Reports

Amid Ukraine-Russia crisis, our analysts and industry experts are closely monitoring the markets and working hard to identify, gather and timely deliver analysis of the impact of the situation and the impact that it has on various markets. All our reports are updated with the latest impact on the market before being sent out to our customers.

Global Healthcare Regulatory Affairs Outsourcing Market: By Services: Regulatory Writing and Publishing, Regulatory Submissions, Others; By Stage; By End Use; Regional Analysis; Historical Market and Forecast (2017-2027); Market Dynamics: SWOT Analysis; Value Chain Analysis; Competitive Landscape; Industry Events and Developments

Global Healthcare Regulatory Affairs Outsourcing Market Outlook

The global market for healthcare regulatory affairs outsourcing is expected to grow at a CAGR of about 9.10% in the forecast period of 2022-2027, owing to the rising prevalence of several chronic diseases.

 

North America and Asia Pacific to be Among the Significant Regional Markets for Healthcare Regulatory Affairs Outsourcing

North America is expected to be one of the dominant regions in the global healthcare regulatory affairs outsourcing market due to the increasing presence of the major international regulatory agencies in the region. The region has a significant presence of multinational biotech and pharma companies that carry out many clinical trials and have a well-developed and advanced healthcare infrastructure. The growth can also be attributed to the increased focus on reducing investment costs and capitalising on the availability of cheap labour, rising concentration on the optimum utilisation of resources, and changing regulatory scenarios across the region.

During the forecast period, Asia Pacific is expected to grow significantly due to the increasingly low cost of labour and increased availability of skilled labour, along with the increase in the number of clinical trials and firms attempting to penetrate markets in countries such as India and China.

 

Europe Expected to Witness Considerable Growth in the Coming Years

Europe is likely to be a key market for healthcare regulatory affairs outsourcing owing to the presence of a significant international regulatory agency, the European Medicines Agency (EMA). The presence of established pharmaceutical and medical device players is one of the key factors driving the market growth in the region. Moreover, many pharma and biotech companies have started outsourcing their drug development services to countries like Italy, Germany, and France, further augmenting the market growth for the healthcare regulatory affairs outsourcing market.

 

Market Segmentations

Healthcare regulatory affairs outsourcing refers to regulatory rules implemented to guarantee that organisations adhere to operational requirements. In general, these policies strive to protect public health and welfare by ensuring the safety of pharmaceutical and healthcare products. Medical writing and publishing regulatory paperwork given by expert medical writers, quality control, and publishers play a crucial role in creating high-quality documents for clinical research initiatives as part of healthcare regulatory affairs outsourcing.

The various services provided by the market are:

  • Regulatory Writing and Publishing
  • Regulatory Submissions
  • Clinical Trial Applications and Services Registrations
  • Regulatory Consulting and Legal Representation
  • Others

Based on stage, the market is divided into:

  • Preclinical
  • Clinical
  • PMA

The end-uses of the market are:

  • Pharmaceutical Companies
  • Biotechnology Companies
  • Medical Device Companies

The regional markets for healthcare regulatory affairs outsourcing can be divided into North America, Europe, the Asia Pacific, Latin America, the Middle East and Africa.

 

Rising Cases of Chronic Ailments Propelling the Market Growth

The rapidly rising cases of various chronic diseases and high expenses connected with research and development operations are the primary drivers fuelling the global healthcare regulatory affairs outsourcing market. Cancer and other infectious diseases encourage biopharmaceutical companies to develop many new products, which is vital in escalating the market growth. Besides this, the rapid increase in clinical trial product development and research and development activities, clinical trial applications, product registration, and drug pipeline, a rising shift toward an outcome-based model, an increase in the use of generics, and an increase in demand for drugs and medical devices at a lower cost are the significant factors propelling the market growth of healthcare regulatory affairs outsourcing.

