Colorectal Cancer Diagnostics Market

Colorectal Cancer Diagnostics Market Size and Share Forecast Outlook 2025 to 2035

The global colorectal cancer diagnostics market is forecast to reach USD 6.3 billion by 2035, up from USD 2.8 billion in 2025. During the forecast period, the industry is projected to register at a CAGR of 8.5%. The escalating incidence of colorectal cancer worldwide directly catalyzes the need for precise and timely detection.

An additional significant factor is the growing preference for less invasive screening procedures, as this encourages more people to come forward for testing. Market progression is also supported by newer diagnostic methodologies, such as some tests based on stool samples and blood-based tumor markers.

Quick Stats of Colorectal Cancer Diagnostics Market

• Colorectal Cancer Diagnostics Market Size (2025): USD 2.8 billion
• Projected Colorectal Cancer Diagnostics Market Size (2035): USD 6.3 billion
• Forecast CAGR of Colorectal Cancer Diagnostics Market (2025 to 2035): 8.5%
• Leading Test Type Segment of Colorectal Cancer Diagnostics Market: FOB Tests
• Leading End-User Segment of Colorectal Cancer Diagnostics Market: Hospital-associated Labs
• Key Growth Regions of Colorectal Cancer Diagnostics Market: United States, United Kingdom, Japan
• Prominent Players in the Colorectal Cancer Diagnostics Market: Danaher Corporation; Rosetta Genomics, Epigenomics AG, Exact Science Corporation, Others

Metric	Value
Industry Size (2025E)	USD 2.8 billion
Industry Size (2035F)	USD 6.3 billion
CAGR (2025-2035)	8.5%

The colorectal cancer diagnostics market is projected to grow from USD 2.8 billion in 2025 to USD 6.3 billion by 2035, registering a CAGR of 8.5 percent. This expansion represents an absolute dollar opportunity of USD 3.5 billion, translating into a 2.25x growth multiple over the forecast horizon.

Revenue gains are expected to accelerate in the latter half of the period, with incremental additions averaging about USD 250 million to USD 300 million annually between 2025 and 2029, and rising to nearly USD 400 million to USD 450 million annually between 2030 and 2035.

This curve reflects the broader adoption of advanced diagnostics, as both early detection and personalized testing become standard practice. The growth trajectory also suggests significant potential for companies developing innovative biomarker-driven and non-invasive diagnostic tools.

Expansion in this market is strongly tied to increasing colorectal cancer incidence and the rising emphasis on early detection. Public health initiatives and screening programs across North America, Europe, and parts of Asia are stimulating adoption of fecal immunochemical tests (FIT), colonoscopy-based diagnostics, and molecular testing.

Demand is also supported by growing awareness among aging populations and improved reimbursement for diagnostic procedures. Companies offering minimally invasive and high-sensitivity tests are positioned to benefit as patient and physician preferences shift toward more accessible screening methods.

However, challenges remain. High procedural costs, limited access in low-income countries, and compliance gaps in population-based screening programs can slow growth. Regulatory hurdles and the need for clinical validation of novel assays also extend the commercialization timeline for innovative solutions.

Despite these barriers, the integration of liquid biopsies, AI-powered pathology, and companion diagnostics is expected to create a wave of adoption after 2030. The market’s momentum therefore rests on balancing affordability, accessibility, and technological advancement to reach wider patient populations.

Key Colorectal Cancer Diagnostics Market Trends Analyzed

Rising Prevalence of Colorectal Cancer

The steady increase in colorectal cancer incidence worldwide serves as a primary demand catalyst. With the disease ranking among the most common cancers globally, there is heightened pressure on healthcare systems to strengthen early detection.

Screening is widely recognized as a cost-effective intervention that improves survival rates by identifying precancerous lesions and localized tumors before progression. This epidemiological burden has compelled governments and insurers to expand coverage for diagnostic programs, thereby broadening access.

Population aging further intensifies this need. As colorectal cancer risk increases with age, the expanding elderly demographic in regions such as North America, Europe, Japan, and China magnifies diagnostic demand. This demographic shift, coupled with lifestyle-related risk factors, ensures a sustained pipeline of patients requiring regular screening, positioning diagnostics at the center of oncology strategies.

