The National Assembly Library said Wednesday it has published the 48th issue of its "Data & Law" series (2026, No. 10), focusing on advanced regenerative medicine as seen through data. Advanced regenerative medicine refers to treatments that use human cells and related materials to regenerate, restore or form the body's structures or functions, or to treat and prevent disease — encompassing cell therapy, gene therapy and tissue engineering.
According to the 48th issue, the global advanced regenerative medicine market is projected to grow from $23.2 billion in 2024 to $62.1 billion in 2030, with an average annual growth rate of 17.7 percent. Gene therapy is expected to post the highest growth rate among subcategories at 19.1 percent. Advanced regenerative medicine treatments are administered to patients with serious, rare or intractable conditions, and only for technologies whose safety and efficacy have been confirmed through prior clinical research. More than 80 percent of gene-related diseases are rare conditions caused by genetic defects, and approximately 390,000 people in South Korea are currently living with a rare disease based on treated prevalence figures.
The United States and the EU lead the world in gene and cell therapy technology. As of 2024, South Korea's gene and cell therapy capabilities stood at 80 percent of the US level, a slight decline from 82.5 percent in 2022. The technology gap between South Korea and the United States remained at three years in 2024, unchanged from 2022.
Because clinical research involving human subjects is central to advanced regenerative medicine, the Ministry of Health and Welfare's Advanced Regenerative Medicine and Advanced Biopharmaceutical Deliberation Committee reviews research plans submitted by regenerative medicine institutions. Under the second basic plan for advanced regenerative medicine and advanced biopharmaceuticals (2026–2030), the number of review applications rose from 51 in 2024 to 118 in 2025 and is expected to reach 193 in 2026. As applications have increased, the average processing time for research plans has also lengthened — from 56 days in the second quarter of 2024 to 112 days in the first quarter of 2026.
Meanwhile, the domestic advanced biopharmaceutical market is skewed toward cell therapy rather than gene therapy. As of July 2026, cell therapy products accounted for the largest share of ongoing domestic clinical trial approvals for advanced biopharmaceuticals, with 53 cases. In terms of product authorizations, the United States has approved 46 advanced biopharmaceuticals — led by gene therapy products — while South Korea has approved only 19, including 12 cell therapy products.
Park Cheol-ho, director of the Legal Information Division at the National Assembly Library, said that as gene therapy drives up the value of the advanced regenerative medicine market, global competition to secure a leading position is intensifying. He added that he hopes the latest "Data & Law" issue "will serve as a useful reference for evidence-based legislative discussions and policy development related to advanced regenerative medicine."
tiger@heraldcorp.com
