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저등급 신경교종 : 시장 인사이트, 역학 및 시장 예측(2036년)

Low-Grade Glioma - Market Insights, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 200 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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저등급 신경교종(LGG)에 대한 인사이트와 동향

  • 저등급 신경교종(LGG)은 젊고 그 외에는 건강한 환자들에게서 흔히 나타나는 다양한 원발성 뇌종양 그룹으로, 고악성도 신경교종에 비해 진행 속도가 완만하고 성장 속도가 느리며 생존 기간이 긴 특징을 가지고 있습니다. 예후가 양호하고 생존 기간이 길다는 점을 고려하여, 치료 방침을 결정할 때에는 치료의 이점과 치료에 수반되는 잠재적 위험을 신중하게 비교 검토할 필요가 있습니다.
  • 이소쿠엔산 탈수소효소 1(IDH1) 및 이소쿠엔산 탈수소효소 2(IDH2)는 LGG에서 가장 빈번하게 변이가 관찰되는 유전자로, 전체 사례의 70% 이상에서 확인됩니다. BRAF V600E 돌연변이는 비교적 드물지만, 모양세포성 성상세포종과 신경절교종, 이형성 영아 신경절교종, 그리고 다형성 황성세포종을 포함한 일부 비모양세포성 소아 저악성도 교종에서 약 3분의 2의 비율로 관찰됩니다.
  • 2차 조사에 따르면, 2등급 성세포종의 발생률은 10만 명당 0.44명, 3등급의 발생률은 10만 명당 0.39명입니다. 올리고덴드로글리오마는 비교적 드문 질환으로, 미국에서의 발생률은 2등급의 경우 10만 명당 0.23명, 3등급의 경우 10만 명당 0.11명입니다.
  • LGG는 침습성이 낮고, 전이 가능성도 낮으며, 성장 속도가 느려 치료가 비교적 용이하기 때문에 1등급 또는 2등급으로 분류되는 종양입니다.
  • 소아 저등급 신경교종(LGG)은 뇌나 척수에 발생하는 종양의 일종입니다. LGG는 소아 중추신경계(CNS) 종양 중 가장 흔하며, 소아 중추신경계 종양 전체의 약 30%를 차지합니다.
  • 소아 저등급 신경교종(PLGG)은 소아에게서 가장 흔한 뇌종양입니다. 고악성 종양에 비해 성장 속도는 느리지만, 수술을 받은 환자의 약 50%에서 재발이 나타나며, 추가 치료가 필요합니다.
  • LGG 치료에는 안전한 범위 내에서 가능한 한 광범위한 수술, 방사선 치료, 화학요법, 표적 치료를 포함한 다각적인 접근법이 채택되고 있으며, 특정 사례에서는 적극적인 경과 관찰도 이루어집니다.
  • LGG에 대한 승인된 치료법은 주로 분자 아형에 따라 결정되며, IDH 변이를 가진 2등급 신경교종에는 보라시데닙(VORANIGO), BRAF V600E 변이를 가진 소아 LGG에는 더브라페닙 + 트라메티닙(TAFINLAR + MEKINIST), 재발 또는 난치성 BRAF 변이를 동반한 소아 LGG에 대한 토브라페닙(OJEMDA) 등이 있습니다.
  • LGG는 비교적 증식 속도가 느린 침윤성 원발성 뇌종양으로, 거의 예외 없이 악성화를 일으킵니다. 표준 치료는 안전한 범위 내에서 최대한의 절제, 고위험 환자에 대한 화학방사선요법의 적용, 그리고 평생에 걸친 영상 검사를 통한 경과 관찰로 구성되며, 치료의 목적은 악화를 지연시키고 삶의 질을 최대한 높이는 데 있습니다.
  • LGG의 파이프라인은 점차 확대되고 있으며, 그 주요 초점은 광범위한 새로운 작용 기전이 아니라 표적 치료, 특히 IDH 및 BRAF 억제제에 맞춰져 있습니다.

주요 7개국 저등급 신경교종(LGG)의 시장 규모 및 전망

  • 2025년 LGG 시장 규모 : 약 10억 달러
  • LGG의 성장률(2026-2036년) : 연평균 성장률(CAGR) 약 4%

수치는 보고서 갱신이나 임상 정보 갱신 등에 따라 변경될 수 있습니다.

저등급 신경교종(LGG) 시장 보고서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재 시장 상황에 대한 종합적인 분석을 제공합니다. 본 보고서에서는 LGG 환자의 부담 추이, 수익 및 시장 점유율 추이, 피크 시기의 환자 점유율 및 치료 도입 현황에 대한 분석을 평가함과 동시에, 전 세계 각 지역의 시장 규모에 대한 상세한 평가 및 성장률 예측(과거 데이터 및 2022-2036년 예측)을 제공합니다. 본 보고서는 저등급 신경교종(LGG) 분야에서 주요 미충족 의료 수요를 부각시키고, 경쟁 구도와 임상 환경을 분석함으로써 고부가가치 기회를 도출하며, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

저등급 신경교종(LGG) 시장을 주도하는 주요 요인

LGG 발병률의 증가

저등급 신경교종(LGG)의 전체 발생률은 특히 젊은 층과 소아에서 서서히 증가하고 있으며, 이것이 LGG 시장의 확장을 이끄는 주요 요인이 되고 있습니다. 미국에서는 2025년에 약 9,400건의 LGG 신규 사례가 보고될 것으로 예상되며, 2036년까지 그 수가 더욱 증가할 것으로 전망됩니다.

LGG에서의 기회 확대

LGG 치료 분야의 새로운 기회는 새로운 작용 기전(MoA), 특히 IDH 억제제, BRAF/MEK 억제제, 그리고 특정 유전자 변이를 표적으로 하는 분자 표적 치료에 의해 주도되고 있습니다. 또한, 면역요법, 후성유전학적 조절제 및 병용요법에 대한 연구의 진전으로 인해, 기존의 접근법을 뛰어넘는 치료 선택지가 점차 확대되고 있습니다.

저등급 신경교종(LGG)에 대한 이해와 치료 알고리즘

저등급 신경교종(LGG)의 개요 및 진단

LGG는 WHO 2등급으로 분류되는 성장 속도가 느린 원발성 뇌종양 그룹으로, 일반적으로 젊은 층, 특히 인생의 전성기를 맞이한 사람들에게 발병합니다. 이러한 종양은 고악성도 신경교종에 비해 비교적 양호한 예후를 기대할 수 있으며, 특히 IDH1/IDH2 돌연변이와 경우에 따라 BRAF 돌연변이와 같은 주요 분자적 돌연변이를 특징으로 합니다. 서서히 진행되는 경향을 보임에도 불구하고, LGG는 이질성이 높아 시간이 지남에 따라 진행되거나 재발할 가능성이 있으며, 그 결과 임상적 예후에 차이가 나타납니다.

저등급 신경교종(LGG)의 진단

LGG 진단에는 영상 검사, 조직병리학적 검사 및 분자 검사를 종합적으로 실시합니다. MRI가 권장되는 검사 방법이며, LGG는 일반적으로 T1 강조 영상에서 저신호를, T2 강조 영상 및 FLAIR 강조 영상에서 고신호를 보이며, 조영제에 의한 신호 증강은 극히 미미하거나 반점 형태로 나타납니다. CT 촬영에서는 특히 올리고덴드로글리오마의 경우, 저밀도 병변이나 때때로 석회화가 관찰될 수 있습니다. MRS나 PET와 같은 첨단 영상 진단 기술도 평가에 도움이 되지만, 진단 및 병기 분류에 있어서는 여전히 조직병리학적 검사가 표준으로 간주됩니다. IDH 돌연변이 및 1p/19q 공동 결실과 같은 분자 표지자는 정확한 분류에 필수적입니다.

저등급 신경교종(LGG)의 치료

LGG 치료에는 종양의 특성과 환자의 상황에 맞춘 다각적인 접근법이 사용됩니다. 종양 부하를 줄이고 진단용 조직을 채취하기 위한 일차 치료법은, 안전 범위 내에서 가능한 한 최대한의 외과적 절제술입니다. 특정 증례, 특히 무증상 환자의 경우, 적극적인 경과 관찰(워치 앤 웨이트)을 고려할 수 있습니다. 진행성 사례나 고위험 사례에서는 종양의 증식을 억제하기 위해 방사선 치료가 시행됩니다. 고위험군 환자의 경우, 테모졸로미드나 PCV 요법 등의 항암요법이 병용되는 경우가 많습니다. 또한, 분자 변이를 바탕으로 표적 치료제(IDH 억제제나 BRAF 억제제 등)가 치료 계획에 포함되는 사례도 늘어나고 있습니다.

저등급 신경교종(LGG)의 역학

저등급 신경교종(LGG)의 역학 분석 및 예후에 관한 주요 연구 결과

  • DelveInsight사의 추산에 따르면, 2025년 미국의 LGG 총 발병자 수는 약 3,800명이며, 조사 기간 동안 연평균 성장률(CAGR)로 증가할 것으로 전망됩니다.
  • 2025년 미국의 저등급 신경교종(LGG) 사례 분포를 살펴보면, 1등급 종양에 비해 2등급 종양의 부담이 더 크며, 진단된 사례의 대부분을 2등급 LGG가 차지하고 있는 것으로 나타났습니다.
  • 미국에서는 저등급 신경교종 사례 중 확산성 성세포종(약 35%)이 가장 높은 비율을 차지하고 있으며, 그 다음으로 모양세포성 성세포종(약 30%)이 뒤를 잇고 있습니다. 이는 이 두 가지가 LGG의 주요 조직병리학적 아형임을 보여줍니다.
  • LGG에서 환자 수가 가장 많은 연령대는 18세 미만이며, 그 다음으로 18-44세 연령대이고, 75세 이상 환자의 경우 환자 수가 가장 적은 것으로 보고되고 있습니다.
  • 미국에서는 저등급 신경교종(LGG)에서 IDH 돌연변이(80%)가 주요 분자적 돌연변이로 확인되며, BRAF 돌연변이는 더 적은 비율의 사례에서 관찰됩니다.
  • 미국의 LGG(2등급)에서는 조영 증강이 관찰되지 않는 종양이 주를 이루며, 조영 증강이 관찰되는 종양은 전체 사례에서 차지하는 비율이 적습니다.

저등급 신경교종(LGG) 시장의 전망

LGG 시장은 세계보건기구(WHO)의 분류 체계 발전과 치료 방침 결정에 기여하는 분자 프로파일링(예 : 1p/19q 공동 결실)에 대한 중요성이 커짐에 따라 변화하고 있습니다. 표준 치료에는 수술, 방사선 치료, 화학요법이 포함되며, 생존 기간 연장을 위해 테모졸로미드나 PCV 요법이 널리 사용되고 있지만, 이러한 치료법은 근치적이지 않을 뿐만 아니라 장기적인 독성을 동반합니다.

치료의 흐름은 특정 유전자 변이를 표적으로 하는 분자 표적 치료로 전환되고 있습니다. 사프시데닙(IDH1 억제제), 밀다메티닙(MEK 억제제), 토보라페닙(OJEMDA) 등의 신약은 질병을 더 효과적으로 제어하고 진행을 늦추는 동시에, 방사선 치료에 대한 의존도를 낮출 가능성이 기대되고 있습니다.

LGG 시장은 진단 기술의 발전, 맞춤형 의료의 확산, 그리고 탄탄한 파이프라인에 힘입어 꾸준한 성장이 예상됩니다. 그러나 악성 전환 지연, 치료 순서의 최적화, 인지 기능 장애 및 장기적인 치료 관련 부작용의 최소화 등 여전히 해결되지 않은 중요한 요구 사항들이 남아 있습니다.

전반적으로, 동종 최초의 치료법 등장, 진단 기법의 발전, 그리고 질병에 대한 인식 제고에 힘입어 2022년부터 2036년까지 주요 7개국 규모의 LGG 시장은 꾸준한 성장을 이룰 것으로 예상되며, 이는 시판 제품과 신약 파이프라인 모두에 큰 상업적 영향을 미칠 것으로 전망됩니다.

  • 추산에 따르면, LGG 시장에서 가장 큰 비중을 차지하는 것은 미국이며, 2025년에는 약 6억 달러에 달할 것으로 전망됩니다.
  • LGG 시장은 기존 치료법에서 표적 치료로 전환되고 있으며, 테모졸로미드 등 기존의 치료 옵션에 비해 효능 향상과 장기적인 독성 감소가 기대됨에 따라 IDH, MEK 및 RAF 억제제가 주목받고 있습니다.
  • 사프시데닙이나 밀다메티닙 등 중기-후기 단계의 후보 약물이 시장에 진입함에 따라, 예측 기간 동안 LGG 치료 분야의 경쟁 구도가 격화될 것으로 예상됩니다.

수치는 보고서 갱신이나 임상 정보 갱신 등에 따라 변경될 수 있습니다. 자세한 내용은 보고서에서 설명해 드리겠습니다.

  • 저등급 신경교종(LGG) : 파이프라인은 주로 사프시데닙(IDH1 억제제) 및 밀다메티닙(MEK 억제제)과 같은 표적 지향성 저분자 화합물로 구성되어 있습니다. 이러한 약물은 IDH 돌연변이 및 MAPK 경로의 이상과 같은 특정 분자적 유발 인자를 억제하도록 설계되어, 선택성을 높이고 잠재적으로 우수한 안전성 프로파일을 제공합니다.
  • RAF 키나아제 억제제(MAPK 경로 억제제) : Day One Biopharmaceuticals사와 Ipsen사가 개발한 OJEMDA(토보라페닙)는 pLGG에서 발생하는 MAPK 경로의 이상을 표적으로 하는 선택적 II형 RAF 키나아제 억제제입니다. 이러한 승인은 BRAF 돌연변이에 의해 유발된 종양의 치료에서 RAF를 표적으로 하는 치료법의 역할이 확대되고 있음을 보여줍니다.
  • IDH 억제제(대사 경로 억제제) : Servier사의 VORANIGO(보라시데닙)는 IDH1/IDH2 이중 억제제로, 변이형 IDH에 의해 유도되는 종양 대사산물의 생성을 억제합니다. 이는 2등급 성세포종 및 올리고덴드로글리오마의 주요 유발 인자를 표적으로 하는 것으로, LGG에 대한 표적 치료의 큰 진전을 상징합니다.

자주 묻는 질문

  • 저등급 신경교종(LGG)의 시장 규모는 어떻게 예측되나요?
  • 저등급 신경교종(LGG)의 주요 유전자 변이는 무엇인가요?
  • 소아 저등급 신경교종(LGG)의 치료 방법은 무엇인가요?
  • 저등급 신경교종(LGG)의 발생률은 어떻게 되나요?
  • 저등급 신경교종(LGG)의 치료에 사용되는 주요 약물은 무엇인가요?
  • 저등급 신경교종(LGG)의 진단 방법은 무엇인가요?

목차

제1장 주요 인사이트

제2장 소개

제3장 주요 요약

제4장 주요 사건

제5장 역학 및 시장 예측 조사 방법

제6장 저등급 신경교종 : 시장 개요

제7장 저등급 신경교종 : 질환 배경과 개요

제8장 저등급 신경교종 : 치료 가이드라인

제9장 저등급 신경교종 : 역학 및 환자 인구

제10장 저등급 신경교종 : 환자 경과

제11장 시판 치료제

제12장 새로운 치료법

제13장 저등급 신경교종 : 주요 7개국 분석

제14장 저등급 신경교종 : 미충족 수요

제15장 저등급 신경교종 : SWOT 분석

제16장 저등급 신경교종 : KOL의 견해

제17장 저등급 신경교종 : 시장 진입 및 상환

제18장 부록

제19장 DelveInsight의 서비스 내용

제20장 면책사항

제21장 DelveInsight 소개

KSM 26.07.20

Low Grade Glioma (LGG) Insights and Trends

  • Low-grade gliomas (LGGs) are a diverse group of primary brain tumors that often occur in young, otherwise healthy patients and are characterized by an indolent, slow-growing course with longer survival compared to high-grade gliomas. Given their favorable prognosis and prolonged survival, treatment decisions must carefully balance benefits against potential treatment-related risks.
  • Isocitrate dehydrogenase 1 (IDH1) and Isocitrate dehydrogenase 2 (IDH2) are the most frequently mutated genes in LGG, occurring in over 70% of cases. BRAF V600E mutations are less common but are seen in pilocytic astrocytoma and several non-pilocytic pediatric low-grade gliomas, including ganglioglioma, desmoplastic infantile ganglioglioma, and about two-thirds of pleomorphic xanthoastrocytomas.
  • According to the secondary search, the incidence of Grade 2 astrocytoma is 0.44 per 100,000 persons, and that of Grade 3 is 0.39 per 100,000 persons. Oligodendroglioma is less common, with an incidence of 0.23 per 100,000 persons for Grade 2 and 0.11 per 100,000 persons for Grade 3 in the United States.
  • LGG are tumors categorized as Grades 1 or 2, because they are not very aggressive, are less likely to spread, and are slow-growing which makes them more treatable.
  • Pediatric LGG is a type of tumor that affects the brain and spinal cord. LGG is the most common central nervous system (CNS) tumor in children, accounting for approximately 30% of all childhood CNS tumors.
  • Pediatric low-grade gliomas (PLGG) are the most common brain tumors in children. Although they are slow-growing compared to high-grade tumors, approximately 50% of patients who undergo surgery experience relapse and require further treatment.
  • LGG are managed using a multimodal approach including maximal safe surgery, radiotherapy, chemotherapy, and targeted therapies, with active surveillance in selected cases.
  • Approved therapies for LGG is primarily driven by molecular subtypes, including vorasidenib (VORANIGO) for IDH-mutant Grade 2 glioma, dabrafenib + trametinib (TAFINLAR + MEKINIST) for BRAF V600E-mutant pediatric LGG, and tovorafenib (OJEMDA) for relapsed or refractory BRAF-altered pediatric LGG.
  • LGG are relatively slow-growing infiltrative primary brain tumors that almost invariably undergo malignant transformation. The standard of care consists of maximum safe resection, the potential use of chemo radiation for high-risk patients, and lifelong radiographic surveillance, with the goal of treatment to delay malignant transformation and maximize the quality of life.
  • The LGG pipeline is gradually expanding, with a primary focus on targeted therapies, particularly IDH and BRAF inhibitors rather than a broad range of novel mechanisms.

Low Grade Glioma (LGG) Market Size and Forecast in the 7MM

  • 2025 LGG Market Size: ~USD 1,000 million
  • LGG Growth Rate (2026-2036): ~4% CAGR

Numbers are subjected to change with report updation, clinical information updates etc.

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

The Low Grade Glioma (LGG) market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates LGG 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 Low Grade Glioma (LGG) 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 Low Grade Glioma (LGG) Market

Rising LGG Incidence

The overall incidence of low-grade glioma (LGG) is gradually increasing, particularly among younger populations and children, acting as a key driver of the LGG market expansion. In the United States, there were approximately 9,400 incident cases of LGG in 2025, which are projected to increase further by 2036.

Rising Opportunities in LGG

Emerging opportunities in LGG treatment are driven by novel mechanisms of action (MoA), particularly IDH inhibitors, BRAF/MEK inhibitors, and targeted molecular therapies addressing specific genetic alterations. Additionally, growing research into immunotherapy, epigenetic modulators, and combination strategies is expanding the therapeutic landscape beyond conventional approaches.

Emerging LGG Competitive Landscape

Safusidenib, mirdametinib, and other emerging targeted therapies are shaping the evolving competitive landscape in LGG.

