The rising demand from pharmaceutical and biopharmaceutical industries to meet the demand for fill/finish gap is expected to drive the market growth. According to the US Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER), biologics have accounted for 20% to 29% of approvals of new molecular entities (NMEs) in 2020.  In 2019, small molecules accounted for 79% of all NME approvals, representing 38 of the 48 NMEs approved by the FDA and biologics accounted for 10 of the 48 NMEs approved or 21% of all NME approvals. In 2018, small molecules accounted for 71% of NME approvals and biologics 29% of NME approvals. In-house capacities companies sometimes lack the ability to manufacture new products. This factor supports the growth of the market. Specialized capabilities, such as lyophilization, filling prefilled syringes and cartridges, or novel therapeutics, require unique manufacturing techniques that biotech technology companies find beneficial to outsource from contract manufacturing organizations, as they are cost-effective. Companies with in-house aseptic fill-and-finish capacity outsource on average 39% of their fill-and-finish needs.

North America is likely to continue its dominance in the pharmaceutical fill and finish outsourcing market during 2021–2028. The US holds the largest share of the market in North America and is expected to continue this trend during the forecast period. Automation advancements such as robotics have been one of the areas of progress for the US fill/finish operations. This primarily reduces the contamination risk to a great extent, thus aiding the regional growth. The overall integration of the supply chain that reduces human interactions is driving the pharmaceutical fill and finish outsourcing market growth. For instance, ABL adopted automation in their fill/finish operations in 2017. The company completed an expansion of aseptic fill/finish operations at its GMP biomanufacturing facility in Rockville, MD. The company installed a fully automated vial filling system. Such factors are expected to aid the growth of the overall pharmaceutical fill and finish outsourcing market.

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