Prostate Cancer Diagnostics Market Size
The global prostate cancer diagnostics market reached US$ 9.42 billion in 2025 and is expected to reach US$ 11.6 billion by 2031 growing at a CAGR of 11.1% during the forecast period 2026-2031.
Early diagnosis of prostate cancer is crucial. Once the staging begins, treating with any available procedure becomes challenging. It is also diagnosed with a prostate biopsy, which removes tissue from the prostate to examine it for cancer cells. Some urologists use MRI and ultrasound technology to achieve a more apparent biopsy target. The PSA blood test is used mainly to screen for prostate cancer in men without symptoms. It’s also one of the first tests done in men suspecting prostate cancer.
Prostate Cancer Diagnostics Market Scope
| Metrics | Details |
| CAGR | 11.1% |
| Size Available for Years | 2025-2031 |
| Forecast Period | 2026-2031 |
| Data Availability | Value (US$) |
| Segments Covered | Test Type, Cancer Type, Stage, End User, and Region |
| Regions Covered | North America, Europe, Asia-Pacific, South America, and Middle East & Africa |
| Fastest Growing Region | Asia-Pacific |
| Largest Region | North America |
| Report Insights Covered | Competitive Landscape Analysis, Company Profile Analysis, Market Size, Share, Growth, Demand, Recent Developments, Mergers and Acquisitions, New Product Launches, Growth Strategies, Revenue Analysis, Porter’s Analysis, Pricing Analysis, Regulatory Analysis, Supply-Chain Analysis, and Other key Insights. |
Prostate Cancer Diagnostics Market Dynamics
Rising Pipeline products
Several Pipeline products are on the rise as the demand for prostate cancer diagnosis increased in recent years due to the rising incidence of prostate cancer among males. For instance, in 2023, Lantheus is working on the development of 1404, which is a Tc-99m-labeled molecule that binds to PSMA and is used as a SPECT/CT imaging agent to diagnose and detect localized prostate cancer as well as soft tissue and bone metastases. ROTOP has exclusive rights to develop, manufacture, and commercialize 1404 in Europe.
For instance, St Vincent's Hospital collaborated with Clarity Pharmaceuticals Ltd to conduct phase 2 clinical trials to evaluate Copper-64 SAR Bombesin in PSMA Negative Prostate Cancer. Radiolabeled antagonist analog of bombesin to explore the diagnostic potential of 64Cu-SAR-BBN PET In men with rising PSA and negative PSMA PET. The estimated completion date is June 2024.
Improvements in Diagnosis with the Integration of Artificial Intelligence
Research on AI-assisted prostate cancer diagnosis is also evolving rapidly and has the potential to facilitate all aspects of the current standard diagnostic pathway. Moreover, AI models can help cancer diagnosis by reducing supporting tasks in cancer detection that are labor and experience-intensive, such as prostate gland segmentation, MRI-ultrasound registration, MRI-ultrasound fusion biopsies, and MRI-histopathology registration for developing cancer detection models.
For instance, in March 2023, Qritive introduced QAi Prostate, an advanced artificial intelligence (AI)-powered prostate cancer diagnosis tool. By leveraging advanced machine learning (ML) algorithms, QAi Prostate can accurately identify prostatic adenocarcinoma regions and classify malignant and benign tumor areas in biopsy tissue samples.
Complications related to Biopsy procedures
TRUS biopsy is associated with some risks, including pain, acute urinary retention, haematuria, haematospermia, rectal bleeding, erectile dysfunction, infection, and sepsis. The rising rates of disease and sepsis internationally are of concern. Historically, infection complicated approximately 1% of patients who underwent TRUS biopsy, but this figure has risen to 2–4% in recent years. Men with significant risk factors for sepsis, such as immunocompromise, type 2 diabetes mellitus, recent hospitalization, and COPD (Chronic obstructive pulmonary disease), could be considered for procedures other than TRUS biopsy.
Prostate Cancer Diagnostics Market Segment Analysis
The global prostate cancer diagnostics is segmented based on test type, cancer type, stage, end-user, and region.
The Segment Accounted for Approximately 45.3% of the Market Share
Prostate-specific Antigen (PSA) is a protein produced by prostate cells, and the PSA test is performed to diagnose prostate cancer (PCa) in men and for follow-up post-treatment to check if the cancer relapses. PSA testing is essential for detecting prostate cancer, which measures PSA levels in a man’s blood.
