Impatient Idealist

https://www.science.org/content/blog-post/2025-fda-approvals

This is a brief but informative article at Nature Reviews Drug Discovery from folks at Boston Consulting Group looking at the 2025 drug approvals at the FDA. There were 54 such (excluding diagnostic imaging agents), which is consistent with the landscape since 2014 (the average since then has been exactly that!) 2005-2013 average, by contrast, was 30 new drug approvals. In fact, in that post 2014-period, there’s only been one year (2016, with 28 approvals) that wasn’t higher than any year in the 2005-2013 era. We are clearly approving a lot more drugs in this era.

But are we making more money from them? Total peak sales (inflation-adjusted) are indeed higher in the post 2014-era, as they certainly should be. But it’s quite possible that we’re looking at third year in a row of declining peak sales, which has not happened over the last 20 years at all. 

2022 peaks sales are listed as 114 billion, and 2023 as 94. Then 2024 is 81 billion (which is an upwards revision from the initial estimate of about 60 billion), and 2025 is estimated at 62 billion. Now that one will likely be revised upwards over the next year or two - that’s typically what happens, because we’re (a) not all that great at forecasting sales and (b) motivated not to overestimate them beforehand, preferring to surprise people with better-than-expected figures. But we’ll have to see if 2025 manages to not be that third year of decline.

Where is this trend coming from? Almost certainly due to a relative shortage of great big huge blockbuster drugs. As the article notes, only 4 of the approved drugs from 2025 are forecast to hit peak sales of over three billion per year. It’s not that the industry hasn’t had some underperforming years in the modern era (like 2108, with 62 approvals and $59 billion in peak sales, or 2020, with 56 approvals and $49 billion peak sales). But 2022, by contrast, had a relatively low 43 approvals but hit $114 billion in peak sales, and no one’s sure when and if we’ll get back to a figure like that.

I’d say that some of this is likely due to the more “orphan-y” small disease focus of drug development at many smaller companies. And you can’t ignore the more-targeted nature of modern drugs, particularly in oncology. This trend has been coming on for a long time, and as our knowledge increases of the different drivers behind what appear to be similar disease in a patient population, we’re likely to see even more of it. Oncology indeed was the most-represented drug category in this year’s list (16 of the 54, but it has to be said that the estimates for those drugs’ share of peak sales does hold its own (30% of the approvals, 36% of estimated peak sales).

We’ll revisit these figures in another year or two and see how they hold up. It will be interesting - likely not cheering, but definitely interesting - to see how four years of the current FDA leadership will affect these numbers as well. . .

https://www.science.org/content/blog-post/2025-fda-approvals