The North America Bioprocess Validation Market would witness market growth of 7.2% CAGR during the forecast period (2022-2028).
A process validation is the analysis of data gathered throughout the manufacturing and design of a product to confirm that the process can reliably output products of preset standards. Various regulatory authorities have published guidelines relating to process validation. Process validation ensures that different inputs lead to high-quality and consistent outputs.
Process validation is an ongoing procedure that must be frequently adapted as manufacturing feedback is attained. End-to-end validation processes are necessary for determining product quality because the finished-product inspection cannot always determine it. Process validation can be classified into three steps: process design, process qualification, and continued process verification.
The federal government of Canada provided $126 million to the National Research Council of Canada to build a now-completed Biologics Manufacturing center in Montreal. The government of Canada also partnered with the University of Saskatchewan’s vaccine and infectious Disease Organization, providing them with a fund of $105.2 million to aid their vaccine and biomanufacturing capacity. With these investments, the government is rebuilding the Canadian ecosystem. That is why, the budget for 2021 doubled the progress made and provided $2.2 billion for implementing the Biomanufacturing and Life Science Strategy.
The US market dominated the North America Bioprocess Validation Market by Country in 2021, and would continue to be a dominant market till 2028; thereby, achieving a market value of $165.7 Million by 2028. The Canada market is poised to grow at a CAGR of 9.6% during (2022 - 2028). Additionally, The Mexico market would witness a CAGR of 8.7% 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 U.S., Mexico, Canada, and Rest of North America.
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.
A process validation is the analysis of data gathered throughout the manufacturing and design of a product to confirm that the process can reliably output products of preset standards. Various regulatory authorities have published guidelines relating to process validation. Process validation ensures that different inputs lead to high-quality and consistent outputs.
Process validation is an ongoing procedure that must be frequently adapted as manufacturing feedback is attained. End-to-end validation processes are necessary for determining product quality because the finished-product inspection cannot always determine it. Process validation can be classified into three steps: process design, process qualification, and continued process verification.
The federal government of Canada provided $126 million to the National Research Council of Canada to build a now-completed Biologics Manufacturing center in Montreal. The government of Canada also partnered with the University of Saskatchewan’s vaccine and infectious Disease Organization, providing them with a fund of $105.2 million to aid their vaccine and biomanufacturing capacity. With these investments, the government is rebuilding the Canadian ecosystem. That is why, the budget for 2021 doubled the progress made and provided $2.2 billion for implementing the Biomanufacturing and Life Science Strategy.
The US market dominated the North America Bioprocess Validation Market by Country in 2021, and would continue to be a dominant market till 2028; thereby, achieving a market value of $165.7 Million by 2028. The Canada market is poised to grow at a CAGR of 9.6% during (2022 - 2028). Additionally, The Mexico market would witness a CAGR of 8.7% 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 U.S., Mexico, Canada, and Rest of North America.
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
- US
- Canada
- Mexico
- Rest of North America
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
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- The highest number of market tables and figures
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Table of Contents
Chapter 1. Market Scope & Methodology1.1 Market Definition
1.2 Objectives
1.3 Market Scope
1.4 Segmentation
1.4.1 North America Bioprocess Validation Market, by Stage
1.4.2 North America Bioprocess Validation Market, by Mode
1.4.3 North America Bioprocess Validation Market, by Testing Type
1.4.4 North America 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. North America Bioprocess Validation Market by Stage
4.1 North America Continued Process Verification Market by Country
4.2 North America Process Qualification Market by Country
4.3 North America Process Design Market by Country
Chapter 5. North America Bioprocess Validation Market by Mode
5.1 North America In House Market by Country
5.2 North America Outsourced Market by Country
Chapter 6. North America Bioprocess Validation Market by Testing Type
6.1 North America Bioprocess Residuals Testing Market by Country
6.2 North America Extractables & Leachables Testing Market by Country
6.3 North America Viral Clearance Testing Market by Country
6.4 North America Filtration & Fermentation Systems Testing Market by Country
6.5 North America Others Market by Country
Chapter 7. North America Bioprocess Validation Market by Country
7.1 US Bioprocess Validation Market
7.1.1 US Bioprocess Validation Market by Stage
7.1.2 US Bioprocess Validation Market by Mode
7.1.3 US Bioprocess Validation Market by Testing Type
7.2 Canada Bioprocess Validation Market
7.2.1 Canada Bioprocess Validation Market by Stage
7.2.2 Canada Bioprocess Validation Market by Mode
7.2.3 Canada Bioprocess Validation Market by Testing Type
7.3 Mexico Bioprocess Validation Market
7.3.1 Mexico Bioprocess Validation Market by Stage
7.3.2 Mexico Bioprocess Validation Market by Mode
7.3.3 Mexico Bioprocess Validation Market by Testing Type
7.4 Rest of North America Bioprocess Validation Market
7.4.1 Rest of North America Bioprocess Validation Market by Stage
7.4.2 Rest of North America Bioprocess Validation Market by Mode
7.4.3 Rest of North America 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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