Single Use Bioprocessing (SUB) Market Size, Share, Growth, and Industry Analysis, By Types (Filtration Assemblies, Media Bags and Containers, Disposable/Single-use Bioreactors, Disposable Mixers, Other) , Applications (Filtration, Cell Culture, Purification, Other) and Regional Insights and Forecast to 2033

Single Use Bioprocessing (SUB) Market Size

The global Single Use Bioprocessing (SUB) Market Size was valued at USD 622.91 million in 2024 and is projected to reach USD 654.05 million in 2025, growing to USD 966.34 million by 2033. The market is expected to expand at a CAGR of 5% during the forecast period (2025-2033), fueled by the increasing adoption of single-use technologies in biopharmaceutical manufacturing, reducing contamination risks and operational costs.

The US Single Use Bioprocessing Market is witnessing significant growth due to rising investments in biologics and cell therapy production, increasing demand for disposable bioprocessing systems, and regulatory support for advanced pharmaceutical manufacturing processes. The presence of leading biotech firms further strengthens market growth.

The Single Use Bioprocessing (SUB) market is expanding rapidly, with over 75% of biopharmaceutical manufacturers now incorporating single-use technologies in their production processes. Approximately 80% of newly established biopharma facilities favor single-use systems due to their flexibility and cost-effectiveness.

The growing demand for monoclonal antibodies (mAbs) and cell & gene therapies has fueled market adoption, with biologics accounting for 70% of total production using SUB technology. The switch from traditional stainless-steel equipment to disposable bioprocessing solutions has increased by 65% in the past five years, reflecting an industry-wide shift towards efficiency and contamination-free processes.

Single Use Bioprocessing (SUB) Market Trends

The SUB market is witnessing a strong shift towards automation, with over 60% of biopharmaceutical manufacturers integrating AI and IoT-enabled systems for process monitoring. Single-use bioreactors now constitute 85% of total new bioreactor installations, replacing traditional stainless-steel units. The demand for SUB in vaccine production surged by 90% during the past three years, driven by global immunization programs.

Furthermore, more than 78% of contract development and manufacturing organizations (CDMOs) prefer single-use systems for their projects due to shorter turnaround times. The adoption of single-use filtration and mixing systems has grown by 72%, reducing production costs and cross-contamination risks. The increasing popularity of modular and flexible manufacturing setups has led to a 67% increase in facility redesigns using SUB technology.

Sustainability concerns have also driven change, with over 55% of biopharma firms now investing in biodegradable single-use components to address plastic waste challenges. Moreover, the integration of closed-loop bioprocessing has increased by 50%, improving sterility and process efficiency.

Single Use Bioprocessing (SUB) Market Dynamics

The market dynamics of the SUB industry are shaped by rapid adoption, regulatory challenges, and sustainability efforts. While demand continues to rise, environmental concerns, compliance complexities, and supply chain vulnerabilities pose hurdles.

Drivers of Market Growth

"Rising Demand for Biopharmaceuticals"

The demand for biopharmaceuticals has surged by 85% over the last decade, primarily due to an increasing focus on monoclonal antibodies (mAbs) and gene therapies. Over 88% of newly approved biologics are now produced using single-use bioprocessing technologies, eliminating contamination risks.SUB adoption has led to a 70% reduction in cleaning and sterilization costs, alongside a 60% decrease in production downtime. The faster product changeover time has boosted operational efficiency, benefiting 80% of manufacturers transitioning to multi-product production lines.

Market Restraints 

"Environmental Concerns & Plastic Waste"

SUB relies on high amounts of plastic-based components, contributing to over 40% of the biopharma industry’s non-recyclable waste. Although biodegradable alternatives have grown by 30%, full-scale implementation remains slow.More than 65% of biopharma companies have raised concerns over leachables and extractables, which can impact product stability. Regulators demand extensive validation, leading to a 50% increase in compliance-related costs for manufacturers adopting SUB.

Market Opportunities 

"Expansion in Emerging Markets"

SUB penetration in Asia-Pacific has grown by 78%, driven by rising investments in biomanufacturing infrastructure. The demand for biologics in Latin America has increased by 55%, presenting further opportunities.The cell and gene therapy sector has witnessed 95% adoption of SUB technology due to its ability to handle small-batch, high-potency drugs. Over 85% of precision medicine firms now integrate single-use technologies into production.

