The Head of the Food and Drug Authority (BPOM), Taruna Ikrar, said the ambition is driven by the rapid global growth of gene therapy, cell therapy, and ribonucleic acid-based therapies. He noted that 4,164 ATMPs are currently under development worldwide, with 148 already approved in various countries.
Speaking in Jakarta on Saturday, Ikrar said the global ATMP market is projected to rise sharply from US$41.46 billion in 2026 to US$86.76 billion in 2031.
“This trend shows how regenerative medicine is shaping the future of healthcare. Indonesia must be prepared to become part of this transformation by building an adaptive regulatory system while ensuring patient safety,” Ikrar said.
He stressed that becoming a regional powerhouse of ATMP requires Indonesia to foster enabling ecosystems for research and industrial development while improving regulations and pursuing international collaboration.
The challenge, says Ikrar, is not only to encourage scientific innovation but also to ensure each product has a strong evidence base in terms of safety, efficacy, and quality.
“Many innovative therapies are still hampered by limited scientific evidence, dose standardization, production process consistency, and long-term safety monitoring after public use,” he added.
To address these challenge, he said BPOM is strengthening the national regulatory framework to ensure compliance with international standards in developing cell-based therapies, noting the agency had issued a 2025 regulation governing ATMP assessments.
Ikrar added that Indonesia has five GMP-certified stem cell facilities developing novel therapeutic products, with 43 others already receiving BPOM guidance to meet GMP standards.
He further noted that the agency is developing a tripartite collaboration model to advance national health innovations, with universities conducting research, businesses handling production, and the government enforcing safety, efficacy, and quality standards.
BPOM has partnered with 186 higher education institutions in Indonesia to support innovation, supported by 270 GMP-certified pharmaceutical manufacturing facilities, he added.
He further emphasized the agency’s readiness to attract investment and strengthen international cooperation to accelerate the development of regenerative medicine in Indonesia.
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Translator: Mecca Yumna, Tegar Nurfitra
Editor: Bayu Prasetyo
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