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Single-Use Bioprocessing Systems Market Analysis & Forecast: 2025-2032

Single-Use Bioprocessing Systems Market, By Product Type (Bioreactors, Bags and Containers, Filtration Devices, Tubing Assemblies and Connectors, Sensors and Probes, Others (Accessories & Consumables, etc.)), By Application (Monoclonal Antibody Production, Vaccine Production, Cell Therapy, Viral Vector Production, Gene Therapy, Other, Biopharmaceutical Production Processes), By End User (Biopharmaceutical Companies, CROs & CMOs, Others (Research Labs & Institutes, etc.)), By Geography (North America, Europe, Asia Pacific, Latin America, Middle East and Africa).

  • Published In : 04 Nov, 2025
  • Code : CMI1754
  • Pages :160
  • Formats :
      Excel and PDF
  • Industry : Medical Devices
  • Historical Range: 2020 - 2024
  • Forecast Period: 2025 - 2032

Global Single-Use Bioprocessing Systems Market Size and Share Analysis

The global single-use bioprocessing systems market was valued USD 35.31 Bn in 2025 and is expected to reach USD 105.97 Bn by 2032 exhibiting a compound annual growth rate (CAGR) of 17% from 2025 to 2032.

Key Takeaways

  • Based on End User, Biopharmaceutical Companies Segment dominates the market with 48.0% market share. This is due to their high demand for flexible, scalable, and contamination-free manufacturing processes.
  • North America is expected to be the largest market for substance abuse treatment during the forecast period, accounting for over 43.7% of the market share in 2025.
  • Asia Pacific is expected to be the second-largest market for single-use bioprocessing systems, accounting for over 25.2% of the market share in 2025.

Market Overview

The global single-use bioprocessing systems market is expected to grow significantly in the forecast period due to rising demand for low-cost, flexible, and contamination-free biomanufacturing options. The growth in the manufacture of biologics such as monoclonal antibodies, vaccines, and cell and gene therapies is driving adoption of disposable technologies in upstream and downstream processes.

Single-use systems offer key benefits, including lower cleaning needs, quicker batch turnaround, and improved sterility assurance, that make them especially appealing for clinical trials, contract manufacturing, and personalized medicine applications.

Current Events and Its Impact on Single-Use Bioprocessing Systems Market

Current Events

Description and its impact

 

Biologics Manufacturing Growth Drives Increased Use of Single-use Bioprocessing Systems

 

  • Description: Early in 2025, global biopharmaceutical titans such as Roche, Samsung Biologics, and Lonza made massive investments in new biologics manufacturing plants that give top priority to single-use technology. For instance, Samsung Biologics broke ground for its fifth plant in Incheon, South Korea, at an estimated investment of $1.5 billion. The company is modelled on a hybrid concept utilizing high-capacity single-use bioreactors for flexible batch manufacturing. These investments are owing to increasing global demand for monoclonal antibodies, vaccines, and personalized medicine. Also driving this are greater outsourcing to CDMOs, which are forcing rapid deployment of modular cleanroom installations with pre-sterilized disposable parts.
  • Impact: This trend is greatly hastening the embrace of single-use bioprocessing systems by both clinical and commercial scale manufacturing. The demand for quicker changeovers, less risk of contamination, and lower capital outlay renders single-use solutions extremely appealing. Cutting-edge technology companies such as Thermo Fisher Scientific, Sartorius, and Cytiva are answering by introducing integrated, pre-validated single-use platforms that simplify upstream and downstream processing. The trend, however, does bring with it challenges, such as supply chain stability concerns in disposable components, waste disposal, and scalability of single-use systems for high-volume biologics manufacturing. However, the sector's movement in the direction of flexible manufacturing paradigms cement single-use systems as a key enabler in the bioproduction of the future.

 

Cell and Gene Therapy Surge Accelerates Bioprocessing Technologies in Single-use

 

  •   Description: In mid-2024, prominent cell and gene therapy manufacturers such as Bluebird Bio, Novartis, and Bristol Myers Squibb dramatically increased their autologous and allogeneic therapies' manufacturing capacity. To satisfy the high sterility, batch segregation, and flexibility demands of these treatments, firms increasingly embraced single-use bioprocessing systems. To fill this gap, suppliers such as Pall Corporation (Danaher) and Sartorius developed highly advanced closed-system single-use platforms tailored for small-batch, high-value treatment. These platforms feature automated liquid handling, onboard quality control sensors, and modular process modules that can be easily deployed across decentralized manufacturing centers.
  • Impact: The emergence of cell and gene therapies is transforming the demand within single-use bioprocessing, driving innovation to smaller-volume, highly regulated systems that focus on sterility and scalability. Single-use technology is now being developed for conventional biologics as well as for niche, patient-directed therapies that demand very controlled environment and process control. This is promoting the establishment of standardized, GMP-compliant single-use platforms for advanced therapy medicinal products (ATMPs). But the sophistication of these therapies creates integration and validation issues, particularly in automated processes and regulatory records.