Shift Toward Non-Invasive and Advanced Testing

Growing patient preference for less invasive diagnostics is accelerating adoption of molecular tests, fecal immunochemical tests (FIT), and liquid biopsies. Colonoscopy remains the gold standard, yet its invasiveness, cost, and patient discomfort often reduce compliance.

Non-invasive alternatives with high sensitivity, such as DNA-based stool tests and circulating tumor DNA assays, are gaining prominence as they improve participation rates while maintaining diagnostic accuracy.

Technology-driven innovation also strengthens this trend. AI-assisted pathology, digital imaging, and next-generation sequencing are enabling earlier, more precise detection of tumor markers. Diagnostic companies that can merge non-invasiveness with high accuracy are seeing heightened interest from healthcare providers and payers eager to boost compliance in screening programs.

Supportive Government and Institutional Initiatives

Screening guidelines and public health campaigns play a critical role in expanding diagnostic uptake. In the United States, initiatives such as the USPSTF recommendation to begin screening at age 45 have broadened the eligible population. In Europe, national programs mandate regular fecal testing or colonoscopy at defined ages, ensuring strong institutional support for diagnostics.

These programs are increasingly backed by reimbursement frameworks, lowering cost barriers and encouraging participation. Beyond developed regions, global NGOs and health organizations are working with governments in Asia Pacific, Latin America, and Africa to improve awareness and deploy cost-effective tests. Policy-driven adoption ensures stable long-term demand and incentivizes innovation in affordable diagnostic formats.

High Costs and Limited Affordability

Despite clinical benefits, the high costs of advanced diagnostics remain a major restraint. Colonoscopies are expensive and require infrastructure, while molecular assays and genetic testing are priced beyond reach for many patients in low- and middle-income countries. Even in developed regions, out-of-pocket expenses can reduce compliance, particularly when patients face repeated testing requirements.

Healthcare systems under budgetary pressure often prioritize essential care over widespread screening, limiting penetration. This cost sensitivity highlights the need for affordable, accurate, and scalable testing methods. Until such solutions become widely available, adoption will remain uneven across socioeconomic segments.

Regulatory Hurdles and Long Approval Timelines

The regulatory environment for diagnostic approvals is stringent, reflecting the high stakes of cancer detection. Novel assays must demonstrate clinical validity, reproducibility, and long-term outcomes through rigorous trials. This extends time-to-market for innovative products and creates uncertainty around reimbursement readiness.

Smaller diagnostic firms often lack the resources to navigate these hurdles, leading to consolidation or delayed commercialization. While regulatory rigor protects patient safety, it can also stifle the speed of innovation and delay access to breakthrough technologies, slowing the overall market trajectory.

Low Compliance and Awareness Gaps

Even when screening programs are available, patient compliance remains inconsistent. Cultural stigma, fear of invasive procedures, lack of awareness, and misconceptions about colorectal cancer symptoms often deter participation. In many regions, uptake of voluntary testing falls below target thresholds, undermining program effectiveness.

Awareness campaigns have made progress, but gaps remain in rural and underserved populations. Without consistent patient education and community-level outreach, the effectiveness of advanced diagnostics is limited. Increasing compliance through education and trust-building remains a fundamental challenge for both public health authorities and diagnostic providers.

Regional Trends of the Colorectal Cancer Diagnostics Market

North America remains the largest market, driven by advanced healthcare infrastructure, early adoption of molecular diagnostics, and strong reimbursement policies. The US leads, supported by guideline expansions and a large base of at-risk patients.

Europe benefits from structured national screening programs and high public health spending. Countries like Germany, France, and the UK have well-established fecal test and colonoscopy frameworks, while adoption of non-invasive tests is rising.

Asia Pacific shows high growth potential due to increasing cancer incidence, expanding middle-class populations, and government focus on preventive healthcare. Japan and Australia have mature programs, while China and India are rapidly expanding access.

Latin America and Middle East & Africa are emerging regions, constrained by affordability and infrastructure gaps but increasingly influenced by awareness campaigns and NGO-driven initiatives. Brazil, Mexico, and GCC countries represent early movers in expanding diagnostics availability.

