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위장관 기질종양(GIST) : 시장 인사이트, 역학 및 시장 예측(2036년)

Gastrointestinal Stromal Tumor (GIST) - Market Insight, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 200 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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위장관 기질 종양(GIST)에 대한 인사이트와 동향

  • GIST는 식도에서 항문에 이르는 소화관의 모든 부위에서 발생할 가능성이 있습니다. 증례의 약 55%가 위에서 발생하며, 이는 가장 흔한 발생 부위입니다. 그 다음으로 십이지장과 소장(30%)이 이어집니다. 발생 빈도는 낮지만, 식도(5%), 직장(5%), 결장(2%)에서도 GIST가 발생할 수 있습니다. 드문 경우이긴 하지만, 원발성 GIST는 소화관 외부, 즉 복막, 장간막, 대망, 간, 췌장, 난소, 자궁, 전립선 등에서 발생할 수 있습니다.
  • GIST는 전체 소화관 종양의 1% 미만을 차지할 뿐이지만, 소화관에서 가장 흔한 간엽성 종양입니다.
  • GIST는 양성인지 악성인지에 따른 분류가 아니라, 재발이나 진행의 위험도에 따라 분류됩니다. 위험도 평가는 종양의 크기, 유사분열 지수, 발생 부위 및 변이 상태를 바탕으로 이루어집니다. 수용체 티로신 키나아제(KIT) 또는 혈소판 유래 성장 인자 수용체 α(PDGFRA)의 변이에 대한 분자 검사가 권장되며, 두 변이 모두 음성인 종양의 경우 SDH(숙신산 탈수소효소) 검사가 실시됩니다.
  • GIST는 일반적으로 소화관에서 발생하며, 전체 사례의 80%는 종양 세포의 증식, 성장 및 생존을 유발하는 KIT 유전자의 돌연변이에 의해 발생합니다. 증례의 약 12-15%는 두 유전자 모두에서 검출 가능한 변이가 확인되지 않아, KIT/PDGFRA 야생형(WT) GIST로 분류됩니다. 또한, GIST의 5% 미만은 제1형 신경섬유종증(NF1), 카니 삼징후 증후군 및 기타 가족성 질환을 포함하여 유전성 질환이나 증후군과 관련이 있습니다.
  • GIST는 모든 연령대의 환자에서 발병할 가능성이 있지만, 고령자(연령 중앙값: 65-69세)에게서 가장 많이 나타납니다.
  • GIST 환자의 상당수가 진행 단계에서 발병하며, 진단 시 최대 50%의 환자에서 전이 또는 다발성 종양이 확인됩니다.
  • 그동안 GIST 치료는 주로 외과적 절제에 의존해 왔으며, 진행된 사례에서 화학요법의 유효성은 제한적이었습니다. 리프레티닙(QINLOCK)이나 아바프레티닙(AYVAKIT)과 같은 차세대 치료제는 내성 돌연변이에 대응하여 후기 치료 단계에서 질병 통제력을 향상시킵니다.
  • GIST의 약 15-20%는 원발성 내성을 보이며, 치료 시작 초기부터 이러한 약물에 반응하지 않습니다. GIST 치료제로 승인된 티로신 키나제 억제제(TKI)로는 이마티닙(GLEEVEC)(1차 치료제), 수니티닙(SUTENT)(2차 치료제), 레골라페닙(STIVARGA)(3차 치료제), 리플레티닙(QINLOCK)(4차 치료제)가 있습니다.
  • GIST에 대해 승인된 치료법에는 오노제약(리프레티닙), 블루프린트 메디신스 코퍼레이션, 사노피(아바프레티닙), 바이엘(라로트렉티닙) 등의 기업이 참여하고 있습니다.
  • GIST 치료제를 개발 중인 제약사로는 코젠트 바이오사이언시스(베즈클라스티닙), GSK(베르자티닙), 살터 테라퓨틱스(SAR003), 쿰콰트 바이오사이언시스(KQB198) 등이 있습니다.

위장관 기질 종양(GIST) 시장 보고서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재 시장 상황에 대한 종합적인 분석을 제공합니다. 또한, GIST 환자의 부담 추이, 수익 및 시장 점유율 추이, 정점 시기의 환자 점유율 및 치료법 보급 현황에 대한 분석을 평가함과 동시에, 세계 각 지역 시장 규모에 대한 상세한 평가 및 성장률 예측(과거 데이터 및 2022년-2036년 예측)을 제시하고 있습니다. 본 보고서에서는 GIST 분야의 주요 미충족 의료 수요에 초점을 맞추어, 경쟁 구도와 임상 현황을 분석함으로써 고부가가치 기회를 도출하는 한편, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

위장관 기질 종양(GIST) 시장을 주도하는 주요 요인

발병률 증가와 진단 기술의 발전

인식이 높아지고, KIT 및 PDGFRA 돌연변이에 대한 분자 검사를 포함한 진단 기술이 발전함에 따라, GIST를 조기에 정확하게 발견할 수 있게 되었습니다. 이로 인해 치료 가능한 환자층이 확대되고 있습니다. 또한, 병리 진단 기법의 개선으로 오진율도 낮아지고 있습니다.