Low Grade Glioma (LGG) Understanding and Treatment Algorithm

Low Grade Glioma (LGG) Overview and Diagnosis

LGG is a group of slow-growing primary brain tumors classified as WHO Grade II that typically affect younger individuals, often in the prime of life. These tumors are associated with a relatively favorable prognosis compared to high-grade gliomas and are characterized by key molecular alterations, particularly IDH1/IDH2 mutations and sometimes BRAF mutations. Despite their indolent nature, LGGs are heterogeneous and can progress or recur over time, leading to variable clinical outcomes.

Low Grade Glioma (LGG) Diagnosis

Diagnosis of LGG involves a combination of imaging, histopathology, and molecular testing. MRI is the preferred modality, where LGGs typically appear T1 hypointense and T2/FLAIR hyperintense, with minimal or patchy contrast enhancement. CT scans may show low-density lesions with occasional calcifications, especially in oligodendrogliomas. While advanced imaging techniques like MRS and PET can support evaluation, histopathological examination remains the gold standard for diagnosis and grading. Molecular markers such as IDH mutation and 1p/19q codeletion are essential for accurate classification.

Low Grade Glioma (LGG) Treatment

Treatment of LGG involves a multimodal approach tailored to tumor characteristics and patient factors. Maximal safe surgical resection is the primary treatment to reduce tumor burden and obtain tissue for diagnosis. In selected cases, especially asymptomatic patients, active surveillance (watch-and-wait) may be considered. Radiotherapy is used for progressive or high-risk disease to control tumor growth. Chemotherapy, such as temozolomide or PCV regimen, is often added in higher-risk patients. Increasingly, targeted therapies (e.g., IDH and BRAF inhibitors) are being incorporated based on molecular alterations.

Low Grade Glioma (LGG) Unmet Needs

The section "unmet needs of Low Grade Glioma (LGG)" 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. Limited approved targeted therapies, especially for non-IDH/BRAF patients

2. Risk of tumor progression and recurrence despite treatment

3. Need for better biomarkers for prognosis and treatment selection

4. Long-term treatment-related toxicities impacting quality of life, and others.....

Comprehensive unmet needs insights in Low Grade Glioma (LGG) and their strategic implications are provided in the full report.

Low Grade Glioma (LGG) Epidemiology

Key Findings from Low Grade Glioma (LGG) Epidemiological Analysis and Forecast

  • According to DelveInsight's estimates, the total incident population of LGG in the United States was ~3,800 in 2025 with a growing at a CAGR in the study period.
  • In 2025, the distribution of low-grade glioma (LGG) cases in the United States shows a higher burden in Grade II tumors compared to Grade I tumors, indicating that Grade II LGGs constitute the majority of diagnosed cases.
  • In the United States, diffuse astrocytoma (~35%) represents the highest proportion of low-grade glioma cases, followed closely by pilocytic astrocytoma (~30%), indicating these as the dominant histopathological subtypes within LGG.
  • In LGG, the highest number of cases is observed in the <18 years age group, followed by the 18-44 years group, while the lowest cases are reported in patients aged >=75 years.
  • In the United States, IDH mutations (80%) represent the predominant molecular alteration in low-grade glioma (LGG), while BRAF alterations are observed in a smaller proportion of cases.
  • In LGG (Grade II) in the United States, non-enhancing tumors predominate, while enhancing tumors represent a smaller proportion of cases.

Low Grade Glioma (LGG) Drug Chapters & Competitive Analysis

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

Approved Therapies for Low Grade Glioma (LGG)

Tovorafenib (OJEMDA): Day One Biopharmaceuticals and Ipsen

OJEMDA is a kinase inhibitor indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric LGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. OJEMDA can shrink tumors. It is a clinically proven oral targeted therapy for children as young as 6 months living with pLGG that's returned or is unresponsive to current treatment caused by an abnormal BRAF gene. Once-a-week OJEMDA is available in both tablet and liquid form. It can be taken conveniently at home, or where your family is most comfortable.

Vorasidenib (VORANIGO): Servier Pharmaceutical

VORANIGO (40 mg tablets) is a prescription medicine used to treat adults and children 12 years of age and older with certain types of brain tumors called astrocytoma or oligodendroglioma with an isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation, following surgery. Your healthcare provider will perform a test to make sure that VORANIGO is right for you. It is not known if VORANIGO is safe and effective in children under 12 years of age.

Low Grade Glioma (LGG) Pipeline Analysis

Safusidenib: Nuvation Bio

Safusidenib is a novel, oral, potent, brain-penetrant, selective inhibitor of mutant IDH1. In Phase I and Phase II clinical studies, safusidenib delayed disease progression and provided durable responses across grades and risk groups with a favorable risk-benefit profile. The drug is currently being evaluated in the ongoing Phase III (SIGMA) study for the maintenance treatment of patients with IDH1-mutant astrocytoma who have high-risk features following standard-of-care.

SIGMA is a pivotal Phase III study that will evaluate safusidenib compared to placebo as a maintenance therapy after standard-of-care in IDH1-mutant astrocytoma with high-risk features. The pivotal portion of the study will enroll approximately 300 patients. The data is anticipated to be available in 2029.

Mirdametinib: Springworks Therapeutics

Mirdametinib was designed to inhibit MEK1 and MEK2, which occupy pivotal positions in the MAPK pathway. The MAPK pathway is a key signaling network that regulates cell growth and survival and plays a central role in multiple cancers and rare diseases when dysregulated. Mirdametinib is an investigational agent whose safety and efficacy have not been demonstrated. In the middle of 2021, the company initiated a Phase I/II clinical trial, which St. Jude Children's Research Hospital sponsored, to evaluate mirdametinib in patients with LGG.

Low Grade Glioma (LGG) Key Players, Market Leaders and Emerging Companies

  • Day One Biopharmaceuticals
  • Ipsen
  • Servier Pharmaceutical
  • Kazia Therapeutics
  • Novartis
  • Nuvation Bio
  • Springworks Therapeutics, and others

Low Grade Glioma (LGG) Drug Updates

  • In April 2026, Nuvation Bio announced the company had amended its existing exclusive license agreement for safusidenib with Daiichi Sankyo to include Japan rights, effectively securing exclusive global development and commercialization rights of the investigational medicine. Which enables Nuvation Bio to expand its ongoing pivotal SIGMA study of safusidenib into Japan, and provides rights to all previously generated and future data to support further publication of safusidenib results in IDH1-mutant glioma.
  • According to the March 2026 corporate presentation of Day One Biopharmaceuticals, FIREFLY-2 (pivotal Phase III) is evaluating tovorafenib in the front-line RAF-altered pLGG setting, with full enrollment expected in 1H 2026 and topline data anticipated by mid-2027 to support potential approval in 2028.
  • In February 2026, Ipsen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had issued a positive opinion recommending the conditional marketing authorization of tovorafenib as monotherapy for the treatment of patients 6 months of age and older with pLGG harbouring a BRAF fusion or rearrangement or BRAF V600 mutation, who have progressed after one or more prior systemic therapies.
  • In November 2025, Day One Biopharmaceuticals announced three-year results from the OJEMDA pivotal Phase II (FIREFLY-1) trial in an oral presentation at the 30th Annual Meeting & Education Day of the Society for Neuro-Oncology.

Drug Class Insights

Low Grade Glioma (LGG) Market Outlook

The LGG market is evolving with advances in classification by the World Health Organization and growing emphasis on molecular profiling (e.g., 1p/19q co-deletion) to guide treatment decisions. Standard care includes surgery, radiotherapy, and chemotherapy, with Temozolomide and PCV regimen widely used to extend survival, though these approaches are not curative and are associated with long-term toxicities.

The treatment landscape is shifting toward targeted therapies aimed at specific genetic alterations. Emerging drugs such as safusidenib (IDH1 inhibitor), mirdametinib (MEK inhibitor), and tovorafenib (OJEMDA) are expected to improve disease control and delay progression while potentially reducing reliance on radiation.

LGG market is projected to grow steadily, driven by better diagnosis, increasing use of personalized medicine, and a robust pipeline. However, key unmet needs remain, including delaying malignant transformation, optimizing treatment sequencing, and minimizing cognitive and long-term treatment-related side effects.

Overall, the launch of first-in-class therapies, improved diagnostic approaches, and increasing disease awareness are expected to drive steady growth in the 7MM LGG market from 2022-2036, with strong commercial implications for both marketed products and emerging pipelines.

  • According to the estimates, the largest market size of LGG was captured by the United States, i.e., ~USD 600 million in 2025.
  • The LGG market is shifting from conventional treatments toward targeted therapies, with IDH, MEK, and RAF inhibitors gaining traction due to improved efficacy and potential for reduced long-term toxicity compared to traditional options like Temozolomide.
  • The entry of mid- to late-stage candidates such as safusidenib and mirdametinib is expected to intensify competition in the LGG treatment landscape during the forecast period.

Numbers are subjected to change with report updation, clinical information updates etc. Further details will be provided in the report....

Drug Class/Insights into Leading Emerging and Marketed Therapies in Low Grade Glioma (LGG) (2022-2036 Forecast)

The LGG market comprises targeted small molecules and biologics, and T-cell co-stimulation modulators alongside conventional and supportive therapies, each addressing distinct immunologic pathways and inflammatory mechanisms underlying LGG.

  • Small molecules: The pipeline is largely composed of targeted small molecules, including safusidenib (IDH1 inhibitor), mirdametinib (MEK inhibitor). These agents are designed to inhibit specific molecular drivers such as IDH mutations and MAPK pathway alterations, offering improved selectivity and potentially better safety profiles.
  • RAF kinase inhibitors (MAPK pathway inhibitors): OJEMDA (tovorafenib), developed by Day One Biopharmaceuticals and Ipsen, is a selective type II RAF kinase inhibitor that targets MAPK pathway alterations in pLGG. Its approval highlights the growing role of RAF-targeted therapies in managing tumors driven by BRAF alterations.
  • IDH inhibitors (Metabolic pathway inhibitors): VORANIGO (vorasidenib), from Servier, is a dual IDH1/IDH2 inhibitor that blocks mutant IDH-driven oncometabolite production, addressing a key driver in grade 2 astrocytoma and oligodendroglioma and representing a major advancement in targeted LGG therapy.

