This ‘Gastrointestinal Stromal Tumor (GIST)-Market Insights, Epidemiology, and Market Forecast-2032' report deliver an in-depth understanding of the GIST, historical and forecasted epidemiology as well as the GIST market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
The GIST market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM GIST market size from 2019 to 2032. The Report also covers current GIST treatment practice, market drivers, market barriers, SWOT analysis, reimbursement and market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
GIST progression is driven by mutations in KIT or PDGFRA or by other rare gene alterations, all of which are mutually exclusive. It is known that the majority of tumors of GIST will have mutations in the KIT gene, and a minority, in the PDGFR gene.
Wild-type GIST do not have mutations of the KIT or PDGFR genes. Some of the cases of wild-type GIST have been linked to genes involved in the succinate dehydrogenase (SDH) enzyme complex (i.e., SDHA, SDHB, SDHC, or SDHD genes). Additional genes have been linked to wild-type GIST, includes BRAF, KRAS, and NRAS mutations.
After physical examination, CT scan (CAT scan), MRI, Endoscopic ultrasound and biopsy, Immunohistochemistry, Mitotic rate, PET scan can be performed to confirm the disease and its severity.
Tyrosine kinase inhibitors (TKIs) are the standard therapy for metastatic/recurrent GIST. Molecular alterations are the most reliable biomarkers for TKIs and for other drugs, such as NTRK inhibitors. The pathological and genetic diagnosis prior to treatment has been challenging; however, a newly developed endoscopic device may be useful for diagnosis. In the era of precision medicine, cancer genome profiling by targeted gene panel analysis may enable potential targeted therapy even for GIST without KIT or PDGFRA mutations.
In addition, it is used for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia, myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene rearrangement, and adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP)
The US FDA had granted Fast Track designation for Crenolanib to treat patients with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRα) D842V mutation.
Currently, the molecule is in Phase III clinical development for GIST in Japan and for solid tumors in Phase I clinical development in the US and Europe.
Targeted therapy with imatinib, an oral, small molecule, selective tyrosine-kinase inhibitor of KIT, PDGFRA, and ABL that was approved for first-line treatment for advanced GIST in 2002, for adjuvant treatment in high-risk patients in 2008, and for use in adult patients following surgical removal of CD117-positive GIST in 2012 by USFDA (the United States Food and Drug Administration), in 2001 by EMA (European Medicines Agency), and 2003 by PMDA (Pharmaceuticals and Medical Devices Agency), revolutionized treatment for GIST. Though the management of GIST was transformed after the arrival of imatinib which became the standard first-line treatment for metastatic GIST. On the other hand, despite a clinical benefit rate of 80%, half of those having a clinical benefit eventually progress after 2 years of therapy due to acquired imatinib resistance.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
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The GIST market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM GIST market size from 2019 to 2032. The Report also covers current GIST treatment practice, market drivers, market barriers, SWOT analysis, reimbursement and market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Geography Covered
- The United States
- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
- Japan
Gastrointestinal Stromal Tumor (GIST) Disease Understanding and Treatment Algorithm
As per GIST Support International, gastrointestinal stromal tumor (GIST) is rare cancer affecting the digestive tract or nearby structures within the abdomen. It is a sarcoma that arises either from cells called interstitial cells of Cajal (ICCs) or from less differentiated stem cells or precursor cells that can develop into ICCs.GIST progression is driven by mutations in KIT or PDGFRA or by other rare gene alterations, all of which are mutually exclusive. It is known that the majority of tumors of GIST will have mutations in the KIT gene, and a minority, in the PDGFR gene.
Wild-type GIST do not have mutations of the KIT or PDGFR genes. Some of the cases of wild-type GIST have been linked to genes involved in the succinate dehydrogenase (SDH) enzyme complex (i.e., SDHA, SDHB, SDHC, or SDHD genes). Additional genes have been linked to wild-type GIST, includes BRAF, KRAS, and NRAS mutations.
Gastrointestinal Stromal Tumor (GIST) Diagnosis
A GIST diagnosis is typically made or ruled out based on a patient's medical history, a comprehensive physical examination, and the results of a series of tests. The testing methods used to confirm or rule out a GIST can vary based on a patient's symptoms and other individual factors.After physical examination, CT scan (CAT scan), MRI, Endoscopic ultrasound and biopsy, Immunohistochemistry, Mitotic rate, PET scan can be performed to confirm the disease and its severity.
