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Focus on Type of Biomarker, Application,
End User, and Region
Analysis and Forecast: 2022-2030
November 2022
U.S. Prostate
Cancer Testing
Market -
A Country
Analysis
Table of Content
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BIS Research is a leading market intelligence and technology research company. BIS Research publishes in-
depth market intelligence reports focusing on the market estimations, technology analysis, emerging high-
growth applications, deeply segmented granular country-level market data and other important market
parameters useful in the strategic decision making for senior management. BIS Research provides multi-client
reports, company profiles, databases, and custom research services.
Copyright © 2022 BIS Research Inc.
All Rights Reserved. This document contains highly confidential information and is the sole property of BIS
Research. Disclosing, copying, circulating, quoting, or otherwise reproducing any or all contents of this
document is strictly prohibited. Access to this information is provided exclusively for the benefit of the people
or organization concerned. It may not be accessed by or offered whether for sale or otherwise to any third
party.
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Table of Content
Executive Summary..........................................................................20
1. Markets .....................................................................................25
1.1 Product Definition............................................................................................26
1.1.1 Inclusion and Exclusion Criteria................................................................26
1.2 Market Scope ...................................................................................................27
1.2.1 Scope of the Study......................................................................................27
1.2.2 Key Questions Answered in the Report ....................................................28
1.3 Research Methodology ...................................................................................29
1.3.1 U.S. Prostate Cancer Testing Market: Research Methodology ...............29
1.3.2 Data Sources ...............................................................................................29
1.3.2.1 Primary Data Sources........................................................................................ 29
1.3.2.2 Secondary Data Sources................................................................................... 30
1.3.3 Market Estimation Model ............................................................................31
1.3.4 Criteria for Company Profiling ...................................................................33
1.4 Market: Overview.............................................................................................33
1.4.1 Market Definition .........................................................................................33
1.4.2 Market Footprint and Growth Potential .....................................................34
1.4.3 Future Potential ...........................................................................................35
1.4.4 Evolution of Prostate Cancer Testing........................................................36
1.4.5 Epidemiology of Prostate Cancer in the U.S.............................................36
1.4.5.1 Southern U.S. .................................................................................................... 40
1.4.5.2 Midwest U.S....................................................................................................... 41
1.4.5.3 Mid-Atlantic U.S................................................................................................. 42
1.4.5.4 West U.S............................................................................................................ 43
1.4.5.5 Southwest U.S................................................................................................... 44
1.4.5.6 New England ..................................................................................................... 45
1.4.6 COVID-19 Impact on U.S. Prostate Cancer Testing Market .....................45
1.4.6.1 COVID-19 Impact on Cancer Care in the U.S. .................................................. 46
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1.4.6.2 COVID-19 Impact on Prostate Cancer in the U.S.............................................. 47
2. Industry Analysis ......................................................................48
2.1 Overview...........................................................................................................49
2.2 Legal Requirements and Framework in the U.S............................................49
2.2.1 National Comprehensive Cancer Network (NCCN) Guidelines ...............49
2.2.2 American Urological Association (AUA) ...................................................50
2.2.3 American Cancer Society (ACS) ................................................................52
2.2.4 U.S. Preventive Services Task Force (USPSTF) .......................................52
2.3 Patent Analysis................................................................................................53
2.3.1 Patent Filing Trend......................................................................................53
2.3.1.1 Patent Analysis (by Year) .................................................................................. 53
2.4 Role of Biomarkers In Prostate Cancer Management (Guidelines for
treatment of PCa in the U.S) ...........................................................................54
3. U.S. Prostate Cancer Testing Market: Market Dynamics ............56
3.1 Overview...........................................................................................................57
3.1.1 Impact Analysis ...........................................................................................57
3.2 Market Drivers..................................................................................................58
