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

  • Published On : Oct 2019 |
  • Pages : 166 Pages |
  • Format : CMI Insight PPT Format CMI Insight PDF Format

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

Regulatory Affairs Outsourcing  | Coherent Market Insights

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

Regulatory Affairs Outsourcing  | Coherent Market Insights

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.

Regulatory affairs outsourcing market has grown significantly over the last decade. Increasing research and development expenditure in healthcare sector and increasing adoption of various growth strategies has boosted demand for regulatory outsourcing services in recent years. These services are majorly offered in the pharmaceutical and medical devices segment. Rising number of clinical trials is expected to fuel the Regulatory affairs outsourcing market growth over the forecast period.

Market Dynamics

Increasing number of clinical trials and research and development expenditure in the healthcare sector is expected to drive the market growth. According to Clinical Trials.gov, the number of clinical studies registered in 50 states and 209 countries in 2018 and around 293,353 and 262,371 in 2017.

Companies engaged in the Regulatory affairs outsourcing market are expected to generate significant return-on-investment (ROI) over the forecast period owing to the increasing adoption of business growth strategies such as partnership, acquisition by the market players.  For instance, in June 2018, Medpace, Inc. and International Health Management Associates, Inc. announced collaboration for offering clinical trials in the infectious diseases domain. Similarly, in August 2018, Synchrogenix, subsidiary of Certara, L.P., announced partnership with PleaseTech Ltd., a review specialist and provider of document redaction services

Key players in the market are focused on facility expansions in order to enhance their share in potential markets, which, in turn, is expected to propel the market growth over the forecast period. For instance, in July 2019, Health Advances LLC, a healthcare consulting and subsidiary of Parexel International Corporation, launched Health Advances Asia Limited and extended its offering in drug development and commercialization services to the Asia Pacific region.

Key features of the study:

  • This report provides in-depth analysis of the Regulatory affairs outsourcing market and provides market size (US$ million) and Compound Annual Growth Rate (CAGR %) for the forecast period (2019 – 2027), considering 2019 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends,  regional outlook, and competitive strategy adopted by key players
  • It profiles key players in the global Regulatory affairs outsourcing market based on the following parameters – company overview, financial performance, product portfolio, market presence, distribution strategies, key developments, strategies, and future plans
  • Key companies covered as a part of this study 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.
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, technology up-gradation, market expansion, and marketing tactics.
  • The global Regulatory affairs outsourcing market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the regulatory outsourcing market

Detailed Segmentation:

  • Global Regulatory Affairs Outsourcing Market, By Service Type:
    • Regulatory Consulting and Legal Representation
    • Product Registration and Clinical Trial Applications
    • Regulatory Writing and Publishing
    • Regulatory Submission
    • Others
  • Global Regulatory Affairs Outsourcing Market, By Application:
    • Pharma and Biotech Products
    • Medical Devices
  • Global Regulatory Affairs Outsourcing Market, By Geography/Region:
    • North America
      • By Service Type:
        • Regulatory Consulting and Legal Representation
        • Product Registration and Clinical Trial Applications
        • Regulatory Writing and Publishing
        • Regulatory Submission
        • Others
      • By Application:
        • Pharma and Biotech Products
        • Medical Devices
      • By Country:
        • U.S.
        • Canada
    • Latin America
      • By Service Type:
        • Regulatory Consulting and Legal Representation
        • Product Registration and Clinical Trial Applications
        • Regulatory Writing and Publishing
        • Regulatory Submission
        • Others
      • By Application:
        • Pharma and Biotech Products
        • Medical Devices
      • By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Service Type:
        • Regulatory Consulting and Legal Representation
        • Product Registration and Clinical Trial Applications
        • Regulatory Writing and Publishing
        • Regulatory Submission
        • Others
      • By Application:
        • Pharma and Biotech Products
        • Medical Devices
      • By Country:
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Service Type:
        • Regulatory Consulting and Legal Representation
        • Product Registration and Clinical Trial Applications
        • Regulatory Writing and Publishing
        • Regulatory Submission
        • Others
      • By Applications:
        • Pharma and Biotech Products
        • Medical Devices
      • By Country:
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • By Service Type:
        • Regulatory Consulting and Legal Representation
        • Product Registration and Clinical Trial Applications
        • Regulatory Writing and Publishing
        • Regulatory Submission
        • Others
      • By Application:
        • Pharma and Biotech Products
        • Medical Devices
      • By Country:
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Service Type:
        • Regulatory Consulting and Legal Representation
        • Product Registration and Clinical Trial Applications
        • Regulatory Writing and Publishing
        • Regulatory Submission
        • Others
      • By Application:
        • Pharma and Biotech Products
        • Medical Devices
      • By Country:
        • South Africa
        • Central Africa
        • North Africa
  • Company Profiles
    • WuXi AppTec Co., Ltd.*
      • Company Overview
      • Product Portfolio
      • Financial Performance
      • Key Highlights
      • Market Strategies
    • Charles River Laboratories, Inc.
    • Accell Clinical Research, LLC
    • PRA Health Sciences, Inc.
    • Parexel International Corporation
    • Clinilabs Inc.
    • Criterium Inc.
    • IQVIA Holdings Inc.
    • Medpace Inc.
    • Certara, L.P.

“*” marked represents similar segmentation in other categories in the respective section.

Table of Contents

  1. Research Objectives and Assumptions
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. 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)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints
      • Market Opportunities
    • Impact Analysis
    • Key Highlights
    • PEST Analysis
    • Collaborations and Agreements
  4. 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)
  5. 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)
  6. 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
  7. 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
  8. Section
    • References
    • Research Methodology
    • About us and Sales Contact

*Browse 27 market data tables and 22 figures on "Regulatory Affairs Outsourcing Market - Global forecast to 2027”.

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