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Glioma - Market Insight, Epidemiology And Market Forecast - 2032

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    Report

  • 394 Pages
  • April 2023
  • Region: Global
  • DelveInsight
  • ID: 5524075
UP TO OFF until Dec 31st 2024

Key Highlights

  • As per the American Association of Neurological Surgeons (AANS), gliomas are the most prevalent type of adult brain tumor, accounting for 78% of malignant brain tumors.
  • According to the publisher's estimates, in 2022, the highest number of incident cases were observed in the United States among the 7MM.
  • The current standard of care for glioma management - surgical resection, radiation therapy, temozolomide, and temozolomide maintenance therapy - is largely ineffective, with 95% of patients suffering a relapse.
  • In 2022, the total market size of glioma was around USD 1,000 million in the 7MM - the increasing incidence of the disease is expected to fuel the market during 2022-2032.
  • Our estimates show that the market is anticipated to witness a significant positive shift owing to the positive outcomes of several products during the developmental stage, such as AV-GBM-1, ITI-1000, LAM561, DCVax-L, INO-5401+, INO-9012 + LIBTAYO, SurVaxM, Enzastaurin Hydrochloride, VAL-083, temferon, DAY101, vorasidenib, and others.
  • Although the label expansion of Novartis' TAFINLAR (dabrafenib) + MEKINIST (trametinib) for treating pediatric patients 1 year old and older with low-grade glioma with a BRAF V600E mutation offers a more commercial opportunity with a wide target pool, a single approved therapy for low-grade glioma segment indicate a lucrative opportunity to develop more treatment options.
This “Glioma Market - Market Insights, Epidemiology and Market Forecast - 2032 report delivers an in-depth understanding of the glioma, historical and forecasted epidemiology as well as the glioma market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

The Glioma market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM glioma market size from 2019 to 2032. The report also covers current glioma treatment practice/algorithm and unmet medical needs to curate the best of the opportunities and assess the market's underlying potential.

Geography Covered

  • The United States
  • The EU4 (Germany, France, Italy, Spain) and the United Kingdom
  • Japan
Study Period: 2019-2032

Glioma Disease Understanding and Treatment Algorithm

Glioma Overview

Glioma is the most common central nervous system (CNS) neoplasm originating from glial cells. They are very diffusely infiltrative tumors that affect the surrounding brain tissue. Three common types of gliomas are classified based on phenotypic cell characteristics: Astrocytomas, ependymomas, and oligodendrogliomas. Gliomas are caused by the accumulation of genetic mutations in glial stem or progenitor cells, leading to their uncontrolled growth. Gliomas are further classified into Grades I-IV. Glioblastoma (GBM Grade IV) is the most malignant type, while pilocytic astrocytomas (Grade I) are the least malignant brain tumors among these Grades I-IV. Mutated genes are typically involved in the etiology of glioma. Examples of mutated genes in certain types of glioma include TP53, PTEN (tumor suppressor genes), BRAF (involved in cell growth), and IDH1 (involved in cellular metabolism).

Glioma Diagnosis

The diagnosis of glioma includes neurological exams (this exam tests vision, hearing, speech, strength, sensation, balance, coordination, reflexes, and the ability to think and remember), angiograms, magnetic resonance imaging (MRI), computerized tomography (CT), surgical biopsy, and others. The patient's journey typically starts with the onset of symptoms like seizures, unusual headaches, mood and sensory disturbances, and difficulties in walking. Following an initial visit with a general practitioner, during which the patient underwent a complete physical examination, and the results revealed a few alarming findings related to a brain tumor, the patient was referred to a neuro-oncologist. Further, a neuro-oncologist will immediately recommend an MRI, given that it is the most prominent imaging method, gives good brain images, and aids in the accurate differential diagnosis of brain cancers. A biopsy is carried out to determine the disease's stage if the MRI scans reflect glioma. Moreover, molecular examination of biomarkers may be applied to evaluate the type and grade. Once the grade of the glioma is determined, the appropriate treatment is provided to the patient.

Note: Further details related to diagnosis are provided in the report.

Glioma Treatment

Therapeutic management depends on the type of glioma, its size and location, and the specific characteristics of the patient. Especially in patients where the tumor cannot be entirely removed because it invades the brain in crucial areas or is not accessible, chemotherapy and radiation therapy will follow surgery. The standard treatment regimen includes surgery, chemotherapy, and radiation. Chemotherapy includes carmustine (BCNU), lomustine (CCNU), or gleostine (generic), Gliadel wafer (biodegradable discs infused with BCNU), temozolomide (TEMODAR) cisplatin, carboplatin, etoposide, and irinotecan. They may be given as a single agent or combination, i.e., PCV (procarbazine, CCNU, and vincristine), carboplatin/ etoposide. Temozolomide (TEMODAR) and bevacizumab (AVASTIN) are the most commonly used drugs to treat brain tumors. However, the current treatment market lacks an effective strategy to cure glioma, so the survival rate of patients diagnosed with glioma remains low. Glioma is not curable, and approved treatment options are limited. Moreover, the tumor has a high recurrence rate and poor patient prognosis. Also, currently, there is no approved therapy for unmethylated MGMT patient pool.

Glioma Epidemiology

As the market is derived using the patient-based model, the glioma epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incident cases of glioma, grade-specific cases of glioma, age-specific cases of glioma, and type-specific cases of glioma in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2019 to 2032. The total incident cases of glioma in the 7MM comprised approximately 47,000 cases in 2022 and are projected to increase during the forecast period.
  • The United States contributed to the largest incident population of glioma, acquiring ~40% of the 7MM in 2022.
  • 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.
  • According to the publisher's estimates, in the 7MM, of all the grades, Grade IV accounted for the highest number of incident cases, followed by Grade II glioma, while Grade I had the least number of cases.
  • In 7MM, among all the age groups, 60-74 years accounted for the highest number of glioma cases, i.e., around 36%, in 2022, followed by the age-group 45-59 years (25%).

Glioma Drug Chapters

The drug chapter segment of the glioma report encloses a detailed analysis of glioma-marketed drugs and emerging (Phase-III and Phase II and Phase I/II) pipeline drugs. It also helps understand the glioma clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Current therapies

AVASTIN: Genentech

AVASTIN (Bevacizumab) is a recombinant humanized monoclonal IgG1 antibody, which acts as an angiogenesis inhibitor by blocking its target, vascular endothelial growth factor (VEGF). Bevacizumab binds to the vascular endothelial growth factor (VEGF) with its receptor VEGFR-1 and VEGFR-2, which are present on the surface of endothelial cells. In December 2017, the US FDA approved bevacizumab (AVASTIN) for treating adults with recurrent GBM that has progressed following prior therapy.

Owing to AVASTIN's (bevacizumab) patent term expiration, the US FDA has approved three biosimilars: MVASI (Amgen), ZIRABEV (Pfizer), and ALYMSYS (Amneal Pharma). In 2017, the US FDA approved the first AVASTIN biosimilar, Amgen's MVASI. The analysis indicates that the market for AVASTIN brand may undergo a significant negative shift due to the drop in therapy costs following the introduction of its biosimilar in the United States.

TEMODAR (temozolomide): Merck

The active pharmaceutical ingredient in TEMODAR/TEMODAL is an imidazotetrazine derivative of the alkylating agent dacarbazine. Temozolomide is used for the treatment of several brain cancer forms, e.g., as a second-line treatment for astrocytoma and as a first-line treatment for GBM. The therapeutic benefit of temozolomide is due to its ability to alkylate/methylate DNA. In July 2006, the Japan Ministry of Health, Labor and Welfare (MHLW) approved TEMODAL (temozolomide) Capsules for the treatment of malignant glioma. Generic versions of the drug are also available due to patent expiration.

According to our estimates, temozolomide is the most commonly prescribed chemotherapy drug to treat GBM. Whereas, in case of low grade glioma, lomustine, irinotecan, vincristine and procarbazine are used majorly.

Note: Detailed current therapies assessment will be provided in the full report of glioma.

Emerging Drugs

Ofranergene obadenovec (VB-111): VBL Therapeutics

Ofranergene obadenovec (VB-111) is a first-in-class, targeted anticancer gene-therapy agent that VBL Therapeutics is developing to treat a wide range of solid tumors such as GBM. It is a non-replicating adenovirus 5 (Ad-5, El-deleted) carrying a proapoptotic human Fas-chimera transgene that targets angiogenic blood vessels and leads to vascular disruption. The drug has been rewarded Orphan Drug Designation from both US FDA and EMA for the treatment of patients with GBM. In addition, it has also been granted Fast Track Designation by the US FDA for prolongation of survival in patients with rGBM. Currently, the drug has completed the Phase III stage of clinical development for patients with rGBM. In November 2017, VBL Therapeutics signed an exclusive license agreement with NanoCarrier for developing, commercializing, and supplying ofranergene obadenovec (VB-111) in Japan.

SurVaxM: MimiVax

SurVaxM by MimiVax is a first-of-its-kind, patented peptide mimic immunotherapeutic vaccine (immunotherapy) that targets survivin, a cell-survival protein in 95% of GBM and other cancers. The vaccine has dual mechanisms of action to stimulate a patient's T-cell immunity and employs antibody-directed inhibition of the survivin pathway to control tumor growth and prevent or delay tumor recurrence. The Phase IIa study showed that the overall survival was 25.9 months in MGMT methylated patients at 41.4 months, and in MGMT unmethylated patients was 16.5 months. Similarly, the FSecorded was 17.9 months MGMT methylated patients higher than in MGMT unmethylated patients. Apart from SurVaxM other players developing vaccines are Aivita Biomedical, Immunomic Therapeutics, Northwest Therapeutics and TVAX Biomedical.

Vorasidenib (AG-881): Servier

Vorasidenib (AG-881), a first-in-class, dual inhibitor of mIDH1/2, was specifically developed for improved penetration across the blood-brain barrier and showed brain penetrance and reduced tumor growth in an orthotopic model of mIDH glioma. Phase I interim data suggested that tumor-intrinsic and -extrinsic mechanisms underlie 2-HG suppression by vorasidenib and ivosidenib. Vorasidenib demonstrated a favorable safety profile and is currently being evaluated in the registration-enabling Phase III INDIGO study as a potential treatment for patients with residual or recurrent Grade II low-grade glioma.

Tovorafenib (DAY101): Day One Biopharmaceuticals

Tovorafenib (DAY101) is an investigational, oral, brain-penetrant, highly selective type II pan-RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway, which may offer an important alternative for people with primary brain tumors or brain metastases of solid tumors. Currently, DAY101 is under evaluation in a pivotal Phase II clinical trial (FIREFLY-1) evaluating its safety and efficacy in pediatric, adolescent, and young adult patients with recurrent or progressive low-grade glioma (pLGG) harboring a known BRAF alteration. Based on the initial FIREFLY-1 data, the company plans to expand the development of tovorafenib as a front-line therapy for patients newly diagnosed with pLGG and anticipates reporting topline data from this trial in the first quarter of 2023, and if the data are supportive, the company expects to file an NDA to FDA, in first of half 2023.

Note: Detailed emerging therapies assessment will be provided in the final report.

Drug Class Insights

The existing glioma treatment is mainly dominated by classes such as vascular endothelial growth factor (VEGF) inhibitors, alkylating agents, multikinase inhibitors, MAPK pathway inhibitors, IDH1 inhibitors, and others.

AVASTIN (bevacizumab) is a tumor-starving (anti-angiogenic) therapy designed to block a protein called VEGF, a chemical signal that stimulates angiogenesis in various diseases, especially cancer. Normal cells make VEGF, but some cancer cells make too much VEGF. Blocking VEGF may prevent the growth of new blood vessels, including normal blood vessels and blood vessels that feed tumors. Unlike chemotherapy which attacks the cancer cells, the purpose of AVASTIN is to block the blood supply that feeds the tumor. This can stop the tumor from growing by stopping the formation of blood vessels that bring oxygen and nutrients to tumors
Moving onto alkylating agents, TEMODAR/TEMODAL (temozolomide) is a traditional alkylating agent that acts by producing DNA cross-linkages, thus inhibiting DNA and cellular replication. The proposed mechanism of action is based on the ability of its metabolites to deposit methyl groups on DNA guanine bases. The widespread prescriptions and guideline recommendations for temozolomide regimen in glioma management are due to its ability to alkylate/methylate DNA, which leads to the destruction of DNA and triggers the death of the tumor cells.

IDH1 and IDH2 are the most commonly mutated genes in low-grade glioma, with mutations estimated to occur in >70% of cases, due to which Servier's investigational drug, vorasidenib, can be a promising option for low-grade glioma patient pool. BRAF V600E point mutations are occasionally observed in pilocytic astrocytoma; the mutations are also observed in nonpilocytic pediatric low-grade glioma.

TAFINLAR (dabrafenib) and MEKINIST (trametinib) target two distinct points - BRAF and MEK1/2 proteins on the MAPK pathway studied extensively as monotherapies and in combination. TAFINLAR capsules inhibit cell growth of various BRAF V600E mutation-positive tumors in vitro and in vivo, and inhibition of MEK1 and MEK2 with MEKINIST tablets can suppress downstream signaling of the MAPK pathway as alterations in the MAP-kinase pathway can inhibit normal, nontumor cells and result in side effects, some of which may be serious. The nearest competitor to the combination of dabrafenib + trametinib is DAY101, which belongs to the same therapeutic class with comparable efficacy.

Moreover, the upcoming glioma treatment landscape is poised to see further expansion after the emergence of new classes such as cancer vaccines, protein kinase C beta inhibitors, dendritic cell immunotherapy, cell and gene therapy, and others.

Glioma Market Outlook

Gliomas can have four different grades of differentiation. Grade I gliomas show the highest level of differentiation and are the least malignant, while Grade IV tumors are the least differentiated and most malignant. A large multidisciplinary team of medical specialists and health professionals is required to treat patients with gliomas. Glioma treatment is quite challenging as some cells may respond well to certain therapies while others may not be affected at all. Because of this, the treatment plan for glioma may combine several approaches. The treatment often comprises a combination of several therapies, including surgery, chemotherapy, radiation, or stereotactic radiosurgery, followed by additional/adjuvant treatments, such as chemotherapy or radiation therapy, after surgery.

The first step in treating glioma is a surgical procedure to make a diagnosis, relieve pressure on the brain, and safely remove as much tumor as possible. Glioma surgery is performed to achieve a “maximum safe resection” or remove as much of the tumor as possible without causing lasting neurological damage.

From a commercial perspective, there is more focus on high-grade glioma than low-grade glioma, as patients with low-grade glioma typically live longer than those with high-grade glioma. Hence, only a few drugs are in the late phases, while most are being evaluated in early-phase trials. On the contrary, in the case of GBM, the pipeline is robust and possesses multiple potential drugs in late and mid-stage developments, which are yet to be launched. The pipeline involves drugs with various mechanisms of action along with different routes of administration. It is interesting to note that the emerging market of glioma includes budding gene therapy, i.e., ofranergene obadenovec (VB-111) by VBL Therapeutics, followed by four vaccine/immunotherapy candidates such as VBI-1901, AV-GBM-1 and ITI-1000 (pp65 DC Vaccine), tasadenoturev (DNX-2401) by VBI Vaccines, Aivita Biomedical, Immunomic Therapeutics, and DNAtrix, respectively, and these therapies are going to alter the market dynamics in the upcoming years.

The current market has been segmented based on the prevailing treatment pattern across the 7MM, which presents minor variations in the overall prescription pattern. Surgery ± chemotherapy/radiation therapy, chemotherapy ± radiation therapy, bevacizumab + radiotherapy/chemotherapy, and OPTUNE with temozolomide are considered in the forecast model.

The expected launch of upcoming therapies and greater integration of early patient screening, medication in secondary care and other clinical settings, research on best methods for implementation, and an upsurge in awareness will eventually facilitate the development of effective treatment options. However, there are a few barriers to the timely diagnosis and treatment of these patients; for instance, there is a lack of a reliable biomarker that can help with diagnosis and patient stratification, as well as diagnosing recurrence and indicating therapy response. Also, the trial failure rate of high-phased drugs is high, making it difficult to anticipate the success of trials, further intensifying the need for therapies that could help ease the patient segment with this aggressive form of cancer.

Few players like Day One Biopharmaceuticals (tovorafenib (DAY101)), Novartis (TAFINLAR + MEKINIST), AnHeart Therapeutics (AB-218), TVAX Biomedical (TVI-Brain-1), Servier (vorasidenib (AG- 881), and others are evaluating their lead candidates in different stages of clinical development, respectively, for the treatment of low-grade glioma. In contrast, the GBM pipeline is robust, with a handful of therapeutic assets in the late-to-mid stage of the drug development process.
  • The total market size of glioma in the United States is approximately USD 650 million in 2022 and is projected to grow during the forecast period (2022-2032).
  • According to the estimates, the United States recorded the highest market share, i.e., around 63% of the total market size of glioma, in 2022.
  • Among the EU4 (Germany, France, Italy, Spain) and the UK, Germany has the maximum revenue share in 2022, while Spain has the lowest market share.
  • In 2022, OPTUNE ± TMZ captured the highest market size of glioma in Japan. This combination is expected to generate maximum revenue during the forecast period (2022-2032).
  • Conditional and time-limited approval of Daiichi's DELYTACT, an intratumoral oncolytic virus therapy, has opened new doors for other players, such as DNAtrix and Istari Oncology, to develop oncolytic virus therapies, which can prove to be a potential mechanism of action in brain cancer treatment in future.

Glioma Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to get launched in the market during the study period 2019-2032. For example, for VAL-083, we expect the drug uptake in the US to be medium-fast with a probability-adjusted peak share of approximately 9%in the first line and a lower peak share in the second line, years to peak is expected to be 6+ years from the year of launch.

Note: Further detailed analysis of emerging therapies drug uptake in the report.

Glioma Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I/II stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisition and merger, licensing, and patent details for glioma emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on glioma evolving treatment landscape, patient reliance on conventional therapies, patient's therapy switching acceptability, drug uptake along with challenges related to accessibility, include Medical/scientific writers, Medical Oncologists, and Professors: MD, Oncologist at Memorial Sloan Kettering Cancer Center, Deputy Director of Miami Cancer Institute, and Others.

This analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as MD Anderson Cancer Center, National Brain Tumor Society, Cancer Research UK, etc., were contacted. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or glioma market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

The publisher performs Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in glioma, the essential efficacy parameters considered were ORR, PFS, OS, and CBR. Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed. It sets a clear understanding of the side effects posed by the drug in the trials.

Market Access and Reimbursement

Reimbursement of rare disease therapies can be limited due to lack of supporting policies and funding, challenges of high prices, lack of specific approaches to evaluating rare disease drugs given limited evidence, and payers' concerns about budget impact. The high cost of rare disease drugs usually has a limited impact on the budget due to the small number of eligible patients being prescribed the drug. The US FDA has approved several rare disease therapies in recent years. From a patient perspective, health insurance and payer coverage guidelines surrounding rare disease treatments restrict broad access to these treatments, leaving only a small number of patients who can bypass insurance and pay for products independently.

Glioma carries a high economic burden for patients and caregivers associated with initial surgery. The National Brain Tumor Society (2018) reported that brain cancer has the highest per-patient initial cost of care for any cancer group, with an annualized mean net cost of care approaching USD 150,000. As per a study conducted by Chandra et al. (2019), out of 227 patients with GBM (median age 62, 37.9% females), 31 (13.7%) had Medicaid, 94 (41.4%) had Medicare, and 102 (44.9%) had private insurance.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

  • The report covers a segment of key events, an executive summary, and a descriptive overview of glioma, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
  • Additionally, an all-inclusive account of the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will impact the current treatment landscape.
  • A detailed review of the glioma market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
  • The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM glioma market.

Glioma Report Insights

  • Patient Population
  • Therapeutic Approaches
  • Glioma Pipeline Analysis
  • Glioma Market Size and Trends
  • Existing and Future Market Opportunity

Glioma Report Key Strengths

  • Ten Years Forecast
  • 7MM Coverage
  • Glioma Epidemiology Segmentation
  • Key Cross Competition
  • Attribute Analysis
  • Drugs Uptake and Key Market Forecast Assumptions

Glioma Report Assessment

  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Market Attractiveness
  • Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions Answered

Market insights

  • What was the glioma market share (%) distribution in 2019, and what would it look in 2032? What are the contributing factors for this growth?
  • How will MAPK pathway inhibitors as a class affect the treatment paradigm in the first and second lines of glioma?
  • What will be the impact of TAFINLAR + MEKINIST expected patent expiry in 2030?
  • How will tovorafenib (DAY101) compete with TAFINLAR + MEKINIST in the first and second-line respectively?
  • What are the pricing variations among different geographies for approved and off-label therapies?
  • How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology insights

  • What are the disease risk, burdens, and unmet needs of glioma? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to glioma?
  • What is the historical and forecasted glioma patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
  • Why do only limited patients appear with symptoms? Why is the current year diagnosis rate not high?
  • Which type of glioma is the largest contributor to the glioma patient pool?
  • Which age group account for the major share of the incident glioma population? Or which age group is more susceptible to glioma in the 7MM?
Current Treatment Scenario and Emerging Therapies
  • What are the current options for the treatment of glioma? What are the current guidelines for treating glioma in the US and Europe?
  • How many companies are developing therapies for the treatment of glioma?
  • How many emerging therapies are in the mid-stage and late stage of development for treating glioma?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
  • What are the key designations that have been granted for emerging therapies for glioma?
  • What is the cost burden of approved therapies on the patient?
  • What are the key designations that have been granted for emerging therapies for glioma?
  • Patient acceptability in terms of preferred treatment options as per real-world scenarios?
  • What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.
  • What is the 7MM historical and forecasted market of glioma?

Reasons to Buy

  • The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the glioma market.
  • Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
  • Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
  • Identifying strong upcoming players in the market will help devise strategies that will help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential current and emerging therapies under the Conjoint analysis section to provide visibility around leading classes.
  • Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
  • To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1. Key Insights2. Report Introduction3. Executive Summary of Glioma4. Key Events5. Epidemiology and Market Forecast Methodology
6. Glioma Market Overview at a Glance
6.1. Market Share (%) Distribution of Glioma by Therapies in 2022
6.2. Market Share (%) Distribution of Glioma by Therapies in 2032
7. Disease Background and Overview: Gliomas
7.1. Introduction
7.2. Classification of gliomas
7.2.1. Low-grade Gliomas
7.2.2. High-grade Gliomas
7.3. Signs and symptoms
7.4. Causes
7.5. Diagnosis
7.5.1. Neurological exams
7.5.2. Angiograms
7.5.3. Computerized tomography (CT)
7.5.4. Magnetic resonance imaging (MRI)
7.5.5. Perfusion MRI
7.5.6. MR spectroscopy
7.5.7. Histological diagnosis
7.5.8. Surgical biopsy
8. Treatment and management
8.1. Treatment of LGGs
8.2. Treatment of HGGs
8.3. Symptom management
8.4. Treatment guidelines and recommendations
8.4.1. American Society of Clinical Oncology (ASCO) Endorsed American Society for Radiation Oncology (ASTRO) Guideline on Radiation Therapy for Glioblastoma (2017)
8.4.2. American Society of Therapeutic Radiology and Oncology (ASTRO) Clinical Practice Guideline for LGGs (2021)
8.4.3. National Comprehensive Cancer Network [NCCN] Guidelines for the Management of Gliomas (2022)
8.4.4. National Institute for Health and Care Excellence Guidelines for the Management of Newly Diagnosed Glioblastoma (2021)
8.4.5. Japanese Society of Neurological Surgery Guidelines for the Treatment of Adult Glioblastoma (2019)
8.4.6. Society for Neuro-Oncology (SNO) and European Society of Neuro-Oncology (EANO) Consensus Review on Current Management and Future Directions for Glioblastoma in Adults (2020)
8.4.7. Clinical Recommendation for Glioblastoma (Associazione Italiana di Oncologia Medica [AIOM], 2021)
8.4.8. Medical Oncology Spanish Society (SEOM) Clinical Guidelines for Diagnosis and Treatment of Glioblastoma
8.4.9. European Association of Neuro-Oncology (EANO) Guidelines for the Diagnosis and Management of Adult Patients with Diffuse Gliomas (2021)
8.4.10. SEOM Guideline Recommendations for LGGs (2017)
9. Epidemiology and Patient Population of Glioma in the 7MM
9.1. Key Findings
9.2. Assumptions and Rationale
9.3. Total Incident Cases of Glioma in the 7MM
9.4. The United States
9.4.1. Total Incident Cases of Glioma in the United States
9.4.2. Grade-specific Cases of Glioma in the United States
9.4.3. Age-specific Cases of Glioma in the United States
9.4.4. Type-specific Cases of Glioma in the United States
9.5. EU4 and the UK
9.5.1. Total Incident Cases of Glioma in EU4 and the UK
9.5.2. Grade-specific Cases of Glioma in EU4 and the UK
9.5.3. Age-specific Cases of Glioma in EU4 and the UK
9.5.4. Type-specific Cases of Glioma in EU4 and the UK
9.6. Japan
9.6.1. Total Incident Cases of Glioma in Japan
9.6.2. Grade-specific Cases of Glioma in Japan
9.6.3. Age-specific Cases of Glioma in Japan
9.6.4. Type-specific cases of Glioma in Japan
10. Patient Journey11. Key Endpoints in Glioma
12. Marketed Products
12.1. Key Competitors
12.2. OPTUNE: Novocure Limited
12.2.1. Product description
12.2.2. Regulatory milestones
12.2.3. Other developmental activities
12.2.4. Current pipeline activity
12.2.5. Safety and efficacy
12.2.6. Product profile
12.3. AVASTIN (bevacizumab): Genentech
12.3.1. Product description
12.3.2. Regulatory milestones
12.3.3. Other developmental activities
12.3.4. Safety and efficacy
12.3.5. Product profile
12.4. TEMODAR (temozolomide): Merck
12.4.1. Product description
12.4.2. Regulatory milestones
12.4.3. Other development activities
12.4.4. Current pipeline activity
12.4.5. Safety and efficacy
12.4.6. Product profile
12.5. DELYTACT: Daiichi Sankyo
12.5.1. Product description
12.5.2. Regulatory milestones
12.5.3. Other developmental activities
12.5.4. Safety and efficacy
12.5.5. Product profile
12.6. TAFINLAR (dabrafenib) + MEKINIST (trametinib): Novartis
12.6.1. Product description
12.6.2. Regulatory milestones
12.6.3. Other Developmental Activities
12.6.4. Clinical development
12.6.5. Safety and efficacy
12.6.6. Product profile
13. Emerging Drugs
13.1. Key Competitors
13.2. Regorafenib: Bayer
13.2.1. Product description
13.2.2. Other developmental activities
13.2.3. Clinical development
13.2.4. Safety and efficacy
13.3. ONC201: Chimerix
13.3.1. Product description
13.3.2. Other developmental activities
13.3.3. Clinical development
13.3.4. Safety and efficacy
13.4. AV-GBM-1: Aivita Biomedical
13.4.1. Product description
13.4.2. Clinical development
13.4.3. Safety and efficacy
13.5. Enzastaurin (DB-102): Denovo Biopharma
