The Global Single-Use Bio-Processing Systems Market is witnessing a transformative era, transitioning from traditional stainless-steel infrastructure to flexible, disposable solutions. According to Western Market Research, the market was valued at USD 24.5 Billion in 2025 and is projected to reach an estimated value of USD 78.2 Billion by the year 2036. This growth represents a robust Compound Annual Growth Rate (CAGR) of 11.1% globally.
This shift is primarily driven by the biopharmaceutical industry's need for greater agility, reduced capital expenditure, and the elimination of complex cleaning and sterilization processes. Single-use technologies (SUT) utilize disposable plastic components that are pre-sterilized (usually via gamma irradiation), allowing for rapid setup and reduced risk of cross-contamination between batches.
Market Description
Single-use bio-processing systems comprise a range of disposable equipment designed for the development and manufacturing of biopharmaceuticals, such as monoclonal antibodies, vaccines, and cell and gene therapies. Unlike traditional fixed-tank systems that require extensive "Cleaning-in-Place" (CIP) and "Sterilization-in-Place" (SIP) procedures, single-use systems are discarded after a single production run.
This modular approach significantly lowers the risk of batch failure due to contamination and allows manufacturers to switch between different products with minimal downtime. As the pharmaceutical landscape shifts toward personalized medicine and smaller batch sizes, the scalability and flexibility of single-use systems have become indispensable. The market encompasses everything from small-scale laboratory vessels to large-scale 2,000-liter bioreactors, integrated with sophisticated sensors and automated control systems.
Global Single-Use Bio-Processing Systems Segmentation
The market is segmented based on product type and application, reflecting the diverse needs of the biotechnology and pharmaceutical sectors.
By Type:
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Disposable Bioreactors: The heart of the upstream process, providing the environment for cell growth and protein expression.
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Mixers: Essential for preparing buffers, media, and drug substances with high homogeneity.
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Containers: Including storage bags and specialized carboys for transporting biological fluids.
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Tubing: Flexible conduits that facilitate the movement of fluids between various units without exposure to the environment.
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Connectors: Critical components that ensure sterile transfers and "plug-and-play" connectivity between different modules.
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Sampling Systems: Devices that allow for the sterile withdrawal of samples for quality control and process monitoring.
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Purification Devices And Columns: Used in downstream processing to isolate the target molecule from impurities.
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Probes/Sensors: Single-use pH, dissolved oxygen, and temperature sensors that provide real-time data to control systems.
By Application:
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R&D Support Bio-processing Systems: Utilized in laboratory settings for drug discovery, process optimization, and pilot-scale production.
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GMP Single-use Bio-processing Systems: Designed for commercial manufacturing under strict Good Manufacturing Practice (GMP) regulations, ensuring safety and efficacy for clinical use.
Top Key Players
The market is dominated by several global leaders who provide end-to-end solutions, alongside specialized manufacturers focusing on niche components.
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GE Healthcare (Cytiva)
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Merck & Co. (MilliporeSigma)
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Sartorius
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Broadly-James
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Cellexus
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Eppendorf
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Finesse Solutions (Thermo Fisher Scientific)
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Parker Hannifin
-
Saint-Gobain
Market Dynamics (DROT Analysis)
Drivers:
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Reduced Capital Investment: SUT significantly lowers the initial cost of building a bioprocessing facility by eliminating the need for expensive stainless-steel vats and heavy-duty piping for steam and water.
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Speed to Market: The time required to set up a single-use facility is roughly half that of a traditional facility, allowing companies to respond faster to clinical trial results or pandemic outbreaks.
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Cross-Contamination Mitigation: Since the product contact surfaces are replaced after every run, the risk of batch-to-batch contamination is virtually eliminated, which is critical for multi-product facilities.
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Operational Efficiency: SUT reduces water and energy consumption by removing the need for high-temperature steam sterilization and chemical cleaning.
Restraints:
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Extractables and Leachables (E&L): One of the primary concerns is the potential for chemicals from the plastic components to migrate into the drug product, requiring rigorous testing and regulatory scrutiny.
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Scalability Limits: While technology is improving, single-use bioreactors currently peak at around 2,000 to 6,000 liters, making them less suitable for the massive-scale production of high-volume blockbuster drugs compared to 20,000-liter stainless steel tanks.
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Environmental Impact: The generation of significant amounts of plastic waste raises sustainability concerns, though many manufacturers are exploring recycling and waste-to-energy programs.
Opportunities:
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Cell and Gene Therapy: These high-growth sectors require small-scale, highly sterile, and specialized environments, making them a perfect fit for single-use technology.
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Emerging Markets: Expanding biotech sectors in China, India, and Southeast Asia are skipping traditional infrastructure in favor of the more affordable and faster-to-implement single-use systems.
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Continuous Bio-processing: The industry is moving toward continuous manufacturing, where single-use components provide the necessary modularity to keep the process running 24/7.
Threats:
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Supply Chain Vulnerability: High reliance on specialized plastic polymers means that disruptions in the global supply chain can lead to manufacturing delays for life-saving drugs.
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Standardization Issues: The lack of universal standards for connectors and tubing across different vendors can lead to "vendor lock-in," where a facility becomes dependent on a single supplier for all replacement parts.
Value Chain Analysis
The value chain of single-use bio-processing systems is a complex journey from raw material sourcing to final drug production.
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Raw Materials: It begins with specialized polymer manufacturers who provide medical-grade plastics (PE, PP, EVA) that are resistant to degradation and low in leachables.
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Component Manufacturing: Key players like Sartorius and Saint-Gobain transform these plastics into bags, filters, and connectors through molding and extrusion in cleanroom environments.
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System Integration: Manufacturers assemble these components into complete bioreactor systems or customized "kits" designed for specific pharmaceutical processes.
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Sterilization: Completed systems undergo gamma irradiation or ethylene oxide sterilization to ensure they are 100% free of microbes before reaching the customer.
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Distribution: Systems are shipped to biopharma companies and Contract Development and Manufacturing Organizations (CDMOs).
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End-Use: The drug manufacturer uses the system for a single production run, after which it is decommissioned and processed for waste management.
Impact of COVID-19
The COVID-19 pandemic acted as a massive catalyst for the single-use market. The urgent need for vaccines (mRNA and viral vector-based) required unprecedented speed in manufacturing scale-up. Single-use systems were the only technology capable of being deployed rapidly enough to meet global demand. This led to a surge in orders for Disposable Bioreactors and Connectors. However, the pandemic also exposed supply chain weaknesses, as the sudden spike in demand led to global shortages of tubing and storage bags, forcing companies to reconsider their inventory management and source multi-vendor alternatives.
Regional Analysis
North America remains the dominant market, driven by the presence of major biopharma giants and a high concentration of cell and gene therapy startups in the U.S. Europe follows closely, with Germany and Switzerland serving as hubs for high-tech bio-processing machinery. The Asia-Pacific region is the fastest-growing market; government support for biotechnology in China and the rise of biosimilars in India have led to a massive increase in the adoption of GMP-grade single-use systems. The Middle East & Africa and South America are in the early stages of adoption, primarily utilizing SUT for local vaccine production and R&D activities.
Outlook
The outlook for the Single-Use Bio-Processing Systems market through 2036 is exceptionally positive. We expect to see "Single-Use 2.0," characterized by advanced automation and the integration of Artificial Intelligence (AI) to monitor real-time data from Probes/Sensors. As sustainability becomes a corporate priority, innovations in biodegradable or fully recyclable medical-grade polymers will likely emerge. Furthermore, as the industry masters the manufacturing of complex therapies, single-use systems will become the default standard for all new biopharmaceutical facilities, eventually relegating stainless steel to only the most massive-scale commodity drug productions.
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1. Market Overview of Single-Use Bio-Processing Systems
1.1 Single-Use Bio-Processing Systems Market Overview
1.1.1 Single-Use Bio-Processing Systems Product Scope
1.1.2 Market Status and Outlook
1.2 Single-Use Bio-Processing Systems Market Size by Regions: 2015 VS 2021 VS 2026
1.3 Single-Use Bio-Processing Systems Historic Market Size by Regions
1.4 Single-Use Bio-Processing Systems Forecasted Market Size by Regions
1.5 Covid-19 Impact on Key Regions, Keyword Market Size YoY Growth
1.5.1 North America
1.5.2 East Asia
1.5.3 Europe
1.5.4 South Asia
1.5.5 Southeast Asia
1.5.6 Middle East
1.5.7 Africa
1.5.8 Oceania
1.5.9 South America
1.5.10 Rest of the World
1.6 Coronavirus Disease 2019 (Covid-19) Impact Will Have a Severe Impact on Global Growth
1.6.1 Covid-19 Impact: Global GDP Growth, 2019, 2020 and 2021 Projections
1.6.2 Covid-19 Impact: Commodity Prices Indices
1.6.3 Covid-19 Impact: Global Major Government Policy
2. Covid-19 Impact Single-Use Bio-Processing Systems Sales Market by Type
2.1 Global Single-Use Bio-Processing Systems Historic Market Size by Type
2.2 Global Single-Use Bio-Processing Systems Forecasted Market Size by Type
2.3 Disposable Bioreactors
2.4 Mixers
2.5 Containers
2.6 Tubing
2.7 Connectors
2.8 Sampling Systems
2.9 Purification Devices And Columns
2.10 Probes/Sensors
3. Covid-19 Impact Single-Use Bio-Processing Systems Sales Market by Application
3.1 Global Single-Use Bio-Processing Systems Historic Market Size by Application
3.2 Global Single-Use Bio-Processing Systems Forecasted Market Size by Application
3.3 R&D Support Bio-processing Systems
3.4 GMP Single-use Bio-processing Systems
4. Covid-19 Impact Market Competition by Manufacturers
4.1 Global Single-Use Bio-Processing Systems Production Capacity Market Share by Manufacturers
4.2 Global Single-Use Bio-Processing Systems Revenue Market Share by Manufacturers
4.3 Global Single-Use Bio-Processing Systems Average Price by Manufacturers
5. Company Profiles and Key Figures in Single-Use Bio-Processing Systems Business
5.1 GE Healthcare
5.1.1 GE Healthcare Company Profile
5.1.2 GE Healthcare Single-Use Bio-Processing Systems Product Specification
5.1.3 GE Healthcare Single-Use Bio-Processing Systems Production Capacity, Revenue, Price and Gross Margin
5.2 Merck & Co.
5.2.1 Merck & Co. Company Profile
5.2.2 Merck & Co. Single-Use Bio-Processing Systems Product Specification
5.2.3 Merck & Co. Single-Use Bio-Processing Systems Production Capacity, Revenue, Price and Gross Margin
5.3 Santorius
5.3.1 Santorius Company Profile
5.3.2 Santorius Single-Use Bio-Processing Systems Product Specification
5.3.3 Santorius Single-Use Bio-Processing Systems Production Capacity, Revenue, Price and Gross Margin
5.4 Broadly-James
5.4.1 Broadly-James Company Profile
5.4.2 Broadly-James Single-Use Bio-Processing Systems Product Specification
5.4.3 Broadly-James Single-Use Bio-Processing Systems Production Capacity, Revenue, Price and Gross Margin
5.5 Cellexus
5.5.1 Cellexus Company Profile
5.5.2 Cellexus Single-Use Bio-Processing Systems Product Specification
5.5.3 Cellexus Single-Use Bio-Processing Systems Production Capacity, Revenue, Price and Gross Margin
5.6 News Coverage
5.6.1 News Coverage Company Profile
5.6.2 News Coverage Single-Use Bio-Processing Systems Product Specification
5.6.3 News Coverage Single-Use Bio-Processing Systems Production Capacity, Revenue, Price and Gross Margin
5.7 Eppendorf
5.7.1 Eppendorf Company Profile
5.7.2 Eppendorf Single-Use Bio-Processing Systems Product Specification
5.7.3 Eppendorf Single-Use Bio-Processing Systems Production Capacity, Revenue, Price and Gross Margin
5.8 Finesse Solutions
5.8.1 Finesse Solutions Company Profile
5.8.2 Finesse Solutions Single-Use Bio-Processing Systems Product Specification
5.8.3 Finesse Solutions Single-Use Bio-Processing Systems Production Capacity, Revenue, Price and Gross Margin
5.9 Parker Hannifin
5.9.1 Parker Hannifin Company Profile
5.9.2 Parker Hannifin Single-Use Bio-Processing Systems Product Specification
5.9.3 Parker Hannifin Single-Use Bio-Processing Systems Production Capacity, Revenue, Price and Gross Margin
5.10 Saint-Gobain
5.10.1 Saint-Gobain Company Profile
5.10.2 Saint-Gobain Single-Use Bio-Processing Systems Product Specification
5.10.3 Saint-Gobain Single-Use Bio-Processing Systems Production Capacity, Revenue, Price and Gross Margin
6. North America
6.1 North America Single-Use Bio-Processing Systems Market Size
6.2 North America Single-Use Bio-Processing Systems Key Players in North America
6.3 North America Single-Use Bio-Processing Systems Market Size by Type
6.4 North America Single-Use Bio-Processing Systems Market Size by Application
7. East Asia
7.1 East Asia Single-Use Bio-Processing Systems Market Size
7.2 East Asia Single-Use Bio-Processing Systems Key Players in North America
7.3 East Asia Single-Use Bio-Processing Systems Market Size by Type
7.4 East Asia Single-Use Bio-Processing Systems Market Size by Application
8. Europe
8.1 Europe Single-Use Bio-Processing Systems Market Size
8.2 Europe Single-Use Bio-Processing Systems Key Players in North America
8.3 Europe Single-Use Bio-Processing Systems Market Size by Type
8.4 Europe Single-Use Bio-Processing Systems Market Size by Application
9. South Asia
9.1 South Asia Single-Use Bio-Processing Systems Market Size
9.2 South Asia Single-Use Bio-Processing Systems Key Players in North America
9.3 South Asia Single-Use Bio-Processing Systems Market Size by Type
9.4 South Asia Single-Use Bio-Processing Systems Market Size by Application
10. Southeast Asia
10.1 Southeast Asia Single-Use Bio-Processing Systems Market Size
10.2 Southeast Asia Single-Use Bio-Processing Systems Key Players in North America
10.3 Southeast Asia Single-Use Bio-Processing Systems Market Size by Type
10.4 Southeast Asia Single-Use Bio-Processing Systems Market Size by Application
11. Middle East
11.1 Middle East Single-Use Bio-Processing Systems Market Size
11.2 Middle East Single-Use Bio-Processing Systems Key Players in North America
11.3 Middle East Single-Use Bio-Processing Systems Market Size by Type
11.4 Middle East Single-Use Bio-Processing Systems Market Size by Application
12. Africa
12.1 Africa Single-Use Bio-Processing Systems Market Size
12.2 Africa Single-Use Bio-Processing Systems Key Players in North America
12.3 Africa Single-Use Bio-Processing Systems Market Size by Type
12.4 Africa Single-Use Bio-Processing Systems Market Size by Application
13. Oceania
13.1 Oceania Single-Use Bio-Processing Systems Market Size
13.2 Oceania Single-Use Bio-Processing Systems Key Players in North America
13.3 Oceania Single-Use Bio-Processing Systems Market Size by Type
13.4 Oceania Single-Use Bio-Processing Systems Market Size by Application
14. South America
14.1 South America Single-Use Bio-Processing Systems Market Size
14.2 South America Single-Use Bio-Processing Systems Key Players in North America
14.3 South America Single-Use Bio-Processing Systems Market Size by Type
14.4 South America Single-Use Bio-Processing Systems Market Size by Application
15. Rest of the World
15.1 Rest of the World Single-Use Bio-Processing Systems Market Size
15.2 Rest of the World Single-Use Bio-Processing Systems Key Players in North America
15.3 Rest of the World Single-Use Bio-Processing Systems Market Size by Type
15.4 Rest of the World Single-Use Bio-Processing Systems Market Size by Application
16 Single-Use Bio-Processing Systems Market Dynamics
16.1 Covid-19 Impact Market Top Trends
16.2 Covid-19 Impact Market Drivers
16.3 Covid-19 Impact Market Challenges
16.4 Porter
Global Single-Use Bio-Processing Systems Segmentation
The market is segmented based on product type and application, reflecting the diverse needs of the biotechnology and pharmaceutical sectors.
By Type:
-
Disposable Bioreactors: The heart of the upstream process, providing the environment for cell growth and protein expression.
-
Mixers: Essential for preparing buffers, media, and drug substances with high homogeneity.
-
Containers: Including storage bags and specialized carboys for transporting biological fluids.
-
Tubing: Flexible conduits that facilitate the movement of fluids between various units without exposure to the environment.
-
Connectors: Critical components that ensure sterile transfers and "plug-and-play" connectivity between different modules.
-
Sampling Systems: Devices that allow for the sterile withdrawal of samples for quality control and process monitoring.
-
Purification Devices And Columns: Used in downstream processing to isolate the target molecule from impurities.
-
Probes/Sensors: Single-use pH, dissolved oxygen, and temperature sensors that provide real-time data to control systems.
By Application:
-
R&D Support Bio-processing Systems: Utilized in laboratory settings for drug discovery, process optimization, and pilot-scale production.
-
GMP Single-use Bio-processing Systems: Designed for commercial manufacturing under strict Good Manufacturing Practice (GMP) regulations, ensuring safety and efficacy for clinical use.
Top Key Players
The market is dominated by several global leaders who provide end-to-end solutions, alongside specialized manufacturers focusing on niche components.
-
GE Healthcare (Cytiva)
-
Merck & Co. (MilliporeSigma)
-
Sartorius
-
Broadly-James
-
Cellexus
-
Eppendorf
-
Finesse Solutions (Thermo Fisher Scientific)
-
Parker Hannifin
-
Saint-Gobain
