Single-use Bioprocessing Market Size & Share 2026-2035

Single-Use Bioprocessing Market Size

The global single-use bioprocessing market was valued at USD 13.9 billion in 2025 and is projected to grow from USD 15 billion in 2026 to USD 35.8 billion by 2035, expanding at a CAGR of 10.1%, according to the latest report published by Global Market Insights Inc.

The steady growth of the market is driven by the rising demand for biologics and biosimilars, lower capital investment compared to stainless-steel systems, reduced risk of cross-contamination, rising outsourcing to CDMOs and CMOs and increasing adoption of personalized medicines and cell & gene therapies, among other factors.

The major players in the global market are Sartorius AG, Thermo Fisher Scientific Inc., Danaher Corporation, Merck KGaA, and Avantor Inc. These companies maintain their competitive position through consistent product innovation, global market presence, and collaboration with pharma and biotech companies, among others.

The market increased from USD 10.7 billion in 2022 to USD 12.7 billion in 2024, registering a historical growth rate of 9%. The growing global demand for biologics, including monoclonal antibodies, recombinant proteins, and biosimilars, is expected to significantly drive the adoption of single-use bioprocessing technologies during the forecast period. Biopharmaceutical manufacturers increasingly prefer single-use systems because they offer greater flexibility, shorter production timelines, and lower capital investment compared to traditional stainless-steel facilities. Additionally, biosimilar manufacturers benefit from the lower operational costs and faster facility deployment enabled by single-use technologies, further supporting market growth.

Further, the increasing outsourcing of biopharmaceutical manufacturing to contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs) is expected to be a major contributor to market growth. Biopharma companies are increasingly relying on external partners to reduce capital expenditures, accelerate time-to-market, and access specialized manufacturing expertise. To support multiple clients and diverse product pipelines, CDMOs and CMOs require highly flexible and scalable production platforms, making single-use bioprocessing systems a preferred solution.

Single-use bioprocessing refers to the use of disposable, pre-sterilized biomanufacturing components such as bioreactors, bags, tubing, filters, mixers, and connectors for the production of biologics, vaccines, and advanced therapies. These systems improve operational flexibility, reduce contamination risk, lower cleaning requirements, and accelerate manufacturing processes.

Single-Use Bioprocessing Market Trends

Growing adoption of continuous and intensified bioprocessing, rising investment in modular and flexible manufacturing facilities, integration of automation and digital monitoring technologies, focus on sustainable single-use materials and waste reduction, and expansion of cell and gene therapy manufacturing are among the key trends shaping the market growth in an upward trajectory.

• Biopharmaceutical manufacturers are increasingly adopting continuous and intensified processing approaches to improve productivity and maximize facility utilization. Single-use bioreactors, filtration systems, and perfusion technologies support higher cell densities and longer production runs, helping companies achieve greater manufacturing efficiency while reducing operational costs.
• Additionally, environmental concerns associated with disposable plastic components are encouraging manufacturers to develop recyclable materials, waste-reduction programs, and more sustainable single-use solutions. Companies are investing in innovative materials and circular-economy initiatives to improve sustainability while preserving the operational benefits of single-use bioprocessing technologies.
• Furthermore, modern single-use systems are increasingly being combined with advanced sensors, process analytical technologies (PAT), automation platforms, and real-time monitoring tools. This trend is improving process control, reducing human intervention, enhancing data collection, and enabling more consistent product quality across biologics manufacturing operations.

Single-Use Bioprocessing Market Analysis

Based on product type, the single-use bioprocessing market is segmented into single-use bioreactors, bags and containers, tubing assemblies, connectors and fittings, filtration devices, mixing systems, sensors and probes, and sampling systems. The bags and containers segment held a leading market share and was valued at USD 4.1 billion in 2025.

• Bags and containers are essential single-use components used for media preparation, buffer storage, product collection, fluid transfer, and intermediate storage throughout bioprocessing workflows. These systems provide a sterile and closed environment while reducing the risk of contamination.
• Available in a wide range of capacities and configurations, they support both upstream and downstream manufacturing operations. Their ease of handling, lower infrastructure requirements, and compatibility with disposable assemblies contribute to increased operational efficiency.
• Additionally, growing biologics production and demand for flexible manufacturing facilities continue to drive widespread adoption of single-use bags and containers.
• The single-use bioreactors segment accounted for USD 3.7 billion in 2025. Single-use bioreactors are disposable cultivation systems used for the production of biologics, vaccines, recombinant proteins, and advanced therapies. They eliminate the need for cleaning and sterilization, reducing turnaround times and operational complexity. These systems are available in various formats, including stirred-tank, wave-mixed, bubble-column, and hollow-fiber designs, supporting applications from process development to commercial manufacturing.
• Growing demand for flexible manufacturing, rapid facility deployment, and contamination control is driving adoption across biopharmaceutical production facilities.
• Further, their scalability and compatibility with modern automation platforms make them a critical component of contemporary bioprocessing operations.
• The filtration devices segment accounted for USD 2.6 billion in 2025 and is projected to grow at a robust CAGR over the forecast period. Single-use filtration devices are widely utilized for clarification, purification, sterile filtration, viral removal, and concentration processes in biopharmaceutical manufacturing. These devices include depth filters, membrane filters, tangential flow filtration (TFF) systems, and ultrafiltration units. They help improve product quality, process efficiency, and contamination control while reducing cleaning requirements.
• In addition, the increasing complexity of biologics, vaccines, and cell and gene therapies is driving demand for advanced filtration solutions.
• Furthermore, manufacturers increasingly rely on disposable filtration technologies to accelerate process development, simplify operations, and support scalable production environments.

Based on workflow stage, the single-use bioprocessing market is segmented into upstream processing, downstream processing, and final processing. The upstream processing segment was valued at USD 7.4 billion in 2025.

• Upstream processing involves cell culture development, media preparation, inoculation, and cell expansion stages required for biologic production.
• Single-use technologies have become highly prevalent in upstream applications due to their flexibility, ease of deployment, and reduced contamination risks.
• Additionally, disposable bioreactors, bags, mixing systems, sensors, and tubing assemblies enable rapid process setup and minimize downtime between production batches.
• Further, the growing production of monoclonal antibodies, vaccines, and cell therapies continues to increase demand for upstream single-use solutions.
• The downstream processing segment accounted for USD 4.6 billion in 2025. Downstream processing includes harvesting, purification, concentration, filtration, and formulation activities that occur after cell cultivation.
• Single-use filtration systems, chromatography assemblies, tubing, connectors, and storage solutions are increasingly utilized to simplify purification workflows and improve operational efficiency. These technologies help manufacturers reduce cleaning validation requirements while maintaining product quality and process consistency.
• Moreover, the rising complexity of biologic products and stricter regulatory requirements are encouraging wider adoption of disposable downstream systems. Their flexibility and scalability make them valuable for both large-scale biologics manufacturing and specialized therapy production applications.

Based on application, the single-use bioprocessing market is segmented into monoclonal antibodies (mAbs), vaccine production, cell and gene therapy, plasma-derived products, and other biologics. The monoclonal antibodies segment was valued at USD 5.3 billion in 2025.

• Monoclonal antibodies represent one of the largest application areas for single-use bioprocessing technologies. Their manufacturing requires efficient upstream cell culture and downstream purification processes, making disposable bioreactors, filtration systems, and fluid management solutions attractive options.
• In addition, single-use systems enable rapid scale-up, lower contamination risks, and reduced capital expenditure compared to traditional stainless-steel facilities.
• Furthermore, as demand for therapeutic antibodies continues to grow across oncology, autoimmune, and rare disease treatments, manufacturers increasingly rely on flexible single-use platforms. Their ability to support efficient and cost-effective mAb production continues to drive significant market demand.
• The vaccine production segment accounted for USD 2.9 billion in 2025. Vaccine manufacturing is a major application area for single-use bioprocessing technologies, particularly for viral, protein subunit, and mRNA-based vaccines.
• Single-use systems provide rapid deployment capabilities and help manufacturers respond quickly to changing production requirements.
• Additionally, disposable bioreactors, filtration devices, and fluid handling systems improve manufacturing flexibility while reducing contamination risks.
• Further, these systems also enable efficient small-scale and large-scale production, making them well-suited for diverse vaccine development and commercialization needs.
• The cell and gene therapy segment accounted for USD 2.3 billion in 2025 and is projected to grow at a robust CAGR over the forecast period. Cell and gene therapy manufacturing requires highly controlled, flexible, and contamination-free production environments.
• Single-use bioprocessing technologies are particularly well suited for these applications because they support small-batch production and eliminate cleaning-related concerns.
• Moreover, growing investments in CAR-T therapies, viral vectors, plasmid DNA, and regenerative medicine are accelerating the adoption of single-use systems. Their ability to support personalized and patient-specific treatments positions them as a key enabling technology within advanced therapy manufacturing.

Based on end use, the single-use bioprocessing market is segmented into biopharmaceutical and pharmaceutical companies, CMOs and CROs, and academic and research institutes. The biopharmaceutical and pharmaceutical companies segment held a leading market share of 61.5% in 2025.

