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위장췌장 신경내분비종양 : 시장 인사이트, 역학 및 시장 예측(2036년)

Gastroenteropancreatic Neuroendocrine Tumors - Market Insight, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 224 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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한글목차
영문목차

위장췌장 신경내분비종양(GEP-NET)에 대한 인사이트와 동향

  • GEP-NET은 소화관 및 췌장의 신경내분비 세포에서 유래하는 이질성이 높은 종양으로, 최근 수십 년 동안 발생률이 증가하고 있습니다. 이는 검출 방법이나 영상 진단 기술의 발전도 한 원인이지만, 정확한 발생률은 지역이나 아형에 따라 다릅니다. 그에 대한 인지도가 높아지고 있다는 사실은 충족되지 않은 수요를 여실히 드러내고 있습니다.
  • GEP-NET의 상당 부분, 특히 고분화형 및 중분화형 종양에서는 소마토스타틴 수용체가 발현되어 있으며, 이것이 소마토스타틴 유사체나 펩타이드 수용체 방사성동위원소 요법의 사용 근거가 되고 있습니다.
  • GEP-NET은 가장 흔한 NET의 하위 유형으로, 전체 NET의 50-70%를 차지합니다.
  • GEP-NET에 대한 유일한 근치적 치료법인 수술은 일반적으로 국소성 NET의 1차 치료법으로 간주됩니다. 그러나 진단 기술의 발전에도 불구하고, GEP-NET의 증상은 비특이적이기 때문에 임상 증상이 나타난 지 5-7년이 지나도 진단되지 않는 경우가 종종 있습니다.
  • Radiomedix사와 Orano Med사는 BTD 승인을 받은 최초의 방사성 리간드 치료법인 'AlphaMedix'를 개발하고 있습니다. AlphaMedix는 과거에 LUTATHERA를 이용한 펩타이드 수용체 방사성동위원소 치료(PRRT)를 받은 적이 없는 GEP-NET 환자에서 62.5%의 반응률을 보였습니다.
  • 혁신적인 치료법, 특히 방사성 리간드 요법이나 알파선 방출체를 이용한 치료법의 개발이 GEP-NET 시장의 성장을 주도하고 있습니다. 한편, GEP-NET의 복잡한 특성뿐만 아니라, 약제 제조 및 투여와 관련된 과제들이 시장 진출과 성장에 큰 걸림돌이 되고 있습니다. 또한, 제네릭 의약품과의 경쟁도 승인된 의약품의 매출에 영향을 미치고 있습니다.
  • LUTATHERA는 유의미한 무악화 생존 기간 연장 효과를 입증하고, 성인 소마토스타틴 수용체 양성 GEP-NET에 대한 승인을 획득함에 따라, 방사성 리간드 요법은 계속해서 발전하고 있습니다.
  • 표적 치료 및 병용요법에 관한 임상 연구가 지속적으로 진행되고 있으며, 치료 선택지는 계속해서 확대되고 있습니다. 예를 들어, RYZ101은 소마토스타틴 수용체를 발현하는 종양을 표적으로 삼아 알파선을 조사하도록 설계된 새로운 방사성 리간드 요법입니다.
  • GEP-NET의 새로운 치료 환경에 관여하는 주요 기업으로는 ITM Isotope Technologies Munich, Camurus AB, RadioMedix 등이 있습니다.

위장췌장 신경내분비종양(GEP-NET) 시장 보고서는 표준 치료, 임상 실무 및 진화하는 치료 알고리즘을 포함하여 현재의 치료 현황에 대한 종합적인 분석을 제공합니다. 본 보고서에서는 GEP-NET 환자의 부담 추세, 수익 및 시장 점유율 동향, 피크 시기의 환자 점유율 및 치료 도입 현황에 대한 분석을 평가함과 동시에, 세계 각 지역의 시장 규모에 대한 상세한 평가 및 성장률 예측(과거 데이터 및 2022-2036년 예측)을 제공합니다. 또한, GEP-NET의 주요 미충족 요구 사항을 부각시키고, 경쟁 구도와 임상 환경을 분석하여 고부가가치 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

위장췌장 신경내분비종양(GEP-NET) 시장을 주도하는 주요 요인

발병률 증가와 조기 진단

GEP-NET의 발생률 증가에 더해, 내시경 초음파 검사(EUS)나 다단 컴퓨터 단층촬영(CT)과 같은 첨단 진단 기술의 보급으로 인해 검출률이 향상되어, 치료 가능한 환자층이 확대되고 있습니다.

활발한 연구 개발과 새로운 파이프라인

제약 업계의 투자가 GEP-NET에 대한 새로운 치료법 개발을 가속화하고 있습니다. 이를 통해 표적 치료, 펩타이드 수용체 방사성동위원소 치료(PRRT), 그리고 정밀 의료 접근 방식에서의 혁신이 촉진되고 있습니다.

질병에 대한 인식 제고

최신 임상 지침에 근거한 임상의들의 인식 제고와 환자 진단율 향상으로 인해, 치료법의 도입이 가속화되고 있습니다.

위장췌장 신경내분비종양(GEP-NET)의 이해와 치료 알고리즘

위장췌장 신경내분비종양(GEP-NET)의 개요 및 진단

GEP-NET은 췌장 및 소화관에서 발생하는 희귀하고 이질성이 높은 암의 일종입니다. 이러한 복잡성과 진행 단계에서 발병한다는 특징으로 인해, 종양의 악성 정도, 발생 부위, 호르몬 활성 및 환자의 증상에 기반한 맞춤형 치료가 필요하며, 치료 관리는 주로 진행 단계 및 전이성 질환에 중점을 두고 있습니다. 진단 기술의 발전에도 불구하고, GEP-NET은 증상이 비특이적이기 때문에 임상 증상이 나타난 지 5-7년이 지나도 진단되지 않는 경우가 종종 있습니다.

GEP-NET의 진단은 생화학 검사, 영상 검사, 경우에 따라 유전자 검사를 조합하여 이루어집니다. 일반적인 생화학적 지표로는 크로모그라닌 A, 췌장 호르몬(인슐린, 가스트린, 글루카곤) 및 종양의 기능에 따라 소변 내 5-HIAA와 같은 세로토닌 대사산물이 포함됩니다. 조영 CT나 MRI 등의 영상 검사는 원발 종양의 위치를 파악하고 전이의 범위를 평가하기 위해 사용됩니다.

현재 위장췌장 신경내분비종양(GEP-NET)의 치료 현황

GEP-NET에 대한 유일한 근치적 치료법인 수술은 일반적으로 국소성 NET의 1차 치료법으로 간주됩니다. 진행성, 전이성 또는 절제 불가능한 질환의 경우, 치료 옵션으로는 LUTATHERA를 이용한 펩타이드 수용체 방사성동위원소 요법(PRRT), 옥트레오타이드나 란레오타이드와 같은 소마토스타틴 유사체를 통한 호르몬 관련 증상 및 종양 증식 억제, 췌장 신경내분비종양(NET)에 대한 에베로리무스나 수니티닙 등의 표적 치료, 그리고 고악성도 종양에 대한 세포독성 화학요법(테모졸로미드 또는 카페시타빈 기반 요법) 등이 있습니다.

위장췌장 신경내분비종양(GEP-NET)의 역학

GEP-NET의 역학 분석 및 예측에 관한 주요 결과

  • NET 신규 발병 사례 수는 미국이 가장 많아졌습니다. 2025년 미국에서 발생한 NET 신규 환자 수는 총 31,000명이었습니다.
  • 'NET 프로젝트'의 2차 조사에 따르면, 2000년부터 2007년까지 유럽에서 악성 GEP-NET의 발생률은 인구 10만 명당 연간 1.7건으로, 이는 추정 2만 6,000건의 신규 환자에 해당합니다.
  • 2차 조사에 따르면, 이 질환의 연간 발생률은 인구 10만 명당 6.47건이었으며, 조정 유병률은 0.052%였습니다. 진단 당시의 평균 연령은 58±15세였으며, 성별 분포는 거의 균등했고, 스페인에서는 남성이 51%, 여성이 49%를 차지했습니다.
  • 원발성 종양의 외과적 절제술은 환자의 66%에게 시행되었습니다. 조직병리학적 악성도 분류에 따르면, 대부분의 종양은 고분화형으로, 73%가 1등급(G1), 22%가 2등급(G2), 5%가 3등급(G3)으로 분류되었습니다.
  • 원발성 종양이 가장 많이 발생하는 부위는 췌장(52%)이었으며, 그 다음은 공장·회장(23%)이었습니다. 진단 시점에서 환자의 24%에서 원격 전이가 확인되었으며, 그 중 대부분은 간(44%), 복막(25%) 또는 다발성 장기(22%)로 전이된 상태였습니다. 종양의 대부분은 산발성이었으며, 비기능성이었습니다.

위장췌장 신경내분비종양(GEP-NET) 시장의 전망

GEP-NET 시장은 종양의 생물학적 특성과 수용체 발현 양상에 대한 이해가 깊어짐에 따라 치료 접근법이 재구성되면서 꾸준한 변화를 겪고 있습니다. 기존에는 증식 속도는 느리지만 병태가 복잡한 것이 특징으로 여겨져 온 GEP-NET의 치료 관리는 현재, mTOR 억제나 소마토스타틴 수용체를 표적으로 하는 전략 등 표적 경로 분야의 발전으로 인해 혜택을 보고 있습니다. 이러한 진전으로 인해, 특히 고분화형 종양을 가진 환자에서 병세가 안정화되고 진행이 지연되고 있습니다.

동시에, 방사성 리간드를 이용한 치료법도 계속 발전하고 있으며, LUTATHERA나 요오드-131 메타요오드벤질구아니딘(131I-MIBG) 등의 약제에서 볼 수 있듯이, 치료의 정밀도를 높이는 것을 목적으로 한 펩타이드 수용체 표적화 및 방사성 핵종의 설계에 있어 지속적인 개선이 이루어지고 있습니다. 임상 개발 파이프라인은 차세대 수용체 표적 화합물, 수니티닙 등의 혈관신생 억제제, 그리고 내성 및 종양의 이질성에 대응하기 위해 고안된 병용요법 등 새로운 약제들로 확대되고 있습니다. Ga-68 DOTATATE PET/CT를 비롯한 기능적 영상 기술의 발전과 바이오마커 연구의 진전 또한 보다 정확한 질환 모니터링과 치료법 선택을 가능하게 하고 있습니다.

전반적으로, 임상적 관심의 증가, 진단율 향상, 그리고 표적 치료 및 방사성 리간드 치료 분야의 지속적인 혁신이 주요 지역의 GEP-NET 시장의 지속적인 성장을 뒷받침할 것으로 예상됩니다.

  • 방사성 리간드 요법 및 표적 치료제는 앞으로도 시장 확대의 주요 원동력으로 작용할 것으로 예상됩니다.
  • 수용체 표적화, 혈관 신생, 그리고 설파티닙이나 177Lu-에드트레오티드 등의 병용요법에 초점을 맞춘 새로운 파이프라인 후보들은 경쟁을 심화시키고 향후 치료 전략을 형성할 것으로 예상됩니다.
  • 방사성 리간드 요법 : LUTATHERA, 177Lu-에드트레오티드, [212Pb] VMT-a-NET 등의 신약은 소마토스타틴 수용체 양성 신경내분비종양에 대한 표적형 방사성의약품 치료법으로, 펩타이드 수용체 방사성동위원소 치료(PRRT)나 차세대 알파선 방출 플랫폼을 통해 종양 세포에 직접 세포 독성을 일으키는 방사선을 조사합니다.
  • 저분자 약물 : 수니티닙(SUTENT) 등 이미 승인된 치료제 외에도, 설파티닙이나 카보잔티닙 등 개발 중인 후보 약물은 mTOR 신호 전달, 혈관 신생, 소마토스타틴 수용체 조절과 같은 주요 경로를 표적으로 하여 종양의 증식과 진행을 억제합니다.

저분자 약물은 현재 진행 중인 혁신의 주요 분야를 정의하는 한편, 방사성 리간드 요법은 임상적으로 확립된 치료법이며, 이 두 가지가 결합되어 현재의 치료 패러다임과 향후 파이프라인 확장을 주도하고 있습니다.

자주 묻는 질문

  • 위장췌장 신경내분비종양(GEP-NET)의 발생률은 어떻게 변화하고 있나요?
  • GEP-NET의 주요 치료법은 무엇인가요?
  • GEP-NET 환자에 대한 방사성 리간드 치료의 효과는 어떤가요?
  • GEP-NET의 진단 방법은 무엇인가요?
  • GEP-NET 시장의 주요 성장 요인은 무엇인가요?
  • GEP-NET의 주요 기업은 어디인가요?
  • GEP-NET의 치료 환경은 어떻게 변화하고 있나요?

목차

제1장 주요 인사이트

제2장 소개

제3장 주요 요약

제4장 주요 사건

제5장 위장췌장 신경내분비종양 : 역학 및 시장 조사 방법

제6장 위장췌장 신경내분비종양 : 시장 개요

제7장 위장췌장 신경내분비종양 : 질환 배경과 개요

제8장 위장췌장 신경내분비종양 : 역학 및 환자 인구

제9장 위장췌장 신경내분비종양 : 환자 경과

제10장 시판 치료제

제11장 새로운 치료법

제12장 위장췌장 신경내분비종양 : 주요 7개국 분석

제13장 위장췌장 신경내분비종양 : 미충족 수요

제14장 위장췌장 신경내분비종양 : SWOT 분석

제15장 위장췌장 신경내분비종양 : KOL의 견해

제16장 위장췌장 신경내분비종양 : 시장 진입 및 상환

제17장 부록

제18장 DelveInsight의 서비스 내용

제19장 면책사항

제20장 DelveInsight 소개

KSM 26.07.20

Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Insights and Trends

  • GEP-NET are heterogeneous tumors arising from neuroendocrine cells in the gastrointestinal tract and pancreas, with incidence increasing over recent decades, partly due to enhanced detection and imaging practices while exact rates vary by region and subtype, their rising recognition underscores unmet clinical needs.
  • A significant proportion of GEP-NET express somatostatin receptors, particularly in well and moderately differentiated tumors, which underpins the use of somatostatin analogs and peptide receptor radionuclide therapies.
  • GEP NETs represent the most common NET subtype, comprising 50-70% of all NETs.
  • Surgery, the only curative treatment for GEP-NET, is generally considered a first-line treatment for localized NETs. However, despite advances in diagnostics, GEP-NET are often not identified for up to 5-7 years after clinical symptoms appear, as the symptoms are not specific.
  • Radiomedix and Orano Med are developing AlphaMedix, the first radioligand therapy to receive BTD. AlphaMedix has demonstrated a response rate of 62.5% in GEP-NET patients who had not previously undergone peptide receptor radionuclide therapy (PRRT) with LUTATHERA.
  • The development of innovative therapies, particularly radioligand treatments and alpha emitter-based therapies, is driving growth in the GEP-NET market. On the other hand, the complex nature of GEP-NET, combined with challenges in drug manufacturing and administration, poses significant barriers to market entry and growth. Additionally, the impact of generic competition impacts the sales of approved drugs.
  • Radioligand therapies continue to advance as LUTATHERA has demonstrated meaningful progression free survival benefits and is approved for somatostatin receptor-positive GEP-NET in adults.
  • Ongoing clinical research into targeted therapies and combination regimens continues to expand the therapeutic landscape like RYZ101 is an emerging radioligand therapy designed to deliver targeted alpha radiation to somatostatin receptor-expressing tumors.
  • Key Companies involved in the emerging treatment landscape of GEP-NET are ITM Isotope Technologies Munich, Camurus AB, RadioMedix, and others.

DelveInsight's 'Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the GEP-NET, historical and forecasted epidemiology, as well as the GEP-NET market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates, GEP-NET patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in GEP-NET and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Key Factors Driving the Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Market

Increasing Incidence and Early Diagnosis

The rising incidence of GEP-NET, coupled with advanced diagnostics like endoscopic ultrasound (EUS) and, multi-phase computed tomography (CT), has improved detection rates, expanding the treatable patient pool.

Robust R&D and Emerging Pipeline

Pharmaceutical investment is accelerating the development of new therapies for GEP-NET. This is driving innovation in targeted treatments, peptide receptor radionuclide therapy (PRRT), and precision medicine approaches.

Rising Disease Awareness

Increased awareness among clinicians and better patient diagnosis rates, supported by updated clinical guidelines, are accelerating treatment adoption.

Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Understanding and Treatment Algorithm

Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Overview and Diagnosis

GEP-NET are rare, heterogeneous cancers of the pancreas and gastrointestinal tract. Their complexity and late-stage presentation require individualized treatment based on tumor grade, location, hormone activity, and patient symptoms, with management primarily focused on advanced and metastatic disease. Despite advances in diagnostics, GEP-NET are often not identified for up to 5-7 years after clinical symptoms appear, as the symptoms are not specific.

Diagnosis of GEP-NET relies on a combination of biochemical testing, imaging, and sometimes genetic evaluation. Common biochemical markers include chromogranin A, pancreatic hormones (insulin, gastrin, glucagon), and serotonin metabolites such as 5-HIAA in urine, depending on tumor functionality. Imaging studies such as contrast-enhanced CT and MRI are used to localize primary tumors and assess metastatic spread.

Current Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Treatment Landscape

Surgery, the only curative treatment for GEP-NET, is generally considered a first-line treatment for localized NETs. For advanced, metastatic, or unresectable disease, treatment options include peptide receptor radionuclide therapy (PRRT) with LUTATHERA, somatostatin analogs such as octreotide and lanreotide to control hormone-related symptoms and tumor growth, targeted therapies like everolimus and sunitinib for pancreatic NETs, and cytotoxic chemotherapy (temozolomide or capecitabine-based regimens) for high-grade tumors.

Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Unmet Needs

The section "unmet needs of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

1. Diagnostic delays and disease presentation

2. Treatment resistance & disease progression

3. Resistance to standard therapies

4. Gaps in long-term disease management, and others.....

Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Epidemiology

Key Findings from GEP-NET Epidemiological Analysis and Forecast

  • The US contributed to the highest incident cases of NETs. The total incident cases of NETs in the United States in 2025 were 31,000.
  • According to the secondary search, net project, the incidence of malignant GEP-NET during 2000-2007 was 1.7 per 100,000 population per year in Europe, corresponding to an estimated 26,000 new cases.
  • As per the secondary sesrch, the annual incidence of the disease was 6.47 cases per 100,000 population, with an adjusted prevalence of 0.052%. The mean age at diagnosis was 58 +- 15 years, and the sex distribution was nearly equal, with 51% men and 49% women in Spain.
  • Surgical resection of the primary tumor was performed in 66% of patients. Histopathological grading showed that most tumors were well differentiated, with 73% classified as Grade 1 (G1), 22% as Grade 2 (G2), and 5% as Grade 3 (G3).
  • The most common primary tumor site was the pancreas (52%), followed by the jejunum-ileum (23%). At the time of diagnosis, 24% of patients presented with distant metastases, most frequently involving the liver (44%), peritoneum (25%), or multiple organs (22%). The majority of tumors were sporadic and non-functional.

Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Drug Analysis & Competitive Landscape

The GEP-NET drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase III-I clinical trials. It covers mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, strategic partnerships upcoming Key catalyst for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the GEP-NET treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the GEP-NET therapeutics market.

Approved Therapies for Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)

LUTATHERA (lutetium Lu 177 DOTATATE): Novartis

LUTATHERA, is indicated for adult patients with somatostatin receptor-positive GEP-NET. Peptide receptor radionuclide therapy (PRRT), either with 90-Yttrium-labeled compounds or with LUTATHERA (lutetium-177 oxodotreotide) is approved for supply in Australia and is listed on the Australian Register of Therapeutic Goods (ARTG) under ARTG number 455452, with a registration date of November 2025. In September 2017, the EMA approved LUTATHERA for the treatment of GEP-NET. This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NET.

SOMATULINE DEPOT (lanreotide): Ipsen Biopharmaceuticals

SOMATULINE DEPOT is a SSA indicated for the treatment of adult patients with unresectable well or moderately differentiated, locally advanced, or metastatic GEP-NET to improve progression-free survival. The drug is also approved for the treatment of adults with carcinoid syndrome by reducing the frequency of short-acting SSA rescue therapy. The drug is administered subcutaneously.

Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Pipeline Analysis

ITM-11 (n.c.a. 177Lu-edotreotide): ITM Isotope Technologies Munich

ITM-11 (n.c.a. 177Lu-edotreotide), being developed by ITM Isotope Technologies Munich, is an innovative targeted radionuclide therapy agent consisting of two components: firstly, Edotreotide (DOTATOC). It is currently being investigated in two Phase III clinical trials, COMPETE (GEP-NET G1/G2) and COMPOSE (GEP-NET G3/G4). While COMPETE is evaluating ITM-11 for the treatment of patients with Grade 1 and Grade 2 GEP-NET, the radiopharmaceutical candidate is also being investigated in COMPOSE, for patients with well-differentiated high Grade 2 and Grade 3 GEP-NET. ITM Isotope Technologies Munich announced that the FDA completed its filing review and accepted the company's New Drug Application for 177Lu-edotreotide.

CAM2029: Camurus AB

CAM2029, being developed by Camurus AB, is a ready-to-use, long-acting, subcutaneous depot of octreotide under development to treat rare diseases, acromegaly, GEP-NET, and polycystic liver disease (PLD). Studies completed to date demonstrate that CAM2029 has the potential to provide significantly higher octreotide bioavailability and octreotide exposure with the potential for improved treatment efficacy, compared to current market leading products. CAM2029 is designed to enable easy self-administration, including the option of a pre-filled pen device. The drug is currently being evaluated in a Phase III SORENTO study (Subcutaneous Octreotide Randomized Efficacy in Neuroendocrine Tumors) in patients with GEP-NET. According to the company's presentation, they anticipated to present PFS readout data of Phase III (SORENTO) clinical trial in mid to late 2026.

Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Key Players, Market Leaders and Emerging Companies

  • Novartis
  • Pfizer
  • Exelixis
  • Ipsen Biopharmaceuticals
  • ITM Isotope Technologies Munich
  • Camurus AB
  • Bristol Myers Squibb
  • RayzeBio, and others

Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Drug Updates

  • According to the Camurus AB's 2026 presentation, results from the Phase III (SORENTO) trial are expected to be presented in 2026.
  • In March 2025, US FDA approved cabozantinib (CABOMETYX, RayzeBio, Inc.) for adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) and well-differentiated extra-pancreatic neuroendocrine tumors (epNET).
  • In November 2025, ITM Isotope Technologies Munich announced that the FDA completed its filing review and accepted the company's New Drug Application for 177Lu-edotreotide (also known as ITM-11 or 177Lu-edotreotide). 177Lu-edotreotide is ITM's proprietary, synthetic, targeted radiotherapeutic investigational agent for the treatment of GEP-NET. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of August 28, 2026.

Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Market Outlook

The GEP-NET market is undergoing a steady shift as deeper insights into tumor biology and receptor expression patterns reshape treatment approaches. Historically characterized by slow-growing but complex disease behavior, GEP-NET management is now benefiting from advances in targeted pathways, including mTOR inhibition and somatostatin receptor directed strategies. These developments are improving disease stabilization and delaying progression, particularly in patients with well-differentiated tumors.

At the same time, radioligand-based therapies continue to evolve, with ongoing refinements in peptide receptor targeting and radionuclide design aimed at enhancing therapeutic precision, as seen with agents such as LUTATHERA and Iodine-131 metaiodobenzylguanidine (131I-MIBG). The clinical pipeline is expanding with novel agents, including next-generation receptor-targeted compounds, angiogenesis inhibitors such as sunitinib, and combination regimens designed to address resistance and tumor heterogeneity. Improvements in functional imaging, including Ga-68 DOTATATE PET/CT, and biomarker research are also enabling more accurate disease monitoring and treatment selection.

Overall, growing clinical interest, increasing diagnosis rates, and continued innovation in targeted and radioligand therapies are expected to support sustained growth in the GEP-NET market across major regions.

  • Radioligand therapies and targeted agents are expected to remain key drivers of market expansion.
  • Emerging pipeline candidates focusing on receptor targeting, angiogenesis, and combination approaches such as surufatinib, and 177Lu-edotreotide are anticipated to increase competition and shape future treatment strategies.

Drug Class/Insights into Leading Emerging and Marketed Therapies in GEP-NET (2022-2036 Forecast)

The GEP-NET market comprises radioligand therapies, and small molecules, each targeting different aspects of GEP-NET.

  • Radioligand therapies: LUTATHERA and emerging agents such as 177Lu-edotreotide and [212Pb]VMT-a-NET represent targeted radiopharmaceutical approaches for somatostatin receptor-positive neuroendocrine tumors, delivering cytotoxic radiation directly to tumor cells through peptide receptor radionuclide therapy (PRRT) or next-generation alpha-emitting platforms.
  • Small molecules: Approved therapy such as sunitinib (SUTENT) along with pipeline candidates including surufatinib and cabozantinib target key pathways like mTOR signaling, angiogenesis, and somatostatin receptor modulation to inhibit tumor growth and progression.

Small molecules define a major area of ongoing innovation, while radioligand therapies remain clinically established, together driving both current treatment paradigms and future pipeline expansion.

Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the GEP-NET drug's uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.

The uptake of therapies in GEP-NET is expected to vary based on clinical positioning, mechanism of action, and stage of development. Approved targeted therapy such as LUTATHERA (lutetium Lu 177 DOTATATE) is projected to demonstrate steady uptake, driven established efficacy and physician familiarity in advanced disease settings.

In contrast, pipeline candidates surufatinib is expected to follow a moderate uptake trajectory, reflecting its investigational status and gradual adoption as clinical evidence emerges.

Detailed insights of emerging therapies' drug uptake is included in the report

Market Access and Reimbursement of Approved therapies in Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Therapies Price Scenario & Trends

Pricing and analogue assessment of GEP-NET therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market access, adherence, and long-term uptake.

  • Pricing of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Approved Drugs

If the patient has private insurance, they could be eligible for Co-Pay Plus and pay as little as USD 25 for their LUTATHERA treatment. Limitations apply - Up to USD 15,000 throughout the treatment. Offer not valid under Medicare, Medicaid, or any other federal or state programs. Novartis reserves the right to rescind, revoke, or amend this program without notice.

Industry Experts and Physician Views for Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)

To keep up with GEP-NET market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on the GEP-NET emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in GEP-NET, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 15+ KOLs to gather insights at country level. Centers such as the Center for Gastrointestinal Cancers at Smilow Cancer Hospital and Yale Cancer Center, National Institutes of Health in the USA, and MD Anderson Cancer Center Madrid, etc. were contacted.Their opinion helps understand and validate current and emerging GEP-NET therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in GEP-NET.

Germany "Resection of the disease continues to be a treatment for patients with well-differentiated GEP- NETs and is still conducted in more than 70% of patients with these tumors. However, the recurrence rate for patients who received a resection is 100% at 10 years, changing the treatment paradigm as this was previously considered a curative therapy."

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of GEP-NET, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, a descriptive overview of GEP-NET, explaining their causes, signs and symptoms, pathogenesis, and currently available treatments.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
  • Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
  • A detailed review of the GEP-NET 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 in shaping and driving the 7MM GEP-NET market.

Report Insights

  • Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Patient Population Forecast
  • Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Therapeutics Market Size
  • Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Pipeline Analysis
  • Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Market Size and Trends
  • Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Market Opportunity (Current and forecasted)

Report Key Strengths

  • Epidemiology-based (Epi-based) Bottom-up Forecasting
  • Artificial Intelligence (AI)-Enabled Market Research Report
  • 11-Year Forecast
  • Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (By Geography)
  • Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Treatment Addressable Market (TAM)
  • Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Competitive Landscape
  • Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Major Companies Insights
  • Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Price Trends and Analogue Assessment
  • Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Therapies Drug Adoption/Uptake
  • Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Therapies Peak Patient Share Analysis

Report Assessment

  • Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Current Treatment Practices
  • Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Unmet Needs
  • Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Clinical Development Analysis
  • Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Emerging Drugs Product Profiles
  • Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Market attractiveness
  • Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Qualitative Analysis (SWOT and conjoint analysis)

FAQs:

Market Insights

  • What was the GEP-NET market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
  • What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
  • What can be the future treatment paradigm of GEP-NET?
  • What are the disease risks, burdens, and unmet needs of GEP-NET? What will be the growth opportunities across the 7MM concerning the patient population with GEP-NET?
  • Who is the major future competitor in the market, and how will the competitors affect their market share?
  • What are the current options for the treatment of GEP-NET? What are the current guidelines for treating GEP-NET in the US, Europe, and Japan?

Reasons to Buy:

  • The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the GEP-NET market.
  • Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
  • Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
  • Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
  • To understand KOLs' perspectives on the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
  • This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets with in the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary

4. Key Events

  • 4.1. Key Conferences And Meetings
  • 4.2. Key Transactions And Collaborations
  • 4.3. News Flow

5. Epidemiology and Market Methodology of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)

6. Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Market Overview at a Glance

  • 6.1. Clinical Landscape Analysis (By Molecule Type, Phase, and Route of Administration [ROA])
  • 6.2. Market Share of GEP-NET By Therapies (%) in the 7MM in 2025
  • 6.3. Market Share of GEP-NET By Therapies (%) in the 7MM in 2036

7. Disease Background And Overview of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)

  • 7.1. Introduction
  • 7.2. Types of GEP-NET
  • 7.3. Molecular Classification of GEP-NET
  • 7.4. Causes
  • 7.5. Signs And Symptoms
  • 7.6. Diagnosis
    • 7.6.1. Differential Diagnosis
    • 7.6.2. Diagnostic Algorithm
    • 7.6.3. Diagnostic Guidelines
      • 7.6.3.1. NCCN Guidelines for Diagnosis of GEP-NET
      • 7.6.3.1.1. NCCN Guidelines Version 2.2024 Neuroendocrine Tumors (NET) of the Gastrointestinal Tract (Well-Differentiated Grade 1/2), Lung, and Thymus
      • 7.6.3.1.2. NCCN Guidelines Version 2.2024 Well-Differentiated, Grade 3 NET
      • 7.6.3.1.3. NCCN Guidelines Version 2.2024 NETs of the Pancreas (Well-differentiated Grade 1/2)
      • 7.6.3.2. European Neuroendocrine Tumor Society (ENETS) 2023 Guidance Paper for Gastroduodenal NET G1-G3
  • 7.7. Treatment and Management
  • 7.8. Treatment Algorithm
  • 7.9. Treatment Guidelines
    • 7.9.1. NCCN Guidelines for GEP-NET
    • 7.9.2. NCCN Guidelines Version 2.2024 Neuroendocrine Tumors (NET) of the Gastrointestinal Tract (Well-Differentiated Grade 1/2), Lung, and Thymus
    • 7.9.3. NCCN Guidelines: Well-Differentiated, Grade 3 NET
    • 7.9.4. NCCN Guidelines: NETs of the Pancreas (Well-differentiated Grade 1/2)
    • 7.9.5. European Neuroendocrine Tumor Society (ENETS): Guidance Paper for Gastroduodenal NETs G1-G3

