Lyophilized drugs are a form of pharmaceutical storage that protects sensitive materials and allows them to be kept at room temperature without the use of a preservative. Without lyophilization, many biopharmaceuticals would not be commercially viable. Lyophilized pharmaceutical products are difficult to use for injections without reconstitution. Reconstitution requires mixing the lyophilized pharmaceutical product with a diluent, such as sterile water or normal saline solution. The process can take as long as half an hour, and requires several steps. Generally, reconstitution kits contain a medication vial, diluent, syringe, and reconstitution needle.
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Increasing number of product launches for lyophilized drugs is contributing to growth of the global lyophilized drugs market. For instance, in July 2021, SP Scientific Products (SP) announces the launch of its SP Hull LyoStar® 4.0 R&D and process development freeze dryer designed and built to enhance speed to market of biopharmaceutical products, such as biological drugs. The new LyoStar 4.0 results from SP’s extensive lyophilization expertise and represents a significant advancement in freeze dryer engineering.
Increasing focus of manufacturers to invest on development of innovative lyophilization technologies and services, in order to manufacture lyophilized drug with utmost quality and capacity, is contributing to lyophilized drugs market growth. For instance, in in September 2021, Lonza will invest to expand its drug product manufacturing network in Switzerland. This investment will fund an additional aseptic flexible filling line for clinical supply of drug product in Stein (CH). The new line will support liquid and lyophilized vial filling and processing, cartridges and pre-filled syringes.
Increasing regulatory approval for lyophilized drug is contributing to lyophilized drugs market growth. For instance, in September 2018, Novartis Pharmaceuticals Corporation received the U.S. Food and Drug Administration approval for its Xolair (omalizumab) prefilled syringe formulation, for the treatment of moderate to severe persistent allergic asthma and chronic idiopathic urticarial. The drug is available in a 150 mg single-dose vial with lyophilized, sterile powder for reconstitution.
Key Takeaways of the Global Lyophilized Drugs Market:
- The global lyophilized drugs market is expected to expand at a CAGR of 7.1% during the forecast period (2018–2026), owing to increasing initiatives by key players to develop prominent technologies for patient identification
- Increasing acquisitions by key players for expanding lyophilized drugs business is expected to drive the global lyophilized drugs market growth. For instance, in November 2018, Argonaut Manufacturing Services, a contract development and manufacturing organization (CDMO) serving molecular diagnostic and biopharmaceutical companies, acquired LyoGen LLC. With this acquisition, Argonaut expanded its reagent lyophilization capabilities from process development through production scale deployment.
- Major 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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Table of Content
Chapter 1 Industry Overview
1.3 Research Scope
1.4 Market Analysis by Regions
1.5 Lyophilized Drugs Market Size Analysis from 2022 to 2028
11.6 COVID-19 Outbreak: Lyophilized Drugs Industry Impact
Chapter 2 Global Lyophilized Drugs Competition by Types, Applications, and Top Regions and Countries
2.1 Global Lyophilized Drugs (Volume and Value) by Type
2.3 Global Lyophilized Drugs (Volume and Value) by Regions
Chapter 3 Production Market Analysis
3.1 Global Production Market Analysis
3.2 Regional Production Market Analysis
Chapter 4 Global Lyophilized Drugs Sales, Consumption, Export, Import by Regions (2017-2022)
Chapter 5 North America Lyophilized Drugs Market Analysis
Chapter 6 East Asia Lyophilized Drugs Market Analysis
Chapter 7 Europe Lyophilized Drugs Market Analysis
Chapter 8 South Asia Lyophilized Drugs Market Analysis
Chapter 9 Southeast Asia Lyophilized Drugs Market Analysis
Chapter 10 Middle East Lyophilized Drugs Market Analysis
Chapter 11 Africa Lyophilized Drugs Market Analysis
Chapter 12 Oceania Lyophilized Drugs Market Analysis
Chapter 13 South America Lyophilized Drugs Market Analysis
Chapter 14 Company Profiles and Key Figures in Lyophilized Drugs Business
Chapter 15 Global Lyophilized Drugs Market Forecast (2022-2028)
Chapter 16 Conclusions
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