13.5.1. Product description
13.5.2. Other developmental activities
13.5.3. Clinical development
13.5.4. Safety and efficacy
13.6. DCVax-L: Northwest Therapeutics
13.6.1. Product description
13.6.2. Other developmental activity
13.6.3. Clinical development
13.6.4. Safety and efficacy
13.7. Ofranergene Obadenovec (VB-111): VBL Therapeutics
13.7.1. Product Description
13.7.2. Other Developmental Activities
13.7.3. Clinical development
13.7.4. Safety and efficacy
13.8. LAM561 (2-OHOA): Laminar Pharmaceuticals
13.8.1. Product description
13.8.2. Other developmental activities
13.8.3. Clinical development
13.8.4. Safety and efficacy
13.9. MEDI4736 (durvalumab): MedImmune
13.9.1. Product description
13.9.2. Clinical Development
13.9.3. Safety and efficacy
13.10. Tasadenoturev (DNX-2401): DNAtrix
13.10.1. Product description
13.10.2. Other developmental activities
13.10.3. Clinical development
13.10.4. Safety and efficacy
13.11. ITI-1000 (pp65 DC Vaccine): Immunomic Therapeutics
13.11.1. Product description
13.11.2. Other developmental activities
13.11.3. Clinical development
13.11.4. Safety and efficacy
13.12. IGV-001: Imvax
13.12.1. Product description
13.12.2. Other developmental activities
13.12.3. Clinical development
13.12.4. Safety and efficacy
13.13. SurVaxM: MimiVax
13.13.1. Product description
13.13.2. Other developmental activities
13.13.3. Clinical development
13.13.4. Safety and efficacy
13.14. Berubicin: CNS Pharmaceuticals
13.14.1. Product description
13.14.2. Other developmental activities
13.14.3. Clinical development
13.14.4. Safety and efficacy
13.15. GLIOVAC (Sitoiganap): Epitopoietic Research Corporation (ERC)
13.15.1. Product description
13.15.2. Other developmental activities
13.15.3. Clinical development
13.15.4. Safety and efficacy
13.16. Lerapolturev + Pembrolizumab: Istari Oncology
13.16.1. Product description
13.16.2. Other developmental activities
13.16.3. Clinical development
13.16.4. Safety and efficacy
13.17. SONALA-001 + Exablate 2.0 Device: SonALAsense
13.17.1. Product description
13.17.2. Clinical development
13.17.3. Safety and efficacy
13.18. VAL-083 (dianhydrogalactitol): Kintara Therapeutics
13.18.1. Product description
13.18.2. Other developmental activities
13.18.3. Clinical development
13.18.4. Safety and efficacy
13.19. Pomalidomide: Bristol Myers Squibb
13.19.1. Product description
13.19.2. Other developmental activities
13.19.3. Clinical development
13.19.4. Safety and efficacy
13.20. MDNA55: Medicenna Therapeutics
13.20.1. Product description
13.20.2. Other developmental activities
13.20.3. Clinical development
13.20.4. Safety and efficacy
13.21. BMX-001: BioMimetix
13.21.1. Product description
13.21.2. Other developmental activity
13.21.3. Clinical development
13.21.4. Safety and efficacy
13.22. Lenvatinib ± Pembrolizumab: Eisai and Merck Sharp & Dohme
13.22.1. Product description
13.22.2. Clinical development
13.22.3. Safety and efficacy
13.23. Paxalisib (GDC-0084): Kazia Therapeutics
13.23.1. Product description
13.23.2. Other developmental activities
13.23.3. Clinical development
13.23.4. Safety and efficacy
13.24. OKN-007: Oblato
13.24.1. Product description
13.24.2. Other developmental Activity
13.24.3. Clinical development
13.24.4. Safety and efficacy
13.25. Temferon: Genenta Science
13.25.1. Product description
13.25.2. Clinical development
13.25.3. Safety and efficacy
13.26. EO2401: Enterome
13.26.1. Product description
13.26.2. Clinical development
13.26.3. Safety and efficacy
13.27. INO-5401+ INO-9012+ LIBTAYO (cemiplimab): Inovio Pharmaceuticals
13.27.1. Product description
13.27.2. Clinical development
13.27.3. Safety and efficacy
13.28. Selinexor (KPT-330): Karyopharm Therapeutics
13.28.1. Product description
13.28.2. Clinical development
13.28.3. Safety and efficacy
13.29. VBI-1901: VBI Vaccines
13.29.1. Product description
13.29.2. Other developmental activities
13.29.3. Clinical development
13.29.4. Safety and efficacy
13.30. NOX-A12 (Olaptesed Pegol): TME Pharma
13.30.1. Product description
13.30.2. Other developmental activities
13.30.3. Clinical development
13.30.4. Safety and efficacy
13.31. Tovorafenib (DAY101): Day One Biopharmaceuticals
13.31.1. Product description
13.31.2. Other developmental activities
13.31.3. Clinical development
13.31.4. Safety and efficacy
13.32. Vorasidenib (AG-881): Servier
13.32.1. Product description
13.32.2. Other developmental activities
13.32.3. Clinical development
13.32.4. Safety and efficacy
13.33. Eflornithine: Orbus Therapeutics
13.33.1. Product description
13.33.2. Other developmental activities
13.33.3. Clinical development
13.33.4. Safety and efficacy
13.34. TVI-Brain-1: TVAX Biomedical
13.34.1. Product description
13.34.2. Other developmental activities
13.34.3. Clinical development
13.35. AB-218: AnHeart Therapeutics
13.35.1. Product description
13.35.2. Other developmental activities
13.35.3. Clinical development
13.35.4. Safety and efficacy
13.36. BGB-290: Beigene
13.36.1. Product description
13.36.2. Clinical development
13.36.3. Safety and efficacy
13.37. Mirdametinib: SpringWorks Therapeutics
13.37.1. Product description
13.37.2. Other developmental activities
13.37.3. Clinical development
13.37.4. Safety and efficacy
13.38. FT-2102 (Olutasidenib): Forma Therapeutics
13.38.1. Product description
13.38.2. Other developmental activities
13.38.3. Clinical development
13.38.4. Safety and efficacy
13.39. Vinblastine + Bevacizumab: Hoffmann-La Roche
13.39.1. Product description
13.39.2. Clinical development
13.39.3. Safety and efficacy
13.40. Cobimetinib: Hoffmann-La Roche
13.40.1. Product description
13.40.2. Clinical development
13.40.3. Safety and efficacy
13.41. PEMAZYRE (Pemigatinib): Incyte Corporation
13.41.1. Product description
13.41.2. Clinical development
13.42. VERZENIO (abemaciclib): Eli Lilly
13.42.1. Product description
13.42.2. Clinical development
13.42.3. Safety and efficacy
14. Glioma: Seven Major Market Analysis
14.1. Market Outlook
14.2. Conjoint Analysis
14.3. Total Market Size of Glioma in the 7MM
14.4. United States Market Size
14.4.1. Total Market Size of Glioma in the United States
14.4.2. Market Size of Glioma by Current and Emerging Therapies in the United States
14.5. EU4 and the UK Market Size
14.5.1. Total Market Size of Glioma in EU4 and the UK
14.5.2. Market Size of Glioma by Current and Emerging Therapies in EU4 and the UK
14.6. Japan Market Size
14.6.1. Total Market Size of Glioma in Japan
14.6.2. Market Size of Glioma by Current and Emerging Therapies in Japan
15. Unmet Needs16. SWOT Analysis17. KOL Views
18. Market Access and Reimbursement for Glioma
18.1. United States
18.2. Europe
18.3. Japan
19. Appendix
19.1. Bibliography
19.2. Report Methodology
20. Publisher Capabilities21. Disclaimer22. About the Publisher
List of Tables
Table 1: Key Events
Table 2: Grading Within Types
Table 3: Glioma Grading Scale
Table 4: Indication and Timing for RT
Table 5: Optimal Dose of RT and Target Volume Based on Risk Stratification
Table 6: Adult Glioma: WHO Grade 1
Table 7: Adult Glioma: Oligodendroglioma (IDH-mutant, 1p19q Codeleted)
Table 8: Adult Glioma: IDH-Mutant Astrocytoma
Table 9: Adjuvant Treatment of GBM Based on age and Karnofsky Performance Status
Table 10: Summary of Recommendations
Table 11: Key Treatment Recommendations for Adult Patients with Common Diffuse Gliomas
Table 12: Total Incident Cases of Glioma in the 7MM (2019-2032)
Table 13: Total Incident Cases of Glioma in the US (2019-2032)
Table 14: Grade-specific Cases of Glioma in the US (2019-2032)
Table 15: Age-specific Cases of Glioma in the US (2019-2032)
Table 16: Type-specific Cases of Glioma in the US (2019-2032)
Table 17: Total Incident Cases of Glioma in EU4 and the UK (2019-2032)
Table 18: Grade-specific Cases of Glioma in EU4 and the UK (2019-2032)
Table 19: Age-specific Cases of Glioma in EU4 and the UK (2019-2032)
Table 20: Type-specific Cases of Glioma in EU4 and the UK (2019-2032)
Table 21: Total Incident Cases of Glioma in Japan (2019-2032)
Table 22: Grade-specific Cases of Glioma in Japan (2019-2032)
Table 23: Age-specific Cases of Glioma in Japan (2019-2032)
Table 24: Type-specific Cases of Glioma in Japan (2019-2032)
Table 25: Comparison of Marketed Products
Table 26: OPTUNE, Clinical Trial Description, 2022
Table 27: TEMODAR, Clinical Trial Description, 2022
Table 28: Recommended Weight-based Dosing for TAFINLAR and MEKINIST for Liquid Formulations
Table 29: Trametinib + Dabrafenib ,Clinical Trial Description, 2022
Table 30: Comparison of Emerging Drugs
Table 31: Regorafenib, Clinical Trial Description, 2022
Table 32: ONC201, Clinical Trial Description, 2022
Table 33: AV-GBM-1, Clinical Trial Description, 2022
Table 34: Enzastaurin Hydrochloride, Clinical Trial Description, 2022
Table 35: DCVAX-L, Clinical Trial Description, 2022
Table 36: VB-111, Clinical Trial Description, 2022
Table 37: 2-OHOA, Clinical Trial Description, 2022
Table 38: MEDI4736, Clinical Trial Description, 2022
Table 40: Tasadenoturev (DNX-2401), Clinical Trial Description, 2022
Table 41: ITI-1000, Clinical Trial Description, 2022
Table 42: IGV-001, Clinical Trial Description, 2022
Table 43: SurVaxM, Clinical Trial Description, 2022
Table 44: Berubicin, Clinical Trial Description, 2022
Table 45: Sitoiganap, Clinical Trial Description, 2022
Table 46: Lerapolturev, Clinical Trial Description, 2022
Table 47: SONALA-001 + Exablate 2.0 Device, Clinical Trial Description, 2022
Table 48: VAL-083 (dianhydrogalactitol), Clinical Trial Description, 2022
Table 49: Pomalidomide (CC-4047), Clinical Trial Description, 2022
Table 50: MDNA55, Clinical Trial Description, 2022
Table 51: BMX-001, Clinical Trial Description, 2022
Table 52: Pembrolizumab ± Lenvatinib, Clinical Trial Description, 2022
Table 53: Paxalisib (GDC-0084), Clinical Trial Description, 2022
Table 54: OKN-007, Clinical Trial Description, 2022
Table 55: Temferon, Clinical Trial Description, 2022
Table 56: EO2401, Clinical Trial Description, 2022
Table 57: INO-5401+ INO-9012+ LIBTAYO, Clinical Trial Description, 2022
Table 58: Selinexor (KPT-330), Clinical Trial Description, 2022
Table 59: Olutasidenib, Clinical Trial Description, 2022
Table 60: VBI-1901, Clinical Trial Description, 2022
Table 61: NOX-A12 (Olaptesed Pegol), Clinical Trial Description, 2022
Table 62: DAY101, Clinical Trial Description, 2022
Table 63: Vorasidenib, Clinical Trial Description, 2022
Table 64: Eflornithine, Clinical Trial Description, 2022
Table 65: TVI-Brain-1, Clinical Trial Description, 2022
Table 66: AB-218, Clinical Trial Description, 2022
Table 67: BGB-290, Clinical Trial Description, 2022
Table 68: Mirdametinib, Clinical Trial Description, 2022
Table 69: Olutasidenib, Clinical Trial Description, 2022
Table 70: Vinblastine + Bevacizumab, Clinical Trial Description, 2022
Table 71: Cobimetinib, Clinical Trial Description, 2022
Table 72: Pemigatinib, Clinical Trial Description, 2022
Table 73: Verzenio, Clinical Trial Description, 2022
Table 74: Limitations of Current Treatments in Glioblastoma
Table 75: Key Market Forecast Assumptions for ITI-1000
Table 76: Key Market Forecast Assumptions for SurVaxM
Table 77: Key Market Forecast Assumptions for AV-GBM-1
Table 78: Key Market Forecast Assumptions for Tasadenoturev (DNX-2401)
Table 79: Key Market Forecast Assumptions for EO2401
Table 80: Key Market Forecast Assumptions for berubicin
Table 81: Key Market Forecast Assumptions for sitoiganap
Table 82: Key Market Forecast Assumptions for lerapolturev + pembrolizumab
Table 83: Key Market Forecast Assumptions for INO-5401+ INO-9012+ LIBTAYO (cemiplimab)
Table 84: Key Market Forecast Assumptions for Temferon
Table 85: Key Market Forecast Assumptions for VAL-083
Table 86: Key Market Forecast Assumptions for VBI-1901
Table 87: Key Market Forecast Assumptions for MDNA55
Table 89: Key Market Forecast Assumptions for DCVax
Table 90: Key Market Forecast Assumptions for Regorafenib
Table 91: Key Market Forecast Assumptions for LAM561 (2-OHOA)
Table 92: Key Market Forecast Assumptions for ONC201
Table 93: Key Market Forecast Assumptions for Paxalisib
Table 94: Key Market Forecast Assumptions for Enzastaurin
Table 95: Total Market Size of Glioma in the 7MM
Table 96: Total Market Size of Glioma in the United States
Table 97: Market Size of Glioma by Current and Emerging Therapies in the United States
Table 98: Total Market Size of Glioma in EU4 and the UK
Table 99: Market Size of Glioma by Current and Emerging Therapies in EU4 and the UK
Table 100: Total Market Size of Glioma in Japan
Table 101: Market Size of Glioma by Current and Emerging Therapies in Japan
Table 102: Temozolomide Reimbursement in France
List of Figures
Figure 1: Changes From WHO 2016 to 2021 Classification
Figure 2: Types of Gliomas
Figure 3: Generalized Transcription Pathways Related to Glioblastoma Disease
Figure 4: NCCN Guidelines for Treatment of GBM (age =70)
Figure 5: NCCN Guidelines for Treatment of GBM (age >70)
Figure 6: Management Options for People with Newly Diagnosed Grade IV Glioma (GBM)
Figure 7: Global Heat Map of Brain and CNS Tumor
Figure 8: Total Incident Cases of Glioma in the 7MM (2019-2032)
Figure 9: Total Incident Cases of Glioma in the US (2019-2032)
Figure 10: Grade-specific Cases of Glioma in the US (2019-2032)
Figure 11: Age-specific Cases of Glioma in the US (2019-2032)
Figure 12: Type-specific Cases of Glioma in the US (2019-2032)
Figure 13: Total Incident Cases of Glioma in EU4 and the UK (2019-2032)
Figure 15: Grade-specific Cases of Glioma in EU4 and the UK (2019-2032)
Figure 16: Age-specific Cases of Glioma in EU4 and the UK (2019-2032)
Figure 17: Type-specific Cases of Glioma in EU4 and the UK (2019-2032)
Figure 18: Total Incident Cases of Glioma in Japan (2019-2032)
Figure 19: Grade-specific Cases of Glioma in Japan (2019-2032)
Figure 20: Age-specific Cases of Glioma in Japan (2019-2032)
Figure 21: Type-specific Cases of Glioma in Japan (2019-2032)
Figure 22: Novocure's second-generation OPTUNE System
Figure 23: GBM AGILE two-stage study design
Figure 24: Total Market Size of Glioma in the 7MM
Figure 25: Total Market Size of Glioma in the United States
Figure 26: Market Size of Glioma by Current and Emerging Therapies in the United States
Figure 27: Total Market Size of Glioma in EU4 and the UK
Figure 28: Market Size of Glioma by Current and Emerging Therapies in EU4 and the UK
Figure 29: Total Market Size of Glioma in Japan
Figure 30: Market Size of Glioma by Current and Emerging Therapies in Japan

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Bayer
  • Chimerix
  • Aivita Biomedical
  • Denovo Biopharma
  • Northwest Therapeutics
  • VBL Therapeutics
  • Laminar Pharmaceuticals
  • MedImmune
  • DNAtrix
  • Immunomic Therapeutics
  • Imvax
  • MimiVax
  • CNS Pharmaceuticals
  • Epitopoietic Research Corporation (ERC)
  • Istari Oncology
  • SonALAsense
  • Kintara Therapeutics
  • Bristol Myers Squibb
  • Medicenna Therapeutics
  • BioMimetix
  • Eisai and Merck Sharp & Dohme
  • Kazia Therapeutics
  • Oblato
  • Genenta Science
  • Enterome
  • Inovio Pharmaceuticals
  • Karyopharm Therapeutics
  • VBI Vaccines
  • TME Pharma
  • Day One Biopharmaceuticals
  • Servier
  • Orbus Therapeutics
  • TVAX Biomedical
  • AnHeart Therapeutics
  • Beigene
  • SpringWorks Therapeutics
  • Forma Therapeutics
  • Hoffmann-La Roche
  • Incyte Corporation
  • Eli Lilly