A quick peek into the report
Table of Contents
1.1 Product Definition
1.1.1 Inclusion and Exclusion Criteria
1.2 Market Scope
1.2.1 Scope of the Study
1.2.2 Key Questions Answered in the Report
1.3 Research Methodology
1.3.1 U.S. Prostate Cancer Testing Market: Research Methodology
1.3.2 Data Sources
1.3.2.1 Primary Data Sources
1.3.2.2 Secondary Data Sources
1.3.3 Market Estimation Model
1.3.4 Criteria for Company Profiling
1.4 Market: Overview
1.4.1 Market Definition
1.4.2 Market Footprint and Growth Potential
1.4.3 Future Potential
1.4.4 Evolution of Prostate Cancer Testing
1.4.5 Epidemiology of Prostate Cancer in the U.S.
1.4.5.1 Southern U.S.
1.4.5.2 Midwest U.S.
1.4.5.3 Mid-Atlantic U.S.
1.4.5.4 West U.S.
1.4.5.5 Southwest U.S.
1.4.5.6 New England
1.4.6 COVID-19 Impact on U.S. Prostate Cancer Testing Market
1.4.6.1 COVID-19 Impact on Cancer Care in the U.S.
1.4.6.2 COVID-19 Impact on Prostate Cancer in the U.S.
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
2.3.1.1 Patent Analysis (by Year)
2.4 Role of Biomarkers In Prostate Cancer Management (Guidelines for treatment of PCa in the U.S)
3.1 Overview
3.1.1 Impact Analysis
3.2 Market Drivers
3.2.1 Rising Prevalence of Prostate Cancer in the U.S.
3.2.2 Increasing Number of Prostate Cancer Screening and Testing
3.2.3 Government Initiatives Related to Prostate Cancer
3.3 Market Restraints
3.3.1 High Probability of False Positives during Prostate Cancer Testing
3.3.2 Clinical Gaps Related to Prostate Cancer Testing
3.4 Market Opportunities
3.4.1 New Treatment Therapy and Technique for Prostate Cancer
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 Regulatory and Legal Activities
