Secretome Therapy in Indonesia: What's Actually Happening

WHAT THIS ARTICLE COVERS

Over the second half of 2026, Indonesia's drug regulator, its Ministry of Health, and its state-owned pharmaceutical sector have all started treating secretome therapy — cell-free regenerative products made from the proteins, growth factors, and extracellular vesicles that stem cells secrete, rather than the cells themselves — as a distinct category worth building rules and partnerships around. That is a genuinely interesting regulatory and industry story. It is not the same thing as a secretome product being proven safe, effective, or approved for sale. This article separates what is actually documented — a new BPOM assessment framework, a Ministry of Health briefing naming secretome explicitly, and an exploratory MoU between a state pharma company and a Malaysian medical group — from what remains unestablished: that any specific secretome product on the Indonesian market has cleared full marketing authorization or been validated in rigorous human trials.

What Secretome Therapy Actually Is

"Secretome" refers to the full set of molecules a cell secretes into its environment. In regenerative medicine, it usually means the cell-free fraction harvested from cultured stem cells — typically mesenchymal stem cells from fat tissue, umbilical cord, or bone marrow — after the cells themselves are filtered out. A 2021 peer-reviewed review in the journal Biomolecules describes this secretome as containing growth factors (VEGF, FGF-2, HGF, EGF), immunomodulatory cytokines (IL-6, IL-10), and extracellular vesicles, chiefly exosomes roughly 30-100 nanometers wide carrying proteins, lipids, and regulatory RNAs. The appeal, per the review's authors, is that a cell-free product may avoid some risks of injecting living, dividing cells — such as uncontrolled growth — while still delivering much of cell therapy's biological signaling. The same review is explicit that most supporting evidence so far comes from laboratory and animal studies, with human clinical trial data still limited. That caveat applies to everything that follows.

Indonesia's Regulatory Build-Out: BPOM's New Framework

Indonesia's drug and food regulator, BPOM (Badan Pengawas Obat dan Makanan), issued Regulation No. 8 of 2025 — officially "Pedoman Penilaian Produk Terapi Advanced" (Assessment Guidelines for Advanced Therapy Products) — signed March 6, 2025. It replaced an earlier 2020 rule covering only human cell-based drugs, broadening the scope to a category BPOM defines as covering cell products, tissue-engineered products, and gene therapies, and setting out how evaluators and applicants should assess them for registration and development.

BPOM's head framed this regionally on July 3, 2026, at the first Asia Pacific Regenerative Medicine Congress (APREMIC) in Jakarta, arguing Indonesia should move beyond adopting regenerative medicine technology and help create it — while insisting faster, adaptive regulation cannot come at the expense of patient safety. He cited five Indonesian stem cell processing facilities with GMP certification for developing new drug products, BPOM's GMP regulatory assistance to 43 facilities nationwide, and global market projections showing the advanced therapy medicinal products (ATMP) market growing from roughly $41.46 billion in 2026 to about $86.76 billion by 2031 — part of the case for building domestic capacity now.

The Ministry of Health Puts Secretome on the Record

On August 29, 2026, Indonesia's Ministry of Health held a public briefing, "Update on Stem Cell Therapy and Its Derivatives in Indonesia," at a hospital in Jakarta. Remarks prepared by the ministry's Director of Referral Health Service Development and read by a representative of its Regenerative Therapy and Medical Innovation Working Group named secretome, exosomes, and extracellular vesicles specifically as derivative products showing promise in orthopedics, aesthetics, and neurology.

The framing, notably, was not promotional. The ministry's position included explicit guardrails: stem cell therapy and its derivatives "cannot be provided without strong clinical governance and oversight"; products must come from licensed processing laboratories with traceable sourcing; and the public needs accurate information on proven benefits, risks, and limitations to distinguish real innovation from claims "not yet supported by adequate scientific evidence." That last point is the crux of this story — a ministry naming secretome and exosomes as a field worth regulating well, precisely because it recognizes unproven claims are already circulating.

The State Pharmaceutical Company–Medical Group MoU

On October 9, 2026, in Jakarta, a state-owned pharmaceutical company signed a memorandum of understanding with a Malaysian medical group, witnessed by officials including a representative of Indonesia's Ministry of Investment and Downstreaming.

The MoU covers registration, commercialization, and distribution of stem cell and secretome products in Indonesia specifically. Both sides described it in exploratory terms, not as a finished product launch — the pharmaceutical company's R&D director called it an exploratory step, and the medical group's chief executive framed the partnership as a chance to understand Indonesia's regulatory requirements. Neither side's public remarks claimed any secretome product has secured BPOM marketing authorization (izin edar) as a result. The MoU signals corporate and state interest in building a secretome pipeline inside Indonesia's regulatory system — not evidence that pipeline has yet produced an approved product.

The company is not alone. Another state pharma company has been expanding stem cell partnerships with Ministry of Health-affiliated hospitals, building on a GMP-certified facility established in 2024, with stated ambitions for BPOM authorization of stem cell-related services in skin, nerve, and neurology indications. That reporting centers on stem cells broadly, not secretome specifically, so it's best read as context rather than direct evidence about secretome approval.

Taken together — a new BPOM framework covering cell-based advanced therapies, a ministry briefing naming secretome and exosomes directly, and a state pharma MoU aimed at secretome products — these threads show a country methodically assembling regulatory scaffolding for an emerging field. That is worth watching as industry news. It is a different claim from the field having arrived.

What Remains Unproven and Unapproved

None of this constitutes proof that a specific secretome product offered in Indonesia is safe, effective, or has cleared full BPOM marketing approval for any indication. Regulation No. 8 of 2025 is an assessment framework, not a marketing approval. The Ministry of Health's briefing called secretome and exosome applications promising while warning against claims outrunning evidence. The MoU between the state pharmaceutical company and the medical group is, by both companies' own description, exploratory. Independent scientific review, including the 2021 Biomolecules paper cited above, continues to describe clinical evidence for secretome and exosome therapies as limited relative to the preclinical work behind the field's promise. Anyone considering a secretome-based treatment anywhere, including in Indonesia, should ask specifically whether the product has documented marketing authorization for the indication offered — general claims of being "licensed" or "GMP-certified" are not the same thing.

Bottom Line

Indonesia is building real regulatory and institutional infrastructure around secretome therapy: a 2025 BPOM assessment framework for advanced therapy products, explicit Ministry of Health acknowledgment of secretome and exosomes as an emerging category, and a state pharmaceutical company's MoU aimed specifically at secretome registration and distribution. That is a legitimate, forward-looking industry development, suggesting Indonesia intends to regulate this space deliberately. But as of October 2026, none of it amounts to a specific secretome product being proven safe or effective, or holding full market approval in Indonesia. The country's own regulators and health ministry are drawing that distinction themselves — readers should hold onto it just as firmly.