Tracking Solid-Dosage Equipment

Solid-dosage manufacturing is a significant part of the pharmaceutical industry's manufacturing activities. Pharmaceutical Technology's Annual Equipment and Machinery Survey (see "Spending More or Less, and on What?" of this issue for complete survey results and survey methodology) examined the spending and innovation trends for pharmaceutical machinery and equipment across all sectors. So how did survey respondents rank solid-dosage equipment in terms of their purchasing decisions and level of innovation, and what are some of the broader trends affecting this area?

Purchasing decisions

Solid-dosage manufacturing. The survey showed that the majority of respondents are either maintaining or reducing their expenditures of machinery and equipment for solid-dosage manufacturing. Seventy percent of respondents kept their spending on solid-dosage equipment either the same or decreased spending in 2009 compared with 2008 levels. Fifty-two percent kept spending at the same level, and 18.1% decreased spending. Almost 30% (29.9%) of respondents increased spending in 2009.

A similar pattern holds true for planned expenditures for 2010, although slightly more respondents anticipate that their companies will increase spending on solid-dosage manufacturing equipment in 2010 compared with 2009. The survey showed that 32.7% of respondents plan to increase their expenditures on solid-dosage manufacturing equipment in 2010, 50.5% will keep it the same, and 16.8% plan to decrease spending.

IMAGE: INFLUX PRODUCTIONS, PHOTODISK, GETTY IMAGES

In drilling down to specific equipment types, the survey showed that 27.4% of respondents increased their spending on tablet presses or capsule-filling machines in 2009 compared with 2008 levels, 52.7% kept spending the same, and 20% decreased spending. In 2010, slightly fewer respondents plan to increase their expenditures on tablet presses or capsule-filling machines. Roughly one-quarter (25.3%) plan to increase spending in 2010 compared with 2009 levels, 52.9% plan to keep it the same, and 21.8% decreased spending.

Other product forms. How do the solid-dosage spending levels compare with spending for manufacturing equipment of other product forms? The survey showed more robust spending for equipment and machinery used in parenteral manufacturing, sterile manufacturing, and aseptic processing. Almost 35% (34.9%) of respondents increased spending on equipment and machinery used in parenteral manufacturing, sterile manufacturing, and aseptic processing in 2009 compared with 2008 levels. Approximately half (50.4%) kept spending at the same level, and 14.7% decreased spending.

The spending levels for equipment and machinery used in parenteral manufacturing, sterile manufacturing, and aseptic processing planned for 2010 are on par with 2009 levels. The survey showed that 32.8% of respondents plan to increase spending, 50.6% plan to keep it the same, and 17.2% plan to decrease it.

Small molecules versus biologics. Another way to evaluate spending trends that can influence demand for solid-dosage manufacturing equipment is to examine purchasing trends for small-molecule and biologic-based drug substances. Consistent with overall industry trends that show increased drug development in biologics, more respondents increased spending in 2009 and plan to increase spending in 2010 for equipment and machinery used in biologic-based active pharmaceutical ingredient (API) manufacturing than for small-molecule API manufacturing. The survey showed that 36.5% of respondents increased spending on machinery and equipment used in biologic-based API manufacturing in 2009 compared with 2008, 50.5% kept it the same, and 13.2% decreased spending. In contrast, less than one-quarter (21.7%) of respondents increased spending on small-molecule API manufacturing, 56.6% kept it the same, and 21.7% decreased it.

A similar distribution holds for 2010 as well. The survey showed that 31.9% of respondents plan to increase expenditures on equipment for biologic-based API manufacturing in 2010 compared with 2009, 51.4% plan to keep it the same, and 16.7% will decrease it. On the small-molecule API side, only 23.3% of respondents expect to increase purchasing, 54.8% will keep it the same, and 21.9% will decrease it.

High-containment or high-potency manufacturing. The survey also examined the extent of spending in specialized areas such as high-containment or high-potency manufacturing for all product forms. The survey showed that 25.3% of respondents increased their spending on equipment and machinery used for high-containment or high-potency finished-drug product manufacturing, 55.8% kept it the same, and 18.9% decreased spending in this area.

Planned expenditures for 2010 are commensurate with 2009 levels. The survey showed that 24.6% of respondents plan to increase their spending on equipment and machinery used for high-containment or high-potency finished-drug product manufacturing, 52.3% kept it the same, and 18.9% decreased spending in this area.

Continuous processing. One area for more robust spending was machinery and equipment used in continuous processing for finished-drug products. Although the pharmaceutical industry primarily uses batch manufacturing, certain functions in solid-dosage manufacturing may operate in a semicontinuous mode, and in general, there is ongoing interest in continuous processing under a quality-by-design paradigm. The survey showed that 30.4% of respondents plan to increase their expenditures on equipment and machinery used in continuous processing in 2010, 53.4% plan to keep it the same, and 16% plan to decrease it. The number of respondents planning to increase spending in this area (30.4%) is up significantly from 2009, when only 19.1% of survey respondents increased spending for equipment used in continuous processing.Approximately two-thirds (62.8%) spent the same, and 18.1% decreased their expenditures.

Innovation trends

The survey examined to what extent companies were involved with specialized manufacturing or newer manufacturing technologies. Despite the uptick in spending for equipment and machinery used in continuous processing of finished-drug products, the majority of respondents (61.3%) said they do not use such equipment in their manufacturing process.

Survey respondents, however, were largely favorable of the level of product innovation for equipment and machinery used in continuous processing for finished-drug products. Almost two-thirds (62.5%) of respondents said that the level of product innovation in this area has been "high" and "medium" during the past two years (2008 and 2009). Thirty-nine percent said there has been "little or no" innovation in continuous-processing equipment for finished-drug product manufacturing during the past two years.

Respondents were fairly satisfied with the level of product innovation in solid-dosage manufacturing overall, but were less satisfied with the level of innovation for specific equipment types. More than half (58.3%) of respondents said that the level of product innovation in solid-dosage manufacturing equipment was "high" or "medium" during the past two years. Nearly one-quarter (24.5%) said it was "low," and 17.2% said there has been no innovation during the past two years.

Respondents were slightly less sanguine about advances in tablet presses and capsule-filling machines. Only about half (52.4%) of respondents said that product innovation of these equipment types was "high" or "medium" during the past two years. Only 13.6% of respondents characterized innovation for tablet presses or capsule-filling machines as "high," and 38.8% ranked it as "medium." Almost half (47.6%) of respondents said there has been "little or no" innovation in tablet presses or capsule-filling machines during the past two years (2008 and 2009). The survey showed that 28.6% of respondents said there has been "little" innovation, and 19.0% said there has been "no" innovation.