In addition, the strict government regulations imposed by the regulatory authorities to hire skilled regulatory professionals capable of handling evaluation, registration, and compilation of regulatory compliant documentation will propel the market growth. Rising demand for speedy product approval and increasing investments in the regulatory information system to automate activities like regulatory publishing and operations are expected to influence market growth.

Several companies in the healthcare regulatory affairs outsourcing market are expected to see significant growth during the projection period due to the extensive acceptance of the company's growth strategies such as collaboration, acquisition, and partnerships. For instance, in April 2020, Pfizer Inc. and ICON plc signed a three-year agreement. This agreement expands on the firms' current collaboration, in which ICON provides global expertise in clinical trial planning, execution, management, and execution, which will likely add growth to the market in the coming years.

 

Key Players in the Global Market for Healthcare Regulatory Affairs Outsourcing

The report gives a detailed analysis of the following key players in the global healthcare regulatory affairs outsourcing market, covering their competitive landscape, capacity, and latest developments like mergers, acquisitions, and investments, expansions of capacity, and plant turnarounds:

  • WuXi AppTec
  • Freyr
  • Parexel International Corporation
  • Medpace, Inc.
  • ICON plc
  • IQVIA Inc.
  • Labcorp Drug Development
  • Others

The comprehensive EMR report provides an in-depth assessment of the market based on the Porter's five forces model along with giving a SWOT analysis.

 

Key Highlights of the Report

REPORT FEATURES DETAILS
Base Year 2021
Historical Period 2017-2021
Forecast Period 2022-2027
Scope of the Report

Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:

  • Services
  • Stage
  • End Use 
  • Region
Breakup by Services
  • Regulatory Writing and Publishing
  • Regulatory Submissions
  • Clinical Trial Applications and Services Registrations
  • Regulatory Consulting and Legal Representation
  • Others
Breakup by Stage
  • Preclinical
  • Clinical
  • PMA
Breakup by End Use
  • Pharmaceutical Companies
  • Biotechnology Companies
  • Medical Device Companies
Breakup by Region
  • North America
    • United States of America 
    • Canada
  • Europe
    • United Kingdom
    • Germany
    • France
    • Italy
    • Others
  • Asia Pacific
    • China
    • Japan
    • India
    • ASEAN
    • Australia
    • Others
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Others
  • Middle East and Africa
    • Saudi Arabia
    • United Arab Emirates
    • Nigeria
    • South Africa
    • Others
Market Dynamics
  • SWOT
  • Porter's Five Forces
  • Key Indicators for Demand
  • Key Indicators for Price
Competitive Landscape
  • Market Structure
  • Company Profiles
    • Company Overview
    • Product Portfolio
    • Demographic Reach and Achievements
    • Certifications
Companies Covered
  • WuXi AppTec
  • Freyr
  • Parexel International Corporation
  • Medpace, Inc.
  • ICON plc
  • IQVIA Inc.
  • Labcorp Drug Development
  • Others
Report Price and Purchase Option Explore our purchase options that are best suited to your resources and industry needs.
Delivery Format Delivered as an attached PDF and Excel through email, with an option of receiving an editable PPT, according to the purchase option.

 

*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.

1    Preface 
2    Report Coverage – Key Segmentation and Scope
3    Report Description

    3.1    Market Definition and Outlook
    3.2    Properties and Applications
    3.3    Market Analysis
    3.4    Key Players
4    Key Assumptions   
5    Executive Summary

    5.1    Overview
    5.2    Key Drivers
    5.3    Key Developments  
    5.4    Competitive Structure
    5.5    Key Industrial Trends
6    Market Snapshot
    6.1    Global
    6.2    Region
7    Opportunities and Challenges in the Market
8    Global Healthcare Regulatory Affairs Outsourcing Market Analysis