8. Epidemiology and Patient Population of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)

  • 8.1. Key Findings
  • 8.2. Assumption and Rationale
  • 8.3. Total Incident Cases of GEP-NET in the 7MM
  • 8.4. The United States
    • 8.4.1. Total Incident Cases of NET in the United States
    • 8.4.2. Total Incident Cases of GEP-NET in the United States
    • 8.4.3. Grade-specific Incident Cases of GEP-NET in the United States
    • 8.4.4. Functional status Incident Cases of GEP-NET in the United States
    • 8.4.5. Stage-specific Incident Cases of GEP-NET in the United States
    • 8.4.6. SSR Positive Incident Cases of GEP-NET in the United States
    • 8.4.7. Total Treated Cases of GEP-NET
  • 8.5. EU4 and the UK
    • 8.5.1. Total Incident Cases of NET in EU4 and the UK
    • 8.5.2. Total Incident Cases of GEP-NET in EU4 and the UK
    • 8.5.3. Grade-specific Incident Cases of GEP-NET in EU4 and the UK
    • 8.5.4. Functional status Incident Cases of GEP-NET in EU4 and the UK
    • 8.5.5. Stage-specific Incident Cases of GEP-NET in EU4 and the UK
    • 8.5.6. SSR Positive Incident Cases of GEP-NET in EU4 and the UK
    • 8.5.7. Total Treated Cases of GEP-NET
  • 8.6. Japan
    • 8.6.1. Total Incident Cases of NET in Japan
    • 8.6.2. Total Incident Cases of GEP-NET in Japan
    • 8.6.3. Grade-specific Incident Cases of GEP-NET in Japan
    • 8.6.4. Functional status Incident Cases of GEP-NET in Japan
    • 8.6.5. Stage-specific Incident Cases of GEP-NET in Japan
    • 8.6.6. SSR Positive Incident Cases of GEP-NET in Japan
    • 8.6.7. Total Treated Cases of GEP-NET

9. Patient Journey of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)

10. Marketed Therapies

  • 10.1. Marketed Competitive Landscape of GEP-NET
  • 10.2. LUTATHERA (lutetium Lu 177 DOTATATE): Novartis
    • 10.2.1. Product Description
    • 10.2.2. Regulatory Milestones
    • 10.2.3. Other Developmental Activities
    • 10.2.4. Summary of Pivotal Trials
    • 10.2.5. Analyst Views
  • 10.3. SOMATULINE DEPOT (lanreotide): Ipsen Biopharmaceuticals
    • 10.3.1. Product Description
    • 10.3.2. Regulatory Milestones
    • 10.3.3. Summary of Pivotal Trials
    • 10.3.4. Analyst Views

11. Emerging Therapies

  • 11.1. Emerging Competitive Landscape of GEP-NET
  • 11.2. ITM-11 (n.c.a. 177Lu-edotreotide): ITM Isotope Technologies Munich
    • 11.2.1. Product Description
    • 11.2.2. Other Developmental Activities
    • 11.2.3. Clinical Development
      • 11.2.3.1. Clinical Trial Information
    • 11.2.4. Safety and Efficacy
    • 11.2.5. Analyst Views
  • 11.3. CAM2029: Camurus AB
    • 11.3.1. Product Description
    • 11.3.2. Clinical Development
      • 1.1.1.1. Clinical Trial Information
    • 11.3.3. Analyst Views

12. Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET): Seven Major Market Analysis

  • 12.1. Key Findings
  • 12.2. Market Outlook of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)
  • 12.3. Conjoint Analysis of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)
  • 12.4. Key Market Forecast Assumptions
    • 12.4.1. Cost Assumptions
    • 12.4.2. Pricing Trends
    • 12.4.3. Analogue Assessment
    • 12.4.4. Launch Year and Therapy Uptakes
  • 12.5. Total Market Size of GEP-NET in the 7MM
  • 12.6. The United States
    • 12.6.1. Total Market Size of GEP-NET in the United States
    • 12.6.2. Market Size of GEP-NET by Therapies in the United States
  • 12.7. EU4 and the UK
    • 12.7.1. Total Market Size of GEP-NET in EU4 and the UK
    • 12.7.2. Market Size of GEP-NET by Therapies in EU4 and the UK
  • 12.8. Japan
    • 12.8.1. Total Market Size of GEP-NET in Japan
    • 12.8.2. Market Size of GEP-NET by Therapies in Japan

13. Unmet Needs of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)

14. SWOT Analysis of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)

15. KOL Views of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)

  • 15.1. Expert/KOL Interview Highlights

16. Market Access and Reimbursement of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)

  • 16.1. The US
  • 16.2. In EU4 and the UK
    • 16.2.1. Germany
    • 16.2.2. France
    • 16.2.3. Italy
    • 16.2.4. Spain
    • 16.2.5. United Kingdom
  • 16.3. Japan
  • 16.4. Summary and Comparison of Market Access and Pricing Policy Developments in 2025
  • 16.5. Market Access and Reimbursement of GEP-NET Therapies

17. Appendix

  • 17.1. Bibliography
  • 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

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