KRAS Inhibitors - Market Size, Target Population, Competitive Landscape and Forecast - 2036 | Pan-KRAS Pipelines and New Cancer Indications Drive 7MM Growth
Dublin, Oct. 01, 2026 (GLOBE NEWSWIRE) -- "KRAS Inhibitors - Market Size, Target Population, Competitive Landscape & Market Forecast - 2036" has been added to ResearchAndMarkets.com's offering.
The "Kirsten Rat Sarcoma Virus (KRAS) Inhibitors - Market Insights, Epidemiology, and Market Forecast - 2036" report provides a comprehensive assessment of the KRAS inhibitors market across the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. Covering the study period from 2022 to 2036, the report examines market size, treatment practices, epidemiology, marketed products, emerging therapies, drug uptake, competitive activity, and unmet medical needs.
Key KRAS Inhibitors Market Highlights
KRAS Mutation Epidemiology
The epidemiology analysis includes incident cases of NSCLC, colorectal cancer, pancreatic cancer, and LGSOC, together with KRAS mutation and variant-specific segmentation across the 7MM. In 2025, approximately 539,400 incident NSCLC cases were identified across the covered markets, including about 203,000 cases in the United States. Total incident colorectal cancer cases reached approximately 570,800.
Within EU4 and the United Kingdom, Germany accounted for approximately 26% of KRAS mutation cases, while Spain represented about 14%. In the United States, KRAS G12C was present in approximately 36.8% of KRAS-mutated NSCLC cases. KRAS G12D accounted for approximately 41.8% of pancreatic cancer cases and 41.7% of LGSOC cases involving KRAS mutations.
KRAS mutation testing generally uses tumor tissue sequencing or liquid biopsy. The diagnostic assessment considers tissue selection, tumor enrichment, DNA extraction, sequencing practices, and the role of representative metastatic tissue in advanced disease.
Current KRAS-Targeted Treatment Landscape
Treatment strategies for KRAS-mutated cancers may include surgery, radiation therapy, chemotherapy, targeted therapy, immunotherapy, and combination regimens. The commercial landscape currently includes LUMAKRAS/LUMYKRAS, KRAZATI, and AVMAPKI + FAKZYNJA Co-Pack.
LUMAKRAS/LUMYKRAS (sotorasib): Amgen
LUMAKRAS is approved for adults with KRAS G12C-mutated locally advanced or metastatic NSCLC after at least one prior systemic therapy. The FDA granted accelerated approval in May 2021, followed by authorization in the European Union and approval in Japan. Amgen has reported multiple patents in the United States and Europe that could provide exclusivity through 2040. The company reported approximately USD 211 million in United States LUMAKRAS sales during 2025.
KRAZATI (adagrasib): Bristol Myers Squibb
KRAZATI is an oral therapy for adults with KRAS G12C-mutated locally advanced or metastatic NSCLC following prior systemic treatment. It launched in the United States in December 2022 and received conditional marketing authorization in Europe in January 2024. The development program includes studies in first-line and later-line NSCLC and colorectal cancer. KRAZATI has gained commercial and clinical momentum, although resistance to KRAS G12C inhibition remains a major treatment challenge.
KRAS Inhibitors Pipeline
The late-stage pipeline includes mutation-specific, pan-KRAS, and RAS(ON) programs designed to expand treatment across tumor types and KRAS variants.
Additional companies targeting KRAS G12D and other high-potential variants include AstraZeneca, Astellas Pharma, PAQ Therapeutics, Tyligand Pharmaceuticals, Verastem Oncology, and GenFleet Therapeutics. These programs may address patient populations not served by current G12C-directed products.
Recent KRAS Inhibitors Market Developments
KRAS Inhibitors Market Outlook
KRAS G12C inhibitors have established a targeted treatment segment in NSCLC and colorectal cancer, but primary and acquired resistance continue to restrict long-term clinical benefit. The next phase of market growth is expected to come from earlier-line use, combination regimens, additional tumor indications, and therapies directed at G12D and other KRAS variants.
Pan-KRAS and RAS(ON) programs could address a substantially broader patient population than mutation-specific products. Combination strategies involving chemotherapy, immune checkpoint inhibitors, and other targeted agents are also expected to influence treatment sequencing and market share through 2036. Companion diagnostics and biomarker-driven patient selection will remain important to commercial adoption.
Report Coverage and Strategic Value
The report supports pharmaceutical companies, investors, healthcare organizations, and strategy teams seeking to evaluate the KRAS inhibitors market, identify high-value pipeline opportunities, assess competitive threats, and develop evidence-based commercialization strategies across the 7MM.
Key Topics Covered:
1. Key Insights
2. Report Introduction
3. Executive Summary
4. Key Events
5. Epidemiology and Market Forecast Methodology
6. KRAS Inhibitor Market Overview at a Glance
6.1. Market Share (%) Distribution by Therapies in 2025 in the 7MM
6.2. Market Share (%) Distribution by Therapies in 2036 in the 7MM
6.3. Market Share (%) Distribution by Indications in 2025 in the 7MM
6.4. Market Share (%) Distribution by Indications in 2036 in the 7MM
7. Disease Background and Overview
7.1. Introduction
7.2. Clinical Significance
7.2.1. RAS Oncogene and Carcinogenesis as a Multistep Process
7.2.2. KRAS Mutation as a Prognostic Biomarker
7.2.3. KRAS Mutation and Personalized Medicine
7.3. Diagnosis
7.3.1. Biomarker testing for KRAS mutation
7.3.1.1. NSCLC
7.3.1.2. Colorectal Cancer
7.3.1.3. Pancreatic Cancer
7.3.2. Clinical Relevance of KRAS Mutation by Cancer Type
7.3.2.1. Pancreatic Cancer
7.3.2.2. Colorectal Cancer
7.3.2.3. Tumor-based Tests for KRAS Gene Mutations
7.3.2.4. Lung Cancer
7.3.2.5. Ovarian Cancer
7.3.2.6. Hepatocellular Carcinoma (HCC)
7.4. Diagnostic Guidelines and Recommendations for KRAS Inhibitors
7.4.1. ESMO Guidelines for Metastatic Colorectal Cancer [2025]
7.4.2. NCCN Guidelines for KRAS, NRAS, and BRAF Mutation Testing in Metastatic Colorectal Cancer [2025]
7.4.3. NCCN Guideline for Biomarker Testing in NSCLC [2025]
7.4.4. Japanese Society of Medical Oncology Clinical Guidelines: Molecular Testing for CRC Treatment
8. Treatment
8.1. Treatment of NSCLC
8.1.1. Surgery
8.1.2. Radiofrequency Ablation (RFA)
8.1.3. Radiation Therapy
8.1.4. Chemotherapy
8.1.5. Immunotherapy
8.2. Treatment of Pancreatic Cancer
8.2.1. Surgery
8.2.2. Ablation or Embolization Treatments
8.2.3. Radiation Therapy
8.2.4. Chemotherapy
8.2.5. Immunotherapy
8.3. Treatment of Hepatocellular Cancer
8.3.1. Surgery
8.3.2. Ablation
8.3.3. Embolization Therapy
8.3.4. Radiation Therapy
8.3.5. Targeted Drug Therapy
8.3.6. Immunotherapy
8.3.7. Chemotherapy
8.4. Treatment of Ovarian Cancer
8.4.1. Local Treatments
8.4.1.1. Surgery
8.4.1.2. Radiation Therapy
8.4.2. Systemic Treatment
8.4.2.1. Chemotherapy
8.4.2.2. Targeted Therapy
8.4.2.3. Hormone Therapy
8.5. Treatment for Colorectal Cancer
8.5.1. Local Treatments
8.5.1.1. Surgery
8.5.1.2. Radiation Therapy
8.5.2. Systemic Therapy
8.5.2.1. Chemotherapy
8.5.2.2. Targeted Therapy
8.5.2.3. Immunotherapy
8.6. Treatment Guidelines and Recommendations for KRAS Inhibitors
8.6.1. NCCN Guidelines for the Treatment of CRC
8.6.2. NCCN Guidelines for NSCLC
8.6.3. ESMO Guidelines for the Treatment of Metastatic Colorectal Cancer
8.6.3.1. First-line Therapy Guidelines
8.6.3.2. Second-line Therapy Guidelines
8.6.3.3. Third-line Therapy and Beyond Guidelines
8.6.4. Pan-asian Guidelines for the Management of NSCLC
9. Epidemiology and Patient Population
9.1. Key Findings
9.2. Assumptions and Rationale
9.3. KRAS Mutation in NSCLC
9.3.1. United States
9.3.1.1. Total Incident Cases of NSCLC in the United States
9.3.1.2. KRAS Incident Cases in NSCLC in the United States
9.3.1.3. KRAS Variant Cases in NSCLC in the United States
9.3.2. EU4 and the UK
9.3.2.1. Total Incident Cases of NSCLC in EU4 and the UK
9.3.2.2. KRAS Incident Cases in NSCLC in EU4 and the UK
9.3.2.3. KRAS Variant Cases in NSCLC in EU4 and the UK
9.3.3. Japan
9.3.3.1. Total Incident Cases of NSCLC in Japan
9.3.3.2. KRAS Incident Cases in NSCLC in Japan
9.3.3.3. KRAS Variant Cases in NSCLC in Japan
9.4. KRAS Mutation in CRC
9.4.1. United States
9.4.1.1. Total Incident Cases of CRC in the United States
9.4.1.2. KRAS Incident Cases in CRC in the United States
9.4.1.3. KRAS Variant Cases in CRC in the United States
9.4.2. EU4 and the UK
9.4.2.1. Total Incident Cases of CRC in EU4 and the UK
9.4.2.2. KRAS Incident Cases in CRC in EU4 and the UK
9.4.2.3. KRAS Variant Cases in CRC in EU4 and the UK
9.4.3. Japan
9.4.3.1. Total Incident Cases of CRC in Japan
9.4.3.2. KRAS Incident Cases in CRC in Japan
9.4.3.3. KRAS Variant Cases in CRC in Japan
9.5. KRAS Mutation in Pancreatic Cancer
9.5.1. United States
9.5.1.1. Total Incident Cases of Pancreatic Cancer in the United States
9.5.1.2. KRAS Incident Cases in Pancreatic Cancer in the United States
9.5.1.3. KRAS Variant Cases in Pancreatic Cancer in the United States
9.5.2. EU4 and the UK
9.5.2.1. Total Incident Cases of Pancreatic Cancer in EU4 and the UK
9.5.2.2. KRAS Incident Cases in Pancreatic Cancer in EU4 and the UK
9.5.2.3. KRAS Variant Cases in Pancreatic Cancer in EU4 and the UK
9.5.3. Japan
9.5.3.1. Total Incident Cases of Pancreatic Cancer in Japan
9.5.3.2. KRAS Incident Cases in Pancreatic Cancer in Japan
9.5.3.3. KRAS Variant Cases in Pancreatic Cancer in Japan
9.6. KRAS Mutation in LGSOC
9.6.1. United States
9.6.1.1. Total Incident Cases of LGSOC in the United States
9.6.1.2. KRAS Incident Cases in LGSOC in the United States
9.6.1.3. KRAS Variant Cases in LGSOC in the United States
9.6.2. EU4 and the UK
9.6.2.1. Total Incident Cases of LGSOC in EU4 and the UK
9.6.2.2. KRAS Incident Cases in LGSOC in EU4 and the UK
9.6.2.3. KRAS Variant Cases in LGSOC in EU4 and the UK
9.6.3. Japan
9.6.3.1. Total Incident Cases of LGSOC in Japan
9.6.3.2. KRAS Incident Cases in LGSOC in Japan
9.6.3.3. KRAS Variant Cases in LGSOC in Japan
10. Marketed 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)
10.3.1. Product Description
10.3.2. Regulatory Milestones
10.3.3. Other Developmental Activities
10.3.4. Clinical Development
10.3.4.1. Clinical Trial Information
10.3.5. Safety and Efficacy
10.3.6. Analyst Views
10.4. AVMAPKI + FAKZYNJA Co-Pack (avutometinib + defactinib): Verastem Oncology
10.4.1. Product Description
10.4.2. Regulatory Milestones
10.4.3. Other Developmental Activities
10.4.4. Clinical Development
10.4.4.1. Clinical Trials Information
10.4.5. Safety and Efficacy
10.4.6. Analyst Views
11. Emerging 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
11.4.1. Product Description
11.4.2. Other Developmental Activities
11.4.3. Clinical Development
11.4.3.1. Clinical Trials Information
11.4.4. Safety and Efficacy
11.4.5. Analyst Views
11.5. Daraxonrasib (RMC-6236): Revolution Medicines
11.5.1. Product Description
11.5.2. Other Developmental Activities
11.5.3. Clinical Development
11.5.3.1. Clinical Trials Information
11.5.4. Safety and Efficacy
11.5.5. Analyst Views
11.6. Olomorasib (LY3537982): Eli Lilly and Company
11.6.1. Product Description
11.6.2. Other Developmental Activities
11.6.3. Clinical Development
11.6.3.1. Clinical Trials Information
11.6.4. Safety and Efficacy
11.6.5. Analyst Views
11.7. MK-1084: Merck, Taiho, and Astex Pharmaceuticals
11.7.1. Product Description
11.7.2. Other Developmental Activities
11.7.3. Clinical Development
11.7.3.1. Clinical Trials Information
11.7.4. Safety and Efficacy
11.7.5. Analyst Views
11.8. Onvansertib: Cardiff Oncology
11.8.1. Product Description
11.8.2. Other Developmental Activities
11.8.3. Clinical Development
11.8.3.1. Clinical Trials Information
11.8.4. Safety and Efficacy
11.8.5. Analyst Views
11.9. DUPERT (fulzerasib/GFH925): Genfleet Therapeutics and Innovent
11.9.1. Product Description
11.9.2. Other Developmental Activities
11.9.3. Clinical Development
11.9.3.1. Clinical Trials Information
11.9.4. Safety and Efficacy
11.9.5. Analyst Views
11.10. ELI-002: Elicio Therapeutics
11.10.1. Product Description
11.10.2. Other Developmental Activities
11.10.3. Clinical Development
11.10.3.1. Clinical Trials Information
11.10.4. Safety and Efficacy
11.10.5. Analyst Views
11.11. D3S-001: D3 Bio
11.11.1. Product Description
11.11.2. Other Developmental Activities
11.11.3. Clinical Development
11.11.3.1. Clinical Trials Information
11.11.4. Safety and Efficacy
11.11.5. Analyst Views
12. KRAS Inhibitors: Seven Major Market Analysis
12.1. Key Findings
12.2. Market Outlook
12.3. Conjoint Analysis
12.4. Key Market Forecast Assumptions
12.4.1. Cost Assumptions and Rebate
12.4.2. Pricing Trends
12.4.3. Analogue Assessment
12.4.4. Launch Year and Therapy Uptake
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 Market Size
12.7.1. Total Market Size of KRAS Inhibitors in the United States
12.7.2. Market Size of KRAS Inhibitors by Therapies in the United States
12.8. EU4 and the UK Market Size
12.8.1. Total Market Size of KRAS Inhibitors in EU4 and the UK
12.8.2. Market Size of KRAS Inhibitors by Therapies in EU4 and the UK
12.9. Japan
12.9.1. Total Market Size of KRAS Inhibitors in Japan
12.9.2. Market Size of KRAS Inhibitors by Therapies in Japan
13. Unmet Needs
14. SWOT Analysis
15. KOL Views
16. Market Access and Reimbursement
16.1. United States
16.1.1. Centre for Medicare and Medicaid Services (CMS)
16.2. EU4 and the UK
16.2.1. Germany
16.2.2. France
16.2.3. Italy
16.2.4. Spain
16.2.5. United Kingdom
16.3. Japan
16.3.1. MHLW
16.4. Market Access and Reimbursement of KRAS Inhibitors
17. Appendix
17.1. Bibliography
17.2. Report Methodology
18. Analyst's Capabilities
19. Disclaimer
20. About the Publisher
List of Tables [72]
List of Figures [56]
A selection of companies mentioned in this report includes, but is not limited to:
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