U.S. Colorectal Cancer Screening Market Size, Share & Industry Analysis, By Type (Stool-based {Fecal Immunochemical Test (FIT), Fecal Occult Blood Test (FOBT), and Stool-DNA Test}, Colonoscopy, and Others), By End-user (Hospitals & Clinics, Clinical Laboratories, Diagnostic Imaging Centers, and Others), and Country Forecast, 2024-2032

The U.S. colorectal cancer screening market size was valued at USD 11.18 billion in 2023. The market is projected to grow from USD 11.99 billion in 2024 to USD 17.53 billion by 2032, exhibiting a CAGR of 4.9% during the forecast period.

Colorectal Cancer (CRC) screening is the detection of colorectal cancer in individuals who do not have any symptoms, but are at high risk of getting impacted by the disease. The increase in the number of cases of colorectal cancer has fueled the demand for its early detection for effective and on-time treatment. This factor has been fueling the demand for regular screening for colorectal cancer among individuals who are at a high risk of getting impacted by the disease.

Government regulatory bodies in the U.S. have been focusing on creating awareness for increasing screening rates to control the burden of the disease, which has increased the demand for CRC screening. As a result, the high economic burden of colorectal cancer in the country boosts the market growth. Additionally, this high economic burden has prompted healthcare agencies to collaborate with regional and national government agencies in efforts to boost screening rates for at-risk populations.

• For instance, in 2023, according to the Centers for Disease Control and Prevention (CDC), the economic burden of treating colorectal cancer in the U.S. was approximately USD 24.0 billion. The condition has the second most expensive treatment among all cancers in the U.S. Based on estimates from a few population-based studies in the U.S., the annual per-patient cost (direct costs) for treatment of colorectal cancer in the U.S. is around USD 58,300.

During the COVID-19 pandemic in 2020, the U.S. colorectal cancer screening market experienced a decline due to fewer people undergoing CRC screening procedures through government-organized screening programs. Moreover, key players in the market reported a significant decline in their revenues owing to the reduced sales of colorectal cancer screening products.

• For instance, in 2020, Eiken Chemical Co., Ltd. reported a decline of 7.0% in the revenue of its FIT reagents (OC) segment, which is USD 68.5 million, as compared to 2019.

U.S. Colorectal Cancer Screening Market Trends

Increasing Focus of Prominent Players on Advanced Technologies and Innovative Products

The rising burden of colorectal cancer in both developed and developing countries has stimulated the major players to focus on the development of novel and cutting-edge technologies for screening tests.

In the past few years, prominent market players have developed a technology that detects cells released by colorectal polyps and tumors in the bloodstream for cancer screening and has received FDA approval for colorectal cancer screening tests. The approval of colorectal cancer screening tests is anticipated to stimulate other market players to introduce additional tests, leading to a rise in the volume of screening tests for colorectal cancer.

• For instance, in May 2022, Guardant Health introduced Shield, a blood test designed to detect early-stage Colorectal Cancer (CRC). This non-invasive test utilizes a blood sample from at-risk individuals, which is analyzed in a laboratory. This test is recommended for adults aged 45 and older who are not compliant with screening guidelines and have an average risk for colorectal cancer. For such individuals, the Shield served as a convenient and effective screening option.

On the other hand, colonoscopy with innovative features, such as increased definition of imaging, broadening field of view, virtual technologies to support Conventional Chromocolonoscopy (CC), computer-assisted detection, and Artificial Intelligence (AI) have also been developed in recent years.

Thus, the growing focus of prominent market players on novel screening technologies is fueling the demand for colorectal cancer screening tests and devices.

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U.S. Colorectal Cancer Screening Market Growth Factors

Growing Prevalence of Colorectal Cancer to Boost Demand for Colorectal Cancer Screening

Among all cancer types, colorectal cancer is the third leading cause of death in terms of cancer in the U.S. However, if colorectal cancer is detected at an early stage, the disease can effectively be treated.

In recent years, there has been a significant growth in the number of new cases reported from colorectal cancer in the U.S. This rising number of cases was dominant among men, which is expected to fuel the utilization of screening tests in the country.

• For instance, in September 2023, according to the American Society of Clinical Oncology (ASCO), approximately 153,020 new cases were reported among adults in the U.S. In addition, the proportion of these cases was 71,160 in women and 81,860 in men.

This increasing incidence of colorectal cancer in the U.S. further boosts awareness regarding the benefits of early detection of the disease, which is expected to fuel the demand for screening tests in the country, thereby increasing the U.S. colorectal cancer screening market growth.

Increase in Alcohol Consumption and Smoking to Increase At-risk Population, Spurring Market Growth

Colorectal cancer ranks among the top 10 most common cancers in the U.S. and is the second leading cause of cancer-related death in the country. Moreover, the American Cancer Society stated that approximately 53,000 deaths in the U.S. were attributed to colorectal cancer, and an estimated 106,590 new cases were diagnosed annually in 2024.

Sedentary lifestyle, obesity, and comorbid conditions, possess a certain risk for colorectal cancer, which is expected to boost the demand for screening, thereby driving the market growth.

• For instance, according to the American Lung Association and the Centers for Disease Control and Prevention (CDC), although there has been a significant decrease in the smoking population in the U.S. over the past decade, approximately 28.0 million adults still smoked cigarettes in 2022-2023.

This encouraged the general and at-risk population toward regular screening for the condition, which was further augmented by the launch of advanced kits for home testing by prominent players in the U.S.

RESTRAINING FACTORS

Adverse Effects Associated with Use of Colonoscopes for Screening to Limit Market Growth

The screening tests through colonoscopes are more accurate than other screening tests. However, certain side effects are associated with the procedure, such as infection, bleeding, and others. These side effects restrict people from opting for colonoscopy as a screening test.

Currently, only reusable colonoscopes are available for screening colorectal cancer. Reusing colonoscopies can cause various adverse effects, such as perforation of the colon, bleeding, and the risk of device-related patient infections. These factors are expected to negatively impact the number of colorectal cancer screenings conducted through colonoscopy, thereby slowing the market’s growth.

• For instance, according to a study published by the International Surgery Journal in October 2021, colon perforation was common in around 0.07% of diagnostic colonoscopies.

Such side effects associated with colonoscopy procedures can limit the adoption of colonoscopes for screening.

U.S. Colorectal Cancer Screening Market Segmentation Analysis

By Type Analysis

Increasing Burden of Colorectal Cancer in Country Boosts Colonoscopy Segment’s Growth

Based on type, the market is classified into stool-based, colonoscopy, and others. The stool-based segment is further segmented into Fecal Immunochemical Test (FIT), Fecal Occult Blood Test (FOBT), and stool-DNA test.

The colonoscopy segment dominated the market in 2023 owing to the high accuracy of colonoscopy compared to other screening tests. Moreover, the increasing burden of colorectal cancer in the country has also been fueling the demand for colonoscopies for effective and early diagnosis of the disease.

• For instance, as per the data published by the American Cancer Society, Inc., in March 2023, colorectal cancer was the second most common cancer detected among the U.S. population.

The stool-based segment accounted for a significant market share in 2023 and is expected to expand at the highest CAGR during the forecast period. Prominent market players are emphasizing the provision of new non-invasive tests, such as stool-based FIT and FOBT tests, as well as the launch of Over-the-Counter (OTC) and at-home testing kits. This is expected to result in a preferential shift in the number of patients opting for colonoscopy procedures during the forecast period.

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By End-user Analysis

Growing Number of Hospitals & Clinics in the U.S. to Boost Colorectal Cancer Screening Procedures

By end-user, the market is segmented into hospitals & clinics, diagnostic imaging centers, clinical laboratories, and others.

The hospitals & clinics segment dominated the market in 2023. The segment’s dominance was mainly due to the increasing number of hospitals in the U.S. and the rising trend of conducting colorectal cancer screening through colonoscopies in the country.

• For instance, as per the survey published by the American Hospital Association in January 2024, there are around 6,120 active hospitals in the U.S.

The clinical laboratories segment is expected to grow at the highest CAGR during the forecast timeframe. This growth can be attributed to the growing popularity of non-invasive tests, such as stool-based tests, among healthcare providers and patients, coupled with better reimbursement for innovative tests. This is expected to lead to a shift of patients from hospitals and clinics to clinical laboratories in the upcoming years.

KEY INDUSTRY PLAYERS

Prominent Market Players Join Forces to Launch New Products and Retain Market Position

Key players in the U.S. colorectal cancer screening market, such as Exact Sciences Corporation, Olympus Corporation, and Laboratory Corporation of America Holdings, accounted for the significant U.S. colorectal cancer screening market share in 2023. The significant growth of these players in the market is attributed to their focus on new product launches.

• In October 2023, Olympus Corporation introduced the next-generation EVIS X1 endoscopy system, which several American physicians used during a colonoscopy screening.

Other market players, such as Everlywell, Inc., Hoya Corporation, and Medtronic, have increased their focus on partnerships to expand their offerings.

• In February 2022, Everlywell, Inc. partnered with a leading provider of at-home cancer testing kits to offer early-detection tests to individuals enrolled in employer health plans.

List of Top Colorectal Cancer Screening Companies in U.S./List of Top Colorectal Cancer Screening Companies:

• Olympus Corporation (Japan)


• Exact Sciences Corporation (U.S.)


• 3T Medical Complete Systems (U.S.)


• Everlywell, Inc. (U.S.)


• Eiken Chemical Co., Ltd. (Japan)


• Laboratory Corporation of America Holdings (U.S.)


• FUJIFILM Holdings Corporation (Japan)


• Pinnacle BioLabs (U.S.)


• BIOMÉRIEUX (France)


• Medtronic (Ireland)

KEY INDUSTRY DEVELOPMENTS:

• March 2024 – Exact Sciences Corporation launched the Riskguard, a hereditary cancer test in the U.S. It was designed to identify genetic alterations that may elevate the likelihood of developing ten prevalent cancers, some of which are, colorectal, prostate, skin, breast, and ovarian cancers.


• March 2024 – Olympus Corporation and the Colorectal Cancer Alliance (CCA), in collaboration, highlighted the importance of routine screenings to prevent colorectal cancer in response to the rising mortality rates among colorectal cancer patients under 50 in the U.S.


• May 2023 – Olympus Corporation announced the FDA clearance for the EVIS X1 endoscopy system to treat, diagnose, and observe gastrointestinal diseases. This system was utilized for colonoscopy screening during examinations by American physicians to observe the growth of cancer.


• February 2022 – Everlywell, Inc. emphasized its comprehensive digital platform and user-friendly at-home lab tests to provide widespread screenings for colorectal cancer prevention.


• November 2022 – Eiken Chemical Co., Ltd. launched the fully automated fecal immunochemical test/fecal calprotectin analyzer OC-SENSOR Ceres to ensure the seamless use of the OC-SENSOR series.

REPORT COVERAGE

The report provides a detailed competitive landscape and includes key insights, incidence of colorectal cancer in the U.S., new product launches, key industry developments, and COVID-19 impact. Furthermore, the report covers the U.S. market forecast, company profiles of key market players, market trends, and company market share analysis. Additionally, the report consists of quantitative and qualitative insights that have contributed to the market's growth.

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Report Scope & Segmentation