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시장보고서
상품코드
2082861
위장췌장 신경내분비종양 : 시장 인사이트, 역학 및 시장 예측(2036년)Gastroenteropancreatic Neuroendocrine Tumors - Market Insight, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
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.
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 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.
GEP-NET의 역학 분석 및 예측에 관한 주요 결과
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.
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.
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) 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.
Key Findings from GEP-NET Epidemiological Analysis and Forecast
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
Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET) Drug Updates
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.
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.
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.
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.
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