Monoclonal Antibody Therapeutics - launch of novel monoclonal antibodies: Pfizer, Inc., Novartis International AG, Amgen, Inc., Sanofi S.A., Merck & Co., Inc., GlaxoSmithKline Plc
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However, high costs of these products is a major concern (in regions with underdeveloped reimbursement facilities) in the healthcare system and to address this problem, manufacturers have resorted to biosimilar products. Biosimilars cost much lower than the original products as the cost of development is relatively low. Majority of the available monoclonal antibody therapeutics (cancer treatments) are expected to lose patent protection by 2020 and some by 2025. For instance, drugs such as Herceptin and Avastin are expected to lose patent protection in 2019. These factors are expected to restrain the global monoclonal antibody therapeutics market growth over the forecast period.
Similarly, in 2017, Roche was granted accelerated approval to TECENTRIQ (atezolizumab) from the U.S FDA for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy.
Moreover, approvals to several combination therapies are further expected to boost the global monoclonal antibody therapeutics market growth over the forecast period. For instance, in 2017, the U.S. FDA approved Darzalex (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients suffering from multiple myeloma. Moreover, different monoclonal antibodies with unique mechanism of actions have been approved over the past few years, which work on immune checkpoints such as CTLA-4, PD-1, and PD-L1.
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Robust pipeline, success of monoclonal antibodies such as Humira (AbbVie, Inc.) and therapeutic advantages offered by these drugs over existing medications are expected to boost growth of the global monoclonal antibody therapeutics market. Moreover, key players in the market are focused on research and development of new monoclonal antibodies in order to enhance their market share.
For instance, in 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab (BAVENCIO, EMD Serono, Inc.) for the treatment of a rare disease, Metastatic Merkel Cell Carcinoma (MCC).
Similarly, in 2017, the U.S FDA granted accelerated approval to immunotherapy product- TECENTRIQ (atezolizumab) for the treatment of people with locally-advanced or metastatic urothelial carcinoma (mUC). In 2015, Sanofi and Regeneron Pharmaceuticals, Inc. entered into a strategic collaboration to develop and commercialize new antibody cancer treatment (SAR439684) in the oncology market. Sanofi and Regeneron are developing an antibody-based cancer therapy- REGN2810 (SAR439684) for the treatment of cutaneous squamous cell carcinoma, which is currently in phase 2 clinical trials.
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Some of the major players operating in the global monoclonal antibody therapeutics market include, Pfizer, Inc., Novartis International AG, Amgen, Inc., Sanofi S.A., Merck & Co., Inc., GlaxoSmithKline Plc., F. Hoffmann-La Roche Ltd., AbbVie, Inc., Eily, Lilly, and Company, and Bristol-Myers Squibb Company.
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