FEATURED COMPANIES
- Bayer
- DNAtrix
- Genentech
- Karyopharm Therapeutics
- MedImmune
- Merck
This ‘Brain Cancer - Market Insights, Epidemiology and Market Forecast- 2030' report delivers an in-depth understanding of the Brain Cancer, historical and forecasted epidemiology as well as the Brain Cancer market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
The Brain Cancer market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Brain Cancer market size from 2018 to 2030. The report also covers current Brain Cancer treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Study Period: 2018-2030
A brain tumor, known as an intracranial tumor, central nervous system (CNS) tumors represent a group of diseases that have in common the abnormal development of mass lesions in the brain, spinal cord or its coverings. A brain tumor can be classified into two main groups, i.e. primary and metastatic. A primary brain tumor is often described as “low grade” or “high grade.” A low-grade tumor generally grows slowly, but it can turn into a high-grade tumor, whereas a high-grade tumor is more likely to grow faster. Secondary brain tumors, also called brain metastases, are much more common than primary tumors in adults. The most common types of primary tumors in adults are meningiomas and astrocytomas, such as glioblastomas. In children, the most common types of brain tumors include medulloblastomas, low-grade astrocytomas (pilocytic), ependymomas, craniopharyngiomas, and brainstem gliomas. All types of brain tumors produce symptoms that vary depending on the part of the brain involved. These symptoms may include headaches, seizures, problems with vision, vomiting and mental changes. Even though the exact cause of most brain tumors is unknown, some uncommon risk factors include exposure to chemicals, radiation, and family history of brain tumors.
Most brain tumors are not diagnosed until after symptoms appear. In general, diagnosing a brain tumor usually begins with magnetic resonance imaging (MRI). Once MRI shows a tumor in the brain, the most common way to determine the type of brain tumor is to look at the results from a tissue sample after a biopsy or surgery. Blood tests are also done to help diagnose certain brain tumors such as pituitary gland, pineal region and germ cell tumors.
Sophisticated imaging techniques are used to pinpoint brain tumors. Diagnostic tools used for this purpose include computed tomography (CT or CAT scan) and MRI. Other MRI sequences can help the surgeon plan the resection of the tumor based on the location of the normal nerve pathways of the brain. Intraoperative MRI is also used during surgery to guide tissue biopsies and tumor removal. Magnetic resonance spectroscopy (MRS) is used to examine the tumor's chemical profile and determine the nature of the lesions seen on the MRI. Positron emission tomography (PET scan) can help detect recurring brain tumors.
Treatment options for brain cancers include surgery, radiation therapy, chemotherapy, and targeted therapy. The treatment options and recommendations depend on several factors like the size, type, and grade of the tumor, whether the tumor is putting pressure on vital parts of the brain, if the tumor has spread to other parts of the CNS or the body, the possible side effects and finally, the treatment preferences and overall health of the patient.
For a low-grade brain tumor, surgery may be the only treatment needed, especially if all of the tumor can be removed. If there is visible tumor remaining after surgery, radiation therapy and chemotherapy may be used. For higher-grade tumors, treatment usually begins with surgery, followed by radiation therapy and chemotherapy.
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Incidence of Primary Brain Tumors, Grade-specific Incidence of Brain Tumors, Type-specific Incidence of Brain Tumors, Gender-specific Incidence of Brain Tumors, and Age-specific Incidence of Brain Tumors in the 7MM market covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom) and Japan from 2018 to 2030.
This section provides glimpse of the Brain Cancer epidemiology in the 7MM.
The epidemiology segment also provides the Brain Cancer epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
The drug chapter segment of the Brain Cancer report encloses the detailed analysis of Brain Cancer marketed drugs and mid and late stage pipeline drugs. It also helps to understand the Brain Cancer clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details of each included drug and the latest news and press releases.
Avastin: Genentech
Avastin (Bevacizumab) is a recombinant humanized monoclonal IgG1 antibody, which acts as 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. This helps in reducing the activity of VEGF and regressing the vascularization of tumors, which normalizes the tumor vasculature and inhibits the formation of new tumor vasculature, thereby preventing the tumor growth. VEGF is a chemical signal that stimulates angiogenesis in a variety of diseases, especially in cancer. Bevacizumab was the first clinically available angiogenesis inhibitor in the United States. Avastin is indicated for the treatment of glioblastoma with progressive disease in adult patients following prior therapy as a single agent.
Temodar/Temodal: Merck
The active pharmaceutical ingredient in Temodar/Temodal, is an imidazotetrazine derivative of the alkylating agent dacarbazine, used for the treatment of newly diagnosed glioblastoma multiforme and refractory anaplastic astrocytoma. The therapeutic benefit of temozolomide is due to its ability to alkylate/methylate DNA. This alkylation/methylation destroys the DNA and triggers the death of the tumor cells. Temozolomide targets selectively tumoral tissues; it has an anti-neoplastic effect; it has minimum influence on adjacent brain tissues; it has no severe systemic toxicity, and it is eliminated rapidly. Temodar/Temodal was initially commercialized by Merck in the different countries, whereas Baxter Oncology was responsible for the manufacture of Temodar injection. However, due to patent expiry, the market holds the generic version of the drug. Recently, the gel formulation of Temozolomide has also been approved by Double Bond Pharmaceuticals.
Eflornithine + Lomustine: Orbus Therapeutics
Eflornithine (a-difluoromethylornithine or DFMO) is an orally bioavailable small molecule and an irreversible inhibitor of ornithine decarboxylase (ODC) that presents a cytostatic effect in rapidly dividing cells. ODC is a key enzyme in the first step of the synthesis of polyamines, converting ornithine to putrescine and it is known that ODC is up-regulated in certain types of cancer. Eflornithine has already been approved by the FDA in intravenous form to treat patients with African trypanosomiasis (sleeping sickness) and was subsequently approved by FDA in a topical form to treat patients with excessive facial hair, or hirsutism. Historically, the company has investigated this drug in several combinations for recurrent malignant gliomas, AA and anaplastic oligoastrocytoma, as well as for recurrent or progressive gliomas.
Ofranergene obadenovec (VB-111): VBL Therapeutics
Ofranergene obadenovec (VB-111) is a first-in-class, targeted anticancer gene-therapy agent that is being developed by VBL Therapeutics 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. In patients, improvement has been experienced in post treatment fever suggesting that VB-111's mode of action involves induction of a tumor-directed immune response. This mechanism retains activity regardless of baseline tumor mutations or the identity of the proangiogenic factors secreted by the tumor. VB-111 is the first agent, based on transcriptional targeting of tumor endothelium, to be assessed in a clinical trial. The drug is being investigated using VBL's proprietary Vascular Targeting System (VTS) platform Technology to target endothelial cells in the tumor vasculature for cancer therapy, which is conveniently administered as an intravenous infusion once every 2 months.
Regorafenib: Bayer
Regorafenib is an oral multi-kinase inhibitor that potently blocks multiple protein kinases involved in tumor angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF), metastasis (VEGFR3, PDGFR, FGFR) and tumor immunity (CSF1R). It is an inhibitor of multiple membrane-bound and intracellular kinases involved in normal cellular functions and pathologic processes such as oncogenesis, tumor angiogenesis, and maintenance of the tumor microenvironment. Regorafenib is already approved under the brand name Stivarga in more than 90 countries, including the US, countries of the European Union, China and Japan for metastatic colorectal cancer, metastatic gastrointestinal stromal tumors and hepatocellular carcinoma.
Durvalumab (MEDI4736): MedImmune
Durvalumab is an investigational human monoclonal antibody directed against the programmed cell death ligand 1 (PD-L1) protein in development by MedImmune. Signals from PD-L1 help tumors avoid detection by the immune system. Durvalumab blocks these signals, countering the tumor's immune-evading strategies. The antibody belongs to an emerging class of immunotherapies commonly referred to as checkpoint inhibitors; because they remove checks, the body places on immune activation. The mechanism of action of Durvalumab includes PD-L1 expression on tumor cells and tumor-associated immune cells in the tumor microenvironment that can be induced by inflammatory signals and cytokines. PD-L1 blocks T-cell function and activation by interacting with PD-1 and CD80 (B7.1) and reduces cytotoxic T-cell activity, proliferation, and cytokine production.
Tasadenoturev (DNX-2401): DNAtrix
DNX-2401, explored by DNAtrix, is oncolytic immunotherapy designed to fulfill the dual requirements of high potency and safety. In order to achieve this, two stable genetic changes in the adenovirus genome were engineered that cause it to replicate selectively in retinoblastoma (Rb) pathway deficient cells and infect tumor cells efficiently. Results from preclinical and clinical studies indicate that DNX-2401 replicates in human tumors, elicits tumor necrosis, triggers intratumoral immune cell infiltration and can lead to long term tumor destruction. DNAtrix is planning a Phase III study to investigate the drug as a monotherapy for glioblastoma patients. Additionally, the company is also evaluating DNX-2401 in a Phase I study for the treatment of diffuse intrinsic pontine glioma, where the company received FDA Fast Track and Rare Pediatric Disease designations.
ONC201: Oncoceutics
A novel therapeutic intervention of Imipridone class is in development by Oncoceutics, i.e., ONC201, which is a highly selective antagonist of dopamine receptor D2 (DRD2) and ClpP agonist that can penetrate the blood-brain-barrier effectively. ONC201 engages proven anticancer pathways that lead to apoptosis in cancer cells. It is a small molecule originally identified as TNF-related apoptosis-inducing ligand (TRAIL)-inducing compound. It has a unique ability to induce expression of both pro-death ligand TRAIL and its receptor DR5 through the engagement of the cellular integrated stress response (ISR) pathway. ONC201 has demonstrated single-agent efficacy in eliminating cancer stem cells CSCs in glioblastoma, colorectal, and prostate cancer models.
