Healthcare Regulatory Affairs Outsourcing Market

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.

The healthcare regulatory affairs outsourcing market share is expected to reach USD 9.8 billion by 2030 at 9.4% CAGR during the forecast period 2022-2030. 

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.

Healthcare Regulatory Affairs Outsourcing Market Outlook And Growth Analysis By Service (Regulatory Writing And Publishing & Regulatory Submissions) And End User (Mid-Size Pharmaceutical Companies & Biotechnology Companies) - Forecast Till 2030.

Major Key Players:

Some Of The Key Market Players 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.

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 by the end of 2023. 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  Regulatory Affairs Outsourcing Market, 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.

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