Colorectal Cancer Screening and Diagnostic Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Screening (Stool-Based Test, Colonoscopy and Sigmoidoscopy, Others), By Diagnostics (Biomarker Test, Colonoscopy), By End User (Hospitals and Clinics, Clinical Laboratories, Others), By Region and Competition, 2020-2030F

Market Overview

Global Colorectal Cancer Screening and Diagnostic Market was valued at USD 15.08 Billion in 2024 and is expected to reach USD 20.63 Billion in the forecast period with a CAGR of 5.34% through 2030. The Global Colorectal Cancer Screening and Diagnostic Market is witnessing significant growth due to increasing global awareness regarding cancer prevention, early detection, and advancements in diagnostic technologies. Rising incidence rates of colorectal cancer, particularly among individuals aged 50 and above, are propelling the demand for early and accurate screening methods. Governments and healthcare organizations are launching awareness campaigns that emphasize the importance of routine screening, contributing to a surge in testing volumes. Public-private partnerships and healthcare funding initiatives are enabling greater access to diagnostic services, especially in underserved populations. Moreover, the growing acceptance of non-invasive screening methods such as fecal immunochemical tests (FIT), fecal DNA tests, and blood-based diagnostics is making screening more accessible and acceptable to a broader patient demographic.

Technological innovations are playing a vital role in reshaping the market landscape. The development of AI-based colonoscopy systems, digital pathology tools, and liquid biopsy technologies is improving detection accuracy and reducing the need for invasive procedures. Integration of machine learning in diagnostic imaging is assisting clinicians in identifying polyps and early-stage tumors more effectively. Rising interest in home-based and point-of-care testing options is also transforming patient behavior, with more individuals opting for convenient, self-administered diagnostic tools. Leading diagnostic companies are investing in research to enhance biomarker-based screening approaches that offer higher specificity and sensitivity, which is opening new revenue streams. The emergence of multi-cancer detection panels, which include colorectal cancer markers, is expected to further stimulate innovation and competition within the industry.

Despite these opportunities, the market faces certain challenges that could hinder its long-term potential. Limited awareness in low-income countries and cultural stigmas associated with colorectal screening often result in low participation rates. High costs of advanced diagnostic equipment and testing procedures can be a barrier in price-sensitive markets. Inadequate reimbursement policies in some regions may deter healthcare providers and patients from adopting newer, more effective screening methods. Diagnostic accuracy can also vary depending on the method used, leading to false positives or missed diagnoses, which may undermine patient trust. Data privacy concerns surrounding genetic and biomarker testing are becoming more relevant as digital health integration increases. Addressing these challenges will require coordinated efforts among stakeholders to ensure equitable access, improve education, and foster innovation in screening and diagnostic approaches to effectively manage and reduce the global burden of colorectal cancer.

Advancements in Technology

​High-definition (HD) colonoscopy utilizes advanced imaging technology to provide clearer and more detailed images of the colon, enhancing the detection of precancerous polyps and early-stage colorectal cancer during procedures. According to the Centers for Disease Control and Prevention (CDC), in 2019, there were 142,462 reported cases of colon and rectum cancer in the United States, emphasizing the importance of improved detection methods. ​

CT colonography, a non-invasive imaging technique using computed tomography (CT) scans to create three-dimensional images of the colon, offers an alternative to traditional colonoscopy and is less invasive, making it more patient-friendly. The American Cancer Society estimates that in 2025, there will be about 107,320 new cases of colon cancer and 46,950 new cases of rectal cancer in the United States. ​

Magnification endoscopy employs specialized endoscopes capable of magnifying the colon's surface, allowing healthcare providers to closely examine suspicious areas and enhance the detection of abnormalities. Narrow Band Imaging (NBI) uses specific wavelengths of light to improve visualization of blood vessels and surface structures in the colon, aiding in identifying abnormalities that may not be visible with standard white light. Chromoendoscopy involves applying contrast agents or dyes to the colon's surface during endoscopy, highlighting abnormal tissue and improving the detection of precancerous lesions.​