3.2.1 Rising Prevalence of Prostate Cancer in the U.S. ....................................58
3.2.2 Increasing Number of Prostate Cancer Screening and Testing..............59
3.2.3 Government Initiatives Related to Prostate Cancer .................................60
3.3 Market Restraints.............................................................................................61
3.3.1 High Probability of False Positives during Prostate Cancer Testing......61
3.3.2 Clinical Gaps Related to Prostate Cancer Testing ...................................61
3.4 Market Opportunities.......................................................................................62
3.4.1 New Treatment Therapy and Technique for Prostate Cancer .................62
4. U.S. Prostate Cancer Testing Market: Competitive
Landscape.................................................................................63
4.1 Overview...........................................................................................................64
4.2 Corporate Strategies .......................................................................................64
4.2.1 Mergers and Acquisitions...........................................................................64
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4.2.2 Synergistic Activities ..................................................................................66
4.2.3 Business Expansions and Funding...........................................................67
4.3 Business Strategies ........................................................................................68
4.3.1 Product Launches and Approvals .............................................................68
4.3.2 Regulatory and Legal Activities .................................................................70
4.3.3 Licenses and Agreements..........................................................................71
4.3.4 Other Activities............................................................................................72
4.4 Reimbursement Scenario in the U.S. .............................................................74
4.4.1 State Efforts to Ensure Prostate Cancer Screening Coverage................75
4.4.2 Medicare Coverage for Prostate Cancer Screening .................................75
4.4.3 Biomarker Testing Reimbursement Scenario in the U.S. ........................75
4.5 Market Share Analysis (by Company)............................................................77
5. U.S. Prostate Cancer Testing Market (by Biomarker Type),
Value ($Million), 2021-2030........................................................80
5.1 Overview...........................................................................................................81
5.1.1 Initial Evaluation: Prostate-Specific Antigen (Total PSA, Free PSA) ......84
5.1.2 Pre-Biopsy/Post-Negative Biopsy Testing ................................................86
5.1.2.1 Blood-Based Biomarker..................................................................................... 87
5.1.2.2 Urine-Based Biomarker ..................................................................................... 88
5.1.2.3 Imaging.............................................................................................................. 89
5.1.2.3.1 Multiparametric Magnetic Resonance Imaging (mp-MRI) ....................................... 89
5.1.3 Post-Biopsy Tissue Testing .......................................................................89
5.1.3.1 Tissue-Based Biomarker ................................................................................... 90
6. U.S. Prostate Cancer Testing Market (by Application), Value
($Million), 2021-2030..................................................................92
6.1 Overview...........................................................................................................93
6.2 Diagnostic Biomarkers (PHI, 4KScore, SelectMDx, etc.)..............................95
6.3 Prognostic Biomarkers (Prolaris, OncotypeDx, Decipher, etc.) ..................97
7. U.S. Prostate Cancer Testing Market (by End User), Value
($Million), 2021-2030..................................................................99
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7.1 Overview.........................................................................................................100
7.2 Cancer Research Institutes...........................................................................101
7.3 Diagnostic Laboratories................................................................................102
7.4 Hospitals and Clinics ....................................................................................103
7.5 Ambulatory Surgical Centers (ASCs) ..........................................................104
7.6 Others .............................................................................................................104
8. U.S. Prostate Cancer Testing Market (by Region), Value
($Million), 2021-2030................................................................106
8.1 Overview.........................................................................................................107
8.2 Northeast U.S.................................................................................................110
8.2.1 Northeast U.S. (Prostate-Specific Antigen (PSA)) ..................................110
8.2.2 Northeast U.S. (Pre-Biopsy/Post-Negative Biopsy Testing) ..................111
8.2.3 Northeast U.S. (Post-Biopsy Tissue Testing) .........................................112
8.3 Midwest U.S....................................................................................................113
8.3.1 Midwest U.S. (Prostate-Specific Antigen (PSA)).....................................113
8.3.2 Midwest U.S. (Pre-Biopsy/Post-Negative Biopsy Testing).....................114
8.3.3 Midwest U.S. (Post-Biopsy Tissue Testing) ............................................115
8.4 South U.S........................................................................................................116
