PR Newswire
The non-metastatic prostate cancer market is expected to witness significant growth, driven by increasing disease awareness, improved screening practices, and advances in early-stage diagnosis. Additionally, a growing pipeline of therapies such as Relugolix (ORGOVYX) (Myovant/Sumitomo Pharma/Takeda/Accord), CAN-2409 (Candel Therapeutics), KPG-121 (Kangpu Biopharmaceuticals), and others is expected to create new opportunities and strengthen market expansion in the coming years.
Recently published Non-Metastatic Prostate Cancer Market Insights report includes a comprehensive understanding of current treatment practices, non-metastatic prostate cancer emerging drugs, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Non-Metastatic Prostate Cancer Market Summary
- The market size for non-metastatic prostate cancer was found to be USD 3.6 billion in the 7MM in 2025.
- The United States accounted for the largest non-metastatic prostate cancer treatment market size in the 7MM in 2025, compared to other major markets, including the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- The total diagnosed prevalent cases of non-metastatic prostate cancer were 386K in the 7MM in 2025.
- Leading non-metastatic prostate cancer companies, such as Myovant, Sumitomo Pharma, Takeda, Accord, Candel Therapeutics, Kangpu Biopharmaceuticals, Janssen Research & Development, Amgen, and others, are developing new non-metastatic prostate cancer treatment drugs that can be available in the non-metastatic prostate cancer market in the coming years.
- The promising non-metastatic prostate cancer therapies in clinical trials include Relugolix (ORGOVYX), CAN-2409, KPG-121, ERLEADA (apalutamide), XALURITAMIG (formerly AMG 509), and others.
- In 2036, among all the therapies for nmPC, XTANDI (enzalutamide) is expected to remain the top revenue-generating therapy in the non-metastatic prostate cancer market over the forecast period due to its market leadership and expanded indications.
Discover new treatment options for non-metastatic prostate cancer @ https://www.delveinsight.com/report-store/non-metastatic-prostate-cancer-market
Key Factors Driving the Growth of the Non-Metastatic Prostate Cancer Market
- Rising Disease Prevalence and Increasing Diagnosis Rates: The growing burden of prostate cancer worldwide, coupled with improved screening practices and increased awareness, is leading to the identification of more non-metastatic cases at earlier stages. Advances in PSA testing, imaging techniques, and clinical monitoring are contributing to higher diagnosis rates.
- Growing Adoption of Advanced Imaging Technologies: The increasing use of next-generation imaging modalities, such as prostate-specific membrane antigen positron emission tomography (PSMA-PET), is improving the detection and staging of non-metastatic prostate cancer. These technologies enable more accurate risk assessment and guide personalized treatment decisions.
- Advancements in Precision Medicine and Biomarker Development: The integration of genomic testing, molecular profiling, and biomarker-driven approaches is enabling better patient stratification and treatment selection. These advancements are supporting the development of targeted therapies tailored to specific disease characteristics.
- Expanding Clinical Pipeline and Emerging Therapies: A strong pipeline of investigational therapies, including next-generation AR inhibitors, targeted agents, immunotherapies, and radiopharmaceutical approaches, is expected to create new growth opportunities. Ongoing clinical trials are focused on improving outcomes and addressing unmet treatment needs.
Sadaf Javed, Functional Head of Forecasting & Analytics at DelveInsight, said that the next-generation androgen receptor inhibitors are expected to maintain consistent and competitive uptake as long-term efficacy and safety data continue to mature, and as they become more firmly embedded in treatment guidelines. Their adoption is further supported by increasing physician confidence, expanding clinical evidence, and a growing emphasis on early intervention to delay disease progression, reinforcing their central role in the evolving nmPC treatment landscape.
Non-Metastatic Prostate Cancer Market Analysis
- The prostate cancer market is experiencing a significant evolution, shifting from conventional treatment approaches centered on androgen deprivation therapy (ADT) and chemotherapy toward increasingly targeted and precision-based therapeutic strategies.
- The growing adoption of next-generation androgen receptor inhibitors, including enzalutamide and apalutamide, alongside PARP inhibitors and radioligand therapies, highlights the transition toward mechanism-driven and disease-modifying treatment approaches.
- These innovations are enhancing clinical confidence in targeted therapies while reshaping the competitive environment by expanding treatment options across both non-metastatic and metastatic disease settings.
- Ongoing advancements in DNA damage repair-targeted therapies, radiopharmaceuticals, and combination treatment strategies are further transforming the prostate cancer treatment landscape, mirroring trends observed across other oncology segments where early breakthroughs in targeted therapies continue to accelerate pipeline development.
- Among the major markets, the United States holds the largest share, driven by a high disease burden, established PSA screening practices, rapid uptake of advanced therapies, and a robust healthcare ecosystem, compared with European countries and Japan.
- Overall, the emergence of innovative targeted therapies, advancements in diagnostic and imaging technologies, and growing emphasis on early disease detection and management are anticipated to fuel consistent growth in the 7MM prostate cancer market through 2036.
- This evolving landscape is expected to create substantial commercial opportunities for both established therapies and next-generation pipeline candidates.
Non-Metastatic Prostate Cancer Competitive Landscape
Some of the non-metastatic prostate cancer drugs under development include Relugolix (ORGOVYX) (Myovant/Sumitomo Pharma/Takeda/Accord), CAN-2409 (Candel Therapeutics), KPG-121 (Kangpu Biopharmaceuticals), ERLEADA (apalutamide) (Janssen Research & Development), XALURITAMIG (formerly AMG 509) (Amgen), and others.
Myovant/Sumitomo Pharma/Takeda/Accord's ORGOVYX (relugolix) is an orally administered gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the FDA for the treatment of adult patients with advanced prostate cancer. The therapy works by inhibiting GnRH receptor signaling, thereby suppressing testicular testosterone production, a key androgen involved in promoting prostate cancer progression. Relugolix is a non-peptide GnRH receptor antagonist that competitively binds to pituitary GnRH receptors, leading to decreased secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), ultimately resulting in reduced testosterone levels.
In the clinical trial, eligible patients receiving leuprolide acetate or degarelix in combination with abiraterone or apalutamide before baseline were transitioned to relugolix. The study evaluated safety and treatment outcomes through monitoring of adverse events, clinical laboratory parameters, vital signs, electrocardiogram (ECG) findings, and serum testosterone concentrations. ORGOVYX is currently being assessed in a Phase I clinical trial to further evaluate its safety profile and tolerability in patients.
CAN-2409, Candel's most advanced viral immunotherapy candidate, is a replication-deficient adenoviral-based therapy designed to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene directly into tumor cells. HSV-tk converts orally administered valacyclovir into a cytotoxic metabolite within the tumor environment, resulting in the destruction of cancer cells. Intratumoral delivery of CAN-2409 promotes the release of tumor-specific neoantigens, while the adenovirus serotype 5 capsid protein stimulates a strong inflammatory response in the tumor microenvironment. This mechanism is intended to generate a targeted CD8+ T-cell-mediated immune response against both the injected tumor and distant metastatic lesions, providing a broad anti-tumor effect. CAN-2409 is currently being evaluated in a Phase III clinical trial to determine its safety and tolerability in patients.
Amgen's Xaluritamig is an investigational bispecific T-cell engager based on the XmAb® platform that targets six-transmembrane epithelial antigen of the prostate 1 (STEAP1) on tumor cells and CD3 on T cells. The therapy is being studied as a potential treatment option for patients with prostate cancer.
The anticipated launch of these emerging therapies are poised to transform the non-metastatic prostate cancer market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the non-metastatic prostate cancer market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
Discover more about which pipeline drugs could transform non-metastatic prostate cancer treatment @ Non-Metastatic Prostate Cancer Therapeutics Market
Recent Developments in the Non-Metastatic Prostate Cancer Market
- In March 2026, Candel Therapeutics to present extended follow-up data from Phase III CAN-2409 trial in localized prostate cancer at AUA 2026 annual meeting.
- In October 2025, Astellas to showcase innovative portfolio and pipeline developments at ESMO 2025.
- In September 2025, Candel Therapeutics showcases Phase III CAN-2409 clinical trial in localized prostate cancer at ASTRO 2025.
- In May 2025, FDA grants Regenerative Medicine Advanced Therapy (RMAT) designation to Candel Therapeutics' CAN-2409 for prostate cancer treatment.
Non-Metastatic Prostate Cancer Epidemiology Segmentation
The non-metastatic prostate cancer epidemiology section provides insights into the historical and current non-metastatic prostate cancer patient pool and forecasted trends for the leading markets. The majority of prostate cancer cases are diagnosed before distant spread, with approximately 70% of cases identified at a localized (non-metastatic) stage in the United States, reflecting the impact of early detection and PSA-based screening.
The non-metastatic prostate cancer treatment market report proffers epidemiological analysis for the study period 2022–2036 in the leading markets, segmented into:
- Total Diagnosed Prevalent Cases of Non-metastatic Prostate Cancer
- Age-specific Diagnosed Prevalent Cases of Non-metastatic Prostate Cancer
- Stage-specific Diagnosed Prevalent Cases of Non-metastatic Prostate Cancer
- Line-wise Treated Cases of Non-metastatic Prostate Cancer
Non-Metastatic Prostate Cancer Market Report Metrics | Details |
Study Period | 2022–2036 |
Coverage | 7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. |
Non-Metastatic Prostate Cancer Market CAGR | 4 % |
Non-Metastatic Prostate Cancer Market Size in 2025 | USD 3.6 Billion |
Key Non-Metastatic Prostate Cancer Companies | Myovant, Sumitomo Pharma, Takeda, Accord, Candel Therapeutics, Kangpu Biopharmaceuticals, Janssen Research & Development, Amgen, Astellas Pharma, Pfizer, Bayer, and others |
Key Non-Metastatic Prostate Cancer Therapies | Relugolix (ORGOVYX), CAN-2409, KPG-121, ERLEADA (apalutamide), XALURITAMIG (formerly AMG 509), XTANDI, NUBEQA, and others |
Scope of the Non-Metastatic Prostate Cancer Market Report
- Non-Metastatic Prostate Cancer Patient Population Forecast
- Non-Metastatic Prostate Cancer Therapeutics Market Size
- Non-Metastatic Prostate Cancer Pipeline Analysis
- Non-Metastatic Prostate Cancer Market Size and Trends
- Non-Metastatic Prostate Cancer Market Opportunity
- Non-Metastatic Prostate Cancer Market Unmet Needs
- KOL's Views on Non-Metastatic Prostate Cancer
- Non-Metastatic Prostate Cancer Market Access and Reimbursement
Download the report to understand the top emerging non-metastatic prostate cancer therapies @ Non-Metastatic Prostate Cancer Clinical Trials
Table of Contents
1 | Non-Metastatic Prostate Cancer Market Key Insights |
2 | Non-Metastatic Prostate Cancer Market Report Introduction |
3 | Executive Summary |
4 | Key Events |
5 | Epidemiology and Market Forecast Methodology |
6 | nmPC Market Overview at a Glance |
6.1 | Clinical Landscape Analysis (By Phase, Molecule Type, and RoA) |
6.2 | Market Share (%) Distribution of nmPC By Therapies in the 7MM, in 2025 |
6.3 | Market Share (%) Distribution of nmPC By Therapies in the 7MM, in 2036 |
7 | Disease Background and Overview of Non-Metastatic Prostate Cancer (nmPC) |
7.1 | Introduction |
7.2 | Types |
7.3 | Symptoms |
7.4 | Causes |
7.5 | Pathophysiology |
7.6 | Diagnosis |
7.7 | Treatment |
8 | Treatment Guidelines of Non-Metastatic Prostate Cancer (nmPC) |
9 | Epidemiology and Patient Population of Non-Metastatic Prostate Cancer (nmPC) |
9.1 | Key Findings |
9.2 | Assumptions and Rationale |
9.3 | Diagnosed Prevalent Cases of nmPC in the 7MM |
9.4 | The United States |
9.4.1 | Total Diagnosed Prevalent Cases of nmPC in the United States |
9.4.2 | Age-specific Diagnosed Prevalent Cases of nmPC in the United States |
9.4.3 | Stage-specific Diagnosed Prevalent Cases of nmPC in the United States |
9.4.4 | Total Line-wise Treated Cases of nmPC in the United States |
9.5 | EU4 and the UK |
9.6 | Japan |
10 | Patient Journey of Non-Metastatic Prostate Cancer (nmPC) |
11 | Marketed Therapies |
11.1 | Marketed Competitive Landscape of Non-Metastatic Prostate Cancer (nmPC) |
11.2 | Apalutamide (ERLEADA): Janssen Pharmaceutical |
11.2.1 | Drug Description |
11.2.2 | Regulatory Milestones |
11.2.3 | Other Developmental Activities |
11.2.4 | Summary of Pivotal Trials |
11.2.5 | Clinical Development |
11.2.5.1 | Clinical Trial Information |
11.2.6 | Analyst Views |
11.3 | Enzalutamide (XTANDI): Astellas Pharma/Pfizer |
11.4 | Darolutamide (NUBEQA): Bayer |
12 | Emerging Drugs |
12.1 | Emerging Competitive Landscape of Non-Metastatic Prostate Cancer (nmPC) |
12.2 | Relugolix (ORGOVYX): Myovant/Sumitomo Pharma/Takeda/Accord |
12.2.1 | Drug Description |
12.2.2 | Other Developmental Activities |
12.2.3 | Clinical Development |
12.2.3.1 | Clinical Trials Information |
12.2.4 | Analyst Views |
12.3 | CAN-2409: Candel Therapeutics |
12.4 | KPG-121: Kangpu Biopharmaceuticals |
13 | Non-Metastatic Prostate Cancer (nmPC): 7MM Analysis |
13.1 | Key Findings |
13.2 | Market Outlook of Non-Metastatic Prostate Cancer (nmPC) |
13.3 | Conjoint Analysis of Non-Metastatic Prostate Cancer (nmPC) |
13.4 | Key Market Forecast Assumptions |
13.5 | Total Market Size of nmPC in the 7MM |
13.6 | Total Market Size of nmPC by Therapies in the 7MM |
13.7 | The United States Non-Metastatic Prostate Cancer Market |
13.7.1 | Total Market Size of nmPC in the United States |
13.7.2 | Total Market Size of nmPC by Therapies in the United States |
13.8 | EU4 and the UK Non-Metastatic Prostate Cancer Market |
13.9 | Japan Non-Metastatic Prostate Cancer Market |
14 | Unmet Needs of Non-Metastatic Prostate Cancer (nmPC) |
15 | SWOT Analysis of Non-Metastatic Prostate Cancer (nmPC) |
16 | KOL Views of Non-Metastatic Prostate Cancer (nmPC) |
17 | Market Access and Reimbursement of Non-Metastatic Prostate Cancer (nmPC) |
17.1 | The United States |
17.2 | EU4 and the UK |
17.3 | Japan |
17.4 | Summary and comparison of Market Access and Pricing Policy Developments in 2025 |
17.5 | Market Access and Reimbursement of Non-Metastatic Prostate Cancer (nmPC) Therapies |
18 | Bibliography |
19 | Non-Metastatic Prostate Cancer Market Report Methodology |
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