Monoclonal Antibody Therapeutics Market Is Booming Worldwide| Pfizer, Inc., Novartis International AG, Amgen, Inc., Sanofi S.A., Merck & Co., Inc., GlaxoSmithKline Plc

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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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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Increasing product launches and regulatory support for the treatment of rare diseases is expected to support growth of the monoclonal antibody therapeutics market. Several companies have received the U.S FDA approvals for drugs used in treatment of diseases ranging from cancers to rare diseases. For instance, in August 2018, Kyowa Hakko Kirin Co., Ltd received the U.S. FDA approval for Poteligeo (mogamulizumab-kpkc) for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.

Moreover, in August 2018, Shire plc. received the U.S. FDA approval for TAKHZYRO (lanadelumab-flyo) injection for a rare disease hereditary angioedema (HAE) in patients 12 years of age and older.

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.

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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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