8.4.1 South U.S. (Prostate-Specific Antigen (PSA)).........................................116
8.4.2 South U.S. (Pre-Biopsy/Post-Negative Biopsy Testing).........................117
8.4.3 South U.S. (Post-Biopsy Tissue Testing) ................................................118
8.5 West U.S. ........................................................................................................119
8.5.1 West U.S. (Prostate-Specific Antigen (PSA)) ..........................................119
8.5.2 West U.S. (Pre-Biopsy/Post-Negative Biopsy Testing) ..........................120
8.5.3 West U.S. (Post-Biopsy Tissue Testing)..................................................121
9. Company Profiles....................................................................122
9.1 Abbott. ............................................................................................................123
9.1.1 Company Overview ...................................................................................123
9.1.2 Role of Abbott. in the U.S. Prostate Cancer Testing Market..................123
9.1.3 Key Competitors of the Company............................................................124
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9.1.4 Financials...................................................................................................124
9.1.5 Key Insights about the Financial Health of the Company......................126
9.1.6 Analyst Perspective ..................................................................................126
9.2 Abcam plc.......................................................................................................127
9.2.1 Company Overview ...................................................................................127
9.2.2 Role of Abcam plc. in the U.S. Prostate Cancer Testing Market ...........127
9.2.3 Key Customers of the Company ..............................................................129
9.2.4 Key Competitors of the Company............................................................129
9.2.5 Financials...................................................................................................129
9.2.6 Analyst Perspective ..................................................................................131
9.3 Agilent Technologies, Inc. ............................................................................132
9.3.1 Company Overview ...................................................................................132
9.3.2 Role of Agilent Technologies, Inc. in the U.S. Prostate Cancer
Testing Market ...........................................................................................132
9.3.3 Key Competitors of the Company............................................................133
9.3.4 Financials...................................................................................................133
9.3.5 Analyst Perspective ..................................................................................135
9.4 Bio-Techne. (ExoDx)......................................................................................137
9.4.1 Company Overview ...................................................................................137
9.4.2 Role of Bio-Techne. (ExoDx) in the U.S. Prostate Cancer Testing
Market.........................................................................................................137
9.4.3 Key Competitors of the Company............................................................138
9.4.4 Financials...................................................................................................138
9.4.5 Key Insights about the Financial Health of the Company......................140
9.4.6 Corporate Strategies.................................................................................140
9.4.7 Business Strategies ..................................................................................140
9.4.8 Analyst Perspective ..................................................................................141
9.5 Cleveland Diagnostics, Inc. ..........................................................................142
9.5.1 Company Overview ...................................................................................142
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9.5.2 Role of Cleveland Diagnostics, Inc. in the U.S. Prostate Cancer
Testing Market ...........................................................................................142
9.5.3 Key Competitors of the Company............................................................143
9.5.4 Corporate Strategies.................................................................................143
9.5.5 Business Strategies ..................................................................................143
9.5.6 Analyst Perspective ..................................................................................143
9.6 Danaher. (Beckman Coulter, Inc.) ................................................................144
9.6.1 Company Overview ...................................................................................144
9.6.2 Role of Danaher. (Beckman Coulter, Inc.) in the U.S. Prostate
Cancer Testing Market..............................................................................144
9.6.3 Key Competitors of the Company............................................................145
9.6.4 Financials...................................................................................................145
9.6.5 Key Insights about the Financial Health of the Company......................147
9.6.6 Analyst Perspective ..................................................................................148
9.7 Exact Sciences Corporation .........................................................................149
9.7.1 Company Overview ...................................................................................149
9.7.2 Role of Exact Sciences Corporation in the U.S. Prostate Cancer
Testing Market ...........................................................................................149
