US Prostate Cancer Biomarkers Market Size, Share, Trends and Forecast by Type, Application, End Use, and Region, 2026-2034

US Prostate Cancer Biomarkers Market Overview:

The US prostate cancer biomarkers market size reached USD 1.33 Billion in 2025. The market is projected to reach USD 4.59 Billion by 2034, exhibiting a growth rate (CAGR) of 14.74% during 2026-2034. The market is driven by the integration of artificial intelligence and machine learning technologies in biomarker discovery and risk stratification, expansion of liquid biopsy technologies and non-invasive testing platforms, and FDA regulatory approvals combined with clinical guideline adoption driving market standardization and reimbursement frameworks. Additionally, the rising prevalence of prostate cancer affecting one in eight American men during their lifetime, coupled with increasing awareness around early detection and personalized treatment planning, is expanding the US prostate cancer biomarkers market share.

US Prostate Cancer Biomarkers Market Trends:

Integration of Artificial Intelligence and Machine Learning in Biomarker Discovery and Risk Stratification

The market is experiencing transformative growth driven by the rapid integration of artificial intelligence and machine learning technologies that are revolutionizing diagnostic precision and clinical decision-making. Advanced AI algorithms are being deployed to analyze complex datasets including digital pathology images, genomic profiles, clinical parameters, and molecular signatures to develop novel biomarkers with superior prognostic and predictive capabilities compared to traditional risk stratification tools. These computational approaches enable the identification of subtle patterns and morphological features within tissue samples that are imperceptible to human observation, facilitating more accurate differentiation between aggressive and indolent forms of prostate cancer. Leading healthcare institutions and diagnostic companies are investing substantially in AI-powered platforms that leverage deep learning techniques to process whole slide images from prostate biopsies, generating quantitative risk scores that inform treatment decisions regarding active surveillance versus definitive intervention. In February 2025, Myriad Genetics partnered with PATHOMIQ to exclusively license PATHOMIQ_PRAD, an AI-driven technology platform for prostate cancer, in the United States, integrating AI-enabled diagnostics into Myriad's oncology portfolio to support more informed treatment decisions before and after prostate cancer therapy by leveraging advanced artificial intelligence to strengthen diagnostic precision and align with evolving needs in precision medicine. Healthcare providers are increasingly adopting these advanced diagnostic tools as they offer objective, reproducible assessments that reduce inter-observer variability inherent in conventional pathological evaluation. The integration of AI technology with multi-omic data including transcriptomics, proteomics, and metabolomics is enabling the discovery of novel molecular subtypes and therapeutic targets, supporting the transition toward truly personalized cancer care.

Expansion of Liquid Biopsy Technologies and Non-Invasive Testing Platforms

The US prostate cancer biomarkers market growth is being accelerated by remarkable advancements in liquid biopsy technologies that are fundamentally reshaping diagnostic paradigms by enabling non-invasive detection, monitoring, and molecular characterization of prostate cancer through simple blood or urine samples. Liquid biopsy platforms analyze circulating tumor cells, cell-free DNA, extracellular vesicles, and various molecular biomarkers present in bodily fluids, providing real-time insights into tumor biology without requiring invasive tissue biopsies that carry risks of infection, bleeding, and patient discomfort. These technologies are particularly valuable for patients with metastatic castration-resistant prostate cancer where obtaining fresh tumor tissue is challenging or clinically impractical, enabling comprehensive genomic profiling to identify actionable mutations that guide selection of targeted therapies including PARP inhibitors for BRCA-mutated tumors. Blood-based tests such as the Prostate Health Index, 4Kscore panel, and various gene expression assays are being increasingly utilized in clinical practice to refine risk assessment and reduce unnecessary prostate biopsies in men with elevated PSA levels, addressing the long-standing challenge of PSA's limited specificity that historically led to overdiagnosis and overtreatment. In January 2025, Foundation Medicine received approval from the United States Food and Drug Administration for FoundationOne Liquid CDx to be used as a companion diagnostic for AKEEGA (niraparib and abiraterone acetate) for adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, demonstrating the expanding role of liquid biopsy in identifying patients eligible for targeted therapies. Urinary biomarker tests including PCA3, SelectMDx, ExoDx Prostate IntelliScore, and MyProstateScore are gaining clinical adoption as they offer convenient, non-invasive alternatives that can be performed after digital rectal examination in the physician's office, providing enhanced diagnostic accuracy compared to PSA alone while improving patient compliance and satisfaction. The development of next-generation liquid biopsy platforms capable of detecting minimal residual disease and monitoring treatment response in real-time is enabling dynamic therapeutic adjustments based on evolving tumor characteristics, representing a paradigm shift from static diagnostic snapshots to continuous disease surveillance.

