The global healthcare regulatory affairs outsourcing market size is expected to reach USD 16.67 billion in 2028 and register a revenue CAGR of 12.5% over the forecast period, according to the latest report by Reports and Data. Market revenue growth is significantly driven by increasing R&D activities across the pharmaceutical and biotechnology sectors, rising volumes of clinical trial applications, and growing need for timely product registration and approvals. Healthcare regulatory affairs outsourcing services predominantly include regulatory writing & publishing, regulatory submissions, clinical trial application, product registration, and regulatory consulting and legal services offered by highly experienced medical writers, publishers, and quality control (QC) auditors. These services are mostly utilized by large and mid-sized pharmaceutical companies, biotechnology companies, and medical device manufacturing companies. Regulatory affairs outsourcing ensures that these companies strictly comply with the product quality and safety standards and policies set by regulatory authorities.
This study aims to define market sizes and forecast the values for different segments and countries in the coming eight years. The study aims to include qualitative and quantitative perspectives about the industry within the regions and countries covered in the report. The report also outlines the significant factors, such as driving factors and challenges, that will determine the market’s future growth.
Some Key Highlights from the Report:
Competitive Landscape:
The report also focuses on details of each market player including its global position, financial standing, revenue generation, company overview, and product & service portfolio. The Healthcare Regulatory Affairs Outsourcing market is extremely competitive and consists of several key players at the regional and global levels. Key players are focused on adopting various strategies such as new product launches, mergers and acquisitions, investments in R&D, partnerships, joint ventures, and collaborations to strengthen their market position and enhance their product portfolio.
Leading companies operating in the market are:
Covance Group Ltd., Parexel International Corporation, Accell Clinical Research LLC, Clinilabs Inc., Pharmaceutical Product Development, Medelis Inc., Freyr Solutions, Quintiles Transnational Holdings, Inc., Charles River Laboratories International, Inc., KAI Research, Inc., Medpace Inc., Criterium Inc., Cardinal Health, IQVIA, and ICON Plc.
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The report also offers detailed insights about market segmentation based on type, application and regional bifurcation:
Healthcare Regulatory Affairs Outsourcing Market Segmentation:
Service Type Outlook (Revenue, USD Billion; 2018-2028)
Stage Outlook (Revenue, USD Billion; 2018-2028)
Category Outlook (Revenue, USD Billion; 2018-2028)
End-use Outlook (Revenue, USD Billion; 2018-2028)
Regional Outlook:
Some essential purposes of the Healthcare Regulatory Affairs Outsourcing market research report:
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