Artificial intelligence (AI) and machine learning algorithms are being developed to assist healthcare providers in analyzing colonoscopy and imaging data, helping to identify and characterize polyps and lesions, thereby reducing the risk of missed diagnoses. Research is ongoing in developing blood-based tests that detect specific biomarkers associated with colorectal cancer, aiming to provide non-invasive and convenient screening options. Stool-based tests like fecal immunochemical tests (FIT) and DNA stool tests have evolved with improved sensitivity and specificity, detecting blood or genetic mutations associated with colorectal cancer in stool samples. According to the CDC, in 2021, 71.6% of adults aged 50–75 years reported receiving the recommended colorectal cancer screening, highlighting the importance of accessible screening methods. ​

Advances in molecular diagnostics have led to the identification of genetic and molecular markers associated with colorectal cancer, which can be used for early detection and personalized treatment strategies. Liquid biopsies involve analyzing blood or other bodily fluids for circulating tumor DNA (ctDNA) or other biomarkers, with the potential to detect colorectal cancer and monitor treatment response. Telemedicine allows for remote consultations and discussions of colorectal cancer screening and diagnostic results, while telepathology enables pathologists to review tissue samples remotely, improving access to expertise. 3D printing technology has been used to create anatomical models of the colon and rectum, aiding in surgical planning and education for both patients and healthcare providers. Mobile apps and digital platforms are being developed to educate patients about colorectal cancer, remind them of screening appointments, and provide post-screening support. Data analytics and electronic health records (EHRs) help healthcare providers track and manage patient screening histories, identify high-risk individuals, and improve overall healthcare management. These advancements contribute to the development of the Global Colorectal Cancer Screening and Diagnostic Market.

Increasing Colorectal Cancer Incidence

​Colorectal cancer (CRC) predominantly affects older adults, with risk significantly increasing after age 50. In 2019, the United States reported 142,462 new cases of colon and rectal cancer, highlighting the impact of an aging population on cancer incidence. ​

Unhealthy lifestyle choices further elevate CRC risk. Diets high in processed foods and red meat, coupled with low fiber intake, contribute to rising cases. Sedentary behavior and obesity are also significant factors; as of 2017–March 2020, the U.S. adult obesity prevalence was 41.9%, with severe obesity at 9.2%. Additionally, excessive alcohol consumption is a known risk factor.​

Environmental exposures to certain toxins and pollutants may increase cancer risk. Genetic predispositions and family history also play roles in CRC susceptibility. Despite effective screening methods, disparities in healthcare access and awareness lead to suboptimal screening rates, resulting in late-stage diagnoses. In 2021, 141,902 new CRC cases were reported in the U.S., underscoring the need for improved screening outreach. Addressing these factors is crucial for enhancing early detection and treatment outcomes.

Rising Awareness Campaigns

Awareness campaigns provide essential information about colorectal cancer, including its risk factors, symptoms, and the value of early detection. Educated individuals are more likely to seek out screening options. These campaigns help dispel common myths and misconceptions about colorectal cancer, reducing fear and stigma associated with the disease. This, in turn, encourages more people to consider screening. Awareness campaigns often emphasize the importance of adhering to recommended screening guidelines. This helps individuals understand when they should start screening and which methods are suitable for them. Campaigns inform individuals about the various colorectal cancer screening methods available, such as colonoscopy, stool-based tests, and virtual colonoscopy. This information allows people to make informed choices based on their preferences and risk factors. Campaigns encourage individuals to discuss colorectal cancer screening with their healthcare providers. Open dialogues with healthcare professionals can lead to informed decisions about screening. By raising awareness about the importance of screening, these campaigns aim to boost screening rates, especially among those who may not have previously considered it. Awareness campaigns often target high-risk populations, such as those with a family history of colorectal cancer or specific genetic factors. By reaching these groups, campaigns can drive more targeted screening efforts.