9.7.3 Key Customers of the Company ..............................................................150
9.7.4 Key Competitors of the Company............................................................150
9.7.5 Financials...................................................................................................150
9.7.6 Key Insights about the Financial Health of the Company......................152
9.7.7 Corporate Strategies.................................................................................152
9.7.8 Business Strategies ..................................................................................153
9.7.9 Analyst Perspective ..................................................................................153
9.8 F. Hoffmann-La Roche Ltd (FOUNDATION MEDICINE, INC.) .....................154
9.8.1 Company Overview ...................................................................................154
9.8.2 Role of F. Hoffmann-La Roche Ltd (FOUNDATION MEDICINE, INC.)
in the U.S. Prostate Cancer Testing Market ............................................154
9.8.3 Key Competitors of the Company............................................................155
9.8.4 Financials...................................................................................................156
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9.8.5 Key Insights about the Financial Health of the Company......................158
9.8.6 Corporate Strategies.................................................................................158
9.8.7 Business Strategies ..................................................................................159
9.8.8 Analyst Perspective ..................................................................................159
9.9 H.U. Group Holdings, Inc. (Fujeribio)...........................................................160
9.9.1 Company Overview ...................................................................................160
9.9.2 Role of H.U. Group Holdings, Inc. (Fujeribio) in the U.S. Prostate
Cancer Testing Market..............................................................................160
9.9.3 Key Competitors of the Company............................................................161
9.9.4 Financials...................................................................................................161
9.9.5 Analyst Perspective ..................................................................................163
9.10 mdxhealth.......................................................................................................164
9.10.1 Company Overview ...................................................................................164
9.10.2 Role of mdxhealth. in the U.S. Prostate Cancer Testing Market ...........164
9.10.3 Financials...................................................................................................165
9.10.4 Key Insights about the Financial Health of the Company......................166
9.10.5 Corporate Strategies.................................................................................166
9.10.5.1 Mergers and Acquisitions ................................................................................ 166
9.10.6 Business Strategies ..................................................................................167
9.10.7 Analyst Perspective ..................................................................................167
9.11 Siemens Healthcare GmbH...........................................................................168
9.11.1 Company Overview ...................................................................................168
9.11.2 Role of Siemens Healthcare GmbH in the U.S. Prostate Cancer
Testing Market ...........................................................................................168
9.11.3 Key Competitors of the Company............................................................169
9.11.4 Financials...................................................................................................170
9.11.5 Key Insights about the Financial Health of the Company......................172
9.11.6 Analyst Perspective ..................................................................................172
9.12 Myriad Genetics, Inc......................................................................................173
9.12.1 Company Overview ...................................................................................173
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9.12.2 Role of Myriad Genetics, Inc. in the U.S. Prostate Cancer Testing
Market.........................................................................................................173
9.12.3 Key Competitors of the Company............................................................173
9.12.4 Corporate Strategies.................................................................................174
9.12.5 Business Strategies ..................................................................................174
9.12.6 Financials...................................................................................................175
9.12.7 Key Insights about the Financial Health of the Company......................176
9.12.8 Analyst Perspective ..................................................................................176
9.13 NeoGenomics Laboratories..........................................................................177
9.13.1 Company Overview ...................................................................................177
9.13.2 Role of NeoGenomics Laboratories. in the U.S. Prostate Cancer
Testing Market ...........................................................................................177
9.13.3 Key Competitors of the Company............................................................178
9.13.4 Financials...................................................................................................179
9.13.5 Key Insights about the Financial Health of the Company......................180
9.13.6 Business Strategies ..................................................................................180
9.13.7 Analyst Perspective ..................................................................................181
9.14 OPKO Health, Inc. (GenPath)........................................................................182
9.14.1 Company Overview ...................................................................................182
9.14.2 Role of OPKO Health, Inc. (GenPath) in the U.S. Prostate Cancer
Testing Market ...........................................................................................182
9.14.3 Key Customers of the Company ..............................................................183
9.14.4 Key Competitors of the Company............................................................183
9.14.5 Financials...................................................................................................184
9.14.6 Key Insights about the Financial Health of the Company......................185
9.14.7 Corporate Strategies.................................................................................186
9.14.8 Business Strategies ..................................................................................186
9.14.9 Analyst Perspective ..................................................................................186
9.15 Veracyte, Inc...................................................................................................188
9.15.1 Company Overview ...................................................................................188
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9.15.2 Role of Veracyte, Inc. in the U.S. Prostate Cancer Testing Market .......188
9.15.3 Key Customers of the Company ..............................................................189
9.15.4 Key Competitors of the Company............................................................189
9.15.5 Financials...................................................................................................189
9.15.6 Corporate Strategies.................................................................................191
9.15.7 Analyst Perspective ..................................................................................193
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List of Figures
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
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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
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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
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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
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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
17
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List of Tables
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
18
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BIS Research Offerings:
We are on a mission to harness the potential of disruptive technologies to make businesses thrive in today’s
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Table of Content - U.S. Prostate Cancer Testing Market.pdf

  • 1. 1 All rights reserved at BIS Research Inc. U . S . P R O S T A T E C A N C E R T E S T I N G M A R K E T res Focus on Type of Biomarker, Application, End User, and Region Analysis and Forecast: 2022-2030 November 2022 U.S. Prostate Cancer Testing Market - A Country Analysis Table of Content
  • 2. 2 All rights reserved at BIS Research Inc. U . S . P R O S T A T E C A N C E R T E S T I N G M A R K E T BIS Research is a leading market intelligence and technology research company. BIS Research publishes in- depth market intelligence reports focusing on the market estimations, technology analysis, emerging high- growth applications, deeply segmented granular country-level market data and other important market parameters useful in the strategic decision making for senior management. BIS Research provides multi-client reports, company profiles, databases, and custom research services. Copyright © 2022 BIS Research Inc. All Rights Reserved. This document contains highly confidential information and is the sole property of BIS Research. Disclosing, copying, circulating, quoting, or otherwise reproducing any or all contents of this document is strictly prohibited. Access to this information is provided exclusively for the benefit of the people or organization concerned. It may not be accessed by or offered whether for sale or otherwise to any third party.
