U.S. FDA approvals in 2022 are down by more than 30%, while new molecular entity approvals have been cut in half. So far this year, the U.S. FDA has approved 93 drugs and biologics, including expansions into new indications. In comparison with each of the last three years, it is a significant drop. There were 136 approvals in 2021, 143 in 2020 and 134 in 2019 announced by the end of August.

With potential regulatory approvals and filings for lymphoproliferative disease and mastocytosis drugs on the horizon, as well as high-money antibody-drug conjugate deals, the BioWorld Cancer Index (BCI) has shown some signs of life this summer. BCI is still down by 23.4% in 2022, but that is significantly better than the end of May when the index was down by 41%.

While there are significantly fewer initial public offerings in 2022 than in 2021 and 2020, the caution expressed by biopharma companies and investors seems to be paying off, with this year showing the best average performance of the three years.

As amounts raised through financings are significantly shy of last year, med-tech deals and M&As appear strong, with digital health dominating the landscape.

Med-tech financings are still down by 55% in comparison with the same time frame last year, but they have gained some ground by narrowing the gap with the pre-pandemic year of 2019.

Medtech Europe, the European trade association for the medical technology industry covering diagnostics, medical devices and digital health, released its latest survey. This study analyses the availability of medical devices in 2022 in light of the Medical Devices Regulation (MDR) being implemented.