The report, authored by Max Smock, CFA, provides a comprehensive analysis of FDA approvals for new drugs in 2024, extending the study to cover a decade of data from 2015 to 2024. This analysis is particularly relevant for the pharmaceutical outsourcing and services industry, especially the contract development and manufacturing organizations (CDMOs) subsector.
In 2024, the biotech industry raised approximately $75 billion, a 30% increase compared to 2023. The funding increase was broad-based, with significant contributions from follow-on offerings, PIPEs, and venture funding. The FDA approved 59 new molecules in 2024, a slight decrease from the record 66 approvals in 2023 but still above the 10-year average of 49 approvals. Biologics accounted for 47% of approvals, while small molecules represented 53%. Approved therapies were analyzed by therapeutic modality, dosage form, and innovator size. The shift toward biologics and injectables is highlighted as a key trend benefiting certain CDMOs.
Total drug sales increased by 8% in 2024 and are forecast to grow at an 8% compound annual rate over the next five years. Biologics sales grew by 10% year-over-year, accounting for 50% of all drug sales. Forecasts indicate robust growth in biologics sales, driven by monoclonal antibodies and other new modalities.
While the CDMO market remains fragmented, it experienced a significant uptick in outsourcing penetration for both API and finished dose production. In 2024, 74% of approved therapies outsourced API production and 61% outsourced finished dose production.
For more information about our healthcare research, please contact us or your William Blair representative.