Smaller Pharma Drives Innovation Amid 15% Drop in FDA Drug Approvals

The number of FDA-approved innovator and biosimilar drugs has decreased by 15.44%, from 149 in 2023 to 126 in 2024. According to data and analytics firm GlobalData, the pharmaceutical innovation scene is still thriving despite this slump, especially among smaller businesses that are making great progress in meeting unmet medical needs.

The Bio/Pharmaceutical Outsourcing study from GlobalData highlights the necessity of advanced manufacturing skills to support creative drug development and clarifies how smaller pharmaceutical companies rely on contract development and manufacturing organizations (CDMOs) for production.

In 2024, a number of small pharmaceutical companies received their first market approval, including Verona Pharma Inc.'s Ohtuvayre (ensifentrine), which treats adult patients with chronic obstructive pulmonary disease (COPD), and Madrigal Pharmaceuticals' Rezdiffra (resmetirom), which was the first treatment for patients with liver scarring from fatty liver disease.

“These companies are not only addressing critical gaps in patient care but are also leveraging the expertise of CDMOs to overcome manufacturing complexities, ensuring they can scale innovative therapies in an increasingly competitive market,” Adam Bradbury, Pharma Analyst at GlobalData, said.

Every month, events and trends impacting pharmaceutical contract manufacturing companies are analyzed in the Bio/Pharmaceutical Outsourcing Report. The report also includes information on new regulatory developments, such as the European Medicines Agency's introduction of a Shortages Monitoring Platform to improve drug supply transparency, as well as the most recent contract manufacturing agreements, CDMO opportunities and threats, M&A, and financing.