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(Albany, US) On November 04, 2026, DelveInsight’s “Glioma Market Insights, Epidemiology and Market Forecast – 2036” report provides comprehensive insights into the Glioma market and pipeline landscape across the 7MM. It covers marketed and emerging drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type, and examines the market drivers and barriers shaping the space.

Discover the latest drugs and treatment options in the Glioma Market @ https://www.delveinsight.com/report-store/glioma-market

Key Takeaways from the Glioma Report

• In October 2026, Rznomics announced that the EMA’s Committee for Orphan Medicinal Products adopted a positive opinion on orphan designation for RZ-001 (taspitimagene advec), an RNA-based gene therapy using a trans-splicing ribozyme to target hTERT mRNA in glioma. The designation allows up to 10 years of market exclusivity and protocol assistance.

• In August 2026, Nuvation Bio received FDA Fast Track designation for safusidenib, an investigational oral therapy for IDH1-mutant glioma.

• In January 2026, Bayer reported ongoing evaluation of regorafenib in glioblastoma through platform trials such as GBM AGILE.

• In November 2025, Northwest Biotherapeutics advanced regulatory engagement for DCVax-L following Phase III data showing improved overall survival in glioblastoma. Also in November 2025, the Phase 1 REGOMA-2 study showed regorafenib with temozolomide and radiotherapy was tolerable in MGMT-methylated, IDH wild-type glioblastoma.

• In August 2025, the FDA granted accelerated approval to dordaviprone (MODEYSO, Jazz Pharmaceuticals) for patients 1 year and older with H3 K27M-mutant diffuse midline glioma with progressive disease after prior therapy. It is the first approved treatment for this ultra-rare tumor.

• The 7MM glioma market was over USD 1 billion in 2025, with the US the largest at about 65%. DelveInsight estimates about 51,000 incident cases in the 7MM in 2025.

• DelveInsight’s report depicts a space shifting toward biomarker-driven targeted therapy, vaccines, oncolytic viruses, and combination strategies.

• Leading Glioma companies include Novocure, Genentech, Merck, Daiichi Sankyo, Novartis, Bayer, Servier Pharmaceuticals, Kazia Therapeutics, Aivita Biomedical, Northwest Therapeutics, VBL Therapeutics, Laminar Pharmaceuticals, Immunomic Therapeutics, and others.

• Promising therapies include dordaviprone (MODEYSO), vorasidenib (VORANIGO), regorafenib, AV-GBM-1, enzastaurin, DCVax-L, LAM561, DNX-2401, ITI-1000, IGV-001, SurVaxM, berubicin, and others.

Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Glioma Treatment Drugs

Glioma Overview

Glioma is the most common central nervous system neoplasm and arises from glial cells. These tumors are diffusely infiltrative and include astrocytomas, ependymomas, and oligodendrogliomas, graded I to IV. Glioblastoma (Grade IV) is the most malignant, and pilocytic astrocytoma (Grade I) the least. Genetic alterations in genes such as TP53, PTEN, BRAF, and IDH1 are involved. Diagnosis combines neurological examination, MRI, CT, biopsy, and molecular biomarker testing. Standard care is maximum safe resection followed by radiation and temozolomide, with tumor treating fields (OPTUNE) for eligible patients and bevacizumab in recurrent disease. Glioma remains largely incurable, with high recurrence in high-grade disease, and no approved therapy exists for unmethylated MGMT patients.

Common presentations include:

• Seizures

• Unusual or persistent headaches

• Mood and sensory disturbances

• Difficulty walking

• Cognitive changes

Glioma Emerging Drugs Profile

DCVax-L: Northwest Therapeutics DCVax-L is a dendritic cell vaccine that incorporates the full set of tumor antigens to make it harder for tumors to evade the immune response. It is given by intradermal injection. Regulatory engagement advanced in November 2025 after Phase III data showed improved overall survival in glioblastoma. Currently, the vaccine is in Phase III.

Paxalisib (GDC-0084): Kazia Therapeutics Paxalisib is an oral small-molecule PI3K pathway inhibitor being studied in newly diagnosed glioblastoma, diffuse midline glioma, and progressive or recurrent high-grade glioma. Currently, the drug is in Phase II/III.

