Summary

Market Size & Trends

The U.S. prostate cancer biomarkers market size was estimated at USD 1.7 billion in 2024 and is expected to grow at a CAGR of 14.74% from 2025 to 2033. The market growth is driven by the rising prevalence of prostate cancer, awareness around early detection, and adoption of precision diagnostics. Advancements in liquid biopsy, genomics, and non-invasive biomarker technologies are enhancing screening accuracy and patient stratification. Additionally, the rising demand for personalized treatment planning, along with favorable reimbursement frameworks for diagnostic tests such as PSA, PCA3, and gene-expression panels (e.g., Decipher, Oncotype DX), is further accelerating market growth. Strategic collaborations and continuous R&D investment are also expanding the biomarker pipeline and commercial availability.

Prostate cancer is one of the most prevalent malignancies affecting men in the United States. According to the American Cancer Society, 1 in 8 men will be diagnosed with the disease in their lifetime. In 2022 alone, an estimated 268,500 new cases were reported, with approximately 34,500 deaths, making it the second leading cause of cancer death among American men. Today, over 3.1 million men in the U.S. are living with prostate cancer. This substantial patient population, along with limitations in traditional diagnostics such as PSA testing, which lacks specificity to distinguish between benign and malignant conditions, has created strong demand for novel biomarkers that can enable earlier detection, improved risk stratification, and treatment personalization.

U.S. Prostate Cancer Biomarkers Market Report Segmentation

This report forecasts revenue growth and provides an analysis of the latest industry trends in each of the sub-markets from 2021 to 2033. For this study, Grand View Research has segmented the U.S. prostate cancer biomarkers market report based on type, application, and end-use:

• Type Outlook (Revenue, USD Million, 2021 - 2033)
o Genetic Biomarkers
o Protein Biomarkers
o Cell-based Biomarkers
o Metabolomic Biomarkers
• Application Outlook (Revenue, USD Million, 2021 - 2033)
o Screening and Early Detection
o Diagnosis and Risk Stratification
o Prognosis and Treatment Monitoring
o Companion Diagnostics
• End-use Outlook (Revenue, USD Million, 2021 - 2033)
o Hospitals and Diagnostic Laboratories
o Academic and Research Institutes
o Biopharmaceutical Companies