Early detection of colorectal cancer is associated with better treatment outcomes. Awareness campaigns emphasize the benefits of catching the disease at an early, more treatable stage. Some individuals may face barriers to colorectal cancer screening, such as cost or lack of access to healthcare facilities. Awareness campaigns often address these barriers and provide information about available resources and assistance programs. By providing information and resources, awareness campaigns empower individuals to take control of their health and make informed decisions about their colorectal cancer screening and diagnostic needs. Awareness campaigns also provide support and resources for colorectal cancer survivors, helping them navigate post-treatment care and monitoring. Some awareness campaigns engage in advocacy efforts to promote policies that improve access to screening and reduce barriers. Awareness campaigns can have a global impact, raising awareness about colorectal cancer in regions where screening rates are low and encouraging governments and healthcare systems to invest in screening programs. This factor will accelerate the demand of Global Colorectal Cancer Screening and Diagnostic Market.

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Key Market Challenges

False Positives and Over diagnosis

False positives occur when a screening test suggests the presence of colorectal cancer or precancerous lesions when they are not actually present. False positives can cause unnecessary anxiety and stress for patients. They often lead to additional testing and procedures, which can be invasive and carry their own risks. False positives can result in increased healthcare costs due to follow-up tests and procedures. This can strain healthcare resources and increase the financial burden on individuals and healthcare systems. Experiencing a false positive result can deter individuals from participating in future screening, as they may be apprehensive about undergoing another potentially stressful experience. Over diagnosis occurs when a screening test detects a condition that, if left untreated, would not have progressed to clinical significance, or caused harm during the patient's lifetime. Over diagnosis can lead to unnecessary treatment, including surgery, chemotherapy, or radiation therapy. These interventions can have physical and psychological side effects. Treating cases that would not have caused harm can lead to overtreatment, which poses risks to the patient's overall health and quality of life. Overdiagnosis and overtreatment contribute to higher healthcare costs. Resources are allocated to treating conditions that may not require intervention. Efforts are made to enhance the specificity of screening tests to reduce false positives. This includes refining the criteria for test positivity and adopting more accurate diagnostic criteria. Tailoring screening recommendations based on an individual's risk factors, such as family history and genetic predisposition, can help reduce over diagnosis by targeting screening efforts where they are most needed.

Limited Screening Options in Developing Regions

Many developing regions lack the necessary healthcare infrastructure to support widespread colorectal cancer screening programs. This includes a shortage of healthcare facilities, trained professionals, and diagnostic equipment. Economic constraints in developing regions often limit the availability of funding for healthcare programs, including cancer screening. Screening tests, especially advanced ones, can be expensive, making them inaccessible to a large portion of the population. In many developing regions, there is a lack of awareness about colorectal cancer and the importance of screening. This leads to low demand for screening services and delays in diagnosis. Cultural beliefs and social stigmas can deter individuals from seeking colorectal cancer screening. Lack of education about the benefits of screening can also contribute to this issue. The procurement and distribution of screening tests and diagnostic equipment can be challenging in developing regions due to poor supply chain infrastructure and logistics issues. Developing regions often face a shortage of healthcare professionals, including oncologists and gastroenterologists, who can perform and interpret screening tests.

Key Market Trends

Shift Towards Non-Invasive Tests

Non-invasive tests, such as stool-based tests or blood tests, are generally more acceptable to patients because they do not involve invasive procedures like colonoscopy. This improved patient acceptance can lead to higher screening participation rates. The avoidance of invasive procedures can reduce patient discomfort and anxiety associated with colorectal cancer screening. This can encourage individuals to undergo testing. Non-invasive tests often require minimal preparation and can be performed at home, making them more convenient for patients. This convenience can lead to higher compliance with screening recommendations. Unlike colonoscopy, which typically requires sedation or anesthesia, non-invasive tests do not involve the use of these medications, eliminating the associated risks and recovery time. Non-invasive tests are generally more cost-effective compared to invasive procedures like colonoscopy, making them an attractive option for both patients and healthcare systems. Some non-invasive tests, such as stool-based tests, can be performed more frequently, allowing for regular monitoring and early detection of changes in colorectal health. Non-invasive tests can be used to reach populations with limited access to healthcare facilities or those who may be hesitant to undergo invasive procedures. Advances in non-invasive screening technologies, such as the development of highly sensitive fecal immunochemical tests (FIT), have improved their ability to detect colorectal cancer and precancerous lesions.

Segmental Insights

Screening Insights

Based on the Screening, Stool-Based Test emerged as the dominant segment in the Global Colorectal Cancer Screening and Diagnostic Market in 2024. Stool-based tests are non-invasive and relatively easy to administer, making them more acceptable to many individuals who may be reluctant to undergo more invasive procedures like colonoscopy. This non-invasiveness can help increase overall screening rates. Stool-based tests are generally more cost-effective compared to colonoscopy or other imaging-based methods. This affordability can make them accessible to a larger portion of the population. Collecting a stool sample can be done in the privacy of one's home, and it doesn't require dietary restrictions or bowel preparation, which is necessary for colonoscopy. This convenience encourages more people to participate in screening programs.

Diagnostics Insights

Based on the Diagnostics, Colonoscopy emerged as the dominant segment in the Global Colorectal Cancer Screening and Diagnostic Market in 2024. Colonoscopy is considered the gold standard for colorectal cancer screening due to its high diagnostic accuracy. It allows for direct visualization of the entire colon and rectum, enabling the detection of precancerous polyps and early-stage cancers. Unlike some other screening methods, colonoscopy not only detects abnormalities but also enables the removal of precancerous polyps during the same procedure. This immediate intervention can prevent colorectal cancer from developing. Colonoscopy provides a comprehensive examination of the colon, allowing for the detection of abnormalities throughout the entire length of the colon, including the cecum, ascending colon, transverse colon, descending colon, and sigmoid colon. colonoscopy is typically recommended every 10 years for individuals at average risk of colorectal cancer, which means fewer screenings over time compared to annual or biennial stool-based tests. This makes it a convenient option for patients.

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Regional Insights

North America emerged as the dominant region in the Global Colorectal Cancer Screening and Diagnostic Market in 2024. This is owing to its well-established healthcare infrastructure, high awareness levels, and strong adoption of advanced diagnostic technologies. The region benefits from comprehensive national screening programs, such as the U.S. Preventive Services Task Force (USPSTF) guidelines, which recommend routine colorectal cancer screening for adults aged 45 and older. This has driven a steady increase in the number of individuals undergoing early screening, thereby boosting demand for diagnostic tests like colonoscopy, sigmoidoscopy, and fecal immunochemical tests (FIT). Additionally, the presence of major market players and ongoing research initiatives in the region have contributed to the early adoption of innovative, non-invasive screening solutions, such as liquid biopsies and stool DNA tests.

Asia-Pacific emerged as the fastest growing region in the Global Colorectal Cancer Screening and Diagnostic Market during the forecast period. This is due to increasing government initiatives and rising awareness about early cancer detection. Several countries in the region, including China, Japan, South Korea, and India, are witnessing a significant rise in the incidence of colorectal cancer, which has prompted public health agencies to implement national screening programs. These programs aim to improve participation rates in routine screenings through the integration of cost-effective testing methods such as fecal occult blood tests (FOBT), fecal immunochemical tests (FIT), and colonoscopies. In addition, growing healthcare expenditure and the strengthening of healthcare infrastructure across the region are enhancing the accessibility of diagnostic services in both urban and semi-urban areas. Collaborations between regional governments and global diagnostic firms are further improving the adoption of advanced screening tools, thereby contributing to the market’s rapid growth.

Recent Developments

• In February 2025, Oxford BioDynamics Plc announced the publication of promising results from a multi-centre study showcasing the effectiveness of its EpiSwitch 3D genomics platform. The study demonstrated high accuracy in using blood tests to detect colorectal cancer (CRC), including early-stage cases and non-cancerous polyps.
• In January 2025, Geneoscopy, Inc., a diagnostics company specializing in gastrointestinal health, secured USD 105 million in a Series C funding round led by Bio-Rad Laboratories. Other investors included Labcorp, Petrichor, Morningside Ventures, Lightchain Capital, and Mercy Health. The funding will support the commercial launch of Geneoscopy’s at-home colorectal cancer screening test, ColoSense, and advance its pipeline of diagnostic solutions for inflammatory bowel disease.
• In October 2024, Exact Sciences Corp. received U.S. FDA approval for Cologuard Plus, its next-generation multitarget stool DNA test for colorectal cancer (CRC) screening in adults aged 45 and older at average risk. Approval was supported by the pivotal BLUE-C study, involving nearly 19,000 participants. Cologuard Plus demonstrated 95% sensitivity for overall CRC, 43% sensitivity for advanced precancerous lesions, and 94% specificity in individuals with no findings on colonoscopy. The test significantly outperformed an independent fecal immunochemical test (FIT) across multiple measures, including early-stage CRC and advanced lesion detection.
• In August 2024, Universal DX (UDX) announced the successful closure of its Series B funding round to support the clinical trial of Signal-C, a blood-based screening test for early colorectal cancer detection, with the goal of securing FDA premarket approval. The trial, launched in January 2024, is progressing on schedule and aims to enroll over 15,000 participants across 100 sites. Testing is being centralized at Quest Diagnostics’ oncology center in Lewisville, Texas.
• In November 2023, Guardant Health, Inc. announced the launch of its blood-based colorectal cancer screening test, Shield, in partnership with Samsung Medical Center in South Korea. Shield analyzes circulating tumor DNA (ctDNA) to detect early-stage colorectal cancer (CRC), which ranks among the most diagnosed cancers and is the third-leading cause of cancer-related deaths in South Korea. The test demonstrated strong performance in the ECLIPSE study involving over 20,000 U.S. patients, showing 83% sensitivity and 90% specificity for detecting CRC in average-risk adults. This launch marks a significant step in expanding access to non-invasive cancer screening in Asia.

Key Market Players

• Clinical Genomics Technologies Pty Ltd.
• Danaher Corporation
• DiaCarta, Inc.
• Eiken Chemical Co., Ltd.
• Epigenomics AG
• Freenome Holdings, Inc.
• Guardant Health, Inc.
• Lepu Medical Technology (Beijing) Co., Ltd.
• Novigenix SA
• FUJIFILM Holdings Corporation
• Olympus Corporation
• QuidelOrtho Corporation

Report Scope:

In this report, the Global Colorectal Cancer Screening and Diagnostic Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

•  Colorectal Cancer Screening and Diagnostic Market, By Screening:

o    Stool-Based Test

o    Colonoscopy and Sigmoidoscopy

o    Others

•  Colorectal Cancer Screening and Diagnostic Market, By Diagnostics:

o    Biomarker Test

o    Colonoscopy

•  Colorectal Cancer Screening and Diagnostic Market, By End User:

o    Hospitals and Clinics

o    Clinical Laboratories

o    Others

• Colorectal Cancer Screening and Diagnostic Market, By region:

o   North America

§  United States

§  Canada

§  Mexico

o   Asia-Pacific

§  China

§  India

§  South Korea

§  Australia

§  Japan

o   Europe

§  Germany

§  France

§  United Kingdom

§  Spain

§  Italy

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Colorectal Cancer Screening and Diagnostic Market.

Available Customizations:

Global Colorectal Cancer Screening and Diagnostic Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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