Building new business models to support high-cost cell and gene therapies

Lev Gerlovin (pictured, left) and Walter Colasante are vice presidents at the life sciences division of Charles River Associates. Writing for The Pharma Letter, they seek to address the challenges posed to the existing biopharma business model by revolutionary, but prohibitively expensive, cell and gene therapies.

After many decades of both progress and challenges in clinical research, there is substantial evidence to indicate that we are entering a promising period in the development of new cell and gene therapies. There are now clinical-stage development programs in gene therapy targeting almost 50 different diseases, up from 10 only a few years ago, and many are reaching the later stages of regulatory review.

Development programs for cell and gene therapies are now underway around the world, with the largest share led by US and European Union companies (53% and 32%, respectively), and the remainder based primarily in China and South Korea.