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시장보고서
상품코드
2126043
KRAS 저해제 : 시장 규모, 대상 환자층, 경쟁 구도 및 시장 예측(2036년)KRAS Inhibitors - Market Size, Target Population, Competitive Landscape & Market Forecast - 2036 |
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DelveInsight
KRAS 억제제 시장 보고서에서는 현재의 치료 실무, 신흥 의약품, 개별 치료법의 시장 점유율, 그리고 2022-2036년까지 주요 7개국의 KRAS 억제제 시장 규모 현황 및 전망에 대해 다루고 있습니다. 또한 이 보고서에서는 현재의 KRAS 억제제 치료 실무 및 알고리즘과 미충족 의료 수요에 대해서도 다루며, 최적의 비즈니스 기회를 파악하고 시장의 잠재력을 평가하고 있습니다.
조사 기간: 2022-2036년
KRAS 억제제 개요
KRAS는 RAS 슈퍼패밀리 또는 RAS-유사 GTP아제로 알려진 소 GTP 결합 단백질 그룹에 속합니다. 발암 유전자인 쥐 육종 바이러스(RAS)는 신호 전달 인자로 기능하며, 정상 세포 및 악성 세포의 증식, 분화, 생존 조절에 중요한 역할을 합니다. RAS-마이토젠 활성화 단백질 키나아제-ERK 키나아제-세포외 신호 관련 키나아제(RAS-RAF-MEK-ERK) 경로는 가장 상세하게 규명된 신호 전달 경로 중 하나이며, 이 경로의 이상은 다양한 유형의 암 발병에 관여하는 것으로 널리 알려져 있습니다. KRAS 돌연변이란 세포 신호전달 경로에서 단백질을 암호화하는 KRAS 유전자에 발생하는 유전적 변화를 말합니다. 이러한 돌연변이는 대장암(CRC), 폐암, 췌장암 등 다양한 유형의 암에서 널리 관찰됩니다. 안타깝게도, KRAS 돌연변이에 대해서는 지금까지 특정 치료법을 이용한 표적 치료를 시행하기 어려웠습니다. 그러나 최근 동향에 따라 KRAS 돌연변이를 가진 암을 치료하기 위한 유망한 전략이 몇 가지 개발되었으나, 이러한 치료법은 비소세포폐암(NSCLC)으로 한정되어 있습니다.
일반적으로 KRAS 돌연변이 암의 치료에는 수술, 방사선 치료, 화학요법, 표적 치료, 면역 요법 등이 포함됩니다. 고주파 절제술(RFA)은 폐 외연 부근에 작은 폐 종양이 있는 환자, 특히 수술을 견딜 수 없는 경우 등에 고려될 수 있습니다.
KRAS 억제제 진단
KRAS 돌연변이 진단은 종양 조직의 유전자 염기서열 분석을 수행하거나, 체액 생검을 통해 이루어질 수 있습니다.
일반적으로 KRAS 검사 의뢰는 임상의가 수행합니다. 검사에는 대개 과거 수술이나 생검을 통해 환자에게서 채취한 종양 조직이 사용됩니다. 진행된 병기의 종양을 가진 환자가 KRAS 검사를 받는 경우, 일반적으로 보조 요법이 필요합니다. 전이성 질환이 있는 경우, 검사에 필요한 검체가 원발 종양이 아니라 전이 병변에서 채취한 대표적인 조직 샘플임을 명확히 하는 것이 중요합니다. DNA는 일반적으로 FFPE 조직 블록에서 추출됩니다. 검사에 사용할 최적의 종양 절편을 선정하는 것은 병리 전문의의 책임입니다. 여기에는 절편 또는 조직 블록의 평가 외에도, 괴사된 종양 부분이나 비종양성 조직을 제거하여 종양을 농축하기 위한 미세 절제술 및 거시 절제술이 포함됩니다. 일반적으로 종양이 농축된 영역은 조직 소견을 비교적 쉽게 식별할 수 있으며, 양성 조직에서 분리하여 채취할 수 있습니다. 이 작업에서는 고정된 조직의 절편을 미염색 슬라이드에 올리고, 비교를 위해 동일한 조직 절편의 표준 H&E 염색(헤마톡실린·에오신 염색) 슬라이드를 준비하는 것이 종종 도움이 됩니다.
