• In 2021, the U.S. Food and Drug Administration (U.S. FDA) announced the approval of GI Genius, a device that uses artificial intelligence based on machine learning. It is revealed to help clinicians identify lesions such as polyps or suspected tumors in the colon during a colonoscopy.

• In February 2022, QIAGEN Manchester Ltd. has received FDA approval for the Therascreen KRAS RGQ PCR Kit, designed for screening colorectal cancer.

In this report, the Global In Vitro Colorectal Cancer Screening Tests Market has been segmented by Imaging Type, Application, Product, End-User, and Geography.

Global In Vitro Colorectal Cancer Screening Tests Market, Segmentation by Imaging Type

In this report, the Global In Vitro Colorectal Cancer Screening Tests Market has been segmented by Imaging Type into Colonoscopy, Proctoscopy, CT Scan, Ultrasound, MRI, and PET Scan.

Colonoscopy

Colonoscopy leads the colorectal cancer imaging segment with a 45% market share due to its ability to both detect and treat abnormalities. Its direct visualization technique makes it highly effective in identifying precancerous polyps, encouraging its widespread use in routine screening programs.

Proctoscopy

Representing around 10% of the market, proctoscopy is primarily used for evaluating the rectum. Although limited in scope compared to colonoscopy, it serves as a quick and cost-effective diagnostic tool for lower rectal examinations and early-stage evaluations.

CT Scan

CT scans, particularly CT colonography, account for nearly 15% of imaging tests for colorectal screening. This non-invasive technique offers a clear visual of the colon and rectum, providing a comfortable alternative to conventional colonoscopy, especially for screening-resistant populations.

Ultrasound

Holding an estimated 8% share, ultrasound is more commonly used as a supplemental tool in colorectal cancer management. While not a primary diagnostic option, it assists in tumor localization and monitoring, particularly in facilities with limited imaging access.

MRI

MRI contributes approximately 12% to the imaging diagnostics market. With its advanced imaging resolution, MRI is ideal for staging colorectal cancer and guiding surgical or radiation planning, making it a preferred option in complex diagnostic scenarios.

PET Scan

PET scans make up about 10% of the market, offering valuable insights into cancer metabolism and spread. This imaging type is especially useful for detecting metastatic disease and evaluating treatment response through functional imaging.

Global In Vitro Colorectal Cancer Screening Tests Market, Segmentation by Application

In this report, the Global In Vitro Colorectal Cancer Screening Tests Market has been segmented by Application into MarCarePlex, Cologic, Colox, miRDIGN, PanCDx, and MeSorce CRC.

MarCarePlex MarCarePlex

With a market share of 18%, MarCarePlex is recognized for its non-invasive, blood-based biomarker detection capabilities. It supports early diagnosis of colorectal cancer by targeting tumor-associated proteins, enhancing screening convenience for both patients and providers.

Cologic

Cologic holds a 15% share in the market and is known for its innovative stool-based DNA testing approach. It identifies multiple genetic and epigenetic markers, offering high sensitivity and better detection rates for colorectal neoplasms, especially in average-risk populations.

Colox

Colox contributes 14% to the market and uses advanced epigenetic analysis to detect colorectal cancer through simple blood tests. Its appeal lies in its quick results and non-invasive methodology, making it ideal for routine screenings.

miRDIGN

miRDIGN comprises 13% of the application segment and specializes in identifying microRNA signatures related to colorectal cancer. Its strong diagnostic potential through minimally invasive liquid biopsy gives it an edge in personalized screening approaches.

PanCDx

PanCDx makes up around 20% of the application market, offering a broad-spectrum cancer detection solution. It integrates molecular diagnostics to precisely identify colorectal cancer cells among various tumor types, enhancing cross-cancer screening efficiency.

MeSorce CRC

MeSorce CRC also accounts for 20% and is highly valued for its methylation-based DNA testing. The platform delivers high sensitivity and specificity, aiding in early detection and the monitoring of high-risk patients, ensuring better screening outcomes.

Global In Vitro Colorectal Cancer Screening Tests Market, Segmentation by Product

In this report, the Global In Vitro Colorectal Cancer Screening Tests Market has been segmented by Product into Fecal Occult Blood Tests, Biomarker Tests Market, and CRC DNA Screening Tests.

Fecal Occult Blood Tests

Fecal Occult Blood Tests (FOBTs) dominate the market with over 40% share, primarily due to their cost-effectiveness and widespread use in non-invasive stool-based screening. These tests help detect occult blood in the stool, a potential early sign of colorectal cancer, and are often used in routine diagnostic programs.

Biomarker Tests Market

The biomarker tests segment holds approximately 35% of the market and is favored for its ability to identify tumor-specific genetic or protein biomarkers. These tests enable early detection and personalized screening strategies, offering improved outcomes in colorectal cancer diagnostics.

CRC DNA Screening Tests

CRC DNA Screening Tests contribute around 25% to the product segment and are known for their high sensitivity and specificity. They analyze DNA mutations in stool samples, allowing for the early identification of colorectal malignancies, especially in high-risk groups.

Global In Vitro Colorectal Cancer Screening Tests Market, Segmentation by End-User

In this report, the Global In Vitro Colorectal Cancer Screening Tests Market has been segmented by End-User into Hospitals, Clinics, Diagnostics laboratories, and Ambulatory Surgical Centers.

Hospitals

Hospitals contribute over 40% to the market due to their advanced diagnostic infrastructure, presence of specialized healthcare professionals, and ability to perform comprehensive colorectal cancer screening. They remain the cornerstone for in-depth testing and treatment in both public and private healthcare systems.

