The KRAS inhibitors market is projected to witness strong expansion, fueled by the growing burden of cancer, wider access to advanced therapies, and a promising pipeline featuring candidates such as Olomorasib (Eli Lilly), MK-1084 (Merck/Taiho/Astex Pharmaceuticals), Divarasib (Roche), Daraxonrasib (Revolution Medicines), Onvansertib (Cardiff Oncology), ELI-002 (Elicio Therapeutics), among others across the 7MM.
DelveInsight’s KRAS Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, addressable patient population, which includes top indications such as Pancreatic Cancer, Non-small Cell Lung Cancer, Ovarian Cancer, Colorectal Cancer, and others. The selected indications are based on approved therapies and ongoing pipeline activity. The report also provides insights into the emerging KRAS inhibitors, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets (the US, EU4, UK, and Japan).
Key Takeaways from the KRAS Inhibitors Market Report
- The KRAS inhibitors market in leading markets reached approximately USD 475 million in 2024. The United States remained the dominant market, representing around 70% of the total KRAS inhibitor market across the 7MM, ahead of major regions such as the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- Among currently approved KRAS inhibitors, AVMAPKI + FAKZYNJA is anticipated to maintain a larger market share than KRAZATI and LUMAKRAS throughout 2020–2034. The report also outlines the overall addressable patient pool across multiple indications, including pancreatic cancer, non-small cell lung cancer, ovarian cancer, colorectal cancer, and others.
- In 2024, KRAS-mutated cases in the 7MM exceeded 509,000 and are expected to rise over the forecast period.
- Several major pharmaceutical and biotech companies, including Roche, Chugai, Genentech, Revolution Medicines, Eli Lilly, Merck, Taiho, Astex Pharmaceuticals, Cardiff Oncology, Elicio Therapeutics, Jiangsu Hengrui, Genfleet, Innovent, Jacobio Pharma, Tyligand, Silexion, Catalent, Astellas, Incyte, Pfizer, Bayer, Kumquat Biosciences, Quanta Therapeutics, and others, are advancing next-generation KRAS inhibitors that may enter the market in the coming years.
- Key investigational KRAS inhibitors in the pipeline include Divarasib (RG6330) and its combination with pembrolizumab, Daraxonrasib (RMC-6236), several olomorasib- and MK-1084-based combinations, Onvansertib with bevacizumab and FOLFIRI/FOLFOX, ELI-002, HRS-4642 combinations, DUPERT with cetuximab, JAB-23E73, TSN1611, SIL204, ASP3082, INCB186748, multiple RMC-9805 combination regimens, PF-07985045, PF-07934040, BAY3498264, KQB365 combinations, QTX3544, and others.
- Among emerging KRAS inhibitors, Onvansertib is projected to achieve the highest revenue by 2034.
Discover which indication is expected to grab the major KRAS inhibitors market share @ KRAS Inhibitors Market Report
What are KRAS Inhibitors?
KRAS belongs to the RAS superfamily, a group of small GTP-binding proteins often referred to as RAS-like GTPases. The RAS oncogene, first identified in the rat sarcoma virus, plays a central role in transmitting signals that regulate key cellular functions, such as growth, differentiation, and survival, in both healthy and malignant cells. Among the pathways it influences, the RAS–RAF–MEK–ERK cascade is among the most extensively studied, and its dysregulation is frequently associated with cancer development.
KRAS Inhibitors Epidemiology Segmentation
The KRAS inhibitors market report is a comprehensive and specialized analysis, offering in-depth epidemiological insights for the study period 2020–2034 across the leading markets. Among the selected cancer types, the most KRAS mutant cases are found in CRC, followed by pancreatic cancer, NSCLC, and LGSOC. In the United States, there were about ~66,000 cases of KRAS mutant colorectal cancer in 2024.
The KRAS inhibitor target patient pool is segmented into:
- Total Incident Cases in Selected Indications
- Total KRAS Mutated Cases of Selected Indications
- Total KRAS Variant Cases of Selected Indications
KRAS Inhibitors Market Analysis
KRAS is a prominent oncogene commonly mutated in cancers such as NSCLC, PDAC, CRC, and ovarian cancer. Long considered “undruggable,” it has re-emerged as a key therapeutic target with the development of mutation-selective agents, especially those aimed at KRAS G12C. First-generation inhibitors like sotorasib (LUMAKRAS/LUMYKRAS) and adagrasib (KRAZATI) bind specifically to the inactive, GDP-bound form of KRAS, delivering meaningful clinical benefit in previously treated patients with KRAS G12C–mutated tumors.