• Biopharmaceutical and pharmaceutical companies represent the largest end users of single-use bioprocessing technologies. These organizations utilize disposable systems to manufacture biologics, biosimilars, vaccines, and advanced therapies efficiently while reducing operational costs.
• Single-use equipment supports rapid facility setup, flexible production scheduling, and lower contamination risks compared to traditional manufacturing systems. As product pipelines become increasingly diversified, manufacturers are adopting these technologies to improve agility and accelerate time-to-market.
• Further, continued investment in biologics production capacity and advanced therapeutic development is expected to sustain strong demand from this end-user segment.
• The CMOs and CROs segment accounted for USD 4.6 billion in 2025 and is projected to grow at a robust CAGR over the forecast period. Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs) are important adopters of single-use bioprocessing systems due to their need to support multiple clients and product types.
• Disposable technologies enable rapid changeovers between manufacturing campaigns while minimizing downtime and contamination risks. These organizations benefit from the flexibility, scalability, and lower capital investment associated with single-use platforms.
• Furthermore, growing outsourcing trends within the biopharmaceutical industry are increasing reliance on CMOs and CROs for development and manufacturing services. As a result, demand for single-use bioreactors, filtration devices, and fluid management systems continues to expand within this segment.

North America Single-Use Bioprocessing Market

The North America region accounted for 38% of the market in 2025. The market is experiencing robust expansion, driven by the region’s advanced healthcare infrastructure, focusing on reducing the risk of cross-contamination, and growing demand for biologics, among others.

• The U.S. market was valued at USD 3.9 billion and USD 4.2 billion in 2022 and 2023, respectively. In 2025 the market size increased to USD 5 billion from USD 4.6 billion in 2024.
• North America represents a leading market for single-use bioprocessing due to its strong biopharmaceutical manufacturing base, extensive biologics pipeline, and significant presence of major biotechnology companies.
• The region continues to witness growing adoption of disposable bioreactors, filtration systems, and fluid management technologies as manufacturers seek greater flexibility and faster product commercialization.
• In addition, rising investments in cell and gene therapy development, vaccine manufacturing, and biosimilar production are further supporting market expansion.
• Additionally, increasing outsourcing to specialized CDMOs and growing demand for modular manufacturing facilities are accelerating the deployment of single-use technologies.

Europe Single-Use Bioprocessing Market

Europe single-use bioprocessing industry accounted for USD 3.8 billion in 2025 and is anticipated to show lucrative growth over the forecast period.

• Europe is experiencing steady growth in the market, driven by expanding biologics production, increasing biosimilar development activities, and continuous investments in advanced biomanufacturing facilities.
• Biopharmaceutical companies across the region are adopting disposable technologies to improve manufacturing efficiency, reduce contamination risks, and lower operational costs.
• Additionally, the region is also witnessing increased investments in process automation and continuous bioprocessing technologies.
• Furthermore, strong regulatory standards and ongoing efforts to modernize production facilities are encouraging wider implementation of single-use solutions across both established pharmaceutical companies and emerging biotechnology firms.

Asia Pacific Single-Use Bioprocessing Market

The Asia Pacific region is projected to show a lucrative growth of about 11.5% during the forecast period.

• Asia Pacific is emerging as one of the fastest-growing markets for single-use bioprocessing, supported by expanding biopharmaceutical production capabilities and rising healthcare investments. Countries such as China, India, South Korea, Japan, and Singapore are strengthening their biologics manufacturing infrastructure to meet growing domestic and international demand.
• Further, increasing contract manufacturing activities, favourable government initiatives, and rapid growth of biotechnology startups are driving adoption of disposable bioprocessing technologies.
• In addition, growing investments in biosimilars, vaccines, monoclonal antibodies, and advanced therapies are expected to further accelerate market expansion throughout the region.

Latin America Single-Use Bioprocessing Market

Latin America is experiencing significant growth in the single-use bioprocessing industry .

• The market in Latin America is experiencing gradual growth as regional pharmaceutical and biotechnology industries continue to expand.
• Single-use systems offer significant advantages by reducing infrastructure requirements and simplifying manufacturing operations, making them attractive for developing markets. Countries such as Brazil, Mexico, and Argentina are investing in biotechnology research and local pharmaceutical production capabilities.
• Additionally, growing partnerships with global biopharmaceutical companies and increasing contract manufacturing activities are contributing to the adoption of single-use bioprocessing technologies across the region.

