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Single-Use Assemblies Market
With a compound annual growth rate (CAGR) of XX% from 2024 to 2033, the worldwide single-use assembly market is projected to reach approximately US$ XX billion by 2033 from its estimated US$ XX billion in 2023. The single-use assemblies market is expanding due to the growing use of 2D and 3D single-use assemblies and solutions. These methods address a variety of applications from media and buffer preparation to final fill, providing effective and scalable bioprocessing fluid management solutions. Their mobility and flexibility offer major benefits, making it easy for manufacturers to adjust to changing requirements.
Organizations may choose the best solution for their requirements thanks to the wide range of options available, all of which have different certification levels. Because of its adaptability and support for single-use technologies, the market is becoming more and more in demand as companies want to save expenses and improve operational efficiency.

Market Overview
Market for single-use assemblies is expanding quickly because to its adaptability and applicability in a range of biopharmaceutical processes. Whether off-the-shelf or custom-designed, single-use assemblies offer targeted solutions for bioprocessing requirements, including vaccine production, patient delivery systems, lab and drug discovery, cell culture, upstream and downstream processing, and viral production.
Single-use assemblies are especially necessary in the rapidly expanding field of cell and gene therapy. To reduce toxicological hazards, thorough testing is vital, as seen by the rise in single-use systems in the biopharmaceutical industry. Leachable and extractable testing is being used by businesses more frequently to guarantee security. To ensure product integrity and patient safety, leachable testing, for example, evaluates whether chemical components migrate from single-use solutions into the process solution under typical conditions.

Key Insights

•    On the basis of geography, the North America captured largest market share.
•    On the basis of geography, The Asia Pacific market is anticipated to rise at a faster CAGR in forecast period.
•    On the basis of product, the filtration assemblies segment dominated the market with a significant market share.
•    On the basis of application, the filtration segment dominated the market with a significant market share.
•    On the basis of solution, the customized segment was held the largest market share.
•    On the basis of end-user, the biopharmaceuticals & pharmaceutical businesses segment held the major market share

Regional Stance
Market for single-use assembly is dominated by North America, where notable developments in biomedical, energy, advanced food, and industrial technologies may be found in the U.S. Biosciences industry. Additionally, a wide variety of career options with good living standards are supported by this industry. Because of this steady expansion, state and local stakeholders are now more aware of the critical role that biosciences enterprises play.
In the states, towns, and municipalities where they do business, these businesses play a crucial role in creating a sense of community, creating ground-breaking concepts, and promoting economic development.

Report Highlights
By Technology
Worldwide single-use assemblies market is still dominated by the filtration assemblies segment, which commands a sizeable market share. These assemblies are essential for joining devices and equipment in labs and the medical industry. One recent technological development in final filtering is the use of single-use assemblies. From simple designs consisting of a capsule with tubing, these assemblies have developed into more complex configurations that allow for sampling, blow-down, and pre-use integrity testing. The biopharmaceutical and medical industries rely heavily on single-use filtering assemblies, and this progression highlights their increasing significance and technological advancement.
With a wide range of solutions including mixing systems, microcarrier separation systems, and motion bioreactor bags, the bag assemblies market is predicted to grow at the fastest rate. These sophisticated bag assemblies offer creative and effective solutions for the biopharmaceutical sector, meeting the changing demands of the quickly growing single-use bioprocessing applications. This growth trajectory emphasizes the segment's technological relevance in the market and its critical role in satisfying evolving bioprocessing requirements.

By Application
Filtering category dominates the global single-use biorefinery sector with a significant profit share, and it is anticipated to continue to do so for the duration of the projected period. In order to handle greater diversity, the growing range of therapies, treatments, and drugs requires adaptable and flexible solutions. Systems that can handle both big and small volumes are needed for the burgeoning tailored treatments, unlike ten years ago when bulk compound manufacture was the norm. This change emphasizes the requirement for flexible filtering systems that can facilitate the creation of both conventional and customized treatments, increasing their viability and efficacy.
.The segment with the highest predicted compound annual growth rate (CAGR) throughout the projected period is cell culture and mixing. The dissolution of cell culture media, which are complex combinations of synthetic and biological components intended to supply the necessary nutrients for healthy cell growth and high protein production, is greatly aided by single-use mixing methods. This expansion is a result of the growing need in the biopharmaceutical manufacturing industry for dependable and efficient solutions, underscoring the significance of sophisticated single-use mixing systems for maximizing cell culture procedures and guaranteeing superior results.

By Solution
Due to the need for customized solutions that enhance productivity and streamline workflows in biopharmaceutical and biotechnology laboratories, this market segment has the biggest revenue share. These specialized solutions are made to order to satisfy certain operational requirements, increasing efficiency and guaranteeing a smooth integration with current workflows. This emphasis on customized, high-performance solutions highlights how important the market is to meeting the unique needs of advanced bioprocessing and lab settings.
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By End User
When it comes to single-use assemblies and technologies, the biopharmaceutical and pharmaceutical industries have the biggest market shares. Single-use substitutes for conventional stainless steel equipment have been more popular during the last ten years in almost all sterile industries. Single-use equipment improves product quality, saves cleaning costs, cuts downtime, and dramatically eliminates the danger of cross-contamination and batch contamination. It offers a reduced manufacturing footprint, lowers setup costs for facilities, and increases the flexibility and adaptability of facilities. These advantages highlight the growing trend in pharmaceutical and biopharmaceutical manufacturing processes toward single-use solutions.
Over the course of the forecast period, the CROs and CMOs segment is anticipated to grow at the fastest rate. Single-use assemblies are widely used by Contract Manufacturing Organizations (CMOs) to speed up processing and process changeovers. The efficiency of CMOs is greatly increased by the short turnaround times and flexibility that single-use equipment offers between process runs and different customer projects. The significant expansion of this market is attributed to CMOs' important adaptability and efficiency in satisfying a wide range of customer requests and streamlining operational operations.

Market Dynamics
Driver Single-Use Systems Revolutionize Biopharmaceutical Manufacturing
Biopharmaceutical production sector is undergoing a tremendous transformation due to the growing adoption of Single-Use Systems (SUS), which provide significant advantages over traditional stainless-steel equipment. Polymeric systems can be swapped out between products, which removes the need for labor-intensive cleaning, validation, and sterilization procedures. This simplifies manufacturing processes and shortens turnaround times. This development offers a scalable, economical option for both small- and large-scale production while improving flexibility and reducing the chance of cross-contamination. As a result, these advantages are fueling the market expansion for single-use assemblies by meeting the industry's need for more flexible and efficient manufacturing techniques.

Restraints
Challenges of Single-Use Assemblies
Despite its benefits, the use of Single-Use Systems (SUS) in biopharmaceutical manufacturing is fraught with difficulties that could limit market expansion. The need for bags and connectors results in continuous expenses for consumables, and supply security is an important factor to take into account. Due to the restricted recycling infrastructure and the difficulty of dissecting Single-Use Technologies (SUTs) and SUSs into their homogenous components, high disposal prices represent a serious problem. Variations in performance and compatibility can arise from the non-standard selection of the best plastic resins for single-use bioprocessing materials, making their use even more challenging. Furthermore, the requirement for significant storage space for extra single-use consumables can raise facility expenses, especially in large-scale bioproduction facilities, which will restrict the market's ability to develop overall for single-use assemblies.

Opportunities

Advances in Single-Use Technologies
Biopharmaceutical sector is experiencing a rapid transformation of bioprocesses and the facilities they operate in due to ongoing advancements in single-use bioreactors, mixing vessels, harvest technologies, and downstream bioprocess equipment. Single-use technologies (SUT) are driving this transformation by enabling continuous biomanufacturing processes and high cell density perfusion, which in turn enable bioprocess intensification. Bioreactors, tangential-flow filtering devices, depth filters, disposable filter cartridges, media biocontainers, mixing systems, tubing assemblies, sampling systems, and other components are all included in the single-use category. Compared to traditional stainless-steel systems, these single-use components provide a number of benefits, including greater flexibility, less cleaning and validation work, and a less chance of cross-contamination. As such, the market for single-use assemblies has significant development prospects as a result of the adoption of these technologies.
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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.

Key Players in the 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
U.S.
Canada
Europe
Germany
France
United Kingdom
Rest of Europe
Asia Pacific
China
Japan
India
Southeast Asia
Rest of Asia Pacific
Latin America
Brazil
Rest of Latin America
Middle East & Africa (MEA)
GCC
North Africa
South Africa
Rest of Middle East & Africa

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Single-Use Assemblies Market

Report ID : 615

Category : Biotechnology

No Of Pages : 120

Published on: August 2024

Status: Published

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