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Global Single-use Bioprocessing Systems Market - Drivers

  • Increased Use of Single-Use Systems for Vaccine and Therapeutics Manufacturing

Single-use bioprocessing systems offer significant advantages in responding quickly to public health crises by enabling faster production timelines and flexible manufacturing capacities compared to traditional stainless-steel facilities. The pandemic response involved unprecedented investments and collaborations to develop and distribute vaccines in record time using single-use technologies.

Regulatory approvals are also faster since these systems present lower risks of cross-contamination. Going forward, regulatory agencies and governments are likely to emphasize the development of rapid vaccine production capabilities to prepare for future pandemics. Pfizer-BioNTech partnered with contract manufacturers like Thermo Fisher Scientific to deploy single-use technologies across multiple sites globally, facilitating flexible and rapid manufacturing scale-up.

  • Increased Bioproduction of Complex and Novel Biologic Therapies

The biopharmaceutical industry is witnessing rapid development and approval of complex novel biologic therapies such as monoclonal antibodies, gene therapies, and cell therapies to treat cancer, autoimmune diseases, and other serious medical conditions. Production of these complex biologics requires advanced manufacturing capabilities and highly controlled environments compared to traditional small molecule drugs.

Single-use bioprocessing systems are particularly well-suited for manufacturing such sensitive therapies since they eliminate issues like leachables, particles and bioburden associated with the reuse and cleaning of stainless-steel equipment. 

As the pipeline of novel biologic drugs grows, especially those involving regenerative medicine and gene/cell therapy approaches, demand is increasing for specialized single-use technologies fitted with sensors and controllers that can carefully regulate critical manufacturing parameters.

Global Single-use Bioprocessing Systems Market - Trends

  • Increasing outsourcing of bioproduction

The growing trend of outsourcing bioproduction processes to contract development and manufacturing organizations (CDMOs) has significantly impacted the global single-use bioprocessing systems market in recent years. More pharmaceutical and biotech companies are outsourcing their biomanufacturing needs to specialized CDMOs that offer flexible, cost-effective single-use technologies. This allows product developers to focus on their core competencies in R&D and reduces their capital investment in manufacturing infrastructure.

CDMOs are increasingly adopting standardized, pre-validated single-use platforms that offer speed, flexibility, and aseptic safety. They can easily customize the processes as per client requirements and handle fluctuating production demands. This has enabled even small biotech startups and mid-sized firms to access large-scale biomanufacturing capabilities.

Major elements of single-use bioprocessing infrastructure like bioreactors, mixers, tangential flow filtration devices, storage bags, and connectors are being rapidly added at several CDMO facilities. For example, Chinese CDMO WuXi Biologics has invested USD 600 million since 2018 to expand its aseptic drug substance manufacturing capacity based on standardized perfusion-based single-use bioprocessing technologies, as stated on their corporate website. This has propelled overall sales of single-use systems among leading suppliers.

Global Single-use Bioprocessing Systems Market - Opportunities

  • Growing Bio Pharmaceutical Industry

Biologics have become the fastest-growing segment of the pharmaceutical market. This rapid growth of biologics drives the demand for single-use technologies that provide the benefits of flexible operations, easy scale-up, and lower initial capital investments.

Segmental Insights

Single-Use Bioprocessing Systems Market By End User

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Single-use Bioprocessing Systems Market Insights, By End User

Based on end user, Biopharmaceutical companies dominate the market. Biopharmaceutical companies dominate the single-use bioprocessing systems market due to their high demand for flexible, scalable, and contamination-free manufacturing processes.

These companies frequently develop biologics, which require stringent sterility and rapid production cycles—ideally suited for single-use technologies. Single-use systems reduce cleaning validation and downtime, enabling faster turnaround and lower operating costs. 

Regional Insights 

Single-Use Bioprocessing Systems Market Regional Insights

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Global Single-use Bioprocessing Systems Market - Regional Insights

  • North America is expected to be the largest market for substance abuse treatment during the forecast period, accounting for over 43. 7% of the market share in 2025. North America continues to dominate the global single-use bioprocessing systems market owing to the presence of large biopharmaceutical companies and growing adoption of single-use technologies in the region.

The major market for single-use systems is the U.S., which is home to the majority of world's largest biopharma companies. These companies are actively investing in the development of novel biologics and biosimilars driving the need for single-use bioprocessing. Moreover, a supportive regulatory environment is also encouraging biopharma industries to incorporate single-use systems into their manufacturing operations to enhance flexibility and lower costs.

  • Asia Pacific is expected to be the second-largest market for single-use bioprocessing systems, accounting for over 25. 2%of the market share in 2025. Asia Pacific region has emerged as the fastest growing regional market for single-use bioprocessing systems globally. Countries like China, India, South Korea and Japan are witnessing the expansion of their domestic biopharmaceutical industries at an unprecedented rate over the past decade.

Local biopharma companies in Asia Pacific have ramped up investments to cater to growing healthcare demands as well as expand their international footprint. This has bolstered the sales of single-use bioprocessing equipment in the region.

Single-use Bioprocessing Systems Market Dominating Countries

United States Single-use Bioprocessing Systems Market Analysis and Trend

The United States remains the leader in the single-use bioprocessing systems market due to a developed biopharmaceutical industry, high R&D spending, and high uptake of versatile manufacturing solutions. Thermo Fisher Scientific, Pall Corporation, and GE Healthcare are some of the big names based in the U.S., which bolsters innovation and local supply of cutting-edge single-use technologies. Growing emphasis on biologics and customized medicines also drives demand.

Germany Single-use Bioprocessing Systems Market Analysis and Trend

Germany dominates the European market with its robust biopharmaceutical production infrastructure and government backing of biotech innovation. Major CDMOs and biotech companies in the country depend strongly on single-use technology for upstream and downstream processes. A focus on GMP compliance and efficiency in production also hastens the adoption of disposable technology in bioprocessing.

China Single-use Bioprocessing Systems Market Analysis and Trend

China is becoming a force to be reckoned with in the single-use bioprocessing market, led by heavy government investment in biopharma facilities and a jump in home-grown biologics output. Domestic manufacturers are increasingly turning to single-use systems to minimize contamination risk and operating expenses. Collaborations with international suppliers such as Sartorius and Merck also are spurring adoption.

Market Report Scope

Single-Use Bioprocessing Systems Market Report Coverage

Report Coverage Details
Base Year: 2024 Market Size in 2025: USD 35.31 Bn
Historical Data for: 2020 To 2024 Forecast Period: 2025 To 2032
Forecast Period 2025 to 2032 CAGR: 17% 2032 Value Projection: USD 105.97 Bn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC Countries, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Product Type: Bioreactors, Bags and Containers, Filtration Devices, Tubing Assemblies and Connectors, Sensors and Probes, Others (Accessories & Consumables, etc.)
  • By Application: Monoclonal Antibody Production, Vaccine Production, Cell Therapy, Viral Vector Production, Gene Therapy, Other, Biopharmaceutical Production Processes
  • By End User: Biopharmaceutical Companies, CROs & CMOs, Others (Research Labs & Institutes, etc.)
Companies covered:

Merck KGaA, Thermo Fisher Scientific Inc., Liquidyne, Corning Incorporated, Foxx Life Sciences., PARKER HANNIFIN CORP, Danaher Corporation., Sartorius, GE Healthcare, Eppendorf, Getinge AB, PBS Biotech, Esco Bioengineering, Distek, Bionet and Other Prominent Players

Growth Drivers:
  • Reduced complexity in process development and optimization
  • Lower capital requirements 
Restraints & Challenges:
  • Risk of product contamination
  • Extractability and leachability issues

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Global Single-use Bioprocessing Systems Market- Recent Developments

Product Launch & Product Approval

  • In September 2023, Getinge, one of the leading medtech companies, announced the launch of AppliFlex ST GMP, a single-use bioreactor system designed for clinical production in cell and gene therapy as well as mRNA production.
  • In May 2023, DuPont, a chemical company, showcased DuPon Liveo single-use biopharma processing solutions for critical fluid transport applications at BioProcess International Europe, which was held on May 9-12, 2024.

Acquisition and Partnership

  • On May 31, 2024, Getinge announced an agreement to acquire 100%of the shares in High Purity New England, Inc., one of the leading U.S.-based companies in the area of custom single-use solutions for bioprocessing applications.

Analyst’s Views

  • The global single-use bioprocessing systems market is experiencing strong growth driven by the rising adoption of disposable bioprocess containers across biopharmaceutical manufacturers. The flexibility and cost savings provided by single-use systems as compared to traditional stainless-steel facilities are major factors boosting their popularity. Additionally, advances in single-use sensor technology that allow for real-time data monitoring are further expanding the capabilities of these systems.
  • North America currently dominates the market due to presence of large biopharma companies and biotech startups rapidly replacing their conventional infrastructure with single-use options. In the coming years, the Asia Pacific region is expected to see the fastest gains in market share. This can be attributed to increasing research and development investments by emerging biologics manufacturers in China, India, and other Asian countries looking to rapidly develop biologic drugs. While the market shows promising growth opportunities, the replacement of traditional manufacturing assets poses a challenge to adoption.
  • Additionally, concerns around reliability and extractability/recoverability of single-use components are key restraints that vendors must address through improved quality systems and extraction methods. Furthermore, a lack of globally recognized regulatory guidelines for these systems may slow widespread market acceptance.

