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시장보고서
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신경교종 : 시장 인사이트, 역학 및 예측(2036년)Glioma - Market Insight, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
이 '신경교종 시장 보고서'에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재 시장 상황에 대한 종합적인 분석을 제공합니다. 또한, 신경교종 환자의 부담 추이, 매출액 및 시장 점유율 동향, 정점 시기의 환자 점유율 및 치료 도입 현황에 대한 분석을 평가하는 한편, 전 세계 각 지역 시장 규모에 대한 상세한 평가 및 성장률 예측(과거 데이터 및 2022-2036년 예측)을 제시하고 있습니다. 본 보고서는 신경교종 분야에서 주요 미충족 의료 수요를 부각시키고, 경쟁 구도와 임상 현황을 분석하여 고부가가치 성장 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.
교모세포종의 유병률 증가
신경교종, 특히 교모세포종(글리오블라스토마)과 같은 침습성이 높은 형태의 발생률 및 유병률 증가는 여전히 시장 성장의 주요 촉진요인으로 작용하고 있습니다. 신경교종는 비교적 드문 암이지만, 높은 사망률과 재발률로 인해 지속적인 치료가 필요한 환자층이 꾸준히 존재하고 있습니다. 미국 등 주요 시장에서는 매년 수천 건의 새로운 신경교종 사례가 진단되고 있으며, 진단 능력의 향상과 고령화에 따라 환자 부담은 더욱 증가할 것으로 예측됩니다.
치료법의 발전
기존의 외과 수술, 방사선 치료, 화학 요법을 뛰어넘는 신경교종 치료법의 발전은 시장 확대에 크게 기여하고 있습니다. 종양 치료 분야(OPTUNE), 특정 돌연변이를 표적으로 하는 표적 치료(예 : BRAF 억제제), 면역 요법, 종양 용해성 바이러스 요법 등 새로운 치료법의 도입으로 임상 성과가 향상되고 치료 선택지가 확대됨에 따라, 이러한 치료법의 채택이 촉진되고 있습니다.
교모종 분야에서의 기회 확대
면역요법, 백신 기반 접근법 및 정밀 의학 분야의 최근 발전은 신경교종 시장 내 신생 기업들에게 큰 기회를 제공합니다. DCVax-L이나 AV-GBM-1과 같은 수지상 세포 백신, 그리고 SurVaxM과 같은 펩타이드 백신을 포함한 혁신적인 치료법은 지속적인 항종양 면역 반응을 유도할 가능성이 있어 주목을 받고 있습니다. 특정 유전자 변이를 표적으로 하는 표적 치료도 치료 선택의 폭을 넓히고 있습니다. H3K27M 돌연변이형 교모세포종에 대한 돌다비프론(MODEYSO), BRAF V600E 변이형 종양에 대한 다브라페닙(TAFINLAR) + 트라메티닙(MEKINIST), IDH 변이형 신경교종에 대한 보라시데닙(VORANIGO)과 같은 약물은 바이오마커 기반 치료 접근법의 중요성이 높아지고 있음을 보여줍니다.
이와 병행하여, DNX-2401이나 테셀파투레브와 같은 종양 용해성 바이러스, 레고라페닙이나 AV-GBM-1과 같은 표적 치료제 등 새로운 플랫폼에 대한 연구가 활발히 진행되고 있으며, 이를 통해 개발 파이프라인을 한층 더 강화하고 있습니다.
또 다른 중요한 경쟁군에는 DNX-2401, 테셀파투레브, 오프라넬진 오바데노벡 등의 종양 용해성 바이러스가 포함됩니다. 이러한 약물은 종양 세포의 직접적인 용해와 면역 활성화라는 이중 작용기전을 가지고 있어, 종양의 내성 및 면역 억제적 미세환경을 극복하는 데 특히 유망한 것으로 평가받고 있습니다. 중기-후기 임상시험에서 지속적으로 이루어지고 있는 진전은 그 경쟁력을 입증하고 있습니다. 표적 치료 분야에서는 몇 가지 후기 단계 및 신약 후보 물질들이 경쟁을 심화시키고 있습니다. 여기에는 엔자스타우린, 레고라페닙, 팍사리시브 등이 포함됩니다. 이러한 치료법은 교모세포종의 진행에 관여하는 특정 분자 경로를 표적으로 삼도록 설계되었으며, 바이오마커 기반 치료 접근법에서 중요한 역할을 할 것으로 기대됩니다.
