The 18th Annual Report of Biopharmaceutical Manufacturing Capacity and Production, 2021, a mammoth, annual effort from BioPlan Associates, provides a comprehensive snapshot of significant, paradigm-affecting trends in biomanufacturing. You may not agree with everything the BioPlan team concludes, but their observations are always worthy of serious consideration.

The report summarizes BioPlan’s survey findings over the past year, provides historical perspective, and is chock full of thought-provoking numbers.

For example, respondents were asked about their companies’ plans to increase capacity for mammalian and microbial cultures. While a lower percentage of those surveyed expected capacity increases, estimates for the extent of build-outs were in line with 2019 numbers but significantly lower than last year’s. That is understandable given the uncertainty surrounding the COVID epidemic, and the fact that respondents were operating under the long-held “Tufts” approval paradigm of, approximately “15 years and three billion dollars,” which industry experts have been pushing as gospel for years.

The average expected five-year capacity increases for 2019, 2020, and 2021, respectively, were 43%, 57%, and 43%.

“The slight overall decline over this brief time period suggests overall satisfaction with access to mammalian and microbial capacity,” says Eric Langer, managing partner and chief editor of the 2021 report.

Cell therapy guesstimates

Anticipated increases in microbial systems also declined compared with the 2020 poll, from 48% to 35%. Interestingly, despite the all the press reports extolling the future of cell and gene therapies, guesstimates for “cell therapy” production remained steady year-over-year, in the 30% range, while respondents predicted just modest growth for gene therapies, 29% in 2020 and 36% in the 2021 survey.

Langer, however, predicted a worsening “capacity crunch” for these new therapeutic areas where, he says, “much more capacity than what we see in the survey will probably be needed.”

According to Langer, the biopharmaceutical sector grows at around 12% annually, a doubling time of six years, and that FDA approves approximately 20 new biological drugs every year. Thus, capacity needs are cumulative. “A hundred new products will be approved during the next five years, which are added to the 100 or so already marketed.

Assuming approval rates continue, this surge in biopharmaceutical products suggests that respondents are underestimating, to some degree, the industry’s capacity needs. “Another factor to consider, [from Langer’s report:] the majority of biomanufacturing facilities undergo significant expansion, upgrade, or construction about every five years.”

One could say then that facility expansion and upgrades are already built into the system, with emerging or novel products adding to the already thick layer of icing on that particular cake.