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Table of Contents

Table of Contents

Chapter 1 Methodology and Scope
1.1 Market Segmentation And Scope
1.1.1 Segment Definition
1.1.1.1 Application Segment
1.1.1.2 Type Segment
1.1.1.3 End USE Segment
1.2 Regional Scope
1.3 Estimates And Forecast Timeline
1.4 Objectives
1.4.1 Objective - 1
1.4.2 Objective - 2
1.4.3 Objective - 3
1.5 Research Methodology
1.6 Information Procurement
1.6.1 Purchased Database
1.6.2 GVR’s Internal Database
1.6.3 Secondary Sources
1.6.4 Primary Research
1.7 Information Or Data Analysis
1.7.1 Data Analysis Models
1.8 Market Formulation & Validation
1.9 Model Details
1.9.1 Commodity Flow Analysis
1.10 List Of Secondary Sources
1.11 List Of Abbreviations
Chapter 2 Executive Summary
2.1 Market Outlook
2.2 Application And Type Snapshot
2.3 End USE Snapshot
2.4 Competitive Landscape Snapshot
Chapter 3 U.S. Prostate Cancer Biomarkers Market Variables, Trends, And Scope
3.1 U.S. Prostate Cancer Biomarkers Market Lineage Outlook
3.1.1 Parent Market Outlook
3.2 Penetration And Growth Prospect Mapping
3.3 Pipeline Analysis
3.3.1 Screening And Early Detection
3.3.2 Diagnosis And Risk Stratification
3.3.3 Prognosis And Treatment Monitoring
3.3.4 Companion Diagnostics
3.4 Market Dynamics
3.4.1 Market Driver Analysis
3.4.1.1 Rising Prevalence Of Prostate Cancer
3.4.1.2 Advancements In Genomic And Proteomic Technologies
3.4.1.3 Supportive Government And Research Initiatives
3.4.2 Market Restraint Analysis
3.4.2.1 High Cost Of Biomarker-based Tests
3.4.2.2 Uneven Access To Advanced Diagnostic Infrastructure
3.5 Prostate Cancer Biomarkers: Market Analysis Tools
3.5.1 Industry Analysis - Porter’s
3.5.2 Pestle Analysis
Chapter 4 U.S. Prostate Cancer Biomarkers Market: Segment Analysis, By Type, 2021 - 2033 (USD Million)
4.1 U.S. Prostate Cancer Biomarkers Market: Type Movement Analysis
4.1.1 Genetic Biomarkers
4.1.1.1 Genetic Biomarkers U.S. Prostate Cancer Biomarkers Market, 2021 - 2033 (USD Million)
4.1.2 Protein Biomarkers
4.1.2.1 Protein Biomarkers U.S. Prostate Cancer Biomarkers Market, 2021 - 2033 (USD Million)
4.1.3 Cell-based Biomarkers
4.1.3.1 Cell-based Biomarkers U.S. Prostate Cancer Biomarkers Market, 2021 - 2033 (USD Million)
4.1.5 Metabolomic Biomarkers
4.1.5.1 Metabolomic Biomarkers U.S. Prostate Cancer Biomarkers Market, 2021 - 2033 (USD Million)
Chapter 5 U.S. Prostate Cancer Biomarkers Market: Segment Analysis, By Application, 2021 - 2033 (USD Million)
5.1 U.S. Prostate Cancer Biomarkers Market: Application Movement Analysis
5.1.1 Screening And Early Detection
5.1.1.1 Screening And Early Detection Market, 2021 - 2033 (USD Million)
5.1.2 Diagnosis And Risk Stratification
515.2.1 Diagnosis And Risk Stratification Market, 2021 - 2033 (USD Million)
5.1.3 Prognosis And Treatment Monitoring
51.3.1 Prognosis And Treatment Monitoring Market, 2021 - 2033 (USD Million)
5.1.4 Companion Diagnostics
5.1.4.1 Companion Diagnostics Market, 2021 - 2033 (USD Million)
Chapter 6 U.S. Prostate Cancer Biomarkers Market: Segment Analysis, By End USE, 2021 - 2033 (USD Million)
6.1 U.S. Prostate Cancer Biomarkers Market: End USE Movement Analysis
6.1.1 Hospitals And Diagnostic Laboratories
6.1.1.1 Hospitals And Diagnostic Laboratories Market, 2021 - 2033 (USD Million)
6.1.2 Academic And Research Institutes
6.1.2.1 Academic And Research Institutes Market, 2021 - 2033 (USD Million)
6.1.3 Biopharmaceutical Companies
6.1.3.1 Biopharmaceutical Companies Market, 2021 - 2033 (USD Million)
Chapter 7 U.S. Prostate Cancer Biomarkers Market: Competitive Analysis
7.1 Company Categorization
7.2 Strategy Mapping
7.2.1 New Product Launch
7.2.2 Partnerships
7.2.3 Acquisition
7.2.4 Collaboration
7.2.5 Funding
7.3 Company Market Share Analysis, 2022
7.4 Company Profiles
7.4.1 Exact Sciences Corporation
7.4.1.1 Company Overview
7.4.1.2 Financial Performance
7.4.1.3 Product Benchmarking
7.4.1.4 Strategic Initiatives
7.4.2 Myriad Genetics, Inc.
7.4.2.1 Company Overview
7.4.2.2 Financial Performance
7.4.2.3 Product Benchmarking
7.4.2.4 Strategic Initiatives
7.4.3 Bio-techne
7.4.3.1 Company Overview
7.4.3.2 Financial Performance
7.4.3.3 Product Benchmarking
7.4.3.4 Strategic Initiatives
7.4.4 Exodx
7.4.4.1 Company Overview
7.4.4.2 Product Benchmarking
7.4.5 Opko Health, Inc.
7.4.5.1 Company Overview
7.4.5.2 Product Benchmarking
7.4.5.3 Strategic Initiatives
7.4.6 Mdxhealth
7.4.6.1 Company Overview
7.4.6.2 Financial Performance
7.4.6.3 Product Benchmarking
7.4.6.4 Strategic Initiatives
7.4.7 Veracyte, Inc.
7.4.7.1 Company Overview
7.4.7.2 Financial Performance
7.4.7.3 Product Benchmarking
7.4.7.4 Strategic Initiatives
7.4.8 Beckman Coulter, Inc.
7.4.8.1 Company Overview
7.4.8.2 Product Benchmarking
7.4.9 Nucleix
7.4.9.1 Company Overview
7.4.9.2 Financial Performance
7.4.9.3 Product Benchmarking
7.4.9.4 Strategic Initiatives
7.4.10 Diacarta
7.4.10.1 Company Overview
7.4.10.2 Product Benchmarking
7.4.10.3 Strategic Initiatives