Press Releases

Regulatory Affairs Outsourcing Market Set to Surpass US$ 16.6 Billion by 2030

According to a news release by Precedence Research, the global regulatory affairs outsourcing market size is expected to pass the $16.6 billion mark by 2030 and is anticipated to grow with a healthy growth rate of more than 10.2% over the forecast period 2022-2030.

The report contains 150+ pages with detailed analysis. The base year for the study has been considered 2021, the historic year 2017 to 2020, the forecast period considered is from 2021 to 2030. The regulatory affairs outsourcing market is analyzed on the basis of value (US$ Million), volume (Unit), and price (US$/Unit). The report offers exclusive insights to help companies make informed decisions to sustain growth through the assessment period.

Download Free Sample Copy with TOC, Graphs & List of Figures @

The global regulatory affairs outsourcing market is primarily driven by the globalization and the rising investments by the firms for the expansion. The increased research and development activities adopted by the players operating in the pharmaceutical and medical device industries augments the volume of clinical trials and product registration. This is a major driving force of the global regulatory affairs outsourcing market. The strict government regulations regarding the various medical products and complying to these stringent regulations in various countries is a major challenge to the drug and device manufacturers, which compels them to outsource the regulatory affairs to the third-party service providers.

Asia Pacific was the dominating market in 2020. The increased presence of pharmaceutical and medical device manufacturers in the countries like China, India, South Korea, and Singapore is one of the primary and the most significant factors that propels the growth of the regulatory affairs outsourcing market. The easy and cheap availability of the factors of production in this region and the favorable government policies to attract FDIs are the major factors that attracts the global players to invest in this region. This rising number of production activities in this region requires a huge volume of regulatory affairs activities including product registration, regulatory writing, and clinical trials, which augments the market growth in this region.

The rising demand for the cost-reduction in the life sciences industry is augmenting the demand for the third party services for the regulatory affairs. Moreover, the introduction of various software that keeps the track of the various regulatory affairs is expected to provide lucrative growth opportunities to the market players in the foreseeable future.

The growing focus of the pharmaceutical companies and the medical devices manufacturing companies in the core activities coupled with the growing importance of complying to the regulatory standards is a major factors that is expected to drive the growth of the global regulatory affairs outsourcing market.

Report Scope of the Regulatory Affairs Outsourcing Market

Report HighlightsDetails
Market SizeUSD 16.6 Billion by 2030
GrowthCAGR of 10.2% From 2022 to 2030
Base Year2021
Forecast Period2022 to 2030
Segments CoveredService, Category, End User, Indication, Stage
Regional Scope
  • North America
  • Europe
  • Asia Pacific

Based on service, the regulatory writing & publication segment dominated the market in 2020, garnering over 35% of the market share. The regulatory writing plays an essential role in communicating regarding the research and development works related to the new drugs and new medical devices developed by a company to the regulatory authorities like FDA. Regulatory writing is an integral part of the regulatory affairs activities, which is necessary for the acquisition of approvals in the concerned countries, and hence it captures the huge amount of the market share.

Based on the category, the biologics is estimated to be the most opportunistic segment during the forecast period. The rising investments in the development of various biologic medicines that provides an effective treatment for the chronic diseases like cancer, diabetes, and leukemia is a significant factor that propels the demand for the regulatory affairs outsourcing in order to get market authorization in various nations. Moreover, rising prevalence of chronic diseases among the population is expected to drive the growth of the biologics market, which in turn would propel the growth of the regulatory affairs outsourcing market in the foreseeable future.

Based on end user, the pharmaceutical company segment dominated the market, accounting for over 37% of the market share in 2020. The rapid growth of the biopharmaceuticals across the globe, and development of new and innovative medicines has fostered the growth in the volume of regulatory activities in the past few years. Moreover, the introduction of various blockbuster biopharmaceutical products and increased investments by the government and the private sector has played an influential role in the development of this segment.

Based on the indication, the neurology is estimated to be the most opportunistic segment during the forecast period. The rising prevalence of neurological disorders is boosting the need for the development of new drugs and medical devices. According to the Global Burden of Diseases report, around 95% people were suffering from the neurological disorders in the year 2016. Hence, rising investments in the new drug development for the neurological disorders is expected to foster the growth of this segment.

Based on the stage, the clinical segment dominated the market, accounting for more than 45% of the market share in 2020. The rising demand for the clinical trials among the drug developers and medical device manufacturers has augmented the market growth. According to the, around 326,000 clinical trials were registered in 2019 in the US which increased to more than 347,000 clinical trials in 2020.

Competitive Intelligence

The report provides an understanding of the market composition and explains the role of established players and regional contributors. It is essential for the market players to make calculative moves and focus on client acquisition and retention. The detailed company profiles will provide the necessary intelligence to the reader. In order to maintain their share, the market players are focusing on strategies such as cross-border expansion, product differentiation and so on.

Some of the prominent players in the global regulatory affairs outsourcing market are listed as below:

  • Medpace
  • ICON Plc
  • WuXiAppTec, Inc.
  • Covance
  • Genpact Ltd.
  • Pharmaceutical Product Development LLC.
  • Freyr
  • PRA Health Sciences
  • Criterium, Inc.
  • Accell Clinical Research, LLC.

Market Segmentation

By Service

  • Legal Representation
  • Regulatory Consulting
  •  Product Registration & Clinical Trial Application
  • Regulatory Writing & Publication
  • Others

By Category

  • Biologics
  • Drugs
  • Medical Devices

By End User

  • Medical Device Company
  • Biotechnology Company
  • Pharmaceutical Company

By Indication

  • Neurology
  • Oncology
  • Immunology
  • Cardiology
  • Others

By Stage

  •  Clinical
  • Preclinical
  • Post Market Authorization

Regional Segmentation

– North America (U.S. and Canada)

 – Europe (Germany, France, U.K., Italy, Spain, Rest of Europe)

 – Asia-Pacific (China, Japan, India, Southeast Asia and Rest of APAC)

 – Latin America (Brazil and Rest of Latin America)

– Middle East and Africa (GCC, North Africa, South Africa, Rest of MEA)

Why should you invest in this report?

If you are aiming to enter the global regulatory affairs outsourcing market, this report is a comprehensive guide that provides crystal clear insights into this niche market. All the major application areas for regulatory affairs outsourcing are covered in this report and information is given on the important regions of the world where this market is likely to boom during the forecast period of 2021-2030 so that you can plan your strategies to enter this market accordingly.

Besides, through this report, you can have a complete grasp of the level of competition you will be facing in this hugely competitive market and if you are an established player in this market already, this report will help you gauge the strategies that your competitors have adopted to stay as market leaders in this market. For new entrants to this market, the voluminous data provided in this report is invaluable. 

Purchase Full Research Report (Single User License US$ 4500) @

Contact Us:         

Mr. Alex

Sales Manager

Call: +1 9197 992 333


Show More

Precedence Research

Precedence Research is a worldwide market research and consulting organization. We give unmatched nature of offering to our customers present all around the globe across industry verticals. Precedence Research has expertise in giving deep-dive market insight along with market intelligence to our customers spread crosswise over various undertakings.

Related Articles

Back to top button