Regulatory Affairs Market Size, Share & Trends Analysis Report By Service, By Category (Biologics, Drugs), By Indication, By Product Stage, By End-use, By Service, By Company Size, By Region, And Segment Forecasts, 2020 - 2027

Regulatory Affairs Market Size, Share & Trends Analysis Report By Service, By Category (Biologics, Drugs), By Indication, By Product Stage, By End-use, By Service, By Company Size, By Region, And Segment Forecasts, 2020 - 2027

Regulatory Affairs Market Growth & Trends

The global regulatory affairs market size is expected to reach USD 20.9 billion by 2027, expanding at a CAGR of 8.4%, according to a new report by Grand View Research, Inc. Rise in drug approvals, label expansions of approved products, along with the presence of fast-track government pathways are anticipated to facilitate market growth over the forecast period. In addition, technological advancements in related software and the growing digital transformation in the healthcare industry are also expected to contribute to market growth.

In addition, the introduction of Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) is anticipated to not only change the EU governing landscape and increase the stringency of regulations but also increase the number of documents required to be created and maintained by companies. Furthermore, the changes in the Central Administration for Pharmaceutical Affairs (CAPA) scope in Egypt are anticipated to change the medical device registration process in the country. Such changes in local regulations are anticipated to favor market growth.

Furthermore, several regulatory changes related to clinical trials, vaccine development, and product approvals are anticipated to positively impact the market. These changes are initiated by global and local supervising authorities to expedite patient access to COVID-19 treatments and vaccines.

Market players are actively involved in the adoption of advanced technologies, strategic collaborations, and mergers and acquisition, to strengthen their market positions and outperform the competition. For instance, in 2020, ICON acquired MedPass, a medical device CRO, reimbursement, and regulatory consultancy firm. This acquisition is aimed at strengthening the medical device and diagnostic research services portfolio of ICON through the addition of new clinical and regulatory capabilities in Europe.

Asia Pacific dominated the market and accounted for the largest revenue share in 2019. The region is expected to witness the highest CAGR over the forecast period. This is attributed to the availability of workforce in the region at a lower cost. In addition, the expanding healthcare industry and tax benefits in countries including Singapore, India, and China are driving the market in the region.

Regulatory Affairs Market Report Highlights

Regulatory writing and publishing was the leading segment in 2019 owing to an increase in the outsourcing of selected functions by major life sciences companies while focusing on the core functions

The biologics segment is anticipated to witness lucrative growth over the forecast period due to the increasing popularity of personalized medicine and biosimilars

The oncology segment dominated the market in 2019 due to the increasing prevalence and mortality rate of cancer along with the presence of several innovative pipeline products.

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