Colorectal Cancer Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Diagnosis Type (Diagnostics Imaging (Sigmoidoscopy, Colonoscopy, Others), Stool Test (Guaiac FOBT, Fecal immunochemical Test (FIT), FIT-DNA Test), Biopsy (Image Guided Biopsy, Liquid Biopsy, Others), Others), By Application (Hospitals & Specialty Clinics, Ambulatory Care Centers, and Others), By Region & Competition, 2020-2030F

Market Overview

Global Colorectal Cancer Diagnostics Market was valued at USD 18.05 billion in 2024 and is expected to reach USD 23.79 billion by 2030 with a CAGR of 4.85% during the forecast period. The global colorectal cancer diagnostics market is witnessing significant growth, driven by a rising prevalence of colorectal cancer, growing awareness about early detection, and continuous advancements in diagnostic technologies. Colorectal cancer ranks among the most commonly diagnosed cancers worldwide, and early diagnosis plays a critical role in improving patient outcomes and survival rates. For instance, according to the International Agency for Research on Cancer (IARC), over 1.9 million colorectal cancer cases were diagnosed worldwide in 2022. As one of the most common cancers, colorectal cancer poses significant economic and societal challenges. This increasing prevalence underscores a rising demand for effective diagnostic solutions, highlighting the urgent need for early detection and improved screening methods to manage the growing global burden of the disease.

As healthcare systems increasingly emphasize preventive care and early detection, the demand for advanced diagnostic tools continues to rise. Key diagnostic methods include imaging techniques such as colonoscopy, CT scans, and MRI, along with biomarker testing, stool-based tests, and blood-based assays. These methods are evolving with the integration of artificial intelligence and machine learning, enhancing diagnostic accuracy and enabling earlier detection. Non-invasive and at-home screening solutions are also gaining popularity, as they offer convenience and improved patient compliance.

Healthcare providers, especially hospitals and diagnostic laboratories, are the primary users of colorectal cancer diagnostics, owing to their access to advanced equipment and trained professionals. However, the growing availability of self-screening kits and mobile health services is shifting some of the demand toward home-based diagnostics, particularly in developed countries. Geographically, while developed regions like North America and Europe currently dominate the market due to their robust healthcare infrastructure and high screening rates, emerging economies in Asia-Pacific and Latin America are rapidly expanding. This growth is fueled by rising healthcare investments, increasing awareness programs, and improving access to diagnostic facilities. The colorectal cancer diagnostics market is set to expand steadily, supported by technological innovations, strategic partnerships among diagnostic firms, and governmental initiatives promoting regular screening. As patient awareness continues to grow and diagnostic options become more accessible, the market is expected to play an increasingly vital role in the global fight against colorectal cancer.

Key Market Drivers

Rising Incidence of Colorectal Cancer

The rising incidence of colorectal cancer is a critical driver of growth in the global colorectal cancer diagnostics market. For instance, in 2023, research from the National Center for Biotechnology Information reported that the incidence of colorectal cancer in Japan was approximately 26.7 per 100,000 men and 22.7 per 100,000 women aged 40 to 44. This highlights the growing prevalence of colorectal cancer in this age group within the country. Colorectal cancer is now one of the most common cancers worldwide, affecting both men and women across diverse age groups. This upward trend is closely linked to changes in lifestyle, including increased consumption of processed foods, sedentary behavior, obesity, alcohol intake, and smoking. The aging global population significantly contributes to the higher prevalence of the disease, as the risk of colorectal cancer increases with age. As the number of cases continues to climb, there is a corresponding surge in demand for early and accurate diagnostic tools. The UK is witnessing an increase in colorectal cancer cases, driven by an aging population, sedentary lifestyles, and changing dietary habits. This highlights the urgent need for comprehensive diagnostic solutions. For instance, Cancer Research UK reports that around 44,100 new bowel cancer cases are diagnosed annually, emphasizing the importance of early detection and effective screening programs. Early detection of colorectal cancer significantly improves prognosis and treatment outcomes. Consequently, healthcare systems across the world are investing more in screening and diagnostic technologies. Colonoscopy remains the gold standard, but there is growing interest in non-invasive tests such as stool-based DNA assays, fecal immunochemical tests (FIT), and blood-based biomarker tests. The increase in cases has also prompted public health authorities to launch nationwide screening programs and awareness campaigns, particularly in developed countries. In emerging economies, rising disease burden and healthcare infrastructure improvements are leading to greater adoption of diagnostic services. This rise in incidence is not just increasing volume demand but also encouraging innovation in diagnostic approaches. Companies are developing faster, more sensitive, and patient-friendly diagnostic solutions, including AI-powered imaging and home-based test kits. Overall, the growing number of colorectal cancer cases globally is fueling advancements and expansions within the diagnostics market, making it a key area of focus for both public and private healthcare stakeholders.

Growing Awareness About Early Detection

Growing awareness about early detection is playing a pivotal role in driving the global colorectal cancer diagnostics market. Early diagnosis significantly increases survival rates and enables more effective and less invasive treatment options, making it a central focus for healthcare systems, policymakers, and advocacy groups worldwide. Over the past decade, global health campaigns and education initiatives have intensified efforts to inform the public about the importance of regular screening for colorectal cancer. Awareness programs by government agencies, non-profit organizations, and medical societies have emphasized the benefits of early detection, leading to increased participation in routine screening—particularly among at-risk populations aged 50 and above. This heightened awareness has contributed to a rise in demand for diagnostic procedures such as colonoscopy, CT colonography, fecal immunochemical tests (FIT), and emerging non-invasive tests like stool DNA assays and liquid biopsies. The market has also seen the introduction of user-friendly, home-based testing kits that align with patients’ preferences for convenience and privacy, encouraging broader screening compliance.

Increased awareness is also influencing physician recommendations and healthcare policies. Many countries have adopted national screening guidelines, mandating or strongly encouraging routine colorectal cancer screening at certain age thresholds. In parallel, private healthcare providers and insurers are expanding coverage for diagnostic tests, further promoting uptake. As more people understand the critical role of early detection in preventing colorectal cancer deaths, the global diagnostics market is witnessing sustained growth. This trend is expected to continue, as educational outreach and access to advanced diagnostic technologies become more widespread, particularly in emerging markets.

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Key Market Challenges

High Cost of Advanced Diagnostics

The high cost of advanced diagnostics remains a significant barrier to the widespread adoption of colorectal cancer screening and detection methods across the globe. While technological innovations such as high-definition colonoscopy, molecular biomarker testing, next-generation sequencing (NGS), and liquid biopsies have significantly improved diagnostic accuracy and patient outcomes, they often come with a high price tag. These costs can be prohibitive for both healthcare providers and patients, particularly in low- and middle-income countries where healthcare resources are limited and out-of-pocket payments are common. Advanced diagnostics typically require sophisticated equipment, skilled personnel, and specialized laboratory infrastructure, all of which contribute to high operational costs. For example, procedures like colonoscopy not only involve expensive imaging devices but also require sedation, trained endoscopists, and post-procedure recovery, adding to the overall expense. Similarly, liquid biopsies and genomic tests demand advanced platforms and reagents, which can drive up costs further. The financial burden can deter individuals from undergoing routine screening, especially in regions without robust public health coverage or insurance systems. As a result, many cases are detected at later stages when treatment is more complex and expensive, ultimately increasing the overall burden on healthcare systems.

To address this challenge, governments and healthcare stakeholders are exploring cost-effective alternatives, such as fecal immunochemical tests (FIT) and stool DNA tests, which offer reasonable sensitivity at a lower cost. The efforts are being made to subsidize testing and expand public screening programs. Despite these efforts, the affordability gap remains a key issue. For the global colorectal cancer diagnostics market to achieve inclusive growth and equitable outcomes, reducing the cost of advanced diagnostics and improving access across socioeconomic groups must become a central focus of future strategies and innovations.

Limited Access to Screening in Developing Region

Limited access to screening in developing regions poses a significant challenge to the growth and effectiveness of the global colorectal cancer diagnostics market. In many low- and middle-income countries, the lack of healthcare infrastructure, trained personnel, and public awareness hampers early detection and timely diagnosis of colorectal cancer. As a result, a large proportion of cases are identified at advanced stages, when treatment is less effective and more expensive. One of the primary barriers is the scarcity of diagnostic facilities, such as endoscopy centers and pathology labs. Many rural and underserved areas lack access to essential equipment like colonoscopy machines or advanced imaging systems. Even when such services are available, long travel distances, high costs, and extended wait times often discourage people from seeking preventive care. There is a shortage of trained medical professionals, including gastroenterologists, oncologists, and laboratory technicians, which limits the capacity to perform and interpret diagnostic tests. This workforce gap leads to inconsistent quality of care and delays in diagnosis. Public health awareness around colorectal cancer is also low in developing countries. Many individuals are unaware of the importance of screening or are deterred by cultural taboos, fear, or stigma associated with cancer. The absence of national screening programs in several regions means there is no systemic effort to promote early detection. Addressing these issues requires coordinated efforts from governments, NGOs, and international health organizations. Investment in healthcare infrastructure, training programs, mobile screening units, and awareness campaigns can help bridge the access gap. Expanding the use of low-cost, non-invasive screening tools like fecal immunochemical tests (FIT) could also significantly improve screening coverage. Enhancing access to colorectal cancer diagnostics in developing regions is essential not only for market expansion but also for reducing global disparities in cancer care and outcomes.

Key Market Trends

Shift Towards Non-Invasive and Home-Based Testin

The global colorectal cancer diagnostics market is witnessing a significant shift towards non-invasive and home-based testing methods, reflecting a broader trend aimed at improving patient comfort, compliance, and early detection rates. Traditional diagnostic procedures like colonoscopy, while effective, are invasive, often uncomfortable, and require specialized medical facilities and trained personnel. These factors have historically limited widespread screening, particularly among populations reluctant to undergo invasive procedures or those with limited access to healthcare centers. Non-invasive tests such as fecal immunochemical tests (FIT), stool DNA assays, and emerging blood-based biomarker tests offer a convenient and less intrusive alternative. These tests can detect early signs of colorectal cancer or precancerous lesions through analysis of stool or blood samples, allowing for easier screening in routine check-ups or even at home. The availability of home-based testing kits has particularly boosted participation in colorectal cancer screening programs by providing privacy, reducing the need for hospital visits, and simplifying sample collection.

This shift is also supported by advancements in molecular biology and biomarker discovery, which have enhanced the sensitivity and specificity of non-invasive tests. Improved diagnostic accuracy helps reduce false positives and negatives, thereby optimizing patient management and follow-up procedures. In developing countries and remote areas, where access to specialized medical facilities is limited, non-invasive and home-based testing has become an essential tool in expanding screening coverage. It also aligns with growing patient preference for minimally disruptive healthcare experiences. The move toward non-invasive and home-based colorectal cancer diagnostics is driving market growth by making early detection more accessible, affordable, and acceptable, ultimately improving outcomes and reducing the global colorectal cancer burden.

Expansion in Emerging Markets

Healthcare infrastructure improvements are a key factor in this market expansion. Many emerging economies are investing heavily in modernizing hospitals, diagnostic laboratories, and screening programs. Increased availability of advanced diagnostic equipment, such as colonoscopy systems and molecular testing platforms, is enabling better access to colorectal cancer screening and diagnosis in urban and semi-urban areas. In addition to infrastructure, rising public awareness about colorectal cancer and the importance of early screening is contributing to market growth. Awareness campaigns by governments, NGOs, and healthcare organizations encourage routine screening, helping to overcome cultural taboos and misinformation about cancer. These initiatives are gradually increasing patient participation in screening programs. Affordability is also improving as local manufacturers and healthcare providers introduce cost-effective diagnostic options, such as fecal immunochemical tests (FIT) and simpler molecular assays, which are more accessible for lower-income populations. The growing health insurance coverage and government reimbursement policies in these regions support the adoption of colorectal cancer diagnostics. The expansion in emerging markets represents a significant growth opportunity for the global colorectal cancer diagnostics market, as increased demand for early detection aligns with improved healthcare delivery and patient awareness.

