BOSTON – The American Society for Gene and Cell Therapy (ASGCT) has released its latest Landscape Report for the first quarter of 2026, revealing a robust expansion in the gene and RNA therapy sectors. CEO David Barrett, JD, noted that there are currently 42 gene therapies, 38 RNA therapies, and 76 non-genetically modified cell therapies approved globally, with two new cell therapies gaining approval in Japan during Q1.
This report, developed in collaboration with Citeline, indicates a slight uptick in deal-making and a notable 30% increase in startup funding compared to Q1 2025, suggesting a recovery in the sector. Barrett emphasized that the approval of eight gene therapies in the past year, with half occurring in the U.S. and three in China, reflects an accelerating regulatory environment.
With over 4,200 therapies in development, predominantly in gene and genetically modified cell therapies, the pipeline shows promise. CAR T therapies lead the charge, while growth is also seen in treatments for immunological diseases. The clinical trial landscape is expanding, with 350 Phase I, 319 Phase II, and 41 Phase III trials underway, a significant increase from the previous year. Barrett highlighted that over 60% of gene therapy trials are now focused on non-oncology indications, indicating a shift in therapeutic focus.
Despite a decline in mRNA therapies, RNAi therapies are experiencing growth, particularly in rare diseases. The report also points to an increase in startup activity, with 26 new ventures launched in Q1, signaling renewed investor confidence. As the FDA continues to expedite review processes, the outlook for gene and RNA therapies remains optimistic, with potential catalysts anticipated through 2027.
The full Landscape Report is available online from the ASGCT website.
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