In-vitro Colorectal Cancer Screening Tests Market Report 2025

The in-vitro colorectal cancer screening tests market size has grown strongly in recent years. It will grow from $1.21 billion in 2024 to $1.3 billion in 2025 at a compound annual growth rate (CAGR) of 7.4%. The growth during the historic period can be attributed to rising awareness of early cancer detection, the expansion of government screening programs, increased adoption of non-invasive testing methods, growing healthcare expenditure, and greater availability of at-home screening kits.

The in-vitro colorectal cancer screening tests market size is expected to see strong growth in the next few years. It will grow to $1.71 billion in 2029 at a compound annual growth rate (CAGR) of 7%. The growth during the forecast period can be attributed to an increasing focus on personalized medicine, rising demand for cost-effective diagnostics, growing investments in cancer research, expanding adoption of molecular diagnostic techniques, increasing prevalence of colorectal cancer, and greater accessibility of testing in emerging markets. Major trends expected in the forecast period include advancements in liquid biopsy technologies, innovations in biomarker discovery, integration of artificial intelligence in test analysis, development of multi-target stool deoxyribonucleic acid tests, innovations in sample collection and processing, progress in automation and digital pathology, and the adoption of cloud-based diagnostic platforms.

The rising prevalence of colorectal cancer is expected to drive growth in the in vitro colorectal cancer screening tests market in the coming years. Colorectal cancer is a type of cancer that originates in the colon or rectum, often developing from precancerous polyps. The increasing incidence of colorectal cancer is largely linked to unhealthy lifestyle habits, as poor diet, physical inactivity, and obesity elevate the risk of polyp formation and cancer development. In vitro colorectal cancer screening tests support early diagnosis by providing non-invasive methods to detect cancer at initial stages. These tests enhance screening accuracy through advanced biomarker detection, enabling timely intervention and improved patient outcomes. For example, in February 2025, according to the American Cancer Society, a US-based nonprofit organization, the estimated number of new colorectal cancer cases reached 154,270, up from 152,810 cases in 2024. Therefore, the rising prevalence of colorectal cancer is fueling the expansion of the in vitro colorectal cancer screening tests market.

Companies in the in vitro colorectal cancer screening tests market are focusing on developing advanced diagnostic solutions, such as multi-target stool DNA tests, to improve early detection, enhance patient convenience, and reduce colorectal cancer mortality. Multi-target stool DNA tests are innovative screening tools that analyze stool samples for genetic and biochemical markers linked to colorectal cancer and precancerous lesions. For instance, in March 2025, Exact Sciences Corp., a US-based molecular diagnostics company, introduced Cologuard Plus, an enhanced at-home colorectal cancer screening test for average-risk adults aged 45 and older. This test incorporates advanced biomarker technology to deliver higher sensitivity and specificity than its predecessor. It uses a refined algorithm to detect DNA mutations and hemoglobin biomarkers, improving detection of both colorectal cancer and advanced adenomas. Cologuard Plus offers a non-invasive, convenient screening option that eliminates the need for bowel preparation or dietary restrictions, thereby improving patient adherence to recommended screening guidelines.

In February 2025, Mainz Biomed N.V., a Germany-based biotech company, partnered with Labor Team W AG to launch ColoAlert. This collaboration aims to expand the availability of ColoAlert across Switzerland, leveraging Labor Team W AG’s diagnostic network to enhance early colorectal cancer detection and improve patient outcomes. Labor Team W AG is a Switzerland-based diagnostic services company specializing in in vitro colorectal cancer screening tests.

Major players in the in-vitro colorectal cancer screening tests market are Thermo Fisher Scientific Inc., Abbott Laboratories, Siemens Healthineers, Quest Diagnostics Incorporated, Roche Diagnostics International AG, Illumina Inc., Sysmex Corporation, Bio-Rad Laboratories Inc., Qiagen N.V., Exact Sciences Corporation, Natera Inc., Leica Biosystems Nussloch GmbH, BGI Genomics Co. Ltd., NeoGenomics Inc., Guardant Health Inc., CellMax Life Inc., Epigenomics AG, Acuamark Diagnostics Inc., Beacon Biomedical Inc., Mainz Biomed NV.

North America was the largest region in the in-vitro colorectal cancer screening tests market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in in-vitro colorectal cancer screening tests market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the in-vitro colorectal cancer screening tests market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the healthcare sector, particularly in the supply of critical medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are facing higher costs for imported surgical instruments, imaging equipment, and consumables such as syringes and catheters, many of which have limited domestic alternatives. These increased costs are straining healthcare budgets, leading some providers to delay equipment upgrades or pass on expenses to patients. Additionally, tariffs on raw materials and components are disrupting the production of essential drugs and devices, causing supply chain bottlenecks. In response, the industry is diversifying sourcing strategies, boosting local manufacturing where possible, and advocating for tariff exemptions on life-saving medical products.

In-vitro colorectal cancer screening tests are non-invasive, laboratory-based tests that examine stool or blood samples to identify indicators of colorectal cancer or precancerous conditions. These tests enable early detection of colorectal cancer in asymptomatic individuals, facilitating timely intervention and reducing cancer-related mortality.

The primary types of in-vitro colorectal cancer screening tests include the fecal occult blood test, stool deoxyribonucleic acid (DNA) test, blood biomarker test, and others. The fecal occult blood test is a non-invasive diagnostic method used to detect hidden (occult) blood in the stool, which may indicate early colorectal cancer or other gastrointestinal disorders. Various imaging techniques, including colonoscopy, proctoscopy, computed tomography (CT) scans, ultrasound, magnetic resonance imaging (MRI), and positron emission tomography (PET) scans, support a wide range of applications such as screening, diagnosis, monitoring, risk assessment, and post-treatment surveillance. These tests and techniques serve a variety of end users, including hospitals, diagnostic laboratories, outpatient clinics, home care settings, and research institutions.

The in-vitro colorectal cancer screening tests market research report is one of a series of new reports that provides in-vitro colorectal cancer screening tests market statistics, including in-vitro colorectal cancer screening tests industry global market size, regional shares, competitors with a in-vitro colorectal cancer screening tests market share, detailed in-vitro colorectal cancer screening tests market segments, market trends and opportunities, and any further data you may need to thrive in the in-vitro colorectal cancer screening tests industry. This in-vitro colorectal cancer screening tests market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The in-vitro colorectal cancer screening tests market consists of revenues earned by entities by providing services such as molecular diagnostic testing, lab sample collection and processing services, risk assessment and genetic counseling services, telehealth-based screening consultations, screening program management for institutions, and electronic health record (EHR) integration services. The market value includes the value of related goods sold by the service provider or included within the service offering. The in vitro colorectal cancer screening tests market also includes sales of sample collection devices, automated screening instruments, sample preservation and transport systems, and digital diagnostic platforms. Values in this market are ‘factory gate’ values; that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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