Colorectal Cancer Diagnostics Market

The global Colorectal Cancer Diagnostics Market is valued at USD 14.34 Billion in 2024 and is projected to reach a value of USD 35.1 Billion by 2035 at a CAGR (Compound Annual Growth Rate) of 8.50% between 2025 and 2035.

Key Highlights

• North America led the Colorectal Cancer Diagnostics market in 2024, with 40.5% of the total market share
• Asia Pacific is projected to remain the fastest-growing region during the forecast period
• The Imaging Test segment significantly contributed to the market’s growth, constituting over 49.1% of the overall revenue share in 2024
• Based on End-use, the Hospitals category dominated the market in 2024, accounting for a significant 41.5% of the total revenue

Regional Overview

In 2024, North America market held a significant dominance with 40.5% of the total revenue. Growing awareness regarding colorectal cancer and the significance of regular screening is evident among both the general public and healthcare professionals in North America. Screening programs are being actively supported by governments, health organizations and lobby groups leading to a rise in diagnostic procedures such as colonoscopies, fecal occult blood tests or fecal immunochemical testing. The region sees frequent collaborations among research institutes, pharmaceutical companies, and diagnostic businesses on R&D projects aimed at enhancing colorectal cancer detection.

Addressing the substantial unmet need for increased colorectal cancer screening, Pfizer and Exact Sciences Corporation have established a co-promotion agreement for Cologuard®, the first and only noninvasive stool DNA screening test for colorectal cancer approved by the U.S. Food and Drug Administration. Pfizer leverages its top tier sales, marketing, media, account management, and medical teams, while Exact Sciences brings its sales expertise, medical knowledge, and industry-leading diagnostic capabilities to this partnership. The partnership is focused on addressing colorectal cancer, a largely preventable yet frequently under-detected illness responsible for 50,000 deaths each year in the United States. Early detection significantly improves survival rates, with nine out of ten people surviving more than five years when diagnosed at an early stage.

U.S. Market Overview

Colorectal cancer is the second-leading cause of cancer death in the United States, with approximately 100,000 new cases of colon cancer and 50,000 new cases of rectal cancer diagnosed each year. This type of cancer predominantly affects older adults, with 90% of cases occurring in individuals over 50 years old. The high fatality rate, with around 50,000 deaths annually, underscores its severity. Consequently, colorectal cancer stands as the third-most common cancer and the third-most common cause of cancer-related deaths for both men and women in the U.S., leading to substantial healthcare costs. Despite the treatability of colorectal cancer when detected early, an estimated 60 million average-risk adults in the United States remain unscreened.

Test Type Overview

• In 2024, the Imaging Test segment dominated the Global market with a 49.1% revenue share.
• Unprecedented ability to detect anomalies in the colon and rectum is offered by imaging modalities such as computed tomography, magnetic resonance imaging, and positron emission tomography. Such tests significantly improve patient outcomes by detecting possible growths, polyps or tumors at an early stage and allowing timely intervention. They offer a thorough assessment of the scope and dissemination of colorectal cancer, providing intricate details regarding aspects such as size, position, infiltration of neighboring tissues, and engagement of distant organs or adjacent lymph nodes. Accurate diagnosis and treatment decisions heavily rely on the thorough assessment provided by imaging testing.
• The Imaging Test segment within the Global Colorectal Cancer Diagnostics market encompasses various modalities, including Computed Tomography (CT) Scan, Ultrasound, Magnetic Resonance Imaging (MRI) Scan, Positron Emission Tomography (PET) Scan, Colonoscopy, and Other Imaging Tests. For e.g., MRI scanning, which utilizes a magnetic field to generate anatomical images, offers distinct advantages. MRI provides detailed images which are useful for rectal and liver imaging, despite the slower pace compared to CT scans. Its mainly an anatomical information source, although specific techniques like diffusion weighted imaging can provide functional insights as well.