  • 3. 3 All rights reserved at BIS Research Inc. U . S . P R O S T A T E C A N C E R T E S T I N G M A R K E T Table of Content Executive Summary..........................................................................20 1. Markets .....................................................................................25 1.1 Product Definition............................................................................................26 1.1.1 Inclusion and Exclusion Criteria................................................................26 1.2 Market Scope ...................................................................................................27 1.2.1 Scope of the Study......................................................................................27 1.2.2 Key Questions Answered in the Report ....................................................28 1.3 Research Methodology ...................................................................................29 1.3.1 U.S. Prostate Cancer Testing Market: Research Methodology ...............29 1.3.2 Data Sources ...............................................................................................29 1.3.2.1 Primary Data Sources........................................................................................ 29 1.3.2.2 Secondary Data Sources................................................................................... 30 1.3.3 Market Estimation Model ............................................................................31 1.3.4 Criteria for Company Profiling ...................................................................33 1.4 Market: Overview.............................................................................................33 1.4.1 Market Definition .........................................................................................33 1.4.2 Market Footprint and Growth Potential .....................................................34 1.4.3 Future Potential ...........................................................................................35 1.4.4 Evolution of Prostate Cancer Testing........................................................36 1.4.5 Epidemiology of Prostate Cancer in the U.S.............................................36 1.4.5.1 Southern U.S. .................................................................................................... 40 1.4.5.2 Midwest U.S....................................................................................................... 41 1.4.5.3 Mid-Atlantic U.S................................................................................................. 42 1.4.5.4 West U.S............................................................................................................ 43 1.4.5.5 Southwest U.S................................................................................................... 44 1.4.5.6 New England ..................................................................................................... 45 1.4.6 COVID-19 Impact on U.S. Prostate Cancer Testing Market .....................45 1.4.6.1 COVID-19 Impact on Cancer Care in the U.S. .................................................. 46
  • 4. 4 All rights reserved at BIS Research Inc. U . S . P R O S T A T E C A N C E R T E S T I N G M A R K E T 1.4.6.2 COVID-19 Impact on Prostate Cancer in the U.S.............................................. 47 2. Industry Analysis ......................................................................48 2.1 Overview...........................................................................................................49 2.2 Legal Requirements and Framework in the U.S............................................49 2.2.1 National Comprehensive Cancer Network (NCCN) Guidelines ...............49 2.2.2 American Urological Association (AUA) ...................................................50 2.2.3 American Cancer Society (ACS) ................................................................52 2.2.4 U.S. Preventive Services Task Force (USPSTF) .......................................52 2.3 Patent Analysis................................................................................................53 2.3.1 Patent Filing Trend......................................................................................53 2.3.1.1 Patent Analysis (by Year) .................................................................................. 53 2.4 Role of Biomarkers In Prostate Cancer Management (Guidelines for treatment of PCa in the U.S) ...........................................................................54 3. U.S. Prostate Cancer Testing Market: Market Dynamics ............56 3.1 Overview...........................................................................................................57 3.1.1 Impact Analysis ...........................................................................................57 3.2 Market Drivers..................................................................................................58 3.2.1 Rising Prevalence of Prostate Cancer in the U.S. ....................................58 3.2.2 Increasing Number of Prostate Cancer Screening and Testing..............59 3.2.3 Government Initiatives Related to Prostate Cancer .................................60 3.3 Market Restraints.............................................................................................61 3.3.1 High Probability of False Positives during Prostate Cancer Testing......61 3.3.2 Clinical Gaps Related to Prostate Cancer Testing ...................................61 3.4 Market Opportunities.......................................................................................62 3.4.1 New Treatment Therapy and Technique for Prostate Cancer .................62 4. U.S. Prostate Cancer Testing Market: Competitive Landscape.................................................................................63 4.1 Overview...........................................................................................................64 4.2 Corporate Strategies .......................................................................................64 4.2.1 Mergers and Acquisitions...........................................................................64
