Biopharma financings in 2022 are now tracking 12% higher than the pre-pandemic year of 2019, but they still pale in comparison with each of the last two years, both of which were standout years by every measure.
While weekly global and U.S. confirmed cases of COVID-19 are below each of the last two years, infectious disease experts remain on guard. There are still about 1,500 people dying around the world each day, including 350 in the U.S., and the SARS-CoV-2 virus may continue to find ways to outmaneuver current treatments and vaccines.
Despite a busy September, U.S. FDA approvals and global regulatory news fell in October to the lowest point this year. So far in 2022, the FDA has approved 127 drugs and biologics, including supplemental filings. This is 25% less than each of the last two years, which had 170 approvals in 2021 and 169 approvals in 2020 through the end of October. The last time approvals were lower than this year was 2016 when there were 121.
South Korea’s regenerative medicine market is expected to grow from $51 million in 2016 to $320 million by 2026, growing at a compound annual growth rate of 20%, So Ra Park, chair and founder of Korea’s Regenerative Medicine Acceleration Foundation said.
Clinical data through the last week of October 2022 has dropped 17% in comparison with 2021. So far in 2022, there have been a total of 2,812 phase I, II and III clinical entries, compared with 3,389 during the first 10 months of 2021.
Ernst & Young’s (EY) annual Pulse of the Industry report offers plenty of reasons for optimism within med tech as the impact of the pandemic recedes, while identifying several key areas that will require continued focus for the sector’s long-term success.