Key Trends

1. Increased use of next-generation sequencing (NGS) and other advanced molecular diagnostic techniques to identify genetic mutations and biomarkers associated with colorectal cancer. Development of personalized medicine approaches based on genetic profiling, leading to more targeted and effective treatments.
2. Rise in the popularity and adoption of non-invasive tests such as fecal immunochemical tests (FIT), stool DNA tests (e.g., Cologuard), and blood-based biomarkers. These methods offer more convenient and patient-friendly alternatives to traditional invasive procedures like colonoscopy, increasing compliance rates.
3. Governments, healthcare organizations, & advocacy groups are intensifying efforts to raise awareness about colorectal cancer and the importance of regular screening. In particular in high risk populations, implementation of national and regional screening programs aimed at early detection and prevention.
4. Growing use of liquid biopsy as a minimally invasive diagnostic tool to detect circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in blood samples. Liquid biopsy offers the potential for early detection, monitoring treatment response, detecting recurrence, making it a valuable addition to traditional diagnostic methods.
5. Development and deployment of point-of-care (POC) diagnostic devices that provide rapid and accurate results at the patient’s bedside or in primary care settings. These devices enhance accessibility to diagnostic services, particularly in remote or underserved areas.
6. Increased emphasis on early detection strategies and preventive measures to reduce the incidence & mortality rates of colorectal cancer. Adoption of lifestyle interventions, dietary modifications, and prophylactic treatments for individuals with a high risk of developing colorectal cancer.

Government Initiatives and Collaborative Efforts

• Sysmex Egypts Early Screening Program: Sysmex Egypt, in partnership with the Ministry of Health, has initiated an early screening programme for colorectal cancer. This strategic project, announced at a press conference in September 2023, aims to revolutionize colorectal cancer screening technology in Egypt, addressing the significant challenge posed by the disease, with approximately 134,000 new cases reported annually according to the World Health Organization (WHO).
• QIAGENs FDA Approval for Companion Diagnostic: QIAGEN has received FDA approval for its therascreen® KRAS RGQ PCR kit as a companion diagnostic to aid in identifying non-small cell lung cancer (NSCLC) patients eligible for treatment with Mirati Therapeutics’ KRAZATI® (adagrasib). This approval expands treatment options for NSCLC patients with KRAS mutations, reflecting a crucial advancement in precision medicine for cancer therapy.
• Epigenomics' Licensing of Protein Biomarker Technology: Epigenomics Inc. has licensed protein biomarker technology from The University of Texas MD Anderson Cancer Center for the development of a blood-based colorectal cancer screening test. This initiative aims to enhance the accuracy and accessibility of colorectal cancer screening, complementing existing diagnostic approaches with potentially improving patient outcomes.
• Grants for Quality Improvement Initiatives in Canada: Pfizer Canada, Colorectal Cancer Canada, and Thermo Fisher Scientific have announced grants exceeding $300,000 for quality improvement initiatives in Canadian healthcare centers. Such grants are intended to empower centers without in-house molecular testing capacity and improve molecular testing turnaround times for individuals with metastatic colorectal cancer and other advanced cancers, enhancing access to precision medicines.
• Epigenomics' Multi-center Clinical Trial: Epigenomics Inc. has initiated a prospective multi-center clinical trial, CRC-DRAW, supporting the development of its "Next-Generation" blood-based colorectal cancer screening test. With enrollment of over 15,000 subjects, this trial aims to achieve statistical endpoints necessary for Pre-Market Approval (PMA) submission to the FDA, potentially advancing the landscape of Colorectal Cancer Diagnostics.

Premium Insights

According to the Colorectal Cancer Statistics 2023 report from the American Cancer Society (ACS), there is a rapid shift towards more advanced stages of colorectal cancer affecting younger individuals. Researchers noted an increase in the proportion of individuals diagnosed with advanced-stage colorectal cancer in the United States, rising from 52% in the mid-2000s to 60% in 2019. Additionally, diagnoses among individuals under 55 years of age doubled from 11% (1 in 10) in 1995 to 20% (1 in 5) in 2019. In 2023, it is estimated that 153,020 people will be diagnosed with colorectal cancer in the U.S., with 52,550 deaths attributed to the disease. Despite being the third most commonly diagnosed cancer and the third leading cause of cancer-related death in both men and women in the U.S., the incidence of colorectal cancer declined rapidly among individuals aged 50 and older during the 2000s, largely due to increased screening efforts with colonoscopy. However, this progress has slowed in the past decade, with decreasing trends now primarily observed among individuals aged 65 and older.

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Market Dynamics

• Exact Sciences, a prominent provider of cancer screening and diagnostic tests, has allocated $1.3 million to 23 organizations through its Funding Opportunities for CRC Screening Uptake Strategies (FOCUS) Program. Such grants are dedicated to enhancing colorectal cancer screening rates, particularly among medically underserved populations, thereby promoting accessibility to healthcare.
• Sysmex Europe GmbH, in collaboration with Sysmex Inostics GmbH, is set to introduce the Plasma-SeqSensei™ liquid biopsy research use only (RUO) kits for colorectal cancer (CRC) and other cancers. Liquid biopsy, which uses next generation sequencing technology to offer an uninvasive alternative to Tissue Biopsy and provides immediate insight on disease progression and the treatment response thus facilitating clinical research efforts.
• Exact Sciences Corp. has published the results of the BLUE-C study in The New England Journal of Medicine, evaluating the performance of its next-generation multitarget stool DNA test, Cologuard Plus, for colorectal cancer screening. The study compared the performance of Cologuard Plus to the fecal immunochemical test (FIT), a commonly used noninvasive screening method. Pending FDA approval, Exact Sciences plans to make Cologuard Plus available in 2025, based on comprehensive results from the BLUE-C study.
• Recent data highlight a 33% higher colorectal cancer incidence rate in men compared to women, likely influenced by varying risk factor prevalence such as excess body weight, processed meat consumption, and historical smoking. Despite increased screening efforts, there has been a shift towards more advanced stages of the disease, with the proportion of regional or distant stage cancers rising from 52% in the mid-2000s to 60% in 2019. These findings underscore the ongoing challenges in early detection and the importance of continued innovation in diagnostic approaches.

Competitive Landscape

• A key role in fostering innovation and stimulating market growth is played by collaboration between healthcare organizations, diagnostic companies, academic institutions and research consortia. These partnerships aim at developing cutting edge diagnostic technologies, conducting rigorous clinical validation studies, and increasing market reach.
• In January 2024, Merck KGaA, Darmstadt, Germany, took a significant step in expanding its colorectal cancer portfolio through a licensing agreement with Inspirna. This strategic move involves the licensing of ompenaclid (RGX-202), a first-in-class oral inhibitor of the creatine transport channel SLC6A8, currently in Phase II development for RAS-mutated advanced or metastatic colorectal cancer (mCRC). The collaboration includes exclusive licensing rights outside the US, with an option to co-develop and co-promote ompenaclid in the U.S., as well as global co-development and co-commercialization rights for follow-on compounds. This strategic agreement builds upon Merck KGaAs established heritage in colorectal cancer therapeutics, particularly complementing its expertise and ongoing development programs.

Recent Market Developments

• By May 2024, Exact Sciences showcases ongoing scientific progress in colorectal cancer screening through several presentations at DDW® 2024. As a leading provider of cancer screening and diagnostic tests, Exact Sciences Corp. will unveil six abstracts focusing on strategies and advancements aimed at enhancing colorectal cancer screening rates and improving patient outcomes. The presentations, scheduled for Digestive Disease Week® (DDW) 2024, taking place from May 18 to 21 in Washington, D.C., will cover a range of topics, including insights into Cologuard®, recognized as the premier non-invasive screening test for colorectal cancer in individuals aged 45 and above with average risk. Additionally, data on the development of the next-generation Cologuard test, known as Cologuard Plus™, will also be highlighted during the event.

The global Colorectal Cancer Diagnostics market can be categorized as Test Type, End-use, and Region.