A continued drive towards process efficiency and automation continues to spur the sector forward. But manufacturing demands for COVID-19 drugs and the rising demand for antibody-drug conjugates (ADCs) is also driving demand.
Given the growing market, single-use systems will be in the spotlight at CPhI North America.
Ever important: process efficiency
The global single-use bioprocessing market size was valued at $15.8bn in 2020 and is expected to grow at a CAGR of 16% from 2021 to 2028, according to stats from Grand View Research. A dramatic increase in global bioreactor capacity to meet demands of manufacturers is one of the factors behind this growth.
Single-use systems are champioined for their role in cost reduction, thanks to minimalized cleaning steps and a reduced risk of cross-contamination. There can also be a reduction in labor costs as additional hold-times and validation steps can be eliminated. They also allow companies to work with smaller quantities.
And experts say that such systems could become all the more important as the focus on bioprocess and continuous manufacturing continues to grow.
“Single-use platforms are more amenable to automation; there has been considerable discussion on automation and the increase in transparency that new software will bring – potentially filling a substantial gap in the processes of today,” note CPhI experts in a note ahead of the show.
Meanwhile, increased demand for antibody-drug conjugates (ADCs) is also driving the growth of the single-use systems market.
The ADC market is estimated to reach $9.3bn by 2027, with a CAGR of 13.7%. ADCs – which consist of a mAb chemically linked to small molecule therapeutics – show particular promise as oncology drugs. As scientists look for more targeted therapies and more clinically efficacious drugs, biopharmaceutical companies are increasing research and product development in this area.
Increased demand for ADCs is driving high demand for HP-APIs: an area where single-use systems are of particular interest.
“Single-use systems have proven to be effective at significantly reducing the risk of cross-contamination of HP-APIs as single-use flexible isolators can be used for handling solids (toxic APIs) during synthesis and in downstream processing,” notes the CPhI preview note.
The flexibility of single-use systems has brought them further into demand during the pandemic. While the demand for COVID-19 drugs is evident, the exact quantities required has been hard to predict. In addition, single-use systems require lower capital investment.
This means that pandemic-related new facilities have turned to single-use systems, often of modular construction.
In September, for example, the Serum Institute of India announced it had ordered six 4,000L custom single run (CSR) single-use bioreactors from ABEC to allow it to double capacity as it readied to manufacture 1 billion doses of Novavax’s COVID-19 vaccine candidate. The order made helped it become the largest single-use bioreactor-based vaccine manufacturing line in the world.
Stainless steel facilities are likely to follow: but only after pandemic-related products show steady and predictable long-term demand.