Regulatory Affairs Market Size, Share & Trends Analysis Report By Service, By Category (Biologics, Drugs), By Indication, By Product Stage, By End-use, By Service, By Company Size, By Region, And Segment Forecasts, 2020 - 2027

Regulatory Affairs Market Size, Share & Trends Analysis Report By Service, By Category (Biologics, Drugs), By Indication, By Product Stage, By End-use, By Service, By Company Size, By Region, And Segment Forecasts, 2020 - 2027

Regulatory Affairs Market Growth & Trends

The global regulatory affairs market size is expected to reach USD 20.9 billion by 2027, expanding at a CAGR of 8.4%, according to a new report by Grand View Research, Inc. Rise in drug approvals, label expansions of approved products, along with the presence of fast-track government pathways are anticipated to facilitate market growth over the forecast period. In addition, technological advancements in related software and the growing digital transformation in the healthcare industry are also expected to contribute to market growth.

In addition, the introduction of Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) is anticipated to not only change the EU governing landscape and increase the stringency of regulations but also increase the number of documents required to be created and maintained by companies. Furthermore, the changes in the Central Administration for Pharmaceutical Affairs (CAPA) scope in Egypt are anticipated to change the medical device registration process in the country. Such changes in local regulations are anticipated to favor market growth.

Furthermore, several regulatory changes related to clinical trials, vaccine development, and product approvals are anticipated to positively impact the market. These changes are initiated by global and local supervising authorities to expedite patient access to COVID-19 treatments and vaccines.

Market players are actively involved in the adoption of advanced technologies, strategic collaborations, and mergers and acquisition, to strengthen their market positions and outperform the competition. For instance, in 2020, ICON acquired MedPass, a medical device CRO, reimbursement, and regulatory consultancy firm. This acquisition is aimed at strengthening the medical device and diagnostic research services portfolio of ICON through the addition of new clinical and regulatory capabilities in Europe.

Asia Pacific dominated the market and accounted for the largest revenue share in 2019. The region is expected to witness the highest CAGR over the forecast period. This is attributed to the availability of workforce in the region at a lower cost. In addition, the expanding healthcare industry and tax benefits in countries including Singapore, India, and China are driving the market in the region.

Regulatory Affairs Market Report Highlights

Regulatory writing and publishing was the leading segment in 2019 owing to an increase in the outsourcing of selected functions by major life sciences companies while focusing on the core functions

The biologics segment is anticipated to witness lucrative growth over the forecast period due to the increasing popularity of personalized medicine and biosimilars

The oncology segment dominated the market in 2019 due to the increasing prevalence and mortality rate of cancer along with the presence of several innovative pipeline products.

Please note: The report will be updated with the latest data and delivered to you within 2-3 business days.


