Healthcare Regulatory Affairs Outsourcing Market Size Worth USD 11.5 Billion by 2032 | MRFR

Pune, India, May, 2023 /press release/- Market Research Future Published a Half Cooked Research Report on Healthcare Regulatory Affairs Outsourcing Market Research Report.

Market Research Future (MRFR) announces the publication of its research report –Global Healthcare Regulatory Affairs Outsourcing Market, 2023-2032. The global healthcare regulatory affairs outsourcing market is projected to reach USD 11.5 Billion at 9.40% CAGR over the forecast period. The healthcare regulatory affairs outsourcing offers medical writing and publishing which plays an important role to develop high-quality documents for the clinical research process. The rising, increasing number of patent expirations and growing research and development activities are some factors that are likely to propel the market growth during the assessment period.

Additionally, the rising incidence of several chronic diseases such as cancer and other infectious diseases have encouraged biopharmaceutical companies to develop a large number of new products. This rising development of products in clinical trials, the demand for clinical trial application and product registration services is increasing, thus driving the growth of this market. For instance, the International Federation of Pharmaceutical Manufacturers & Associations stated that around 1,919 and 1,308 drugs are in development for cancer and neurology, respectively. Additionally, IFPMA stated that in 2014, there were 401 drugs in the pipeline for diabetes and 208 drugs in development for HIV/AIDS. Furthermore, IFPMA specified that their members have 119 ongoing R&D projects related to neglected tropical diseases.

On the other hand, the risk associated with data security and lack of standardization may hamper the market growth during the assessment period.

Currently, the global healthcare regulatory affairs outsourcing market is dominated by numerous prominent players. The key players operating in this market offer comprehensive knowledge in managing healthcare regulatory affairs. These companies mainly intend to help firms overcome challenges and accelerate clinical processes.

On a regional basis, the global healthcare regulatory affairs outsourcing market in the Americas is segmented into two major regions, i.e., North America and Latin America. The North American region is likely to hold the major share in the region is due 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.

Key Players

Some Of The Prominent Players In The Global Healthcare Regulatory Affairs Outsourcing Market Are 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.

Browse In-depth Market Details [Table of Content, List of Figures, List of Tables] of Healthcare Regulatory Affairs Outsourcing Market Research Report

Segment Analysis

The global Healthcare Regulatory Affairs Outsourcing Market is segmented into application, product and end user. On the basis of application, the market is segmented into therapy, research and cell, and tissue banking. The global Healthcare Regulatory Affairs Outsourcing Market by product is segmented into stem cell lines, instruments, consumables and culture media. The stem cell lines segment is expected to lead the market and register a substantial CAGR to reach USD 9,366.9 million during the forecast period. Due to its unique capabilities for tissue repair, replacement, and regeneration is expected to drive the market growth. On the basis of end user, the market is segmented into pharmaceutical/biotechnology companies & CRO and hospitals & stem cell banks.

Regional Analysis

Geographically, the global Healthcare Regulatory Affairs Outsourcing Market has been segmented into North America, Europe, Asia-Pacific, and the Middle East & Africa. As per MRFR analysis, the Americas was the largest market for Carotid Artery Disease Market in 2017 and is expected to remain dominant during the review period. Europe accounted for a significant market share and is projected to be the second-largest market during the forecast period. Major factors influencing the growth of the market include the presence of major manufacturers, growing prevalence of cancer, growing healthcare expenditure, and increase in technologically-advanced products in Europe are driving the growth of the Healthcare Regulatory Affairs Outsourcing Market in the region. The Asia-Pacific Healthcare Regulatory Affairs Outsourcing Market is one of the fastest growing regions across the globe. Growing population and rising incidence of cancer are likely to drive the growth of the Asia-Pacific market.

Key Findings of the Study:

• Americas accounted for the largest market share with North America being the major contributor to the growth of the market.


• By product, the stem cell line segment is projected to register the highest CAGR of 7.9% during the forecast period due to the unique capabilities for tissue repair, replacement, and regeneration.


• Key manufacturers are adopting geographic expansions, corporate acquisitions, and product launches as growth strategies. Moreover, they are focusing on e-commerce for distribution.