일회용 바이오프로세싱 시장 : 제품별, 용도별, 최종사용자별, 워크플로우별, 지역별 - 시장 규모, 산업 역학, 기회, 분석 및 예측(2026-2035년)

The Single-Use Bioprocessing Market is undergoing remarkable expansion, with its valuation reaching USD 30.12 billion in 2025. This impressive market size is expected to experience substantial growth over the next decade, projected to soar to USD 122.92 billion by 2035. This translates to a robust compound annual growth rate (CAGR) of 15.1% during the forecast period from 2026 to 2035, reflecting the increasing adoption and importance of single-use technologies in biopharmaceutical manufacturing.

Several key factors are driving this rapid market growth. One of the primary advantages of single-use bioprocessing systems is their significantly lower capital costs compared to traditional stainless steel infrastructure. By eliminating the need for expensive, fixed equipment and extensive facility construction, companies can reduce upfront investment and allocate resources more efficiently. Additionally, the faster setup times associated with single-use systems enable manufacturers to accelerate project timelines, bringing products to market more quickly and adapting more readily to changing production needs.

Noteworthy Market Developments

The competitive landscape of the single-use bioprocessing market is characterized by an oligopolistic structure dominated by a few global giants: Thermo Fisher Scientific, Sartorius, Danaher (through its Cytiva division), and Merck KGaA. These companies have historically competed on the basis of product innovation, continuously advancing the performance, reliability, and integration of single-use technologies. However, the focus of competition has increasingly shifted toward supply chain regionalization, as manufacturers seek to localize production and distribution networks to improve responsiveness, reduce lead times, and mitigate risks associated with global supply chain disruptions.

A significant development illustrating this strategic shift occurred in December 2025 when the state government of Telangana inaugurated India's first dedicated single-use bioprocess design and scale-up facility named Telangana 1 Bio, located within Genome Valley. This launch is especially noteworthy as it coincides with the 25th anniversary of Genome Valley. This well-established life sciences hub has become a focal point for biotechnology and pharmaceutical innovation in the region.

Further reflecting the rising global demand for single-use bioprocessing solutions, Sartorius Stedim Biotech notably expanded its cleanroom capacity in June 2025, nearly doubling its space to 9,000 square meters. This expansion enables the company to significantly increase production volumes and meet the surging needs of biopharmaceutical manufacturers worldwide. These strategic moves-regional facility launches and capacity expansions-highlight how leading players are adapting their operations to address supply chain challenges while continuing to support innovation and growth in the single-use bioprocessing market.

Core Growth Drivers

The increasing prevalence of chronic diseases, coupled with aging populations worldwide, is significantly driving demand for advanced biopharmaceutical treatments such as monoclonal antibodies, vaccines, and cell therapies. These therapies have become essential tools in managing and treating conditions like cancer, autoimmune disorders, infectious diseases, and age-related ailments. As the global population ages and the incidence of chronic illnesses rises, there is a growing need for efficient and scalable production methods capable of meeting this expanding therapeutic demand.

Emerging Opportunity Trends

A critical and somewhat counterintuitive trend reshaping the Single-Use Bioprocessing Market is the emergence of the "Green Bio" initiative. Traditionally, this market segment has faced criticism due to the substantial volume of plastic waste generated by biopharmaceutical manufacturing processes. Estimates indicate that the biopharma industry produces between 94,000 and 200,000 metric tons of disposable plastic waste annually, raising significant environmental concerns. Critics have viewed this accumulation of single-use plastics as a major ecological liability, questioning the sustainability of disposable systems despite their operational advantages.

Barriers to Optimization

As the single-use bioprocessing market increasingly shifts toward plastic fill-finish applications, regulatory scrutiny surrounding chemical migration from plastic materials has become significantly more stringent. This heightened focus reflects growing concerns over the potential for leachables and extractables (L&E)-chemical substances that can migrate from plastic components into pharmaceutical products-to affect drug safety and efficacy. Regulatory agencies, particularly the U.S. Food and Drug Administration (FDA), have responded by enforcing more rigorous testing and validation requirements to ensure that single-use systems meet the highest standards of product integrity and patient safety.

Detailed Market Segmentation

By Workflow, the upstream segment of the single-use bioprocessing market, which encompasses cell culture and fermentation processes, commands a substantial portion of the overall revenue share. This dominance is closely tied to the maturation of bioreactor technology, which has evolved into a highly efficient, plug-and-play solution that simplifies and accelerates biomanufacturing operations. The widespread adoption of single-use bioreactor systems has transformed upstream processing by offering manufacturers increased flexibility, reduced downtime, and enhanced control over critical production parameters.

By Product, the Simple and Peripheral Elements segment, which includes components such as tubing, filters, and connectors, serves as the primary revenue driver within the single-use bioprocessing market. This segment captures the largest revenue share, accounting for approximately 40% of the market. The dominance of these peripheral components is largely attributed to the industry-wide emphasis on maintaining "closed system" bioprocessing environments, which are essential for minimizing contamination risks and ensuring product integrity throughout production.

Segment Breakdown

By Product

• Simple & Peripheral Elements
• Tubing, Filters, Connectors, & Transfer Systems
• Bags
• Sampling Systems
• Probes & Sensors
• pH Sensor
• Oxygen Sensor
• Pressure Sensors
• Temperature Sensors
• Conductivity Sensors
• Flow Sensors
• Others
• Others
• Apparatus & Plants
• Bioreactors
• Upto 1000 L
• Above 1000 L to 2000 L
• Above 2000 L
• Mixing, Storage, & Filling Systems
• Filtration System
• Chromatography Systems
• Pumps
• Others
• Work Equipment
• Cell Culture System
• Syringes
• Others

By Workflow

• Upstream Bioprocessing
• Fermentation
• Downstream Bioprocessing

By End-Use

• Biopharmaceutical Manufacturers
• CMOs & CROs
• In-house Manufacturers
• Academic & Clinical Research Institutes

By Region

• North America
• The US
• Canada
• Mexico
• Europe
• Western Europe
• The UK
• Germany
• France
• Italy
• Spain
• Rest of Western Europe
• Eastern Europe
• Poland
• Russia
• Rest of Eastern Europe
• Asia Pacific
• China
• India
• Japan
• Australia and New Zealand
• South Korea
• ASEAN
• Rest of Asia Pacific
• Middle East and Africa
• Saudi Arabia
• South Africa
• UAE
• Rest of MEA
• South America
• Argentina
• Brazil
• Rest of South America

Geography Breakdown

• North America's leadership in the single-use bioprocessing market is largely anchored in a strategic approach centered on retrofitting existing facilities rather than constructing entirely new greenfield sites. This approach leverages the region's extensive legacy infrastructure, transforming and upgrading it with modern single-use technologies to enhance efficiency and flexibility. By retrofitting, companies can reduce capital expenditures and shorten implementation timelines compared to building new facilities from scratch, allowing for quicker adaptation to evolving market demands and regulatory requirements.
• Several key factors contribute to North America's dominant position in this market. The region is home to major industry players with vast production capacities, which enables large-scale adoption of single-use bioprocessing systems. These disposables offer notable advantages, such as reduced risk of cross-contamination, faster turnaround times between production batches, and decreased need for cleaning and sterilization, making them increasingly attractive to manufacturers. Additionally, North America's growing healthcare expenditure reflects a broader commitment to advancing medical technologies and therapies, driving demand for more efficient and scalable bioprocessing solutions.

Leading Market Participants

• ABEC Inc.
• Avantor Inc.
• Cellexus
• Celltainer Biotech BV
• CESCO Bioengineering Co.
• Danaher Corp
• Distek Inc.
• Entegris Inc.
• Eppendorf AG
• GEA Group
• Meissner Filtration Products
• Merck
• OmniBRx Biotechnologies
• Parker Hannifin (Domnick Hunter)
• PBS Biotech Inc.
• Repligen Corporation
• Saint-Gobain Life Sciences
• Sartorius AG
• Solventum
• Thermo Fisher Scientific Inc.
• Other Prominent Players

Table of Content

Chapter 1. Executive Summary: Global Single-Use Bioprocessing Market

Chapter 2. Report Description

• 2.1. Research Framework
  • 2.1.1. Research Objective
  • 2.1.2. Market Definitions
  • 2.1.3. Market Segmentation
• 2.2. Research Methodology
  • 2.2.1. Market Size Estimation
  • 2.2.2. Qualitative Research
    • 2.2.2.1. Primary & Secondary Sources
  • 2.2.3. Quantitative Research
    • 2.2.3.1. Primary & Secondary Sources
  • 2.2.4. Breakdown of Primary Research Respondents, By Region
  • 2.2.5. Data Triangulation
  • 2.2.6. Assumption for Study

Chapter 3. Global Single-Use Bioprocessing Market Overview

• 3.1. Industry Value Chain Analysis
  • 3.1.1. Raw Material Sourcing
  • 3.1.2. Manufacturing and Assembly
  • 3.1.3. Distributors
  • 3.1.4. End Users
• 3.2. Industry Outlook
  • 3.2.1. Global Biopharmaceutical Production Outlook
  • 3.2.2. EXIM Analysis
  • 3.2.3. Regulatory Framework
• 3.3. PESTLE Analysis
• 3.4. Porter's Five Forces Analysis
  • 3.4.1. Bargaining Power of Suppliers
  • 3.4.2. Bargaining Power of Buyers
  • 3.4.3. Threat of Substitutes
  • 3.4.4. Threat of New Entrants
  • 3.4.5. Degree of Competition
• 3.5. Market Growth and Outlook
  • 3.5.1. Market Revenue Estimates and Forecast (US$ Mn), 2020-2035
  • 3.5.2. Pricing Analysis, By Product
• 3.6. Market Attractiveness Analysis
  • 3.6.1. By Product
• 3.7. Actionable Insights (Analyst's Recommendations)

Chapter 4. Competition Dashboard

• 4.1. Market Concentration Rate
• 4.2. Company Market Share Analysis (Value %), 2025
• 4.3. Competitor Mapping & Benchmarking

Chapter 5. Global Single-Use Bioprocessing Market Analysis

• 5.1. Market Dynamics and Trends
  • 5.1.1. Growth Drivers
  • 5.1.2. Restraints
  • 5.1.3. Opportunity
  • 5.1.4. Key Trends
• 5.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 5.2.1. By Product
    • 5.2.1.1. Key Insights
      • 5.2.1.1.1. Simple & Peripheral Elements
        • 5.2.1.1.1.1. Tubing, Filters, Connectors, & Transfer Systems
        • 5.2.1.1.1.2. Bags
        • 5.2.1.1.1.3. Sampling Systems
        • 5.2.1.1.1.4. Probes & Sensors
          • 5.2.1.1.1.4.1. pH Sensor
          • 5.2.1.1.1.4.2. Oxygen Sensor
          • 5.2.1.1.1.4.3. Pressure Sensors
          • 5.2.1.1.1.4.4. Temperature Sensors
          • 5.2.1.1.1.4.5. Conductivity Sensors
          • 5.2.1.1.1.4.6. Flow Sensors
          • 5.2.1.1.1.4.7. Others
        • 5.2.1.1.1.5. Others
      • 5.2.1.1.2. Apparatus & Plants
        • 5.2.1.1.2.1. Bioreactors
          • 5.2.1.1.2.1.1. Upto 1000 L
          • 5.2.1.1.2.1.2. Above 1000 L to 2000 L
          • 5.2.1.1.2.1.3. Above 2000 L
        • 5.2.1.1.2.2. Mixing, Storage, & Filling Systems
        • 5.2.1.1.2.3. Filtration System
        • 5.2.1.1.2.4. Chromatography Systems
        • 5.2.1.1.2.5. Pumps
        • 5.2.1.1.2.6. Others
      • 5.2.1.1.3. Work Equipment
        • 5.2.1.1.3.1. Cell Culture System
        • 5.2.1.1.3.2. Syringes
        • 5.2.1.1.3.3. Others
  • 5.2.2. By Workflow
    • 5.2.2.1. Key Insights
      • 5.2.2.1.1. Upstream Bioprocessing
      • 5.2.2.1.2. Fermentation
      • 5.2.2.1.3. Downstream Bioprocessing
  • 5.2.3. By End Use
    • 5.2.3.1. Key Insights
      • 5.2.3.1.1. Biopharmaceutical Manufacturers
      • 5.2.3.1.2. CMOs & CROs
      • 5.2.3.1.3. In-house Manufacturers
      • 5.2.3.1.4. Academic & Clinical Research Institutes
  • 5.2.4. By Region
    • 5.2.4.1. Key Insights
      • 5.2.4.1.1. North America
        • 5.2.4.1.1.1. The U.S.
        • 5.2.4.1.1.2. Canada
        • 5.2.4.1.1.3. Mexico
      • 5.2.4.1.2. Europe
        • 5.2.4.1.2.1. Western Europe
          • 5.2.4.1.2.1.1. The UK
          • 5.2.4.1.2.1.2. Germany
          • 5.2.4.1.2.1.3. France
          • 5.2.4.1.2.1.4. Italy
          • 5.2.4.1.2.1.5. Spain
          • 5.2.4.1.2.1.6. Rest of Western Europe
        • 5.2.4.1.2.2. Eastern Europe
          • 5.2.4.1.2.2.1. Poland
          • 5.2.4.1.2.2.2. Russia
          • 5.2.4.1.2.2.3. Rest of Eastern Europe
      • 5.2.4.1.3. Asia Pacific
        • 5.2.4.1.3.1. China
        • 5.2.4.1.3.2. India
        • 5.2.4.1.3.3. Japan
        • 5.2.4.1.3.4. South Korea
        • 5.2.4.1.3.5. Australia & New Zealand
        • 5.2.4.1.3.6. ASEAN
          • 5.2.4.1.3.6.1.1. Indonesia
          • 5.2.4.1.3.6.1.2. Malaysia
          • 5.2.4.1.3.6.1.3. Thailand
          • 5.2.4.1.3.6.1.4. Singapore
          • 5.2.4.1.3.6.1.5. Rest of ASEAN
        • 5.2.4.1.3.7. Rest of Asia Pacific
      • 5.2.4.1.4. Middle East & Africa
        • 5.2.4.1.4.1. UAE
        • 5.2.4.1.4.2. Saudi Arabia
        • 5.2.4.1.4.3. South Africa
        • 5.2.4.1.4.4. Rest of MEA
      • 5.2.4.1.5. South America
        • 5.2.4.1.5.1. Argentina
        • 5.2.4.1.5.2. Brazil
        • 5.2.4.1.5.3. Rest of South America

Chapter 6. North America Single-Use Bioprocessing Market Analysis

• 6.1. Market Dynamics and Trends
  • 6.1.1. Growth Drivers
  • 6.1.2. Restraints
  • 6.1.3. Opportunity
  • 6.1.4. Key Trends
• 6.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 6.2.1. By Product
  • 6.2.2. By Workflow
  • 6.2.3. By End Use
  • 6.2.4. By Country

Chapter 7. Europe Single-Use Bioprocessing Market Analysis

• 7.1. Market Dynamics and Trends
  • 7.1.1. Growth Drivers
  • 7.1.2. Restraints
  • 7.1.3. Opportunity
  • 7.1.4. Key Trends
• 7.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 7.2.1. By Product
  • 7.2.2. By Workflow
  • 7.2.3. By End Use
  • 7.2.4. By Country

Chapter 8. Asia Pacific Single-Use Bioprocessing Market Analysis

• 8.1. Market Dynamics and Trends
  • 8.1.1. Growth Drivers
  • 8.1.2. Restraints
  • 8.1.3. Opportunity
  • 8.1.4. Key Trends
• 8.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 8.2.1. By Product
  • 8.2.2. By Workflow
  • 8.2.3. By End Use
  • 8.2.4. By Country

Chapter 9. Middle East & Africa Single-Use Bioprocessing Market Analysis

• 9.1. Market Dynamics and Trends
  • 9.1.1. Growth Drivers
  • 9.1.2. Restraints
  • 9.1.3. Opportunity
  • 9.1.4. Key Trends
• 9.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 9.2.1. By Product
  • 9.2.2. By Workflow
  • 9.2.3. By End Use
  • 9.2.4. By Country

Chapter 10. South America Single-Use Bioprocessing Market Analysis

• 10.1. Market Dynamics and Trends
  • 10.1.1. Growth Drivers
  • 10.1.2. Restraints
  • 10.1.3. Opportunity
  • 10.1.4. Key Trends
• 10.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 10.2.1. By Product
  • 10.2.2. By Workflow
  • 10.2.3. By End Use
  • 10.2.4. By Country

Chapter 11. Company Profile (Company Overview, Company Timeline, Organization Structure, Key Product landscape, Financial Matrix, Key Customers/Sectors, Key Competitors, SWOT Analysis, Contact Address, and Business Strategy Outlook)

• 11.1. ABEC Inc.
• 11.2. Avantor Inc.
• 11.3. Cellexus
• 11.4. Celltainer Biotech BV
• 11.5. ESCO Bioengineering Co.
• 11.6. Danaher Corp
• 11.7. Distek Inc.
• 11.8. Entegris Inc.
• 11.9. Eppendorf AG
• 11.10. GEA Group
• 11.11. Meissner Filtration Products
• 11.12. Merck
• 11.13. OmniBRx Biotechnologies
• 11.14. Parker Hannifin (Domnick Hunter)
• 11.15. PBS Biotech Inc.
• 11.16. Repligen Corporation
• 11.17. Saint-Gobain Life Sciences
• 11.18. Sartorius AG
• 11.19. Solventum
• 11.20. Thermo Fisher Scientific Inc.
• 11.21. Other Prominent Players

Chapter 12. Annexure

• 12.1. List of Secondary Sources
• 12.2. Key Country Markets- Macro Economic Outlook/Indicators