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North America In-vitro Colorectal Cancer Screening Tests Market: By Testing Type: Fecal Occult Blood Tests, Biomarker Tests, CRC DNA Screening Tests, Flexible Sigmoidoscopy, Others; By Imaging Type: Colonoscopy, Proctoscopy, CT Scan, Ultrasound, MRI, PET Scan; By End User: Hospitals, Others; Regional Analysis; Supplier Landscape; 2024-2032
North America In-vitro Colorectal Cancer Screening Tests Market Outlook
The North America in-vitro colorectal cancer screening tests market size was valued at USD 4.2 billion in 2023, driven by the increasing prevalence of colorectal cancer in the region. The market is expected to grow at a CAGR of 7.16% during the forecast period of 2024-2032, with the values likely to rise from USD 4.5 billion in 2024 to USD 7.9 billion by 2032.
Key Takeaways
- In the United States, colorectal cancer is the fourth most commonly diagnosed cancer and ranks as the second leading cause of cancer mortality in the region.
- In March 2024, a study published in the New England Journal of Medicine tested the performance characteristics of Guardant Health’s Shield blood test, revealing the sensitivity of the in-vitro diagnostic method for detecting colorectal cancer to be 83.1%.
- The preference for minimally invasive devices is likely to impact the market positively. In September 2023, ColoTest, an at-home Fecal Immunochemical Test (FIT) developed by Reese Pharmaceutical received FDA approval for the screening of colorectal cancer.
North America In-vitro Colorectal Cancer Screening Tests Market Analysis
In the United States, colorectal cancer is the fourth most commonly diagnosed cancer. It ranks as the second leading cause of cancer mortality in the region. According to the American Cancer Society, around 152,810 people are estimated to be diagnosed with this cancer type in 2024. Moreover, deaths from colorectal cancer are predicted to be 53,010 . This indicates that colorectal cancer is a significant cause of concern in North America. The growing number of colorectal cancer cases also impacts the demand for efficient screening methods, which in turn is expected to propel the North America in-vitro colorectal cancer screening tests market growth.
The market comprises a range of diagnostic tests performed outside the body in laboratory settings to screen and detect colorectal cancer. These tests are generally non-invasive or minimally invasive which encourages higher patient compliance rates and thus facilitates early detection of colorectal cancer.
The surge in regulatory approvals from health authorities such as the United States Food and Drug Administration (FDA) is expected to fuel North America in-vitro colorectal cancer screening tests market demand. In September 2023, ColoTest, an at-home Fecal Immunochemical Test (FIT) developed by Reese Pharmaceutical (United States based pharmaceutical company) received FDA approval to detect early stages of colorectal cancer and other gastrointestinal disorders. ColoTest is deemed 100% non-invasive with an accuracy of 98.8% in detecting invisible blood in stool. Further, in February 2024, the company announced that the convenient and affordable screening option is available at a retail price of USD 19.99 in pharmacies across the United States. The increased access and availability of such effective at-home colorectal screening tests are likely to positively impact the market growth in the forecast period.
The launch of innovative cancer screening blood tests to detect colorectal tumors is likely to boost North America in-vitro colorectal cancer screening tests market share. In March 2024, a study published in the New England Journal of Medicine tested the performance characteristics of a cell-free DNA (cfDNA) blood-based test called Shield blood test, revealing the sensitivity of the in-vitro diagnostic method for detecting colorectal cancer to be 83.1%, which is in par with the performance of other non-invasive screening tests. The Shield test, developed by an American biotechnology company, Guardant Health, has also demonstrated 65% sensitivity in detecting the earliest stage of cancer in pathology-confirmed cases.
North America In-vitro Colorectal Cancer Screening Tests Market Segmentation
The market report offers a detailed analysis of the market based on the following segments:
| Market Breakup | Categories |
| Testing Type | Fecal Occult Blood Tests, Biomarker Tests, CRC DNA Screening Tests, Flexible Sigmoidoscopy, Others |
| Imaging Type | Colonoscopy, Proctoscopy, CT Scan, Ultrasound, MRI, PET Scan |
| End User | Hospitals, Clinics, Diagnostics Laboratories |
| Country | United States, Canada |
North America In-vitro Colorectal Cancer Screening Tests Market: Competitor Landscape
The key features of the market report include patent analysis, grants analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:
- Abbott
- Exact Sciences Corporation
- Hemosure
- SEKISUI Diagnostics
- Beckman Coulter, Inc.
- Quest Diagnostics
- Oncocyte Corporation
- Immunostics Inc.
- Medline Industries, LP
- GeneNews Ltd
Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.
Key Highlights of the Report
| REPORT FEATURES | DETAILS |
| Base Year | 2023 |
| Historical Period | 2017-2023 |
| Forecast Period | 2024-2032 |
| Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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| Breakup by Testing Type |
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| Breakup by Imaging Type |
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| Breakup by End User |
|
| Breakup by Region |
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| Market Dynamics |
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| Supplier Landscape |
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| Companies Covered |
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*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.
1 Preface
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage – Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 North America In-vitro Colorectal Cancer Screening Tests Market Overview
3.1 North America In-vitro Colorectal Cancer Screening Tests Market Historical Value (2017-2023)
3.2 North America In-vitro Colorectal Cancer Screening Tests Market Forecast Value (2024-2032)
4 North America In-vitro Colorectal Cancer Screening Tests Market Landscape*
4.1 North America In-vitro Colorectal Cancer Screening Tests: Developers Landscape
4.1.1 Analysis by Year of Establishment
4.1.2 Analysis by Company Size
4.1.3 Analysis by Region
4.2 North America In-vitro Colorectal Cancer Screening Tests: Product Landscape
4.2.1 Analysis by Test Type
4.2.2 Analysis by Imaging Type
5 North America In-vitro Colorectal Cancer Screening Tests Market Dynamics
5.1 Market Drivers and Constraints
5.2 SWOT Analysis
5.2.1 Strengths
5.2.2 Weaknesses
5.2.3 Opportunities
5.2.4 Threats
5.3 Porter’s Five Forces Model
5.3.1 Bargaining Power of Suppliers
5.3.2 Bargaining Power of Buyers
5.3.3 Threat of New Entrants
5.3.4 Threat of Substitutes
5.3.5 Degree of Rivalry
5.4 Key Demand Indicators
5.5 Key Price Indicators
5.6 Industry Events, Initiatives, and Trends
5.7 Value Chain Analysis
6 North America In-vitro Colorectal Cancer Screening Tests Market Segmentation (2017-2032)
6.1 North America In-vitro Colorectal Cancer Screening Tests Market (2017-2032) by Testing Type
6.1.1 Market Overview
6.1.2 Fecal Occult Blood Tests
6.1.3 Biomarker Tests
6.1.4 CRC DNA Screening Tests
6.1.5 Flexible Sigmoidoscopy
6.1.6 Others
6.2 North America In-vitro Colorectal Cancer Screening Tests Market (2017-2032) by Imaging Type
6.2.1 Market Overview
6.2.2 Colonoscopy
6.2.3 Proctoscopy
6.2.4 CT Scan
6.2.5 Ultrasound
6.2.6 MRI
6.2.7 PET Scan
6.3 North America In-vitro Colorectal Cancer Screening Tests Market (2017-2032) by End User
6.3.1 Market Overview
6.3.2 Hospitals
6.3.3 Clinics
6.3.4 Diagnostics Laboratories
6.4 North America In-vitro Colorectal Cancer Screening Tests Market (2017-2032) by Country
6.4.1 Market Overview
6.4.2 United States
6.4.3 Canada
7 United States In-vitro Colorectal Cancer Screening Tests Market (2017-2032)
7.1 United States In-vitro Colorectal Cancer Screening Tests Market (2017-2032) by Testing Type
7.1.1 Market Overview
7.1.2 Fecal Occult Blood Tests
7.1.3 Biomarker Tests
7.1.4 CRC DNA Screening Tests
7.1.5 Flexible Sigmoidoscopy
7.1.6 Others
7.2 United States In-vitro Colorectal Cancer Screening Tests Market (2017-2032) by Imaging Type
7.2.1 Market Overview
7.2.2 Colonoscopy
7.2.3 Proctoscopy
7.2.4 CT Scan
7.2.5 Ultrasound
7.2.6 MRI
7.2.7 PET Scan
7.3 United States In-vitro Colorectal Cancer Screening Tests Market (2017-2032) by End User
7.3.1 Market Overview
7.3.2 Hospitals
7.3.3 Clinics
7.3.4 Diagnostics Laboratories
8 Canada In-vitro Colorectal Cancer Screening Tests Market (2017-2032)
8.1 Canada In-vitro Colorectal Cancer Screening Tests Market (2017-2032) by Testing Type
8.1.1 Market Overview
8.1.2 Fecal Occult Blood Tests
8.1.3 Biomarker Tests
8.1.4 CRC DNA Screening Tests
8.1.5 Flexible Sigmoidoscopy
8.1.6 Others
8.2 Canada In-vitro Colorectal Cancer Screening Tests Market (2017-2032) by Imaging Type
8.2.1 Market Overview
8.2.2 Colonoscopy
8.2.3 Proctoscopy
8.2.4 CT Scan
8.2.5 Ultrasound
8.2.6 MRI
8.2.7 PET Scan
8.3 Canada In-vitro Colorectal Cancer Screening Tests Market (2017-2032) by End User
8.3.1 Market Overview
8.3.2 Hospitals
8.3.3 Clinics
8.3.4 Diagnostics Laboratories
9 Regulatory Framework
10 Patent Analysis
10.1 Analysis by Type of Patent
10.2 Analysis by Publication Year
10.3 Analysis by Issuing Authority
10.4 Analysis by Patent Age
10.5 Analysis by CPC Analysis
10.6 Analysis by Patent Valuation
10.7 Analysis by Key Players
11 Grants Analysis
11.1 Analysis by Year
11.2 Analysis by Amount Awarded
11.3 Analysis by Issuing Authority
11.4 Analysis by Grant Application
11.5 Analysis by Funding Institute
11.6 Analysis by Departments
11.7 Analysis by Recipient Organization
12 Funding and Investment Analysis
12.1 Analysis by Funding Instances
12.2 Analysis by Type of Funding
12.3 Analysis by Funding Amount
12.4 Analysis by Leading Players
12.5 Analysis by Leading Investors
12.6 Analysis by Geography
