Modern pharmaceutical manufacturing equipment and associated analytical instrumentation is the fundamental ‘hardware’ required to produce safe, effective, high-quality medicinal products. To meet the challenges from increasingly downward price pressure, stringent regulation, shifting markets and outcome-based insurance reimbursement, modern manufacturing processes rely heavily on innovative, integral, flexible equipment to achieve quality, efficiency and cost-effectiveness.
The trend to invest in pharmaceutical equipment continues, as observed in the 2017 Nice Insight Pharmaceutical Equipment Survey.1 Other prominent trends revealed in this survey include strong interest in purchasing biopharmaceutical processing equipment, and in purchasing software systems for process automation, simulation, validation and integration. Equipment contributing to manufacturing process integrity plays an increasingly important role in making equipment-purchasing decisions. Equipment providers with the ability to provide GMP-compliant equipment that improves process integrity have a strong competitive advantage.
For the 2017 survey, Nice Insight polled over 100 more respondents in comparison to the 2016 survey (597 vs. 489) from pharmaceutical and biotechnology companies worldwide. Additionally, there were several key differences in respondents’ backgrounds, including location, company type and size.
Geographically, the new survey recruited more respondents from Europe (32% vs. 19%), while respondents from North America decreased to 27% from 41% in 2016. Respondents from small and emerging pharmaceutical companies represent the largest portion of the buyer group (44%), up by 28% from 2016, while representation from large and midsized pharmaceutical companies was down.
Measured by type of product, the percentage of respondents from biopharmaceutical and biotechnology companies was even more dominant than before, rising from 45% to 54%, while the proportion from branded pharmaceutical companies decreased from 27% to 19%. The percentage for the rest of the buyer groups was close to last year’s level, including generic (17%) and over-the-counter (OTC) pharmaceutical companies (4%), contract manufacturing organizations (CMOs) and nutraceutical companies (3% each).
With respect to respondents’ job title, the 2017 survey included feedback from two new groups of professionals — engineers (14%) and technicians (9%) — so that a more comprehensive industry perspective on equipment purchasing can be explored.1,2 To some extent, these differences in respondents’ profiles may contribute to the data variations observed in the 2017 survey, since companies of different types and/or sizes have different equipment needs.
Despite the differences, however, the vast majority of those surveyed in both 2016 and 2017 possess a sound knowledge of the technical and financial aspects of the categories of pharmaceutical equipment being analyzed. Additionally, 88% play a supporting role in the internal processes for specification and purchase of process and production technologies; 78% of them are authorized to approve capital equipment spending.
The trend of budget increase for equipment purchasing continues into 2017. As many as 38% of respondents reported an annual budget for equipment purchasing exceeding $100 million, a remarkable increase from 2016. The second leading budget category is between $50 million to $100 million (27%), followed by $10 million to $50 million (25%). The outlook for equipment budget in the near future also looks quite positive, with 73% of respondents projecting a budget increase.
Investing in equipment has been a strategy for the pharmaceutical and biotechnology industry to increase productivity, lower cost and shorten the development timeline, as well as to access specialized technologies and capabilities. In the case of the 2017 survey, the significant budget increase may indicate a strong intention on the part of these companies, particularly those that are small and emerging, to improve or expand their in-house manufacturing capability.
In the 2017 survey, 98% of the respondents’ companies indicated in-house manufacturing capability: 48% with both clinical and commercial scale in-house, 41% with clinical scale in-house and 9% with clinical scale in-house manufacturing capability but no scale-up capability. The remaining 2% outsource their manufacturing needs completely. The large percentage of small and emerging companies in the survey may partially contribute to this pattern of in-house manufacturing capability.
To gain a full picture of respondents’ equipment purchasing needs, the 2017 Nice Insight Pharmaceutical Equipment Survey breaks down pharmaceutical equipment into five categories: oral solid-dose processing equipment, oral solid-dose packaging equipment, bioprocessing equipment, sterile process equipment and sterile packaging equipment. Each is further divided into sub-categories, such as primary and secondary equipment for packaging equipment; and upstream, downstream and accessory equipment for bioprocessing equipment.
A deep drop in the interest level in purchasing equipment and systems was observed in all of the five categories surveyed, in comparison with 2016. Despite this, however, 64% of respondents expressed interest in purchasing biopharmaceutical processing equipment, followed by pharmaceutical processing equipment (56%). This observation reflects the shifting focus of R&D to biologicals, as well as the rapid market growth of this sector. The interest in purchasing the remaining three categories (fill, finish and packaging equipment, laboratory equipment and cleanroom equipment) is moderate (31%, 28% and 20%, respectively).
With respect to respondents’ intention to purchase a specific type of bioprocessing equipment, the interest level is relatively higher for downstream equipment than upstream equipment. The top three highly demanded downstream equipment includes filtration (43%), purification (40%) and separation (39%) equipment, while the top three items of upstream equipment are mixers, blenders and millers (37%), incubators (34%) and fermenters (29%). The greater demand in downstream equipment is largely due to the shift of the biomanufacturing bottleneck to downstream, mainly because the productivity in upstream bioreactors has increased dramatically.
Oral solid dosage forms accounts for the largest formulation category on the market. However, due to increasing development efforts in novel biopharmaceuticals and biosimilars, parenteral dosage forms are gaining a higher market share. The 2017 survey results reflect this trend: 61% of respondents reported that their companies manufacture liquid dosage forms (parenteral, injectable and vials) while 55% reported manufacture of oral solid dosage forms (capsules, tablets, etc.).
One prominent trend in the demand for a variety of oral solid-dose processing equipment is the strong interest in purchasing software for solid-dose equipment, especially for process automation software (41%) and computer and automation systems (39%). Over one-third of the respondents are also interested in purchasing software for manufacturing execution, process simulation, system validation and computer-integrated manufacturing.
The application of this technology goes beyond oral drug manufacturing. Automation and robotic technology has been steadily incorporated into every aspect of modern pharmaceutical manufacturing processes to replace manual labor, reduce human error and improve line efficiency.
These technologies also have been used in process optimization, real-time monitoring and quality control. For highly potent drug manufacturing, they can be especially useful in decreasing human contact while creating a safer working environment and addressing regulatory concerns. The demand in this area is more likely to increase in the future.
Oral solid dosage forms accounts for the largest formulation category on the market. However, due to increasing development efforts in novel biopharmaceuticals and biosimilars, parenteral dosage forms are gaining a higher market share. The 2017 survey results reflect this trend: 61% of respondents reported that their companies manufacture liquid dosage forms (parenteral, injectable and vials) while 55% reported manufacture of oral solid dosage forms (capsules, tablets, etc.).
One prominent trend in the demand for a variety of oral solid-dose processing equipment is the strong interest in purchasing software for solid-dose equipment, especially for process automation software (41%) and computer and automation systems (39%). Over one-third of the respondents are also interested in purchasing software for manufacturing execution, process simulation, system validation and computer-integrated manufacturing.
The application of this technology goes beyond oral drug manufacturing. Automation and robotic technology has been steadily incorporated into every aspect of modern pharmaceutical manufacturing processes to replace manual labor, reduce human error and improve line efficiency.
These technologies also have been used in process optimization, real-time monitoring and quality control. For highly potent drug manufacturing, they can be especially useful in decreasing human contact while creating a safer working environment and addressing regulatory concerns. The demand in this area is more likely to increase in the future.
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