4.3.3 Licenses and Agreements
4.3.4 Other Activities
4.4 Reimbursement Scenario in the U.S.
4.4.1 State Efforts to Ensure Prostate Cancer Screening Coverage
4.4.2 Medicare Coverage for Prostate Cancer Screening
4.4.3 Biomarker Testing Reimbursement Scenario in the U.S.
4.5 Market Share Analysis (by Company)
5.1 Overview
5.1.1 Initial Evaluation: Prostate-Specific Antigen (Total PSA, Free PSA)
5.1.2 Pre-Biopsy/Post-Negative Biopsy Testing
5.1.2.1 Blood-Based Biomarker
5.1.2.2 Urine-Based Biomarker
5.1.2.3 Imaging
5.1.2.3.1 Multiparametric Magnetic Resonance Imaging (mp-MRI)
5.1.3 Post-Biopsy Tissue Testing
5.1.3.1 Tissue-Based Biomarker
6.1 Overview
6.2 Diagnostic Biomarkers (PHI, 4KScore, SelectMDx, etc.)
6.3 Prognostic Biomarkers (Prolaris, OncotypeDx, Decipher, etc.)
7.1 Overview
7.2 Cancer Research Institutes
7.3 Diagnostic Laboratories
7.4 Hospitals and Clinics
7.5 Ambulatory Surgical Centers (ASCs)
7.6 Others
8.1 Overview
8.2 Northeast U.S.
8.2.1 Northeast U.S. (Prostate-Specific Antigen (PSA))
8.2.2 Northeast U.S. (Pre-Biopsy/Post-Negative Biopsy Testing)
8.2.3 Northeast U.S. (Post-Biopsy Tissue Testing)
8.3 Midwest U.S.
8.3.1 Midwest U.S. (Prostate-Specific Antigen (PSA))
8.3.2 Midwest U.S. (Pre-Biopsy/Post-Negative Biopsy Testing)
8.3.3 Midwest U.S. (Post-Biopsy Tissue Testing)
8.4 South U.S.
8.4.1 South U.S. (Prostate-Specific Antigen (PSA))
8.4.2 South U.S. (Pre-Biopsy/Post-Negative Biopsy Testing)
8.4.3 South U.S. (Post-Biopsy Tissue Testing)
8.5 West U.S.
8.5.1 West U.S. (Prostate-Specific Antigen (PSA))
8.5.2 West U.S. (Pre-Biopsy/Post-Negative Biopsy Testing)
8.5.3 West U.S. (Post-Biopsy Tissue Testing)
9.1 Abbott.
9.1.1 Company Overview
9.1.2 Role of Abbott. in the U.S. Prostate Cancer Testing Market
9.1.3 Key Competitors of the Company
9.1.4 Financials
9.1.5 Key Insights about the Financial Health of the Company
9.1.6 Analyst Perspective
9.2 Abcam plc.
9.2.1 Company Overview
9.2.2 Role of Abcam plc. in the U.S. Prostate Cancer Testing Market
9.2.3 Key Customers of the Company
9.2.4 Key Competitors of the Company
9.2.5 Financials
9.2.6 Analyst Perspective
9.3 Agilent Technologies, Inc.
9.3.1 Company Overview
9.3.2 Role of Agilent Technologies, Inc. in the U.S. Prostate Cancer Testing Market
9.3.3 Key Competitors of the Company
9.3.4 Financials
9.3.5 Analyst Perspective
9.4 Bio-Techne. (ExoDx)
9.4.1 Company Overview
9.4.2 Role of Bio-Techne. (ExoDx) in the U.S. Prostate Cancer Testing Market
9.4.3 Key Competitors of the Company
9.4.4 Financials
9.4.5 Key Insights about the Financial Health of the Company
9.4.6 Corporate Strategies
9.4.7 Business Strategies
9.4.8 Analyst Perspective
9.5 Cleveland Diagnostics, Inc.
9.5.1 Company Overview
9.5.2 Role of Cleveland Diagnostics, Inc. in the U.S. Prostate Cancer Testing Market
9.5.3 Key Competitors of the Company
9.5.4 Corporate Strategies
9.5.5 Business Strategies
9.5.6 Analyst Perspective
9.6 Danaher. (Beckman Coulter, Inc.)
9.6.1 Company Overview
9.6.2 Role of Danaher. (Beckman Coulter, Inc.) in the U.S. Prostate Cancer Testing Market
9.6.3 Key Competitors of the Company
9.6.4 Financials
9.6.5 Key Insights about the Financial Health of the Company
9.6.6 Analyst Perspective
9.7 Exact Sciences Corporation
9.7.1 Company Overview
9.7.2 Role of Exact Sciences Corporation in the U.S. Prostate Cancer Testing Market
9.7.3 Key Customers of the Company
9.7.4 Key Competitors of the Company
9.7.5 Financials
9.7.6 Key Insights about the Financial Health of the Company
9.7.7 Corporate Strategies
9.7.8 Business Strategies
9.7.9 Analyst Perspective
9.8 F. Hoffmann-La Roche Ltd (FOUNDATION MEDICINE, INC.)
9.8.1 Company Overview
9.8.2 Role of F. Hoffmann-La Roche Ltd (FOUNDATION MEDICINE, INC.) in the U.S. Prostate Cancer Testing Market
9.8.3 Key Competitors of the Company
9.8.4 Financials
9.8.5 Key Insights about the Financial Health of the Company
9.8.6 Corporate Strategies
9.8.7 Business Strategies
9.8.8 Analyst Perspective
9.9 H.U. Group Holdings, Inc. (Fujeribio)
9.9.1 Company Overview
9.9.2 Role of H.U. Group Holdings, Inc. (Fujeribio) in the U.S. Prostate Cancer Testing Market
9.9.3 Key Competitors of the Company
9.9.4 Financials
9.9.5 Analyst Perspective
9.10 mdxhealth.
