U.S. Prostate-Specific Antigen Test Market Size & Share 2026-2035

U.S. Prostate-Specific Antigen Test Market Size

The U.S. prostate-specific antigen test market was estimated at USD 1.5 billion in 2025. The market is expected to grow from USD 1.6 billion in 2026 to USD 2.7 billion in 2035, at a CAGR of 6.1% during the forecast period, according to the latest report published by Global Market Insights Inc.

The market is driven by numerous factors such as rising adoption of early-stage cancer screening, technological advancements in PSA assay platforms and increasing incidence of prostate cancer in the country, among other factors.

Increasing reimbursement coverage for PSA testing, advancements in biomarker science improving test accuracy and strategic partnerships between biotech companies and diagnostic labs are expected to fuel the industry's growth. Roche, LabCorp, SIEMENS Healthineers and Quest Diagnostics are among the leading players operating in the market. These players mainly focus on service availability across the country, geographic expansion, strong research and development, and partnership with local healthcare facilities, among other factors.

The market has increased from USD 1.3 billion in 2022 and reached USD 1.4 billion in 2024, with a historic growth rate of 5.9%. The U.S. PSA testing market continues to expand steadily, driven by rising prostate cancer awareness, increasing emphasis on early detection, and broader adoption of routine screening among aging male populations. Growing clinical acceptance of PSA testing as a first‑line diagnostic tool, coupled with advancements in assay sensitivity and multi‑parametric screening techniques, is strengthening demand for reliable, accessible testing solutions across healthcare settings.

Additionally, the market is positioned for long‑term growth, supported by demographic trends, clinical innovation, and a growing focus on precision detection of prostate cancer. With rising demand for accuracy, faster turnaround times, and patient‑centric diagnostics, the market is moving toward advanced PSA platforms, multi‑marker testing strategies, and modernized screening programs that improve outcomes while reducing unnecessary interventions.

Prostate-Specific Antigen (PSA) test is a blood test that measures the level of PSA, a protein produced by cells of the prostate gland, in the bloodstream. It is primarily used to screen for prostate cancer, as elevated PSA levels may indicate malignancy, benign prostatic hyperplasia (BPH), or prostate inflammation. The test also supports monitoring of treatment response and detection of cancer recurrence in diagnosed patients.

U.S. Prostate-Specific Antigen Test Market Trends

The development of next‑generation and multi‑marker diagnostic platforms and expansion of AI‑enhanced PSA interpretation and decision‑support tools are among the key trends shaping the market growth positively.

• The U.S. PSA testing landscape is expected to evolve significantly as healthcare shifts toward precision diagnostics, multi‑modal screening pathways, and technology‑assisted interpretation. These innovations aim to enhance clinical decision‑making, reduce unnecessary biopsies, and strengthen early detection of clinically significant prostate cancer.
• As prostate cancer incidence rises and screening guidelines shift toward risk‑adapted models, emerging technologies such as genomic classifiers, AI‑based diagnostic tools, ultrasensitive PSA assays, and hybrid imaging are gaining substantial clinical relevance. Such advancements and developments may fuel the industry's growth over the analysis period.
• Further, innovative assays capable of detecting subtle molecular or structural variations in PSA play a key role in the reduction of unnecessary biopsies, thereby reshaping diagnostic accuracy, patient management, and clinical decision‑making.

U.S. Prostate-Specific Antigen Test Market Analysis

Based on product, the market is segmented into preliminary tests and confirmatory tests. The preliminary tests segment accounted for a majority share of 73.4% in 2025. Clinical recommendations supporting routine screenings is anticipated to fuel the segmental growth. The segment is expected to reach USD 2 billion by 2035, growing at a CAGR of 5.7% during the forecast period.