    8.1    Key Industry Highlights
    8.2    Global Healthcare Regulatory Affairs Outsourcing Historical Market (2017-2021) 
    8.3    Global Healthcare Regulatory Affairs Outsourcing Market Forecast (2022-2027)
    8.4    Global Healthcare Regulatory Affairs Outsourcing Market by Services
        8.4.1    Regulatory Writing and Publishing
            8.4.1.1    Market Share
            8.4.1.2    Historical Trend (2017-2021)
            8.4.1.3    Forecast Trend (2022-2027)
        8.4.2    Regulatory Submissions
            8.4.2.1    Market Share
            8.4.2.2    Historical Trend (2017-2021)
            8.4.2.3    Forecast Trend (2022-2027)
        8.4.3    Clinical Trial Applications and Services Registrations
            8.4.3.1    Market Share
            8.4.3.2    Historical Trend (2017-2021)
            8.4.3.3    Forecast Trend (2022-2027)
        8.4.4    Regulatory Consulting and Legal Representation
            8.4.4.1    Market Share
            8.4.4.2    Historical Trend (2017-2021)
            8.4.4.3    Forecast Trend (2022-2027)
        8.4.5    Others
    8.5    Global Healthcare Regulatory Affairs Outsourcing Market by Stage
        8.5.1    Preclinical
            8.5.1.1    Market Share
            8.5.1.2    Historical Trend (2017-2021)
            8.5.1.3    Forecast Trend (2022-2027)
        8.5.2    Clinical
            8.5.2.1    Market Share
            8.5.2.2    Historical Trend (2017-2021)
            8.5.2.3    Forecast Trend (2022-2027)
        8.5.3    PMA
            8.5.3.1    Market Share
            8.5.3.2    Historical Trend (2017-2021)
            8.5.3.3    Forecast Trend (2022-2027)
    8.6    Global Healthcare Regulatory Affairs Outsourcing Market by End Use 
        8.6.1    Pharmaceutical Companies
            8.6.1.1    Market Share
            8.6.1.2    Historical Trend (2017-2021)
            8.6.1.3    Forecast Trend (2022-2027)
        8.6.2    Biotechnology Companies
            8.6.2.1    Market Share
            8.6.2.2    Historical Trend (2017-2021)
            8.6.2.3    Forecast Trend (2022-2027)
        8.6.3    Medical Device Companies
            8.6.3.1    Market Share
            8.6.3.2    Historical Trend (2017-2021)
            8.6.3.3    Forecast Trend (2022-2027)
    8.7    Global Healthcare Regulatory Affairs Outsourcing Market by Region
        8.7.1    North America
            8.7.1.1    Market Share
            8.7.1.2    Historical Trend (2017-2021) 
            8.7.1.3    Forecast Trend (2022-2027)
        8.7.2    Europe
            8.7.2.1    Market Share
            8.7.2.2    Historical Trend (2017-2021) 
            8.7.2.3    Forecast Trend (2022-2027)
        8.7.3    Asia Pacific
            8.7.3.1    Market Share
            8.7.3.2    Historical Trend (2017-2021) 
            8.7.3.3    Forecast Trend (2022-2027)
        8.7.4    Latin America
            8.7.4.1    Market Share
            8.7.4.2    Historical Trend (2017-2021) 
            8.7.4.3    Forecast Trend (2022-2027)
        8.7.5    Middle East and Africa
            8.7.5.1    Market Share
            8.7.5.2    Historical Trend (2017-2021) 
            8.7.5.3    Forecast Trend (2022-2027)
9    North America Healthcare Regulatory Affairs Outsourcing Market Analysis
    9.1    United States of America 
        9.1.1    Market Share
        9.1.2    Historical Trend (2017-2021) 
        9.1.3    Forecast Trend (2022-2027)
    9.2    Canada
        9.2.1    Market Share
        9.2.2    Historical Trend (2017-2021) 
        9.2.3    Forecast Trend (2022-2027)
10    Europe  Healthcare Regulatory Affairs Outsourcing Market Analysis
    10.1    United Kingdom
        10.1.1    Market Share
        10.1.2    Historical Trend (2017-2021) 
        10.1.3    Forecast Trend (2022-2027)
    10.2    Germany
        10.2.1    Market Share
        10.2.2    Historical Trend (2017-2021) 
        10.2.3    Forecast Trend (2022-2027)
    10.3    France
        10.3.1    Market Share
        10.3.2    Historical Trend (2017-2021) 
        10.3.3    Forecast Trend (2022-2027)
    10.4    Italy
        10.4.1    Market Share
        10.4.2    Historical Trend (2017-2021) 
        10.4.3    Forecast Trend (2022-2027)
    10.5    Others
11    Asia Pacific Healthcare Regulatory Affairs Outsourcing Market Analysis
    11.1    China
        11.1.1    Market Share
        11.1.2    Historical Trend (2017-2021) 
        11.1.3    Forecast Trend (2022-2027)
    11.2    Japan
        11.2.1    Market Share
        11.2.2    Historical Trend (2017-2021) 
        11.2.3    Forecast Trend (2022-2027)
    11.3    India
        11.3.1    Market Share
        11.3.2    Historical Trend (2017-2021) 
        11.3.3    Forecast Trend (2022-2027)
    11.4    ASEAN
        11.4.1    Market Share
        11.4.2    Historical Trend (2017-2021) 
        11.4.3    Forecast Trend (2022-2027)
    11.5    Australia
        11.5.1    Market Share
        11.5.2    Historical Trend (2017-2021) 
        11.5.3    Forecast Trend (2022-2027)
    11.6    Others
12    Latin America Healthcare Regulatory Affairs Outsourcing Market Analysis
    12.1    Brazil
        12.1.1    Market Share
        12.1.2    Historical Trend (2017-2021) 
        12.1.3    Forecast Trend (2022-2027)
    12.2    Argentina
        12.2.1    Market Share
        12.2.2    Historical Trend (2017-2021) 
        12.2.3    Forecast Trend (2022-2027)
    12.3    Mexico
        12.3.1    Market Share
        12.3.2    Historical Trend (2017-2021) 
        12.3.3    Forecast Trend (2022-2027)
    12.4    Others
13    Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market Analysis
    13.1    Saudi Arabia
        13.1.1    Market Share
        13.1.2    Historical Trend (2017-2021) 
        13.1.3    Forecast Trend (2022-2027)
    13.2    United Arab Emirates
        13.2.1    Market Share
        13.2.2    Historical Trend (2017-2021) 
        13.2.3    Forecast Trend (2022-2027)
    13.3    Nigeria
        13.3.1    Market Share
        13.3.2    Historical Trend (2017-2021) 
        13.3.3    Forecast Trend (2022-2027)
    13.4    South Africa
        13.4.1    Market Share
        13.4.2    Historical Trend (2017-2021) 
        13.4.3    Forecast Trend (2022-2027)
    13.5    Others
14    Market Dynamics
    14.1    SWOT Analysis
        14.1.1    Strengths
        14.1.2    Weaknesses
        14.1.3    Opportunities
        14.1.4    Threats
    14.2    Porter’s Five Forces Analysis
        14.2.1    Supplier’s Power
        14.2.2    Buyer’s Power
        14.2.3    Threat of New Entrants
        14.2.4    Degree of Rivalry
        14.2.5    Threat of Substitutes
    14.3    Key Indicators for Demand
    14.4    Key Indicators for Price
15    Competitive Landscape
    15.1    Market Structure
    15.2    Company Profiles
        15.2.1    WuXi AppTec
            15.2.1.1    Company Overview
            15.2.1.2    Product Portfolio
            15.2.1.3    Demographic Reach and Achievements
            15.2.1.4    Certifications
        15.2.2    Freyr
            15.2.2.1    Company Overview
            15.2.2.2    Product Portfolio
            15.2.2.3    Demographic Reach and Achievements
            15.2.2.4    Certifications
        15.2.3    Parexel International Corporation
            15.2.3.1    Company Overview
            15.2.3.2    Product Portfolio
            15.2.3.3    Demographic Reach and Achievements
            15.2.3.4    Certifications
        15.2.4    Medpace, Inc.
            15.2.4.1    Company Overview
            15.2.4.2    Product Portfolio
            15.2.4.3    Demographic Reach and Achievements
            15.2.4.4    Certifications
        15.2.5    ICON plc
            15.2.5.1    Company Overview
            15.2.5.2    Product Portfolio
            15.2.5.3    Demographic Reach and Achievements
            15.2.5.4    Certifications
        15.2.6    IQVIA Inc.
            15.2.6.1    Company Overview
            15.2.6.2    Product Portfolio
            15.2.6.3    Demographic Reach and Achievements
            15.2.6.4    Certifications
        15.2.7    Labcorp Drug Development
            15.2.7.1    Company Overview
            15.2.7.2    Product Portfolio
            15.2.7.3    Demographic Reach and Achievements
            15.2.7.4    Certifications
        15.2.8    Others
16    Key Trends and Developments in the Market

