The upcoming new cases of CRC in the U.S. are driving the need for advanced molecular diagnostics, extensive screening initiatives, & implementation of AI-powered approaches.
Market Glimpse
Primarily, the U.S. colorectal cancer diagnostics market refers to the various screening & diagnostic tests to determine precancerous polyps or cancer, typically starting at age 45. These adoptions support the analysis of symptoms & hereditary risk, with routine testing for asymptomatic individuals. Onwards to the positive screening or symptoms, the market uses a comprehensive colonoscopy for seamless histological diagnosis.
Global Market Trends
The global colorectal cancer diagnostics market size was estimated at USD 18.7 billion in 2025 and is predicted to increase from USD 20.36 billion in 2026 to approximately USD 43.87 billion by 2035, expanding at a CAGR of 8.9% from 2026 to 2035. A gradual rise in CRC incidence & broadening awareness, with robust screening programs, are driving the demand for these diagnostics. Besides this, the market is transforming AI-assisted solutions & the latest molecular diagnostics.
Market Forecasts
Eventually, the U.S. healthcare providers will foster the AI-integrated endoscopy to support the detection of tiny polyps & characterize lesions. Besides this, the U.S. colorectal cancer diagnostics market will have a key opportunity in the development of lab-on-a-chip technologies for expedited, high-sensitivity detection of CRC-related biomarkers from small blood or stool samples. Subsidiary research activities will promote the strength of circulating tumor DNA (ctDNA), microRNAs, & DNA methylation markers.
Approximate New Cases & Deaths of CRC in 2025 & 2026 in the U.S.
& CRI
These prospective cases will mainly occur in the population those are under 50 years old; the older adult numbers will decrease due to the rising screening, and early detection increases nearly 3% per year. Moreover, the U.S. companies will increasingly revolutionise high-sensitivity stool DNA tests and liquid biopsies for these early detections.
Market Segmentation Overview
- By test type, the stool-based tests segment led with a 32% share of the U.S. colorectal cancer diagnostics market in 2025. The segmental dominance is fueled by the increasing need for non-invasive, home-based, & highly accessible alternatives to enhance CRC screening. The U.S. is highly leveraging the latest multitarget stool DNA, which provides greater sensitivity for determining cancers & advanced lesions.
- By technology, the molecular diagnostics segment dominated with a 38% in 2025. A key driver is the surging requirement of testing for specific biomarkers, like KRAS, NRAS, BRAF, HER2, MSI-H/dMMR, to advise anti-EGFR therapy & immunotherapy. Elevating the step towards high-throughput NGS panels enables entire profiling of numerous changes in a single assay, assisting in customized treatment strategies.
- By application, the screening segment captured a dominant share of 42% of the U.S. colorectal cancer diagnostics market in 2025. This is primarily driven by the recommended lowered screening age to 45 by the American Cancer Society (2018) & USPSTF (2021), which majorly raises the eligible population. CDC has executed the Colorectal Cancer Control Program by joining with states, universities, and tribal organizations to execute evidence-based screening interventions, particularly for medically underserved populations.
- By end user, the hospitals segment led with a 46% share of the market in 2025. Giant hospitals offer accessibility to specialized gastroenterologists, pathologists, & modern imaging technology, with diverse tests, like colonoscopy, virtual colonoscopy, & advanced stool-based DNA tests to enable tailored screening planning. Certain major hospitals provide access to clinical trials for cutting-edge screening & diagnostic technologies.
Top Companies in the U.S. Colorectal Cancer Diagnostics Market
Exact Sciences Corporation, Guardant Health, Inc., F. Hoffmann-La Roche Ltd. (Roche Diagnostics), and Quest Diagnostics Incorporated are the four top firms of the respective market, which explore diversity in non-invasive screening & molecular diagnostics. Exact Sciences Corporation is perceived as a key leader in the U.S., which has rolled out the Cologuard, a non-invasive at-home screening test by assessing stool for a combination of DNA markers & hemoglobin.
Segments Covered in the Report
By Test Type
- Stool-based Tests
- Fecal Immunochemical Test (FIT)
- Guaiac Fecal Occult Blood Test (gFOBT)
- Stool DNA Test
- Blood-Based Tests
- Circulating Tumor DNA (ctDNA)
- Methylated DNA Biomarkers
- Protein Biomarkers
- Imaging Tests
- Endoscopic Tests
- Colonoscopy
- Flexible Sigmoidoscopy
- Biopasy
- Tissue Biopsy
- Liquid Biopsy
By Technology
- Molecular Diagnostics
- PCR
- Next-Generation Sequencing (NGS)
- Microarrays
- Immunoassays
- ELISA
- Chemiluminescence Immunoassay (CLIA)
- Clinical Chemistry
- Imaging Technology
By Application
- Screening
- Diagnosis
- Prognosis
- Monitoring & Recurrence Detection
By End User
- Hospitals
- Diagnostic Laboratories
- Research Institutes
- Ambulatory Surgical Centers
