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KRAS 저해제 : 시장 규모, 대상 환자층, 경쟁 구도 및 시장 예측(2036년)

KRAS Inhibitors - Market Size, Target Population, Competitive Landscape & Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 120 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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주요 하이라이트 :

  • 3가지 RAS 유전자 중 KRAS에서 변이가 가장 빈번하게 관찰되며, 그 다음으로 NRAS, HRAS 순입니다. KRAS 변이는 췌장암, 대장암, 폐선암, 난소암 등 여러 유형의 암과 관련이 있는 것이 일반적입니다.
  • 주요 7개국(주요 7개 시장) 중 2025년에는 미국이 KRAS 억제제 시장에서 가장 큰 규모를 차지하여 전체 시장 점유율의 70% 가까이를 기록했습니다.
  • 미국에서 승인된 치료제 중, 조사 기간(2022-2036년) 동안의 매출 측면에서는 ‘KRAZATI’가 ‘LUMAKRAS’를 앞설 것으로 예상됩니다.
  • 주요 7개국 중 비소세포폐암(NSCLC)에서 KRAS 돌연변이 사례 수가 가장 많았던 곳은 미국이었습니다. 주요 7개국내 NSCLC KRAS 돌연변이 사례 전체의 약 46%가 미국에서 보고되었습니다.
  • G12D 돌연변이는 치료가 어려운 경우가 많은 췌장암이나 난소암에서 특히 많이 관찰되는 반면, G12C 돌연변이는 비소세포폐암(NSCLC)에서 더 흔합니다.
  • 많은 KRAS 아형에는 치료 선택지가 없지만, 그러한 경우에는 pan-KRAS를 표적으로 하는 약물이 유용할 가능성이 있습니다. 이러한 치료법의 대상 환자층은 더욱 확대될 것입니다. 대장암(CRC)에서 pan-KRAS 억제 효과를 보인 약물 중 하나로 온반셀티브가 있습니다. ELICIO와 Revolution Medicines를 포함한 여러 기업이 pan-KRAS 치료법 연구를 진행하고 있습니다.
  • Cardiff Oncology(onvansertib), Immuneering Corporation(IMM-1-104),Jacobio Pharma(JAB-23E73), Eli Lilly and Company(LY4066434) 등 많은 기업이 범-KRAS 영역의 후보 약물 개발에 주력하고 있으며, 대상 환자층이 광범위하므로 이러한 치료법에는 매우 큰 시장 잠재력이 기대되고 있습니다.
  • KRAS를 표적으로 한 신약 개발 현황은 G12C 돌연변이에 중점을 두고 있으며, 승인된 치료제나 임상시험용 약물의 대부분은 이 돌연변이형에 특화되어 설계되었습니다.
  • Revolution의 독자적인 강점은 KRAS 단백질의 활성 상태, 즉 ‘온(on)’ 상태를 표적으로 삼고 있다는 점에 있습니다. 이 회사에 따르면 통제 불가능한 세포 증식을 유발하는 것은 RAS의 지속적인 ‘온’ 신호라고 합니다. 따라서 Revolution사는 자사의 접근 방식이 LUMAKRAS나 KRAZATI와 같은 KRAS ‘오프’ 억제제에 비해 치료적 우위를 가져올 가능성이 있다고 보고 있습니다.
  • 최근 몇몇 제약사가 KRAS G12D 변이를 표적으로 하는 치료법 개발 경쟁에 뛰어들고 있습니다. 주요 기업으로는 Tyligand Pharmaceuticals(쑤저우), Verastem Oncology, GenFleet Therapeutics, AstraZeneca, PAQ Therapeutics, Astellas Pharma 등이 있으며, 이 높은 잠재력을 지닌 표적에 대한 관심이 계속 높아지는 가운데 더 많은 기업이 빠르게 부상하고 있습니다.
  • KRAS를 표적으로 하는 치료제를 개발중인 주요 기업으로는 Roche/Chugai/Genentech(Divarasib), Revolution Medicines(Daraxonrasib), Eli Lilly and Company(Olomorasib), Merck, Taiho, Astex Pharmaceuticals(MK-1084), 카디프 종양학(Onvansertib), 젠플리트 테라퓨틱스와 이노벤트(DUPERT), 엘리시오 테라퓨틱스(ELI-002), D3 바이오(D3S-001) 등이 있으며, 각사의 후보 약물은 임상 개발의 다양한 단계에 있습니다.

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.

대상 지역 :

  • 미국
  • EU4(독일, 프랑스, 이탈리아, 스페인) 및 영국
  • 일본

조사 기간: 2022-2036년

KRAS 억제제에 대한 질환 이해 및 치료 알고리즘

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.

KRAS 억제제의 역학

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.

  • DelveInsight의 분석에 따르면 2025년 미국, EU4(독일, 프랑스, 이탈리아, 스페인), 영국 및 일본에서 비소세포폐암(NSCLC)의 신규 발병 환자 총수는 약 539,400건이었습니다.
  • 주요 7개국 중 2025년 NSCLC 신규 발병자 총수에서는 미국이 약 203,000건으로 가장 많았습니다.
  • 2025년, 주요 7개국에서 대장암 신규 환자 총수는 약 57만 800건이었습니다.
  • EU4 및 영국 중에서 독일의 환자 비중이 가장 커서 KRAS 돌연변이 사례의 약 26%를 차지했습니다. 반면, 스페인의 환자 비중은 가장 적어 약 14%였습니다.
  • KRAS 돌연변이는 결장직장암에서 가장 빈번하게 관찰되며, LGSOC에서는 환자 비율이 가장 낮습니다. 비소세포폐암(NSCLC)에서 가장 빈번하게 관찰되는 KRAS 돌연변이체는 G12C입니다. 미국에서는 NSCLC 사례의 약 36.8%에서 KRAS G12C가 확인됩니다. KRAS G12D의 유병률은 췌장암 및 LGSOC에서 각각 약 41.8%와 약 41.7%로 가장 높았습니다.

KRAS 억제제 시장의 최근 동향

  • 2026년 6월, 카디프 종양학(Cardiff Oncology)는 RAS 변이를 가진 1차 치료 대상 대장암 환자를 대상으로, 온반셀티브와 표준 치료(SoC) 요법의 병용 요법을 평가하는 2상 임상시험 ‘CRDF-004’의 긍정적인 결과를 발표했습니다. 그 결과, 온반셀티브는 객관적 반응률(ORR) 및 무진행 생존 기간(PFS)에서 임상적으로 유의미한 개선을 포함하여 현저하고 지속적인 종양 축소를 보인 것으로 밝혀졌습니다.
  • 2026년 5월, Silexion Therapeutics는 인간의 KRAS 돌연변이 췌장암 세포에서 SIL204를 평가하는 진행 중인 중개 면역종양학 연구에서 긍정적인 전임상 결과를 발표했습니다. 그 결과, HLA-ABC로도 알려진 주요 조직 적합성 복합체 클래스 I(MHC-I)의 표면 발현에서 통계적으로 유의미한 증가가 확인되었습니다.
  • 2026년 4월, Revolution Medicines는 이전에 치료를 받은 적이 있는 전이성 췌장 선암(PDAC) 환자를 대상으로 다락손라시브를 평가하는 제3상 임상시험 ‘RASolute 302’의 유망한 톱라인 결과를 발표했습니다. 이 임상시험에서는 정맥내 투여를 통한 표준 치료인 세포독성 화학요법과 비교하여, 무재발 생존 기간(PFS) 및 전체 생존 기간(OS)에서 통계적으로 유의미하고 임상적으로 의미 있는 개선이 나타났습니다.
  • 2026년 1월, 머크사는 KRAS G12C 변이를 가진 진행성 또는 전이성 비편평상피 비소세포폐암(NSCLC) 환자를 대상으로 칼데라시브 + 펨브롤리주맙 및 벨라히알루로니다제를 1차 치료제로 평가하는 제3상 임상시험 ‘KANDLELIT-007’의 개시를 발표했습니다.

KRAS 억제제 시장의 전망

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.

  • 현재 승인된 KRAS 표적 치료제는 단 3가지뿐입니다. 여기에는 2021년 5월 미국 FDA로부터 비소세포폐암(NSCLC) 치료제로 승인된 소트라시브, 2022년 12월 미국 FDA로부터 NSCLC 치료제로 승인된 아다그라시브,그리고 2025년 5월 미국 FDA로부터 저악성 난소암(LGSOC) 치료제로 승인된 아브토메티닙과 데파크티닙의 병용 요법이 포함됩니다.
  • 선정된 적응증 중 비소세포폐암(NSCLC)에 대한 KRAS 억제제 시장 규모가 가장 크며, 2025년 미국 시장 규모는 111억 달러에 육박할 것으로 전망됩니다.
  • 추정에 따르면 비소세포폐암(NSCLC)에서 KRAS 억제제 시장 규모는 미국이 가장 크며, 2025년에는 주요 7개국 시장의 약 70%를 차지하고 2036년까지 크게 성장할 것으로 예상됩니다.
  • EU4 및 영국에서는 아브토메티닙과 데파크티닙의 병용 요법이 가장 큰 시장 규모를 차지하는 반면, 그레실라시브는 2036년에는 최하위에 머물 것으로 예상됩니다.
  • Amgen의 2025년 연차 보고서에 따르면 소토라시브(LUMAKRAS)의 2025년 미국내 매출은 약 2억 1,100만 달러에 달했습니다.

자주 묻는 질문

  • KRAS 억제제 시장에서 2025년 미국의 시장 점유율은 어떻게 되나요?
  • KRAS 억제제 시장의 주요 기업은 어디인가요?
  • KRAS G12C 변이를 표적으로 하는 치료제의 개발 현황은 어떤가요?
  • 2025년 비소세포폐암(NSCLC)의 신규 발병 환자 수는 어떻게 되나요?
  • KRAS 억제제 시장의 향후 전망은 어떤가요?

목차

제1장 주요 인사이트

제2장 서론

제3장 개요

제4장 주요 이벤트

제5장 역학 및 시장 예측의 조사 방법

제6장 KRAS Inhibitor : 시장 개요

제7장 질환 배경과 개요

제8장 치료

제9장 역학 및 환자 인구

제10장 일반의약품(OTC)

제11장 신규 치료법

제12장 KRAS 저해제 : 주요 7개국 분석

제13장 미충족 수요

제14장 SWOT 분석

제15장 KOL의 견해

제16장 시장 참여 및 보험 상환

제17장 부록

제18장 DelveInsight의 서비스 내용

제19장 면책사항

제20장 DelveInsight 소개

KSA 26.09.10

Key Highlights:

  • KRAS is the most frequently mutated of the three RAS genes, followed by NRAS and HRAS. KRAS mutations are commonly associated with several types of cancer, including pancreatic, colorectal, lung adenocarcinomas, ovarian, and others.
  • Among the 7MM, the United States captured the highest KRAS-inhibitors market size in 2025, accounting for nearly 70% of the total market share.
  • Among the approved therapies in the United States, KRAZATI is expected to have the edge over LUMAKRAS in revenue generated during the study period (2022-2036).
  • The United States had the highest number of KRAS mutation cases in NSCLC among the 7MM. Approximately 46% of all KRAS mutation cases in NSCLC in the 7MM were reported in the United States.
  • The G12D variant is especially found in pancreatic and ovarian cancers, which are often hard to treat, while the G12C mutation is more common in NSCLC.
  • Many KRAS subtypes have no treatment options; in these casepan-KRAS-targetinging medicines can be helpful. A wider patient base will be available for such therapies. One drug that has demonstrated a pan-KRAS inhibitory impact in CRC is onvansertib. A few other companies, including ELICIO and Revolution Medicines, are researching pan-KRAS therapies.
  • Many companies are focusing on developing their candidates in pan-KRAS, like Cardiff Oncology (onvansertib), Immuneering Corporation (IMM-1-104), Jacobio Pharma (JAB-23E73), Eli Lilly and Company (LY4066434), and others are expected to have tremendous market potential due to the broad target patient population they can address.
  • The current landscape of KRAS-targeted drug development is heavily focused on the G12C mutation, with the majority of approved therapies and investigational agents specifically designed for this variant.
  • Revolution's unique selling proposition lies in its focus on targeting the active, or "on," states of KRAS proteins. According to the company, it is the persistent "on" signaling of RAS that drives uncontrolled cellular proliferation. As such, Revolution believes its approach may offer a therapeutic advantage over KRAS "off" inhibitors such as LUMAKRAS and KRAZATI.
  • Several pharmaceutical companies have recently entered the race to develop therapies targeting the KRAS G12D mutation. A few players are Tyligand Pharmaceuticals (Suzhou), Verastem Oncology and GenFleet Therapeutics, AstraZeneca, PAQ Therapeutics, Astellas Pharma, and others with additional companies rapidly emerging as interest in this high-potential target continues to grow.
  • Leading Pharma companies developing therapies targeting KRAS include Roche/Chugai/Genentech (Divarasib), Revolution Medicines (Daraxonrasib), Eli Lilly and Company (Olomorasib), Merck, Taiho, and Astex Pharmaceuticals (MK-1084), Cardiff Oncology (Onvansertib), Genfleet Therapeutics and Innovent (DUPERT), Elicio Therapeutics (ELI-002), D3 Bio (D3S-001), and others with their candidates in different stages of clinical development.

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.

Geography Covered:

  • The United States
  • EU4 (Germany, France, Italy, and Spain) and the United Kingdom
  • Japan

Study Period: 2022-2036

KRAS Inhibitors Disease Understanding and Treatment Algorithm

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.

KRAS Inhibitors Epidemiology

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.

  • According to DelveInsight's analysis, the total incident cases of NSCLC were approximately 539,400 in the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan in 2025.
  • Among the 7MM, the US accounted for the highest number of total incident cases of NSCLC with ~203,000 cases in 2025.
  • The total incident cases of colorectal cancer were ~570,800 in the 7MM in 2025.
  • Germany had the largest patient share within EU4 and the UK, accounting for ~26% of KRAS mutation cases. Whereas, Spain had the smallest patient share, i.e., ~14%.
  • KRAS mutations are seen most frequently in Colorectal Cancer, and LGSOC capturing the lowest patient share. The most frequent KRAS variant observed in NSCLC is G12C. In the US, KRASG12C is present in ~36.8% of NSCLC cases. The highest rates of KRASG12D, i.e., ~41.8% and ~41.7%, were found in pancreatic cancer and LGSOC, respectively.

KRAS Inhibitors Drug Chapters

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.

  • In December 2024, Amgen stated in its Q4 presentation that LUMAKRAS has multiple patents in the US and Europe, ensuring market exclusivity until 2040.
  • In December 2023, Amgen announced that the FDA issued a complete response letter for its supplemental new drug application for full approval of LUMAKRAS, based on the CodeBreaK 200 trial. The FDA also set a new postmarketing requirement for a confirmatory study to be completed by February 2028.

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.

  • 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.
  • According to the company's SEC filing, the confirmatory results from the KRYSTAL-12 trial in patients with 2L+ mutated NSCLC are expected in 2025 or 2026.
  • According to Q1 2025 company's presentations, KRAZATI (KRYSTAL-17) early-stage data for 1L NSCLC (TPS <50%) are expected in 2025.

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

  • In June 2026, Cardiff Oncology announced positive results from CRDF-004, Phase II clinical trial evaluating onvansertib in combination with SoC regimens in patients with first-line RAS-mutated mcolorectal cancer. Results showed that onvansertib demonstrated deep and durable tumor shrinkage, including clinically meaningful improvements in ORR and PFS.
  • In May 2026, Silexion Therapeutics announced positive preclinical findings from an ongoing translational immuno-oncology study evaluating SIL204, in human KRAS-mutated pancreatic cancer cells. Findings showed statistically significant increase in surface expression of major histocompatibility complex class I (MHC-I), also known as HLA-ABC.
  • In April 2026, Revolution Medicines announced positive topline results from its Phase III RASolute 302 clinical trial evaluating daraxonrasib in patients with metastatic PDAC who had been previously treated. It demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) compared with standard of care cytotoxic chemotherapy delivered intravenously.
  • In January 2026, Merck announced the initiation of KANDLELIT-007, a Phase III clinical trial evaluating calderasib + pembrolizumab and berahyaluronidase for the first-line treatment of patients with KRAS G12C-mutant, advanced or metastatic non squamous NSCLC.

KRAS Inhibitors Market Outlook

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.

  • Currently, there are only three KRAS based approved drugs including sotorasib, which was approved by the US FDA in May 2021 for NSCLC, adagrasib by the US FDA in December 2022 for NSCLC, and avutometinib and defactinib co-pack by US FDA in May 2025 for LGSOC.
  • Among the selected indications, KRAS in NSCLC accounted for the largest market size, with nearly USD 11,100 million in the US in 2025.
  • According to the estimates, the largest market size for KRAS inhibitors in NSCLC was in the US, accounting for ~70% of the 7MM market in 2025, and is anticipated to grow significantly by 2036.
  • Among EU4 and the UK, avutometinib and defactinib co-pack will account for the largest market size, while Glecirasib is anticipated to stand at the bottom of the ladder in 2036.
  • Amgen's 2025 annual report indicated that US sales of sotorasib (LUMAKRAS) reached approximately USD 211 million in 2025.

KRAS Inhibitors Drugs Uptake

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.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, and a descriptive overview of KRAS inhibitors, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
  • Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
  • Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
  • A detailed review of the KRAS inhibitors market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
  • The report provides an edge while developing business strategies by understanding the trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM KRAS inhibitors market.

KRAS Inhibitors Report Insights

  • KRAS-targeted patient pool
  • Therapeutic approaches
  • KRAS inhibitors pipeline analysis
  • KRAS inhibitors market size and trends
  • Existing and future market opportunity

KRAS Inhibitors Report Key Strengths

  • 11 years forecast
  • The 7MM coverage
  • KRAS inhibitors epidemiology segmentation
  • Key cross competition
  • Drugs uptake and key market forecast assumptions

KRAS Inhibitors Report Assessment

  • Current treatment practices
  • Unmet needs
  • Pipeline product profiles
  • Market attractiveness
  • Qualitative analysis (SWOT and analyst views)

FAQs:

Market Insights

  • What was the KRAS mutated cancers total market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like in 2036? What are the contributing factors for this growth?
  • How will KRAZATI affect the treatment paradigm in NSCLC?
  • What will be the market share of NSCLC, CRC, and pancreatic cancer in 2036?
  • Which drug is going to be the largest contributor in 2036?
  • What are the pricing variations among different geographies for approved therapies?

Epidemiology Insights

  • What are the disease risk, burdens, and unmet needs of KRAS inhibitors? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to KRAS inhibitors?
  • What is the historical and forecasted KRAS inhibitors patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
  • Which type of KRAS mutation is the largest contributor in patients affected with NSCLC, CRC, and pancreatic cancer?
  • Among EU4 and the UK, which country will have the highest number of patients during the forecast period?
  • What are the key findings pertaining to the KRAS mutant cancer epidemiology across the 7MM, and which country will have the highest number of patients during the forecast period?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

  • Which are the approved KRAS inhibitors? What are the current treatment guidelines for treating KRAS-mutated cancers in the US and Europe?
  • How many companies are developing therapies for the treatment of KRAS-mutated cancers?
  • How many emerging therapies are in the mid-stage and late stage of development for treating KRAS-mutated cancers?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
  • What key designations have been granted for the emerging therapies for KRAS inhibitors?
  • What is the cost burden of approved therapies on the patient?
  • Patient acceptability in terms of preferred treatment options as per real-world scenarios?
  • What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to Buy:

  • The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the KRAS inhibitors market.
  • Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of KRAS-mutated cancers during the forecast years.
  • Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
  • Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
  • Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
  • Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
  • To understand key opinion leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

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
  • 11.1. 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. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

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