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Healthcare Regulatory Affairs Outsourcing Market Analysis

The Global Healthcare Regulatory Affairs Outsourcing Market size is estimated at USD 8.35 billion in 2024, and is expected to reach USD 12.71 billion by 2029, growing at a CAGR of 8.74% during the forecast period (2024-2029).

During the pandemic, the massive influx of COVID-19 patients resulted in mass lockdowns, which disrupted clinical studies of various chronic diseases such as cancer. The reduction in the number of clinical trials amid the pandemic resulted in a decrease in the demand for healthcare regulatory affairs outsourcing services. For instance, a study published in the Frontiers in Medicine1 in December 2021 highlighted that clinical trial activities decreased during the pandemic as the number of COVID-19 patients increased. The source also stated that new drug submissions dropped in non-COVID-19 clinical developments amid the pandemic.

Therefore, disruptions in the global supply chain affected the manufacturing and distribution of pharmaceutical products during the pandemic's initial phase, significantly impacting the market growth. Regulatory affairs teams had to navigate challenges related to ensuring the availability and safety of essential drugs, necessitating regulatory adaptations.

Moreover, growing R&D expenditure, the increasing number of clinical trials, and the cost-effectiveness of outsourcing are expected to drive market growth. For instance, according to Global Observatory on Health R&D analysis published on February 2022, there was a constant rise in the number of newly recruiting trials registered on the WHO International Clinical Trials Registry Platform (ICTRP) for most WHO regions. Moreover, the number of trials registered in WHO's Europe, Americas, and Western Pacific regions increased at a higher rate than in other regions. For instance, in 2021, Western Pacific registered 16,860 clinical trials, around 20 times higher than that in Africa, which accounted for 851 clinical trials. Thus, an increasing number of clinical trial studies are expected to increase regulatory affairs outsourcing over the forecast period.

Furthermore, increasing research and development investment by pharmaceutical and biotechnology firms is anticipated to drive market growth. As per the PhRMA, the members of PhRMA invested about USD 102.3 billion in R&D activities in 2021. As per the data published by the European Federation of Pharmaceutical Industries and Associations in 2022, the research-based European pharmaceutical industry has increased from the past years and reached the value of EUR 300 billion (USD 323.7 billion) in 2021. The same source also stated that this industry received a significant R&D investment of EUR 41.5 billion (USD 44.77 billion) in 2021.

Additionally, various strategic activities by key market players, such as mergers and acquisitions, are anticipated to drive market growth. For instance, in July 2021, Covance acquired GlobalCare, a global leader in patient-centric decentralized clinical trials (DCTs), to expand Covance's DCT offerings into international markets and meet the growing demand for patient-centric trial designs.

Thus, the factors mentioned above are expected to increase the demand for healthcare regulatory services in the industry, thereby driving market growth over the forecast period. However, the risk associated with data security and lack of standardization is the major restraining factor for the studied market.

Healthcare Regulatory Affairs Outsourcing Market Trends

Product Registration & Clinical Trial Application Segment is Expected to Hold Significant Market Share Over the Forecast Period

Healthcare Regulatory Affairs Outsourcing Industry Segmentation

Regulatory affairs outsourcing is the services utilized by pharmaceutical, biotech, and medical devices manufacturing companies for fast regulatory approvals from various organizations and cost-saving. Healthcare Regulatory Affairs Outsourcing market is segmented by Services (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Applications, and Other Services), End User (Pharmaceutical and Biotechnology Companies and Medical Device Companies), and Geography (North America, Europe, Asia-Pacific, Middle East, and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD) for the above segments.