Regulatory Affairs Outsourcing Market Size, Share, Growth Analysis, By Services(Regulatory Consulting (Strategy & Development Planning, QA Consulting, Others), Legal Representation), By Company Size(Small, Medium, Large), By Category(Pharmaceuticals (Regulatory Consulting (Strategy & Development Planning, QA Consulting, Others), Legal Representation), By Indication(Oncology, Neurology, Cardiology, Immunology), By Product Stage(Preclinical, Clinical, PMA (Post Market Authorization)), By End Use(Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies), By Region - Industry Forecast 2024-2031

The Asia-Pacific region dominated the market and controlled the largest revenue share of over 39.9% in 2023. The region is also expected to witness the fastest CAGR during the forecast period this from increasing number of clinical trials. Apart from the reason that could be the availability of skilled labor in the region which is cheaper compared to the US. It is another driver for the regional market growth China is one of the attractive markets for the biopharmaceutical industry. The growing elderly population and the presence of a large middle-income population further increases the demand for new low-cost drugs, which are expected to attract major pharmaceutical companies of devices in this category for 12 to 24 months is needed while the approval process may need more than six years. In addition to receiving state approval, the new drug must be approved at the provincial and municipal levels, which could require an additional 4 to 5 years. 

North America is the dominant region in the market. The North America region in the market also reported a significant share of the global industry. Presence of large pharmaceutical and medical device companies and high R&D expenditure in the region are some of the key factors driving the market in North America. Along with patented products, cost-effective generic biosimilars are also in high demand in this segment. For example, as of January 2022, there were approximately FDA-approved biosimilars in the US. Thus, the increasing development and approval of new biosimilars is expected to drive demand for regulatory services in the US, driving the market.