
North America Colorectal Cancer Screening Tests Market Analysis by Âé¶¹ÊÓÆµ
The North America Colorectal Cancer Screening Tests market size is expected to grow from USD 7.63 billion in 2025 to USD 8.14 billion in 2026 and is forecast to reach USD 11.21 billion by 2031 at 6.62% CAGR over 2026-2031.
- The North American colorectal cancer screening tests market is experiencing growth due to several factors, such as the increasing prevalence of colorectal cancer, technological advancements, and cancer prevention initiatives. The high prevalence of colorectal cancers in the region is one of the major factors driving the market growth, as it is expected to increase the usage of colorectal cancer screening tests.
- For instance, according to data published by the Canadian Cancer Society in May 2024, colorectal cancer is expected to be the fourth most commonly diagnosed cancer in Canada in 2024. In addition, according to the same source, 25,200 new colorectal cancer cases are estimated to be diagnosed in Canada in 2024. Similarly, according to the data published by the International Agency for Research on Cancer in February 2024, the number of new colorectum cancer cases was reported to be 16.1 thousand cases in 2022 and is estimated to reach 17.5 thousand cases in Mexico by 2025. Thus, the increasing prevalence of colorectal cancer is driving the need for screening, which is expected to contribute to market growth during the forecast period significantly. Moreover, colorectal cancer prevention initiatives are expected to boost the market growth. For instance, according to the data updated by Ohio State University in 2023, the Ohio Colorectal Cancer Prevention Initiative (OCCPI) is a statewide initiative in Ohio, United States, to screen newly diagnosed colorectal cancer (CRC) patients and their biological relatives for Lynch syndrome. This cancer-causing condition occurs when a person inherits a mutation in one of four genes. These initiatives increase the awareness of colorectal cancer screening, thereby boosting the demand, and are expected to drive market growth during the forecast period.
- Thus, the above factors, such as the rising prevalence of colorectal cancer and cancer prevention initiatives, are expected to boost the market growth. However, high screening test costs are expected to impede market growth during the forecast period.
Note: Market size and forecast figures in this report are generated using Âé¶¹ÊÓÆµâ€™s proprietary estimation framework, updated with the latest available data and insights as of 2026.
North America Colorectal Cancer Screening Tests Market Trends and Insights
Guaiac Fecal Occult Blood Test (gFOBT) is Expected to be Hold a Significant Share in the Market During the Forecast Period
- The guaiac fecal occult blood test (gFOBT) is one of the tests used to detect colorectal cancer (CRC). It involves detecting hidden blood in the feces and identifying cancer cells or tumors in the colon or rectum. The guaiac fecal occult blood test is often preferred over other screening tests due to its high efficacy in detecting colorectal cancer. Thus, it is expected to hold a significant market share. Other factors, such as the rising prevalence of colorectal cancer and the increasing usage of guaiac fecal occult blood tests (gFOBT), are expected to boost segment growth.
- For example, in April 2022, an article published by the Multidisciplinary Digital Publishing Institute (MDPI) stated that CRC was considered one of the most common cancers in Canada, with around 24,800 cases projected to be diagnosed in 2021. Although the incidence of CRC among adults under the age of 50 represents approximately 8% of CRC cases in Canada, recent studies have shown that the incidence of colorectal cancer in younger people is rising rapidly in Canada. Thus, the rising prevalence of colorectal cancer is expected to boost the usage of guaiac fecal occult blood tests (gFOBT).
- Also, advancements made by market players are driving increased utilization of the products within this segment. For example, in June 2022, W.H.P.M. Inc. obtained 510(k) marketing approval from the United States FDA for Hemosure Accu-Reader A100, a guaiac-based fecal occult blood test (gFOBT). Thus, the approval of the new products will increase the availability of these gFOBT tests, thereby boosting market growth in the coming years.

