Outsourcing regulatory activities in pharma

Outsourcing has become a necessity for many pharmaceutical companies; even the outsourcing of regulatory functions has grown over the past several years and is expected to increase steadily in future. The pharmaceutical regulatory affairs outsourcing market is thus projected to rise from $7 billion in 2022 to $15 billion in 2032,¹ driven by the growing number of clinical trial applications (see Figure 1)² and product registrations. Clinical trials are expected to account for the largest share of the market – approximately 46 percent.¹

Collectively, Europe and the US are anticipated to account for 60 percent of the global outsourcing regulatory affairs demand to 2032. However, the Asia-Pacific region is set to be the fastest growing, driven by rapid expansion, particularly in India and China.¹

In the regulatory space, the trend is typically to subcontract about half of the work and do the other half internally, explains Olivier Saslawski, an expert in chemistry, manufacturing and controls (CMC), regulation and pharma outsourcing. Saslawski has over 30 years’ experience in the industry in various companies, having served most recently as Head of Global Regulatory CMC, Worldwide Regulatory Affairs at Servier, an international pharmaceutical company, headquartered in France. Servier is active in cardiology, metabolic diseases, oncology, and neuroscience both in medicinal chemistry and biotechnology.

Saslawski’s perspective is reinforced by a recent industry survey of biotechnology and pharmaceutical companies,³ which found that 54 percent currently outsource their regulatory activities, while 46 percent do not.