Dramatic changes in the pharmaceutical and biopharmaceutical landscape over the past decade have reshaped manufacturers' equipment and technology needs and purchasing patterns. The leading trends driving the transformation include the changing pharmaceutical pipeline, the shift to overseas manufacturing sites, new regulatory guidelines calling for use of the latest technologies to improve quality and efficiency, and a significant increase in outsourcing. Compounding these changes are continuous pressures to cut costs, improve efficiency, elevate quality and boost productivity. Together, these trends have had a significant impact on equipment and technology acquisition strategies.
What are purchasing and operations managers seeking today when determining when and whether to replace equipment and which equipment is optimal for their needs? How can suppliers best compete? To better equip pharmaceutical manufacturers and contract research and manufacturing organizations (CROs/CMOs) to make purchasing decisions, and help suppliers understand manufacturers' needs, Nice Insight conducted a global survey of 560 purchasing decision-makers from various types of buying groups in the pharmaceutical and biotech industries in North America (47%), Europe (25%) and Asia (28%)1. The 2015 Nice Insight Pharmaceutical Equipment Report covers the following categories: bioprocessing; processing; cleanroom; packaging, inspection and testing; process automation, controls and monitoring; and facility design and engineering, construction/commissioning, and maintenance equipment.
According to the study, equipment quality and performance is the leading consideration of pharmaceutical manufacturers when making purchasing decisions, as companies seek products that will outperform others in quantity or efficiency. Interestingly, price ranks far lower in priority, following durability and reliability to ensure the equipment is dependable, and regulatory compliance at all stages of manufacturing with validation support that establishes evidence to demonstrate compliance. Customer service and products offering a comprehensive service agreement are of lesser importance.
The rankings are highly consistent across all buyer groups — big pharma, mid-sized pharma, emerging pharma, big biotech, mid-sized biotech, emerging biotech and CROs/CMOs. CROs and CMOs show slightly higher expectations for regulatory compliance and validation. For all equipment categories, more than half or nearly half of those responsible for equipment decisions — including those from 98 original equipment manufacturers (OEMs), service and system providers — have a good technical understanding of the equipment used in-house. Less than 10 percent in each category had a limited knowledge of the equipment.
MARKET TRENDS IMPACTING EQUIPMENT SOURCING
The changing nature of drug development, with an accelerating growth rate of specialty drugs, biopharmaceuticals and biosimilars and increased use of genetics, calls for new types of equipment and technologies. These sophisticated new therapies have impacted equipment purchasing considerations. Continuous production, advanced technology and flexibility through automation and single-use technologies are in high demand for manufacturing, processing and packaging. Companies also seek equipment that can manufacture and package these increasingly complex drug products with short start-up times and easy changeovers. They want highly efficient processing equipment that is easy to use from development to scale-up. Whether a company decides to make repairs to existing equipment or purchase new or used machinery, manufacturers need a reliable process that produces a quality product on a regular basis.
Generic producers and contract manufacturers require very robust, flexible machinery with high output, while complex medicines for targeted treatments demand flexible platforms and smaller batch sizes. Markets around the globe need safe, high-quality, consistent and highly efficient operations. Spending on equipment is focused on highly targeted technology and services.
Many drug manufacturers have shifted their focus to the development of new drug formulations and have outsourced their end production, such as commercial manufacturing and filling and closing operations, to contract manufacturers. The trend to more complex formulations has led to a higher demand for sophisticated technologies, while the trend toward small amounts of targeted drugs calls for flexible platforms that can handle small batches and ensure the highest safety for operators and products.2 With the rising pace of mergers and acquisitions, companies hope to reduce costs through synergies and access to new therapeutic classes or regional markets, as well as through consolidation of equipment and infrastructure. Interest in continuous processes is intensifying, and emphasis is placed on deploying equipment and technologies that enable higher production yields, a reduced need for purification and more rapid scale-up and commercialization.