The United States is Expected to be Hold a Significant Market Share During the Forecast Period
- The United States is expected to hold a significant share of the colorectal cancer screening tests market in North America due to the robust healthcare infrastructure for cancer screening and the rising burden of colorectal cancer. Also, awareness programs and the launch of new products are expected to augment the market's growth in the United States during the forecast period.
- For instance, according to the data published by the American Cancer Society in 2024, 106,590 new cases of colon cancer and 46,220 cases of rectal cancer are estimated to be in the United States by the end of 2024. Moreover, according to the same source, around 106,970 cases were estimated to have colon cancers, and 46,050 cases were estimated to have rectum cancer in 2023. Thus, the country's high incidence of colon and rectum cancers is expected to boost market growth.
- Also, according to the same source, it has been observed that screening can help prevent colorectal cancers by detecting and removing precancers in the colon, rectum, and uterine cervix, and screening can also reduce mortality for these cancers. Thus, the rising importance of colorectal cancer screening is also expected to boost market growth.
- Moreover, major market players' rising product approvals, recommendations, and launches are expected to boost market growth, increasing access to technologically advanced products. For instance, in March 2024, Guardant Health Inc. stated that the US FDA Medical Devices Advisory Committee, reviewing the Molecular and Clinical Genetics Panel, strongly recommended the FDA approval of Guardant Health's Shield blood test. This test is designed for colorectal cancer (CRC) screening in adults aged 45 and above. Thus, the factors above, such as the rising prevalence of colorectal cancer and the new product recommendations, are expected to boost the market growth in the region during the forecast period.

Competitive Landscape
The North American colorectal cancer screening tests market is fragmented due to the presence of many small and large market players. These market players are involved in various strategic activities such as agreements, partnerships, and developments to increase the product portfolio of the companies in the region. Some key North American colorectal cancer screening tests market players are Abbott Laboratories, Epigenomics Inc., Exact Sciences Corporation, F. Hoffmann-La Roche AG, Novigenix SA, Siemens Healthineers, and Sysmex Corporation.
North America Colorectal Cancer Screening Tests Industry Leaders
Abbott Laboratories
Epigenomics Inc.
Exact Sciences Corporation
Clinical Genomics Technologies Pty Ltd.
Hemosure Inc.
- *Disclaimer: Major Players sorted in no particular order

Market Opportunities and Future Outlook
Clinical guideline alignment and a larger eligible pool created by screening starting at age 45 continue to open whitespace for noninvasive modalities alongside endoscopy, particularly where health systems seek higher participation from average-risk adults. The American Cancer Society updated its colorectal cancer screening guideline in May 2026, continuing to frame stool-based options as preferred noninvasive approaches for average-risk adults. FDA actions during 2024-2026, including Guardant Health's Shield blood test approval in August 2024 and supplements supporting manufacturing and process changes for Exact Sciences' Cologuard Plus and Geneoscoopy's ColoSense, add commercially available choices and operational headroom for broader deployment.
A measurable implementation gap supports opportunity for providers, labs, and test manufacturers to link screening tests with workflow and outreach programs that convert eligibility into completed tests and follow-up colonoscopy when indicated. Healthy People 2030 sets a 72.8% target for colorectal cancer screening prevalence among adults aged 45 to 75, versus 61.4% prevalence reported in a CDC 2022 analysis. CDC's Colorectal Cancer Control Program focuses on evidence-based interventions (for example, patient reminders and provider alerts enabled by EHR workflows) in under-screened settings, creating demand for scalable test logistics, results integration, and navigation services across the United States, Canada, and Mexico.
Recent Industry Developments
- May 2026: Abbott referenced the American Cancer Society updated colorectal cancer screening guideline and positioned Cologuard and Cologuard Plus as preferred noninvasive screening options for average-risk adults aged 45 and older. This reinforced the role of stool-based molecular testing within guideline-driven screening pathways and supported commercial emphasis on noninvasive uptake.
- March 2026: Abbott completed its acquisition of Exact Sciences, bringing the Cologuard franchise and pipeline assets into Abbotts diagnostics portfolio. The combination strengthened Abbotts scale in colorectal cancer screening and created a larger platform for payer, provider, and distribution execution across North America.
- March 2024: Exact Sciences highlighted publication of pivotal BLUE-C study results for Cologuard Plus in The New England Journal of Medicine. The visibility of late-stage clinical evidence supported differentiation of next-generation stool DNA testing and underpinned subsequent regulatory and commercialization steps for upgraded noninvasive screening.
Research Methodology Framework and Report Scope
Market Definition and Coverage
For this study, the market covers the value of colorectal cancer screening tests and procedures used to screen eligible populations in North America. This includes test kits, diagnostic services, and procedure-based screening delivered through healthcare providers and labs.
Scope exclusions: This sizing does not count colorectal cancer treatment, post-diagnosis monitoring, or broad GI diagnostics that are not used for screening.
Segmentation Overview
- By Screening Tests
- Stool-based Tests
- Fecal Immunochemical Test (FIT)
- Guaiac-based Fecal Occult Blood Test (gFOBT)
- Stool DNA Test
- Colonoscopy
- CT Colonography (Virtual Colonoscopy)
- Flexible Sigmoidoscopy
- Other Screening Tests
- Stool-based Tests
- By End User
- Hospitals
- Diagnostic Centers/Laboratories
- Other End Users
- Geography
- United States
- Canada
- Mexico
Data Sources, Market Sizing, and Validation
Desk Research
Desk work starts by mapping how CRC screening is recommended and practiced across North America, then pulling the most dependable public data series we can reuse in the model. Sources typically include guidance and screening utilization releases from agencies such as the CDC, along with cancer burden statistics from the National Cancer Institute. We also use public health reporting from Health Canada and comparable national portals. Recommendation statements from groups such as the US Preventive Services Task Force are treated as the backbone for eligibility and interval assumptions. Clinical practice patterns are cross-checked using peer-reviewed gastroenterology and oncology journals.
From there, pricing and volume signals are compiled using public payer references, procedure coding documentation, and provider-level publications. For category revenue context, we also review company filings and investor presentations for the CRC screening test and service categories relevant to the North America definition. Paid subscriptions are used selectively for company financials and intelligence, news and financials, and patent databases to confirm product positioning and timing. This list is not exhaustive, and other public sources were used to collect inputs, validate assumptions, and clarify open questions during research.
Primary Interviews and Surveys
Primary work is used to convert guideline intent into real-world volumes, prices, and adoption patterns, which are then reconciled with desk inputs. We interview test suppliers and distributors, diagnostic laboratories, hospitals, and GI clinics. We also include payers and clinical leaders who influence screening pathways across the United States, Canada, and Mexico. When an assumption seems fragile, we recheck it with a different respondent type so the final sizing is not driven by a single viewpoint.
Distribution of primary research fieldwork respondents
| Company type | Respondent position | Region |
|---|---|---|
| Top tier: 27% | CXOs: 18% | |
| Mid tier: 51% | Functional/Unit leaders: 25% | |
| Smaller Players: 22% | Managers: 57% |
Market-Sizing & Forecasting
Sizing is built using a top-down demand pool reconstruction tied to North America screening eligibility and the practical mix of modalities used in programs and routine care, then checked with selective bottom-up approximations from supplier and channel inputs. The model starts from population in screening age bands, applies screening rate assumptions by country, and splits volumes across stool-based tests and procedure-based screening. Pricing logic is then applied using typical payer reimbursement and out-of-pocket patterns. Where the market is service heavy (for example, colonoscopy), we treat the unit as a completed procedure, and we treat kit-based tests as completed tests. This approach helps prevent double counting across modalities.
Forecasts use scenario analysis supported by a set of variables stakeholders can explain clearly. Key inputs include guideline age cutoffs and interval patterns, screening participation rates, the stool test versus endoscopy mix, average reimbursement by modality, and the rate at which newer test formats move from early adoption into routine ordering. If country-level data is thin, the gap is handled through proxy adoption curves anchored in expert interviews, then adjusted using public utilization signals before totals are finalized.
Data Validation & Update Cycle
Outputs are checked against independent signals such as procedure utilization trends, lab testing activity direction, and the implied spend per screened person. Variances are investigated before sign-off. When a number appears off, we trace it back to the driver level, usually a participation rate, a modality mix shift, or a price assumption that needs revalidation.
The work is reviewed in steps by another analyst, and any material disagreements trigger follow-up calls with respondents to confirm what changed and why. Reports are refreshed annually, and interim updates are made when major guideline changes, reimbursement shifts, or new test approvals materially alter expected demand. Before delivery, a final pass is completed so clients receive the most current view available at that time.
Âé¶¹ÊÓÆµ's North America Colorectal Cancer Screening Tests Market Market Size Compared Against Other Published Estimates
Published market sizes for colorectal cancer screening tests can vary even when the same region is mentioned. Each publisher draws the line differently on what counts as a screening test and how services are priced. Differences also come from the base year used, how procedure volumes are converted into value, and how quickly adoption is assumed to change after policy or guideline updates.
The table shows a spread that is mainly driven by scope and valuation logic. Some sources focus only on in vitro test kits and lab testing, while others bundle broader screening services without clearly separating follow-up diagnostics. The table also reflects country-coverage choices and refresh cadence. For example, a model that drops Mexico or keeps older reimbursement assumptions can land lower than a model that updates modality pricing and participation inputs closer to the base year.
Benchmark comparison
| Source | Market Size | Gaps in Research Methodology |
|---|---|---|
| Âé¶¹ÊÓÆµ | USD 7.63 B (2025) | |
| Regional Consultancy A | USD 6.27 B (2025) | Narrows regional coverage to the United States and Canada, which can understate value where Mexico screening volumes are rising from a smaller base. The write-up also does not clearly explain how procedure-based screening is monetized versus kit-based tests, so pricing and unit definitions may not be consistent across modalities. |
| Industry Association B | USD 4.50 B (2024) | Uses an earlier base year and appears to focus on in-vitro screening tests only, which excludes procedure-led screening value such as colonoscopy and CT colonography. Reported totals may also be impacted by using static reimbursement references instead of reflecting year-to-year pricing and modality mix changes. |
The spread is easier to interpret once the inclusion rules are made explicit and the model drivers are kept observable. The table highlights that, in Âé¶¹ÊÓÆµ's model, North America includes the United States, Canada, and Mexico, and the value calculation counts stool-based tests alongside procedure-based screening. This shifts totals versus sources that only track in vitro tests or a smaller country set.
Key Questions Answered in the Report
How big is the North America Colorectal Cancer Screening Tests Market?
The North America Colorectal Cancer Screening Tests Market size is expected to reach USD 8.14 billion in 2026 and grow at a CAGR of 6.62% to reach USD 11.21 billion by 2031.
What is the current North America Colorectal Cancer Screening Tests Market size?
In 2026, the North America Colorectal Cancer Screening Tests Market size is expected to reach USD 8.14 billion.
Who are the key players in North America Colorectal Cancer Screening Tests Market?
Abbott Laboratories, Epigenomics Inc., Exact Sciences Corporation, Clinical Genomics Technologies Pty Ltd. and Hemosure Inc. are the major companies operating in the North America Colorectal Cancer Screening Market.
What years does this North America Colorectal Cancer Screening Tests Market cover, and what was the market size in 2025?
In 2025, the North America Colorectal Cancer Screening Tests Market size was estimated at USD 7.63 billion. The report covers the North America Colorectal Cancer Screening Tests Market historical market size for years: 2020, 2021, 2022, 2023, 2024 and 2025. The report also forecasts the North America Colorectal Cancer Screening Tests Market size for years: 2026, 2027, 2028, 2029, 2030 and 2031.
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