Regenerative medicine sector set for a record-breaking year

Published: 20 August 2021

New Alliance for Regenerative Medicine (ARM) report documents a ‘year of firsts’ for the cell and gene therapy sector.

According to the new ARM report, which focuses on the first half of 2021, the regenerative medicine and advanced therapies sector has seen a best-ever six-month period of financing, raising $14.1B from January through June, reaching 71% of the record amount raised in the entirety of the previous year. 

With four new regenerative medicine products having already gained regulatory approval this year, and decisions pending on six more, 2021 could also see the sector break the previous record of nine approvals seen back in 2016.

“The regenerative medicine sector is accelerating across all fronts simultaneously,” said Janet Lambert, CEO of ARM, in a press release. “Scientific progress is driving intense interest among investors. Companies are forming, maturing, and increasingly moving promising therapies toward approval. And we’re seeing rising global competition to cultivate this sector and deliver access for patients.”

More highlights from the ARM report include:

  • Funding for cell-based immuno-oncology has outpaced gene therapy for the first time ($6.6 billion versus $6.4 billion).
  • Developers increased by 23% in the United States and 119% in the Asia-Pacific region, while Europe saw a decline of 4%.
  • Since 2018, more than twice the number of trials have started in the US and Asia-Pacific than in Europe.
  • 1,320 industry-sponsored clinical trials are ongoing worldwide with 158 trials in Phase III, up from 1,220 and 152 at the end of 2020. In addition there are 1,328 trials sponsored by government and academia, with 85 in Phase III.
  • There are 1,195 regenerative medicine and advanced therapy developers active worldwide, up from 1,085 at the end of 2020.