SDH-Deficient Gastrointestinal Stromal Tumor (GIST) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032

SDH-Deficient Gastrointestinal Stromal Tumor (GIST) Market Outlook

Thelansis’s “SDH-Deficient Gastrointestinal Stromal Tumor (GIST) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential SDH-Deficient Gastrointestinal Stromal Tumor treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

SDH-Deficient Gastrointestinal Stromal Tumor (GIST) Overview

Gastrointestinal stromal tumors (GISTs) are the predominant mesenchymal tumors in the gastrointestinal tract. They primarily occur in the stomach (50%-60%) and small intestine (30%-35%), while their occurrence in the colon and rectum is less common (5%), and in the esophagus, it is rare (<1%). Additionally, GISTs can develop within the abdominal cavity, specifically in the omentum, mesentery, or retroperitoneum (occurring in less than 5% of all GISTs). Specific mutations in the KIT gene drive the majority of GISTs (75%-80%) or PDGFRA gene (10%). However, around 10%-15% of GISTs do not exhibit detectable mutations in KIT or PDGFRA and are called KIT/PDGFRA wild-type GISTs. Succinate dehydrogenase comprises four subunit proteins (SDHA, SDHB, SDHC, and SDHD) and two assembly factors (SDHAF1 and SDHAF2). SDHA and SDHB form the catalytic component of succinate-coenzyme Q reductase, whereas SDHC and SDHD comprise the anchoring component that attaches the complex to the inner mitochondrial membrane. These tumors are more commonly observed in children and young adults. Most gastric GIST patients under 18 years old and a significant percentage of patients under 30 years old fall into this category. While the exact cause of SDH deficiency in these tumors remains unclear, the association between SDH deficiency and SDH gene mutations is well-established. The primary function of SDH is to participate in the interface between the tricarboxylic acid cycle and the electron transport chain. It catalyzes the oxidation of succinate to fumarate. This complex plays a crucial role in regulating hypoxia-inducible factor 1α (HIF1α), which is a subunit of HIF1. HIF1 is a transcriptional activator of IGF2 and VEGF. SDH-deficient GISTs present clinical manifestations similar to other gastric tumors, including gastrointestinal bleeding and epigastric discomfort. Some patients diagnosed with SDH-deficient GISTs may exhibit symptoms associated with metastatic tumors in the abdomen or liver. The differential diagnosis for SDH-deficient GISTs is comparable to that of other gastrointestinal stromal tumors, which include carcinoma, perivascular epithelioid cell tumor, melanoma, epithelioid leiomyosarcoma, epithelioid angiosarcoma, glomus tumor, and even neuroendocrine tumors, especially when the tumor demonstrates epithelioid morphology. Traditional chemotherapy has limited efficacy in treating GISTs; however, the tyrosine kinase inhibitor imatinib has shown promising results in inhibiting their growth.

• The overall incidence of GISTs was 0.70 per 100,000 people per year. Approximately 5% to 7.5% of all GISTs are SDH-deficient.

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2022-2032

Current Clinical Practice and Treatment Algorithm

This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.

KOL Insights:

KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- Data Inputs with sourcing

- Market Event and Product Event

- Country-specific Forecast Model

- Market uptake and patient share uptake

- Attribute Analysis

- Analog Analysis

- Disease burden and pricing scenario

- Summary and Insights

NPV/ IRR Calculator-

Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.

Competitive Landscape:

The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.

Clinical Trial Assessment-

Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.

Unmet Medical Needs Overview-

This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.

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