Product Code: GVR-1-68038-556-4
Regulatory Affairs Outsourcing Market Growth & Trends:
The global regulatory affairs outsourcing market size is expected to reach USD 13.9 billion by 2030, registering a CAGR of 8.9% over the forecast period, according to a new report by Grand View Research, Inc. Significant increase in the fixed costs of in-house resources for regulatory affairs & operation activities like training, technology, specialized knowledge, and facilities are driving outsourcing of regulatory affair functions. Addressing local regulatory challenges and constant changes in the regulations of the major markets, such as the U.S., Europe, and Asia, is creating demand for these services. Compliance with the current regulations has become an immense chore, leave alone trying to stay up to date with developments around the world. Amendments to current regulations are likely to simplify the regulatory pathway for the industry but in turn, complicate the operation for healthcare product manufacturing companies.
Thus, leading to the regulatory affairs outsourcing to service providers. The market witnessed a significant decline in 2020 due to the outbreak of the COVID-19 pandemic, as there was a halt in clinical trial activities including regulatory updates. Disruption in the supply chain and closure of R&D sites resulted in a significant loss of revenues in 2020 across the industry. However, due to the pandemic, various healthcare companies are opting for more regulatory advice, as companies push to speed up the product development & approvals in therapies, vaccines, & devices for COVID-19. Owing to the urgent need for medical devices and therapies for COVID-19, regulatory authorities are providing emergency use authorization for the majority of products. Such actions have further promoted the demand for these services post 2020 and the positive rebound of sales across the industry can be witnessed from 2021.
Regulatory Affairs Outsourcing Market Report Highlights:
- The regulatory writing & publishing services segment dominated the market with the maximum revenue share in 2021as they are offered from the early stages of development to the post-marketing authorization phase and are vital for the success of a product
- The large companies segment is projected to witness the fastest CAGR during the forecast period. The availability of a wide variety of services and the presence of these providers in various geographies are the key factors driving the segment growth
- The clinical studies stage segment accounted for the largest market share in 2021 due to the increasing demand for clinical trials in developing countries
- The pharmaceutical companies end-use segment is anticipated to witness the fastest growth rate over the forecast period due to evolving areas, such as orphan drugs and personalized therapies
- Asia Pacific held the maximum revenue share of the global market in 2021 owing to higher off shoring of such services into regions of economic benefits and the expansion of life sciences companies in countries, such as India & China
Table of Contents
Chapter 1 Methodology and Scope
- 1.1 Market Segmentation & Scope
- 1.1.1 Services
- 1.1.2. Company Size
- 1.1.3. Category
- 1.1.4 Indication
- 1.1.5 Stage
- 1.1.6 End User
- 1.1.7 Estimates And Forecast Timeline
- 1.2 Research Methodology
- 1.3 Information Procurement
- 1.3.1 Purchased Database
- 1.3.2 Gvr's Internal Database
- 1.3.3 Secondary Sources
- 1.3.4 Primary Research
- 1.3.5 Details Of Primary Research
- 1.4 Information or Data Analysis
- 1.4.1 Data Analysis Models
- 1.5 Market Formulation & Validation
- 1.6 Region Wise Market Calculation
- 1.6.1 Region Wise Market: Base Estimates
- 1.6.2 Global Market: CAGR Calculation
- 1.7 List of Secondary Sources
- 1.8 Objectives
- 1.8.1 Objective - 1: Understanding market dynamics
- 1.8.2 Objective - 2: Understanding market estimates and forecasts
- 1.8.3 Objective - 3: Understanding attributes such as strategy framework and competitor categorization
- 1.8.4 Objective - 4: Understanding the key service and application scopes to conclude on the market size.
Chapter 2 Executive Summary
Chapter 3 Regulatory Affairs Outsourcing Market: Variables, Trends, & Scope
- 3.1 Market Segmentation and Scope
- 3.2 Market Dynamics
- 3.2.1 Market Driver 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 Analysis
- 3.2.2.1 Risk associated with data security
- 3.2.2.2 Monitoring issues and lack of standardization
- 3.3 Penetration & Growth Prospect Mapping
- 3.4 Industry Challenges
- 3.4.1 Managing Relationships
- 3.5 Major Deals and Strategic Alliances Analysis
- 3.6 Regulatory Affairs: Market Analysis Tools
- 3.6.1 SWOT
- 3.6.2 Industry Analysis - Porter's
- 3.6.3 PESTEL Analysis
Chapter 4 Regulatory Affairs Outsourcing Market: Service Segment Analysis
- 4.1 Regulatory Affairs Outsourcing Market: Service Market Share Analysis, 2020 & 2028
- 4.2 Regulatory Consulting
- 4.2.1 Regulatory Consulting Market, 2018 - 2030 (USD Million)
- 4.3 Legal Representation
- 4.3.1 Legal Representation Market, 2018 - 2030 (USD Million)
- 4.4 Regulatory Writing and Publishing
- 4.4.1 Regulatory Writing and Publishing Market, 2018 - 2030 (USD Million)
- 4.5 Product Registration and Clinical Trial Application
- 4.5.1 Product Registration and Clinical Trial Application Market, 2018 - 2030 (USD Million)
- 4.6 Other Services
- 4.6.1 Other Services Market, 2018 - 2030 (USD Million)
Chapter 5 Regulatory Affairs Outsourcing Market: Company Size Segment Analysis
- 5.1 Regulatory Affairs Outsourcing Market: Company Size Market Share Analysis, 2020 & 2028
- 5.2 Small Sized Companies
- 5.2.1 Small Sized Companies Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 5.3 Medium Sized Companies
- 5.3.1 Medium Sized Companies Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 5.4 Large Sized Companies
- 5.4.1 Large Companies Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
Chapter 6 Regulatory Affairs Outsourcing Market: Categories Segment Analysis
- 6.1 Regulatory Affairs Outsourcing Market: Categories Market Share Analysis, 2020 & 2028
- 6.2 Drugs
- 6.2.1 Drugs Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 6.2.2 Generics
- 6.2.2.1 Generics Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 6.2.3 Innovator
- 6.2.3.1 Innovator Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 6.3 Biologics
- 6.3.1 Biologics Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 6.3.2 Biotech
- 6.3.2.1 Biotech Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 6.3.3 ATMPs
- 6.3.3.1 ATMPs Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 6.3.4 Biosimilars
- 6.3.4.1 Biosimilar Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 6.4 Medical Devices
- 6.4.1 Medical Devices Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 6.4.2 Diagnostics
- 6.4.2.1 Diagnostics Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 6.4.3 Therapeutics
- 6.4.3.1 Therapeutics Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
Chapter 7 Regulatory Affairs Outsourcing Market: Stage Segment Analysis
- 7.1 Regulatory Affairs Market: Stage Market Share Analysis, 2020 & 2028
- 7.2 Preclinical
- 7.2.1 Preclinical-based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 7.3 Clinical
- 7.3.1 Clinical-based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 7.4 PMA
- 7.4.1 PMA-based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
Chapter 8 Regulatory Affairs Outsourcing Market: Indication Segment Analysis
- 8.1 Regulatory Affairs Outsourcing Market: Indication Market Share Analysis, 2020 & 2028
- 8.2 Oncology
- 8.2.1 Oncology Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 8.3 Neurology
- 8.3.1 Neurology Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 8.4 Cardiology
- 8.4.1 Cardiology Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 8.5 Immunology
- 8.5.1 Immunology Indication Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (Usd Million)
- 8.6 Other Indications
- 8.6.1 Other Indication Based Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
Chapter 9 Regulatory Affairs Outsourcing Market: End-use Segment Analysis
- 9.1 Regulatory Affairs Outsourcing Market: End-use Market Share Analysis, 2020 & 2028
- 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 Market Share Analysis, 2020 & 2028
- 10.2 North America
- 10.2.1 North America Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.2.2 U.S.
- 10.2.2.1 U.S. Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.2.3 Canada
- 10.2.3.1 Canada Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.3 Europe
- 10.3.1 Europe Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.3.2 U.K.
- 10.3.2.1 U.K. Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.3.3 Germany
- 10.3.3.1 Germany Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.3.4 France
- 10.3.4.1 France Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.3.5 Italy
- 10.3.5.1 Italy Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.3.6 Spain
- 10.3.6.1 Spain Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.3.7 Russia
- 10.3.7.1 Russia Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.3.8 Turkey
- 10.3.8.1 Turkey Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.3.9 The Netherlands
- 10.3.9.1The Netherlands Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.3.10 Switzerland
- 10.3.10.1 Switzerland Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.3.11 Sweden
- 10.3.11.1 Sweden Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.3.12 CIS Countries
- 10.3.12.1 CIS Countries Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.4 Asia Pacific
- 10.4.1 Asia Pacific Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.4.2 Japan
- 10.4.2.1 Japan Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.4.3 China
- 10.4.3.1 China Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.4.4 India
- 10.4.4.1 India Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.4.5 Australia
- 10.4.5.1 Australia Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.4.6 South Korea
- 10.4.6.1 South Korea Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.4.7 Indonesia
- 10.4.7.1 Indonesia Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.4.8 Malaysia
- 10.4.8.1 Malaysia Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.4.9 Singapore
- 10.4.9.1 Singapore Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.4.10 Thailand
- 10.4.10.1 Thailand Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.4.11 Taiwan
- 10.4.11.1 Taiwan Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.4.12 CIS Countries
- 10.4.12.1 Taiwan Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.5 Latin America
- 10.5.1 Latin America Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.5.2 Brazil
- 10.5.2.1 Brazil Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.5.3 Mexico
- 10.5.3.1 Mexico Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.5.4 Argentina
- 10.5.4.1 Argentina Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.5.5 Colombia
- 10.5.5.1 Colombia Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.5.6 Chile
- 10.5.6.1 Chile Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.6 MEA
- 10.6.1 MEA Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.6.2 South Africa
- 10.6.2.1 South Africa Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.6.3 Saudi Arabia
- 10.6.3.1 Saudi Arabia Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.6.4 UAE
- 10.6.4.1 UAE Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.6.5 Egypt
- 10.6.5.1 Egypt Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
- 10.6.6 Israel
- 10.6.6.1 Israel Regulatory Affairs Outsourcing Market, 2018 - 2030 (USD Million)
Chapter 11 Company Profiles
- 11.1 Accell Clinical Research, LLC.
- 11.1.1 Company Overview
- 11.1.2 Service Benchmarking
- 11.1.3 Geographic Presence
- 11.1.4 Strategic Intiatives
- 11.1.5 SWOT
- 11.2 GenPact Ltd.
- 11.2.1 Company Overview
- 11.2.2 Financial Performance
- 11.2.3 Service Benchmarking
- 11.2.4 Geographic Presence
- 11.2.5 Strategic Initiatives
- 11.2.6 SWOT
- 11.3 Criterium, Inc.
- 11.3.1 Company Overview
- 11.3.2 Service Benchmarking
- 11.3.3 Geographic Presence
- 11.3.4 Swot
- 11.4 PRA Health Sciences
- 11.4.1 Company Overview
- 11.4.2 Financial Performance
- 11.4.3 Service Benchmarking
- 11.4.4 Geographic Presence
- 11.4.5 Strategic Initiatives
- 11.4.6 SWOT
- 11.5 Promedica International
- 11.5.1 Company Overview
- 11.5.2 Service Benchmarking
- 11.5.3 Geographic Presence
- 11.5.4 SWOT
- 11.6 WuXi AppTec, Inc.
- 11.6.1 Company Overview
- 11.6.2 Financial Performance
- 11.6.3 Service Benchmarking
- 11.6.4 Geographic Presence
- 11.6.5 Strategic Initiatives
- 11.6.6 SWOT
- 11.7 Medpace
- 11.7.1 Company Overview
- 11.7.2 Financial Performance
- 11.7.3 Service Benchmarking
- 11.7.4 Geographic Presence
- 11.7.5 Swot
- 11.8 Charles River Laboratories International, Inc.
- 11.8.1 Company Overview
- 11.8.2 Financial Performance
- 11.8.3 Service Benchmarking
- 11.8.4 Geographic Presence
- 11.8.5 Strategic Initiatives
- 11.8.6 SWOT
- 11.9 ICON plc
- 11.9.1 Company Overview
- 11.9.2 Financial Performance
- 11.9.3 Service Benchmarking
- 11.9.4 Geographic Presence
- 11.9.5 Strategic Initiatives
- 11.9.6 SWOT
- 11.10 Covance
- 11.10.1 Company Overview
- 11.10.2 Financial Performance
- 11.10.3 Service Benchmarking
- 11.10.4 Geographic Presence
- 11.10.5 Strategic Initiatives
- 11.10.6 SWOT
- 11.11 PAREXEL International Corporation, Inc.
- 11.11.1 Company Overview
- 11.11.2 Financial Performance
- 11.11.3 Service Benchmarking
- 11.11.4 Geographic Presence
- 11.11.5 Strategic Initiatives
- 11.11.6 SWOT
- 11.12 Freyr
- 11.12.1 Company Overview
- 11.12.2 Service Benchmarking
- 11.12.3 Geographic Presence
- 11.12.4 Strategic Initiatives
- 11.12.5 SWOT
- 11.13 Pharmalex GMBH
- 11.13.1 Company Overview
- 11.13.2 Service Benchmarking
- 11.13.3 Geographic Presence
- 11.13.4 Strategic Initiatives
- 11.13.5 SWOT
- 11.14 NDA Group AB
- 11.14.1 Company Overview
- 11.14.2 Service Benchmarking
- 11.14.3 Geographic Presence
- 11.14.4 SWOT
- 11.15 Pharmexon Consulting s.r.o
- 11.15.1 Company Overview
- 11.15.2 Service Benchmarking
- 11.15.3 SWOT
- 11.16 Qvigilance
- 11.16.1 Company Overview
- 11.16.2 Service Benchmarking
- 11.16.3 SWOT
- 11.17 BlueReg Group
- 11.17.1 Company Overview
- 11.17.2 Service Benchmarking
- 11.17.3 Geographic Presence
- 11.17.4 Strategic Initiatives
- 11.17.5 SWOT
- 11.18 Cambridge Regulatory Services
- 11.18.1 Company Overview
- 11.18.2 Service Benchmarking
- 11.18.3 SWOT
- 11.19 APCER Life Sciences, Inc
- 11.19.1 Company Overview
- 11.19.2 Service Benchmarking
- 11.19.3 Geographic Presence
- 11.19.4 Strategic Initiatives
- 11.19.5 SWOT
- 11.20 Real Regulatory Ltd.
- 11.20.1 Company Overview
- 11.20.2 Service Benchmarking
- 11.20.3 SWOT
- 11.21 Voisin Consulting Life Sciences
- 11.21.1 Company Overview
- 11.21.2 Service Benchmarking
- 11.21.3 Geographic Presence
- 11.21.4 Strategic Initiatives
- 11.21.5 SWOT
- 11.22 PrimeVigilance
- 11.22.1 Company Overview
- 11.22.2 Service Benchmarking
- 11.22.3 Geographic Presence
- 11.22.4 Strategic Initiatives
- 11.22.5 SWOT
- 11.23 ProPharma Group MIS Limited
- 11.23.1 Company overview
- 11.23.2 Service Benchmarking
- 11.23.3 Geographic Presence
- 11.23.4 Strategic Initiatives
- 11.23.5 SWOT
- 11.24 Regulatory Pharma Net srl
- 11.24.1 Company Overview
- 11.24.2 Service Benchmarking
- 11.24.3 Geographic Presence
- 11.24.4 SWOT
- 11.25 Zeincro Group
- 11.25.1 Company Overview
- 11.25.2 Service Benchmarking
- 11.25.3 Geographic Presence
- 11.25.4 Strategic Initiatives
- 11.25.5 SWOT
- 11.26 BioMapas
- 11.26.1 Company Overview
- 11.26.2 Service Benchmarking
- 11.26.3 Geographic Presence
- 11.26.4 Strategic Initiatives
- 11.26.5 SWOT
- 11.27 Dr. Regenold GmbH
- 11.27.1 Company Overview
- 11.27.2 Service Benchmarking
- 11.27.3 SWOT