Monoclonal Antibody Therapeutics Market– Increasing Drug Approvals and Launch of Novel By Leading Companies: Pfizer, Inc., Novartis International AG, Amgen, Inc., Sanofi S.A., Merck & Co., Inc

Monoclonal antibody therapeutics market is driven by active research and development of novel drugs and significant number of new drug launches and approval. There are number of monoclonal antibodies in the pipeline, which are expected to receive approval over the forecast period. For instance, manufacturers such as Amgen, Inc., Novartis International AG, Merck & Co., Inc., Eily, Lilly, and Company, and others have several monoclonal antibodies in the pipeline. Moreover, efforts of manufacturers to increase number of indications (oncology) for monoclonal antibodies is further expected to boost the market growth over the forecast period. For instance, in June 2018, the U.S. Food & Drug Administration (FDA), expanded the indication of pembrolizumab (Keytruda) to include recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

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Frequent approvals of novel monoclonal antibodies and their launches in developed economies are expected to significantly drive monoclonal antibody therapeutics market growth over the forecast period. Key players in the market have gained regulatory approvals and have launched their therapies in the market. For instance, in 2015, the U.S. FDA approved Darzalex, developed by Johnson & Johnson for multiple myeloma. 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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