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

Global Regulatory Affairs Outsourcing Market size was valued at USD 6.1 billion in 2022 and is poised to grow from USD 6.65 billion in 2023 to USD 12.62 billion by 2031, growing at a CAGR of 8.34% during the forecast period (2024-2031).

Healthcare companies are under constant pressure to obtain timely clinical approvals from regulators in various countries. Such activities further increase the demand for legal information services, thereby contributing to the growth of the market. Furthermore, increased demand for new product approvals while maintaining regulatory compliance, drives market growth. According to a survey sponsored by Genpact, 72.0% of life sciences agency executives consider compliance to be one of the top three challenges facing life sciences companies and legal departments are often burdened with dealing with multiple tasks role simultaneously and must ensure compliance with strict regulatory standards. Increased efforts by companies to gain faster approvals in the global market to expand their geographical reach is expected to further help adopt outsourcing strategies for legal services. Increased use of pharmaceutical products and demand for cheaper drugs and medical devices are expected to drive down healthcare costs, increasing the preference for legal outsourcing. 

Increasing out-of-pocket debt in developed and developing countries, uneven economic growth and measures taken by many governments to reduce drug costs are some of the factors exerting economic and competitive pressures comes into being, which in turn is expected to drive demand for the outsourcing of regulatory functions in life sciences companies. Drug-specific medical advice & compliance with policies and regulations in the early stages of drug development can be critical to drug approval.

US Regulatory Affairs Outsourcing Market is poised to grow at a sustainable CAGR for the next forecast year.