Annual Growth in Spending
We measured annual growth in spending for 14 common disposable devices (Figure 4). The fastest growth rate in per-facility spending was for mixing systems, which was reported to have increased 239% over the past 12 months.
Other fast-growing areas were membrane absorbers, media bags—purchased dry, and disposable filter cartridges. Much of this increase has been the result of more systems becoming available and greater confidence and experience in those currently on the market. This has also caused the shift from prefilled bags and dry bags.
To determine where the greatest increase in spending on disposable and single-use systems will occur, we asked respondents to indicate which type of disposable devices they plan to budget the greatest increase for over the next 12 months.
The single largest budgetary increase for disposable components will be in bioreactors over 100 liters. This was indicated by 16.6% of respondents, and suggests an industry focus on extending the scale of disposable bioreactors at least into scale-up production. Buffer bags, 100–500 L, were the second largest area of budgetary increase.
Satisfaction with Vendors
We tested end-users’ perception of eight attributes associated with disposables, including quality, product selection, and service received from vendors. This may point out potential areas of dissatisfaction that could impact adoption rates for disposable technologies.
A majority, 75.6% of respondents, indicated that for quality of product they were satisfied or very satisfied. This also points out that a quarter of end users are not fully satisfied with quality. Regarding strength of the product, 62.8% were satisfied or very satisfied. Not unexpectedly, regarding cost of products, only 24.7% indicated satisfaction. This is consistent, however, with price analysis in other industries.
The industry’s concerns regarding disposable products continue to center on how leachables and extractables associated with disposables may affect their specific project or system. Further, over half of respondents indicated that they would restrict their usage of disposables if forced to rely on a single vendor.
Standardization could improve the overall rate of adoption for these products. Downstream disposables are moving toward greater industry acceptance in most manufacturing areas. Once this is achieved, more companies, both CMOs and biotherapeutic developers, are likely to increase use of disposable technologies as they increase their ability to fully integrate overall production processes.
This study suggests that, as new biomanufacturers and new products enter the industry and products pipeline, disposable options are becoming a fundamental part of the decision process.