The development of gene therapy has come a long way over the past two decades after getting off to a rocky start following the death of a young patient after being treated with an experimental therapy. Since that time continuing scientific progress has enabled the development of a robust product pipeline of promising therapies that could lead to, according to FDA estimates, 10 to 20 cell and gene therapy products a year within the next five years. The renaissance of the sector has also attracted record amounts of investment capital and significant business development.
FDA approvals for biopharma products have reached their highest point in six years for a first quarter, while regulatory data is up a full 45% over last year. A total of 265 regulatory items were tracked by BioWorld in March 2021, representing the highest monthly volume, not only for this year, but for last year as well.
It has been a challenging opening first quarter for companies developing new therapeutics, with the BioWorld Drug Developers index recording a 9% drop in value, representing a stark contrast to its more than 35% growth last year.
More than a quarter of all biopharma/nonprofit deals and grant awards in 2021, as well as 79% of the disclosed funding, targets the COVID-19 pandemic, following a trend that began in the early months of last year as SARS-CoV-2 reared its ugly head.
With less uncertainty surrounding the pandemic, the biopharma industry appears on track to shift efforts back to its internal programs and possibly meet, if not exceed, the record-breaking deal level of 2020. Strong financial markets, however, may continue to hold M&As down.
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