United States Prostate Cancer Biomarkers Market Size & Forecast 2025–2033

The United States Prostate Cancer Biomarkers Market is entering a transformative era—one shaped by genomic innovation, precision diagnostics, and increased awareness of personalized healthcare. According to Renub Research, the U.S. market is expected to grow from US$ 1.48 billion in 2024 to US$ 3.54 billion by 2033, advancing at a CAGR of 10.16% throughout 2025–2033.

This upward trajectory reflects a powerful combination of rising prostate cancer prevalence, limitations of traditional screening tools such as PSA tests, and robust advancements in molecular technologies. As healthcare systems shift toward precision medicine, biomarkers are rapidly becoming indispensable diagnostic assets—guiding treatment strategies, predicting disease progression, and helping physicians personalize patient care.

United States Prostate Cancer Biomarkers Industry Overview

Prostate cancer remains one of the most prevalent cancers affecting men in the United States. According to the American Cancer Society, 1 in every 8 men will be diagnosed with prostate cancer in their lifetime, and it stands as the second leading cause of cancer-related deaths among American men. In 2022 alone, an estimated 268,500 new cases and 34,500 deaths were reported, while more than 3.1 million men currently live with the disease nationwide.

Despite being widely used for decades, PSA testing continues to draw criticism due to its low specificity and high rate of false positives. This has intensified the demand for advanced biomarkers capable of distinguishing between benign and malignant conditions, detecting aggressive tumor variants, and reducing unnecessary biopsies.

The industry’s momentum accelerated further during the American Urological Association (AUA) Annual Meeting 2025, where OncoAssure introduced its next-generation OncoAssure Prostate Test—a genomic-driven assay that combines analysis of “Master Driver” genes with risk-scoring tools like CAPRA. This test, processed at DiaCarta Inc.’s CAP/CLIA-certified facility in Pleasanton, California, offers deeper insights into tumor aggressiveness and recurrence risk.

As the biomarker landscape expands, demand for non-invasive diagnostics, genomic profiling, AI-based analytics, and liquid biopsy methods continues to surge across U.S. healthcare systems.

Key Market Growth Drivers

1. Rising Prevalence of Prostate Cancer

Prostate cancer cases continue increasing in the United States, driving demand for accurate and cost-effective diagnostic tools. Traditional PSA testing often leads to false alarms, unnecessary biopsies, and patient distress.

In contrast, advanced biomarkers offer:

Higher specificity and sensitivity

Risk stratification for aggressive vs. indolent tumors

Better decision-making for clinicians

Reduced overtreatment and healthcare burden

The disease’s growing footprint—particularly among aging populations—makes early detection essential. Biomarkers now serve as the backbone of personalized screening and treatment planning.

2. Advancements in Genomics, Proteomics, and Molecular Diagnostics

Technological innovation is unlocking new clinical applications:

Genomic biomarkers identify key mutations and tumor signatures.

Proteomic biomarkers reveal protein overexpression linked to cancer progression.

Metabolomic biomarkers assess metabolic changes signaling malignancy.

Liquid biopsies (blood or urine) enable non-invasive diagnostics and real-time monitoring.

Companies and research institutes are leveraging multi-omics platforms to achieve unprecedented diagnostic accuracy. These advancements support early detection, patient monitoring, and targeted treatment—while reducing reliance on invasive tissue biopsies.

3. Surge in Precision Medicine and Personalized Oncology

Precision medicine is rapidly changing how prostate cancer is diagnosed and treated. Biomarkers help clinicians:

Predict treatment response

Evaluate recurrence risk

Monitor disease in real time

Personalize therapy based on molecular profiles

Pharmaceutical companies increasingly incorporate biomarkers into drug discovery and clinical trials, using them for patient segmentation and therapy monitoring.

As patient-centric care becomes the norm, precision diagnostics—supported by biomarker assays—are becoming an integral component of U.S. oncology protocols.

Challenges Impacting Market Expansion

High Diagnostic Costs and Reimbursement Gaps

Despite their clinical value, many genomic and biomarker-based tests are expensive. Insurance reimbursement varies, leaving many patients unable to access advanced diagnostics. Smaller clinical facilities may find it difficult to adopt these technologies due to cost constraints.

Overcoming reimbursement barriers is essential for expanding equitable access across the U.S.

