The Gastrointestinal Stromal Tumor (GIST) market, estimated to be valued at USD 1.32 billion in 2025, is projected to exhibit a robust CAGR of 9.8%, reaching USD 2.54 billion by 2032. Market growth is primarily driven by the increasing prevalence of gastrointestinal cancers, advancements in molecular diagnostics, and the rising adoption of targeted therapies such as tyrosine kinase inhibitors (TKIs). The availability of novel treatment options, improved disease awareness, and expanding clinical research for drug development are further accelerating the market expansion. Additionally, growing healthcare investments, early diagnosis initiatives, and regulatory approvals for innovative therapies are expected to boost the market growth across both developed and emerging regions over the forecast period.

Market Takeaways

• By Product, the Marketed Drugs segment is projected to dominate the gastrointestinal stromal tumor (GIST) market with a 65.5% share in 2025, driven by the widespread adoption of approved tyrosine kinase inhibitors (TKIs) such as imatinib and sunitinib, which remain the first-line treatment options for GIST patients.
• By Drug Category, Tyrosine Kinase Inhibitors (TKIs) are expected to lead the market with a 52.8% share in 2025, owing to their proven efficacy in targeting KIT and PDGFRA mutations, along with the continuous development of next-generation TKIs to address drug resistance in advanced stages.
• By Route of Administration, the Oral segment is anticipated to capture the majority of market share in 2025, as most approved GIST therapies, including TKIs, are orally administered, offering improved patient compliance and convenience over parenteral alternatives.
• By Region, North America is projected to hold the largest market share in 2025, supported by high GIST diagnosis rates, strong adoption of targeted therapies, robust clinical research activity, and favorable reimbursement policies for advanced oncology treatments.

Gastrointestinal Stromal Tumor (GIST) Report Coverage

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Market Dynamics

The gastrointestinal stromal tumor (GIST) market is witnessing robust growth, fueled by the rising prevalence of gastrointestinal cancers and increasing adoption of precision medicine in oncology. Strong focus on early diagnosis and the widespread use of molecular testing for KIT and PDGFRA mutations are enabling timely detection and improved treatment outcomes. Market expansion is further supported by the availability of targeted therapies, primarily tyrosine kinase inhibitors (TKIs), which remain the cornerstone of GIST management, significantly improving survival rates for patients with unresectable or metastatic tumors.

Innovation in drug development is a key market driver, with pharmaceutical companies investing heavily in next‑generation TKIs and immunotherapies aimed at overcoming resistance to first‑line treatments such as imatinib. Several Phase III pipeline candidates are expected to further diversify treatment options over the forecast period. Additionally, increasing regulatory approvals and expanded indications for existing drugs are propelling the market growth.

The market is also benefiting from rising healthcare expenditure, favorable reimbursement policies in developed economies, and growing clinical trial activity across the U.S., Europe, and the Asia Pacific. However, challenges such as high treatment costs, the emergence of resistance mutations, and limited efficacy of conventional chemotherapy continue to pose constraints.

In June 2022, Taiho Pharmaceutical Co., Ltd. announced that it had obtained manufacturing and marketing approval from Japan’s Ministry of Health, Labour and Welfare for the oral heat shock protein (HSP) 90 inhibitor Jeselhy Tablets 40 mg (generic name: pimitespib; development code: TAS-116), for the indication of gastrointestinal stromal tumor (GIST) that has progressed after chemotherapy.

Market Trends

• Shift Toward Precision Medicine & Molecular Diagnostics

The market is increasingly embracing personalized medicine via widespread molecular profiling (e.g., KIT, PDGFRA mutations) enabled by next-generation sequencing (NGS) and companion diagnostics. These tools guide therapy selection and drive treatment optimization—boosting early detection and tailored interventions.

In August 2024, Molecular Laboratories (MLabs) launched its next‑generation sequencing (NGS) assay for KIT and PDGFRA mutations, following CLIA certification effective June 4, 2024. The test replaces prior exon‑only Sanger assays, offering improved sensitivity (≥ 10% allele frequency) and broader exon coverage—including KIT exon 8 and PDGFRA exon 14—enabling more accurate mutation detection for precision‑guided therapy decisions.

