Figure 14 Total Treated Cases of nmCRPC by Line of Therapies in the 7MM (2017–2030)

Figure 15 Total Treated Cases of mCRPC by Line of Therapies in the 7MM (2017–2030)

Figure 16 Total Diagnosed Cases of Prostate Cancer in the United States (2017–2030)

Figure 17 Age-specific Cases of Prostate Cancer in the United States (2017–2030)

Figure 18 Total Diagnosed Cases of Prostate Cancer by Clinical Stages in the United States (2017–2030)

Figure 19 Total Non-metastatic Cases of CRPC in the United States (2017–2030)

Figure 20 Total Metastatic Cases of CRPC in the United States (2017–2030)

Figure 21 Total Treated Cases of nmCRPC by Line of Therapies in the United States (2017–2030)

Figure 22 Total Treated Cases of mCRPC by Line of Therapies in the United States (2017–2030)

Figure 23 Total Diagnosed Prevalent cases of Prostate Cancer in Germany (2017–2030)

Figure 24 Age-specific Diagnosed Prevalent cases of Prostate Cancer in Germany (2017–2030)

Figure 25 Total Diagnosed Prevalent cases of Prostate Cancer by Clinical Stages in Germany (2017–2030)

Figure 26 Total Non-metastatic Cases of CRPC in Germany (2017–2030)

Figure 27 Total Metastatic Cases of CRPC in Germany 2017–2030)

Figure 28 Total Treated Cases of nmCRPC by Line of Therapies in Germany (2017–2030)

Figure 29 Total Treated Cases of mCRPC by Line of Therapies in Germany (2017–2030)

Figure 30 Total Diagnosed Prevalent cases of Prostate Cancer in France (2017–2030)

Figure 31 Age-specific Diagnosed Prevalent cases of Prostate Cancer in France (2017–2030)

Figure 32 Total Diagnosed Prevalent cases of Prostate Cancer by Clinical Stages in France (2017–2030)

Figure 33 Total Non-metastatic Cases of CRPC in France (2017–2030)

Figure 34 Total Metastatic Cases of CRPC in France2017–2030)

Figure 35 Total Treated Cases of nmCRPC by Line of Therapies in France (2017–2030)

Figure 36 Total Treated Cases of mCRPC by Line of Therapies in France (2017–2030)

Figure 37 Total Diagnosed Prevalent cases of Prostate Cancer in Italy (2017–2030)

Figure 38 Age-specific Diagnosed Prevalent cases of Prostate Cancer in Italy (2017–2030)

Figure 39 Total Diagnosed Prevalent cases of Prostate Cancer by Clinical Stages in Italy (2017–2030)

Figure 40 Total Non-metastatic Cases of CRPC in Italy (2017–2030)

Figure 41 Total Metastatic Cases of CRPC in Italy 2017–2030)

Figure 42 Total Treated Cases of nmCRPC by Line of Therapies in Italy (2017–2030)

Figure 43 Total Treated Cases of mCRPC by Line of Therapies in Italy (2017–2030)

Figure 44 Total Diagnosed Prevalent cases of Prostate Cancer in Spain (2017–2030)

Figure 45 Age-specific Diagnosed Prevalent cases of Prostate Cancer in Spain (2017–2030)

Figure 46 Total Diagnosed Prevalent cases of Prostate Cancer by Clinical Stages in Spain (2017–2030)

Figure 47 Total Non-metastatic Cases of CRPC in Spain (2017–2030)

Figure 48 Total Metastatic Cases of CRPC in Spain (2017–2030)

Figure 49 Total Treated Cases of nmCRPC by Line of Therapies in Spain (2017–2030)

Figure 50 Total Treated Cases of mCRPC by Line of Therapies in Spain (2017–2030)

Figure 51 Total Diagnosed Prevalent cases of Prostate Cancer in the United Kingdom (2017–2030)

Figure 52 Age-specific Diagnosed Prevalent cases of Prostate Cancer in the United Kingdom (2017–2030)

Figure 53 Total Diagnosed Prevalent cases of Prostate Cancer by Clinical Stages in the United Kingdom (2017–2030)

Figure 54 Total Non-metastatic Cases of CRPC in the United Kingdom (2017–2030)

Figure 55 Total Metastatic Cases of CRPC in the United Kingdom (2017–2030)

Figure 56 Total Treated Cases of nmCRPC by Line of Therapies in the United Kingdom (2017–2030)

Figure 57 Total Treated Cases of mCRPC by Line of Therapies in the United Kingdom (2017–2030)

Figure 58 Total Diagnosed Prevalent cases of Prostate Cancer in Japan (2017–2030)

Figure 59 Age-specific Diagnosed Prevalent cases of Prostate Cancer in Japan (2017–2030)

Figure 60 Total Diagnosed Prevalent cases of Prostate Cancer by Clinical Stages in Japan (2017–2030)

Figure 61 Total Non-metastatic Cases of CRPC in Japan (2017–2030)

Figure 62 Total Metastatic Cases of CRPC in Japan (2017–2030)

Figure 63 Total Treated Cases of nmCRPC by Line of Therapies in Japan (2017–2030)

Figure 64 Total Treated Cases of mCRPC by Line of Therapies in Japan (2017–2030)

Figure 65 Localized Disease Treatment Algorithm

Figure 66 High-risk Localized and Locally Advanced Disease Treatment Algorithm

Figure 67 Metastatic Disease Treatment Algorithm

Figure 68 Suggested Treatment Paradigm for Molecular Biomarkers in Advanced Prostate Cancer

Figure 69 Summary of Recommendations

Figure 70 Unmet Needs

Figure 71 Major mechanisms of therapeutic resistance to androgen axis-targeting therapies in prostate cancer

Figure 72 Market Size of Prostate Cancer in the 7MM Countries in USD Million (2017–2030)

Figure 73 Market Size of CRPC by Therapies in the 7MM, in USD Millions (2017–2030)

Figure 74 Market Size of Prostate Cancer in the United States, in USD Millions (2017–2030)

Figure 75 Market Size of CRPC by Therapies in the United States, in USD Millions (2017–2030)

Figure 76 Market Size of Prostate Cancer in Germany, in USD Millions (2017–2030)

Figure 77 Market Size of CRPC by Therapies in Germany, in USD Millions (2017–2030)

Figure 78 Market Size of Prostate Cancer in France, in USD Millions (2017–2030)

Figure 79 Market Size of CRPC by Therapies in France, in USD Millions (2017–2030)

Figure 80 Market Size of Prostate Cancer in Italy, in USD Millions (2017–2030)

Figure 81 Market Size of CRPC by Therapies in Italy, in USD Millions (2017–2030)

Figure 82 Market Size of Prostate Cancer in Spain, in USD Millions (2017–2030)

Figure 83 Market Size of CRPC by Therapies in Spain, in USD Millions (2017–2030)

Figure 84 Market Size of Prostate Cancer in the United Kingdom, in USD Millions (2017–2030)

Figure 85 Market Size of CRPC by Therapies in the United Kingdom, in USD Millions (2017–2030)

Figure 86 Market Size of Prostate Cancer in Japan, in USD Millions (2017–2030)

Figure 87 Market Size of CRPC by Therapies in the Japan, in USD Millions (2017–2030)

Figure 88 Market Drivers

Figure 89 Market Barriers

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