U.S. colorectal cancer screening market size was valued at US$ 5.95 Bn in 2023 and is expected to reach US$ 10.62 Bn by 2031, grow at a compound annual growth rate (CAGR) of 7.5% from 2024 to 2031.

Colorectal cancer is one of the most commonly diagnosed cancers in the U.S. Regular screening is crucial to detect pre-cancerous polyps or early-stage cancer that can then be treated appropriately. Common screening tests include fecal occult blood test (FOBT), Sigmoidoscopy, and colonoscopy. Early detection through screening significantly improves survival rates, yet screening rates remain lower than optimal, especially among racial/ethnic minority and underserved populations.

U.S. colorectal cancer screening market is segmented into test type, imaging type, and end user. U.S. colorectal cancer screening market growth is primarily driven by rising incidence of colorectal cancer and increasing awareness about the importance of early detection. According to the American Cancer Society, in May 2020, colorectal cancer is the third most commonly diagnosed cancer in the U.S. Population aging is another important factor contributing to the market growth as colorectal cancer risk increases with age. However, factors such as lack of symptoms in early stages, lower screening adherence rates, especially in rural areas, and unwillingness to undergo invasive screening tests negatively impact the market. Ongoing innovations in less invasive screening technologies and initiatives to improve screening rates through Medicaid expansions are expected to create significant opportunities for market players in the near future.

U.S. Colorectal Cancer Screening Market- Drivers

• Increasing prevalence of colorectal cancer: Increasing prevalence of colorectal cancer in the U.S. is expected to drive the U.S. colorectal cancer screening market growth. Colorectal cancer is one of the most commonly diagnosed cancers in the U.S., and early detection through screening can greatly improve treatment outcomes. Screening tests, such as colonoscopies, fecal immunochemical tests (FIT), and stool DNA tests, can detect colorectal cancer in its early stages when treatment is more likely to be successful. As the population ages, the number of individuals at higher risk for colorectal cancer also increases, leading to a greater need for regular screening. Increased public awareness about the importance of colorectal cancer screening has led to more people seeking out screening services. Insurance coverage for colorectal cancer screening has expanded under the Affordable Care Act, reducing the financial barrier for many Americans, which can increase screening rates. Medical guidelines that lower the recommended age for beginning routine screening from 50 to 45 years for average-risk adults broaden the screening eligible population, thus, potentially increasing the number of screenings conducted. Improvements in screening technologies, including non-invasive tests and improved endoscopic equipment, make it easier and more comfortable for individuals to undergo screening. For instance, in 2022, according to the American Cancer Society's (ACS) publication, the number of colorectal cancers in the U.S. in 2023 was 106,970 new cases of colon cancer, 46,050 new cases of rectal cancer, and overall, the lifetime risk of developing colorectal cancer is about 1 in 23 for men and 1 in 26 for women.
• Growing adoption of non-invasive screening methods: Growing adoption of non-invasive screening methods is expected to drive the U.S. colorectal cancer screening market growth. Non-invasive tests offer several advantages that contribute to their increased popularity and adoption. Non-invasive methods, such as stool-based tests like the fecal immunochemical test (FIT) or stool DNA tests, are typically more acceptable to patients than invasive procedures like colonoscopies. This can lead to higher rates of screening compliance. Since non-invasive tests can often be carried out at home, and these eliminate the need for patients to undergo bowel preparation or sedation, making the screening process simpler and more convenient. These methods reduce the risk of complications such as bowel perforation or adverse reactions to anesthesia that are associated with more invasive procedures. Non-invasive screening methods can be more cost-effective, saving on both the procedure itself and the resources necessary for aftercare or hospital stays caused by potential complications.

U.S. Colorectal Cancer Screening Market- Opportunities

• Adoption of mobile health (mHealth) technologies: The adoption of mobile health (mHealth) technologies presents an opportunity for U.S. colorectal cancer screening market growth. mHealth technologies, which include smartphone apps, wearable devices, and other wireless technologies, offer innovative ways to promote, manage, and improve health services. mHealth apps can provide educational content on colorectal cancer risk factors, screening importance, and procedure options, increasing awareness and encouraging individuals to get screened. Smartphone apps can send reminders for scheduled screening appointments or alert users when these are due for screening, ensuring adherence to recommended screening intervals. Some mHealth apps can guide users through the process of at-home non-invasive screening tests, providing instructions and ensuring proper test completion. Patients can receive screening results securely through mHealth platforms, facilitating prompt follow-up actions if any abnormalities are detected. mHealth technologies can integrate with electronic medical records (EMRs), allowing healthcare providers to track a patient’s screening history and make informed clinical decisions. Apps can include risk assessment tools that take user input about family history and lifestyle factors to personalize screening recommendations
• The emergence of a personalized screening approach: The emergence of a personalized screening approach indeed presents an opportunity for growth within the U.S. colorectal cancer screening market. Personalized screening is a tailored approach that considers individual risk factors such as age, genetics, family history, and lifestyle choices to determine the most appropriate screening method and frequency for colorectal cancer. By evaluating personal risk factors, healthcare providers can recommend screenings more suited to the individual’s likelihood of developing colorectal cancer, potentially aiding in early detection, especially in high-risk individuals. A personalized screening schedule can lead to better healthcare outcomes by identifying cancer at an earlier and more treatable stage. Personalized screening can help in determining optimal screening intervals for each patient, avoiding one-size-fits-all annual or biennial schedules, which may not be necessary for every individual. By tailoring screening schedules to individual needs, personalized screening can prevent overuse of resources on low-risk populations and allocate medical attention where it is most needed.

U.S. Colorectal Cancer Screening Market- Restraint

• Risks and complications associated with colorectal cancer screening: Risks and complications associated with colorectal cancer screening procedures can indeed pose challenges to the growth of the U.S. colorectal cancer screening market. While screening is crucial for early detection and has been shown to reduce mortality from colorectal cancer, the potential adverse effects linked to some screening methods may lead to reluctance or avoidance among eligible individuals. Screening methods such as colonoscopies carry risks of complications, including bowel perforations, bleeding, and adverse reactions to sedatives. Screening tests can sometimes yield false-positive results, leading to unnecessary stress and additional invasive diagnostic procedures. Conversely, false negatives can result in delayed diagnoses. Screening can sometimes detect cancers that may not have caused issues during the patient's lifetime, leading to overtreatment and the associated burdens. The prospect of undergoing invasive procedures like colonoscopies can cause anxiety and discomfort, leading some individuals to forego recommended screening. The bowel preparation required for a colonoscopy can be unpleasant and might discourage individuals from undergoing the procedure.

• The shift towards a preventive healthcare approach: The shift towards a preventive healthcare approach is indeed a key trend in the U.S. colorectal cancer screening market. This trend towards preventive care is driven by the understanding that it is more effective to prevent disease or detect it early rather than to treat it once it has progressed. There is an increasing emphasis on the early detection of colorectal cancer, as outcomes are typically better when the disease is diagnosed at an earlier stage. Preventive screenings like colonoscopies, FIT tests, and stool DNA tests can detect precancerous polyps or early-stage cancers before symptoms appear. Medical guidelines now recommend earlier screening for colorectal cancer, with some suggesting that screening begin at age 45 instead of 50 for average-risk individuals. This change in recommendations is reflective of the move towards a preventive healthcare approach. Governmental public health organizations and private groups are actively promoting awareness about the importance of regular colorectal cancer screening, highlighting its role in preventing cancer and improving survival rates. Preventive screenings, including those for colorectal cancer, are often covered without out-of-pocket costs under many health insurance plans, including the Affordable Care Act, encouraging more people to undergo routine screenings. Advances in screening technologies are making it easier and more convenient to perform preventive screenings. For example, home-based FIT kits and other non-invasive methods broaden access to preventive care

U.S. Colorectal Cancer Screening Market- Regional Insights

• Northeast: Northeast region is the largest colorectal cancer market in the U.S., with a market share of over 40%. The region is home to some of the largest and most affluent cities in the US, as well as a number of major pharmaceutical companies.
• West: The West region is the second-largest colorectal cancer in the US, with a market share of over 30%. The region is home to a number of large and growing cities, as well as a number of biotech companies.
• South: The South region is the third-largest colorectal cancer in the US, with a market share of over 15%. The region is home to a number of large and growing cities, as well as a number of pharmaceutical companies.
• Midwest: The Midwest region is the smallest colorectal cancer in the US, with a market share of under 15%. The region is home to a number of large and growing cities, but it also has a number of rural areas.

Figure 1.  U.S. Colorectal Cancer Screening Market Value (US$ Bn), 2023

Major Players operating in the U.S. colorectal cancer screening market include Polymedco Inc., Eiken Chemical Co. Ltd., Sysmex Corporation, Quidel Corporation, Novigenix SA, Hemosure Inc., Exact Sciences Corp., Epigenomics Inc., Olympus Corporation, Clinical Genomics Technologies Pty Ltd., Abbott, F. Hoffmann-La Roche Ltd, Siemens Healthineers, Koninklijke Philips N.V., Thermo Fisher Scientific Inc., Illumina, Inc., Myriad Genetics Inc., QIAGEN, Merck KGaA

New product launches:

• In January 2022, QIAGEN, a biotechnology company, announced new additions to the growing number of applications for QIAcuity, its ultrasensitive digital PCR (dPCR) platform that has set new standards by using so-called nanoplates to process samples in two hours rather than the five hours required by other systems
• In August 2021, Pillar Biosciences, an innovative next-generation sequencing (NGS) solutions in-vitro diagnostics (IVD) company, announced that it had received the U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) for its oncoReveal Dx Lung and Colon Cancer Assay, an NGS tissue-based companion diagnostic test for the qualitative detection of somatic mutations in DNA derived from non-small cell lung cancer (NSCLC) and colorectal (CRC) cancer tumors

Acquisition and partnerships:

• In August 2022, Bio-Rad Laboratories, Inc., a global leader in life science research and clinical diagnostic products, announced the acquisition of Curiosity Diagnostics, Sp. Z. o. o., a late-stage, pre-commercial platform company that is in the process of developing a sample-to-answer, rapid diagnostics PCR system for the molecular diagnostics market
• In October 2020, Exact Sciences Corp., a biotechnology company, and Pfizer Inc., a pharmaceutical company, announced an extension and amendment of agreement to promote Cologuard, the first and only U.S. FDA-approved non-invasive stool DNA screening test for colorectal cancer. Under terms of the nationwide agreement, Pfizer Inc. continue to provide marketing and related support for Cologuard and join Exact Sciences Corp efforts to educate patients, physicians, and health systems about Cologuard.

• By Test Type
• • Fecal Immunochemical Test (FIT)
  • Guaiac-based Fecal Occult Blood Test
  • Stool DNA Test
  • Others
• By Imaging Type
• • Sigmoidoscopy
  • Colonoscopy
  • Virtual Colonoscopy
  • Others
• By End User
• • Hospitals
  • Diagnostic Laboratories
  • Academic and Research Institutes
  • Others
• By Region
• • Northeast
  • West
  • South
  • Midwest