Number of novel drugs approved annually by CDER 2008-2022

In 2022, 37 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. There were 50 approvals for novel drugs in 2021.

Biopharma medicines in development

Many new drugs are being developed in 2020, and that is especially true for the U.S. pharmaceutical industry. As of December 2020, 560 new medicines were in development for pediatric conditions alone in the United States. Hundreds of novel medicines were also in development for diabetes, neurological disorders, and mental health.

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 2021, the percentage stood at over 21 percent.