Healthcare Regulatory Affairs Outsourcing Market Research Report - Forecast till 2030

Healthcare Regulatory Affairs Outsourcing Market Trends, Application And Growth Analysis By Service (Regulatory Writing And Publishing & Regulatory Submissions) And End User (Mid-Size Pharmaceutical Companies & Biotechnology Companies) - Forecast Till 2030

ID: MRFR/HC/6334-HCR | February 2023 | Region: Global | 90 Pages         

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Healthcare Regulatory Affairs Outsourcing Market

Healthcare Regulatory Affairs Outsourcing Market is expected to reach USD 9.8 Billion at CAGR of 9.4% during the forecast period

Segmentation
By Service Regulatory Writing and Publishing Regulatory Submissions Clinical Trial Applications sand Services Registrations Regulatory Consulting and Legal Representation
By End Users Mid-Size Pharmaceutical Companies Large Pharmaceutical Companies Biotechnology Companies Medical Device Companies Food and Beverage Companies
Key Players
Companies Profiled   Accell Clinical Research LLC   Charles River Laboratories International Inc.   Clinilabs Inc.   Covance Inc.   Criterium Inc.   ICON plc   Medpace Inc.   PAREXEL International Corporation   Pharmaceutical Product Development (PPD) LLC   Promedica International
Drivers
Market Driving Forces   Rising development of products in clinical trials   The demand for clinical trial applications
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Healthcare Regulatory Affairs Outsourcing Market Overview


The healthcare regulatory affairs outsourcing market size is expected to reach USD 9.8 billion by 2030 at 9.4% CAGR during the forecast period 2022-2030. 


Outsourcing regulations have become a common practice in the healthcare industry. Corporations' rise in geographical operations for quick approvals in local markets is contributing to the market's growth. R&D activities develop the regulatory affairs outsourcing market, and the increased rate of clinical trials and product registration is driving the market.


The rise in the number of patent expirations and increased research activities will fuel the market's growth in the forecast period. Furthermore, the growing concern for chronic diseases, like cancer and infectious diseases, promotes the market.


The recent development of goods in clinical trials and the demand for clinical trial applications with product registration services is resulting in market expansion. Driving the expansion of this market. All these activities will lead to market growth in the forecast period.


Segmentation


The global healthcare regulatory affairs outsourcing market has been segmented into services, and end user.


By services, the market has been segmented into regulatory writing and publishing, regulatory submissions, clinical trial applications and services registrations, regulatory consulting and legal representation and other regulatory affairs.


On the basis of end user, the market has been segmented into mid-size pharmaceutical companies, large pharmaceutical companies, biotechnology companies, medical device companies, and food and beverage companies.


The global market of healthcare regulatory affairs outsourcing has been segmented, by region, into the Americas, Europe, Asia-Pacific, and the Middle East & Africa. The market of healthcare regulatory affairs outsourcing in the Americas has further been segmented into North America and Latin America, with the North American market divided into the US and Canada.


The European healthcare regulatory affairs outsourcing market has been segmented into Western Europe and Eastern Europe. The Western Europe market for healthcare regulatory affairs outsourcing has further been classified as Germany, France, the UK, Italy, Spain, and the rest of Western Europe.


The market of healthcare regulatory affairs outsourcing in Asia-Pacific has been segmented into Japan, China, India, South Korea, Australia, and the rest of Asia-Pacific. The market for healthcare regulatory affairs outsourcing in the Middle East & Africa has been segmented into the Middle East and Africa.


Key players


Accell Clinical Research, LLC, Charles River Laboratories International, Inc., Clinilabs, Inc., Criterium Inc., ICON plc, Covance, Inc., Medpace, Inc., PAREXEL International Corporation, Pharmaceutical Product Development, (PPD) LLC, Promedica International, Quintiles Transnational Corporation, WuXi App Tec and others are some of the prominent players in the global healthcare regulatory affairs outsourcing market.


Regional Market Summary


Global Healthcare Regulatory Affairs Outsourcing Market Share (%), by Region, 2017

Global Healthcare Regulatory Affairs Outsourcing Market Share by Region,2017


Geographically, the Americas is anticipated to dominate the global healthcare regulatory affairs outsourcing market owing to the increasing prevalence of chronic diseases. The rising prevalence of cancer and other chronic diseases demands the discovery of newer and effective drugs which is anticipated to fuel the market growth in this region. For instance, according to the Centers for Disease Control and Prevention, in 2014, 9,421 new cases of tuberculosis were registered in the US. Moreover, according to the National Cancer Institute, in 2016, around 1,685,210 new cases of cancer had been diagnosed in the US.


