Regulatory Affairs Outsourcing Market Size, Share & Trends Analysis Report By Category (Pharmaceuticals, Medical Devices), By Company Size, By Indication, By Stage, By Services, By End-use, By Region, And Segment Forecasts, 2023 - 2030

Table of Contents

Chapter 1 Methodology and Scope
                   1.1 Market Segmentation & Scope
                   1.2 Information Procurement
                       1.2.1 Information analysis
                       1.2.2 Market formulation & data visualization
                       1.2.3 Data validation & publishing
                   1.3 Research Scope and Assumptions
                       1.3.1 List to Data Sources
Chapter 2 Executive Summary
                   2.1 Market Snapshot
                   2.2 Segment Snapshot
                   2.3 Competitive Landscape Snapshot
Chapter 3 Regulatory Affairs Outsourcing Market Variables and Trends
                   3.1 Market Lineage Outlook
                   3.2 Market Dynamics
                       3.2.1 Market Driver Impact Analysis
                           3.2.1.1 Changing regulatory landscape
                           3.2.1.2 Entry of companies in the global market
                           3.2.1.3 Life science companies focusing on their core competencies
                           3.2.1.4 Economic and competitive pressures
                           3.2.1.5 Demand for faster approval process for breakthrough drugs and devices
                           3.2.1.6 Growth in emerging areas such as personalized medicine, biosimilars, and orphan drugs
                       3.2.2 Market Restraint Impact Analysis
                           3.2.2.1 Risk associated with data security
                           3.2.2.2 Monitoring issues and lack of standardization
                   3.3 Industry Challenges
                       3.3.1 Managing Relationships
                   3.4 Major Deals and Strategic Alliances Analysis
                   3.5 Service mapping, by drug/device lifecycle
                   3.6 Service Price Analysis
                       3.6.1 Organization Structure
                       3.6.2 Price Level Analysis
                           3.6.2.1 Regulatory Affairs Service Price Analysis By Phase
                           3.6.2.2 Segement Category Level
                       3.6.3 Unit Level
                       3.6.4 Pricing Models
                   3.7 Technology Landscape
                       3.7.1 Existing and emerging use of technology and preferred tools
                       3.7.2 Differentiating in-house tools vs widely available
                       3.7.3 Tools that have seal of approval from regulatory authorities
                       3.7.4 Key technology pillars
                   3.8 COVID-19 Impact on Regulatory Affairs Outsourcing Market
                       3.8.1 Covid-19 Impact on Clinical Trial Services Market
                       3.8.2 Covid-19 Impact on Regulatory Services Market
                       3.8.3 Covid-19 Impact on Key Market Players
                           3.8.3.1 Medpace
                           3.8.3.2 Icon plc
                           3.8.3.3 Labcorp
                           3.8.3.4 Ppd
                           3.8.3.5 Charles River Laboratories
                       3.8.4 Post Covid-19 Impact on the Market
                   3.9 Top Regional Player Analysis
                   3.10 Total Number of Clinical Trials (2021):
                       3.10.1 Total Number of Clinical Trials (2021) by Major Countries In North America
                       3.10.2 Total Number of Clinical Trials (2021) by Major Countries In Europe
                       3.10.3 Total Number of Clinical Trials (2021) by Major Countries In Asia Pacific
                       3.10.4 Total Number of Clinical Trials (2021) by Major Countries In Latin America
                       3.10.5 Total Number of Clinical Trials (2021) by Major Countries In the Middle East & Africa
                   3.11 Average Cost/Price of Clinical Trials
                       3.11.1 Average Cost/Price of Clinical Trials by Phase
                       3.11.2 Average Cost/Price of Clinical Trials by Therapeutic Areas
                       3.11.3 Average Cost/Price of Clinical Trials by Major Countries/Region
                   3.12 Cost Breakdown analysis for CRO's
                       3.12.1 Percent of Outsourced vs In-house Clinical trial Categories
                   3.13 Regulatory affairs: Industry Analysis Tools
                       3.13.1 SWOT
                       3.13.2 Porter’s analysis
                       3.13.3 Macroeconomic Analysis
Chapter 4 Regulatory Affairs Outsourcing Market: Service Segment Analysis
                   4.1 Regulatory Affairs Outsourcing Market : Service Market Share Analysis, 2022 & 2030
                   4.2 Regulatory Consulting
                       4.2.1 Regulatory Consulting Market, 2018 - 2030 (USD Million)
                       4.2.2 Strategy & Development Planning
                           4.2.2.1 Strategy & Development Planning Market, 2018 - 2030 (USD Million)
                       4.2.3 QA Consulting
                           4.2.3.1 QA Consulting Market, 2018 - 2030 (USD Million)
                       4.2.4 Others
                           4.2.4.1 Others Market, 2018 - 2030 (USD Million)
                   4.3 Legal Representation
                       4.3.1 Legal Representation Market, 2018 - 2030 (USD Million)
                   4.4 Regulatory Writing & Publishing
                       4.4.1 Regulatory Writing & Publishing Market, 2018 - 2030 (USD Million)
                   4.5 Product registration & clinical trial applications
                       4.5.1 Product registration & clinical trial applications Market, 2018 - 2030 (USD Million)
                   4.6 Regulatory Submissions
                       4.6.1 Regulatory Submissions Market, 2018 - 2030 (USD Million)
                   4.7 Regulatory Operations
                       4.7.1 Regulatory Operations Market, 2018 - 2030 (USD Million)
                   4.8 Other services
                       4.8.1 Other services Market, 2018 - 2030 (USD Million)
Chapter 5 Regulatory Affairs Outsourcing Market: Category Estimates & Trend Analysis
                   5.1 Regulatory Affairs Outsourcing Market : Category Market Share Analysis, 2022 & 2030
                   5.2 Pharmaceutical
                       5.2.1 Pharmaceutical Market, 2018 - 2030 (USD Million)
                       5.2.2 Regulatory consulting
                           5.2.2.1 Regulatory consulting Market, 2018 - 2030 (USD Million)
                           5.2.2.2 Strategy & Development Planning
                               5.2.2.2.1 Strategy & Development Planning Market, 2018 - 2030 (USD Million)
                           5.2.2.3 QA ConsultingPlanning
                               5.2.2.3.1 QA Consulting Market, 2018 - 2030 (USD Million)
                           5.2.2.4 Others
                               5.2.2.4.1 Others Market, 2018 - 2030 (USD Million)
                       5.2.3 Legal Representation
                           5.2.3.1 Legal Representation Market, 2018 - 2030 (USD Million)
                       5.2.4 Regulatory Writing & Publishing
                           5.2.4.1 Regulatory Writing & Publishing Market, 2018 - 2030 (USD Million)
                       5.2.5 Product registration & clinical trial applications
                           5.2.5.1 Product registration & clinical trial applications Market, 2018 - 2030 (USD Million)
                       5.2.6 Regulatory Submissions
                           5.2.6.1 Regulatory Submissions Market, 2018 - 2030 (USD Million)
                       5.2.7 Regulatory Operations
                           5.2.7.1 Regulatory Operations Market, 2018 - 2030 (USD Million)
                       5.2.8 Other services
                           5.2.8.1 Other services Market, 2018 - 2030 (USD Million)
                   5.3 Medical Device
                       5.3.1 Medical Device Market, 2018 - 2030 (USD Million)
                       5.3.2 Regulatory consulting
                           5.3.2.1 Regulatory consulting Market, 2018 - 2030 (USD Million)
                           5.3.2.2 Strategy & Development Planning
                               5.3.2.2.1 Strategy & Development Planning Market, 2018 - 2030 (USD Million)
                           5.3.2.3 QA ConsultingPlanning
                               5.3.2.3.1 QA Consulting Market, 2018 - 2030 (USD Million)
                           5.3.2.4 Others
                               5.3.2.4.1 Others Market, 2018 - 2030 (USD Million)
                       5.3.3 Legal Representation
                           5.3.3.1 Legal Representation Market, 2018 - 2030 (USD Million)
                       5.3.4 Regulatory Writing & Publishing
                           5.3.4.1 Regulatory Writing & Publishing Market, 2018 - 2030 (USD Million)
                       5.3.5 Product registration & clinical trial applications
                           5.3.5.1 Product registration & clinical trial applications Market, 2018 - 2030 (USD Million)
                       5.3.6 Regulatory Submissions
                           5.3.6.1 Regulatory Submissions Market, 2018 - 2030 (USD Million)
                       5.3.7 Regulatory Operations
                           5.3.7.1 Regulatory Operations Market, 2018 - 2030 (USD Million)
                       5.3.8 Other services
                           5.3.8.1 Other services Market, 2018 - 2030 (USD Million)
Chapter 6 Regulatory Affairs Outsourcing Market: Company Size Estimates & Trend Analysis
                   6.1 Regulatory Affairs Outsourcing Market: Company Size Market Share Analysis, 2022 & 2030
                   6.2 Small Companies
                       6.2.1 Small Companies Market, 2018 - 2030 (USD Million)
                   6.3 Medium Companies
                       6.3.1 Medium Companies Market, 2018 - 2030 (USD Million)
                   6.4 Large Companies
                       6.4.1 Large Companies Market, 2018 - 2030 (USD Million)
Chapter 7 Regulatory Affairs Outsourcing Market: Indication Estimates & Trend Analysis
                   7.1 Regulatory Affairs Outsourcing Market: Indication Market Share Analysis, 2022 & 2030
                   7.2 Oncology
                       7.2.1 Oncology Market, 2018 - 2030 (USD Million)
                   7.3 Neurology
                       7.3.1 Neurology Market, 2018 - 2030 (USD Million)
                   7.4 Cardiology
                       7.4.1 Cardiology Market, 2018 - 2030 (USD Million)
                   7.5 Immunology
                       7.5.1 Immunology Market, 2018 - 2030 (USD Million)
                   7.6 Other Indications
                       7.6.1 Other Indications Market, 2018 - 2030 (USD Million)
Chapter 8 Regulatory Affairs Outsourcing Market: Product Stage Estimates & Trend Analysis
                   8.1 Regulatory Affairs Outsourcing Market: Product Stage Market Share Analysis, 2022 & 2030
                   8.2 Preclinical
                       8.2.1 Preclinical Market, 2018 - 2030 (USD Million)
                   8.3 Clinical
                       8.3.1 Clinical Market, 2018 - 2030 (USD Million)
                   8.4 Premarket Approval (PMA)
                       8.4.1 Premarket Approval (PMA) Market, 2018 - 2030 (USD Million)
Chapter 9 Regulatory Affairs Outsourcing Market: End-Use Estimates & Trend Analysis
                   9.1 Regulatory Affairs Outsourcing Market: End-Use Market Share Analysis, 2022 & 2030
                   9.2 Medical Device Companies
                       9.2.1 Medical Device Companies Market, 2018 - 2030 (USD Million)
                   9.3 Pharmaceutical Companies
                       9.3.1 Pharmaceutical Companies Market, 2018 - 2030 (USD Million)
                   9.4 Biotechnology Companies
                       9.4.1 Biotechnology Companies Market, 2018 - 2030 (USD Million)
Chapter 10 Regulatory Affairs Outsourcing Market: Regional Analysis
                   10.1 Regulatory Affairs Outsourcing Market: Regional Outlook
                   10.2 North America
                       10.2.1 North America Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.2.2 U.S.
                           10.2.2.1 U.S. Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.2.3 Canada
                           10.2.3.1 Canada Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
                   10.3 Europe
                       10.3.1 Europe Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.3.2 U.K.
                           10.3.2.1 UK Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.3.3 Germany
                           10.3.3.1 Germany Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.3.4 France
                           10.3.4.1 France Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.3.5 Italy
                           10.3.5.1 Italy Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.3.6 Spain
                           10.3.6.1 Spain Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.3.7 Russia
                           10.3.7.1 Russia Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.3.8 Sweden
                           10.3.8.1 Sweden Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.3.9 Turkey
                           10.3.9.1 Turkey Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.3.10 Netherlands
                           10.3.10.1 Netherlands Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.3.11 Switzerland
                           10.3.11.1 Switzerland Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.3.12 Europe CIS
                           10.3.12.1 Europe CIS Countries Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                   10.4 Asia Pacific
                       10.4.1 Asia Pacific Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.4.2 Japan
                           10.4.2.1 Japan Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.4.3 China
                           10.4.3.1 China Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
                       10.4.4 India
                           10.4.4.1 India Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.4.5 Australia
                           10.4.5.1 Ausrtralia Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.4.6 South Korea
                           10.4.6.1 South Korea Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.4.7 Thailand
                           10.4.7.1 Thailand Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.4.8 Indonesia
                           10.4.8.1 Indonesia Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.4.9 Malaysia
                           10.4.9.1 Malaysia Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.4.9 Singapore
                           10.4.9.1 Singapore Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.4.10 Taiwan
                           10.4.10.1 Taiwan Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.4.11 Asia Pacific CIS
                           10.4.11.1 Asia Pacific CIS Countries Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                   10.5 Latin America
                       10.5.1 Latin America Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.5.2 Brazil
                           10.5.2.1 Brazil Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.5.3 Mexico
                           10.5.3.1 Mexico Regulatory Affairs Outsourcing Market Estimates and Forecasts, 2018 - 2030 (USD Million)
                       10.5.4 Argentina
                           10.5.4.1 Argentina Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.5.5 Colombia
                           10.5.5.1 Colombia Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.5.6 Chile
                           10.5.6.1 Chile Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                   10.6 Middle East & Africa
                       10.6.1 Middle East & Africa Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.6.2 South Africa
                           10.6.2.1 South Africa Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.6.3 Saudi Arabia
                           10.6.3.1 Saudi Arabia Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.6.4 UAE
                           10.6.4.1 UAE Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.6.5 Egypt
                           10.6.5.1 Egypt Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
                       10.6.6 Israel
                           10.6.6.1 Israel Regulatory Affairs Outsourcing Market Estimates And Forecasts, 2018 - 2030 (USD Million)
Chapter 11 Competitive Landscape
                   11.1 Company Market Share Analysis (2022)
                   11.2 Service Heat map analysis
                   11.3 Company profiles
                       11.3.1 Accell Clinical Research, LLC
                           11.3.1.1 Company overview
                           11.3.1.2 Financial performance
                           11.3.1.3 Service benchmarking
                           11.3.1.4 Strategic initiatives
                       11.3.2 Genpact
                           11.3.2.1 Company overview
                           11.3.2.2 Financial performance
                           11.3.2.3 Service benchmarking
                           11.3.2.4 Strategic initiatives
                       11.3.3 CRITERIUM, INC
                           11.3.3.1 Company overview
                           11.3.3.2 Financial performance
                           11.3.3.3 Service benchmarking
                           11.3.3.4 Strategic initiatives
                       11.3.4 Promedica International
                           11.3.4.1 Company overview
                           11.3.4.2 Financial performance
                           11.3.4.3 Service benchmarking
                           11.3.4.4 Strategic initiatives
                       11.3.5 WuXi AppTec
                           11.3.5.1 Company overview
                           11.3.5.2 Financial performance
                           11.3.5.3 Service benchmarking
                           11.3.5.4 Strategic initiatives
                       11.3.6 Medpace
                           11.3.6.1 Company overview
                           11.3.6.2 Financial performance
                           11.3.6 3 Service benchmarking
                           11.3.6.4 Strategic initiatives
                       11.3.7 Charles River Laboratories
                           11.3.7.1 Company overview
                           11.3.7.2 Financial performance
                           11.3.7.3 Service benchmarking
                           11.3.7.4 Strategic initiatives
                       11.3.8 ICON plc
                           11.3.8.1 Company overview
                           11.3.8.2 Financial performance
                           11.3.8.3 Service benchmarking
                           11.3.8.4 Strategic initiatives
                       11.3.9 Covance, Inc. (Labcorp Drug Development)
                           11.3.9.1 Company overview
                           11.3.9.2 Financial performance
                           11.3.9.3 Service benchmarking
                           11.3.9.4 Strategic initiatives
                       11.3.10 Parexel International Corporation
                           11.3.10.1 Company overview
                           11.3.10.2 Financial performance
                           11.3.10.3 Service benchmarking
                           11.3.10.4 Strategic initiatives
                       11.3.11 Freyr
                           11.3.11.1 Company overview
                           11.3.11.2 Financial performance
                           11.3.11.3 Service benchmarking
                           11.3.11.4 Strategic initiatives
                       11.3.12 PHARMALEX GMBH
                           11.3.12.1 Company overview
                           11.3.12.2 Financial performance
                           11.3.12.3 Service benchmarking
                           11.3.12.4 Strategic initiatives
                       11.3.13 NDA Group AB
                           11.3.13.1 Company overview
                           11.3.13 2 Financial performance
                           11.3.13.3 Service benchmarking
                           11.3.13.4 Strategic initiatives
                       11.3.14 Pharmexon
                           11.3.14.1 Company overview
                           11.3.14 2 Financial performance
                           11.3.14.3 Service benchmarking
                           11.3.14.4 Strategic initiatives
                       11.3.15 Qvigilance
                           11.3.15.1 Company overview
                           11.3.15 2 Financial performance
                           11.3.15.3 Service benchmarking
                           11.3.15.4 Strategic initiatives
                       11.3.16 BlueReg
                           11.3.16.1 Company overview
                           11.3.16 2 Financial performance
                           11.3.16.3 Service benchmarking
                           11.3.16.4 Strategic initiatives
                       11.3.17 Cambridge Regulatory Services
                           11.3.17.1 Company overview
                           11.3.17 2 Financial performance
                           11.3.17.3 Service benchmarking
                           11.3.17.4 Strategic initiatives
                       11.3.18 APCER Life Sciences, Inc.
                           11.3.18.1 Company overview
                           11.3.18 2 Financial performance
                           11.3.18.3 Service benchmarking
                           11.3.18.4 Strategic initiatives
                       11.3.19 Real Regulatory Ltd
                           11.3.19.1 Company overview
                           11.3.19 2 Financial performance
                           11.3.19.3 Service benchmarking
                           11.3.19.4 Strategic initiatives
                       11.3.20 VCLS
                           11.3.20.1 Company overview
                           11.3.20 2 Financial performance
                           11.3.20.3 Service benchmarking
                           11.3.20.4 Strategic initiatives
                       11.3.21 PrimeVigilance
                           11.3.21.1 Company overview
                           11.3.21 2 Financial performance
                           11.3.21.3 Service benchmarking
                           11.3.21.4 Strategic initiatives
                       11.3.22 ProPharma Group MIS Limited
                           11.3.22.1 Company overview
                           11.3.22 2 Financial performance
                           11.3.22.3 Service benchmarking
                           11.3.22.4 Strategic initiatives
                       11.3.23 Regulatory Pharma Net srl
                           11.3.23.1 Company overview
                           11.3.23 2 Financial performance
                           11.3.23.3 Service benchmarking
                           11.3.23.4 Strategic initiatives
                       11.3.24 ZEINCRO
                           11.3.24.1 Company overview
                           11.3.24 2 Financial performance
                           11.3.24.3 Service benchmarking
                           11.3.24.4 Strategic initiatives
                       11.3.25 BioMapas
                           11.3.25.1 Company overview
                           11.3.25 2 Financial performance
                           11.3.25.3 Service benchmarking
                           11.3.25.4 Strategic initiatives
                       11.3.26 REGENOLD GMBH
                           11.3.26.1 Company overview
                           11.3.26 2 Financial performance
                           11.3.26.3 Service benchmarking
                           11.3.26.4 Strategic initiatives

List of Tables

Table 1 Average price range by service type
Table 2 User fees as charged by U.S. FDA
Table 3 Application fees for NCEs and generics
Table 4 Emergence, applications, uses of the following key technology pillars
Table 5 Impact of COVID-19 on new patients entering trials
Table 6 Impact of COVID-19 on other therapeutic areas
Table 7 Global Regulatory Affairs Outsourcing Market Revenue Estimates and Forecast, By Service, 2018 - 2030 (USD Millions)
Table 8 Global Regulatory Affairs Outsourcing Market Revenue Estimates and Forecast, By Regulatory Consulting, 2018 - 2030 (USD Millions)
Table 9 Global Regulatory Affairs Outsourcing Market Revenue Estimates and Forecast, By Category, 2018 - 2030 (USD Millions)
Table 10 Global Regulatory Affairs Outsourcing Market Revenue Estimates and Forecast, By Company Size, 2018 - 2030 (USD Millions)
Table 11 Global Regulatory Affairs Outsourcing Market Revenue Estimates and Forecast, By Indication, 2018 - 2030 (USD Millions)
Table 12 Estimated numbers of survivors for the 10 most prevalent cancers among people in the United States as of January 1, 2022
Table 13 Global Regulatory Affairs Outsourcing Market Revenue Estimates and Forecast, By Product Stage, 2018 - 2030 (USD Millions)
Table 14 Global Regulatory Affairs Outsourcing Market Revenue Estimates and Forecast, By End-Use, 2018 - 2030 (USD Millions)
Table 15 The export and import values for U.S. Medical Devices from 2016 to 2020 in USD billion
Table 16 Company Market Share, 2022
Table 17 Key companies undertaking expansions.
Table 18 Key companies undergoing collaborations, partnerships, agreements.
Table 19 Key companies launching new products.
Table 20 Key companies undergoing acquisitions.

List of Figures

Fig. 1 Regulatory Affairs Outsourcing Market Segmentation
Fig. 2 Information Procurement
Fig. 3 Data Analysis Models
Fig. 4 Market Formulation And Validation
Fig. 5 Data Validating & Publishing
Fig. 6 Market snapshot
Fig. 7 Segment snapshot
Fig. 8 Segment snapshot
Fig. 9 Segment snapshot
Fig. 10 Competitive landscape snapshot
Fig. 11 Regulatory Affairs Market Value, 2022 (USD Million)
Fig. 12 Regulatory Affairs Outsourcing Market Dynamics
Fig. 13 Number of Trials, By WHO Regions
Fig. 14 Personalized Medicine as a percentage of CDER approved novel molecules.
Fig. 15 Generics service demand based on lifecycle stage
Fig. 16 Innovative drugs service demand based on lifecycle stage
Fig. 17 Biologics/ATMPs/biosimilars service demand based on lifecycle stage
Fig. 18 Medical devices service demand based on lifecycle stage
Fig. 19 Organization Structure - Regulatory Affairs
Fig. 20 Regulatory Affairs Phase Wise Price Distribution (In Percent share)
Fig. 21 Usage/adoption of cloud technology for regulatory space
Fig. 22 Top Regional Player Analysis
Fig. 23 Total number of Clinical Trials (2021)
Fig. 24 Countries in North America
Fig. 25 Countries by Europe
Fig. 26 Countries by Asia Pacific
Fig. 27 Countries by Latin America
Fig. 28 Countries by Middle East & Africa
Fig. 29 Average Cost by Phase
Fig. 30 Clinical Trial Cost Per Indication (millions)
Fig. 31 Average Cost of Clinical Trials by Major Countries
Fig. 32 Percent of Outsourced vs In-house of Key Clinical Trial Categories (Trend across 2018-2020)
Fig. 33 SWOT
Fig. 34 Regulatory Affairs Outsourcing Market: PORTER’s Analysis
Fig. 35 Regulatory Affairs Outsourcing Market: PEST Analysis
Fig. 36 Regulatory Affairs Outsourcing Market, by Service: Key Takeaways
Fig. 37 Regulatory Affairs Outsourcing Market, by Service: Market Share, 2022 & 2030
Fig. 38 Regulatory consulting market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 39 Strategy & development planning market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 40 QA consulting market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 41 Others market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 42 Legal representation market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 43 Regulatory writing & publishing market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 44 Product registration & clinical trial applications market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 45 Regulatory submissions market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 46 Regulatory operations market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 47 Other services market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 48 Regulatory Affairs Outsourcing Market, by Category: Key Takeaways
Fig. 49 Regulatory Affairs Outsourcing Market, by Category: Market Share, 2022 & 2030
Fig. 50 Pharmaceuticals Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
Fig. 51 Pharmaceuticals Regulatory Affairs Outsourcing Market by regulatory consulting, 2018 - 2030 (USD Million)
Fig. 52 Pharmaceutical Regulatory Affairs Outsourcing Market by Strategy & Development Planning, 2018 - 2030 (USD Million)
Fig. 53 Pharmaceutical Regulatory Affairs Outsourcing Market by QA consulting market, 2018 - 2030 (USD Million)
Fig. 54 Pharmaceutical regulatory affairs outsourcing market by others, 2018 - 2030 (USD Million)
Fig. 55 Pharmaceuticals Regulatory Affairs Outsourcing Market, by legal representation, 2018 - 2030 (USD Million)
Fig. 56 Pharmaceuticals Regulatory Affairs Outsourcing Market, by regulatory writing & publishing, 2018 - 2030 (USD Million)
Fig. 57 Pharmaceuticals Regulatory Affairs Outsourcing Market, by product registration & clinical trial market, 2018 - 2030 (USD Million)
Fig. 58 Pharmaceuticals Regulatory Affairs Outsourcing Market, by regulatory submissions market, 2018 - 2030 (USD Million)
Fig. 59 Pharmaceuticals Regulatory Affairs Outsourcing Market, by regulatory operations market, 2018 - 2030 (USD Million)
Fig. 60 Pharmaceuticals Regulatory Affairs Outsourcing Market, by other services market, 2018 - 2030 (USD Million)
Fig. 61 Medical Devices Regulatory Affairs Outsourcing market, 2018 - 2030 (USD Million)
Fig. 62 Medical devices regulatory affairs outsourcing market by regulatory consulting market, 2018 - 2030 (USD Million)
Fig. 63 Medical devices Regulatory Affairs Outsourcing Market by strategy & development planning market, 2018 - 2030 (USD Million)
Fig. 64 Medical devices Regulatory Affairs Outsourcing Market by QA consulting market, 2018 - 2030 (USD Million)
Fig. 65 Medical devices Regulatory Affairs Outsourcing Market by Others market, 2018 - 2030 (USD Million)
Fig. 66 Medical devices Regulatory Affairs Outsourcing Market by legal representation market, 2018 - 2030 (USD Million)
Fig. 67 Medical devices Regulatory Affairs Outsourcing Market by regulatory writing and publishing market, 2018 - 2030 (USD Million)
Fig. 68 Medical devices Regulatory Affairs Outsourcing Market by product registration & clinical trial applications, 2018 - 2030 (USD Million)
Fig. 69 Medical devices Regulatory Affairs Outsourcing Market by regulatory submissions market, 2018 - 2030 (USD Million)
Fig. 70 Medical devices Regulatory Affairs Outsourcing Market by regulatory operations market, 2018 - 2030 (USD Million)
Fig. 71 Medical devices Regulatory Affairs Outsourcing Market by other services, 2018 - 2030 (USD Million)
Fig. 72 Regulatory Affairs Outsourcing Market, by Company size: Key Takeaways
Fig. 73 Regulatory Affairs Outsourcing Market, by Company Size: Market Share, 2022 & 2030
Fig. 74 Small companies market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 75 Medium companies market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 76 Large companies market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 77 Regulatory Affairs Outsourcing Market, by Indication: Key Takeaways
Fig. 78 Regulatory Affairs Outsourcing Market, by Indication: Market Share, 2022 & 2030
Fig. 79 Oncology market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 80 Neurology market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 81 Cardiology market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 82 Immunology market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 83 Other indications market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 84 Regulatory Affairs Outsourcing Market, by Product Stage: Key Takeaways
Fig. 85 Regulatory Affairs Outsourcing Market, by Product Stage: Market Share, 2022 & 2030
Fig. 86 Preclinical market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 87 Clinical market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 88 Percentage of Registered Studies by Location (as of February 17, 2023)
Fig. 89 Premarket approval (PMA) market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 90 Regulatory Affairs Outsourcing Market, by End-Use: Key Takeaways
Fig. 91 Regulatory Affairs Outsourcing Market, by End-Use: Market Share, 2022 & 2030
Fig. 92 Medical device companies market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 93 Pharmaceutical companies market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 94 Biotechnology companies market estimates & forecasts, 2018 - 2030 (USD Million)
Fig. 95 Regulatory affairs outsourcing market revenue, by region, 2022 & 2030 (USD Million)
Fig. 96 Regional marketplace: Key takeaways (North America & Europe)
Fig. 97 Regional marketplace: Key takeaways (Asia Pacific, Latin America, and MEA)
Fig. 98 North America market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 99 Key country dynamics
Fig. 100 U.S. Regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 101 Key country dynamics
Fig. 102 Canada regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 103 Europe Regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 104 Key country dynamics
Fig. 105 UK regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 106 Key country dynamics
Fig. 107 Germany Regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 108 Key country dynamics
Fig. 109 France Regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 110 Key country dynamics
Fig. 111 Italy regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 112 Key country dynamics
Fig. 113 Spain regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 114 Russia regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 115 Key country dynamics
Fig. 116 Sweden Regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 117 Turkey regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 118 Netherlands regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 119 Key country dynamics
Fig. 120 Switzerland Regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 121 Europe CIS regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 122 Asia Pacific market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 123 Key country dynamics
Fig. 124 Japan regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 125 Key country dynamics
Fig. 126 China regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 127 Key country dynamics
Fig. 128 India regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 129 Key country dynamics
Fig. 130 Australia regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 131 Key country dynamics
Fig. 132 South Korea regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 133 Key country dynamics
Fig. 134 Thailand regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 135 Indonesia regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 136 Malaysia regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 137 Singapore regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 138 Taiwan regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 139 Asia Pacific CIS regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 140 Latin America market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 141 Key country dynamics
Fig. 142 Brazil regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 143 Key country dynamics
Fig. 144 Mexico regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 145 Reimbursement scenario
Fig. 146 Key country dynamics
Fig. 147 Argentina regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 148 Colombia regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 149 Chile regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 150 Middle East & Africa regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 151 Key country dynamics
Fig. 152 South Africa regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 153 Key country dynamics
Fig. 154 Saudi Arabia regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 155 Key country dynamics
Fig. 156 UAE regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 157 Egypt regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 158 Israel regulatory affairs outsourcing market estimates and forecast, 2018 - 2030 (USD Million)
Fig. 159 Company Market Share Analysis, 2022
Fig. 160 Strategic framework