본 시장은 환자 기반 모델을 사용하여 산출되었으므로, 이 보고서의 KRAS 억제제 역학 관련 장에서는 비소세포폐암(NSCLC),대장암(CRC), 췌장암 및 저악성도 난소암(LGSOC)의 총 신규 환자 수, NSCLC, CRC, 췌장암 및 LGSOC에서 KRAS 양성 신규 환자 수, NSCLC, 대장암,췌장암, 그리고 LGSOC에서 KRAS 변이 사례 수의 합계를 2022-2036년까지의 기간에 대해 미국, EU4(독일, 프랑스, 이탈리아, 스페인), 영국 및 일본을 포함한 주요 7개국을 대상으로 부문별로 제시하고 있습니다.
KRAS 억제제 시장의 최근 동향
KRAS는 비소세포폐암(NSCLC), 췌장선암(PDAC), 대장암(CRC), 난소암 등 여러 암에서 빈번하게 변이가 관찰되는 잘 알려진 발암 유전자입니다. 한때는 ‘약물 표적화가 어렵다’고 여겨졌으나, 돌연변이 특이적 억제제, 특히 KRAS G12C 돌연변이를 표적으로 하는 약물의 등장으로 KRAS는 다시 주목받고 있습니다. LUMAKRAS/LUMYKRAS(소트라시브)나 KRAZATI(아다그라시브)와 같은 이러한 약물은 비활성 GDP 결합 상태에 있는 KRAS를 선택적으로 억제하여, KRAS G12C 변이를 가진 종양을 가진 이전 치료를 받은 환자에게 임상적 이점을 제공하고 있습니다.
암젠의 LUMAKRAS는 2021년에 비소세포폐암(NSCLC)에 대해 FDA 승인을 획득한 최초의 KRAS G12C 억제제이며, 그 후 전 세계 여러 시장에서 승인을 받았습니다. 이후 무재발 생존 기간의 개선을 보여주는 데이터를 바탕으로, VECTIBIX와의 병용 요법을 통한 대장암(CRC)에 대한 적응증 확대가 승인되었습니다. Qiagen사의 therascreen KRAS RGQ PCR 키트와 같은 동반 진단제가 환자 선별을 지원하고 있습니다.
브리스톨-마이어스 스퀴브(Bristol-Myers Squibb)사의 ‘KRAZATI’는 2022년에 시장에 진출한 이래, 임상적 성과 면에서 ‘LUMAKRAS’를 앞지르며 비소세포폐암(NSCLC) 및 전이성 대장암(mCRC) 모두에 대해 신속 승인을 획득했습니다. ‘LUMAKRAS’의 매출은 ‘KRAZATI’의 출시와 시기를 같이하며 감소했습니다. 앰젠(Amgen)은 매출 감소가 주로 독일에서의 보험 급여 합의의 일환으로 시행된 가격 조정에 기인한 것이라고 밝혔습니다. 또한 이 약물은 중추신경계(CNS) 전이성 비소세포폐암(NSCLC)에 관한 NCCN 가이드라인에도 포함되면서, 끊임없이 진화하는 표준 치료에서 그 역할이 확고해졌습니다. 이러한 진전에도 불구하고 KRAS G12C 억제제에 대한 선천적 및 후천적 내성은 여전히 중요한 과제로 남아 있습니다.
G12C 외에도, 다른 KRAS 변이체를 표적으로 하는 효과적인 치료법의 필요성이 차세대 의약품 개발을 주도하고 있습니다. 베라스템(Verastem)사의 ‘AVMAPKI FAKZYNJA Co-Pack’은 최근 KRAS 변이를 동반한 재발성 LGSOC에 대한 최초의 FDA 승인 치료제가 되어, 지금까지 치료 요구가 충분히 충족되지 않았던 적응증을 해결했습니다. 한편, KRAS 억제제와 화학요법, 면역관문 억제제 또는 범-KRAS 약물을 조합한 병용 요법에 대해서도 현재 활발한 연구가 진행되고 있습니다.
