Global Regulatory Affairs Outsourcing Market 2024-2028

Global Regulatory Affairs Outsourcing Market 2024-2028


Regulatory Affairs Outsourcing Market 2024-2028

The regulatory affairs outsourcing market is forecasted to grow by USD 4705.8 mn during 2023-2028, accelerating at a CAGR of 12.3% during the forecast period. The report on the regulatory affairs outsourcing market provides a holistic analysis, market size and forecast, trends, growth drivers, and challenges, as well as vendor analysis covering around 25 vendors.

The report offers an up-to-date analysis regarding the current market scenario, the latest trends and drivers, and the overall market environment. The market is driven by growth of pharmaceutical industry, availability of cost-efficient resources in emerging markets, and high regulatory compliance associated with healthcare.

Technavio's regulatory affairs outsourcing market is segmented as below:

By End-user
  • Pharmaceutical
  • Medical devices
  • Biotechnology
By Geographical Landscape
  • Asia
  • North America
  • Europe
  • Rest of World (ROW)
This study identifies the increasing consumption of class i medical devices as one of the prime reasons driving the regulatory affairs outsourcing market growth during the next few years. Also, technologies and processes advancement and increasing merger and acquisition activities will lead to sizable demand in the market.

The report on the regulatory affairs outsourcing market covers the following areas:
  • Regulatory Affairs Outsourcing Market sizing
  • Regulatory Affairs Outsourcing Market forecast
  • Regulatory Affairs Outsourcing Market industry analysis
The robust vendor analysis is designed to help clients improve their market position, and in line with this, this report provides a detailed analysis of several leading regulatory affairs outsourcing market vendors that include APCER Life Sciences Inc., BlueReg Group, Cambridge Regulatory Services, Certara Inc., Charles River Laboratories International Inc., Freyr Software Services, Genpact Ltd., ICON plc, Laboratory Corp. of America Holdings, Medpace Holdings Inc., NDA Group AB, Parexel International Corp., PHARMALEX GMBH, ProPharma Group Holdings LLC, Qvigilance, Real Regulatory Ltd., Thermo Fisher Scientific Inc., WuXi AppTec Co. Ltd., and Zeincro Group. Also, the regulatory affairs outsourcing market analysis report includes information on upcoming trends and challenges that will influence market growth. This is to help companies strategize and leverage all forthcoming growth opportunities.

The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. The report contains a comprehensive market and vendor landscape in addition to an analysis of the key vendors.

The publisher presents a detailed picture of the market by the way of study, synthesis, and summation of data from multiple sources by an analysis of key parameters such as profit, pricing, competition, and promotions. It presents various market facets by identifying the key industry influencers. The data presented is comprehensive, reliable, and a result of extensive primary and secondary research. The market research reports provide a complete competitive landscape and an in-depth vendor selection methodology and analysis using qualitative and quantitative research to forecast accurate market growth.


1 Executive Summary
1.1 Market overview
Executive Summary - Chart on Market Overview
Executive Summary - Data Table on Market Overview
Executive Summary - Chart on Global Market Characteristics
Executive Summary - Chart on Market By Geographical Landscape
Executive Summary - Chart on Market Segmentation by End-user
Executive Summary - Chart on Incremental Growth
Executive Summary - Data Table on Incremental Growth
Executive Summary - Chart on Company Market Positioning
2 Market Landscape
2.1 Market ecosystem
Parent Market
Data Table on - Parent Market
2.2 Market characteristics
Market characteristics analysis
2.3 Value chain analysis
Value Chain Analysis
3 Market Sizing
3.1 Market definition
Offerings of companies included in the market definition
3.2 Market segment analysis
Market segments
3.3 Market size 2023
3.4 Market outlook: Forecast for 2023-2028
Chart on Global - Market size and forecast 2023-2028 ($ million)
Data Table on Global - Market size and forecast 2023-2028 ($ million)
Chart on Global Market: Year-over-year growth 2023-2028 (%)
Data Table on Global Market: Year-over-year growth 2023-2028 (%)
4 Historic Market Size
4.1 Global Regulatory Affairs Outsourcing Market 2018 - 2022
Historic Market Size - Data Table on Global Regulatory Affairs Outsourcing Market 2018 - 2022 ($ million)
4.2 End-user segment analysis 2018 - 2022
Historic Market Size - End-user Segment 2018 - 2022 ($ million)
4.3 Geography segment analysis 2018 - 2022
Historic Market Size - Geography Segment 2018 - 2022 ($ million)
4.4 Country segment analysis 2018 - 2022
Historic Market Size - Country Segment 2018 - 2022 ($ million)
5 Five Forces Analysis
5.1 Five forces summary
Five forces analysis - Comparison between 2023 and 2028
5.2 Bargaining power of buyers
Bargaining power of buyers - Impact of key factors 2023 and 2028
5.3 Bargaining power of suppliers
Bargaining power of suppliers - Impact of key factors in 2023 and 2028
5.4 Threat of new entrants
Threat of new entrants - Impact of key factors in 2023 and 2028
5.5 Threat of substitutes
Threat of substitutes - Impact of key factors in 2023 and 2028
5.6 Threat of rivalry
Threat of rivalry - Impact of key factors in 2023 and 2028
5.7 Market condition
Chart on Market condition - Five forces 2023 and 2028
6 Market Segmentation by End-user
6.1 Market segments
Chart on End-user - Market share 2023-2028 (%)
Data Table on End-user - Market share 2023-2028 (%)
6.2 Comparison by End-user
Chart on Comparison by End-user
Data Table on Comparison by End-user
6.3 Pharmaceutical - Market size and forecast 2023-2028
Chart on Pharmaceutical - Market size and forecast 2023-2028 ($ million)
Data Table on Pharmaceutical - Market size and forecast 2023-2028 ($ million)
Chart on Pharmaceutical - Year-over-year growth 2023-2028 (%)
Data Table on Pharmaceutical - Year-over-year growth 2023-2028 (%)
6.4 Medical devices - Market size and forecast 2023-2028
Chart on Medical devices - Market size and forecast 2023-2028 ($ million)
Data Table on Medical devices - Market size and forecast 2023-2028 ($ million)
Chart on Medical devices - Year-over-year growth 2023-2028 (%)
Data Table on Medical devices - Year-over-year growth 2023-2028 (%)
6.5 Biotechnology - Market size and forecast 2023-2028
Chart on Biotechnology - Market size and forecast 2023-2028 ($ million)
Data Table on Biotechnology - Market size and forecast 2023-2028 ($ million)
Chart on Biotechnology - Year-over-year growth 2023-2028 (%)
Data Table on Biotechnology - Year-over-year growth 2023-2028 (%)
6.6 Market opportunity by End-user
Market opportunity by End-user ($ million)
Data Table on Market opportunity by End-user ($ million)
7 Customer Landscape
7.1 Customer landscape overview
Analysis of price sensitivity, lifecycle, customer purchase basket, adoption rates, and purchase criteria
8 Geographic Landscape
8.1 Geographic segmentation
Chart on Market share By Geographical Landscape 2023-2028 (%)
Data Table on Market share By Geographical Landscape 2023-2028 (%)
8.2 Geographic comparison
Chart on Geographic comparison
Data Table on Geographic comparison
8.3 Asia - Market size and forecast 2023-2028
Chart on Asia - Market size and forecast 2023-2028 ($ million)
Data Table on Asia - Market size and forecast 2023-2028 ($ million)
Chart on Asia - Year-over-year growth 2023-2028 (%)
Data Table on Asia - Year-over-year growth 2023-2028 (%)
8.4 North America - Market size and forecast 2023-2028
Chart on North America - Market size and forecast 2023-2028 ($ million)
Data Table on North America - Market size and forecast 2023-2028 ($ million)
Chart on North America - Year-over-year growth 2023-2028 (%)
Data Table on North America - Year-over-year growth 2023-2028 (%)
8.5 Europe - Market size and forecast 2023-2028
Chart on Europe - Market size and forecast 2023-2028 ($ million)
Data Table on Europe - Market size and forecast 2023-2028 ($ million)
Chart on Europe - Year-over-year growth 2023-2028 (%)
Data Table on Europe - Year-over-year growth 2023-2028 (%)
8.6 Rest of World (ROW) - Market size and forecast 2023-2028
Chart on Rest of World (ROW) - Market size and forecast 2023-2028 ($ million)
Data Table on Rest of World (ROW) - Market size and forecast 2023-2028 ($ million)
Chart on Rest of World (ROW) - Year-over-year growth 2023-2028 (%)
Data Table on Rest of World (ROW) - Year-over-year growth 2023-2028 (%)
8.7 China - Market size and forecast 2023-2028
Chart on China - Market size and forecast 2023-2028 ($ million)
Data Table on China - Market size and forecast 2023-2028 ($ million)
Chart on China - Year-over-year growth 2023-2028 (%)
Data Table on China - Year-over-year growth 2023-2028 (%)
8.8 US - Market size and forecast 2023-2028
Chart on US - Market size and forecast 2023-2028 ($ million)
Data Table on US - Market size and forecast 2023-2028 ($ million)
Chart on US - Year-over-year growth 2023-2028 (%)
Data Table on US - Year-over-year growth 2023-2028 (%)
8.9 Germany - Market size and forecast 2023-2028
Chart on Germany - Market size and forecast 2023-2028 ($ million)
Data Table on Germany - Market size and forecast 2023-2028 ($ million)
Chart on Germany - Year-over-year growth 2023-2028 (%)
Data Table on Germany - Year-over-year growth 2023-2028 (%)
8.10 Japan - Market size and forecast 2023-2028
Chart on Japan - Market size and forecast 2023-2028 ($ million)
Data Table on Japan - Market size and forecast 2023-2028 ($ million)
Chart on Japan - Year-over-year growth 2023-2028 (%)
Data Table on Japan - Year-over-year growth 2023-2028 (%)
8.11 UK - Market size and forecast 2023-2028
Chart on UK - Market size and forecast 2023-2028 ($ million)
Data Table on UK - Market size and forecast 2023-2028 ($ million)
Chart on UK - Year-over-year growth 2023-2028 (%)
Data Table on UK - Year-over-year growth 2023-2028 (%)
8.12 Market opportunity By Geographical Landscape
Market opportunity By Geographical Landscape ($ million)
Data Tables on Market opportunity By Geographical Landscape ($ million)
9 Drivers, Challenges, and Opportunity/Restraints
9.1 Market drivers
9.2 Market challenges
9.3 Impact of drivers and challenges
Impact of drivers and challenges in 2023 and 2028
9.4 Market opportunities/restraints
10 Competitive Landscape
10.1 Overview
10.2 Competitive Landscape
Overview on criticality of inputs and factors of differentiation
10.3 Landscape disruption
Overview on factors of disruption
10.4 Industry risks
Impact of key risks on business
11 Competitive Analysis
11.1 Companies profiled
Companies covered
11.2 Market positioning of companies
Matrix on companies position and classification
11.3 Cambridge Regulatory Services
Cambridge Regulatory Services - Overview
Cambridge Regulatory Services - Product / Service
Cambridge Regulatory Services - Key offerings
11.4 Certara Inc.
Certara Inc. - Overview
Certara Inc. - Product / Service
Certara Inc. - Key offerings
11.5 Charles River Laboratories International Inc.
Charles River Laboratories International Inc. - Overview
Charles River Laboratories International Inc. - Business segments
Charles River Laboratories International Inc. - Key offerings
Charles River Laboratories International Inc. - Segment focus
11.6 Genpact Ltd.
Genpact Ltd. - Overview
Genpact Ltd. - Business segments
Genpact Ltd. - Key news
Genpact Ltd. - Key offerings
Genpact Ltd. - Segment focus
11.7 ICON plc
ICON plc - Overview
ICON plc - Product / Service
ICON plc - Key offerings
11.8 Laboratory Corp. of America Holdings
Laboratory Corp. of America Holdings - Overview
Laboratory Corp. of America Holdings - Business segments
Laboratory Corp. of America Holdings - Key news
Laboratory Corp. of America Holdings - Key offerings
Laboratory Corp. of America Holdings - Segment focus
11.9 Medpace Holdings Inc.
Medpace Holdings Inc. - Overview
Medpace Holdings Inc. - Product / Service
Medpace Holdings Inc. - Key offerings
11.10 ProPharma Group Holdings LLC
ProPharma Group Holdings LLC - Overview
ProPharma Group Holdings LLC - Product / Service
ProPharma Group Holdings LLC - Key news
ProPharma Group Holdings LLC - Key offerings
11.11 Thermo Fisher Scientific Inc.
Thermo Fisher Scientific Inc. - Overview
Thermo Fisher Scientific Inc. - Business segments
Thermo Fisher Scientific Inc. - Key news
Thermo Fisher Scientific Inc. - Key offerings
Thermo Fisher Scientific Inc. - Segment focus
11.12 WuXi AppTec Co. Ltd.
WuXi AppTec Co. Ltd. - Overview
WuXi AppTec Co. Ltd. - Business segments
WuXi AppTec Co. Ltd. - Key offerings
WuXi AppTec Co. Ltd. - Segment focus
12 Appendix
12.1 Scope of the report
12.2 Inclusions and exclusions checklist
Inclusions checklist
Exclusions checklist
12.3 Currency conversion rates for US$
Currency conversion rates for US$
12.4 Research methodology
Research methodology
12.5 Data procurement
Information sources
12.6 Data validation
Data validation
12.7 Validation techniques employed for market sizing
Validation techniques employed for market sizing
12.8 Data synthesis
Data synthesis
12.9 360 degree market analysis
360 degree market analysis
12.10 List of abbreviations
List of abbreviations
Exhibits:
Exhibits1: Executive Summary - Chart on Market Overview
Exhibits2: Executive Summary - Data Table on Market Overview
Exhibits3: Executive Summary - Chart on Global Market Characteristics
Exhibits4: Executive Summary - Chart on Market By Geographical Landscape
Exhibits5: Executive Summary - Chart on Market Segmentation by End-user
Exhibits6: Executive Summary - Chart on Incremental Growth
Exhibits7: Executive Summary - Data Table on Incremental Growth
Exhibits8: Executive Summary - Chart on Company Market Positioning
Exhibits9: Parent Market
Exhibits10: Data Table on - Parent Market
Exhibits11: Market characteristics analysis
Exhibits12: Value Chain Analysis
Exhibits13: Offerings of companies included in the market definition
Exhibits14: Market segments
Exhibits15: Chart on Global - Market size and forecast 2023-2028 ($ million)
Exhibits16: Data Table on Global - Market size and forecast 2023-2028 ($ million)
Exhibits17: Chart on Global Market: Year-over-year growth 2023-2028 (%)
Exhibits18: Data Table on Global Market: Year-over-year growth 2023-2028 (%)
Exhibits19: Historic Market Size - Data Table on Global Regulatory Affairs Outsourcing Market 2018 - 2022 ($ million)
Exhibits20: Historic Market Size - End-user Segment 2018 - 2022 ($ million)
Exhibits21: Historic Market Size - Geography Segment 2018 - 2022 ($ million)
Exhibits22: Historic Market Size - Country Segment 2018 - 2022 ($ million)
Exhibits23: Five forces analysis - Comparison between 2023 and 2028
Exhibits24: Bargaining power of buyers - Impact of key factors 2023 and 2028
Exhibits25: Bargaining power of suppliers - Impact of key factors in 2023 and 2028
Exhibits26: Threat of new entrants - Impact of key factors in 2023 and 2028
Exhibits27: Threat of substitutes - Impact of key factors in 2023 and 2028
Exhibits28: Threat of rivalry - Impact of key factors in 2023 and 2028
Exhibits29: Chart on Market condition - Five forces 2023 and 2028
Exhibits30: Chart on End-user - Market share 2023-2028 (%)
Exhibits31: Data Table on End-user - Market share 2023-2028 (%)
Exhibits32: Chart on Comparison by End-user
Exhibits33: Data Table on Comparison by End-user
Exhibits34: Chart on Pharmaceutical - Market size and forecast 2023-2028 ($ million)
Exhibits35: Data Table on Pharmaceutical - Market size and forecast 2023-2028 ($ million)
Exhibits36: Chart on Pharmaceutical - Year-over-year growth 2023-2028 (%)
Exhibits37: Data Table on Pharmaceutical - Year-over-year growth 2023-2028 (%)
Exhibits38: Chart on Medical devices - Market size and forecast 2023-2028 ($ million)
Exhibits39: Data Table on Medical devices - Market size and forecast 2023-2028 ($ million)
Exhibits40: Chart on Medical devices - Year-over-year growth 2023-2028 (%)
Exhibits41: Data Table on Medical devices - Year-over-year growth 2023-2028 (%)
Exhibits42: Chart on Biotechnology - Market size and forecast 2023-2028 ($ million)
Exhibits43: Data Table on Biotechnology - Market size and forecast 2023-2028 ($ million)
Exhibits44: Chart on Biotechnology - Year-over-year growth 2023-2028 (%)
Exhibits45: Data Table on Biotechnology - Year-over-year growth 2023-2028 (%)
Exhibits46: Market opportunity by End-user ($ million)
Exhibits47: Data Table on Market opportunity by End-user ($ million)
Exhibits48: Analysis of price sensitivity, lifecycle, customer purchase basket, adoption rates, and purchase criteria
Exhibits49: Chart on Market share By Geographical Landscape 2023-2028 (%)
Exhibits50: Data Table on Market share By Geographical Landscape 2023-2028 (%)
Exhibits51: Chart on Geographic comparison
Exhibits52: Data Table on Geographic comparison
Exhibits53: Chart on Asia - Market size and forecast 2023-2028 ($ million)
Exhibits54: Data Table on Asia - Market size and forecast 2023-2028 ($ million)
Exhibits55: Chart on Asia - Year-over-year growth 2023-2028 (%)
Exhibits56: Data Table on Asia - Year-over-year growth 2023-2028 (%)
Exhibits57: Chart on North America - Market size and forecast 2023-2028 ($ million)
Exhibits58: Data Table on North America - Market size and forecast 2023-2028 ($ million)
Exhibits59: Chart on North America - Year-over-year growth 2023-2028 (%)
Exhibits60: Data Table on North America - Year-over-year growth 2023-2028 (%)
Exhibits61: Chart on Europe - Market size and forecast 2023-2028 ($ million)
Exhibits62: Data Table on Europe - Market size and forecast 2023-2028 ($ million)
Exhibits63: Chart on Europe - Year-over-year growth 2023-2028 (%)
Exhibits64: Data Table on Europe - Year-over-year growth 2023-2028 (%)
Exhibits65: Chart on Rest of World (ROW) - Market size and forecast 2023-2028 ($ million)
Exhibits66: Data Table on Rest of World (ROW) - Market size and forecast 2023-2028 ($ million)
Exhibits67: Chart on Rest of World (ROW) - Year-over-year growth 2023-2028 (%)
Exhibits68: Data Table on Rest of World (ROW) - Year-over-year growth 2023-2028 (%)
Exhibits69: Chart on China - Market size and forecast 2023-2028 ($ million)
Exhibits70: Data Table on China - Market size and forecast 2023-2028 ($ million)
Exhibits71: Chart on China - Year-over-year growth 2023-2028 (%)
Exhibits72: Data Table on China - Year-over-year growth 2023-2028 (%)
Exhibits73: Chart on US - Market size and forecast 2023-2028 ($ million)
Exhibits74: Data Table on US - Market size and forecast 2023-2028 ($ million)
Exhibits75: Chart on US - Year-over-year growth 2023-2028 (%)
Exhibits76: Data Table on US - Year-over-year growth 2023-2028 (%)
Exhibits77: Chart on Germany - Market size and forecast 2023-2028 ($ million)
Exhibits78: Data Table on Germany - Market size and forecast 2023-2028 ($ million)
Exhibits79: Chart on Germany - Year-over-year growth 2023-2028 (%)
Exhibits80: Data Table on Germany - Year-over-year growth 2023-2028 (%)
Exhibits81: Chart on Japan - Market size and forecast 2023-2028 ($ million)
Exhibits82: Data Table on Japan - Market size and forecast 2023-2028 ($ million)
Exhibits83: Chart on Japan - Year-over-year growth 2023-2028 (%)
Exhibits84: Data Table on Japan - Year-over-year growth 2023-2028 (%)
Exhibits85: Chart on UK - Market size and forecast 2023-2028 ($ million)
Exhibits86: Data Table on UK - Market size and forecast 2023-2028 ($ million)
Exhibits87: Chart on UK - Year-over-year growth 2023-2028 (%)
Exhibits88: Data Table on UK - Year-over-year growth 2023-2028 (%)
Exhibits89: Market opportunity By Geographical Landscape ($ million)
Exhibits90: Data Tables on Market opportunity By Geographical Landscape ($ million)
Exhibits91: Impact of drivers and challenges in 2023 and 2028
Exhibits92: Overview on criticality of inputs and factors of differentiation
Exhibits93: Overview on factors of disruption
Exhibits94: Impact of key risks on business
Exhibits95: Companies covered
Exhibits96: Matrix on companies position and classification
Exhibits97: Cambridge Regulatory Services - Overview
Exhibits98: Cambridge Regulatory Services - Product / Service
Exhibits99: Cambridge Regulatory Services - Key offerings
Exhibits100: Certara Inc. - Overview
Exhibits101: Certara Inc. - Product / Service
Exhibits102: Certara Inc. - Key offerings
Exhibits103: Charles River Laboratories International Inc. - Overview
Exhibits104: Charles River Laboratories International Inc. - Business segments
Exhibits105: Charles River Laboratories International Inc. - Key offerings
Exhibits106: Charles River Laboratories International Inc. - Segment focus
Exhibits107: Genpact Ltd. - Overview
Exhibits108: Genpact Ltd. - Business segments
Exhibits109: Genpact Ltd. - Key news
Exhibits110: Genpact Ltd. - Key offerings
Exhibits111: Genpact Ltd. - Segment focus
Exhibits112: ICON plc - Overview
Exhibits113: ICON plc - Product / Service
Exhibits114: ICON plc - Key offerings
Exhibits115: Laboratory Corp. of America Holdings - Overview
Exhibits116: Laboratory Corp. of America Holdings - Business segments
Exhibits117: Laboratory Corp. of America Holdings - Key news
Exhibits118: Laboratory Corp. of America Holdings - Key offerings
Exhibits119: Laboratory Corp. of America Holdings - Segment focus
Exhibits120: Medpace Holdings Inc. - Overview
Exhibits121: Medpace Holdings Inc. - Product / Service
Exhibits122: Medpace Holdings Inc. - Key offerings
Exhibits123: ProPharma Group Holdings LLC - Overview
Exhibits124: ProPharma Group Holdings LLC - Product / Service
Exhibits125: ProPharma Group Holdings LLC - Key news
Exhibits126: ProPharma Group Holdings LLC - Key offerings
Exhibits127: Thermo Fisher Scientific Inc. - Overview
Exhibits128: Thermo Fisher Scientific Inc. - Business segments
Exhibits129: Thermo Fisher Scientific Inc. - Key news
Exhibits130: Thermo Fisher Scientific Inc. - Key offerings
Exhibits131: Thermo Fisher Scientific Inc. - Segment focus
Exhibits132: WuXi AppTec Co. Ltd. - Overview
Exhibits133: WuXi AppTec Co. Ltd. - Business segments
Exhibits134: WuXi AppTec Co. Ltd. - Key offerings
Exhibits135: WuXi AppTec Co. Ltd. - Segment focus
Exhibits136: Inclusions checklist
Exhibits137: Exclusions checklist
Exhibits138: Currency conversion rates for US$
Exhibits139: Research methodology
Exhibits140: Information sources
Exhibits141: Data validation
Exhibits142: Validation techniques employed for market sizing
Exhibits143: Data synthesis
Exhibits144: 360 degree market analysis
Exhibits145: List of abbreviations

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