Regulatory affairs outsourcing market

Regulatory Affairs Outsourcing Market, by Service Type (Regulatory Consulting and Legal Representation, Product Registration and Clinical Trial Applications, Regulatory Writing and Publishing, Regulatory Submission, and Others), by Application (Pharma and Biotech Products, and Medical Devices), and by Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) - Size, Share, Outlook, and Opportunity Analysis, 2019 - 2027

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Oct 2019
CMI2751
166 Pages
Excel & Pdf
Pharmaceutical

Summary

Regulatory Affairs Outsourcing Market – Insights

Regulatory affairs outsourcing are the services utilized by the pharmaceutical, biotech and medical devices manufacturing companies for gaining fast regulatory approvals from various organizations.

The Global Regulatory Affairs Outsourcing Market size was valued at US$ 3,683.7 million in 2019, and is expected to exhibit a CAGR of 12.0% over the forecast period (2019 – 2027).

Figure 1. Global Regulatory Affairs Outsourcing Market Value (US$ Mn), by Region, 2019

Source: Coherent Market Insights Analysis (2019)

Increasing incidence of refractive disorders is expected to propel growth of the regulatory affairs outsourcing market

Increasing research and development expenditure in the healthcare sector is expected to drive growth of the regulatory affairs outsourcing market. According to the National Bureau of Statistics, February 2018, China’s expenditure on research and development increased by 11.6% in 2017 from 10.6% in 2016, reaching US$ 280 Mn in 2017.

The companies offering outsourcing services have higher product approval potential, in comparison to pharmaceutical or biotechnology companies owing to the specific expertise in the field of regulatory affairs. For instance, ProEd Regulatory, a subsidiary of Health Consultancy Group, stated that it has 80% success rate and it takes around 8 to 10 drugs through a regulatory process to get approval each year.

However the risks associated with data sharing and outsourcing are major factors that are expected to hamper the regulatory outsourcing market growth over the forecast period. Moreover, many outsourcing partners have access to sensitive data of pharmaceutical or other industries, which may pose a threat to the companies security and data sharing.

Figure 2. Global Regulatory Affairs Outsourcing Market Share (%), by Therapeutic Applications, 2019 and 2027

Source: Coherent Market Insights Analysis (2019)

Increasing adoption of acquisition strategies in North America is expected to bolster the market growth

North America holds a dominant position in the global regulatory affairs outsourcing market, owing to increasing merger and acquisition strategies adopted by market players. For instance, in 2015, BioClinica, Inc. acquired Synowledge, headquartered in Miami, U.S., to expand its offering in the drug safety and regulatory business process outsourcing market. Synowledge specializes in regulatory affairs and information technology services for biopharmaceutical companies. Similarly, in 2014, Certara, a technology-enabled drug development and drug safety consultancy, announced the acquisition of specialty contract research organization (CRO) Synchrogenix Information Strategies Inc. Synchrogenix offers regulatory writing and related services to pharmaceutical, biotechnology and medical device manufacturers worldwide.

Moreover, increasing research and development expenditure is a major factor driving the regulatory outsourcing market growth in North America. For instance, according to Pharmaceutical Research and Manufacturers of America, in 2016, the biopharmaceutical industry invested an estimated US$ 90 billion in research and development activities in the U.S.

Key Players

Major players operating in the global regulatory affairs outsourcing market include WuXi AppTec Co., Ltd., Charles River Laboratories, Inc., Accell Clinical Research, LLC, PRA Health Sciences, Inc., Parexel International Corporation, Clinilabs Inc., Criterium Inc., IQVIA Holdings Inc., Medpace Inc., and Certara, L.P.

Table of Content

Table of Contents

Research Objectives and Assumptions

Research Objectives
Assumptions
Abbreviations

Market Purview

Report Description

Market Definition and Scope

Executive Summary

Market Snippet, By Service Type
Market Snippet, By Application
Market Snippet, By Region

Coherent Opportunity Map (COM)

Market Dynamics, Regulations, and Trends Analysis

Market Dynamics

Drivers
Restraints
Market Opportunities

Impact Analysis
Key Highlights
PEST Analysis
Collaborations and Agreements

Global Regulatory Affairs Outsourcing Market, By Service Type, 2016 – 2027, (US$ Mn)

Introduction

Market Share Analysis, 2019 and 2027 (%)
Y-o-Y Growth Analysis, 2017 – 2027
Segment Trends

Regulatory Consulting and Legal Representation

Introduction
Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)

Product Registration and Clinical Trial Applications

Introduction
Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)

Regulatory Writing and Publishing

Introduction
Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)

