Glioma Market Summary
In 2023, the United States led the glioma market with an estimated size of USD 650 million. Current treatments—including surgery, radiation, and temozolomide – are largely ineffective, with relapse in about 95% of patients. FDA-approved therapies include OPTUNE, AVASTIN, TEMODAR, and TAFINLAR + MEKINIST, alongside biosimilars of bevacizumab (MVASI and ZIRABEV), which are expected to reduce market value due to lower therapy costs. Recently, the FDA accepted an NDA for tovorafenib monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG), with a decision expected by April 2024. The market outlook is positive, driven by promising late-stage pipeline therapies such as AV-GBM-1, DCVax-L, SurVaxM, and vorasidenib. Additionally, Novartis’ label expansion of TAFINLAR + MEKINIST for pediatric low-grade glioma patients with BRAF V600E mutations highlights the potential for significant growth, while the limited treatment options in this segment present a lucrative opportunity for new entrants.
DelveInsight’s report, “Glioma Market Insights, Epidemiology, and Market Forecast-2034,” offers a comprehensive analysis of Glioma, including historical data, future epidemiological trends, and market dynamics across the United States, the EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. It highlights current treatment approaches, emerging therapies, and the market share of individual drugs, along with projections of the Glioma market size from 2020 to 2034 across these seven key markets. In addition, the report explores existing treatment algorithms, market drivers and barriers, as well as unmet medical needs, to identify growth opportunities and evaluate the untapped potential of the Glioma market.
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Some facts of the Glioma Market Report are:
- The total glioma market across the 7MM was valued at approximately USD 1 billion in 2023 and is expected to expand throughout 2024–2034.
- The United States represented the largest share of the glioma market in 2023.
- Key companies active in glioma research and treatment include Bayer, VBL Therapeutics, Candel Therapeutics, AstraZeneca, DNAtrix, DelMar Pharmaceuticals, Oncoceutics, KaryoPharma, VBI Vaccines, Kazia Therapeutics, Aivita Biomedical, Medicenna Therapeutics, Immunomic Therapeutics, Inovio Pharmaceuticals, MedImmune, Bristol-Myers Squibb, Laminar Pharmaceuticals, Day One Biopharmaceuticals, Servier, and others.
- Major investigational glioma therapies include AV-GBM-1, ITI-1000, LAM561, DCVax-L, INO-5401+, INO-9012 + LIBTAYO, SurVaxM, Enzastaurin Hydrochloride, VAL-083, temferon, DAY101, vorasidenib, among others.
- In 2023, OPTUNE, with or without temozolomide, held the largest share of the glioma market in Japan.
- Across the 7MM, there were more than 47,000 new glioma cases in 2022, with incidence expected to increase during the forecast period.
- In the United States, Grade IV glioma accounted for the most cases, followed by Grade II, while Grade I had the lowest incidence.
- Within EU4 and the UK, Germany reported the highest number of glioma cases in 2022, followed by France, while Spain had the fewest.
- Japan represented around 9% of all glioma cases in the 7MM in 2022, with incidence expected to rise over time.
- In July 2025, Hemispherian AS received FDA Orphan Drug Designation for GLIX1 to treat malignant gliomas, including glioblastoma.
- In April 2025, Telix Pharmaceuticals received a Complete Response Letter from the FDA for its NDA of TLX101-CDx (18F-FET, Pixclara®1), an imaging agent for glioma.
- In March 2025, Chimerix initiated a Phase 3 trial of ONC201 for newly diagnosed H3 K27M-mutant diffuse glioma following frontline radiotherapy to assess survival outcomes.
- In March 2025, Day One Biopharmaceuticals launched a Phase 3 trial evaluating tovorafenib monotherapy versus standard chemotherapy in pediatric low-grade glioma patients with RAF alterations.
- In March 2025, Daiichi Sankyo began a Phase 2 trial testing DS-1001b in untreated patients with IDH1-mutated Grade II glioma.
- In March 2025, Laminar Pharmaceuticals initiated a two-phase study of LAM561, starting with a dose escalation design followed by an expanded safety cohort to determine the recommended Phase 2 dose.
- In February 2025, the FDA accepted Chimerix’s NDA for accelerated approval of dordaviprone (ONC201) for recurrent H3 K27M-mutant diffuse glioma.
- In January 2025, Chimerix submitted an NDA for dordaviprone for recurrent H3K27M-mutant diffuse glioma, requesting priority review, with an expected FDA decision in Q3 2025. The therapy also has rare pediatric disease designation.
- In August 2024, Servier gained FDA approval for VORANIGO®, an IDH1/IDH2 inhibitor for adults and children 12+ with Grade 2 astrocytoma or oligodendroglioma with IDH1/2 mutations, offering a once-daily oral treatment.
- On April 23, 2024, the FDA granted accelerated approval to tovorafenib for pediatric patients (≥6 months) with relapsed/refractory low-grade glioma harboring BRAF alterations.
- In March 2024, Daiichi Sankyo reported results from a Phase 1 trial of DS-1001b in IDH1-mutated gliomas.
- In April 2024, Boehringer Ingelheim released Phase Ib results for BI 764532, a DLL3-targeted therapy, in glioma patients.
Glioma Overview
Gliomas are a diverse group of primary brain tumors that arise from glial cells, which provide structural and functional support to neurons. They are among the most common types of brain tumors and vary widely in terms of aggressiveness, prognosis, and treatment response. Based on their origin, gliomas are classified into several subtypes, including astrocytomas, oligodendrogliomas, ependymomas, and glioblastomas, the latter being the most aggressive form. The World Health Organization (WHO) further grades gliomas from I to IV, with higher grades indicating more malignant behavior.
The exact cause of glioma development remains unclear, though genetic alterations, family history, and exposure to ionizing radiation are recognized risk factors. Symptoms depend on tumor size and location, often including headaches, seizures, nausea, vision or speech problems, and cognitive or motor impairments. Diagnosis typically involves MRI or CT scans, followed by biopsy and molecular testing to determine tumor subtype and genetic markers, such as IDH mutation or 1p/19q co-deletion, which also guide prognosis and treatment planning.
Management of gliomas combines surgery, radiation therapy, and chemotherapy, tailored to tumor type and grade. Despite advancements, high-grade gliomas, particularly glioblastomas, remain challenging to treat, with limited survival rates, underscoring the need for ongoing research and novel therapies.
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Glioma Market
The current Glioma market, valued at around USD 1 billion across the 7MM in 2023, is forecast to grow through 2034. The United States dominated with ~63% share, while Germany led in Europe, and Spain had the lowest. In Japan, OPTUNE ± temozolomide accounted for the largest market share and is expected to remain dominant. Recent approvals, such as Daiichi’s DELYTACT, highlight growing interest in oncolytic virus therapies, potentially opening new opportunities for players like DNAtrix and Istari Oncology.
Gliomas are classified into four grades, with Grade I being the least malignant and Grade IV the most aggressive. Treatment is complex and typically requires a multidisciplinary team, as glioma cells respond variably to therapies. Standard care often involves surgery to achieve “maximum safe resection,” followed by chemotherapy, radiation, or stereotactic radiosurgery. High-grade gliomas, particularly glioblastoma (GBM), attract greater commercial focus due to their poor prognosis, while low-grade gliomas, associated with longer survival, have fewer late-stage drugs in development. The GBM pipeline is robust, with multiple mid- to late-stage assets under investigation. Emerging approaches, including gene therapies like VB-111 and vaccine/immunotherapies such as AV-GBM-1, ITI-1000, and DNX-2401, are expected to shift future market dynamics.
The Glioma market is driven by several key factors, including the rising prevalence of brain tumors, increasing research and development activities, and advancements in precision medicine and immunotherapy. The growing adoption of targeted therapies and novel treatment approaches such as gene therapy, oncolytic viruses, and immuno-oncology agents has significantly enhanced patient outcomes. Additionally, regulatory support and fast-track designations for innovative glioma treatments have accelerated drug approvals, fostering market expansion.
However, the Glioma market faces notable barriers, including the aggressive and heterogeneous nature of gliomas, which complicates treatment development. The high cost of novel therapies, limited penetration of advanced treatment options in emerging markets, and the challenges associated with crossing the blood-brain barrier (BBB) further hinder market growth. Additionally, the recurrence rate of gliomas and resistance to existing therapies pose significant obstacles to long-term disease management. Despite these challenges, ongoing clinical trials, biomarker-driven therapies, and combination treatment strategies are expected to drive future growth in the Glioma market, offering new hope for improved patient survival and quality of life.
According to DelveInsight, the Glioma market in 7MM is expected to witness a major change in the study period 2020-2034.
Glioma Epidemiology
In 2023, the United States accounted for about 40% of glioma cases across the 7MM, with Grade IV glioma making up the majority (~68%), followed by Grade II (~13%), while Grade I had the lowest (~6%). Within EU4 and the UK, Germany reported the most cases, France ranked second, and Spain the least. Glioblastoma was the predominant subtype, representing roughly 67% of all glioma cases. In the U.S., incidence was highest among individuals aged 60–74 years (~36%), followed by those aged 45–59 years (~25%).
Glioma Epidemiology Segmentation:
Total Incident Cases (7MM, 2023)
- The United States contributed ~40% of all glioma cases in the 7MM.
- Within EU4 and the UK, Germany had the highest number of cases, followed by France, while Spain reported the lowest.
Grade-Specific Cases (US, 2023)
- Grade IV: ~68% of total cases (highest incidence).
- Grade II: ~13% of cases.
- Grade I: ~6% of cases (lowest incidence).
Age-Specific Cases (US, 2023)
- 60–74 years: ~36% of cases (highest burden).
- 45–59 years: ~25% of cases.
- Other age groups: Lower proportions compared to these two.
Glioma Type-Specific Cases (7MM, 2023)
- Major glioma types: diffuse astrocytoma, anaplastic astrocytoma, glioblastoma, oligodendroglioma, anaplastic oligodendroglioma, oligoastrocytic tumors, pilocytic astrocytoma, and others.
- Glioblastoma: ~67% of all glioma cases (dominant subtype).
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Glioma Pipeline Outlook and Drugs Uptake
Ofranergene Obadenovec (VB-111) – VBL Therapeutics
VB-111 is a pioneering targeted anticancer gene therapy developed by VBL Therapeutics for multiple solid tumors, including glioblastoma (GBM). It uses a non-replicating adenovirus 5 vector (Ad-5, E1-deleted) that delivers a proapoptotic human Fas-chimera transgene to selectively attack angiogenic blood vessels, resulting in vascular disruption. The therapy has received Orphan Drug Designation from both the US FDA and EMA for GBM, along with Fast Track Designation from the FDA for recurrent GBM (rGBM) survival benefit. VB-111 has completed Phase III trials in rGBM and is licensed to NanoCarrier for development and commercialization in Japan.
SurVaxM – MimiVax
SurVaxM is a novel peptide-mimic immunotherapy vaccine designed to target survivin, a cell-survival protein expressed in 95% of GBM and other cancers. It works by both activating T-cell immunity and blocking survivin signaling through antibody-mediated inhibition, thereby slowing tumor growth and reducing recurrence risk. In a Phase IIa trial, MGMT-methylated patients showed a median overall survival of 41.4 months (25.9 months overall), compared with 16.5 months in unmethylated patients. Other vaccine developers in this space include Aivita Biomedical, Immunomic Therapeutics, Northwest Therapeutics, and TVAX Biomedical.
Vorasidenib (AG-881) – Servier
Vorasidenib is a first-in-class dual mIDH1/2 inhibitor engineered for blood–brain barrier penetration. Preclinical studies demonstrated tumor suppression in IDH-mutant glioma models. Early-phase trials confirmed favorable safety and tumor-suppressive activity. The drug is currently under evaluation in the Phase III INDIGO study for patients with residual or recurrent Grade II low-grade glioma.
Tovorafenib (DAY101) – Day One Biopharmaceuticals
Tovorafenib is an oral, brain-penetrant, highly selective type II pan-RAF kinase inhibitor that blocks a key enzyme in the MAPK pathway, offering potential therapy for brain tumors and metastatic brain lesions. It is being studied in the pivotal Phase II FIREFLY-1 trial to assess its safety and efficacy in pediatric, adolescent, and young adult patients with recurrent or progressive low-grade glioma carrying BRAF alterations.
Gain in-depth insights into emerging glioma therapies, including VB-111, SurVaxM, Vorasidenib, and Tovorafenib—explore clinical progress, regulatory designations, and therapeutic potential. Access the complete analysis here @ Glioma Medication and Companies
Glioma Therapeutics Assessment
Major key companies are working proactively in the Glioma Therapeutics market to develop novel therapies which will drive the Glioma treatment markets in the upcoming years are Bayer (BAYN.DE, XETRA), VBL Therapeutics (VBLT, NASDAQ), Candel Therapeutics (CADL, NASDAQ), AstraZeneca (AZN, NASDAQ & LSE), DNAtrix (Private), DelMar Pharmaceuticals (Now part of Kintara Therapeutics – KTRA, NASDAQ), Oncoceutics (Acquired by Chimerix – CMRX, NASDAQ), KaryoPharma (KPTI, NASDAQ), VBI Vaccines (VBIV, NASDAQ), Kazia Therapeutics (KZIA, NASDAQ), Aivita Biomedical (Private), Medicenna Therapeutics (MDNA, NASDAQ & TSX), Immunomic Therapeutics (Private), Inovio Pharmaceuticals (INO, NASDAQ), MedImmune (Subsidiary of AstraZeneca), Bristol-Myers Squibb (BMY, NYSE), Laminar Pharmaceuticals (Private), Day One Biopharmaceuticals (DAWN, NASDAQ), and Servier, and others.
Learn more about the emerging Glioma therapies & key companies @ Glioma Clinical Trials and FDA Approvals
Glioma Report Key Insights
1. Glioma Patient Population
2. Glioma Market Size and Trends
3. Key Cross Competition in the Glioma Market
4. Glioma Market Dynamics (Key Drivers and Barriers)
5. Glioma Market Opportunities
6. Glioma Therapeutic Approaches
7. Glioma Pipeline Analysis
8. Glioma Current Treatment Practices/Algorithm
9. Impact of Emerging Therapies on the Glioma Market
Table of Contents
1. Key Insights
2. Executive Summary
3. Glioma Competitive Intelligence Analysis
4. Glioma Market Overview at a Glance
5. Glioma Disease Background and Overview
6. Glioma Patient Journey
7. Glioma Epidemiology and Patient Population
8. Glioma Treatment Algorithm, Current Treatment, and Medical Practices
9. Glioma Unmet Needs
10. Key Endpoints of Glioma Treatment
11. Glioma Marketed Products
12. Glioma Emerging Therapies
13. Glioma Seven Major Market Analysis
14. Attribute Analysis
15. Glioma Market Outlook (7 major markets)
16. Glioma Access and Reimbursement Overview
17. KOL Views on the Glioma Market
18. Glioma Market Drivers
19. Glioma Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer
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