13 Partnership and Collaborations Analysis
13.1 Analysis by Partnership Instances
13.2 Analysis by Type of Partnership
13.3 Analysis by Leading Players
13.4 Analysis by Geography
14 Supplier Landscape
14.1 Market Share by Top 5 Companies
14.2 Abbott
14.2.1 Financial Analysis
14.2.2 Product Portfolio
14.2.3 Demographic Reach and Achievements
14.2.4 Mergers and Acquisitions
14.2.5 Certifications
14.3 Exact Sciences Corporation
14.3.1 Financial Analysis
14.3.2 Product Portfolio
14.3.3 Demographic Reach and Achievements
14.3.4 Mergers and Acquisitions
14.3.5 Certifications
14.4 Hemosure
14.4.1 Financial Analysis
14.4.2 Product Portfolio
14.4.3 Demographic Reach and Achievements
14.4.4 Mergers and Acquisitions
14.4.5 Certifications
14.5 SEKISUI Diagnostics
14.5.1 Financial Analysis
14.5.2 Product Portfolio
14.5.3 Demographic Reach and Achievements
14.5.4 Mergers and Acquisitions
14.5.5 Certifications
14.6 Beckman Coulter, Inc
14.6.1 Financial Analysis
14.6.2 Product Portfolio
14.6.3 Demographic Reach and Achievements
14.6.4 Mergers and Acquisitions
14.6.5 Certifications
14.7 Quest Diagnostics
14.7.1 Financial Analysis
14.7.2 Product Portfolio
14.7.3 Demographic Reach and Achievements
14.7.4 Mergers and Acquisitions
14.7.5 Certifications
14.8 Oncocyte Corporation
14.8.1 Financial Analysis
14.8.2 Product Portfolio
14.8.3 Demographic Reach and Achievements
14.8.4 Mergers and Acquisitions
14.8.5 Certifications
14.9 Immunostics Inc
14.9.1 Financial Analysis
14.9.2 Product Portfolio
14.9.3 Demographic Reach and Achievements
14.9.4 Mergers and Acquisitions
14.9.5 Certifications
14.10 Medline Industries, LP
14.10.1 Financial Analysis
14.10.2 Product Portfolio
14.10.3 Demographic
14.10.4 Mergers and Acquisitions
14.10.5 Certifications
14.11 GeneNews Ltd
14.11.1 Financial Analysis
14.11.2 Product Portfolio
14.11.3 Demographic Reach and Achievements
14.11.4 Mergers and Acquisitions
14.11.5 Certifications
15 North America In-vitro Colorectal Cancer Screening Tests Market – Distribution Model (Additional Insight)
15.1 Overview
15.2 Potential Distributors
15.3 Key Parameters for Distribution Partner Assessment
16 Key Opinion Leaders (KOL) Insights (Additional Insight)
17 Company Competitiveness Analysis (Additional Insight)
17.1 Very Small Companies
17.2 Small Companies
17.3 Mid-Sized Companies
17.4 Large Companies
17.5 Very Large Companies
18 Payment Methods (Additional Insight)
18.1 Government Funded
18.2 Private Insurance
18.3 Out-of-Pocket
*Additional insights provided are customisable as per client requirements.
* The coverage of the Market Landscape section depends on the data availability and may cover a minimum of 80% of the total market. The EMR team strives to make this section as comprehensive as possible.
Key Questions Answered in the Report
The market attained a value of about USD 4.2 billion in 2023 driven by the increasing prevalence of colorectal cancer in the region.
The market is anticipated to grow at a CAGR of 7.16% during the forecast period of 2024-2032, likely to reach a market value of USD 7.9 billion by 2032.
The launch of innovative cancer screening blood tests to detect colorectal cancer and heightened patient awareness is fuelling the demand for the market.
One of the significant trends in the market is the surge in regulatory approvals from health authorities such as the United States Food and Drug Administration (FDA). In September 2023 , Reese Pharmaceutical’s ColoTest, an at-home fecal immunochemical test (FIT) received FDA approval for the screening of colorectal cancer.
Based on the testing type, the market is segmented into fecal occult blood tests, biomarker tests, CRC DNA screening tests, and flexible sigmoidoscopy, among others.
By imaging type, the market is divided into colonoscopy, proctoscopy, CT scan, ultrasound, MRI, and PET scan, among others.
End users of the market are hospitals, clinics, and diagnostics laboratories.
The market segmentation by countries includes the United States of America and Canada.
The key players in the market are Abbott, Exact Sciences Corporation, Hemosure, SEKISUI Diagnostics, Beckman Coulter, Inc., Quest Diagnostics, Oncocyte Corporation, Immunostics Inc., Medline Industries, LP, and GeneNews Ltd.
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