In-vitro Colorectal Cancer Screening Tests Market – Global Industry Size, Share, Trends, Opportunity, & Forecast, Segmented By Test Type (Fecal Occult Blood Tests, Biomarker Tests, CRC DNA Screening Tests), By Region, Competition, 2020-2030F

Market Overview

The Global In-vitro Colorectal Cancer Screening Tests Market will grow from USD 890.89 Million in 2024 to USD 1069.98 Million by 2030 at a 3.10% CAGR. In-vitro colorectal cancer screening tests involve diagnostic procedures utilizing biological samples like stool or blood to detect colorectal cancer or its precursors, thereby enabling early disease identification crucial for improved treatment outcomes. The market's growth is primarily driven by the increasing global prevalence of colorectal cancer and heightened awareness regarding early detection methods. According to the American Association for Cancer Research (AACR) Cancer Progress Report 2024, colorectal cancer incidence rates increased by 1.9 percent annually in individuals younger than 50 years between 2011 and 2019, underscoring a critical need for expanded screening. Further growth drivers include the aging global population, continuous technological advancements enhancing test accuracy, and supportive government initiatives promoting organized screening programs.

Despite robust growth drivers, the market faces a significant challenge in the form of variable reimbursement policies and high costs associated with advanced diagnostic technologies, which can impede widespread adoption across diverse healthcare systems. Additionally, patient compliance with recommended screening protocols remains an area requiring sustained effort to maximize market potential and public health benefits.

Key Market Drivers

The escalating global incidence of colorectal cancer represents a paramount driver for the in-vitro screening tests market. The increasing number of new cases, particularly among younger individuals, highlights a pressing public health demand for accessible and accurate diagnostic tools. This growing disease burden necessitates expanded screening to enable early detection, which is vital for enhancing patient survival and reducing mortality. According to the American Cancer Society, in January 2024, their annual report, "Cancer Statistics, 2024", indicated that colorectal cancer became the leading cause of cancer death in men and the second in women under 50 years old. This escalating incidence directly stimulates demand for improved in-vitro screening methods.

Advancements in in-vitro diagnostic technologies significantly propel market growth by providing greater accuracy, convenience, and accessibility in colorectal cancer detection. These technological enhancements include developing more sensitive molecular tests, such as novel blood-based and stool DNA assays. Such innovations mitigate patient aversion to invasive procedures, increasing screening adoption and improving the identification of precancerous lesions and early-stage cancers. For example, according to Healthline, in August 2024, its article "Colon Cancer: FDA Approves New Blood Test for Screening" reported the ECLIPSE trial found Guardant Health's Shield blood test accurately identified colorectal cancer in 83.1% of cases confirmed by colonoscopy. Moreover, according to the American Cancer Society National Colorectal Cancer Roundtable, in 2024, Federally Qualified Health Center patients screened for colorectal cancer reached 3,617,246, showcasing the expanding reach of screening programs.

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Key Market Challenges

Variable reimbursement policies and the high costs associated with advanced diagnostic technologies present a significant impediment to the expansion of the global in-vitro colorectal cancer screening tests market. These financial barriers restrict patient access to advanced screening options across diverse healthcare systems, particularly when insurance coverage is inconsistent or requires substantial out-of-pocket payments. This directly leads to lower adoption rates, as both healthcare providers and individuals may prioritize more affordable or covered alternatives, even if they are less comprehensive.

According to BGI Genomics' 2024 Global Colorectal Cancer Awareness Report, screening costs were cited as a major barrier to colorectal cancer screening by 17.7 percent of global respondents. Furthermore, the report indicated that in some regions, a majority of individuals expressed a preference for inexpensive or moderately priced testing options. This financial sensitivity directly influences market penetration, creating disparities in the utilization of advanced in-vitro tests. Without more consistent and supportive reimbursement frameworks, the market's growth potential remains constrained, impacting the broad application of early detection methods.

Key Market Trends

The growing integration of personalized medicine approaches is a significant trend in colorectal cancer screening, enabling tailored strategies based on individual genetic profiles and risk factors. This facilitates targeted early detection through specific biomarkers. According to the American Cancer Society, in January 2024, their "Cancer Statistics, 2024" report indicated nearly 30% of individuals under 50 diagnosed with colorectal cancer attributed their condition to family history or genetic factors, highlighting the need for individualized screening. Guardant Health, Inc.'s November 2025 report in Current Medical Research and Opinion exemplified this, noting its Shield blood-based screening test achieved 95% patient adherence, showcasing improved compliance with precision diagnostics.

Another key trend is the increasing adoption of at-home screening solutions, driven by preference for convenient, non-invasive tests in the global in-vitro colorectal cancer screening tests market. These home-based options, like fecal immunochemical tests, reduce patient barriers to traditional procedures, enhancing accessibility and overall participation. NYC Health + Hospitals, for instance, announced in March 2025 that it screened nearly 60,000 patients for colorectal cancer in 2024 using the at-home fecal immunochemical test, a 12% increase over 2023. A study by UCLA researchers published in JAMA in August 2025 confirmed that mailing a stool-based test led to over 26% of individuals getting screened, surpassing opt-in strategies for improving rates in adults aged 45 to 49.

Segmental Insights

In the Global In-vitro Colorectal Cancer Screening Tests Market, the Fecal Occult Blood Tests segment is experiencing rapid growth due to several compelling factors. Its non-invasive nature and ease of use make it a widely accessible and convenient screening option for individuals. Furthermore, the cost-effectiveness of these tests supports their broad adoption in national screening programs and public health initiatives globally. Organizations such as the Centers for Medicare & Medicaid Services (CMS) have provided coverage for annual screening FOBTs, increasing patient access and utilization. Additionally, medical guidelines, including those from the American Cancer Society, recommend stool-based tests, further bolstering demand amidst a rising global incidence of colorectal cancer and growing awareness of early detection's importance.

Regional Insights

North America holds a leading position in the global in-vitro colorectal cancer screening tests market, primarily driven by its robust healthcare infrastructure and substantial healthcare expenditure. The region benefits from established national screening guidelines from organizations such as the American Cancer Society and the National Comprehensive Cancer Network, which significantly promote early detection efforts. High public awareness concerning the importance of regular screening, combined with the widespread adoption of advanced, non-invasive testing technologies, further fuels market growth. Additionally, favorable reimbursement policies and extensive health insurance coverage encourage consistent screening participation, thereby reinforcing North America's dominant market presence through comprehensive government initiatives and considerable industry investment.

Recent Developments

• In August 2025, Freenome entered into an exclusive license agreement with Exact Sciences to commercialize its blood-based screening test for colorectal cancer. This strategic company collaboration aimed to accelerate market adoption of Freenome's in-vitro diagnostic. The agreement, valued at up to $885 million based on achieving specific regulatory and screening guideline milestones, allowed Exact Sciences to leverage its existing commercial infrastructure to integrate the test into healthcare workflows and reach a broader patient population.

• In January 2025, Tempus AI, Inc. introduced its xT CDx, an NGS-based in-vitro diagnostic tool designed for colorectal cancer screening. This new product launch expanded the available options within the global in-vitro colorectal cancer screening tests market. The xT CDx received FDA approval, making it accessible to ordering clinicians nationwide. This innovation aimed to provide an advanced diagnostic method, contributing to earlier and more precise detection of colorectal cancer.

• In October 2024, Exact Sciences announced the FDA approval of Cologuard Plus, an upgraded version of its established non-invasive, multi-target stool DNA test. This new product launch in the in-vitro colorectal cancer screening tests market aimed to enhance detection accuracy. The Cologuard Plus test incorporated additional genetic biomarkers to increase sensitivity for detecting colorectal cancers and advanced precancerous polyps while also reducing false positive rates by over 30 percent, based on results from the BLUE-C study.

• In July 2024, Guardant Health received U.S. Food and Drug Administration (FDA) approval for its Shield blood test, an in-vitro diagnostic for colorectal cancer screening. This new product offered a non-invasive option for average-risk individuals aged 45 and older. The test, which detects cancer-derived alterations in cell-free DNA from blood samples, represented a significant advancement in the global in-vitro colorectal cancer screening tests market by providing a convenient alternative to traditional screening methods. The company anticipated that this approval would help address low screening adherence rates.

Key Market Players

• Abbott Laboratories, Inc.
• Beckman Coulter, Inc.
• Eiken Chemical Co., Ltd.
• Sysmex Corporation
• Siemens Healthineers AG
• Quest Diagnostics Incorporated
• Merck KGaA
• Kyowa Kirin Co., Ltd.
• Randox Laboratories Ltd.
• R-Biopharm AG

Report Scope:

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

• In-vitro Colorectal Cancer Screening Tests Market, By Test Type:

o   Fecal Occult Blood Tests

o   Biomarker tests

o   CRC DNA Screening Tests

• In-vitro Colorectal Cancer Screening Tests Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global In-vitro Colorectal Cancer Screening Tests Market.

Available Customizations:

Global In-vitro Colorectal Cancer Screening Tests Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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