Healthcare Regulatory Affairs Outsourcing Market Size, Trends and Growth Analysis by 2027

The healthcare regulatory affairs outsourcing market is anticipated to grow significantly, reaching approximately US$ 14,996.35 million by 2028, up from US$ 7,274.73 million in 2021. This growth represents a compound annual growth rate (CAGR) of 10.9% from 2021 to 2028.

Several factors contribute to this market expansion, including the rising regulatory demands placed on healthcare organizations and the increasing need for expedited approval processes for new products. Nevertheless, a shortage of qualified professionals poses a challenge to this growth trajectory.

Ongoing advancements and enhancements in conventional drug development methodologies are presenting considerable hurdles within the healthcare industry. Pharmaceutical companies and healthcare providers face immense pressure to lower prescription drug costs, even as their operational expenses continue to rise. The intricate nature of regulatory requirements, coupled with diminishing revenues from blockbuster drugs losing patent protection, and governmental as well as health insurer pressures to cut healthcare costs, further complicate the landscape for healthcare businesses. In light of these challenges, pharmaceutical firms have recognized the necessity of optimizing their resources by collaborating with specialized external partners. Numerous high-caliber regulatory consulting firms are now providing their expertise throughout the entire product lifecycle.

Outsourcing regulatory affairs can empower sponsors to acquire valuable experience, streamline costs, and boost productivity. Regulatory outsourcing firms are adept at evaluating regulatory requirements, enabling them to identify the most effective solutions. They possess a deep understanding of the implementation, operation, and maintenance of regulatory publishing systems. Major pharmaceutical and biotechnology companies often seek consulting firms that can also deliver complementary regulatory and pharmacovigilance services.

The growing complexity of regulatory submissions highlights the increasing need for specialized Contract Research Organization (CRO) expertise. It is crucial to have tailored product-specific regulatory guidance and compliance strategies established early in the product development process to facilitate regulatory approvals. Neglecting compliance issues during the initial development stages can result in delays in the approval process due to improperly filed documents, manufacturing errors, missed regulatory studies, and other failures to meet regulatory standards.

Healthcare organizations are now prioritizing their core competencies while outsourcing non-core functions to enhance productivity and operational efficiency. Typically, they delegate regulatory responsibilities to CROs operating in emerging markets, such as the Asia Pacific region and the Middle East and Africa (MEA). This strategy not only helps reduce operational costs but also allows companies to concentrate on essential functions like research and development (R&D) and the sales and distribution of existing products.

The COVID-19 pandemic has emerged as the most significant global health crisis to date. While it has placed considerable strain on regulatory and outsourcing teams, it has also positively influenced the bio/pharmaceutical outsourcing sector, leading to an increased demand for R&D activities and, consequently, regulatory affairs support. This surge in demand has prompted various CROs to enhance their outsourcing capabilities and operational focus.

The healthcare regulatory affairs outsourcing market is categorized by service type into several segments, including:

• Regulatory & Scientific Strategy Development


• Medical & Scientific Writing


• eCTD & e-Submissions


• Data Management Services


• Life Cycle Management Services


• Pharmacovigilance


• Chemistry Manufacturing & Controls (CMC) Services


• Regulatory Labelling


• Regulatory Artwork Services

Among these, the Medical & Scientific Writing segment is projected to capture a significant market share in 2021, while the Pharmacovigilance segment is expected to experience the highest CAGR during the forecast period.

In terms of end users, the market is divided into pharmaceutical companies, biotechnology firms, and medical device manufacturers. The pharmaceutical companies segment is anticipated to dominate the market share in 2021 and is also expected to grow at a higher CAGR from 2021 to 2028.

Key organizations and sources referenced in the preparation of this report on the healthcare regulatory affairs outsourcing market include the Adverse Drug Reactions Committee, India Brand Equity Foundation, International Council for Harmonisation, National Medical Product Administration, Food and Drug Administration, World Health Organization (WHO), and the Centers for Disease Control and Prevention (CDC).