Middle East and Africa Single-Use Bioprocessing Market

• The Middle East & Africa market is witnessing growing interest in single-use bioprocessing technologies as governments and healthcare organizations seek to strengthen local pharmaceutical and vaccine manufacturing capabilities.
• Investments in biotechnology infrastructure, healthcare modernization initiatives, and regional pharmaceutical production are creating opportunities for market growth.
• Additionally, single-use systems are gaining traction due to their lower capital requirements, reduced operational complexity, and faster implementation compared to conventional facilities. Countries in the Gulf region are increasingly exploring biologics and vaccine production capabilities to enhance healthcare self-sufficiency.

Single-Use Bioprocessing Market Share

The single-use bioprocessing industry is characterized by the presence of several global life science and bioprocessing technology providers competing through product innovation, portfolio expansion, manufacturing capacity enhancements, and strategic partnerships. Leading companies such as Sartorius AG, Thermo Fisher Scientific Inc., Danaher Corporation (Cytiva), Merck KGaA, and Avantor Inc. maintain strong market positions through comprehensive product offerings that span single-use bioreactors, bags, filtration systems, tubing assemblies, fluid management solutions, and process monitoring technologies.

Competition is increasingly focused on delivering integrated end-to-end bioprocessing platforms that support upstream and downstream manufacturing workflows. Market participants are investing in advanced automation, real-time sensing technologies, process analytical tools, and scalable manufacturing solutions to improve productivity and operational efficiency. Expansion of production facilities and strengthening of global supply chains have also become key competitive priorities as biopharmaceutical manufacturers seek reliable access to single-use components.

Additionally, the market further includes specialized companies such as Repligen Corporation, Saint-Gobain Life Sciences, Parker Hannifin Corporation, and Cellexus International, among others, which compete through niche technologies in filtration, fluid management, tubing systems, and innovative bioreactor platforms. Hence, growing demand for biologics, vaccines, and cell and gene therapies is encouraging both established and emerging players to develop highly flexible and scalable solutions. As a result, competition continues to intensify around technology differentiation, customization capabilities, product quality, and technical support services.

Single-Use Bioprocessing Market Companies

Few of the prominent players operating in the single-use bioprocessing industry include:

• Avantor Inc.
• Cellexus International Ltd.
• Celltainer Biotech BV
• Danaher Corporation
• Entegris Inc.
• Eppendorf SE
• Getinge AB
• Meissner Filtration Products Inc.
• Merck KGaA
• Parker Hannifin Corporation
• PBS Biotech Inc.
• Repligen Corporation
• Saint-Gobain Life Sciences
• Sartorius AG
• Thermo Fisher Scientific Inc.

• Sartorius AG

Sartorius focuses on expanding its end-to-end single-use bioprocessing portfolio through continuous product innovation, capacity expansion, and strategic partnerships. The company emphasizes integrated biomanufacturing solutions, digital process monitoring, and strong support for biologics, vaccine, and cell & gene therapy manufacturers.

• Danaher Corporation

Through Cytiva and its bioprocessing businesses, Danaher emphasizes integrated platform solutions, workflow optimization, and technology innovation. The company focuses on supporting flexible manufacturing, process intensification, and expanding capabilities for biologics, mRNA, and cell & gene therapy production.

Single-Use Bioprocessing industry News:

• In April 2025, Thermo Fisher Scientific Inc. announced the 5L DynaDrive Single-Use Bioreactor (S.U.B.), designed to meet the evolving needs of modern bioprocessing. This development expands the company's robust portfolio of bioreactors, offering seamless scalability from 1 to 5,000 liters and accelerating bench-scale process development while facilitating the cost-effective transition from bench to commercialization with consistent reactor design and film across all scales.
• In April 2023, MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, announced the launch of its Ultimus Single-Use Process Container Film, designed to provide extreme durability and leak resistance for single-use assemblies used for bioprocessing liquid applications. This product launch may enable the company to expand its portfolio and improve industry positioning.

The single-use bioprocessing market research report includes an in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million and from 2022 - 2035 for the following segments:

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Market, By Product Type

• Single-use bioreactors
  • Stirred tank single-use bioreactors
  • Wave-mixed single-use bioreactors
  • Bubble column single-use bioreactors
  • Other products
• Bags and containers
• Tubing assemblies
• Connectors and fittings
• Filtration devices
• Mixing systems
• Sensors and probes
  • pH sensors
  • Dissolved oxygen sensors
  • Pressure and flow sensors
  • Other sensor types
• Sampling systems

Market, By Workflow Stage

• Upstream processing
• Downstream processing
• Final processing

Market, By Application

• Monoclonal antibodies (mAbs)
• Vaccine production
• Cell and gene therapy
• Plasma-derived products
• Other biologics

Market, By End Use

• Biopharmaceutical and pharmaceutical companies
• CMOs and CROs
• Academic and research institutes
• Other end users

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Netherlands
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• Latin America
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE