Bio-Pharmaceuticals Association and Ministry of Food and Drug Safety Evaluation Institute Hold Meeting to Support Gene Therapy Development

[Asia Economy Reporter Lee Chun-hee] The Korea BioPharmaceutical Association and the Ministry of Food and Drug Safety (MFDS) jointly held the first ‘Sympathy’ meeting with gene therapy developers to establish measures for strengthening public-private communication.

The meeting, held on the afternoon of the 18th at the Grand InterContinental Seoul Parnas in Gangnam-gu, Seoul, was attended by gene therapy developers and practical officers from the Cell and Gene Therapy Division of the MFDS to discuss ▲measures to strengthen public-private communication ▲clarification of gene therapy review standards, and to listen to opinions and field difficulties.

Participants included HK Innoen, Medipost, Bionox, Synex, Cellid, Thermo Fisher Scientific Solutions, Cell Biotech, ICM, Abclon, Eutilex, Innovation Bio, GC Cell, Jin Medicine, Cha Bio Lab, Cartexel, Qurosell, Curigen, Pharos Vaccine, Peroca, and Janssen Korea.

Prior to the meeting, the ‘Visiting Regulatory Science Consultation Day’ of the Cell and Gene Therapy Division was also held. Gene therapy developers and practical officers, including those from the Cell and Gene Therapy Division, participated in in-depth professional technical consultations related to clinical trials and product approval reviews.

According to the Korea Health Industry Development Institute and the UK market research firm Evaluate, the global gene therapy market was approximately $7.47 billion (about 9.48 trillion KRW) as of last year and is expected to grow to approximately $55.59 billion (about 70.55 trillion KRW) by 2026. However, while only 16 gene therapies have been approved worldwide, including 9 gene-modified cell therapies, the gene therapy pipeline (including gene-modified cell therapies) has rapidly increased since 2014, reaching 1,526 as of February this year.

In particular, in Korea, where more than 50% of the cell and gene therapy market is produced through Contract Development and Manufacturing Organizations (CDMO), large domestic pharmaceutical companies have recently accelerated gene therapy development and commercialization by engaging in messenger ribonucleic acid (mRNA)-related CDMO businesses. Currently, only chimeric antigen receptor (CAR)-T cell therapies targeting hematologic cancers have been approved and clinical trials authorized domestically, but active research and development on various indications are underway.

Lee Jung-seok, chairman of the Korea BioPharmaceutical Association, said, "As the gene therapy market shows a high annual growth rate of about 49.1%, this meeting can serve as another stepping stone for Korea to leap forward as a bio-health powerhouse by leading international standards through close public-private collaboration and capacity building."

This content was produced with the assistance of AI translation services.