Chapter 1 Methodology and Scope
1.1 Market Segmentation & Scope
1.1.1 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:
1.8.2 Objective - 2:
1.8.3 Objective - 3:
1.8.4 Objective - 4:
Chapter 2 Executive Summary
2.1 Market Outlook
Chapter 3 Regulatory Affairs 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 Major Deals and Strategic Alliances Analysis (Biotech & ATMPs)
3.7 Regulatory affairs: Market Analysis Tools
3.7.1 SWOT
3.7.2 Industry analysis - Porter’s
3.7.3 PESTEL analysis
Chapter 4 Regulatory affairs Market: Service Segment Analysis
4.1 Regulatory affairs: Service Market Share Analysis, 2019 & 2027
4.2 Regulatory Consulting
4.2.1 Regulatory consulting market, 2016 - 2027 (USD Million)
4.3 Legal Representation
4.3.1 Legal representation market, 2016 - 2027 (USD Million)
4.4 Regulatory Writing and Publishing
4.4.1 Regulatory writing and publishing market, 2016 - 2027 (USD Million)
4.5 Product Registration and Clinical Trial Application
4.5.1 Product registration and clinical trial application market, 2016 - 2027 (USD Million)
4.6 Other Regulatory Services
4.6.1 Other regulatory services market, 2016 - 2027 (USD Million)
Chapter 5 Regulatory Affairs Market: Service Provider Segment Analysis
5.1 Regulatory Affairs: Service Provider Market Share Analysis, 2019 & 2027
5.2 In-house
5.2.1 In-house regulatory affairs market, 2016 - 2027 (USD Million)
5.3 Outsourced
5.3.1 Outsourced market, 2016 - 2027 (USD Million)
Chapter 6 Regulatory Affairs Market: Company Size Segment Analysis
6.1 Regulatory Affairs: Company Size Market Share Analysis, 2019 & 2027
6.2 Small Sized
6.2.1 Small companies based regulatory affairs market, 2016 - 2027 (USD Million)
6.3 Medium Sized
6.3.1 Medium-sized companies based regulatory affairs market, 2016 - 2027 (USD Million)
6.4 Large Companies
6.4.1 Large companies based regulatory affairs market, 2016 - 2027 (USD Million)
Chapter 7 Regulatory Affairs Market: Categories Segment Analysis
7.1 Regulatory Affairs: Categories Market Share Analysis, 2019 & 2027
7.2 Drugs
7.2.1 Drugs based regulatory affairs market, 2016 - 2027 (USD Million)
7.2.1.1 Innovator drugs based regulatory affairs market, 2016 - 2027 (USD Million)
7.2.1.1.1 Preclinical drugs based regulatory affairs market, 2016 - 2027 (USD Million)
7.2.1.1.2 Clinical drugs based regulatory affairs market, 2016 - 2027 (USD Million)
7.2.1.1.3 Post market drugs based regulatory affairs market, 2016 - 2027 (USD Million)
7.2.1.2 Generic drugs based regulatory affairs market, 2016 - 2027 (USD Million)
7.2.1.2.1 Preclinical drugs based regulatory affairs market, 2016 - 2027 (USD Million)
7.2.1.2.2 Clinical drugs based regulatory affairs market, 2016 - 2027 (USD Million)
7.2.1.2.3 Post market drugs based regulatory affairs market, 2016 - 2027 (USD Million)
7.3 Biologics
7.3.1 Biologics based regulatory affairs market, 2016 - 2027 (USD Million)
7.3.1.1 Biotech based regulatory affairs market, 2016 - 2027 (USD Million)
7.3.1.1.1 Preclinical drugs based regulatory affairs market, 2016 - 2027 (USD Million)
7.3.1.1.2 Clinical based regulatory affairs market, 2016 - 2027 (USD Million)
7.3.1.1.3 Post market based regulatory affairs market, 2016 - 2027 (USD Million)
7.3.1.2 ATMP based regulatory affairs market, 2016 - 2027 (USD Million)
7.3.1.2.1 Preclinical based regulatory affairs market, 2016 - 2027 (USD Million)
7.3.1.2.2 Clinical based regulatory affairs market, 2016 - 2027 (USD Million)
7.3.1.2.3 Post market based regulatory affairs market, 2016 - 2027 (USD Million)
7.3.1.3 Biosimilar based regulatory affairs market, 2016 - 2027 (USD Million)
7.3.1.3.1 Preclinical based regulatory affairs market, 2016 - 2027 (USD Million)
7.3.1.3.2 Clinical based regulatory affairs market, 2016 - 2027 (USD Million)
7.3.1.3.3 Post market based regulatory affairs market, 2016 - 2027 (USD Million)
7.4 Medical Devices
7.4.1 Medical devices based regulatory affairs market, 2016 - 2027 (USD Million)
7.4.1.1 Diagnostic based regulatory affairs market, 2016 - 2027 (USD Million)
7.4.1.1.1 Preclinical based regulatory affairs market, 2016 - 2027 (USD Million)
7.4.1.1.2 Clinical based regulatory affairs market, 2016 - 2027 (USD Million)
7.4.1.1.3 Post market based regulatory affairs market, 2016 - 2027 (USD Million)
7.4.1.2 Therapeutic based regulatory affairs market, 2016 - 2027 (USD Million)
7.4.1.2.1 Preclinical based regulatory affairs market, 2016 - 2027 (USD Million)
7.4.1.2.2 Clinical based regulatory affairs market, 2016 - 2027 (USD Million)
7.4.1.2.3 Post market based regulatory affairs market, 2016 - 2027 (USD Million)
Chapter 8 Regulatory Affairs Market: Product Stage Segment Analysis
8.1 Regulatory Affairs: Product Stage Market Share Analysis, 2019 & 2027
8.2 Preclinical
8.2.1 Preclinical based regulatory affairs market, 2016 - 2027 (USD Million)
8.3 Clinical
8.3.1 clinical based regulatory affairs market, 2016 - 2027 (USD Million)
8.4 PMA
8.4.1 PMA based regulatory affairs market, 2016 - 2027 (USD Million)
Chapter 9 Regulatory Affairs Market: Indication Segment Analysis
9.1 Regulatory affairs: Indication Market Share Analysis, 2019 & 2027
9.2 Oncology
9.2.1 Oncology based regulatory affairs market, 2016 - 2027 (USD Million)
9.3 Neurology
9.3.1 Neurology based regulatory affairs market, 2016 - 2027 (USD Million)
9.4 Cardiology
9.4.1 cardiology based regulatory affairs market, 2016 - 2027 (USD Million)
9.5 Immunology
9.5.1 Immunology indication based regulatory affairs market, 2016 - 2027 (USD Million)
9.6 Other Indications
9.6.1 Other indication based regulatory affairs market, 2016 - 2027 (USD Million)
Chapter 10 Regulatory Affairs Market: End-use Segment Analysis
10.1 Regulatory affairs: End-use Market Share Analysis, 2019 & 2027
10.2 Medical Device Companies
10.2.1 Medical device companies market, 2016 - 2027 (USD Million)
10.3 Pharmaceutical Companies
10.3.1 Pharmaceutical companies market, 2016 - 2027 (USD Million)
10.4 Biotechnology Companies
10.4.1 Biotechnology companies market, 2016 - 2027 (USD Million)
Chapter 11 Regulatory Affairs Market: Regional Analysis
11.1 Regulatory affairs: Regional Market Share Analysis, 2019 & 2027
11.2 North America
11.2.1 North America regulatory affairs market, 2016 - 2027 (USD Million)
11.2.2 U.S.
11.2.2.1 U.S. Regulatory affairs market, 2016 - 2027 (USD Million)
11.2.3 Canada
11.2.3.1 Canada regulatory affairs market, 2016 - 2027 (USD Million)
11.3 Europe
11.3.1 Europe regulatory affairs market, 2016 - 2027 (USD Million)
11.3.2 U.K.
11.3.2.1 U.K. regulatory affairs market, 2016 - 2027 (USD Million)
11.3.3 Germany
11.3.3.1 Germany regulatory affairs market, 2016 - 2027 (USD Million)
11.3.4 France
11.3.4.1 France regulatory affairs market, 2016 - 2027 (USD Million)
11.3.5 Italy
11.3.5.1 Italy regulatory affairs market, 2016 - 2027 (USD Million)
11.3.6 Spain
11.3.6.1 Spain regulatory affairs market, 2016 - 2027 (USD Million)
11.3.7 Russia
11.3.7.1 Russia regulatory affairs market, 2016 - 2027 (USD Million)
11.3.8 Turkey
11.3.8.1 Turkey regulatory affairs market, 2016 - 2027 (USD Million)
11.3.9 Netherlands
11.3.9.1 Netherlands regulatory affairs market, 2016 - 2027 (USD Million)
11.3.10 Switzerland
11.3.10.1 Switzerland regulatory affairs market, 2016 - 2027 (USD Million)
11.3.11 Sweden
11.3.11.1 Sweden regulatory affairs market, 2016 - 2027 (USD Million)
11.4 Asia Pacific
11.4.1 Asia Pacific regulatory affairs market, 2016 - 2027 (USD Million)
11.4.2 Japan
11.4.2.1 Japan regulatory affairs market, 2016 - 2027 (USD Million)
11.4.3 China
11.4.3.1 China regulatory affairs market, 2016 - 2027 (USD Million)
11.4.4 India
11.4.4.1 India regulatory affairs market, 2016 - 2027 (USD Million)
11.4.5 Australia
11.4.5.1 Australia regulatory affairs market, 2016 - 2027 (USD Million)
11.4.6 South Korea
11.4.6.1 South Korea regulatory affairs market, 2016 - 2027 (USD Million)
11.4.7 Indonesia
11.4.7.1 Indonesia regulatory affairs market, 2016 - 2027 (USD Million)
11.4.8 Malaysia
11.4.8.1 Malaysia regulatory affairs market, 2016 - 2027 (USD Million)
11.4.9 Singapore
11.4.9.1 Singapore regulatory affairs market, 2016 - 2027 (USD Million)
11.4.10 Thailand
11.4.10.1 Thailand regulatory affairs market, 2016 - 2027 (USD Million)
11.4.11 Taiwan
11.4.11.1 Taiwan regulatory affairs market, 2016 - 2027 (USD Million)
11.5 Latin America
11.5.1 Latin America regulatory affairs market, 2016 - 2027 (USD Million)
11.5.2 Brazil
11.5.2.1 Brazil regulatory affairs market, 2016 - 2027 (USD Million)
11.5.3 Mexico
11.5.3.1 Mexico regulatory affairs market, 2016 - 2027 (USD Million)
11.5.4 Argentina
11.5.4.1 Argentina regulatory affairs market, 2016 - 2027 (USD Million)
11.5.5 Colombia
11.5.5.1 Colombia regulatory affairs market, 2016 - 2027 (USD Million)
11.5.6 Chile
11.5.6.1 Chile regulatory affairs market, 2016 - 2027 (USD Million)
11.6 MEA
11.6.1 MEA regulatory affairs market, 2016 - 2027 (USD Million)
11.6.2 South Africa
11.6.2.1 South Africa regulatory affairs market, 2016 - 2027 (USD Million)
11.6.3 Saudi Arabia
11.6.3.1 Saudi Arabia regulatory affairs market, 2016 - 2027 (USD Million)
11.6.4 UAE
11.6.4.1 UAE regulatory affairs market, 2016 - 2027 (USD Million)
11.6.5 Egypt
11.6.5.1 Egypt regulatory affairs market, 2016 - 2027 (USD Million)
11.6.6 Israel
11.6.6.1 Israel regulatory affairs market, 2016 - 2027 (USD Million)
Chapter 12 Company Profiles
12.1 Accell Clinical Research, LLC.
12.1.1 Company overview
12.1.2 Financial performance
12.1.3 Organization structure & team composition
12.1.3.1 Team composition
12.1.4 Service benchmarking
12.1.5 Geographic presence
12.1.6 Strategic initiatives
12.1.7 SWOT
12.2 Genpact Ltd.
12.2.1 Company overview
12.2.2 Financial performance
12.2.3 Organization structure & team composition
12.2.3.1 Team composition
12.2.4 Service benchmarking
12.2.5 Geographic presence
12.2.6 Strategic initiatives
12.2.7 SWOT
12.3 Criterium, Inc.
12.3.1 Company overview
12.3.2 Financial performance
12.3.3 Organization structure & team composition
12.3.3.1 Team composition
12.3.4 Service benchmarking
12.3.5 Geographic presence
12.3.6 SWOT
12.4 PRA Health Sciences
12.4.1 Company overview
12.4.2 Financial performance
12.4.3 Organization structure & team composition
12.4.3.1 Team composition
12.4.4 Service benchmarking
12.4.5 Geographic presence
12.4.6 Strategic initiatives
12.4.7 SWOT
12.5 ProMedica International
12.5.1 Company overview
12.5.2 Financial performance
12.5.3 Organization structure & team composition
12.5.3.1 Team composition
12.5.4 Service benchmarking
12.5.5 Geographic presence
12.5.6 SWOT
12.6 WuXi AppTec, Inc.
12.6.1 Company overview
12.6.2 Financial performance
12.6.3 Organization structure & team composition
12.6.3.1 Team composition
12.6.4 Service benchmarking
12.6.5 Geographic presence
12.6.6 Strategic initiatives
12.6.7 SWOT
12.7 Medpace
12.7.1 Company overview
12.7.2 Financial performance
12.7.3 Organization structure & team composition
12.7.3.1 Team composition
12.7.4 Service benchmarking
12.7.5 Geographic presence
12.7.6 SWOT
12.8 Charles River Laboratories International, Inc.
12.8.1 Company overview
12.8.2 Financial performance
12.8.3 Organization structure & team composition
12.8.3.1 Team composition
12.8.4 Service benchmarking
12.8.5 Geographic presence
12.8.6 Strategic initiatives
12.8.7 SWOT
12.9 ICON plc
12.9.1 Company overview
12.9.2 Financial performance
12.9.3 Organization structure & team composition
12.9.3.1 Team composition
12.9.4 Service benchmarking
12.9.5 Geographic presence
12.9.6 Strategic initiatives
12.9.7 SWOT
12.10 Covance
12.10.1 Company overview
12.10.2 Financial performance
12.10.3 Organization structure & team composition
12.10.3.1 Team composition
12.10.4 Service benchmarking
12.10.5 Geographic presence
12.10.6 Strategic initiatives
12.10.7 SWOT
12.11 PAREXEL International Corporation, Inc.
12.11.1 Company overview
12.11.2 Financial performance
12.11.3 Organization structure & team composition
12.11.3.1 Team composition
12.11.4 Service benchmarking
12.11.5 Geographic presence
12.11.6 Strategic initiatives
12.11.7 SWOT
12.12 Freyr
12.12.1 Company overview
12.12.2 Financial performance
12.12.3 Organization structure & team composition
12.12.3.1 Team composition
12.12.4 Service benchmarking
12.12.5 Geographic presence
12.12.6 Strategic initiatives
12.12.7 SWOT
List of Tables
Table 1 List of secondary sources
Table 2 List of Abbreviations

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