Single-Use Bioprocessing Market Overview

The global Single-Use Bioprocessing Market is poised for rapid expansion, reaching a value of USD 34.0 billion in 2025 and projected to grow to USD 110.1 billion by 2033, at a CAGR of 16.3% during the forecast period. Single-use technologies are increasingly becoming the backbone of modern biomanufacturing, providing benefits such as reduced contamination risk, lower capital investment, and faster turnaround times compared to traditional stainless-steel systems.          

This shift is being driven by rising demand for biologics, including monoclonal antibodies, vaccines, and advanced therapies such as cell and gene therapies, which require flexible, scalable, and cost-effective production solutions. Moreover, the COVID-19 pandemic accelerated the adoption of disposable bioprocessing equipment, as manufacturers sought rapid production capabilities for vaccines and biologics without long installation timelines. The growing outsourcing of manufacturing activities to CROs and CMOs has further fueled adoption, as these facilities favor single-use systems for their operational efficiency and ability to switch between production lines seamlessly. Despite challenges such as plastic waste management and concerns over extractables and leachables, the advantages of speed, cost-efficiency, and compliance with evolving regulatory frameworks position single-use bioprocessing as a dominant manufacturing platform in the global biopharmaceutical industry.

Single-Use Bioprocessing Market Drivers and Opportunities

Growing demand for biologics and biosimilars accelerates adoption of single-use bioprocessing technologies

The surge in demand for biologics, including monoclonal antibodies, vaccines, and recombinant proteins, is a central growth driver for the single-use bioprocessing market. As the prevalence of chronic diseases such as cancer, autoimmune disorders, and infectious diseases rises, the need for targeted biologic therapies continues to expand. Unlike small molecules, biologics require highly specialized manufacturing environments that can adapt to variable batch sizes, shifting market demands, and accelerated timelines. Single-use systems offer scalability, reduced cross-contamination, and faster production cycles, aligning perfectly with these requirements. Additionally, the global push toward biosimilars and next-generation biologics is intensifying pressure on manufacturers to optimize cost efficiency without compromising quality. Single-use technologies support this by lowering upfront infrastructure costs and enabling more rapid changeovers between products. With healthcare expenditure climbing worldwide and payers increasingly demanding affordability in biologics, the adoption of disposable bioprocessing solutions will remain a core enabler for cost-competitive, high-quality biologic production in the coming years.

Cost efficiency and operational flexibility of single-use systems drive market expansion

One of the most compelling advantages of single-use bioprocessing is its ability to reduce capital expenditure and operating costs compared to traditional stainless-steel systems. Conventional systems often require extensive cleaning, sterilization, and validation processes that consume time, labor, and resources, slowing down production and adding significant operational complexity. In contrast, single-use systems eliminate the need for cleaning validation, dramatically shortening turnaround times between production batches. This flexibility enables biopharmaceutical companies, CROs, and CMOs to bring products to market more quickly and to adapt rapidly to fluctuating demand. Moreover, the modular nature of disposable bioprocessing allows facilities to scale up or scale out more efficiently, particularly important in clinical trial manufacturing or niche therapy production such as rare disease biologics. As companies prioritize leaner operations and faster time-to-market in a competitive biologics landscape, the economic and operational benefits of single-use technologies position them as a preferred choice across global biomanufacturing networks.

Opportunity for the Single-Use Bioprocessing Market

Growing investment in cell and gene therapy manufacturing presents significant opportunities in the global Single-Use Bioprocessing Market.

Advanced therapies such as CAR-T cell treatments, viral vector-based gene therapies, and regenerative medicines require highly flexible and sterile production environments that single-use technologies can uniquely support. These therapies are often produced in smaller, customized batches, making traditional large-scale stainless-steel systems impractical. Single-use platforms enable faster setup, contamination control, and cost-efficient small-batch production, aligning well with the evolving needs of precision medicine. With regulatory agencies increasingly approving advanced therapies and venture capital inflows into biotech companies surging, the demand for specialized bioprocessing solutions is expected to accelerate. As a result, suppliers of single-use technologies are expanding their portfolios to include advanced bioreactors, closed-system solutions, and integrated automation tools designed specifically for cell and gene therapy manufacturing. This emerging segment is anticipated to be one of the strongest growth drivers for the single-use bioprocessing market over the next decade.

Single-Use Bioprocessing Market Scope

Single-Use Bioprocessing Market Report Segmentation Analysis

The global Single-Use Bioprocessing Market industry analysis is segmented by Product, by Application, by End-user, and by region.

The bioreactors segment accounted for the largest market share in the global Single-Use Bioprocessing Market

By product, the market is divided into Bioreactors, Bags and Containers, Filtration Devices, Tubing Assemblies and Connectors, Sensors and Probes, and Others. Bioreactors dominated the market with a 31.8% share in 2025, driven by rising monoclonal antibody production, cell culture expansion, and the growing need for scalable manufacturing platforms. Single-use bioreactors are favored for their flexibility, reduced contamination risk, and ability to streamline workflows in both clinical and commercial manufacturing. Bags and containers represent another fast-growing segment, supported by their widespread use in storage, media handling, and transport of biopharmaceutical products. Filtration devices and tubing assemblies are essential for ensuring sterility and seamless integration across bioprocess steps. Meanwhile, sensors, probes, and other ancillary tools are increasingly being integrated into automated systems, enhancing real-time monitoring and process control.

The Monoclonal Antibody Production segment accounted for the largest market share in the global Single-Use Bioprocessing Market

By application, the market is categorized into Monoclonal Antibody Production, Vaccine Production, Cell Therapy, Viral Vector Production, Gene Therapy, and Other Biopharmaceutical Production Processes. Monoclonal antibody production holds the leading share, as single-use systems are extensively used in upstream and downstream workflows for mAbs, which dominate global biologics sales. The rapid uptake of biosimilars, coupled with expanding indications for therapeutic antibodies, continues to drive this segment. Vaccine production is another strong contributor, fueled by global immunization efforts and the surge in pandemic preparedness investments. Cell therapy and gene therapy applications are expanding rapidly, reflecting the growing pipeline of advanced therapies requiring small-batch, flexible manufacturing enabled by disposable technologies.

The biopharmaceutical companies segment dominates end-user adoption in the single-use bioprocessing market.

By End-user, the market is segmented into Biopharmaceutical Companies, CROs & CMOs, and others. Biopharmaceutical companies lead adoption, as they are the primary drivers of biologics, biosimilars, and novel therapy production worldwide. These companies rely on single-use technologies to enhance efficiency, reduce infrastructure investments, and accelerate product launches. CROs & CMOs represent a rapidly growing customer base, given the trend of outsourcing biomanufacturing to achieve cost efficiency and access specialized expertise. CROs and CMOs benefit particularly from the operational flexibility of disposable systems, which allow them to serve multiple clients with diverse production requirements. Other end-users include academic and research institutions focusing on biologics development and pilot-scale production, where single-use systems offer cost-effective entry points.

The following segments are part of an in-depth analysis of the global Single-Use Bioprocessing Market:

Single-Use Bioprocessing Market Share Analysis by Region

The North America region is projected to hold the largest share of the global single-use bioprocessing market over the forecast period.

North America accounted for the largest market share of 34.5% in 2025, driven by a robust biopharmaceutical industry, strong investment in biologics R&D, and widespread adoption of advanced bioprocessing technologies. The region’s dominance is reinforced by the presence of leading players such as Sartorius, Thermo Fisher Scientific, and Danaher, along with supportive regulatory frameworks that encourage innovation in biologics and biosimilars manufacturing. Moreover, strong venture capital inflows into biotech startups and ongoing demand for monoclonal antibodies and vaccines underpin sustained growth in the U.S. and Canada.

Asia Pacific, meanwhile, is anticipated to record the highest CAGR during the forecast period, supported by rapidly expanding biologics manufacturing hubs in China, India, and South Korea. Governments across the region are investing heavily in biopharma infrastructure, while multinational companies are increasingly establishing local production facilities to meet rising regional demand. Favorable cost structures, skilled labor availability, and growing clinical trial activity further strengthen the Asia Pacific’s position as a high-growth market. Europe continues to play a critical role with established regulatory frameworks and innovation in cell and gene therapy manufacturing, while Latin America and the Middle East & Africa present emerging opportunities as healthcare systems expand biologics access.

Single-Use Bioprocessing Market Competition Landscape Analysis

The global Single-Use Bioprocessing Market is highly competitive, with key players including Sartorius AG, Danaher Corporation, Thermo Fisher Scientific Inc., Merck KGaA, Avantor Inc., 3M Company, Repligen Corporation, Entegris, Getinge AB, Parker Hannifin Corporation, Alfa Laval Corporate AB, Saint-Gobain, Eppendorf SE, Corning Incorporated, Eaton Corporation plc, METTLER TOLEDO, Porvair PLC, Lonza, ABEC INC., NewAge Industries, PBS Biotech Inc., Sentinel Process Systems Inc., Meissner Filtration Products Inc., SATAKE MultiMix Corporation, Hamilton Company, Membrane Solutions, Cole-Parmer Instrument Company LLC, Distek Inc., Esco Lifesciences Group Ltd., and TECNIC Bioprocess Solutions. These companies are focusing on portfolio expansion, strategic partnerships, and technological innovation to strengthen market presence.

Global Single-Use Bioprocessing Market Recent Developments News:

• In April 2024 – Cytiva launched the Xcellerex magnetic mixer, a single-use mixing system available in 2,000 L and 3,000 L capacities, designed to streamline large-scale manufacturing of monoclonal antibodies (mAbs), vaccines, and genomic therapies. The system enhances operational efficiency and scalability in bioprocessing.

• In April 2023 – Merck KGaA introduced the Ultimus single-use process container film, engineered to deliver exceptional durability and leak resistance for single-use bioprocessing assemblies. This innovation ensures reliability and safety in handling sensitive bioprocessing liquids.

The Global Single-Use Bioprocessing Market is dominated by a few large companies, such as

●        Sartorius AG

●        Danaher Corporation

●        Thermo Fisher Scientific Inc.

●        Merck KGaA

●        Avantor Inc.

●        3M Company

●        Repligen Corporation

●        Entegris

●        Getinge AB

●        Parker Hannifin Corporation

●        Alfa Laval Corporate AB

●        Saint-Gobain

●        Eppendorf SE

●        Corning Incorporated

●        Eaton Corporation plc

●        METTLER TOLEDO

●        Porvair PLC

●        Lonza

●        ABEC INC.

●        NewAge Industries

●        PBS Biotech Inc.

●        Sentinel Process Systems Inc.

●        Meissner Filtration Products Inc.

●        SATAKE MultiMix Corporation

●        Hamilton Company

●        Membrane Solutions

●        Cole-Parmer Instrument Company LLC

●        Distek Inc.

●        Esco Lifesciences Group Ltd.

●        TECNIC Bioprocess Solutions

●        Other Prominent Players