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Regulatory Affairs Outsourcing Market, By Service (Regulatory Writing & Publishing, Regulatory Consulting, Clinical Trial & Product Registration, and Legal Representation), and Geography (NA, EU, APAC, and RoW) – Analysis, Share, Trends, Size, & Forecast From 2016 – 2027- COVID- 19 Updated
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Published by AnalystView: 01 Jul 2020 | 270566 | In Stock
Related Topics: COVID , Drug , Publishing

Introduction

REPORT HIGHLIGHT

The regulatory affairs outsourcing market is estimated to represent a global market of USD 6.57 billion by 2019 with growth rate of 12.3%.

Market Dynamics

Outsourcing is an integral part of any pharmaceutical and biotechnology companies’ value chain during the phase of research and development. A significant rise in clinical studies conducted in emerging economies has fueled the demand for outsourcing activities in regulatory services, providing a healthy platform for this industry growth. Regions such as Asia-Pacific offers a cost-effective environment for conducting drug development studies. For instance, countries such as China and India provide lower costs for clinical trials. Cost for conducting studies in these regions are 25% to 40% lower than that of the U.S. and European countries. Due to these facts, the trend of regulatory outsourcing has taken over the pharma and biotech companies operating in developed regions. In addition, a notable change in regulatory landscape coupled with the globalization of life-science organizations plays an important role in fostering the development of this industry. However, the risk associated with data security coupled with lack of standardization is a major challenge as organizations are outsourcing their clinical activities to offshore regions like the Asia Pacific and Latin America.

COVID-19 Impact and Recovery Analysis

The recent outburst of the COVID-19 has led the global regulatory affairs outsourcing market to render new offering for combatting with the rising demand for protection against the virus. Due to this outbreak, regulatory affairs outsourcing market is projected to gain grip in future.

The published research on regulatory affairs outsourcing market provides a bird’s eye view of the current COVID-19 outbreak. Further, the study also considers the post-COVID-19 impact and offers a clear assessment of the projected industry fluctuations. The different factors that are likely to impact the overall market dynamics, including top performer segments, marginal growth segments and top loser segments and more are discussed in detail in this research report.

Regional Takeaway

Asia Pacific region is considered to be the fastest growing, at a 15.2% CAGR versus North America’s 10.8% from 2019 to 2021-2027. This region is accounted for the largest share of the total market as it is well positioned to become a preferred destination for pharmaceutical studies. Attractive traits such as large patient pool, speedy recruitment, high-quality infrastructure and cost-effectiveness support the regional growth significantly. On contrary, North America captured 20.98% share of the overall market. Drug approval procedures are becoming more stringent and time-consuming in this regions. On other side, pharmaceutical industries are aimed to receive product approvals at the first attempt to gain higher shares. Thereby, companies are required to outsource their regulatory affairs in emerging regions which will pull back the growth of this industry in developed regions.

Key Vendor Takeaway

Key players such as Quintiles Transnational, ICON plc, Pharmaceutical Product Development, PAREXEL International, and Covance, Inc. are profiled extensively. Collectively, these players accounted for more than 50% share of the total market revenue. Global players have realized that timely marketing and clinical approvals from government bodies are the key parameters in drug development. Therefore, companies either strengthen their in-house regulatory department or outsource this process to the consulting firms. It has been noticed that industries are mainly focusing on their core competencies and outsourcing non-core functions to increase their productivity and operational efficiency, supporting the industry growth.

The market size and forecast for each segment has been provided for the period 2016 to 2027, considering 2019 as the base year. The report also provides the compounded annual growth rate (% CAGR) for the forecast period 2021 to 2027 for every reported segment.

The years considered for the study are:

Historical Year – 2016 to 2018

Base Year – 2019

Estimated Year – 2020

Projected Year – 2027

The proposed reports analyse and evaluates the COVID-19 impact, and anticipated change on the future market scenario on this industry, by taking into the account the economic, political, technological, and social, parameters.

SCOPE OF THE REPORT

The scope of this report covers the market by its major segments, which include as follows:

MARKET, BY SERVICE

Regulatory Writing & Publishing

Regulatory Consulting

Clinical Trial & Product Registration

Legal Representation

Others

MARKET, BY REGION

North America

U.S.

Canada

Europe

Germany

France

Rest of Europe

Asia Pacific

India

China

Rest of APAC

Rest of the World

Middle East and Africa

Latin America

Table of Contents
for Regulatory Affairs Outsourcing Market, By Service (Regulatory Writing & Publishing, Regulatory Consulting, Clinical Trial & Product Registration, and Legal Representation), and Geography (NA, EU, APAC, and RoW) – Analysis, Share, Trends, Size, & Forecast From 2016 – 2027- COVID- 19 Updated

