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Castration-sensitive Prostate Cancer (CSPC) – Market Insights, Epidemiology, and Market Forecast – 2034

Publisher DelveInsight
Published Jul 01, 2025
Length 285 Pages
SKU # DEL20495171

Description

Key Highlights

CSPC market remained a dry space since a long time, however since the approval and usage of ZYTIGA in 2017, followed by XTANDI in 2019, ERLEADA in 2020, NUBEQA and ORGOVYX in 2022, the metastatic segment of CSPC witnessed a significant growth.

Within overall prostate cancer cases, CSPC ( both metastatic and non-metastatic) is the major contributor in terms of patient size and volume, however the more aggressive type, CRPC has been leading with multiple approvals in its bucket during last decade due to its aggressive nature, unmet need and broader commercial opportunity.

Improved screening and awareness are leading to earlier diagnosis, keeping more patients in the CSPC stage for longer periods before progression.

Real-world CSPC treatment patterns vary widely due to differences in geography, physician practices, access to therapy, and patient characteristics, often resulting in underuse of intensified regimens despite guideline recommendations.

The non-metastatic CSPC (nmCSPC) space was previously unaddressed, with ADT or surveillance as the only options. XTANDI’s 2023 approval alongside leuprolide marks the first major breakthrough, bringing a targeted anti-androgen approach to this underserved population.

XTANDI is currently the only approved therapy for nmCSPC with high-risk biochemical recurrence (BCR). In the pipeline, NUBEQA + ADT and MVI-816 + Nivolumab are being investigated as potential alternatives in this setting.

ZYTIGA’s revenue has plateaued due to the entry of generics. XTANDI and ERLEADA dominates the current market, with NUBEQA and ORGOVYX further strengthening the competitive landscape.

Approval of ERLEADA for mCSPC has put a barrier to the growth of the sales of ZYTIGA, which is already facing competition. After the launch of generic versions in the Q4 of 2019, ZYTIGA’s sales in the US dropped by 59% to USD 198 million in the second quarter.

Radioligand therapies (e.g., PLUVICTO) and PARP inhibitors (e.g., TALZENNA) are advancing from mCRPC to mCSPC, with approvals expected in 2026.

Companies like AstraZeneca, Tavanta Therapeutics, Janssen/Merck/Tesaro, Johnson & Johnson, Bayer/Orion, and others are investigating their key products for managing mCSPC.

Eli Lilly and Merck faced setbacks in prostate cancer trials. Lilly ended the CYCLONE-3 trial of VERZENIO plus ZYTIGA in mHSPC due to futility, while Merck discontinued the KEYNOTE-991 trial after interim analysis. Highlighting ongoing challenges in advancing new therapies for mHSPC.

The CSPC market is expected to witness significant growth owing to the rising prevalence of prostate cancer cases due to the rapidly aging population and growing disease awareness among people. In addition, extensive market penetration of approved therapies in CSPC due to label expansions and the entry of new emerging therapies will be crucial factors facilitating the market growth.

DelveInsight’s “Castration-sensitive Prostate Cancer (CSPC) – Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of the CSPC, historical and forecasted epidemiology as well as the CSPC market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

CSPC market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM CSPC market size from 2020 to 2034. The report also covers current CSPC treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

Geography Covered

The United States

EU4 (Germany, France, Italy, and Spain) and the United Kingdom

Japan

Study Period: 2020–2034

Castration-sensitive Prostate Cancer (CSPC) Understanding and Treatment Algorithm

Castration-sensitive Prostate Cancer (CSPC) Overview

Prostate cancer is a common malignancy that develops in the prostate gland and primarily affects men. It typically grows slowly and often remains confined to the prostate in its early stages, where it may not cause significant harm. Advanced stages of the disease include metastatic castration-sensitive prostate cancer (mCSPC)—also known as metastatic hormone-sensitive prostate cancer (mHSPC). This form is characterized by cancer that has spread beyond the prostate to other parts of the body but still responds to hormone (androgen deprivation) therapy. Based on imaging, metastatic prostate cancer is further classified into:

M0 CSPC: No visible metastases on conventional imaging.

M1 CSPC: Confirmed metastases present.

Differentiating M0 CSPC from local recurrence after curative treatment can be challenging. In such cases, histology and PSA (prostate-specific antigen) levels play a key role in diagnosis. While, nmCSPC refers to prostate cancer confined to the pelvis with no evidence of distant spread on imaging, but that still responds to hormone-lowering therapy.

Castration-sensitive Prostate Cancer (CSPC) Diagnosis

Advanced cancer may be found before, at the same time, or later than the main tumor. Most diagnosed with advanced prostate cancer have had biopsy and treatment in the past. When a new tumor is found in someone who has been treated for cancer in the past, usually cancer has spread. Initial evaluation involves a combination of PSA testing, digital rectal examination (DRE), prostate biopsy, and imaging studies such as MRI, CT scans, or bone scans to assess the extent of disease spread. Based on imaging, CSPC is categorized as either non-metastatic (M0) or metastatic (M1). Differentiating between local recurrence and metastatic disease can be challenging in some cases, where histological confirmation and PSA kinetics provide important diagnostic clues. Accurate diagnosis and staging are essential at this point, as they form the basis for selecting an appropriate treatment strategy—ranging from curative intent therapies in localized disease to systemic treatment in metastatic settings.

Further details related to country-based variations in diagnosis are provided in the report…

Castration-sensitive Prostate Cancer (CSPC) Treatment

The treatment of nmCSPC has evolved significantly over time. Initially, management was limited to ADT or observation, especially for patients with high-risk biochemical recurrence after primary therapy. As understanding of disease progression improved, first-line treatments such as salvage radiotherapy. The approval of XTANDI in 2023, marked a major advancement by providing the first targeted anti-androgen therapy specifically for nmCSPC with high-risk biochemical recurrence, establishing a new standard of care and enabling earlier, more effective intervention.

Several systemic therapies have been introduced into the mHSPC space. While ADT remains the mainstay of treatment, docetaxel chemotherapy and second-generation antiandrogens, such as abiraterone, apalutamide, and enzalutamide, have demonstrated survival benefits when added to ADT. The addition of these medications and potential therapies has expanded the array of treatments available but also presented the clinician with the conundrum of selecting the optimal agent for treatment intensification for the appropriate patient.

Note: Further Details are provided in the final report

Castration-sensitive Prostate Cancer (CSPC) Epidemiology

The epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Prevalent cases of Prostate cancer, Five-year Prevalent cases of Prostate cancer, Age-specific cases of Prostate cancer, Total cases of Prostate cancer by clinical stages, Five-year Prevalent cases of CSPC, Total Prevalent cases of mCSPC and nmCSPC in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

Widespread PSA screening, earlier detection, aging populations, and improved cancer registry coverage are all fueling the rise in prostate cancer cases across the 7MM. In 2024, the 7MM had approximately 7.5 million prevalent cases of prostate cancer. These are expected to rise during the forecast period (2025-2034).

As per the estimates, prostate cancer commonly occur in people aged 65–74 years.

As per the estimates, in the US, majority of the cases were found to be localized/locally advanced cases (Stage I-III), comprising approximately 56% of total cases, while nearly 33% belonged to biochemical recurrence/ progressive cases, and ~11% belonged to metastatic cases.

The five-year prevalent cases of CSPC in the US comprised was about more than 300,000 cases in 2024 and are projected to increase during the forecast period.

In Japan, during 2024, mCSPC cases made up approximately 21% of the total prevalent cases of CSPC.

Castration-sensitive Prostate Cancer (CSPC) Drug Chapters

The drug chapter segment of the CSPC report encloses a detailed analysis of marketed and emerging drugs of late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the CSPC pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations. XTANDI and ERLEADA lead the CSPC market with broad adoption and clinical validation, while newer entrants like NUBEQA and ORGOVYX are gaining ground, enhancing competition with differentiated benefits and expanding market share.

Marketed Drugs

NUBEQA (darolutamide): Bayer and Orion Corporation

NUBEQA is an oral ARI with a unique chemical structure that binds with high affinity to the androgen receptor and exhibits a strong antagonistic effect against the androgen receptor, inhibiting the receptor function and growth of prostate cancer cells. Additionally, preclinical models and neuroimaging data in healthy humans support darolutamide’s low potential for blood–brain barrier penetration. Developed jointly by Bayer and Orion Corporation, NUBEQA is indicated for treating adults with mCSPC combined with docetaxel.

In April 2025, Bayer presented new data on NUBEQA at the AUA Annual Meeting. Highlights included post-hoc analyses from the Phase III ARANOTE trial linking ultra-low PSA responses to better outcomes in mHSPC, long-term safety data from the ARASENS Rollover trial, and an update from the ongoing ARASTEP trial in high-risk biochemical recurrence.

XTANDI (enzalutamide): Astellas Pharma/Pfizer

XTANDI is an androgen receptor signaling inhibitor. Enzalutamide is a standard of care and has received regulatory approvals in one or more countries around the world for use in men with mHSPC and nmHSPC with high-risk BCR. The extended approval for XTANDI is based on results from the Phase III EMBARK trial in men with high-risk BCR nmHSPC. The European Association of Urology (EAU) revised its treatment guidelines in April 2024, recommending enzalutamide for men with high-risk BCR nmHSPC with or without ADT after radiation therapy or surgery.

According to Pfizer’s Q1 2025 SEC filing, beginning in August 2024, the company initiated patent infringement lawsuits against the generic applicants in the US District Court for the District of New Jersey, asserting both the validity and infringement of the patents involved.

Emerging Drugs

TRUQAP (capivasertib, AZD 5363): AstraZeneca

TRUQAP is a novel pyrrolopyrimidine derivative and an orally available inhibitor of the serine/threonine-protein kinase AKT (protein kinase B) with potential antineoplastic activity. The company has completed the Phase Ib and Phase I/II trial of capivasertib for the treatment of prostate cancer. Moreover, AstraZeneca is currently investigating capivasertib in combination with ZYTIGA in the Phase III clinical stage in the CAPItello-281 study for the treatment of mHSPC and LCM projects’ clinical development in combination with docetaxel in the CAPItello-280 study for the treatment of mCRPC.

Saruparib (AZD5305): AstraZeneca

AZD5305 is a potent and selective oral PARP inhibitor (PARPi) that specifically targets and traps PARP1, in contrast to approved PARPis, which target both PARP1 and PARP2. Preclinical data suggest that PARP1 inhibition confers antiproliferative effects, while PARP2 inhibition is a major driver of hematological toxicity. Thus, AZD5305 may have an improved therapeutic index with less toxicity. Currently, it is in the Phase III of development in HRRm and non-HRRm mCSPC. As per AstraZeneca’s Q1 2025 clinical trial appendix, the company anticipates data of saruparib Phase III (EvoPAR-Prostate01/NCT06120491) and Phase I/IIa (PETRANHA/NCT05367440) beyond 2026.

Drug Class Insights

Currently, the market holds a diverse range of therapeutic alternatives for treatment, including androgen receptor inhibitors, CYP17 inhibitors, PARP inhibitors, AKT inhibitor, PSMA-targeted radioligand therapy, GnRH receptor antagonists, and others in different lines of treatment.

Androgen receptor pathway inhibitors are a mainstay of treatment for patients with CSPC. There are currently four approved androgen receptor pathway inhibitors in the United States: three anti-androgens — ERLEADA, XTANDI, and NUBEQA. CYP17 inhibitors, like ZYTIGA acts by reducing the availability of androgens that fuel tumor progression. GnRH receptor antagonists (e.g., ORGOYVX) represent a newer approach to androgen deprivation by directly and rapidly suppressing LH and testosterone levels without the initial testosterone surge seen with LHRH agonists.

In addition to these hormone-directed therapies, PARP inhibitors (e.g., saruparib, TALZENNA) have emerged as a promising class, particularly for patients with HRR gene mutations such as BRCA. Another novel approach is PSMA-targeted radioligand therapy, which delivers radiation directly to prostate-specific membrane antigen (PSMA)-expressing cells using agents like [^177Lu] Lu-PSMA-617. While currently approved in mCRPC, it is being evaluated for use in earlier stages, including mCSPC.

Together, these diverse classes reflect a move toward mechanism-driven and biomarker-guided treatment in CSPC, combining hormonal blockade with targeted and precision therapies to improve outcomes in both non-metastatic and metastatic settings.

