Colorectal Cancer Diagnostics Market

Colorectal Cancer Diagnostics Market Size

The global colorectal cancer diagnostics market was estimated at USD 14.5 billion in 2024. The market is expected to grow from USD 15.3 billion in 2025 to USD 26.6 billion in 2034, at a CAGR of 6.4% during the forecast period. There is an expected growth in the market due to the rise in the occurrence of CRC, technological advancements, and untapped opportunities for growth.

The cases of CRC are continually growing. For instance, according to the International Agency for Research on Cancer (IARC), more than 1.9 million CRC cases were diagnosed in 2022 globally. CRC has considerable economic and societal impacts and is one of the most common forms of cancer. This implies a growing demand for diagnostics in the foreseeable future.

Additionally, the colorectal cancer diagnostics market is seeing considerable spending on research and development as firms attempt to launch new products. The large industry players are likely to benefit in the next few years from rising revenues due to an increase in favourable outcomes from the growing demand for early diagnosis. For instance, in July 2024, Guardant Health announced the U.S. Food and Drug Administration (FDA) approval of its Shield non-invasive blood test indicated for CRC screening in individuals aged 45 years and older with a minimal risk of cancer development. This was the first blood-based test approved by the FDA as a primary option for CRC screening.

Furthermore, technological advancements such as next-generation sequencing, artificial intelligence (AI)-integrated imaging, and liquid biopsy are enhancing screening accuracy and promoting early diagnosis. These advancing technologies alongside expected new biomarker and molecular-based tests are expected to boost the expansion of the CRC diagnostics market. Colorectal cancer diagnostics refer to the tools and procedures conducted to screen and detect colorectal cancer (CRC), a cancer developed in the rectum or colon. Cancer diagnostics, which is estimated to reach USD 372.5 billion by 2034, helps determine the cancer progression, early detection, and plan treatment strategies.

Colorectal Cancer Diagnostics Market Trends

• There is an ongoing shift towards blood-based biomarker tests, liquid biopsies, and stool-based tests as more non-invasive methods are being introduced into the market. Such methods enables early diagnosis, patient convenience, ease of access, and compliance.
  
• Japan, Germany, the UK, and the US are focusing towards promoting early detection by conducting countrywide CRC screening programs and awareness campaigns. In addition, regulatory authorities in these countries are facilitating the rapid approval of new diagnostic tests to improve diagnosis.
  
• For instance, on October 2024 the U.S. FDA approved Exact Sciences Corporation's Cologuard Plus test for the diagnosis of colorectal cancer in high risk patients at 45 years or older.
  

Colorectal Cancer Diagnostics Market Analysis

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In 2021, the global market was valued at USD 12.7 billion. The following year, it saw a slight increase to USD 13.2 billion, and by 2023, the market further climbed to USD 13.8 billion. Based on test type, the market is segmented into blood tests, stool tests, imaging tests, biopsy, and other test types. Additionally, the stool tests segment is further sub-segmented into fecal occult blood test, fecal biomarker tests, and CRC DNA screening test. Furthermore, the imaging tests segment is further sub-segmented into CT, ultrasound, MRI, PET, colonoscopy, and other imaging tests. The imaging tests segment dominated the market with the largest revenue share of 34.3% in 2024.

• Growing cases of CRC is increasing the need for diagnostic imaging tests and cancer detection at an early stage. For example, as reported by the Colorectal Cancer Alliance, 1 in 24 individuals is forecasted to be diagnosed with colorectal cancer at some point in their life. The large number of cancer cases being reported requires advanced imaging techniques to be employed for supporting precise diagnosis and ensuring better treatment results, which is promoting the growth of the segment.
  
• Furthermore, the adoption of new technologies such as liquid biopsy-guided imaging, PET-CT scanning alongside AI-assisted imaging has increased the focus on achieving high accuracy in diagnosis which has increased the demand for the imaging CRC test significantly.
  

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Based on end use, the colorectal cancer diagnostics market is segmented into hospitals, diagnostic imaging centers, cancer research centers, and other end users. The hospitals segment dominated the market with the largest revenue share of 44.2% in 2024.

• Hospitals encompass advanced technological screening capabilities such as gastroenterology labs, radiology units, and oncology departments. These capabilities enable the hospital to undertake substantial volume of accurate CRC testing procedures, driving the segment growth.
  
• Additionally, many developed countries are focusing towards implementing nationwide CRC screening programs, which is expected to promote the hospital-based CRC testing.
  

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The North America colorectal cancer diagnostics market dominated the global market with a market share of 35.2% in 2024. The market is driven by advanced healthcare infrastructure, strong awareness, and rapid adoption of colorectal cancer diagnostics tests in the region.

The U.S. market was valued at USD 4.1 billion and USD 4.2 billion in 2021 and 2022, respectively. The market size reached USD 4.7 billion in 2024, growing from USD 4.4 billion in 2023.

• The increasing cases of CRC in the U.S., especially among young adults owing to factors such as changes in  gut microbiota, environmental exposures, and dietary habits is promoting the requirement for effective diagnostic tools. For instance, as per the American Cancer Society, about 152,810 new cases of CRC were diagnosed in the U.S. in 2024.
  
• Additionally, availability of at-home tests such as stool and blood biomarker tests has increased the demand for early diagnosis of colorectal cancers in the region. For example, in May 2024, the U.S. FDA declared approval for Geneoscopy’s ColoSense, a non-invasive colorectal cancer screening test, which can be done at home for patients above 45 years old.
  

Europe colorectal cancer diagnostics market accounted for USD 4.3 billion in 2024 and is anticipated to show lucrative growth over the forecast period.

• One of the key catalysts for the growth of the market in the region is the rising aging populations, as the risk of colorectal cancer significantly higher among the people with age group 50 and above.
• For instance, according to the European Commission, 21.1% of the EU population was aged 65 or older in 2022, a figure projected to reach 32.5% by 2100.
  
• Therefore, as the population age so does the demand for the advanced and effective colorectal cancer diagnostics devices in the region is anticipated to rise in the foreseeable future.
  

UK colorectal cancer diagnostics devices market is anticipated to witness considerable growth over the analysis period.

• The UK is experiencing a rise in the cases of colorectal cancer which can be attributed to the growing geriatric population, sedentary lifestyles, and changing dietary habits. This places a strong emphasis on the need for comprehensive diagnostic solutions. For example, as stated by Cancer Research UK, 44,100 new cases of bowel cancer are diagnosed in the UK every year.
  
• Moreover, there is an increased focus on the CRC diagnosis owing to initiative introduced by the government and regulatory bodies such as NHS. For example, the NHS has set up cancer screening programs for people aged 50 years and older with the goal of improving cancer survival and early diagnosis rates in the population.
  

The Asia Pacific colorectal cancer diagnostics market is anticipated to grow at the highest CAGR of 6.8% during the analysis timeframe.

• The rising prevalence of colorectal cancer in the region is one of the key factor pushing the market in the forward direction.
  
• For instance, as per the data from the Wiley journal, in 2022 the Asia region accounted for 50.2% of the global colorectal cancer cases, among this 10% of the cases were from the younger age population.
  
• Therefore, as the case of colorectal cancer increases, so does the demand for effective and advanced diagnostic kits, thereby propelling the market growth in the region.
  

Japan colorectal cancer diagnostics market is predicted to grow significantly over the forecast period.

• Japan has largest share of geriatric population in the world, that is resulting in a higher risk and prevalence of CRC. For instance, as per the World Economic Forum, over 10% of the Japanese population is aged 80 years and older, which escalates the demand for effective diagnostic tools for early diagnosis among high-risk individuals.
  
• Moreover, the implementation of community-based screening programs backed by the government of Japan is also contributing to the market growth.
  

Brazil is experiencing significant growth in the Latin America colorectal cancer diagnostics market.

• Brazilian health authorities and organizations have launched extensive awareness campaigns and screening programs.
  
• Initiatives such as those by the Brazilian Association of Intestinal Cancer Prevention (ABRAPRECI) have significantly increased public awareness and screening rates, leading to earlier detection and treatment.
  

Saudi Arabia colorectal cancer diagnostics market is poised to witness substantial growth in Middle East and Africa market during the forecast period.

• Saudi Arabia has a very high incidence rate of early-onset CRC owing to its high young population, which is contributing to the demand for early diagnostics for timely intervention. For instance, according to the National Institutes of Health, more than 85% of the Saudi population is aged less than 50 years old and are at a high risk of early-onset CRC.
  
• Additionally, high rates of obesity and diabetes coupled with a growing unorganized lifestyle is also contributing to the high incidence of CRC in the country, thereby driving the demand for effective diagnostic solutions.
  

Colorectal Cancer Diagnostics Market Share

The market is competitive, that includes global as well as local players. The top 5 players in this market include Exact Sciences Corporation, Guardant Health, GE HealthCare Technologies, Siemens Healthineers, and Olympus Corporation. These players collectively account for about 50% market share. The top players are investing in the development of advanced treatments to enhance treatment efficiency.

Moreover, these companies are also focusing towards establishing strategic partnerships with research institutions and healthcare providers, which is critical for integrating modern technologies and expanding distribution. This has enabled the companies to address the surge in demand for non-invasive and cost-effective diagnostic solutions. The market experiences a regulatory support and streamlines approval processes which further motivates to innovate and facilitates market entry.

Colorectal Cancer Diagnostics Market Companies

Some of the eminent market participants operating in the colorectal cancer diagnostics industry include:

• Abbott Laboratories
• Danaher Corporation
• DiaCarta
• Exact Sciences Corporation
• F-Hoffmann-La Roche
• GE HealthCare Technologies
• Geneoscopy
• Guardant Health
• H.U. Group Holdings
• New Day Diagnostics
• Olympus Corporation
• Phase Scientific International
• QIAGEN N.V.
• Siemens Healthineers
• Sysmex Corporation
• Thermo Fisher Scientific

• Exact Sciences Corporation is one of the major player that offer non-invasive CRC screening products. Cologuard, an FDA approved stool-based DNA screening test, is one of its flagship products, that offers early detection with a high accuracy.
  
• Guardant Health is another major player that specializes in liquid-based biopsy CRC diagnostics. Its shield test provides a substitute for conventional tissue and stool-based methods, offering non-invasive advanced diagnostic capabilities for early detection.
  
• F. Hoffmann-La Roche has strong presence in market due to its advanced Cobas test platform that offers automated CRC screening. Additionally, the company’s high research and development investments coupled with its vast global presence offers it a competitive advantage.
  

Colorectal Cancer Diagnostics Industry News:

• In November 2024, Thermo Fisher Scientific, through its subsidiary Life Technologies Corporation, announced a collaboration agreement with Mainz Biomed N.V. to jointly develop and potentially commercialize Mainz Biomed’s next-generation colorectal cancer screening product. This partnership strengthens Thermo Fisher’s position in the CRC diagnostics market by expanding its molecular diagnostics portfolio.
  
• In October 2024, Exact Sciences Corporation announced the U.S FDA approval of its Cologuard Plus multitarget stool-based DNA test. This test was indicated for the detection of CRC in medium-risk patients aged 45 years and older. This approval was expected to significantly boost the company’s reach in the colorectal cancer diagnostics market.
  
• In July 2024, Guardant Health announced that it had received FDA approval for Shield, a blood-based test designed for colorectal cancer (CRC) screening in adults aged 45 and older who are at average risk. This regulatory milestone enabled the company to expand its market presence by offering Shield as a primary, non-invasive screening option. With approval, Shield also became eligible for Medicare coverage, significantly enhancing accessibility and positioning Guardant Health as a key player in the CRC diagnostics landscape.
  
• In May 2024, Geneoscopy announced the U.S. FDA approval of its ColoSense non-invasive screening test for detecting colorectal cancer. ColoSense is an RNA biomarker test intended for CRC screening in adults with average risk. This product approval expanded the company’s CRC diagnostics product portfolio.
  

The colorectal cancer diagnostics market research report includes an in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million from 2021 – 2034 for the following segments:

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Market, By Test Type

• Blood tests
• Stool tests
  • Fecal occult blood test (FOBT)
  • Fecal biomarker test
  • CRC DNA screening test 
• Imaging tests
  • CT
  • Ultrasound
  • MRI
  • PET
  • Colonoscopy
  • Other imaging tests
• Biopsy
• Other test types

Market, By End Use

• Hospitals
• Diagnostic imaging centers
• Cancer research centers
• Other end use

The above information is provided for the following regions and countries:

• North America 
  • U.S.
  • Canada 
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands 
• Asia Pacific 
  • China
  • Japan
  • India
  • Australia
  • South Korea 
• Latin America
  • Brazil
  • Mexico
  • Argentina 
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE