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Single Use Assemblies Market

The market for Single Use Assemblies was estimated at $3.8 billion in 2025; it is anticipated to increase to $7.7 billion by 2030, with projections indicating growth to around $15.7 billion by 2035.

Report ID:DS1806028
Author:Debadatta Patel - Senior Consultant
Published Date:
Datatree
Life Science
Other Healthcare
Single Use Assemblies
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Report Summary
Market Data
Methodology
Table of Contents

Global Single Use Assemblies Market Outlook

Revenue, 2025

$3.8B

Forecast, 2035

$15.7B

CAGR, 2026 - 2035

15.4%

The Single Use Assemblies industry revenue is expected to be around $3.8 billion in 2026 and expected to showcase growth with 15.4% CAGR between 2026 and 2035. Growing industry adoption of single use assemblies highlights their value to the biopharmaceutical industry by enabling the use of flexible single use technologies which reduce risk of product contamination, speed up equipment changeover and lower the expense of cleaning validation. The industry is being driven by demand for units which are able to produce several products, strict acceptance by the regulatory bodies of the equipments ability to handle sterile fluids and the prevalence of high value filters. By 2025, the revenues generated from assemblies utilising filtration are predicted to be $1.26 billion, thereby solidifying the importance of single use assemblies in bioprocessing as a critical factor in both efficiency and quality.

Pre assembled single use systems comprise a range of components including tubing, filters, connectors, bags and sensors which are supplied sterile and pre connected, thereby allowing them to be easily integrated into single use bioreactors. This offers several key advantages including modularity, the ability to scale up or down, a closed system and reduced risk of contamination. Cell and tissue culture, harvest, filtration and purification, media and buffer preparation, vaccine production and fill and finish operations are the main uses of this product. Cell culture and harvest along with filtration and purification applications take up the majority of the market. Assembly filters are the leading product. The key drivers in this sector are the move towards intensified bio processing, the increase in production of complex biologics and vaccines and the need for flexible manufacturing lines to produce personalised medicine. The use of disposable technology is becoming increasingly popular as it allows for quicker product development and better compliance.

Single Use Assemblies market outlook with forecast trends, drivers, opportunities, supply chain, and competition 2025-2035
Single Use Assemblies Market Outlook

Market Key Insights

  • The Single Use Assemblies market is projected to grow from $3.8 billion in 2025 to $15.7 billion in 2035. This represents a CAGR of 15.4%, reflecting rising demand across Filtration & Purification, Storage & Transport, and Cell Culture/Harvest.

  • Leading participants in this market include Sartorius AG, Merck KGaA and Thermo Fisher Scientific. They are the ones who decide the competitive landscape.

  • The US and Germany are projected to dominate the Single Use Assemblies market and these are anticipated to achieve a compound annual growth rate of 13.9 to 18.5 % between the years 2025 and 2030.

  • The highest growth rates are expected to be observed in emerging markets, such as India, South Africa and Brazil, where compound annual growth rates are estimated at between 10.8% and 16.2%.

  • The shift towards single use technologies is predicted to contribute $1 billion by 2030 to the single use assemblies market.

  • Between 2025 and 2035, Single Use Assemblies are expected to increase by $12 billion. Manufacturers are targeting the storage and transport sectors and cell culture/harvest applications for growth.

  • The demand for single use assemblies is set to see significant growth in the biopharmaceuticals sector. By 2035 the market is predicted to expand by 319% when compared to that of 2025.

single use assemblies market size with pie charts of major and emerging country share, CAGR, trends for 2025 and 2032
Single Use Assemblies - Country Share Analysis

Opportunities in the Single Use Assemblies

The trend towards the use of biotechnology and the development of vaccines is also necessitating North American manufacturers to switch to single use assembly systems. The global market for filtration assemblies will be 1.26 billion in the year 2025 and is expected to grow to 2.34 billion by 2030 with a Compound Annual Growth Rate of 13.2%. The dominant growth sector of this market is likely to be Single Use Assemblies filtration, because under researched regional vaccine manufacturers and contract producers of pharmaceutical development and manufacturing will be doing this.

Growth Opportunities in North America and Asia-Pacific

Primarily in North America, single use assemblies are heavily driven by the cell and gene therapy and biologics sectors, rapidly scaling up. Single use technologies in the filtration and purification process are most often used due to regulatory and contamination control requirements in the pharmaceutical industry. Key region's of focus include single use bioprocessing assemblies for downstream filtration trains, integrated fluid management systems, and pre validated, automation ready assemblies for GMP environments and contract development organisations. With a market place that is highly competitive, large multinationals which provide single use systems along with smaller niche companies offering high performance connectors, sensors and customised engineering capabilities are driving companies to differentiate themselves through the provision of regulatory compliant documentation, the compilation of extractables and leachables data and comprehensive technical support. Key motivators for growth in this region include its strong pipeline of innovative technologies, widespread adoption of single use solutions in full scale production and a growing requirement for rapid commercialisation. North America is thus an ideal region for both premium, fully integrated single use assemblies and business models based on service which focus on filtration, purification, cell culture and harvesting.
Across Asia Pacific the single use assemblies are being increasingly adopted in the cell culture/harvest and storage and transport sectors. This growth is largely due to the construction of new biologic, vaccine and biosimilar manufacturing facilities in the region. These facilities are in need of flexible and modular single use bioprocessing units. Key region's of opportunity exist in the development of cost effective, pre assembled harvest and transfer equipment for use in single use bioreactors, as well as in sterile fluid management systems suitable for production of multiple products. Further opportunities exist in the creation of robust shipping ready assemblies that will enable cold chain and bulk drug substance transport between regional manufacturing sites. Companies operating in a competitive market must adapt to a situation where global companies are shifting their production and distribution to local regions, at the same time regional companies are cutting prices in order to increase sales. As a result businesses are using a variety of strategies to differentiate themselves. This includes the localising of products to meet local tastes and preferences, the quick modification of products to suit customer needs and offering extensive support and training. The main factors behind the growth of the industry are government backed expansion projects, CDMO companies increasing their capacity, and companies preferring to install single use systems rather than the traditional steel, giving the Asia Pacific region investment appeal.

Market Dynamics and Supply Chain

01

Driver: Growing Biologics Production and Demand for Flexible, Contamination‑Free Manufacturing Workflows

The single use assemblies market is also significantly driven by the rapid expansion of biologics production and the industry’s increasing preference for flexible, contamination‑free manufacturing workflows. Biologics such as monoclonal antibodies, vaccines and cell therapies require highly controlled environments to maintain product integrity. Single use assemblies eliminate the need for cleaning‑in‑place and sterilization‑in‑place systems, reducing cross‑contamination risk and validation burdens. Their adoption allows biotech manufacturers to quickly scale up or switch production campaigns with minimal downtime, meeting the accelerated demand cycles of modern biologics. At the same time, the need for flexible manufacturing, especially in contract development and manufacturing organization (CDMO) settings, supports modular facilities that use disposable assemblies to rapidly adapt to varying batch sizes and products. This dual demand from biologics pipelines and flexible facility architectures is also driving broad uptake of single use solutions in upstream and downstream bioprocessing, enhancing operational efficiency and reducing cost per batch.
Another key driver for the single use assemblies market is also the ongoing innovation in integrated single use systems featuring real‑time monitoring and connectivity. Advanced assemblies now incorporate sensors, RFID tracking, and digital interfaces that support real‑time monitoring of parameters such as pressure, flow and fluid integrity. These enhancements improve process control, reduce risk of failures, and support automation in bioprocess workflows. As manufacturers adopt Industry 4.0 and smart biomanufacturing strategies, the integration of digital monitoring with disposable assemblies becomes increasingly important. This trend not only elevates data quality and regulatory compliance but also strengthens confidence in single use technologies across complex production environments.
02

Restraint: High Material and Operational Costs Restrict Adoption in Cost‑Sensitive Manufacturing Environments

A key restraint for single use assemblies is the relatively high cost of disposable components and consumables, especially in large‑scale bioprocessing. Although single use systems reduce cleaning‑validation expenses, the ongoing expenditure on bags, filters and tubing can outweigh savings for high‑volume facilities. This limits adoption in cost‑sensitive markets and encourages continued use of reusable stainless‑steel systems, dampening revenue growth for single use suppliers and slowing market penetration in emerging regions where price sensitivity is acute.
03

Opportunity: Emerging Asian biopharmaceutical startups demanding cost-efficient bag and bottle Single Use Assemblies solutions and Rapid expansion of cell and gene therapy CDMOs in Europe boosting mixing Single Use Assemblies

In India, China and South Korea, there is a growing focus among the developing Asian biopharmaceutical manufacturing bases and the nascent biotechnology industry on cost effective large scale production equipment. The highest predicted growth in bag assemblies will come from sterile goods packaging for aseptic processing, media transport and storage. By 2030 this is estimated to reach 2.24 billion from 2025s 1.05 billion at a 16.3% compound annual growth rate. Demand for smaller fill and finish capabilities is expected to increase from 0.48 billion to 0.94 billion bottle assemblies, due in part to smaller batch vaccine production. These smaller fill and finish capabilities are likely to be used by cash strapped biologic innovators and regional vaccine manufacturers.
The European biotech sector is experiencing a marked increase in the development of cell and gene therapies, which is having a direct impact on the demand for single use assemblies amongst contract development and manufacturing organisations with specialist expertise. The greatest potential is realised in mixing systems which are used for suspension cultures, buffer preparation and feeding media for single use bioreactors. Revenues are predicted to rise to 1.48 billion dollars by 2030 from 0.61 billion dollars in 2025, at 19.4% CAGR. In Europe, it is Single Use Assemblies that are the most rapidly growing configuration for the smaller contract development and manufacturing businesses.
04

Challenge: Concerns Over Supply Chain Reliability and Limited Standardization Hinder Broad Deployment

Another significant challenge for single use assemblies is supply chain reliability and lack of industry standardization. Biopharma manufacturers depend on consistent availability of specific disposable components. Disruptions in supply, raw material shortages or lead time variability can delay production campaigns. Additionally, varying connector standards and incompatibility between vendors’ systems force firms to commit to single suppliers, reducing flexibility and increasing switching costs. These dynamics constrain broader adoption and impact demand patterns across upstream and downstream bioprocessing workflows.

Supply Chain Landscape

1

Polymer Resins

BASF SEDow Inc
2

Single Use Components

Saint-Gobain Life SciencesParker Hannifin
3

Single Use Assemblies

Thermo Fisher Scientific Inc.Sartorius AGMerck KGaA
4

Biopharmaceutical manufacturing

BiopharmaceuticalVaccine productionCell and gene therapy
Single Use Assemblies - Supply Chain

Use Cases of Single Use Assemblies in Filtration & Purification & Cell Culture/Harvest

Filtration & Purification : In the filtration and purification application, single use assemblies such as sterile filtration units, depth filters, and membrane filter cassettes are widely used to remove contaminants and impurities from biologics, vaccines, and therapeutic proteins, ensuring product safety and regulatory compliance. These assemblies reduce contamination risk, eliminate cleaning and sterilization validation, and enhance operational flexibility compared with traditional stainless‑steel systems. Key players like Merck KGaA, Danaher, Sartorius AG and Thermo Fisher Scientific offer extensive single‑use filtration portfolios that support both upstream and downstream bioprocessing, helping biopharmaceutical manufacturers accelerate batch turnover and maintain high sterility assurance across production workflows. Adoption is driven by the need for cost‑effective, contamination‑free operations in the rapidly expanding biologics segment.
Storage & Transport : For storage and transport, single‑use assemblies such as bag systems, bottle assemblies, and container solutions are essential for securely holding, moving, and preserving buffers, media, bulk drug substances and intermediates throughout the bioprocessing cycle. These disposable assemblies offer sterile containment, reduced cross‑contamination risk and improved handling convenience without requiring cleaning‑in‑place systems, enhancing supply chain efficiency for biopharma production. Companies including Thermo Fisher Scientific, Entegris and Avantor provide customizable single‑use bag assemblies and containment solutions that support cold‑chain transport and aseptic storage, meeting stringent quality requirements across pharmaceutical and biotech facilities. 
Cell Culture/Harvest : In cell culture and harvest applications, single‑use assemblies like bioreactor bags, tubing manifolds, and harvest filter assemblies streamline cell growth, media exchange and product collection while maintaining sterility throughout the process. These assemblies obviate cleaning steps and facilitate rapid process changeovers, enabling consistent cell expansion and efficient harvest operations. Leading providers such as Sartorius AG, Cytiva and Thermo Fisher Scientific deliver integrated single‑use solutions that enhance bioreactor performance and simplify fluid handling during upstream cell culture and downstream harvest, boosting productivity and reducing contamination risks. 

Recent Developments

The single use assemblies market is evolving with increasing focus on sustainable bioprocess solutions and modular disposable technologies that support flexible, contamination‑free manufacturing. Recent developments highlight integration of sensor‑enabled, single use fluidics and eco‑friendly materials that reduce plastic waste and enhance process traceability. This emphasis on environmental sustainability and real‑time process monitoring is shaping supplier portfolios, encouraging adoption across upstream cell culture, downstream filtration, and sterile storage workflows while aligning with broader industry goals for greener, efficient biomanufacturing.

May 2025 : Avantor announced the expansion of its sterile PETG single‑use bottle assemblies, enhancing product offerings for bioprocessing fluid storage and transport applications to meet growing demand.
March 2025 : Entegris introduced an advanced line of single‑use filtration assemblies aimed at improving sterility and process efficiency in biopharmaceutical production.
April 2023 : Merck’s Ultimus single‑use container film with enhanced durability and leak resistance was introduced in 2023 and widely cited as a key innovation in single‑use assemblies.

Impact of Industry Transitions on the Single Use Assemblies Market

As a core segment of the Other Healthcare industry, the Single Use Assemblies market develops in line with broader industry shifts. Over recent years, transitions such as Shift Towards Single-Use Technologies and Growing Emphasis on Sustainability have redefined priorities across the Other Healthcare sector, influencing how the Single Use Assemblies market evolves in terms of demand, applications and competitive dynamics. These transitions highlight the structural changes shaping long-term growth opportunities.
01

Shift Towards Single-Use Technologies

The growth of single use technology is driving growth in the single use assemblies market with an estimated increase of $1 billion by 2030. The trend in the industry of biopharmaceutical manufacture to reduce cleaning validation procedures, to improve the efficiency of production workflows and to speed up the time it takes to bring a product to market has led to the growing adoption of single use assemblies. The use of sterile technology in single use bioreactors and disposable bioprocessing systems allows for the creation of flexible manufacturing processes and the efficient deployment of manufacturing capacity across a variety of facilities which produce different products. The reduction in the use of water, energy and cleaning agents supports more sustainable manufacturing processes. In this way, the shift is not only changing manufacturing operations and facilities, but also how the biopharmaceutical industry will compete in the future by having a flexible manufacturing plant.
02

Growing Emphasis on Sustainability

The single use assemblies market is witnessing a clear shift toward sustainable and eco‑friendly solutions, driven by rising environmental awareness among manufacturers and regulatory encouragement for greener practices. Companies are increasingly adopting recyclable, biodegradable or reduced-plastic materials in single use bags, tubing, and filtration systems to minimize environmental impact. This transition influences related industries, including bioprocessing equipment suppliers, waste management, and polymer manufacturing, prompting innovation in sustainable raw materials and recycling programs. Biopharmaceutical manufacturers benefit by reducing carbon footprint, improving compliance with environmental regulations, and meeting corporate sustainability goals. Leading players such as Sartorius AG, Thermo Fisher Scientific, and Cytiva are integrating environmentally conscious designs into their product portfolios, supporting broader adoption while maintaining sterility, operational efficiency, and process flexibility across upstream and downstream bioprocessing workflows.