In-vitro Colorectal Cancer Screening Tests Market Size, Share & Trends Analysis Report By Test Type (Fecal Occult Blood Tests, Biomarker Tests, CRC DNA Screening Tests), By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global in-vitro colorectal cancer screening tests market size was valued at USD 864.55 million in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 3.02% from 2023 to 2030. The growing prevalence of colon and rectal melanoma cases and increasing demand for effective genetic testing are the prime factors boosting the market. According to data published by the American Cancer Society in March 2023, colorectal cancer ranks as the third most common cause of cancer-related deaths in the United States. The report estimates that approximately 153,020 individuals will receive a diagnosis of colorectal cancer in the same year, with 52,550 deaths attributed to the disease. These statistics highlight the significant impact of colorectal malignancy on the population and the need for effective prevention, early detection, and treatment measures to reduce its burden.

The increasing prevalence of colorectal cancer is a significant driver for market growth. A study published in the Chinese Medical Journal in March 2022 highlighted the rising incidence of cancer in China, with approximately 4,820,000 new cases reported in 2022. Among these cases, there were 592,232 individuals diagnosed with colorectal cancer. This higher incidence has resulted in an increased demand for screening tests and treatments for tumors.

Further, according to a study published by MDPI in April 2022, colorectal cancer is recognized as one of the most prevalent in Canada, with an estimated 24,800 cases diagnosed in 2021. While colorectal cancer cases in adults under the age of 50 account for approximately 8% of all cases in Canada, recent research has revealed a significant increase in the incidence of colon malignancy among younger individuals. This upward trend in the prevalence of colon cancer, particularly among the younger population, is projected to have a positive impact on market growth. The need for effective screening and treatment options is expected to rise in order to address this emerging public health concern.

Furthermore, early and accurate detection of colon disease through in-vitro screening tests is crucial in reducing the burden of the disease and improving mortality rates. Regular screening enables the early identification of CRC, which has been associated with a potential 60% reduction in CRC-related deaths. The utilization of in-vitro screening tests is expected to contribute to an improvement in an average 5-year survival rate from 46% to 73% when regular periodic screening is conducted annually. These screening tests play a significant role in the early detection and management of CRC, ultimately leading to better patient outcomes and increased survival rates.

The market experienced a significant impact from the COVID-19 pandemic, leading to a decline in screenings during the initial phase of the pandemic. According to an article published by MDPI in May 2022, a study in the Canada revealed a decline in the amount of colorectal cancer diagnoses throughout the COVID-19 pandemic compared to the pre-pandemic period. However, as the pandemic situation has improved and healthcare services have resumed normal operations, colorectal malignance screening procedures are gradually returning to normal, resulting in the market regaining its momentum. As a result, the market is expected to exhibit regular growth during the forecast period, as screening activities continue to be conducted as per standard protocols.

Moreover, the market is driven by the increasing focus of federal regulatory bodies on the effectiveness of biomarker tests. Key companies are incorporating highly informative biomarkers, such as protein biomarkers, KRAS gene, and DNA methylation biomarkers (NDRG4 and BMP3), to ensure high sensitivity in the identification of colorectal cancer (CRC). Similarly, rising initiatives aimed at creating awareness about the diagnosis of colon and rectal tumour, which contribute to revenue generation. Two charitable organizations of UK, Bowel Cancer UK and the Beating Bowel Cancer every year host an annual event in the month of April to educate the public, raise the awareness about bowel disorders, and funds for treating this medical condition.

Test Type Insights

Based on test type, fecal occult blood tests dominated the market with a revenue share of 82.0% in 2022. The presence of blood in the stool can indicate various conditions, including colorectal cancer, polyps, ulcers, or hemorrhoids. The fecal occult blood test is a commonly preferred screening test due to its high effectiveness in detecting bowel malignance. Factors such as the increasing prevalence of colorectal cancer and the growing utilization of fecal occult blood test are anticipated to drive the growth of this segment.  

The segment growth is further driven by the advancements made by market players, which have led to increased usage of their products. For instance, in June 2022, W.H.P.M., Inc obtained 510(k) marketing approval from the U.S. FDA for their Hemosure Accu-Reader A100, Fecal Occult Blood Test. These developments, coupled with the rising prevalence of colorectal cancer, are anticipated to contribute to the growth of the market.

The biomarker tests segment is expected to experience fastest growth rate throughout the projection period. The use of Tumor M2-PK stool tests is gaining traction in the biomarker testing field and is projected to hold a significant market share. These tests offer increased accuracy and sensitivity by analyzing the presence of biomarkers for colorectal disease diagnosis. On the other hand, methylated gene testing provides information on pre-malignant colorectal neoplasia and is expected to exhibit the fastest CAGR during the forecast period.

Regional Insights

North America region dominated the market with a share of over 43.17% in 2022. The growth of the region is expected to be fueled by the rising prevalence of colon malignancy, advancements in technology, and increasing initiatives focused on malignancy prevention.The United States is projected to hold a significant share in the market in North America due to its advanced healthcare infrastructure for screening and the increasing burden of colorectal malignancy.

According to data published by the American Cancer Society in 2023, it is estimated that there will be 153,020 new cases of colon and rectum malignances in the U.S. Among these cases, 106,970 are expected to be colon tumors, while 46,050 are expected to be rectum malignancies. Additionally, data from the same source indicates that 151,030 colon and rectum malignance cases were detected in 2022, and 149,500 cases were detected in 2021. These statistics highlight the high prevalence of colon and rectum cancers in the country, which is expected to drive the growth of the market.

Asia Pacific is anticipated to experience the highest growth rate during the projection period, primarily driven by developing economies such as China and India. These countries possess significant growth potential due to their large customer base. The region is witnessing a growing concern for colorectal malignancy, particularly among the rising geriatric population and due to changes in lifestyle in Asian countries. This increasing prevalence of colorectal cancer in Asia Pacific is expected to drive the demand for in-vitro screening, contributing to the market's growth in the region.

Key Companies & Market Share Insights

Key players are undertaking various strategic initiatives to increase their share in themarket.The market is highly competitive due to frequent acquisitions, collaborations, partnerships, and strategic alliances. This is further influenced by growth in R&D spending as most vendors are focusing on the introduction of CRC DNA and biomarker screening tests. For instance,in February 2022, QIAGEN Manchester Ltd. received FDA approval for the Therascreen KRAS RGQ PCR Kit, which is used for colorectal cancer screening. Some of the key players in the global in-vitro colorectal cancer screening tests market include:

• Abbott

• Epigenomics

• Beckman Coulter, Inc.

• Eiken Chemical Co., Ltd.

• SysmexCorporation

• Siemens Healthcare GmbH

• Quest Diagnostics Incorporated

• OncocyteCorporation

• Merck KGaA

• ImmunosticsInc.

• Kyowa Kirin Co., Ltd.

• Randox Laboratories Ltd.

• R-Biopharm AG

In-Vitro Colorectal Cancer Screening Tests Market Report Scope

Global In-vitro Colorectal Cancer Screening Tests Market Report Segmentation

This report forecasts revenue growth and provides an analysis on the latest trends in each of the sub-segments from 2018 to 2030. For this report, Grand View Research has segmented the in-vitro colorectal cancer screening tests market based on test type and region:

• Test Type Outlook (Revenue, USD Million, 2018 - 2030)

  • 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

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • France

    • Italy

    • Russia

    • Spain

    • UK

    • Netherlands

    • Sweden

    • Denmark

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • Thailand

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait