The in vivo CAR-T therapy is emerging as a next-generation technology in the chimeric antigen receptor T-cell (CAR-T) treatment market, which has faced criticism for high costs and complex production processes. Major global pharmaceutical companies are increasingly investing in this technology, prompting domestic biotech firms to compete for a foothold in the next-generation cell therapy market.
According to industry sources, traditional CAR-T therapies involve extracting a patient's blood, manipulating immune cells outside the body, and reinfusing them. This personalized process results in lengthy manufacturing times and costs that can reach millions of won. To date, seven CAR-T therapies have received approval from the U.S. Food and Drug Administration (FDA).
In vivo CAR-T is gaining attention as a next-generation approach to address these limitations. This method directly delivers genetic information into the body, prompting T-cells to convert into CAR-T cells without the need for separate cell extraction. This could lead to cost reductions and improved accessibility to treatment.
Hah Hyun-soo, a researcher at Yuanta Securities, explained, "In vivo CAR-T generates CAR-T cells within the patient's body, utilizing the patient's T-cells while administering genes instead of cells. This eliminates the need for personalized drug production." He noted that global pharmaceutical giants like Eli Lilly and AstraZeneca are also competing to secure related pipelines.
In the global market, investments and mergers and acquisitions are actively taking place. A report from the National Drug Development Foundation indicates that as of last year, there were over 100 in vivo CAR-T-related pipelines worldwide. While most are still in preclinical or early clinical stages, the competition among major pharmaceutical companies is intensifying.
Eli Lilly has pursued the acquisition of Orna Therapeutics and Calyxt, both companies involved in in vivo CAR-T development. AstraZeneca acquired IsobioTech, which has a lentiviral vector-based in vivo gene therapy platform, for $1 billion (approximately 1.54 trillion won). At that time, the company outlined plans to reduce a process that previously took weeks to just a few minutes.
Industry insiders expect that global pharmaceutical companies that have not yet secured related technologies will continue to take action. A source from the biotech sector remarked, "Despite being in the early stages, global pharmaceutical companies are showing significant interest by acquiring technologies or entire companies. The competition for investment and development in this area is likely to expand in the coming years."
Domestic companies are also responding to the next-generation market. GC Green Cross and Apclon have recently embarked on joint research and development for in vivo CAR-T. Their strategy involves combining GC Green Cross's mRNA-LNP-based delivery technology with Apclon's CAR-T expertise to develop next-generation therapies. The companies stated that their approach allows for mass production in a ready-to-use format, eliminating the complex process of extracting patient cells, enabling "same-day administration."
Kurosel, a domestic CAR-T specialist, has also identified in vivo CAR-T as a key component of its long-term growth strategy. Algogenomics is pursuing technology development aimed at directly targeting immune cells in the body based on its RNA platform and polymer delivery technology.
A source in the biotech industry stated, "In vivo CAR-T has the potential to overcome the production and supply limitations of existing cell therapies. If successful in commercialization, it could significantly change the landscape of the cell therapy market."
* This article has been translated by AI.
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