Europe is expected to hold the second largest position in the global healthcare regulatory affairs outsourcing market. The market growth in this region is attributed to the growing research and development activities in the European countries. For instance, according to the National Institute for Health Research, the Association of the British Pharmaceutical Industry (ABPI) invested over Euro 4.1 billion just in the UK on R&D, looking for breakthroughs for conditions such as cancer, dementia, and rare genetic diseases.


The market of healthcare regulatory affairs outsourcing in Asia-Pacific region consists of countries namely China, Japan, Republic of Korea, India, Australia and Rest of Asia-Pacific. The Asia-Pacific region is expected to be the fastest growing region owing to the increasing number of biopharmaceutical companies and high growth opportunities for major key players for setting up their regional headquarters and manufacturing plants in this region.


The Middle East & Africa is expected to hold the lowest share of the global healthcare regulatory affairs outsourcing market. Majority of the market of the region is anticipated to be held by the Middle East region owing to the growing government initiatives for the healthcare sector.

Recent Development


In May 2022


Rimsys, the leading provider of Regulatory Information Management (RIM) software for the MedTech industry, has announced the development of Rimsys 5 at the MedTech Forum in Barcelona, Spain. The three-year-old cloud-based software, used by 10 out of 30 largest medical device manufacturers globally, helped the companies strengthen compliance and immediately bring products to market. The new version includes a comprehensive regulatory submissions module and provides integration. 


In May 2022


Global biopharmaceutical services leader, CATO SMS, revealed its new name, Allucent, with bold branding to emphasize its spotlight on meeting the specialized needs of small and medium-sized biotech companies. 


This move follows a three-year series of strategic acquisitions; recent clinical research provider, Pharm-Olam, has doubled the company's size, and expanded its global reach. Now, Allucent is a unified organization with 30 years of experience supporting small and mid-sized biotech companies.


Currently, smaller companies hold 70% of the biopharmaceutical industry's intellectual property and benefit from third-party experts. Allucent was formed to meet this need, and it is now offering full-service clinical trial capabilities, product development, deep therapeutic expertise, and consulting services.


Service Outlook



  • Regulatory Writing and Publishing

  • Regulatory Submissions

  • Clinical Trial Applications sand Services Registrations

  • Regulatory Consulting and Legal Representation

  • Other Regulatory Affairs


End User Outlook



  • ┬áMid-Size Pharmaceutical Companies

  • ┬áLarge Pharmaceutical Companies

  • ┬áBiotechnology Companies

  • Medical Device Companies

  • Food and Beverage Companies


Region Outlook



  • AmericasNorth America

    • US

    • Canada





  • Latin America



  • Europe

  • Western Europe

    • Germany

    • France

    • Italy

    • Spain

    • UK

    • Rest of Western Europe





  • Eastern Europe



  • Asia-Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Rest of Asia-Pacific



  • Middle East & Africa

    • Middle East

    • Africa




Company Profiles



  • Accell Clinical Research, LLC

  • Charles River Laboratories International, Inc.

  • Clinilabs, Inc.

  • Covance, Inc.┬á

  • Criterium, Inc.

  • ICON plc

  • Medpace, Inc.

  • PAREXEL International Corporation

  • Pharmaceutical Product Development, (PPD) LLC

  • Promedica International

  • Quintiles Transnational Corporation

  • WuXi App Tec

  • Others


 Intended Audience



  • Traders, Distributors, and Suppliers

  • Manufacturers

  • Hospitals

  • Government and Regional Agencies and Research Organizations

  • Consultants

  • Distributors



Report Scope:

Report Attribute/Metric Details
  Market Size   USD 9.8 Billion
  CAGR   9.4%
  Base Year   2021
  Forecast Period   2022-2030
  Historical Data   2020
  Forecast Units   Value (USD Billion)
  Report Coverage   Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
  Segments Covered   Services and End user
  Geographies Covered   North America, Europe, Asia-Pacific, and Rest of the World (RoW)
  Key Vendors   Accell Clinical Research, LLC, Charles River Laboratories International, Inc., Clinilabs, Inc., Criterium Inc., ICON plc, Covance, Inc., Medpace, Inc., PAREXEL International Corporation, Pharmaceutical Product Development, (PPD) LLC, Promedica International, Quintiles Transnational Corporation, WuXi App Tec
  Key Market Opportunities

  • Increasing number of patent expirations
  • Growing research and development activities
  •   Key Market Drivers

  • Rising development of products in clinical trials
  • The demand for clinical trial applications


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    Frequently Asked Questions (FAQ) :

    The healthcare regulatory affairs outsourcing market size is expected to reach USD 9.8 billion by 2030.

    The market is expected to exhibit a strong 9.4% CAGR over the forecast period from 2022 to 2030.

    The growing prevalence of chronic diseases such as cancer is the major driver for the market.

    The risk of data breach and lack of standardization are the key restraints on the global healthcare regulatory affairs outsourcing market.

    The Americas, followed by Europe, hold the largest share in the market.