CDMO Capacity: Stainless by Volume, Single-Use by Number

At Sartorius’ Process Intensification Forum in Hyderabad, India in June, Miriam Monge, the bioprocess firm’s head of Customer and Industry Advocacy, questioned the billions being spent on large stainless-steel capacity across the industry.

She highlighted North Carolina, where contract development and manufacturing organization (CDMO) Fujifilm Biotechnologies has opened the first phase of a $3.2 billion site with eight 20,000-liter bioreactors, and Amgen and Genentech have committed a further $1 billion and $2 billion respectively nearby. As such, Monge asked delegates whether capacity on that scale could ever be filled, and whether the local grid and water supply could feed several plants of that capacity in one region.

And North Carolina is not alone. A run of large stainless-steel projects has been announced by – specifically – CDMOs elsewhere. Among them Lonza, which is adding six 20,000-liter bioreactors at its headquarters and manufacturing center in Visp, Switzerland; Samsung Biologics, which has built a fifth plant at its Songdo site in South Korea for around $1.5 billion, adding 180,000 liters across twelve 15,000-liter bioreactors; and Lotte Biologics, whose $3.3 billion Songdo Bio Campus will run three plants of eight 15,000-liter stainless-steel bioreactors each, the first due in 2027.

Beyond the headlines, it is important to put these news stories in context, according to Dawn Ecker, Managing Director of bioTRAK Database Services at the BioProcess Technology Group, a division of BDO USA. The industry holds about 8.6 million liters of installed bioreactor capacity, with roughly 35% of it run by CDMOs, she told us. By 2030, the total is expected to grow to 10.6 million liters, with nearly half the new capacity – around 915,000 liters – installed by CDMOs.

Of that new CDMO capacity, 71% by volume is large-scale stainless steel, she said, but this is being installed by just a handful of companies. When looking at the number of systems, single-use leads, making up 61% of the roughly 120 bioreactors CDMOs are projected to install.

The Quiet Rise of Single-Use Capacity

The single-use build-out is less headline-happy than that of a billion-dollar stainless campus, so it often runs under the radar. Some of the larger examples include WuXi Biologics, which has built up a large single-use based network (including running twelve 4,000-liter single-use bioreactors at its Dundalk site in Ireland); AGC Biologics doubling its single-use capacity in Copenhagen; and Fujifilm, stainless in North Carolina, going single-use in the UK at Teesside.

The quieter single-use investments reflect demand moving toward smaller volumes, said Ecker. The share of pipeline products that could be made in a single 2,000-liter bioreactor has risen from 42% in 2021 to 55% today, and among those products the proportion outsourced has risen from 38% to 43% over the same period. “Demand fragmenting is present in the CDMO data,” and the trend is expected to continue, she said.

Despite this, the large steel plants are not necessarily under-utilized. Ecker was wary of giving utilization specifics but said the market is mostly full. CDMOs do not announce capacity they cannot fill, she noted, because utilization is their main revenue. “Over a quarter of all CDMOs are expanding,” she said, “so I would say overall we are mostly full rather than mostly underused.” In her experience, expansion talk starts once a site has been booked above 80% for several years running.

Scale, of course, is driven by product volume demand. Products above roughly 350,000 liters a year still favor a 20,000-liter stainless line, and those below 20,000 liters suit single-use. The middle, 20,000 to 350,000 liters a year, is harder to define now that single-use runs beyond the one-time ceiling of 2,000 liter bags, and up to 6,000 liters.

“As an example, if we estimate that a product has an annual volumetric demand of 180,000 liters per year, we know we could run nine batches in a 20,000 liter reactor and meet demand. But we also know that we could manufacture 180,000 liters per year in single use,” she said, either from a bank of 2,000-liter single-use reactors or a smaller number of 5,000 or 6,000-liter ones, depending on the product’s cost of goods and whether the capacity is free.

Furthermore, intensified processes could reach the same output from smaller equipment again. “As an industry, we keep improving our manufacturing processes for new products – whether that be increasing our titers and process yields or employing N-1 strategies,” said Ecker. “The whole idea is to make more in (and with) less – less space, less media, smaller or fewer batches.”

Based on bioTRAK’s numbers, Monge’s question goes from rhetorical to measurable. The big stainless plants are largely justified for the high-volume products and the handful of firms building them, while most of the market, and most of the pipeline it now serves, is heading toward smaller, single-use, and more flexible capacity.

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