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시장보고서
상품코드
2082966
위장관 기질종양(GIST) : 시장 인사이트, 역학 및 시장 예측(2036년)Gastrointestinal Stromal Tumor (GIST) - Market Insight, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
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.
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 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.
GIST의 역학 분석 및 예측에 관한 주요 조사 결과
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.
많은 약물이 KIT/PDGFRA를 표적으로 하는 TKI이므로, GIST 시장을 주도하는 주요 약물군은 티로신 키나제 억제제(TKI)입니다.
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) 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.
Key Findings from GIST Epidemiological Analysis and Forecast
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
Gastrointestinal Stromal Tumor (GIST) Drug Updates
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.
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.
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.
Market Insights