Colorectal Cancer Screening and Diagnostic Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Screening (Stool-Based Test, Colonoscopy and Sigmoidoscopy, Others), By Diagnostics (Biomarker Test, Colonoscopy), By End User (Hospitals and Clinics, Clinical Laboratories, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 18.78 Billion
CAGR (2026-2031)	4.78%
Fastest Growing Segment	Biomarker Test
Largest Market	North America
Market Size (2031)	USD 24.85 Billion

Market Overview

The Global Colorectal Cancer Screening and Diagnostic Market will grow from USD 18.78 Billion in 2025 to USD 24.85 Billion by 2031 at a 4.78% CAGR. The Global Colorectal Cancer Screening and Diagnostic Market comprises medical devices, stool-based assays, and imaging systems utilized for detecting precancerous lesions and malignancies in the colon and rectum. Primary drivers fueling growth include the increasing prevalence of colorectal cancer and an aging global population necessitating frequent monitoring. Additionally, national screening programs and guidelines lowering the recommended screening age are actively broadening the patient base. According to the American Cancer Society, in 2025, projections indicated that 154,270 individuals in the United States would be diagnosed with colorectal cancer, highlighting the urgent need for diagnostic interventions.

However, market expansion is significantly challenged by low patient compliance regarding screening mandates. The invasive nature of standard procedures like colonoscopies, coupled with discomfort and preparation requirements, often deters eligible populations from undergoing necessary testing. This resistance to invasive methods, alongside limited healthcare reimbursement in developing regions, creates a substantial barrier to the widespread adoption of screening technologies and impedes market trajectory.

Key Market Drivers

The Escalating Global Incidence of Colorectal Cancer is a primary force propelling the market, particularly as detection protocols expand to address rising rates among younger demographics. Healthcare systems worldwide are intensifying their diagnostic efforts in response to this growing burden, necessitating the widespread deployment of both traditional and novel screening tools. This surge in disease prevalence is not limited to aging populations but is increasingly evident in early-onset cases, driving a persistent demand for diagnostic consumables and advanced imaging infrastructure across international healthcare networks. According to the World Health Organization, in February 2024, new estimates revealed that colorectal cancer had become the second leading cause of cancer death globally, with approximately 1.9 million new cases diagnosed in 2022. This sheer volume of disease burden underscores the critical necessity for scalable diagnostic interventions.

Simultaneously, the Proliferation of Non-Invasive Screening Modalities is reshaping the diagnostic landscape by overcoming historic barriers to patient compliance. The market is witnessing a rapid shift from invasive colonoscopies toward stool-based DNA tests and liquid biopsies, which offer convenient alternatives that significantly boost participation rates. This trend is exemplified by the commercial success of next-generation screening products that integrate seamlessly into routine care. According to Guardant Health, July 2024, in the 'Shield FDA Approval Press Release', data demonstrated that their blood-based test achieved a completion rate of over 90% in real-world settings, addressing the urgent need for accessible testing options. Furthermore, the financial trajectory of established players highlights this segment's vitality; according to Exact Sciences, November 2024, in the 'Third Quarter 2024 Earnings Report', the company generated screening revenue of $545 million, reflecting the robust adoption of non-invasive diagnostic solutions.

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Key Market Challenges

Low patient compliance regarding screening mandates acts as a significant impediment to the growth of the Global Colorectal Cancer Screening and Diagnostic Market. This resistance is primarily driven by the invasive nature of standard diagnostic procedures, such as colonoscopies, which often require rigorous preparation and cause physical discomfort. Consequently, a large segment of the eligible population avoids or delays necessary testing, directly reducing the procedural volume that drives demand for imaging systems and diagnostic consumables.

This gap between the eligible patient base and actual participation creates a substantial bottleneck for market expansion. Even with guidelines expanding the target demographic, the reluctance to undergo invasive testing restricts the addressable market size for device and assay manufacturers. According to the National Colorectal Cancer Roundtable, in 2025, more than one in three adults aged 45 and older were not screened as recommended. This statistic underscores that market trajectory is not solely defined by disease prevalence or technological availability, but is critically limited by the persistent inability to secure widespread patient adherence to screening protocols.

Key Market Trends

The Integration of Artificial Intelligence in Endoscopy is fundamentally elevating the diagnostic precision of traditional colonoscopies by mitigating human error during polyp detection. This trend focuses on deploying Computer-Aided Detection (CADe) systems that analyze video feeds in real-time to highlight potential lesions, thereby addressing the variability in endoscopist performance. Unlike the shift towards non-invasive tools, this development reinforces the clinical value of invasive procedures by ensuring higher efficacy in identifying adenomas. According to Medscape, November 2024, in the 'AI-Assisted Colonoscopy Increases Adenoma Detection Rate by 20%: Meta-Analysis' article, a systematic review demonstrated that AI-assisted colonoscopy increased the adenoma detection rate by 20%, validating the technology's critical role in reducing missed diagnoses and improving patient outcomes.

Advancements in Multi-Omics and Novel Biomarker Discovery are simultaneously expanding the market by targeting the substantial unscreened population through highly sensitive, next-generation assays. This trend is driven by the identification of complex RNA and DNA signatures that offer superior accuracy over traditional fecal testing, incentivizing manufacturers to develop proprietary solutions for early-stage detection. The commercial impetus for this innovation lies in the vast untapped potential of eligible individuals who remain non-compliant with current protocols. According to Mainz Biomed, December 2024, in the 'Mainz Biomed Enters Agreement with Quest Diagnostics' press release, the persistent gap in screening among United States residents represents a $4.0B+ total market opportunity, fueling intense investment in novel biomarker validation to capture this addressable segment.

Segmental Insights

The biomarker test segment represents the fastest-growing area in the global colorectal cancer screening and diagnostic market, driven by a distinct shift toward non-invasive detection methods. Patients and providers increasingly favor these tests because they analyze stool or blood samples for specific genetic indicators, eliminating the need for invasive procedures like colonoscopy. Continued approvals by regulatory authorities such as the US Food and Drug Administration enhance market confidence and accessibility. Furthermore, the capacity of biomarker assays to identify early-stage cancer risks promotes timely treatment, thereby accelerating their adoption across healthcare systems worldwide.

Regional Insights

North America leads the global colorectal cancer screening and diagnostic market due to the high prevalence of the disease and a well-established healthcare infrastructure. This regional dominance is driven by proactive government initiatives that encourage early detection and the presence of major industry players. Regulatory support from the U.S. Food and Drug Administration facilitates the approval of new diagnostic products. Furthermore, favorable reimbursement policies from the Centers for Medicare & Medicaid Services improve patient access to essential screening procedures, thereby securing the leading market position of North America.

Recent Developments

• In December 2024, Mainz Biomed announced a strategic agreement with Quest Diagnostics to advance the commercialization of its NextGen colorectal cancer screening test. Under the collaboration, the partner agreed to provide clinical trial laboratory services for the pivotal ReconAAsense study, which was designed to support a premarket approval application to the FDA. The company stated that the study would enroll approximately 15,000 subjects from various sites across the United States. This partnership aimed to leverage the diagnostic information service provider's operational expertise to validate the stool-based DNA test for the early detection of colorectal cancer and advanced adenomas.
• In October 2024, Exact Sciences announced that the U.S. Food and Drug Administration (FDA) approved Cologuard Plus, the company’s next-generation multitarget stool DNA test. The regulatory clearance covered the use of the test for adults aged 45 and older who are at average risk for colorectal cancer. The company reported that the new device demonstrated 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions in the pivotal BLUE-C study. The organization highlighted that this updated version used novel biomarkers to minimize unnecessary follow-up colonoscopies by reducing the likelihood of false-positive results compared to the previous generation of the test.
• In July 2024, Guardant Health announced that the U.S. Food and Drug Administration (FDA) approved its Shield blood test for colorectal cancer screening in adults aged 45 and older at average risk for the disease. This marked the first FDA approval of a blood test as a primary screening option for this malignancy. The decision was supported by data from the ECLIPSE study, which demonstrated the test's performance in detecting colorectal cancer. The company indicated that this non-invasive method was intended to improve adherence rates by offering a more convenient alternative to traditional stool-based tests and colonoscopies for eligible patients.
• In May 2024, Geneoscopy received FDA approval for ColoSense, a noninvasive multi-target stool RNA screening test for colorectal cancer. The approval indicated the test for use in adults aged 45 or older who are at average risk of developing the disease. The company noted that this was the first noninvasive screening tool to utilize RNA biomarkers to provide a dynamic view of disease activity. The regulatory decision was based on the results of the CRC-PREVENT trial, which showed high sensitivity for detecting colorectal cancer and advanced adenomas. The firm also announced a collaboration with Labcorp to facilitate commercial availability of the test.

Key Market Players

• Exact Sciences Corporation
• Abbott Laboratories, Inc.
• F. Hoffmann‑La Roche Ltd.
• Thermo Fisher Scientific Inc.
• Danaher Corporation
• Siemens Healthineers AG
• Hologic, Inc.
• Sysmex Corporation
• Bio‑Rad Laboratories, Inc.
• Becton, Dickinson and Company

By Screening	By Diagnostics	By End User	By Region
Stool-Based Test Colonoscopy and Sigmoidoscopy Others	Biomarker Test Colonoscopy	Hospitals and Clinics Clinical Laboratories Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Colorectal Cancer Screening and Diagnostic Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Colorectal Cancer Screening and Diagnostic Market, By Screening:

• Stool-Based Test
• Colonoscopy and Sigmoidoscopy
• Others

• Colorectal Cancer Screening and Diagnostic Market, By Diagnostics:

• Biomarker Test
• Colonoscopy

• Colorectal Cancer Screening and Diagnostic Market, By End User:

• Hospitals and Clinics
• Clinical Laboratories
• Others

• Colorectal Cancer Screening and Diagnostic Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE