바이오프로세스 기술 시장 : 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, bioprocess technology market size in 2026 is estimated at USD 43.95 billion, growing from 2025 value of USD 38.45 billion with 2031 projections showing USD 85.73 billion, growing at 14.3% CAGR over 2026-2031.

This report is Segmented by Product (Instruments, Consumables & Accessories), Process Type (Upstream Processing, and More), Technology (Batch, and More), Application (Recombinant Proteins, and More), End User (Biopharmaceutical Companies, and More), and Geography (North America, Europe, Asia Pacific, Middle East & Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Bioprocess Technology Market Trends and Insights

Expansion in the Biopharmaceutical Industry

Biopharmaceutical sales climbed lifting biologics' contribution within overall drug spending from 41% in 2024 toward 45% by 2028. FDA projections of up to 20 CGT approvals annually from 2025 underline a new wave of complex modalities that require high-precision, GMP-compliant manufacturing suites. Samsung Biologics' digital-twin deployment demonstrates how advanced modeling can compress validation timelines while maintaining data integrity. Capital-intensive upgrades are therefore migrating toward flexible, single-use configurations that accommodate multiple modalities without compromising regulatory expectations.

Growing Contract Development & Manufacturing Outsourcing

The biologics CDMO segment is on course, fueled by large pharma's strategic divestment of non-core manufacturing assets. Samsung Biologics' USD 1.4 billion Plant 5 expansion and Lonza's USD 1.2 billion acquisition of Roche's Vacaville site (330,000 L) illustrate an arms race for large-scale capacity. Potential passage of the BIOSECURE Act could redirect outsourced volumes from Chinese providers to Western and Korean suppliers; 49% of executives surveyed in 2024 expected stronger contract services growth during 2025. The shift cements the bioprocess technology market as a pivotal enabler of global capacity realignment.

High Capital Cost of Integrated Systems

Up-front investments for state-of-the-art facilities can exceed USD 500 million, exemplified by Lonza's planned Vacaville upgrades that target next-gen mammalian platforms. Inflationary pressures have lifted equipment and clean-room construction costs by double-digit percentages since 2023, forcing smaller biotech firms to lean on CDMOs for access to modern capacity. Continuous-manufacturing conversions are particularly capital heavy because parallel batch suites must stay online during validation, extending payback horizons. As a result, technology adoption cycles often hinge on demonstrable ROI and regulatory clarity, delaying penetration in cash-constrained geographies.

Other drivers and restraints analyzed in the detailed report include:

1. Surge in Cell & Gene Therapy Pipelines
2. Rising Demand for Single-Use Bioprocessing Systems
3. Chronic Skilled-Labor Shortages

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

Segment Analysis

Consumables and accessories accounted for 60.55% of the bioprocess technology market share in 2025 and are forecast to advance at a 16.42% CAGR through 2031. This growth cements single-use bags, sterile connectors, and custom media as recurring revenue pillars within the bioprocess technology market. Culture media optimized for CGT has underscored value potential, with growing demand for gene-therapy media.

Instrument demand is comparatively steadier, underpinned by innovations such as the 5 L DynaDrive bioreactor and Sartorius' BIOSTAT RM TX platform for automated cell expansion. Process analyzers are benefiting from heightened PAT adoption as facilities transition toward continuous workflows. The consumables boom embodies the larger structural shift away from stainless-steel dependencies, enabling faster turnarounds and lighter capital footprints across the bioprocess technology market.

Downstream operations captured 51.20% of bioprocess technology market size in 2025, led by chromatography, filtration, and viral clearance solutions. Chromatography is evolving toward multi-column continuous formats that reclaim resin capacity and buffer efficiency. Upstream, perfusion culture adoption is propelling a 14.55% CAGR, as high cell-density systems cut bioreactor volume requirements while sustaining volumetric productivity.

Planova FG1's seven-fold performance jump underscores the ongoing innovation race in virus filtration. Yet perfusion systems demonstrated at 2,000 L by Samsung Biologics embody upstream's acceleration by offering steady-state cultures that pair seamlessly with continuous downstream platforms. These dynamics are tightening integration between unit operations, improving overall facility throughput across the bioprocess technology market.

Complete Report Scope:

• By Product
  • Instruments
    • Bioprocess Analyzers
    • Osmometers
    • Bioreactors
    • Incubators
    • Other Instruments
  • Consumables & Accessories
    • Culture Media
    • Reagents
    • Other Consumables & Accessories
• By Process Type
  • Upstream Processing
  • Downstream Processing
• By Technology
  • Batch
  • Fed-Batch
  • Continuous
• By Application
  • Recombinant Proteins
  • Monoclonal Antibodies
  • Cell & Gene Therapy Products
  • Antibiotics
  • Other Applications
• By End User
  • Biopharmaceutical Companies
  • Contract Manufacturing Organizations
  • Academic & Research Institutes
  • Other End Users
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • 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's 38.90% market leadership is anchored by FDA regulatory depth and an ecosystem of established innovators. GSK's USD 120 million single-use plant in Pennsylvania and Thermo Fisher's pending Solventum deal reinforce domestic capacity commitments. Canada's and Mexico's cross-border supply chains complement United States strengths, leveraging USMCA provisions for frictionless component trade.

