Dublin, Sept. 29, 2021 (GLOBE NEWSWIRE) -- The "Global Regulatory Affairs Market Size, Share & Trends Analysis Report by Service, by Categories (Biologics, Drugs), by Indication, by Product Stage, by End Use, by Service Providers, by Company Size, by Region, and Segment Forecasts, 2021-2028" report has been added to ResearchAndMarkets.com's offering.
The global regulatory affairs market size is expected to reach USD 22.7 billion by 2028 registering a CAGR of 8.4%. Rise in drug approvals, label expansions of approved products, along with the presence of Fastrack regulatory pathways are anticipated to facilitate the market growth over the forecast period. Technological advancements in regulatory 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 regulatory 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 is 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, initiated by the global and local regulatory authorities to expedite patient access to Covid-19 treatments and vaccines, are anticipated to positively affect the market growth. Market players are actively involved in the adoption of advanced technologies, strategic collaborations, and mergers & 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.
Regulatory Affairs Market Report Highlights
- Regulatory writing and publishing was the leading service segment in 2019 and is projected to retain its dominant position throughout the forecast years
- This growth is credited to an increase in the outsourcing of selected regulatory functions by major life sciences companies
- The Biologics segment is anticipated to witness the fastest CAGR over the forecast period due to the increasing popularity of personalized medicines and biosimilars
- The oncology indication segment dominated the market in 2019 and will expand further at a steady CAGR from 2020 to 2027
- This growth can be attributed to the rising cancer cases and mortality rate along with the presence of several innovative pipeline products
Key Topics Covered:
Chapter 1 Methodology and Scope
Chapter 2 Executive Summary
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, 2020 & 2028
4.2 Regulatory Consulting
4.2.1 Regulatory consulting market, 2016 - 2028 (USD Million)
4.3 Legal Representation
4.3.1 Legal representation market, 2016 - 2028 (USD Million)
4.4 Regulatory Writing and Publishing
4.4.1 Regulatory writing and publishing market, 2016 - 2028 (USD Million)
4.5 Product Registration and Clinical Trial Application
4.5.1 Product registration and clinical trial application market, 2016 - 2028 (USD Million)
4.6 Other Regulatory Services
4.6.1 Other regulatory services market, 2016 - 2028 (USD Million)
Chapter 5 Regulatory Affairs Market: Service Provider Segment Analysis
5.1 Regulatory Affairs: Service Provider Market Share Analysis, 2020 & 2028
5.2 In-house
5.2.1 In-house regulatory affairs market, 2016 - 2028 (USD Million)
5.3 Outsourcing
5.3.1 Outsourcing market, 2016 - 2028 (USD Million)
Chapter 6 Regulatory Affairs Market: Company Size Segment Analysis
6.1 Regulatory Affairs: Company Size Market Share Analysis, 2020 & 2028
6.2 Small Sized
6.2.1 Small companies based regulatory affairs market, 2016 - 2028 (USD Million)
6.3 Medium Sized
6.3.1 Medium-sized companies based regulatory affairs market, 2016 - 2028 (USD Million)
6.4 Large Companies
6.4.1 Large companies based regulatory affairs market, 2016 - 2028 (USD Million)
Chapter 7 Regulatory Affairs Market: Categories Segment Analysis
7.1 Regulatory Affairs: Categories Market Share Analysis, 2020 & 2028
7.2 Drugs
7.3 Biologics
7.4 Medical Devices
Chapter 8 Regulatory Affairs Market: Product Stage Segment Analysis
8.1 Regulatory Affairs: Product Stage Market Share Analysis, 2020 & 2028
8.2 Preclinical
8.2.1 Preclinical based regulatory affairs market, 2016 - 2028 (USD Million)
8.3 Clinical
8.3.1 clinical based regulatory affairs market, 2016 - 2028 (USD Million)
8.4 PMA
8.4.1 PMA based regulatory affairs market, 2016 - 2028 (USD Million)
Chapter 9 Regulatory Affairs Market: Indication Segment Analysis
9.1 Regulatory affairs: Indication Market Share Analysis, 2020 & 2028
9.2 Oncology
9.2.1 Oncology based regulatory affairs market, 2016 - 2028 (USD Million)
9.3 Neurology
9.3.1 Neurology based regulatory affairs market, 2016 - 2028 (USD Million)
9.4 Cardiology
9.4.1 cardiology based regulatory affairs market, 2016 - 2028 (USD Million)
9.5 Immunology
9.5.1 Immunology indication based regulatory affairs market, 2016 - 2028 (USD Million)
9.6 Other Indications
9.6.1 Other indication based regulatory affairs market, 2016 - 2028 (USD Million)
Chapter 10 Regulatory Affairs Market: End-use Segment Analysis
10.1 Regulatory affairs: End-use Market Share Analysis, 2020 & 2028
10.2 Medical Device Companies
10.2.1 Medical device companies market, 2016 - 2028 (USD Million)
10.3 Pharmaceutical Companies
10.3.1 Pharmaceutical companies market, 2016 - 2028 (USD Million)
10.4 Biotechnology Companies
10.4.1 Biotechnology companies market, 2016 - 2028 (USD Million)
Chapter 11 Regulatory Affairs Market: Regional Analysis
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
For more information about this report visit https://www.researchandmarkets.com/r/4zi8p8
