Glioma Drugs Market 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Medication, Revenue, Statistics, Companies and Market Forecast by DelveInsight

(New York, USA) Glioma Market Summary
In 2023, DelveInsight estimates the U.S. glioma market at approximately USD 650 million, the largest globally. Despite standard treatments-surgical resection, radiation, temozolomide, and maintenance temozolomide-relapse occurs in ~95% of patients, underscoring limited efficacy. Approved therapies include OPTUNE (Novocure), AVASTIN (Genentech), TEMODAR (Merck), and the TAFINLAR + MEKINIST combo (Novartis). The introduction of bevacizumab biosimilars, such as ZIRABEV (Pfizer, approved 2019) and MVASI (Amgen, approved 2017), is expected to drive cost reductions and pressure AVASTIN revenues. The pipeline is robust, with the FDA accepting tovorafenib for pLGG under Priority Review (PDUFA date: April 30, 2024), and promising late-stage assets like AV-GBM-1, ITI-1000, LAM561, DCVax-L, INO-5401+, SurVaxM, Enzastaurin, VAL-083, temferon, DAY101, and vorasidenib indicating market expansion potential. Furthermore, Novartis' label expansion of TAFINLAR + MEKINIST to include pediatric low-grade glioma with BRAF V600E mutations highlights a broader addressable population but also reflects a significant unmet need, with only one approved therapy in this segment, presenting substantial opportunities for novel treatments.

DelveInsight's "Glioma Market Insights, Epidemiology, and Market Forecast-2034" report delivers an in-depth understanding of Glioma, historical and forecasted epidemiology as well as the Glioma market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

The Glioma market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Glioma market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Glioma treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Glioma market.

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Some facts of the Glioma Market Report are:
• The total Glioma market size in the 7MM is around USD 1,000 million in 2023 and is projected to grow during the forecast period (2024-2034).
• According to the estimates, the highest Glioma market size is from the United States in 2023.
• Leading Glioma companies working in the treatment market are 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.
• Some of the Glioma drugs covered are AV-GBM-1, ITI-1000, LAM561, DCVax-L, INO-5401+, INO-9012 + LIBTAYO, SurVaxM, Enzastaurin Hydrochloride, VAL-083, temferon, DAY101, vorasidenib, and others.
• In 2023, OPTUNE ± TMZ captured the highest market size of glioma in Japan.
• The total incident cases of Glioma in the 7MM comprised of around 47,000+ in 2022 and are projected to increase during the forecast period.
• In the United States, Grade IV accounted for the highest number of incident cases, followed by Grade II glioma, while Grade I had the least number of cases.
• Among EU4 and the UK, Germany accounted for the highest number of glioma cases, followed by France, whereas Spain had the lowest number of cases in 2022.
• Japan accounted for approximately 9% of the total 7MM incident cases of glioma in 2022. These cases are expected to rise in the study period.
• In July 2025, Hemispherian AS, a pioneering biotech company developing next-generation therapeutics for aggressive cancers, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for GLIX1 for the treatment of malignant glioma, a category of devastating brain cancers that includes glioblastoma.
• In April 2025, Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces that it has received a Complete Response Letter (CRL) from the United States (U.S.) Food and Drug Administration (FDA) for its New Drug Application (NDA) for TLX101-CDx (Floretyrosine F18 or 18F-FET, Pixclara®1), an investigational agent for the imaging of glioma, a rare and life-threatening brain cancer.
• In March 2025, Chimerix announced a phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.
• In March 2025, Day One Biopharmaceuticals, Inc . announced a phase 3 study trial to evaluate the efficacy, safety, and tolerability of tovorafenib monotherapy versus standard of care (SoC) chemotherapy in patients with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring front-line systemic therapy.
• In March 2025, Daiichi Sankyo Co., Ltd announced a phase 2 study is conducted to assess the efficacy and safety of DS-1001b in patients with chemotherapy- and radiotherapy-naive IDH1 mutated WHO grade II glioma.
• In March 2025, Laminar Pharmaceuticals announced a study will be performed in two phases: a dose escalation phase in up to 18 patients following a standard "3+3" design to establish dose-limiting toxicity (DLT) and a "safe" dose of LAM561 followed by an expanded safety cohort of up to 10 patients treated at the Maximum Tolerated Dose (MTD). If the MTD is well tolerated in the expanded safety cohort, that dose becomes the Recommended Phase 2 Dose (RP2D).
• In Feb 2025, the FDA accepted a new drug application for accelerated approval of dordaviprone (ONC201; Chimerix) as a treatment for recurrent H3 K27M-mutant diffuse glioma.
• In January 2025, Chimerix submitted an NDA for accelerated approval of dordaviprone for patients with recurrent H3K27M-mutant diffuse glioma. The company has requested priority review, aiming for a target action date in Q3 2025 under PDUFA. Dordaviprone previously received a rare pediatric disease designation for this indication.
• In August 2024, Servier today announced that the U.S. Food and Drug Administration (FDA) has approved VORANIGO®, an isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor, indicated for the treatment of 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. VORANIGO is available and offers glioma patients the ability to actively manage their disease with the convenience of a once-daily pill.
• On April 23, 2024, the FDA granted accelerated approval to tovorafenib for the treatment of pediatric patients 6 months of age or older with relapsed/refractory low-grade glioma harboring a BRAF rearrangement or fusion, or a BRAF V600 mutation.
• On March 2024, Daiichi Sankyo announced results of a Phase 1 Study of DS-1001b in Patients With IDH1 Mutated Gliomas.
• On April 2024, Boehringer Ingelheim announced results of a Phase Ib Open-label, Multi-center, Dose Escalation Trial of BI 764532 Given as Monotherapy Administered by Repeated Intravenous Infusions in Patients With Glioma Expressing DLL3.

