In-vitro Colorectal Cancer Screening Tests Market Outlook: Early Detection Demand and Growth Opportunities

According to IMARC Group's latest research publication, The global in-vitro colorectal cancer screening tests market size was valued at USD 1,049.22 Million in 2024. The market is projected to reach USD 1,658.67 Million by 2033, exhibiting a CAGR of 4.96% from 2025-2033.

How AI is Reshaping the Future of In-vitro Colorectal Cancer Screening Tests Market

• Better Polyp Detection During Colonoscopy: AI-powered systems are now used during colonoscopy procedures to help doctors find polyps more easily. These systems automatically highlight suspicious areas in real time, making it harder to miss small or hidden growths. As a result, doctors can detect precancerous polyps earlier and remove them before they turn into cancer.
• Early Risk Prediction and Screening Support: Machine learning is also helping doctors identify people who are at high risk of colorectal cancer much earlier than before. AI systems analyze electronic health records, including age, medical history, symptoms, and test results. These tools can flag high-risk patients up to five years before a traditional diagnosis would happen.
• Automated Pathology Analysis and Faster Diagnosis: AI is improving how tissue samples are analyzed after biopsies. Deep learning systems can examine pathology slides and detect cancer-related changes with accuracy similar to expert pathologists. This reduces the workload for doctors and lowers the chance of human error.

Explore Updated 2026 Market Trends & Analysis

In-vitro Colorectal Cancer Screening Tests Industry Overview:

The in-vitro colorectal cancer screening market is growing strongly because more people around the world are being diagnosed with cancer, and governments are focusing on early detection. Finding cancer early makes treatment easier and saves lives, which is increasing the demand for screening tests. Government programs are playing a big role in this growth. For example, the CDC’s Colorectal Cancer Control Program screened nearly 198,000 people between July 2021 and June 2022. This was a 35% increase compared to the previous year, showing that more people are getting tested. The Cancer Moonshot program also invested USD 110 million to support proven screening methods, especially for people in underserved and low-income communities.

In-vitro Colorectal Cancer Screening Tests Market Trends & Drivers:

The rising number of colorectal cancer cases is the main reason driving growth in the screening market. In 2020, around 1.93 million new colorectal cancer cases were reported worldwide. Experts expect this number to grow by more than 60% by 2040. In the United States alone, about 154,270 new cases and nearly 52,900 deaths are expected in 2025. Treating this disease is very expensive. In 2020, colorectal cancer treatment costs reached USD 24.3 billion, making up 11.6% of all cancer treatment spending. Medicare spends an average of USD 63,063 per patient each year.

Early detection through screening can reduce the risk of death by more than 60%, but only about 33% of colorectal cancers are found at an early stage. A worrying trend is the rise of colorectal cancer among younger people aged 15 to 39, where cases are increasing by 3.8% every year. Because of this, health organizations lowered the recommended screening age from 50 to 45 years. Screening has proven to be very effective—colonoscopy can reduce new cancer cases by 69% and lower the risk of death by 88%. These factors are creating strong demand for easy and accessible in-vitro screening tests for people of all ages.

There is also a major shift toward non-invasive and home-based screening tests. Many people avoid colonoscopy because it is uncomfortable, time-consuming, and requires bowel preparation. In-vitro tests such as fecal immunochemical tests (FIT) and stool DNA tests are much easier. They are painless, can be done at home, and do not require a hospital visit. The COVID-19 pandemic increased the use of home testing when access to clinics was limited, proving that remote testing works well. Programs that mail stool test kits to patients have shown higher participation rates, especially in community health centers. Insurance coverage under the Affordable Care Act removed out-of-pocket costs for preventive screening, making tests more affordable and widely used.

Leading Companies Operating in the Global In-vitro Colorectal Cancer Screening Tests Industry:

• Beckman Coulter Inc. (Danaher Corporation)
• Eiken Chemical Co. Ltd.
• Epigenomics AG
• Exact Sciences Corporation
• Hemosure Inc.
• Immunostics Inc. (Boditech Med Inc.)
• Medline Industries LP
• Merck KGaA
• Qiagen N.V.
• Quest Diagnostics Incorporated
• R-Biopharm AG
• Siemens AG
• Sysmex Corporation

In-vitro Colorectal Cancer Screening Tests Market Report Segmentation:

By Product:

• Fecal Occult Blood Tests
• Guaiac FOB Stool Test
• Immuno-FOB Agglutination Test
• Lateral Flow Immuno-FOB Test
• Immuno-FOB ELISA Test
• Biomarker Tests
• Tumor M2-PK Stool Test
• Transferrin Assays
• CRC DNA Screening Tests
• Methylated Gene Testing
• Panel DNA Tests

Fecal occult blood tests represent the largest segment due to affordability, ease of use, and widespread availability in population screening programs.

By Imaging Type:

• Colonoscopy
• Proctoscopy
• CT Scan
• Ultrasound
• MRI
• PET Scan

Colonoscopy accounts for the largest share as the gold standard for detection, allowing direct visualization and removal of precancerous polyps.

By End User:

• Hospitals
• Clinics
• Diagnostic Laboratories
• Others

Diagnostic laboratories dominate the market owing to established infrastructure, advanced testing capabilities, and ability to process large sample volumes efficiently.

Regional Insights:

• North America (United States, Canada)
• Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, Others)
• Europe (Germany, France, United Kingdom, Italy, Spain, Russia, Others)
• Latin America (Brazil, Mexico, Others)
• Middle East and Africa

North America exhibits clear dominance in the in-vitro colorectal cancer screening tests market due to advanced healthcare infrastructure and strong government screening programs.

Recent News and Developments in In-vitro Colorectal Cancer Screening Tests Market

• In May 2025, Sysmex Europe SE launched a new automated solution for colorectal cancer screening. The company added a fully automated stool testing system to its FIT DX Series. This new system helps laboratories handle more samples quickly and efficiently. It supports the fight against colorectal cancer by making large-scale screening easier and more reliable through automation.
• In March 2025, Exact Sciences announced an important update to its well-known Cologuard test. The new version, called Cologuard Plus, includes additional genetic markers to improve accuracy. It lowers the number of false positive results while still effectively detecting advanced precancerous polyps and early-stage colorectal cancer. This improvement strengthens multi-target stool DNA testing technology.
• In January 2025, Tempus AI, Inc. introduced xT CDx, a next-generation sequencing (NGS)-based in-vitro diagnostic test for colorectal cancer. The test received FDA approval and is available to doctors across the United States. It uses one of the most comprehensive gene panels in the market, helping doctors make more precise and personalized treatment decisions.
• In July 2024, the U.S. Food and Drug Administration (FDA) approved Guardant Shield, a blood-based test for colorectal cancer screening. This test detects changes in cell-free DNA in the blood that may indicate cancer. It is designed for adults aged 45 and older who are at average risk. This approval marked a major step forward in non-invasive screening options.
• In June 2024, the CDC’s Colorectal Cancer Control Program reported new and innovative ways to improve screening rates. The program works with 35 partner organizations, including clinics, hospitals, and community health centers. These groups focus on increasing screening among underserved populations where screening rates are low.

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