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.
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- 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 TablesTable 1 List of secondary sourcesTable 2 List of Abbreviations