Home > Healthcare & Medical Devices > In-Vitro Colorectal Cancer Screening Tests Market

In-Vitro Colorectal Cancer Screening Tests Market Size By Test Type (Fecal Occult Blood Tests {Guaiac FOB Stool Test, Immuno-FOB Agglutination Test, Lateral Flow Immuno-FOB Test, Immuno-FOB ELISA Test}, Biomarker Tests {Tumor M2-PK Stool Test, Transferrin Assays}, CRC DNA Screening Tests {Methylated Gene Testing, Panel DNA Tests}), By End-use (Hospitals, Clinics, Diagnostics Laboratories), COVID-19 Industry Analysis, Regional Outlook, Application Potential, Competitive Market Share & Forecast, 2021 – 2027

  • Report ID: GMI451
  • Published Date: Oct 2021
  • Report Format: PDF

Industry Trends

In-Vitro Colorectal Cancer Screening Tests Market size exceeded USD 765 million in 2020 and is anticipated to grow at a CAGR of over 5.9% between 2021 and 2027. Rising incidence of colorectal cancer (CRC) owing to various factors such as adoption of unhealthy lifestyle, diabetes, and aging population among others are stimulating the market growth. Moreover, growing awareness regarding in-vitro colorectal cancer screening tests and increasing use of biomarkers are expected to promote the market expansion.

Get more details on this report - Request Free Sample PDF

However, several restraints associated with the use of in-vitro colorectal cancer screening tests such as lack of qualified staff and screening guidelines in developing regions may negatively impact the in-vitro colorectal cancer screening tests market growth. Inadequate reimbursement scenario pertaining to in-vitro colorectal cancer screening tests may further restrict the industry expansion. Shortage of trained medical workers in APAC region with the aging demographics and increased workload of physicians is poised to rise dramatically.

Additionally, dearth of favourable policies & campaigns for promoting the knowledge and use of in-vitro colorectal cancer screening tests is set to hamper the in-vitro colorectal cancer screening tests market progression. Furthermore, the U.S. FDA reviews and approves cancer screening tests, prescription drugs, and medical devices for colorectal cancer screening. These screening tests are mandated to obtain a premarket approval (PMA) before commercializing the product. The PMA approval refers to a complex process that requires safety & effectiveness data and has to undergo clinical trials study. The U.S. FDA regulates these tests to maintain regulatory standards.

The COVID-19 pandemic arose as an unparalleled health concern that has rendered negative impact on the in-vitro colorectal cancer screening tests market. The coronavirus outbreak affected global economy and multiple sectors. Revised standard operating protocols, travel restrictions, and social distancing measures further limited the hospital admissions related to non-COVID patients. Nationwide lockdowns, travel limitations, and emergencies declared in several countries disrupted the supply chain of healthcare products, further limiting the industry progression. Negligence towards non-COVID related medical operations hampered the use of in-vitro colorectal cancer screening tests globally.

However, several initiatives adopted by the public organizations to facilitate the colorectal cancer screening has benefitted the in-vitro colorectal cancer screening tests market demand. For instance, as per the Cancer.org, recent reports indicate that healthcare systems in California continued the supply of FIT kits in April and May of 2020. The FIT response rates remained high, despite the onset of the pandemic. Moreover, the European Cancer community mobilised its resources to assess, address, and mitigate the negative impact of COVID-19 crisis on colorectal cancer screening.

Growing prevalence of colorectal cancer to proliferate the in-vitro colorectal cancer screening tests market revenue

Colorectal cancer is amongst the leading cause of morbidity and mortality globally. CRC accounts for 9.4% mortality rate that is the second-most lethal cause of cancer death after lung cancer. According to the NCBI article, in 2020, over 1.9 million new cases and 935,000 deaths from were reported associated with colorectal cancer globally. In some countries, the incidence and mortality associated with CRC are substantially high. This is majorly due to factors such as acceptance of westernized diet, lifestyle, and lack of healthcare infrastructure & resources, especially in the emerging economies. A study conducted by the Clinical and Translational Gastroenterology linked the rising incidence of obesity with surging prevalence of CRC. The prevalence is predicted to surge with increasing incidence of obesity among all age groups. With the obesity prevalence estimates set to multiply in the coming years, the prevalence of CRC to increase, further facilitating the in-vitro colorectal cancer screening tests market growth.

The early detection of CRC through in-vitro colorectal cancer screening tests is essential to reduce the disease burden and improve the mortality rate associated with CRC. Regular screening facilitates early detection that might lead to approximately 60% reduction in CRC mortalities. The use of in-vitro colorectal cancer screening tests is also projected to promote the average 5-year survival rate from 46% to 73%, with regular periodic screening every year.

Affordable testing options with high clinical success rate will boost the industry growth

The fecal occult blood tests (FOBT) segment in the in-vitro colorectal cancer screening tests market was valued at around USD 625 million in 2020 led by the high preference for cost-effective fecal occult blood tests. Fecal occult blood tests (FOBT) uses the stool samples for detection of occult blood in the faeces.  The United States Preventative Services Task Force suggests colorectal cancer screening by the means of FOBT among other tests for individuals corresponding to 50-75 age group. FOBT is based on chemical reaction that detects the presence of blood in faeces and provides an inexpensive, simple, & accessible screening option. A clinical study that randomized 46,551 participants concluded that FOBT with rehydration reduced the 13-year cumulative mortality associated with CRC by 33%.

High number of hospital admissions associated with colorectal cancer to surge the demand

Get more details on this report - Request Free Sample PDF


The hospitals end-use segment held more than 24% of the in-vitro colorectal cancer screening tests market share in 2020 owing to the growing usage of in-vitro colorectal cancer screening tests in the hospital settings to counter and support the significant number of hospital admissions. According to the JAMA Network, approximately 15% to 30% of patients diagnosed with colorectal cancer represent emergency and are admitted to the hospital. The CRC patients inflict substantial healthcare burden as they spend 50% more days in the hospitals as compared to non-emergency CRC.

High prevalence of colorectal cancer and favorable initiatives in the North America will promote the regional growth

Get more details on this report - Request Free Sample PDF


U.S. in-vitro colorectal cancer screening tests market is slated to reach around USD 392 million by 2027. This high revenue share is attributed to multiple factors including high prevalence of CRC, favourable reimbursement scenario, and increasing incidence of obesity across the country. Colorectal cancer is amongst the common cancers inflicting significant mortalities in the U.S. The American Cancer Society and the National Center for Health Statistics, in 2020, estimated that approximately 147,950 individuals were diagnosed with CRC. The incidence rate of CRC increased from 2012 to 2016, from 30 (per 100,000 individuals) to 45.7. These numbers are further estimated to rise with augmented incidence of obesity in the country. According to the Centers for Disease Control and Prevention (CDC), in 2017, obesity affects more than 18.5% of the children and adolescents in the U.S. Additionally, the current trends indicate around 33% increase in the prevalence of obesity in the coming years. These developments will expand the market size in the U.S. during the forecast period.

Strategies adopted by major players to influence the industry value

Some of the major companies operating in the in-vitro colorectal cancer screening tests market are Abbott Molecular, Epigenomics AG, Novigenix, Sysmex Corporation, Eiken Chemical, Quest Diagnostics, BioMarCare Technologies, Randox Laboratories, OncoCyte Corporation-Bio time, Exact Sciences Corporation, and Immunostics. These prominent leaders concentrate on adoption of several initiatives such as strategic agreements, new product launch, mergers & acquisition for business expansion. Furthermore, these participants are heavily investing in research that enables them to launch advanced products and channelize maximum market share.


In-vitro colorectal cancer screening tests market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2016 to 2027, for the following segments:

Market, By Test Type, 2016 - 2027 (USD Million)

  • Fecal occult blood test (FOBT)
    • Guaiac FOB stool test
    • Immuno-FOB agglutination test
    • Lateral flow immuno-FOB test
    • Immuno-FOB ELISA test     
  • Biomarker test        
    • Tumor M2-PK stool test
    • Transferrin assays   
  • CRC DNA screening test     
    • Methylated gene test
    • Panel DNA test

Market, By End-use, 2016 - 2027 (USD Million)

  • Hospital
  • Clinics
  • Diagnostic Laboratories
  • Others

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

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


Authors: Rupali Swain, Subodh Kharad

Frequently Asked Questions (FAQ) :

The global market size of in-vitro colorectal cancer screening tests was worth USD 765 million in 2020 and will witness a growth rate of around 5.9% through 2027 owing to the increasing adoption of unhealthy lifestyles and the rising burden of colorectal cancer (CRC).
Fecal occult blood tests, biomarker tests, and CRC DNA screening tests are some of the well-known tests used for in-vitro colorectal cancer screening.
The U.S. market is estimated to exceed USD 392 million through 2027 due to the rising prevalence of obesity and CRC, along with the presence of favorable reimbursement scenarios in the country.

Buy Now

Premium Report Details

  • Base Year: 2020
  • Companies covered: 12
  • Tables & Figures: 294
  • Countries covered: 18
  • Pages: 150
  • Upcoming Report: Details can be customized to meet your information and data needs. Feel free to share your detailed research requirements via this form.

Get a report that explains COVID-19 impact on this market

 Request Free Sample

Budget constraints? Get in touch with us for special pricing

Request Discount