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U.S. Colorectal Cancer Screening - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2026-2031)

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    Report

  • 90 Pages
  • June 2026
  • Region: United States
  • Mordor Intelligence
  • ID: 6254615
The u.S. colorectal cancer screening market size was valued at USD 6.44 billion in 2025 and is estimated to grow from USD 6.93 billion in 2026 to reach USD 10.02 billion by 2031, at a CAGR of 7.65% during the forecast period (2026-2031). This report is Segmented by Test Type (Stool-Based Tests, Colonoscopy-Based Screening, and More), Technology (FIT and GFOBT, Multitarget Stool DNA, Cell-Free DNA and Methylation-Based Assays, and More), and End User (Hospitals and Specialty Clinics, Independent Diagnostic Laboratories, and More). The Market Forecasts are Provided in Terms of Value (USD).

U.S. Colorectal Cancer Screening Market Trends and Insights

Increased Screening Eligibility After Age 45 Expansion

The expansion of routine screening to include individuals aged 45-49 has significantly increased the eligible population in the United States colorectal cancer screening market. Between 2019 and 2024, screenings for this age group rose by 62%, with their share of total screenings increasing from 2.9% to 17.8%. Monthly screenings for ages 45-49 surged by 955%, compared to a 46% rise for adults aged 50-75. This younger demographic, largely employed and commercially insured, enhances reimbursement quality across test categories. Despite this growth, screening penetration for ages 45-49 remains below older adults, leaving room for further market expansion. Colorectal cancer is now the leading cancer killer in men under 50 and the second in women under 50, driving early detection efforts through employer plans and awareness programs.

Rising Adoption of Non-Invasive Screening Pathways

The shift toward non-invasive testing is transforming the United States colorectal cancer screening market by prioritizing access and completion. Stool-based testing has gained widespread acceptance, with Exact Sciences reporting over 20 million cumulative uses of Cologuard and Cologuard Plus, generating USD 2.53 billion in screening revenue for 2025, a 20.2% year-over-year increase. Cologuard Plus reduced false positives by nearly 40%, improving clinical workflows and reducing follow-up burdens. At-home sample collection addresses barriers like scheduling and travel, giving vendors with streamlined logistics a competitive edge. As non-invasive adoption grows, effective follow-up management becomes critical to ensure positive patients proceed to confirmatory colonoscopy.

Follow-Up Colonoscopy Attrition After Positive Non-Invasive Tests

Follow-up rates after positive non-invasive test results highlight a critical gap in the United States colorectal cancer screening market. Across 38 health systems, only 47.9% of patients with abnormal stool-based results completed a colonoscopy within six months, with rates ranging from 13.1% to 66.9%. An Optum database analysis showed just 43.3% follow-up within 90 days, which the American Academy of Family Physicians deemed inconsistent with clinical screening recommendations. A 2026 study in the Journal of General Internal Medicine demonstrated that structured outreach could achieve a 59.6% colonoscopy completion rate within 180 days. This indicates that the challenge lies not only in patient reluctance but also in the transition from screening results to scheduling and completion. Low diagnostic completion rates impact the commercial value of screening kits and reduce payer confidence.

Other drivers and restraints analyzed in the detailed report include:
  • FDA-Backed Innovation in Blood-Based and Stool RNA Testing
  • CMS and Commercial Coverage Broadening for Approved Tests
  • Sensitivity Gap for Precancerous Lesions in Blood-Based Tests

Segment Analysis

In 2025, colonoscopy screenings accounted for 45.95% of the United States colorectal cancer screening market, maintaining its position as the leading test category. Its dual role as a primary screening method and a follow-up for positive non-invasive results ensures consistent demand. While non-invasive tests are gaining traction, colonoscopy remains central for confirmation, diagnosis, and surveillance.

Stool-based tests are projected to grow at a 9.65% CAGR from 2026 to 2031, driven by broader coverage and improved product performance. Exact Sciences reported USD 2.53 billion in screening revenue for 2025, a 20.2% year-over-year increase, highlighting the growing adoption of stool-based testing. Cologuard Plus has reduced false positives by nearly 40%, enhancing workflow efficiency. Blood-based screenings, such as Shield, are gaining attention but face adoption challenges due to evidence requirements and uneven insurance coverage. CT colonography has gained momentum with Medicare coverage, while flexible sigmoidoscopy remains limited to specific clinical settings.

Complete Report Scope:

  • By Test Type
    • Stool-Based Tests
    • Colonoscopy-Based Screening
    • Blood-Based Screening Tests
    • CT Colonography
    • Flexible Sigmoidoscopy
  • By Technology
    • FIT and gFOBT
    • Multitarget Stool DNA
    • Cell-Free DNA and Methylation-Based Assays
    • Stool RNA Assays
    • Imaging and Endoscopic Systems
  • By End User
    • Hospitals and Specialty Clinics
    • Independent Diagnostic Laboratories
    • Ambulatory Surgical Centers
    • Primary Care and Physician Offices

List of Companies Covered in this Report:

  • Abbott Laboratories
  • Beckton Dickinson
  • Clinical Genomics
  • Danaher
  • Eiken Chemical Co., Ltd.
  • Epigenomics
  • Roche
  • Freenome Holdings, Inc.
  • FUJIFILM
  • Geneoscopy, Inc.
  • Guardant Health, Inc.
  • Hemosure, Inc.
  • Hologic
  • LabCorp
  • Medline Industries
  • Olympus
  • Polymedco, Inc.
  • Quest Diagnostics
  • Siemens Healthineers
  • Sysmex

Additional Benefits:

  • The market estimate (ME) sheet in Excel format
  • 3 months of analyst support

Table of Contents

1 INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2 RESEARCH METHODOLOGY3 EXECUTIVE SUMMARY
4 MARKET LANDSCAPE
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increased Screening Eligibility After Age 45 Expansion
4.2.2 Rising Adoption of Non-Invasive Screening Pathways
4.2.3 Payer Preference for Earlier Detection and Lower Downstream Treatment Cost
4.2.4 FDA-Backed Innovation in Blood-Based and Stool RNA Testing
4.2.5 CMS and Commercial Coverage Broadening for Approved Tests
4.2.6 Primary Care Workflow Shift Toward At-Home Screening Completion
4.3 Market Restraints
4.3.1 Follow-Up Colonoscopy Attrition After Positive Non-Invasive Tests
4.3.2 Sensitivity Gap for Precancerous Lesions in Blood-Based Tests
4.3.3 High Cost and Coverage Friction for Newer Modalities
4.3.4 Patient Preference Bias Toward Existing Colonoscopy Networks in Some Systems
4.4 Value Chain Analysis
4.5 Regulatory Landscape
4.6 Technological Outlook
4.7 Porter's Five Forces Analysis
4.7.1 Threat of New Entrants
4.7.2 Bargaining Power of Buyers
4.7.3 Bargaining Power of Suppliers
4.7.4 Threat of Substitutes
4.7.5 Competitive Rivalry
5 MARKET SIZE AND GROWTH FORECASTS (VALUE, USD)
5.1 By Test Type
5.1.1 Stool-Based Tests
5.1.2 Colonoscopy-Based Screening
5.1.3 Blood-Based Screening Tests
5.1.4 CT Colonography
5.1.5 Flexible Sigmoidoscopy
5.2 By Technology
5.2.1 FIT and gFOBT
5.2.2 Multitarget Stool DNA
5.2.3 Cell-Free DNA and Methylation-Based Assays
5.2.4 Stool RNA Assays
5.2.5 Imaging and Endoscopic Systems
5.3 By End User
5.3.1 Hospitals and Specialty Clinics
5.3.2 Independent Diagnostic Laboratories
5.3.3 Ambulatory Surgical Centers
5.3.4 Primary Care and Physician Offices
6 COMPETITIVE LANDSCAPE
6.1 Market Concentration
6.2 Market Share Analysis
6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
6.3.1 Abbott Laboratories
6.3.2 Becton, Dickinson and Company
6.3.3 Clinical Genomics Technologies Pty Ltd
6.3.4 Danaher Corporation
6.3.5 Eiken Chemical Co., Ltd.
6.3.6 Epigenomics AG
6.3.7 F. Hoffmann-La Roche Ltd
6.3.8 Freenome Holdings, Inc.
6.3.9 Fujifilm Holdings Corporation
6.3.10 Geneoscopy, Inc.
6.3.11 Guardant Health, Inc.
6.3.12 Hemosure, Inc.
6.3.13 Hologic, Inc.
6.3.14 Laboratory Corporation of America Holdings
6.3.15 Medline Industries, LP
6.3.16 Olympus Corporation
6.3.17 Polymedco, Inc.
6.3.18 Quest Diagnostics Incorporated
6.3.19 Siemens Healthineers AG
6.3.20 Sysmex Corporation
7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK
7.1 White-Space and Unmet-Need Assessment

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Abbott Laboratories
  • Becton, Dickinson and Company
  • Clinical Genomics Technologies Pty Ltd
  • Danaher Corporation
  • Eiken Chemical Co., Ltd.
  • Epigenomics AG
  • F. Hoffmann-La Roche Ltd
  • Freenome Holdings, Inc.
  • Fujifilm Holdings Corporation
  • Geneoscopy, Inc.
  • Guardant Health, Inc.
  • Hemosure, Inc.
  • Hologic, Inc.
  • Laboratory Corporation of America Holdings
  • Medline Industries, LP
  • Olympus Corporation
  • Polymedco, Inc.
  • Quest Diagnostics Incorporated
  • Siemens Healthineers AG
  • Sysmex Corporation