In a March 2021 market report, Meticulous Research predicts that demand for products and services related to continuous bioprocessing (CBP) will grow at a blistering 23% per year, reaching $200 billion by 2027.
The study covers filtration and chromatography systems and consumables, bioreactors, sterilizers, centrifuges, incubators, shakers, mixing systems, cell culture media, buffers, and reagents. Key global players include 3M, Cytiva, Thermo Fisher Scientific, Merck KGaA, Sartorius, Repligen, Eppendorf, Applikon Biotechnology, Pall, and Bionet.
Factors driving growth include rising demand for biopharmaceuticals, the quest for greater efficiencies, biopharma expansion beyond the industrialized world, and advances in continuous processing technology itself.
Continuous processing has been a staple of discrete manufacturing, including process industries, for decades. One could have argued 15 years ago that production lines for potato chips and cement were more advanced, from a technology perspective, than manufacturing for billion-dollar antibody therapies.
The FDA’s initiatives around quality by design, risk-based drug evelopment/manufacturing, and process analytics were designed to alter that landscape—to improve compliance while allowing greater latitude in the deployment of novel manufacturing methodology.
The topic of CBP is currently in ascendancy thanks to buzz over Industry 4.0. Yet the reasons adoption has been so slow, and why each partial deployment is accompanied by publicity worthy of the discovery of penicillin, persist. In no particular order, those reasons are 1) inertia, 2) regulatory risk, and 3) the economic disconnect that insulates drug pricing from the meat-and-potatoes economy.
According to Viren Shrivastava, an analyst who worked on the Meticulous Research study, industry’s enthusiasm for continuous processing is further challenged by:
- Huge infrastructure investments required to integrate continuous unit ops into otherwise conventional processes
- An entirely different skill set for operators, requiring even more investment
- As a high-margin industry, biopharmaceuticals are traditionally focused on new treatments rather than bioprocess improvements
- Higher levels of controls and greater reliance on software/IT for continuous vs. batch processing
“Biomanufacturers are currently applying quality by design and process analytic-based strategies to implement control strategy in continuous processing,” Shrivastava tells GEN. “In addition, the digital revolution will involve the convergence of bioprocessing technologies and such concepts as the Internet of Things (IoT), automation and analytics, software, digital twins and artificial intelligence (AI), virtual or augmented reality (VR/AR), and machine learning, all of which will be required for the successful implementation of continuous bioprocessing.”