Single use bioreactors (SUBs) are used in research and development (R&D) carried out by biopharmaceutical manufacturers, research institutes and contract research organizations (CROs), as well as in biopharmaceutical manufacturing.
It's a growing market, driven by the low capital investment required to set up a facility, reduced complexity of automation, and energy efficiency. A new report by Research and Markets predicts that the global SUB market will expand at a compound annual growth rate (CAGR) of 18.4 percent over the coming years, reaching a value of $470.9 million by 2019 compared with $202.5 million in 2014.
Holding back the market to some extent will be regulatory concerns regarding the mixing process, contamination by leachables and extractables, and difficulties in meeting standards on good manufacturing practices (GMP).
Monoclonal antibodies (MAbs) represent the biggest segment of the single use bioreactor market by molecule type. The research firm attributes the high growth rate of this segment to rising demand for SUBs in small-scale manufacturing of MAbs as a result of low investment costs, low requirement of manpower and reduction in time-consuming changeover procedures.
In terms of cell type, the mammalian cells segment of the market is the largest and fastest-growing segment due to the successful employment of SUBs for mammalian cell cultures for clinical and commercial drug manufacturing.
The report looks at the SUB market on the basis of molecule type (monoclonal antibodies [MAbs], vaccines, gene therapy, recombinant proteins, stem cells and others [growth factors, interferons, antisense, RNA interference]), type of cell (mammalian cell, bacterial cell, yeast cell and others [insect cell and plant cell]), technology (wave-induced motion SUBs, stirred SUBs, single-use bubble column bioreactors and others [single-use reactors with vertically perforated discs and single-use hybrid reactors]), end users (R&D [CROs, biopharmaceutical manufacturers and research institutes] and biopharmaceutical manufacturers) and region (North America, Europe, Asia-Pacific, rest of the world).
Europe dominates the SUB market, followed by North America. But growth will be strongest in the Asia-Pacific region over the next few years.
Key market players are US companies Thermo Fischer Scientific, Inc., GE Healthcare and Pall Corporation and Germany's Sartorius AG and Merck KGaA.