Regulatory Affairs Outsourcing Market Size, Share, Opportunities And Trends By Services (Regulatory Affairs, Clinical Trial Applications, Product Registrations, Regulatory Writing And Publishing, Regulatory Consulting, Legal Representation Others) And Geography - Forecasts From 2019 To 2024

Published:  Apr 2021 Report Code: KSI061611988 Pages: 114

The regulatory affairs outsourcing market is projected to grow at a CAGR of XX.XX% to reach US$XX.XXX billion by 2023, from US$XX.XXX billion in 2017. Regulatory affairs outsourcing is becoming a common practice in the Pharma and Biotech industry. Outsourcing is also practised in pharmacovigilance as well and most companies are looking for partnerships in order to manage the operational tasks which include report publishing and submission as well. Incidences of rising disease prevalence especially in the regions of Asia Pacific and MEA are driving the growth of the global regulatory affairs outsourcing market in the forecast period. Also, with the advent of new and rare diseases, the number of clinical trials is also increasing, thus leading to an increase in the demand of these services. Furthermore, the growing trend of biosimilars is expected to create a demand for regulatory expertise which will lead to the growth of the regulatory affairs outsourcing market in the forecast period and beyond.

This research study examines the current market trends related to demand, supply, and sales, in addition to the recent developments. Major drivers, restraints, and opportunities have been covered to provide an exhaustive picture of the market. The analysis presents in-depth information regarding the development, trends, and industry policies and regulations implemented in each of the geographical regions. Further, the overall regulatory framework of the market has been exhaustively covered to offer stakeholders a better understanding of the key factors affecting the overall market environment.

Identification of key industry players in the industry and their revenue contribution to the overall business or relevant segment aligned to the study have been covered as a part of competitive intelligence done through extensive secondary research. Various studies and data published by industry associations, analyst reports, investor presentations, press releases and journals among others have been taken into consideration while conducting the secondary research. Both bottom-up and top down approaches have been utilized to determine the market size of the overall market and key segments. The values obtained are correlated with the primary inputs of the key stakeholders in the regulatory affairs outsourcing value chain. The last step involves complete market engineering which includes analyzing the data from different sources and existing proprietary datasets while using various data triangulation methods for market breakdown and forecasting.

Market intelligence is presented in the form of analysis, charts, and graphics to help the clients in gaining a faster and more efficient understanding of the regulatory affairs outsourcing market.

Major industry players profiled as part of the report are Syneos Health, Genpact, CRITERIUM, INC., PRAHEALTHSCIENCES and PMI among others.

Segmentation

The regulatory affairs outsourcing market has been analyzed through following segments:

By Services

Regulatory Affairs

Cinical Trial Applications

Product Registrations

Regulatory Writing and Publishing

Regulatory Consulting

Legal Representation

Others

 

By Geography

North America

USA

Canada

Mexico

Others

 

South America

Brazil

Argentina

Others

 

Europe

Germany

France

United Kingdom

Spain

Others

 

Middle East and Africa

Saudi Arabia

Israel

Others

 

Asia Pacific

China

Japan

South Korea

India

Others

 

Target audience

Manufacturers

Suppliers

Distributors

Service Providers

Government Agencies

Research Organizations

Consultants

 

Key insights offered

What will be the regulatory affairs outsourcing market size from 2017 to 2023?

How are the major drivers and restraints affecting the regulatory affairs outsourcing market growth and the opportunities which exist for key vendors?

Which segment and region will drive or lead the market growth and why?

A comprehensive analysis of competitive landscape and key market participants’ behaviour

 

Key strategies being adopted by vendors, with in-depth analysis along with their impact on competition and market growth.

1. INTRODUCTION
1.1. Market Overview
1.2. Market Definition
1.3. Scope of the Study
1.4. Currency
1.5. Assumptions
1.6. Base, and Forecast Years Timeline
2. RESEARCH METHODOLOGY  
2.1. Research Design
2.2. Secondary Sources
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1. Market Segmentation
4.2. Market Drivers
4.3. Market Restraints
4.4. Market Opportunities
4.5. Porter’s Five Force Analysis
4.5.1. Bargaining Power of Suppliers
4.5.2. Bargaining Power of Buyers
4.5.3. Threat of New Entrants
4.5.4. Threat of Substitutes
4.5.5. Competitive Rivalry in the Industry
4.6. Life Cycle Analysis - Regional Snapshot
4.7. Market Attractiveness
5. REGULATORY AFFAIRS OUTSOURCING MARKET BY SERVICES
5.1. Regulatory Affairs
5.2. Cinical Trial Applications
5.3. Product Registrations
5.4. Regulatory Writing and Publishing
5.5. Regulatory Consulting 
5.6. Legal Representation
5.7. Others
6. REGULATORY AFFAIRS OUTSOURCING MARKET BY GEOGRAPHY
6.1. North America
6.1.1. USA
6.1.2. Canada
6.1.3. Mexico
6.1.4. Others
6.2. South America
6.2.1. Brazil
6.2.2. Argentia
6.2.3. Others
6.3. Europe
6.3.1. Germany
6.3.2. France
6.3.3. United Kingdom
6.3.4. Spain
6.3.5. Others
6.4. Middle East and Africa
6.4.1. Saudi Arabia
6.4.2. Israel
6.4.3. Others
6.5. Asia Pacific
6.5.1. China
6.5.2. Japan
6.5.3. South Korea
6.5.4. India
6.5.5. Others
7. COMPETITIVE INTELLIGENCE
7.1.  Market Share of Key Players
7.2.  Recent Investment and Deals
7.3. Strategies of Key Players
8. COMPANY PROFILES
8.1. Syneos Health
8.1.1. Company Overview
8.1.2. Financials
8.1.3. Products and Services
8.1.4. Recent Developments
8.2. Genpact
8.2.1. Company Overview
8.2.2. Financials
8.2.3. Products and Services
8.2.4. Recent Developments
8.3.  CRITERIUM, INC.
8.3.1. Company Overview
8.3.2. Financials
8.3.3. Products and Services
8.3.4. Recent Developments
8.4.  PRAHEALTHSCIENCES
8.4.1. Company Overview
8.4.2. Financials
8.4.3. Products and Services
8.4.4. Recent Developments
8.5.  PMI
8.5.1. Company Overview
8.5.2. Financials
8.5.3. Products and Services
8.5.4. Recent Developments
8.6. WuXi AppTec
8.6.1. Company Overview
8.6.2. Financials
8.6.3. Products and Services
8.6.4. Recent Developments
8.7. Medpace, Inc.
8.7.1. Company Overview
8.7.2. Financials
8.7.3. Products and Services
8.7.4. Recent Developments
8.8. Pharmaceutical Product Development, LLC
8.8.1. Company Overview
8.8.2. Financials
8.8.3. Products and Services
8.8.4. Recent Developments
8.9. PAREXEL International Corporation
8.9.1. Company Overview
8.9.2. Financials
8.9.3. Products and Services
8.9.4. Recent Developments
8.10. IQVIA
8.10.1. Company Overview
8.10.2. Financials
8.10.3. Products and Services
8.10.4. Recent Developments
LIST OF FIGURES
LIST OF TABLES
DISCLAIMER 

Syneos Health

Genpact

CRITERIUM, INC.

PRAHEALTHSCIENCES

PMI

WuXi AppTec

Medpace, Inc.

Pharmaceutical Product Development, LLC

PAREXEL International Corporation

IQVIA

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