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

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

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

•  Mid-Size Pharmaceutical Companies


•  Large Pharmaceutical Companies


•  Biotechnology 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. 


• 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