  • 5. 5 All rights reserved at BIS Research Inc. U . S . P R O S T A T E C A N C E R T E S T I N G M A R K E T 4.2.2 Synergistic Activities ..................................................................................66 4.2.3 Business Expansions and Funding...........................................................67 4.3 Business Strategies ........................................................................................68 4.3.1 Product Launches and Approvals .............................................................68 4.3.2 Regulatory and Legal Activities .................................................................70 4.3.3 Licenses and Agreements..........................................................................71 4.3.4 Other Activities............................................................................................72 4.4 Reimbursement Scenario in the U.S. .............................................................74 4.4.1 State Efforts to Ensure Prostate Cancer Screening Coverage................75 4.4.2 Medicare Coverage for Prostate Cancer Screening .................................75 4.4.3 Biomarker Testing Reimbursement Scenario in the U.S. ........................75 4.5 Market Share Analysis (by Company)............................................................77 5. U.S. Prostate Cancer Testing Market (by Biomarker Type), Value ($Million), 2021-2030........................................................80 5.1 Overview...........................................................................................................81 5.1.1 Initial Evaluation: Prostate-Specific Antigen (Total PSA, Free PSA) ......84 5.1.2 Pre-Biopsy/Post-Negative Biopsy Testing ................................................86 5.1.2.1 Blood-Based Biomarker..................................................................................... 87 5.1.2.2 Urine-Based Biomarker ..................................................................................... 88 5.1.2.3 Imaging.............................................................................................................. 89 5.1.2.3.1 Multiparametric Magnetic Resonance Imaging (mp-MRI) ....................................... 89 5.1.3 Post-Biopsy Tissue Testing .......................................................................89 5.1.3.1 Tissue-Based Biomarker ................................................................................... 90 6. U.S. Prostate Cancer Testing Market (by Application), Value ($Million), 2021-2030..................................................................92 6.1 Overview...........................................................................................................93 6.2 Diagnostic Biomarkers (PHI, 4KScore, SelectMDx, etc.)..............................95 6.3 Prognostic Biomarkers (Prolaris, OncotypeDx, Decipher, etc.) ..................97 7. U.S. Prostate Cancer Testing Market (by End User), Value ($Million), 2021-2030..................................................................99
  • 6. 6 All rights reserved at BIS Research Inc. U . S . P R O S T A T E C A N C E R T E S T I N G M A R K E T 7.1 Overview.........................................................................................................100 7.2 Cancer Research Institutes...........................................................................101 7.3 Diagnostic Laboratories................................................................................102 7.4 Hospitals and Clinics ....................................................................................103 7.5 Ambulatory Surgical Centers (ASCs) ..........................................................104 7.6 Others .............................................................................................................104 8. U.S. Prostate Cancer Testing Market (by Region), Value ($Million), 2021-2030................................................................106 8.1 Overview.........................................................................................................107 8.2 Northeast U.S.................................................................................................110 8.2.1 Northeast U.S. (Prostate-Specific Antigen (PSA)) ..................................110 8.2.2 Northeast U.S. (Pre-Biopsy/Post-Negative Biopsy Testing) ..................111 8.2.3 Northeast U.S. (Post-Biopsy Tissue Testing) .........................................112 8.3 Midwest U.S....................................................................................................113 8.3.1 Midwest U.S. (Prostate-Specific Antigen (PSA)).....................................113 8.3.2 Midwest U.S. (Pre-Biopsy/Post-Negative Biopsy Testing).....................114 8.3.3 Midwest U.S. (Post-Biopsy Tissue Testing) ............................................115 8.4 South U.S........................................................................................................116 8.4.1 South U.S. (Prostate-Specific Antigen (PSA)).........................................116 8.4.2 South U.S. (Pre-Biopsy/Post-Negative Biopsy Testing).........................117 8.4.3 South U.S. (Post-Biopsy Tissue Testing) ................................................118 8.5 West U.S. ........................................................................................................119 8.5.1 West U.S. (Prostate-Specific Antigen (PSA)) ..........................................119 8.5.2 West U.S. (Pre-Biopsy/Post-Negative Biopsy Testing) ..........................120 8.5.3 West U.S. (Post-Biopsy Tissue Testing)..................................................121 9. Company Profiles....................................................................122 9.1 Abbott. ............................................................................................................123 9.1.1 Company Overview ...................................................................................123 9.1.2 Role of Abbott. in the U.S. Prostate Cancer Testing Market..................123 9.1.3 Key Competitors of the Company............................................................124
  • 7. 7 All rights reserved at BIS Research Inc. U . S . P R O S T A T E C A N C E R T E S T I N G M A R K E T 9.1.4 Financials...................................................................................................124 9.1.5 Key Insights about the Financial Health of the Company......................126 9.1.6 Analyst Perspective ..................................................................................126 9.2 Abcam plc.......................................................................................................127 9.2.1 Company Overview ...................................................................................127 9.2.2 Role of Abcam plc. in the U.S. Prostate Cancer Testing Market ...........127 9.2.3 Key Customers of the Company ..............................................................129 9.2.4 Key Competitors of the Company............................................................129 9.2.5 Financials...................................................................................................129 9.2.6 Analyst Perspective ..................................................................................131 9.3 Agilent Technologies, Inc. ............................................................................132 9.3.1 Company Overview ...................................................................................132 