Segmental Insights

Diagnosis Type Insights

Based on diagnosis type, diagnostic imaging, particularly colonoscopy, remains the dominant approach. Colonoscopy is considered the gold standard because it allows direct visualization of the colon and rectum, enabling detection and removal of polyps during the same procedure, which helps prevent cancer progression. The dominance of diagnostic imaging stems from its high accuracy, ability to provide immediate treatment, and wide clinical acceptance. While non-invasive tests like stool-based assays and blood tests are gaining popularity due to convenience and patient compliance, they primarily serve as preliminary screening tools and often require follow-up colonoscopy for confirmation. Biopsy, although crucial for definitive cancer diagnosis and staging, is generally performed during colonoscopy or surgery, making it a secondary diagnostic step rather than a first-line screening method. Therefore, despite advancements in less invasive testing, diagnostic imaging maintains a dominant role because of its comprehensive diagnostic and therapeutic capabilities, which are critical for effective colorectal cancer management.

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Regional Insights

North America dominated the global colorectal cancer diagnostics market due to a combination of advanced healthcare infrastructure, high disease prevalence, and strong public health initiatives. The region benefits from state-of-the-art medical facilities equipped with the latest diagnostic technologies, such as high-definition colonoscopy and molecular testing platforms, which enable accurate and early detection of colorectal cancer. This technological edge ensures that patients receive timely and effective diagnosis, which is critical for improving treatment outcomes. A relatively high incidence of colorectal cancer in North America has led to increased demand for screening and diagnostic services. This demand is supported by well-established national screening programs and widespread awareness campaigns that encourage early detection and regular screening among the population. These initiatives help in identifying colorectal cancer at earlier, more treatable stages.

The presence of leading diagnostic companies and research institutions in North America fosters continuous innovation, contributing to the development of new and improved diagnostic methods, including non-invasive blood-based tests. The comprehensive insurance coverage and reimbursement policies make advanced diagnostic procedures more accessible and affordable for patients, driving higher adoption rates. The combination of advanced technology, proactive healthcare policies, strong industry presence, and patient accessibility factors positions North America as the dominant market for colorectal cancer diagnostics, with continued growth expected in the foreseeable future.

Recent Developments

• In July 2024, Guardant Health received FDA approval for its Shield non-invasive blood test, designed for colorectal cancer screening in individuals aged 45 and older with minimal cancer risk. This marked the first FDA-approved blood-based test to be used as a primary screening option for colorectal cancer.
• In October 2024, Exact Sciences Corporation received FDA approval for its Cologuard Plus multitarget stool DNA test, aimed at detecting colorectal cancer in medium-risk individuals aged 45 and older. This approval is expected to greatly enhance the company’s market presence and expand access to non-invasive colorectal cancer screening.
• In May 2024, Geneoscopy received FDA approval for its ColoSense non-invasive RNA biomarker test for colorectal cancer screening in average-risk adults. This approval expanded the company’s colorectal cancer diagnostics portfolio, enhancing its offerings in the early detection market.

Key Market Players

• Abbott Laboratories
• Illumina, Inc.
• Sysmex Corporation
• Beckman Coulter
• Siemens Healthineers AG
• Quest Diagnostics
• Danaher Corporation
• Cancer Genetics Inc.
• Biocept Inc.
• Epigenomics AG

Report Scope:

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

• Colorectal Cancer Diagnostics Market, By Diagnosis Type:

o   Diagnostics Imaging

o   Stool Test

o   Biopsy

o   Others

• Colorectal Cancer Diagnostics Market, By Application:

o   Hospitals & Specialty Clinics

o   Ambulatory Care Centers

o   Others     

• Colorectal Cancer Diagnostics Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia-Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

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 Diagnostics Market.

Available Customizations:

Global Colorectal Cancer Diagnostics 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).