9.10.1 Company Overview
9.10.2 Role of mdxhealth. in the U.S. Prostate Cancer Testing Market
9.10.3 Financials
9.10.4 Key Insights about the Financial Health of the Company
9.10.5 Corporate Strategies
9.10.5.1 Mergers and Acquisitions
9.10.6 Business Strategies
9.10.7 Analyst Perspective
9.11 Siemens Healthcare GmbH
9.11.1 Company Overview
9.11.2 Role of Siemens Healthcare GmbH in the U.S. Prostate Cancer Testing Market
9.11.3 Key Competitors of the Company
9.11.4 Financials
9.11.5 Key Insights about the Financial Health of the Company
9.11.6 Analyst Perspective
9.12 Myriad Genetics, Inc.
9.12.1 Company Overview
9.12.2 Role of Myriad Genetics, Inc. in the U.S. Prostate Cancer Testing Market
9.12.3 Key Competitors of the Company
9.12.4 Corporate Strategies
9.12.5 Business Strategies
9.12.6 Financials
9.12.7 Key Insights about the Financial Health of the Company
9.12.8 Analyst Perspective
9.13 NeoGenomics Laboratories.
9.13.1 Company Overview
9.13.2 Role of NeoGenomics Laboratories. in the U.S. Prostate Cancer Testing Market
9.13.3 Key Competitors of the Company
9.13.4 Financials
9.13.5 Key Insights about the Financial Health of the Company
9.13.6 Business Strategies
9.13.7 Analyst Perspective
9.14 OPKO Health, Inc. (GenPath)
9.14.1 Company Overview
9.14.2 Role of OPKO Health, Inc. (GenPath) in the U.S. Prostate Cancer Testing Market
9.14.3 Key Customers of the Company
9.14.4 Key Competitors of the Company
9.14.5 Financials
9.14.6 Key Insights about the Financial Health of the Company
9.14.7 Corporate Strategies
9.14.8 Business Strategies
9.14.9 Analyst Perspective
9.15 Veracyte, Inc.
9.15.1 Company Overview
9.15.2 Role of Veracyte, Inc. in the U.S. Prostate Cancer Testing Market
9.15.3 Key Customers of the Company
9.15.4 Key Competitors of the Company
9.15.5 Financials
9.15.6 Corporate Strategies
9.15.7 Analyst Perspective
Table 1: Impact Analysis of Market Drivers, Restraints, and Opportunities on the U.S. Prostate Cancer Testing Market
Table 2: Likert Scale
Table 3: Numerous Risk Categories for Clinically Localized Prostate Cancer
Table 4: Summary of Guidelines for Prostate Cancer Testing
Table 5: Recommendations Related to Prostate Cancer Screening
Table 6: Screening and Diagnosis Rate in 2019 (by Age Group)
Table 7: List of States with Passed Laws for Biomarker Testing Coverage by Health Insurer
Table 8: Some of the Emerging Biomarkers Associated with Prostate Cancer and its Clinical Trials
Table 9: Prostate-Specific Antigen (PSA) Age Range
Table 10: Summary of Prostate-Specific Antigen (PSA) Screening Guidelines
Table 11: Blood-Based Biomarkers for Prostate Cancer Testing
Table 12: Urine-Based Biomarkers for Prostate Cancer Testing
Table 13: Tissue-Based Biomarkers for Prostate Cancer Testing
Table 14: Summary of Biomarkers, Clinical Use, and Guidelines
Table 15: Estimated Cancer Cases and Deaths due to Prostate Cancer in the U.S. States, 2022
Figure 1: U.S. Prostate Cancer Testing Market, $Million, 2021 and 2030
Figure 2: U.S. Prostate Cancer Testing Market Segmentation
Figure 3: Share of U.S. Prostate Cancer Testing Market (by Biomarker Type), Excluding PSA Tests, $Million, 2021 and 2030
Figure 4: Share of U.S. Prostate Cancer Testing Market (by Application), $Million, 2021 and 2030
Figure 5: Share of U.S. Prostate Cancer Testing Market (by End User), $Million, 2021 and 2030
Figure 6: U.S. Prostate Cancer Testing Market Segmentation
Figure 7: U.S. Prostate Cancer Testing Market: Research Methodology
Figure 8: Primary Research Methodology
Figure 9: Bottom-Up Approach (Segment-Wise Analysis)
Figure 10: Top-Down Approach (Segment-Wise Analysis)
Figure 11: Overview of Prostate Cancer Testing
Figure 12: Evolution of Prostate Cancer Testing
Figure 13: Percent of Cases by Stage of Prostate Cancer, 2012-2018
Figure 14: 5-Year Relative Survival by Stage of Prostate Cancer (2012-2018)
Figure 15: Commonality of Prostate Cancer in 2022
Figure 16: New Cases (2015-2019) and Death Rates (2016-2020) per 100,000 Persons of Prostate Cancer (by Ethnicity)
Figure 17: New Cases (2015-2019) and Death Rates (2016-2020) of Prostate Cancer (by Age Group)
Figure 18: Estimated Number of New Prostate Cancer Cases in Southern U.S. (by State), %, 2022
Figure 19: Estimated Number of New Prostate Cancer Cases in Midwest U.S. (by State), %, 2022
Figure 20: Estimated Number of Prostate Cancer Cases in Mid-Atlantic U.S. (by State), %, 2022
Figure 21: Estimated Number of Prostate Cancer Cases in West U.S. (by State), %, 2022
Figure 22: Estimated Number of Prostate Cancer Cases in Southwest U.S. (by State), %, 2022
Figure 23: Estimated Number of New Prostate Cancer Cases in New England (by State), %, 2022
Figure 24: COVID-19 Impact on U.S Prostate Cancer
Figure 25: NCCN Guidelines for Prostate Cancer Propose Germline Testing for Patients
Figure 26: Year-Wise Analysis of Patents Related to U.S. Prostate Cancer Testing, January 2019-October 2022
Figure 27: Role of Biomarkers in Prostate Cancer Management
Figure 28: U.S. Prostate Cancer Testing Market - Market Dynamics
Figure 29: Likert Scale
Figure 30: Impact Analysis of Market Drivers and Market Challenges on the U.S. Prostate Cancer Testing Market
Figure 31: Incidence of Prostate Cancer in the U.S. (2015-2020)
Figure 32: Share of Key Developments, January 2019-November 2022
Figure 33: Share of Mergers and Acquisitions (by Company), January 2019-November 2022
Figure 34: Share of Synergistic Activities (by Company), January 2019-November 2022
Figure 35: Number of Business Expansions and Funding Activities (by Company), January 2019-November 2022
Figure 36: Number of Product Launches and Approvals (by Company), January 2019-November 2022
Figure 37: Share of Regulatory and Legal Activities (by Company), January 2019-November 2022
Figure 38: Number of Licenses and Agreements (by Company), January 2019-November 2022
Figure 39: Number of Other Activities (by Company), January 2019-November 2022
Figure 40: Impact on Coverage Expansion ($) of Biomarker Testing on Member Premiums (2022)
Figure 41: Market Share Analysis of U.S. Prostate Cancer Testing Market (Pre-Biopsy/Post-Negative Biopsy Testing), 2021
Figure 42: Market Share Analysis of U.S. Prostate Cancer Testing Market (Post-Biopsy Tissue Testing), 2021
Figure 43: Phases of Biomarker Development
Figure 44: Classification of Biomarkers
Figure 45: U.S. Prostate Cancer Testing Market (by Biomarker Type)
Figure 46: U.S. Prostate Cancer Testing Market for Prostate-Specific Antigen (PSA) (TAM and SAM), $Million, 2021-2030
Figure 47: Share of U.S. Prostate Cancer Testing Market (by Biomarker Type), Excluding PSA Tests, $Million, 2021 and 2030
Figure 48: U.S. Prostate Cancer Testing Market for Pre-Biopsy/Post-Negative Biopsy Testing (TAM, SAM, and SOM), $Million, 2021-2030
Figure 49: U.S. Prostate Cancer Testing Market for Blood-Based Biomarker (SAM), $Million, 2021-2030
Figure 50: U.S. Prostate Cancer Testing Market, Urine-Based Biomarker (SAM), $Million, 2021-2032
Figure 51: U.S. Prostate Cancer Testing Market, Multiparametric Magnetic Resonance Imaging (mp-MRI) (SAM), $Million, 2021-2030
Figure 52: U.S. Prostate Cancer Testing Market for Post-Biopsy Tissue Testing (TAM, SAM, and SOM), $Million, 2021-2030
Figure 53: Utility of Tissue-Based Biomarker in Prostate Cancer Management