Regulatory Complexity and Clinical Validation Requirements

Biomarker diagnostics require:

Large-scale clinical validation

FDA approvals

Demonstrated clinical utility in diverse populations

These processes can be time-consuming and costly. Physicians may also hesitate to fully adopt newer biomarkers until real-world data confirms accuracy and reliability.

As a result, market entry timelines for novel solutions may be prolonged.

United States Prostate Cancer Biomarkers Market: State-Wise Overview

Adoption of biomarker-based diagnostics varies across states, influenced by healthcare infrastructure, awareness levels, research activity, and demographics.

California

California leads the market thanks to its:

High concentration of biotech firms

Major academic research centers

Widespread use of molecular diagnostics

Advanced oncology centers in Los Angeles, San Diego, and San Francisco

Public health campaigns and strong precision medicine initiatives further boost biomarker use. California’s diverse population also drives demand for personalized care approaches.

Texas

Texas has emerged as a major hub for prostate cancer diagnostics, supported by:

Strong clinical networks in Houston, Dallas, and Austin

Large patient populations

Growing research collaborations

Increasing clinical trial activity

However, rural-urban disparities remain a concern, prompting initiatives to expand screening and biomarker testing across underserved areas.

New York

New York offers a robust landscape for biomarker adoption due to:

Leading academic institutions

Advanced oncology centers

High insurance coverage rates

State-sponsored health initiatives

New York City hospitals and laboratories routinely use genomic and molecular tests, helping reduce disparities and improve early detection among diverse communities.

Florida

Florida’s large senior population significantly contributes to the demand for prostate cancer diagnostics. Urban centers like Miami, Orlando, and Tampa have rapidly embraced biomarker technologies for early detection and personalized care.

Awareness campaigns, screening programs, and increasing clinical adoption support market growth, though rural regions still face access challenges.

Recent U.S. Market Developments

1. Myriad Genetics & PATHOMIQ Partnership (February 2025)

Myriad Genetics secured exclusive rights to PATHOMIQ’s AI-driven prostate cancer technology platform PATHOMIQ_PRAD. The integration will enhance Myriad’s oncology diagnostics portfolio and support more accurate pre- and post-treatment clinical decisions.

2. DiaCarta–OncoAssure Collaboration (February 2024)

A strategic partnership between DiaCarta and OncoAssure aims to commercialize a six-gene expression assay predicting:

Biochemical recurrence within five years

Aggressiveness of the disease post-diagnosis

This validates the growing role of biomarker-based risk stratification in precision oncology.

United States Prostate Cancer Biomarkers Market Segmentation

By Type

Genetic Biomarkers

Cell-based Biomarkers

Metabolomic Biomarkers

By Application

Screening & Early Detection

Diagnostic & Risk Stratification

Prognosis & Treatment Monitoring

Companion Diagnostics

By End Use

Hospitals & Diagnostic Laboratories

Academic & Research Institutes

Biopharmaceutical Companies

By States

California, Texas, New York, Florida, Illinois, Pennsylvania, Ohio, Georgia, New Jersey, Washington, North Carolina, Massachusetts, Virginia, Michigan, Maryland, Colorado, Tennessee, Indiana, Arizona, Minnesota, Wisconsin, Missouri, Connecticut, South Carolina, Oregon, Louisiana, Alabama, Kentucky, and the Rest of the U.S.

Key Companies Covered (with Overviews, SWOT, Revenue, & Recent Updates)

The U.S. market is shaped by both diagnostic innovators and pharmaceutical giants:

Exact Sciences Corp

Myriad Genetics Inc.

BIO-TECHNE Corp

OPKO Health, Inc.

MDxHealth SA

Veracyte Inc.

Roche Diagnostics Ltd.

Pfizer Inc.

These companies lead in biomarker discovery, assay development, liquid biopsy advancements, and AI-powered analytics—reinforcing personalized care across prostate cancer treatment pathways.

Final Thoughts

The United States Prostate Cancer Biomarkers Market is on an upward growth trajectory, driven by rising disease incidence, technological breakthroughs, and expanding adoption of precision medicine. As validated genomic tools and non-invasive diagnostics replace outdated screening methods, patients and clinicians gain access to accurate, actionable insights that enhance care outcomes and reduce unnecessary treatments.

With strategic collaborations, AI integration, and broader insurance coverage on the horizon, biomarker-based diagnostics are set to become a foundational pillar in the future of U.S. oncology care.