Single-use assemblies, also known as single-use systems, are pre-assembled sets of fluid handling components that are designed for single use in the biopharmaceutical manufacturing process. These provide benefits like reduced risk of cross-contamination, lower costs of cleaning and sterilization as compared to traditional stainless-steel bioreactors. As the demand for biologics and cell therapies escalates, there is a heightened need for solid and scalable production capabilities. Single-use assemblies contribute to quicker production cycles and adaptable scalability. They also enable more compact manufacturing spaces and enhanced operational efficiency.
Compared to traditional stainless steel equipment, single-use assemblies provide advantages such as reduced capital investment, lower cleaning and maintenance costs, elimination of cross-contamination risks. However, their widespread adoption also raises concerns about increased solid waste generation. Overall, single-use assemblies have enabled faster process development with reduced costs and improved productivity for manufacturers.
Market Dynamics:
Global single-use assemblies market growth is driven by increasing demand for biopharmaceuticals, fast adoption of single-use technologies by biopharmaceutical companies, and advantages like flexible scalability, lower facility footprint and reduced validation costs compared to stainless steel assemblies. However, concerns about extractable and leachable from materials used in single-use assemblies and lack of standardization are some of the factors restraining the market growth. Growing demand for biosimilars and advanced therapies like gene and cell therapies present lucrative opportunities for players in this market.
The key market players are focusing on various growth strategies such as expansion, and this is expected to propel the market growth over the forecast period. For instance, in June 2021, NewAge Industries, a manufacturer of AdvantaPure high purity tubing products used in single-use systems for biopharmaceutical manufacturing, announced expansion of capacity at its headquarters facility in southeastern Pennsylvania, U.S. The initiative will expand the current facility by adding over 3000 square feet of ISO Class 7 certified cleanroom space. This space is designated for the production of AdvantaFlex weldable and sealable tubing, AdvantaSil silicone tubing, reinforced hose, and molded single-use tubing assemblies.
Key features of the study:
Detailed Segmentation:
Global Single Use Assemblies Market- Segmentation
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