Selinexor (KPT-330): Karyopharm Therapeutics
Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export/SINE compound in development by Karyopharm Therapeutics. It functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus, which subsequently reinitiates and amplifies their tumor suppressor function; this is supposed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. The drug has been approved with a brand name Xpovio for patients in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
Ad-RTS-hIL-12 + Veledimex: Ziopharm
Ad-RTS-hIL-12 plus veledimex is gene therapy with an Adenoviral vector (Ad) providing the vehicle engineered to express IL-12 under the control of the RheoSwitch Therapeutic System (RTS). IL-12 is a protein that can improve the body's natural response to disease by enhancing the immune system's ability to kill tumor cells that may interfere with blood flow to the tumor. The drug is being investigated using Ziopharm's Controlled IL-12 platform to help provide therapy for cold tumors - ones that exhibit little or no immune system activity - to hot by calling in an immune response.
Everolimus (RAD001): Novartis
Everolimus (RAD001) is an orally administered drug that works by interrupting the PI3K/Akt/mTOR cell-signaling pathway that is overactive in certain tumors. The drug inhibits explicitly mTOR, a protein that may help many tumors grow, thereby stopping the hyperactivation. It binds to an intracellular protein, FKBP-12, resulting in an inhibitory complex formation with mTOR complex 1 (mTORC1) and thus inhibition of mTOR kinase activity. The drug has already been approved as an anti-cancer agent for other tumor types and is currently being investigated to treat low-grade gliomas..
Brain tumors are solid tumors arising from transformed cells of the brain. These tumors can be of low grade (Grade I and II) or high grade (Grade III and IV). Of these, high grade tumours tend to grow rapidly and spread faster than tumours of a lower grade.
Though, there are several subtypes of these tumours but the publisher has only considered the most common ones for which certain pipeline therapies are being investigated.
Brain tumors, specifically HGGs are very difficult tumors to treat due to the problems in completely removing the tumor and their resistance to radiotherapy and chemotherapy. As there is no ideal treatment, therefore it 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 the indication may combine several approaches. The treatment often comprises a combination of several therapies, including surgery, chemotherapy, radiation, or stereotactic radiosurgery followed by the additional/adjuvant treatments, such as chemotherapy or radiation therapy, after surgery. Treatment is palliative and may include surgery, radiation therapy and/or chemotherapy. The best treatment options for each person depends on many factors like the size and location of the tumor, the extent to which the tumor has grown into the surrounding normal brain tissues, and the affected person's age and overall health.
Other than these current therapies, the brain tumor pipeline is robust and possesses multiple potential drugs in late and mid-stage developments, which is yet to be launched. The pipeline involves drugs with a varied mechanism of action along with different routes of administration, ranging from oral, intravenous, intratumoral, subcutaneous, etc. It is interesting to note that the emerging market of brain tumor includes budding gene therapies, i.e., Ofranergene obadenovec (VBL Therapeutics) and Ad-RTS-hIL-12 in combination with Veledimex (Ziopharm) along with 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.
The potential candidates with promising results in late- or phase III stage of clinical development include Ofranergene obadenovec (VB-111; VBL Therapeutics), Trans Sodium Crocetinate (Diffusion Pharmaceuticals), Eflornithine (Orbus Therapeutics) and Regorafenib (Bayer). Out of these, Orbus therapeutics' Eflornithine is the only therapy being investigated solely for recurrent anaplastic astrocytoma (AA) while a majority of therapies in the pipeline are being investigated for GBM.
Followed by the late-stage products, a wide array of mid-stage or phase II promising interventions are expected to be launched in the near future in the market which include Durvalumab (MEDI4736; MedImmune), Tasadenoturev (DNX-2401; DNAtrix), ONC201 (Oncoceutics), Selinexor (KPT-330; Karyopharm Therapeutics), VBI-1901 (VBI Vaccines), Paxalisib (GDC-0084; Kazia Therapeutics), AV-GBM-1 (Aivita Biomedical), MDNA55 (Medicenna Therapeutics), VAL-083 (Dianhydrogalactitol; DelMar Pharmaceuticals), ITI-1000 (pp65 DC Vaccine; Immunomic Therapeutics), Everolimus (Novartis), Ad-RTS-hIL-12 in combination with Veledimex (Ziopharm) and INO-5401 + INO-9012 + Cemiplimab (REGN2810; Inovio Pharmaceuticals).
This section includes a glimpse of the Brain Tumor 7MM market.
This section provides the total Brain Tumor market size and market size by therapies in the United States.
The total Brain Tumor market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.
The total Brain Tumor market size and market size by therapies in Japan are provided.
This section focusses on the rate of uptake of the potential drugs recently launched in the Brain Cancer market or expected to get launched in the market during the study period 2018-2030. The analysis covers Brain Cancer market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allow the comparison of the drugs on the basis of market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
The report provides insights into different therapeutic candidates in phase II, and phase III stage. It also analyzes key players involved in developing targeted therapeutics.
The report covers the detailed information of collaborations, acquisition and merger, licensing and patent details for Brain Cancer emerging therapies.
