The report’s analysis is from CPhI Annual Report expert, Dawn Ecker, consultant and bioTRAK database manager with BioProcess Technology Consultants (BPTC), in which she looks collectively at the overall growth in demand and capacity for biologicals over the next five years. Europe’s capacity is shown to be growing the fastest and will overtake the U.S. by 2020—rising from around 1,100L to nearly 2,200L within the next five years.
Globally both demand and supply are predicted to rise quickly, with demand slightly outpacing capacity expansions. This is forecast to result in an easing of capacity constraints in the short-term, but in the long-term, smaller companies may have difficultly accessing the capacity they need as products progress through the clinical pipeline—even in 2020 the majority of supply will remain at branded facilities (rising to 35 percent from 30 percent in 2017).
“In 2017, the annual volumetric requirements were just over 2,300 kL, while in 2022, the volumetric requirement is projected to be just over 4,300 kL, a five-year growth rate of nearly 14 percent. However, mammalian cell culture supply is around 3,700 kL and it will grow to approximately 5,600 kL by 2022, a five-year growth rate of around 8 percent,” commented Ecker.
Interestingly, it appears that a two-tier market is beginning to open-up with 55 percent of 2020 capacity being prospectively met by single reactors of 2,000L or 5,000L capacity, which perhaps sheds light on the recent trend towards single-use technologies in biopharma development. However, some 45 percent of future capacity will require reactors with volumes of 10,000L or above. If two or three 2,000L bioreactors are used up to 60 percent of the products in development could be met using just 2,000L capacity reactors.
In terms of areas of potential variance in overall capacity, Ecker identifies a continued focus on orphan drugs leading to lower overall capacity, or slightly higher should Alzheimer’s drugs and PDL/PDL-1 checkpoints in cancer get approved—shifting demand much higher and potentially leading to capacity shortages.
“In recent years, we have noted that the industry was experiencing some capacity constraints at the clinical scales due to very high clinical demand and the industry has responded in kind with a wave of facility expansions not seen in the recent past," Ecker said. "The type and scale of capacity being installed will also be important as the demand for nearly half of products in mid-to-late stage development can be met with 5,000L of capacity or less; while the remaining half of products will need larger capacity to meet future demand. With new bioreactor installations mimicking the demand profile, we are keenly watching how the industry is responding to these demands for capacity as it is critically important to ensure current and future products are available to the patients.”
The full findings of the CPhI Annual Report were released at CPhI Worldwide—with more than 45,000 industry executives and 2,500 companies in attendance—and include 12 in-depth expert contributions, as well as the CPhI Manufacturing and Bio league tables.