Number of novel drugs approved annually by CDER 2008-2019

In 2019, almost 50 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.

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 2015 and 2018, the percentage reached and remained closer to 20 percent.

Total number of novel drugs approved by CDER from 2008 to 2019

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Release date

January 2020


United States

Survey time period

2008 to 2019

Supplementary notes

CDER (Center for Drug Evaluation and Research) is a regulatory agency and part of the U.S. Food and Drug Administration.

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Statistics on "U.S. pharmaceutical industry"

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