With 48 drugs approved by the U.S. Food and Drug Administration (FDA), 2019 was another highly productive year for the pharmaceutical industry. The new medicines include treatments for various cancers, sickle cell disease, migraines and postpartum depression. However, the steady flow of drugs could be masking troubling signs about the health of the industry, according to Chemical & Engineering News (C&EN), the weekly newsmagazine of the American Chemical Society.
2019 showed several notable trends for new drugs, according to Senior Correspondent Lisa M. Jarvis. First, about 42% of the medicines had new mechanisms of action -- so-called "first-in-class drugs" -- to treat a disease. As in past years, most of FDA's approvals were for small-molecule drugs, but 2019 also saw an influx of new molecular entities, including antibody-drug conjugates, an antisense oligonucleotide and a small interfering RNA. Another trend was the introduction of new therapies for underserved diseases, such as sickle cell anemia, treatment-resistant tuberculosis and postpartum depression.
Despite these successes, some analysts say certain aspects of the list point to trouble ahead for the pharmaceutical industry. For example, the proportion of new drugs produced by big pharma is declining. One explanation is that the industry has shifted its focus from primary-care treatments, which require large, expensive clinical trials, to rare diseases and specialty care indications, like cancer. These classes of drugs can be approved on the basis of much smaller studies, making it easier for small companies to bring a drug to market. Another concerning trend is that the number of companies directly contributing to drug development is shrinking, as large companies acquire the most productive small and medium biotech firms. Analysts worry that this industry consolidation will threaten the ability to introduce new medicines.