또한, LAM561과 같은 새로운 대사 표적 치료법이나 막 표적 치료법, 그리고 벨비신과 같은 혈액-뇌 장벽(BBB) 투과성 세포독성 약물은 혈액-뇌 장벽을 통과하는 약물 전달 및 종양의 내성이라는 중요한 과제를 해결함으로써 경쟁 구도를 확대되고 있습니다.
전반적으로, 신흥 교모세포종 치료 파이프라인은 다중 기전 및 병용 요법에 기반한 전략으로의 전환을 반영하고 있으며, 면역요법, 정밀 의학, 그리고 중추신경계(CNS)로의 침투성 향상에 대한 중점이 점점 더 커지고 있습니다. 임상 데이터가 축적되고 규제 관련 주요 단계가 달성됨에 따라, 활발히 개발되고 있는 이러한 신흥 치료법들은 경쟁을 심화시키고 치료 패러다임을 재구축하며, 교모세포종 시장의 향후 성장을 견인할 것으로 기대됩니다.
신경교종의 개요 및 진단
신경교종는 글리아 세포에서 유래하는 중추신경계(CNS)에서 가장 흔한 종양입니다. 이들은 주변 뇌 조직에 영향을 미치는 매우 광범위하게 침윤하는 종양입니다. 교종의 3가지 일반적인 유형은 세포의 표현형 특성에 따라 성세포종, 상피종, 그리고 올리고덴드로교종으로 분류됩니다. 신경교종는 글리아 줄기세포 또는 전구세포에서 유전자 변이가 축적됨으로써 발생하며, 그 결과 세포가 통제 불가능하게 증식하게 됩니다. 신경교종는 다시 1-4등급으로 분류됩니다. 글리오블라스토마(GBM, 4등급)가 가장 악성도가 높은 유형인 반면, 모양세포성 성세포종(1등급)은 1-4등급 중 가장 악성도가 낮은 뇌종양입니다. 교모종의 발병에는 대개 변이된 유전자가 관여합니다. 특정 유형의 신경교종에서 변이된 유전자의 예로는 TP53, PTEN(종양 억제 유전자), BRAF(세포 증식에 관여) 및 IDH1(세포 대사에 관여) 등이 있습니다.
교종 진단
교종 진단에는 신경학적 검사(시력, 청력, 언어 기능, 근력, 감각, 평형 감각, 협응력, 반사 신경, 사고 및 기억 능력을 검사합니다), 혈관조영술, 자기공명영상(MRI), 컴퓨터 단층촬영(CT), 외과적 생검 등이 포함됩니다. 환자의 경과는 대개 발작, 비정상적인 두통, 기분이나 감각의 이상, 보행 곤란 등의 증상이 나타나는 것으로 시작됩니다. 주치의의 초진에서 환자는 전신 신체 검사를 받았으며, 그 결과 뇌종양과 관련된 몇 가지 우려할 만한 소견이 확인되어 신경종양 전문의에게 의뢰되었습니다. 또한, 신경종양 전문의는 MRI가 가장 유력한 영상 진단법이며, 뇌의 선명한 영상을 얻을 수 있고 뇌종양의 정확한 감별 진단에 도움이 되기 때문에 즉시 MRI 검사를 권장합니다. MRI 검사 결과, 신경교종이 의심되는 경우, 질병의 병기를 확정하기 위해 생검이 시행됩니다. 또한, 바이오마커 분자 검사를 실시하여 유형나 악성도를 평가하기도 합니다. 교종의 악성도가 확정되는 대로 환자에게 적절한 치료가 이루어집니다.
교종 치료
치료 방침은 신경교종의 유형, 크기, 위치 및 환자의 구체적인 상태에 따라 달라집니다. 특히, 종양이 뇌의 중요한 부위로 침윤되어 있거나 수술로 접근할 수 없어 완전히 절제할 수 없는 환자의 경우, 수술 후 화학요법이나 방사선 치료가 시행됩니다. 표준 치료법에는 수술, 화학요법 및 방사선 요법이 포함됩니다. 화학요법에는 칼무스틴(BCNU), 롬스틴(CCNU) 또는 글레오스틴(제네릭), 글리아델-웨버(BCNU가 함침된 생분해성 디스크), 테모졸로미드(TEMODAR), 시스플라틴, 카보플라틴, 에토포사이드, 이리노테칸 등이 포함됩니다. 이 약제들은 단독 요법 또는 병용 요법(예 : PCV(프로카르바진, CCNU, 빈크리스틴), 카보플라틴/에토포사이드)으로 투여됩니다. 테모졸로미드와 베바시주맙은 뇌종양 치료에 가장 일반적으로 사용되는 약물입니다. 그러나 현재 치료 시장에는 신경교종을 완치할 수 있는 효과적인 전략이 부족하기 때문에 신경교종 진단을 받은 환자의 생존율은 여전히 낮은 수준입니다. 신경교종는 완치가 어렵고, 승인된 치료 옵션은 제한적입니다. 게다가 이 종양은 재발률이 높으며, 환자의 예후도 좋지 않습니다. 또한, 현재 MGMT 비메틸화 환자군에 대해 승인된 치료법은 존재하지 않습니다.
신경교종의 역학적 분석 및 예측에 관한 주요 조사 결과
교모세포종은 분화도에 따라 4가지 등급으로 분류되며, 1등급이 가장 악성도가 낮고, 4등급(교모세포종, GBM)이 가장 침습성이 높으며 예후가 불량합니다. 종양의 이질성과 치료 반응의 편차가 존재하기 때문에 치료에는 다학제적 접근이 필요합니다. 현재의 표준 치료에는 안전 범위 내에서 가능한 한 광범위한 외과적 절제술에 이어, 방사선 치료 및 테모졸로미드(TEMODAR)를 이용한 화학요법이 포함되며, 적격 환자에게는 OPTUNE(종양 치료 전기장)이 추가로 시행됩니다. 재발 사례의 경우, 베바시주맙(아바스틴)이 여전히 주요 치료 옵션으로 자리 잡고 있습니다.
시장 관점에서 볼 때, 미충족 의료 수요가 높고 예후가 불량하기 때문에 고악성도 신경교종, 특히 GBM이 계속해서 시장을 독점하고 있습니다. 저악성도 신경교종의 경우, 기존에는 치료 선택지가 제한적이었으나, 최근 더블라페닙(TAFINLAR)과 트라메티닙(MEKINIST) 등의 표적 치료제가 승인되고 치료법이 발전함에 따라, 분자 표적에 따라 정의된 환자 집단에서 치료 기회가 확대되고 있습니다.
개발 파이프라인은 활발하지만, 후기 임상시험에서 적격 환자의 중도 탈락률이 중간 수준인 등 여전히 과제가 남아 있습니다. 주목할 만한 신흥 치료법으로는 DCVax-L이나 SurVaxM 등의 백신, DNX-2401이나 테셀파투레브(DELYTACT) 등의 종양용해성 바이러스가 있습니다. 또한, 레고라페닙도 긍정적으로 평가받고 있으며, 일부 상황에서는 재발성 GBM 치료 지침에 포함되어 있습니다.
주요 시장에서 현재 시행되고 있는 치료 패턴은 수술 후 화학방사선요법을 시행하는 것을 중심으로 일관되게 유지되고 있으며, 표적 치료나 새로운 치료법이 점차 도입되고 있습니다. 향후 성장은 정밀 의학, 바이오마커 기반 치료(예 : IDH, H3K27M) 및 병용 요법에 의해 주도될 것입니다. 그러나 확실한 바이오마커의 부재, 임상시험의 높은 실패율, 면역억제적인 종양 미세환경과 같은 과제들이 여전히 진전을 가로막고 있습니다.
