The prevalence of colorectal cancer (CRC) is surging across the eight major markets (8MM*) due to an aging population and increased mutation testing. With a projected market expansion from $15.8 billion in 2021 to $21.8 billion in 2031, at a CAGR of 3.3%, CRC presents a significant growth opportunity. This uptrend is primarily driven by rising diagnosis rates, notably in key markets like the US and China and approvals of 13 pipeline agents, according to GlobalData, a leading data and analytics company.

GlobalData’s latest report, “Colorectal Cancer: Eight-Market Drug Forecast and Market Analysis,” reveals that the number of globally diagnosed incident cases is expected to increase from 1 million in 2021 to 1.32 million in 2031. Against this backdrop, there is a focus on developing targeted therapies for KRAS and MSI-H mutant CRCs in the second and third line across the 8MM.

However, the market growth is expected to be hindered by patent expiries of key marketed CRC therapies, as well as the lack of first-line therapies in development.

Thomas Wales, Oncology Analyst at GlobalData, comments: “While the CRC market will see steady growth throughout the forecast period, the patent expiry of MSD’s popular immunotherapy Keytruda (pembrolizumab) in 2028 is expected to cause some contraction in the market. This patent expiration will be more than offset by developing KRAS-G12C targeted therapies, immunotherapies, and tyrosine kinase inhibitors. Some countries like Germany and Japan will see reduced growth over the forecast period due to high base rates of genetic mutation testing and slowing aging populations.”

Genentech’s Tecentriq (atezolizumab), if approved in 2026, will have a noticeable impact on the existing immunotherapy sales. Patient-based forecast sales for Tecentriq are predicted to reach $416 million in 2031.

Wales adds: “While the development of Mirati Therapeutics’ Krazati (adagrasib) and Amgen’s Lumakras (sotorasib) is a step in the right direction, they will only capture a small portion of the RAS-mutant CRC population. Further developments are needed, as these therapies will only target KRAS G12C mutant subtypes, which represent a fraction of the available RAS mutant patients.”

The key opinion leaders (KOLs) interviewed by GlobalData highlighted that tolerability remains a highly sought-after quality with developing therapies, as highly prescribed chemotherapies containing oxaliplatin often lead to serious adverse events and discontinuation. There is also widespread sentiment among KOLs that emphasis should be placed on developing a diverse RAS-targeting therapy, as KRAS/NRAS mutants are present in ~45% of CRC patients.

Wales concludes: “The primary focus of future developments should take into consideration the highly relevant RAS-mutant subtype of CRC. While well-appraised by KOLs, the utility of Krazati and Lumakras remains limited to a specific subtype of RAS patients, though their success inspires more research in this area. Developments of various immunotherapies for this indication are proving to be highly fruitful, and there is growing interest in developing targetable biomarkers in micro-satellite stable patients for potentially curative avenues of therapy. Overall, the landscape for CRC looks bright, but with a quickly growing incidence in the 8MM, areas of unmet need will remain.”

*8MM = US, France, Germany, Italy, Spain, the UK, Japan, and China.