Enzastaurin (DB-102): Denovo Pharma Enzastaurin is an oral small molecule that inhibits protein kinase C beta, being studied in newly diagnosed glioblastoma. Currently, the drug is in Phase II.

Regorafenib: Bayer Regorafenib is an oral multi-kinase inhibitor targeting angiogenesis, oncogenesis, metastasis, and tumor immunity pathways. It is being evaluated in glioblastoma through platform trials such as GBM AGILE, in both newly diagnosed and recurrent settings.

AV-GBM-1: Aivita Biomedical AV-GBM-1 is an immunotherapy of autologous dendritic cells loaded with autologous tumor antigens from tumor-initiating cells, given by subcutaneous injection as adjunctive therapy. It is designed to be pan-antigenic, targeting multiple antigens on cells responsible for growth and resistance to standard therapy.

Explore groundbreaking therapies and clinical trials in the Glioma Pipeline @ Glioma Treatment Drugs

Glioma Market Drivers

• Rising incidence and burden: High mortality and recurrence sustain a large patient pool needing continuous treatment, and aging populations and better diagnostics add to it.

• Biomarker-driven approvals: Vorasidenib, dordaviprone, and dabrafenib plus trametinib show growing value for precision treatment in IDH-, H3 K27M-, and BRAF-mutant tumors.

• Novel modalities: Tumor treating fields, vaccines, oncolytic viruses, and gene therapy have broadened treatment options.

• Active pipeline: DCVax-L, SurVaxM, AV-GBM-1, regorafenib, paxalisib, and others target glioblastoma and recurrent disease.

• Large unmet need: Current standards are non-curative, and recurrence approaches 90 to 95% in high-grade disease.

• Regulatory support: Accelerated approval, Fast Track, and orphan designations speed development.

• Strong US market: The US accounts for about 65% of the 7MM market.

Glioma Market Barriers

• Biosimilar pressure: Bevacizumab biosimilars (ZIRABEV, MVASI) are reducing Avastin’s share and pricing.

• Non-curative standard of care: Temozolomide and radiation are entrenched, and survival benefits from new agents are modest.

• High clinical trial failure rates: Late-stage attrition is a persistent challenge in glioma development.

• Blood-brain barrier and tumor heterogeneity: Drug delivery and resistance limit efficacy.

• Immunosuppressive microenvironment: It restricts the benefit of immunotherapies.

• Lack of robust biomarkers: There is no approved therapy for the unmethylated MGMT population.

• Rare subtype markets: Targeted indications such as H3 K27M-mutant glioma are very small, and accelerated approvals depend on confirmatory trials.

Learn about new drugs, pipeline developments, and key players with DelveInsight’s expert analysis @ Glioma Market Drivers and Barriers

Scope of the Glioma Report

• Coverage: 7MM (US, EU4, UK, Japan)

• Companies: As listed above

• Therapies: Dordaviprone (MODEYSO), vorasidenib (VORANIGO), bevacizumab (AVASTIN), temozolomide (TEMODAR), TAFINLAR + MEKINIST, DELYTACT, regorafenib, AV-GBM-1, enzastaurin, DCVax-L, LAM561, DNX-2401, ITI-1000, IGV-001, SurVaxM, berubicin, and others

• Assessment by Product Type: Mono, Combination, Mono/Combination

• Assessment by Clinical Stage: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Download DelveInsight’s in-depth Glioma report today! @ Glioma Companies

Table of Contents

1. Introduction

2. Executive Summary

3. Glioma: Overview

4. Pipeline Therapeutics

5. Therapeutic Assessment

6. DelveInsight’s Analytical Perspective

7. Late Stage Products (Phase III): DCVax-L (Northwest Therapeutics); Paxalisib (Kazia Therapeutics), Phase II/III

8. Mid Stage Products (Phase II): Enzastaurin (Denovo Pharma)

9. Early Stage Products (Phase I): None specified

10. Preclinical and Discovery Stage Products

11. Inactive Products

12. Key Companies

13. Key Products

14. Unmet Needs

15. Market Drivers and Barriers

16. Future Perspectives and Conclusion

17. Analyst Views

18. Appendix

19. About Us

About DelveInsight DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe.

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