The global In-vitro Colorectal Cancer Screening Tests Market is entering a decade of transformative growth, powered by rising awareness, technological advancements, and an urgent global need for early cancer detection. Valued at US$ 1.2 billion in 2023, the market is projected to more than double, reaching US$ 2.5 billion by 2034, registering a CAGR of 7.1% from 2024 to 2034.

This press release provides an in-depth analysis of the market outlook, growth drivers, competitive landscape, emerging trends, and regional developments shaping the industry.

1. Market Overview

Colorectal cancer (CRC) remains a major global health challenge, ranking among the most common and deadliest cancers worldwide. According to the WHO, colon and rectal cancers collectively represent around 10% of all cancer cases globally and stand as a leading cause of cancer-related deaths.

The increasing incidence of CRC has intensified global emphasis on early screening. In-vitro colorectal cancer screening tests—particularly Fecal Immunochemical Tests (FIT), Fecal DNA Test Kits, and Guaiac-based FOBT (gFOBT)—offer convenient, non-invasive, and effective methods for identifying cancer risk at earlier stages.

By detecting biomarkers such as hidden blood, hemoglobin levels, or DNA mutations in stool samples, these tests allow for timely intervention, significantly improving patient prognosis and reducing healthcare burden.

2. Analysts’ Viewpoint

Industry analysts emphasize that early detection is the most powerful tool in preventing colorectal cancer progression. The global surge in lifestyle-related risk factors—including low fiber intake, physical inactivity, obesity, smoking, and high alcohol consumption—continues to elevate CRC prevalence. Consequently, screening compliance and adoption of home-based testing kits have intensified in recent years.

Hospitals and clinics remain the dominant end-users, owing to their established infrastructure, strong diagnostic pathways, and the trust patients place in these facilities. As national screening programs expand across regions, test volumes are expected to rise substantially, strengthening the market’s long-term trajectory.

3. Market Drivers

3.1 Rising Prevalence of Colorectal Cancer

The number of global CRC cases continues to increase, particularly among adults aged 45 and above. Medical institutions and policymakers are shifting strategies to emphasize the importance of routine screening, with many countries lowering the eligible age for CRC screening from 50 to 45.

In-vitro tests have become an essential component of screening programs because they are:

• Non-invasive

• Cost-effective

• Easy to perform at home

• Suitable for mass population screening

By facilitating regular annual screening, these tests play a vital role in early diagnosis and prevention.

3.2 High Demand for Fecal Immunochemical Tests (FIT)

Among all test types, FIT dominates the global market and accounts for the largest share. This dominance stems from:

• Higher sensitivity and specificity compared to traditional gFOBT tests

• The ability to detect globin molecules from lower intestinal bleeding

• Quantitative testing options for risk stratification

• Ease of use and minimal dietary restrictions

Countries such as Japan, South Korea, the U.S., and many EU nations heavily rely on FIT-based national screening programs, reinforcing ongoing market leadership.

3.3 Increased Adoption of DNA-based Screening Tests

Advancements in molecular diagnostics have strengthened the credibility and popularity of fecal DNA tests. These high-precision tests detect multiple DNA mutation markers associated with colorectal cancer and precancerous lesions.

Cologuard—currently the only FDA-approved multi-target stool DNA test in the U.S.—has influenced demand trends significantly. Growing R&D in genomics and precision oncology is expected to broaden the applications of DNA-based screening globally.

3.4 Expansion of Hospital & Clinic Infrastructure

Hospitals and clinics account for the major share of test utilization, driven by:

• Physician referrals

• Strong diagnostic workflows

• Availability of specialized equipment

• Patient preference for professional guidance

• Integration with colonoscopy and follow-up procedures

This segment will remain central to market growth throughout the forecast period.

4. Market Segmentation (2024–2034)

Test Type

• Fecal DNA Test Kits

• Fecal Immunochemical Test (FIT)

• Guaiac Fecal Occult Blood Test (gFOBT) Kits

• Others

End-user

• Hospitals & Clinics

• Diagnostic Centers

• Others

5. Regional Outlook

5.1 North America – The Global Leader

North America remains the most dominant region in 2024–2034, driven by high disease awareness, strong screening recommendations, and favorable insurance coverage.

In the U.S. alone:

• 106,590 new colon cancer cases and

• 46,220 rectal cancer cases
  are expected in 2024, according to the American Cancer Society.

High adoption of FIT, DNA tests, and blood-based screening technologies continues to boost regional growth.

5.2 Europe – Strong Screening Programs

European countries have some of the world’s most structured national CRC screening programs. High compliance rates, wide reimbursement coverage, and government-led initiatives fuel regional market expansion.

5.3 Asia Pacific – Fastest-growing Market

CRC incidence is rising dramatically across China, India, Japan, and South Korea due to urbanization, lifestyle shifts, and growing aging populations.

South Korea and Japan have already established advanced screening ecosystems, while India and Southeast Asia are witnessing gradual adoption.

5.4 Latin America, MEA – Emerging Potential

Although still in early stages of adoption, improving healthcare investment and awareness campaigns are creating new market opportunities.

6. Competitive Landscape

The global market is highly competitive and features a strong presence of diagnostic giants and emerging biotechnology companies. Key strategies include:

• New product development

• Strategic partnerships with hospitals & diagnostic chains

• Geographical expansion

• R&D in molecular diagnostics and biomarker discovery

Leading Companies Profiled

• Abbott Laboratories

• Thermo Fisher Scientific Inc.

• Eiken Chemical Co., Ltd

• Qiagen

• Quest Diagnostics Incorporated

• Sentinel CH. SpA

• Quidel Corporation

• Freenome Holdings, Inc.

• Immunostics, Inc.

• BTNX, Inc.

7. Key Developments

2023 – Guardant Health Launches Shield™

Guardant Health introduced Shield™, a blood-based colorectal cancer screening test, in collaboration with Samsung Medical Centre (South Korea). The innovation supports patients who prefer non-stool-based testing options.

2023 – Geneoscopy Partners with Labcorp

Geneoscopy announced a multi-year partnership with Labcorp to expand access to its next-generation stool-based CRC screening test across the United States.

These developments indicate a clear market shift toward next-generation non-invasive screening platforms.

8. Market Outlook & Future Trends (2024–2034)

The market is set for notable transformation driven by:

8.1 Rise of Multi-target Biomarker Tests

Next-generation assays capable of detecting multiple molecular markers simultaneously will become crucial differentiators.

8.2 Growth of Artificial Intelligence Integration

AI-enhanced diagnostic platforms will help improve test interpretation accuracy and screening efficiency.

8.3 Adoption of Blood-based Screening Tests

Liquid biopsy technologies are rapidly gaining traction as convenient alternatives to stool-based testing.

8.4 Home-based Diagnostic Innovations

Remote testing kits and telehealth integration are revolutionizing patient convenience and compliance.

8.5 Expansion of National Screening Programs

Governments worldwide are preparing to strengthen colorectal cancer screening frameworks—boosting test volume demand.

9. Conclusion

The In-vitro Colorectal Cancer Screening Tests Market is set for sustained expansion as early detection becomes a global healthcare priority. The combined impact of rising CRC incidence, expanding screening programs, advancements in FIT and DNA-based testing, and strong participation from diagnostic leaders will ensure robust market momentum through 2034.

With its projected growth to US$ 2.5 billion by 2034, the market offers significant opportunities for innovation, investment, and public health impact.