Country-Wise Outlook

Countries	CAGR (2025-2035)
United States	8.4%
United Kingdom	8.7%
Japan	9.0%

U.S. is Witnessing Advancements in the Non-Invasive Screening Tests Market

The market for diagnosing colorectal cancer in the US is supported by the high prevalence of the disease, particularly in younger people. There is an increasing case load and a greater emphasis on early diagnosis, which escalates the Need for tools. Increased prevalence of obesity and diabetes is also a contributing factor to the risk of CRC.

In addition, there is a strong market demand for non-invasive screening tests, which is also beneficial. Newer stool and blood tests are gaining acceptance due to increased patient acceptance and higher screening compliance. Healthy reimbursement policies and universal coverage for these screening tests also aid market growth.

The development of new technologies for diagnosis and the use of artificial intelligence in interpreting results are critical factors in the US. America has in place a well-functioning healthcare system as well as a large number of innovators, which means that new diagnostic tools and services are easily embraced.

UK Government Screening Programs and Aging Population Drives the Market

The position of the UK in the international market is mainly influenced by the existing interstate national screening programs. The programs are tailored for early diagnosis and have a lot of influence on the population to get tested. The government initiatives aimed at minimizing cancer mortality immensely contribute to the market expansion.

The enlarging population is a major factor, as the incidence of colorectal cancer among aged persons is high. This shift in population structure guarantees a perpetual need for diagnostic tests and services. The campaigns sponsored by the government are also aimed at educating patients regarding their readiness for screening, particularly the minimal invasive procedures.

In addition to the above, the UK market is supported by the increasing emphasis on personalized medicine and new technologies for the diagnosis of diseases. The integrated approach to the development of new diagnostic tests, as well as the investment in healthcare in the country, improves the effectiveness and precision of the diagnosis of CRC.

Japan has Rising Cancer Incidence and Advanced Technology for Market

Japan’s market is fueled by the growing cases of colorectal cancer common in the elderly population. There is an increasing number of people suffering from the disease, which creates a positive market outlook for the need for accurate and effective diagnostic tools.

Public initiatives alongside civic awareness are driving factors. Japan has implemented programs for screening, which are important for detecting the disease at an early stage and which have, in turn, improved the diagnostic services being offered. This goes a long way in increasing the chances of people surviving cancer.

Diagnostic precision is also enhanced by the rapid expansion of the market’s technologically sophisticated AI-powered radiological image evaluative systems and the latest liquid biopsy procedures. These innovations, alongside the universal health coverage in Japan, further aid in the accessibility of the services offered.

Category-wise Analysis

Colorectal Cancer FOB Tests Remains the Preferred Test Type

The FOB tests segment continues to dominate the share of the colorectal cancer diagnostics market. This stems from numerous reasons that make it a popular and widely available form of screening.

FOB tests are non-invasive, low in cost, and in many cases, are provided in the form of kits to be used at home. Their ease of use and non-invasive nature enhance patient compliance with screening guidelines compared to more elaborate tests.

Many public health programs and large-scale screening drives across the globe make use of these tests due to their economy and effectiveness, coupled with the ability to be used for large population screening.

Their tested effectiveness in major markets, along with the volume of tests done, solidifies their dominant position. Even with the emergence of advanced technologies, the wide acceptance of FOB tests and their proven effectiveness will always ensure their first-line screening tool.

KRAS Mutation Tests are Gathering Significant Momentum for Colorectal Cancer Diagnostics

KRAS mutation tests are also projected to grow at the fastest rate. This is accelerated by the shift toward personalized and more targeted therapies for managing cancer. KRAS mutations, which are often referred to as ‘classical mutations,’ are one of the most common genetic alterations in colorectal cancer, and the tests that confirm these mutations are essential for devising an appropriate treatment for the patients.

With the mutation test results in hand, doctors are able to determine whether a patient is likely to benefit from certain targeted therapies and, in turn, avoid unnecessary treatment and improve patient results. With a growing understanding of genetic markers in cancer, these advanced therapies and understanding the need for advanced treatment are essential.

