Gastrointestinal Neuroendocrine Tumors Therapies Poised for Rapid Uptake with Positive Phase III Data Across Key Assets | DelveInsight

Gastrointestinal Neuroendocrine Tumors Therapies Poised for Rapid Uptake with Positive Phase III Data Across Key Assets | DelveInsight
Gastrointestinal Neuroendocrine Tumors Market Insight, Epidemiology And Market Forecast
DelveInsight’s GI-NETs market report covers 7MM analysis through 2034, featuring companies like Novartis, Ipsen, ITM Solucin, Camurus, Bristol Myers Squibb, with key drugs LUTATHERA, SOMATULINE DEPOT, ITM-11, CAM2029, RYZ101. Market expected to grow significantly with 15,500 US cases in 2024.

Gastrointestinal Neuroendocrine Tumors Key Takeaways

  • Gastrointestinal Neuroendocrine Tumors Market size projection: As per DelveInsight’s analysis, the total market size of gastrointestinal neuroendocrine tumors in the 7MM is expected to surge significantly by 2034 due to rising incidence, earlier diagnosis, and expanding treatment options.

  • Gastrointestinal Neuroendocrine Tumors Patient population data: The report provides the total gastrointestinal neuroendocrine tumors potential pool with nearly 15,500 incident cases in the US in 2024, projected to increase during the forecasted period due to improved diagnostic capabilities and enhanced imaging and endoscopic techniques.

  • Key Gastrointestinal Neuroendocrine Tumors companies: Leading gastrointestinal neuroendocrine tumors companies, such as Novartis, Ipsen Biopharmaceutical, ITM Solucin GmbH, Camurus, Bristol Myers Squibb, RayzeBio, Crinetics Pharmaceuticals, Perspective Therapeutics, PharmaMar, Elicera Therapeutics, Shanghai EpimAb Biotherapeutics, and others are actively developing innovative therapeutic solutions.

  • Gastrointestinal Neuroendocrine Tumors Pipeline assets: Some of the key gastrointestinal neuroendocrine tumors therapies in the pipeline include ITM-11 (n.c.a. 177Lu-edotreotide), CAM2029, RYZ101 (actinium-225 DOTATATE), and others representing diverse mechanisms of action and targeted approaches.

  • Recent developments:

    • On August 12, 2025, the FDA accepted a supplemental new drug application for cabozantinib in gastroenteropancreatic NETs

    • In August 2025, Chimeric Therapeutics reported advancement to Dose Level 2 in the Phase I CAR-T trial of CDM CDH17 for GI NETs, colorectal, and gastric cancers, reflecting no safety concerns at the initial dose and early signs of stable disease and tumor shrinkage.

    • On June 3, 2025, the FDA granted Fast Track designation to CHM-CDH17, a third-generation CAR-T therapy targeting CDH17 for advanced gastroenteropancreatic NETs, to expedite interactions and potential accelerated approval in patients progressing after ≥1 prior therapy.

    • In May 2025, Advanced Accelerator Applications withdrew the Type II variation application to extend LUTATHERA indication for newly diagnosed GEP-NETs.

    • In June 2025, ITM Isotope Technologies Munich SE presented positive Phase III COMPETE trial data at the SNMMI annual meeting.

    • In March 2025, ITM presented positive topline data from Phase III COMPETE trial at the European Neuroendocrine Tumor Society meeting.

Discover more recent advancements in the Gastrointestinal Neuroendocrine Tumors landscape @ Gastrointestinal Neuroendocrine Tumors Recent Developments.

Gastrointestinal Neuroendocrine Tumors Market Dynamics

The gastrointestinal neuroendocrine tumors market represents a rapidly evolving therapeutic landscape characterized by significant unmet medical needs and emerging innovative treatment modalities. According to DelveInsight’s comprehensive Gastrointestinal Neuroendocrine Tumors Market Insight, Epidemiology And Market Forecast report, the current market is dominated by established somatostatin analogs and peptide receptor radionuclide therapy, with LUTATHERA, SOMATULINE DEPOT, and SANDOSTATIN LAR DEPOT serving as cornerstone treatments for managing both functional and nonfunctional NETs.

Market momentum is driven by several key factors including improved diagnostic capabilities, enhanced imaging and endoscopic techniques enabling earlier detection, and the growing recognition of GI-NETs as a distinct oncological entity requiring specialized therapeutic approaches. The management paradigm is increasingly shifting towards endoscopic approaches, reducing surgical intervention requirements, while radioactive isotopes have garnered significant pharmaceutical industry attention for their dual diagnostic and therapeutic applications.

