Buffers and process liquids for biopharmaceutical production: considerations for scale-up and outsourcing

• The global biopharmaceutical market is rapidly growing, with small and midsize organizations outpacing large organizations in market share growth.
• When scaling up manufacturing, biopharmaceutical organizations are increasingly opting to outsource buffer and process liquid preparation.
• Many factors should be considered before an organization decides to outsource, including manufacturing space, personnel needs, and analytical capabilities.

Current trends in biopharmaceutical manufacturing

Small and midsize biopharmaceutical organizations are increasingly important drivers of innovation in the development of novel therapeutics, and biopharmaceuticals account for a rapidly growing percentage of new candidates in the clinical pipeline. The size of the total global biopharmaceuticals market in late 2022 was estimated to be $333.1 billion with a projected increase to $856.1 billion by 2030. The market share of small and midsize biopharmaceutical organizations is expected to increase at a projected compound annual growth rate (CAGR) of about 11% to reach $22 billion by 2025. In contrast, the CAGR of the 20 largest biopharmaceutical companies is projected to be just 5% to reach $24 billion over the same timeframe.

The explosive growth in the number of biopharmaceutical candidates in the clinical pipeline is due in part to fast-track processes recently implemented by regulatory agencies in the US and European Union for therapeutics intended to treat serious conditions and fulfill unmet medical needs.