In 2014, the US FDA accepted 41 NDA and BLA applications. The number of approvals by the FDA rose to 45 in 2015, marking an eight-year (and counting) trend of increasing approvals. Oncology lead both years in terms of therapeutic area, with 11 new molecular entities in 2014 and 15 in the following year, but a total of 15 therapeutic areas garnered at least one new approval in 2015.
The road to FDA approval is long and expensive, with total costs running into the billions of dollars over as many as 15 years. A company’s entire makeup can change when their pipeline transitions from preclinical development to clinical trials, with discovery budgets slashed as companies focus on clinical development to rapidly bring their product to market. Such seismic shifts have been the trend over the past decade, especially for the largest pharmaceutical companies. However, the industry appears to be gaining momentum, with both 2014 and 2015 recording the highest FDA approval rates in two decades. The record set in 1996, now within striking distance, is 53.
2016 has gotten off to an energetic start, with many companies securing new funding rounds and several filing IPOs. Mergers, acquisitions and partnerships, some exceeding $30 billion USD, were announced within days of the New Year. It’s impossible to know what the future holds, but the industry is obviously in motion and gaining momentum.
For more on what happened in 2014 and laid some of the groundwork for 2015, read Pharmaceutical R&D – Early Signs of a Change in Fortune.