일회용 바이오프로세싱 시장 기회, 성장 촉진요인, 업계 동향 분석 및 예측(2026-2035년)

The Global Single-Use Bioprocessing Market was valued at USD 13.9 billion in 2025 and is estimated to grow at a CAGR of 10.1% to reach USD 35.8 billion by 2035.

Market expansion is supported by the increasing need for biologic manufacturing, growing adoption of biosimilars, lower capital requirements than conventional stainless-steel infrastructure, and a reduced likelihood of cross-contamination. Greater reliance on contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs) is also creating favorable conditions for single-use technologies. At the same time, the expanding use of personalized medicine and cell and gene therapies is encouraging biopharmaceutical manufacturers to adopt more flexible processing platforms. Single-use systems can help manufacturers streamline production, shorten facility deployment timelines, and reduce upfront investment. Their ability to support flexible manufacturing strategies is becoming increasingly valuable as biopharmaceutical companies manage more complex production requirements. Biosimilar manufacturers are also turning to disposable processing solutions because these systems can reduce operating expenses and enable faster facility implementation. As manufacturers continue to prioritize efficiency, flexibility, scalability, and contamination control, demand for single-use bioprocessing solutions is expected to maintain strong momentum throughout the forecast period.

The growing tendency among biopharmaceutical manufacturers to outsource production is becoming another important factor driving market development. CDMOs and CMOs are increasingly being selected by biopharma companies seeking to control capital spending, shorten commercialization timelines, and obtain access to specialized production capabilities. External manufacturing providers often serve multiple customers with different production requirements, which increases the need for adaptable and scalable processing infrastructure. Single-use bioprocessing systems can address these requirements by allowing production platforms to be configured according to changing manufacturing needs. Their flexibility also enables service providers to manage diverse production schedules while maintaining efficient facility utilization. As outsourcing continues to become a more important component of biopharmaceutical manufacturing strategies, demand for disposable processing technologies is expected to increase accordingly.

The bags and containers segment generated USD 4.1 billion in 2025. These disposable components support several stages of bioprocessing operations, including material preparation, storage, collection, transfer, and intermediate handling. Their closed and sterile design helps manufacturers maintain controlled processing environments while limiting contamination exposure. Bags and containers are available across different capacities and configurations, allowing manufacturers to select solutions that align with specific production requirements. Their relatively simple handling characteristics and reduced infrastructure needs can also contribute to more efficient facility operations. Compatibility with disposable assemblies further supports their integration into single-use manufacturing workflows. As biopharmaceutical production continues to expand and manufacturers seek greater flexibility in facility design and production management, the demand for single-use bags and containers is expected to remain strong.

The biopharmaceutical and pharmaceutical companies segment accounted for a 61.5% share in 2025. These organizations constitute the primary users of disposable bioprocessing technologies and increasingly rely on these systems to support efficient manufacturing while controlling operational expenses. Single-use equipment enables manufacturers to establish production operations more rapidly and adjust manufacturing schedules according to changing requirements. Technology can also help limit contamination exposure compared with conventional processing approaches. As pharmaceutical and biopharmaceutical companies manage increasingly diverse development pipelines, they are placing greater emphasis on manufacturing flexibility and operational responsiveness. Single-use platforms can support these objectives by providing adaptable processing capabilities that allow manufacturers to respond more efficiently to production changes and commercialization requirements.

North America Single-Use Bioprocessing Market held a 38% share in 2025. The regional market is expanding steadily as manufacturers place greater emphasis on contamination control and respond to increasing demand for biologic production. North America remains one of the most important markets for single-use bioprocessing because of its established biopharmaceutical manufacturing infrastructure, substantial development activity, and concentration of biotechnology companies. Manufacturers throughout the region are increasingly adopting disposable processing technologies as they seek production systems that provide greater flexibility and support quicker commercialization. The use of single-use bioreactors, filtration technologies, and fluid management solutions is also increasing as companies seek to streamline manufacturing operations. Strong industry infrastructure and continued investment in biopharmaceutical production are expected to support further adoption of single-use technologies across the region.

Key companies operating in the global single-use bioprocessing market include Sartorius AG, Danaher Corporation, Avantor Inc., Thermo Fisher Scientific Inc., Merck KGaA, Getinge AB, Eppendorf SE, Repligen Corporation, Saint-Gobain Life Sciences, Entegris Inc., Parker Hannifin Corporation, Meissner Filtration Products Inc., Celltainer Biotech BV, PBS Biotech Inc., and Cellexus International Ltd. Companies operating in the single-use bioprocessing market are strengthening their positions by expanding their technology portfolios, improving disposable processing solutions, and investing in product development. Market participants are also focusing on strategic collaborations, regional expansion, and stronger distribution networks to reach a broader customer base. Companies are enhancing manufacturing capabilities to address rising demand for flexible and scalable bioprocessing platforms. Investments in research and development are helping suppliers improve system performance, process efficiency, and contamination control. Leading participants are also developing integrated solutions that can simplify manufacturing workflows and improve operational flexibility. In addition, companies are strengthening customer support and technical service capabilities to build long-term relationships with biopharmaceutical manufacturers.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definition
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Data mining sources
  • 1.3.1 Global
  • 1.3.2 Regional/Country
• 1.4 Base estimates and calculations
  • 1.4.1 Base year calculation
  • 1.4.2 Key trends for market estimation
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
• 1.6 Forecast model
• 1.7 Research assumptions and limitations

