What developments occurred during 2024 for Pfizer CentreOne?

We had a remarkable year. Pfizer CentreOne is a multi-specialist, focusing on APIs and intermediates, biologic drug substances, sterile injectables for both small and large molecules, and solid oral dose products. In solid oral dose, we now offer continuous manufacturing. In sterile injectables, we are investing in facility upgrades, expanding beyond traditional liquid and lyophilized vials into cartridges for auto-injectors and pre-filled syringes at small, medium, and large scales.

Our APIs and intermediates division prioritizes green chemistry by shifting from chemical synthesis to biological reactions, from organic synthesis to fermentation, reducing environmental impact while keeping communities cleaner and safer. We broadened beyond gene therapy to include mammalian drug substance manufacturing, focusing on 1K, 2K and 500L disposable scales. We continue advancing in ADCs and gene therapies like AAV. ADCs are on a growth trajectory. After an initial hype cycle, the technology is maturing, creating new opportunities. We see ADCs linked not just to cytotoxics but also to high-containment products like OEB4 and OEB5. This diversification reduces risks while enabling innovative cancer treatments. We continue to expand, innovate, and deliver life-changing therapies. How has the funding landscape for CDMOs evolved?

The funding drought after COVID prompted us to rethink how we engage with the market. We began working directly with clients’ investors—venture capitalists, private equity firms, and others—to build their confidence in our model. Historically, investment decisions focused on time-to-market: fund in year one, monetize in year four. Investors realized success depends on more than launch timing. They began examining regulatory strategies. When clinical milestones slipped, attention turned to integrating manufacturing strategies—not just for commercial launch but throughout the clinical development process. We work closely with client partners to align their clinical, regulatory, and manufacturing strategies. Our ability to flex our capacity without overselling allows us to support evolving clinical timelines while ensuring on-time delivery. A healthy CMO capability globally means the industry’s ability to bring new innovative, creative products to market has a higher probability of success. What trends will dominate the industry going forward?

Solid oral dose products remain essential due to their simplicity and ease of use. This demand will not fade because convenience for patients is critical. ADCs have matured past early excitement and technical challenges, entering a phase of commercial viability with promising potential.

The industry is scaling practically. In mammalian drug substance manufacturing, improvements in yields, from < 1g /l to as much as 13 g/l, shifted production strategies. Using smaller reactors reduces the risk of overproducing or losing entire multi-year supplies in a single failed batch. This supports regionalized supply chains. Companies increasingly seek redundant production capabilities in different regions to reduce risk and ensure continuous supply.

The cost of entry in digital solutions is going down, enabling smaller and mid-sized companies to better predict demand, manage supply chains, and maintain appropriate safety stocks. The industry moved beyond “just-in-time” inventory models, which proved insufficient during the COVID-19 pandemic. Demand planning has become more sophisticated, reducing scheduling changes and creating a more stable supply chain environment. What catalysts do you foresee impacting the CDMO space?

There is a growing awareness of the criticality of CDMOs in the market landscape. COVID-19 was the ultimate black swan, highlighting the importance of a resilient and responsive CDMO network.

Unlike traditional regulatory challenges from agencies like the FDA or EMA, the Biosecure Act's threat comes from the intelligence and national security sectors—an unfamiliar regulatory environment for the industry. WuXi’s scale and reach create uncertainty, particularly for companies in critical development phases. For early-stage companies still preparing for clinical trials, pivoting from WuXi is possible but costly. Those nearing product filing need to secure approvals while preparing tech transfers to other CDMOs. The greatest risk lies with companies between phase one and three.

Many large pharma companies are restructuring. This will result in plant divestitures, creating growth opportunities for CDMOs. Acquiring well-maintained, fully staffed, and compliant plants allows CDMOs to generate revenue from day one. The industry landscape will resemble a checkerboard for a while, but I don't know too many days when it isn't one.