PUBLISHER: KBV Research | PRODUCT CODE: 1839404
PUBLISHER: KBV Research | PRODUCT CODE: 1839404
Europe Bioprocess Validation Market Size, Share & Industry Analysis Report By Mode, By Stage, By Testing Type, By Country and Growth Forecast, 2025 - 2032
The Europe Bioprocess Validation Market would witness market growth of 8.4% CAGR during the forecast period (2025-2032).
The Germany market dominated the Europe Bioprocess Validation Market by Country in 2024, and would continue to be a dominant market till 2032; thereby, achieving a market value of USD 57.4 million by 2032. The UK market is exhibiting a CAGR of 7.3% during (2025 - 2032). Additionally, The France market would experience a CAGR of 9.1% during (2025 - 2032). The Germany and UK led the Europe Bioprocess Validation Market by Country with a market share of 24% and 16.9% in 2024.
The bioprocess validation market in Europe has grown from simple equipment checks to a full-fledged discipline that follows strict EMA guidelines and is in line with ICH and GMP standards throughout the product's life cycle. Early validation focused on cleaning and testing the final product for small biologics. Now, however, modern methods include process design, risk assessment, and continuous verification. Adopting new technologies like single-use systems, modular facilities, faster processing, and process analytical technologies (PAT) requires complicated validation for extractables, leachables, and system integrity. Digital monitoring and real-time analytics make it possible to control things ahead of time and get products out faster. Biotech clusters in Germany, the UK, France, Switzerland, and the Nordics all work together to create a healthy ecosystem. Contract development and manufacturing organizations (CDMOs) have taken on more responsibilities by providing specialized validation services to meet a wide range of regulatory and manufacturing needs.
Some important trends in the market are real-time, model-based validation, a lot of rules for single-use and modular systems, and more work being sent to specialized providers. Leading companies use strategies like putting hardware and validation services together, putting money into digital tools and predictive analytics, and keeping a strong presence in each region to follow local rules. Partnerships, acquisitions, and lean, risk-based validation methods make a business more competitive. Thought leadership and regulatory engagement, on the other hand, make a business more credible. There is competition among global OEMs that offer integrated solutions, independent validation specialists, and local firms. In a market where audit readiness and regulatory trust define success, innovation in automation and digital platforms is becoming an important way to stand out. A good reputation for compliance is still important.
Stage Outlook
Based on Stage, the market is segmented into Continued Process Verification, Process Qualification, and Process Design. The Continued Process Verification market segment dominated the UK Bioprocess Validation Market by Stage is expected to grow at a CAGR of 6.6 % during the forecast period thereby continuing its dominance until 2032. Also, The Process Design market is anticipated to grow as a CAGR of 7.8 % during the forecast period during (2025 - 2032).
Testing Type Outlook
Based on Testing Type, the market is segmented into Bioprocess Residuals Testing, Extractables & Leachables Testing, Viral Clearance Testing, Wireless and IoT Penetration Testing, and Other Testing Type. Among various Germany Bioprocess Validation Market by Testing Type; The Bioprocess Residuals Testing market achieved a market size of USD $9.5 Million in 2024 and is expected to grow at a CAGR of 6.1 % during the forecast period. The Viral Clearance Testing market is predicted to experience a CAGR of 7.7% throughout the forecast period from (2025 - 2032).
Country Outlook
Germany is a major European center for bioprocess validation because it has a strong biotech and pharmaceutical base, advanced research infrastructure, and strict regulations from the EMA. Big companies like Bayer, Boehringer Ingelheim, BioNTech, Merck KGaA, and Sartorius work with specialized CROs to make sure that process design, qualification, and ongoing verification are all done correctly. IoT-enabled bioreactors, real-time digital monitoring, and predictive analytics are some of the Industry 4.0 technologies that are changing validation by automating it and using data to control it. As more money goes into biologics, cell, and gene therapies, the need for more advanced analytical methods, like viral clearance and extractables testing, grows. More and more small and medium-sized businesses are hiring CROs to do validation work because they have specialized knowledge and can do it faster. Competition is based on new technologies, following the rules, and combining digital tools. This strengthens Germany's position as a European leader in high-quality, technology-driven bioprocess validation.
List of Key Companies Profiled
- Merck KGaA
- Thermo Fisher Scientific, Inc.
- SGS S.A.
- Eurofins Scientific SE
- Sartorius AG
- Charles River Laboratories International, Inc.
- Lonza Group Ltd.
- WuXi AppTec Co., Ltd.
- Danaher Corporation
- Cobetter Filtration equipment Co., Ltd.
Europe Bioprocess Validation Market Report Segmentation
By Mode
- In house
- Outsourced
By Stage
- Continued Process Verification
- Process Qualification
- Process Design
By Testing Type
- Bioprocess Residuals Testing
- Extractables & Leachables Testing
- Viral Clearance Testing
- Wireless and IoT Penetration Testing
- Other Testing Type
By Country
- Germany
- UK
- France
- Russia
- Spain
- Italy
- Rest of Europe
Table of Contents
Chapter 1. Market Scope & Methodology
- 1.1 Market Definition
- 1.2 Objectives
- 1.3 Market Scope
- 1.4 Segmentation
- 1.4.1 Europe Bioprocess Validation Market, by Mode
- 1.4.2 Europe Bioprocess Validation Market, by Stage
- 1.4.3 Europe Bioprocess Validation Market, by Testing Type
- 1.4.4 Europe Bioprocess Validation Market, by Country
- 1.5 Methodology for the research
Chapter 2. Market at a Glance
- 2.1 Key Highlights
Chapter 3. Market Overview
- 3.1 Introduction
- 3.1.1 Overview
- 3.1.1.1 Market Composition and Scenario
- 3.1.1 Overview
- 3.2 Key Factors Impacting the Market
- 3.2.1 Market Drivers
- 3.2.2 Market Restraints
- 3.2.3 Market Opportunities
- 3.2.4 Market Challenges
Chapter 4. Market Trends - Europe Bioprocess Validation Market
Chapter 5. State of Competition - Europe Bioprocess Validation Market
Chapter 6. Value Chain Analysis of Bioprocess Validation Market
Chapter 7. Product Life Cycle - Bioprocess Validation Market
Chapter 8. Market Consolidation - Bioprocess Validation Market
Chapter 9. Key Customer Criteria - Bioprocess Validation Market
Chapter 10. Competition Analysis - Global
- 10.1 Market Share Analysis, 2024
- 10.2 Recent Strategies Deployed in Bioprocess Validation Market
- 10.3 Porter Five Forces Analysis
Chapter 11. Europe Bioprocess Validation Market by Mode
- 11.1 Europe In house Market by Country
- 11.2 Europe Outsourced Market by Country
Chapter 12. Europe Bioprocess Validation Market by Stage
- 12.1 Europe Continued Process Verification Market by Country
- 12.2 Europe Process Qualification Market by Country
- 12.3 Europe Process Design Market by Country
Chapter 13. Europe Bioprocess Validation Market by Testing Type
- 13.1 Europe Bioprocess Residuals Testing Market by Country
- 13.2 Europe Extractables & Leachables Testing Market by Country
- 13.3 Europe Viral Clearance Testing Market by Country
- 13.4 Europe Wireless and IoT Penetration Testing Market by Country
- 13.5 Europe Other Testing Type Market by Country
Chapter 14. Europe Bioprocess Validation Market by Country
- 14.1 Germany Bioprocess Validation Market
- 14.1.1 Germany Bioprocess Validation Market by Mode
- 14.1.2 Germany Bioprocess Validation Market by Stage
- 14.1.3 Germany Bioprocess Validation Market by Testing Type
- 14.2 UK Bioprocess Validation Market
- 14.2.1 UK Bioprocess Validation Market by Mode
- 14.2.2 UK Bioprocess Validation Market by Stage
- 14.2.3 UK Bioprocess Validation Market by Testing Type
- 14.3 France Bioprocess Validation Market
- 14.3.1 France Bioprocess Validation Market by Mode
- 14.3.2 France Bioprocess Validation Market by Stage
- 14.3.3 France Bioprocess Validation Market by Testing Type
- 14.4 Russia Bioprocess Validation Market
- 14.4.1 Russia Bioprocess Validation Market by Mode
- 14.4.2 Russia Bioprocess Validation Market by Stage
- 14.4.3 Russia Bioprocess Validation Market by Testing Type
- 14.5 Spain Bioprocess Validation Market
- 14.5.1 Spain Bioprocess Validation Market by Mode
- 14.5.2 Spain Bioprocess Validation Market by Stage
- 14.5.3 Spain Bioprocess Validation Market by Testing Type
- 14.6 Italy Bioprocess Validation Market
- 14.6.1 Italy Bioprocess Validation Market by Mode
- 14.6.2 Italy Bioprocess Validation Market by Stage
- 14.6.3 Italy Bioprocess Validation Market by Testing Type
- 14.7 Rest of Europe Bioprocess Validation Market
- 14.7.1 Rest of Europe Bioprocess Validation Market by Mode
- 14.7.2 Rest of Europe Bioprocess Validation Market by Stage
- 14.7.3 Rest of Europe Bioprocess Validation Market by Testing Type
Chapter 15. Company Profiles
- 15.1 Merck KGaA
- 15.1.1 Company Overview
- 15.1.2 Financial Analysis
- 15.1.3 Segmental and Regional Analysis
- 15.1.4 Research & Development Expenses
- 15.1.5 Recent strategies and developments:
- 15.1.5.1 Partnerships, Collaborations, and Agreements:
- 15.1.6 SWOT Analysis
- 15.2 Thermo Fisher Scientific, Inc.
- 15.2.1 Company Overview
- 15.2.2 Financial Analysis
- 15.2.3 Segmental and Regional Analysis
- 15.2.4 Research & Development Expenses
- 15.2.5 Recent strategies and developments:
- 15.2.5.1 Product Launches and Product Expansions:
- 15.2.6 SWOT Analysis
- 15.3 SGS S.A.
- 15.3.1 Company Overview
- 15.3.2 Financial Analysis
- 15.3.3 Segmental and Regional Analysis
- 15.3.4 SWOT Analysis
- 15.4 Eurofins Scientific SE
- 15.4.1 Company Overview
- 15.4.2 Financial Analysis
- 15.4.3 Regional Analysis
- 15.4.4 SWOT Analysis
- 15.5 Sartorius AG
- 15.5.1 Company Overview
- 15.5.2 Financial Analysis
- 15.5.3 Segmental and Regional Analysis
- 15.5.4 Research & Development Expenses
- 15.5.5 Recent strategies and developments:
- 15.5.5.1 Partnerships, Collaborations, and Agreements:
- 15.5.5.2 Geographical Expansions:
- 15.5.6 SWOT Analysis
- 15.6 Charles River Laboratories International, Inc.
- 15.6.1 Company Overview
- 15.6.2 Financial Analysis
- 15.6.3 Segmental and Regional Analysis
- 15.6.4 SWOT Analysis
- 15.7 Lonza Group Ltd.
- 15.7.1 Company Overview
- 15.7.2 inancial Analysis
- 15.7.3 Segmental and Regional Analysis
- 15.7.4 Research & Development Expenses
- 15.7.5 Recent strategies and developments:
- 15.7.5.1 Product Launches and Product Expansions:
- 15.7.6 SWOT Analysis
- 15.8 WuXi AppTec Co., Ltd.
- 15.8.1 Company Overview
- 15.8.2 Financial Analysis
- 15.8.3 Segmental Analysis
- 15.8.4 Research & Development Expenses
- 15.9 Danaher Corporation
- 15.9.1 Company Overview
- 15.9.2 Financial Analysis
- 15.9.3 Segmental and Regional Analysis
- 15.9.4 Research & Development Expense
- 15.9.5 SWOT Analysis
- 15.10. Cobetter Filtration equipment Co., Ltd.
- 15.10.1 Company Overview
LIST OF TABLES
- TABLE 1 Europe Bioprocess Validation Market, 2021 - 2024, USD Million
- TABLE 2 Europe Bioprocess Validation Market, 2025 - 2032, USD Million
- TABLE 3 Key Customer Criteria - Bioprocess Validation Market
- TABLE 4 Europe Bioprocess Validation Market by Mode, 2021 - 2024, USD Million
- TABLE 5 Europe Bioprocess Validation Market by Mode, 2025 - 2032, USD Million
- TABLE 6 Europe In house Market by Country, 2021 - 2024, USD Million
- TABLE 7 Europe In house Market by Country, 2025 - 2032, USD Million
- TABLE 8 Europe Outsourced Market by Country, 2021 - 2024, USD Million
- TABLE 9 Europe Outsourced Market by Country, 2025 - 2032, USD Million
- TABLE 10 Europe Bioprocess Validation Market by Stage, 2021 - 2024, USD Million
- TABLE 11 Europe Bioprocess Validation Market by Stage, 2025 - 2032, USD Million
- TABLE 12 Europe Continued Process Verification Market by Country, 2021 - 2024, USD Million
- TABLE 13 Europe Continued Process Verification Market by Country, 2025 - 2032, USD Million
- TABLE 14 Europe Process Qualification Market by Country, 2021 - 2024, USD Million
- TABLE 15 Europe Process Qualification Market by Country, 2025 - 2032, USD Million
- TABLE 16 Europe Process Design Market by Country, 2021 - 2024, USD Million
- TABLE 17 Europe Process Design Market by Country, 2025 - 2032, USD Million
- TABLE 18 Europe Bioprocess Validation Market by Testing Type, 2021 - 2024, USD Million
- TABLE 19 Europe Bioprocess Validation Market by Testing Type, 2025 - 2032, USD Million
- TABLE 20 Europe Bioprocess Residuals Testing Market by Country, 2021 - 2024, USD Million
- TABLE 21 Europe Bioprocess Residuals Testing Market by Country, 2025 - 2032, USD Million
- TABLE 22 Europe Extractables & Leachables Testing Market by Country, 2021 - 2024, USD Million
- TABLE 23 Europe Extractables & Leachables Testing Market by Country, 2025 - 2032, USD Million
- TABLE 24 Europe Viral Clearance Testing Market by Country, 2021 - 2024, USD Million
- TABLE 25 Europe Viral Clearance Testing Market by Country, 2025 - 2032, USD Million
- TABLE 26 Europe Wireless and IoT Penetration Testing Market by Country, 2021 - 2024, USD Million
- TABLE 27 Europe Wireless and IoT Penetration Testing Market by Country, 2025 - 2032, USD Million
- TABLE 28 Europe Other Testing Type Market by Country, 2021 - 2024, USD Million
- TABLE 29 Europe Other Testing Type Market by Country, 2025 - 2032, USD Million
- TABLE 30 Europe Bioprocess Validation Market by Country, 2021 - 2024, USD Million
- TABLE 31 Europe Bioprocess Validation Market by Country, 2025 - 2032, USD Million
- TABLE 32 Germany Bioprocess Validation Market, 2021 - 2024, USD Million
- TABLE 33 Germany Bioprocess Validation Market, 2025 - 2032, USD Million
- TABLE 34 Germany Bioprocess Validation Market by Mode, 2021 - 2024, USD Million
- TABLE 35 Germany Bioprocess Validation Market by Mode, 2025 - 2032, USD Million
- TABLE 36 Germany Bioprocess Validation Market by Stage, 2021 - 2024, USD Million
- TABLE 37 Germany Bioprocess Validation Market by Stage, 2025 - 2032, USD Million
- TABLE 38 Germany Bioprocess Validation Market by Testing Type, 2021 - 2024, USD Million
- TABLE 39 Germany Bioprocess Validation Market by Testing Type, 2025 - 2032, USD Million
- TABLE 40 UK Bioprocess Validation Market, 2021 - 2024, USD Million
- TABLE 41 UK Bioprocess Validation Market, 2025 - 2032, USD Million
- TABLE 42 UK Bioprocess Validation Market by Mode, 2021 - 2024, USD Million
- TABLE 43 UK Bioprocess Validation Market by Mode, 2025 - 2032, USD Million
- TABLE 44 UK Bioprocess Validation Market by Stage, 2021 - 2024, USD Million
- TABLE 45 UK Bioprocess Validation Market by Stage, 2025 - 2032, USD Million
- TABLE 46 UK Bioprocess Validation Market by Testing Type, 2021 - 2024, USD Million
- TABLE 47 UK Bioprocess Validation Market by Testing Type, 2025 - 2032, USD Million
- TABLE 48 France Bioprocess Validation Market, 2021 - 2024, USD Million
- TABLE 49 France Bioprocess Validation Market, 2025 - 2032, USD Million
- TABLE 50 France Bioprocess Validation Market by Mode, 2021 - 2024, USD Million
- TABLE 51 France Bioprocess Validation Market by Mode, 2025 - 2032, USD Million
- TABLE 52 France Bioprocess Validation Market by Stage, 2021 - 2024, USD Million
- TABLE 53 France Bioprocess Validation Market by Stage, 2025 - 2032, USD Million
- TABLE 54 France Bioprocess Validation Market by Testing Type, 2021 - 2024, USD Million
- TABLE 55 France Bioprocess Validation Market by Testing Type, 2025 - 2032, USD Million
- TABLE 56 Russia Bioprocess Validation Market, 2021 - 2024, USD Million
- TABLE 57 Russia Bioprocess Validation Market, 2025 - 2032, USD Million
- TABLE 58 Russia Bioprocess Validation Market by Mode, 2021 - 2024, USD Million
- TABLE 59 Russia Bioprocess Validation Market by Mode, 2025 - 2032, USD Million
- TABLE 60 Russia Bioprocess Validation Market by Stage, 2021 - 2024, USD Million
- TABLE 61 Russia Bioprocess Validation Market by Stage, 2025 - 2032, USD Million
- TABLE 62 Russia Bioprocess Validation Market by Testing Type, 2021 - 2024, USD Million
- TABLE 63 Russia Bioprocess Validation Market by Testing Type, 2025 - 2032, USD Million
- TABLE 64 Spain Bioprocess Validation Market, 2021 - 2024, USD Million
- TABLE 65 Spain Bioprocess Validation Market, 2025 - 2032, USD Million
- TABLE 66 Spain Bioprocess Validation Market by Mode, 2021 - 2024, USD Million
- TABLE 67 Spain Bioprocess Validation Market by Mode, 2025 - 2032, USD Million
- TABLE 68 Spain Bioprocess Validation Market by Stage, 2021 - 2024, USD Million
- TABLE 69 Spain Bioprocess Validation Market by Stage, 2025 - 2032, USD Million
- TABLE 70 Spain Bioprocess Validation Market by Testing Type, 2021 - 2024, USD Million
- TABLE 71 Spain Bioprocess Validation Market by Testing Type, 2025 - 2032, USD Million
- TABLE 72 Italy Bioprocess Validation Market, 2021 - 2024, USD Million
- TABLE 73 Italy Bioprocess Validation Market, 2025 - 2032, USD Million
- TABLE 74 Italy Bioprocess Validation Market by Mode, 2021 - 2024, USD Million
- TABLE 75 Italy Bioprocess Validation Market by Mode, 2025 - 2032, USD Million
- TABLE 76 Italy Bioprocess Validation Market by Stage, 2021 - 2024, USD Million
- TABLE 77 Italy Bioprocess Validation Market by Stage, 2025 - 2032, USD Million
- TABLE 78 Italy Bioprocess Validation Market by Testing Type, 2021 - 2024, USD Million
- TABLE 79 Italy Bioprocess Validation Market by Testing Type, 2025 - 2032, USD Million
- TABLE 80 Rest of Europe Bioprocess Validation Market, 2021 - 2024, USD Million
- TABLE 81 Rest of Europe Bioprocess Validation Market, 2025 - 2032, USD Million
- TABLE 82 Rest of Europe Bioprocess Validation Market by Mode, 2021 - 2024, USD Million
- TABLE 83 Rest of Europe Bioprocess Validation Market by Mode, 2025 - 2032, USD Million
- TABLE 84 Rest of Europe Bioprocess Validation Market by Stage, 2021 - 2024, USD Million
- TABLE 85 Rest of Europe Bioprocess Validation Market by Stage, 2025 - 2032, USD Million
- TABLE 86 Rest of Europe Bioprocess Validation Market by Testing Type, 2021 - 2024, USD Million
- TABLE 87 Rest of Europe Bioprocess Validation Market by Testing Type, 2025 - 2032, USD Million
- TABLE 88 key Information - Merck KGaA
- TABLE 89 Key Information - Thermo Fisher Scientific, Inc.