Market Segmentation

  • Global Single-use Bioprocessing Systems Market, By Product Type
    • Bioreactors
    • Bags and Containers
    • Filtration Devices
    • Tubing Assemblies and Connectors
    • Sensors and Probes
    • Others (Accessories & Consumables, etc.)
  • Global Single-use Bioprocessing Systems Market, By Application
    • Monoclonal Antibody Production
    • Vaccine Production
    • Cell Therapy
    • Viral Vector Production
    • Gene Therapy
    • Other Biopharmaceutical Production Processes
  • Global Single-use Bioprocessing Systems Market, By End User
    • Biopharmaceutical Companies
    • CROs & CMOs
    • Others (Research Labs & Institutes, etc.)
  • Global Single-use Bioprocessing Systems Market, By Region
    • North America
      • U.S.
      • Canada
    • Latin America
      • Brazil
      • Argentina
      • Mexico
      • Rest of Latin America
    • Europe
      • Germany
      • U.K.
      • Spain
      • France
      • Italy
      • Russia
      • Rest of Europe
    • Asia Pacific
      • China
      • India
      • Japan
      • Australia
      • South Korea
      • ASEAN
      • Rest of Asia Pacific
    • Middle East
      • GCC Countries
      • Israel
      • Rest of Middle East
    • Africa
      • South Africa
      • North Africa
      • Central Africa
  • Top Companies in the Global Single-use Bioprocessing Systems Market
    • Merck KGaA 
    • Thermo Fisher Scientific Inc.
    • Liquidyne
    • Corning Incorporated
    • Foxx Life Sciences.
    • PARKER HANNIFIN CORP
    • Danaher Corporation.
    • Sartorius
    • GE Healthcare
    • Eppendorf
    • Getinge AB
    • PBS Biotech
    • Esco Bioengineering
    • Distek
    • Bionet
    • Other Prominent Players

Sources

Primary Research Interviews

  • Director of Bioprocessing Operations (Top 10 Biotech Firm)
  • Single-Use Technology Manager (Global CMO)
  • Supply Chain Specialist (Pharma Equipment Manufacturer)
  • Regulatory Affairs Lead (Bioprocess Solutions Provider)
  • Others

Databases

  • BioProcess International Insights Hub
  • PharmSource Biopharmaceutical Database
  • Global New Drugs Database (GNDD)
  • Others

Magazines

  • BioProcess International Magazine
  • BioProcessing Journal
  • BioProcess Online
  • Others

Journals

  • Biotechnology and Bioengineering
  • Journal of Chemical Technology & Biotechnology
  • Bioprocess and Biosystems Engineering
  • Others

Newspapers

  • Financial Times (Pharma & Biotech Section)
  • Wall Street Journal (Healthcare Innovations)
  • BioSpace Industry Briefings
  • Others

Associations

  • Bio Process Systems Alliance (BPSA)
  • International Society for Pharmaceutical Engineering (ISPE)
  • Biotechnology Innovation Organization (BIO)
  • Others

Public Domain Sources

  • FDA Biologics Guidance Documents
  • EMA Scientific Guidelines
  • ClinicalTrials.gov Regulatory Filings
  • Others

Proprietary Elements

  • CMI Data Analytics Tool
  • Proprietary CMI Existing Repository of Information (Last 8 Years)

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About Author

Komal Dighe is a Management Consultant with over 8 years of experience in market research and consulting. She excels in managing and delivering high-quality insights and solutions in Health-tech Consulting reports. Her expertise encompasses conducting both primary and secondary research, effectively addressing client requirements, and excelling in market estimation and forecast. Her comprehensive approach ensures that clients receive thorough and accurate analyses, enabling them to make informed decisions and capitalize on market opportunities.

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Frequently Asked Questions

The Single-use Bioprocessing Systems Market size is estimated to be valued at USD 35.31 Bn in 2025, and is expected to reach USD 105.97 Bn by 2032.

Risk of product contamination and extractability and leachability issues are the key factor hampering the growth of the global market.

Reduced complexity in process development and optimization and lower capital requirements are the major factors driving the global market.

The biopharmaceutical companies’ segment is the leading end user segment in the market.

The major players operating in the global market are Merck KGaA, Thermo Fisher Scientific Inc., Liquidyne, Corning Incorporated, Foxx Life Sciences., PARKER HANNIFIN CORP, Danaher Corporation., Sartorius, GE Healthcare, Eppendorf, Getinge AB, PBS Biotech, Esco Bioengineering, Distek, Bionet and Other Prominent Players

North America leads the global single-use bioprocessing systems industry.

The CAGR of the global Market is projected to be 17% from 2025 to 2032.

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