Cell and Gene Therapy Manufacturing Costs Limiting Access
High production costs are limiting patient access to cell and gene therapies, according to researchers who say optimizing manufacturing methods and increasing capacity industry-wide would help. Cell and gene therapies are expensive. Analysisby the Institute for Clinical and Economic Review (ICER) suggests the average cost of a gene therapy is between $1 million and $2 million per dose.
Similarly, while cell therapy prices differ more widely depending on the indication and the type of product, the average cost per treatment is $1 million, according to the ICER.
Developers set prices based on a number of factors with things like level of R&D investment, predicted market demand, and likely competition are playing a part.
“Cell and gene therapies cost much more because producing, handling, and controlling the cells or viral vectors required to make them is far more complicated than working with the chemicals used to make traditional pharmaceuticals and even biopharmaceuticals,”says Giulio Cossu, MD, from the division of cell matrix biology & regenerative medicine at the University of Manchester in the U.K.
“To circumvent the bottleneck of GMP production, government-sponsored or academic GMP-grade facilities are needed,” points out Cossu. “Some of these could eventually be qualified to produce and administer cell or gene products on a regular basis upon approval, with regulatory authorities involved to minimize costs and to ensure safety.”
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