Colorectal Cancer Therapeutics Market Trends

Growth Drivers

• Critical benefits offered by early interventions: With the proven validations offered by reputed organizations, the market displays greater acceptance. Testifying to the same, the National Cancer Institute report published in March 2025 states that a new blood test called Shield was approved by the FDA in 2024 for early detection of colon cancer. Further, the report states that 8000 people where test using the new test and 83% of the people results were positive. Such evidence and scaling liquid biopsy-based screening in emerging markets is anticipated to replicate the cost savings witnessed in the U.S. and EU.
• Vigorous strategies implemented by global giants: Considering the efficacy and acceptance offered by the colorectal cancer therapeutics sector, the global players are implementing continued strategies to facilitate revenue. For instance, in 2024, the U.S. FDA reported that Roche, in partnership with EU hospitals, deployed AI-based CRC technologies. Simultaneously, In September 2024, Merck’s KEYTRUDA has approved Plus Pemetrexed and Platinum Chemotherapy, which is a first line treatment for adult patient with advanced or metastatic malignant pleural mesothelioma.
• Precision medicine & biomarker-driven therapies: Biomarker testing (KRAS, NRAS, BRAF, MSI/dMMR) and companion diagnostics are demanding the targeted therapies and immunotherapies by enabling patient selection and higher response rates. Further, increased guideline recommendations and payer acceptance for molecular profiling expand the eligible patient pool and justify premium pricing for companion drug–diagnostic bundles. Manufacturers should prioritize co-development or partnerships with diagnostic firms to secure preferred access and real-world evidence programs.

Historical Patient Growth and Death Rate 2010–2022

Source: National Cancer Institute

Analyzing the Cost Metrics of Colorectal Cancer Between India and U.S. (2022)

Sources: PMC October 2022, PMC April 2022

Challenge

• Regulatory and clinical trial recruitment hurdles: Constraints in terms of bureaucratic delays and hurdles in clinical trial recruitment significantly hampers growth in the colorectal cancer therapeutics sector. As per the FDA report, the clinical trial enrollment lacks diversity, with some pivotal studies reporting no participation from certain racial or ethnic groups, while Japan’s PMDA notes that additional domestic clinical data requirements can extend review timelines compared to the U.S. and EU. However, organizations address these with domestic trials and the launch of specific trial portals, thereby boosting participation and mitigating these roadblocks.