 

List of Key Figures and Tables

1.    Global Healthcare Regulatory Affairs Outsourcing Market: Key Industry Highlights, 2017 and 2027
2.    Global Healthcare Regulatory Affairs Outsourcing Historical Market: Breakup by Services (USD Billion), 2017-2021
3.    Global Healthcare Regulatory Affairs Outsourcing Market Forecast: Breakup by Services (USD Billion), 2022-2027
4.    Global Healthcare Regulatory Affairs Outsourcing Historical Market: Breakup by Stage (USD Billion), 2017-2021
5.    Global Healthcare Regulatory Affairs Outsourcing Market Forecast: Breakup by Stage (USD Billion), 2022-2027
6.    Global Healthcare Regulatory Affairs Outsourcing Historical Market: Breakup by End Use (USD Billion), 2017-2021
7.    Global Healthcare Regulatory Affairs Outsourcing Market Forecast: Breakup by End Use (USD Billion), 2022-2027
8.    Global Healthcare Regulatory Affairs Outsourcing Historical Market: Breakup by Region (USD Billion), 2017-2021
9.    Global Healthcare Regulatory Affairs Outsourcing Market Forecast: Breakup by Region (USD Billion), 2022-2027
10.    North America Healthcare Regulatory Affairs Outsourcing Historical Market: Breakup by Country (USD Billion), 2017-2021
11.    North America Healthcare Regulatory Affairs Outsourcing Market Forecast: Breakup by Country (USD Billion), 2022-2027
12.    Europe Healthcare Regulatory Affairs Outsourcing Historical Market: Breakup by Country (USD Billion), 2017-2021
13.    Europe Healthcare Regulatory Affairs Outsourcing Market Forecast: Breakup by Country (USD Billion), 2022-2027
14.    Asia Pacific Healthcare Regulatory Affairs Outsourcing Historical Market: Breakup by Country (USD Billion), 2017-2021
15.    Asia Pacific Healthcare Regulatory Affairs Outsourcing Market Forecast: Breakup by Country (USD Billion), 2022-2027
16.    Latin America Healthcare Regulatory Affairs Outsourcing Historical Market: Breakup by Country (USD Billion), 2017-2021
17.    Latin America Healthcare Regulatory Affairs Outsourcing Market Forecast: Breakup by Country (USD Billion), 2022-2027
18.    Middle East and Africa Healthcare Regulatory Affairs Outsourcing Historical Market: Breakup by Country (USD Billion), 2017-2021
19.    Middle East and Africa Healthcare Regulatory Affairs Outsourcing Market Forecast: Breakup by Country (USD Billion), 2022-2027
20.    Global Healthcare Regulatory Affairs Outsourcing Market Structure.

Key Questions Answered in the Report

The global healthcare regulatory affairs outsourcing market is projected to grow at a CAGR of 9.10% between 2022 and 2027.