9.3.2 Role of Agilent Technologies, Inc. in the U.S. Prostate Cancer Testing Market ...........................................................................................132 9.3.3 Key Competitors of the Company............................................................133 9.3.4 Financials...................................................................................................133 9.3.5 Analyst Perspective ..................................................................................135 9.4 Bio-Techne. (ExoDx)......................................................................................137 9.4.1 Company Overview ...................................................................................137 9.4.2 Role of Bio-Techne. (ExoDx) in the U.S. Prostate Cancer Testing Market.........................................................................................................137 9.4.3 Key Competitors of the Company............................................................138 9.4.4 Financials...................................................................................................138 9.4.5 Key Insights about the Financial Health of the Company......................140 9.4.6 Corporate Strategies.................................................................................140 9.4.7 Business Strategies ..................................................................................140 9.4.8 Analyst Perspective ..................................................................................141 9.5 Cleveland Diagnostics, Inc. ..........................................................................142 9.5.1 Company Overview ...................................................................................142
  • 8. 8 All rights reserved at BIS Research Inc. U . S . P R O S T A T E C A N C E R T E S T I N G M A R K E T 9.5.2 Role of Cleveland Diagnostics, Inc. in the U.S. Prostate Cancer Testing Market ...........................................................................................142 9.5.3 Key Competitors of the Company............................................................143 9.5.4 Corporate Strategies.................................................................................143 9.5.5 Business Strategies ..................................................................................143 9.5.6 Analyst Perspective ..................................................................................143 9.6 Danaher. (Beckman Coulter, Inc.) ................................................................144 9.6.1 Company Overview ...................................................................................144 9.6.2 Role of Danaher. (Beckman Coulter, Inc.) in the U.S. Prostate Cancer Testing Market..............................................................................144 9.6.3 Key Competitors of the Company............................................................145 9.6.4 Financials...................................................................................................145 9.6.5 Key Insights about the Financial Health of the Company......................147 9.6.6 Analyst Perspective ..................................................................................148 9.7 Exact Sciences Corporation .........................................................................149 9.7.1 Company Overview ...................................................................................149 9.7.2 Role of Exact Sciences Corporation in the U.S. Prostate Cancer Testing Market ...........................................................................................149 9.7.3 Key Customers of the Company ..............................................................150 9.7.4 Key Competitors of the Company............................................................150 9.7.5 Financials...................................................................................................150 9.7.6 Key Insights about the Financial Health of the Company......................152 9.7.7 Corporate Strategies.................................................................................152 9.7.8 Business Strategies ..................................................................................153 9.7.9 Analyst Perspective ..................................................................................153 9.8 F. Hoffmann-La Roche Ltd (FOUNDATION MEDICINE, INC.) .....................154 9.8.1 Company Overview ...................................................................................154 9.8.2 Role of F. Hoffmann-La Roche Ltd (FOUNDATION MEDICINE, INC.) in the U.S. Prostate Cancer Testing Market ............................................154 9.8.3 Key Competitors of the Company............................................................155 9.8.4 Financials...................................................................................................156
  • 9. 9 All rights reserved at BIS Research Inc. U . S . P R O S T A T E C A N C E R T E S T I N G M A R K E T 9.8.5 Key Insights about the Financial Health of the Company......................158 9.8.6 Corporate Strategies.................................................................................158 9.8.7 Business Strategies ..................................................................................159 9.8.8 Analyst Perspective ..................................................................................159 9.9 H.U. Group Holdings, Inc. (Fujeribio)...........................................................160 9.9.1 Company Overview ...................................................................................160 9.9.2 Role of H.U. Group Holdings, Inc. (Fujeribio) in the U.S. Prostate Cancer Testing Market..............................................................................160 9.9.3 Key Competitors of the Company............................................................161 9.9.4 Financials...................................................................................................161 9.9.5 Analyst Perspective ..................................................................................163 9.10 mdxhealth.......................................................................................................164 9.10.1 Company Overview ...................................................................................164 9.10.2 Role of mdxhealth. in the U.S. Prostate Cancer Testing Market ...........164 9.10.3 Financials...................................................................................................165 9.10.4 Key Insights about the Financial Health of the Company......................166 9.10.5 Corporate Strategies.................................................................................166 9.10.5.1 Mergers and Acquisitions ................................................................................ 