Iran Advances in Cell Therapy, Joining Global Leaders in Regenerative Medicine

Iran has significantly expanded its capabilities in regenerative medicine, achieving regulatory approval for six advanced therapy medicinal products (ATMPs) and joining the ranks of countries manufacturing these cutting-edge treatments. This advancement elevates Iran’s global standing in the field and promises increased access to innovative therapies for patients within the country.

Breakthrough in Advanced Therapy Medicinal Products

The Royan Research Institute, a leading center for regenerative medicine and cell therapy in Iran, has successfully obtained regulatory approval and is ready to market six novel products. These products fall under the umbrella of ATMPs, which are defined as medicines for human use based on genes, tissues, or cells [Royan Research Institute]. ATMPs represent a new frontier in treating diseases and injuries.

Global Ranking and Impact

This achievement places Iran among the 110 countries worldwide with approved ATMPs [Mehr News Agency]. Iran has risen from 12th to 7th place globally in this sector. A recent global report indicated that 148 ATMPs were approved in 2025 by 12 regulatory organizations, with seven originating from Iran [ANA].

Expanding Treatment Options

In March 2024, only one licensed regenerative medicine product was available in Iran. By March 2025, that number had increased to seven [ABNA English]. These include therapies for a range of conditions, such as:

• Vitiligo
• Graft-versus-host disease (GVHD)
• Cerebral palsy (CP)
• Burns
• Diabetic foot ulcers
• Arthritis
• B-cell acute lymphoblastic leukemia (B cell ALL)

Some of these high-tech medical products too hold export potential, contributing to Iran’s knowledge-based economy.

The Rise of Regenerative Medicine

Regenerative medicine, often called the “future of medicine,” focuses on finding new ways to prevent, diagnose, and treat diseases by moving beyond traditional methods relying on chemical drugs and biotechnology [Royan Research Institute]. ATMPs, encompassing gene therapy, cell therapy, tissue engineering, and combination therapies, are central to this approach.

Looking Ahead

Iran’s progress in developing and approving ATMPs signifies a commitment to advancing healthcare and reducing reliance on imported medical products. Continued investment in regenerative medicine research and development will likely further strengthen Iran’s position as a regional and global leader in this rapidly evolving field.