Editor’s (re)View: Sterile injectable manufacturing gets a shot in the arm from industry and academia
As the fastest-growing segment of the pharmaceutical market, sterile injectables are more important than ever. Fueled by the need for biologics, vaccines, and emergency care treatments, the global sterile injectable drugs market is expected to expand significantly reaching $1.4 trillion by 2030, with a compound annual growth rate of 9.7%.
However, demand for commercial and clinical-scale capacity continues to outstrip supply, which has led to shortages. Not surprisingly, manufacturing capacity for sterile injectables is at an absolute premium, as the industry looks to make much-needed advancements in efficiency and quality.
To address critical capacity shortages in the U.S. injectable supply chain, The Noramco Group announced this week a $25 million investment in its Halo Pharma facility in Whippany, New Jersey, to establish sterile injectable manufacturing capabilities including ready-to-use syringe, cartridge, and vial filling.
Pharma Manufacturing this week also reported on a new collaboration between Eli Lilly, Merck, and Purdue University focused on sterile injectables. Purdue’s Young Institute Pharmaceutical Manufacturing Consortium is looking to advance AI-driven automation, robotics, and novel aseptic processing methods to improve efficiency, quality, and safety in the manufacture of injectable drugs.
In Purdue’s announcement, it said the collaboration “underscores a commitment to onshoring pharmaceutical manufacturing while bolstering domestic production.”
Eli Lilly last month announced it will spend $27 billion to build four new U.S. pharmaceutical manufacturing sites, one of which is meant to “extend the company’s global parenteral manufacturing network for future injectable therapies.” In December 2024, Lilly announced a $3 billion expansion of a Wisconsin manufacturing facility acquired last year to bolster the production of injectable medicines for diabetes and obesity.
Not to be outdone, Pfizer CEO Albert Bourla last week boasted at the TD Cowen Annual Health Care Conference that the company’s 13 U.S. sites are the largest manufacturing network in the country for any drugmaker, with some “mega” sterile injectables facilities.
Pfizer, a major supplier of more than 600 generic sterile injectable medicines, noted in a 2024 policy paper that while drug shortages can occur in all areas of the pharmaceutical supply chain, it is “particularly acute” for generic sterile injectables which are “complex, challenging, and expensive to manufacture.”
Sterile injectables are especially vulnerable to supply chain disruptions when compared to solid oral dose medications due to their increased manufacturing complexity, and they are also susceptible to quality disruptions because of their sensitivity to contamination. Among the challenges Purdue’s Young Institute is working to address are bottlenecks in efficiency and contamination control.
“AI, robotics, and digital technology have the potential to transform pharmaceutical manufacturing,” according to Elizabeth Topp, director of the Young Institute. “Digital twins and other modeling techniques could support adaptable manufacturing processes, and AI and machine learning could enable automated process control to ensure product quality.”
