FDA drug approvals drop 15.44% but smaller pharma leads innovation, reveals GlobalData biopharma outsourcing report

New Delhi: Innovator and biosimilar drug approvals by the FDA have declined by 15.44%, from 149 in 2023 to 126 in 2024. Despite this downturn, the landscape of pharmaceutical innovation remains vibrant, particularly among smaller companies, which are making significant strides in addressing unmet medical needs, says GlobalData, a leading data and analytics company.

GlobalData’s Bio/Pharmaceutical Outsourcing report sheds light on the reliance of smaller pharma companies on contract development and manufacturing organizations (CDMOs) for production, emphasizing the need for sophisticated manufacturing capabilities to support innovative drug development.

Numerous small pharma companies secured their first market approval in 2024, such as Madrigal Pharmaceuticals’ Rezdiffra (resmetirom), the first treatment for patients with liver scarring due to fatty liver disease, and Verona Pharma Inc’s Ohtuvayre (ensifentrine), for chronic obstructive pulmonary disease (COPD) in adult patients.

Adam Bradbury, Pharma Analyst at GlobalData, notes: “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.”

The Bio/Pharmaceutical Outsourcing Report is a monthly analysis of news and trends affecting pharmaceutical contract manufacturing organizations. In addition to drug approvals, the report lists the latest contract manufacturing agreements, opportunities and threats for CDMOs, M&A and financing of CDMOs, and emerging regulatory news, including the European Medicines Agency’s launch of a Shortages Monitoring Platform to enhance drug supply transparency.