Summary

U.S. Prostate Cancer Testing Market Industry Overview

The growth in the U.S. prostate cancer testing market is expected to be driven by high investments in the field of cancer research and the rising prevalence of prostate cancer in the U.S. In addition, the focus of business leaders is establishing a deep understanding to address the unmet needs in clinical research to understand the U.S. prostate cancer testing market.

Market Lifecycle Stage

The U.S. prostate cancer testing market is in the progressing phase. PSA screening or testing in a general population has increased the incidence of prostate cancer in recent decades. In addition, prostate cancer testing is essential in precision medicine because it assures the safe and successful use of tailored therapies. The majority of the companies in the U.S. prostate cancer testing market provide biomarker tests that are urine, blood, and tissue-based, as well as testing services. Furthermore, applications of prostate cancer testing are primarily clinical and research.

Impact

One of the main reasons for the expansion of the U.S. prostate cancer testing market in the upcoming years is the rise in prostate cancer cases. Prostate cancer is the second most frequent disease diagnosed in men, and its frequency is rising across the globe. Prostate cancer is thought to be diagnosed in one million additional cases worldwide each year. Due to an aging population, growing urbanization, and accompanying lifestyle changes, the overall incidence of prostate cancer has increased over the past few decades.

Market Segmentation:

Segmentation 1: by Biomarker Type
• Initial Evaluation: Prostate-Specific Antigen (Total PSA, Free PSA)
• Pre-Biopsy/Post-Negative Biopsy Testing
• Post-Biopsy Tissue Testing

Based on biomarker type, the pre-biopsy test in the U.S. prostate cancer testing market is expected to be dominated by the biomarker type segment. This is due to the increasing popularity of prostate cancer testing and rising awareness related to prostate cancer testing.

Segmentation 2: by Cancer Type
• Prostatic Adenocarcinoma
• Small Cell Carcinoma
• Other Prostate Cancer Types

Based on Cancer type, prostatic adenocarcinoma accounted for the largest share of the U.S. prostate cancer testing market. This is due to the increasing incidences of prostate cancer and increasing popularity of prostate cancer testing.

Segmentation 3: by Application
• Diagnostics Biomarkers
• Prognostics Biomarkers

Based on application, the U.S. prostate cancer testing market is dominated by the diagnostics biomarkers segment owing to the rising R&D activity focused on the development of prostate cancer testing. The diagnosis of prostate cancer has developed a new molecular-based diagnostics technology. To detect clinically relevant cancer upon diagnosis, several tools or therapeutic options are required to improve the patient’s quality of life.

Segmentation 4: by End User
• Cancer Research Institutes
• Diagnostic Laboratories
• Hospitals and Clinics
• Ambulatory Surgical Centers (ASCs)
• Others

Based on end user, the U.S. prostate cancer testing market is dominated by the ambulatory surgical centers (ASCs) segment owing to their rise in number. They are dedicated to offering same-day surgical care, including testing and protective procedures. ASCs, which have a proven track record of providing high-quality treatment and successful patient outcomes, have altered the outpatient experience for millions of Americans by giving patients a more convenient option for hospital-based outpatient operations.

Segmentation 5: by Region
• Northeast U.S.
• Midwest U.S
• South U.S.
• West U.S.

Recent Developments in the U.S. Prostate Cancer Testing Market

• In September 2022, Veracyte, Inc. announced the publishing of data in the Journal of the National Cancer Institute to demonstrate the company’s decipher prostate genomic classifier may help identify African American men with early, localized prostate cancer who are most likely to harbor more aggressive disease.
• In August 2019, BioReference Laboratories, Inc. announced the selection by The IPA Association of America (TIPAAA) as its provider of laboratory services and to assist with data analytics for its members’ patients. The agreement is designed to enhance patient care and offers collaborative health management tools to TIPAAA members, which includes more than 667 medical organizations in 39 states. The members can have convenient access to BioReference’s comprehensive laboratory testing menu, including routine and specialty tests, as well as the 4Kscore for detecting aggressive prostate cancer.
• In June 2021, Thermo Fisher Scientific announced submissions open for the Oncomine Clinical Research Grant program to support clinical research projects in oncology. The grant aims to provide funding for high-quality molecular profiling studies focusing on the impact of immune-based treatments for cancer patients.

Demand - Drivers and Limitations

The following are the demand drivers for the U.S. prostate cancer testing market:

• Rising prevalence of prostate cancer in the U.S.
• Increasing number of prostate cancer screening and testing
• Government initiatives related to prostate cancer

The market is expected to face some limitations due to the following challenges:

• High Probability of false positive results of prostate cancer testing
• Clinical gaps related to prostate cancer testing

How can this report add value to an organization?

Workflow/Innovation Strategy: The workflow segment helps the reader understand the two prostate cancer testing, i.e., initial evaluation: prostate-specific antigen (total PSA, free PSA), pre-biopsy/post-negative biopsy testing, and post-biopsy tissue testing, which further aid in diagnosis. Moreover, the study provides the reader with a detailed understanding of the different applications of prostate cancer testing in clinical and research applications.

Growth/Marketing Strategy: Prostate cancer testing is being used for both research and clinical application. Various companies are providing urine and blood, and tissue-based biomarkers that aid in the diagnosis, which is also the key strategy for U.S. prostate cancer testing market players to excel in the current U.S. prostate cancer testing market.

Competitive Strategy: Key players in the U.S. prostate cancer testing market are analyzed and profiled in the study, including manufacturers who are involved in new product launches, acquisitions, expansions, and strategic collaborations. Moreover, a detailed competitive benchmarking of the players operating in the U.S. prostate cancer testing market has been done to help the reader understand how players stack against each other, presenting a clear market landscape. Additionally, comprehensive competitive strategies such as partnerships, agreements, and collaborations will aid the reader in understanding the untapped revenue pockets in the U.S. prostate cancer market.

Key Market Players and Competition Synopsis

A new wave of prostate cancer (PCa) biomarkers with greater PCa specificity than PSA and its isoforms have emerged to enhance PCa screening techniques. Biomarkers are molecules that, when detected or assessed, reveal details about a disease that goes beyond conventional clinical characteristics. They can be found in a number of places, including blood, urine, and tissue samples. Both diagnostic and prognostic data can be provided by biomarkers, supporting healthcare professionals in formulating illness projections intended to inform treatment choices on an individual basis. The U.S. prostate cancer testing market (by biomarker type) excluding PSA Tests is segmented into pre-biopsy/post-negative biopsy testing and post-biopsy tissue testing.

Some of the prominent names in the U.S. prostate cancer testing market are:

• Danaher. (Beckman Coulter, Inc.)
• Opko Health, Inc. (Genpath, Inc.)
• Bio-Techne
• Cleaveland Diagnostics, Inc.
• mdxhealth
• Myriad Genetics, Inc.
• Exact Sciences Corporation
• Veracyte, Inc.
• mdxhealth

Companies that are not a part of the aforementioned pool have been well represented across different sections of the report (wherever applicable).

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Table of Contents

Executive Summary
Scope and Definition
Market/Product Definition
Inclusion and Exclusion
Key Questions Answered
Analysis and Forecast Note
Research Methodology
1. Markets Overview
1.1 Market Footprint and Growth Potential
1.2 Future Potential
1.3 Evolution of Prostate Cancer Testing
1.4 Epidemiology of Prostate Cancer in the U.S.
1.4.1 Southern U.S.
1.4.2 Midwest U.S.
1.4.3 Mid-Atlantic U.S.
1.4.4 West U.S.
1.4.5 Southwest U.S.
1.4.6 New England e
2. Industry Analysis
2.1 Overview
2.2 Legal Requirements and Framework in the U.S
2.2.1 National Comprehensive Cancer Network (NCCN) Guidelines
2.2.2 American Urological Association (AUA)
2.2.3 American Cancer Society (ACS)
2.2.4 U.S. Preventive Services Task Force (USPSTF)
2.3 Patent Analysis
2.3.1 Patent Filing Trend
2.4 Role of Biomarkers in Prostate Cancer Management
3. Market Dynamics
3.1 Overview
3.1.1 Impact Analysis
3.2 Market Drivers
3.3 Market Restraints
3.4 Market Opportunities
4. U.S. Prostate Cancer Testing Market: Competitive Landscape
4.1 Overview
4.2 Corporate Strategies
4.2.1 Mergers and Acquisitions
4.2.2 Synergistic Activities
4.2.3 Business Expansions and Funding
4.3 Business Strategies
4.3.1 Product Launches and Approvals
4.3.2 Publications
4.3.3 Licenses and Agreements
4.3.4 Other Activities
4.4 Reimbursement Scenario in the U.S.
5. U.S. Prostate Cancer Testing Market (by Biomarker Type), ($Million), 2023-2035
5.1 Overview
5.2 Initial Evaluation: Prostate-Specific Antigen (Total PSA, Free PSA)
5.3 Pre-Biopsy/Post-Negative Biopsy Testing
5.3.1 Blood-Based Biomarker
5.3.2 Urine-Based Biomarker
5.3.3 Imaging
5.3.3.1 Multiparametric Magnetic Resonance Imaging (mp-MRI)
5.4 Post-Biopsy Tissue Testing
5.5 Post-Biopsy Test
6. U.S. Prostate Cancer Testing Market (by Cancer Type), ($Million), 2023-2035
6.1 Overview
6.2 Prostatic Adenocarcinoma
6.3 Small Cell Carcinoma
6.4 Other Prostate Cancer Type
7. U.S. Prostate Cancer Testing Market (by Application), ($Million), 2023-2035
7.1 Overview
7.2 Clinical Diagnostic Biomarkers
7.3 Prognostic Biomarkers (Prolaris, OncotypeDx, Decipher, etc.)
8. U.S. Prostate Cancer Testing Market (by End User), ($Million), 2023-2035
8.1 Overview
8.2 Cancer Research Institutes
8.3 Diagnostic Laboratories
8.4 Hospitals and Clinics
8.5 Ambulatory Surgical Centers (ASCs)
8.6 Others
9. U.S. Prostate Cancer Testing Market (by Region), ($Million), 2023-2035
9.1 Overview
9.2 Northeast U.S.
9.2.1 Northeast U.S. (Prostate-Specific Antigen (PSA)
9.2.2 Northeast U.S. (Pre-Biopsy/Post-Negative Biopsy Testing)
9.2.3 Northeast U.S. (Post-Biopsy Tissue Testing)
9.3 Midwest U.S.
9.3.1 Midwest U.S. (Prostate-Specific Antigen (PSA)
9.3.2 Midwest U.S. (Pre-Biopsy/Post-Negative Biopsy Testing)
9.3.3 Midwest U.S. (Post-Biopsy Tissue Testing)
9.4 South U.S.
9.4.1 South U.S. (Prostate-Specific Antigen (PSA)
9.4.2 South U.S. (Pre-Biopsy/Post-Negative Biopsy Testing)
9.4.3 South U.S. (Post-Biopsy Tissue Testing)
9.5 West U.S.
9.5.1 West U.S. (Prostate-Specific Antigen (PSA)
9.5.2 West U.S. (Pre-Biopsy/Post-Negative Biopsy Testing)
9.5.3 West U.S. (Post-Biopsy Tissue Testing)
10. Company Profiles
10.1 Abbott
10.1.1 Overview
10.1.2 Top Products / Product Portfolio
10.1.3 Top Competitors
10.1.4 Target Customers/End-Users
10.1.5 Key Personnel
10.1.6 Analyst View
10.2 Abcam plc.
10.2.1 Overview
10.2.2 Top Products / Product Portfolio
10.2.3 Top Competitors
