Glioblastoma multiforme (GBM) is a high-grade gliomas and the most malignant astrocytic tumor, composed of complexly differentiated neoplastic astrocytes, a subtype of central nervous system (CNS). Glioblastoma is clinically classified as grade IV astrocytoma and differs from anaplastic astrocytoma (grade III) due to the presence of necrotic tissue and hyperplastic blood vessels. The diagnosis of GBM is carried out with imaging modules such as computed tomography (CT), magnetic resonance imaging (MRI), and positron emission tomography (PET).
In case of GBM treatment, there are many restraints and challenges such as its resistance against DNA-modifying agents, migration of malignant cells into adjacent brain tissues increases the complexity of the surgery, and current FDA approved treatments may cause neurotoxicity in patients. Thus, as available treatment options lack in efficiency, the mortality rate of glioblastoma is characterized by rapid progression and poor survival rate with only 8.7% of the patients surviving more than two years post diagnosis.
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According to Centers for Disease Control and Prevention (CDC), in 2011, approximately 22,000 adults in the U.S. were diagnosed with primary malignant tumors of the brain and spinal cord out of which gliomas accounted for the highest rate of incidence. Although, the rising mortality rate of GBM has made it one of the lethal type of cancers; the pipeline of GBM is well equipped with various types of novel therapies including immunotherapy, biologics, small molecules and other drugs. The pipeline of GBM is currently rich in number of various therapeutic drugs and devices that are expected to receive FDA approvals for conducting the clinical trials. The FDA approved drugs currently present in market are temozolomide (Temodar, Temodal and Temcad), bevacizumab (Avastin) and carmustine wafers (BiCNU).
The geographical segmentation of GBM market comprises North America, Europe, Asia Pacific and Rest of the World. Bevacizumab (Avastin) is the latest addition to this artillery, while temozolomide was leading the GBM market in 2013 due to it’s effectiveness when combined with surgery. Bevacizumab is the first monoclonal antibody drug approved for GBM treatment which is more efficient than temozolomide and is expected to surpass its revenue by 2016.
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Temozolomide market was drastically affected in 2013 as it has lost the market exclusivity in 2012 and generics manufactured by Teva Pharmaceutical Industries Ltd, and Sun Pharmaceutical Industries Ltd. entered the market. Geographically, in 2013 North America was observed as the most leading GBM market due to increasing support from government and non-government organizations to raise public awareness by and advanced healthcare infrastructure to boost the pipeline research in this market. Asia Pacific is the fastest growing market, rising awareness against GBM is boosting the diagnostic rate in this region and developing healthcare infrastructure is also assisting the market growth.
The pipeline analysis of GBM treatment include biologics, small molecules, devices, surgeries, and immunotherapy. In the current scenario, the pipeline review of glioblastoma seems to be strong as more than 50 molecules are in phase I and phase II clinical trials. The most promising drugs in phase III trials are Rindopepimut or CDX-110 (Celldex Therapeutics) and DCVax-L (Northwest Biotherapeutics). These molecules have performed well in phase II of the clinical trials in terms of exceeding the overall survival rate.
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The key players involved in the GBM market are Abbvie, Inc., Celldex Therapeutics, Inc., Exellixis, Inc., Brostol-Myers Squibb Co. and F. Hoffman La Roche. In 2013, F. Hoffman La Roche was observed to be the most promising and efficient source of GBM treatment due to its novel drug delivery system known as “brain shuttle.
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