Clinics

Clinics make up around 20% of the market and are valued for offering convenient early screening services. Their easy accessibility and personalized care improve initial cancer detection rates, especially in suburban and rural regions.

Diagnostics Laboratories

Accounting for nearly 25% of the market, diagnostic laboratories excel in processing high-volume and complex screening tests. Their role in biomarker detection and DNA analysis supports hospitals and clinicians with accurate and timely test results.

Ambulatory Surgical Centers

Ambulatory Surgical Centers (ASCs) hold close to 15% of the segment, catering to patients needing outpatient colorectal procedures such as colonoscopy screenings. They offer a cost-effective and efficient alternative to hospital-based diagnostics.

Global In Vitro Colorectal Cancer Screening Tests Market, Segmentation by Geography

In this report, the Global In Vitro Colorectal Cancer Screening Tests Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Global In Vitro Colorectal Cancer Screening Tests Market Share (%), by Geographical Region, 2024

North America

North America contributes over 35% to the global market, driven by high awareness levels, extensive screening programs, and strong reimbursement policies. The U.S. leads the charge with rapid adoption of molecular diagnostic technologies.

Europe

Europe holds nearly 30% of the market share, bolstered by government-led cancer screening campaigns and advanced healthcare infrastructure. Countries like the UK, Germany, and France show a strong commitment to early cancer detection.

Asia Pacific

Asia Pacific is the fastest-growing regional segment, with a growth rate exceeding 8% CAGR. The market is expanding due to an aging population, rising cancer incidence, and growing investment in modern diagnostic solutions.

Middle East and Africa

Middle East and Africa contribute about 5–7% to the global market. Growth is supported by developing healthcare infrastructure, increased non-invasive screening demand, and improved healthcare access in several countries.

Latin America

Latin America comprises roughly 7–10% of the market, with Brazil and Mexico emerging as key contributors. Investments in diagnostic infrastructure and increasing adoption of preventive screening programs are accelerating market growth.

This report provides an in depth analysis of various factors that impact the dynamics of Global In Vitro Colorectal Cancer Screening Tests Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Drivers

• Increasing Prevalence of Colorectal Cancer
• Technological Advancements in Screening Tests

• Growing Awareness About Early Cancer Detection - The growing global emphasis on early cancer detection is a key factor driving demand in the oncology diagnostics and therapeutics market. As awareness campaigns, public health initiatives, and patient education efforts increase, individuals are becoming more informed about the benefits of detecting cancer at an early stage. Early diagnosis significantly enhances the success rate of treatment, lowers overall healthcare costs, and improves survival outcomes, encouraging governments and private organizations to invest in screening programs and diagnostic infrastructure.

  Technological innovations, such as liquid biopsies, molecular diagnostics, and AI-enabled imaging tools, are now making non-invasive and accurate early detection more accessible across regions. Coupled with rising awareness, these advancements are enabling broader population reach and accelerating market penetration. Consequently, this proactive shift in cancer care is stimulating continuous innovation and expansion within the oncology-focused diagnostics landscape.

Restraints

• High Cost of Screening Tests
• Limited Access to Healthcare Services
• Concerns About False Positives and False Negatives

• Regulatory Hurdles for Approval of New Tests - The approval process for new in vitro colorectal cancer screening tests is often hindered by complex and time-consuming regulatory requirements. Agencies such as the FDA and EMA mandate rigorous validation of safety, efficacy, and reliability, which can significantly delay market entry. These regulations, while essential for public health, can act as a bottleneck for innovation, particularly for small and mid-sized companies with limited resources. The need to comply with multiple regional standards adds to the burden, raising the cost and time investment required for commercialization.

  Moreover, the evolving landscape of diagnostic technologies makes regulatory navigation even more difficult, as agencies must frequently update their assessment frameworks to account for novel biomarkers and platforms. This uncertainty discourages investment and slows the pace of bringing potentially life-saving diagnostic tools to the market. As a result, despite increasing demand for advanced screening solutions, regulatory hurdles remain a key restraint to growth in this segment.

Opportunities

• Emerging Markets Expansion
• Development of Novel Biomarkers
• Integration of Artificial Intelligence in Screening

• Collaborations for Research and Development - The increasing number of collaborations for research and development in colorectal cancer diagnostics is unlocking significant opportunities for the global in vitro screening tests market. Strategic alliances among academic institutions, biotechnology firms, and healthcare providers are accelerating the development of non-invasive, cost-effective, and highly sensitive screening tools. These partnerships are facilitating the exchange of scientific knowledge, improving access to funding, and enhancing technological innovation, which in turn supports faster clinical validation and commercialization of new test methods.

  Such collaborations are crucial in advancing the understanding of biomarker discovery, improving assay performance, and integrating AI and data analytics to enhance diagnostic accuracy. Additionally, multinational initiatives and public-private partnerships are actively working to expand screening programs in underserved populations, which not only improves early detection rates but also boosts market penetration. With colorectal cancer being one of the leading causes of cancer mortality globally, R&D collaborations have the potential to significantly improve disease prognosis and patient outcomes, driving demand for innovative in vitro screening solutions.

Key players in Global In Vitro Colorectal Cancer Screening Tests Market include :

• Beckman Coulter Inc
• Eiken Chemical
• Epigenomics AG Corporation
• Sysmex Corporation
• Siemens Healthcare Ltd
• Quest Diagnostics Incorporated
• CompanianDx
• OncoCyte Corporation-Biotime

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Market Share Analysis
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis