What are “3 Key Trends” shaping the CDMO industry in 2023 and beyond? Woodstock Sterile Solutions’ president and chief executive officer, Paul Josephs, shares his thoughts with Contract Pharma.

Innovation by Specialty Pharma
Innovation in our space is driven by smaller specialty organizations rather than large multinational companies. These smaller companies typically do not have the infrastructure of the multinationals, which means they will continue to drive market growth in the CDMO space. With this lack of infrastructure, specialty and virtual sponsors are looking to their CDMO partners to not only provide a “pair of hands” in support of their programs but to also deliver the strategy behind the development or manufacturing solution to their customers’ needs. CDMOs that will thrive in this environment will need to provide high-quality, full-service capabilities to ensure that their customers can efficiently bring their development programs from concept to commercialization.

Supply Chain Challenges
Inflationary pressure on material costs, rising shipping costs, and material availability all during the pandemic Defense Production Act made it challenging to maintain a robust supply chain. You combine this with the fact that the challenges a CDMO faces are even more complex, since they are supporting a significant number of commercial customers whose forecasts are typically inaccurate at some level. It is critical that CDMOs have a robust process that is proactive in its approach for managing your customers forecast along with a strong procurement team with excellent supplier relationships to ensure that your customer and corresponding patients’ needs are met on a consistent basis.

Regulatory Compliance
Coming out of the pandemic, it is clear that on-site FDA surveillance is on the rise along with an increase in domestic manufacturing. In this environment, it is critically important that you have a continuous improvement mindset regarding compliance, as the FDA’s expectations are dynamic. In addition, as domestic manufacturing increases, we see partners seeking providers who are not only compliant domestically, but also have the ability to support European, Asian and emerging markets. Having the capability to confidently source a product from one supplier for multiple geographies will continue to be a key differentiator for many CDMOs going forward.