The first three quarters of 2023 delivered a mix of approval news, with an uptick in U.S. FDA clearances over the previous year, but still tracking lower than 2017-2021. Global approvals are on a different trajectory, down year over year.

While biopharma dealmaking remains active, a strong third quarter (Q3) was not enough to bring it to the same level seen during each of the last three years, although values are coming close. At the same time, M&As appear to be rising above 2022, but even with the increase, they still lag behind other years. If the Pfizer Inc./Seagen Inc. merger, worth $43 billion, closes before the end of 2023, for example, M&As will still not come close to the overall value seen in 2019 and 2020.

The official end of the COVID-19 public health emergency in the U.S. in May did not mark the end of interest and investment in the area. In the shifting landscape, attention has pivoted to new markets, emerging strains, boosters, and the commercialization and distribution of COVID-19 vaccines and therapies.

Through Q3 2023 biopharma values are down 4.5% year over year, with 1,007 deals valued at $130.58 billion this year, compared to 1,179 deals worth $136.73 billion in the same time period in 2022. Biopharma deals have averaged $14.51 billion per month this year, a decrease from 2022’s average of $17.18 billion per month. September deals outpaced the average of both years, reaching $18.46 billion.

Biopharma financings in 2023 – at $49.3 billion raised through the third quarter (Q3) – are tracking ahead of, or only slightly behind, several years since 2011, except for the two outlier years of 2020 and 2021 when there was a flurry of investments in response to the COVID-19 pandemic.

The BioWorld Biopharmaceutical Index (BBI) has fallen from its highest point this year to close September up 5.91% since the start of the year. BBI was down 3.65% at the end of February, peaked at 7.87% at the end of August, then closed up 5.91% on Sept. 29, tracking higher than both the Nasdaq Biotechnology Index (NBI) and Dow Jones Industrial Average.