Global Single-Use Assemblies Market Size, Share, Growth Analysis, By Product(Bag Assemblies, 2D bag assemblies), By Application(Filtration, Cell Culture & Mixing), By Solution(Customized Solutions, and Standard Solutions) - Industry Forecast 2024-2031

Global Single-Use Assemblies Market size was valued at USD 2.7 billion in 2022 and is poised to grow from USD 3.21 billion in 2023 to USD 12.73 billion by 2031, growing at a CAGR of 18.80% during the forecast period (2024-2031).

Single-use assemblies encompass pre-assembled plastic fluid pathways and self-contained products, created by combining various standard components that are often ready for immediate use and gamma irradiated to ensure sterility. Common components include sampling bottles, filters, tubing, check valves, clamps, sterile connectors, fittings, and seals. The expanding biologics market, along with ongoing technological advancements in bioprocessing, has significantly boosted biopharmaceutical Research and Development (R&D). The widespread adoption of single-use assemblies by diverse Contract Manufacturing Organizations (CMOs) is expected to drive industry growth in the foreseeable future. However, regulatory considerations related to leachable and extractables, waste management, and the availability of multi-use systems may restrain the widespread adoption of single-use assemblies. The emergence of COVID-19 has further accelerated the demand for such assemblies, as disposable technology facilitates rapid production and development of therapies and vaccines, improving precision and efficiency. A notable example is Entegris, Inc.'s Aramus single-use bag assembly, utilized for storing COVID-19 vaccines requiring ultra-low temperatures for preservation. The increasing prevalence of cancer and infectious diseases is driving the production of novel biologics for diagnosis and treatment. The rise in cancer cases and infectious diseases such as lower respiratory infections and HIV, attributed to factors like climate shifts and urbanization, enhances the industry's prospects. Innovative vaccine developments, exemplified by Moderna's mRNA-based HIV vaccine clinical trial, underscore the pivotal role of cutting-edge technologies in the biologics arena. Collaborative efforts to address emerging infectious diseases with pandemic potential further emphasize the push towards novel vaccine alternatives.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Single-Use Assemblies Market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Single-Use Assemblies Market Segmental Analysis

The Global Single-Use Assemblies Market is segmented on the basis of Product, Application, Solution, End - Use, Region. By Product, the market is segmented into Bag Assemblies, 2D bag assemblies, 3D bags assemblies, Filtration Assemblies, Others. By Application, the market is segmented into Filtration, Cell Culture & Mixing, Storage, Sampling, Fill-finish Applications, Others. By End - User, the market is segmented into Biopharmaceutical & Pharmaceutical Companies, CROs & CMOs. By Solution, the market is segmented into Customized Solutions, and Standard Solutions. By Region, the market is segmented into North America, Europe, Latin America, Asia- Pacific, Middle East and Africa.

Drivers of the Global Single-Use Assemblies Market

The use of single-use assemblies reduces the potential for cross-contamination, thereby elevating the safety and quality of products. This disposability feature minimizes the risk associated with reusing components, ensuring a higher level of product integrity.

Restraints in the Global Single-Use Assemblies Market

Single-use assemblies inherently lack reusability, potentially leading to elevated long-term operational expenses and the generation of unnecessary waste.

Market Trends of the Global Single-Use Assemblies Market

Single-Use Assemblies are gaining widespread acceptance in the pharmaceuticals, biotechnology, and food processing sectors owing to their versatile nature, lower risk of contamination, and enhanced operational efficiency.