Global Single-use Bioprocessing Systems Market Size, Share and Trends Analysis Report – Industry Overview and Forecast to 2033

Single-use Bioprocessing Systems Market Size

• The global single-use bioprocessing systems market size was valued at USD 36.35 billion in 2025 and is expected to reach USD 108.53 billion by 2033, at a CAGR of 14.65% during the forecast period
• The market growth is largely fueled by the growing adoption and use of single-use technologies in biopharmaceutical manufacturing and research driven by increasing demand for biologics, vaccines, and cell & gene therapies which is accelerating the shift from traditional stainless-steel bioreactors to more flexible and cost-effective disposable systems
• Furthermore, rising industry emphasis on reducing contamination risk, shorter turnaround times, lower capital expenditure, and ease of scalability is establishing single-use bioprocessing systems as the preferred choice for many contract manufacturing organizations (CMOs), biotech firms, and research labs

Single-use Bioprocessing Systems Market Analysis

• Single-use bioprocessing systems, including disposable bioreactors, mixers, filters, and fluid-handling assemblies, are increasingly vital components of modern biopharmaceutical manufacturing due to their ability to reduce contamination risks, eliminate cleaning requirements, and offer flexible, rapid-deployment solutions for producing biologics, vaccines, and advanced therapies
• The escalating demand for single-use bioprocessing solutions is primarily fueled by the surge in biologics and cell- and gene-therapy development, rising biomanufacturing capacity expansions, and a growing industry preference for cost-efficient, scalable, and contamination-controlled production systems that support faster process changeovers
• North America dominated the single-use bioprocessing systems market with the largest revenue share of 38.9% in 2025, supported by a well-established biopharma ecosystem, strong R&D investments, and early adoption of advanced disposable technologies across major biopharmaceutical companies and contract development and manufacturing organizations (CDMOs)
• Asia-Pacific is expected to be the fastest-growing region in the single-use bioprocessing systems market during the forecast period due to rapid expansion of biopharmaceutical manufacturing infrastructure, increasing government and private investments in biotechnology, and a rising shift toward flexible, cost-effective production systems across emerging biotech hubs
• The single-use bioreactor segment dominated the global market with a market share of 33.8% in 2025, driven by its central role in upstream processing, strong demand for scalable disposable reactor formats, and its ability to support both clinical-scale and commercial-scale biologics and vaccine manufacturing

Report Scope and Single-use Bioprocessing Systems Market Segmentation 

Single-use Bioprocessing Systems Market Trends

Enhanced Efficiency Through Automation and Integrated Analytics

• A significant and accelerating trend in the global single-use bioprocessing systems market is the deepening integration of automation, advanced process analytics, and data-driven control within disposable manufacturing platforms, enhancing scalability, consistency, and operational efficiency across biologics production
  • For instance, leading bioprocessing companies offer single-use bioreactor systems integrated with advanced monitoring tools, enabling seamless control of parameters such as pH, dissolved oxygen, and temperature to support fully automated workflows
• Automation combined with real-time analytics allows single-use systems to learn process behavior, optimize runs, and deliver intelligent alerts for deviations, while improved sensor technologies offer greater accuracy in upstream and downstream operations. Furthermore, closed automated systems reduce contamination risks, enhance batch-to-batch consistency, and shorten production timelines for biologics and cell-based therapies
• The seamless integration of single-use systems with digital platforms and Manufacturing Execution Systems (MES) enables centralized oversight of multiple processing units, allowing manufacturers to coordinate upstream, downstream, and fill-finish operations from a unified digital interface
• This trend toward intelligent, automated, and highly integrated single-use systems is fundamentally reshaping expectations for modern bioprocessing workflows. Consequently, companies such as Sartorius and Thermo Fisher Scientific are developing automation-ready single-use bioreactors and mixers equipped with advanced sensors and data integration capabilities for optimized bioproduction
• The demand for single-use solutions with automated control and integrated analytics is growing rapidly across both biopharmaceutical and contract manufacturing sectors, as organizations increasingly prioritize efficiency, flexibility, and speed in biologics production

Single-use Bioprocessing Systems Market Dynamics

Driver

Growing Need Due to Rising Biologics Demand and Flexible Manufacturing Adoption

• The increasing prevalence of biologics, vaccines, and advanced therapies, coupled with the accelerating adoption of flexible and modular manufacturing environments, is a significant driver for the heightened demand for single-use bioprocessing systems
  • For instance, in 2025, several biomanufacturers announced expansions of modular facilities equipped with fully disposable technologies to accelerate clinical and commercial biologics production, reaffirming industry-wide shifts toward flexible infrastructure
• As biopharma companies seek to reduce contamination risks, scale processes quickly, and minimize downtime, single-use systems offer advantages such as rapid turnaround, reduced cleaning requirements, and improved operational agility compared to stainless-steel equipment
• Furthermore, the growing popularity of decentralized biomanufacturing and the rise of smaller clinical batches are increasing reliance on single-use platforms, which provide scalability and ease of integration across diverse production needs
• The ability to enable plug-and-play operations, simplify process transfer between sites, and reduce capital investment requirements are key factors propelling adoption across biologics developers and CDMOs. The increasing availability of advanced single-use systems for upstream and downstream processing further contributes to market growth

