According to DelveInsight, over 195 major companies are actively engaged in developing more than 200 therapeutic candidates for the treatment of colorectal cancer.
Colorectal Cancer Overview:
Colorectal cancer (CRC) is a malignancy that arises in the colon or rectum due to abnormal growth of glandular epithelial cells. It is broadly categorized into three types: sporadic, hereditary, and colitis-associated. Globally, the incidence of CRC is on the rise, driven by both genetic predisposition and environmental influences. Individuals with long-standing inflammatory bowel diseases such as ulcerative colitis or Crohn’s disease are at a heightened risk, with the likelihood increasing with age. Research highlights the significant roles of diet, lifestyle, family history, and chronic inflammation in CRC development.
CRC progresses through a multistep process, beginning with epithelial hyperplasia, advancing through stages of atypical hyperplasia and adenoma formation, and ultimately leading to carcinoma. This progression is fueled by carcinogens that induce DNA damage, triggering the transformation of normal cells into cancerous ones. Morphological stages include hyperplasia, adenomas, carcinoma in situ, and invasive carcinoma. In 1990, Fearon and Vogelstein introduced a model outlining the molecular events involved in CRC development. Subsequent studies have identified three primary molecular mechanisms: (i) chromosomal instability, commonly observed in familial adenomatous polyposis (FAP); (ii) mutations in mismatch repair (MMR) genes, as seen in Lynch syndrome and sporadic cases; and (iii) CpG island hypermethylation, which silences tumor suppressor genes. These pathways involve alterations in several critical genes, including APC, DCC, P53, K-ras, c-MYC, MCC, and MMR-related genes such as hMLH1, hMLH3, hMSH2, hMSH3, hMSH6, hPMS1, and hPMS2. Notably, these molecular changes often overlap, with many CRC cases exhibiting a combination of these mechanisms.
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“Colorectal Cancer Pipeline Insight 2025” report by DelveInsight provides a comprehensive analysis of the ongoing clinical development activities and growth prospects across the Colorectal Cancer Therapeutics Market.
Key Takeaways from the Colorectal Cancer Pipeline Report
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DelveInsight’s Colorectal Cancer pipeline report depicts a robust space with 195+ active players working to develop 200+ pipeline therapies for Colorectal Cancer treatment.
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In October 2025, U.S. regulators extended the evaluation period for Amgen’s LUMAKRAS (sotorasib) for second-line colorectal cancer (CRC) by three months, delaying a potential approval decision until January 17 of the following year. This extension also temporarily reduces the competitive pressure on Bristol Myers Squibb’s KRAS inhibitor, KRAZATI (adagrasib).
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In June 2025, Bristol Myers Squibb announced that the US FDA granted accelerated approval for KRAZATI (adagrasib) in combination with cetuximab for adult patients with previously treated kras G12C-mutated locally advanced or metastatic colorectal cancer.
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In April 2025, ENHERTU was approved in the US as the first tumor-agnostic HER2-directed therapy for patients with metastatic HER2-positive solid tumors, including colorectal cancer, who had been previously treated.
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In November 2023, the US FDA approved Takeda’s FRUZAQLA for adults with metastatic colorectal cancer who had previously received specific chemotherapies and targeted therapies.
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Key Colorectal Cancer companies such as 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, and others are evaluating new drugs for Colorectal Cancer to improve the treatment landscape.
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Promising Colorectal Cancer pipeline therapies in various stages of development include XL092, Adagrasb, Olaparib, DS-8201, Ompenaclid, LYL845, RG6286, and others.
Colorectal Cancer Pipeline Analysis
The report provides insights into:
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The report provides detailed insights into the key companies that are developing therapies in the Colorectal Cancer Market.
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The report also evaluates different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Colorectal Cancer treatment.
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It analyzes the key companies involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
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It navigates the emerging drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
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Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement, and financing details for future advancement of the Colorectal Cancer market.
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Colorectal Cancer Emerging Drugs
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XL092 : Exelixis
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Adagrasb : Mirati Therapeutics
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Olaparib : Merck Sharp & Dohme LLC/Astrazeneca
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DS-8201: Daiichi Sankyo
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Ompenaclid: Inspirna
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LYL845: Lyell Immunopharma
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RG6286: Genentech
Colorectal Cancer Companies
There are over 195 key companies working on developing therapies for Colorectal Cancer. Among them, Exelixis has drug candidates for Colorectal Cancer in the most advanced stage, Phase III.
DelveInsight’s report covers around 200+ products under different phases of clinical development like
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Late stage products (Phase III)
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Mid-stage products (Phase II)
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Early-stage product (Phase I) along with the details of
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Pre-clinical and Discovery stage candidates
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Discontinued & Inactive candidates
Colorectal Cancer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
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Intravenous
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Subcutaneous
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Oral
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Intramuscular
Colorectal Cancer Products have been categorized under various Molecule types such as
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Monoclonal antibody
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Small molecule
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Peptide
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Colorectal Cancer Pipeline Therapeutic Assessment
• Colorectal Cancer Assessment by Product Type
• Colorectal Cancer By Stage
• Colorectal Cancer Assessment by Route of Administration
• Colorectal Cancer Assessment by Molecule Type
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Table of Content
1. Report Introduction
2. Executive Summary
3. Colorectal Cancer Current Treatment Patterns
4. Colorectal Cancer – DelveInsight’s Analytical Perspective
5. Therapeutic Assessment
6. Colorectal Cancer Late-Stage Products (Phase-III)
7. Colorectal Cancer Mid-Stage Products (Phase-II)
8. Early Stage Products (Phase-I)
9. Pre-clinical Products and Discovery Stage Products
10. Inactive Products
11. Dormant Products
12. Colorectal Cancer Discontinued Products
13. Colorectal Cancer Product Profiles
14. Colorectal Cancer Key Companies
15. Colorectal Cancer Key Products
16. Dormant and Discontinued Products
17. Colorectal Cancer Unmet Needs
18. Colorectal Cancer Future Perspectives
19. Colorectal Cancer Analyst Review
20. Appendix
21. Report Methodology
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