U.S. Colorectal Cancer Screening Market to be USD 10.77 Bn by 2032

The U.S. colorectal cancer screening market, projected to reach a valuation of US$ 6.41 billion in 2025, is set for substantial expansion. Estimates indicate the market will reach US$ 10.77 billion by 2032, registering a CAGR of 7.7% during the forecast period. Key growth drivers include the rising incidence of colorectal cancer, increasing awareness regarding early detection, advancements in screening technologies, and supportive government initiatives promoting routine screening. Additionally, the growing preference for non-invasive testing methods and the integration of AI and digital health solutions are propelling the market forward.

Market Takeaways

• By test type, the Fecal Immunochemical Test (FIT) segment is projected to account for the largest share at 38.1% in 2025, driven by its non-invasive nature, higher sensitivity, and growing adoption in population-based screening programs.
• By imaging type, colonoscopy remains the preferred diagnostic method due to its high accuracy, ability to perform polyp removal during the procedure, and widespread availability in clinical settings.
• By end user, hospitals are expected to dominate the market, owing to their comprehensive diagnostic infrastructure, access to advanced screening technologies, and increased patient throughput.
• Regionally, the Northeast is expected to hold the largest regional share of 40% in 2025, supported by well-established healthcare infrastructure, higher awareness levels, and active regional screening initiatives.

U.S. Colorectal Cancer Screening Market Report Coverage

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 Market Dynamics

The U.S. colorectal cancer screening market is experiencing steady growth, fueled by increasing public health awareness, favorable insurance coverage, and technological advancements in screening methods. As national efforts intensify to promote early cancer detection and reduce mortality rates, demand for reliable and accessible screening solutions—such as colonoscopy, fecal immunochemical tests (FIT), and emerging non-invasive technologies—is on the rise across the healthcare landscape.

For instance, in January 2025, Guardant Health's blood-based test, Guardant Reveal, received expanded Medicare coverage, allowing broader use for detecting recurrent colorectal cancer. This development significantly enhances access to non-invasive screening options.

Additionally, the implementation of public health policies and insurance mandates aimed at expanding access to preventive care. Under the Affordable Care Act, most health insurance plans are required to cover colorectal cancer screening without out-of-pocket costs for adults aged 45 to 75, significantly improving screening rates. Public health initiatives led by organizations like the Centers for Disease Control and Prevention (CDC) and the American Cancer Society further reinforce these efforts by educating the public and promoting routine screenings.

However, the market faces notable challenges, including test accessibility in underserved regions, psychological and physical barriers to invasive procedures, and concerns about false positives or overdiagnosis. Despite these limitations, ongoing research and government-backed screening campaigns are expected to continue driving growth in the U.S. colorectal cancer screening market.

Market Trends

• Innovations in Non-Invasive Colorectal Cancer Screening Technologies

Technological advancements are reshaping the colorectal cancer screening landscape.

The development of non-invasive, at-home screening kits such as FIT and stool DNA tests (e.g., Cologuard) is making early detection more convenient and less intimidating for patients, especially those averse to invasive procedures like colonoscopy. These innovations are expanding the reach of screening programs and enhancing patient compliance.

In May 2023, Universal DX developed a blood test named Signal-C, demonstrating a 93% sensitivity in detecting colorectal cancer and 54% sensitivity for pre-cancerous growths. This test offers a less invasive alternative to traditional colonoscopies.

• Expansion of At-Home Colorectal Cancer Screening Solutions

The U.S. Food and Drug Administration (FDA) had approved Cologuard Plus, an enhanced version of the at-home stool DNA test, developed by Exact Sciences in October 2024. This test demonstrated a 95% sensitivity for detecting colorectal cancer and a 43% sensitivity for identifying advanced precancerous lesions, with a specificity of 94%. The approval was based on a prospective study involving over 20,000 patients, including a significant representation of Hispanic and Latino, Black, Asian, American Indian, Alaska Native, and Pacific Islander populations.

Market Opportunities

• Integration of Artificial Intelligence (AI) in Screening Procedures

The incorporation of AI-driven tools in colorectal cancer screening, especially in enhancing the accuracy of colonoscopy through real-time polyp detection and segmentation, presents a major opportunity. AI tools assist physicians in identifying precancerous lesions that might be missed by the human eye, improving diagnostic outcomes and reducing false negatives. For example, in August 2023, United Digestive launched a colonoscopy offering through the GI Genius endoscopy module by Medtronic, which uses AI to detect colorectal polyps, providing physicians with a powerful new solution to help patients fight against colorectal cancer.

In October 2024, GI Alliance, the nation's leading network of managed gastroenterology practices, announced a strategic collaboration with Medtronic to introduce the GI Genius intelligent endoscopy module across more than 400 of its site locations. Following a trial that demonstrated a significant improvement in polyp detection rates, this adoption aims to enhance diagnostic accuracy and patient outcomes in colorectal cancer screenings.

• Growth of Multi-Cancer Early Detection (MCED) Tests

The development and adoption of innovative blood-based Multi-Cancer Early Detection (MCED) tests present a significant growth opportunity in the U.S. colorectal cancer screening market. These tests enable simultaneous screening for multiple cancers, including colorectal cancer, through a single, minimally invasive blood draw. By facilitating earlier diagnosis, MCED tests can expand screening reach beyond traditional methods and improve patient compliance, especially among individuals reluctant to undergo invasive procedures. This advancement supports a shift toward more comprehensive and accessible cancer screening paradigms in the U.S. healthcare system.

In July 2024, the U.S. Food and Drug Administration (FDA) approved the Shield blood test as a primary screening tool for individuals at average risk of colorectal cancer. This test detects specific DNA changes in the blood that indicate the presence of tumors or precancerous growths in the colon, offering a less invasive alternative to traditional screening methods.

Analyst View

“The U.S. colorectal cancer screening market is poised for dynamic growth, fueled by a combination of technological innovation, policy support, and increasing public health awareness,” explains Ms. Manisha Vibhute, a senior analyst. “The ongoing shift toward non-invasive and at-home screening solutions is a game-changer, addressing key patient concerns around convenience, privacy, and procedure-related anxiety. Innovations like the enhanced stool DNA tests and highly sensitive blood-based assays are broadening the reach of early detection efforts, especially among populations previously underserved or reluctant to undergo traditional colonoscopies.”

“The integration of artificial intelligence into screening workflows is another pivotal trend, significantly improving polyp detection rates and reducing diagnostic errors. This not only enhances clinical outcomes but also boosts physician confidence and patient trust in screening protocols. Meanwhile, supportive government policies, including expanded insurance coverage and public awareness campaigns, are lowering barriers to screening adoption across diverse demographic groups.”

“Looking ahead, the emergence of multi-cancer early detection (MCED) tests represents a promising frontier—these blood-based technologies have the potential to revolutionize cancer screening paradigms by offering comprehensive, minimally invasive diagnostics that can simultaneously detect multiple cancer types, including colorectal cancer. As these innovations gain regulatory approval and insurance backing, they are expected to drive increased screening compliance and earlier interventions, ultimately improving patient survival rates.”

Key Developments

• In February 2024 – Exact Sciences Corp., a leading provider of cancer screening and diagnostic tests, announced the launch of Riskguard hereditary cancer test in the U.S. The Riskguard test provides an individualized patient report that includes gene specific and familial risks using a simple blood or saliva sample for 10 common cancers, including colorectal, breast, prostate, skin, ovarian, endometrial, pancreatic, gastric, kidney and endocrine.
• In May 2023, Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, announced the FDA clearance of the new EVIS X1 endoscopy system, along with two compatible gastrointestinal endoscopes: the GIF-1100 gastrointestinal videoscope indicated for use within the upper digestive tract including the esophagus, stomach, and duodenum; and the CF-HQ1100DL/I colonovideoscope indicated for use within the lower digestive tract including the anus, rectum, sigmoid colon, colon, and ileocecal valve.

Competitors Insights

Key players in the U.S. colorectal cancer screening market include:

• Polymedco Inc.
• Eiken Chemical Co. Ltd.
• Sysmex Corporation
• Quidel Corporation
• Novigenix SA
• Hemosure Inc.
• Exact Sciences Corp
• Epigenomics Inc
• Olympus Corporation
• Clinical Genomics Technologies Pty Ltd.
• Abbott
• Hoffmann-La Roche Ltd
• Siemens Healthineers
• Koninklijke Philips N.V.
• Thermo Fisher Scientific Inc.
• Illumina, Inc.
• Myriad Genetics Inc
• QIAGEN
• Merck KGaA

 U.S. Colorectal Cancer Screening Market Segmentation

• By Test Type
  • Fecal Immunochemical Test (FIT)
  • Guaiac-based Fecal Occult Blood Test
  • Stool DNA Test
  • Others
• By Imaging Type
  • Sigmoidoscopy
  • Colonoscopy
  • Virtual Colonoscopy
  • Others
• By End User
  • Hospitals
  • Diagnostic Laboratories
  • Academic and Research Institutes
  • Others
• By Region
  • Northeast
  • West
  • South
  • Midwest