Amgen’s LUMAKRAS became the first FDA-approved KRAS G12C inhibitor in 2021 for NSCLC, later receiving international approvals and an expanded indication for CRC when used with VECTIBIX, supported by improved progression-free survival and diagnostics such as Qiagen’s therascreen KRAS RGQ PCR Kit. Bristol Myers Squibb’s KRAZATI, launched in 2022, has since surpassed LUMAKRAS in uptake, securing accelerated approvals for NSCLC and mCRC and being incorporated into NCCN Guidelines for CNS-metastatic NSCLC. However, both drugs face persistent challenges from primary and acquired resistance.
Research is now moving beyond G12C to other KRAS mutations. The FDA recently approved Verastem’s AVMAPKI FAKZYNJA Co-Pack as the first therapy for KRAS-mutated recurrent LGSOC. Combination approaches combining KRAS inhibitors with chemotherapy, immunotherapies, or pan-KRAS agents are also advancing rapidly. Biopharma companies, including Cardiff Oncology (onvansertib), Immuneering (IMM-1-104), and Verastem (avutometinib + defactinib), are developing pan-KRAS strategies, while Roche, Revolution Medicines, and Eli Lilly are pushing next-generation candidates such as divarasib, daraxonrasib, and olomorasib to target a broader spectrum of mutations and tumor types.
Although progress has been significant, KRAS-driven cancers remain difficult to treat due to heterogeneity and evolving resistance. Continued advancements in precision targeting, biomarker-led therapy, and rational combinations will be essential to fully realize the potential of KRAS inhibition in oncology.
Learn more about the KRAS inhibitors @ KRAS Inhibitors Analysis
Key Factors Driving the KRAS Inhibitors Market
Broad and Growing Patient Pool Across Solid Tumors
KRAS is the most commonly mutated gene among the RAS family, ahead of NRAS and HRAS, and is frequently implicated in cancers such as pancreatic, colorectal, lung adenocarcinoma, ovarian, and others. Within the 7MM, the United States accounts for the largest share of KRAS-mutated NSCLC cases, representing about 46% of the total.
Rising Potential of Combination KRAS Therapies
Combining KRAS inhibitors with other therapeutic modalities, including immunotherapies and standard chemotherapies, shows significant potential to improve clinical outcomes. These combination strategies not only strengthen treatment effectiveness but also create new avenues for market expansion.
Growing Momentum in the Pan-KRAS Segment
A number of companies are developing pan-KRAS inhibitors, aiming to target a wider patient base. Key players such as Cardiff Oncology (onvansertib), Immuneering (IMM-1-104), Jacobio Pharma (JAB-23E73), and Eli Lilly (LY4066434) are expected to capture substantial market opportunities due to the broad applicability of their candidates.
Progress Across Mutation Variants and Cancer Types
Leading developers, including Roche, Revolution Medicines, and Eli Lilly, are advancing next-generation molecules like divarasib, daraxonrasib, and olomorasib. These programs aim to extend the reach of KRAS-targeted therapies across multiple mutation subtypes and a wider range of tumor types.
KRAS Inhibitors Competitive Landscape
The clinical development landscape for KRAS inhibitors features a robust pipeline of early-, mid-, and late-stage candidates, several of which are expected to move toward regulatory approval in the near term. This expanding field includes a broad mix of innovative therapies such as Olomorasib (Eli Lilly), MK-1084 (Merck/Taiho/Astex), Divarasib (Roche), Daraxonrasib (Revolution Medicines), Onvansertib (Cardiff Oncology), ELI-002 (Elicio Therapeutics), and others.
Eli Lilly’s Olomorasib is an oral, next-generation, highly selective KRAS G12C inhibitor designed specifically to address this mutation. Its optimized pharmacokinetic profile supports strong target engagement and potent activity both as a monotherapy and in combination regimens. According to Lilly’s annual report, a Phase III trial evaluating Olomorasib in first-line KRAS G12C–positive NSCLC commenced in 2024.
Merck, in collaboration with Taiho Pharmaceutical and Astex Pharmaceuticals, is advancing MK-1084, a potent and selective covalent inhibitor of KRAS G12C. Astex Pharmaceuticals operates as a wholly owned subsidiary of Otsuka Pharmaceutical.
As these next-generation therapies progress through clinical development and approach approval, they are expected to significantly reshape the KRAS inhibitors market. Their introduction will likely establish new benchmarks of care while stimulating further scientific innovation and market growth.
To know more about KRAS inhibitors clinical trials, visit @ KRAS Inhibitors Treatment
Recent Developments in the KRAS Inhibitors Market
- In September 2025, Eli Lilly announced that the US FDA had granted Breakthrough Therapy designation to olomorasib in combination with pembrolizumab for the first-line treatment of patients with unresectable advanced or metastatic NSCLC with a KRAS G12C mutation and PD-L1 expression ≥ 50%, as determined by FDA-approved tests.
- In July 2025, Silexion Therapeutics announced groundbreaking new preclinical data revealing unprecedented inhibition rates of up to 97% in pancreatic cancer cells and almost 90% in colorectal cancer cells. Company on track for the initiation of a Phase II/III clinical trial in Q2 2026.
- In May 2025, Verastem Oncology announced that the US FDA approved AVMAPKI + FAKZYNJA Co-Pack for the treatment of adult patients with KRAS-mutated recurrent Low-grade Serous Ovarian Cancer (LGSOC) who received prior systemic therapy. AVMAPKI and FAKZYNJA Co-Pack is the first and only FDA-approved medicine for this disease.
- In May 2025, Merck anticipated the data readout of its Phase I KANDLELIT-001 study at ASCO 2025 for patients with KRAS G12C-mutated advanced CRC and NSCLC.
- In May 2025, Cardiff Oncology stated in its SEC filing that, contingent upon the results of the CRDF-004 study, it plans to initiate CRDF-005, a Phase III, randomized trial with registrational intent. The FDA has agreed that a seamless trial design incorporating an interim endpoint of ORR, along with DoR, is acceptable for the pursuit of accelerated approval. PFS and the absence of detriment to overall survival will serve as the endpoints for full approval.
- In April 2025, Bristol Myers Squibb announced anticipation of Phase III trial data readouts for KRYSTAL-10 by 2026 for 2L CRC, KRYSTAL-7 trial results in 2028 for 1L NSCLC PD-L1≥50%, and KRYSTAL-4 trial results in 2029 for 1L NSCLC.
| KRAS Inhibitors Report Metrics | Details |
| Study Period | 2020–2034 |
| KRAS Inhibitors Report Coverage | 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] |
| Key Indications Covered in the Report | Pancreatic Cancer, Non-small Cell Lung Cancer, Ovarian Cancer, Colorectal Cancer, and others |
| KRAS Inhibitors Market CAGR | 35% |
| KRAS Inhibitors Market Size in 2024 | USD 475 Million |
| Key KRAS Inhibitor Companies | Roche, Chugai, Genentech, Revolution Medicines, Eli Lilly and Company, Merck, Taiho, Astex Pharmaceuticals, Cardiff Oncology, Elicio Therapeutics, Jiangsu Hengrui Pharmaceuticals, Genfleet Therapeutics, Innovent, Jacobio Pharma, Tyligand Pharmaceuticals (Suzhou), Silexion Therapeutics, Catalent, Astellas Pharma, Incyte, Pfizer, Bayer, Kumquat Biosciences, Quanta Therapeutics, Amgen, Bristol Myers Squibb (Mirati Therapeutics), Verastem Oncology, and others |
| Key KRAS Inhibitors | Divarasib (RG6330), Divarasib + Pembrolizumab, Daraxonrasib (RMC-6236), Olomorasib + Pembrolizumab ± Chemotherapy, Olomorasib + Pembrolizumab, MK-1084 + Pembrolizumab, Onvansertib + Bevacizumab + FOLFIRI/ FOLFOX, ELI-002, HRS-4642 + Gemcitabine + Albumin-bound Paclitaxel, DUPERT (Fulzerasib/GFH925) + Cetuximab, JAB-23E73, TSN1611, SIL204, ASP3082, INCB186748, RMC-9805 ± RMC-6236 + cetuximab ± mFOLFOX6, RMC-9805 ± RMC-6236 + gemcitabine + nab-paclitaxel, PF-07985045, PF-07934040, BAY3498264, KQB365 ± cetuximab, QTX3544, LUMAKRAS/LUMYKRAS, KRAZATI, AVMAPKI + FAKZYNJA Co-Pack, and others |
Scope of the KRAS Inhibitors Market Report
- KRAS Inhibitors Therapeutic Assessment: KRAS Inhibitors current marketed and emerging therapies
- KRAS Inhibitors Market Dynamics: Conjoint Analysis of Emerging KRAS Inhibitors Drugs
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL’s views, Analyst’s views, KRAS Inhibitors Market Access and Reimbursement
Discover more about KRAS inhibitors in development @ KRAS Inhibitors Clinical Trials
Table of Contents
| 1 | KRAS Inhibitor Market Key Insights |
| 2 | KRAS Inhibitor Market Report Introduction |
| 3 | Executive Summary |
| 4 | Key Events |
| 5 | Epidemiology and Market Forecast Methodology |
| 6 | KRAS Inhibitor Market Overview at a Glance |
| 6.1 | KRAS Inhibitor Market Share (%) Distribution by Therapies in 2024 in the 7MM |
| 6.2 | KRAS Inhibitor Market Share (%) Distribution by Therapies in 2034 in the 7MM |
| 6.3 | KRAS Inhibitor Market Share (%) Distribution by Indications in 2024 in the 7MM |
| 6.4 | KRAS Inhibitor Market Share (%) Distribution by Indications in 2034 in the 7MM |
| 7 | Disease Background and Overview |
| 7.1 | Introduction |
| 7.2 | Clinical Significance |
| 7.3 | Diagnosis |
| 7.4 | Diagnostic Guidelines and Recommendations for KRAS Inhibitors |
| 8 | KRAS Inhibitor Treatment |
| 9 | Epidemiology and Patient Population |
| 9.1 | Key Findings |
| 9.2 | Assumptions and Rationale |
| 9.3 | KRAS Inhibitors Patient Pool |
| 9.3.1 | United States |
| 9.3.1.1 | Total Incident Cases in Selected Indications |
| 9.3.1.2 | Total KRAS Mutated Cases of Selected Indications |
| 9.3.1.3 | Total KRAS Variant Cases of Selected Indications |
| 9.4.2 | EU4 and the UK |
| 9.4.3 | Japan |
| 10 | Marketed KRAS Inhibitor Drugs |
| 10.1 | Key Competitors |
| 10.2 | LUMAKRAS/LUMYKRAS (sotorasib): Amgen |
| 10.2.1 | Product Description |
| 10.2.2 | Regulatory Milestones |
| 10.2.3 | Other Developmental Activities |
| 10.2.4 | Clinical Development |
| 10.2.4.1 | Clinical Trial Information |
| 10.2.5 | Safety and Efficacy |
| 10.2.6 | Analyst Views |
| 10.3 | KRAZATI (adagrasib): Bristol Myers Squibb (Mirati Therapeutics) |
| 10.4 | AVMAPKI + FAKZYNJA Co-Pack (avutometinib + defactinib): Verastem Oncology |
| 11 | Emerging KRAS Inhibitor Therapies |
| 11.1 | Key Cross Competition |
| 11.2 | Safety and Efficacy Data of Phase I/II Emerging Drugs |
| 11.3 | Safety and Efficacy Data of Phase I Emerging Drugs |
| 11.4 | Divarasib (RG6330): Roche/Chugai/Genentech |
| 11.5 | Daraxonrasib (RMC-6236): Revolution Medicines |
| 11.6 | Olomorasib (LY3537982): Eli Lilly and Company |
| 11.7 | MK-1084: Merck, Taiho, and Astex Pharmaceuticals |
| 11.8 | Onvansertib: Cardiff Oncology |
| 11.9 | DUPERT (fulzerasib/GFH925): Genfleet Therapeutics and Innovent |
| 11.1 | ELI-002: Elicio Therapeutics |
| 11.11 | D3S-001: D3 Bio |
| 12 | KRAS Inhibitors Market: Seven Major Market Analysis |
| 12.1 | Key Findings |
| 12.2 | KRAS Inhibitor Market Outlook |
| 12.3 | Conjoint Analysis |
| 12.4 | Key KRAS Inhibitor Market Forecast Assumptions |
| 12.5 | Total Market Size of KRAS Inhibitors by Country in the 7MM |
| 12.6 | Total Market Size of KRAS Inhibitors by Indications in the 7MM |
| 12.7 | United States KRAS Inhibitor Market Size |
| 12.8 | EU4 and the UK KRAS Inhibitor Market Size |
| 12.9 | Japan KRAS Inhibitor Market Size |
| 13 | KRAS Inhibitor Market Unmet Needs |
| 14 | KRAS Inhibitor Market SWOT Analysis |
| 15 | KOL Views on KRAS Inhibitor |
| 16 | KRAS Inhibitor Market Access and Reimbursement |
| 16.1 | United States |
| 16.2 | EU4 and the UK |
| 16.3 | Japan |
| 16.4 | Market Access and Reimbursement of KRAS Inhibitors |
| 17 | Bibliography |
| 18 | KRAS Inhibitor Market Report Methodology |
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