Number of novel drugs approved annually by CDER 2008-2023

In 2023, 55 novel drugs were approved by the Center for Drug Evaluation and Research (CDER). The number of new medicinal products entering the pharmaceutical market each year varies heavily: just over 20 novel drugs were introduced in 2016, while about 60 new products were approved in 2018. 2023 was the year with the second highest number of approvals so far.

Biopharma medicines in development

Many new drugs are being developed as of 2023, and that is especially true for the U.S. pharmaceutical industry with its high R&D intensity. As of begin of 2023, around 4,500 new immunological anticancer products were in development worldwide. Additionally, more than 3,600 other anticancer drugs were in R&D phases.

Cost of drug development: then vs. now

Back in the 1970s, developing a pharmaceutical drug in the United States cost an estimated 180 million U.S. dollars. Over the past few decades, such expenses have increased, reaching roughly 2.6 billion U.S. dollars per drug in the 2000s and early 2010s. In 1990, almost 15 percent of the revenue generated by the U.S. pharmaceutical industry was spent on research and development for new medicines. In 2022, the percentage stood at 19 percent.