The U.S. Food and Drug Administration (FDA) has approved 50 new molecular entities in 2024, with 24 designated as first-in-class therapies. This trend is expected to continue in 2025, with several first-in-class drugs set to be approved. These innovative treatments offer new approaches to challenging diseases, including schizophrenia, metabolic-associated steatohepatitis, and rare genetic disorders.
Forecast for 6 months: Expect a significant increase in FDA approvals for first-in-class drugs, with at least 10 new therapies receiving approval within the next 6 months. This will be driven by the growing pipeline of innovative treatments and the FDA’s efforts to streamline the approval process.
Forecast for 1 year: By the end of 2025, we expect to see at least 20 first-in-class drugs approved by the FDA, with several more in late-stage clinical trials. This will mark a significant milestone in the development of innovative treatments for rare and complex diseases.
Forecast for 5 years: Over the next 5 years, we anticipate a significant shift in the biotech industry, with first-in-class drugs becoming the norm for treating complex diseases. This will be driven by advances in gene editing, RNA interference, and other innovative technologies.
Forecast for 10 years: By 2035, we expect to see a significant reduction in the number of patients suffering from rare and complex diseases, thanks to the widespread adoption of first-in-class therapies. This will be a major breakthrough in the field of biotech and will have a profound impact on public health.