  • TABLE OF CONTENT

    1. REGULATORY AFFAIRS OUTSOURCING MARKET OVERVIEW

    1.1. Study Scope

    1.2. Assumption and Methodology

    2. EXECUTIVE SUMMARY

    2.1. Key Market Facts

    2.2. Geographical Scenario

    2.3. Companies in the Market

    3. REGULATORY AFFAIRS OUTSOURCING KEY MARKET TRENDS

    3.1. Market Drivers

    3.1.1. Impact Analysis of Market Drivers

    3.2. Market Restraints

    3.2.1. Impact Analysis of Market Restraints

    3.3. Market Opportunities

    3.4. Market Future Trends

    4. REGULATORY AFFAIRS OUTSOURCING INDUSTRY STUDY

    4.1. Porter’s Analysis

    4.2. Market Attractiveness Analysis

    4.3. Regulatory Framework Analysis

    4.4 REGULATORY AFFAIRS OUTSOURCING MARKET: COVID-19 IMPACT ANALYSIS

    4.4.1 Pre-COVID-19 Impact Analysis

    4.4.2 Post-COVID-19 Impact Analysis

    4.4.3 Top Performing Segments

    4.4.4 Marginal Growth Segments

    4.4.5 Top Looser Segments

    4.4.6 Marginal Loss Segments

    5. REGULATORY AFFAIRS OUTSOURCING MARKET LANDSCAPE

    5.1. Market Share Analysis

    6. REGULATORY AFFAIRS OUTSOURCING MARKET – BY SERVICE

    6.1. Overview

    6.2. Regulatory Writing & Publishing

    6.2.1. Overview

    6.2.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2016 – 2026, (US$ Billion)

    6.3. Regulatory Consulting

    6.3.1. Overview

    6.3.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2016 – 2026, (US$ Billion)

    6.4. Clinical Trial & Product Registration

    6.4.1. Overview

    6.4.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2016 – 2026, (US$ Billion)

    6.5. Legal Representation

    6.5.1. Overview

    6.5.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2016 – 2026, (US$ Billion)

    6.6. Others

    6.6.1. Overview

    6.6.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2016 – 2026, (US$ Billion)

    7. REGULATORY AFFAIRS OUTSOURCING MARKET– BY GEOGRAPHY

    7.1. Introduction

    7.2. North America

    7.2.1. Overview

    7.2.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2016 – 2026, (US$ Billion)

    7.2.3. U.S.

    7.2.3.1. Overview

    7.2.3.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2016 – 2026, (US$ Billion)

    7.2.4. Canada

    7.2.4.1. Overview

    7.2.4.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2016 – 2026, (US$ Billion)

    7.3. Europe

    7.3.1. Overview

    7.3.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2016 – 2026, (US$ Billion)

    7.3.3. France

    7.3.3.1. Overview

    7.3.3.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2016 – 2026, (US$ Billion)

    7.3.4. Germany

    7.3.4.1. Overview

    7.3.4.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2016 – 2026, (US$ Billion)

    7.3.5. Rest of Europe

    7.3.5.1. Overview

    7.3.5.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2016 – 2026, (US$ Billion)

    7.4. Asia Pacific (APAC)

    7.4.1. Overview

    7.4.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2016 – 2026, (US$ Billion)

    7.4.3. China

    7.4.3.1. Overview

    7.4.3.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2016 – 2026, (US$ Billion)

    7.4.4. India

    7.4.4.1. Overview

    7.4.4.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2016 – 2026, (US$ Billion)

    7.4.5. Rest of APAC

    7.4.5.1. Overview

    7.4.5.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2016 – 2026, (US$ Billion)

    7.5. Rest of the World

    7.5.1. Overview

    7.5.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2016 – 2026, (US$ Billion)

    7.5.3. Latin America

    7.5.3.1. Overview

    7.5.3.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2016 – 2026, (US$ Billion)

    7.5.4. Middle East and Africa

    7.5.4.1. Overview

    7.5.4.2. Market Analysis, Forecast, and Y-O-Y Growth Rate, 2016 – 2026, (US$ Billion)

    8. KEY VENDOR ANALYSIS

    8.1. Quintiles Transnational

    8.1.1. Company Overview

    8.1.2. Product Benchmarking

    8.1.3. Key Developments

    8.2. ICON plc

    8.2.1. Company Overview

    8.2.2. Product Benchmarking

    8.2.3. Key Developments

    8.3. Pharmaceutical Product Development

    8.3.1. Company Overview

    8.3.2. Product Benchmarking

    8.3.3. Key Developments

    8.4. PAREXEL International

    8.4.1. Company Overview

    8.4.2. Product Benchmarking

    8.4.3. Key Developments

    8.5. Covance, Inc.

    8.5.1. Company Overview

    8.5.2. Product Benchmarking

    8.5.3. Key Developments

    9. 360 DEGREE ANALYSTVIEW

    10. APPENDIX

    10.1. Research Methodology

    10.2. Abbreviations

    10.3. Disclaimer

    10.4. Contact Us

List Of Tables
in Regulatory Affairs Outsourcing Market, By Service (Regulatory Writing & Publishing, Regulatory Consulting, Clinical Trial & Product Registration, and Legal Representation), and Geography (NA, EU, APAC, and RoW) – Analysis, Share, Trends, Size, & Forecast From 2016 – 2027- COVID- 19 Updated

