According to Precedence Research, the global single-use assemblies market size was evaluated at US$ 11.34 billion in 2023 and is expected to attain around US$ 52.20 billion by 2033, growing at a CAGR of 16.5% from 2024 to 2033. North America single-use assemblies market share was 37.45% in 2023.
The increasing adoption of 2D and 3D single-use assemblies and solutions is driving growth in the single-use assemblies market. These technologies offer efficient and scalable bioprocessing fluid management solutions, addressing a range of applications from media and buffer preparation to final fill. Their flexibility and mobility provide significant advantages, enabling manufacturers to adapt to changing requirements with ease. The availability of a comprehensive spectrum of solutions, each with varying levels of certification, ensures that organizations can select the most appropriate option for their needs. This versatility and support for single-use technologies contribute to the expanding market demand, as businesses seek to enhance operational efficiency and reduce costs.
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Single-Use Assemblies Market Overview
The single-use assemblies market is experiencing rapid growth, driven by their versatility and application in various biopharmaceutical processes. Single-use assemblies, whether custom-designed or off-the-shelf, provide specific solutions for bioprocessing needs, encompassing viral production, lab and drug discovery, cell cultivation, upstream and downstream processing, vaccine production, patient delivery systems, and fill-and-finish operations. A particularly fast-growing area necessitating single-use assemblies is cell and gene therapy.
The proliferation of single-use systems in biopharmaceuticals underscores the critical importance of rigorous testing to mitigate toxicological risks. Companies are increasingly implementing leachable and extractable testing to ensure safety. Leachable testing, for instance, assesses whether chemical compounds migrate from single-use solutions into the process solution under normal conditions, thereby ensuring product integrity and patient safety.
Why is North America dominates the single-use assemblies market?
North America dominates the single-use assemblies market, with the U.S. Biosciences industry exemplifying significant advancements in biomedical, energy, advanced food, and industrial technologies. This industry also supports a diverse range of employment opportunities that offer quality standards of living. This consistent growth has heightened awareness among state and local stakeholders about the vital role of Biosciences companies. These companies are instrumental in fostering community, developing groundbreaking ideas, and driving economic prosperity in states, cities, and municipalities where they operate.
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By Technology
The filtration assemblies segment holds a significant market share and continues to dominate the global single-use assemblies market. These assemblies are crucial in connecting equipment and instruments across laboratories and the medical field. A recent technological advancement is the adoption of single-use assemblies for final filtration. These assemblies have evolved from basic designs featuring a capsule with tubing to more sophisticated configurations that enable pre-use integrity testing, blow-down, and sampling. This evolution underscores the growing importance and technological advancement of single-use filtration assemblies, reinforcing their critical role in the biopharmaceutical and medical industries.
The bag assemblies segment is expected to achieve the highest CAGR, driven by a comprehensive suite of solutions that includes motion bioreactor bags, mixing systems, and microcarrier separation systems. These advanced bag assemblies cater to the evolving needs of rapidly expanding single-use bioprocessing applications, providing innovative and efficient solutions for the biopharmaceutical industry. This growth trajectory highlights the segment’s pivotal role in meeting emerging bioprocessing requirements and underscores its technological significance in the market.
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By Application
With a notable profit share, the filtering category leads the global single-use biorefinery industry and is expected to maintain its dominance throughout the projected period. The expanding portfolio of therapies, treatments, and medications necessitates versatile and flexible solutions to accommodate increased diversity. Unlike a decade ago when bulk compound production was standard, the rise of personalized treatments demands systems capable of handling both large and small volumes. This shift underscores the need for adaptable filtering solutions that can support the production of traditional and personalized therapies, enhancing their feasibility and effectiveness.
The cell culture and mixing segment is anticipated to grow at the largest CAGR during the forecast period. Single-use mixing systems play a crucial role in facilitating the dissolution of cell culture media, which are intricate mixtures of synthetic and biological components designed to provide the essential nutrients for healthy cell propagation and high protein expression. This growth is driven by the increasing demand for efficient and reliable solutions in biopharmaceutical production, highlighting the importance of advanced single-use mixing systems in optimizing cell culture processes and ensuring high-quality outputs.
By Solution
The customized solutions segment holds the largest revenue share in the market, driven by the demand for tailored solutions that maximize efficiency and optimize workflows in biopharmaceutical and biotechnology laboratories. These custom solutions are specifically designed to meet unique operational needs, enhancing productivity and ensuring seamless integration into existing processes. This focus on bespoke, high-performance solutions underscores the segment’s pivotal role in supporting the specialized requirements of advanced bioprocessing and laboratory environments.
By End User
The biopharmaceutical and pharmaceutical sectors hold the largest market share for single-use assemblies and technologies. Over the past decade, there has been widespread adoption of single-use alternatives to traditional stainless steel equipment across nearly all sterile industries. Single-use equipment significantly reduces cross-product and batch contamination risks, enhances product integrity, decreases downtime, and lowers cleaning costs. It reduces facility set-up expenses, offers a smaller manufacturing footprint, and improves facility flexibility and adaptability. These benefits underscore the growing preference for single-use solutions in biopharmaceutical and pharmaceutical manufacturing processes.
The CROs and CMOs segment is projected to achieve the strongest CAGR over the forecast period. Contract Manufacturing Organizations (CMOs) frequently utilize single-use assemblies to expedite processing and process changeovers. The quick turnaround times and flexibility provided by single-use equipment between process runs and various client projects significantly enhance CMO efficiency. This adaptability and efficiency are crucial for CMOs in meeting diverse client demands and optimizing operational workflows, driving the robust growth of this segment.
Related Reports
· Single-use Bioprocessing Market: https://www.precedenceresearch.com/single-use-bioprocessing-market
· Single-use Bioreactors Market: https://www.precedenceresearch.com/single-use-bioreactors-market
· Single-use Consumables Market: https://www.precedenceresearch.com/single-use-consumables-market
Market Dynamics
Driver Single-Use Systems Revolutionize Biopharmaceutical Manufacturing
The increasing adoption of Single-Use Systems (SUS) in biopharmaceutical manufacturing is significantly transforming the industry by offering substantial advantages over traditional stainless-steel equipment. The replacement of polymeric systems between different products eliminates the need for extensive cleaning, validation, and sterilization processes, thus streamlining manufacturing operations and reducing turnaround times. This advancement enhances flexibility, minimizes the risk of cross-contamination, and provides a scalable, cost-effective solution for both small-scale and large-scale production. Consequently, these benefits are driving the growth of the single-use assemblies market, as they cater to the industry’s demand for more efficient and adaptable manufacturing processes.
Restraint
Challenges of Single-Use Assemblies
The adoption of Single-Use Systems (SUS) in biopharmaceutical manufacturing, while advantageous, presents several challenges that may constrain market growth. The requirement for bags and connectors generates ongoing consumable costs, and the security of supply is a critical consideration. High disposal costs pose a significant issue due to the limited recycling infrastructure and the complexity of separating Single-Use Technologies (SUTs) and SUSs into their homogeneous components. The lack of standardization in selecting optimal plastic resins for single-use bioprocessing materials can lead to variations in performance and compatibility, further complicating their use. Moreover, the need for substantial storage space for spare single-use consumables can increase facility costs, particularly in large-scale bioproduction facilities, thereby limiting the overall growth of the single-use assemblies market.
Opportunity
Advances in Single-Use Technologies
The biopharmaceutical industry is continually witnessing advances in single-use bioreactors, mixing vessels, harvest technology, and downstream bioprocess equipment, which are rapidly transforming bioprocesses and the facilities they operate in. This evolution is driven by Single-Use Technologies (SUT), which enable bioprocess intensification through high cell density perfusion and continuous biomanufacturing processes. The single-use segment encompasses a diverse range of components, including bioreactors, tangential-flow filtration devices, depth filters, disposable filter cartridges, media biocontainers, mixing systems, tubing assemblies, sampling systems, and more. These single-use components offer significant advantages over conventional stainless-steel systems, such as increased flexibility, reduced cleaning and validation requirements, and lower risk of cross-contamination. Consequently, the adoption of these technologies presents substantial growth opportunities for the single-use assemblies market.
Recent Developments
§ In May 2024, Novo Holdings acquired a majority stake in Single Use Support.
§ In April 2024, Watson-Marlow Fluid Technology Solutions launched new single-use solutions for fluid management.
Who are the top manufacturers in Single-Use Assemblies Market?
§ Antylia Scientific
§ Avantor, Inc.
§ Corning Incorporated
§ Danaher Corporation
§ Entegris
§ Flexbiosys
§ Kuhner AG
§ Lonza
§ Meissner Filtration Products
§ Merck KGaA
§ Newage Industries
§ Pall Corporation
§ Parker-Hannifin Corporation
§ Repligen Corporation
§ Romynox
§ Saint-Gobain Performance Plastics
§ Sartorius Stedim Biotech
§ Thermo Fisher Scientific, Inc.
Market Segmentation
By Product
· Bag Assemblies
· Filtration Assemblies
· Tubing Assemblies
· Bottle Assemblies
· Others
By Application
· Filtration
· Storage
· Cell Culture & Mixing
· Fill-finish Applications
· Sampling
· Others
By Solution
· Customized
· Standard
By End-User
· Biopharmaceutical & Pharmaceutical Companies
· CROs & CMOs
· Academic & Research Institutes
By Geography
· North America
· Europe
· Asia Pacific
· Latin America
· Middle East & Africa (MEA)
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