The publisher performs competitive and market Intelligence analysis of the Brain Cancer market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
The Brain Cancer market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Brain Cancer market size from 2018 to 2030. The report also covers current Brain Cancer treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Geography Covered
- The United States
- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
- Japan
Study Period: 2018-2030
Brain Cancer Disease Understanding and Treatment Algorithm
Brain Cancer Overview
A brain tumor, known as an intracranial tumor, central nervous system (CNS) tumors represent a group of diseases that have in common the abnormal development of mass lesions in the brain, spinal cord or its coverings. A brain tumor can be classified into two main groups, i.e. primary and metastatic. A primary brain tumor is often described as “low grade” or “high grade.” A low-grade tumor generally grows slowly, but it can turn into a high-grade tumor, whereas a high-grade tumor is more likely to grow faster. Secondary brain tumors, also called brain metastases, are much more common than primary tumors in adults. The most common types of primary tumors in adults are meningiomas and astrocytomas, such as glioblastomas. In children, the most common types of brain tumors include medulloblastomas, low-grade astrocytomas (pilocytic), ependymomas, craniopharyngiomas, and brainstem gliomas. All types of brain tumors produce symptoms that vary depending on the part of the brain involved. These symptoms may include headaches, seizures, problems with vision, vomiting and mental changes. Even though the exact cause of most brain tumors is unknown, some uncommon risk factors include exposure to chemicals, radiation, and family history of brain tumors.
Brain Cancer Diagnosis
Most brain tumors are not diagnosed until after symptoms appear. In general, diagnosing a brain tumor usually begins with magnetic resonance imaging (MRI). Once MRI shows a tumor in the brain, the most common way to determine the type of brain tumor is to look at the results from a tissue sample after a biopsy or surgery. Blood tests are also done to help diagnose certain brain tumors such as pituitary gland, pineal region and germ cell tumors.
Sophisticated imaging techniques are used to pinpoint brain tumors. Diagnostic tools used for this purpose include computed tomography (CT or CAT scan) and MRI. Other MRI sequences can help the surgeon plan the resection of the tumor based on the location of the normal nerve pathways of the brain. Intraoperative MRI is also used during surgery to guide tissue biopsies and tumor removal. Magnetic resonance spectroscopy (MRS) is used to examine the tumor's chemical profile and determine the nature of the lesions seen on the MRI. Positron emission tomography (PET scan) can help detect recurring brain tumors.
Brain Cancer Treatment
Treatment options for brain cancers include surgery, radiation therapy, chemotherapy, and targeted therapy. The treatment options and recommendations depend on several factors like the size, type, and grade of the tumor, whether the tumor is putting pressure on vital parts of the brain, if the tumor has spread to other parts of the CNS or the body, the possible side effects and finally, the treatment preferences and overall health of the patient.
For a low-grade brain tumor, surgery may be the only treatment needed, especially if all of the tumor can be removed. If there is visible tumor remaining after surgery, radiation therapy and chemotherapy may be used. For higher-grade tumors, treatment usually begins with surgery, followed by radiation therapy and chemotherapy.
Brain Cancer Epidemiology
The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Incidence of Primary Brain Tumors, Grade-specific Incidence of Brain Tumors, Type-specific Incidence of Brain Tumors, Gender-specific Incidence of Brain Tumors, and Age-specific Incidence of Brain Tumors in the 7MM market covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom) and Japan from 2018 to 2030.
Key Findings
This section provides glimpse of the Brain Cancer epidemiology in the 7MM.
- The total incident population of Primary Brain Tumors in the seven major markets was estimated to be 60,246 in 2020. In case of Primary Brain Tumors patients in the United States, the incident cases were 23,056 in 2020.
- The total incident population of Primary Brain Tumors in the 7MM is expected to increase at a CAGR of 0.96% during the forecast period 2021-2030.
- Brain Tumors can be divided into, Low-grade (I and II) and High-grade (III and IV) tumors. In the United States, these cases were 6,917 and 16,139, respectively, in 2020.
- In the United States, the incidence of Brain Tumors was 13,534 in males and 9,522 in females, in 2020.
- There are many types of Brain Tumors; however, the types that are considered in this report include Pilocytic Astrocytoma, Diffuse Astrocytoma, Anaplastic Astrocytoma, Oligodendrogliomas, Glioblastoma Multiforme (GBM), Diffuse midline glioma (Earlier called as DIPG), and others, which represented 1,383, 3,458, 1,844, 1,614, 11,989, 853, and 1,914 cases, respectively, in the United States, in 2020.
- In the United States, the highest incidence of Brain Tumors was in the age-group 40-64 years with 10,144 cases, followed by the age-group =65 years with 8,992 cases in 2020. The lowest incidence of Brain Tumors was reorted in the age-group 0-39 years with 3,919 cases in 2020.
- In the EU5 countries, the incident population of Primary Brain Tumors was maximum in Italy with 7,320 cases, followed by the Germany with 7,173 cases in 2020. While, the United Kingdom accounted for the lowest incident population of the indication with 4,433 cases in 2020.
- As per the publisher's analysis, Japan had 8,275 incident cases of Primary Brain Tumors in 2020.
Country Wise- Brain Cancer Epidemiology
The epidemiology segment also provides the Brain Cancer epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
Brain Cancer Drug Chapters
The drug chapter segment of the Brain Cancer report encloses the detailed analysis of Brain Cancer marketed drugs and mid and late stage pipeline drugs. It also helps to understand the Brain Cancer clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details of each included drug and the latest news and press releases.
Brain Cancer Marketed Drugs
Avastin: Genentech
Avastin (Bevacizumab) is a recombinant humanized monoclonal IgG1 antibody, which acts as 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. This helps in reducing the activity of VEGF and regressing the vascularization of tumors, which normalizes the tumor vasculature and inhibits the formation of new tumor vasculature, thereby preventing the tumor growth. VEGF is a chemical signal that stimulates angiogenesis in a variety of diseases, especially in cancer. Bevacizumab was the first clinically available angiogenesis inhibitor in the United States. Avastin is indicated for the treatment of glioblastoma with progressive disease in adult patients following prior therapy as a single agent.
Temodar/Temodal: Merck
The active pharmaceutical ingredient in Temodar/Temodal, is an imidazotetrazine derivative of the alkylating agent dacarbazine, used for the treatment of newly diagnosed glioblastoma multiforme and refractory anaplastic astrocytoma. The therapeutic benefit of temozolomide is due to its ability to alkylate/methylate DNA. This alkylation/methylation destroys the DNA and triggers the death of the tumor cells. Temozolomide targets selectively tumoral tissues; it has an anti-neoplastic effect; it has minimum influence on adjacent brain tissues; it has no severe systemic toxicity, and it is eliminated rapidly. Temodar/Temodal was initially commercialized by Merck in the different countries, whereas Baxter Oncology was responsible for the manufacture of Temodar injection. However, due to patent expiry, the market holds the generic version of the drug. Recently, the gel formulation of Temozolomide has also been approved by Double Bond Pharmaceuticals.
Brain Cancer Emerging Drugs
Eflornithine + Lomustine: Orbus Therapeutics
Eflornithine (a-difluoromethylornithine or DFMO) is an orally bioavailable small molecule and an irreversible inhibitor of ornithine decarboxylase (ODC) that presents a cytostatic effect in rapidly dividing cells. ODC is a key enzyme in the first step of the synthesis of polyamines, converting ornithine to putrescine and it is known that ODC is up-regulated in certain types of cancer. Eflornithine has already been approved by the FDA in intravenous form to treat patients with African trypanosomiasis (sleeping sickness) and was subsequently approved by FDA in a topical form to treat patients with excessive facial hair, or hirsutism. Historically, the company has investigated this drug in several combinations for recurrent malignant gliomas, AA and anaplastic oligoastrocytoma, as well as for recurrent or progressive gliomas.
Ofranergene obadenovec (VB-111): VBL Therapeutics
Ofranergene obadenovec (VB-111) is a first-in-class, targeted anticancer gene-therapy agent that is being developed by VBL Therapeutics 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. In patients, improvement has been experienced in post treatment fever suggesting that VB-111's mode of action involves induction of a tumor-directed immune response. This mechanism retains activity regardless of baseline tumor mutations or the identity of the proangiogenic factors secreted by the tumor. VB-111 is the first agent, based on transcriptional targeting of tumor endothelium, to be assessed in a clinical trial. The drug is being investigated using VBL's proprietary Vascular Targeting System (VTS) platform Technology to target endothelial cells in the tumor vasculature for cancer therapy, which is conveniently administered as an intravenous infusion once every 2 months.
Regorafenib: Bayer
Regorafenib is an oral multi-kinase inhibitor that potently blocks multiple protein kinases involved in tumor angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF), metastasis (VEGFR3, PDGFR, FGFR) and tumor immunity (CSF1R). It is an inhibitor of multiple membrane-bound and intracellular kinases involved in normal cellular functions and pathologic processes such as oncogenesis, tumor angiogenesis, and maintenance of the tumor microenvironment. Regorafenib is already approved under the brand name Stivarga in more than 90 countries, including the US, countries of the European Union, China and Japan for metastatic colorectal cancer, metastatic gastrointestinal stromal tumors and hepatocellular carcinoma.
Durvalumab (MEDI4736): MedImmune
Durvalumab is an investigational human monoclonal antibody directed against the programmed cell death ligand 1 (PD-L1) protein in development by MedImmune. Signals from PD-L1 help tumors avoid detection by the immune system. Durvalumab blocks these signals, countering the tumor's immune-evading strategies. The antibody belongs to an emerging class of immunotherapies commonly referred to as checkpoint inhibitors; because they remove checks, the body places on immune activation. The mechanism of action of Durvalumab includes PD-L1 expression on tumor cells and tumor-associated immune cells in the tumor microenvironment that can be induced by inflammatory signals and cytokines. PD-L1 blocks T-cell function and activation by interacting with PD-1 and CD80 (B7.1) and reduces cytotoxic T-cell activity, proliferation, and cytokine production.
Tasadenoturev (DNX-2401): DNAtrix
DNX-2401, explored by DNAtrix, is oncolytic immunotherapy designed to fulfill the dual requirements of high potency and safety. In order to achieve this, two stable genetic changes in the adenovirus genome were engineered that cause it to replicate selectively in retinoblastoma (Rb) pathway deficient cells and infect tumor cells efficiently. Results from preclinical and clinical studies indicate that DNX-2401 replicates in human tumors, elicits tumor necrosis, triggers intratumoral immune cell infiltration and can lead to long term tumor destruction. DNAtrix is planning a Phase III study to investigate the drug as a monotherapy for glioblastoma patients. Additionally, the company is also evaluating DNX-2401 in a Phase I study for the treatment of diffuse intrinsic pontine glioma, where the company received FDA Fast Track and Rare Pediatric Disease designations.
ONC201: Oncoceutics
A novel therapeutic intervention of Imipridone class is in development by Oncoceutics, i.e., ONC201, which is a highly selective antagonist of dopamine receptor D2 (DRD2) and ClpP agonist that can penetrate the blood-brain-barrier effectively. ONC201 engages proven anticancer pathways that lead to apoptosis in cancer cells. It is a small molecule originally identified as TNF-related apoptosis-inducing ligand (TRAIL)-inducing compound. It has a unique ability to induce expression of both pro-death ligand TRAIL and its receptor DR5 through the engagement of the cellular integrated stress response (ISR) pathway. ONC201 has demonstrated single-agent efficacy in eliminating cancer stem cells CSCs in glioblastoma, colorectal, and prostate cancer models.
Selinexor (KPT-330): Karyopharm Therapeutics
Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export/SINE compound in development by Karyopharm Therapeutics. It functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus, which subsequently reinitiates and amplifies their tumor suppressor function; this is supposed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. The drug has been approved with a brand name Xpovio for patients in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
Ad-RTS-hIL-12 + Veledimex: Ziopharm
Ad-RTS-hIL-12 plus veledimex is gene therapy with an Adenoviral vector (Ad) providing the vehicle engineered to express IL-12 under the control of the RheoSwitch Therapeutic System (RTS). IL-12 is a protein that can improve the body's natural response to disease by enhancing the immune system's ability to kill tumor cells that may interfere with blood flow to the tumor. The drug is being investigated using Ziopharm's Controlled IL-12 platform to help provide therapy for cold tumors - ones that exhibit little or no immune system activity - to hot by calling in an immune response.
Everolimus (RAD001): Novartis
Everolimus (RAD001) is an orally administered drug that works by interrupting the PI3K/Akt/mTOR cell-signaling pathway that is overactive in certain tumors. The drug inhibits explicitly mTOR, a protein that may help many tumors grow, thereby stopping the hyperactivation. It binds to an intracellular protein, FKBP-12, resulting in an inhibitory complex formation with mTOR complex 1 (mTORC1) and thus inhibition of mTOR kinase activity. The drug has already been approved as an anti-cancer agent for other tumor types and is currently being investigated to treat low-grade gliomas..
Brain Cancer Market Outlook
Brain tumors are solid tumors arising from transformed cells of the brain. These tumors can be of low grade (Grade I and II) or high grade (Grade III and IV). Of these, high grade tumours tend to grow rapidly and spread faster than tumours of a lower grade.
Though, there are several subtypes of these tumours but the publisher has only considered the most common ones for which certain pipeline therapies are being investigated.
Brain tumors, specifically HGGs are very difficult tumors to treat due to the problems in completely removing the tumor and their resistance to radiotherapy and chemotherapy. As there is no ideal treatment, therefore it 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 the indication may combine several approaches. The treatment often comprises a combination of several therapies, including surgery, chemotherapy, radiation, or stereotactic radiosurgery followed by the additional/adjuvant treatments, such as chemotherapy or radiation therapy, after surgery. Treatment is palliative and may include surgery, radiation therapy and/or chemotherapy. The best treatment options for each person depends on many factors like the size and location of the tumor, the extent to which the tumor has grown into the surrounding normal brain tissues, and the affected person's age and overall health.
Other than these current therapies, the brain tumor pipeline is robust and possesses multiple potential drugs in late and mid-stage developments, which is yet to be launched. The pipeline involves drugs with a varied mechanism of action along with different routes of administration, ranging from oral, intravenous, intratumoral, subcutaneous, etc. It is interesting to note that the emerging market of brain tumor includes budding gene therapies, i.e., Ofranergene obadenovec (VBL Therapeutics) and Ad-RTS-hIL-12 in combination with Veledimex (Ziopharm) along with 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.
The potential candidates with promising results in late- or phase III stage of clinical development include Ofranergene obadenovec (VB-111; VBL Therapeutics), Trans Sodium Crocetinate (Diffusion Pharmaceuticals), Eflornithine (Orbus Therapeutics) and Regorafenib (Bayer). Out of these, Orbus therapeutics' Eflornithine is the only therapy being investigated solely for recurrent anaplastic astrocytoma (AA) while a majority of therapies in the pipeline are being investigated for GBM.
Followed by the late-stage products, a wide array of mid-stage or phase II promising interventions are expected to be launched in the near future in the market which include Durvalumab (MEDI4736; MedImmune), Tasadenoturev (DNX-2401; DNAtrix), ONC201 (Oncoceutics), Selinexor (KPT-330; Karyopharm Therapeutics), VBI-1901 (VBI Vaccines), Paxalisib (GDC-0084; Kazia Therapeutics), AV-GBM-1 (Aivita Biomedical), MDNA55 (Medicenna Therapeutics), VAL-083 (Dianhydrogalactitol; DelMar Pharmaceuticals), ITI-1000 (pp65 DC Vaccine; Immunomic Therapeutics), Everolimus (Novartis), Ad-RTS-hIL-12 in combination with Veledimex (Ziopharm) and INO-5401 + INO-9012 + Cemiplimab (REGN2810; Inovio Pharmaceuticals).
Key Findings
This section includes a glimpse of the Brain Tumor 7MM market.
- The market size of Brain Tumors in the seven major markets was estimated to be USD 2,089.4 Million in 2020, which is expected to show a positive growth at a CAGR of 4.19% during the study period 2018-2030.
- The United States accounts for the largest market size of USD 986.0 Million in 2020 of brain tumors throughout the study period of 2018-2030, in comparison to EU5 (Italy, Germany, France, Spain, the UK) and Japan, respectively.
- Among the EU5 countries, Italy had the highest market size with USD 214.4 Million in 2020, while United Kingdom had the lowest market size with USD 129.8 Million in 2020.
- The Japan Brain Tumors market accounted for USD 256.7 Million in 2020.
The United States Market Outlook
This section provides the total Brain Tumor market size and market size by therapies in the United States.
EU-5 Market Outlook
The total Brain Tumor market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.
Japan Market Outlook
The total Brain Tumor market size and market size by therapies in Japan are provided.
Brain Cancer Drugs Uptake
This section focusses on the rate of uptake of the potential drugs recently launched in the Brain Cancer market or expected to get launched in the market during the study period 2018-2030. The analysis covers Brain Cancer market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allow the comparison of the drugs on the basis of market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
Brain Cancer Development Activities
The report provides insights into different therapeutic candidates in phase II, and phase III stage. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing and patent details for Brain Cancer emerging therapies.
Competitive Intelligence Analysis
The publisher performs competitive and market Intelligence analysis of the Brain Cancer market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
Scope of the Report
- The report covers the descriptive overview of Brain Cancer, explaining its causes, signs and symptoms, pathogenesis and currently available therapies.
- Comprehensive insight has been provided into the Brain Cancer epidemiology and treatment.
- Additionally, an all-inclusive account of both the current and emerging therapies for Brain Cancer are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
- A detailed review of Brain Cancer market; historical and forecasted is included in the report, covering the 7MM drug outreach.
- The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Brain Cancer market.
Report Highlights
- In the coming years, Brain Cancer market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
- The companies and academics are working to assess challenges and seek opportunities that could influence Brain Cancer R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
- The publisher has analysed incident population of Primary Brain Tumors in the 7MM which suggests that the cases of Primary Brain Tumors will increase during the forecast period of 2021-2030.
- In addition, gender-specific incidence of Brain Tumors was assessed as well. As per the analysis, Brain Tumors is slightly more incident in males than in females.
- The scope of the report also encompasses another major segment, i.e., grade-specific incidence Brain Cancer, wherein the number of patients suffering from Low-grade (I and II) and High-grade (III and IV) tumors was calculated.
- Age-specific data of Brain Tumors suggests that incidence of Brain Tumors in the US, was highest in the age group of 40-64 years, followed by =65 years and 0-39 years.
- There are many types of Brain Tumors; however, the types that are considered in this report include Pilocytic Astrocytoma, Diffuse Astrocytoma, Anaplastic Astrocytoma, Oligodendrogliomas, Glioblastoma Multiforme (GBM), Diffuse midline glioma (Earlier called as DIPG), and others.
- Currently, the first-line treatment involves Surgery ± Radiation Therapy/ Chemotherapy, Temozolomide + Radiation Therapy (RT) or Radiation Alone- Maintanance therapy and Temozolomide Monotherapy. While the second-line treatment for Brain Tumors includes Bevacizumab Monotherapy, Bevacizumab Combination Therapy, Temozolomide (Both as Combination and Monotherapy), and Other Systemic Therapies (Concomitant and Adjuvant Chemotherapy agents).
- Expected Launch of potential therapies, such as Bayer (Regorafenib), Diffusion Pharmaceuticals (Trans Sodium Crocetinate), VBL Therapeutics (Ofranergene obadenovec (VB-111)), AstraZeneca (Durvalumab), DNAtrix (Tasadenoturev (DNX-2401) + Pembrolizumab), Kintara Therapeutics (VAL-083 (Dianhydrogalactitol)), Oncoceutics (ONC201), KaryoPharma (Selinexor (KPT-330)), VBI Vaccines (VBI-1901), Kazia Therapeutics (Paxalisib (GDC-0084)), Aivita Biomedical (AV-GBM-1), Medicenna Therapeutics (MDNA55), Immunomic Therapeutics (pp65-shLAMP DC with GM-CSF (ITI-1000)), Inovio Pharmaceuticals (INO-5401+ INO-9012 + Cemiplimab (REGN2810)), Orbus Therapeutics (Eflornithine + Lomustine), Novartis (Everolimus (RAD001)) and Ziopharm (Ad-RTS-hIL-12 + Veledimex ± Cemiplimab-Rwlc), may increase market size in the coming years, assisted by an increase in Brain Tumors incident population pool.
Analyst Comments
- The marketed drugs for HGG include Avastin (Genentech) and Temodar/Temodal (Merck). However, due to patent expiry, the market holds the generic version of both the drugs. This creates a huge competition among the generic version of these drugs and the emerging therapies due to the fact that generics are more cost-effective for the patients than a novel therapy. Additionally, due to limited knowledge about the overall survival benefit of bevacizumab, it is not indicated in unselected patients with newly diagnosed GBM.
- There have been substantial advances in understanding of the molecular aberrations found in malignant gliomas. These key discoveries include the isocitrate dehydrogenase (IDH) mutation, codeletion of the short arm of chromosome 1 and long arm of chromosome 19 (1p19q), O6-methylguanine-DNA methyltransferase (MGMT) gene promoter methylation and histone H3-K27M mutation.
- Currently, both Grade III and Grade IV HGGs follow similar treatment regimens due to lack of research and developmental activities about Grade III tumours. Therefore, moving further, there is a need for development of therapies specific for anaplastic form of tumors.
Brain Cancer Report Insights
- Patient Population
- Therapeutic Approaches
- Brain Cancer Pipeline Analysis
- Brain Cancer Market Size and Trends
- Market Opportunities
- Impact of upcoming Therapies
Brain Cancer Report Key Strengths
- Ten Years Forecast
- 7MM Coverage
- Brain Cancer Epidemiology Segmentation
- Key Cross Competition
- Highly Analyzed Market
- Drugs Uptake
Brain Cancer Report Assessment
- Current Treatment Practices
- Unmet Needs
- Pipeline Product Profiles
- Market Attractiveness
- Market Drivers and Barriers
Key Questions Answered
Market Insights:
- What was the Brain Cancer market share (%) distribution in 2018 and how it would look like in 2030?
- What would be the Brain Cancer total market size as well as market size by therapies across the 7MM during the forecast period (2021-2030)?
- What are the key findings pertaining to the market across the 7MM and which country will have the largest Brain Cancer market size during the forecast period (2021-2030)?
- At what CAGR, the Brain Cancer market is expected to grow at the 7MM level during the forecast period (2021-2030)?
- What would be the Brain Cancer market outlook across the 7MM during the forecast period (2021-2030)?
- What would be the Brain Cancer market growth till 2030 and what will be the resultant market size in the year 2030?
- How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
Epidemiology Insights:
- What is the disease risk, burden and unmet needs of Brain Cancer?
- What is the historical Brain Cancer patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK) and Japan?
- What would be the forecasted patient pool of Brain Cancer at the 7MM level?
- What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Brain Cancer?
- Out of the above-mentioned countries, which country would have the highest incident population of Brain Cancer during the forecast period (2021-2030)?
- At what CAGR the population is expected to grow across the 7MM during the forecast period (2021-2030)?
Current Treatment Scenario, Marketed Drugs and Emerging Therapies:
- What are the current options for the treatment of Brain Cancer along with the approved therapy?
- What are the current treatment guidelines for the treatment of Brain Cancer in the US and Europe?
- What are the Brain Cancer marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
- How many companies are developing therapies for the treatment of Brain Cancer?
- How many therapies are developed by each company for the treatment of Brain Cancer?
- How many emerging therapies are in the mid-stage and late stage of development for the treatment of Brain Cancer?
- What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Brain Cancer therapies?
- What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
- What are the clinical studies going on for Brain Cancer and their status?
- What are the key designations that have been granted for the emerging therapies for Brain Cancer?
- What are the 7MM historical and forecasted market of Brain Cancer?
Reasons to Buy
- The report will help in developing business strategies by understanding trends shaping and driving the Brain Cancer.
- To understand the future market competition in the BRAIN CANCER market and Insightful review of the key market drivers and barriers.
- Organize sales and marketing efforts by identifying the best opportunities for Brain Cancer in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan.
- Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
- Organize sales and marketing efforts by identifying the best opportunities for Brain Cancer market.
- To understand the future market competition in the Brain Cancer market.
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FEATURED COMPANIES
- Bayer
- DNAtrix
- Genentech
- Karyopharm Therapeutics
- MedImmune
- Merck
1 Key Insights2 Executive Summary5 Recognized Establishments10 Treatment Algorithm13 Unmet Needs19 Case Reports20 Market Drivers21 Market Barriers22 SWOT Analysis23 KOL Reviews25 Publisher Capabilities
3 Brain Cancer Market Overview at a Glance
4 Disease Background and Overview: Brain Cancer
6 Treatment
7 National Comprehensive Cancer Network (NCCN) Guidelines for Central Nervous System Cancers (2020)
8 Neurological and vascular complications of primary and secondary brain tumors: EANO-ESMO Clinical Practice Guidelines for prophylaxis, diagnosis, treatment and follow-up (2020)
9 NICE Guidelines: Brain tumors (primary) and brain metastases in adults (2018)
11 Epidemiology and Patient Population
12 Country-wise Epidemiology of Brain Tumors
14 Marketed Drugs
15 Emerging Drugs
16 Market Access and Reimbursement
17 Brain Cancer: Seven Major Market Analysis
18 7MM Market Outlook
24 Appendix
List of Tables
List of Figures
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A selection of companies mentioned in this report includes:
- Genentech
- Merck
- Orbus Therapeutics
- VBL Therapeutics
- Bayer
- MedImmune
- DNAtrix
- Oncoceutics
- Karyopharm Therapeutics
- Ziopharm
- Novartis
Note: Product cover images may vary from those shown