The scientific rationale underlying current and emerging therapies centers on somatostatin receptor targeting, with most GI-NETs expressing somatostatin receptors making them ideal candidates for receptor-mediated therapeutic interventions. Long-acting somatostatin analogs demonstrate both symptomatic control and antiproliferative properties, while peptide receptor radionuclide therapy represents a paradigm shift toward precision radiotherapy targeting tumor-specific receptors.

The Gastrointestinal Neuroendocrine Tumors clinical development activity remains robust with multiple Phase III trials advancing next-generation radioligand therapies and improved somatostatin receptor modulators. The competitive landscape features established pharmaceutical giants alongside specialized radiopharmaceutical companies, creating a dynamic environment for innovation and market expansion.

Key challenges include managing receptor-negative tumors, addressing high-grade neuroendocrine carcinomas, and overcoming resistance mechanisms to first-line therapies. However, opportunities abound in developing more precise diagnostic tools, expanding treatment options for aggressive variants, and improving patient selection strategies through biomarker-driven approaches.

The future outlook suggests continued market growth driven by demographic trends, improved awareness among healthcare providers, enhanced diagnostic precision, and the introduction of novel therapeutic modalities that promise improved efficacy and tolerability profiles compared to existing treatment options.

Download the Gastrointestinal Neuroendocrine Tumors Market report to understand which factors are driving the therapeutic market @ Gastrointestinal Neuroendocrine Tumors Market Trends.

Gastrointestinal Neuroendocrine Tumors Epidemiology

The epidemiological landscape of gastrointestinal neuroendocrine tumors across the seven major markets reveals significant disease burden with distinct geographic and demographic patterns. The comprehensive analysis encompasses the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan, providing detailed insights into disease prevalence and incidence trends from 2020 through 2034.

In the United States, the total number of incident cases reached approximately 15,500 in 2024, with projections indicating continued growth throughout the forecast period. The overall incidence rate stands at 4 cases per 100,000 population, reflecting the relatively rare nature of these tumors while highlighting their clinical significance. The epidemiological segmentation reveals distinct anatomical distribution patterns, with hindgut tumors representing the most common subtype at 60% of all cases, followed by foregut tumors at 30.4%, and midgut tumors comprising 9.6% of the total patient population.

Geographic segmentation across the 7MM demonstrates site-specific prevalence variations, with rectal involvement accounting for 17.5% of cases, making it the most frequent individual anatomical location. Small intestine involvement represents 12% of cases, stomach involvement accounts for 5%, and colon involvement comprises 3.5% of the total disease burden. The epidemiological analysis includes comprehensive segmentation by tumor grade, staging classification, functional status, and anatomical site distribution, providing crucial insights for treatment planning and resource allocation.

The forecast period from 2025 to 2034 anticipates continued epidemiological growth driven by enhanced diagnostic capabilities, improved imaging technologies, increased physician awareness, and aging population demographics. The total eligible patient pool reflects both diagnosed prevalent cases and the expanding population at risk, with detailed stratification enabling precise market sizing and therapeutic targeting strategies.

Discover evolving trends in the Gastrointestinal Neuroendocrine Tumors epidemiology forecasts @ Gastrointestinal Neuroendocrine Tumors Patient Pool Analysis.

Key Gastrointestinal Neuroendocrine Tumors Companies and Treatment Market Context

The gastrointestinal neuroendocrine tumors therapeutic landscape encompasses a diverse array of established pharmaceutical companies and emerging biotechnology firms developing innovative treatment modalities. The current treatment paradigm relies heavily on somatostatin analogs for symptomatic control and tumor growth inhibition, with peptide receptor radionuclide therapy representing the most significant recent advancement in targeted oncological intervention.

Key Gastrointestinal Neuroendocrine Tumors companies include Novartis (LUTATHERA, SANDOSTATIN LAR DEPOT, AFINITOR), Ipsen Biopharmaceutical (SOMATULINE DEPOT), ITM Solucin GmbH (ITM-11), Camurus (CAM2029), Bristol Myers Squibb/RayzeBio (RYZ101), Crinetics Pharmaceuticals, Perspective Therapeutics, PharmaMar, Elicera Therapeutics, and Shanghai EpimAb Biotherapeutics, each contributing unique therapeutic approaches and development expertise to advance patient care outcomes.

