PUBLISHER: DelveInsight | PRODUCT CODE: 1951024
PUBLISHER: DelveInsight | PRODUCT CODE: 1951024
Castration Sensitive Prostate Cancer Market and Epidemiology Analysis
Castration Sensitive Prostate Cancer Market Size and Forecast
Key Factors Driving the Growth of the Castration-sensitive Prostate Cancer Market
Prostate cancer incidence is strongly associated with age, most frequently diagnosed in men between 65 and 74 years. However, age-specific patterns vary across regions, with the lowest prevalence observed in individuals over 84 years in the US, while in Japan, cases are least common among men aged 54 years or younger. Overall, prostate cancer risk rises with advancing age, and ongoing global demographic shifts toward older populations are expanding the diagnosed patient pool, thereby increasing the addressable market for CSPC therapies and diagnostics.
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 CSPC market share.
The development of therapies targeting specific mutations is expected to perform better in the future, such as AKEEGA (HRR gene-mutated mCSPC), TALZENNA (DDR-deficient mCSPC), TRUQAP (de novo PTEN-deficient mHSPC), and others.
The emergence of radioligand and PARP inhibitor therapies in CSPC makes it a lucrative market in the future. Johnson & Johnson, the first to demonstrate the benefits of the PARP + androgen receptor pathways combo (niraparib + abiraterone) in HRR-mutated mCSPC, may gain an early-mover advantage in precision CSPC.
DelveInsight's "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.
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
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 is an oral androgen receptor inhibitor (ARI) with a distinct chemical structure that binds strongly to the androgen receptor, effectively blocking its activity and suppressing the growth of prostate cancer cells. Preclinical studies and neuroimaging in healthy volunteers indicate that darolutamide has minimal potential to cross the blood-brain barrier. Developed collaboratively by Bayer and Orion Corporation, NUBEQA is approved for use in adults with metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
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 is an inhibitor of androgen receptor signaling. Enzalutamide, recognized as a standard of care, has obtained regulatory approval in multiple countries for treating men with mHSPC and nmHSPC who are at high risk of BCR. The expanded approval of XTANDI is supported by findings from the Phase III EMBARK trial in men with high-risk BCR nmHSPC. In April 2024, the European Association of Urology (EAU) updated its treatment guidelines to recommend enzalutamide for men with high-risk BCR nmHSPC, either with or without ADT, following radiation therapy or surgery.
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 is a novel pyrrolopyrimidine compound that functions as an orally administered inhibitor of the serine/threonine kinase AKT (protein kinase B), showing potential anticancer effects. The company has completed Phase Ib and Phase I/II trials of capivasertib for prostate cancer. Additionally, AstraZeneca is evaluating capivasertib in combination with ZYTIGA in the Phase III CAPItello-281 study for metastatic hormone-sensitive prostate cancer (mHSPC) and in the CAPItello-280 study alongside docetaxel for metastatic castration-resistant prostate cancer (mCRPC).
AZD5305 is a highly potent and selective oral PARP inhibitor (PARPi) that primarily targets and traps PARP1, unlike currently approved PARPis, which inhibit both PARP1 and PARP2. Preclinical studies indicate that inhibiting PARP1 produces antiproliferative effects, whereas PARP2 inhibition is largely responsible for hematological toxicities. This suggests that AZD5305 could offer a better therapeutic index with reduced toxicity. The drug is currently in Phase III development for both HRRm and non-HRRm metastatic castration-sensitive prostate cancer (mCSPC). According to AstraZeneca's Q1 2025 clinical trial appendix, results from the saruparib Phase III trial (EvoPAR-Prostate01/NCT06120491) and Phase I/IIa trial (PETRANHA/NCT05367440) are expected after 2026.
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.
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.
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.
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 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 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.
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