Restraint/Challenge

Material Interaction Concerns and Regulatory Compliance Hurdle

• Concerns surrounding material compatibility, extractables and leachables, and regulatory approval challenges pose a significant restraint to broader single-use bioprocess adoption. As these systems rely on polymer-based components, ensuring product safety and stability requires extensive validation
  • For instance, reports highlighting variability in polymer quality and the presence of extractable compounds in certain single-use components have raised caution among biopharmaceutical manufacturers and regulators
• Addressing these concerns through rigorous testing standards, improved material formulations, and transparent supplier documentation is crucial for building industry confidence. Companies such as Merck and Cytiva emphasize high-purity materials and validated supply chains to reassure end users. In addition, the relatively higher recurring cost of consumables compared to stainless-steel systems can be a barrier for budget-constrained manufacturers, particularly in emerging markets
• While sourcing efficiency and improved sustainability initiatives are helping reduce costs, the long-term expense associated with disposable components can still hinder widespread adoption for large-scale operations
• Overcoming these challenges through enhanced material science, regulatory alignment, better extractables management, and improved cost optimization strategies will be vital for sustained market growth

Single-use Bioprocessing Systems Market Scope

The market is segmented on the basis of product, application, and end user.

• By Product

On the basis of product, the market is segmented into media bags and containers, filtration assemblies, disposable or single-use bioreactors, disposable mixers, bioreactors, tangential-flow filtration devices, depth filters, sampling systems, mixing systems, tubing assemblies, and other products. The single-use bioreactors segment dominated the market with the largest market revenue share of 33.8% in 2025, driven by their critical role in upstream biologics and vaccine production. Biopharmaceutical manufacturers prefer single-use bioreactors for their flexibility in scaling production from clinical to commercial batches. These systems reduce cross-contamination risks and eliminate complex cleaning and sterilization procedures, which are major advantages over traditional stainless-steel reactors. In addition, their compatibility with advanced sensors and automation allows precise control over process parameters such as pH, temperature, and dissolved oxygen. The modular design and ease of integration into existing facilities further reinforce their dominance.

The filtration assemblies segment is anticipated to witness the fastest growth rate of 20.5% from 2026 to 2033, fueled by increasing adoption in downstream processing for purification and cell culture clarification. Filtration assemblies support rapid, single-use workflows that minimize contamination and operational downtime. They are critical in ensuring product quality and consistency, particularly in biologics and cell and gene therapy production. Manufacturers are increasingly deploying high-performance filtration solutions to improve yield and process efficiency. Growing regulatory emphasis on product sterility and process validation also drives adoption. Filtration assemblies offer flexibility across multiple applications, making them highly attractive to contract manufacturers and emerging biotech companies.

• By Application

On the basis of application, the market is segmented into filtration, storage, cell culture, mixing, and purification. The cell culture segment dominated the market with the largest market revenue share of 29.3% in 2025, owing to the critical role of single-use systems in producing biologics, vaccines, and advanced therapies. Single-use platforms provide a sterile, closed environment for cell expansion, significantly reducing contamination risks and process variability. Automated control over bioreactor parameters enhances reproducibility, while disposable systems allow faster batch turnover compared to traditional stainless-steel vessels. The ease of scalability from laboratory to pilot and commercial production further strengthens this segment. Integration with advanced sensors and monitoring systems enables precise control, supporting regulatory compliance and high-quality output.

The mixing segment is expected to witness the fastest growth rate of 18.9% from 2026 to 2033, driven by increasing demand for rapid and homogeneous blending of culture media, buffers, and process fluids. Single-use mixers provide flexibility for both upstream and downstream processes and reduce risks of contamination associated with cleaning-intensive traditional systems. The growing adoption of closed-system manufacturing and modular facility designs further accelerates the use of disposable mixing solutions. Enhanced process control, integration with digital monitoring, and compatibility with automated workflows are key factors driving market growth in this subsegment.

• By End User

On the basis of end user, the market is segmented into biopharmaceutical manufacturers, life science research and development, and contract research organizations and manufacturers. The biopharmaceutical manufacturers segment dominated the market with the largest market revenue share of 41.2% in 2025, supported by increasing global demand for biologics, vaccines, and advanced therapies. Large and mid-sized manufacturers are rapidly adopting single-use systems to reduce capital expenditure, shorten process timelines, and improve production flexibility. Single-use platforms allow manufacturers to rapidly scale production without investing in costly stainless-steel infrastructure. Enhanced regulatory compliance and operational efficiency further reinforce their dominance. Manufacturers benefit from the reduced risk of cross-contamination and simplified cleaning validation, enabling faster product launches.

The contract research organizations and manufacturers (CROs/CMOs) segment is expected to witness the fastest growth rate of 19.6% from 2026 to 2033, fueled by the outsourcing trend in biologics and gene therapy production. CROs and CMOs prefer single-use systems for their modularity, cost-effectiveness, and ability to handle multiple client projects simultaneously. Single-use technologies allow these organizations to provide flexible, scalable, and contamination-free manufacturing solutions for small-batch clinical production. The growing presence of emerging biotech companies and startups outsourcing production is a key factor driving adoption. In addition, CROs/CMOs leverage single-use platforms to meet regulatory requirements efficiently while maintaining high-quality standards.

Single-use Bioprocessing Systems Market Regional Analysis

• North America dominated the single-use bioprocessing systems market with the largest revenue share of 38.9% in 2025, supported by a well-established biopharma ecosystem, strong R&D investments, and early adoption of advanced disposable technologies across major biopharmaceutical companies and contract development and manufacturing organizations (CDMOs)
• Manufacturers in the region prioritize operational efficiency, contamination control, and scalability, leading to widespread deployment of single-use bioreactors, mixers, filtration assemblies, and other disposable components across upstream and downstream processes
• This strong adoption is further supported by robust R&D infrastructure, a technologically advanced workforce, and supportive regulatory and funding environments, positioning North America as a key hub for innovative and large-scale biologics manufacturing

U.S. Single-use Bioprocessing Systems Market Insight

The U.S. single-use bioprocessing systems market captured the largest revenue share of 82% in 2025 within North America, fueled by the rapid expansion of biologics, vaccines, and cell & gene therapy production. Manufacturers are increasingly adopting disposable systems to enhance operational efficiency, reduce contamination risks, and scale production rapidly. The growing trend of modular and flexible biomanufacturing facilities, combined with advanced process automation and analytics, is further propelling market growth. Moreover, the presence of leading biopharma companies and contract manufacturing organizations (CMOs) investing in single-use technologies significantly contributes to the market's expansion.

Europe Single-use Bioprocessing Systems Market Insight

The Europe single-use bioprocessing systems market is projected to expand at a substantial CAGR throughout the forecast period, primarily driven by stringent regulatory standards for biologics manufacturing and increasing demand for flexible production platforms. Rising biopharma investments, urbanization of research hubs, and adoption of disposable systems in both clinical and commercial production are fostering market growth. European manufacturers are also drawn to the cost-effectiveness, operational efficiency, and reduced turnaround times offered by single-use systems. The region is experiencing notable adoption across contract manufacturers, research facilities, and commercial biologics production sites.

U.K. Single-use Bioprocessing Systems Market Insight

The U.K. single-use bioprocessing systems market is anticipated to grow at a noteworthy CAGR during the forecast period, driven by the increasing focus on biopharmaceutical innovation and accelerated biologics production. The demand for modular, disposable manufacturing solutions is supported by both government-backed research initiatives and the rising number of biotech startups. In addition, concerns regarding contamination and operational efficiency are encouraging companies to transition from stainless-steel equipment to single-use platforms. The U.K.’s established life sciences ecosystem and strong CMO presence are expected to continue stimulating market growth.

Germany Single-use Bioprocessing Systems Market Insight

The Germany single-use bioprocessing systems market is expected to expand at a considerable CAGR during the forecast period, fueled by rising awareness of efficient, contamination-free biomanufacturing processes and the demand for environmentally sustainable production solutions. Germany’s advanced biopharma infrastructure and focus on process innovation promote adoption of single-use bioreactors, mixers, and filtration assemblies. The integration of disposable technologies with automated monitoring systems is becoming increasingly prevalent, with manufacturers prioritizing regulatory compliance, product quality, and operational efficiency in both clinical and commercial production.

Asia-Pacific Single-use Bioprocessing Systems Market Insight

The Asia-Pacific single-use bioprocessing systems market is poised to grow at the fastest CAGR of 25% during 2026–2033, driven by increasing biopharmaceutical R&D, capacity expansions, and investments in modular manufacturing in countries such as China, India, and Japan. The region’s growing inclination towards flexible, cost-effective production systems, supported by government initiatives promoting biotech innovation, is driving adoption. Furthermore, as APAC emerges as a hub for biologics contract manufacturing, the availability and affordability of single-use systems are expanding, enabling broader deployment across emerging biotech companies and CDMOs.

Japan Single-use Bioprocessing Systems Market Insight

The Japan single-use bioprocessing systems market is gaining momentum due to the country’s advanced biotech ecosystem, high adoption of automated manufacturing solutions, and increasing demand for biologics and regenerative therapies. Japanese manufacturers prioritize contamination-free, flexible production platforms to enhance process efficiency and meet regulatory compliance. The integration of single-use systems with digital monitoring and analytics tools is fueling growth. In addition, Japan’s aging population and rising healthcare needs are expected to further spur demand for rapid, safe, and scalable biologics production in both clinical and commercial sectors.

India Single-use Bioprocessing Systems Market Insight

The India single-use bioprocessing systems market accounted for the largest market revenue share in Asia-Pacific in 2025, attributed to the country’s rapidly expanding biopharmaceutical manufacturing sector, rising R&D investments, and strong presence of contract manufacturing organizations. India is becoming a key market for biologics, vaccines, and cell & gene therapy production, and single-use systems are increasingly adopted in clinical and commercial manufacturing. Government support for biotech hubs, availability of affordable disposable technologies, and growing demand for flexible, contamination-free manufacturing solutions are key factors propelling market growth in India.

Single-use Bioprocessing Systems Market Share

The Single-use Bioprocessing Systems industry is primarily led by well-established companies, including:

• Thermo Fisher Scientific Inc. (U.S.)
• Sartorius AG (Germany)
• Merck KGaA (Germany)
• Danaher (U.S.)
• Pall Corporation (U.S.)
• Eppendorf SE (Germany)
• Corning Incorporated (U.S.)
• Avantor, Inc. (U.S.)
• Saint Gobain Life Sciences (France)
• Parker Hannifin (U.S.)
• Entegris, Inc. (U.S.)
• Meissner Filtration Products, Inc. (U.S.)
• Repligen Corporation (U.S.)
• PBS Biotech, Inc. (U.S.)
• ABEC, Inc., (U.S.)
• Cellexus Ltd (U.K.)
• Distek, Inc. (U.S.)
• Applikon Biotechnology B.V. (Netherlands)
• GE Healthcare (U.S.)
• Rentschler Biopharma SE (Germany)

What are the Recent Developments in Global Single-use Bioprocessing Systems Market?

• In March 2025, Cytiva expanded its Xcellerex X‑platform bioreactor portfolio by adding 500‑L and 2,000‑L single‑use bioreactors. This extension allows scientists and manufacturers to scale seamlessly from smaller lab/pilot scales up to commercial‑scale production (2,000 L), improving operational flexibility and speeding up the transition from clinical‑trial batches to large‑volume commercial manufacturing
• In June 2024, Aragen Bioscience (a CDMO) validated Getinge’s SUPR single‑use bioreactors (50 L & 250 L) for large‑scale recombinant antibody production. The validation demonstrated that a full upstream process can be seamlessly scaled up using single‑use systems without performance loss consistent cell growth, stable metabolite/pH/osmolality profiles, and high yields. This real-world adoption underscores growing trust in single‑use bioreactors for high-quality, large-scale biologics manufacturing
• In April 2024, Cytiva unveiled its Xcellerex magnetic mixer single‑use mixing system at the INTERPHEX 2024 conference. Offered in 2,000 L and 3,000 L capacities, this mixer addresses a critical bottleneck: large‑scale preparation of media, buffers, and other solutions for mAb, vaccine, and genomic‑medicine manufacturing. Its design helps reduce risks associated with leaks or contamination in large‑volume single‑use operations, making large‑scale bioprocessing safer and more reliable
• In March 2024, Getinge introduced the SUPR single‑use production reactor (SUPR) system a larger single‑use bioreactor platform aimed at pilot and GMP manufacturing. Initially launched with 50 L and 250 L versions. The SUPR arrives gamma‑irradiated and pre‑assembled, reducing the need for in‑facility sterilization or cleaning. Its “click-n-go” bag loading, configurable control systems, and scalable design help bridge lab-scale research and large‑scale production making single‑use bioprocessing more accessible and reducing infrastructure burdens
• In April 2023, Cytiva launched the “X‑platform” single‑use bioreactor series (initially 50 L and 200 L) to simplify upstream bioprocessing operations. The X‑platform comes with automation software (Figurate) and a built-in scaling tool (Bioreactor Scaler), which helps standardize processes and reduce trial‑and‑error in scale‑up. As a result, manufacturing of biologics including monoclonal antibodies (mAbs), viral vectors, gene therapies becomes more efficient, with streamlined supply‑chain operations and potentially lower costs and shorter timelines

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