표적 치료의 발전

기존의 화학요법에서 표적 TKI로 전환됨에 따라, GIST의 치료 성과는 획기적으로 개선되었습니다. 변이 특이성과 내성 커버 범위가 향상된 신약이 시장 성장을 더욱 견인하고 있습니다. 지속적인 혁신을 통해 치료 선택지는 계속해서 확대되고 있습니다.

유리한 규제상의 지원

희귀질환 치료제 심사 지정, 패스트트랙 승인, 우선 심사 제도를 통해 개발 기간이 단축되고 있습니다. 규제상의 인센티브는 GIST와 같은 희귀암 분야의 혁신을 촉진하고 있습니다. 이로 인해 시장 진입 장벽이 낮아졌습니다.

위장관 기질 종양(GIST)의 이해와 치료 알고리즘

위장관 기질 종양(GIST)의 개요 및 진단

GIST는 소화관에서 발생하는 희귀한 중간엽성 종양의 일종으로, 주로 위나 소장에서 발생합니다. 주로 KIT 유전자 또는 PDGFRA 유전자의 활성화 돌연변이에 의해 유발되며, 이로 인해 통제 불가능한 세포 증식이 일어납니다. 비록 드문 암이긴 하지만, 진단 기술의 발전과 분자 검사의 보급으로 인해 최근 보고되는 발병률은 증가하고 있습니다.

진단에는 일반적으로 영상 검사, 조직병리학적 검사 및 분자 검사를 종합적으로 실시합니다. CT 촬영이나 내시경 검사 등의 방법을 통해 종양의 위치와 크기를 파악하고, 생검을 통해 진단을 확정합니다. KIT(CD117)나 DOG1과 같은 면역조직화학적 표지자는 GIST를 다른 종양과 구별하기 위해 일반적으로 사용됩니다. KIT 또는 PDGFRA의 변이를 확인하기 위해서는 유전자 검사가 필수적이며, 이는 치료 방침의 결정 및 치료법 선택에 직접적인 영향을 미칩니다.

현재 위장관 기질 종양(GIST)의 치료 현황

치료법은 종양의 크기, 위치, 돌연변이의 유형 및 병기에 따라 달라집니다. 국소성 GIST의 경우 여전히 외과적 절제가 첫 번째 선택이지만, 진행된 사례나 전이된 사례에 대해서는 분자 표적 치료가 주된 치료법으로 자리 잡고 있습니다. TKI(티로신 키나제 억제제)는 발암성 드라이버 유전자를 특이적으로 표적으로 삼음으로써 치료 성과를 현저히 개선하고 있습니다. 주요 승인된 치료법에는 진행성 GIST의 후기 치료 단계에서 사용되는 리플레티닙이 포함됩니다. 아바프리티닙은 치료가 어려운 D842V 변이를 포함한 PDGFRA 엑손 18 변이를 가진 환자에게 특히 효과적입니다.

위장관 기질 종양(GIST)의 역학

GIST의 역학 분석 및 예측에 관한 주요 조사 결과

  • 2025년에는 미국 내 GIST 신규 발병 건수가 5,600건을 넘어 가장 많아질 것으로 예측됩니다. 이러한 사례 수는 예측 기간 동안 증가할 것으로 예측됩니다.
  • 미국에서 GIST의 연간 신규 환자 수는 5,000-6,000건으로 추정됩니다.
  • GIST는 모든 소화관 신생물의 0.1-3%를 차지합니다. 추정 연간 발생률은 인구 100만 명당 10-15건으로, 즉 미국에서는 연간 약 3,000-5,000건으로 추정됩니다. GIST는 모든 연령대에서 발생할 수 있지만, 발병이 가장 많이 나타나는 시기는 60대이며, 남성에게서 약간 더 많이 나타납니다.
  • 미국에서는 GIST가 위(약 60%)와 소장(약 35%)에서 가장 많이 발생하며, 식도, 결장, 직장에서 발생하는 비율은 그보다 낮고, 드물게는 복강 내 소화관 외부에서 발생하기도 합니다.
  • GIST는 여성보다 남성에게서 더 많이 나타납니다.
  • GIST는 다른 병기와 비교했을 때, 국소 병기에서 진단되는 경우가 더 흔합니다.

위장관 기질 종양(GIST) 시장 전망

GIST 시장은 꾸준한 변화를 겪고 있으며, 오랫동안 수술에 의존해 왔고, 주로 TKI를 중심으로 한 제한된 수의 전신 요법만 활용되어 왔습니다. 국소성 질환의 경우, 여전히 외과적 절제가 치료의 주축을 이루고 있습니다. 정밀 종양학 분야의 최근 발전, 특히 KIT 및 PDGFRA 돌연변이의 이질성에 대한 이해가 깊어짐에 따라, 보다 표적화된 돌연변이 특이적 치료 접근이 가능해지면서 치료 방식이 변화하고 있습니다.