The Gastrointestinal Neuroendocrine Tumors clinical pipeline activity demonstrates robust investment in next-generation radioligand therapies, with ITM-11 representing an innovative targeted radionuclide therapy agent combining edotreotide with no-carrier-added lutetium-177, currently advancing through Phase III clinical evaluation. CAM2029 offers a long-acting octreotide subcutaneous depot formulation designed to improve patient convenience and treatment adherence, while RYZ101 explores actinium-225 DOTATATE for patients refractory to standard lutetium-177 treatment approaches.

Market positioning reflects the evolution from traditional chemotherapy and surgical interventions toward precision medicine approaches targeting specific tumor biology and receptor expression patterns. The current treatment algorithms emphasize multidisciplinary care coordination, combining surgical resection when feasible with systemic therapies tailored to tumor characteristics, functional status, and disease stage.

Development milestones include significant regulatory achievements and clinical trial successes, with ITM Solucin presenting positive Phase III COMPETE trial results demonstrating improved therapeutic outcomes compared to existing standards of care. Commercial arrangements and strategic partnerships are increasingly common as companies seek to leverage complementary expertise in radiopharmaceutical development, regulatory navigation, and global market access strategies.

Delve deeper into the major and specialised companies in the Gastrointestinal Neuroendocrine Tumors market @ Gastrointestinal Neuroendocrine Tumors Competitive Landscape.

Conclusion

The gastrointestinal neuroendocrine tumors market represents a dynamic and rapidly evolving therapeutic area with significant growth potential driven by improved diagnostic capabilities, expanding treatment options, and increasing disease recognition. DelveInsight’s comprehensive analysis provides essential insights for stakeholders seeking to understand market dynamics, competitive positioning, and emerging opportunities in this specialized oncological segment through 2034.

Scope of the Gastrointestinal Neuroendocrine Tumors Market Report

  • The report covers a segment of key events, an executive summary, and a descriptive overview of GI-NETs, explaining its causes, signs, symptoms, pathogenesis, and currently used therapies

  • Comprehensive insight into the Gastrointestinal Neuroendocrine Tumors epidemiology segments and forecasts, disease progression, and treatment guidelines has been provided

  • Additionally, an all-inclusive account of the emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape

  • A detailed review of the GI-NETs market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach

  • The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM GI-NETs market

  • Ten Years Forecast coverage spanning 2025-2034

  • The 7MM Coverage including United States, EU4 (Germany, France, Italy, and Spain), United Kingdom, and Japan

  • GI-NETs Epidemiology Segmentation by total incident cases, cases by grade, stage-specific cases, cases by site, and cases by functional status

  • Key Cross Competition analysis among marketed and pipeline therapies

  • Gastrointestinal Neuroendocrine Tumors Drugs Uptake and Key Market Forecast Assumptions based on real-world evidence and clinical data

  • Qualitative Analysis including SWOT Analysis and Conjoint Analysis for comprehensive market assessment

Table of Contents

1. Key Insights

2. Executive Summary of Gastrointestinal Neuroendocrine Tumors

3. Competitive Intelligence Analysis for Gastrointestinal Neuroendocrine Tumors

4. Gastrointestinal Neuroendocrine Tumors Market Overview at a Glance

5. Gastrointestinal Neuroendocrine Tumors: Disease Background and Overview

6. Gastrointestinal Neuroendocrine Tumors Patient Journey

7. Gastrointestinal Neuroendocrine Tumors Epidemiology and Patient Population

8. Treatment Algorithm, Current Treatment, and Medical Practices

9. Gastrointestinal Neuroendocrine Tumors Unmet Needs

10. Key Endpoints of Gastrointestinal Neuroendocrine Tumors Treatment

11. Gastrointestinal Neuroendocrine Tumors Marketed Products

12. Gastrointestinal Neuroendocrine Tumors Emerging Therapies

13. Gastrointestinal Neuroendocrine Tumors: Seven Major Market Analysis

14. Attribute analysis

15. 7MM: Market Outlook

16. Access and Reimbursement Overview of Gastrointestinal Neuroendocrine Tumors

17. KOL Views

18. Gastrointestinal Neuroendocrine Tumors Market Drivers

19. Gastrointestinal Neuroendocrine Tumors Market Barriers

20. Appendix

21. DelveInsight Capabilities

22. Disclaimer

23. About DelveInsight

About DelveInsight

DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.

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