Single-Use Becomes the CGT Baseline

In the nascent days of commercial biologics, work was concentrated among a small number of contract development and manufacturing organizations (CDMOs) with the capital to build and maintain large-scale stainless-steel infrastructure. Companies like Lonza and Boehringer Ingelheim invested hundreds of millions into facilities boasting 20,000 liter bioreactors, dedicated clean-in-place (CIP) and sterilization-in-place (SIP) systems, along with water treatment plants to support them.

That scale-driven model continued into the 2010s and has not gone away. Samsung Biologics built 784,000 L of bioreactor capacity made up of predominantly 15,000 L tanks in Songdo, South Korea, and continues to invest in large-scale stainless steel. Fujifilm Biotechnologies, meanwhile, opened a $3.2 billion facility in Holly Springs, North Carolina in September 2025 with 8 x 20,000 L stainless-steel bioreactors, and plans to double that.

Compared to the upfront cost of a stainless-steel facility, the initial capital outlay for a single-use plant is significantly less, while facility build is significantly quicker. According to a recent report from Coherent Market Insights, for a mid-scale monoclonal antibody plant upfront investment can be up to 30% less and build 12-18 months faster than an equivalent stainless-steel site.

Thus, over the past 15 years, single-use’s reduction in barriers to entry have allowed a new generation of CDMOs to compete in the space—even in the commercial arena. WuXi Biologics, perhaps, is the poster child having built its entire manufacturing strategy around disposable technology. The China-based CDMO went from zero to over 220,000 liters of bioreactor capacity in a decade. AGC Biologics, meanwhile, has significantly expanded by installing single-use systems across its global locations, including numerous 2,000 L suites in Denmark and 5,000 L single-use lines in Japan. And Avid Bioservices, which has described itself as an early adopter of single-use, has built up and widened its offering using such tech, creating a position that helped attract a $1.1 billion acquisition by GHO Capital and Ampersand Capital in February 2025.

Ravi Narayanan, Americas commercial leader for DuPont Healthcare Solutions and a board member of the Bio-Process Systems Alliance (BPSA), acknowledged the shift during his presentation at INTERPHEX 2026 in New York. He described visiting Indian CDMOs that had replaced 20,000 L stainless steel setups with banks of 6,000 L single-use bioreactors, manufacturing vaccines and monoclonal antibodies for the World Health Organization. “I’ve seen a lot of well-set flu vaccine providers outside the U.S. who used to have these 20,000 L [tanks], now they’re gravitating to 6,000 L bioreactors,” he said.

Narayanan’s broader talk focused on the cost pressures bearing down on CDMOs. An April 2 executive order imposed a default 100% tariff on patented pharmaceutical imports from countries including China, India, and Singapore. Raw material and logistics costs are climbing—container shipping from China to the U.S. has risen from $1,800 to roughly $9,000 per box, Narayanan noted—but CDMOs are contractually unable to pass increases through, and their OEM customers, locked into GPO contracts and government tenders, cannot absorb them either. One major med device company he cited is cutting its supplier base from 1,200 to 200. Drug customers now routinely demand six-week lead times where 12 or 20 weeks were standard.

“Geopolitical impact to cost and supply chain disruptions is real and more than ever,” he said. “So empathize with us when we come and say, hey, this is the amount of impact we have.” In that environment, the capex gap between single-use and stainless steel carries additional weight. A mid-scale single-use facility requires $20 million to $60 million in upfront investment versus $80 million to $300 million for stainless steel, according to BioPlan Associates.

This capex gap becomes more consequential at the smaller end of the production spectrum where cell and gene therapies (CGTs) sit. The sector has over 2,000 active clinical trials globally, more than 2,500 active INDs on file with the FDA, and a market valued at $36.5 billion in 2025 and projected to reach $183 billion by 2035. CGTs by their nature require smaller production volumes and patient-specific batches, particularly in autologous therapies like CAR-T, making single-use essentially the only option.

This has led to a cohort of specialist CDMOs building their operations around disposable systems from the ground up. Cellipont Bioservices in Texas completed a new single-use cleanroom in December 2025 to expand its iPSC and MSC manufacturing. ProBio, a GenScript subsidiary, opened a 128,000 sq ft purpose-built CGT facility in New Jersey in June 2025 running GMP viral vector production on single-use bioreactors. And Matica Biotechnology built a fully single-use viral vector facility in Texas that surpassed its entire 2024 revenue by Q2 2025.

While Samsung and Fujifilm will keep welding steel at the top end, the expanding layer of specialist CDMOs underneath is where the sector’s structural growth sits. These companies are built on single-use, serving both a biologics pipeline and a CGT pipeline that increasingly favor flexibility over scale.

Meanwhile, the vendor ecosystem is accelerating the shift. Sartorius’s Eveo Cell Therapy Platform, launched in March 2026, processes eight autologous patient batches in the cleanroom space typically needed for two, modeling a 90% reduction in CAR-T manufacturing costs. It is one of a growing number of integrated, modular manufacturing systems designed specifically to lower the operational threshold for CGT production. Prefabricated cleanroom pods, closed automated processing systems, and turnkey single-use suites are compressing both the capital and the timeline required to stand up a GMP facility from scratch.

The biopharma CDMO market is projected to reach roughly $375 billion by 2031, and the CGT manufacturing segment is growing at more than double the broader rate. Single-use opened the biologics CDMO space to a generation of companies that could not have competed on stainless steel capex alone, and now it is doing the same in cell and gene therapy.

Dan Stanton is a journalist with 15 years’ experience covering bioprocessing and biomanufacturing. He currently works as an editorial expert at Sartorius.