Low Grade Glioma (LGG) 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 LGG market's uptake by drugs, patient uptake by therapy, and sales of each drug.

The LGG treatment landscape is evolving with moderate to fast-paced development, driven by targeted therapies addressing key molecular pathways. Recently approved agents such as OJEMDA (tovorafenib) and VORANIGO (vorasidenib), along with the combination of TAFINLAR + MEKINIST, demonstrate medium-fast uptake by targeting MAPK and IDH pathways. Emerging therapies such as mirdametinib (MEK inhibitor) and safusidenib (IDH1 inhibitor) show moderate development progress, further strengthening the precision medicine approach. Overall, the LGG market is characterized by a focused but steadily advancing pipeline, with innovation concentrated on molecularly defined subgroups.

Low Grade Glioma (LGG) Therapies Price Scenario & Trends

Pricing and analogue assessment of LGG 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.

Further details are provided in the final report....

Industry Experts and Physician Views for Low Grade Glioma (LGG)

To keep up with LGG 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 LGG 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 LGG, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 6+ KOLs in the 7MM. Centers such as the University of North Carolina at Chapel Hill, Berlin Institute of Health at Charite, and the University of Nottingham, etc. were contacted. Their opinion helps understand and validate current and emerging LGG therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in LGG.

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 Low Grade Glioma (LGG), 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 LGG, explaining its 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 LGG 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 LGG market.

Report Insights

  • Low Grade Glioma (LGG) Patient Population Forecast
  • Low Grade Glioma (LGG) Therapeutics Market Size
  • Low Grade Glioma (LGG) Pipeline Analysis
  • Low Grade Glioma (LGG) Market Size and Trends
  • Low Grade Glioma (LGG) 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
  • Low Grade Glioma (LGG) Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (by geography)
  • Low Grade Glioma (LGG) Treatment Addressable Market (TAM)
  • Low Grade Glioma (LGG) Competitive Landscape
  • Low Grade Glioma (LGG) Major Companies Insights
  • Low Grade Glioma (LGG) Price Trends and Analogue Assessment
  • Low Grade Glioma (LGG) Therapies Drug Adoption/Uptake
  • Low Grade Glioma (LGG) Therapies Peak Patient Share analysis

Report Assessment

  • Low Grade Glioma (LGG) Current Treatment Practices
  • Low Grade Glioma (LGG) Unmet Needs
  • Low Grade Glioma (LGG) Clinical Development Analysis
  • Low Grade Glioma (LGG) Emerging Drugs Product Profiles
  • Low Grade Glioma (LGG) Market Attractiveness
  • Low Grade Glioma (LGG) Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

Market Insights

  • What was the Low Grade Glioma (LGG) 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 Low Grade Glioma (LGG)?
  • What are the disease risks, burdens, and unmet needs of Low Grade Glioma (LGG)? What will be the growth opportunities across the 7MM concerning the patient population with Low Grade Glioma (LGG)?
  • 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 Low Grade Glioma (LGG)? What are the current guidelines for treating Low Grade Glioma (LGG) 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 Low Grade Glioma (LGG) 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 within 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. Upcoming Key Catalysts
  • 4.2. Key Transactions And Collaborations
  • 4.3. Key Conference Highlights
  • 4.4. News Flow

5. Epidemiology and Market Forecast Methodology

6. Low Grade Glioma (LGG) Market Overview at a Glance

  • 6.1. Clinical Landscape Analysis (By Phase, Molecule Type, and RoA)
  • 6.2. Market Share (%) Distribution of LGG By Therapies in the 7MM, in 2025
  • 6.3. Market Share (%) Distribution of LGG By Therapies in the 7MM, in 2036

7. Disease Background and Overview of Low Grade Glioma (LGG)

  • 7.1. Introduction
  • 7.2. Types
  • 7.3. Symptoms
  • 7.4. Causes
  • 7.5. Pathophysiology
  • 7.6. Diagnosis
  • 7.7. Treatment

8. Treatment Guidelines of Low Grade Glioma (LGG)

  • 8.1. National Comprehensive Cancer Network (NCCN) Guidelines
  • 8.2. SEOM (Spanish Society of Medical Oncology) Guideline Recommendations for Low-grade glioma
  • 8.3. European Association of Neuro-oncology (EANO) Guidelines on the Diagnosis and Treatment of Grade 2 Diffuse Glioma of Adulthood

9. Epidemiology and Patient Population of Low Grade Glioma (LGG)

  • 9.1. Key Findings
  • 9.2. Assumptions and Rationale
  • 9.3. Total Incident Population of Low-grade Glioma in the 7MM
  • 9.4. The United States
    • 9.4.1. Total Incident Population of Glioma in the United States
    • 9.4.2. Total Incident Population of Low-grade Glioma in the United States
    • 9.4.3. Grade-specific Incident Cases of Low-grade Glioma in the United States
    • 9.4.4. Age-specific Incident Cases of Low-grade Glioma in the United States
    • 9.4.5. Type-specific Incident Cases of Low-grade Glioma in the United States
    • 9.4.6. Low-grade Glioma Cases Based on Molecular Alterations in the United States
    • 9.4.7. Enhancing and Non-enhancing Grade II Glioma Cases in the United States
  • 9.5. EU4 and the UK
    • 9.5.1. Total Incident Population of Glioma in EU4 and the UK
    • 9.5.2. Total Incident Population of Low-grade Glioma in EU4 and the UK
    • 9.5.3. Grade-specific Incident Cases of Low-grade Glioma in EU4 and the UK
    • 9.5.4. Age-specific Incident Cases of Low-grade Glioma in EU4 and the UK
    • 9.5.5. Type-specific Diagnosed Prevalent Cases of LGG in EU4 and the UK
    • 9.5.6. Low-grade Glioma Cases Based on Molecular Alterations in EU4 and the UK
    • 9.5.7. Enhancing and Non-enhancing Grade II Glioma Cases in EU4 and the UK
  • 9.6. Japan
    • 9.6.1. Total Incident Population of Glioma in Japan
    • 9.6.2. Total Incident Population of Low-grade Glioma in Japan
    • 9.6.3. Grade-specific Incident Cases of Low-grade Glioma in Japan
    • 9.6.4. Age-specific Incident Cases of Low-grade Glioma in Japan
    • 9.6.5. Type-specific Diagnosed Prevalent Cases of LGG in Japan
    • 9.6.6. Low-grade Glioma Cases Based on Molecular Alterations in Japan
    • 9.6.7. Enhancing and Non-enhancing Grade II Glioma Cases in Japan

10. Patient Journey of Low Grade Glioma (LGG)

11. Marketed Therapies

  • 11.1. Marketed Competitive Landscape of Low Grade Glioma (LGG)
  • 11.2. Tovorafenib (OJEMDA): Day One Biopharmaceuticals and Ipsen
    • 11.2.1. Drug Description
    • 11.2.2. Regulatory Milestones
    • 11.2.3. Other Developmental Activities
    • 11.2.4. Summary of Pivotal Trials
    • 11.2.5. Clinical Development
      • 11.2.5.1. Clinical Trial Information
    • 11.2.6. Analyst Views
  • 11.3. Vorasidenib (VORANIGO): Servier Pharmaceutical
    • 11.3.1. Drug Description
    • 11.3.2. Regulatory Milestones
    • 11.3.3. Other Developmental Activities
    • 11.3.4. Summary of Pivotal Trials
    • 11.3.5. Clinical Development
      • 11.3.5.1. Clinical Trial Information
    • 11.3.6. Analyst Views

12. Emerging Therapies

  • 12.1. Emerging Competitive Landscape of Low Grade Glioma (LGG)
  • 12.2. Safusidenib: Nuvation Bio
    • 12.2.1. Drug Description
    • 12.2.2. Other Developmental Activities
    • 12.2.3. Clinical Development
      • 12.2.3.1. Clinical Trials Information
    • 12.2.4. Analyst Views
  • 12.3. Mirdametinib: Springworks Therapeutics
    • 12.3.1. Drug Description
    • 12.3.2. Other Developmental Activity
    • 12.3.3. Clinical Development
      • 12.3.3.1. Clinical Trials Information
    • 12.3.4. Analyst Views

13. Low Grade Glioma (LGG): 7MM Analysis

  • 13.1. Key Findings
  • 13.2. Market Outlook of Low Grade Glioma (LGG)
  • 13.3. Conjoint Analysis of Low Grade Glioma (LGG)
  • 13.4. Key Market Forecast Assumptions
    • 13.4.1. Cost Assumptions
    • 13.4.2. Pricing Trends
    • 13.4.3. Analogue Assessment
    • 13.4.4. Launch Year and Therapy Uptakes
  • 13.5. Total Market Size of LGG in the 7MM
  • 13.6. Total Market Size of LGG by Therapies in the 7MM
  • 13.7. The United States
    • 13.7.1. Total Market Size of LGG in the United States
    • 13.7.2. Total Market Size of LGG by Therapies in the United States
  • 13.8. EU4 and the UK
    • 13.8.1. Total Market Size of LGG in EU4 and the UK
    • 13.8.2. Total Market Size of LGG by Therapies in EU4 and the UK
  • 13.9. Japan
    • 13.9.1. Total Market Size of LGG in Japan
    • 13.9.2. Total Market Size of LGG by Therapies in Japan

14. Unmet Needs of Low Grade Glioma (LGG)

15. SWOT Analysis of Low Grade Glioma (LGG)

16. KOL Views of Low Grade Glioma (LGG)

17. Market Access and Reimbursement of Low Grade Glioma (LGG)

  • 17.1. The United States
  • 17.2. EU4 and the UK
    • 17.2.1. Germany
    • 17.2.2. France
    • 17.2.3. Italy
    • 17.2.4. Spain
    • 17.2.5. United Kingdom
  • 17.3. Japan
  • 17.4. Summary and comparison of Market Access and Pricing Policy Developments in 2025
  • 17.5. Market Access and Reimbursement of LGG Therapies

18. Appendix

  • 18.1. Bibliography
  • 18.2. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

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