Approvals from the U.S. FDA are up more than 16% from last year, with 113 drugs approved in the first eight months of 2023. New approvals include two different treatments for relapsed or refractory multiple myeloma, two treatments for ultra-rare diseases and a biosimilar to Biogen Inc.’s Tysabri. In August the FDA greenlighted 13 drugs, approving three NDAs, six BLAs, two supplemental NDAs and two supplemental BLAs.
Biopharma deal values through August are down 13.05% year-over-year, while the number of deals has fallen by 18.51% compared to 2022. M&A value, meanwhile, is down just 3.6% from last year. Through August, 2023 saw 885 biopharma deals worth $111.87 billion, compared to 1,086 deals totaling $128.66 billion in the same period in 2022. The first eight months of 2021 saw 1,386 deals worth $121.22 billion, 1,381 deals valued at $129.96 billion in 2020 and 1,051 deals worth $111.93 billion in 2019.
Med-tech deal values continued their upward swing, increasing nearly 90% from last year. Med-tech M&A volume and value remained in a slump compared to the previous two years, though values are higher than 2020.
In August 2023, med-tech firms raised a total of $1.88 billion through 27 transactions, an increase of 94.12% from the $971 million raised in July. Value is down 42.83%, however, from the $3.3 billion raised in August 2022. The volume of med-tech financings is tracking at an average of 41 per month in 2023, down from an average of 43 per month in 2022, 59 per month through 2021 and 60 per month in 2020.
In August 2023 biopharma companies raised a collective $4.02 billion through 86transactions, down from the previous seven months’ average of $5.53 billion.
Biopharma grants are up nearly 150% compared to the same time period last year, largely due to a number of $100 million-plus grants from the Biomedical Advanced Research and Development Authority (BARDA). Meanwhile, nonprofit deal value has declined year-over-year, with the number of transactions down 42.21%.
The first seven months of 2023 saw clinical trial data up 1.43% compared to the same time period last year. From January through July this year, BioWorld reported on 2,064 drugs in phase I-III, compared to 2,035 in the same time period in 2022. The number of trial updates is down 14.07% from the 2,402 in 2021 and down from 2020’s 2,096, but up 18.15% from 2019’s 1,747.
The first seven months of 2023 saw clinical trial data up 1.43% compared to the same time period last year. From January through July this year, BioWorld reported on 2,064 drugs in phase I-III, compared to 2,035 in the same time period in 2022. The number of trial updates is down 14.07% from the 2,402 in 2021 and down from 2020’s 2,096, but up 18.15% from 2019’s 1,747.
Drug approvals by the U.S. FDA increased 20.48% compared to the first seven months of 2022, even with July approvals slightly down to 13 from the previous six months’ average of 14.5 per month. Worldwide approvals from January to July are down 13.8% from the same period last year.