United States Prostate Cancer Testing Market By Biomarker Type (Pre-Biopsy/Post-Negative Biopsy Testing, Initial Evaluation: Prostate-Specific Antigen (Total PSA, Free PSA), Post-Biopsy Tissue Testing), By Application (Diagnostics Biomarkers, Prognostics Biomarkers), By End User (Cancer Research Institutes, Diagnostic Laboratories, Hospitals and Clinics, Ambulatory Surgical Center (ASCs), and Others), By Region, Competition Forecast & Opportunities, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 1.89 Billion
CAGR (2026-2031)	6.96%
Fastest Growing Segment	Diagnostics Biomarkers
Largest Market	West
Market Size (2031)	USD 2.83 Billion

Market Overview

The United States Prostate Cancer Testing Market will grow from USD 1.89 Billion in 2025 to USD 2.83 Billion by 2031 at a 6.96% CAGR. Prostate cancer testing encompasses diagnostic evaluations designed to detect malignant neoplasms in the prostate gland, principally utilizing Prostate-Specific Antigen blood tests and Digital Rectal Examinations. The market is fundamentally driven by the expanding geriatric population that is inherently more prone to developing this condition, coupled with enhanced public health initiatives that emphasize the critical nature of early detection. Additionally, comprehensive reimbursement frameworks for screening procedures have substantially incentivized patient participation and clinical adoption.

Despite these growth factors, the market faces a substantial challenge regarding the high prevalence of false-positive results, which often precipitates overdiagnosis and unnecessary invasive biopsies. This issue not only inflates healthcare costs but also deters some individuals from undergoing routine screening. According to the 'American Cancer Society', in '2025', 'there were an estimated 313,780 new cases of prostate cancer and 35,770 deaths projected in the United States'.

Key Market Drivers

The rapid commercialization of advanced genomic and molecular biomarker tests is fundamentally reshaping the diagnostic capabilities within the sector. These genomic assays provide clinicians with granular insights into tumor aggressiveness, allowing for more personalized treatment pathways compared to traditional methods. By analyzing genetic expressions, these tools significantly reduce the rate of unnecessary interventions for indolent cases while ensuring high-risk patients receive immediate attention. This shift toward high-precision diagnostics is evidenced by the financial performance of key industry players who are expanding their test volumes. According to Veracyte, November 2024, in the 'Third Quarter 2024 Financial Results', the company reported total revenue of $115.9 million, driven significantly by the sustained volume growth of their Decipher Prostate genomic classifier.

Concurrently, the integration of artificial intelligence and machine learning in diagnostic workflows is addressing the critical need for enhanced imaging accuracy. AI-driven algorithms are increasingly utilized to augment multiparametric MRI scans, enabling radiologists to identify suspicious lesions with greater sensitivity and speed. This technological progression is attracting substantial investment aimed at scaling accessible screening solutions to meet market needs. According to Ezra, February 2024, in the 'Ezra Raises $21M to Expand Full Body MRI Screening' announcement, the company secured $21 million to accelerate the rollout of their AI-enhanced imaging services. This momentum extends across the broader competitive landscape where, according to MDxHealth, November 2024, the company achieved a quarterly revenue of $23.3 million, reflecting a robust demand for precision diagnostic solutions.

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Key Market Challenges

The high frequency of false-positive results and the consequent risk of overdiagnosis constitute a significant restraint on the expansion of the United States Prostate Cancer Testing Market. When screening tools yield inaccurate indications of malignancy, patients are often subjected to invasive secondary procedures, such as biopsies, which carry risks of infection, pain, and psychological distress without providing clinical benefit. This potential for physical and emotional harm creates substantial hesitancy among the eligible male population, leading to reduced adherence to routine screening schedules. As patient confidence in the reliability of initial diagnostics diminishes, the overall volume of tests performed declines, directly impacting market revenue and slowing the adoption of testing protocols in primary care settings.

Furthermore, the clinical ambiguity surrounding low-risk diagnoses complicates the market landscape by discouraging physicians from aggressively recommending mass screening. The concern that testing leads to the treatment of indolent conditions that would not otherwise cause harm fuels debate regarding the value of universal testing, limiting market penetration. This dynamic is reinforced by data illustrating the disparity between diagnosis and mortality. According to the 'American Cancer Society', in '2025', 'the 5-year relative survival rate for prostate cancer diagnosed in its earliest stages is over 99%'. This high survival rate suggests that while testing is effective at detection, the market struggles to justify the costs and patient burdens associated with the current prevalence of false alarms and unnecessary interventions.

Key Market Trends

The market is witnessing a significant shift towards precision imaging with the emergence of Prostate-Specific Membrane Antigen (PSMA)-targeted PET radiotracers. Unlike conventional imaging modalities that rely on anatomical changes, these radiopharmaceuticals bind specifically to PSMA proteins overexpressed on prostate cancer cells, enabling the detection of micro-metastases with superior specificity. This transition is establishing PSMA PET as a critical standard for staging high-risk patients and localizing biochemical recurrence, directly influencing treatment decisions. The commercial traction of these agents is evident in the substantial revenues of leading developers. According to Lantheus, November 2024, in the 'Third Quarter 2024 Financial Results', sales of its PSMA-targeted agent PYLARIFY reached $259.8 million, highlighting the rapid clinical integration of this precision modality.

Concurrently, there is an accelerated adoption of non-invasive liquid biopsy and urine-based assays designed to mitigate the risks associated with tissue biopsies. These diagnostics utilize biofluid biomarkers to assess cancer risk prior to invasive procedures, providing a reliable exclusion mechanism that spares low-risk individuals from unnecessary interventions. This pre-biopsy risk stratification optimizes resource allocation for patients with a higher probability of significant disease and is fueling growth within the sector's diagnostic segments. According to Bio-Techne, October 2024, in the 'First Quarter Fiscal 2025 Results', the company's Diagnostics and Spatial Biology segment, which includes exosome-based prostate cancer tests, reported net sales of $83.2 million, reflecting a 14% increase driven by continued adoption.

Segmental Insights

The Diagnostic Biomarkers segment is the fastest-growing category in the United States Prostate Cancer Testing Market due to a significant shift toward non-invasive testing methods that improve accuracy. Clinicians are increasingly utilizing these tests to overcome the low specificity of traditional Prostate-Specific Antigen screening and reduce the frequency of unnecessary biopsies. Growth is further accelerated by the United States Food and Drug Administration approving novel blood and urine assays which validates their clinical utility. This regulatory endorsement drives adoption among healthcare providers seeking to enhance risk stratification and ensure appropriate patient management strategies.

Regional Insights

The West US holds a commanding position in the United States Prostate Cancer Testing Market, primarily driven by the strategic concentration of leading diagnostic manufacturers and biotechnology hubs in California and Utah. This region benefits from the highest state-level patient volumes and an advanced healthcare ecosystem where premier research institutions facilitate the rapid adoption of high-value genomic and molecular assays. Additionally, the West exhibits robust healthcare expenditure and a supportive reimbursement landscape that fosters the commercialization of precision oncology tools. These factors collectively establish the West US as the foremost region for diagnostic innovation and market revenue.

Recent Developments

• In December 2025, Cleveland Diagnostics obtained premarket approval from the U.S. Food and Drug Administration (FDA) for its IsoPSA in vitro diagnostic kit. This blood-based test was indicated as a clinical aid for determining the necessity of a prostate biopsy in men aged 50 and older who presented with elevated prostate-specific antigen (PSA) levels. The approval was supported by results from a large prospective study which demonstrated the test's efficacy in distinguishing between benign PSA elevations and those associated with high-grade cancer. The company announced that this regulatory milestone would allow for the direct distribution of the test kits to laboratories throughout the United States.
• In March 2025, Telix Pharmaceuticals received approval from the U.S. Food and Drug Administration (FDA) for its new prostate cancer imaging agent, branded as Gozellix. The agent was indicated for use with Positron Emission Tomography (PET) scans to identify prostate-specific membrane antigen (PSMA) positive lesions in men with suspected metastasis or biochemical recurrence. The company emphasized that the product featured an extended shelf life compared to existing gallium-based options, a characteristic intended to improve distribution efficiency and patient access to advanced diagnostic imaging, particularly for individuals residing in underserved areas where access to radiopharmaceuticals had historically been limited.
• In December 2024, Veracyte reported that its prostate genomic classifier had been designated as the only gene expression test included in the updated "Advanced Tools" table of the 2025 National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. The company highlighted that this specific inclusion in the Principles of Risk Stratification and Biomarkers section validated the test's performance and clinical utility based on extensive data. Management noted that this development was expected to significantly increase the test's accessibility and reinforce its role in guiding treatment decisions for patients with localized prostate cancer across the medical community.
• In March 2024, MDxHealth announced the commercial introduction of a new non-invasive genetic germline test for prostate cancer, available through its established urology sales channels in the United States. This testing solution, which utilized a saliva sample, was designed to provide clinicians and patients with essential insights regarding the risk of developing the disease, its potential progression, and the likelihood of response to specific therapies. The company stated that this portfolio expansion aligned with national clinical guidelines recommending germline testing for eligible patients and aimed to facilitate more personalized treatment planning for men where genetic factors were a critical component of their diagnosis.

Key Market Players

• AbbottLaboratories
• RocheDiagnostics
• SiemensHealthineers
• BeckmanCoulter
• OPKOHealth
• MyriadGenetics
• NeoGenomicsLaboratories
• AgilentTechnologies
• Bio‑RadLaboratories
• DiaSorin

By Biomarker Type	By Application	By End User	By Region
Pre-Biopsy/Post-Negative Biopsy Testing Initial Evaluation: Prostate-Specific Antigen (Total PSA Free PSA) Post-Biopsy Tissue Testing	Diagnostics Biomarkers Prognostics Biomarkers	Cancer Research Institutes Diagnostic Laboratories Hospitals and Clinics Ambulatory Surgical Center (ASCs) Others	Northeast Midwest South West

Report Scope:

In this report, the United States Prostate Cancer Testing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• United States Prostate Cancer Testing Market, By Biomarker Type:

• Pre-Biopsy/Post-Negative Biopsy Testing
• Initial Evaluation: Prostate-Specific Antigen (Total PSA
• Free PSA)
• Post-Biopsy Tissue Testing

• United States Prostate Cancer Testing Market, By Application:

• Diagnostics Biomarkers
• Prognostics Biomarkers

• United States Prostate Cancer Testing Market, By End User:

• Cancer Research Institutes
• Diagnostic Laboratories
• Hospitals and Clinics
• Ambulatory Surgical Center (ASCs)
• Others

• United States Prostate Cancer Testing Market, By Region:

• Northeast
• Midwest
• South
• West