이러한 변화는 여러 KIT 및 PDGFRA 돌연변이에 대해 광범위한 억제 작용을 나타내며, 2차 치료제로 사용되는 리플레티닙(QINLOCK), 내성 돌연변이인 D842V를 포함한 PDGFRA 엑손 18 돌연변이에 특화되어 설계된 아바프리티닙(AYVAKIT)과 같은 차세대 약물의 개발 및 승인에도 반영되어 있습니다. 또한, 라로트렉티닙(VITRAKVI)은 희귀한 GIST 사례를 포함하여 NTRK 유전자 융합을 가진 암에 대해, 종양 유형에 관계없이 적용되는 표적 치료제입니다. 이러한 치료법들은 전반적으로 정밀 의학에 기반한 치료로의 전환을 여실히 보여주고 있습니다.

개발 중인 신약 파이프라인은 임상 개발 단계로 접어들었으며, 이는 GIST 치료 분야의 지속적인 혁신을 반영하고 있습니다. 주요 후보 약물로는 활성화 루프 변이를 표적으로 하는 선택적 KIT 억제제인 베즈클라스티닙(CGT9486); IDRX-42(GSK6042981)는 원발성 돌연변이와 내성 돌연변이 모두를 표적으로 하도록 설계된 광범위한 스펙트럼을 가진 범KIT 억제제이며, SAR003은 KIT 유도성 종양에서 잠재적인 활성을 보이는 신흥 임상시험용 약물입니다. 이러한 파이프라인 치료제들은 병용 요법 전략 및 차세대 억제제에 대한 진행 중인 연구와 더불어, 내성 기전의 극복, 치료 효과 지속 기간의 연장, 그리고 치료 선택지의 확대를 목표로 하고 있습니다.

  • GIST의 치료 현황은 진행성 사례와 돌연변이 특이적 질환 분류 모두에서 널리 채택되고 있기 때문에 TKI가 대부분을 차지하고 있습니다.
  • 베즈클라스티닙(CGT9486)이나 베르자티닙(IDRX-42)과 같은 후기 임상시험 단계에 있는 후보 약물의 등장으로 인해, 예측 기간 후반에 GIST 치료 분야에서의 경쟁이 격화될 것으로 예측됩니다.
  • TKI: TKI는 GIST의 주요 치료제군으로, 종양의 증식과 생존을 촉진하는 발암성 키나아제를 표적으로 합니다. 리프레티닙이나 아바프리티닙과 같은 승인된 약물은 KIT 및/또는 PDGFRA 신호전달을 억제하는 반면, 베즈크라스티닙, 벨자티닙, SAR003 등의 신흥 치료제는 KIT의 1차 및 2차 내성 돌연변이에 대해 보다 광범위한 억제 작용을 발휘하도록 설계되었습니다.
  • TRK: 라로트렉티닙은 TRK 융합 단백질을 선택적으로 억제하는 독자적인 표적 치료제 군을 대표하는 약물입니다. GIST에서 NTRK 융합은 드물지만, TRK 억제제는 이러한 치료 가능한 유전적 변이를 가진 환자에게 정밀의료적 접근법을 제공합니다.

많은 약물이 KIT/PDGFRA를 표적으로 하는 TKI이므로, GIST 시장을 주도하는 주요 약물군은 티로신 키나제 억제제(TKI)입니다.

자주 묻는 질문

  • 위장관 기질 종양(GIST)의 주요 발생 부위는 어디인가요?
  • GIST의 치료 방법은 무엇인가요?
  • GIST의 발병률은 어떻게 되나요?
  • GIST의 주요 치료제는 무엇인가요?
  • GIST의 진단 방법은 무엇인가요?
  • GIST 시장의 성장 요인은 무엇인가요?
  • GIST 치료제 개발에 참여하고 있는 주요 기업은 어디인가요?

목차

제1장 주요 인사이트

제2장 서론

제3장 주요 요약

제4장 주요 이벤트

제5장 위장관 기질종양(GIST) : 역학 및 시장 조사 방법

제6장 위장관 기질종양(GIST) : 시장 개요

제7장 위장관 기질종양(GIST) : 질환 배경과 개요

제8장 위장관 기질종양(GIST) : 역학 및 환자 인구

제9장 위장관 기질종양(GIST) : 환자 경과

제10장 시판 치료제

제11장 신흥 치료법

제12장 위장관 기질종양(GIST) : 주요 7개국 분석

제13장 위장관 기질종양(GIST) : 미충족 요구

제14장 위장관 기질종양(GIST) : SWOT 분석

제15장 위장관 기질종양(GIST) : KOL(Key Opinion Leader)의 견해

제16장 시장 참여 및 상환

제17장 부록

제18장 DelveInsight의 서비스 내용

제19장 면책사항

제20장 DelveInsight에 대해

LSH 26.07.27

Gastrointestinal Stromal Tumor (GIST) Insights and Trends

  • GISTs can develop anywhere along the gastrointestinal tract, from the esophagus to the anus. The stomach accounts for approximately 55% of cases, making it the most common site of origin, followed by the duodenum and small intestine (30%). Less frequently, GISTs arise in the esophagus (5%), rectum (5%), and colon (2%). In rare cases, primary GISTs may develop outside the gastrointestinal tract, including the peritoneum, mesentery, omentum, liver, pancreas, ovaries, uterus, and prostate.
  • GISTs comprise less than 1% of all gastrointestinal tumors but are the most common mesenchymal tumors of the gastrointestinal tract.
  • GIST are classified by their risk of recurrence or progression rather than as benign or malignant. Risk assessment is based on tumor size, mitotic index, location, and mutation status. Molecular testing for Receptor Tyrosine Kinase (KIT) or Platelet-Derived Growth Factor Receptor Alpha (PDGFRA) mutations is recommended, with SDH (succinate dehydrogenase) testing performed in tumors that are negative for both mutations.
  • GIST typically presents in the gastrointestinal tract with 80% of cases driven by mutations in the KIT gene that lead to the growth, proliferation and survival of tumour cells. Around 12-15% of cases lack detectable mutations in both genes and are classified as KIT/PDGFRA wild-type (WT) GISTs. Additionally, <5% of GISTs are associated with hereditary or syndromic conditions, including neurofibromatosis type 1 (NF1), Carney triad syndrome, and other familial disorders.
  • GISTs can affect patients of all ages but are most predominant in older adults (median age, 65-69 years).
  • A substantial proportion of GIST patients present with advanced disease, with up to 50% exhibiting metastases or multifocal tumor involvement at diagnosis.
  • Historically, GIST management relied mainly on surgical resection, with chemotherapy showing limited efficacy in advanced disease. Next-generation therapies such as ripretinib (QINLOCK) and Avapritinib (AYVAKIT) address resistance mutations and improve later-line disease control.
  • About 15-20% of GISTs have primary resistance; they don't respond to these drugs, right from the start of treatment. The Tyrosine kinase inhibitors (TKIs) approved for GIST include; imatinib (GLEEVEC) (1st line), sunitinib (SUTENT) (2nd line), regorafenib (STIVARGA) (3rd line), and ripretinib (QINLOCK) (4th line).
  • Approved therapies for GIST includes companies such as ONO Pharmaceutical (ripretinib), Blueprint Medicines Corporation, Sanofi (avapritinib), Bayer (larotrectinib), and others.
  • Pharmaceutical companies developing therapies for GIST include: Cogent Biosciences (Bezuclastinib), GSK (Velzatinib), Sartar Therapeutics (SAR003), Kumquat Biosciences (KQB198) and others.

DelveInsight's 'Gastrointestinal Stromal Tumor (GIST) - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the GIST, historical and forecasted epidemiology, as well as the GIST market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The Gastrointestinal Stromal Tumor (GIST) market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates, GIST patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in GIST and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Key Factors Driving the Gastrointestinal Stromal Tumor (GIST) Market

Rising Incidence and Improved Diagnosis

Increasing awareness and better diagnostic techniques, including molecular testing for KIT and PDGFRA mutations, are leading to earlier and more accurate detection of GIST. This expands the treatable patient population. Improved pathology practices are also reducing misdiagnosis rates.

Advancements in Targeted Therapies

The shift from conventional chemotherapy to targeted TKIs has transformed GIST treatment outcomes. Newer agents with improved mutation specificity and resistance coverage are further driving market growth. Ongoing innovation continues to expand therapeutic options.

Favorable Regulatory Support

Orphan drug designations, fast track approvals, and priority review pathways are expediting development timelines. Regulatory incentives encourage innovation in rare cancers like GIST. This reduces barriers for market entry.

Gastrointestinal Stromal Tumor (GIST) Understanding and Treatment Algorithm

Gastrointestinal Stromal Tumor (GIST) Overview and Diagnosis

GIST is a rare type of mesenchymal tumor of the gastrointestinal tract, most commonly arising in the stomach or small intestine. It is primarily driven by activating mutations in the KIT or PDGFRA genes, which lead to uncontrolled cell growth. Despite its rarity, reported incidence has increased in recent years due to improved diagnostic techniques and wider use of molecular testing.

Diagnosis typically involves a combination of imaging, histopathology, and molecular testing. Techniques such as CT scans and endoscopy help identify tumor location and size, while a biopsy confirms the diagnosis. Immunohistochemical markers like KIT (CD117) and DOG1 are commonly used to distinguish GIST from other tumors. Genetic testing is essential to identify KIT or PDGFRA mutations, as this directly guides treatment decisions and therapy selection.

Current Gastrointestinal Stromal Tumor (GIST) Treatment Landscape

Treatment depends on tumor size, location, mutation type, and stage of disease. Surgical resection remains the primary approach for localized GIST, while targeted therapies are the mainstay for advanced or metastatic cases. TKIs have significantly improved outcomes by specifically targeting oncogenic drivers. Key approved therapies include ripretinib, which is used in later-line settings for advanced GIST. Avapritinib is specifically effective in patients with PDGFRA exon 18 mutations, including the difficult-to-treat D842V mutation.

Gastrointestinal Stromal Tumor (GIST) Unmet Needs

The section "unmet needs of Gastrointestinal Stromal Tumor (GIST)" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

1. Development of treatment resistance to existing targeted therapies

2. Emergence of drug-resistant tumor subclones and molecular heterogeneity

3. Limited treatment options for wild-type and SDH-deficient GIST

4. Challenges in long-term survivorship and disease monitoring, and others.....

Gastrointestinal Stromal Tumor (GIST) Epidemiology

Key Findings from GIST Epidemiological Analysis and Forecast

  • In 2025, the US accounted for the highest incident cases of GIST with more than 5,600 cases. These cases are anticipated to increase during the forecast period.
  • The number of new cases of GISTs in the United States each year has been estimated at 5,000-6,000.
  • GISTs constitute 0.1-3% of all GI neoplasms. The estimated annual incidence is 10-15 new cases per million people or approximately 3,000-5,000 new cases in the US yearly. Although GISTs may occur at all ages, the peak incidence is in the sixth decade of life, with a slight male predominance.
  • In the United States, GISTs most commonly arise in the stomach (~60%) and small intestine (~35%), while a smaller proportion occur in the esophagus, colon, rectum, or, rarely, outside the gastrointestinal tract within the abdominal cavity.
  • GIST is more common among males than females.
  • GIST is more commonly diagnosed at the localized stage compared to other stages.

Gastrointestinal Stromal Tumor (GIST) Drug Analysis & Competitive Landscape

The GIST drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Preclinical and Phase III clinical trials. It covers mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, strategic partnerships upcoming Key catalyst for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the GIST treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the GIST therapeutics market.

Approved Therapies for Gastrointestinal Stromal Tumor (GIST)

Ripretinib (QINLOCK): ONO Pharmaceutical

Ripretinib (QINLOCK) is an oral switch-control TKI designed to treat GIST, targeting a broad range of KIT and PDGFRA mutations, including initiating and resistance mutations in exons 9, 11, 13, 14, 17, and 18. Beyond its approved use, it is also under Phase III (INSIGHTS) investigation as a second-line therapy, underscoring its potential to expand treatment options and address resistance challenges in GIST. QINMOCK was designated an orphan medicine in October 2017 by the EMA. The US FDA granted Fast Track Designation (FTD) and Orphan Drug Designation (ODD) for advanced GIST treatment after prior therapies. ONO Pharmaceutical, acquired Deciphera in April 2024. As per ONO pharma financial results 2025-26, sales of ripretinib for GIST increased by USD 80 million (50.6%) year on year to USD 239.5 million.

Avapritinib (AYVAKIT): Sanofi (Blueprint Medicines Corporation)

Avapritinib (AYVAKIT) is a selective kinase inhibitor approved for adults with unresectable or metastatic GIST harboring PDGFRA exon 18 mutations, including D842V, and Advanced Systemic Mastocytosis (AdvSM). The US FDA granted AYVAKIT ODD, Breakthrough Therapy Designation (BTD), and FTD for GIST. Approved in January 2020 for PDGFRA D842V-mutant GIST, it also received EU marketing authorization in September 2020 and orphan medicine designation from the EC in July 2017.

Gastrointestinal Stromal Tumor (GIST) Pipeline Analysis

Bezuclastinib: Cogent Biosciences

Bezuclastinib, developed by Cogent Biosciences, is a selective type I tyrosine kinase inhibitor targeting KIT activation loop mutations, particularly KIT D816V. It is the first positive 2nd -line GIST trial in over 20 year. The NDA for bezuclastinib in combination with sunitinib was accepted under Priority Review, with a PDUFA target action date of November 30, 2026. Cogent also plans to present detailed results from the PEAK trial at an upcoming scientific conference in the first half of 2026. Bezuclastinib received ODD from the US FDA in 2021. With a global annual market opportunity of over USD 4 billion, the therapy became the first to report positive second-line GIST trial results in more than two decades, reducing the risk of progression or death by 50%.

Velzatinib (IDRX-42/GSK6042981): GSK

IDRX-42 is a highly selective, investigational small molecule TKI designed to target all key KIT mutations in GIST. The US FDA has granted IDRX-42 FTD for the treatment of patients with GIST after disease progression on or intolerance to imatinib, and ODD for the treatment of GIST. According to the company's annual report 2025, GSK is aiming to initiate the first-line (1L) phase III study in 2026. Velzatinib has demonstrated activity pre-clinically against all clinically relevant primary and secondary KIT mutations, a key medical need in current GIST treatment.

Gastrointestinal Stromal Tumor (GIST) Key Players, Market Leaders and Emerging Companies

  • Eli lily and company
  • Sanofi
  • ONO Pharmaceutical
  • Blueprint Medicines Corporation
  • Bayer
  • Loxo Oncology
  • Cogent Biosciences
  • GSK
  • Sartar Therapeutics, and others