Castration-sensitive Prostate Cancer (CSPC) Market Outlook

mCSPC, also referred to as mHSPC, is an advanced form of prostate cancer where the cancer has spread to other parts of the body and remains responsive to hormone therapy. The treatment landscape for mCSPC has evolved significantly over the past two decades, from ADT alone to a range of intensified approaches including doublet therapy with ZYTIGA, ERLEADA, or XTANDI, triplet therapy with docetaxel and ZYTIGA or NUBEQA, or ADT combined with external beam radiotherapy (EBRT) for patients with low metastatic burden, reflecting a shift from ADT monotherapy, which is now discouraged unless contraindications to combination therapy exist. Future research and ongoing clinical trials will continue to refine our understanding of optimal treatment strategies, ultimately improving outcomes and quality of life for patients with mCSPC.

In nmHSPC or nmCSPC, there is no detectable spread of cancer to distant parts of the body using standard imaging methods like CT or MRI, and the disease still responds to treatments that lower testosterone levels. nmCSPC was an untouched market as there was no approved therapy before XTANDI received approval in 2023. The standard treatment has been ADT or surveillance for a long time, and now an anti-androgen, XTANDI combined with leuprolide, is a significant addition.

In 2023, XTANDI became the first therapy approved in the US for nmCSPC with high-risk BCR based on results from the EMBARK trial. A statistically significant improvement in metastasis-free survival (MFS) was demonstrated for XTANDI plus leuprolide compared with placebo plus leuprolide.

XTANDI has seen strong global sales growth in recent years, driven by its proven effectiveness across various stages of prostate cancer, including mHSPC disease, as well as expansion into combination therapy settings. Astellas reported a 21.6% year-over-year revenue increase from 2023 to 2024, with sales growth across all regions. However, Astellas has forecasted a 4.9% decline in future sales due to the anticipated loss of exclusivity in Europe and Japan in 2026 and the US in 2027.

The total market size of CSPC in the United States was approximately USD 2,585 million in 2024 and is projected to increase during the forecast period (2025–2034).

In 2024, XTANDI accounted for the majority of the market share i.e. ~USD 630 million in the United States.

As per DelveInsight’s analysis, by 2034, among the therapies, the highest revenue is expected to be generated by NUBEQA in the EU4 and the UK.

Castration-sensitive Prostate Cancer (CSPC) Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025–2034, which depends on the competitive landscape, safety, efficacy data, and order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

NUBEQA has shown consistent, nearly doubled quarter-on-quarter growth, and in recent quarters reached all-time high revenue levels, reflecting its accelerating uptake globally. ERLEADA appears to deliver the strongest real-world survival and PSA response advantage, followed by XTANDI and then ZYTIGA. However, uptake in clinical practice lags behind evidence.

Further detailed analysis of emerging therapies drug uptake in the report…

Castration-sensitive Prostate Cancer (CSPC) Pipeline Development Activities

The report provides insights into therapeutic candidates in Phase III and II. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for CSPC emerging therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including Medical/scientific Writers, Professors, and others.

DelveInsight’s analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 18+ KOLs in the 7MM. Centers such as Emory University School of Medicine, Anderson Cancer Center, Southwestern Medical Center etc. were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Castration-sensitive Prostate Cancer (CSPC) market trends.

Qualitative Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in trials for CSPC, one of the most important primary endpoints was achieving Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4), Progression-Free Survival (PFS), Plaque Lesion Response Rates With Extended Treatment (Cycle 1 and 2 SGX301 vs Cycle 1 Placebo), and others. Based on these, the overall efficacy is evaluated.

Further, the therapies’ safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Reimbursement is a crucial factor that affects the drug’s access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.

In August 2024, Accord Healthcare announced that the NICE had published its final guidance recommending ORGOVYX for the treatment of HSPC, recognizing the treatment as cost-effective in England. The recommendation offers patients the choice to receive an oral preparation of an ADT for the first time

XTANDI combined with ADT, is a first-line option in treating patients with mHSPC. In February 2023, HAS gave an opinion in favor of reimbursement in the treatment of mHSPC in adult men in association with ADT.

Note: Further Details are provided in the final report

Conference highlights

In June 2025, Johnson & Johnson Innovative Medicine presented late-breaking data from the Phase III AMPLITUDE (Oral Abstract: LBA5006) trial evaluating AKEEGA plus prednisone for patients with mCSPC and alterations in homologous recombination repair genes at the American Society of Clinical Oncology (ASCO), 2025 in Chicago.

In June 2025, Astellas Pharma presented new clinical insights at ASCO 2025 across its approved cancer therapies. Key highlights included post hoc analyses from the EMBARK trial evaluating secondary outcomes in high-risk biochemically recurrent prostate cancer patients treated with enzalutamide alone (#5103) or in combination with leuprolide (#e17127), as well as a separate study on corticosteroid use and associated adverse events in mHSPC patients (#e17097).

In April 2025, real-world, head-to-head study data from TITAN evaluating ERLEADA versus XTANDI in patients with mCSPC were presented at the 50th Annual Oncology Nursing Society (ONS) Congress.

In April 2025, Bayer presented new data on NUBEQA at the American Urological Association (AUA) Annual Meeting, reinforcing its potential as a treatment option across the prostate cancer disease spectrum and in diverse patient populations. Key presentations included post-hoc analyses from the Phase III ARANOTE trial, highlighting the significance of ultra-low PSA responses (<0.02 ng/mL) and their correlation with improved clinical outcomes in patients with mHSPC treated with NUBEQA plus ADT.

Note: Further Details are provided in the final report

Scope of the Report

The report covers a segment of key events, an executive summary, and a descriptive overview of CSPC, explaining its causes, signs and symptoms, and currently available therapies.

Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential, disease progression, and treatment guidelines.

Additionally, an all-inclusive account of the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will impact the current treatment landscape.

A detailed review of the castration-sensitive prostate cancer market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.

The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM castration-sensitive prostate cancer.

Castration-sensitive Prostate Cancer (CSPC) Report Insights

Patient Population

Therapeutic Approaches

CSPC Pipeline Analysis

CSPC Market Size and Trends

Existing and future Market Opportunity

Castration-sensitive Prostate Cancer (CSPC) Report Key Strengths

Ten Years Forecast

The 7MM Coverage

CSPC Epidemiology Segmentation

Key Cross Competition

Conjoint analysis

Drugs Uptake and Key Market Forecast Assumptions

Castration-sensitive Prostate Cancer (CSPC) Report Assessment

Current Treatment Practices

Unmet Needs

Pipeline Product Profiles

Market Attractiveness

Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

What is the historical and forecasted castration-sensitive prostate cancer patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?

What was the total CSPC market size, the market size by therapies, market share (%) distribution in 2024, and what would it look like in 2034? What are the contributing factors for this growth?

What are the pricing variations among different geographies for approved and off-label therapies?

How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

What are the current and emerging options for treating CSPC?

How many companies are developing therapies to treat CSPC?

What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?

Patient acceptability in terms of preferred treatment options as per real-world scenarios?

What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy

The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the CSPC Market.

Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years

Understand the existing market opportunities in varying geographies and the growth potential over the coming years.

Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.

Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.

To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.

Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

285 Pages
1. Key Insights
2. Report Introduction
3. Executive Summary of CSPC
4. Key Events
5. Epidemiology and Market Forecast Methodology
6. CSPC Market Overview at a Glance
6.1. Market Share of CSPC by Class (%) in 2024 in the 7MM
6.2. Market Share of CSPC by Class (%) in 2034 in the 7MM
6.3. Market Share of CSPC by Therapies (%) in the 7MM in 2024
6.3.1.1. Market Share of nmCSPC by Therapies (%)
6.3.1.2. Market Share of mCSPC by Therapies (%)
6.4. Market Share of CSPC by Therapies (%) in the 7MM in 2034
6.4.1.1. Market Share of nmCSPC by Therapies (%)
6.4.1.2. Market Share of mCSPC by Therapies (%)
7. Disease Background and Overview
7.1. Signs and Symptoms of Prostate Cancer
7.2. Grading and Staging
7.3. Risk Factors and Causes of Prostate Cancer
7.4. Biochemical Recurrence
7.5. Diagnosis
8. Treatment and Management
8.1. Impact of PSMA PET on Prostate Cancer Management
8.2. Guidelines
8.2.1. National Comprehensive Cancer Network Guidelines for Prostate Cancer (NCCN) (2025)
8.2.2. Updates to Advanced Prostate Cancer: American Urology Association/Society of Urologic Oncology Guideline (2023)
8.2.3. Recommendations From the US Prostate Cancer Conference (USPCC) (2024)
8.2.4. European Association of Urology Guidelines for mHSPC (2025)
8.2.5. European Society for Medical Oncology (ESMO) Treatment Recommendations for Prostate Cancer
8.2.6. National Institute for Health and Care Excellence (NICE) (2021)
8.2.7. Advanced Prostate Cancer Consensus Conference (APCCC) (2024)
8.2.8. Japanese Clinical Practice Guidelines for Prostate Cancer (2023)
8.2.8.1. Prostate Cancer Screening
8.2.8.2. mCSPC Treatment
9. Epidemiology and Patient Population
9.1. Key Findings
9.2. Assumptions and Rationale
9.3. Total Prevalent Cases of Prostate Cancer in the 7MM
9.4. Five-year Prevalent Cases of Prostate Cancer in the 7MM
9.5. Total Prevalent Cases of CSPC in the 7MM
9.5.1. Total Prevalent Cases of nmCSPC in the 7MM
9.5.2. Total Prevalent Cases of mCSPC in the 7MM
9.6. The United States
9.6.1. Five-year Prevalent Cases of Prostate Cancer in the US
9.6.2. Age-specific Cases of Prostate Cancer in the US
9.6.3. Total Prevalent Cases of Prostate Cancer by Clinical Stages in the US
9.6.4. Total Prevalent Cases of CSPC in the US
9.6.4.1. Total Prevalent Cases of nmCSPC in the US
9.6.4.2. Total Prevalent Cases of mCSPC in the US
9.7. EU4 and the UK
9.7.1. Five-year Prevalent Cases of Prostate Cancer in EU4 and the UK
9.7.2. Age-specific Cases of Prostate Cancer in EU4 and the UK
9.7.3. Total Prevalent Cases of Prostate Cancer by Clinical Stages in EU4 and the UK
9.7.4. Total Prevalent Cases of CSPC in EU4 and the UK
9.7.4.1. Total Prevalent Cases of nmCSPC in EU4 and the UK
9.7.4.2. Total Prevalent Cases of mCSPC in EU4 and the UK
9.8. Japan
9.8.1. Five-year Prevalent Cases of Prostate Cancer in Japan
9.8.2. Age-specific Cases of Prostate Cancer in Japan
9.8.3. Total Prevalent Cases of Prostate Cancer by Clinical Stages in Japan
9.8.4. Total Prevalent Cases of CSPC in Japan
9.8.4.1. Total Prevalent Cases of nmCSPC in Japan
9.8.4.2. Total Prevalent Cases of mCSPC in Japan
10. Patient Journey
11. Marketed Drugs
11.1. Key Competitors
11.1. ZYTIGA (abiraterone acetate): Johnson & Johnson Innovative Medicine (Janssen Pharmaceutical)
11.1.1. Product Description
11.1.2. Regulatory Milestones
11.1.3. Other Developmental Activities
11.1.4. Clinical Development activity
11.1.4.1. Clinical Trial Information in mCSPC
11.1.5. Safety and Efficacy
11.1.6. Analyst Views
11.2. XTANDI (enzalutamide): Astellas Pharma/Pfizer
11.2.1. Product Description
11.2.2. Regulatory Milestones
11.2.3. Other Developmental Activities
11.2.4. Clinical Development activity
11.2.4.1. Clinical Trial Information in nmCSPC
11.2.5. Safety and Efficacy
11.2.6. Analyst Views
11.3. NUBEQA (darolutamide): Bayer and Orion Corporation
11.3.1. Product Description
11.3.2. Regulatory Milestones
11.3.3. Other Development Activities
11.3.4. Clinical Development
11.3.4.1. Clinical Trials Information in mCSPC
11.3.4.2. Clinical Trials Information in nmCSPC
11.3.5. Safety and Efficacy
11.3.6. Analyst Views
11.4. ERLEADA (apalutamide): Johnson & Johnson Innovative Medicine (Janssen Pharmaceutical)
11.4.1. Product Description
11.4.2. Regulatory Milestones
11.4.3. Other Developmental Activities
11.4.4. Clinical Development
11.4.4.1. Clinical Trials Information in mCSPC
11.4.5. Safety and Efficacy
11.4.6. Analyst Views
11.5. ORGOVYX (relugolix): Sumitovant Biopharma/Myovant Sciences, Pfizer, and Accord Healthcare
11.5.1. Product Description
11.5.2. Regulatory Milestones
11.5.3. Other Developmental Activities
11.5.4. Safety and Efficacy
11.5.5. Analyst Views
12. Emerging Therapies
12.1. Key Competitors
12.2. TRUQAP (capivasertib/AZD5363): AstraZeneca
12.2.1. Product Description
12.2.2. Other Developmental Activities
12.2.3. Clinical Development
12.2.3.1. Clinical Trials Information in mCSPC
12.2.4. Safety and Efficacy
12.2.5. Analyst Views
12.3. TAVT-45 (abiraterone acetate): Tavanta Therapeutics
12.3.1. Product Description
12.3.2. Other Developmental Activities
12.3.3. Clinical Development
12.3.3.1. Clinical Trials Information in mCSPC
12.3.4. Safety and Efficacy
12.3.5. Analyst Views
12.4. Saruparib (AZD5305): AstraZeneca
12.4.1. Product Description
12.4.2. Other Developmental Activities
12.4.3. Clinical Development
12.4.3.1. Clinical Trials Information in mCSPC
12.4.4. Safety and Efficacy
12.4.5. Analyst Views
12.5. MVI-816 (pTVG-HP): Madison Vaccines
12.5.1. Product Description
12.5.2. Other Developmental Activity
12.5.3. Clinical Development
12.5.3.1. Clinical Trials Information in nmPSA-RPC
12.5.4. Safety and Efficacy
12.5.5. Analyst Views
12.6. AKEEGA (niraparib and abiraterone acetate): Johnson & Johnson Innovative Medicine (Janssen Pharmaceuticals)
12.6.1. Product Description
12.6.2. Other Developmental Activities
12.6.3. Clinical Development
12.6.3.1. Clinical Trial Information in mCSPC
12.6.4. Safety and Efficacy
12.6.5. Analyst Views
12.7. TALZENNA (talazoparib): Pfizer
12.7.1. Product Description
12.7.2. Other Developmental Activities
12.7.3. Clinical Development
12.7.3.1. Clinical Trial Information in mCSPC
12.7.4. Analyst Views
12.8. PLUVICTO (177Lu-PSMA-617): Novartis
12.8.1. Product Description
12.8.2. Other Development Activities
12.8.3. Clinical Development
12.8.3.1. Clinical Trials Information in mCSPC
12.8.3.2. Clinical Trials Information in Oligometastatic Prostate Cancer
12.8.4. Safety and Efficacy
12.8.5. Analyst Views
13. CSPC: 7MM Market Analysis
13.1. Key Findings
13.2. Market Outlook
13.3. Conjoint Analysis
13.4. Key Market Forecast Assumptions
13.4.1. Cost Assumptions and Rebates
13.4.2. Pricing Trends
13.4.3. Analogue Assessment
13.4.4. Launch Year and Therapy Uptake
13.5. Total Market Size of CSPC in the 7MM
13.6. Total Market Size of CSPC by Class in the 7MM
13.7. Total Market Size of CSPC by Therapies in the 7MM
13.7.1. Market Size of nmCSPC by Therapies in the 7MM
13.7.2. Market Size of mCSPC by Therapies in the 7MM
13.8. United States
13.8.1. Total Market Size of CSPC
13.8.2. Total Market Size of CSPC by Therapies in the US
13.8.2.1. Market Size of nmCSPC by Therapies in the US
13.8.2.2. Market Size of mCSPC by Therapies in the US
13.9. EU4 and the UK
13.9.1. Total Market Size of CSPC in EU4 and the UK
13.9.2. Total Market Size of CSPC by Therapies in EU4 and the UK
13.9.2.1. Market Size of nmCSPC by Therapies in EU4 and the UK
13.9.2.2. Market Size of mCSPC by Therapies in EU4 and the UK
13.1. Japan
13.10.1. Total Market Size of CSPC in Japan
13.10.2. Total Market Size of CSPC by Therapies in Japan
13.10.2.1. Market Size of nmCSPC by Therapies in Japan
13.10.2.2. Market Size of mCSPC by Therapies in Japan
14. Unmet Needs
15. SWOT Analysis
16. KOL Views
17. Market Access and Reimbursement
17.1. United States
17.1.1. Centre for Medicare and Medicaid Services (CMS)
17.2. EU4 and the UK
17.2.1. Germany
17.2.2. France
17.2.3. Italy
17.2.4. Spain
17.2.5. United Kingdom
17.3. Japan
17.3.1. MHLW
17.4. CSPC Market Access and Reimbursement
18. Appendix
18.1. Bibliography
18.2. Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
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