In-vitro Colorectal Cancer Screening Tests Market Size, Share & Trends Analysis Report By Test (Fecal Occult Blood Tests, Biomarker Tests), By End-use (Hospitals & Clinics, Diagnostic Laboratories),By Region, And Segment Forecasts, 2025 - 2030

In-vitro Colorectal Cancer Screening Tests Market Growth & Trends

The global in-vitro colorectal cancer screening tests market size is expected to reach USD 1.7 billion by 2030, registering a CAGR of 4.7% from 2025 to 2030, according to a new report by Grand View Research, Inc. Rising number of novel screening models to combat the increasing incidences of colon and rectal malignancy cases is the major factor influencing the market growth. The emergence of newly developed genetic and biomarker tests such as tumor M2-PK stool tests and methylated gene testing is anticipated to drive the adoption rate of tumor diagnostic models.

The increasing incidence of colorectal malignancy is a significant driver for the growth of the segment. For example, according to data released by the National Cancer Center Japan in June 2022, it was projected that there would be approximately 1,019,000 new cases of cancer in Japan in 2022, with Colorectal Cancer (CRC) accounting for an estimated 158,200 new cases. Similarly, data updated by Cancer Australia in August 2022 indicated that 15,713 new cases of CRC were expected to be diagnosed in Australia in 2022, with 8,300 cases among males and 7,413 cases among females. As a result, the increasing prevalence of colorectal malignance is anticipated to drive the demand for colonoscopy devices.

The implementation of various initiatives by public organizations to promote screening has positively impacted the demand for in-vitro CRC screenings. For instance, according to reports from Cancer.org, healthcare systems in California continued to provide FIT kits (fecal immunochemical tests) during the months of April and May 2020, and the response rates for FIT remained high despite the onset of the COVID-19 pandemic. Additionally, the European Cancer community has mobilized its resources to evaluate, address, and mitigate the adverse effects of COVID-19 on screening. These efforts have contributed to the sustained demand for in-vitro screening tests.

Furthermore, market growth is expected to be driven by the increasing number of product launches by major market players. These product launches are aimed at providing access to technologically advanced and innovative products. For instance, Pillar Biosciences, Inc. received FDA approval for the ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA) in July 2021 for the detection of CRC.

In-vitro Colorectal Cancer Screening Tests Market Report Highlights

• The fecal occult blood tests segment dominated the in-vitro colorectal cancer screening tests industry, with the largest revenue share of 82.3% in 2024. The biomarker tests segment is anticipated to emerge as the fastest-growing segment and grow at a CAGR of 5.8% from 2025 to 2030.
• The diagnostic laboratories segment held the largest revenue share in 2024, attributed to their advanced technology, high accuracy, and comprehensive testing capabilities. The hospitals and clinics segment is expected to grow at a significant pace during the forecast period, fueled by the increasing demand for early diagnosis and noninvasive testing options.
• North America in-vitro colorectal cancer screening tests market dominated the global market with the largest revenue share of 39.5% in 2024. The U.S. in-vitro colorectal cancer screening tests market held the largest share in 2024.
• Asia Pacific in-vitro colorectal cancer screening tests market is set to expand at the fastest CAGR of 5.2% from 2025 to 2030.