Fecal Occult Testing Market Size, Share and Industry Analysis, By Test Type (Guaiac Fecal Occult Blood Test (gFOBT), Fecal Immunochemical Test (FIT), and FIT-DNA), By Application (Colorectal Cancer, Gastrointestinal Bleeding, Anemia, and Others), By End-user (Hospital-based Laboratories, Standalone Laboratories, Clinic-based Laboratories, and Others), and Regional Forecast, 2025-2032

The global fecal occult testing market is witnessing significant growth due to the increasing prevalence of colon cancer and other disorders that can be diagnosed with the aid of these tests. The fecal occult test is a method for the detection of blood in the stool sample that can help diagnose some chronic conditions including colorectal cancer, gastrointestinal disorder, and others. The growing prevalence of these conditions amongst the general population along with increasing product approvals and launches by the major companies are expected to boost the demand and adoption of these test kits in the market.

• In 2020, Coloclear, a multi-target stool DNA test method was approved by the National Medical Products Administration for registration under the innovative Class III medical devices. It is the first certified colorectal cancer screening method in China.

Fecal Occult Testing Market Driver

Rising Prevalence of Colorectal Cancer and Gastrointestinal Disorders to Boost Adoption of these Tests

The growing prevalence of colorectal cancers among the population globally coupled with the rising awareness regarding these tests’ ability to detect and diagnose these condition are expected to spur the demand for these tests among the population. 

• In July 2024, the National Bowel Cancer Screening Program was conducted in Australia to increase the screening rates for bowel cancer by providing free home test kits to the eligible individuals aged 45 and older. This initiative was conducted in collaboration with Sonic Healthcare Limited.

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According to a 2022 report published by the World Cancer Research Fund (WCRF) International, there were more than 1.9 million new cases of colorectal cancer among the population globally in 2022. Among the total new cases, China accounted for a major share of around 26.8% globally.

Fecal Occult Testing Market Restraint

Limited Awareness Regarding these Tests in Emerging Countries May Hamper Adoption

The limited awareness among healthcare providers regarding the fecal occult testing kits for the colorectal cancer screening and the diagnosis of other conditions is resulting into a lack of provider recommendations. This is expected to hinder the adoption of these tests among the population, especially in emerging countries such as India, China, Brazil, and others with limited healthcare resources.

• According to a 2019 study published by Preventive Medicine Reports, among 860 survey respondents, the most common barrier for the utilization of fecal occult testing among the population was lack of knowledge that accounted for around 42.5% which was followed by the lack of provider recommendation that accounted for 32.5% among survey participants.

Fecal Occult Testing Market Opportunity

Favorable Government Policies to Propel Industry Expansion

The rising focus of government bodies and other healthcare organizations to improve the clinical guidelines and recommendations for colorectal cancer screening is expected to support the increasing awareness and adoption of these fecal occult testing services among healthcare providers and the patient population.

• According to the 2022 report published by the Hong Kong’s Centre for Health Protection, the guidelines on colorectal cancer screening was updated in June 2022 which recommended the fecal occult testing annually or biennially among the individuals aged 50 to 75 years at average risk.

Key Insights

The report covers the following key insights:

• Prevalence of Key Diseases, By Key Countries/Regions, 2023


• Overview: Ageing Population Statistics, By Key Countries, 2023


• Overview: Regulatory and Reimbursement Scenario, By Key Countries/Regions


• Key Industry Developments (Mergers, Acquisitions, Partnerships)


• Impact of COVID-19 on the Market 


• Overview: Technological Advancements in Fecal Occult Testing

Segmentation

Analysis by Test Type

By test type, the market is categorized into guaiac fecal occult blood test (gFOBT), fecal immunochemical test (FIT), and FIT-DNA.

The fecal immunochemical test (FIT) segment accounted for a significant proportion of the market in 2023. The growing prevalence of colorectal cancer among the general population along with the increasing awareness and screening rate among the patient population and the healthcare providers regarding the fecal occult testing are contributing to the segment growth.

• According to 2023 statistics published by the American Cancer Society, the total number of patients screened for colorectal cancer in 2023 was nearly 3.3 million witnessing a growth of around 19.5% compared to 2022 wherein the screening rate was approximately 2.8 million in the U.S. 

Analysis by Application

By application, the market is categorized into colorectal cancer, gastrointestinal bleeding, anemia, and others.

The colorectal cancer segment accounted for a substantial share in the market. The growing screening rate of colorectal cancer among the general population in the U.S., U.K., Germany and other countries and the rising efficiency of fecal occult blood testing products in the early detection of colorectal cancer are the major factors favoring the segment growth.

• According to 2021 statistics published by the National Health Interview Survey, the fecal occult blood testing and fecal immunochemical testing utilization for the diagnosis of colorectal cancer increased from 5.3% in 2018 to 5.5% in 2021 in the U.S.

Analysis by End-user

Based on end-user, the market is segmented into hospital-based laboratories, standalone laboratories, clinic-based laboratories, and others.

The hospital-based laboratories segment held a prominent share in the global market in 2023. The dominance of the segment is majorly due to the rising number of patient visits to hospitals for the screening and diagnosis of various chronic conditions including colorectal cancer and other diseases.

• According to a 2023 article published by the New York City (NYC) Health + Hospitals, the hospitals screened more than 50,000 patients for colorectal cancer in 2023 using fecal immunochemical tests (FIT), witnessing an increase of nearly 20% compared to the previous year.

Regional Analysis

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By region, the market has been studied across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

In 2023, the region of North America accounts for the largest share in the global fecal occult testing market. The increasing screening rate and utilization of fecal occult test kits among patients in the region along with rising reimbursement for these services are some of the prominent factors contributing to the growth of the region over the forecast period.

• According to Medicare, the fecal occult blood tests are covered once every 12 months for the individuals aged 45 years and above.

The Europe region is projected to witness growth prospects over the forecast period. The growing prevalence of colorectal cancer, gastrointestinal bleeds, and other chronic conditions among the population in the U.K., Germany, France, and others along with rising awareness regarding the available fecal occult screening options for these conditions are some of the vital factors expected to fuel the product demand in the region.

• According to a 2022 report published by the National Health Service (NHS), nearly 4.8 million individuals participated in NHS Bowel Cancer Screening Programme in England, which was a 68.9% increase in the uptake.

The growing initiatives by government bodies, national organizations, and others to increase the awareness and utilization of fecal occult blood testing products among the general population for the detection of colorectal cancer, and other chronic conditions is projected to spur the market growth in the region.

The Asia Pacific region is estimated to account for a substantial share in 2023, due to a strong incidence of key diseases in the region, leading to a robust procedural volume across the forecast period.

Key Players Covered

The fecal occult testing market reflects a fragmented competitive landscape, with numerous companies operating in the market with various services. Furthermore, there is a significant presence of the regional players in key regions. The report includes the profiles of the following players:

The report includes the profiles of the following key players:

• Laboratory Corporation of America (U.S.)


• Quest Diagnostics Incorporated (U.S.)


• Eurofins Scientific (Luxembourg)


• DDRC SRL Diagnostics (SRL Diagnostics) (India)


• UNILABS (A.P. Moller Holding A/S) (Switzerland)


• ARUP Laboratories (U.S.)


• Sonic Healthcare Limited (Australia)


• Atlantic Diagnostic Laboratories (U.S.)

Key Industry Developments

• In December 2023, DiaCarta announced that it received U.S. FDA 510(k) clearance for its over-the-counter (OTC) at-home iColon Fecal Occult Blood Test (FOT), which enables the early detection of blood in stool at home, which is clinically relevant in gastrointestinal disorders and colorectal cancer.


• In May 2023, New Horizon Health announced a strategic partnership to launch ColoClear, a non-invasive stool DNA test. The partnership is aimed toward the expansion of the company’s presence in Southeast Asian market.