Process design is the first of the three stages of process validation. In the process design stage, the data from the development phase are gathered and analyzed to define the commercial manufacturing process. By understanding the retail process, a framework for quality specification can be established and utilized as the foundation of a control strategy.
Data from the development phase is collected and analyzed to understand end-to-end system processes. This data is then used for benchmark establishment for production and quality control. In the process qualification stage, the process design is assessed to conclude if the process can meet the determined manufacturing.
All production processes and manufacturing equipment in this stage are proofed to confirm quality & output capabilities. Critical quality attributes are evaluated, while essential parameters of the process are considered to assure the product's quality. Once the process qualification stage has been accomplished, production can be initiated.
UK researchers have played an essential role in scientific endeavors and breakthroughs globally. For instance, the Human genome project, with the UK’s Wellcome Sangar Institute leading nearly a third of the effort. The UK has also taught on many ground-breaking world-first research efforts, like the formation of the UK Biobank, the National Institute for Health Research, and the 100,000 genomes project. Building on these capabilities, the nation has developed a core biopharma industry with EUR 36.7 billion annual turnovers and a service and supply chain industry worth EUR 18.4 billion in 2019.
The Germany market dominated the Europe Bioprocess Validation Market by Country in 2021, and would continue to be a dominant market till 2028; thereby, achieving a market value of $42.1 Million by 2028. The UK market is anticipated to grow at a CAGR of 6.9% during (2022 - 2028). Additionally, The France market would exhibit a CAGR of 8.6% during (2022 - 2028).
Based on Stage, the market is segmented into Continued Process Verification, Process Qualification, and Process Design. Based on Mode, the market is segmented into In House and Outsourced. Based on Testing Type, the market is segmented into Bioprocess Residuals Testing, Extractables & Leachables Testing, Viral Clearance Testing, Filtration & Fermentation Systems Testing, and Others. Based on countries, the market is segmented into Germany, UK, France, Russia, Spain, Italy, and Rest of Europe.
The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Thermo Fisher Scientific, Inc., Eurofins Scientific SE, Sartorius AG, Merck KGaA, Lonza Group AG, Danaher Corporation, Charles River Laboratories International, Inc., SGS S.A., Labcorp Corporation, and Cobetter Filtration equipment Co., Ltd.
Scope of the Study
Market Segments Covered in the Report:
By Stage
- Continued Process Verification
- Process Qualification
- Process Design
By Mode
- In House
- Outsourced
By Testing Type
- Bioprocess Residuals Testing
- Extractables & Leachables Testing
- Viral Clearance Testing
- Filtration & Fermentation Systems Testing
- Others
By Country
- Germany
- UK
- France
- Russia
- Spain
- Italy
- Rest of Europe
Key Market Players
List of Companies Profiled in the Report:
- Thermo Fisher Scientific, Inc
- Eurofins Scientific SE
- Sartorius AG
- Merck KGaA
- Lonza Group AG
- Danaher Corporation
- Charles River Laboratories International, Inc
- SGS S.A
- Labcorp Corporation
- Cobetter Filtration equipment Co., Ltd
Unique Offerings
- Exhaustive coverage
- The highest number of market tables and figures
- Subscription-based model available
- Guaranteed best price
- Assured post sales research support with 10% customization free
Table of Contents
Chapter 1. Market Scope & Methodology1.1 Market Definition
1.2 Objectives
1.3 Market Scope
1.4 Segmentation
1.4.1 Europe Bioprocess Validation Market, by Stage
1.4.2 Europe Bioprocess Validation Market, by Mode
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 Overview
2.1 Introduction
2.1.1 Overview
2.1.1.1 Market Composition & Scenario
2.2 Key Factors Impacting the Market
2.2.1 Market Drivers
2.2.2 Market Restraints
Chapter 3. Strategies Deployed in Bioprocess Validation Market
Chapter 4. Europe Bioprocess Validation Market by Stage
4.1 Europe Continued Process Verification Market by Country
4.2 Europe Process Qualification Market by Country
4.3 Europe Process Design Market by Country
Chapter 5. Europe Bioprocess Validation Market by Mode
5.1 Europe In House Market by Country
5.2 Europe Outsourced Market by Country
Chapter 6. Europe Bioprocess Validation Market by Testing Type
6.1 Europe Bioprocess Residuals Testing Market by Country
6.2 Europe Extractables & Leachables Testing Market by Country
6.3 Europe Viral Clearance Testing Market by Country
6.4 Europe Filtration & Fermentation Systems Testing Market by Country
6.5 Europe Others Market by Country
Chapter 7. Europe Bioprocess Validation Market by Country
7.1 Germany Bioprocess Validation Market
7.1.1 Germany Bioprocess Validation Market by Stage
7.1.2 Germany Bioprocess Validation Market by Mode
7.1.3 Germany Bioprocess Validation Market by Testing Type
7.2 UK Bioprocess Validation Market
7.2.1 UK Bioprocess Validation Market by Stage
7.2.2 UK Bioprocess Validation Market by Mode
7.2.3 UK Bioprocess Validation Market by Testing Type
7.3 France Bioprocess Validation Market
7.3.1 France Bioprocess Validation Market by Stage
7.3.2 France Bioprocess Validation Market by Mode
7.3.3 France Bioprocess Validation Market by Testing Type
7.4 Russia Bioprocess Validation Market
7.4.1 Russia Bioprocess Validation Market by Stage
7.4.2 Russia Bioprocess Validation Market by Mode
7.4.3 Russia Bioprocess Validation Market by Testing Type
7.5 Spain Bioprocess Validation Market
7.5.1 Spain Bioprocess Validation Market by Stage
7.5.2 Spain Bioprocess Validation Market by Mode
7.5.3 Spain Bioprocess Validation Market by Testing Type
7.6 Italy Bioprocess Validation Market
7.6.1 Italy Bioprocess Validation Market by Stage
7.6.2 Italy Bioprocess Validation Market by Mode
7.6.3 Italy Bioprocess Validation Market by Testing Type
7.7 Rest of Europe Bioprocess Validation Market
7.7.1 Rest of Europe Bioprocess Validation Market by Stage
7.7.2 Rest of Europe Bioprocess Validation Market by Mode
7.7.3 Rest of Europe Bioprocess Validation Market by Testing Type
Chapter 8. Company Profiles
8.1 Thermo Fisher Scientific, Inc.
8.1.1 Company Overview
8.1.2 Financial Analysis
8.1.3 Segmental and Regional Analysis
8.1.4 Research & Development Expense
8.1.5 Recent strategies and developments:
8.1.5.1 Geographical Expansions:
8.1.6 SWOT Analysis
8.2 Eurofins Scientific SE
8.2.1 Company Overview
8.2.2 Financial Analysis
8.2.3 Regional Analysis
8.2.4 Recent strategies and developments:
8.2.4.1 Partnerships, Collaborations, and Agreements:
8.2.4.2 Acquisition and Mergers:
8.3 Sartorius AG
8.3.1 Company Overview
8.3.2 Financial Analysis
8.3.3 Segmental and Regional Analysis
8.3.4 Research & Development Expenses
8.3.5 Recent strategies and developments:
8.3.5.1 Partnerships, Collaborations, and Agreements:
8.3.5.2 Acquisition and Mergers:
8.4 Merck KGaA
8.4.1 Company Overview
8.4.2 Financial Analysis
8.4.3 Segmental and Regional Analysis
8.4.4 Research & Development Expense
8.4.5 Recent strategies and developments:
8.4.5.1 Partnerships, Collaborations, and Agreements:
8.4.5.2 Product Launches and Product Expansions:
8.5 Lonza Group AG
8.5.1 Company Overview
8.5.2 Financial Analysis
8.5.3 Segmental and Regional Analysis
8.5.4 Research & Development Expenses
8.5.5 Recent strategies and developments:
8.5.5.1 Partnerships, Collaborations, and Agreements:
8.6 Danaher Corporation
8.6.1 Company Overview
8.6.2 Financial Analysis
8.6.3 Segmental and Regional Analysis
8.6.4 Research & Development Expense
8.7 Charles River Laboratories International, Inc.
8.7.1 Company Overview
8.7.2 Financial Analysis
8.7.3 Segmental and Regional Analysis
8.8 SGS S.A.
8.8.1 Company Overview
8.8.2 Financial Analysis
8.8.3 Segmental and Regional Analysis
8.9 Labcorp Corporation
8.9.1 Company Overview
8.9.2 Financial Analysis
8.9.3 Segmental and Regional Analysis
8.10. Cobetter Filtration equipment Co., Ltd.
8.10.1 Company Overview
Companies Mentioned
- Thermo Fisher Scientific, Inc.
- Eurofins Scientific SE
- Sartorius AG
- Merck KGaA
- Lonza Group AG
- Danaher Corporation
- Charles River Laboratories International, Inc.
- SGS S.A.
- Labcorp Corporation
- Cobetter Filtration equipment Co., Ltd.
Methodology
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