Gastrointestinal Stromal Tumor (GIST) Drug Updates

  • In May 2026, Cogent Biosciences announced detailed clinical data from the primary analysis of the PEAK Phase III trial of bezuclastinib in combination with sunitinib in patients GIST. The data demonstrate statistically significant advantage against active comparator in GIST patients; median PFS of 16.5 months versus 9.2 months for bezuclastinib combination compared to sunitinib alone.
  • In January 2026, Cogent Biosciences announced that the US FDA has granted Breakthrough Therapy Designation (BTD) for bezuclastinib in combination with sunitinib for patients with GIST who have received prior treatment with imatinib.
  • In November 2025, Cogent Biosciences reported positive data from its Phase III PEAK trial of bezuclastinib plus sunitinib in patients with imatinib-resistant or intolerant GIST. The results showed 50% reduction in risk of progression or death, with a 16.5-month median PFS.
  • In September 2025, Sartar Therapeutics received ODD for SAR003 for GIST from both the EMA and FDA.
  • In July 2025, Sanofi announced the completion of its acquisition of Blueprint Medicines Corporation.
  • In May 2025, the results of ripretinib versus sunitinib in patients with GIST were published in ASCO publications. The results showed that OS from the analysis was similar between arms, and second PFS suggests that receiving ripretinib did not adversely affect the PFS of third-line therapy.

Gastrointestinal Stromal Tumor (GIST) Market Outlook

The GIST market is undergoing a steady transformation, with years of reliance on surgery and a limited number of systemic therapies, primarily TKIs. Surgical resection remains the cornerstone for localized disease. Recent advances in precision oncology, particularly improved understanding of KIT and PDGFRA mutation heterogeneity, have begun to reshape the treatment landscape by enabling more targeted and mutation-specific therapeutic approaches.

This shift is reflected in the development and approval of next-generation agents such as Ripretinib (QINLOCK), which provides broad-spectrum inhibition across multiple KIT and PDGFRA mutations and is used in later-line settings, and Avapritinib (AYVAKIT), specifically designed for PDGFRA exon 18 mutations, including the resistant D842V variant. Additionally, Larotrectinib (VITRAKVI), represents a tumor-agnostic targeted therapy for cancers harboring NTRK gene fusions, including rare cases of GIST. Together, these therapies highlight the transition toward precision-based treatment.

The pipeline of investigational agents is advancing through clinical development, reflecting continued innovation in GIST treatment. Key candidates include Bezuclastinib (CGT9486), a selective KIT inhibitor targeting activation loop mutations; IDRX-42 (GSK6042981), a broad-spectrum pan-KIT inhibitor designed to address both primary and resistance mutations, and SAR003, an emerging investigational therapy with potential activity in KIT-driven tumors. These pipeline agents, along with ongoing research into combination strategies and next-generation inhibitors, aim to overcome resistance mechanisms, improve the durability of response, and expand treatment options.

  • The GIST treatment landscape is largely dominated by TKI, supported by strong adoption in both advanced and mutation-specific disease settings.
  • The entry of late-stage candidates such as Bezuclastinib (CGT9486) and Velzatinib (IDRX-42) is expected to intensify competition in the GIST treatment landscape during the latter half of the forecast period.

Drug Class/Insights into Leading Emerging and Marketed Therapies in GIST (2022-2036 Forecast)

The GIST market comprises TKI and TRK inhibitors, each targeting different aspects of GIST.

  • TKI: TKIs constitute the dominant therapeutic class in GIST, targeting oncogenic kinases that drive tumor growth and survival. Approved agents such as ripretinib and avapritinib inhibit KIT and/or PDGFRA signaling, while emerging therapies including bezuclastinib, velzatinib, and SAR003 are designed to provide broader inhibition of primary and secondary KIT resistance mutations.
  • TRK: Larotrectinib represents a distinct targeted therapy class that selectively inhibits TRK fusion proteins. Although NTRK fusions are uncommon in GIST, TRK inhibitors offer a precision medicine approach for patients harboring these actionable genomic alterations.

Since many of the drugs are KIT/PDGFRA-directed TKIs, the key drug class driving the GIST market is Tyrosine Kinase Inhibitors (TKIs).

Gastrointestinal Stromal Tumor (GIST) Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the GIST drug's uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.

The uptake of therapies in GIST is expected to vary based on clinical positioning, mechanism of action, and stage of development. Approved targeted therapy such as ripretinib (QINLOCK) is projected to demonstrate relatively faster uptake, driven switch-control tyrosine kinase inhibition of KIT and PDGFRA, along with broad activity across primary and secondary resistance mutations. In contrast, pipeline candidate bezuclastinib (CGT9486) is expected to follow a moderate uptake trajectory, reflecting its investigational status and gradual adoption as clinical evidence emerges. Meanwhile, SAR003 is anticipated to show gradual uptake, as it is in the preclinical development stage.

Detailed insights of emerging therapies' drug uptake is included in the report

Market Access and Reimbursement of Approved therapies in Gastrointestinal Stromal Tumor (GIST)

Reimbursement is a crucial factor that affects the drug's access to the market. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, many payment models are being considered by payers and other industry insiders.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

NOTE: Further Details are provided in the final report....

Gastrointestinal Stromal Tumor (GIST) Therapies Price Scenario & Trends

Pricing and analogue assessment of GIST therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.

Industry Experts and Physician Views for Gastrointestinal Stromal Tumor (GIST)

To keep up with GIST market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (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 the GIST emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in GIST, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 15+ KOLs to gather insights at country level. Centers such as the Michigan State University, Birmingham University Hospitals, Fujita Health University, etc. were contacted.Their opinion helps understand and validate current and emerging GIST therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in GIST.

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of GIST, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint analysis analyzes 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.

The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, 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, a descriptive overview of GIST, explaining their causes, signs and symptoms, pathogenesis, and currently available treatments.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
  • Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
  • A detailed review of the GIST 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 trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM GIST market.

Report Insights

  • Gastrointestinal Stromal Tumor (GIST) Patient Population Forecast
  • Gastrointestinal Stromal Tumor (GIST) Therapeutics Market Size
  • Gastrointestinal Stromal Tumor (GIST) Pipeline Analysis
  • Gastrointestinal Stromal Tumor (GIST) Market Size and Trends
  • Gastrointestinal Stromal Tumor (GIST) Market Opportunity (Current and forecasted)

Report Key Strengths

  • Epidemiology-based (Epi-based) Bottom-up Forecasting
  • Artificial Intelligence (AI)-Enabled Market Research Report
  • 11-Year Forecast
  • Gastrointestinal Stromal Tumor (GIST) Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (By Geography)
  • Gastrointestinal Stromal Tumor (GIST) Treatment Addressable Market (TAM)
  • Gastrointestinal Stromal Tumor (GIST) Competitive Landscape
  • Gastrointestinal Stromal Tumor (GIST) Major Companies Insights
  • Gastrointestinal Stromal Tumor (GIST) Price Trends and Analogue Assessment
  • Gastrointestinal Stromal Tumor (GIST) Therapies Drug Adoption/Uptake
  • Gastrointestinal Stromal Tumor (GIST) Therapies Peak Patient Share Analysis

Report Assessment

  • Gastrointestinal Stromal Tumor (GIST) Current Treatment Practices
  • Gastrointestinal Stromal Tumor (GIST) Unmet Needs
  • Gastrointestinal Stromal Tumor (GIST) Clinical Development Analysis
  • Gastrointestinal Stromal Tumor (GIST) Emerging Drugs Product Profiles
  • Gastrointestinal Stromal Tumor (GIST) Market attractiveness
  • Gastrointestinal Stromal Tumor (GIST) Qualitative Analysis (SWOT and conjoint analysis)

FAQs:

Market Insights

  • What was the GIST market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
  • What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
  • What can be the future treatment paradigm of GIST?
  • What are the disease risks, burdens, and unmet needs of GIST? What will be the growth opportunities across the 7MM concerning the patient population with GIST?
  • Who is the major future competitor in the market, and how will the competitors affect their market share?
  • What are the current options for the treatment of GIST? What are the current guidelines for treating GIST in the US, Europe, and Japan?

Reasons to Buy:

  • The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the GIST market.
  • Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
  • Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
  • 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.
  • To understand KOLs' perspectives on 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.
  • This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets with in the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary

4. Key Events

  • 4.1. Upcoming Key Catalyst
  • 4.2. Key Conferences And Meetings
  • 4.3. Key Transactions And Collaborations
  • 4.4. News Flow

5. Epidemiology and Market Methodology of Gastrointestinal Stromal Tumor (GIST)

6. Gastrointestinal Stromal Tumor (GIST) Market Overview at a Glance

  • 6.1. Clinical Landscape Analysis (By Molecule Type, Phase, and Route of Administration [ROA])
  • 6.2. Market Share of Gastrointestinal Stromal Tumor (GIST) By Therapies (%) in the 7MM in 2025
  • 6.3. Market Share of Gastrointestinal Stromal Tumor (GIST) By Therapies (%) in the 7MM in 2036

7. Disease Background And Overview of Gastrointestinal Stromal Tumor (GIST)

  • 7.1. Introduction
  • 7.2. Causes
  • 7.3. Signs And Symptoms
  • 7.4. Diagnosis
    • 7.4.1. Differential Diagnosis
    • 7.4.2. Diagnostic Algorithm
    • 7.4.3. Diagnostic Guidelines
  • 7.5. Treatment and Management
    • 7.5.1. Treatment Algorithm

8. Epidemiology and Patient Population of Gastrointestinal Stromal Tumor (GIST)

  • 8.1. Key Findings
  • 8.2. Assumption and Rationale
  • 8.3. Total Incident Cases of Gastrointestinal Stromal Tumor (GIST) in the 7MM
  • 8.4. The United States
    • 8.4.1. Total Incident Cases of Gastrointestinal Stromal Tumor (GIST) in the United States
    • 8.4.2. Age-specific Incident Cases of Gastrointestinal Stromal Tumor (GIST) in the United States
    • 8.4.3. Stage-specific Incident Cases of Gastrointestinal Stromal Tumor (GIST) in the United States
    • 8.4.4. Gender-specific Incident Cases of Gastrointestinal Stromal Tumor (GIST) in the United States
    • 8.4.5. Mutation-specific Incident Cases of Gastrointestinal Stromal Tumor (GIST) in the United States
    • 8.4.6. Treated Cases of Gastrointestinal Stromal Tumor (GIST) in the United States
  • 8.5. EU4 and the UK
    • 8.5.1. Total Incident Cases of Gastrointestinal Stromal Tumor (GIST) in EU4 and the UK
    • 8.5.2. Age-specific Incident Cases of Gastrointestinal Stromal Tumor (GIST) in EU4 and the UK
    • 8.5.3. Stage-specific Incident Cases of Gastrointestinal Stromal Tumor (GIST) in EU4 and the UK
    • 8.5.4. Gender-specific Incident Cases of Gastrointestinal Stromal Tumor (GIST) in EU4 and the UK
    • 8.4.5. Mutation-specific Incident Cases of Gastrointestinal Stromal Tumor (GIST) in EU4 and the UK
    • 8.4.6. Treated Cases of Gastrointestinal Stromal Tumor (GIST) in EU4 and the UK
  • 8.6. Japan
    • 8.6.1. Total Incident Cases of Gastrointestinal Stromal Tumor (GIST) in Japan
    • 8.6.2. Age-specific Incident Cases of Gastrointestinal Stromal Tumor (GIST) in Japan
    • 8.6.3. Stage-specific Incident Cases of Gastrointestinal Stromal Tumor (GIST) in Japan
    • 8.6.4. Gender-specific Incident Cases of Gastrointestinal Stromal Tumor (GIST) in Japan
    • 8.4.5. Mutation-specific Incident Cases of Gastrointestinal Stromal Tumor (GIST) in Japan
    • 8.4.6. Treated Cases of Gastrointestinal Stromal Tumor (GIST) in Japan

9. Patient Journey of Gastrointestinal Stromal Tumor (GIST)

10. Marketed Therapies

  • 10.1. Marketed Competitive Landscape of Gastrointestinal Stromal Tumor (GIST)
  • 10.2. Ripretinib (QINLOCK): ONO Pharmaceutical
    • 10.2.1. Product Description
    • 10.2.2. Regulatory Milestones
    • 10.2.3. Other Developmental Activities
    • 10.2.4. Summary of Pivotal Trials
    • 10.2.5. Analyst Views
  • 10.3. Avapritinib (AYVAKIT): Blueprint Medicines Corporation/Sanofi
    • 10.3.1. Product Description
    • 10.3.2. Regulatory Milestones
    • 10.3.3. Other Developmental Activities
    • 10.3.4. Summary of Pivotal Trials
    • 10.3.5. Analyst Views

11. Emerging Therapies

  • 11.1. Emerging Competitive Landscape of Gastrointestinal Stromal Tumor (GIST)
  • 11.2. Bezuclastinib (CGT9486): Cogent Biosciences
    • 11.2.1. Product Description
    • 11.2.2. Other Developmental Activities
    • 11.2.3. Clinical Development
      • 11.2.3.1. Clinical Trial Information
    • 11.2.4. Safety and Efficacy
    • 11.2.5. Analyst Views
  • 11.3. Velzatinib (IDRX-42/GSK6042981): GSK
    • 11.3.1. Product Description
    • 11.3.2. Other Developmental Activities
      • 11.1.3.3. Clinical Development
      • 11.3.3.1. Clinical Trial Information
      • 11.1.3.4. Safety and Efficacy
      • 11.1.3.5. Analyst Views

12. Gastrointestinal Stromal Tumor (GIST): Seven Major Market Analysis

  • 12.1. Key Findings
  • 12.2. Market Outlook of Gastrointestinal Stromal Tumor (GIST)
  • 12.3. Conjoint Analysis of Gastrointestinal Stromal Tumor (GIST)
  • 12.4. Key Market Forecast Assumptions
    • 12.4.1. Cost Assumptions
    • 12.4.2. Pricing Trends
    • 12.4.3. Analogue Assessment
    • 12.4.4. Launch Year and Therapy Uptakes
  • 12.5. Total Market Size of Gastrointestinal Stromal Tumor (GIST) in the 7MM
  • 12.6. The United States
    • 12.6.1. Total Market Size of Gastrointestinal Stromal Tumor (GIST) in the United States
    • 12.6.2. Market Size of Gastrointestinal Stromal Tumor (GIST) by Therapies in the United States
  • 12.7. EU4 and the UK
    • 12.7.1. Total Market Size of Gastrointestinal Stromal Tumor (GIST) in EU4 and the UK
    • 12.7.2. Market Size of Gastrointestinal Stromal Tumor (GIST) by Therapies in EU4 and the UK
  • 12.8. Japan
    • 12.8.1. Total Market Size of Gastrointestinal Stromal Tumor (GIST) in Japan
    • 12.8.2. Market Size of Gastrointestinal Stromal Tumor (GIST) by Therapies in Japan

13. Unmet Needs of Gastrointestinal Stromal Tumor (GIST)

14. SWOT Analysis of Gastrointestinal Stromal Tumor (GIST)

15. KOL Views of Gastrointestinal Stromal Tumor (GIST)

  • 15.1. Expert/KOL Interview Highlights

16. Market Access and Reimbursement

  • 16.1. The US
  • 16.2. In 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
  • 16.4. Summary and Comparison of Market Access and Pricing Policy Developments in 2025
  • 16.5. Market Access and Reimbursement of Gastrointestinal Stromal Tumor (GIST) Therapies

17. Appendix

  • 17.1. Bibliography
  • 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

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