"Designing Growth Strategies is in our DNA"

Healthcare Regulatory Affairs Outsourcing Market Size, Share and Global Trend By Service Type (Traditional Services, Software Services, Others), By Organization Type (Large Organizations, Mid-Sized Organizations, Small Organizations), By End User (Pharmaceutical Companies, Medical Devices Manufacturing Companies, Healthcare Institutions, Others), and Regional Forecast, 2024-2032

Region : Global | Report ID: FBI100719 | Status : Ongoing



Regulatory affairs service providers offer services such as product development, product registration, commercialization of the product, and others. Regulatory solutions in healthcare are essential as it provides co-ordination between international regulations and home government regulations, better manufacturing practice, new drug or medical device development support, product registration and approval, clinical trial exemptions and legal advice to healthcare institutions. The strive for successful product launch, high budget research, worldwide product approvals by the companies to survive in the highly competitive healthcare environment have increased the demand for contract-based regulatory solution providers.

Furthermore, strategic collaborations among the regulatory solution and service providers are poised to surge the market. For example, in November 2018, one of the major players in healthcare regulatory affairs outsourcing PAREXEL International Corporation and SHYFT Analytics, a company of Medidata Solutions agreed upon strategic partnership for providing Real-World Evidence (RWE) to biopharmaceutical and medical device manufacturing organizations.

To gain extensive insights into the market, Request for Customization

Growing competition amongst healthcare companies, highly uncertain geopolitical conditions such as Brexit, stringent regulations & policies of the home government, and rising need for optimized healthcare resources are significant factors for the growth of the global healthcare regulatory affairs outsourcing market. Also, advantages of healthcare regulatory affairs outsourcing such as enhanced effectiveness in clinical operations, reduction in approval time, easy commercialization of product and assistance of strategic planning in product development & registration provided by regulatory affairs service providers are boosting the demand for regulatory affairs solutions and services.

However, lack of proper communication between regulatory affairs service provider companies and healthcare institutions has reported cases of cultural clash and difficulties in keeping track of service providers’ performance, which is a factor that can hinder the growth in the global healthcare regulatory affairs outsourcing market.

Key Players Covered

Some of the major companies that are present in the global healthcare regulatory affairs outsourcing market are WuXi AppTec, Freyr, Covance Inc., PAREXEL International Corporation, CRITERIUM, INC., Medpace, Inc., Accell Clinical Research, LLC, Promedica International, PRA HEALTHSCIENCES, and others.




By Service Type

· Traditional Services

· Software Services

· Others

By Organization Type

· Large Organizations

· Mid-Sized Organizations

· Small Organizations

By End User

· Pharmaceutical Companies

· Medical Devices Manufacturing Companies

· Healthcare Institutions

· Others

By Geography

· North America (USA and Canada)

· Europe (UK, Germany, France, Italy, Spain, Scandinavia and Rest of Europe)

· Asia Pacific (Japan, China, India, Australia, Southeast Asia and Rest of Asia Pacific)

· Latin America (Brazil, Mexico and Rest of Latin America)

· Middle East & Africa (South Africa, GCC and Rest of Middle East & Africa)


Among the service type, the software services segment is expected to have a remarkable growth during the projected period owing to the launch of advanced software for data and compliance management, ease of establishing co-ordination and communications, and rapid adoption of software.

Key Insights

  • PEST analysis

  • Healthcare regulatory affairs outsourcing service - pricing analysis

  • Recent industry developments such as partnerships, mergers, and acquisitions

Regional Analysis

North America is anticipated to dominate the global healthcare regulatory affairs outsourcing market during the forecast period owing to the rise in a number of patent expiry, focus on new product launch and approvals to compete in the healthcare environment. In Europe, the healthcare regulatory affairs outsourcing market is expected to have a significant expansion in the forecast duration due to the emphasis on cost reduction, focus on core competencies, and stringent government regulations. Asia Pacific is anticipated to emerge as a lucrative market for healthcare regulatory affairs outsourcing due to the increased efforts of pharmaceutical companies to establish distribution networks in emerging nations and rising need for optimum utilization of resources.

Key Industry Developments

  • In December 2018, GHO Capital Partners LLP, one of the European investor in healthcare acquired major stake of Validant, a consulting firm for regulatory affairs which is expected to accelerate to growth of the firm.

