KRAS Inhibitors Drugs Market 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Target Population, Revenue, Statistics, MOA, ROA and Companies DelveInsight

KRAS Inhibitors companies working in the market are 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
(Albany, USA) In 2024, the United States held nearly 70% of the KRAS inhibitors market across the 7MM, driven by a high burden of KRAS-mutated cancers, especially NSCLC, which accounts for 46% of such cases in the region. KRAS, the most commonly mutated RAS gene, is linked to pancreatic, colorectal, lung, and ovarian cancers. While current therapies mainly target the G12C mutation, newer pan-KRAS approaches, like onvansertib, aim to treat multiple KRAS variants, broadening patient reach. Key players include Roche, Revolution Medicines, Eli Lilly, Merck, AstraZeneca, and Cardiff Oncology, intensifying efforts to develop therapies for hard-to-treat KRAS mutations such as G12D.

The report titled "KRAS Inhibitors Market Insights, Epidemiology, and Market Forecast- 2034" by DelveInsight provides a comprehensive analysis of KRAS Inhibitors. It presents a detailed overview of the historical and projected epidemiological data, along with the market trends for KRAS Inhibitors in the United States, EU5 countries (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

The report on the KRAS Inhibitors market offers up-to-date treatment methods, upcoming medications, the market share of different therapies, and the present as well as projected size of the KRAS Inhibitors market from 2020 to 2034. The market is divided into seven major segments. Additionally, the report examines the existing treatment practices and strategies for KRAS Inhibitors, factors driving market growth, obstacles encountered, and medical needs that have yet to be addressed. This comprehensive assessment aims to identify the most promising opportunities and evaluate the inherent potential of the KRAS Inhibitors market.

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Some facts of the KRAS Inhibitors Market Report are:

* According to DelveInsight, KRAS Inhibitors market size is expected to grow at a decent CAGR by 2034.
* Leading KRAS Inhibitors companies working in the market are 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 KRAS Inhibitors Therapies expected to launch in the market are LUMAKRAS/LUMYKRAS (sotorasib), KRAZATI (adagrasib), JDQ443, Divarasib, and others.
* On May 8, 2025, the Food and Drug Administration granted accelerated approval to the combination of avutometinib and defactinib (Avmapki Fakzynja Co-pack, Verastem, Inc.) for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.
* In April 2025, Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of VS-7375, an oral KRAS G12D (ON/OFF) inhibitor for clinical evaluation. The Company expects to initiate a Phase 1/2a study in mid-2025 with plans for multiple expansion cohorts, including combinations, in advanced solid tumors, such as pancreatic cancer, colorectal cancer, and non-small cell lung cancer.
* In January 2025, Quanta Therapeutics, a privately held clinical-stage biopharmaceutical company at the forefront of developing innovative oral therapies for RAS-driven cancers, announced advancements in its pipeline of KRAS-directed drug candidates. This includes the clearance of a U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application for QTX3544, an oral G12V-preferring, dual ON/OFF state, multi-KRAS inhibitor, which allows the initiation of a Phase 1 clinical trial.
* In June 2024, Quanta Therapeutics, a privately held clinical-stage biopharmaceutical company focused on developing innovative oral treatments for RAS-driven cancers, announced the progress of two clinical trials from its pipeline of KRAS-directed drug candidates. The first patient has been dosed in the monotherapy phase of a Phase 1 trial evaluating QTX3046, a KRASG12D-selective inhibitor. Additionally, patient dosing has commenced in the combination phase of the ongoing Phase 1 trial assessing QTX3034, a multi-KRAS inhibitor that preferentially targets G12D, in combination with cetuximab. Both trials are enrolling patients with KRASG12D-mutated advanced solid tumors.
* In February 2024, Bristol Myers Squibb reported that the US FDA has granted priority review status to the supplemental New Drug Application (sNDA) for KRAZATI in combination with cetuximab for the treatment of KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024.
* In April 2023, BridgeBio Pharma Announces First Lung Cancer Patient Dosed in Phase 1 Trial and US FDA Fast Track Designation for SHP2 inhibitor BBP-398 in Combination with Amgen's LUMAKRAS Registered (sotorasib)
* In May 2023, Mirati Therapeutics announced Phase Ib Trial of the KRASG12C Inhibitor Adagrasib (MRTX849) in KRAS G12C Mutant Metastatic Pancreatic Cancer Patients.
* In Jan 2023, Pfizer and Array BioPharma announced the Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the MEK Inhibitor Binimetinib (MEK162) for Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer

KRAS Inhibitors Overview

KRAS inhibitors are a specific form of targeted therapy devised to hinder the function of the KRAS gene, which plays a vital role in numerous types of cancer. The KRAS gene is part of a gene family called RAS genes and is responsible for regulating cellular division and growth. Mutations in the KRAS gene can prompt uncontrolled cell growth and division, ultimately leading to the formation of cancer.

Traditionally, it has been challenging to address KRAS mutations using conventional treatments, making KRAS-driven cancers particularly difficult to manage. However, considerable advancements have been made in recent years with the development of KRAS inhibitors that effectively impede the abnormal activity of mutated KRAS proteins. These inhibitors are specifically designed to target the altered KRAS protein, aiming to disrupt its signalling pathways and hinder the growth of cancerous cells.

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KRAS Inhibitors Market

The KRAS Inhibitors market outlook of the report helps to build a detailed comprehension of the historical, current, and forecasted KRAS Inhibitors market trends by analyzing the impact of current KRAS Inhibitors therapies on the market and unmet needs, and drivers, barriers, and demand for better technology.

This segment gives a thorough detail of the KRAS Inhibitors market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated KRAS Inhibitors market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

According to DelveInsight, the KRAS Inhibitors market in 7MM is expected to witness a major change in the study period 2020-2034.

KRAS Inhibitors Epidemiology

The KRAS Inhibitors epidemiology section provides insights into the historical and current KRAS Inhibitors patient pool and forecasted trends for seven individual major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the KRAS Inhibitors market report also provides the diagnosed patient pool, trends, and assumptions.

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KRAS Inhibitors Drugs Uptake

The KRAS Inhibitors Drugs Uptake section emphasizes the rate at which the newly introduced KRAS Inhibitors medications in the market, or those projected to be launched between 2020 and 2034, are being adopted. The examination encompasses the adoption of drugs in the KRAS Inhibitors market, the acceptance of therapies by patients, and the sales figures for each medication.

KRAS Inhibitors Drugs Uptake helps in understanding the drugs with the most rapid uptake and the reasons behind the maximal use of new drugs and allows the comparison of the drugs based on KRAS Inhibitors market share and size, which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

KRAS Inhibitors Pipeline Development Activities

The KRAS Inhibitors report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses KRAS Inhibitors key players involved in developing targeted therapeutics.

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KRAS Inhibitors Therapeutics Assessment

Major key companies are working proactively in the KRAS Inhibitors Therapeutics market to develop novel therapies which will drive the KRAS Inhibitors treatment markets in the upcoming years are 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.

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KRAS Inhibitors Report Key Insights

1. KRAS Inhibitors Patient Population

2. KRAS Inhibitors Market Size and Trends

3. Key Cross Competition in the KRAS Inhibitors Market

4. KRAS Inhibitors Market Dynamics (Key Drivers and Barriers)

5. KRAS Inhibitors Market Opportunities

6. KRAS Inhibitors Therapeutic Approaches

7. KRAS Inhibitors Pipeline Analysis

8. KRAS Inhibitors Current Treatment Practices/Algorithm

9. Impact of Emerging Therapies on the KRAS Inhibitors Market

Table of Contents

1. Key Insights

2. Executive Summary

3. KRAS Inhibitors Competitive Intelligence Analysis

4. KRAS Inhibitors Market Overview at a Glance

5. KRAS Inhibitors Disease Background and Overview

6. KRAS Inhibitors Patient Journey

7. KRAS Inhibitors Epidemiology and Patient Population

8. KRAS Inhibitors Treatment Algorithm, Current Treatment, and Medical Practices

9. KRAS Inhibitors Unmet Needs

10. Key Endpoints of KRAS Inhibitors Treatment

11. KRAS Inhibitors Marketed Products

12. KRAS Inhibitors Emerging Therapies

13. KRAS Inhibitors Seven Major Market Analysis

14. Attribute Analysis

15. KRAS Inhibitors Market Outlook (7 major markets)

16. KRAS Inhibitors Access and Reimbursement Overview

17. KOL Views on the KRAS Inhibitors Market

18. KRAS Inhibitors Market Drivers

19. KRAS Inhibitors Market Barriers

20. Appendix

21. DelveInsight Capabilities

22. Disclaimer

About DelveInsight

DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

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