The Global Lyophilization Services for Biopharmaceuticals Market size was valued at US$ 774.86 million in 2021 and is expected to grow at a compound annual growth rate (CAGR) of 10.1% from 2022 to 2030. Lyophilization is a method that involves freezing a substance at extremely low temperatures and then extracting liquid via sublimation, thereby transforming solid water into gaseous water. A significant advantage of this process is that the extracted water goes directly from solid to gas without passing through the liquid phase. This process is exceptional at extending a product's shelf life and storage time while preserving its three-dimensional structure and integrity. It is a modern alternative to the cryopreservation technique, which was generally used for cell and tissue preservation. Lyophilizers freeze the material, then reduce the pressure and add heat to allow the frozen water in the material to sublimate. The lyophilized formulation has the advantage of better stability and provides easy handling, i.e. shipping and storage. To minimize detrimental effects, lyophilized products sensitive to oxidation can be stoppered and sealed within an inert atmosphere (i.e. nitrogen). This technique is useful in developing thermolabile and unstable drugs in an aqueous medium. The majority of lyophilized or freeze-dried products in the pharmaceutical industry are used for parenteral application.
Increasing investment, demand for easy drug packaging and transport, and the need for better preservation of heat-sensitive drugs will be responsible for the fast growth of the service industry. Technical advancement in lyophilization equipment and continuous research on process validation will support the development of the Lyophilization Services for Biopharmaceuticals market. In Nov 2021, Baxter Biopharma announced an approximately $100 million expansion of its sterile fill/finish manufacturing facility in Germany. This investment expands Baxter's manufacturing footprint and improves shelf life through Lyophilization. It is a long and cost-intensive process, and it requires sterile diluents for reconstitution. Lyophillization is mostly used when the product is unstable and heat-liable. The limited amount of vials processed in each process run restricts the overall production capacity. Alternatives for Lyophilization like spray drying, High cost of setup and maintenance of machines and methods, and strict regulatory guidelines will hinder the market growth to some extent.
The Asia Pacific and North America will hold the largest market share due to expansions of drug and biotechnology companies and extensive research on drug development. Companies are doing collaborations and strategic partnerships for rapid growth to achieve the production goals.
Global Lyophilization Services for Biopharmaceuticals Market is segmented into two main segments, Type of Biologic Lyophilized and Type of Primary Packaging System. The type of biologic lyophilized is again sub-segmented into four parts antibodies, cell and gene therapies in which living cells are preserved at room temperature for a prolonged period without loss of viability, vaccines and other biologics. The type of primary packaging system is divided into vials, syringes, cartridges, ampoules and others.
Major market key players are AB BioTechnologies, Inc., Albany Molecular Research (AMRI), ATTWILL Medical Solutions, Axcellerate Pharma LLC., Baxter BioPharma Solutions, Berkshire Sterile Manufacturing, Inc., Biofortuna Ltd, BioZed Engineering, CinnaGen, CordenPharma, Curia, Emergent BioSolutions, Jubilant HollisterStier LLC, LSNE Contract Manufacturing, Lyophilization Technology, Inc., MabPlex, Northway Biotech, ProJect Pharmaceutics, Samsung Biologics, Synerlab Group, Vetter Pharma, and WuXi Biologics
- AB BioTechnologies, Inc.
- Albany Molecular Research (AMRI)
- ATTWILL Medical Solutions
- Axcellerate Pharma LLC.
- Baxter BioPharma Solutions
- Berkshire Sterile Manufacturing, Inc.
- Biofortuna Ltd
- BioZed Engineering
- Emergent BioSolutions
- Jubilant HollisterStier LLC
- LSNE Contract Manufacturing
- Lyophilization Technology, Inc.
- Northway Biotech
- ProJect Pharmaceutics
- Samsung Biologics
- Synerlab Group
- Vetter Pharma
- WuXi Biologics