On 2025-3-13 Global Info Research released【Global Biologics Regulatory Affairs Outsourcing Market 2025 by Manufacturers, Regions, Type and Application, Forecast to 2031】. This report includes an overview of the development of the Biologics Regulatory Affairs Outsourcing industry chain, the market status of Consumer Electronics (Nickel-Zinc Ferrite Core, Mn-Zn Ferrite Core), Household Appliances (Nickel-Zinc Ferrite Core, Mn-Zn Ferrite Core), and key enterprises in developed and developing market, and analysed the cutting-edge technology, patent, hot applications and market trends of Biologics Regulatory Affairs Outsourcing.
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https://www.globalinforesearch.com/reports/2479898/biologics-regulatory-affairs-outsourcing
According to our (Global Info Research) latest study, the global Biologics Regulatory Affairs Outsourcing market size was valued at US$ 2082 million in 2024 and is forecast to a readjusted size of USD 3968 million by 2031 with a CAGR of 8.8% during review period.
Market segment by Type：Regulatory Consulting、Legal Representation、Regulatory Writing & Publishing、Product Registration、Regulatory Submissions、Regulatory Operations、Others
Market segment by Application：Monoclonal Antibodies (mAbs)、Recombinant Proteins、Vaccines、Cell & Gene Therapies、Biosimilars、Others
Major players covered： Lonza AG、Wuxi AppTec Inc.、Thermo Fisher Scientific Inc.、Eurofins Scientific SE、Freyr solutions、Catalent Inc.、Piramal Group、AGC Biologics、ICON Plc.、Charles River Laboratories International, Inc.、Labcorp、Parexel International、Medpace Holdings, Inc.、IQVIA、Syneos Health、SGS SA (SGS)
Table of Contents
1 Market Overview
1.1 Product Overview and Scope
1.2 Market Estimation Caveats and Base Year
1.3 Classification of Biologics Regulatory Affairs Outsourcing by Type
1.3.1 Overview: Global Biologics Regulatory Affairs Outsourcing Market Size by Type: 2020 Versus 2024 Versus 2031
1.3.2 Global Biologics Regulatory Affairs Outsourcing Consumption Value Market Share by Type in 2024
1.3.3 Regulatory Consulting
1.3.4 Legal Representation
1.3.5 Regulatory Writing & Publishing
1.3.6 Product Registration
1.3.7 Regulatory Submissions
1.3.8 Regulatory Operations
1.3.9 Others
1.4 Global Biologics Regulatory Affairs Outsourcing Market by Application
1.4.1 Overview: Global Biologics Regulatory Affairs Outsourcing Market Size by Application: 2020 Versus 2024 Versus 2031
1.4.2 Monoclonal Antibodies (mAbs)
1.4.3 Recombinant Proteins
1.4.4 Vaccines
1.4.5 Cell & Gene Therapies
1.4.6 Biosimilars
1.4.7 Others
1.5 Global Biologics Regulatory Affairs Outsourcing Market Size & Forecast
1.6 Global Biologics Regulatory Affairs Outsourcing Market Size and Forecast by Region
1.6.1 Global Biologics Regulatory Affairs Outsourcing Market Size by Region: 2020 VS 2024 VS 2031
1.6.2 Global Biologics Regulatory Affairs Outsourcing Market Size by Region, (2020-2031)
1.6.3 North America Biologics Regulatory Affairs Outsourcing Market Size and Prospect (2020-2031)
1.6.4 Europe Biologics Regulatory Affairs Outsourcing Market Size and Prospect (2020-2031)
1.6.5 Asia-Pacific Biologics Regulatory Affairs Outsourcing Market Size and Prospect (2020-2031)
1.6.6 South America Biologics Regulatory Affairs Outsourcing Market Size and Prospect (2020-2031)
1.6.7 Middle East & Africa Biologics Regulatory Affairs Outsourcing Market Size and Prospect (2020-2031)
2 Company Profiles
2.1 Lonza AG
2.1.1 Lonza AG Details
2.1.2 Lonza AG Major Business
2.1.3 Lonza AG Biologics Regulatory Affairs Outsourcing Product and Solutions
2.1.4 Lonza AG Biologics Regulatory Affairs Outsourcing Revenue, Gross Margin and Market Share (2020-2025)
2.1.5 Lonza AG Recent Developments and Future Plans
2.2 Wuxi AppTec Inc.
2.2.1 Wuxi AppTec Inc. Details
2.2.2 Wuxi AppTec Inc. Major Business
2.2.3 Wuxi AppTec Inc. Biologics Regulatory Affairs Outsourcing Product and Solutions
2.2.4 Wuxi AppTec Inc. Biologics Regulatory Affairs Outsourcing Revenue, Gross Margin and Market Share (2020-2025)
2.2.5 Wuxi AppTec Inc. Recent Developments and Future Plans
2.3 Thermo Fisher Scientific Inc.
2.3.1 Thermo Fisher Scientific Inc. Details
2.3.2 Thermo Fisher Scientific Inc. Major Business
2.3.3 Thermo Fisher Scientific Inc. Biologics Regulatory Affairs Outsourcing Product and Solutions
2.3.4 Thermo Fisher Scientific Inc. Biologics Regulatory Affairs Outsourcing Revenue, Gross Margin and Market Share (2020-2025)
2.3.5 Thermo Fisher Scientific Inc. Recent Developments and Future Plans
2.4 Eurofins Scientific SE
2.4.1 Eurofins Scientific SE Details
2.4.2 Eurofins Scientific SE Major Business
2.4.3 Eurofins Scientific SE Biologics Regulatory Affairs Outsourcing Product and Solutions
2.4.4 Eurofins Scientific SE Biologics Regulatory Affairs Outsourcing Revenue, Gross Margin and Market Share (2020-2025)
2.4.5 Eurofins Scientific SE Recent Developments and Future Plans
2.5 Freyr solutions
2.5.1 Freyr solutions Details
2.5.2 Freyr solutions Major Business
2.5.3 Freyr solutions Biologics Regulatory Affairs Outsourcing Product and Solutions
2.5.4 Freyr solutions Biologics Regulatory Affairs Outsourcing Revenue, Gross Margin and Market Share (2020-2025)
2.5.5 Freyr solutions Recent Developments and Future Plans
2.6 Catalent Inc.
2.6.1 Catalent Inc. Details
2.6.2 Catalent Inc. Major Business
2.6.3 Catalent Inc. Biologics Regulatory Affairs Outsourcing Product and Solutions
2.6.4 Catalent Inc. Biologics Regulatory Affairs Outsourcing Revenue, Gross Margin and Market Share (2020-2025)
2.6.5 Catalent Inc. Recent Developments and Future Plans
2.7 Piramal Group
2.7.1 Piramal Group Details
2.7.2 Piramal Group Major Business
2.7.3 Piramal Group Biologics Regulatory Affairs Outsourcing Product and Solutions
2.7.4 Piramal Group Biologics Regulatory Affairs Outsourcing Revenue, Gross Margin and Market Share (2020-2025)
2.7.5 Piramal Group Recent Developments and Future Plans
2.8 AGC Biologics
2.8.1 AGC Biologics Details
2.8.2 AGC Biologics Major Business
2.8.3 AGC Biologics Biologics Regulatory Affairs Outsourcing Product and Solutions
2.8.4 AGC Biologics Biologics Regulatory Affairs Outsourcing Revenue, Gross Margin and Market Share (2020-2025)
2.8.5 AGC Biologics Recent Developments and Future Plans
2.9 ICON Plc.
2.9.1 ICON Plc. Details
2.9.2 ICON Plc. Major Business
2.9.3 ICON Plc. Biologics Regulatory Affairs Outsourcing Product and Solutions
2.9.4 ICON Plc. Biologics Regulatory Affairs Outsourcing Revenue, Gross Margin and Market Share (2020-2025)
2.9.5 ICON Plc. Recent Developments and Future Plans
2.10 Charles River Laboratories International, Inc.
2.10.1 Charles River Laboratories International, Inc. Details
2.10.2 Charles River Laboratories International, Inc. Major Business
2.10.3 Charles River Laboratories International, Inc. Biologics Regulatory Affairs Outsourcing Product and Solutions
2.10.4 Charles River Laboratories International, Inc. Biologics Regulatory Affairs Outsourcing Revenue, Gross Margin and Market Share (2020-2025)
2.10.5 Charles River Laboratories International, Inc. Recent Developments and Future Plans
2.11 Labcorp
2.11.1 Labcorp Details
2.11.2 Labcorp Major Business
2.11.3 Labcorp Biologics Regulatory Affairs Outsourcing Product and Solutions
2.11.4 Labcorp Biologics Regulatory Affairs Outsourcing Revenue, Gross Margin and Market Share (2020-2025)
2.11.5 Labcorp Recent Developments and Future Plans
2.12 Parexel International
2.12.1 Parexel International Details
2.12.2 Parexel International Major Business
2.12.3 Parexel International Biologics Regulatory Affairs Outsourcing Product and Solutions
2.12.4 Parexel International Biologics Regulatory Affairs Outsourcing Revenue, Gross Margin and Market Share (2020-2025)
2.12.5 Parexel International Recent Developments and Future Plans
2.13 Medpace Holdings, Inc.
2.13.1 Medpace Holdings, Inc. Details
2.13.2 Medpace Holdings, Inc. Major Business
2.13.3 Medpace Holdings, Inc. Biologics Regulatory Affairs Outsourcing Product and Solutions
2.13.4 Medpace Holdings, Inc. Biologics Regulatory Affairs Outsourcing Revenue, Gross Margin and Market Share (2020-2025)
2.13.5 Medpace Holdings, Inc. Recent Developments and Future Plans
2.14 IQVIA
2.14.1 IQVIA Details
2.14.2 IQVIA Major Business
2.14.3 IQVIA Biologics Regulatory Affairs Outsourcing Product and Solutions
2.14.4 IQVIA Biologics Regulatory Affairs Outsourcing Revenue, Gross Margin and Market Share (2020-2025)
2.14.5 IQVIA Recent Developments and Future Plans
2.15 Syneos Health
2.15.1 Syneos Health Details
2.15.2 Syneos Health Major Business
2.15.3 Syneos Health Biologics Regulatory Affairs Outsourcing Product and Solutions
2.15.4 Syneos Health Biologics Regulatory Affairs Outsourcing Revenue, Gross Margin and Market Share (2020-2025)
2.15.5 Syneos Health Recent Developments and Future Plans
2.16 SGS SA (SGS)
2.16.1 SGS SA (SGS) Details
2.16.2 SGS SA (SGS) Major Business
2.16.3 SGS SA (SGS) Biologics Regulatory Affairs Outsourcing Product and Solutions
2.16.4 SGS SA (SGS) Biologics Regulatory Affairs Outsourcing Revenue, Gross Margin and Market Share (2020-2025)
2.16.5 SGS SA (SGS) Recent Developments and Future Plans
3 Market Competition, by Players
3.1 Global Biologics Regulatory Affairs Outsourcing Revenue and Share by Players (2020-2025)
3.2 Market Share Analysis (2024)
3.2.1 Market Share of Biologics Regulatory Affairs Outsourcing by Company Revenue
3.2.2 Top 3 Biologics Regulatory Affairs Outsourcing Players Market Share in 2024
3.2.3 Top 6 Biologics Regulatory Affairs Outsourcing Players Market Share in 2024
3.3 Biologics Regulatory Affairs Outsourcing Market: Overall Company Footprint Analysis
3.3.1 Biologics Regulatory Affairs Outsourcing Market: Region Footprint
3.3.2 Biologics Regulatory Affairs Outsourcing Market: Company Product Type Footprint
3.3.3 Biologics Regulatory Affairs Outsourcing Market: Company Product Application Footprint
3.4 New Market Entrants and Barriers to Market Entry
3.5 Mergers, Acquisition, Agreements, and Collaborations
4 Market Size Segment by Type
4.1 Global Biologics Regulatory Affairs Outsourcing Consumption Value and Market Share by Type (2020-2025)
4.2 Global Biologics Regulatory Affairs Outsourcing Market Forecast by Type (2026-2031)
5 Market Size Segment by Application
5.1 Global Biologics Regulatory Affairs Outsourcing Consumption Value Market Share by Application (2020-2025)
5.2 Global Biologics Regulatory Affairs Outsourcing Market Forecast by Application (2026-2031)
6 North America
6.1 North America Biologics Regulatory Affairs Outsourcing Consumption Value by Type (2020-2031)
6.2 North America Biologics Regulatory Affairs Outsourcing Market Size by Application (2020-2031)
6.3 North America Biologics Regulatory Affairs Outsourcing Market Size by Country
6.3.1 North America Biologics Regulatory Affairs Outsourcing Consumption Value by Country (2020-2031)
6.3.2 United States Biologics Regulatory Affairs Outsourcing Market Size and Forecast (2020-2031)
6.3.3 Canada Biologics Regulatory Affairs Outsourcing Market Size and Forecast (2020-2031)
6.3.4 Mexico Biologics Regulatory Affairs Outsourcing Market Size and Forecast (2020-2031)
7 Europe
7.1 Europe Biologics Regulatory Affairs Outsourcing Consumption Value by Type (2020-2031)
7.2 Europe Biologics Regulatory Affairs Outsourcing Consumption Value by Application (2020-2031)
7.3 Europe Biologics Regulatory Affairs Outsourcing Market Size by Country
7.3.1 Europe Biologics Regulatory Affairs Outsourcing Consumption Value by Country (2020-2031)
7.3.2 Germany Biologics Regulatory Affairs Outsourcing Market Size and Forecast (2020-2031)
7.3.3 France Biologics Regulatory Affairs Outsourcing Market Size and Forecast (2020-2031)
7.3.4 United Kingdom Biologics Regulatory Affairs Outsourcing Market Size and Forecast (2020-2031)
7.3.5 Russia Biologics Regulatory Affairs Outsourcing Market Size and Forecast (2020-2031)
7.3.6 Italy Biologics Regulatory Affairs Outsourcing Market Size and Forecast (2020-2031)
8 Asia-Pacific
8.1 Asia-Pacific Biologics Regulatory Affairs Outsourcing Consumption Value by Type (2020-2031)
8.2 Asia-Pacific Biologics Regulatory Affairs Outsourcing Consumption Value by Application (2020-2031)
8.3 Asia-Pacific Biologics Regulatory Affairs Outsourcing Market Size by Region
8.3.1 Asia-Pacific Biologics Regulatory Affairs Outsourcing Consumption Value by Region (2020-2031)
8.3.2 China Biologics Regulatory Affairs Outsourcing Market Size and Forecast (2020-2031)
8.3.3 Japan Biologics Regulatory Affairs Outsourcing Market Size and Forecast (2020-2031)
8.3.4 South Korea Biologics Regulatory Affairs Outsourcing Market Size and Forecast (2020-2031)
8.3.5 India Biologics Regulatory Affairs Outsourcing Market Size and Forecast (2020-2031)
8.3.6 Southeast Asia Biologics Regulatory Affairs Outsourcing Market Size and Forecast (2020-2031)
8.3.7 Australia Biologics Regulatory Affairs Outsourcing Market Size and Forecast (2020-2031)
9 South America
9.1 South America Biologics Regulatory Affairs Outsourcing Consumption Value by Type (2020-2031)
9.2 South America Biologics Regulatory Affairs Outsourcing Consumption Value by Application (2020-2031)
9.3 South America Biologics Regulatory Affairs Outsourcing Market Size by Country
9.3.1 South America Biologics Regulatory Affairs Outsourcing Consumption Value by Country (2020-2031)
9.3.2 Brazil Biologics Regulatory Affairs Outsourcing Market Size and Forecast (2020-2031)
9.3.3 Argentina Biologics Regulatory Affairs Outsourcing Market Size and Forecast (2020-2031)
10 Middle East & Africa
10.1 Middle East & Africa Biologics Regulatory Affairs Outsourcing Consumption Value by Type (2020-2031)
10.2 Middle East & Africa Biologics Regulatory Affairs Outsourcing Consumption Value by Application (2020-2031)
10.3 Middle East & Africa Biologics Regulatory Affairs Outsourcing Market Size by Country
10.3.1 Middle East & Africa Biologics Regulatory Affairs Outsourcing Consumption Value by Country (2020-2031)
10.3.2 Turkey Biologics Regulatory Affairs Outsourcing Market Size and Forecast (2020-2031)
10.3.3 Saudi Arabia Biologics Regulatory Affairs Outsourcing Market Size and Forecast (2020-2031)
10.3.4 UAE Biologics Regulatory Affairs Outsourcing Market Size and Forecast (2020-2031)
11 Market Dynamics
11.1 Biologics Regulatory Affairs Outsourcing Market Drivers
11.2 Biologics Regulatory Affairs Outsourcing Market Restraints
11.3 Biologics Regulatory Affairs Outsourcing Trends Analysis
11.4 Porters Five Forces Analysis
11.4.1 Threat of New Entrants
11.4.2 Bargaining Power of Suppliers
11.4.3 Bargaining Power of Buyers
11.4.4 Threat of Substitutes
11.4.5 Competitive Rivalry
12 Industry Chain Analysis
12.1 Biologics Regulatory Affairs Outsourcing Industry Chain
12.2 Biologics Regulatory Affairs Outsourcing Upstream Analysis
12.3 Biologics Regulatory Affairs Outsourcing Midstream Analysis
12.4 Biologics Regulatory Affairs Outsourcing Downstream Analysis
13 Research Findings and Conclusion
14 Appendix
14.1 Methodology
14.2 Research Process and Data Source
14.3 Disclaimer
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