Glioma Overview
A glioma is a central nervous system tumor that arises from glial stem or progenitor cells. Glial cells are a type of cell widely present in the nervous system. Gliomas mostly occur in the brain and, rarely, in the spinal cord.
Classification of gliomas is complex and based partly on the microscopic appearance of the tumor (histologic classification) and partly on the gene changes (mutations) that are implicated in tumor development. Differentiation is an important concept for the histologic classification of gliomas and refers to the "specialization" of the cell.
Gliomas can have four different grades of differentiation. Grade 1 gliomas show the highest level of differentiation and are the least malignant, while grade 4 tumors are the least differentiated and most malignant. Loss of differentiation is known as anaplasia, hence the name of several grade 3 gliomas. Grade 1 and grade 2 gliomas are often referred to as low-grade gliomas, while grades 3 and 4 are referred to as malignant gliomas. Further classification is possible depending on the genetic alterations that occurred in the affected cells.

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Glioma Market
The Glioma market outlook of the report helps to build a detailed comprehension of the historical, current, and forecasted Glioma market trends by analyzing the impact of current Glioma therapies on the market and unmet needs, and drivers, barriers, and demand for better technology.

This segment gives a thorough detail of the Glioma market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated Glioma market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

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
The Glioma epidemiology section provides insights into the historical and current Glioma patient pool and forecasted trends for seven individual major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the Glioma market report also provides the diagnosed patient pool, trends, and assumptions.

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Glioma Drugs Uptake
This section focuses on the uptake rate of the potential Glioma drugs recently launched in the Glioma market or expected to be launched in 2020-2034. The analysis covers the Glioma market uptake by drugs, patient uptake by therapies, and sales of each drug.

Glioma Drugs Uptake helps in understanding the drugs with the most rapid uptake and the reasons behind the maximal use of new drugs and allows the comparison of the drugs based on Glioma market share and size, which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Glioma Pipeline Development Activities
The Glioma report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses Glioma key players involved in developing targeted therapeutics.

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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.

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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

Related Reports:

Glioma Pipeline Insights 2025
https://www.delveinsight.com/report-store/glioma-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

"Glioma Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights of present clinical development scenarios and growth prospects across the Glioma market. A detailed picture of the Glioma pipeline landscape is provided, which includes the disease overview and Glioma treatment guidelines.

Contact Us:
Ankit Nigam
Manager Marketing
info@delveinsight.com
+14699457679
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About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

This release was published on openPR.