DelveInsight’s “Colorectal Cancer Market Insight, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of colorectal cancer, historical and forecasted epidemiology, as well as the colorectal cancer market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

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Key Takeaways from the Colorectal Cancer Market Report

• In September 2025, Biocartis Group of Companies announced that its Idylla™ CDx MSI Test, developed in partnership with Bristol Myers Squibb, has received the first-ever Premarket Approval (PMA) from the U.S. FDA. This approval marks a significant achievement for the cartridge-based, fully automated “sample-to-result” companion diagnostic test.

• In September 2025, Rgenta Therapeutics received FDA Orphan Drug Designation for RGT-61159, an oral small molecule targeting MYB via RNA splicing modulation, for the treatment of adenoid cystic carcinoma (ACC). The drug is currently in a Phase 1a/b trial for relapsed/refractory ACC and colorectal cancer.

• In Aug 2025, Quest Diagnostics’ Haystack MRD® test received FDA Breakthrough Device Designation for detecting MRD-positive stage II colorectal cancer patients who may benefit from adjuvant therapy.

• In August 2025, Anbogen Therapeutics announced that the FDA approved its Investigational New Drug (IND) application for ABT-301. This approval enables the start of a Phase 1/2 trial combining ABT-301 with tislelizumab and bevacizumab to treat metastatic colorectal cancer patients with proficient mismatch repair or non-MSI-high tumors. The multi-center study will enroll 66 patients in Taiwan and Australia.

• In August 2025, Agilent Technologies announced that its MMR IHC Panel pharmDx (Dako Omnis) received FDA approval as a companion diagnostic for colorectal cancer, helping identify mismatch repair deficient colorectal cancer patients eligible for treatment with Opdivo (nivolumab) alone or in combination with Yervoy (ipilimumab).

• In June 2025, Guardant Health, Inc. (Nasdaq: GH) announced that its Shield multi-cancer detection (MCD) test received Breakthrough Device designation from the FDA. The methylation-based blood test is designed to screen for multiple cancers—including bladder, colorectal, esophageal, gastric, liver, lung, ovarian, and pancreatic—in adults aged 45+ at average risk.

• In May 2025, UTR Therapeutics Inc. announced the submission of an IND application to the FDA for UTRxM1-18, a novel therapy designed to target c-MYC driven cancers, including triple-negative breast, pancreatic, colorectal, and ovarian cancers. Leveraging its 3’UTR engineering platform, UTRxM1-18 selectively degrades cancer-specific transcripts while sparing healthy cells. In preclinical studies, the drug showed strong, dose-dependent efficacy across tumor types with no dose-limiting toxicities.

• The leading colorectal cancer companies include Mirati Therapeutics, Exelixis, Enterome, Arcus Biosciences, Lyell Immunopharma, AstraZeneca, Novartis Pharmaceuticals, Surgimab, Numab Therapeutics, SOTIO Biotech, Amgen, Sichuan Baili Pharmaceutical, Qilu Pharmaceutical, Bristol-Myers Squibb, NGM Biopharmaceuticals, Takeda, PureTech, Pfizer, Kezar Life Sciences, Salubris Biotherapeutics, and others.

• Rising global incidence of colorectal cancer — driven by aging populations, lifestyle changes, obesity, sedentary habits, diets high in processed meats, smoking, and alcohol consumption — is accelerating demand for more effective, personalized treatment approaches.

• Advances in molecular profiling (MSI-H, BRAF V600E, HER2, and KRAS G12C) are enabling more precise, targeted treatment strategies, while emerging targets such as KRAS G12C, NTRK fusions, and PIK3CA mutations are opening new avenues for drug development.

• The total colorectal cancer market size across the 7MM was estimated at nearly USD 13,000 million in 2023 and is expected to grow at a CAGR of approximately 5% during the forecast period (2024–2034).

• In 2023, the United States accounted for approximately 40% of the total colorectal cancer market share among the 7MM, while among EU4 and the UK, Germany is expected to capture the maximum colorectal cancer revenue share by 2034, followed by the UK.

• Nearly 40% of total colorectal cancer incidence in the US was classified as metastatic colorectal cancer, with MSS (Microsatellite Stable) mutations representing the highest number of mutation-specific cases in 2023.

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Colorectal Cancer Epidemiology Segmentation in the 7MM

• Total Incident Cases of Colorectal Cancer in the 7MM

• Gender-specific Cases of Colorectal Cancer in the 7MM

• Age-specific Cases of Colorectal Cancer in the 7MM

• Tumor Localization-specific Cases of Colorectal Cancer in the 7MM

• Stage-specific Cases of Colorectal Cancer in the 7MM

• Mutation-specific Cases of Colorectal Cancer in the 7MM

• Total Treated Cases of Colorectal Cancer in the 7MM

• Market Size by Therapies Market Size by Class

Colorectal Cancer Pipeline Analysis

Favezelimab + pembrolizumab: Merck Favezelimab is an investigational anti-LAG-3 antibody designed to restore T cell effector function by preventing LAG-3 from binding to MHC class II molecules, while pembrolizumab blocks the PD-1 receptor’s interaction with PD-L1 and PD-L2. The combination is currently being evaluated in the Phase III KEYFORM-007 trial for colorectal cancer.

LUMAKRAS (sotorasib): Amgen LUMAKRAS is a KRAS G12C small molecule inhibitor under investigation for advanced colorectal cancer, being studied in previously treated KRAS G12C-mutated CRC in combination with other therapies. In August 2023, Amgen announced that the FDA granted Breakthrough Therapy Designation to LUMAKRAS. In January 2025, the FDA approved Lumakras in combination with Vectibix for treating advanced colorectal cancer.

Onvansertib: Cardiff Oncology Onvansertib is an oral small molecule PLK1 inhibitor currently in Phase II development for colorectal cancer.

Nibrozetone (RRx-001): EpicentRx Nibrozetone is an IV small molecule CD47 antigen inhibitor currently in Phase II development for colorectal cancer.

Colorectal Cancer Market Insights

The current treatment landscape includes surgery, chemotherapy, and radiation therapy, with treatment plans personalized based on cancer type, stage, and patient health. Surgery remains the main treatment, especially in early stages, while chemotherapy and radiation are used before or after surgery, or for advanced and later-stage disease.

The competitive landscape features major colorectal cancer companies such as Pfizer, Merck, and Roche, with growth driven by targeted therapies addressing specific mutations such as RAS and BRAF, where EGFR and BRAF inhibitors are proving particularly effective for these genetic subgroups. Immune checkpoint inhibitors targeting PD-1/PD-L1 have also reshaped treatment for microsatellite instability-high (MSI-H) tumors, leading to broader adoption and market expansion.

Rising healthcare spending in developed regions, enhanced infrastructure, favorable reimbursement policies, and partnerships between pharmaceutical companies, academia, and research institutions are further accelerating innovation in colorectal cancer therapies and diagnostics. However, high treatment costs and tumor resistance present ongoing challenges, while emerging markets and personalized medicine represent key opportunities for future growth.

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Colorectal Cancer Market Outlook

Colorectal cancer originates in the colon or rectum, typically developing from precancerous polyps that gradually transform into malignancies. It is one of the most prevalent cancers worldwide, with risk factors including age, family history, inflammatory bowel disease, and lifestyle factors such as diets high in red and processed meats, sedentary behavior, and smoking. Genetic mutations — both inherited (e.g., Lynch syndrome) and acquired — play a crucial role in disease development, and colorectal cancer often progresses silently, with symptoms such as changes in bowel habits, rectal bleeding, and abdominal discomfort manifesting only in later stages.

Diagnosis typically begins with routine screening or evaluation of symptoms, with colonoscopy as the primary diagnostic tool, supported by stool-based tests such as the fecal immunochemical test (FIT) and non-invasive imaging methods like CT colonography. Once CRC is suspected, CT scans or MRI are used to assess tumor size, lymph node involvement, and metastasis for staging and treatment planning.

The colorectal cancer therapeutics market is expected to grow at a CAGR of approximately 5% through 2034, driven by an aging population, increased screening, and innovative treatments. Key trends shaping the market include the rise of targeted therapies such as KRAS inhibitors, advancements in immunotherapy including checkpoint inhibitors and CAR-T therapies, and early detection methods such as liquid biopsies and genetic screening that are enhancing diagnosis and shifting treatment approaches.

Scope of the Colorectal Cancer Market Report

• Coverage: 7MM

• Study Period: 2020–2034

• Forecast Period: 2024–2034

• Colorectal Cancer Companies: Mirati Therapeutics, Exelixis, Enterome, Arcus Biosciences, Lyell Immunopharma, AstraZeneca, Novartis Pharmaceuticals, Surgimab, Numab Therapeutics, SOTIO Biotech, Amgen, Sichuan Baili Pharmaceutical, Qilu Pharmaceutical, Bristol-Myers Squibb, NGM Biopharmaceuticals, Takeda, PureTech, Pfizer, Kezar Life Sciences, Salubris Biotherapeutics, and others

• Colorectal Cancer Therapies: FRUZAQLA, ENHERTU, TUKYSA, KEYTRUDA, KRAZATI, BRAFTOVI, Favezelimab + pembrolizumab, LUMAKRAS, Onvansertib, Nibrozetone (RRx-001), and others

• Colorectal Cancer Market Access & Reimbursements, Unmet Needs and Perspectives Colorectal Cancer SWOT Analysis, Conjoint Analysis, and KOL Views

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Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Colorectal Cancer

4. Key Events

5. Colorectal Cancer Epidemiology and Market Forecast Methodology

6. Colorectal Cancer Market Overview at a Glance

7. Disease Background and Overview: Colorectal Cancer

8. Colorectal Cancer Treatment and Management

9. Epidemiology and Patient Population of Colorectal Cancer in the 7MM

10. Colorectal Cancer Patient Journey

11. Key Endpoints in Colorectal Cancer

12. Colorectal Cancer Marketed Therapies

13. Colorectal Cancer Emerging Therapies

14. Colorectal Cancer: Seven Major Market Analysis

15. Colorectal Cancer Unmet Needs

16. SWOT Analysis

17. KOL Views

18. Market Access and Reimbursement

19. Appendix

20. DelveInsight Capabilities

21. Disclaimer

22. About DelveInsight

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