Chapter 2 Executive Summary

• 2.1 Industry 360° synopsis
• 2.2 Key market trends
  • 2.2.1 Regional trends
  • 2.2.2 Product type trends
  • 2.2.3 Workflow stage trends
  • 2.2.4 Application trends
  • 2.2.5 End use trends
• 2.3 CXO perspectives: Strategic imperatives

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Rising demand for biologics and biosimilars
    • 3.2.1.2 Increasing adoption of personalized medicines and cell & gene therapies
    • 3.2.1.3 Rising outsourcing to CDMOs and CMOs
    • 3.2.1.4 Reduced risk of cross-contamination
    • 3.2.1.5 Lower capital investment compared to stainless-steel systems
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 Concerns regarding extractables and leachables
    • 3.2.2.2 Environmental concerns related to plastic waste generation
    • 3.2.2.3 High recurring consumables cost
  • 3.2.3 Market opportunities
    • 3.2.3.1 Continuous bioprocessing integration with single-use platforms
    • 3.2.3.2 Development of advanced high-capacity single-use bioreactors
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
  • 3.4.1 North America
  • 3.4.2 Europe
  • 3.4.3 Asia Pacific
  • 3.4.4 Latin America
  • 3.4.5 Middle East and Africa
• 3.5 Technological advancements
  • 3.5.1 Current technological trends
  • 3.5.2 Emerging technologies
• 3.6 Pricing trend analysis (Driven by primary research)
• 3.7 Future market trends (Driven by primary research)
• 3.8 Porter's analysis
• 3.9 PESTEL analysis
• 3.10 Gap analysis
• 3.11 Impact of AI and Generative AI on the market (Driven by primary research)

Chapter 4 Competitive Landscape, 2025

• 4.1 Introduction
• 4.2 Company matrix analysis
• 4.3 Company market share analysis (Driven by primary research)
  • 4.3.1 Global
  • 4.3.2 North America
  • 4.3.3 Europe
  • 4.3.4 Asia Pacific
• 4.4 Competitive positioning matrix
• 4.5 Competitive analysis of major market players
• 4.6 Key developments
  • 4.6.1 Mergers & acquisitions
  • 4.6.2 Partnerships & collaborations
  • 4.6.3 New product launches
  • 4.6.4 Expansion plans

Chapter 5 Market Estimates and Forecast, By Product Type, 2022 - 2035 ($ Mn)

• 5.1 Key trends
• 5.2 Single-use bioreactors
  • 5.2.1 Stirred tank single-use bioreactors
  • 5.2.2 Wave-mixed single-use bioreactors
  • 5.2.3 Bubble column single-use bioreactors
  • 5.2.4 Other products
• 5.3 Bags and containers
• 5.4 Tubing assemblies
• 5.5 Connectors and fittings
• 5.6 Filtration devices
• 5.7 Mixing systems
• 5.8 Sensors and probes
  • 5.8.1 pH sensors
  • 5.8.2 Dissolved oxygen sensors
  • 5.8.3 Pressure and flow sensors
  • 5.8.4 Other sensor types
• 5.9 Sampling systems

Chapter 6 Market Estimates and Forecast, By Workflow Stage, 2022 - 2035 ($ Mn)

• 6.1 Key trends
• 6.2 Upstream processing
• 6.3 Downstream processing
• 6.4 Final processing

Chapter 7 Market Estimates and Forecast, By Application, 2022 - 2035 ($ Mn)

• 7.1 Key trends
• 7.2 Monoclonal antibodies (mAbs)
• 7.3 Vaccine production
• 7.4 Cell and gene therapy
• 7.5 Plasma-derived products
• 7.6 Other biologics

Chapter 8 Market Estimates and Forecast, By End Use, 2022 - 2035 ($ Mn)

• 8.1 Key trends
• 8.2 Biopharmaceutical and pharmaceutical companies
• 8.3 CMOs and CROs
• 8.4 Academic and research institutes

Chapter 9 Market Estimates and Forecast, By Region, 2022 - 2035 ($ Mn)

• 9.1 Key trends
• 9.2 North America
  • 9.2.1 U.S.
  • 9.2.2 Canada
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 France
  • 9.3.4 Spain
  • 9.3.5 Italy
  • 9.3.6 Netherlands
• 9.4 Asia Pacific
  • 9.4.1 China
  • 9.4.2 India
  • 9.4.3 Japan
  • 9.4.4 Australia
  • 9.4.5 South Korea
• 9.5 Latin America
  • 9.5.1 Brazil
  • 9.5.2 Mexico
  • 9.5.3 Argentina
• 9.6 Middle East and Africa
  • 9.6.1 Saudi Arabia
  • 9.6.2 South Africa
  • 9.6.3 UAE

Chapter 10 Company Profiles

• 10.1 Avantor Inc.
• 10.2 Cellexus International Ltd.
• 10.3 Celltainer Biotech BV
• 10.4 Danaher Corporation
• 10.5 Entegris Inc.
• 10.6 Eppendorf SE
• 10.7 Getinge AB
• 10.8 Meissner Filtration Products Inc.
• 10.9 Merck KGaA
• 10.10 Parker Hannifin Corporation
• 10.11 PBS Biotech Inc.
• 10.12 Repligen Corporation
• 10.13 Saint-Gobain Life Sciences
• 10.14 Sartorius AG
• 10.15 Thermo Fisher Scientific Inc.