市場調査レポート
商品コード
1261060
神経膠腫市場 - 市場の洞察、疫学、市場予測:2032年Glioma - Market Insight, Epidemiology And Market Forecast - 2032 |
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神経膠腫市場 - 市場の洞察、疫学、市場予測:2032年 |
出版日: 受注後更新
発行: DelveInsight
ページ情報: 英文 394 Pages
納期: 2~10営業日
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主要7ヶ国における神経膠腫の市場規模は、2022年に約10億米ドルとなりました。同疾患の発症率は、2022年~2032年にさらに拡大すると予測されています。
当レポートでは、主要7ヶ国における神経膠腫市場について調査し、市場の概要とともに、疫学、患者動向、新たな治療法、2032年までの市場規模予測、および医療のアンメットニーズなどを提供しています。
DelveInsight's "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.
Study Period: 2019-2032.
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).
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.
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.
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 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.
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. DelveInsight 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.
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.
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 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), 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) 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.
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.
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.
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.
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.
The report covers detailed information on collaborations, acquisition and merger, licensing, and patent details for glioma emerging therapies.
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.
Delveinsight's 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.
We perform 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.
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.