Only a handful of years ago, single-use was deemed to be a niche material in biomanufacturing compared to the industry standard of stainless steel bioreactors and systems, but according to some experts this has now been inverted.
And going by recent second quarter 2016 results this seems to be the case with biopharma demand for single-use systems and disposable products the major driver for topline growth among the key players.
Pall and Sartorius both saw continued double-digit growth rates from disposable systems, with the latter describing single-use systems (SUS) to once again be the “growth engine” for the company.
Thermo Fisher described demand for single-use as “an excellent growth market for a number of years for us and one with a very bright future,” while Germany’s Merck – incorporating bioprocessing tech unit MilliporeSigma - attributed much of the growth in its life sciences revenues to disposable demand.
But will such growth levels continue? According to Eric Langer, managing partner of BioPlan Associates, they will.
“Demand for single-use platforms is driven by increased usage and adoption in clinical - and ultimately, commercial - scale processing,” he told Biopharma-Reporter.com.
“Uptake over the past five years has been consistent, on average, and the single-use companies that have been supplying clinical-scale the longest are the ones reaping the benefits of this compound growth.”
And according to his company’s 13th Annual Biomanufacturing Report published earlier this year, demand for disposable products is unlikely to fall.
“Average annual growth in SUS platform adoption at all stages for technical devices is around 12-13%. Once adopted, actual usage, at any scale, will exceed that rate,” he said.
Stainless steel and commercial production
Currently nearly 85% of operations at clinical and pre-commercial scale are being done using single-use platforms, but SUS still pose a problem for commercial production where volumes are often dramatically larger.
While such advances as increased titres and bioreactor configuration are helping SUS make the leap to commercial manufacturing, stainless steel platforms will continue to prevail in this area, according to Langer.
“There will always be demand for stainless platforms,” he said, though added it is not a case of an either-or situation, and a mixture of stainless steel and single-use is most likely to be the reality going forward.
“Hybrid systems, where interconnectivity and flexibility play a major role, are what is currently being engineered.”
M&A
M&A activity in the single-use space has mirrored the growing demand.
Over the past few years, ATMI has been integrated into Pall, Life Technologies and ASI were acquired by Thermo Fisher, Saint Gobain bought ABC, Sigma-Aldrich merged with Germany’s Merck, and Sartorius has also been boosting its single-use offerings through bolt-on acquisitions.
We asked Langer how the uptake of SUS would affect M&A among the vendors going forward:
“At this point, with relatively few major suppliers, the acquisitions are likely to be with adjacent technologies, or novel technologies that may in the long term replace current platforms,” he said.