- TABLE 90 Key Information - SGS S.A.
- TABLE 91 Key Information - Eurofins Scientific SE
- TABLE 92 Key Information - Eurofins Scientific SE
- TABLE 93 key information - Charles River Laboratories International, Inc.
- TABLE 94 Key Information -Lonza Group Ltd.
- TABLE 95 Key Information - WuXi AppTec Co., Ltd.
- TABLE 96 Key Information - Danaher Corporation
- TABLE 97 Key Information - Cobetter filtration equipment co., ltd.
LIST OF FIGURES
- FIG 1 Methodology for the research
- FIG 2 Europe Bioprocess Validation Market, 2021 - 2032, USD Million
- FIG 3 Key Factors Impacting Europe Bioprocess Validation Market
- FIG 4 Value Chain Analysis of Bioprocess Validation Market
- FIG 5 Product Life Cycle - Bioprocess Validation Market
- FIG 6 Market Consolidation - Bioprocess Validation Market
- FIG 7 Key Customer Criteria - Bioprocess Validation Market
- FIG 8 Market Share Analysis, 2024
- FIG 9 Porter's Five Forces Analysis - Bioprocess Validation Market
- FIG 10 Europe Bioprocess Validation Market share by Mode, 2024
- FIG 11 Europe Bioprocess Validation Market share by Mode, 2032
- FIG 12 Europe Bioprocess Validation Market by Mode, 2021 - 2032, USD Million
- FIG 13 Europe Bioprocess Validation Market share by Stage, 2024
- FIG 14 Europe Bioprocess Validation Market share by Stage, 2032
- FIG 15 Europe Bioprocess Validation Market by Stage, 2021 - 2032, USD Million
- FIG 16 Europe Bioprocess Validation Market share by Testing Type, 2024
- FIG 17 Europe Bioprocess Validation Market share by Testing Type, 2032
- FIG 18 Europe Bioprocess Validation Market by Testing Type, 2021 - 2032, USD Million
- FIG 19 Europe Bioprocess Validation Market share by Country, 2024
- FIG 20 Europe Bioprocess Validation Market share by Country, 2032
- FIG 21 Europe Bioprocess Validation Market by Country, 2021 - 2032, USD Million
- FIG 22 Swot Analysis: Merck KGaA
- FIG 23 Swot Analysis: hermo Fisher Scientific, Inc.
- FIG 24 Swot Analysis: SGS S.A.
- FIG 25 SWOT Analysis: Eurofins Scientific SE
- FIG 26 Recent strategies and developments: Sartorius AG
- FIG 27 SWOT Analysis: Sartorius AG
- FIG 28 Swot Analysis: Charles River Laboratories International, Inc.
- FIG 29 Swot Analysis: Lonza Group Ltd.
- FIG 30 SWOT Analysis: Danaher Corporation
