Lyophilized Drugs Market will generate new growth opportunities 2021-2028 | Sanofi S.A, Merck & Co., Inc., Fresenius Kabi USA, LLC., Ciron Drugs & Pharmaceuticals Pvt Ltd.

Lyophilization is a process of removing any moisture from the drug to chemically stabilize the drug after sealing. Lyophilization is done to enhance the shelf-life of the drug and offer easy transportation of bulk drugs. Moreover, the lyophilized drug can be also be stored at room temperature. Manufacturers such as BUCHI Labortechnik AG, SP Scientific, and West Pharmaceutical Services, Inc. are focusing on the development of the lyophilization process to enhance the production capacity of lyophilized drugs. Moreover, pharmaceutical companies are increasing their focus on the production of highly advanced lyophilized drug delivery systems, to 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 projected to be valued at US$ 322.9 Billion in 2018 and is expected to witness a CAGR of 7.1% during the forecast period (2021–2028).

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Increasing regulatory approvals for lyophilized drugs is projected to fuel the growth of the global lyophilized drugs market

Rising regulatory approvals for a wide range of lyophilized drugs is projected to fuel the growth of the 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 prefilled dual-chamber syringe, developed by Otsuka Pharmaceutical Development & Commercialization, Inc. The drug is indicated for the treatment of schizophrenia in adults and in the maintenance of monotherapy treatment of bipolar I disorder in adults

Furthermore, rising initiatives by key players such as acquisitions for advancement and distribution of anesthetics to various healthcare organizations is further projected to significantly fuel the market growth of lyophilized drugs. For instance, in December 2018, North American Partners in Anesthesia (NAPA), 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.

Market – Restraints

On the other hand, an increasing product recalls for lyophilized drugs and packaging type is expected to curb the market growth. 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 a 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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Regional Analysis

North America is projected to witness lucrative growth in the global lyophilized drugs market, and this can be attributed to growing prevalence of diseases in the U.S. Moreover, strong presence of key 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, rising product approvals by regulatory authorities in North America is also projected to foster the 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.

The Asia Pacific is also projected to fuel the growth of the global lyophilized drugs market, due to increasing initiatives by key players to expand their production facility, in order to enhance the production of lyophilized drugs on a 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 a manufacturing capacity of around 20 million vials of liquid injectable and lyophilized concentrations.

Europe is projected to experience growth due to continuous advancements in lyophilization processes and rising 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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