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 2027

Healthcare Regulatory Affairs Outsourcing Market Overview

Over the forecast period, the healthcare regulatory affairs outsourcing market is expected to increase at a CAGR of 9.4 percent. Outsourcing regulatory issues is becoming a more common practice in the healthcare industry. An increase in geographical expansion operations by corporations seeking quick approvals in local markets is projected to contribute to regulatory services outsourcing models. The regulatory affairs outsourcing market is quickly developing as R&D activities increase, increasing the volume of clinical trial applications and product registration.

Aspects such as an increasing number of patent expirations and increased R&D activities are expected to drive the growth of the healthcare regulatory affairs outsourcing market during the forecast period. Furthermore, the rising prevalence of various chronic conditions, such as cancer and other infectious diseases, has prompted biopharmaceutical companies to create a slew of new medications.

With the increased development of goods in clinical trials, there is a greater demand for clinical trial applications and product registration services, driving the expansion of this market. Outsourcing regulatory issues is becoming a more common practice in the healthcare industry. An increase in geographical expansion operations by corporations seeking quick approvals in local markets is projected to contribute to regulatory services outsourcing models. The regulatory affairs outsourcing market is quickly developing as R&D activities increase, increasing the volume of clinical trial applications and product registration.

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 healthcare regulatory affairs outsourcing market has been segmented, by region, into the Americas, Europe, Asia-Pacific, and the Middle East & Africa. The healthcare regulatory affairs outsourcing market 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 healthcare regulatory affairs outsourcing market has further been classified as Germany, France, the UK, Italy, Spain, and the rest of Western Europe.

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

Jan 2022 The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has initiated a public consultation on proposed clinical trials legislation. The ambitious recommendations aim to improve and reinforce the country's clinical trials regulations, making it a better venue to conduct research and produce safe, innovative therapies. The eight-week consultation session is designed to gather public feedback on new proposals to improve government control and regulation of clinical trials. According to MHRA members, the end goal is to provide a streamlined, transparent, and flexible regulatory framework while protecting patient participants who sign up for studies.

Healthcare Regulatory Affairs Outsourcing Market, by Service

•  Regulatory Writing and Publishing


• Regulatory Submissions


• Clinical Trial Applications sand Services Registrations


• Regulatory Consulting and Legal Representation


• Other Regulatory Affairs

Healthcare Regulatory Affairs Outsourcing Market, by End User

•  Mid-Size Pharmaceutical Companies


•  Large Pharmaceutical Companies


•  Biotechnology Companies


• Medical Device Companies


• Food and Beverage Companies

Healthcare Regulatory Affairs Outsourcing Market, by Region

• 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