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Abhishek Kumar
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KRAS Inhibitors: Market, Trials & Regulatory Landscape 2034

KRAS Inhibitors: Market, Trials & Regulatory Landscape 2034

(Albany, USA) DelveInsight's report, "KRAS Inhibitors Market Insights, Epidemiology, and Market Forecast-2034," delivers an in-depth analysis of KRAS Inhibitors, covering historical and projected epidemiological data, market trends, and forecasts for the US, EU5 (Germany, Spain, Italy, France, UK), and Japan.

It details current treatments, emerging medications, therapy market shares, and market size projections from 2020-2034 across seven major segments. The report explores treatment practices, growth drivers, barriers, and unmet needs to highlight opportunities in the KRAS Inhibitors market.

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Key highlights include:

  • Market size expected to grow at a steady CAGR by 2034.
  • Leading companies: Novartis, Roche, Genentech, Verastem Oncology, Revolution Medicines, Cardiff Oncology, Immuneering Corporation, Jacobio Pharmaceuticals, BridgeBio Pharma (Navire Pharma), Mirati Therapeutics, Deciphera Pharmaceuticals, Elicio Therapeutics, InventisBio, Gritstone Bio, D3 Bio, and others.
  • Promising therapies: LUMAKRAS/LUMYKRAS (sotorasib), KRAZATI (adagrasib), JDQ443, Divarasib, and others.
  • Recent developments:
    • May 2025: FDA accelerated approval for avutometinib + defactinib (Avmapki Fakzynja Co-pack, Verastem) for KRAS-mutated recurrent low-grade serous ovarian cancer.
    • April 2025: Verastem's IND clearance for VS-7375 (KRAS G12D inhibitor); Phase 1/2a study planned for mid-2025 in solid tumors like pancreatic, colorectal, and NSCLC.
    • January 2025: Quanta Therapeutics' IND clearance for QTX3544 (G12V-preferring multi-KRAS inhibitor); Phase 1 trial initiation.
    • June 2024: Quanta dosed first patient in Phase 1 trials for QTX3046 (KRAS G12D-selective) and QTX3034 + cetuximab in KRAS G12D-mutated tumors.
    • February 2024: FDA priority review for KRAZATI + cetuximab in KRAS G12C-mutated CRC; PDUFA date June 21, 2024.
    • April 2023: BridgeBio's Phase 1 trial start and FDA Fast Track for BBP-398 + LUMAKRAS in lung cancer.
    • May 2023: Mirati's Phase Ib trial of adagrasib in KRAS G12C-mutated pancreatic cancer.
    • January 2023: Pfizer/Array's study of palbociclib + binimetinib in KRAS-mutant NSCLC.

KRAS Inhibitors Overview KRAS inhibitors target the KRAS gene, crucial in cancer cell growth. Mutations cause uncontrolled proliferation, making KRAS-driven cancers hard to treat. Recent advances block mutated KRAS proteins, disrupting signaling pathways to inhibit tumor growth.

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KRAS Inhibitors Market Outlook The report analyzes historical, current, and forecasted trends, assessing therapy impacts, unmet needs, drivers, barriers, and tech demands. It evaluates marketed drugs and late-stage pipelines by cost, MoA, compliance, patient segments, launch timelines, competition, and KOL views, with data in tables and graphs. The 7MM market is poised for significant change from 2020-2034.

KRAS Inhibitors Epidemiology Insights into patient pools, trends, and forecasts for major countries, based on studies and KOL views, including diagnosed cases and assumptions.

KRAS Inhibitors Drugs Uptake Examines adoption rates of new drugs (2020-2034), patient acceptance, and sales, aiding comparisons by market share and factors influencing uptake for regulatory decisions.

KRAS Inhibitors Pipeline Development Activities Covers Phase II/III candidates and key developers in targeted therapeutics.

KRAS Inhibitors Therapeutics Assessment Major players advancing novel therapies include Novartis, Roche, Genentech, Verastem Oncology, Revolution Medicines, Cardiff Oncology, Immuneering Corporation, Jacobio Pharmaceuticals, BridgeBio Pharma (Navire Pharma), Mirati Therapeutics, Deciphera Pharmaceuticals, Elicio Therapeutics, InventisBio, Gritstone Bio, D3 Bio, and others.

Asian Companies and Sponsors in KRAS Inhibitors Japan: Eli Lilly Japan K.K. is conducting a Phase 1a/1b study of LY4066434 (pan-KRAS inhibitor) in KRAS mutant solid tumors (jRCT2031240563); first participants enrolled in Jan 2025. Amgen K.K. leads a Phase 3 trial of sotorasib + panitumumab and FOLFIRI in treatment-naive metastatic CRC with KRAS p.G12C (jRCT2071240009). Taiho Pharmaceutical collaborates on MK-1084/Calderasib (KRAS G12C inhibitor) in global Phase 3 trials, including Japan sites.

South Korea: No standalone sponsors; primarily participates as sites in global trials (e.g., sotorasib CodeBreaK). Academic efforts, like Phase 1 data from Yonsei Cancer Hospital, show promise but lack corporate sponsorship.

Taiwan: Tyligand Bioscience's TSN1611 (KRAS G12D inhibitor) is in Phase 1/2 trials (NCT06385925), with first patient dosed in 2024 and potential Taiwan sites. Academic trials, such as imatinib + trametinib in KRAS-mutated tumors (NCT06962254), include Taiwan hospitals but are not company-sponsored.

About DelveInsight 

DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach. 

Related report

KRAS Inhibitors – Epidemiology Forecast – 2034

DelveInsight’s “KRAS Inhibitors – Epidemiology Forecast – 2034” report delivers an in-depth understanding of KRAS Inhibitors, historical and forecasted epidemiology in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. The leading KRAS Inhibitor Companies developing potential therapies include 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) and Verastem Oncology.

Media Contact 

Company Name: DelveInsight Business Research LLP

Contact Person: Abhishek kumar

Email: abhishek@delveinsight.com

City: Albany

State: New York

Country: United States

Website: https://www.delveinsight.com