10.2.4 Target Customers/End-Users
10.2.5 Key Personnel
10.2.6 Analyst View
10.3 Agilent Technologies, Inc.
10.3.1 Overview
10.3.2 Top Products / Product Portfolio
10.3.3 Top Competitors
10.3.4 Target Customers/End-Users
10.3.5 Key Personnel
10.3.6 Analyst View
10.4 Bio-Techne. (ExoDx)
10.4.1 Overview
10.4.2 Top Products / Product Portfolio
10.4.3 Top Competitors
10.4.4 Target Customers/End-Users
10.4.5 Key Personnel
10.4.6 Analyst View
10.5 Cleveland Diagnostics, Inc.
10.5.1 Overview
10.5.2 Top Products / Product Portfolio
10.5.3 Top Competitors
10.5.4 Target Customers/End-Users
10.5.5 Key Personnel
10.5.6 Analyst View
10.6 Danaher. (Beckman Coulter, Inc.)
10.6.1 Overview
10.6.2 Top Products / Product Portfolio
10.6.3 Top Competitors
10.6.4 Target Customers/End-Users
10.6.5 Key Personnel
10.6.6 Analyst View
10.7 Exact Sciences Corporation
10.7.1 Overview
10.7.2 Top Products / Product Portfolio
10.7.3 Top Competitors
10.7.4 Target Customers/End-Users
10.7.5 Key Personnel
10.7.6 Analyst View
10.8 F. Hoffmann-La Roche Ltd (FOUNDATION MEDICINE, INC.)
10.8.1 Overview
10.8.2 Top Products / Product Portfolio
10.8.3 Top Competitors
10.8.4 Target Customers/End-Users
10.8.5 Key Personnel
10.8.6 Analyst View
10.9 H.U. Group Holdings, Inc. (Fujeribio)
10.9.1 Overview
10.9.2 Top Products / Product Portfolio
10.9.3 Top Competitors
10.9.4 Target Customers/End-Users
10.9.5 Key Personnel
10.9.6 Analyst View
10.10 Mdxhealth
10.10.1 Overview
10.10.2 Top Products / Product Portfolio
10.10.3 Top Competitors
10.10.4 Target Customers/End-Users
10.10.5 Key Personnel
10.10.6 Analyst View
10.11 Siemens Healthcare GmbH
10.11.1 Overview
10.11.2 Top Products / Product Portfolio
10.11.3 Top Competitors
10.11.4 Target Customers/End-Users
10.11.5 Key Personnel
10.11.6 Analyst View
10.12 Myriad Genetics, Inc.
10.12.1 Overview
10.12.2 Top Products / Product Portfolio
10.12.3 Top Competitors
10.12.4 Target Customers/End-Users
10.12.5 Key Personnel
10.12.6 Analyst View
10.13 NeoGenomics Laboratories
10.13.1 Overview
10.13.2 Top Products / Product Portfolio
10.13.3 Top Competitors
10.13.4 Target Customers/End-Users
10.13.5 Key Personnel
10.13.6 Analyst View
10.14 OPKO Health, Inc. (GenPath)
10.14.1 Overview
10.14.2 Top Products / Product Portfolio
10.14.3 Top Competitors
10.14.4 Target Customers/End-Users
10.14.5 Key Personnel
10.14.6 Analyst View
10.15 Veracyte, Inc.
10.15.1 Overview
10.15.2 Top Products / Product Portfolio
10.15.3 Top Competitors
10.15.4 Target Customers/End-Users
10.15.5 Key Personnel
10.15.6 Analyst View
List of Figures
Figure: U.S. Prostate Cancer Testing Market, Dynamics Impact Analysis
Figure: U.S.Prostate Cancer Testing Market Coverage
Figure: U.S.Prostate Cancer Testing Market Key Trends, Impact Analysis, 2023-2035
Figure: U.S.Prostate Cancer Testing Market, Patent Analysis, January 2022-March 2025
List of Tables
Table: U.S. Prostate Cancer Testing Market, Patent Analysis, January 2022-March 2025
Table: U.S.Prostate Cancer Testing Market Dynamics, Impact Analysis
Table: U.S.Prostate Cancer Testing Market (by Biomarker Type), $Million, 2023-2035
Table: U.S.Prostate Cancer Testing Market (by Cancer Type), $Million, 2023-2035
Table: U.S.Prostate Cancer Testing Market (by Application), $Million, 2023-2035
Table: U.S. Prostate Cancer Testing Market (by End User), $Million, 2023-2035
Table: U.S. Prostate Cancer Testing Market (by Region), $Million, 2023-2035

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