Medicare and several private insurers provide coverage for an annual PSA test for all Medicare-eligible men aged 50 and older. PSA testing is gaining popularity among clinicians and hospitals owing to the increasing number of people affected by prostate cancer. For instance, on February 2023, LynxDx, Inc., a developer of innovative diagnostic solutions, is introducing MyProstateScore 2.0 (MPS2), a non-invasive, data-driven, urine prostate cancer screening test that provides highly accurate, stratified risk assessment insights to guide clinical decisions for patients with elevated prostate-specific antigen (PSA) or abnormal digital rectal exam (DRE) findings. Due to increased innovations and advancements in PSA testing is expected to hold the largest market share in the forthcoming period.
Prostate Cancer Diagnostics Market Geographical Share
North America accounted for Approximately 39.2% of the Market Share in 2022
North America dominates the global prostate cancer diagnostics market, with the United States accounting as the primary contributor. Prostate cancer is one of the most common cancers in American men, which is made apparent by the statistics surrounding it. It affects 1 out of eight men in the U.S. after skin cancer; it is the most common cancer in U.S. men.
American Cancer Society estimated that in 2022, around 268,490 novel cases of prostate cancer were detected. Some of prostate cancers are aggressive, but most of them grow slowly. The number of deaths increases yearly, making prostate cancer the second leading cause of cancer death in men in the United States. Hence, it is considered to have an early diagnosis of the condition.
By Test Type
- Digital Rectal Exam
- PSA Blood Test
- Biopsy
- Prostate Biopsy
- Transrectal Biopsy
- Transperineal Biopsy
- Lymph node Biopsy
- Genetic Testing
- Imaging Tests
- Transrectal Ultrasound (TRUS)
- Magnetic Resonance Imaging (MRI)
- Nuclear Imaging
- Others
By Cancer Type
- Benign Prostate Hyperplasia
- Prostatic Adenocarcinoma
- Small Cell Carcinoma
- Ductal prostate cancer
- Others
By Stage
- I
- II
- III
- IV
By End Users
- Cancer Centers
- Specialty Clinics
- Others
By Region
- North America
- U.S.
- Canada
- Mexico
- Europe
- Germany
- U.K.
- France
- Spain
- Italy
- Rest of Europe
- South America
- Brazil
- Argentina
- Rest of South America
- Asia-Pacific
- China
- India
- Japan
- Australia
- Rest of Asia-Pacific
- Middle East and Africa
Key Developments
• July 2026 – Caris Life Sciences: Caris expanded its precision oncology testing services through PTEN immunohistochemistry testing to support biomarker-based treatment decisions in prostate cancer.
• August 2026 – Siemens Healthineers: The FDA approved an updated indication for the Atellica IM Total PSA II assay, supporting its use in prostate cancer detection alongside digital rectal examination.
• September 2026 – Telix Pharmaceuticals: Telix completed patient enrollment in its Phase III BiPASS study, evaluating PSMA PET imaging combined with MRI for the initial diagnosis of prostate cancer.
• September 2026 – Telix Pharmaceuticals: The FDA granted Fast Track designation to the BiPASS program, which evaluates PSMA PET imaging and MRI for prostate cancer diagnosis.
• October 2026 – NUCLIDIUM: NUCLIDIUM reported the first patient imaging in its Phase II study of the 61Cu-NU101 diagnostic radiotracer for PSMA-targeted PET imaging in metastatic prostate cancer.
Prostate Cancer Diagnostics Market Companies
The major global players in the prostate cancer diagnostics market include Myriad Genetics, Inc., Quanterix Corporation, MDx Health,Siemens Healthineers, F. Hoffman-La Roche AG, OPKO Health, Inc., Thermo Fisher Scientific Inc., Cellanyx Diagnostics Inc., MiR Scientific, and Proteomedix among others.
Why Purchase the Report?
- To visualize the global prostate cancer diagnostics segmentation based on test type, cancer type, stage, end user, and region, as well as understand key commercial assets and players.
- Identify commercial opportunities by analyzing trends and co-development.
- Excel data sheet with numerous data points of prostate cancer diagnostics market-level with all segments.
- PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
- Product mapping available as Excel consisting of key products of all the major players.
The global prostate cancer diagnostics market report would provide approximately 53 tables, 54 figures, and 209 Pages.
Target Audience 2025
- Manufacturers/ Buyers
- Industry Investors/Investment Bankers
- Research Professionals
- Emerging Companies
