Strong and growing trends in biologics — such as antibody-drug conjugates, GLP-1s, and monoclonal antibodies

Strong and growing trends in biologics — such as antibody-drug conjugates, GLP-1s, and monoclonal antibodies

After touring the Fishers facility, William Blair analysts say demand for syringes is “healthy and robust” with a sequential utilization ramp-up expected in coming quarters.

Almost four years ago, Italy-based Stevanato Group began construction of a new manufacturing plant in Fishers, Indiana, meant to better serve U.S. biopharma customers. Fast forward to 2025 and Stevanato’s €500 million investment in Fishers is boosting its production capabilities, as the company targets the growing market for biologics.

Commercial production launched in 2024 at the site, located in a booming life sciences hub near Indianapolis, with the goal of bringing together Stevanato’s drug containment solutions and device manufacturing capabilities to offer customers an integrated offering with localized production in the U.S.

After touring the Fishers facility, William Blair analysts in a note to investors last week observed that demand for syringes is “healthy and robust” with a sequential utilization ramp-up expected at the plant in coming quarters. They noted that several syringe lines are fully operational, while several additional lines are in the process of coming online.

The Fishers plant is “being positioned as the company’s comprehensive North American manufacturing hub for high value solutions, including the production of prefilled syringes and vials,” the analysts wrote, with Stevanato looking to “capitalize on the strong and growing underlying trends in biologics” — such as antibody-drug conjugates, GLP-1s, and monoclonal antibodies — and the “need for higher capacity to support the next wave of growth in the industry post-COVID.”

While the plant’s activity levels for syringe production are high and much of the future demand and line buildouts have already been spoken for, the analysts pointed out that the Fishers site is currently only producing EZ-fill high-value syringes for commercial purposes but is not yet manufacturing Stevanato’s “top-of-the-line” Alba syringe — Stevanato expects Fishers to have Alba capabilities in the coming quarters, they contend.

A report earlier this year from William Blair found that the route of administration for new molecules has gradually shifted toward injectables and infusion, a trend benefiting manufacturers like Stevanato.

“In 2024, 56% of approvals used this delivery route compared to 39% for oral administration,” the analysts found. “Since 2020, we have seen the average proportion of approvals dosed via injection/infusion tick up to 57% and given our expectation for biologics to account for majority of approvals moving forward, we expect this gradual shift to continue since these drugs are more likely to be administered via infusion/injection than small-molecule drugs.”

Although commercial production for vials has not yet started at Fishers, the process to bring production online is underway, according to the analysts, and if Stevanato “wishes to bring in the capability for cartridge production sometime down the road, it would require an add-on to the current facility (there is plenty of available acreage to do so).” They described the current building as state-of-the-art and sitting in the middle of an approximate 35-acre plot of land, strategically located next to many of Stevanato’s key customers.

 

Continue at:  https://www.pharmamanufacturing.com/all-articles/article/55301660/stevanatos-new-indiana-manufacturing-site-poised-for-boost-in-syringe-production

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Manostaxx – Industrial Management Consulting

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