By 2025 contract manufacturing organisations (CMOs) and hybrid companies are expected to account for almost half of the industry’s biomanufacturing capacity.
This is according to the latest CPhI Annual Report which assesses aspects such as the future 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.
Contributor to the report, Dawn Ecker, managing director of bioTRAK Database Services at BDO, expects that biologics manufacturing volume will grow by circa 8% per year, reaching approximately 3,900kL.
However, during the same period, global biological manufacturing capacity will increase to 7,500kL but the location and type of companies that have capacity will show a marked change from five years prior.
The report predicts that in 2025, nearly half of all capacity (44%) will shift from in-house manufacturing to CMO/hybrid companies. According to Ecker’s findings, five of the top six companies by capacity volume in 2025 will be CMO or hybrid. The exception being Hoffman-La Roche, which 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 rapidly rising from outside the top 10 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.
According to Ecker’s research, another significant shift is the scale of manufacturing needed for future products in the pipeline, with over half the recombinant products currently in late phase development forecast to need only a single 2,000L or 5,000L bioreactor to meet commercial demand.
The report also highlights that in the last two years there have been over 230 disclosed contract manufacturing agreements for Covid-19 vaccines and therapies. It’s expected that demand for outsourced vaccine supply will remain strong for several years, as booster shots and more approvals for Covid-19 therapies are to come.
Fiona Barry, editor at GlobalData PharmSource and contributor to the report said: “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 contract development and manufacturing organisations (CDMOs) have also benefited greatly.”
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 in-house capacity are going to have to widen their networks of potential partners. What we see at CPhI Worldwide is that proactive companies are looking ahead now for new partners and how they can ensure continuity and flexibility in supply."