Neuroendocrine Prostate Cancer Market

Key Highlights

• Prostate cancer requires AR-mediated signaling for tumor growth; therefore, androgen deprivation therapy (ADT) is the first-line treatment for advanced prostate cancer. However, prostate cancer cells can eventually adapt to androgen deprivation and relapse by restoring AR signaling even in a low androgen production environment, a status referred to as castration-resistant prostate cancer (CRPC).
• Current treatment options for NEPC are limited to highly toxic platinum drugs, highlighting the urgent need for new therapies.
• Current therapies to treat NEPC are largely based on their success in treating patients with small cell lung cancer (SCLC), a lung cancer that shares the neuroendocrine phenotype with NEPC.
• De novo NEPC patients have no prior diagnosis or treatment for prostate adenocarcinoma. Whereas, treatment-emergent neuroendocrine prostate cancer (T-NEPC) is a kind of advanced CRPC induced by the transition of regular prostate adenocarcinoma after ADT. Regardless of their origins, both types are effective. With a 5-year life expectancy, NEPC patients have a dismal prognosis and low survival rates.
• Docetaxel is the preferred chemotherapy regimen for prostate cancer. However, in small cell carcinoma or t-NEPC, the chemotherapy regimen is similar to that in small cell lung cancer, and the commonly used regimens are cisplatin or carboplatin combined with etoposide. As per the latest corporate presentation of BioXcel Therapeutics, published in April 2025, the company anticipates an FDA meeting for BXCL701 in SCNC.
• BXCL701 shows potential to address unmet needs in small cell neuroendocrine (SCNC) prostate cancer, offering a promising treatment option for these distinct phenotypes.
• In mCRPC, ARPI-related NEPC is often underdiagnosed; due to the lack of biomarkers, routine repeat biopsy is essential to detect t-NEPC transitions.
• The pipeline of NEPC is very robust, emerging therapies such as BXCL701 (OnkosXcel Therapeutics [a subsidiary of BioXcel Therapeutics]), Peluntamig (Phanes Therapeutics), IMDELLTRA/IMDYLLTRA (tarlatamab, Amgen), PLUVICTO (AAA617, Novartis), FPI-2059 (Fusion Pharma), and others are being developed for safe and efficacious treatments.

DelveInsight's “Neuroendocrine Prostate Cancer (NEPC) – Market Insight, Epidemiology and Market Forecast – 2034” report delivers an in-depth analysis of NEPC epidemiology, market, and clinical development in NEPC. In addition to this, the report provides historical and forecasted epidemiology and market data as well as a detailed analysis of the NEPC market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

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

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Neuroendocrine Prostate (NEPC) Understanding and Treatment Algorithm

NEPC Overview

NEPC is an aggressive variant of prostate cancer that may arise de novo or in patients previously treated with hormonal therapies for prostate adenocarcinoma as a mechanism of resistance. Despite being important to recognize, the clinical features of NEPC are poorly defined and could help guide when to perform a biopsy to look for NEPC histologic transformation.

NEPC Diagnosis

The diagnosis of NEPC is currently based on metastatic tumor biopsy, confirming tumor morphology. Although there are no standard criteria for when to perform a biopsy to look for NEPC, one may consider this in patients with particularly aggressive disease, atypical spread, and/or progression with low or non-rising PSA levels. The NCCN guidelines currently recommend consideration of metastatic biopsy in suspected cases of NEPC transformation, as prostate cancer patients who develop small cell carcinoma could be considered for platinum-based chemotherapy regimens (similar to SCLC).

Further details in the diagnosis are provided in the report

NEPC Cancer Treatment

Platinum-based chemotherapy is commonly administered to patients with pure small cell carcinoma based on SCLC data and the accumulating data for Aggressive Variant Prostate Cancer (AVPC). This may consist of a combination of carboplatin (or sometimes cisplatin) plus either etoposide (based on SCLC) or a taxane (especially if mixed histology or AVPC features).

Beyond platinum, therapy for NEPC is not well established. Based on clinical and pathologic features, second-line SCLC regimens or alternative CRPC therapies could be considered. There may be rationale for using immune checkpoint inhibitor therapy based on SCLC data, either upfront, such as atezolizumab with platinum chemotherapy, or in the second-line setting, such as nivolumab plus ipilimumab; however, studies focused on NEPC have not yet been reported.

Currently, there are no approved drugs for the treatment of NEPC.

Neuroendocrine Prostate (NEPC) Cancer Epidemiology

The NEPC cancer epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total incident cases of prostate cancer, total incident cases of NEPC, type-specific cases of NEPC, and treated cases of NEPC in the 7MM, covering the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2020 to 2034.

• In 2024, the US accounted for the highest prevalent cases of prostate cancer among the 7MM, i.e., approximately 3,751,850.
• Prostate cancer is most frequently diagnosed in men aged 65-74, with a median diagnosis age of 66. As life expectancy rises, more men are entering high-risk age groups, driving up case numbers.
• According to secondary research, approximately 60% of patients are diagnosed at localized or locally advanced stages, which is supported by early detection and favorable survival rates. Around 33% go on to develop biochemical recurrence, while the remaining cases involve metastatic progression, often due to resistance to initial therapies, reflecting the ongoing need for effective long-term management strategies.
• As per secondary search, around 1% of prostate cancer patients present with pure neuroendocrine histology at diagnosis, while 15–20% of advanced-stage cases may develop neuroendocrine features over time.

Neuroendocrine Prostate (NEPC) Drug Chapters

The drug chapter segment of the NEPC report encloses a detailed analysis of NEPC’s late-stage (Phase II and Phase I) pipeline drugs. It also deep dives into NEPC’s pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Emerging Drugs

BXCL701: OnkosXcel Therapeutics (a Subsidiary of BioXcel Therapeutics)

BXCL701 is an investigational, oral innate immune activator that demonstrated a 25% composite response rate in a Phase IIa clinical trial to treat patients with small cell neuroendocrine carcinoma (SCNC) phenotype metastatic castration-resistant prostate cancer (mCRPC). BXCL701 is currently being developed as a potential therapy for the treatment of aggressive forms of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors.

• In February 2024, BioXcel Therapeutics received Fast Track Designation from FDA for BXCL701 in combination with a CPI for the treatment of patients with metastatic for the treatment of SCNC with progression on chemotherapy and no evidence of microsatellite instability.
• Earlier in August 2023, the development was paused due to strategic reprioritization.

PT217: Phanes Therapeutics

PT217 is a first-in-class bispecific antibody targeting delta-like ligand 3 (DLL3) and cluster of differentiation 47 (CD47). PT217 is currently being evaluated in the multicenter, dose-escalation and expansion, multicohort Phase I/II SKYBRIDGE trial (NCT05652686), assessing its use as monotherapy or in combination with TECENTRIQ (atezolizumab) in patients with advanced or refractory DLL3-expressing cancers, including small cell lung cancer (SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC), and extra-pulmonary neuroendocrine carcinoma (EP-NEC), including NEPC.

• In August 2024, Phanes Therapeutics announced that the US FDA had granted orphan drug designation (ODD) to PT217 for the treatment of neuroendocrine carcinoma.
• In December 2024, the US FDA granted Fast Track Designation (FTD) to PT217 for the treatment of patients with metastatic de novo or treatment-emergent NEPC.

Note: Detailed emerging therapies assessment will be provided in the final report.

Neuroendocrine Prostate (NEPC) Drug Class Insights

DPP-directed therapies

Dipeptidyl peptidases (DPPs) are serine proteases that are phylogenetically related. DPP8 and DPP9 belong to the S9b subfamily of serine proteases, including DPP IV. Dipeptidyl peptidase IV (DPP-IV, CD26) is frequently dysregulated in cancer and plays an important role in regulating multiple bioactive peptides with the potential to influence cancer progression and the recruitment of immune cells. Therefore, it represents a potential contributing factor to cancer pathogenesis and an attractive therapeutic target.

Neuroendocrine Prostate (NEPC) Market Outlook

Currently, there is no FDA-approved therapy specifically indicated for the treatment of NEPC. Due to its aggressive nature and distinct biology compared to typical prostate adenocarcinoma, treatment options for NEPC remain limited.

The diagnosis of NEPC is currently based on metastatic tumor biopsy, confirming tumor morphology. Although there are no standard criteria for when to perform a biopsy to look for NEPC, one may consider this in patients with particularly aggressive disease, atypical spread, and/or progression with low or non-rising PSA levels. The NCCN guidelines currently recommend consideration of metastatic biopsy in suspected cases of NEPC transformation, as prostate cancer patients who develop small cell carcinoma could be considered for platinum-based chemotherapy regimens similar to SCLC.

Key players, such as OnkosXcel Therapeutics (a Subsidiary of BioXcel Therapeutics), Phanes Therapeutics, Amgen, Novartis, Fusion Pharma, and others, are evaluating their lead candidates in different stages of clinical development. They aim to investigate their products for the treatment of NEPC.

Neuroendocrine Prostate (NEPC) drug 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, and efficacy data, along with the 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.

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

Neuroendocrine Prostate (NEPC) Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase II, Phase I/II, and Phase I stages. 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 NEPC cancer 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 were 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 10+ KOLs in the 7MM. Centers such as Fred Hutchinson Cancer Center, UNC Lineberger Comprehensive Cancer Center, UT Southwestern Medical Center in Dallas, Cancer Research UK Barts Centre in London, LUNGevity Foundation, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or NEPC market trends.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis 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, 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 event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

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 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 may be referred to as the negotiation of a price between a manufacturer and a payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs) and third-party organizations that provide services and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, a descriptive overview of NEPC, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the NEPC 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 in shaping and driving the 7MM NEPC market.

Neuroendocrine Prostate (NEPC) Report Insights

• Patient Population
• Therapeutic Approaches
• NEPC Pipeline Analysis
• NEPC Market Size and Trends
• Existing and future Market Opportunity

Neuroendocrine Prostate (NEPC) Report Key Strengths

• Ten-Years Forecast
• 7MM Coverage
• NEPC Epidemiology Segmentation
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Neuroendocrine Prostate (NEPC) 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 NEPC patient pool/patient burden in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• 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 the treatment of NEPC?
• 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?
• How many key players are developing therapies for NEPC?
• Which drug is the major contributor NEPC market by 2034?

Reasons to buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the NEPC market.
• Insights on patient burden/disease Incidence, 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), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• 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.