The accelerating pace of U.S. FDA approvals for cell and gene therapies is “great for the field and great news for the patients,” but questions remain over commercialization, with “costs remaining stubbornly high.” That was the glass half-full summary of Tim Hunt, president of the industry group, the Alliance for Regenerative Medicine, reprising progress in 2024, and looking forward to the prospects for further growth and the potential impact of the incoming Trump administration in 2025.

Biopharma stocks saw a year of ups and downs in 2024, with the BioWorld Stock Index rising as much as 21% before dipping below 2% and ultimately closing the year up 5.16%. This performance follows a 33.59% gain in 2023 and a sharp 32.75% decline in 2022. Among the 509 stocks analyzed in the index, 169 companies (33%) ended the year with gains, while 340 (67%) saw their shares decline.

Biopharma deal activity closed out the year strong in December, reaching a total value of $29.02 billion – the second highest monthly figure of 2024, just shy of November's $29.34 billion. For the full year, deals amounted to $230.37 billion, marking a nearly 6% increase from $217.69 billion in 2023 and making 2024 the highest value year in in BioWorld’s records.

Med-tech deal values dropped sharply in December to $78.74 million, down from $424.5 million in November. For the full year, deal values reached $2.12 billion, representing a significant decline of 80% from 2023’s $10.63 billion and marking the lowest annual total in recent years

It’s taken nearly a decade for the U.S. FDA to go from zero to 60 in approving biosimilars. Currently, 63 biosimilars have been approved in the U.S., thanks to 18 new approvals in 2024 that stretched the number of biologics referenced by biosimilars from 14 to 17. That’s an all-time record, CDER Director Patrizia Cavazzoni said, as she released the drug center’s annual approval report for 2024.

Modest signs of recovery were seen in the biopharma IPO market in 2024, though activity remains significantly below the levels seen during the 2018-2021 boom. In 2024, 32 biopharma companies went public, a slight increase from 27 in 2023 but a decline from 35 in 2022. These figures pale in comparison to the peak years, with 134 IPOs in 2021, 106 in 2020 and even 65 in 2019. Both the total value and volume of IPOs continue to lag far behind those earlier highs.