FACTORS RESTRICTING GREATER ADOPTION OF DISPOSABLES
While maturing, introduction of single-use, disposable systems is still relatively new, and as such, the number of factors
decision-makers recognize as hurdles continues to evolve. While the market has burgeoned, there are some challenges that the
industry still needs to overcome before the next stage of penetration can be reached. And in this area, we see some interesting
This year, when industry personnel were asked their single most important reason for not increasing use of disposables, of
the 23 potential reasons identified, 1 in 5 respondents focused on one: leachables and extractables. Concern regarding leachables
and extractables has grown steadily in the past few years, doubling from 10.4% of respondents in 2009.
As recently as 2011, this was not the top concern hindering adoption. Instead, the most common reply from respondents was
that they had already invested in equipment for their current system, hindering further use of disposables. Over the years,
however, that reason has gradually become less of an issue, perhaps as current installed equipment has depreciated or worn
out. There was a slight rebound in the percentage of respondents indicating this reason to be their primary concern this year
(from 13.3% to 16.3%), but that this factor remains less of a worry today than leachables and extractables.
Other trends seen include the declining proportion of respondents saying that the high cost of disposables (consumables) is
their top hindrance—as can be expected with greater maturation of the market—and a general increase in the proportion who
are concerned with not becoming vendor-dependent (single-source issues).
DEMAND FOR INNOVATION REMAINS HEALTHY
One reason why the disposables market has been able to overcome the above obstacles is the continued pace of innovation in
this area. Each year BioPlan asks the industry to identify the top five areas they want their suppliers to focus their development
efforts on. And seemingly with every passing year, the industry responds that they want innovation in disposable products.
As mentioned above, this year, a leading 43.8% of respondents indicated that disposable products, bags, and connectors are
an area of interest, up from 40% last year and 36.5% the previous year. Interest in having suppliers improve their single-use
devices is an indication of broader general adoption and a greater number of potential applications that are not being met
with current technologies. Some of these concerns include the need for:
- Better materials with fewer particulates, and lower leachables and extractables
- Stronger, more robust materials, tubing, films
- Products able to withstand freeze/thaw cycles
- Better probes and sensors to meet more varied applications
Suppliers generally have been answering the call: past surveys have indicated that disposable bioreactor bags/consumables,
single-use bags/films, and disposable chromatography have consistently been among the top new technologies or product development
areas suppliers have said their organizations are working on, and expending R&D resources to resolve.