The battle against colorectal cancer (CRC), one of the leading and deadliest cancers worldwide, is seeing significant advancements in clinical research, drug development, and regulatory milestones.
As per DelveInsight’s latest analysis, the “Colorectal Cancer Pipeline Insight, 2025” report provides an in-depth view of the clinical and commercial landscape, highlighting over 195 companies developing more than 200 treatment options at various stages. The report offers a thorough assessment of clinical trials, therapeutic modalities, mechanisms of action (MoA), routes of administration (RoA), and company progress, reflecting the rapid evolution within the colorectal cancer treatment arena.
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Recent Colorectal Cancer Regulatory & Clinical Developments (2024–2025)
- In October 2025, Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics®, Triclonics® and ADClonics®), announced interim clinical data as of a July 29, 2025 data cutoff from the ongoing phase 2 trial of the bispecific antibody petosemtamab in combination with standard of care FOLFOX/FOLFIRI in 1L and 2L metastatic colorectal cancer (mCRC), and petosemtamab monotherapy in 3L+ mCRC.
- In October 2025, Nouscom, a clinical-stage biotech company developing next-generation neoantigen-targeted off-the-shelf and personalized cancer immunotherapies, announced positive results from a completed Phase 2 trial evaluating NOUS-209 in combination with pembrolizumab for patients with microsatellite instability high (MSI-H) metastatic colorectal cancer (mCRC) who are refractory to anti-PD-1 therapy.
- In September 2025, Artios Pharma Limited (“Artios”), a biopharmaceutical company committed to realizing the therapeutic power of targeting the DNA damage response (“DDR”) in cancer, announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its ATR inhibitor, alnodesertib, in combination with a low dose of chemotherapeutic agent irinotecan, for the treatment of adult patients with ATM-negative metastatic colorectal cancer (mCRC) in the third-line setting.
- March 27, 2025 – LIXTE Biotechnology Holdings, in collaboration with the Netherlands Cancer Institute and Roche, dosed its first patient in a clinical trial for unresponsive metastatic colorectal cancer (MSI Low).
- January 25, 2025 – Exelixis presented new results from its Phase Ib/II STELLAR-001 trial combining zanzalintinib with Tecentriq (atezolizumab) at ASCO GI 2025.
- January 2025 – Marengo Therapeutics received FDA Fast Track Designation for invikafusp alfa (STAR0602), a first-in-class dual T cell agonist targeting advanced CRC with TMB-H.
- January 2025 – Mirror Biologics entered a collaboration with Merck KGaA to test its immunotherapy AlloStim with Bavencio (avelumab) in Phase II trials for metastatic CRC.
- January 16, 2025 – FDA approved sotorasib (Lumakras, Amgen) with panitumumab (Vectibix) for KRAS G12C-mutated metastatic CRC.
- December 2024 – Pfizer secured FDA approval for BRAFTOVI® (encorafenib) + cetuximab + mFOLFOX6 for BRAF V600E mutation-positive CRC under the FDA Project FrontRunner pathway.
- September 2024 – FRUZAQLA® (fruquintinib) gained approval as an oral targeted therapy for mCRC, offering a non-chemotherapy option.
- January 2024 – Bristol Myers Squibb (BMS) shared encouraging Phase III CheckMate -8HW results using Opdivo + Yervoy for MSI-H/dMMR mCRC.
- November 2023 – FDA approved fruquintinib (Fruzaqla) for metastatic CRC patients with prior chemotherapy and targeted therapy exposure.
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Key Highlights from the Colorectal Cancer Pipeline Report
- Global R&D Overview: More than 195 companies are actively engaged in developing over 200 pipeline therapies across all stages from preclinical to Phase I, II, and III trials, with several nearing commercial launch.
- Key players in the colorectal cancer treatment market include Plus Therapeutics, Processa Pharmaceuticals, Shanghai Henlius Biotech, Apollomics, Novartis Pharmaceuticals , Sumitomo Pharma Oncology, Purple Biotech Ltd., Nektar Therapeutics, ALX Oncology Inc., Guojian Pharmaceutical, Daiichi Sankyo, Gritstone Bio, Inc., Suzhou Suncadia Biopharmaceuticals Co., Ltd., G1 Therapeutics, Amgen , Mirati Therapeutics, among others, all working to advance colorectal cancer therapies.
- Emerging therapies in various clinical phases include 188RNL-BAM, PCS11T, HLX13, Geptanolimab, HDM201, TP-1454, NT219, NKTR-255, Evorpacept (ALX148), CPGJ 602 Sunshine, Trastuzumab deruxtecan, GRT-C901, SHR-1701, Trilaciclib, Lumakras (sotorasib), MRTX849, and others, anticipated to make a significant impact on the colorectal cancer market in the coming years.
- Innovative mechanisms of action span monoclonal antibodies, small molecules, peptides, gene therapies, and checkpoint inhibitors, diversifying treatment approaches.
- Therapeutic development includes a variety of administration methods such as oral, parenteral, intravenous, subcutaneous, and topical routes to improve patient convenience and adherence.
- Additionally, growing collaborations and partnerships between pharmaceutical companies and academic institutions are accelerating development and approval processes in this field.
Colorectal Cancer Overview
Colorectal cancer (CRC) remains one of the most common and deadly cancers worldwide. In 2025, it is estimated that there will be approximately 1.9 million new cases globally, causing over 900,000 deaths. It ranks as the third most diagnosed cancer and the second leading cause of cancer-related mortality. In the United States alone, around 154,000 new cases are expected, with nearly 53,000 deaths. The disease’s incidence is rising particularly among younger populations, with a concerning trend of increasing cases under age 55. Efforts in early detection, screening, and innovative treatments are critical to combat this growing health challenge.
Stay ahead of the curve with DelveInsight’s “Colorectal Cancer Pipeline Insight, 2025” report. Gain exclusive access to detailed analyses of 195+ companies, 200+ emerging therapies, regulatory milestones (EMA, PDMA, FDA), and the latest clinical trial insights shaping the colorectal cancer treatment landscape @ Colorectal Cancer Competitive Landscape and Therapeutics
Colorectal Cancer Emerging Therapies in the Pipeline
Some of the most promising pipeline therapies include:
- 188RNL-BAM (Plus Therapeutics)
- PCS11T (Processa Pharmaceuticals)
- HLX13 (Shanghai Henlius Biotech)
- Adagrasib (MRTX849) (Mirati Therapeutics)
- Zanzalintinib (XL092) (Exelixis)
- EO2040 (Enterome)
- Etrumadenant (Arcus Biosciences)
- LYL845 (Lyell Immunopharma)
- Geptanolimab (Apollomics)
- HDM201 (Novartis)
- TP-1454 (Sumitomo Pharma Oncology)
- NT219 (Purple Biotech)
- NKTR-255 (Nektar Therapeutics)
- Evorpacept (ALX148) (ALX Oncology)
- Trastuzumab deruxtecan (Daiichi Sankyo)
- GRT-C901 (Gritstone Bio)
- SHR-1701 (Suzhou Suncadia Biopharmaceuticals)
- Trilaciclib (G1 Therapeutics)
- Lumakras (sotorasib) (Amgen)
These candidates demonstrate innovation in targeting KRAS, BRAF, immune checkpoints, angiogenesis, and T-cell pathways, highlighting the diversification of CRC treatment.
Further Colorectal Cancer product details are provided in the report. Download the Colorectal Cancer pipeline report to learn more about the emerging Colorectal Cancer therapies
Colorectal Cancer Therapeutic Assessment
- Molecule Types: monoclonal antibodies, small molecules, peptides, polymers, and gene therapies.
- Route of Administration: oral, intravenous, subcutaneous, parenteral, and topical.
- Stage-wise Development: Phase III (late-stage), Phase II (mid-stage), Phase I (early-stage), pre-clinical, discovery, and discontinued candidates.
Colorectal Cancer Market Dynamics
Colorectal Cancer Market Drivers
The colorectal cancer (CRC) market is driven by several key factors. Increasing global incidence due to aging populations, lifestyle changes, and rising obesity rates contributes to demand for better diagnostics and therapies. Advances in early screening programs and awareness campaigns improve detection rates, expanding the treated patient pool. Innovations in targeted therapies, immunotherapies, and combination regimens offer improved efficacy and patient outcomes, attracting investment and market growth. Additionally, growing healthcare infrastructure and reimbursement support in emerging markets enable broader access.
Colorectal Cancer Market Barriers
However, barriers include high treatment costs that limit affordability and access, especially in low-income regions. Diagnostic delays and under-screening reduce early detection rates. Regulatory complexities and prolonged clinical trial timelines slow the introduction of new therapies. Furthermore, patient heterogeneity in tumor biology presents challenges in developing universally effective treatments. Side effects and resistance to therapies also constrain long-term success and adoption.
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Scope of the Colorectal Cancer Market Report
- Coverage: Global CRC clinical trials and therapies.
- Companies Covered: Amgen, Pfizer, Novartis, Daiichi Sankyo, Mirati, G1 Therapeutics, Plus Therapeutics, Processa, Henlius, Apollomics, and others.
- Therapies Assessed: From monoclonal antibodies to gene therapies.
- Pipeline Segmentation: By stage, RoA, MoA, and molecule type.
- Additional Insights: Collaborations, licensing, mergers & acquisitions, and financing activities.
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