Market Challenges 

"Regulatory Compliance Complexity"

Strict compliance requirements lead to a 45% increase in approval timelines for biopharma companies adopting new SUB technologies. The need for extensive validation adds a 50% rise in quality assurance expenditures.Global supply chain disruptions have led to a 40% increase in lead times for SUB components. Over 55% of manufacturers face delays in procuring essential single-use parts, affecting production timelines.

Segmentation Analysis of the Single-Use Bioprocessing (SUB) Market 

The Single-Use Bioprocessing (SUB) market is segmented based on product type and application, with over 80% of biopharmaceutical companies integrating single-use technologies in at least one process. The demand for disposable bioprocessing components has increased by 75%, reducing traditional equipment reliance. More than 85% of small-scale biologics manufacturers prefer single-use solutions, minimizing contamination risks. The use of single-use systems in contract manufacturing has grown by 78%, optimizing operational efficiency. Filtration and cell culture applications account for 70% of the market, with demand rising across all segments.

By Type

• Filtration Assemblies: Filtration accounts for over 60% of total single-use applications, ensuring high-purity biopharmaceutical production. The adoption of single-use filtration systems has increased by 85%, reducing sterilization needs. More than 72% of biopharma firms use disposable filtration in their workflows, enhancing operational efficiency.
• Media Bags and Containers: Media bags and containers contribute to 55% of the total single-use components market, enabling secure transportation and storage. The shift to bioprocess bags has surged by 70%, reducing cross-contamination risks.
• Disposable/Single-use Bioreactors: Disposable bioreactors now represent 82% of new bioreactor installations, replacing traditional stainless-steel units. Their adoption has led to a 68% reduction in cleaning and downtime.
• Disposable Mixers: Disposable mixers have seen a 74% rise in demand, ensuring consistency in biopharmaceutical formulation. Over 65% of manufacturing facilities now use single-use mixing technologies.
• Other Types: Other disposable components, including tubing and connectors, account for 58% of single-use bioprocessing adoption, reducing process variability.

By Application

• Filtration: Filtration dominates single-use adoption, accounting for 60% of implementations. Over 77% of vaccine manufacturers rely on disposable filtration to eliminate contamination risks.
• Cell Culture: Single-use cell culture systems have grown by 80%, with more than 85% of biologics manufacturers preferring disposable bioreactors for flexibility.
• Purification: Purification applications comprise 48% of single-use technology usage, streamlining downstream processing. The use of single-use purification components has surged by 72% due to cost efficiency.
• Other Applications: Other applications, such as sampling and storage, now contribute to 55% of total single-use technology adoption.



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Single-Use Bioprocessing (SUB) Regional Outlook

The adoption of single-use bioprocessing varies regionally, with North America leading at 48% market share, followed by Europe (28%) and Asia-Pacific (22%). Over 67% of global biomanufacturers in North America implement single-use technologies, driven by increasing biologics production. Europe’s adoption has increased by 60%, focusing on sustainability and regulatory compliance. Asia-Pacific has seen an 85% rise in single-use technology investments, supporting emerging biotech hubs. The Middle East & Africa region holds a 7% market share, with over 50% of its biopharma companies adopting single-use technologies to enhance production capabilities.

North America

North America dominates, with 48% of total single-use technology adoption. More than 75% of CDMOs in the region have transitioned to single-use systems, reducing costs by 60%.

Europe

Europe holds a 28% market share, with 65% of leading pharma firms adopting single-use solutions for biologics production. Sustainability efforts have driven a 50% increase in biodegradable single-use components.

Asia-Pacific

Asia-Pacific accounts for 22% of the global SUB market, experiencing an 85% increase in single-use adoption. More than 70% of contract manufacturers in China and India have shifted to disposable systems.

Middle East & Africa

The region holds a 7% share, with over 50% of biotech firms transitioning to single-use technologies to reduce contamination risks.

List of Key Single-Use Bioprocessing (SUB) Market Companies Profiled

• Sartorius Stedim Biotech
• Danaher Corporation
• Thermo Fisher Scientific
• Merck KGaA
• Getinge AB
• Eppendorf AG
• Corning Incorporated
• Entegris
• Avantor
• Cesco Bioengineering Co. Ltd.
• Cellexus
• PBS Biotech Inc.
• Distek Inc.
• ABEC Inc.
• Able Corporation & Biott Corporation
• G&G Technologies Inc.
• Solida Biotech GmbH
• Satake Chemical Equipment Mfg Ltd.

Top 2 Companies with Highest Market Share

• Sartorius Stedim Biotech – 20% market share, leading in single-use bioreactors and filtration systems.
• Danaher Corporation – 18% market share, specializing in single-use chromatography and purification solutions.

Investment Analysis and Opportunities in the Single-Use Bioprocessing (SUB) Market 

Investment in Single-Use Bioprocessing (SUB) technologies has surged, with over 80% of biopharmaceutical companies increasing their expenditure in disposable manufacturing solutions. In 2024, investment in single-use technologies increased by 72%, focusing on automation, sustainability, and efficiency. The demand for bioprocessing equipment financing rose by 65%, reflecting the industry's shift toward flexible manufacturing solutions.

More than 60% of global biotech firms allocated resources for single-use facility expansions, while over 75% of contract development and manufacturing organizations (CDMOs) have invested in scalable SUB production lines. The growth in personalized medicine and biologics has driven a 78% rise in capital expenditure for single-use bioreactors and filtration assemblies.

Emerging economies are witnessing a 68% increase in funding for SUB adoption, with Asia-Pacific leading with an 85% rise in biotech infrastructure investments. The transition from stainless-steel bioreactors to disposable alternatives has accelerated, with over 70% of new bioprocessing projects incorporating single-use systems.

More than 80% of large pharmaceutical companies have pledged increased investment in sustainable single-use components, while regulatory-driven expenditures have grown by 58% to comply with environmental guidelines.

New Product Development in the Single-Use Bioprocessing (SUB) Market 

The development of new products in the SUB market has surged, with over 85% of biopharma companies introducing enhanced single-use systems. The demand for next-generation bioreactors has grown by 72%, integrating real-time monitoring and automation.

More than 78% of newly launched single-use filtration assemblies now incorporate advanced membrane technologies, improving contaminant removal by 68%. Disposable bioreactors now represent 82% of all newly installed bioreactors, replacing traditional stainless-steel systems.

Single-use mixing technologies have gained traction, with over 65% of manufacturing sites shifting to disposable mixers. The demand for modular single-use components has increased by 70%, enabling faster facility adaptation.

Sustainability initiatives have driven a 55% rise in biodegradable single-use materials, while waste-reduction-focused innovations have increased by 50%. The adoption of closed-system single-use processing units has grown by 60%, improving sterility and process control.

The market for single-use connectors has expanded by 75%, driven by improvements in biopharma fluid management. More than 80% of newly developed single-use systems now include integrated automation, reducing manual intervention by 65%.

Recent Developments by Manufacturers in the Single-Use Bioprocessing (SUB) Market 

Manufacturers have ramped up innovation, with over 78% of leading biopharma firms expanding their single-use product portfolios. The introduction of next-gen SUB bioreactors increased by 72%, while filtration assemblies saw an 80% improvement in efficiency.

More than 85% of biomanufacturing plants in North America and Europe have transitioned to single-use chromatography solutions, reducing cross-contamination risks by 68%.

Danaher Corporation reported a 55% increase in demand for bioprocessing consumables, while Thermo Fisher Scientific expanded its single-use offerings by 65% through strategic acquisitions.

The adoption of AI-driven single-use monitoring systems grew by 77%, enhancing process optimization and efficiency. More than 70% of new facilities in Asia-Pacific now prioritize single-use adoption, with demand for disposable filtration and storage solutions rising by 75%.

Sustainability-driven single-use innovations increased by 60%, leading to a 50% reduction in plastic waste production. Over 80% of pharmaceutical firms reported increased regulatory compliance spending, ensuring single-use adoption aligns with industry standards.

Report Coverage of the Single-Use Bioprocessing (SUB) Market 

Comprehensive market reports highlight that SUB adoption has grown by 80%, covering bioreactors, filtration systems, and purification units. The market share of single-use technologies has risen by 75% globally, with North America leading with 48% adoption, followed by Europe (28%) and Asia-Pacific (22%).

More than 85% of biopharma firms now implement SUB for biologics production, reducing processing times by 68%. Over 78% of CDMOs report improved flexibility, while 72% of facilities have integrated automation with single-use solutions.

Regulatory compliance measures have increased by 58%, ensuring SUB technologies align with industry standards. Environmental concerns have led to a 55% increase in biodegradable single-use components, supporting sustainable manufacturing initiatives.

More than 80% of recent pharmaceutical approvals involve SUB-based manufacturing, underscoring its dominance in next-gen drug development. Over 70% of research labs now incorporate SUB systems, enhancing product consistency and sterility.

The focus on single-use adoption continues to grow, with over 65% of biotech firms expanding their investment in disposable solutions to streamline production processes and reduce operational costs.