Gastrointestinal Stromal Tumor (GIST) Treatment
Gastrointestinal stromal tumor (GIST) is the most frequent malignant mesenchymal tumors in the gastrointestinal tract. The initial work-up with endoscopy and endoscopic ultrasonography plays important roles in the differential diagnosis of GIST. Surgery is the only modality for the permanent cure of localized GISTs. In terms of safety and prognostic outcomes, laparoscopy is similar to laparotomy for GIST treatment, including tumors larger than 5 cm. GIST progression is driven by mutations in KIT or PDGFRA or by other rare gene alterations, all of which are mutually exclusive.Tyrosine kinase inhibitors (TKIs) are the standard therapy for metastatic/recurrent GIST. Molecular alterations are the most reliable biomarkers for TKIs and for other drugs, such as NTRK inhibitors. The pathological and genetic diagnosis prior to treatment has been challenging; however, a newly developed endoscopic device may be useful for diagnosis. In the era of precision medicine, cancer genome profiling by targeted gene panel analysis may enable potential targeted therapy even for GIST without KIT or PDGFRA mutations.
Gastrointestinal Stromal Tumor (GIST) Epidemiology
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total incident cases of GIST, Gender-specific Incident Cases of GIST, Age-specific Incident Cases of GIST, Incident Cases of GIST by Mutation, and Stage-specific Incident Cases of GIST in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2019 to 2032.Key Findings
- In the assessment done by the publisher, the estimated total incident cases of GIST in the 7MM were 14,251 in 2021.
- The highest incident cases of GIST were accounted by the US in 2021 (6,035 cases), which are expected to show a steep rise soon due to the improvement in diagnostic testing and advancements in genetic testing and accounts for 42% of the total cases in the 7MM.
- In 2021, the age-specific incident cases of GIST accounted highest in the age group 66-80 years with 5,384 cases in the 7MM, followed by age group 51-65 years with 4,581 cases. While the least number of cases were seen in the age group 0-17 years.
- Among the European countries, Germany had the highest incident population of GIST with 1,736 cases, followed by Italy, which had incident population of 1,095 in 2021. On the other hand, Spain had the lowest incident population (824 cases).
- Japan had 2,458 incident cases for GIST in 2021, accounting for approximately 17% of total incident cases in the 7MM.
Gastrointestinal Stromal Tumor (GIST) Epidemiology
The epidemiology segment also provides the Gastrointestinal Stromal Tumor (GIST) epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.Gastrointestinal Stromal Tumor (GIST) Drug Chapters
The drug chapter segment of the Gastrointestinal Stromal Tumor (GIST) report encloses the detailed analysis of Gastrointestinal Stromal Tumor (GIST) marketed drugs, mid-phase, and late-stage pipeline drugs. It also helps to understand the Gastrointestinal Stromal Tumor (GIST) clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details of each included drug and the latest news and press releases.Gastrointestinal Stromal Tumor (GIST) Marketed Drugs
Gleevec/Glivec (Imatinib Mesylate): Novartis
Gleevec is a kinase inhibitor indicated for treating patients with Kit (CD117) positive unresectable and/or metastatic malignant GIST. It is also used as adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive GIST.In addition, it is used for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia, myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene rearrangement, and adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP)
Qinlock (Ripretinib): Deciphera Pharmaceuticals
Qinlock (Ripretinib) is an orally administered switch-control kinase inhibitor engineered using a proprietary drug discovery platform and developed for the treatment of GIST. While approved kinase inhibitors control certain initiating and drug resistance-causing mutations in KIT and PDGFRA, the kinases that drive disease progression in most GIST patients, these approved drugs fail to inhibit all known mutations. Qinlock improves the treatment of GIST patients by inhibiting the full spectrum of the known mutations in KIT and PDGFRA. It is a KIT and PDGFRA switch-control kinase inhibitor that blocks initiating and resistance KIT mutations in exons 9, 11, 13, 14, 17, and 18 known to be present in GIST patients.Gastrointestinal Stromal Tumor (GIST) Emerging Drugs
Crenolanib: Arog Pharmaceutical
Crenolanib is a small molecule investigational drug candidate that is being evaluated for safety and efficacy in Phase III clinical trials in acute myeloid leukemia (AML) and gastrointestinal stromal tumor (GIST). Crenolanib is a potent small-molecule inhibitor of wild-type and mutant forms of FLT3 (FMS-like Tyrosine Kinase 3) and PDGFRα/β (Platelet-derived Growth Factor Receptor).The US FDA had granted Fast Track designation for Crenolanib to treat patients with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRα) D842V mutation.
TAS-116: Taiho Pharmaceutical
TAS-116 is an oral compound discovered by Taiho Pharmaceutical, inhibits HSP90, thereby showing an anticancer effect by destabilizing and reducing proteins such as KIT, PDGFRA, HER2, and EGFR involved in the growth and survival of cancer. TAS-116 is a nonansamycin, nonpurine, nonresorcinol, highly selective inhibitor of HSP90α/β with antitumor activity in an imatinib-resistant human GIST xenograft mouse model.Currently, the molecule is in Phase III clinical development for GIST in Japan and for solid tumors in Phase I clinical development in the US and Europe.
Gastrointestinal Stromal Tumor (GIST) Market Outlook
Knowledge about the underlying genetic alterations revealed possible targeted treatment with TKIs such as imatinib and sunitinib. Continuous research efforts helped to further elucidate molecular insights of this disease and allowed the development of new treatment options based on the underlying molecular signature. Currently, there are seven therapies approved for GIST that includes five TKIs, and two NTRK inhibitors such as Gleevec (Imatinib Mesylate), Stivarga (Regorafenib), Sutent (sunitinib malate), Ayvakit (avapritinib), Qinlock (Ripretinib), Rozlytrek (Entrectinib), and Vitrakvi (Larotrectinib), approved in different lines. Along with these, there are certain therapies being used as off-label therapies in patients resistant to approved therapies.Targeted therapy with imatinib, an oral, small molecule, selective tyrosine-kinase inhibitor of KIT, PDGFRA, and ABL that was approved for first-line treatment for advanced GIST in 2002, for adjuvant treatment in high-risk patients in 2008, and for use in adult patients following surgical removal of CD117-positive GIST in 2012 by USFDA (the United States Food and Drug Administration), in 2001 by EMA (European Medicines Agency), and 2003 by PMDA (Pharmaceuticals and Medical Devices Agency), revolutionized treatment for GIST. Though the management of GIST was transformed after the arrival of imatinib which became the standard first-line treatment for metastatic GIST. On the other hand, despite a clinical benefit rate of 80%, half of those having a clinical benefit eventually progress after 2 years of therapy due to acquired imatinib resistance.
Key Findings
- The therapeutic market of GIST in the 7MM was USD 450 million in 2021.
- The United States accounts for the highest market size of GIST approximately 67% of the total market size in 7MM in 2021, in comparison to the other major markets i.e., EU5 countries (the United Kingdom, Germany, Italy, France, and Spain), and Japan.
- Among the EU5 countries, Germany had the highest market size with USD 33 million in 2021, while Spain had the lowest market size of GIST with USD 17 million in 2021.
- The market size for GIST in Japan was estimated to be USD 36 Million in 2021, which accounts for 8% of the total 7MM market.
- With the expected launch of upcoming therapies, such as Crenolanib, Bezuclastinib (CGT9486/PLX9486), and others the total market of GIST is expected to show a decent change in upcoming years.
The United States Market Outlook
This section provides the total Gastrointestinal Stromal Tumor (GIST) market size and; market size by therapies in the United States.EU-5 Market Outlook
The total Gastrointestinal Stromal Tumor (GIST) market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.Japan Market Outlook
The total Gastrointestinal Stromal Tumor (GIST) market size and market size by therapies in Japan are provided.Gastrointestinal Stromal Tumor (GIST) Drugs Uptake
This section focuses on the rate of uptake of the potential drugs recently launched in the GIST market or expected to get launched in the market during the study period 2019-2032. The analysis covers GIST market uptake by drugs; patient uptake by therapies; and sales of each drug.This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
Gastrointestinal Stromal Tumor (GIST) Development Activities
The report provides insights into different therapeutic candidates in phase II, and phase III stages. It also analyzes key players involved in developing targeted therapeutics.Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for Gastrointestinal Stromal Tumor (GIST) emerging therapies.Reimbursement Scenario in Gastrointestinal Stromal Tumor (GIST)
Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.Competitive Intelligence Analysis
The publisher performs competitive and market Intelligence analysis of the Gastrointestinal Stromal Tumor (GIST) market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.Scope of the Report
- The report covers the descriptive overview of GIST, explaining its signs and symptoms, causes, classification, and currently available therapies.
- Comprehensive insight has been provided into the GIST epidemiology and treatment.
