Ten years ago, single-use systems were an emerging technology moving from common use as storage bags for cell culture media and serum, into broader applications that have developed into a major trend in clinical biopharmaceutical manufacturing. Advances continue as more robust, better designed, and standardized technologies, with more inert materials, are developed for GMP applications. As single-use/disposable bioprocessing moves toward commercial-scale manufacturing applications, even more innovation is being demanded by the industry.
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In BioPlan's 10th annual report on the industry, four of the top 21 new product areas being sought by this industry were single-use related: disposable bags and connectors topped the list again this year, with 44% of the industry demanding better technology/products (compared with 40% last year), following were probes and sensors (39.6% this year, vs 34% in 2012) (1). In comparison, stainless equipment once again hit the bottom of the list, with fewer than 5% indicating they would like new products developed in this area (see Figure 1). The reason for this interest is partly because single-use devices allow lower overall facility costs, reduce contamination problems, provide faster changeovers, and reduce shutdown times. As such, they continue to grab the focus of the industry.
Figure 1: Selected new technology and innovation areas demanded by the biopharmaceutical industry (a few of the 21 key areas indicated).
In fact, a separate BioPlan study conducted in late 2012 of the 450 global subject matter experts and senior industry participants who make up BioPlan's Biotechnology Industry Council (BIC), asked participants to identify the key trends and factors they see in the industry. This year 22% of senior industry decision-makers pointed to single-use devices as a key trend, just behind downstream processing (24%) and analytical methods (24%) (2).
While single-use devices remain a hot topic this year, much has changed from when they were first being evaluated by the industry. BioPlan's biomanufacturing industry study includes trends in the use of disposables and single-use systems. Data over a multi-year period offers insights into how the market for single-use equipment has evolved over time, and where it may be headed.