North America Colorectal Cancer Diagnostics Market Outlook

The North America colorectal cancer diagnostics market was valued at US$ 4,315.86 million in 2023 and is projected to reach US$ 6,621.26 million by 2028, growing at a CAGR of 8.9% during the forecast period.

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Key Growth Driver: Launch of New Diagnostic Products

The launch of innovative diagnostic tools continues to drive market growth in North America. Leading manufacturers are developing a wide range of devices to ease the burden of colorectal cancer and related conditions such as colon polyps, Crohn’s disease, colitis, and irritable bowel syndrome.

In July 2022, US Digestive Health (USDH)—a network of top-rated gastrointestinal (GI) practices—commercialized AI-assisted colonoscopy screenings through the largest deployment of Genious Intelligent GI endoscopy modules in the country. These AI-powered tools help physicians identify difficult-to-detect and potentially cancerous polyps in real time, improving diagnostic accuracy and access for patients across southeastern, southwestern, and central Pennsylvania.

In another advancement, Olympus Corporation launched the ENDO-AID platform in September 2020, a next-generation AI-powered solution that includes the ENDO-AID CADe application for computer-aided detection of colon abnormalities. The platform integrates with the EVIS X1 endoscopy system and provides real-time display of suspicious lesions, enhancing early detection and diagnostic efficiency.

Such frequent product innovations and technological advancements are significantly contributing to the growth of the colorectal cancer diagnostics market in the region.

Market Overview: Rising Incidence and Strong Preventive Measures

The market spans the US, Canada, and Mexico, with the US being the dominant contributor.

According to the American Society of Clinical Oncology (ASCO), colorectal cancer is the third most commonly diagnosed cancer among men and women in the US. In 2023, an estimated 153,020 adults are expected to be diagnosed with the disease, including 106,970 cases of colon cancer (54,420 men and 52,550 women) and 46,050 cases of rectal cancer (27,440 men and 18,610 women).

Although incidence is generally higher among older adults, recent years have seen a notable rise in cases among younger individuals. The lifetime risk of developing colorectal cancer is approximately 1 in 22 for men and 1 in 24 for women.

In 2023 alone, the disease is projected to cause approximately 52,550 deaths in the US. However, the mortality rate has declined significantly over the past two decades due to improved screening and treatment practices.

More than 600,000 surgeries are performed annually in the US to treat colon-related conditions. According to the American Cancer Society, the five-year survival rate is 91% for localized colon cancer and 90% for localized rectal cancer.

Efforts to improve early detection have been intensified. The 2018 American Cancer Society screening guidelines recommend regular colorectal cancer screening for adults aged 45 and older, using either high-sensitivity stool-based tests or visual examinations based on patient preference and availability. In May 2021, the US Preventive Services Task Force updated its recommendations to lower the starting age for routine screening from 50 to 45 years, broadening the at-risk population eligible for early detection.

Additionally, strong government support for research and innovation further strengthens the market. Organizations such as the Colorectal Cancer Alliance—the world's largest nonprofit dedicated to colorectal cancer patient advocacy—are making significant investments in research. In 2020, the alliance allocated US$ 1.1 million in funding to individual scientists through research grants.

Conclusion

The North America colorectal cancer diagnostics market is poised for robust growth, driven by rising disease incidence, earlier screening protocols, and rapid technological advancements in diagnostic solutions. Ongoing government initiatives, research funding, and patient advocacy efforts are expected to further fuel market expansion through 2028.

North America Colorectal Cancer Diagnostics Strategic Insights

Strategic insights for the North America Colorectal Cancer Diagnostics provides data-driven analysis of the industry landscape, including current trends, key players, and regional nuances. These insights offer actionable recommendations, enabling readers to differentiate themselves from competitors by identifying untapped segments or developing unique value propositions. Leveraging data analytics, these insights help industry players anticipate the market shifts, whether investors, manufacturers, or other stakeholders. A future-oriented perspective is essential, helping stakeholders anticipate market shifts and position themselves for long-term success in this dynamic region. Ultimately, effective strategic insights empower readers to make informed decisions that drive profitability and achieve their business objectives within the market.

Market leaders and key company profiles

  Bruker Corp

  Clinical Genomics Technologies Pty Ltd

  EDP Biotech Corp

  Eiken Chemical Co., Ltd.

  Epigenomics AG

  F. Hoffmann-La Roche Ltd

  Illumina Inc

  Medtronic Plc

  Quest Diagnostics Inc

  Siemens Healthineers AG

North America Colorectal Cancer Diagnostics – Regional Insights

The regional landscape of the North America colorectal cancer diagnostics market encompasses the distinct areas where companies operate and compete. Effectively addressing regional nuances—such as variations in healthcare infrastructure, patient awareness, diagnostic preferences, economic disparities, and regulatory frameworks—is essential for developing tailored strategies. Companies can identify growth opportunities by targeting underserved regions or customizing solutions to meet local healthcare needs. A focused regional approach enhances resource efficiency, sharpens marketing efforts, and strengthens competitive positioning, ultimately supporting market expansion and improved diagnostic outcomes across North America.

North America Colorectal Cancer Diagnostics Market Segmentation

The North America colorectal cancer diagnostics market is segmented by modality, end user, and country.

• By Modality:
  The market is divided into imaging tests and stool-based tests. In 2023, imaging tests accounted for the larger market share.
• Imaging tests include colonoscopy, CT colonography, flexible sigmoidoscopy, capsule endoscopy, and others.
• Stool-based tests are further segmented into fecal immunochemical test (FIT), guaiac-based fecal occult blood test (gFOBT), and stool DNA test.
• By End User:
  The market is categorized into hospitals, diagnostic laboratories, cancer research institutes, and others. In 2023, hospitals held the largest market share.
• By Country:
  The regional market includes the United States, Canada, and Mexico. The United States dominated the market in 2023, contributing the largest share.

Key Market Players:
Leading companies operating in the North America colorectal cancer diagnostics market include:
Medtronic plc, Illumina Inc., Clinical Genomics Technologies Pty Ltd, EDP Biotech Corp, Epigenomics AG, F. Hoffmann-La Roche Ltd, Quest Diagnostics Inc., Siemens Healthineers AG, Bruker Corp, and Eiken Chemical Co., Ltd.

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Author's Bio
Akshay
Senior Market Research Expert at Business Market Insights