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Report Overview

2024

Base Year

2018-2024

Historical Year

2025-2034

Forecast Year

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 2024, 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 2025-2034, with the values likely to rise from USD 4.5 billion in 2025 to USD 7.9 billion by 2034.

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 2018-2024
Forecast Period 2025-2034
Scope of the Report

Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:

  • Testing Type
  • Imaging Type
  • End User
  • Region
Breakup by Testing Type
  • Fecal Occult Blood Tests
  • Biomarker Tests
  • CRC DNA Screening Tests
  • Flexible Sigmoidoscopy
  • Others
Breakup by Imaging Type
  • Colonoscopy
  • Proctoscopy
  • CT Scan
  • Ultrasound
  • MRI
  • PET Scan
Breakup by End User
  • Hospitals
  • Clinics
  • Diagnostics Laboratories
Breakup by Region
  • United States
  • Canada
Market Dynamics
  • Market Drivers and Constraints
  • SWOT Analysis
  • Porter’s Five Forces Model 
  • Key Demand Indicators
  • Key Price Indicators
  • Industry Events, Initiatives, and Trends 
  • Value Chain Analysis
Supplier Landscape
  • Market Structure
  • Company Profiles
    • Financial Analysis
    • Product Portfolio
    • Demographic Reach and Achievements
    • Mergers and Acquisitions
    • Certifications
Companies Covered
  • Abbott 
  • Exact Sciences Corporation
  • Hemosure 
  • SEKISUI Diagnostics
  • Beckman Coulter, Inc
  • Quest Diagnostics
  • Oncocyte Corporation
  • Immunostics Inc 
  • Medline Industries, LP 
  • GeneNews Ltd 

*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

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Key Questions Answered in the Report

The market attained a value of about USD 4.2 billion in 2024 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 2025-2034, likely to reach a market value of USD 7.9 billion by 2034.

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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