• Regulatory & Reimbursement Trends Supporting Companion Diagnostics

Regulatory pathways for companion diagnostics (CDx) have become increasingly streamlined, enabling faster approvals and broader market access for molecular testing solutions that guide targeted therapy decisions. Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have intensified support for biomarker‑driven diagnostics in oncology, which is directly influencing the development and commercial adoption of precision‑medicine strategies for cancers like the gastrointestinal stromal tumor market.

As of April 2025, the European Union’s In Vitro Diagnostic Regulation (IVDR)—which replaced the previous IVDD in May 2022—requires companion diagnostics to undergo a notified‑body assessment in consultation with the EMA’s CHMP/CAT before CE‑marking. From enactment through the end of 2024, 24 consultation procedures covering 55 therapy indications were completed, most of which involved oncology companion diagnostics.

Market Opportunities

• Expansion of Liquid Biopsy and Minimal Residual Disease (MRD) Testing

The adoption of liquid biopsy and circulating tumor DNA (ctDNA)‑based minimal residual disease (MRD) assays is creating new opportunities for early detection, treatment monitoring, and recurrence prediction in GIST patients. Traditional diagnostic approaches rely heavily on tissue biopsies, which are invasive and often inadequate for repeat testing.

In February 2022, the National Library of Medicine published a clinical study involving 46 GIST patients and 64 plasma samples, where ctDNA-based liquid biopsy using a custom targeted NGS panel detected KIT or PDGFRA mutations in 70% of patients with progressing metastatic disease. ctDNA levels closely correlated with radiological progression and confirmed treatment resistance, while no ctDNA was detected in patients without progression or in those with localized GIST.

• Rising Demand for Next‑Generation KIT/PDGFRA Inhibitors in Resistant Gastrointestinal Stromal Tumor

While first-line imatinib remains the cornerstone therapy for patients with gastrointestinal stromal tumors (GIST), the long-term management of the disease is frequently challenged by the emergence of secondary KIT or PDGFRA mutations. These mutations often develop after initial treatment, leading to progressive drug resistance and limiting the effectiveness of existing tyrosine kinase inhibitors (TKIs) such as imatinib, sunitinib, and regorafenib. As a result, many patients eventually exhaust current therapy options, highlighting a significant unmet medical need for next-generation treatments that can overcome resistance mechanisms and extend survival outcomes.

To address this gap, novel selective inhibitors and multi-kinase inhibitors are being designed to target both primary activating mutations and the broad spectrum of secondary resistance mutations that drive tumor recurrence and progression. These next-generation agents aim to inhibit multiple resistant clones simultaneously, improving durability of response and offering therapeutic options for patients in second‑ and later‑line settings. The ability to control resistant disease also opens the door for personalized therapy strategies, where treatment can be adapted based on molecular profiling of KIT and PDGFRA mutations detected through tissue or liquid biopsy.

In August 2023, the National Library of Medicine published preclinical findings demonstrating the potential of IDRX‑42, a highly selective next-generation KIT inhibitor. In GIST xenograft models, IDRX‑42 showed strong antitumor efficacy, effectively suppressing tumor growth in models harboring both activating mutations (exons 9 and 11) and secondary resistance mutations (exons 13 and 17). The treatment led to marked tumor volume reductions and significant decreases in mitotic activity, indicating potent inhibition of tumor proliferation and progression. These results suggest that IDRX‑42 could address a key limitation of current therapies by targeting a wider mutation spectrum, making it a promising candidate for patients who have developed resistance to first-line and second-line TKIs.

The development of such agents represents a high-value market segment, as resistant GIST accounts for a growing proportion of clinical cases. With several candidates like IDRX‑42 progressing through early clinical trials and generating encouraging data, the market is poised for innovation in precision therapeutics that can effectively extend disease control and improve patient outcomes.

Analyst View

• The gastrointestinal stromal tumor (GIST) market is poised for significant expansion over the next decade, underpinned by the accelerated adoption of precision oncology, evolving diagnostic frameworks, and a strong late‑stage therapeutic pipeline.
• Key market drivers include the rising prevalence of gastrointestinal cancers, which is driving early diagnosis initiatives and the integration of molecular profiling into standard clinical workflows. The widespread use of next‑generation sequencing (NGS) and companion diagnostics is enabling oncologists to identify actionable KIT and PDGFRA mutations, ensuring patients receive the most effective tyrosine kinase inhibitor (TKI) therapy at each stage of disease. The regulatory and reimbursement environment is becoming more favorable for these advanced diagnostics, with the FDA and EMA supporting biomarker-driven drug approvals and Europe’s IVDR framework streamlining companion diagnostic pathways.
• On the therapeutic front, the market is witnessing a dynamic shift toward next‑generation TKIs and emerging immunotherapies. While first‑line imatinib maintains its dominance, resistance driven by secondary KIT/PDGFRA mutations continues to create unmet clinical needs. This challenge is fueling demand for innovative treatments like IDRX‑42 and HSP90 inhibitors (e.g., Pimitespib), which have demonstrated robust preclinical and early clinical efficacy in addressing resistant GIST populations. The pipeline diversity, including multi‑target kinase inhibitors, heat shock protein inhibitors, and experimental immunotherapies, is expected to transform the therapeutic landscape, improving survival outcomes and driving the market growth.
• Regional dynamics also favor expansion, with North America projected to remain the largest market due to high diagnosis rates, strong adoption of TKIs, and broad insurance coverage for advanced oncology therapies. Meanwhile, the Asia Pacific is anticipated to exhibit the fastest growth as healthcare infrastructure improves, molecular testing expands, and regional regulatory bodies accelerate approvals for targeted treatments.
• From an investment perspective, the market presents attractive opportunities in both diagnostics and therapeutics. Companies that can successfully develop mutation‑agnostic or resistance‑targeted therapies, alongside liquid biopsy and MRD solutions, will be well-positioned to capture high‑value segments. However, high treatment costs, TKI resistance emergence, and limited efficacy of conventional chemotherapy remain market constraints, reinforcing the importance of innovative pipeline assets and supportive reimbursement frameworks.
• Overall, analysts expect the next 5–7 years to mark a transformational period for the GIST market, with the convergence of precision medicine, evolving regulatory policies, and novel therapeutic options creating a pathway for sustained double‑digit growth in high‑value patient populations.

Recent Key Developments

• In June 2025, Sanofi and Blueprint Medicines Corporation (Blueprint), a U.S.-based, publicly traded biopharmaceutical company specializing in systemic mastocytosis (SM), a rare immunological disease, and other KIT-driven diseases, entered into an agreement under which Sanofi will acquire Blueprint. The acquisition includes a rare immunology disease medicine, Ayvakit/Ayvakyt (avapritinib), approved in the U.S. and the EU, and a promising advanced and early-stage immunology pipeline. Furthermore, Blueprint’s established presence among allergists, dermatologists, and immunologists is expected to enhance Sanofi’s growing immunology pipeline.
• In November 2024, Novartis announced an upgrade to its mid-term guidance, in advance of its Meet Novartis Management event for investors and analysts in London. Previous guidance for +5% sales CAGR 2023-2028 was upgraded to +6%, driven by strong momentum of in-market growth drivers and upcoming launches, most of which have expected U.S. exclusivity in the 2030s or beyond.

Competitive Landscape

• Novartis AG
• Pfizer Inc.
• Bayer AG
• Roche Holding AG
• Eli Lilly and Company
• Daiichi Sankyo
• Astellas Pharma
• Blueprint Medicines Corporation
• Merck & Co.
• Amgen Inc.

 Gastrointestinal Stromal Tumor (GIST) Market Segmentation

• By Product
• Marketed Drugs
• Phase III Pipeline Drugs
• By Drug Category
• Tyrosine Kinase Inhibitors (TKIs)
• Chemotherapy
• Immunotherapy
• By Route of Administration
• Oral
• Intravenous

Regional Insights

• North America
  • U.S.
  • Canada
• Latin America
  • Mexico
  • Brazil
  • Argentina
  • Rest of Latin America
• Europe
  • Italy
  • Germany
  • U.K.
  • Spain
  • France
  • Russia
  • Rest of Europe
• Asia Pacific
  • South Korea
  • India
  • Japan
  • China
  • Australia
  • ASEAN
  • Rest of Asia Pacific
• Middle East
  • GCC Countries
  • Israel
  • Rest of the Middle East
• Africa
  • South Africa
  • North Africa
  • Central Africa