Rashtriya Newsflash

DelveInsight’s “High-grade Glioma Market Insights, Epidemiology, and Market Forecast-2034″ report offers an in-depth understanding of the High-grade Glioma, historical and forecasted epidemiology as well as the High-grade Glioma market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

To Know in detail about the High-grade Glioma market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; High-grade Glioma Market Forecast

Some of the key facts of the High-grade Glioma Market Report:

• The High-grade Glioma market size was valued approximately USD 830 million in 2023 and is anticipated to grow with a significant CAGR during the study period (2020-2034).

• In January 2026, The FDA has approved an investigational new drug (IND) application for SRN-101, an AAV-based immuno-gene therapy, aimed at treating adult patients with recurrent high-grade glioma, according to a press release from Siren Biotechnology. The company intends to launch a first-in-human clinical trial in this patient population. Siren Biotechnology noted that this represents the first FDA-cleared IND for an AAV-based therapy in an oncology indication.

• In November 2025, enrollment started for the second part of a clinical trial evaluating safusidenib, an investigational oral therapy, as a maintenance treatment for high-grade IDH1-mutant astrocytoma, a severe form of glioma. Sponsored by Nuvation Bio, the study (NCT05303519) plans to enroll 300 adults across sites in the U.S., Australia, and China. Eligible participants must have completed standard-of-care treatments such as chemotherapy, radiation, or surgery. The trial consists of two parts: the first assessed safusidenib’s efficacy, safety, and pharmacokinetics in patients with recurrent or progressive IDH1-mutant glioma, while the second will compare maintenance safusidenib versus placebo following standard-of-care therapy.

• In September 2025, FluoGuide received positive FDA feedback at a pre-IND consultation for its U.S. clinical study of FG001, an intraoperative imaging agent for high-grade glioma, supporting both the IND submission and a future NDA filing.

• In June 2025, Iopofosine I-131 showed clinical activity and a favorable safety profile in pediatric patients with relapsed or refractory high-grade glioma, according to early results from the Phase 1 CLOVER-2 trial (NCT05610891). Observed toxicities were consistent with prior reports for the agent. Among 7 patients who received a cumulative dose of at least 55 mCi, the mean progression-free survival (PFS) was 5.4 months and the mean overall survival (OS) was 8.6 months. All patients in this group achieved disease control based on Response Assessment in Pediatric Neuro-Oncology (RAPNO) criteria, which is associated with improved survival outcomes in this population.

• In June 2025, Initial results from the Phase 1 CLOVER-2 trial (NCT05610891) indicated that iopofosine I-131 was safe and demonstrated clinical activity in pediatric patients with relapsed/refractory high-grade glioma. The therapy showed a favorable safety profile, with observed toxicities aligning with previously reported data for the drug.

• In April 2025, Preliminary findings from the Phase 2 IPAX-Linz study revealed that TLX101 (¹³¹I-iodofalan), an investigational targeted radiotherapy, showed a favorable safety profile and early indications of clinical activity in patients with recurrent high-grade glioma (HGG).

• Across the 7MM, the United States reported the highest number of incident high-grade glioma cases in 2023, with approximately 16,200 new diagnoses.

• Within the EU4 and the UK, Germany reported the highest number of high-grade glioma cases, followed by France, while Spain recorded the lowest incidence.

• Glioblastoma accounts for a substantially higher number of incident cases than anaplastic astrocytoma. In the United States in 2023, glioblastoma recorded approximately 13,100 new cases, compared with around 1,600 cases of anaplastic astrocytoma.

• Across age-specific groups, adult patients represent a significantly larger proportion of cases compared to pediatric patients.

• Key High-grade Glioma Companies: Everfront Biotech Co., Ltd., BioMimetix JV, LLC, Chimerix, Laminar Pharmaceuticals, Nationwide Children’s Hospital, Rigel Pharmaceuticals, Orbus Therapeutics, BioMimetix, Bayer, MedImmune, DNAtrix, Chimerix, CNS Pharmaceuticals, VBI Vaccines, Kazia Therapeutics, Aivita Biomedical, Medicenna Therapeutics, DelMar Pharmaceuticals, Bristol-Myers Squibb, Laminar Pharmaceuticals, Immunomic Therapeutics, Inovio Pharmaceuticals, and others

• Key High-grade Glioma Therapies: Cerebraca wafer, BMX-001, ONC201, LAM561, Ribociclib, Olutasidenib + TMZ, Eflornithine + Lomustine, BMX-001, Regorafenib, Durvalumab (MEDI4736), Tasadenoturev (DNX-2401), ONC201, Berubicin, VBI-1901, Paxalisib (GDC-0084), AV-GBM-1, MDNA55, VAL-083 (Dianhydrogalactitol), Pomalidomide, LP561A1 (2-OHOA), ITI-1000 (pp65 DC Vaccine), INO-5401+ INO-9012+ Cemiplimab (REGN2810), and others

• The High-grade Glioma epidemiology based on gender analyzed that High-grade Glioma is more common in men than in women

• The High-grade Glioma market is expected to surge due to the disease’s increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage High-grade Glioma pipeline products will significantly revolutionize the High-grade Glioma market dynamics.

High-grade Glioma Overview

High-grade glioma (HGG) is an aggressive and fast-growing type of primary brain tumor that arises from glial cells and is classified as World Health Organization (WHO) grade III or IV, with glioblastoma being the most common and severe form. These tumors are characterized by rapid infiltration into surrounding brain tissue, making them difficult to treat. Common symptoms include headaches, seizures, cognitive or personality changes, and neurological deficits, depending on tumor location. Diagnosis typically involves neuroimaging (MRI/CT) and histopathological confirmation through biopsy or surgical resection.

Standard treatment includes maximal safe surgical removal followed by radiation therapy and chemotherapy, most commonly with temozolomide. Despite advances in therapy, high-grade gliomas are associated with a poor prognosis, driving ongoing research into targeted therapies, immunotherapies, and novel treatment approaches.

Get a Free sample for the High-grade Glioma Market Forecast, Size & Share Analysis Report:

https://www.delveinsight.com/report-store/high-grade-glioma-hgg-market

High-grade Glioma Epidemiology

The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

High-grade Glioma Epidemiology Segmentation:

The High-grade Glioma market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

• Total Prevalence of High-grade Glioma

• Prevalent Cases of High-grade Glioma by severity

• Gender-specific Prevalence of High-grade Glioma

• Diagnosed Cases of Episodic and Chronic High-grade Glioma

Download the report to understand which factors are driving High-grade Glioma epidemiology trends @ High-grade Glioma Epidemiology Forecast

High-grade Glioma Drugs Uptake and Pipeline Development Activities

The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the High-grade Glioma market or expected to get launched during the study period. The analysis covers High-grade Glioma market uptake by drugs, patient uptake by therapies, and sales of each drug.

Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.

The report also covers the High-grade Glioma Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

High-grade Glioma Therapies and Key Companies

• Cerebraca wafer: Everfront Biotech Co., Ltd.

• BMX-001: BioMimetix JV, LLC

• ONC201: Chimerix

• LAM561: Laminar Pharmaceuticals

• Ribociclib: Nationwide Children’s Hospital

• Olutasidenib + TMZ: Rigel Pharmaceuticals

• Eflornithine + Lomustine: Orbus Therapeutics

• BMX-001: BioMimetix

• Regorafenib: Bayer

• Durvalumab (MEDI4736): MedImmune

• Tasadenoturev (DNX-2401): DNAtrix

• ONC201: Chimerix

• Berubicin: CNS Pharmaceuticals

• VBI-1901: VBI Vaccines

• Paxalisib (GDC-0084): Kazia Therapeutics

• AV-GBM-1: Aivita Biomedical

• MDNA55: Medicenna Therapeutics

• VAL-083 (Dianhydrogalactitol): DelMar Pharmaceuticals

• Pomalidomide: Bristol-Myers Squibb

• LP561A1 (2-OHOA): Laminar Pharmaceuticals

• ITI-1000 (pp65 DC Vaccine): Immunomic Therapeutics

• INO-5401+ INO-9012+ Cemiplimab (REGN2810): Inovio Pharmaceuticals

Discover more about therapies set to grab major High-grade Glioma market share @ High-grade Glioma Treatment Landscape

High-grade Glioma Market Strengths

• Rising Incidence: Increasing prevalence of high-grade gliomas, particularly glioblastoma, globally is driving market demand.