전반적으로 큰 과제가 있기는 하지만, 면역요법, 표적요법 및 새로운 플랫폼 분야의 지속적인 혁신을 통해 향후 몇 년 동안 신경교종의 치료 현황은 점차 변화해 나갈 것으로 예측됩니다.
알킬화제에 주목해 보면, 테모졸로미드(TEMODAR/TEMODAL)는 여전히 신경교종 치료의 핵심을 이루고 있습니다. 이 약제는 DNA를 메틸화함으로써 작용하여 DNA 손상을 유발하고, 종양 세포의 증식을 억제합니다. 혈액-뇌 장벽을 통과하는 능력과 방사선 요법과의 병용에 대한 강력한 임상적 근거 덕분에, 신규 진단 사례와 재발성 신경교종 모두에서 널리 채택되어 지속적으로 활용되고 있습니다. 칼무스틴이나 롬스틴과 같은 다른 약물들도, 특히 특정 치료 상황에서 이 약물군의 일익을 담당하고 있습니다.
표적 치료는 특히 바이오마커 기반 접근법의 부상과 함께, 신경교종 시장에서 점점 더 중요한 역할을 수행하고 있습니다. 보라시데닙(VORANIGO) 등의 IDH 억제제는 IDH 돌연변이형 신경교종을 표적으로 하여 질병의 진행을 늦추고, 보다 적극적인 치료의 필요성을 미룰 수 있는 능력을 보여주고 있으며, 이는 큰 진전을 상징합니다. 마찬가지로, 돌다비프론(MODEYSO)과 같은 신약들도 특정 분자 아형에서 나타난 효능으로 주목을 받고 있으며, 정밀 종양학으로의 전환을 더욱 가속화하고 있습니다.
MAPK 경로 분야에서는 다브라페닙(TAFINLAR)과 트라메티닙(MEKINIST)이 종양 증식에 관여하는 주요 신호전달 단백질을 억제함으로써 BRAF V600E 돌연변이형 신경교종을 표적으로 삼고 있습니다. 이러한 약물은 단독 요법 또는 병용 요법으로 사용되며, 바이오마커를 바탕으로 선별된 환자 집단에서 치료 성과가 개선된 것으로 나타났습니다. 이 계열의 경쟁 약제로는 토보라페닙(DAY101) 등도 등장하면서, 표적 치료 분야에서의 경쟁이 치열해지고 있음이 뚜렷이 드러나고 있습니다.
또한, 레고라페닙과 같은 다중 키나아제 억제제가 재발성 신경교종 치료제로 검토되고 있으며, 종양의 증식 및 혈관 신생에 관여하는 여러 신호 전달 경로를 표적으로 삼음으로써 새로운 작용기전을 제시하고 있습니다. 또한, 새로운 치료제군의 등장으로 향후 신경교종 치료의 전망은 크게 확대될 것으로 보입니다. 여기에는 암 백신(예 : DCVax-L, SurVaxM), 종양 용해성 바이러스(예 : DNX-2401), 엔자스타우린 등의 단백질 키나아제 Cβ 억제제, 그리고 세포 및 유전자 치료(예 : 오프라넬겐·오바데노벡/VB-111) 등이 포함됩니다. 이러한 새로운 접근 방식은 내성, 종양의 이질성, 장기 예후의 불량 등 현행 치료법이 안고 있는 주요 과제를 극복하는 것을 목적으로 하고 있습니다. 예측 기간(2022-2036년) 동안, 이러한 혁신 기술들은 치료 옵션을 다양화하고 치료 효과를 높이며, 교모세포종 관리 방식을 점차 더 개인화된, 작용기전에 기반한 전략으로 전환시켜 나갈 것으로 기대됩니다.
DelveInsight's 'Glioma - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the Glioma, historical and forecasted epidemiology, as well as the Glioma market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
The Glioma market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates glioma 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 glioma 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 Glioma Market
Rising Glioma Prevalence
The increasing incidence and prevalence of glioma, particularly aggressive forms such as glioblastoma, remain a key driver of market growth. Although glioma is a relatively rare cancer, its high mortality and recurrence rates contribute to a sustained patient pool requiring continuous treatment. In major markets such as the US, thousands of new glioma cases are diagnosed annually, and the burden is expected to rise further due to improved diagnostic capabilities and aging populations.
Advancements in Treatment Approaches
The evolution of glioma treatment beyond conventional surgery, radiation, and chemotherapy has significantly contributed to market expansion. The introduction of novel modalities such as tumor treating fields (OPTUNE), targeted therapies for specific mutations (e.g., BRAF inhibitors), immunotherapies, and oncolytic virus therapies has improved clinical outcomes and broadened treatment options, thereby driving therapeutic adoption.
Rising Opportunities in Glioma
Recent progress in immunotherapy, vaccine-based approaches, and precision medicine has created substantial opportunities for emerging players in the glioma market. Innovative therapies such as dendritic cell vaccines including DCVax-L and AV-GBM-1, along with peptide vaccines like SurVaxM, are gaining traction due to their potential to induce durable anti-tumor immune responses. Targeted therapies addressing specific genetic alterations are also expanding the treatment landscape. Agents such as dordaviprone (MODEYSO) for H3K27M-mutant glioma, dabrafenib (TAFINLAR) + trametinib (MEKINIST) for BRAF V600E-mutant tumors, and vorasidenib (VORANIGO) for IDH-mutant glioma highlight the growing importance of biomarker-driven treatment approaches.
In parallel, novel platforms such as oncolytic viruses including DNX-2401 and teserpaturev and targeted agents like regorafenib and AV-GBM-1 are being actively investigated, further strengthening the pipeline.
Emerging Glioma Competitive Landscape
The emerging glioma competitive landscape is highly dynamic and increasingly driven by innovation across immunotherapy, targeted therapy, and novel delivery platforms. A diverse pipeline of active investigational therapies is being developed to address the significant unmet need in both newly diagnosed and recurrent glioma, particularly glioblastoma, where current standards offer limited survival benefit. Among the most competitive segments, cancer vaccines and cell-based immunotherapies are gaining strong momentum, with candidates such as DCVax-L, SurVaxM, AV-GBM-1, and ITI-1000 showing encouraging clinical outcomes. These therapies aim to induce durable anti-tumor immune responses and are increasingly being evaluated in combination with standard-of-care regimens, positioning them as potential game changers in long-term disease control.
Another key competitive class includes oncolytic viruses, such as DNX-2401, teserpaturev, and Ofranergene Obadenovec. These agents offer a dual mechanism of direct tumor cell lysis and immune activation, making them particularly attractive for overcoming tumor resistance and immunosuppressive microenvironments. Their continued advancement in mid-to-late stage trials highlights their competitive potential. In the targeted therapy space, several late-stage and emerging agents are intensifying competition. These include enzastaurin, regorafenib, and paxalisib. These therapies are designed to target specific molecular pathways involved in glioma progression and are expected to play a critical role in biomarker-driven treatment approaches.
Additionally, novel metabolic and membrane-targeting therapies such as LAM561 and BBB-penetrating cytotoxic agents like berubicin are expanding the competitive landscape by addressing key challenges such as drug delivery across the blood-brain barrier and tumor resistance.
Overall, the emerging glioma pipeline reflects a shift toward multi-mechanistic and combination-based strategies, with increasing emphasis on immunotherapy, precision medicine, and improved CNS penetration. As clinical data matures and regulatory milestones are achieved, these active emerging therapies are expected to intensify competition, reshape treatment paradigms, and drive the future growth of the glioma market.
Glioma Overview and Diagnosis
Glioma is the most common central nervous system (CNS) neoplasm originating from glial cells. They are very diffusely infiltrative tumors that affect the surrounding brain tissue. Three common types of gliomas are classified based on phenotypic cell characteristics: Astrocytomas, ependymomas, and oligodendrogliomas. Gliomas are caused by the accumulation of genetic mutations in glial stem or progenitor cells, leading to their uncontrolled growth. Gliomas are further classified into Grades I-IV. Glioblastoma (GBM Grade IV) is the most malignant type, while pilocytic astrocytomas (Grade I) are the least malignant brain tumors among these Grades I-IV. Mutated genes are typically involved in the etiology of glioma. Examples of mutated genes in certain types of glioma include TP53, PTEN (tumor suppressor genes), BRAF (involved in cell growth), and IDH1 (involved in cellular metabolism).
