In-Vitro Colorectal Cancer Screening Tests Market Size By Test Type (Fecal Occult Blood Tests [Guaiac FOB Stool, Immuno-FOB Agglutination, Lateral Flow Immuno-FOB, Immuno-FOB ELISA], Biomarker Tests [Tumor M2-PK Stool, Transferrin Assays], CRC DNA Screening Tests [Methylated Gene Testing, Panel DNA Tests]), Industry Analysis Report, Regional Outlook (U.S., Canada, UK, Germany, France, Italy, Spain, Japan, China, India, Australia, Brazil, Mexico, South Africa, Saudi Arabia), Application Potential, Price Trends, Competitive Market Share & Forecast, 2017 – 2024
Published Date: May 2016 | 140 Pages | Report ID: GMI451 Report Format: PDF
In-Vitro Colorectal Cancer Screening Tests Market size was valued over USD 785 million in 2016 and is expected to witness more than 5% CAGR from 2017 to 2024.
Germany In-Vitro Colorectal Cancer Screening Tests Market, By Test Type, 2013 - 2024 (USD Million)
Growing prevalence of rectal and colon cancer, advancements in the field of diagnosis and introduction of government regulations for screening are the major driving factors for global in-vitro colorectal cancer screening tests market size.
Growing demand for minimally invasive diagnostic procedures that makes use of genetic biomarkers or DNA for risk determination along with enhanced procedure accuracy will attract R&D investments in this area, thus boosting growth.
Favourable government support and improved awareness will facilitate implementation of massive diagnostic plans, leading in-vitro colorectal cancer screening tests market growth. U.S and European governments issued guidelines for the routine assay of cancer and other associated risk levels. Lack of adequate sensitivity, less awareness about the importance of diagnosis, high price trend, and poor compliance should limit industry growth over the coming years.
In-Vitro Colorectal Cancer Screening Tests Market, By Test Type
Fecal occult blood tests (FOBT) are currently the most extensively used assay valued at over USD 660 million in 2016 and expected to exceed USD 950 million by 2024. Immuno-FOB ELISA and Immuno-FOB agglutination test together have contributed more than 65% to Fecal occult blood tests market in 2016, mainly due to its ease of application and cost effectiveness. Introduction of Immuno-FOBT has improved the sensitivity of stool-based screening in detecting advanced adenomas and early colorectal cancer.
Guaiac FOBT stool test was valued over USD 80 million in 2016, and has been used for a long period in colorectal cancer diagnostic testing. According to an estimate, it showed a specificity of more than 85% with sensitivity of 12.9% - 79.4% for CRC in many studies. However, its specificity and sensitivity is lower than the specific immuno-FOBT.
Tumor M2-PK stool in-vitro colorectal cancer screening tests market is set to see more than 7% CAGR from 2017 to 2024 due to high accuracy over its counterparts. Methylated gene testing may see a robust 10.9% CAGR from 2017 to 2024 to surpass USD 29 million, due to higher sensitivity than other FOBTs available in in-vitro colorectal cancer screening tests market.
In-Vitro Colorectal Cancer Screening Tests Market, By Region
U.S. in-vitro colorectal cancer screening tests market size was valued at over USD 200 million in 2016 due to increasing patient awareness levels, growing healthcare expenditure, sophisticated healthcare infrastructure and launch of favourable government initiatives. According to ACS, more than 132,000 cases were newly diagnosed in 2015. FDA approval of home-based assay will drive the U.S. in-vitro colorectal cancer screening tests market growth.
Germany in-vitro colorectal cancer screening tests market held more than 18% of regional revenue share in 2016. EU recommends implementation of new assays in regular healthcare services only after efficacy has been demonstrated in randomised controlled trials. Potentially promising modifications in existing procedures may also be considered for introduction into regular healthcare diagnosis.
Japan in-vitro colorectal cancer screening tests market size was more than USD 50 million in 2016 and is expected to exceed USD 80 million by 2024. Increasing geriatric population and sedentary lifestyle habits will drive business growth.
Competitive Market Share
Few key industry players include Beckman Coulter, Alere, Abbott Molecular and Eiken Chemical. Other prominent players include Sysmex, EMD Millipore, Epigenomics and Quest Diagnostics. The process of obtaining approvals has been a challenging task for several companies operating in the global in-vitro colorectal cancer screening tests market. Regulatory norms are getting tougher with U.S. FDA and EMA making stringent protocols for new as well as existing companies.
In-Vitro Colorectal Cancer Screening Tests Industry Background
Colorectal cancer screening can improve survival rates, and decrease the overall treatment cost. Novel technologies with more accuracy for early diagnosis will drive global in-vitro colorectal cancer screening tests market. U.S. FDA and European Commission approval is obligatory for biomarker and DNA based tests. Cologuard (Exact Sciences) is a DNA based procedure for detecting presence of RBCs and DNA mutations. It is a home-based procedure with more than 90% accuracy. Its current cost for a regular assay is USD 599 per test and detection of multitargets can raise the price significantly. With improved performance characteristics, the Epi proColon 2.0 test (Epigenomics) will possibly play a significant role in early colorectal cancer detection. At present, it is the single commercially available blood-test for early CRC detection, and was recently approved by the U.S. FDA for average-risk people over 50 years of age.
However, several unmet needs exist within the in-vitro colorectal cancer screening tests market, including accuracy. With a considerable number of false positive results, these procedures enforce a heavy burden on diagnostic colonoscopy services. With an increasing prevalence across the globe, numerous new assays are now in the pipeline, which will help to address these needs and drive the in-vitro colorectal cancer screening tests market expansion.
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