The adoption of single-use technology in biotech has skyrocketed in the past decade, and the uptick shows no sign of abating. According to data from Stratistics MRC, the global market for single use technology is projected to grow from $2.74 billion in 2017 to $13.23 billion by 2026.
Several factors are driving this change. Life science companies are eager to avoid the time and cost of cleaning required with stainless steel. They also want to get to market faster. The accelerated expansion of global biotech industries, as evidenced by the Boston bioboom, has provided a growth environment in which newer, disposable technologies are increasingly critical.
The pace of change is astonishing. As single-use becomes more widely available and cost-effective, the question of whether to deal with single-use or stainless-steel “is no longer a technology question, but a commercial one,” according to Thorsten Adams, director of product management at Sartorius Stedim Biotech. “In other words, does adoption of single-use or stainless-steel technology provide greater advantages?”
Keeping it small
There is little doubt that major pharmaceutical organizations are more receptive these days than ever to the implementation of single-use. And that’s, partially at least, attributable to changes in modern bioprocessing. Although stainless steel may remain better suited for larger-volume processes, the industry is moving in the direction of smaller processes, particularly for bioprocesses below 3,000 liters.
Much of this change is being driven by developments in medical research itself. The growth of personalized medicine has promoted the adoption of smaller-scale processes ideal for the deployment of single-use biotechnology.
Personalized medicine is, by definition, small scale. Its focus on an individual as researchers devise treatments custom to that person’s genome make it a perfect fit for single-use solutions.
Alongside the emergence of personalized medicine, improvements in cell culture processes and the growth of biologics have spurred the growth of single-use technology.
Not that this is a zero-sum game between stainless steel and single-use: hybrid implementation is common across the industry. In some cases, a stainless steel facility is retrofitted for single-use. In others, a new facility is designed to accommodate stainless steel for larger scale processes and single-use for smaller scale.
The emergence of these hybrid arrangements is particularly advantageous to Contract Manufacturing Organizations (CMOs). Being able to provide single-use technology alongside stainless steel helps CDMOs become more flexible and pivot faster for their clients’ needs.
“CDMO business models as service providers force them to look for flexible production capacity, fast campaign changeovers, and rapid production at different scales,” explains an article by Bioprocess International. “Those demands are nicely fulfilled by the use of disposable equipment, which has made CDMOs early adopters of single-use technologies.”
Ken Clapp, senior manager at GE Healthcare Life Sciences, agrees on the benefits of a hybrid approach. Speaking with The Medicine Maker in 2016, Clapp said that one of the biggest drawbacks to using stainless steel is when a drug goes off patent or is no longer commercially viable and production ceases permanently. “The manufacturer may be left with a stainless steel monument to a bygone product,” Clapp stated. “With a single-use technology infrastructure, a company can quickly scale down their operation or transfer the portable equipment within their manufacturing network to support new production demand.”
The argument for continued adoption of single-use is strengthening on several fronts. From a financial perspective, single-use proves more cost effective than stainless steel at most sizes.
“People don’t want to clean and they don’t want to do cleaning validation”, says Mark Sitcoske, CEO and founder of High Purity New England, an international manufacturer and distributor of custom single-use assemblies. “They want to lower their capital expenditure and get in the market as fast as possible.” The fact that many large pharmaceutical companies are building single-use facilities is evidence of this trend, he notes.
Of the environmental concerns surrounding single-use, Sitcoske says that the proportion of dirty plastics produced by the bioprocess sector is incredibly low as a percentage of total plastic production. He points to the uptick in initiatives across biopharma toward recycling and safely disposing of single-use materials.
The next frontier
As pharmaceutical companies, manufacturers, distributors, and CDMOs converge around the benefits of single-use, all eyes will be on the further progress researchers make in the drive to create effective personalized medicines that strike at the heart of difficult-to-treat medical conditions. From therapies for rare diseases to the race for a cure to cancer, the impact of single-use technology in facilitating cutting edge research into these conditions is set to grow.