As the outsourcing market becomes crowded, technical capabilities are table stakes. For smaller biotech clients, the key differentiator is now customer service. Poor service experiences are creating lasting negative impressions, making relationship management critical for CDMOs to win business from this growing segment.

The sterile fill market isn't monolithic; it's segmented by manufacturing type. High-volume, low-mix products like GLP-1s require different CDMO capabilities than high-mix, lower-volume biologics. The latter demands deep expertise in tech transfer and new product launches, a distinct skill set from routine, high-scale production.

The push for supply chain diversification and reduced reliance on China is not a new phenomenon. The COVID-19 pandemic first exposed the critical risks of single-source dependency. Recent tariff threats are not the origin of this strategic realignment but rather a powerful accelerant, forcing companies to act on plans already in motion.

The biopharma outsourcing sector has proven surprisingly resilient to international tariffs. Instead of absorbing costs, well-funded European companies are bypassing tariffs altogether by investing in and building new production facilities directly on U.S. soil, effectively onshoring their manufacturing.

The CDMO market is segmenting, rewarding companies that specialize in complex niches like sterile filling. Rather than trying to do everything, focusing on being a world-class expert attracts clients who need specialized services, much like a patient chooses a heart surgeon over a general pharmacy for a critical procedure.

The true constraint in scaling sterile fill manufacturing is the availability of skilled personnel, not the equipment. The expertise required for compliance and product launches is harder to acquire than capital assets. This makes proactive, long-term hiring and training a critical competitive advantage for growth.

To overcome production bottlenecks, Legend Biotech employs a diversified manufacturing strategy. They operate their own large facilities in the US and Belgium while also contracting with pharmaceutical giant Novartis to produce their CAR T therapy. This enables a rapid scale-up to a planned 10,000 annual doses.

While US tariff policies aim to bring pharmaceutical production back onshore, the immediate beneficiaries are likely to be contract manufacturers. Building new proprietary facilities is a slow and expensive process, so companies will lean on agile contract partners to quickly diversify their supply chains in the interim.

For final drug product manufacturing, Actuate engaged two separate US-based partners. This parallel track strategy provided crucial redundancy during the COVID pandemic, ensuring that a shutdown or material shortage (e.g., glass vials) at one plant wouldn't derail their clinical programs.