• Advancements in Targeted Therapies: Development of novel therapies such as DCVax-L and ONC-201 offering improved survival outcomes.

• Enhanced Diagnostic Capabilities: Better imaging techniques and molecular profiling enable earlier detection and personalized treatment strategies.

• Growing Investment in R&D: Increased focus from biopharmaceutical companies on innovative therapies and clinical trials for high-grade gliomas

• Supportive Regulatory Environment: Accelerated approvals and orphan drug designations facilitating faster market entry of new treatments.

High-grade Glioma Market Opportunities

• High Treatment Costs: Expensive therapies and complex treatment regimens limit patient access, particularly in low- and middle-income countries.

• Limited Efficacy of Current Therapies: Conventional treatments such as chemotherapy and radiotherapy have limited survival benefits.

• Complex Disease Biology: Heterogeneity of tumors and resistance mechanisms pose challenges in developing effective treatments.

• Side Effects and Toxicity: Severe adverse effects associated with aggressive therapies can affect patient compliance.

• Market Fragmentation: Availability of therapies varies across regions, and lack of standardized treatment guidelines hampers uniform adoption.

Scope of the High-grade Glioma Market Report

• Study Period: 2020–2034

• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

• Key High-grade Glioma Companies: Everfront Biotech Co., Ltd., BioMimetix JV, LLC, Chimerix, Laminar Pharmaceuticals, Nationwide Children’s Hospital, Rigel Pharmaceuticals, Orbus Therapeutics, BioMimetix, Bayer, MedImmune, DNAtrix, Chimerix, CNS Pharmaceuticals, VBI Vaccines, Kazia Therapeutics, Aivita Biomedical, Medicenna Therapeutics, DelMar Pharmaceuticals, Bristol-Myers Squibb, Laminar Pharmaceuticals, Immunomic Therapeutics, Inovio Pharmaceuticals, and others

• Key High-grade Glioma Therapies: Cerebraca wafer, BMX-001, ONC201, LAM561, Ribociclib, Olutasidenib + TMZ, Eflornithine + Lomustine, BMX-001, Regorafenib, Durvalumab (MEDI4736), Tasadenoturev (DNX-2401), ONC201, Berubicin, VBI-1901, Paxalisib (GDC-0084), AV-GBM-1, MDNA55, VAL-083 (Dianhydrogalactitol), Pomalidomide, LP561A1 (2-OHOA), ITI-1000 (pp65 DC Vaccine), INO-5401+ INO-9012+ Cemiplimab (REGN2810), and others

• High-grade Glioma Therapeutic Assessment: High-grade Glioma current marketed and High-grade Glioma emerging therapies

• High-grade Glioma Market Dynamics: High-grade Glioma market drivers and High-grade Glioma market barriers

• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies

• High-grade Glioma Unmet Needs, KOL’s views, Analyst’s views, High-grade Glioma Market Access and Reimbursement

To know more about High-grade Glioma companies working in the treatment market, visit @ High-grade Glioma Clinical Trials and Therapeutic Assessment

Table of Contents

1. High-grade Glioma Market Report Introduction

2. Executive Summary for High-grade Glioma

3. SWOT analysis of High-grade Glioma

4. High-grade Glioma Patient Share (%) Overview at a Glance

5. High-grade Glioma Market Overview at a Glance

6. High-grade Glioma Disease Background and Overview

7. High-grade Glioma Epidemiology and Patient Population

8. Country-Specific Patient Population of High-grade Glioma

9. High-grade Glioma Current Treatment and Medical Practices

10. High-grade Glioma Unmet Needs

11. High-grade Glioma Emerging Therapies

12. High-grade Glioma Market Outlook

13. Country-Wise High-grade Glioma Market Analysis (2020–2034)

14. High-grade Glioma Market Access and Reimbursement of Therapies

15. High-grade Glioma Market Drivers

16. High-grade Glioma Market Barriers

17. High-grade Glioma Appendix

18. High-grade Glioma Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

Media Contact
Company Name: DelveInsight
Contact Person: Gaurav Bora
Email: Send Email
Phone: +14699457679
Address:304 S. Jones Blvd #2432
City: Albany
State: New York
Country: United States
Website: https://www.delveinsight.com/