수많은 주요 기업이 대체 KRAS 변이체 탐색에 적극적으로 나서며, 비소세포폐암(NSCLC) 이외의 다른 암 유형로도 조사 범위를 확대하고 있습니다. 이러한 초점의 전환은 보다 광범위한 KRAS 돌연변이에 대응하고, 여러 암종을 표적으로 삼을 수 있는 효과적인 치료법을 개발하는 데 있으며, 유망한 가능성을 내포하고 있습니다. Cardiff Oncology(온반셀티브), Immuneering Corporation(IMM-1-104), Verastem(아브토메티닙+데파크티닙) 등 많은 기업이 범-KRAS 영역의 후보 약물 개발에 주력하고 있습니다.
로슈, 레볼루션 메디신스, 일라이 릴리 등 일부 기업은 디발라시브, 달라크손라시브, 오로모라시브와 같은 유망한 후보 약물을 추진하고 있으며, 돌연변이 아형이나 종양의 유형에 관계없이 KRAS를 표적으로 한 치료의 적용 범위를 확대하는 것을 목표로 하고 있습니다. 일부 진전이 보이기는 하지만, 종양의 이질성과 내성 기전으로 인해 KRAS가 관여하는 암의 치료는 여전히 어려운 과제로 남아 있습니다. 표적 치료, 바이오마커 기반 접근법, 그리고 병용 요법에서의 지속적인 혁신은 종양학 분야에서 KRAS 억제의 잠재력을 충분히 실현하기 위해 필수적일 것입니다.
DelveInsight's "Kirsten Rat Sarcoma Virus (KRAS) Inhibitors - Market Insights, Epidemiology, and Market Forecast - 2036" report delivers an in-depth understanding of the KRAS inhibitors, historical and forecasted epidemiology as well as the KRAS inhibitors market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
KRAS inhibitors market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted the 7MM KRAS inhibitors market size from 2022 to 2036. The report also covers current KRAS inhibitor treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Study Period: 2022-2036
KRAS Inhibitors Overview
KRAS belongs to a group of small GTP-binding proteins known as the RAS superfamily or RAS-like GTPases. Rat sarcoma virus (RAS), an oncogene, functions as a signal transducer, important for regulating cell proliferation, differentiation, and survival in normal and malignant cells. The RAS-mitogen-activated protein kinase-ERK kinase-extracellular signal-related kinase (RAS-RAF-MEK-ERK) pathway is one of the best-characterized signal transduction pathways, and its aberrancies are commonly implicated in the development of multiple different cancer types. KRAS mutations are genetic alterations in the KRAS gene, which encodes a protein in cell signaling pathways. These mutations are commonly found in various types of cancer, including CRC, lung, and pancreatic cancer. Unfortunately, KRAS mutations have historically been challenging to target with specific treatments. However, recent advancements in research have led to the development of some promising strategies to treat KRAS-mutated cancers, but these treatments are limited to NSCLC only.
Generally, treatment for KRAS-mutated cancers includes surgery, radiation therapy, chemotherapy, targeted therapies, immunotherapy, and others. Radiofrequency Ablation (RFA) might be considered for some people with small lung tumors near the outer edge of the lungs, especially if they cannot tolerate surgery.
KRAS Inhibitors Diagnosis
KRAS mutation can be diagnosed by conducting genetic sequencing of the tumor tissue or with the help of a liquid biopsy.