List of Tables

Table 1 List of Acronyms

Table 2 Key Market Facts, 2016 – 2027

Table 3 Market Drivers: Impact Analysis

Table 4 Market Restraint: Impact Analysis

Table 5 Market Opportunity: Impact Analysis

Table 6 PEST Analysis

Table 7 Porter’s Five Forces Analysis

Table 8 Company Market Share Analysis

Table 9 Global Regulatory Affairs Outsourcing Market Analysis, Forecast, and Y-O-Y Growth Rate, 2016 – 2027, (US$ Billion)

Table 10 Regulatory Affairs Outsourcing Market, by Service, 2016 – 2027 (USD Billion)

Table 11 Regulatory Affairs Outsourcing Market, by Geography, 2016 – 2027 (USD Billion)

Table 12 North America Regulatory Affairs Outsourcing Market, 2016 – 2027 (USD Billion)

Table 13 U.S. Regulatory Affairs Outsourcing Market, 2016 – 2027 (USD Billion)

Table 14 Canada Regulatory Affairs Outsourcing Market, 2016 – 2027 (USD Billion)

Table 15 Europe Regulatory Affairs Outsourcing Market, 2016 – 2027 (USD Billion)

Table 16 France Regulatory Affairs Outsourcing Market, 2016 – 2027 (USD Billion)

Table 17 Germany Regulatory Affairs Outsourcing Market, 2016 – 2027 (USD Billion)

Table 18 Asia Pacific Regulatory Affairs Outsourcing Market, 2016 – 2027 (USD Billion)

Table 19 China Regulatory Affairs Outsourcing Market, 2016 – 2027 (USD Billion)

Table 20 India Regulatory Affairs Outsourcing Market, 2016 – 2027 (USD Billion)

Table 21 Latin America Regulatory Affairs Outsourcing Market, 2016 – 2027 (USD Billion)

Table 22 MEA Regulatory Affairs Outsourcing Market, 2016 – 2027 (USD Billion)

List Of Figures, Charts and Diagrams
in Regulatory Affairs Outsourcing Market, By Service (Regulatory Writing & Publishing, Regulatory Consulting, Clinical Trial & Product Registration, and Legal Representation), and Geography (NA, EU, APAC, and RoW) – Analysis, Share, Trends, Size, & Forecast From 2016 – 2027- COVID- 19 Updated

List of Figures

Figure 1 Research Methodology

Figure 2 Research Process Flow Chart

Figure 3 Comparative Analysis, by Geography, 2016-2025 (Value %)

Figure 4 Regulatory Framework Analysis

Figure 5 Regulatory Affairs Outsourcing Market, by Service, 2016 – 2027 (USD Billion)

Figure 6 Regulatory Affairs Outsourcing Market, by Geography, 2016 – 2027 (USD Billion)

Additional Details

Publisher

AnalystView

Publisher Information

AnalystView Market Insights is a market research and consulting firm that adopts a proactive approach to provide the diverse need for accurate and precise market research, custom research, and consulting solutions across geographies and industry verticals. Our company is led by a team of passionate, naturally curious, and strategic thinkers from different industry backgrounds.



These experts are dedicated to creating concrete market data analysis in various industries such as Healthcare, Bulk Chemicals, Semiconductors and Electronics, Foods and Beverages. We strive to develop meaningful and evidence-based research data that helps our clients, empowering organizations and brands of all sizes with strategic analysis, accurate data, and consumer trends.



We aim to be the number one choice for various clients who require credible data to make vital business decisions. We wish to be a trusted and reliable analytics partner to major business organizations.



We understand that critical business decisions can be taken only when verified, authentic information is available. Therefore, our experts work meticulously to provide our clients with the accurate data, so that they need not spend time in verifying it.



It is also our goal to help our clients ignore traditional research methods that require a large amount of capital, manpower, and most important of it all – the time. We know that these factors are precious to a company and always follow the latest research techniques that produce the required result in a short span of time.

Reference

270566 | AV176

Number of Pages

211

Report Format

PDF

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This report is published by AnalystView

AnalystView Market Insights is a market research and consulting firm that adopts a proactive approach to provide the diverse need for accurate and precise market research, custom research, and consulting solutions across geographies and industry verticals. Our company is led by a team of passionate, naturally curious, and strategic thinkers from different industry backgrounds.

These experts are dedicated to creating concrete market data analysis in various industries such as Healthcare, Bulk Chemicals, Semiconductors and Electronics, Foods and Beverages. We strive to develop meaningful and evidence-based research data that helps our clients, empowering organizations and brands of all sizes with strategic analysis, accurate data, and consumer trends.

We aim to be the number one choice for various clients who require credible data to make vital business decisions. We wish to be a trusted and reliable analytics partner to major business organizations.

We understand that critical business decisions can be taken only when verified, authentic information is available. Therefore, our experts work meticulously to provide our clients with the accurate data, so that they need not spend time in verifying it.

It is also our goal to help our clients ignore traditional research methods that require a large amount of capital, manpower, and most important of it all – the time. We know that these factors are precious to a company and always follow the latest research techniques that produce the required result in a short span of time.

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