Europe maintains competitive parity through cohesive regulatory frameworks such as the EMA's revised Annex 1 and upcoming ATMP guidelines, which advocate risk-based sterility assurance. Germany, the United Kingdom, and France provide dense biotech clusters, while Poland and the Czech Republic are capturing spill-over investments through favorable cost structures and EU funding.

Asia-Pacific is the growth pacesetter with an 17.65% CAGR, driven by China's and South Korea's extensive greenfield builds. WuXi Biologics' 15,000 L single-use lines delivered 70% cost savings compared with stainless-steel incumbents. Cytiva's new 6,100 m2 filter plant in Incheon and Samsung Biologics' digital-twin capacity expansion underscore South Korea's vaccine hub ambitions. India is pivoting toward global GMP certification but faces infrastructure bottlenecks, prompting domestic firms to invest overseas rather than upgrade local sites. The Middle East, Africa, and South America remain emergent, with Saudi Arabia and Brazil leading nascent biomanufacturing initiatives.

1. Sartorius
2. Thermo Fisher Scientific
3. Danaher
4. Merck
5. Roche
6. Cytiva (GE Healthcare Life Sciences)
7. Eppendorf
8. Lonza Group
9. Bio-Rad Laboratories
10. Getinge
11. Advanced Instrumentations
12. Agilent Technologies
13. Repligen Corp.
14. PBS Biotech Inc.
15. Applikon Biotechnology (IDEX)
16. Meissner Filtration Products
17. Corning
18. Kuhner Shaker AG
19. FUJIFILM
20. Entegris Inc.
21. Solaris Biotech (Donaldson Co.)

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 Expansion in the Biopharmaceutical Industry
  • 4.2.2 Growing Contract Development & Manufacturing Outsourcing
  • 4.2.3 Surge in Cell & Gene Therapy Pipelines
  • 4.2.4 Rising Demand for Single-Use Bioprocessing Systems
  • 4.2.5 Advent of Continuous & Hybrid Bioprocessing Platforms
  • 4.2.6 AI-Driven Bioprocess Optimization & Digital Twins
• 4.3 Market Restraints
  • 4.3.1 High Capital Cost of Integrated Systems
  • 4.3.2 Stringent cGMP & Validation Requirements
  • 4.3.3 Chronic Skilled-Labor Shortages
  • 4.3.4 Upstream-Downstream Scale-Mismatch Bottlenecks
• 4.4 Regulatory Landscape
• 4.5 Technological Outlook
• 4.6 Porter's Five Forces Analysis
  • 4.6.1 Threat of New Entrants
  • 4.6.2 Bargaining Power of Buyers
  • 4.6.3 Bargaining Power of Suppliers
  • 4.6.4 Threat of Substitutes
  • 4.6.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value in USD)

• 5.1 By Product
  • 5.1.1 Instruments
    • 5.1.1.1 Bioprocess Analyzers
    • 5.1.1.2 Osmometers
    • 5.1.1.3 Bioreactors
    • 5.1.1.4 Incubators
    • 5.1.1.5 Other Instruments
  • 5.1.2 Consumables & Accessories
    • 5.1.2.1 Culture Media
    • 5.1.2.2 Reagents
    • 5.1.2.3 Other Consumables & Accessories
• 5.2 By Process Type
  • 5.2.1 Upstream Processing
  • 5.2.2 Downstream Processing
• 5.3 By Technology
  • 5.3.1 Batch
  • 5.3.2 Fed-Batch
  • 5.3.3 Continuous
• 5.4 By Application
  • 5.4.1 Recombinant Proteins
  • 5.4.2 Monoclonal Antibodies
  • 5.4.3 Cell & Gene Therapy Products
  • 5.4.4 Antibiotics
  • 5.4.5 Other Applications
• 5.5 By End User
  • 5.5.1 Biopharmaceutical Companies
  • 5.5.2 Contract Manufacturing Organizations
  • 5.5.3 Academic & Research Institutes
  • 5.5.4 Other End Users
• 5.6 By Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 Australia
    • 5.6.3.5 South Korea
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East & Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East & Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 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 & Services, and Recent Developments)
  • 6.3.1 Sartorius AG
  • 6.3.2 Thermo Fisher Scientific Inc.
  • 6.3.3 Danaher Corporation
  • 6.3.4 Merck KGaA
  • 6.3.5 F. Hoffmann-La Roche Ltd
  • 6.3.6 Cytiva (GE Healthcare Life Sciences)
  • 6.3.7 Eppendorf SE
  • 6.3.8 Lonza Group AG
  • 6.3.9 Bio-Rad Laboratories Inc.
  • 6.3.10 Getinge AB
  • 6.3.11 Advanced Instruments LLC
  • 6.3.12 Agilent Technologies Inc.
  • 6.3.13 Repligen Corp.
  • 6.3.14 PBS Biotech Inc.
  • 6.3.15 Applikon Biotechnology (IDEX)
  • 6.3.16 Meissner Filtration Products
  • 6.3.17 Corning Inc.
  • 6.3.18 Kuhner Shaker AG
  • 6.3.19 Fujifilm Diosynth Biotechnologies
  • 6.3.20 Entegris Inc.
  • 6.3.21 Solaris Biotech (Donaldson Co.)

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment