This report examines the commercialization of gene therapy in the context of innovation theories that posit a relationship between the maturation of a technology through its life cycle and prospects for successful product development. We show that the field of gene therapy has matured steadily since the 1980s, with the congruent accumulation of >35 000 papers, >16 000 US patents, >1800 clinical trials and >$4.3 billion in capital investment in gene therapy companies. Gene therapy technologies comprise a series of dissimilar approaches for gene delivery, each of which has introduced a distinct product architecture. Using bibliometric methods, we quantify the maturation of each technology through a characteristic life cycle S-curve, from a Nascent stage, through a Growing stage of exponential advance, toward an Established stage and projected limit. Capital investment in gene therapy is shown to have occurred predominantly in Nascent stage technologies and to be negatively correlated with maturity. Gene therapy technologies are now achieving the level of maturity that innovation research and biotechnology experience suggest may be requisite for efficient product development. Asynchrony between the maturation of gene therapy technologies and capital investment in development-focused business models may have stalled the commercialization of gene therapy.
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The authors acknowledge the invaluable contributions of Dr Rick Cleary to quantitative modeling and statistics, the work of our student researchers, Ege Candir, Eric Ndung’u and Cory Kalin, and the helpful comments of Dr Michael Boss, Dr Nancy Hsiung and Dr Frank Szoka. We thank Donna Connor for preparation of the manuscript. This work was supported, in part, by a grant from the National Biomedical Research Foundation.
The authors declare no conflict of interest.
Supplementary Information accompanies this paper on Gene Therapy website
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Ledley, F., McNamee, L., Uzdil, V. et al. Why commercialization of gene therapy stalled; examining the life cycles of gene therapy technologies. Gene Ther 21, 188–194 (2014). https://doi.org/10.1038/gt.2013.72
- technology life cycles
- capital investment
- drug development
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