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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

Publisher Grand View Research
Published Mar 21, 2023
Length 275 Pages
SKU # GV17991425

Description

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


Regulatory Affairs Outsourcing Market Growth & Trends


The global regulatory affairs outsourcing market size is expected to reach USD 12.82 billion by 2030, registering a CAGR of 8.0% 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 2022 and the positive rebound of sales across the industry can be witnessed from 2023.

Regulatory Affairs Outsourcing Market Report Highlights

  • The product registration & clinical trial applications segment dominated the market with the maximum revenue share of 25.9% in 2022, as 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 of 8.4% 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’s growth.
  • The clinical studies stage segment accounted for the largest market share of 47.0% in 2022 due to the increasing demand for clinical trials in developing countries.
  • The pharmaceutical companies by end-use segment is anticipated to witness the fastest growth rate of 8.2% over the forecast period due to evolving areas, such as orphan drugs and personalized therapies.
  • In terms of category, the pharmaceutical segment held the dominant market share of 62.1% in 2022. High shares is expected to be driven by the increasing demand for innovative drugs and therapies, rising prevalence of chronic diseases, and growing investment in research and development activities by key players in the pharmaceutical industry
  • Asia Pacific held the maximum revenue share of 38.5% in 2022, 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
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Table of Contents

275 Pages
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

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