Single-use bioprocessing equipment has become well-accepted technology in a relatively short time. Disposable devices and components have created market niches and new segments that continue to evolve. In this dynamic environment, it is difficult to measure acceptance or assess market growth. Here we project the world market for cell culture single-use systems (SUS) as well as problems affecting that market, including adoption for commercial manufacture. This is based on our 10-year analysis of the industry, with data from our eighth annual survey report on biomanufacturing (1).

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Complex SUS devices with unique attributes continue to emerge. The first single-use bioreactors — Wave rocker platforms (now from GE Healthcare) — entered the market just about 10 years ago. The disposable-bioreactor market remains dynamic, with new entrants and variants continually being tested as alternatives to stainless steel for commercial applications. Single-use technologies (SUTs) now make up a large percentage of small- and mid-scale biopharmaceutical manufacturing, particularly in clinical testing and research and development (R&D). Upstream SUT includes disposable bioreactors, mixers, containers, tubing, connectors, sampling systems, purification devices and columns, and probes/sensors. Almost all such equipment, particularly the critical parts that contact process streams, is composed primarily of various types of polymers (“plastics”).

Market value estimations and the number of devices sold are both moving targets. By now, the industry is well aware that SUTs provide many economic and other advantages over fixed stainless-steel systems, with companies on average spending about US$1 million/year on disposable equipment (1). Even assuming comparable overall costs, SUTs offer compelling advantages over stainless steel. Greater flexibility allows companies to buy and assemble systems as needed and store them on site for future use.

Those advantages have resulted in SUT capturing a majority of the market for new bioreactors in small-scale research and clinical supplies manufacturing. However, new disposable equipment needs to be purchased for each product run/lot manufactured. No matter the scale, even at ≥2,000 L, SUTs involve cycles of equipment one-time use, disposal and replacement. So although up-front, operating, and total costs are generally lower for SUTs than stainless steel, recurring expenses will be higher because of regular repeated purchases (whereas stainless steel equipment is purchased and installed once).

Although SUT dominates much of biopharmaceutical R&D already and is emerging in clinical-scale segments, biopharmaceutical manufacturing is currently dominated by mammalian cell culture capacity, use, and expenditures, especially for monoclonal antibodies (MAbs) that require repeated large doses. Currently, disposable devices have not entered mainstream commercial manufacturing, partly for regulatory reasons. When regulatory agencies approve broad use of plastic single-use devices, the total market for such devices will increase significantly.

SUT Market Estimates

The world market for biopharmaceuticals is ∼$140 billion, which includes ∼$100 billion forrecombinant proteins — of which ∼$40 billion are for MAbs (2). Essentially all of that involves product manufacturing using stainless-steel bioreactors and other permanent equipment. Commercial (bio)-pharmaceutical development generally requires more than a decade; thus, SUT is still considered new technology for commercial applications. No major marketed biopharmaceutical products are yet manufactured using disposable bioreactors.

Table 1 lists some market estimates. The worldwide markets (expenditures) for bioprocessing facilities and equipment are estimated at $10.5 billion (or ∼7.2% of total biopharmaceutical sales). That is roughly split between up- and downstream bioprocessing. Industry consensus among vendors in our eighth annual report is that the overall bioprocessing market and its major niches will continue to grow at a steady 15–18%. That parallels the growth in marketed biological product sales.

Table 1: Disposables and related market estimates; the good manufacturing practice (GMP) market for single-use technology (SUT) today is estimated at US$150 million (for plastic tubing, manifolds, and connectors used with stainless steel systems) (Click to enlarge)

An estimated 90% (4.7 billion) of the current upstream bioprocessing market involves stainless steel equipment, mostly large-scale (≥1,000 L) bioreactor-based systems used for commercial-scale manufacture. By contrast, SUTs currently dominate the research and clinical supplies manufacturing market, which is only ∼10% of the upstream bioprocessing market (∼$525 million) and involves many times more systems but less expensive ones at smaller scales. The current market for SUT equipment in commercial good manufacturing practice (GMP) manufacture is ∼$150 million, mostly representing storage containers, manifolds, tubing, and other disposables used in hybrid systems with stainless steel bioreactor-anchored systems.

The SUT market is currently dominated by a few major vendors. Thermo Fisher is the market leader with ≥50% share, followed by Sartorius Stedim, EMD Millipore, GE Healthcare, and Pall Corporation. A mid-tier group of vendors includes ATMI and Xcellerex. Those are followed by a large number of companies splitting the remaining (10–15%) of the market. So the current market can be seen as both highly concentrated (in terms of large-scale devices and large-scale buyers) and fragmented (in terms of the number and variety of smaller-scale suppliers, components, and technologies). We expect larger vendors to increasingly seek larger sales and market shares by offering bundled systems that provide the convenience of major equipment and documentation, often along with bioprocess consulting, validation studies, installation, training, and service contracts.