The fill-finish manufacturing market is expected to expand by nearly $10 billion between 2026 and 2031, according to a recent Research and Markets report. Driven by demand for biologics, biosimilars, vaccines, and injectable therapies, manufacturers are expanding fill-finish capacity while investing in newer sterile manufacturing technologies. 

The rise of therapeutic modalities like antibody-drug conjugates (ADCs), cell and gene therapies, mRNA products, and other injectable medicines are also pushing manufacturers toward greater use of automation, isolators, and digital manufacturing systems.

The report also highlighted increased outsourcing to contract development and manufacturing organizations (CDMOs) as an important trend driving market growth, reflecting sponsor needs for specialized sterile manufacturing expertise and flexible production capacity.

A separate report from Grand View Research projects that the global sterile injectables CDMO market will grow from $41.6 billion in 2026 to $87.3 billion by 2033 at a compound annual growth rate of 11.2% during those years.

“Growth in markets of biosimilars, biologics, personalized medicine, orphan drugs, companion diagnostics, and adaptive trial designs, among others, is anticipated to boost the demand for sterile injectables,” the report found. “This surge is fueled by the high demand for biologics, complex manufacturing requirements, and regulatory support, which necessitate outsourcing to specialized CDMOs.”

Beyond capacity

Demand for injectable medicines continues to dominate the fill-finish landscape, with GLP-1 and incretin therapies for obesity and diabetes emerging as major contributors to current market growth. Expanding biosimilar, ADC, and advanced therapy pipelines are also increasing demand for fill-finish services.

Larger CDMOs are leading the charge to meet demands of high-volume commercial manufacturing. Thermo Fisher Scientific has said its investments are intended to help ensure reliable supply for the estimated 25 million Americans projected to receive GLP-1 therapies.

“Our ability to scale to high-throughput, high-speed manufacturing enables us to help customers meet growing global demand for therapies such as GLP-1 medicines while maintaining quality and operational efficiency,” says Christy Eatmon, Global SME, sterile drug products at Thermo Fisher.

Meanwhile, smaller and mid-sized CDMOs are helping sponsors manufacture lower-volume and specialized therapies.

“There’s always newer and much more effective therapies coming out, so I feel like there’s always going to be a market for a small-to mid-scale CDMO,” says Nithin Stephen, director of commercial development, drug product at Resilience. “Larger CDMOs are using up the capacity for some of these bigger-volume products. That’s where a small-to mid-size CDMO can support some of these branded, niche-volume products.”

Brian Blagg, general manager and global head of technical operations at PCI Pharma Services, emphasized how sponsors are increasingly relying on CDMOs because they need manufacturing partners that can scale alongside evolving development programs.

“A lot of these companies are developing multiple drug candidates at once and outsourcing to keep timelines in check,” Blagg says. “Whether they’re using an established partner or multiple CDMOs, it’s a good way to build a flexible supply chain that can expand or contract depending on where they are in development.”

Isolators becoming the norm

The Research and Markets report called out greater expectations around sterile manufacturing as a major factor shaping investment decisions. The firm cited EU GMP Annex 1 compliance and broader regulatory harmonization as key drivers of investment in aseptic technologies, and highlighted isolator-based manufacturing as a critical contributor to this growth.

Customers are now more often expecting isolator-based technologies, Stephen contends.

“Newer customers are asking for isolator technology,” he says. “With isolators you can have a complete aseptic process and provide customer assurance that manufacturing is truly aseptic; it’s much easier to meet Annex 1 expectations.”

By separating operators from critical processing areas, isolators reduce contamination risk and minimize manual intervention. At the same time, Restricted Access Barrier Systems (RABS) continue to play an important role in fill-finish. Many commercial facilities still operate successful RABS lines, particularly for legacy products approved for commercial manufacturing. 

RABS also remain necessary for products that can’t tolerate vaporized hydrogen peroxide (VHP), a sterilization method used inside isolators.

“You use VHP to basically coat the entire inner surface of the isolator to make sure it’s sterile,” says Blagg. “The problem is that you can never totally get rid of it. It’s still present in parts per billion levels, and some of the newer biologics are highly sensitive to it. So, you could have a situation where if you’re not controlling VHP, you could have a problem with the product downstream with either stability or effectiveness.”

Automation changes and challenges

Many of the newest isolator-based systems incorporate higher levels of robotics and automation as manufacturers invest in technologies that improve sterile manufacturing. Eatmon said that today’s isolator-based systems incorporate robotics, digital controls, and increasingly sophisticated automation that are transforming sterile manufacturing.

“I think as we change more to isolator lines — which are very complex — we’re bringing new things like robotics technologies inside the isolators, and there’s a lot more automation,” Eatmon says.

Robotics and automation are called out in the Research and Markets report as key technologies reshaping sterile manufacturing. In the category of automation, automated visual inspection (AVI) technologies are becoming increasingly important as filling speeds and batch sizes continue to increase. 

“If you think about formulation, filling and AVI, they all go together,” Blagg says. “A manual inspector can inspect about four syringes per minute. AI can inspect roughly 400 once it’s qualified.”

Blagg said he has seen batch sizes have nearly tripled over the past seven years, especially for syringes, making AVI an increasingly important tool for keeping pace with demand.

Automation is also producing far more manufacturing data than facilities generated in the past. According to Eatmon, the challenge is no longer collecting information but determining how to use it effectively.

“We’re having more robust and repeatable processes because of the data we’re getting,” Eatmon says. “But then it’s creating more data. What do we do with that? How do we get what we need and back up what we might not need right then?”

The growing reliance on automation is also changing the skills manufacturers need to support these increasingly sophisticated systems.

“It’s definitely a higher level of automation, which takes a different skill set,” Eatmon notes. “Now we need computer automation engineers rather than just mechanics to fix things when they go wrong.”

A new workforce

The shift toward automation is also changing the skills companies need from their workforce.

“The specialty world is changing,” Eatmon says. “We depend on reliability engineers now. We depend on people who can manage software and automation systems that we didn’t have before.”

Operators remain essential, but their role is increasingly focused on overseeing automated systems rather than performing manual interventions. Companies are also hiring more controls engineers and automation specialists.

Blagg expects demand for automation engineers and controls specialists to grow as fill-finish technologies become more advanced.

“You still have that people component,” he says. “Technology isn't going to replace that any time soon.”

The Research and Markets report identified workforce constraints as a key constraint in fill-finish manufacturing. To fill gaps in biotech personnel, Blagg observes that industry professionals have turned to virtual training programs. 

“We’re now evaluating virtual training environments where I don’t have to take manufacturing time on the line, and I can do that in a virtual environment,” he says. “You can also weed out operators that might be good in a no-risk situation versus putting them on the floor.”