The major drivers of the market include the increase in clinical trial product development, increase in the use of generics, increase in demand for drugs and medical devices at a lower cost, strict government regulations to hire skilled regulatory professionals capable, rising demand for speedy product approval and increasing investments in the regulatory information system.

Rising cases of chronic diseases and increased research and development activities are the key industry trends propelling the market's growth.

The major regions in the industry are North America, Latin America, the Middle East and Africa, Europe, and the Asia Pacific.

The various services provided by the market include regulatory writing and publishing, regulatory submissions, clinical trial applications and services registrations, and regulatory consulting and legal representation, among others.

Based on stage, the market is divided into preclinical, clinical, and PMA.

The end-use sectors are pharmaceutical, biotechnology, and medical device companies.

The major players in the industry include WuXi AppTec, Freyr, Parexel International Corporation, Medpace, Inc., ICON plc, IQVIA Inc., and Labcorp Drug Development, among others.

Analyst Review

The rising cases of chronic diseases drove the global healthcare regulatory affairs outsourcing market in the historical period. Aided by the increase in demand for drugs and medical devices at a lower cost and increase in research and development activities, the market is expected to grow at a CAGR of 9.10% in the forecast period of 2022-2027. 

EMR’s meticulous research methodology delves deep into the market, covering the macro and micro aspects of the industry. The various services the market provides are regulatory writing and publishing, regulatory submissions, clinical trial applications and services registrations, and regulatory consulting and legal representation, among others. Based on stage, the market is divided into preclinical, clinical, and PMA. The market's end-uses are pharmaceutical, biotechnology, and medical device companies. The major regional markets for healthcare regulatory affairs outsourcing are North America, Europe, the Asia Pacific, Latin America, the Middle East and Africa. The key players in the above market are WuXi AppTec, Freyr, Parexel International Corporation, Medpace, Inc., ICON plc, IQVIA Inc., and Labcorp Drug Development, among others.

EMR’s research methodology uses a combination of cutting-edge analytical tools and the expertise of their highly accomplished team, thus, providing their customers with market insights that are accurate, actionable, and help them remain ahead of their competition. 

Purchase Full Report

Mini Report

$1499
  • Selected Sections, One User
  • Printing Not Allowed
  • Email Delivery in PDF
  • Free Limited Customisation
  • Post Sales Analyst Support
  • 50% Discount on Next Update

Single User License

$2699
  • All Sections, One User
  • One Print Allowed
  • Email Delivery in PDF
  • Free Limited Customisation
  • Post Sales Analyst Support
  • 50% Discount on Next Update

Five User License

$3699
  • All Sections, Five Users
  • Five Prints Allowed
  • Email Delivery in PDF
  • Free Limited Customisation
  • Post Sales Analyst Support
  • 50% Discount on Next Update

Corporate License

$4699
  • All Sections, Unlimited Users
  • Unlimited Prints Allowed
  • Email Delivery in PDF + Excel
  • Free Limited Customisation
  • Post Sales Analyst Support
  • 50% Discount on Next Update

Any Question? Speak With An Analyst

Contact Analyst

View A Sample

Request Sample

Did You Miss Anything, Ask Now

Request Customisation
Why Expert Market Research?

Right People

We are technically excellent, strategic, practical, experienced and efficient; our analysts are hand-picked based on having the right attributes to work successfully and execute projects based on your expectations.

Right Methodology

We leverage our cutting-edge technology, our access to trusted databases, and our knowledge of the current models used in the market to deliver you research solutions that are tailored to your needs and put you ahead of the curve.

Right Price

We deliver in-depth and superior quality research in prices that are reasonable, unmatchable, and shows our understanding of your resource structure. We, additionally, offer attractive discounts on our upcoming reports.

Right Support

Our team of expert analysts are at your beck and call to deliver you optimum results that are customised to meet your precise needs within the specified timeframe and help you form a better understanding of the industry.

NEWSLETTER