North America In-vitro Colorectal Cancer Screening Tests Market Report and Forecast 2024-2032

The North America in-vitro colorectal cancer screening tests market size was valued at USD 4.2 billion in 2023, driven by the increasing prevalence of colorectal cancer in the region. The market is expected to grow at a CAGR of 7.20% during the forecast period of 2024-2032, with the values likely to rise from USD 4.5 billion in 2024 to USD 7.9 billion by 2032.

Key Takeaways

• In the United States, colorectal cancer is the fourth most commonly diagnosed cancer and ranks as the second leading cause of cancer mortality in the region.
• In March 2024, a study published in the New England Journal of Medicine tested the performance characteristics of Guardant Health’s Shield blood test, revealing the sensitivity of the in-vitro diagnostic method for detecting colorectal cancer to be 83.1%.
• The preference for minimally invasive devices is likely to impact the market positively. In September 2023, ColoTest, an at-home Fecal Immunochemical Test (FIT) developed by Reese Pharmaceutical received FDA approval for the screening of colorectal cancer.

North America In-vitro Colorectal Cancer Screening Tests Market Analysis

In the United States, colorectal cancer is the fourth most commonly diagnosed cancer. It ranks as the second leading cause of cancer mortality in the region. According to the American Cancer Society, around 152,810 people are estimated to be diagnosed with this cancer type in 2024. Moreover, deaths from colorectal cancer are predicted to be 53,010 . This indicates that colorectal cancer is a significant cause of concern in North America. The growing number of colorectal cancer cases also impacts the demand for efficient screening methods, which in turn is expected to propel the North America in-vitro colorectal cancer screening tests market growth.

The market comprises a range of diagnostic tests performed outside the body in laboratory settings to screen and detect colorectal cancer. These tests are generally non-invasive or minimally invasive which encourages higher patient compliance rates and thus facilitates early detection of colorectal cancer.

The surge in regulatory approvals from health authorities such as the United States Food and Drug Administration (FDA) is expected to fuel North America in-vitro colorectal cancer screening tests market demand. In September 2023, ColoTest, an at-home Fecal Immunochemical Test (FIT) developed by Reese Pharmaceutical (United States based pharmaceutical company) received FDA approval to detect early stages of colorectal cancer and other gastrointestinal disorders. ColoTest is deemed 100% non-invasive with an accuracy of 98.8% in detecting invisible blood in stool. Further, in February 2024, the company announced that the convenient and affordable screening option is available at a retail price of USD 19.99 in pharmacies across the United States. The increased access and availability of such effective at-home colorectal screening tests are likely to positively impact the market growth in the forecast period.

The launch of innovative cancer screening blood tests to detect colorectal tumors is likely to boost North America in-vitro colorectal cancer screening tests market share. In March 2024, a study published in the New England Journal of Medicine tested the performance characteristics of a cell-free DNA (cfDNA) blood-based test called Shield blood test, revealing the sensitivity of the in-vitro diagnostic method for detecting colorectal cancer to be 83.1%, which is in par with the performance of other non-invasive screening tests. The Shield test, developed by an American biotechnology company, Guardant Health, has also demonstrated 65% sensitivity in detecting the earliest stage of cancer in pathology-confirmed cases.

North America In-vitro Colorectal Cancer Screening Tests Market Segmentation

The market report offers a detailed analysis of the market based on the following segments:

Market Breakup by Testing Type

• Fecal Occult Blood Tests
• Biomarker Tests
• CRC DNA Screening Tests
• Flexible Sigmoidoscopy
• Others

Market Breakup by Imaging Type

• Colonoscopy
• Proctoscopy
• CT Scan
• Ultrasound
• MRI
• PET Scan

Market Breakup by End User

• Hospitals
• Clinics
• Diagnostics Laboratories

Market Breakup by Country

• United States
• Canada

North America In-vitro Colorectal Cancer Screening Tests Market: Competitor Landscape

The key features of the market report include patent analysis, grants analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:

• Abbott
• Exact Sciences Corporation
• Hemosure
• SEKISUI Diagnostics
• Beckman Coulter, Inc.
• Quest Diagnostics
• Oncocyte Corporation
• Immunostics Inc.
• Medline Industries, LP
• GeneNews Ltd

Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.

FAQs

What was the North America in-vitro colorectal cancer screening tests market value in 2023?
The market attained a value of D 4.2 billion in 2023 driven by the increasing prevalence of colorectal cancer in the region.

What is the North America in-vitro colorectal cancer screening tests market forecast outlook for 2024-2032?
The market is anticipated to grow at a CAGR of 7.16% during the forecast period of 2024-2032, likely to reach a market value of USD 7.9 billion by 2032.

What are the major factors aiding the North America in-vitro colorectal cancer screening tests market demand?
The launch of innovative cancer screening blood tests to detect colorectal cancer and heightened patient awareness is fuelling the demand for the market.

What are the major North America in-vitro colorectal cancer screening tests market trends?
One of the significant trends in the market is the surge in regulatory approvals from health authorities such as the United States Food and Drug Administration (FDA). In September 2023, Reese Pharmaceutical’s ColoTest, an at-home fecal immunochemical test (FIT) received FDA approval for the screening of colorectal cancer.

What is the market segmentation based on testing type?
Based on the testing type, the market is segmented into fecal occult blood tests, biomarker tests, CRC DNA screening tests, and flexible sigmoidoscopy, among others.

What is the market breakup by imaging type?
By imaging type, the market is divided into colonoscopy, proctoscopy, CT scan, ultrasound, MRI, and PET scan, among others.

What are the major end users of the market?
End users of the market are hospitals, clinics, and diagnostics laboratories.

What is the market segmentation by countries?
The market segmentation by countries includes the United States of America and Canada.

Who are the key players involved in the North America in-vitro colorectal cancer screening tests market?
The key players in the market are Abbott, Exact Sciences Corporation, Hemosure, SEKISUI Diagnostics, Beckman Coulter, Inc., Quest Diagnostics, Oncocyte Corporation, Immunostics Inc., Medline Industries, LP, and GeneNews Ltd.