• The preliminary testing segment forms the foundational diagnostic tier of the U.S. prostate‑specific antigen test market. These tests serve as the first line of evaluation in prostate cancer detection, offering clinicians rapid, minimally invasive tools to assess early cancer risk before proceeding to confirmatory diagnostics.
• Blood‑based PSA tests, including total and free PSA, remain widely adopted in routine health checkups, annual screenings, and primary care settings, supporting high testing volumes. Growing emphasis on early detection, preventive healthcare, and regular screening among aging male populations continues to expand demand for these tests.
• Further, preliminary PSA tests are especially important given the pronounced racial disparities in prostate cancer incidence observed in the U.S. Epidemiological data show that Black men experience the highest incidence rate of prostate cancer, which is 67% higher than that of white men. These disparities intensify the importance of early, accessible PSA‑based preliminary testing across high-risk populations.
• The confirmatory tests segment was valued at USD 408.4 million in 2025. Confirmatory tests represent a core subsegment within the PSA test market, providing definitive or high‑specificity evaluation following abnormal preliminary PSA findings.
• In addition, these diagnostic tools play a decisive role in validating cancer suspicion, distinguishing malignant from benign conditions, and determining appropriate clinical pathways. By offering direct tissue analysis, anatomical visualization, or molecular‑level assessment, confirmatory modalities ensure that elevated PSA values translate into accurate and evidence‑based diagnostic conclusions.

Based on application, the U.S. prostate-specific antigen test market is segmented into prostate cancer screening and prostate cancer monitoring. The prostate cancer screening segment generated the highest revenue of USD 908.7 million in 2025.

• Prostate cancer screening represents one of the most critical application areas within the U.S. PSA testing market, serving as the foundation for early detection strategies that significantly influence patient outcomes and long‑term survival
• For example, according to CDC‑reported U.S. surveillance data, the majority of prostate cancers diagnosed from 2018 to 2022 were detected at a localized stage, with 70.4% of cases found before the cancer had spread outside the prostate. These figures demonstrate that widespread PSA screening facilitates early‑stage diagnosis for most men, improving opportunities for curative treatment and reducing disease burden across the healthcare system.
• Further, PSA‑based screening also supports informed decision‑making between patients and healthcare providers, particularly for men in higher‑risk categories such as those with genetic predisposition, family history, or demographic risk factors.
• The prostate cancer monitoring segment held a significant share of 40.8% in 2025. PSA‑based monitoring plays a central role in evaluating disease progression, determining treatment effectiveness, and detecting biochemical recurrence after surgery, radiation, or active surveillance protocols.
• Furthermore, as prostate cancer risk increases sharply with age, the growing aging demographic shift is expected to significantly increase the number of men requiring ongoing PSA‑based monitoring following diagnosis and treatment. This is expected to fuel the segmental growth over the analysis period.

Based on end use, the U.S. prostate-specific antigen test market is segmented into independent commercial reference laboratories, hospital-based laboratories, physician practice-owned central laboratories and other end users. The independent commercial reference laboratories segment accounted for the leading market share of 35.9% in 2025.

• These laboratories are equipped with large-scale automated immunoassay systems, advanced quality-controlled workflows, and nationwide logistics networks, enabling fast, reliable, and cost-efficient PSA testing services for hospitals, physician groups, employer health programs, and population health initiatives.
• Quest Diagnostics and LabCorp are the main contenders in this segment, operating the largest commercial laboratory networks in the U.S. Their significant geographic footprint strengthens PSA testing utilization by allowing millions of men to obtain routine screening and monitoring tests with minimal barriers to access.
• Further, the national reference laboratories support clinical practices by offering high-volume PSA processing capacity, rapid turnaround times, and robust integration with electronic health records (EHRs) and payer systems.
• The hospital‑based laboratories segment accounts for a significant share of 30.7% in 2025. Hospital‑based laboratories are among the key end-user segments in the market, performing the majority of diagnostic testing volume nationwide.
• Additionally, hospital‑based laboratories also benefit from access to fully equipped diagnostic infrastructures, including advanced immunoassay platforms, automated analyzers, and multidisciplinary clinical expertise.
• Moreover, increasing patient loads, aging demographics, and rising cancer acuity will further solidify hospital labs as a key driver of PSA test utilization in the U.S. market.
• The physician practice-owned central laboratories segment was valued at USD 427.1 million in 2025. This laboratory model enables physician practices to streamline PSA testing from order to result, enhancing clinical efficiency and supporting same‑day or next‑day treatment decisions.
• In addition, these laboratories are typically established by consolidated urology practices, multispecialty groups, and advanced outpatient care organizations that manage high PSA testing volumes across multiple clinic sites.
• Furthermore, as healthcare continues shifting toward coordinated outpatient care and physician‑practice consolidation, these laboratories are expected to play a growing role in PSA diagnostics.

