Low Grade Glioma Market to Rise by 2034 | Day One Biopharmaceuticals, AnHeart Therapeutics, Beigene, SpringWorks Therapeutics, Servier, Helsinn, Forma Therapeutics, Hoffmann-La Roche, Incyte, Eli Lilly

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

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

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Key highlights from the low-grade glioma market report:

In the 7MM, the total market size for low-grade glioma (LGG) was approximately USD 990 million in 2023. Until 2022, there were no approved therapies specifically for LGG; treatment primarily relied on surgery, chemotherapy, and radiation, used either alone or in combination.

The standard treatment regimen for low-grade glioma typically includes surgery, chemotherapy, and radiation. In June 2022, the US FDA granted accelerated approval for TAFINLAR + MEKINIST by Novartis, intended for adult and pediatric patients aged 6 years and older with unresectable or metastatic solid tumors featuring the BRAF V600E mutation, especially for those who have not responded to previous treatments.

The incidence rate of mixed gliomas remained stable from 2004 to 2013 but then decreased dramatically, reaching nearly zero by 2022. In 2023, the total incident population of low-grade glioma in the 7MM exceeded 9,000 cases.

In April 2024, Day One Biopharmaceuticals announced the FDA's accelerated approval of OJEMDA (tovorafenib) for patients aged 6 months and older with relapsed or refractory pediatric low-grade glioma (pLGG) that harbors a BRAF fusion or rearrangement, or the BRAF V600 mutation. Additionally, the FDA accepted and granted priority review for VORASIDENIB by Servier for treating IDH-mutant diffuse glioma, with a PDUFA action date set for August 20, 2024.

With these upcoming therapies, the low-grade glioma market size is expected to grow, providing the patient population with new treatment options that could establish a standard of care. Major companies in the low-grade glioma sector include Day One Biopharmaceuticals, Novartis, AnHeart Therapeutics, and others.

Low Grade Glioma Overview

Low-Grade Gliomas (LGGs) are a type of brain tumor that arise from glial cells, which support and protect neurons. These tumors are classified as slow-growing and typically have a better prognosis compared to high-grade gliomas. LGGs are most commonly found in adults and can occur in various locations in the brain.

Causes
The exact causes of low-grade gliomas are not well understood, but several factors may contribute to their development:

Genetic Mutations: Changes in genes such as IDH1, TP53, and 1p/19q co-deletion are associated with LGGs.
Environmental Factors: Exposure to radiation (e.g., from previous cancer treatments) may increase the risk.
Family History: Certain genetic syndromes (e.g., neurofibromatosis) can predispose individuals to gliomas.
Signs and Symptoms
Symptoms of low-grade gliomas can vary based on their location and size but may include:

Headaches: Often persistent and may worsen over time.
Seizures: Commonly occur due to irritation of the brain.
Cognitive Changes: Memory issues, confusion, or personality changes.
Motor Weakness: Weakness or coordination difficulties, depending on tumor location.
Vision or Speech Problems: Changes in vision or difficulty speaking may occur if the tumor affects relevant brain areas.
Diagnosis
Diagnosis of low-grade gliomas typically involves several steps:

Neurological Exam: Assessment of neurological function and symptoms.
Imaging Studies:
MRI: Magnetic resonance imaging is the primary tool used to visualize brain tumors, assessing size, location, and characteristics.
CT Scan: May be used in some cases for further evaluation.
Biopsy: A tissue sample may be taken during surgery or through a needle biopsy to confirm the diagnosis and assess tumor grade.
Molecular Testing: Genetic and molecular analysis of the tumor may help guide treatment and predict outcomes.
Treatment Options
Treatment for low-grade gliomas depends on several factors, including the tumor's size, location, patient health, and symptoms. Options may include:

Surgery:

Resection: Surgical removal of the tumor is often the first-line treatment if the tumor is accessible and can be safely removed.
Radiation Therapy:

Used post-surgery or as the primary treatment for tumors that cannot be surgically removed, especially in cases where the tumor is causing significant symptoms.
Chemotherapy:

Drugs such as temozolomide may be used, particularly if there are residual tumor cells post-surgery or if the tumor recurs.
Observation:

In some cases, especially with asymptomatic patients, careful monitoring (watchful waiting) may be appropriate to avoid unnecessary treatment.
Clinical Trials:

Participation in clinical trials may offer access to new and experimental therapies that could be more effective.
Conclusion
Low-grade gliomas are generally slow-growing tumors with a better prognosis compared to their high-grade counterparts. Early diagnosis and a tailored treatment approach are key to managing the disease effectively. Ongoing research is focused on improving understanding and treatment outcomes for patients with LGGs.

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Low Grade Glioma Market

The standard of care for low-grade glioma involves maximizing safe surgical resection, considering chemoradiation for high-risk patients, and implementing lifelong radiographic surveillance. The primary aim is to delay malignant transformation and enhance quality of life. However, the optimal timing and approach for treatment remain controversial, requiring a careful balance between the benefits of intervention and the risk of treatment-related complications.

Treatment modalities may include surgery, radiation therapy, and chemotherapy, either individually or in combination. In select patients, tumor shrinkage has been observed with various agents, such as temozolomide or the "PCV" regimen (procarbazine, lomustine, and vincristine). Oligodendroglioma patients, particularly those with a chromosome 1p deletion, are most likely to benefit from chemotherapy.

DCVax-L is a key marketed drug in this area. In March 2014, it received "Hospital Exemption" approval in Germany, enabling Northwest to provide DCVax-L in hospitals and outpatient clinics for patients with brain tumors of all severities, although it was primarily tested in newly diagnosed glioblastoma multiforme patients. In 2018, the company moved its European manufacturing to the UK and ceased operations in Germany.

Numerous pharmaceutical companies are actively developing innovative treatments for low-grade glioma, including Day One Biopharmaceuticals, Novartis, AnHeart Therapeutics, SpringWorks Therapeutics, and Servier, among others.

The total market size for low-grade glioma in the US was estimated to exceed USD 550 million in 2023, with growth anticipated during the forecast period from 2024 to 2034. Among second-line therapies, chemotherapy held the largest market share in the US for low-grade glioma in 2023. In the EU4 and the UK, Germany led the market size in 2023, while Spain ranked at the bottom.

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Low Grade Glioma Epidemiology

In 2023, the total number of incident low-grade glioma cases in the 7MM exceeded 9,000. The United States reported the highest incidence, with more than 3,700 cases, and this figure is expected to rise during the forecast period.

Within the US, cases of Grade 2 gliomas outnumbered those of Grade 1 gliomas in 2023. Among specific types, Diffuse Astrocytoma represented the largest proportion of cases, followed by Pilocytic Astrocytoma.

In the EU4 and the UK, Germany recorded the highest number of low-grade glioma cases, followed by France, while Spain had the fewest cases in 2023.

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Low Grade Glioma Drugs Uptake

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

Low Grade 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 Low Grade Glioma market share and size, which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Low-Grade Glioma Marketed Drugs
TAFINLAR (dabrafenib) + MEKINIST (trametinib): Novartis
TAFINLAR (dabrafenib) and MEKINIST (trametinib) are oral small-molecule inhibitors that target the MAPK pathway, inhibiting cell growth in various BRAFV600E-positive tumors. In June 2022, Novartis announced that the US FDA granted accelerated approval for this combination to treat adult and pediatric patients aged 6 and older with unresectable or metastatic solid tumors harboring the BRAF V600E mutation who have progressed after previous treatments and have no satisfactory alternative options.

OJEMDA (tovorafenib): Day One Biopharmaceuticals
Tovorafenib is an investigational, oral, selective RAF inhibitor that penetrates the central nervous system and effectively targets both monomeric and dimeric forms of RAS signaling. Unlike type I BRAF inhibitors, it does not cause paradoxical activation of the MAPK pathway. On April 23, 2024, the US FDA granted accelerated approval for tovorafenib for patients aged 6 months and older with relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion, rearrangement, or BRAF V600 mutation, based on results from the Phase II FIREFLY-1 trial.

Low-Grade Glioma Emerging Drugs
Vorasidenib: Servier
Vorasidenib is an investigational oral dual inhibitor targeting mutant IDH1 and IDH2 enzymes. It is currently being assessed in the Phase III INDIGO study as a potential treatment for patients with residual or recurrent Grade 2 low-grade glioma with an IDH1 or IDH2 mutation (NCT04164901). Promising Phase I data indicated a median progression-free survival of 36.8 months for patients with non-enhancing low-grade glioma and showcased a favorable safety profile. Vorasidenib is also under investigation in a Phase I trial for Grade II/III glioma with the IDH1 R132H mutation (NCT03343197).

Safusidenib/AB-218: Nuvation Bio
Nuvation Bio is studying AB-218, a highly selective mutant IDH1 inhibitor with good blood-brain barrier permeability, in patients with IDH1 mutant glioma. The company has initiated a Phase II trial in participants with recurrent or progressive IDH1 mutant WHO Grade 2/3 glioma, though recruitment has not yet begun. Originally developed by Daiichi Sankyo, the drug was acquired by AnHeart Therapeutics in 2020. The Phase I trial has shown promising efficacy and safety profiles in 12 non-enhancing and 35 enhancing glioma patients.

Mirdametinib: SpringWorks Therapeutics
Mirdametinib is an oral small molecule designed to inhibit MEK1 and MEK2, crucial proteins in the MAPK pathway. SpringWorks Therapeutics has initiated a Phase I/II clinical trial to evaluate Mirdametinib for treating children, adolescents, and young adults with low-grade glioma.

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Low Grade Glioma Therapeutics Assessment

Major pharma companies such as Day One Biopharmaceuticals, AnHeart Therapeutics, Beigene, SpringWorks Therapeutics, Servier, Helsinn, Forma Therapeutics, Hoffmann-La Roche, Incyte, Eli Lilly, and others are working proactively in the Low Grade Glioma Therapeutics market to develop novel therapies which will drive the Low Grade Glioma treatment markets in the upcoming years.

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Low Grade Glioma Report Key Insights

1. Low Grade Glioma Patient Population
2. Low Grade Glioma Market Size and Trends
3. Key Cross Competition in the Low Grade Glioma Market
4. Low Grade Glioma Market Dynamics (Key Drivers and Barriers)
5. Low Grade Glioma Market Opportunities
6. Low Grade Glioma Therapeutic Approaches
7. Low Grade Glioma Pipeline Analysis
8. Low Grade Glioma Current Treatment Practices/Algorithm
9. Impact of Emerging Therapies on the Low Grade Glioma Market

Table of Contents

1. Key Insights
2. Executive Summary
3. Low Grade Glioma Competitive Intelligence Analysis
4. Low Grade Glioma Market Overview at a Glance
5. Low Grade Glioma Disease Background and Overview
6. Low Grade Glioma Patient Journey
7. Low Grade Glioma Epidemiology and Patient Population
8. Low Grade Glioma Treatment Algorithm, Current Treatment, and Medical Practices
9. Low Grade Glioma Unmet Needs
10. Key Endpoints of Low Grade Glioma Treatment
11. Low Grade Glioma Marketed Products
12. Low Grade Glioma Emerging Therapies
13. Low Grade Glioma Seven Major Market Analysis
14. Attribute Analysis
15. Low Grade Glioma Market Outlook (7 major markets)
16. Low Grade Glioma Access and Reimbursement Overview
17. KOL Views on the Low Grade Glioma Market
18. Low Grade Glioma Market Drivers
19. Low Grade Glioma Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer

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