Lyophilization of the sterile injectable is necessary to maintain the stability of some unstable bulk ingredients. Lyophilization provides longer shelf life, from two to five years, to the molecule. Lyophilization also enables easy transportation of bulk drugs. Moreover, lyophilized drugs can be stored at room temperature. Manufacturers such as BUCHI Labortechnik AG, SP Scientific, and West Pharmaceutical Services, Inc. are focusing on development of lyophilization process to enhance production capacity of lyophilized drug. Moreover, pharmaceutical companies are focusing on the development of highly advanced lyophilized drug delivery systems, in order to address or meet significant challenges such as multistep drug administration procedures, inconvenience administration of drugs through self-injection, risk of needlestick injuries, and others (lengthy dose preparation timings).
The global lyophilized drugs market is estimated to be valued at US$ 322.9 Billion in 2018, and is expected to witness a CAGR of 7.1% during the forecast period (2018–2026).
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Increasing regulatory approvals for wide range of lyophilized formulations for various disease conditions is expected to drive growth of lyophilized drugs market. For instance, in April 2014, GlaxoSmithKline plc received the U.S. Food and Drug Administration (FDA) approval for its Tanzeum (albiglutide lyophilized for injection), for subcutaneous use, as a once-weekly treatment for type 2 diabetes. Moreover, in September 2014, the U.S. Food and Drug Administration (FDA) approved a new formulation of Abilify Maintena (aripiprazole) for extended-release injectable suspension, a pre-filled dual-chamber syringe, developed by Otsuka Pharmaceutical Development & Commercialization, Inc. The drug is indicated for the treatment of schizophrenia in adults and in maintenance monotherapy treatment of bipolar I disorder in adults.
Furthermore, increasing initiatives such as acquisitions by key players for advancement and distribution of anesthetics to various healthcare providing organizations is expected to significantly drive the lyophilized drugs market growth. For instance, in December 2018, North American Partners in Anesthesia (NAPA), a single-specialty anesthesia and perioperative management firm in the U.S., acquired certain assets of Aisthesis Partners in anesthesia care and its affiliated medical practices (‘Aisthesis’). Aisthesis provides its anesthesia services to 25 ambulatory surgical centers (ASCs), 3 hospitals, and 3 physician offices across four states in the U.S. and the District of Columbia. Thus, this initiative may contribute to increasing demand for the lyophilized anesthetics drug, which in turn is expected to show significant market growth.
Global Lyophilized Drugs Market – Restraints
The growth of the lyophilized drugs market can be hindered due to increasing number of product recalls for lyophilized drugs and packaging type. In January 2019, U.S. Food and Drug Administration issued a product recall notice for three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder), developed by Sun Pharmaceutical Industries, Inc. The product has been recalled due to the presence of glass particulate in the product.
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Global Lyophilized Drugs Market- Regional Analysis
North America is expected to witness lucrative growth in the global lyophilized drugs market, owing to increasing prevalence of diseases in the U.S. Presence of major manufacturers such as Fresenius Kabi, Merck & Co. Inc., and Amneal Pharmaceutical who are extensively engaged in manufacturing of lyophilized injectable is contributing to growth of the North America Lyophilized Drugs Market. Moreover, increasing product approvals by regulatory authorities in North America is expected to bolster growth of North America Lyophilized Drugs Market. For instance, in December 2015, Aurobindo Pharma Limited received the U.S. FDA approval to manufacture and market Methylprednisolone Sodium Succinate Injection USP (lyophilized drug), 40 mg/vial, 125 mg/vial, 500 mg/vial, and 2 g/vial. Asia Pacific is also expected to drive growth of the global lyophilized drugs market, owing to initiatives by key players to expand their production facility, in order to manufacture lyophilized drugs in large scale. For instance, in July 2017, Alembic Pharmaceuticals, based in India, opened its new manufacturing facility in Panelav, Gujarat, India. The new site has manufacturing capacity of around 20 million vials of liquid injectable and lyophilized concentrations.
Europe is expected to experience growth owing to continuous advancements in lyophilization processes and increasing launches of lyophilized drugs. For instance, in April 2017, BÜCHI Labortechnik AG introduced the modular Lyovapor platform for freeze drying (lyophilization). The new product offers continuous sublimation.
Key players operating in the global lyophilized drugs market include Sanofi S.A, Merck & Co., Inc., Fresenius Kabi USA, LLC., Ciron Drugs & Pharmaceuticals Pvt Ltd., GlaxoSmithKline plc., Mylan NV., Pfizer, Inc., Amneal Pharmaceuticals LLC, Otsuka Holdings Co., Ltd. (Otsuka Pharmaceutical Co., Ltd.), and BTG Plc.
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