US Prostate Cancer Biomarkers Market Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the country and regional levels for 2026-2034. Our report has categorized the market based on type, application, and end use.

Type Insights:

• Genetic Biomarkers
• Protein Biomarkers
• Cell-based Biomarkers
• Metabolomic Biomarkers

The report has provided a detailed breakup and analysis of the market based on the type. This includes genetic biomarkers, protein biomarkers, cell-based biomarkers, and metabolomic biomarkers.

Application Insights:

• Screening and Early Detection
• Diagnosis and Risk Stratification
• Prognosis and Treatment Monitoring
• Companion Diagnostics

A detailed breakup and analysis of the market based on the application have also been provided in the report. This includes screening and early detection, diagnosis and risk stratification, prognosis and treatment monitoring, and companion diagnostics.

End Use Insights:

• Hospitals
• Diagnostic Laboratories
• Cancer Research Institutes
• Biopharmaceutical Companies

The report has provided a detailed breakup and analysis of the market based on the end use. This includes hospitals, diagnostic laboratories, cancer research institutes, and biopharmaceutical companies.

Regional Insights:

• Northeast
• Midwest
• South
• West

The report has also provided a comprehensive analysis of all the major regional markets, which include Northeast, Midwest, South, and West.

Competitive Landscape:

The market research report has also provided a comprehensive analysis of the competitive landscape. Competitive analysis such as market structure, key player positioning, top winning strategies, competitive dashboard, and company evaluation quadrant has been covered in the report. Also, detailed profiles of all major companies have been provided.

US Prostate Cancer Biomarkers Market News:

• April 2025: OncoAssure, a medical technology company based in Ireland, introduced the OncoAssure Prostate Test in the United States during the American Urological Association's Annual Meeting. This six-gene expression assay calculates the likelihood of a biochemical recurrence within five years after surgery and assesses the risk of aggressive illness after diagnosis. DiaCarta Inc., a partner of OncoAssure, will carry out testing in its Pleasanton, California, ISO and CAP/CLIA-certified facility.

US Prostate Cancer Biomarkers Market Report Coverage:

Key Questions Answered in This Report:

• How has the US prostate cancer biomarkers market performed so far and how will it perform in the coming years?
• What is the breakup of the US prostate cancer biomarkers market on the basis of type?
• What is the breakup of the US prostate cancer biomarkers market on the basis of application?
• What is the breakup of the US prostate cancer biomarkers market on the basis of end use?
• What is the breakup of the US prostate cancer biomarkers market on the basis of region?
• What are the various stages in the value chain of the US prostate cancer biomarkers market?
• What are the key driving factors and challenges in the US prostate cancer biomarkers market?
• What is the structure of the US prostate cancer biomarkers market and who are the key players?
• What is the degree of competition in the US prostate cancer biomarkers market?

Key Benefits for Stakeholders:

• IMARC's industry report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the US prostate cancer biomarkers market from 2020-2034.
• The research report provides the latest information on the market drivers, challenges, and opportunities in the US prostate cancer biomarkers market.
• Porter's five forces analysis assist stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the US prostate cancer biomarkers industry and its attractiveness.
• Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.