  • In November 2018, PAREXEL International Corporation and SHYFT Analytics, a company of Medidata agreed upon strategic partnership for providing Real-World Evidence (RWE) to biopharmaceutical and medical device manufacturing organizations.

  • In June 2018, Medidata announced the acquisition of SHYFT Analytics in view to aid life sciences companies to streamline their new product introduction to the market.

  • Ongoing
  • 2023
  • 2019-2022

Personalize this Research

  • Granular Research on Specified Regions or Segments
  • Companies Profiled based on User Requirement
  • Broader Insights Pertaining to a Specific Segment or Region
  • Breaking Down Competitive Landscape as per Your Requirement
  • Other Specific Requirement on Customization
Request Customization Banner

Healthcare Clients


Client Testimonials

“This report is really well done and we really appreciate it! Again, I may have questions as we dig in deeper. Thanks again for some really good work.”

- U.S.-based biotechnology company focussing on treatment of chronic pain.

“Kudos to your team. Thank you very much for your support and agility to answer our questions.”

- Europe-based provider of solutions to automate data centre operations.

“We appreciate you and your team taking out time to share the report and data file with us, and we are grateful for the flexibility provided to modify the document as per request. This does help us in our business decision making. We would be pleased to work with you again, and hope to continue our business relationship long into the future.”

- India-based manufacturer of industrial and specialty intermediates with a strong global presence.

“I want to first congratulate you on the great work done on the Medical Platforms project. Thank you so much for all your efforts.”

- One of the largest cosmetics company in the world.

“Thank you very much. I really appreciate the work your team has done. I feel very comfortable recommending your services to some of the other startups that I’m working with, and will likely establish a good long partnership with you.”

- U.S. based startup operating in the cultivated meat market.

“We received the below report on the U.S. market from you. We were very satisfied with the report.”

- Global hearing aids manufacturer.

“I just finished my first pass-through of the report. Great work! Thank you!”

- U.S. based solar racking solutions provider.

“Thanks again for the great work on our last partnership. We are ramping up a new project to understand the imaging and imaging service and distribution market in the U.S.”

- World’s leading advisory firm.

“We feel positive about the results. Based on the presented results, we will do strategic review of this new information and might commission a detailed study on some of the modules included in the report after end of the year. Overall we are very satisfied and please pass on the praise to the team. Thank you for the co-operation!”

- Germany based machine construction company.

“Thank you very much for the very good report. I have another requirement on cutting tools, paper crafts and decorative items.”

- Japanese manufacturing company of stationery products.

“We are happy with the professionalism of your in-house research team as well as the quality of your research reports. Looking forward to work together on similar projects”

- One of the Leading Food Companies in Germany

“We appreciate the teamwork and efficiency for such an exhaustive and comprehensive report. The data offered to us was exactly what we were looking for. Thank you!”

- Intuitive Surgical

“I recommend Fortune Business Insights for their honesty and flexibility. Not only that they were very responsive and dealt with all my questions very quickly but they also responded honestly and flexibly to the detailed requests from us in preparing the research report. We value them as a research company worthy of building long-term relationships.”

- Major Food Company in Japan

“Well done Fortune Business Insights! The report covered all the points and was very detailed. Looking forward to work together in the future”

- Ziering Medical

“It has been a delightful experience working with you guys. Thank you Fortune Business Insights for your efforts and prompt response”

- Major Manufacturer of Precision Machine Parts in India

“I had a great experience working with Fortune Business Insights. The report was very accurate and as per my requirements. Very satisfied with the overall report as it has helped me to build strategies for my business”

- Hewlett-Packard

“This is regarding the recent report I bought from Fortune Business insights. Remarkable job and great efforts by your research team. I would also like to thank the back end team for offering a continuous support and stitching together a report that is so comprehensive and exhaustive”

- Global Management Consulting Firm

“Please pass on our sincere thanks to the whole team at Fortune Business Insights. This is a very good piece of work and will be very helpful to us going forward. We know where we will be getting business intelligence from in the future.”

- UK-based Start-up in the Medical Devices Sector

“Thank you for sending the market report and data. It looks quite comprehensive and the data is exactly what I was looking for. I appreciate the timeliness and responsiveness of you and your team.”

- One of the Largest Companies in the Defence Industry
We use cookies to enhance your experience. By continuing to visit this site you agree to our use of cookies . Privacy.