The global regulatory affairs outsourcing market is poised for substantial growth. Its value is expected to climb from $6.84 billion in 2024 to $11.94 billion by 2030 at a compound annual growth rate (CAGR) of 9.73%.
According to the new Research and Markets report, globalization in the life sciences industry, increased R&D activity, and economic pressures to streamline regulatory operations fuel the demand. The COVID-19 pandemic also accelerated the need for agile and compliant regulatory pathways, particularly in vaccine development.
As biopharmaceutical and medical device companies expand into international markets, they face increasingly complex regulatory frameworks, which allow outsourced experts to manage compliance swiftly and cost-effectively.
Global expansion demands specialized compliance support
A key factor driving the market’s expansion is the globalization of drug and device manufacturers. Each new geographic market introduces distinct regulatory protocols and documentation standards, which can be difficult for in-house teams to navigate without specialized knowledge.
Outsourcing regulatory affairs allows companies to access local expertise, reduce overhead, and meet submission deadlines efficiently. This is particularly attractive in Asia Pacific, Latin America, the Middle East, and Africa, where regulatory environments are evolving rapidly and development costs remain lower.
Infrastructure investments by companies such as B. Braun in Malaysia and Flex Ltd. in India reflect this shift, as global players rely on regulatory partners to ensure compliance in expanding markets.
Outsourcing helps companies manage seasonal project peaks, eliminate training costs, and stay current with shifting regulatory expectations. It provides access to expertise without growing the in-house team, which is crucial for keeping up in fast-paced industries.
Tech-enabled compliance and the benefits of going external
Advances in digital tools are reshaping compliance. Regulatory information management systems (RIMS), cloud-based submission portals, and AI-powered document processing tools make adherence faster and more accurate. These technologies facilitate real-time collaboration between companies and third-party teams to maintain transparency and efficiency.
However, with digital adoption comes heightened cybersecurity concerns. Sensitive data exchanged during drug submissions, especially during mergers or market launches, requires robust encryption and secure transfer protocols to prevent breaches.
Despite these challenges, the benefits of outsourcing regulatory affairs are compelling. It allows life sciences firms to maintain compliance, scale their operations quickly, and focus internal resources on innovation rather than administration. When managed strategically, it becomes a cost-saving measure and a competitive advantage.
As regulatory complexity intensifies and globalization accelerates, the need for agile, tech-savvy, and regionally informed regulatory outsourcing partners will only grow, positioning the market for a strong upward trajectory through 2030.
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Pharmadocx Consultants. (2025, May 23). 10 Tips for Outsourcing Regulatory Affairs Team. Retrieved June 10, 2025, from https://pharmadocx.com/outsourcing-regulatory-affairs-team/
European Medicines Agency. (2023, December 18). Artificial intelligence workplan to guide use of AI in medicines regulation. Retrieved June 11, 2025, from https://www.ema.europa.eu/en/news/artificial-intelligence-workplan-guide-use-ai-medicines-regulation