Regulatory Submission

Introduction
Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)

Others

Introduction
Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)

Global Regulatory Affairs Outsourcing Market, By Application, 2016 – 2027, (US$ Mn)

Introduction

Market Share Analysis, 2019 and 2027 (%)
Y-o-Y Growth Analysis, 2017 – 2027
Segment Trends

Pharma and Biotech Products

Introduction
Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)

Medical Devices

Introduction
Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)

Global Regulatory Affairs Outsourcing Market, By Region, 2016 – 2027, (US$ Mn)

Introduction

Market Share Analysis, By Region, 2019 and 2027 (%)
Y-o-Y Growth Analysis, For Regions, 2017–2026

North America

Market Size and Forecast, By Service Type, 2016 – 2027, (US$ Mn)
Market Size and Forecast, By Application, 2016 – 2027, (US$ Mn)
Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)

U.S.
Canada

Latin America

Market Size and Forecast, By Service Type, 2016 – 2027, (US$ Mn)
Market Size and Forecast, By Application, 2016 – 2027, (US$ Mn)
Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)

Brazil
Mexico
Argentina
Rest of Latin America

Europe

Market Size and Forecast, By Service Type, 2016 – 2027, (US$ Mn)
Market Size and Forecast, By Application, 2016 – 2027, (US$ Mn)
Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)

Germany
U.K.
France
Italy
Spain
Russia
Rest of Europe

Asia Pacific

Market Size and Forecast, By Service Type, 2016 – 2027, (US$ Mn)
Market Size and Forecast, By Application, 2016 – 2027, (US$ Mn)
Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)

China
India
Japan
Australia
South Korea
ASEAN
Rest of APAC

Middle East

Market Size and Forecast, By Service Type, 2016 – 2027, (US$ Mn)
Market Size and Forecast, By Application, 2016 – 2027, (US$ Mn)
Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)

GCC
Israel
Rest of Middle East

Africa

Market Size and Forecast, By Service Type, 2016 – 2027, (US$ Mn)
Market Size and Forecast, By Application, 2016 – 2027, (US$ Mn)
Market Size and Forecast, By Country, 2016 – 2027, (US$ Mn)

South Africa
Central Africa
North Africa

Competitive Landscape

Heat Map Analysis
Company Profiles

WuXi AppTec Co., Ltd.

Company Overview
Product Type Portfolio
Financial Overview
Key Highlights
Market Strategies

Charles River Laboratories, Inc.

Company Overview
Product Type Portfolio
Financial Overview
Key Highlights
Market Strategies

Accell Clinical Research, LLC

Company Overview
Product Type Portfolio
Financial Overview
Key Highlights
Market Strategies

PRA Health Sciences, Inc.

Company Overview
Product Type Portfolio
Financial Overview
Key Highlights
Market Strategies

Parexel International Corporation

Company Overview
Product Type Portfolio
Financial Overview
Key Highlights
Market Strategies

Clinilabs Inc.

Company Overview
Product Type Portfolio
Financial Overview
Key Highlights
Market Strategies

Criterium Inc.

Company Overview
Product Type Portfolio
Financial Overview
Key Highlights
Market Strategies

IQVIA Holdings Inc.

Company Overview
Product Type Portfolio
Financial Overview
Key Highlights
Market Strategies

Medpace Inc.

Company Overview
Product Type Portfolio
Financial Overview
Key Highlights
Market Strategies

Certara, L.P.

Company Overview
Product Type Portfolio
Financial Overview
Key Highlights
Market Strategies

Analyst Views

Section

References
Research Methodology
About us and Sales Contact

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- Frequently Asked Questions -

What are the growth estimates for regulatory affairs outsourcing market till 2027?

The global regulatory affairs outsourcing market is estimated to surpass US$ 9.1 Billion by 2027.

Which are the prominent regulatory affairs outsourcing market players across the globe?

What are the key factors hampering growth of theregulatory affairs outsourcing market?

Risks associated with data sharing and outsourcing aresome of the major factors that are expected to hamper growth of the market over the forecast period.

What are the key factors driving growth of the regulatory affairs outsourcing market?

Increasing research and development expenditure in the healthcare sector is one of the major factors that is expected to propel growth of the market over the forecast period.

What is the Compound Annual Growth Rate (CAGR) of the regulatory affairs outsourcing market for next 8 years?

The global regulatory affairs outsourcing market is estimated to exhibit a CAGR of 12.0% over the forecast period.

Which region is dominating the regulatory affairs outsourcing market growth?

Among regions, North Americais expected to hold dominant position in the global regulatory affairs outsourcing market over the forecast period.