On direction and timing, the prediction is essentially borne out by 2023–2025 developments.

1. Multiple new cell and gene therapies have been approved and brought to market since 2023

• In 2023 the FDA approved a record seven cell and gene therapies, including five gene therapies for rare genetic diseases, according to the Alliance for Regenerative Medicine’s State of the Industry briefing.(biospace.com)
• Elevidys, the first gene therapy for Duchenne muscular dystrophy, received accelerated approval in June 2023 for boys aged 4–5, with a major label expansion in June 2024 to patients 4 and older.(fda.gov)
• Casgevy (exagamglogene autotemcel), a CRISPR-based gene-edited cell therapy, was approved in December 2023 for severe sickle cell disease and in January 2024 for transfusion‑dependent beta thalassemia.(cgtlive.com)
• Lenmeldy (atidarsagene autotemcel), a gene‑edited cell therapy for early‑onset metachromatic leukodystrophy, was approved by the FDA in March 2024.(cgtlive.com)
• Beqvez (fidanacogene elaparvovec), a one‑time AAV gene therapy for hemophilia B, gained FDA approval in April 2024.(investors.com)
• Lifileucel (Amtagvi), the first FDA‑approved tumor‑derived T‑cell (TIL) therapy, was approved for metastatic melanoma in February 2024.(en.wikipedia.org)
• In November 2025 the FDA approved Novartis’s Itvisma, an intrathecal SMA gene therapy that broadens their existing SMA gene therapy franchise.(reuters.com)

These examples, plus the documented record year of approvals in 2023 and expectations of further double‑digit CGT approvals annually, show that many new cell and gene therapies have indeed reached the market starting in 2023.(pharmalive.com)

2. Significant build‑out of manufacturing and delivery infrastructure

• The global cell and gene therapy manufacturing market was about 18.1 billion dollars in 2023 and is projected to grow to roughly 97.3 billion dollars by 2033, reflecting rapid expansion of capacity and specialized infrastructure.(biopharminternational.com)
• Industry analyses report that around 80 percent of cell therapy manufacturers have expanded capacity by adding new facilities, with more than 40 percent of those facilities dedicated to T‑cell manufacturing and most capacity located in North America, indicating large‑scale build‑out.(globenewswire.com)
• Major pharma companies are investing heavily in new CGT plants, such as Johnson & Johnson’s planned investment of over 2 billion dollars in a new biologics and cell therapy manufacturing site in Wilson, North Carolina.(pr.comtex.com)
• The CGT sector attracted 15.2 billion dollars of investment in 2024, up 30 percent from 2023, with thousands of developers and about 2,000 active clinical trials; industry leaders highlight automation, robotics and new distribution models as key to overcoming manufacturing and delivery bottlenecks.(trial.medpath.com)
• On the delivery side, companies like Vertex are explicitly creating networks of authorized treatment centers to administer Casgevy, with an initial set of centers already activated and more being added, reflecting a reconfiguration of care delivery for gene‑edited therapies.(forbes.com)

Some reporting notes that uptake has been slower than scientific progress because existing health systems were not built for these complex one‑time treatments, underscoring that infrastructure is still catching up.(axios.com) But the combination of record numbers of new cell and gene therapy approvals and clear evidence of large, ongoing investments in manufacturing plants, logistics, quality infrastructure, and specialized treatment centers fits the predictor’s claim that these modalities would become more mainstream with more products on the market and a changing infrastructure and delivery system starting from 2023.