US Single Use Assemblies Market

The report "US Single Use Assemblies Market by Product (Bag (2D, 3D), Filtration, Bottle, Mixing, Tubing Assemblies), Solution (Customized, Standard), Modality (mAbs, Vaccines, CGT), Application (Filtration, Cell Culture, Storage, Transfer) - Forecasts to 2029", is projected to reach USD 1,656.8 million by 2029 from an estimated USD 825.1 million in 2024, at a CAGR of 15.0% during the forecast period.

US Single-Use Assemblies Market-Forecast to 2029. Browse over 154 tables, 50 figures, and an in-depth TOC on the US Single-Use Assemblies (SUA) market report. Early buyers will receive 10% customization on the report.

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The rising demand of single-use technologies in biopharmaceutical manufacturing is driving rapid growth in the US Single-Use Assemblies (SUA) market. The 21st Annual Report and Survey from BioPlan indicates that SUA use in 2024 is projected to be 87%. These systems are selected for their ability to facilitate adaptable manufacturing processes, streamline operations, and reduce contamination risks. Biologics, vaccines, and cell and gene therapies find broad applicability in both upstream and downstream processes. Demand is being propelled by the transition to modular and continuous manufacturing facilities. Despite ongoing challenges like as material standardization and sustainability, advancements in material science and a heightened focus on reducing environmental impact are transforming the industry.

The filtration & purification segment accounted for the largest share of the application segment in the US single-use assemblies market in 2023.

Based on Application, The US single-use assemblies services market is segmented into filtration & purification applications, aseptic transfer, storage applications, sampling applications, cell culture, formulation & fill-finish, and mixing applications. In 2023, the filtration & purification segment led the single-use assembly market, significantly contributing to the maintenance of sterility and the elimination of impurities in biopharmaceutical manufacturing. The increase in regulatory approvals for biologics and biosimilars has compelled manufacturers to adopt cost-effective single-use filtration assemblies. Using these assemblies eliminates the need for tasks such as cleaning, sterilization and validation which reduces costs and contamination compared to stainless-steel systems. Single-use technologies reduce process waste, labor expenses, and quality standards, while improving efficiency and safety. Their flexibility makes customized combinations possible, therefore maximizing manufacturing. Originally limited to laboratory, single-use systems have become indispensable in pharmaceutical production, particularly for viral capture in gene therapies and immunizations and bioburden reduction. This shift emphasizes their importance in modern biopharmaceutical production since it helps to improve efficiency and speed of market access.

The monoclonal antibodies segment accounted for the largest share of the modality segment in the US single-use assemblies market in 2023.

Based on Modalities, The US single-use assemblies services market is segmented into monoclonal antibodies (mAbs), vaccines, therapeutic proteins & peptides, and cell & gene therapies. The monoclonal antibodies segment accounted for the largest share of the US single-use assemblies market in 2023. This can be attributed to the increasing demand for single-use assemblies in the manufacturing of mAbs due to low capital investments, low workforce requirements, and reductions in time-consuming changeover procedures and validation. The demand for mAbs is also growing globally due to the increasing popularity of targeted therapeutic options for indications like oncology and autoimmune & inflammatory disorders. mAbs are now included into pipelines of biopharmaceutical companies as a result. Second-largest share of the market came from the vaccinations category. Single-use assemblies provide a solution as vaccine makers try to maximize production capacity while minimizing costs by lowering the requirement for cleaning and validation, fastening manufacturing schedules, and improving general operational efficiency.

The CROs & CMOs segment is estimated to register the highest growth rate during the forecast period in the US single-use assemblies products market.

Based on end user, the US single-use assemblies market is segmented into pharmaceutical & biopharmaceutical companies, CROs & CMOs, and academic & research institutes. The CROs & CMOs companies segment is estimated to register the highest growth rate during the forecast period. The increasing demand for outsourcing services among pharmaceutical & biopharmaceutical industries is anticipated to promote the growth of the CROs & CMOs segment in coming years. This growth is driven by the increasing preference for outsourcing research and manufacturing activities among pharmaceutical, biopharmaceutical, and biotechnology companies. CROs and CMOs provide a range of services, including drug discovery, clinical-scale manufacturing, preclinical and clinical trials, and commercial manufacturing, helping companies reduce operational costs. Despite CROs & CDMOs high growth rate, Pharmaceutical & Biotechnology companies accounted for the largest share of the US single-use assemblies market in 2023.

The report profiles key players in the single-use assemblies market such as Thermo Fisher Scientific Inc. (US), Danaher Corporation (US), Avantor, Inc. (US), Parker Hannfin Corporation (US), Repligen Corporation (US), Corning Incorporated (US), Entregris (US), Lonza (US), and W. L. Gore & Associates, Inc. (US) among others.

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