U.S. Prostate-Specific Antigen Test Market Share

The U.S. prostate‑specific antigen (PSA) test market consists of established leaders in in vitro diagnostics, clinical laboratory testing, and cancer diagnostics, while continued innovation is being driven by both large multinational diagnostic corporations and specialized prostate cancer testing companies. The key industry players are strengthening their competitive positions through strategic initiatives such as assay portfolio expansion, platform integration, technological advancements, and nationwide laboratory network penetration. F. Hoffmann‑La Roche Ltd., Quest Diagnostics, Siemens Healthineers AG, Abbott Laboratories, Danaher Corporation, and LabCorp Holdings Inc. are among the leading companies shaping the U.S. PSA testing industry.

Additionally, these industry leaders are focused on advancing PSA tests, including high‑throughput automated immunoassay systems, chemiluminescent analyzers, and integrated clinical chemistry platforms to improve analytical accuracy, screening efficiency, and clinical decision‑making in prostate cancer management. Their product portfolios support a wide range of U.S. clinical applications, including routine screening, early‑stage prostate cancer detection, treatment monitoring, and post‑therapy surveillance.

Further, their solutions are widely deployed across hospital‑based laboratories, national reference labs, outpatient diagnostic centers, and physician office laboratories throughout the U.S., supporting large‑scale screening programs and centralized testing workflows.

U.S. Prostate-Specific Antigen Test Market Companies

A few of the prominent players operating in the U.S. prostate-specific antigen test industry include:

• Abbott Laboratories
• Advacare Pharma
• Cleveland Diagnostics, Inc.
• CTK Biotech, Inc. (SSI Diagnostica Group)
• Danaher Corporation
• F. Hoffmann‑La Roche Ltd.
• GE HealthCare Technologies Inc.
• Glycanostics, s.r.o.
• Koelis SAS
• Koninklijke Philips N.V.
• LabCorp Holdings Inc.
• MDxHealth SA
• Myriad Genetics, Inc.
• OPKO Health, Inc.
• Quest Diagnostics
• Siemens Healthineers AG
• Veracyte, Inc.

 

• Quest Diagnostics

Leverages nationwide laboratory infrastructure, data analytics, and bundled diagnostic offerings to expand PSA test utilization, improve turnaround times, and support preventive screening initiatives.

• LabCorp Holdings Inc.

Strengthens market position through extensive diagnostic service networks, test menu expansion, and efficient laboratory operations supporting high‑volume PSA screening and advanced reflex testing services.

U.S. Prostate-Specific Antigen Test Industry News

• In March 2026, Abbott acquired Exact Sciences to expand its oncology diagnostics footprint. The deal strengthens Abbott’s capabilities in cancer screening, molecular diagnostics, and liquid biopsy technologies, enabling growth beyond traditional PSA testing and supporting development of next‑generation prostate cancer diagnostic solutions aligned with precision oncology trends.
• In December 2025, the FDA approved IsoPSA, a blood based prostate cancer diagnostic developed to assess structural variants of the PSA protein and support biopsy decision making in men with elevated PSA levels. The FDA approval of IsoPSA significantly strengthened Cleveland Diagnostics’ competitive position in the U.S. prostate cancer diagnostics market.
• In August 2025, mdxhealth completed the acquisition of the ExoDx business from Bio‑Techne, including the ExoDx Prostate test and related CLIA‑certified laboratory assets. This acquisition strengthened mdxhealth’s position of the prostate cancer diagnostics by expanding its liquid biopsy capabilities. It enhanced the company’s ability to integrate PSA‑related clinical workflows, supported broader test offerings for early risk assessment, and improved commercialization potential across urology practices and diagnostic laboratories in the U.S.

The U.S. prostate-specific antigen test market research report includes an in-depth coverage of the industry with estimates and forecasts in terms of revenue in (USD Million) from 2022 - 2035 for the following segments:

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Market, By Product

• Preliminary tests
  • Total prostate specific antigen test
  • Free prostate specific antigen test
  • Other preliminary tests
• Confirmatory tests
  • Imaging tests
  • Tissue-based tests
  • Other confirmatory tests

Market, By Application

• Prostate cancer screening
• Prostate cancer monitoring

Market, By End Use

• Independent commercial reference laboratories
  • National reference laboratories
  • Specialty-focused reference laboratories
  • Regional & super-regional independent laboratories
• Hospital-based laboratories
  • Integrated delivery network (IDN) / Health system laboratories
  • Community hospital laboratories
  • Academic medical center laboratories
• Physician practice-owned central laboratories
• Other end users