The colorectal cancer (CRC) screening market has witnessed significant changes in recent years, driven in large part by the arrival of Exact Science’s Cologuard fecal DNA test, which surpassed $1bn in sales last year. With pivotal clinical trials for new liquid biopsies happening in 2022, the CRC screening market is set to reach $1.4bn in 2022, forecasts GlobalData, a leading data and analytics company.

March is national Colorectal Cancer awareness month, a time aimed at raising awareness for what is the world’s second leading cause of cancer death world-wide.

According to GlobalData, ‘Exact Sciences’ can expect sustained double-digit growth of its stool-based DNA test from pre-pandemic levels till 2030, attaining $2bn in sales by 2028.

Chris Onderisin, Medical Devices Analyst at GlobalData, comments: “With screening guidelines for CRC expanded now to include individuals aged 45 and over, competition for the newly expanded market is heating up. Blood tests that can detect low concentration cancer biomarkers such as freely circulating tumor DNA, or so-called ‘liquid biopsies’ could be on the cusp of further disrupting the CRC screening market.”

Exact Sciences has faced little in the way of competition for biomarker-based early detection screening since the launch of Cologuard in 2015, but other players are poised to move in. Competitors focusing on liquid biopsies such as Freenome and Guardant Health are poised to usher in a new era of biomarker-based early screening.

Freenome has received funding from Roche to the tune of $590m since December and is expecting data from the PREEMPT CRC trial around the year’s end. Guardant Health has successfully completed full recruitment for their ECLIPSE trial in support of their LUNAR-2 liquid biopsy and has sights on launching lab developed tests this year.

Onderisin concludes: “While the most excitement in liquid biopsies is being generated around Multi-Cancer Early Detection (MCED) tests such as the Galleri test from Grail Inc. and Illumina, the CRC screening market will play an important role as a litmus test for the future rollout of such tests. While it’s no doubt that MCED tests will bring significant change to the cancer diagnostics space, the increased cost and pricing of those tests will be a barrier to rapid market penetration compared to cheaper tests. With a lean focus on CRC screening, regulatory and reimbursement hurtles for players like Freenome and Guardant Health will be easier to clear.

“In the meantime, Exact Sciences will be looking ahead to the planned launch of Cologuard 2 in the next 18 months. With preliminary data showing an increased sensitivity and specificity compared to the original Cologuard test, Exact Sciences will be seeking to bridge the gap to their own liquid biopsy offerings moving forward.”