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Single-Use Assemblies Market Analysis

The Single-Use Assemblies Market size is estimated at USD 2.94 billion in 2024, and is expected to reach USD 6.18 billion by 2029, growing at a CAGR of 15.96% during the forecast period (2024-2029).

• The key factors expected to drive the market’s growth are increased demand for low-risk contamination systems, increased R&D investments by biopharmaceutical companies, and a growing biologics market.
• The adoption of single-use assemblies in the global biopharmaceutical industry has increased over time due to its advantages, such as the decreased chances of cross-contamination hazards, simplified cleaning procedures, and increased drug development activities. Moreover, the growing adoption of single-use assemblies and systems in biopharmaceutical manufacturing and increasing new product introductions by market players to foster biopharmaceutical operations are expected to accelerate market growth over the study period. For instance, in April 2023, Cytiva launched X-platform bioreactors to streamline single-use upstream bioprocessing operations.
• The newly launched product boosted process efficiency and streamlined supply chain operations. This rapid implementation allowed manufacturers to respond swiftly to changing market demands and production schedules, thereby increasing operational efficiency and upsurging the growth of single-use assemblies.
• In addition, the growing demand for novel therapeutics and established roles of single-use assemblies in production lines have pushed market players to expand their single-use technology manufacturing capabilities, which in turn is projected to accelerate industry expansion over the study period. For instance, in February 2023, Foxx Life Sciences invested USD 2.5 in India to expand capabilities in pharmaceutical SUT (single-use technology) for new therapeutics manufacturing.
• Similarly, in September 2022, Merck KGaA invested EUR 130 million (USD 132 million) in beefing up the ability of its manufacturing arm—MilliporeSigma—to employ single-use assemblies at its facility in Molsheim, France. Thus, such investments and facility expansions undertaken by industry participants are further projected to drive revenue growth for the market.
• Moreover, the growing biologics market and increasing demand for monoclonal antibodies, vaccines, and cell therapies have accelerated the demand for single-use assemblies such as filtration systems, transfer systems, valves, bags, and other consumables as these reduce the risk of cross-contamination associated with biologics manufacturing. Thus, the growth in the biologics market has driven the demand for single-use assemblies, which, in turn, is expected to drive market growth during the forecast period.
• Furthermore, several strategic initiatives undertaken by industry participants to strengthen their business avenues are further expected to drive market growth. For instance, in April 2023, Merck launched the Ultimus Single-Use Process Container Film. According to the company, the film was designed to provide extreme durability and leak resistance for single-use assemblies used for bioprocessing liquid applications. Thus, the introduction of such products is expected to drive the industry's growth forward.
• Therefore, the advantages of single-use assemblies over traditional processes and increased biopharmaceutical R&D activities propel market growth. However, issues related to extractables and leachables are expected to hamper the market’s growth.

Single-use Assemblies Market Trends

Biopharmaceutical and Pharmaceutical Companies Segment Accounted For Significant Market Share

Single-Use Assemblies Industry Segmentation

A single-use assembly refers to a self-contained and preassembled plastic fluid pathway composed of a mix of standard components that are generally gamma-irradiated for sterility and ready to use. Single-use assemblies are suitable to be customized to fit specific applications and unit activities.

The single-use assemblies market is segmented by product type, application, end user, and geography. By product type, the market is segmented into filtration assemblies, bag assemblies, bottle assemblies, and mixing system assemblies. By application, the market is segmented into cell culture and mixing, filtration, storage, sampling, fill-finish application, and other applications. Other applications include aseptic transfer and fluid management. By end user, the market is segmented into biopharmaceutical and pharmaceutical companies, contract research and contract manufacturing organizations, and academic and research institutes. By geography, the market is segmented into North America, Europe, Asia-Pacific, Middle East and Africa, and South America. The market report also covers the estimated market sizes and trends for 17 different countries across major regions globally. The report offers the value (USD) for all the above segments.