The clinician typically initiates KRAS testing requests for a patient. Usually, the testing is performed on tumor tissue removed from the patient during a previous surgery or biopsy procedure. Typically, patients undergoing KRAS testing with high-stage tumors require adjuvant therapy. If metastatic disease is present, it is important to clarify that the sample needed for testing is not the primary tumor but a representative tissue sample from the metastatic lesion. DNA is usually extracted from FFPE tissue blocks. It is the pathologist's responsibility to identify the best tumor section to be subjected to testing. This includes evaluation of the slide with cut tissue or the tissue block, followed by microdissection and macro dissection for tumor enrichment to eliminate portions of necrotic tumor and nonneoplastic tissue. Typically, tumor-enriched areas will have relatively easily identified histology and can be dissected away from benign tissue. This process is often aided by having the fixed tissue cut placed on an unstained slide and having a standard H&E-stained (hematoxylin and eosin) slide of the same tissue cut available for comparison.
As the market is derived using a patient-based model, the KRAS inhibitors epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incident cases of NSCLC, CRC, pancreatic cancer, and LGSOC, total KRAS incident cases in NSCLC, CRC, pancreatic cancer, and LGSOC, total KRAS variant cases in NSCLC, CRC, pancreatic cancer, and LGSOC in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2022 to 2036.
The drug chapter segment of the KRAS inhibitors reports encloses a detailed analysis of KRAS inhibitors marketed drugs such as LUMAKRAS/LUMYKRAS, KRAZATI, AVMAPKI + FAKZYNJA Co-Pack, and late-stage (Phase III and Phase II) pipeline drugs including divarasib, daraxonrasib, olomorasib, MK-1084, and others. It also helps understand the KRAS inhibitors' clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included the drug, and the latest news and press releases.
Marketed Drugs
LUMAKRAS/LUMYKRAS (sotorasib): Amgen
LUMAKRAS is an inhibitor of the RAS GTPase family indicated for treating adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy. It has also recieved BTD by the US FDA. The drug received accelerated approval from the FDA in May 2021 for treating patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, following at least one prior systemic therapy. Conditional marketing authorization was subsequently granted in the European Union. In January 2022, it was approved in Japan for KRAS G12C-mutated advanced or recurrent NSCLC after prior systemic therapy.
KRAZATI (adagrasib): Bristol Myers Squibb (Mirati Therapeutics)
KRAZATI is an oral targeted treatment option for adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. KRAZATI received approval from the FDA and launched commercially in the US in December 2022. In January 2024, the EC granted conditional marketing authorization for KRAZATI for treating KRASG12C-mutated advanced NSCLC and disease progression after at least one prior systemic therapy.
Emerging Drugs
Olomorasib (LY3537982): Eli Lily and Company
Olomorasib is an investigational, oral, potent, and highly selective second-generation inhibitor of the KRAS G12C protein. Olomorasib is currently being studied in 1L KRAS G12C+ NSCLC clinical trial among two other Phase III trials in NSCLC. The FDA granted BTD for olomorasib for the treatment of certain newly diagnosed metastatic KRAS G12C-mutant lung cancers and ODD for the treatment of KRAS G12C-mutant NSCLC in June 2025.
In September 2025, Eli Lilly announced that the US FDA has granted BTD 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.
Calderasib (MK-1084): Merck
Calderasib is an investigational oral selective KRAS G12C inhibitor being evaluated with or without pembrolizumab for the treatment of certain patients with colorectal cancer and NSCLC. MK-1084 is being developed under a collaboration and license agreement with Taiho Pharmaceutical and Astex Pharmaceuticals. Currently MK-1084 is being evaluated in Phase III KANDLELIT-012 and Phase III KANDLELIT-004 trial. Calderasib was granted BTD by the US FDA for the first-line treatment of patients with advanced or metastatic NSCLC with KRAS G12C-mutation and expressing PD-L1 in May 2026.
In March 2026, Merck announced new data from the Phase I KANDLELIT-001 trial. Findings demonstrated that calderasib both as monotherapy and in combination with pembrolizumab, provides durable antitumor activity and impressive survival rates. The ORR reached 72% in combination group and patients receiving the doublet therapy achieved a median PFS 95%.
Daraxonrasib: Revoltuion Medicines
Daraxonrasib is an investigational, oral, RAS(ON) multi-selective non-covalent inhibitor designed to treat patients with cancers driven by a wide range of common RAS mutations. The company in its SEC filling, anticipate to provide an update on advancing daraxonrasib combination therapy in 1L NSCLC in 2026. It received ODD from the US FDA for the treatment of pancreatic cancer.
In June 2025, Revoltuion Medicines entered into a clinical collaboration with Summit Therapeutics, to evaluate the safety and efficacy of daraxonrasib in combination with Summit's ivonescimab in multiple solid tumor.
Recent Developments in the KRAS Inhibitors Market
KRAS is a well-established oncogene frequently mutated in several cancers, including NSCLC, PDAC, CRC, and ovarian cancer. Historically considered undruggable, KRAS has become a renewed focus with the emergence of mutation-specific inhibitors-most notably those targeting the KRAS G12C mutation. These agents, such as LUMAKRAS/LUMYKRAS (sotorasib) and KRAZATI (adagrasib), selectively inhibit KRAS in its inactive GDP-bound state, offering clinical benefit in previously treated patients with KRAS G12C-mutated tumors.
Amgen's LUMAKRAS was the first KRAS G12C inhibitor to receive FDA approval in 2021 for NSCLC, followed by approvals in multiple global markets. Subsequent approvals were extended to CRC in combination with VECTIBIX, based on data showing improved progression-free outcomes. Companion diagnostics, like Qiagen's therascreen KRAS RGQ PCR Kit, are aiding patient selection.
Bristol Myers Squibb's KRAZATI entered the market in 2022 and has since surpassed LUMAKRAS in clinical momentum, receiving accelerated approvals for use in both NSCLC and mCRC. LUMAKRAS witnessed a decrease in sales, coinciding with the launch of KRAZATI. Amgen stated that the decline in sales was primarily due to a price adjustment implemented as part of a reimbursement agreement in Germany. It has also been incorporated into NCCN Guidelines for CNS-metastatic NSCLC, solidifying its role in the evolving standard of care. Despite these advances, primary and acquired resistance to KRAS G12C inhibitors remains a key hurdle.
Beyond G12C, the need for effective therapies targeting other KRAS variants is driving next-generation drug development. Verastem's AVMAPKI FAKZYNJA Co-Pack recently became the first FDA-approved therapy for KRAS-mutated recurrent LGSOC, addressing an underserved indication. Meanwhile, combination strategies-pairing KRAS inhibitors with chemotherapy, immune checkpoint inhibitors, or pan-KRAS agents-are under active investigation.
Numerous key players actively explore alternative KRAS variants and expand their research to include other types of cancers beyond NSCLC. This shift in focus holds promising potential for developing effective therapies that can address a wider range of KRAS mutations and target multiple cancer types. Many companies are focusing on developing their candidates in pan-KRAS, like Cardiff Oncology (onvansertib), Immuneering Corporation (IMM-1-104), Verastem (Avutometinib + Defactinib), and others.
Several companies, including Roche, Revolution Medicines, Eli Lilly, and others, are advancing promising candidates such as divarasib, daraxonrasib, and olomorasib, aiming to expand the therapeutic scope of KRAS-targeted treatment across mutation subtypes and tumor types. Despite progress, KRAS-driven cancers remain challenging due to tumor heterogeneity and resistance mechanisms. Ongoing innovation in targeted therapies, biomarker-driven approaches, and combination regimens will be essentito realize the potential of KRAS inhibition in oncology fullyogy.
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2022-2036. Further detailed analysis of emerging therapies and drug uptake is in the report.
KRAS Inhibitors Pipeline Development Activities
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for KRAS inhibitors emerging therapies.
KOL- Views
To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on KRAS inhibitors evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along with challenges related to accessibility.
Delveinsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as VCS Research Institute, Florida Cancer Specialists & Research Institute in the US, Japanese Foundation for Cancer Research in Japan, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or KRAS inhibitors market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Qualitative Analysis
We perform qualitative and market intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.
Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.
Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Market Insights
Epidemiology Insights
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies