Metastatic Colorectal Cancer Market Poised for Expansion Across the 7MM During the Forecast Period (2025-2034) as Breakthrough Therapies Gain Traction | DelveInsight
The metastatic colorectal cancer (mCRC) market is experiencing significant growth, driven by advancements in targeted therapies, immunotherapies, and personalized medicine. The increasing prevalence of colorectal cancer, along with growing awareness of early diagnosis and treatment options, is fueling demand for innovative treatments.
LAS VEGAS, April 23, 2025 /PRNewswire/ -- Colorectal cancer (CRC) ranks as the third most prevalent cancer, with metastasis being the leading cause of mortality among affected patients. The liver and peritoneum are the most frequent sites of distant spread. For most individuals, metastatic CRC (mCRC) remains largely incurable, with common metastatic locations including the liver, lungs, lymph nodes, and peritoneum.
Seen in approximately 45% CRC patients, KRAS mutations significantly influence the prognosis and treatment outcomes. These mutations are associated with a more aggressive disease course, resistance to chemotherapy and targeted therapies, and overall poorer survival rates.
In 2024, the incidence of metastatic colorectal cancer was around 294K cases across the seven major markets, with the United States reporting the highest incidence. This number is expected to rise by 2034. Surgical intervention is the mainstay for resectable CRC, while unresectable cases are typically managed with chemotherapy, radiotherapy, and immunotherapy. These conventional therapies, however, often lack specificity and can harm healthy cells, leading to additional health complications.
The treatment paradigm for mCRC involves multiple lines of therapy. First-line (1L) metastatic colorectal cancer treatments include combination chemotherapy regimens such as FOLFOX, FOLFIRI, and CAPEOX, alongside anti-angiogenic agents and targeted therapies like VECTIBIX and ERBITUX, with or without chemotherapy. KEYTRUDA and BRAFTOVI (in combination with ERBITUX and mFOLFOX6) are also approved for use in the first line. In the second-line (2L) setting, treatment options expand to include OPDIVO (± YERVOY), JEMPERLI, TUKYSA (± Trastuzumab), LONSURF (± Bevacizumab), and KRAZATI plus ERBITUX. For third-line (3L) therapy, specific agents such as STIVARGA and FRUZAQLA are utilized.
Learn more about the metastatic colorectal cancer treatment landscape @ Metastatic Colorectal Cancer Drugs Market
FRUZAQLA (fruquintinib) is a once-daily oral capsule developed by Takeda Pharmaceuticals. It is a kinase inhibitor approved for adult patients with metastatic colorectal cancer who have previously been treated with chemotherapy regimens including fluoropyrimidine, oxaliplatin, and irinotecan, as well as anti-VEGF therapy and, for RAS wild-type patients, anti-EGFR therapy. FRUZAQLA works by selectively targeting and inhibiting VEGFR-1, -2, and -3, thereby disrupting VEGF-driven blood vessel formation and tumor growth.
The FDA approved FRUZAQLA for previously treated mCRC in November 2023, followed by the European Commission in June 2024, and Japan in September 2024—marking it as the first new targeted therapy for mCRC in more than ten years in the Japanese market.
OPDIVO QVANTIG (nivolumab and hyaluronidase-nvhy) is indicated for adult patients with MSI-H or dMMR mCRC that has progressed after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan. It can be used as a standalone treatment or following prior combination therapy with intravenous nivolumab and ipilimumab. This drug works by blocking the PD-1 receptor, preventing its interaction with PD-L1 and PD-L2 to boost immune system activity against cancer cells.
In December 2024, the FDA approved OPDIVO QVANTIG as a subcutaneous injection for mCRC, making it the first PD-1 inhibitor available in this form. This new route of administration offers quicker treatment delivery—just 3 to 5 minutes—compared to the traditional 30-minute intravenous infusion of OPDIVO.
To know more about metastatic colorectal cancer treatments, visit @ Metastatic Colorectal Cancer Aggressive Treatment
Despite several advancements, the metastatic colorectal cancer drug market remains highly competitive, with significant unmet needs for durable and long-term treatment responses. Ongoing research into investigational agents like amivantamab, zanzalintinib, and vactosertib highlights the push for more effective, resistance-targeting, and tumor microenvironment-modifying therapies, signaling a dynamic and evolving future for mCRC treatment.
Key companies such as Johnson & Johnson Innovative Medicine, Shanghai Henlius Biotech, Inspirna, Treos Bio, Cardiff Oncology, Agenus, Leap Therapeutics, Arcus Biosciences, Enterome, Tizona Therapeutics, Innovative Cellular Therapeutics, and others are currently active in the metastatic colorectal cancer drug market.
Discover which therapies are expected to grab major metastatic colorectal cancer drug market share @ Metastatic Colorectal Cancer Market Report
Amivantamab is a bispecific antibody designed to target specific genetic alterations, especially EGFR exon 20 insertion mutations. Its dual mechanism focuses on inhibiting both the Epidermal Growth Factor Receptor (EGFR) and the MET receptor—two key players in cancer cell growth and survival. By binding to these receptors, amivantamab interferes with their signaling pathways, helping to overcome resistance that tumors often develop to other treatments.
This dual targeting not only suppresses tumor cell growth but also enhances the body's immune response, leading to greater cancer cell destruction. The drug is currently in Phase III clinical trials for treating metastatic colorectal cancer (mCRC).
Zanzalintinib (XL-092) is a third-generation oral tyrosine kinase inhibitor that blocks several cancer-related receptor tyrosine kinases, including VEGF receptors, MET, AXL, and MER. These kinases play a role in normal cell function as well as pathological processes like cancer development, metastasis, angiogenesis, and resistance to therapies such as immune checkpoint inhibitors. Developed by Exelixis, Zanzalintinib builds on the company's experience with cabozantinib, aiming to improve attributes like pharmacokinetic half-life. It is also in Phase III clinical trials for mCRC.
DKN-01 is a humanized monoclonal antibody that targets the DKK1 protein and is being developed for treating esophagogastric, gynecologic, and colorectal cancers. Initial findings from Part A of the DeFianCe trial were shared at the 2024 ASCO Gastrointestinal Cancers Symposium. Enrollment for Part B of the DeFianCe trial (NCT05480306) concluded in September 2024. This Phase II, randomized, open-label, controlled study is assessing DKN-01 in combination with bevacizumab and chemotherapy as a second-line treatment for advanced colorectal cancer in patients previously treated with one systemic therapy. The study enrolled 188 patients, with early results anticipated by mid-2025.
Discover more about drugs for metastatic colorectal cancer in development @ Metastatic Colorectal Cancer Clinical Trials
The anticipated launch of these emerging metastatic colorectal cancer treatments are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the metastatic colorectal cancer market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
DelveInsight estimates that the market size for metastatic colorectal cancer in the 7MM is expected to grow from USD 13 billion in 2024 with a significant CAGR by 2034. This growth is fueled by advancements in precision medicine, including targeted therapies and immunotherapies, which have shown promise in improving patient outcomes.
DelveInsight's latest published market report titled as Metastatic Colorectal Cancer Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the metastatic colorectal cancer country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The metastatic colorectal cancer market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into:
- Total Incident Cases of CRC
- Gender-specific Cases of CRC
- Age-specific Cases of CRC
- Tumor Location-specific Cases of CRC
- Stage-specific Cases of CRC
- Total Incident Cases of mCRC
- Mutation Type-specific Cases of mCRC
- Total Treated Cases of mCRC by Line of Therapy
The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM metastatic colorectal cancer market. Highlights include:
- 10-year Forecast
- 7MM Analysis
- Epidemiology-based Market Forecasting
- Historical and Forecasted Market Analysis upto 2034
- Emerging Drug Market Uptake
- Peak Sales Analysis
- Key Cross Competition Analysis
- Industry Expert's Opinion
- Access and Reimbursement
Download this metastatic colorectal cancer market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the metastatic colorectal cancer market. Also, stay abreast of the mitigating factors to improve your market position in the metastatic colorectal cancer therapeutic space.
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Metastatic Colorectal Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key metastatic colorectal cancer companies, including Shanghai Henlius Biotech, Eisai Inc., Treos Bio, AUM Biosciences, Leap Therapeutics, Inc., Hoffmann-La Roche, Replimune, Qilu Pharmaceutical, Lutris Pharma, Ipsen, Bold Therapeutics, Pacylex Pharmaceuticals, FivepHusion, SystImmune, Inspirna, Inc., Sapience Therapeutics, Exelixis, Daiichi Sankyo, Hutchmed, Merus N.V., REVOLUTION Medicines, Pure Tech Health, Medicenna Therapeutics, Inc., Verastem Inc., Next Cure Inc., Isofol Medical, Zentalis Pharmaceuticals, Oncoinvent, KaryoPharm Therapeutics, Aadi Biosciences, among others.
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Colorectal Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key colorectal cancer companies, including Exelixis, Mirati Therapeutics, Merck Sharp & Dohme LLC, Daiichi Sankyo Company, Inspirna, Lyell Immunopharma, Genentech, Cantargia AB, Arcus Biosciences, Inc, Neogap Therapeutics AB, Criterium, Inc, Daiichi Sankyo, Inc, Bristol-Myers Squibb, Celyad Oncology SA, Pfizer, Akeso, Menarini Group, Elpiscience (Suzhou) Biopharma, Ltd., BeyondBio Inc., Shanghai Henlius Biotech, Rottapharm Biotech, Innovative Cellular Therapeutics Inc., BioNTech SE, among others.
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