Figure 54: Share of U.S. Prostate Cancer Testing Market (by Application), $Million, 2021 and 2030
Figure 55: U.S. Prostate Cancer Testing Market (Diagnostic Biomarker), $Million, 2021-2030
Figure 56: U.S. Prostate Cancer Testing Market (Prognostic Biomarker), $Million, 2021-2030
Figure 57: U.S. Prostate Cancer Testing Market (by End User)
Figure 58: Share of U.S. Prostate Cancer Testing Market (by End User), $Million, 2021 and 2030
Figure 59: U.S. Prostate Cancer Testing Market (Cancer Research Institute), $Million, 2021-2030
Figure 60: U.S. Prostate Cancer Testing Market (Diagnostic Laboratories), $Million, 2021-2030
Figure 61: U.S. Prostate Cancer Testing Market (Hospitals and Clinics), $Million, 2021-2030
Figure 62: U.S. Prostate Cancer Testing Market (Ambulatory Surgical Centers), $Million, 2021-2030
Figure 63: U.S. Prostate Cancer Testing Market (Others), $Million, 2021-2030
Figure 64: New Prostate Cancer Cases in the U.S., 2019
Figure 65: Northeast U.S. Prostate Cancer Testing Market (by PSA), $Million, 2021-2030
Figure 66: Northeast U.S. Prostate Cancer Testing Market (by Pre-Biopsy/Post-Negative Biopsy Testing), $Million, 2021-2030
Figure 67: Northeast U.S. Prostate Cancer Testing Market (by Post-Biopsy Tissue Testing), $Million, 2021-2030
Figure 68: Midwest U.S. Prostate Cancer Testing Market (by PSA), $Million, 2021-2030
Figure 69: Midwest U.S. Prostate Cancer Testing Market (by Pre-Biopsy/Post-Negative Biopsy Testing), $Million, 2021-2030
Figure 70: Midwest U.S. Prostate Cancer Testing Market (by Post-Biopsy Tissue Testing), $Million, 2021-2030
Figure 71: South U.S. Prostate Cancer Testing Market (by PSA), $Million, 2021-2030
Figure 72: South U.S. Prostate Cancer Testing Market (by Pre-Biopsy/Post-Negative Biopsy Testing), $Million, 2021-2030
Figure 73: South U.S. Prostate Cancer Testing Market (by Post-Biopsy Tissue Testing), $Million, 2021-2030
Figure 74: West U.S. Prostate Cancer Testing Market (by PSA), $Million, 2021-2030
Figure 75: West U.S. Prostate Cancer Testing Market (by Pre-Biopsy/Post-Negative Biopsy Testing), $Million, 2021-2030
Figure 76: West U.S. Prostate Cancer Testing Market (by Post-Biopsy Tissue Testing), $Million, 2021-2030
Figure 77: Abbott.: Product Portfolio
Figure 78: Abbott.: Overall Financials, $Million, 2019-2021
Figure 79: Abbott.: Revenue (by Segment), $Million, 2019-2021
Figure 80: Abbott.: Revenue (by Region), $Million, 2019-2021
Figure 81: Abbott.: R&D Expenditure, $Million, 2019-2021
Figure 82: Abcam plc.: Product Portfolio
Figure 83: Abcam plc.: Overall Financials, $Million, 2018-2020
Figure 84: Abcam plc.: Revenue (by Segment), $Million, 2019-2020
Figure 85: Abcam plc.: Revenue (by Region), $Million, 2018-2020
Figure 86: Abcam plc.: R&D Expenditure, $Million, 2019-2021
Figure 87: Agilent Technologies, Inc.: Product Portfolio
Figure 88: Agilent Technologies, Inc.: Overall Financials, $Million, 2019-2021
Figure 89: Agilent Technologies, Inc.: Revenue (by Segment), $Million, 2019-2021
Figure 90: Agilent Technologies, Inc.: Revenue (by Region), $Million, 2019-2021
Figure 91: Agilent Technologies, Inc: R&D Expenditure, $Million, 2019-2021
Figure 92: Bio-Techne. (ExoDx): Product Portfolio
Figure 93: Bio-Techne. (ExoDx): Overall Financials, $Million, 2020-2022
Figure 94: Bio-Techne. (ExoDx): Revenue (by Segment), $Million, 2020-2022
Figure 95: Bio-Techne. (ExoDx): Revenue (by Region), $Million, 2020-2022
Figure 96: Bio-Techne. (ExoDx): R&D Expenditure, $Million, 2020-2022
Figure 97: Cleveland Diagnostics, Inc.: Product Portfolio
Figure 98: Danaher. (Beckman Coulter, Inc.): Product Portfolio
Figure 99: Danaher. (Beckman Coulter, Inc.): Overall Financials, $Million, 2019-2021
Figure 100: Danaher. (Beckman Coulter, Inc.): Revenue (by Segment), $Million, 2019-2021
Figure 101: Danaher. (Beckman Coulter, Inc.): Revenue (by Region), $Million, 2019-2021
Figure 102: Danaher. (Beckman Coulter, Inc.): R&D Expenditure, $Million, 2019-2021
Figure 103: Exact Sciences Corporation: Product Portfolio
Figure 104: Exact Sciences Corporation: Overall Financials, $Million, 2019-2021
Figure 105: Exact Sciences Corporation.: Revenue (by Segment), $Million, 2019-2021
Figure 106: Exact Sciences Corporation: Revenue (by Region), $Million, 2019-2021
Figure 107: Exact Sciences Corporation: R&D Expenditure, $Million, 2019-2021
Figure 108: F. Hoffmann-La Roche Ltd (FOUNDATION MEDICINE, INC.): Product Portfolio
Figure 109: F. Hoffmann-La Roche Ltd (FOUNDATION MEDICINE, INC.): Overall Financials, $Million, 2019-2021
Figure 110: F. Hoffmann-La Roche Ltd (FOUNDATION MEDICINE, INC.): Revenue (by Segment), $Million, 2019-2021
Figure 111: F. Hoffmann-La Roche Ltd (FOUNDATION MEDICINE, INC.): Revenue (by Region), $Million, 2019-2021
Figure 112: F. Hoffmann-La Roche Ltd (FOUNDATION MEDICINE, INC.): R&D Expenditure, $Million, 2019-2021
Figure 113: H.U. Group Holdings, Inc. (Fujeribio): Product Portfolio
Figure 114: H.U. Group Holdings, Inc. (Fujeribio): Overall Financials, $Million, 2018-2020
Figure 115: H.U. Group Holdings, Inc. (Fujeribio): Revenue (by Segment), $Million, 2019-2021
Figure 116: H.U. Group Holdings, Inc. (Fujeribio): R&D Expenditure, $Million, 2018-2020
Figure 117: mdxhealth.: Product Portfolio
Figure 118: mdxhealth.: Overall Financials, $Million, 2019-2021
Figure 119: mdxhealth.: Revenue (by Segment), $Million, 2019-2021
Figure 120: mdxhealth.: R&D Expenditure, $Million, 2019-2021
Figure 121: Siemens Healthcare GmbH: Product Portfolio
Figure 122: Siemens Healthcare GmbH: Overall Financials, $Million, 2019-2021
Figure 123: Siemens Healthcare GmbH: Revenue (by Segment), $Million, 2019-2021
Figure 124: Siemens Healthcare GmbH: Revenue (by Region), $Million, 2019-2021
Figure 125: Siemens Healthcare GmbH: R&D Expenditure, $Million, 2019-2021
Figure 126: Myriad Genetics, Inc.: Product Portfolio
Figure 127: Myriad Genetics, Inc.: Overall Financials, $Million, 2019-2021
Figure 128: Myriad Genetics, Inc.: Revenue (by Segment), $Million, 2019-2021
Figure 129: Myriad Genetics, Inc.: R&D Expenditure, $Million, 2019-2021
Figure 130: NeoGenomics Laboratories.: Product Portfolio
Figure 131: NeoGenomics Laboratories.: Overall Financials, $Million, 2019-2021
Figure 132: NeoGenomics Laboratories.: Revenue (by Segment), $Million, 2019-2021
Figure 133: NeoGenomics Laboratories.: R&D Expenditure, $Million, 2019-2021
Figure 134: OPKO Health, Inc. (GenPath): Product Portfolio
Figure 135: OPKO Health, Inc. (GenPath): Overall Financials, $Million, 2019-2021
Figure 136: OPKO Health, Inc. (GenPath): Revenue (by Segment), $Million, 2019-2021
Figure 137: OPKO Health, Inc. (GenPath): R&D Expenditure, $Million, 2019-2021
Figure 138: Veracyte, Inc.: Product Portfolio
Figure 139: Veracyte, Inc.: Overall Financials, $Million, 2019-2021
Figure 140: Veracyte, Inc.: Revenue (by Segment), $Million, 2019-2021
Figure 141: Veracyte, Inc.: Revenue (by Region), $Million, 2019-2021
Figure 142: Veracyte, Inc: R&D Expenditure, $Million, 2019-2021
Market Report Coverage
U.S. Prostate Cancer Testing Market |
|||
Base Year |
2021 |
Market Size in 2021 |
$544.1 Million |
Forecast Period |
2022-2030 |
Value Projection and Estimation by 2030 |
$1,901.6 Million |
CAGR During Forecast Period |
14.7% |
Number of Tables |
15 |
Number of Pages |
196 |
Number of Figures |
142 |
