일회용 바이오리액터 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the single-use bioreactor market size is projected to be USD 5.47 billion in 2025, USD 6.28 billion in 2026, and reach USD 13.07 billion by 2031, growing at a CAGR of 15.78% from 2026 to 2031.

This report is Segmented by Product Type (Stirred-Tank, Wave-Induced, Fixed-Bed, Orbitally-Shaken & Other SUBs), Volume Range (Less Than 100 L, 100-500 L, and More), Application (Research & Process Development, and More), End-User (Pharmaceutical & Biopharmaceutical Companies, and More), and Geography (North America, Europe, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Single-use Bioreactor Market Trends and Insights

Intensifying Shift From Stainless-Steel to Disposable Bioprocessing Systems

Pharmaceutical manufacturers are retiring legacy stainless trains in favor of single-use platforms that remove cleaning validation, lower water use by up to 80%, and cut turnaround cycles from weeks to days. Danaher's Cytiva division reported resurgent disposable-consumable sales in late 2024, underscoring dependence on bag assemblies and sensors. Sartorius indicated 75% of Bioprocess Solutions revenue stems from consumables, highlighting customer lock-in once validation is complete. Labor costs for steaming and documentation also tilt economics toward pre-sterilized bags in Western markets, although Indian and Chinese biosimilar firms still favor hybrid plants because import tariffs inflate consumable costs.

Rapid Growth of Cell & Gene Therapies Elevating Demand for Flexible Small-Batch Manufacturing

Autologous CAR-T treatments require 50 mL-10 L runs, volumes incompatible with 500 L stainless reactors. Bristol Myers Squibb reserved USD 380 million in capacity with Cellares in 2024 for its automated Cell Shuttle platform that pairs single-use bioreactors with closed cell-processing hardware. FDA approvals for multiple CAR-T constructs in 2024-2025 and the agency's Advanced Manufacturing Technologies pathway spur decentralized manufacturing near oncology centers. Univercells' 50 L NevoLine system can be shipped in a container to remote clinics, reinforcing modular deployments.

Leachables & Extractables Compliance Uncertainty

Multilayer polyethylene films may leach plasticizers that delay approvals. FDA and EMA require up to 18 months of studies costing USD 0.5-1 million per assembly. High-potency products heighten risk, prompting some Japanese sponsors to retain stainless tanks for commercial lots.

Other drivers and restraints analyzed in the detailed report include:

1. Cost-Saving Potential in Early-Stage Clinical Production
2. Accelerated Vaccine Programs Post-COVID-19
3. High Recurring Consumable Costs

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Stirred-tank systems commanded 57.26% of 2025 revenue, reinforcing their role as the workhorse for mammalian cell culture. The single-use bioreactor market size for stirred-tank units is sustained by antibody titers exceeding 5 g/L. Orbitally-shaken vessels are expanding at 18.68% annually on adoption by academic labs, while wave-induced designs serve seed-train and viral-vector work. PBS Biotech's vertical-wheel approach improves oxygen transfer with lower shear. Thermo Fisher's sensor-embedded DynaDrive extends digital monitoring into benchtop volumes.

Adoption patterns reflect validation stringency. Commercial antibody makers value historical data from stirred tanks, but early-stage gene therapy teams favor orbitals that fit inside biosafety cabinets. Fixed-bed reactors fill perfusion niches, while the single-use bioreactor industry continues to test hybrid perfusion/fed-batch models that reduce media use.

The 500-2,000 L band represented 43.72% of 2025 revenue and remains the core of CDMO offerings. The single-use bioreactor market share for this range aligns with Phase III batch sizes that yield 5-10 kg per run. Danaher's 500 L and 2,000 L X-platform models shorten installation to eight weeks, accelerating client onboarding.

Sub-100 L systems are forecast to grow at 19.42% as CAR-T makers and universities deploy benchtop tools. Conversely, designs above 2,000 L face engineering limits; experimental 4,000 L bags remain scarce and expensive, capping growth despite demand for large-scale biosimilars.

Complete Report Scope:

• By Product Type
  • Stirred-Tank SUBs
  • Wave-Induced SUBs
  • Fixed-Bed SUBs
  • Orbitally-Shaken & Other SUBs
• By Volume Range
  • Less than 100 L
  • 100 - 500 L
  • 500 - 2 000 L
  • More than 2,000 L
• By Application
  • Research & Process Development
  • Clinical-Scale Production
  • Commercial-Scale Biopharmaceutical Manufacturing
• By End-User
  • Pharmaceutical & Biopharmaceutical Companies
  • Contract Development & Manufacturing Organisations (CDMOs/CMOs)
  • Academic & Research Institutes
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • France
    • United Kingdom
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America accounted for 36.11% of 2025 revenue, buoyed by U.S. headquarters and an FDA program that expedites advanced manufacturing reviews. Growth is plateauing as capacity saturates, prompting suppliers to pivot to Asia-Pacific, projected to grow at 17.02% through 2031. Thermo Fisher's 2025 design centers in Singapore and Shanghai reflect this tilt.

Europe ranks second, led by Germany, Switzerland, and the UK, where water-usage rules encourage disposable systems. Merck KGaA's EUR 300 million Darmstadt hub and Sartorius' consumable-centric model illustrate the focus on high-margin supplies. Post-Brexit dual approvals add modest complexity, yet mutual recognition eases trade.

Asia-Pacific governments pursue sovereign production. South Korea's Samsung Biologics signed USD 3.3 billion in contracts in 2024, and China's Suzhou cluster scales single-use suites for domestic biosimilars. India's Serum Institute uses disposable lines to meet WHO prequalification for African supply.

Middle East & Africa and South America nurture containerized facilities. WHO hubs in South Africa and Argentina rely on modular reactors, and Brazil's Farmanguinhos uses single-use equipment to localize vaccine output. The United Arab Emirates' biotech free-zones mirror these moves, signaling continued diffusion.

1. ABEC
2. Bioengineering
3. Cellexus
4. Celltainer
5. CerCell
6. Danaher
7. Entegris
8. Eppendorf
9. Getinge
10. Meissner Filtration
11. Merck
12. PBS Biotech
13. Pierre Guerin
14. Rentschler Biopharma
15. Sartorius
16. Solaris Biotech
17. Thermo Fisher Scientific
18. Univercells Technologies

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Intensifying Shift from Stainless-Steel to Disposable Bioprocessing Systems
  • 4.2.2 Rapid Growth of Cell & Gene Therapies Elevating Demand for Flexible Small-Batch Manufacturing
  • 4.2.3 Cost-Saving Potential in Early-Stage Clinical Production
  • 4.2.4 Accelerated Vaccine Programs Post-COVID-19
  • 4.2.5 Decentralized Micro-Facility Models in Emerging Markets
  • 4.2.6 Growing Availability Of Y-Irradiation Capacity Resolving Sterilization Bottlenecks
• 4.3 Market Restraints
  • 4.3.1 Leachables & Extractables Compliance Uncertainty
  • 4.3.2 High Recurring Consumable Costs
  • 4.3.3 PFAS Regulatory Scrutiny on Single-Use Plastics
  • 4.3.4 Limited Scalability Beyond 6,000 L Hampering Late-Stage Commercial Runs
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts (Value in USD)

• 5.1 By Product Type
  • 5.1.1 Stirred-Tank SUBs
  • 5.1.2 Wave-Induced SUBs
  • 5.1.3 Fixed-Bed SUBs
  • 5.1.4 Orbitally-Shaken & Other SUBs
• 5.2 By Volume Range
  • 5.2.1 Less than 100 L
  • 5.2.2 100 - 500 L
  • 5.2.3 500 - 2 000 L
  • 5.2.4 More than 2,000 L
• 5.3 By Application
  • 5.3.1 Research & Process Development
  • 5.3.2 Clinical-Scale Production
  • 5.3.3 Commercial-Scale Biopharmaceutical Manufacturing
• 5.4 By End-User
  • 5.4.1 Pharmaceutical & Biopharmaceutical Companies
  • 5.4.2 Contract Development & Manufacturing Organisations (CDMOs/CMOs)
  • 5.4.3 Academic & Research Institutes
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 France
    • 5.5.2.3 United Kingdom
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 South Korea
    • 5.5.3.5 Australia
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East & Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East & Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products and Services, and Recent Developments)
  • 6.3.1 ABEC
  • 6.3.2 Bioengineering AG
  • 6.3.3 Cellexus
  • 6.3.4 Celltainer
  • 6.3.5 CerCell
  • 6.3.6 Danaher
  • 6.3.7 Entegris
  • 6.3.8 Eppendorf AG
  • 6.3.9 Getinge
  • 6.3.10 Meissner Filtration
  • 6.3.11 Merck KGaA
  • 6.3.12 PBS Biotech
  • 6.3.13 Pierre Guerin
  • 6.3.14 Rentschler Biopharma
  • 6.3.15 Sartorius Stedim Biotech
  • 6.3.16 Solaris Biotech
  • 6.3.17 Thermo Fisher Scientific
  • 6.3.18 Univercells Technologies

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment