Global Single-use Assemblies Market valued at $2.25 billion in 2021 and is set to witness a healthy CAGR of 22% by 2026

A single-use assembly is a ready-to-use custom-made all-in-one solution made from different plastic components that are assembled into one whole, based on a customer-specific design.

The Global Single-use Assemblies Market valued at $2.25 billion (2021) is set to witness a healthy growth rate of 22% in the next 5 years. Advantages of ready-to-use single-use assemblies, favorable funding for manufacturing of single-use solutions, rising biologics & vaccines market, and growing biopharmaceutical R&D are some of the main factors driving the Global Single-use Assemblies Market.

Advantages of Single-use Assemblies Boosts Its Demand

End users of bioprocessing frequently undertake the in-house assembling of single-use systems. If connections between the various components are not made correctly, it might result in cross-contamination and leakage which in turn might lead to production delays. Ready-to-use single-use assemblies appropriately address these issues.

Some of the major advantages that are driving its demand are:

• Quicker implementation of single-use assembly components in the bioprocess cycle
• Less risks of cross-contamination and leakage
• Reduced labor, expense, and time for end-users resulting in cost reduction
• Eliminates cleaning and downtime, among others

Favorable Funding for Manufacturing of Single-Use Solutions Fuels Single-use Assemblies Market

In the last decade, single-use assemblies and technologies have observed widespread acceptance. Using single use equipment decreases facility set-up expenses, lowers cleaning costs & cross-product/batch contamination risks, rises product integrity, reduces downtime, and improves facility flexibility and adaptability.

Favorable funding for the manufacturing of single-use solutions is anticipated to further drive the demand of the single-use assemblies market.

For instance,

• In January 2022, High Purity New England secured a USD 15M grant from the Biomedical Advanced Research and Development Authority (BARDA). The grant is expected to expand and accelerate the production of single-use assemblies, single-use pumps, single-use mixing systems, and sterile individually packaged components
• Similarly, in April 2021, Meissner Filtration Products, a global manufacturer of advanced microfiltration products and single-use systems secured a $13.4 million contract from the Biomedical Advanced Research and Development Authority (BARDA) to facilitate the expedited expansion of their production capacity for products critical to COVID-19 vaccine and therapeutic manufacturing

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“Single-use technology has a number of benefits in bioprocessing, but making it work requires access to the necessary tools—and lots of them.

A single-use assembly offers everything a bio processor requires: bags, tubing, connectors, and filters. It provides flexible, customized single-use solutions to accelerate pharmaceutical drug development and manufacturing. Ready-to-use assemblies allow the growth and production of products in a wide range of sizes and for a variety of diseases. It is a critical component in the supply chain for the production of vaccines and medications around the world” - Senior Director, Leading Single-use Assembly Manufacturer, United States

Risk of Leachables from Single-use Assembly Products – A Deterrent for Market Growth

Single-use assembly products are made of processed plastic materials and they frequently face the risk of contamination from the container due to leachables.

Leachables are chemical compounds that migrate into the drug formulation from any product contact material (such as elastomeric, plastic, glass, stainless steel, or coating components) as a result of direct contact with the drug formulation under normal process conditions or accelerated storage conditions and are found in the final drug product.

Leachables are a source of process-related impurities that have the potential to alter the product quality of biotherapeutics and affect patient health. However, despite these challenges, single-use technologies uptake is expected to grow as suppliers & end-users are working together on this issue. Proper risk assessments, characterization of extractable profiles according to more standardized protocols, toxicological assessments, leachable studies, and matured guidance guidelines are some of the mitigation steps undertaken by stakeholders to confront the problem of leachables.

Competitive Landscape Analysis of Single-use Assemblies Market

The global single-use assemblies market is marked by the presence of key players such as Thermo Fisher Scientific, Inc., Sartorius Stedim Biotech, Danaher Corporation, Merck KGaA, Avantor, Inc., Saint-Gobain, and others.

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