March 2025 Life Sciences Update

Novel Drug and Biological Approvals Lagged in 2024

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CONTENTS

FDA Drug and Biological Approvals

• After reaching a five-year high in 2023, drug and biological approvals totaled 67 in 20241.

• Despite approvals lagging last year’s record, they surpassed the 10-year average, reflecting continued efficiency in the FDA’s approval process.

Novel Drug Approvals

Biological Approvals

90

• Evaluate’s recent report projects up to 71 novel drug approvals in 2025.

80

• Drug approvals are influenced by several factors such as the complexity of drugs under development and scientific advances in understanding diseases and their targets. • Once a drug is approved by the FDA, it can be marketed and distributed to healthcare providers and patients. This new cash flow enables a company to invest in additional lab space and R&D for projects in the pipeline. To meet increased production needs, manufacturers often need additional space to produce the product. • FDA approvals provide several benefits to the life sciences sector, including boosting investor enthusiasm, and validating innovative technologies and methodologies often used in drug development.

70

21

25

60

22

17

22

8

13

13

50

14

40

30

15

59

55

53

50

50

48

46

45

20

37

22

10

0

2015

2016

2017

2018

2019

2020

2021

2022

2023

2024

1. 2025 Preview, Evaluate

Source: U.S. Food and Drug Administration

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Cushman & Wakefield