The shift toward personalized treatments also drives the swift development of more precise and sophisticated cancer diagnostics, fueling the impressive growth of KRAS mutation tests.

Hospital-associated Labs Remains the Preferred End User

By end user, hospital-associated labs holds the largest share. These hospital-associated labs are an integral component of the healthcare ecosystem. They possess all the necessary instruments for diagnosis, ranging from an endoscopy suite to pathology and molecular testing labs. Since their structure allows for the efficient processing of colonoscopies and biopsies, such labs are able to serve as the central, multi-modal diagnostic and therapeutic hubs.

The trust these patients and doctors have in these facilities, together with the provision of diagnostic and treatment services during the treatment cycle, consolidates their position as market leaders.

Hospitals are the most frequent initial contact for symptomatic patients, further confirming their role in the diagnostic path. Additionally, the presence of experienced clinicians and the capacity to conduct fundamental and advanced genetic screening in the hospital setting guarantee that hospital labs will continue to be the preferred providers for holistic services.

Independent Diagnostic Laboratories are Becoming Popular for Diagnostics

Independent diagnostic laboratories are expected to grow the fastest. Factors such as their specialized focus on certain types of tests and the growing need for non-invasive screening and tests contribute to their growth potential. These diagnostic labs frequently cooperate with physicians and provide genetic and molecular tests that are essential for bespoke medicine and with hospital services.

Another important factor for growth is the at-home collection kits for tests such as FIT and stool DNA tests that are frequently administered by these independent labs. This model is beneficial because it is more convenient and accessible for patients and therefore improves screening and testing rates.

Independent diagnostic laboratories are poised to provide more of these services as health systems shift towards outpatient care, as these more advanced tests are developed and become available.

Competitive Analysis

The market for colorectal cancer diagnostics is one with intense competition. There is an even split between companies focusing on older technologies and those funded by newer techniques. Blood and stool tests are being developed by several companies.

It is aimed at being non-invasive and is aimed to be more convenient for the patients as well as to increase the screening rates. Convenience is the primary strategy being used to increase the market share. There is also a strong emphasis on blending these tests with the current diagnostic pathways to maximize the screening efficiency.

Alliances play an important role in the market. A number of companies are joining other companies and research centers in a bid to accelerate the development of new diagnostic tools.

There is a need for shared skills and shared resources for intricate technologies like molecular and genetic diagnostic tests. Such alliances simplify the processes and accelerate the introduction of new products to the market and the expansion of territories.

Another important trend in competitiveness is a shift towards personalized medicine. Businesses are pouring resources into new biomarkers and genomic variants to enable more effective treatment selection for individual patients. The objective is to develop tests that not only confirm the presence of cancer but also provide vital information to aid in treatment selection.

The shift from broad-based to more tailored and focused testing and diagnostics provides companies with an opportunity to differentiate themselves in the market while adding more value to the health system and patients.

Key Players in the Market

• Danaher Corporation
• Rosetta Genomics
• Epigenomics AG
• Exact Science Corporation
• Pathway Genomics Corporation
• Biocept Inc.
• Cancer Genetics Inc.

Recent Developments

• In July 2025, Thermo Fisher Scientific announced an expanded partnership with Sanofi to increase drug product manufacturing in the US.
• In October 2024, Exact Sciences received approval from the FDA for its Cologuard Plus test, which is an updated version of its popular at-home screening test. This new version has improved accuracy, which is expected to help reduce the number of false positive results.

Segmentation of Colorectal Cancer Diagnostics Market

• By Test Type :

  • Colorectal Cancer FOB Tests
  • Colorectal Cancer CTC Tests
  • Colorectal Cancer CEA Tests
  • Colorectal Cancer BRAF V600 Mutation Tests
  • Colorectal Cancer Immunohistochemistry Tests
  • C-kit/CD117
  • KRAS Mutation Tests
  • Others

• By End User :

  • Hospital-associated Labs
  • Independent Diagnostic Laboratories
  • Cancer Research Institutes
  • Others

• By Region :

  • North America
  • Latin America
  • Western Europe
  • Eastern Europe
  • East Asia
  • South Asia & Pacific
  • Middle East & Africa