2023 September Life Sciences Update

Increasing the Efficiency of the Approval Process Aims at Decreasing Time-to-Market in U.S.

› A commitment by the FDA to improve their approval process is bearing results. Biologicals have seen more approvals in 2023 than the previous three years. Novel drug approvals have already surpassed 2022 levels and are likely to match or exceed 2021 levels. › Post-approval process, facility needs vary depending on the science being developed. Biological drugs are derived using a living source and therefore may require specialized facilities to manufacture, while production of chemically synthesized drugs can be standardized more easily. › Clinical trials often continue following approval, particularly for biologicals, but space requirements may change, as some companies shift their focus to large-scale production.

FDA Drug and Biological Approvals

Novel Drug Approvals Biologicals

90

80

70

60

50

Key Takeaway: Improving the time to market means facilities will need to be ready for faster production as well.

40

30

20

10

0

2015

2016

2017

2018

2019

2020

2021

2022 YTD 2023

Source: U.S. Food and Drug Administration

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LIFE SCIENCES SEPTEMBER 2023