Glioma Diagnosis
The diagnosis of glioma includes neurological exams (this exam tests vision, hearing, speech, strength, sensation, balance, coordination, reflexes, and the ability to think and remember), angiograms, magnetic resonance imaging (MRI), computerized tomography (CT), surgical biopsy, and others. The patient's journey typically starts with the onset of symptoms like seizures, unusual headaches, mood and sensory disturbances, and difficulties in walking. Following an initial visit with a general practitioner, during which the patient underwent a complete physical examination, and the results revealed a few alarming findings related to a brain tumor, the patient was referred to a neuro-oncologist. Further, a neuro-oncologist will immediately recommend an MRI, given that it is the most prominent imaging method, gives good brain images, and aids in the accurate differential diagnosis of brain cancers. A biopsy is carried out to determine the disease's stage if the MRI scans reflect glioma. Moreover, molecular examination of biomarkers may be applied to evaluate the type and grade. Once the grade of the glioma is determined, the appropriate treatment is provided to the patient.
Glioma Treatment
Therapeutic management depends on the type of glioma, its size and location, and the specific characteristics of the patient. Especially in patients where the tumor cannot be entirely removed because it invades the brain in crucial areas or is not accessible, chemotherapy and radiation therapy will follow surgery. The standard treatment regimen includes surgery, chemotherapy, and radiation. Chemotherapy includes carmustine (BCNU), lomustine (CCNU), or gleostine (generic), Gliadel wafer (biodegradable discs infused with BCNU), temozolomide (TEMODAR) cisplatin, carboplatin, etoposide, and irinotecan. They may be given as a single agent or combination, i.e., PCV (procarbazine, CCNU, and vincristine), carboplatin/ etoposide. Temozolomide and bevacizumab are the most commonly used drugs to treat brain tumors. However, the current treatment market lacks an effective strategy to cure glioma, so the survival rate of patients diagnosed with glioma remains low. Glioma is not curable, and approved treatment options are limited. Moreover, the tumor has a high recurrence rate and poor patient prognosis. Also, currently there is no approved therapy for unmethylated MGMT patient pool.
Glioma Unmet Needs
The section "unmet needs of Glioma" 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.
Comprehensive unmet needs insights in Glioma and their strategic implications are provided in the full report.
Key Findings from Glioma Epidemiological Analysis and Forecast
Glioma Drug Chapters & Competitive Analysis
The Glioma 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 glioma treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the glioma therapeutics market.
Approved Therapies for Glioma
Vorasidenib (VORANIGO): Servier Pharmaceuticals
Vorasidenib (VORANIGO) is a first-in-class, brain-penetrant inhibitor targeting IDH1 and IDH2 enzymes. Vorasidenib acts by inhibiting mutant IDH1 and IDH2 enzymes, which reduces the production of the oncometabolite D-2-hydroxyglutarate (2-HG) that drives tumor growth. On August 6, 2024, the US FDA approved vorasidenib (VORANIGO), an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, for adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation, following surgery including biopsy, sub-total resection, or gross total resection.
Emerging Therapies for Glioma
Regorafenib: Bayer
Regorafenib is an oral multi-kinase inhibitor that potently blocks multiple protein kinases involved in tumor angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF), metastasis (VEGFR3, PDGFR, FGFR) and tumor immunity (CSF1R). It is an inhibitor of multiple membrane-bound and intracellular kinases involved in normal cellular functions and pathologic processes such as oncogenesis, tumor angiogenesis, and maintenance of the tumor microenvironment.
In November 2025, Regorafenib (STIVARGA) in combination with temozolomide (TEMODAR) and radiotherapy was tolerable for the treatment of patients with MGMT-methylated, IDH wild-type glioblastoma, according to data from the phase 1 REGOMA-2 study (NCT06095375) presented during the 2025 Society of Neuro-Oncology Annual Meeting.
