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
Gastrointestinal Stromal Tumor (GIST) Report Coverage
The full report is now available for purchase: https://www.coherentmi.com/industry-reports/gastrointestinal-stromal-tumor-gist-market
|
Report Coverage |
Details |
|
Market Revenue in 2025 |
USD 1.32 Billion |
|
Estimated Value by 2032 |
USD 2.54 Billion |
|
Growth Rate |
Poised to exhibit a CAGR of 9.8% |
|
Historical Data |
2020-2024 |
|
Forecast Period |
2025–2032 |
|
Forecast Units |
Value (USD Billion) |
|
Report Coverage |
Revenue Forecast, Competitive Landscape, Growth Factors, and Trends |
|
Segments Covered |
|
|
Geographies Covered |
North America (U.S. and Canada), Latin America (Brazil, Argentina, Mexico, and Rest of Latin America), Europe (Italy, Spain, U.K., Germany, France, Russia, and Rest of Europe), Asia Pacific (China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific), Middle East (GCC Countries, Israel, and Rest of Middle East), and Africa (South Africa, North Africa, and Central Africa) |
|
Growth Drivers |
|
|
Trends |
|
|
Opportunities |
|
|
Restraints & Challenges |
|
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
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 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
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.
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
Recent Key Developments
Competitive Landscape
Gastrointestinal Stromal Tumor (GIST) Market Segmentation
Regional Insights
Related Reports :