Key Market Players and Competition Synopsis
The companies that are profiled have been selected based on inputs gathered from primary experts and analyzing company coverage, product portfolio, and market penetration.
Some of the prominent names in this market are:
• Abbott.
• Abcam plc.
• Agilent Technologies, Inc.
• Bio-Techne. (ExoDx)
• Cleveland Diagnostics, Inc.
• Danaher. (Beckman Coulter, Inc.)
• Exact Sciences Corporation
• F. Hoffmann-La Roche Ltd (FOUNDATION MEDICINE, INC.)
• H.U. Group Holdings, Inc. (Fujeribio)
• mdxhealth.
• Siemens Healthcare GmbH
• Myriad Genetics, Inc.
• NeoGenomics Laboratories.
• OPKO Health, Inc. (GenPath)
• Veracyte, Inc.
Companies that are not a part of the aforementioned pool have been well represented across different sections of the report (wherever applicable).
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, 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 market players to excel in the current 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 market.
Industry and Technology Overview
U.S. Prostate Cancer Testing Market Industry Overview
The U.S. prostate cancer testing market is anticipated to reach $1,901.6 million in 2030 from $544.1 million in 2021, with a CAGR of 14.7%, during the forecast period 2022-2030. 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 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 prostate cancer market.
Market Lifecycle Stage
The U.S. prostate cancer testing market is in 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.
Figure: U.S. Prostate Cancer Testing Market Snapshot
Source: BIS Research Analysis
Impact
One of the main reasons for the expansion of the 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.
Impact of COVID-19
During the coronavirus disease 2019 (COVID-19) pandemic, a number of disease models issued warnings about an excess of cancer fatalities brought on by missed cancer screenings as a result of the general population's quarantine and a lack of healthcare resources. The COVID-19 pandemic has had a negative impact on early diagnosis in the specific case of prostate cancer, the second most common cancer in men, by reducing participation in screening programs and on time from diagnostic testing to surgery/radiotherapy, which may translate into a worse prostate-cancer-specific death rate in the coming years. Additionally, in other areas, including Florida, state governments disallowed non-essential healthcare services.
Significant reductions in cancer screenings were seen in the early stages of the COVID-19 pandemic. According to a research paper published in January 2022 by the University of Florida, screenings for prostate cancer were reduced by 74%. Due to these screening figures, there may have been thousands more cancer deaths in the U.S. than were registered.
For instance, prostate-specific antigen (PSA) testing rates and the identification of several urological malignancies, including prostate cancer, have been found to be declining in significantly afflicted populations. Several Australian urologists worry that men with possibly curable prostate cancer may have missed their chance for a cure due to low screening test uptake during the lockdowns of 2020. According to a research paper published by BMC Urology in June 2022, a total of 4,048,099 PSA tests and 118,328 prostate biopsies were performed in Australia over the six years of data analysis. In the years 2019 and 2020, 68,429 prostate magnetic resonance imaging (MRI) were performed. Between 2015 and 2019, there were, on average, 19,573 prostate biopsies and 678,082 PSA testing performed per year.
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 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 3: by End User
• Cancer Research Institutes
• Diagnostic Laboratories
• Hospitals and Clinics
• Ambulatory Surgical Center (ASCs)
• Others
As of 2021, the U.S. prostate cancer testing market (by end user) was dominated by ambulatory surgical centers (ASCs), holding a 28.55% market share with a market value of $155.3 million.
Segmentation 4: by Region
• Northeast U.S.
• Midwest U.S
• South U.S.
• West U.S.
The TAM of the pre-biopsy/post-negative biopsy testing segment is expected to grow at a CAGR of 4.5% during the forecast period 2022-2030 in the South U.S. prostate cancer testing market. Several established diagnostics manufacturers in this region who are focusing on expanding their portfolios in prostate cancer testing and are collaborating with service providers and pharmaceutical giants to co-market prostate cancer testing solutions with its complementary precision medicine solutions. Moreover, the U.S. government is currently undertaking several initiatives to develop tests for cancer and provide funds to new start-ups in the cancer diagnostics field.
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 Positives during Prostate Cancer Testing
• Clinical Gaps Related to Prostate Cancer Testing
Analyst View
According to Nitish Kumar, Principal Analyst, BIS Research, “Prostate cancer testing includes various tests being followed for past several years. The treatment starts with the prostate cancer screening that includes preliminary tests, i.e., prostate-specific antigen test and digital rectal exam (DRE). If prostate cancer is suspected based on the results of screening tests or symptoms and an elevated PSA test, the patient is referred to a urologist. To determine whether cancer has spread beyond the prostate, the following testing is undertaken, i.e., pre-biopsy test (biomarker test which is blood-based and urine-based biomarker) and imaging (mp-MRI (Multi-parametric Magnetic Resonance Imaging)), prostate biopsy, and post-biopsy procedures such as tissue-based biopsy”.
U.S. Prostate Cancer Testing Market - A Country Analysis
Focus on Type of Biomarker, Application, End User, and Region - Analysis and Forecast, 2022-2030
Frequently Asked Questions
Tests for prostate cancer are crucial for the early diagnosis and effective treatment of the condition. The most frequent initial diagnosis for prostate cancer is prostate-specific antigen (PSA) testing, which may or may not need follow-up tests to confirm the tumor's presence. The use of prostate cancer testing offers a number of advantages, including aiding in the early discovery of the disease at localized stages and assisting individuals in achieving effective health management. The usage of prostate cancer testing is on the rise all around the world, but it is more prevalent in developing nations with rising healthcare standards.
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.
There are high investments in the field of cancer research driven by top-line revenue growth. Business leaders are establishing a deep understanding to address the unmet needs in clinical research to understand the prostate cancer market. One of the major developments in the market for prostate cancer testing is the increased emphasis on biomarker research. With the recent advancements in high throughput technological platforms in proteomics, genomics, and immunology, the discovery of biomarkers has quickened. The producers are concentrating on creating prostate cancer biomarkers that can predict the severity of the disease and guide in making better treatment choices.
The U.S. prostate cancer testing market is currently witnessing several developments, primarily aimed toward bringing new products and services. Major manufacturers of prostate cancer testing products, along with the service providers, are actively undertaking significant business strategies to translate success in research and development into the commercial clinical setting. Companies such as mdxhealth, Danaher., Bio-Techne, Veracyte, Inc., OPKO Health, Inc., and Cleaveland Diagnostics. have majorly adopted partnerships, collaborations, and joint venture strategies.
A new entrant can focus on various prostate cancer testing offerings by the established players in the prostate cancer testing market. The market is fragmented with established market leaders such as mdxhealth, Danaher, Bio-Techne, Veracyte, Inc., and OPKO Health, Inc., who have had their presence in the market for the past many years. The new entrants can focus on their strategy of product launch and expansion for prostate cancer testing.
The following can be considered the USPs of the report:
• Extensive competitive benchmarking of the top 20 players to offer a holistic view of the U.S. prostate cancer testing market landscape
• Market ranking analysis based on product portfolio, recent developments, and regional spread
• Investment landscape, including product adoption scenario, funding, and patent analysis
The companies manufacturing prostate cancer testing, service providers, pharmaceutical companies, research institutions, etc., should buy this report.