166 9.10.6 Business Strategies ..................................................................................167 9.10.7 Analyst Perspective ..................................................................................167 9.11 Siemens Healthcare GmbH...........................................................................168 9.11.1 Company Overview ...................................................................................168 9.11.2 Role of Siemens Healthcare GmbH in the U.S. Prostate Cancer Testing Market ...........................................................................................168 9.11.3 Key Competitors of the Company............................................................169 9.11.4 Financials...................................................................................................170 9.11.5 Key Insights about the Financial Health of the Company......................172 9.11.6 Analyst Perspective ..................................................................................172 9.12 Myriad Genetics, Inc......................................................................................173 9.12.1 Company Overview ...................................................................................173
  • 10. 10 All rights reserved at BIS Research Inc. U . S . P R O S T A T E C A N C E R T E S T I N G M A R K E T 9.12.2 Role of Myriad Genetics, Inc. in the U.S. Prostate Cancer Testing Market.........................................................................................................173 9.12.3 Key Competitors of the Company............................................................173 9.12.4 Corporate Strategies.................................................................................174 9.12.5 Business Strategies ..................................................................................174 9.12.6 Financials...................................................................................................175 9.12.7 Key Insights about the Financial Health of the Company......................176 9.12.8 Analyst Perspective ..................................................................................176 9.13 NeoGenomics Laboratories..........................................................................177 9.13.1 Company Overview ...................................................................................177 9.13.2 Role of NeoGenomics Laboratories. in the U.S. Prostate Cancer Testing Market ...........................................................................................177 9.13.3 Key Competitors of the Company............................................................178 9.13.4 Financials...................................................................................................179 9.13.5 Key Insights about the Financial Health of the Company......................180 9.13.6 Business Strategies ..................................................................................180 9.13.7 Analyst Perspective ..................................................................................181 9.14 OPKO Health, Inc. (GenPath)........................................................................182 9.14.1 Company Overview ...................................................................................182 9.14.2 Role of OPKO Health, Inc. (GenPath) in the U.S. Prostate Cancer Testing Market ...........................................................................................182 9.14.3 Key Customers of the Company ..............................................................183 9.14.4 Key Competitors of the Company............................................................183 9.14.5 Financials...................................................................................................184 9.14.6 Key Insights about the Financial Health of the Company......................185 9.14.7 Corporate Strategies.................................................................................186 9.14.8 Business Strategies ..................................................................................186 9.14.9 Analyst Perspective ..................................................................................186 9.15 Veracyte, Inc...................................................................................................188 9.15.1 Company Overview ...................................................................................188
  • 11. 11 All rights reserved at BIS Research Inc. U . S . P R O S T A T E C A N C E R T E S T I N G M A R K E T 9.15.2 Role of Veracyte, Inc. in the U.S. Prostate Cancer Testing Market .......188 9.15.3 Key Customers of the Company ..............................................................189 9.15.4 Key Competitors of the Company............................................................189 9.15.5 Financials...................................................................................................189 9.15.6 Corporate Strategies.................................................................................191 9.15.7 Analyst Perspective ..................................................................................193
  • 12. 12 All rights reserved at BIS Research Inc. U . S . P R O S T A T E C A N C E R T E S T I N G M A R K E T List of Figures 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
  • 13. 13 All rights reserved at BIS Research Inc. U . S . P R O S T A T E C A N C E R T E S T I N G M A R K E T 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
  • 14. 14 All rights reserved at BIS Research Inc. U . S . P R O S T A T E C A N C E R T E S T I N G M A R K E T 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
  • 15. 15 All rights reserved at BIS Research Inc. U . S . P R O S T A T E C A N C E R T E S T I N G M A R K E T 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
  • 16. 16 All rights reserved at BIS Research Inc. U . S . P R O S T A T E C A N C E R T E S T I N G M A R K E T 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
  • 17. 17 All rights reserved at BIS Research Inc. U . S . P R O S T A T E C A N C E R T E S T I N G M A R K E T List of Tables 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
  • 18. 18 All rights reserved at BIS Research Inc. U . S . P R O S T A T E C A N C E R T E S T I N G M A R K E T BIS Research Offerings: We are on a mission to harness the potential of disruptive technologies to make businesses thrive in today’s digital age. We have the vision to be a leading and preferred knowledge partner for corporates and institutions worldwide and assist them with market intelligence in the area of emerging technologies, advisories, and other innovative solutions. Know More Know More Know More Know More
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