Stevanato’s new Indiana manufacturing site poised for boost in syringe production

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.

In 2022, Stevanato entered into an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response in the U.S. Department of Health and Human Services. Under the agreement, BARDA is making a multi-year investment for up to approximately $95 million for manufacturing capacity for standard and EZ-fill vials in support of U.S. national defense readiness and preparedness programs for current and future public health emergencies.

The process for validating and bringing vial production online at Fishers is underway, according to William Blair analysts, who noted that the $95 million in BARDA funding is earmarked for capacity expansion plans related to vials and not syringes.

“The official timeline for when vial production will come online remains to be determined, but per some of our conversations during the visit, we think the first line and commercial production thereafter could start in the coming quarters,” the analysts wrote.

However, given the robust demand for high-value syringes and the still-available capacity, the analysts said they “do not think the timeline for vial production coming online will have an impact on the financial goals of the plant.”

Revenue targets, tariffs

William Blair analysts highlighted the fact that the first commercial revenue at Fishers was generated in the third quarter of 2024, with the facility expected to “flip to a positive gross margin” in the second half of 2025.

Given the activity levels the analysts saw inside the facility, they “left with the belief that this timeline remains intact.” Although financial metrics were not discussed during their visit, “our sense is that the company’s prior timeline to reach the financial goals it has laid out for the plant (gross margin positive by second half 2025 and 100% capacity utilization with €500 million in annual revenues in 2028) remains on track,” the analysts wrote.  

In May, CEO Franco Stevanato told analysts during the company’s first-quarter 2025 earnings call that activities at Fishers are in “high gear” as part of its early phases of scaling commercial syringe production and ongoing installations of additional manufacturing lines.

“We have a full schedule of customer validation and audit activities booked for the second quarter as more capacity comes online,” Stevanato said. “We also started construction on our device manufacturing area to support customer device programs for biologic treatments.”

While Stevanato’s investment in Fishers predated the threat of U.S. tariffs from the Trump administration, the company believes its capital expenditures at its manufacturing hub in Indiana further strengthen its position in one of the fastest growing markets.

“As we ramp up operation in Fishers, this will further support our customers with a robust in market supply chain as more pharma and biotech companies increase their manufacturing footprints in the U.S.,” Stevanato told analysts. “We do not expect that tariffs will affect our competitive positioning.”