Figure 6: Level of industry innovation in select manufacturing areas during the past two years (2009 and 2010). API is active
pharmaceutical ingredient.
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Also, fewer companies will buy equipment and machinery for expanding facilities or other upgrades in 2011. More than one-half
(57.7%) of respondents said expanding manufacturing facilities had "high" or "medium" impact or on their planned expenditures
in 2011 compared with their spending in 2010, when almost two-thirds regarded these factors as important. Almost 60% (59.7%)
said adding enhancements, upgrades, and/or innovative technology was either of "high" or "medium" impact for planned purchases
in 2011, down slightly from the 63.9% that said so in 2010. Slightly more respondents in 2011 (68.9%) than in 2010 (64.4%)
regard replacing existing equipment as a "high" or "medium" impact factor in purchasing (see Figures 4 and 5).
Figure 7: Level of industry innovation for select equipment and machinery types during the past two years (2009 and 2010).
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Outsourcing will be less influential in purchasing decisions in 2011. For 2011, 38.7% of respondents said that outsourcing
to decrease capital expenditures was a high- or medium- impact factor as compared with 43.3% who said so in 2010 (see Figures
4 and 5). For 2011, 16.0% said outsourcing to reduce capital spending had "high" impact, and 22.7% said it had "medium" impact
(see Figure 5).
Respondents' profiles
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Some newer technologies will have more import in purchasing. The survey showed that 42.8% of respondents regard improving
security and anticounterfeiting capabilities as a high- or medium-impact factor for their planned purchases in 2011 compared
with 45% who did for actual purchases made in 2010. More companies will spend to apply QbD in 2011 and a similar number of
respondents cite PAT as an influential. (see Figures 4 and 5). More than half of respondents (52.2%) said that applying QbD
is a high- or medium- impact factor for planned purchases in 2011, slightly more than the 50/% who did for actual spending
in 2010 (see Figures 4 and 5). For 2011, 44.4% of respondents said PAT will have either "high" or "medium" impact for planned
purchases, compared with 47.0%, who said it had that importance in 2010.
Innovation
About two-third (65.2%) of respondents said that innovation is "extremely" or "very" important in their purchasing decisions
for equipment and machinery. In evaluating innovation, respondents thought the level of innovation was highest during the
last two years in biologic API manufacturing (33.9% said so) and equipment for quality assurance/quality control (26.7% said
so) (see Figure 6). Innovation was considered the lowest for high-potency/high-containment manufacturing for APIs and finished
products, both for which 22.1% of respondents said there has been no innovation during the past two years (see Figure 6).
In terms of specific equipment types, the highest-ranked area was for innovation in process control and automation, followed
by disposables for biopharmaceutical manufacturing, laboratory equipment, and analytical instrumentation. Innovation in tablet
presses, capsule-filling machines and equipment for vial- or syringe-filling ranked the lowest (see Figure 7). Roughly two-thirds
of respondents do not use continuous processing for finished products (66.9%) or APIs (69.4%). For disposables or single-use
components, 63.9% use them in biopharmaceutical manufacturing, and 36.1% do not. For future purchases, respondents show a
slight preference for a mix of stainless-steel equipment and disposables (35.7%), 34.3% will purchase stainless-steel equipment
only, and 27.1% will only buy disposables.
Reference
1. P. Van Arnum, Pharm. Technol. 34 (4), 48–56 (2010).
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