The cell and gene therapy market size is expected to grow from US$ 5.30 billion in 2024 to US$ 25.78 billion by 2031; it is projected to register a CAGR of 25.5% during 2025-2031. The increasing prevalence of chronic and genetic diseases, the rapid popularity of outsourcing cell and gene therapy manufacturing, and surging regulatory approvals and commercialization are noteworthy factors contributing to the expansion of the cell and gene therapy market size. Additionally, the development of next-generation gene editing tools is projected to bring new cell and gene therapy market trends in the near future.

AI and automation are making a revolutionary impact in the realm of CGT. This academic field has been using AI for predictive modeling, in association with automated process improvement for planning, to overcome current challenges. CRISPR-GPT at Stanford Medicine, an AI technology capable of automating the planning of experiments related to editing genes, has reduced the "time burden of trial-and-error" phases from months to mere days. Similarly, the Yale School of Medicine's generative AI model designs "new DNA sequences" to switch genes "on" and "off" for the development of safer "gene therapy vectors" in preclinical studies.

Automation works well with AI as it reduces human involvement in the manufacturing process. In this regard, the Cell Shuttle system by Cellares relies on robotics for completeCAR-T cell manufacturing with higher purity and an increased processing speed of up to 10 times. These developments provide significant benefits. According to BioProcess International, automation can reduce autologous CGT cost by 30-50% through enhanced compliance and flexibility. The synergy between AI and automation fast-tracks CGT, which ensures equal treatment access for those affected by rising chronic diseases, thereby emerging as a significant trend in the cell and gene therapy market.

End User-Based Insights

Based on end user, the cell and gene therapy market is segmented into contract research organizations, pharmaceutical and biopharmaceutical companies, and academic and research institutes. The pharmaceutical and biopharmaceutical companies segment held the largest cell and gene therapy market share in 2024. The driving forces of growth include increasing expenditures in the healthcare sector and favorable government regulations, which accelerate clinical trials; these offer attractions to MNCs looking for varying genetic backgrounds for the development of personalized medications. The growing number of genetic ailments as well as fewer costs of manufacturing act as stimuli for the domestic manufacturing of medications, thus facilitating a transition from generics to more advanced therapies like CAR-T. Improved regulatory harmonization among the countries, with Japan introducing conditional approval of regenerative therapies since 2014, reduces the risks associated with investment. Key players who have successfully developed CAR-T therapies in Japan include the country's own Astellas Pharma and Takeda Pharmaceutical companies, who have developed CAR-T candidates in Japan through clinical trials in patients with leukemia. Japan has the lead in adopting iPS cell technology through the Fujifilm Cellular Dynamics company. In China, Beigene and Legend Biotech (in collaboration with Johnson & Johnson) have commercialized BCMA-targeted therapies for multiple myeloma, benefiting from massive patient pools and government-backed bioclusters in Shanghai, thereby fueling the cell and gene therapy market growth.

The World Health Organization and Australian Institute of Health and Welfare are among the primary and secondary sources referred to while preparing the cell and gene therapy market report.