📈 Cell and gene therapy manufacturing market projected to reach $146B by 2032
The global cell and gene therapy market is expected to grow from $19.3 billion in 2024 to $146.2 billion by 2032. The growth is being driven by the increasing number of CGT approvals, expanding clinical pipelines and the need for scalable manufacturing infrastructure to support commercialization of these therapies.
Manufacturing is still a bottleneck for the CGT industry. As more therapies move into late-stage trials and commercial markets, demand for scalable, automated and cost-effective manufacturing solutions will accelerate. This forecast reinforces that manufacturing innovation and infrastructure investment will be central to unlocking the next wave of CGT commercialization.
Read more via Cision here
🧪 Capricor’s Duchenne cell therapy returns to FDA review after previous rejection
The US FDA has resumed its review of Capricor Therapeutics’ cell therapy deramiocel for Duchenne muscular dystrophy cardiomyopathy after the company submitted additional clinical data following a previous rejection. The therapy is supported by results from the Phase 3 HOPE-3 trial and the FDA has now assigned a new decision of 22 August 2026.
If approved, deramiocel could become a first-in-class therapy targeting both skeletal and cardiac manifestations of Duchenne muscular dystrophy, potentially expanding the role of cell therapy beyond oncology. The decision later this year could also provide important signals about how regulators evaluate late-stage clinical evidence for complex cell-based therapies.
Read more via Fierce Biotech here
⚖️ FDA criticism of uniQure’s Huntington’s gene therapy sparks regulatory debate
A senior US FDA official publicly criticized clinical data from uniQure’s AMT-130 gene therapy for Huntington’s disease, calling the therapy a “failed product” due to concerns about trial design and the absence of a placebo-controlled study. The company has pushed back in a statement that it is “confident in the strength of the data” and that the recent statements made by the FDA are “incomplete or entirely incorrect” with studies showing a 75% improvement in slowing disease progression.
This dispute highlights ongoing regulator tension around clinical trial design for gene therapies, particularly in rare and rapidly progressing diseases where placebo-controlled trials raise ethical concerns. For developers, it underscores the importance of robust evidence frameworks and early regulatory alignment as the field continues pushing into more complex neurological indications.
Read more via Fierce Biotech here
🤖 BioCurie receives ARPA-H funding to build AI platform for scalable gene therapy manufacturing
BioCurie has been awarded up to $9.3 million from the US Advanced Research Projects Agency for Health (ARPA-H) to develop an AI-driven platform designed to improve the scalability and reliability of gene therapy manufacturing. The project is part of ARPA-H’s Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program which aims to accelerate advanced biomanufacturing technologies for genetic medicines.
The platform will use mechanistic artificial intelligence and digital modelling to optimize manufacturing processes, allowing developers to stimulate and test production parameters virtually rather than relying solely on costly laboratory experimentation.
This development reflects the growing role of digital biomanufacturing and AI-enable process development in overcoming CGT manufacturing bottlenecks.
Read more here
🔎 Our takeaway
Across the CGT ecosystem, three themes continue to dominate: scaling manufacturing, navigating regulatory complexity, and integrating digital technologies to accelerate development. These conversations are shaping the future of advanced therapies and the industry’s ability to deliver life-changing treatments to patients worldwide.
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