Ahead of CPhI Worldwide, taking place in Milan, Italy in November, part of the CPhI Annual Report has been released, containing insights for biologics manufacturing, biotechs and CDMOs.
In the report, CPhI contributors Dawn Ecker, MD of bioTRAK Database Services at BDO and Fiona Barry, Editor at GlobalData PharmSource, look ahead to 2025 to predict demand for biologicals by volume, as well as the total capacity available and, the consequential impact in the short-to-medium term of the proliferation of COVID-19 supply contracts.
Tara Dougal, Head of Content and Insights at CPhI Worldwide, said: “This year’s agenda will explore many of these issues, and we have one session, produced in collaboration with BioProduction, which looks specifically at the viability and commercial challenges of manufacturing large biologics. A further webinar will address building viral vector capacity and capabilities to realise the promise of gene therapies, as the latter’s manufacturing challenges been severely exacerbated by the mRNA vaccine demand, which also requires viral vector manufacturing.”
Dawn Ecker predicts that biologics manufacturing volume will grow by circa 8% per annum, reaching approximately 3,900 kL. However, during the same period, global biological manufacturing capacity will increase to 7,500 kL, up from 5,200kL, but significantly, the location and type of companies that have capacity will show a marked change from five years prior.
In 2025, nearly half of all capacity (44%) will shift from in-house manufacturing to CMO/hybrid companies, the report claims. According to Ecker’s findings, 5 of the top 6 companies by capacity volume in 2025 will be CMO or hybrid. The only exception is Hoffman-La Roche, which Ecker predicts will maintain its position as the company with the largest total biologics capacity. A number of CMOs are currently investing heavily in increasing their volumetric capacity and, in 2025, Samsung Biologics, Lonza, WuXi Biologics and Fujifilm Diosynth Biotechnologies respectively will make up places two through five, with the latter two rising from outside the top ten in the 2020 rankings.
“What’s interesting is that at the same time as CMOs are raising capacity, we are also seeing a geographic shift in where capacity is located, with Europe and Asia growing much faster than North America. In 2025 Europe will be home to the largest biologics capacity in the world, overtaking North America,” commented Ecker.
GlobalData reports show that there have been more than 230 disclosed contract manufacturing agreements for COVID-19 vaccines and therapies, with many more (undisclosed) likely to exist. The larger biologics CMOs have been among the big winners of the demand for outsourced vaccine supply. With booster shots already underway and more approvals to, demand will likely remain strong for several years to come.
Fiona Barry, reflecting on how CMOs have gained due to the sudden need for additional capacity, commented: “The CMOs benefiting most from COVID-19 vaccine development by number of contracts are Catalent, Lonza, and Emergent BioSolutions – though the latter may now suffer as a result of its well documented FDA inspection difficulties. Emergent’s contracts skew toward vaccine manufacture, whereas Catalent and Lonza’s contracts are more evenly split between vaccines and therapies. But other large CDMOs have also benefited greatly.”
In fact, many of these supply Covid supply contracts are not only for large volumes, but also run over long periods of time – for example, Lonza signed a ten-year active pharmaceutical ingredient agreement with Moderna.
Orhan Caglayan, Brand Director at CPhI Worldwide, commented: “When we look at the collective findings of Dawn and Fiona, we see that biotechs may continue to face some challenges in accessing available capacity at the right time. Many of the more established CMOs have large COVID contracts and capacity is shifting away from the US. This means that biotechs and pharma partners without sufficient inhouse capacity are going to have to widen their networks of potential partners.”