Glioma Key Players, Market Leaders and Emerging Companies
Glioma Drug Updates
Drug Class Insights
Gliomas are classified into four grades based on differentiation, with Grade I being least malignant and Grade IV (glioblastoma, GBM) being the most aggressive with poor prognosis. Management requires a multidisciplinary approach due to tumor heterogeneity and variable treatment response. The current standard of care includes maximum safe surgical resection followed by radiation and chemotherapy with temozolomide (TEMODAR), with the addition of OPTUNE (tumor treating fields) in eligible patients. In the recurrent setting, bevacizumab (AVASTIN) remains a key therapeutic option.
From a market perspective, high-grade gliomas, particularly GBM, continue to dominate due to high unmet need and poor survival outcomes. While low-grade gliomas historically had limited options, recent approvals and advancements in targeted therapies such as dabrafenib (TAFINLAR) + trametinib (MEKINIST) are expanding treatment opportunities in molecularly defined populations.
The pipeline remains active but challenging, with moderate attrition rates in late-stage trials. Prominent emerging therapies include vaccines such as DCVax-L and SurVaxM, oncolytic viruses such as DNX-2401 and teserpaturev (DELYTACT). Additionally, regorafenib is being actively evaluated and is included in treatment guidelines for recurrent GBM in some settings.
Current treatment patterns across major markets remain consistent, centered on surgery followed by chemoradiation, with targeted and novel therapies gradually being incorporated. Future growth will be driven by precision medicine, biomarker-driven therapies (e.g., IDH, H3K27M), and combination strategies. However, challenges such as lack of robust biomarkers, high clinical trial failure rates, and the immunosuppressive tumor microenvironment continue to limit progress.
Overall, despite significant challenges, continued innovation across immunotherapy, targeted therapy, and novel platforms is expected to gradually reshape the glioma treatment landscape in the coming years.
Drug Class/Insights into Leading Emerging and Marketed Therapies in Glioma (2022-2036 Forecast)
The existing glioma treatment landscape is primarily dominated by therapeutic classes such as vascular endothelial growth factor (VEGF) inhibitors, alkylating agents, MAPK pathway inhibitors, IDH inhibitors, multikinase inhibitors, and emerging targeted and immunotherapy approaches. Among anti-angiogenic agents, bevacizumab (AVASTIN) remains a key therapy designed to inhibit VEGF, a signaling protein that promotes tumor angiogenesis. By blocking VEGF, bevacizumab prevents the formation of new blood vessels that supply nutrients and oxygen to tumors, thereby restricting tumor growth. Although widely used, its role is largely confined to recurrent settings due to modest survival benefits.
Moving to alkylating agents, temozolomide (TEMODAR/TEMODAL) continues to serve as the backbone of glioma therapy. It acts by methylating DNA, leading to DNA damage and inhibition of tumor cell replication. Its ability to cross the blood-brain barrier and its strong clinical evidence in combination with radiation therapy have driven its widespread adoption and sustained utilization in both newly diagnosed and recurrent glioma. Other agents such as carmustine and lomustine also contribute to this class, particularly in specific treatment settings.
Targeted therapies are increasingly shaping the glioma market, particularly with the emergence of biomarker-driven approaches. IDH inhibitors such as vorasidenib (VORANIGO) represent a significant advancement, targeting IDH-mutant gliomas and demonstrating the ability to delay disease progression and postpone the need for more aggressive treatments. Similarly, newer agents such as dordaviprone (MODEYSO) are gaining attention for their activity in specific molecular subtypes, further reinforcing the shift toward precision oncology.
In the MAPK pathway segment, dabrafenib (TAFINLAR) and trametinib (MEKINIST) target BRAF V600E-mutant gliomas by inhibiting key signaling proteins involved in tumor growth. These agents, used as monotherapy or in combination, have demonstrated improved outcomes in biomarker-selected populations. Competing agents within this class, such as tovorafenib (DAY101), are also emerging, highlighting growing competition within targeted therapy segments.
Furthermore, multikinase inhibitors such as regorafenib are being explored in recurrent glioma and offer an alternative mechanism by targeting multiple signaling pathways involved in tumor proliferation and angiogenesis. Moreover, the upcoming glioma treatment landscape is poised for significant expansion with the emergence of novel therapeutic classes. These include cancer vaccines (e.g., DCVax-L, SurVaxM), oncolytic viruses (e.g., DNX-2401), and protein kinase C beta inhibitors such as enzastaurin, and cell and gene therapies (e.g., ofranergene obadenovec/VB-111). These emerging approaches aim to overcome key limitations of current treatments, including resistance, tumor heterogeneity, and poor long-term outcomes. Over the forecast period (2022-2036), these innovations are expected to diversify the therapeutic landscape, enhance treatment efficacy, and gradually shift glioma management toward more personalized and mechanism-driven strategies.
Glioma 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 glioma market's uptake by drugs, patient uptake by therapy, and sales of each drug.
The uptake of therapies in glioma is expected to evolve significantly across standard chemotherapies, targeted therapies, device-based treatments, and emerging immunotherapies. Established treatments such as temozolomide (TEMODAR) and bevacizumab (AVASTIN) are anticipated to maintain baseline utilization due to their long-standing inclusion in clinical guidelines; however, their growth is expected to stabilize given limited impact on long-term survival. Device-based therapy such as OPTUNE will continue to witness steady adoption, particularly in newly diagnosed glioblastoma, supported by survival benefits in combination with chemotherapy.
A major shift in uptake is being driven by newly approved targeted therapies. vorasidenib (VORANIGO), approved in 2024 for IDH-mutant low-grade glioma, is expected to see strong and sustained uptake in early-stage, biomarker-defined populations due to its ability to significantly delay disease progression and defer the need for more toxic therapies. Similarly, dordaviprone (MODEYSO), approved in 2025 for H3 K27M-mutant diffuse midline glioma, represents a breakthrough in a high unmet need segment and is expected to witness rapid uptake in eligible patients, particularly in recurrent settings where treatment options have historically been limited. These agents mark a transition toward precision medicine and are likely to capture increasing market share over the forecast period.
In contrast, other targeted therapies such as dabrafenib (TAFINLAR) + trametinib (MEKINIST) and multikinase inhibitors like regorafenib are expected to see moderate uptake in niche, biomarker-selected populations. Their adoption will be driven by molecular testing uptake and clinical positioning in later lines of therapy.
Emerging therapies including cancer vaccines such as DCVax-L and SurVaxM, oncolytic viruses such as DNX-2401 and teserpaturev, and investigational agents like ONC201 are expected to demonstrate gradual but progressive uptake over the forecast period. Their adoption will depend on clinical trial outcomes, regulatory approvals, and validation of predictive biomarkers. As combination strategies with existing standards of care (including OPTUNE) are optimized, these therapies are anticipated to gain traction, particularly in recurrent and treatment-resistant glioma populations.
Overall, the glioma drug uptake landscape is shifting from a historically chemotherapy-dominated paradigm toward a biomarker-driven, targeted, and immunotherapy-based approach. Newly approved agents such as vorasidenib and dordaviprone are expected to redefine treatment algorithms, while emerging therapies will further diversify the market and gradually improve patient outcomes over the 2022-2036 forecast period.
Glioma Therapies Price Scenario & Trends
Pricing and analogue assessment of glioma 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.
The wholesale acquisition cost (WAC) of temozolomide (TEMODAR) oral capsules varies by strength; for example, a 100 mg capsule costs approximately USD 150-200 per unit, resulting in an estimated annual cost of USD 6,000-12,000 depending on dosing regimen and treatment duration.
The Cost of Therapy is INDICATIVE and will be provided in the updated report...
Industry Experts and Physician Views for Glioma
To keep up with glioma 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 glioma 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 glioma, 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 Michigan State University, University of California, and the Johns Hopkins University School of Medicine, etc. were contacted. Their opinion helps understand and validate current and emerging glioma therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in glioma.
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 Glioma, 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.
Market Insights