Number of novel drugs approved annually by CDER 2008-2020

In 2020, 53 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 53 approvals for novel drugs in 2020.

Biopharma medicines in development

Many new drugs are being developed in 2019, and that is especially true for the U.S. pharmaceutical industry. As of April 2019, over 1,100 new medicines were in development for cancer and cancer-related conditions alone in the United States. Hundreds of novel medicines were also in development for rare diseases, neurological disorders, and skin diseases.

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. Between 2016 and 2019, the percentage was closer to 21 percent.