- Additionally, an all-inclusive account of both the current and emerging therapies for GIST is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
- A detailed review of the GIST market; historical and forecasted is included in the report, covering the 7MM drug outreach.
- The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM GIST market.
Report Highlights
- The robust pipeline with novel MOA and oral ROA and increasing incidence will positively drive the GIST market.
- The companies and academics are working to assess challenges and seek opportunities that could influence GIST R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition and underlying cause.
- Major players are involved in developing therapies for GIST. The launch of emerging therapies will significantly impact the GIST market.
- Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.
Gastrointestinal Stromal Tumor (GIST) Report Insights
- Patient Population
- Therapeutic Approaches
- GIST Pipeline Analysis
- GIST Market Size and Trends
- Market Opportunities
- Impact of upcoming Therapies
Gastrointestinal Stromal Tumor (GIST) Report Key Strengths
- 11-Years Forecast
- 7MM Coverage
- GIST Epidemiology Segmentation
- Key Cross Competition
- Highly Analyzed Market
- Drugs Uptake
Gastrointestinal Stromal Tumor (GIST) Report Assessment
- Current Treatment Practices
- Unmet Needs
- Pipeline Product Profiles
- Market Attractiveness
- Market Drivers and Barriers
- SWOT analysis
Key Questions Answered
Market Insights:
- What was the GIST's market share (%) distribution in 2019 and how it would look like in 2032?
- What would be the GIST's total market size as well as market size by therapies across the 7MM during the forecast period (2022-2032)?
- What are the key findings pertaining to the market across the 7MM and which country will have the largest GIST market size during the forecast period (2022-2032)?
- At what CAGR, the GIST market is expected to grow at the 7MM level during the forecast period (2022-2032)?
- What would be the GIST market outlook across the 7MM during the forecast period (2022-2032)?
- What would be the GIST market growth till 2032 and what will be the resultant market size in the year 2032?
- How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
Epidemiology Insights:
- What is the disease risk, burden, and unmet needs of GIST?
- What is the historical GIST patient population in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
- What would be the forecasted patient population of GIST at the 7MM level?
- What will be the growth opportunities across the 7MM with respect to the patient population pertaining to GIST?
- Out of the above-mentioned countries, which country would have the highest incident population of GIST during the forecast period (2022-2032)?
- At what CAGR the population is expected to grow across the 7MM during the forecast period (2022-2032)?
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:
- What are the current options for the treatment of GIST along with the approved therapy?
- What are the current treatment guidelines for the treatment of GIST in the US and Europe?
- What are the GIST marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
- How many companies are developing therapies for the treatment of GIST?
- How many emerging therapies are in the mid-stage and late stages of development for the treatment of GIST?
- What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the GIST therapies?
- What are the recent therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for GIST and their status?
- What are the key designations that have been granted for the emerging therapies for GIST?
- What are the 7MM historical and forecasted market of GIST?
Reasons to Buy
- The report will help in developing business strategies by understanding trends shaping and driving the GIST.
- To understand the future market competition in the GIST market and an Insightful review of the key market drivers and barriers.
- Organize sales and marketing efforts by identifying the best opportunities for GIST in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
- Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
- Organize sales and marketing efforts by identifying the best opportunities for the GIST market.
- To understand the future market competition in the GIST market.
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Table of Contents
1. Key Insights2. Report Introduction4. Gastrointestinal Stromal Tumor Market: Future Perspective5. Executive Summary of Gastrointestinal Stromal Tumors6. Key Events9. Patient Journey13. Key Opinion Leaders' Views14. Market Drivers15. Market Barriers16. SWOT Analysis17. Unmet Needs18. Reimbursement and Market Access20. Publisher Capabilities21. Disclaimer22. About the Publisher
3. Gastrointestinal Stromal Tumor Market Overview at a Glance
7. Gastrointestinal Stromal Tumor: Disease Background and Overview
8. Epidemiology and Patient Population
10. Marketed Drugs
11. Emerging Drugs
12. Gastrointestinal Stromal Tumor: Seven Major Market Analysis
19. Appendix
List of Tables
List of Figures
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Arog Pharmaceuticals
- Taiho Pharmaceutical
- Turning Point Therapeutics, Inc.
- Cogent Biosciences, Inc.
- Plexxikon Inc.
- Theseus Pharmaceuticals
- Exelixis, Inc.
- Ipsen
- Bristol-Myers Squibb
- Takeda
