There is significant market demand for global sterile capacity says Recipharm. But as the need for COVID-19 vaccine filling decreases, competition between CDMOs will rise.

Swedish contract development manufacturing organization (CDMO) Recipharm has made various investments across the globe to strengthen its fill-finish capabilities and capacity.

In October, the firm scaled up its sterile filling capabilities by investing in Lab+ technology used for low volume blow-fill-seal (BFS) filling at its plant in Kaysersberg, France. Furthermore, the CDMO signed a Memorandum of Understanding (MOU) in July 2021 to invest $500 million to operate a new fill-finish plant, which will be located on a 42-hectare site in Morocco. In the same month, Recipharm said it would build a fill-finish facility in Uttarakhand, India increasing its fill-finish capacity to one billion sterile units per year.

However, as life returns to normal and pandemic-related orders for COVID-19 vaccines drop in size – as experienced by the likes of Sartorius, Danaher Corporation, and Catalent – Recipharm told us that this will lead to an increase in competition between CDMO’s for large-scale projects.

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BioProcess Insider (BI): With demand expected to continue throughout 2023, what challenges do you think the fill-finish space will experience?

Recipharm (R): Throughout 2022, we saw CDMO sterile fill & finish capacity grow considerably and, in 2023, we predict this trend will continue across the sector. However, as demand for COVID-19 vaccine filling slows in the new year, we can expect increasing competition among CDMO’s for other large-volume high-throughput aseptic liquid filling projects.

BI: COVID-19 has also highlighted issues with supply chain security, is this something else that Recipharm has recognized?

R: 2022 has created a new market environment with significant supply chain constraints, high inflation rates and energy insecurity that will last into 2023. In [2023], we expect continued strong demand. CDMO’s will need to carefully manage their growth trajectories and navigate a complex supplier situation in order to continue to support customers effectively.

BI: And what affect do you think this will have on the clients?

R: A shift towards more regional – as opposed to global – supplier relationships is another significant trend we anticipate continuing. Companies are seeking to enhance the robustness and reliability of their supply chains and react to possible moves by some governments – particularly the US and China – to incentivise supply onshoring.

BI: With these factors in mind, does Recipharm think there is still a need to invest and expand?

R: There is considerable market demand for sterile capacity in both Europe and Africa, and we expect this to continue for the foreseeable future. With this in mind, we intend to continue investing in our capabilities and capacities around liquid aseptic vial filling, pre-filled syringes, and lyophilisation services across our site network in Italy, Germany, and France. In Africa, we have the flexibility to expand on short timelines, pending incoming demand.

BI: What does Recipharm identify as the driver for this sustained demand?

R: A key driver behind this growth in sterile filling demand is the increase in the number of biologics products coming through the development pipeline. Biologics commonly require parenteral administration – as such, they require aseptic processing and finishing. As large molecules, these biologics also present a challenge when it comes to filtration processes that needs to be addressed at the fill & finish stage.

BI: As a result of extensive pipelines, does Recipharm think this will affect forms of fill/finish?

R: Over the next few years, we see strong growth in demand for sterile fill & finish – particularly for more complex dosage forms, such as pre-filled syringes, cartridges, and lyophilised products.

Secondly, we see more and more pharma companies exploring self-administration for their products, for example via auto-injectors, soft-mist inhalers, or nasal devices. All these devices require fill & finish services – either sterile or non-sterile – as well as capabilities in assembly and packaging. That makes pharma companies’ supply chains more complex, but the convenience benefits of self-administered dosage forms add considerable value for patients in need. At Recipharm, we are actively working on more integrated services that even include the provision of the devices themselves, simplifying the supply chain for customers.