Key Highlights
- The Castration-sensitive Prostate Cancer Market in the 7MM was valued at approximately USD 5.14 billion in 2025 over the forecast period from 2026 to 2036.
- The Castration-sensitive Prostate Cancer Market is projected to grow at a CAGR of 10% by 2036 in the leading countries (the US, EU4, UK, and Japan)
Castration Sensitive Prostate Cancer Market and Epidemiology Analysis
- 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.
- 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.
- The leading Castration Sensitive Prostate Cancer Companies, such as 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.
Castration Sensitive Prostate Cancer Market Size and Forecast
- 2025 Castration Sensitive Prostate Cancer Market Size: USD 5.14 billion
- 2036 Projected Castration Sensitive Prostate Cancer Market Size: USD 11.75 billion
- Castration Sensitive Prostate Cancer Growth Rate (2026-2036): 10% CAGR
- Largest Castration Sensitive Prostate Cancer Market: United States
Key Factors Driving the Growth of the Castration-sensitive Prostate Cancer Market
- Rising prostate cancer incidence and ageing populations
- Competitive Dynamics in the CSPC Market
- Advances in Mutation-Targeted CSPC Therapies
- Radioligand and PARP Inhibitors Driving Future CSPC Market Growth
The “Castration-sensitive Prostate Cancer Treatment Market Insights, Epidemiology, and Market Forecast - 2036” report delivers an in-depth understanding of the Castration-sensitive Prostate Cancer, historical and forecasted epidemiology as well as the Castration-sensitive Prostate Cancer Market Trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
The Castration-sensitive Prostate Cancer Treatment Market Report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM Castration-sensitive Prostate Cancer market size from 2022 to 2036. The report also covers current Castration-sensitive Prostate Cancer treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.
Castration Sensitive Prostate Cancer Disease Understanding
Castration Sensitive Prostate Cancer 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 still responds to hormone-lowering therapy.Castration Sensitive Prostate Cancer Diagnosis
Advanced cancer can be detected before, simultaneously with, or after the primary tumor. Most individuals diagnosed with advanced prostate cancer have previously undergone a biopsy and some form of treatment. When a new tumor appears in someone with a prior cancer history, it often indicates that the cancer has spread. Initial assessment typically includes PSA testing, a digital rectal examination (DRE), prostate biopsy, and imaging studies such as MRI, CT scans, or bone scans to determine the extent of disease. Based on imaging results, castration-sensitive prostate cancer (CSPC) is classified as either non-metastatic (M0) or metastatic (M1). Distinguishing between local recurrence and metastatic disease can sometimes be difficult, with histological evaluation and PSA trends providing critical diagnostic information. Precise diagnosis and staging at this stage are vital, as they guide treatment decisions - from potentially curative therapies for localized disease to systemic approaches for metastatic cases.Castration Sensitive Prostate Cancer Treatment
The management of nmCSPC has undergone considerable evolution. In the past, treatment options were largely limited to androgen deprivation therapy (ADT) or observation, particularly for patients experiencing high-risk biochemical recurrence following primary therapy. As insights into disease progression advanced, interventions such as salvage radiotherapy emerged as first-line options. The 2023 approval of XTANDI represented a major milestone, introducing the first targeted anti-androgen therapy specifically for nmCSPC with high-risk biochemical recurrence. This approval established a new standard of care, allowing for earlier and more effective treatment.In the metastatic hormone-sensitive prostate cancer (mHSPC) setting, several systemic therapies have become available. While ADT remains the cornerstone of treatment, adding docetaxel chemotherapy or second-generation antiandrogens - such as abiraterone, apalutamide, and enzalutamide - has shown survival benefits. The growing range of therapeutic options has broadened treatment possibilities but also poses a challenge for clinicians in determining the most suitable agent for treatment intensification for each patient.
Castration Sensitive Prostate Cancer 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 2022 to 2036.Castration Sensitive Prostate Cancer Epidemiological Analysis and Forecast
- 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 (2026-2036).
- 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 Epidemiology Segmentation
- Total Prevalent cases of Prostate cancer
- Five-year Prevalent cases of Prostate cancer
- Total cases of Prostate cancer by clinical stages
- Five-year Prevalent cases of CSPC
- Total Prevalent cases of nmCSPC and mCSPC
- Age-specific cases of Prostate cancer
Castration Sensitive Prostate Cancer Drug Analysis
The drug chapter segment of the Castration Sensitive Prostate Cancer Therapeutics Market Report encloses a detailed analysis of marketed and emerging drugs of late-stage (Phase III and Phase II) Castration Sensitive Prostate Cancer 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.Castration Sensitive Prostate Cancer Marketed Drugs
- NUBEQA (darolutamide): Bayer and Orion Corporation
In April 2025, Bayer shared new findings on NUBEQA at the AUA Annual Meeting. Key updates included post-hoc analyses from the Phase III ARANOTE trial showing that ultra-low PSA responses are associated with improved outcomes in metastatic hormone-sensitive prostate cancer (mHSPC), long-term safety results from the ARASENS Rollover trial, and progress from the ongoing ARASTEP trial in patients with high-risk biochemical recurrence.
- XTANDI (enzalutamide): Astellas Pharma/Pfizer
According to Pfizer’s Q1 2025 SEC filing, starting in August 2024, the company filed patent infringement lawsuits against generic drug applicants in the US District Court for the District of New Jersey, asserting both the validity and infringement of the relevant patents.
Castration Sensitive Prostate Cancer Emerging Drugs
- TRUQAP (capivasertib, AZD 5363): AstraZeneca
- Saruparib (AZD5305): AstraZeneca
Castration Sensitive Prostate Cancer Drug Class Insights
The current treatment landscape offers a wide array of therapeutic options, including androgen receptor inhibitors, CYP17 inhibitors, PARP inhibitors, AKT inhibitors, PSMA-targeted radioligand therapy, GnRH receptor antagonists, and other agents across different lines of therapy.Androgen receptor pathway inhibitors remain a cornerstone for patients with CSPC. In the United States, four such inhibitors are approved: three anti-androgens - ERLEADA, XTANDI, and NUBEQA. CYP17 inhibitors, such as ZYTIGA, work by limiting androgen production that drives tumor growth. GnRH receptor antagonists (e.g., ORGOYVX) offer a newer method of androgen deprivation, rapidly reducing LH and testosterone levels without the initial surge associated with LHRH agonists.
Beyond hormone-based therapies, PARP inhibitors (e.g., saruparib, TALZENNA) have shown promise, particularly in patients with HRR gene mutations such as BRCA. Another innovative strategy is PSMA-targeted radioligand therapy, which delivers radiation specifically to PSMA-expressing cells using agents like [^177Lu] Lu-PSMA-617. While currently approved for mCRPC, research is exploring its use in earlier disease stages, including mCSPC.
Overall, these varied therapeutic classes illustrate a shift toward mechanism-based and biomarker-guided strategies in CSPC, combining hormonal therapies with targeted and precision approaches to enhance outcomes in both non-metastatic and metastatic settings.
Castration Sensitive Prostate Cancer Market Outlook
mCSPC, also known as mHSPC, is an advanced stage of prostate cancer in which the disease has metastasized but remains responsive to hormone therapy. Over the past twenty years, the treatment landscape for mCSPC has evolved significantly. Therapy has shifted from relying solely on ADT to more intensive approaches, including doublet regimens with ZYTIGA, ERLEADA, or XTANDI; triplet regimens combining docetaxel with ZYTIGA or NUBEQA; and ADT plus external beam radiotherapy (EBRT) for patients with low metastatic burden. ADT monotherapy is now generally discouraged except when combination therapy is contraindicated. Ongoing research and clinical trials are expected to further refine optimal treatment strategies, ultimately enhancing outcomes and quality of life for patients with mCSPC.In contrast, nmHSPC or nmCSPC refers to prostate cancer that has not yet spread to distant sites detectable via standard imaging techniques such as CT or MRI, and the disease remains sensitive to testosterone-lowering therapies. Until 2023, nmCSPC had no approved treatment options. Standard management had been ADT or active surveillance, but the approval of the anti-androgen XTANDI in combination with leuprolide marked a major advancement.
In 2023, XTANDI became the first therapy in the US approved for nmCSPC with high-risk biochemical recurrence (BCR), based on the EMBARK trial, which demonstrated a statistically significant improvement in metastasis-free survival (MFS) for XTANDI plus leuprolide compared to placebo plus leuprolide.
XTANDI has experienced strong global sales growth in recent years, driven by its proven efficacy across multiple prostate cancer stages, including mHSPC, and its expansion into combination therapy settings. Astellas reported a 21.6% year-over-year revenue increase from 2023 to 2024, with growth across all regions. However, the company anticipates a 4.9% decline in future sales due to expected loss of exclusivity in Europe and Japan in 2026 and in the US in 2027.
- The total market size of CSPC in the United States was approximately USD 2.58 billion in 2024 and is projected to increase during the forecast period (2026-2036).
- 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 2036, among the therapies, the highest revenue is expected to be generated by NUBEQA in the EU4 and the UK.
Castration Sensitive Prostate Cancer Drugs Uptake
This section focuses on the uptake rate of potential Castration prostate Cancer drugs expected to be launched in the market during 2026-2036, 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.
Castration Sensitive Prostate Cancer 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. The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for CSPC emerging therapies.Latest KOL Views on Castration Sensitive Prostate Cancer
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.The 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 market trends.
Castration Sensitive Prostate Cancer Report 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.
Castration Sensitive Prostate Cancer 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 timeXTANDI 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.
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.
Scope of the Castration Sensitive Prostate Cancer Market Report
- The Castration Sensitive Prostate Cancer Therapeutics Market 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 Castration Sensitive Prostate Cancer Therapeutics Market 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 Market Report Insights
- Patient-based Castration Sensitive Prostate Cancer Market Forecasting
- Therapeutic Approaches
- CSPC Pipeline Analysis
- CSPC Market Size and Trends
- Existing and future Market Opportunity
Castration Sensitive Prostate Cancer Market Report Key Strengths
- 11 Years Castration Sensitive Prostate Cancer Market Forecast
- The 7MM Coverage
- CSPC Epidemiology Segmentation
- Key Cross Competition
- Conjoint analysis
- Castration Sensitive Prostate Cancer Drugs Uptake
- Key Castration Sensitive Prostate Cancer Market Forecast Assumptions
Castration Sensitive Prostate Cancer Market Report Assessment
- Current Castration Sensitive Prostate Cancer Treatment Practices
- Castration Sensitive Prostate Cancer Unmet Needs
- Castration Sensitive Prostate Cancer Pipeline Drugs Profiles
- Castration Sensitive Prostate Cancer Drugs Market Attractiveness
- Qualitative Analysis (SWOT and Conjoint Analysis)
Key Questions Answered in the Castration Sensitive Prostate Cancer Market Report
Castration Sensitive Prostate Cancer Market Insights
- 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 2025, and what would it look like in 2036? 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 Castration Sensitive Prostate Cancer Market Report
- The Castration Sensitive Prostate Cancer Therapeutics Market Report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the CSPC Market.
- Insights on patient burden/disease, Castration Sensitive Prostate Cancer 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.
This product will be updated with the latest data at the time of order. Consequently, dispatch time for this product will be 7-10 business days.
Table of Contents
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Janssen Research and Development
- AstraZeneca
- Merck
- Pfizer
- Astellas Pharma
- Bayer
- Novartis

