Key findings
— 1 listed company made its first-ever US FDA filing in the past twelve months, down from 3 a year earlier.
— Of 285 listed companies holding Korean approvals, 74 (26.0%) also hold a US FDA record.
— The forward pipeline is expanding: 286 active clinical trials worldwide across 81 companies, including 51 Phase 3 trials.
— Research output rose: 774 PubMed-indexed publications in the past twelve months, +12.8% year on year.
— Radiology accounts for 43% of Korean 510(k) clearances over 24 months — imaging is Korea's gateway to the US market.
1. US market entry — fewer newcomers, incumbents carry the activity
ASTERASYS was the only listed Korean healthcare company to make a first-ever US FDA filing in the past twelve months. The preceding twelve months produced 3 first-time entrants (HLB · HLB Life Science · MEKICS).
Activity among companies already in the US market continued. The most active filers over the past twelve months:
"First-ever" is verified per candidate against openFDA applicant records; two candidates with earlier filings (2012, 2009) were excluded by this check.
2. Where Korea enters — radiology is the gateway
46 of 106 Korean 510(k) clearances over the past 24 months (43%) fall under the Radiology review panel.
Korean AI reading software is classified under radiology, which this distribution reflects.
3. The global trial pipeline — 284 active trials, 50 in Phase 3
Korean listed companies sponsor 286 active trials worldwide. By phase: 98 in Phase 1, 64 in Phase 2, 51 in Phase 3 and 13 in Phase 4 (60 unphased — observational and other).
Companies with the largest active portfolios:
ClinicalTrials.gov registrations, matched by exact lead-sponsor name. CRO-sponsored registrations are not captured.
4. Domestic regulatory flow — nine full quarters
Domestic pipeline inflow remains steady across approvals and trial authorisations:
| Quarter | MFDS devices | MFDS drugs | Trial authorisations | FDA 510(k) | FDA drugs |
|---|---|---|---|---|---|
| 2024Q2 | 22 | 33 | 9 | 4 | 2 |
| 2024Q3 | 167 | 144 | 71 | 14 | 1 |
| 2024Q4 | 159 | 171 | 72 | 19 | 1 |
| 2025Q1 | 108 | 156 | 63 | 23 | 4 |
| 2025Q2 | 113 | 180 | 72 | 11 | 0 |
| 2025Q3 | 196 | 245 | 79 | 9 | 0 |
| 2025Q4 | 186 | 184 | 77 | 14 | 1 |
| 2026Q1 | 179 | 176 | 69 | 9 | 1 |
| 2026Q2 | 187 | 260 | 77 | 20 | 0 |
| 2026Q3 (partial) | 186 | 175 | 68 | 5 | 0 |
The current quarter is partial. Read the trend, not a single bar.
5. Trial authorisation leaders
The most active recipients of Korean trial authorisations over the past twelve months — all five leaders are established pharmaceutical companies:
6. Commercialisation signals — supply and licensing disclosures
As a leading indicator of commercialisation, we tally Korea Exchange disclosures of supply contracts and technology transfer/licensing agreements: 377 over the last four full quarters.
The collection window opens in Q3 2024; the first quarter is partial.
7. The research base — publications up year on year
774 PubMed-indexed publications in the past twelve months, +12.8% versus the prior period. The most prolific publishers:
Matched by author affiliation. The index also holds 40,387 patents (domestic and foreign); a company ranking is withheld until non-healthcare patents of diversified groups can be separated.
8. From research to product — conversion by sector
Among companies holding research assets (publications or patents), the share that has reached a product approval. The gap between medical devices (91.9%) and biotech (44.6%) quantifies the two sectors' different development cycles and regulatory structures.
| Sector | Companies | With research assets | In clinical stage | With approvals | Research-to-product rate |
|---|---|---|---|---|---|
| Pharma & CDMO | 128 | 119 | 98 | 98 | 77.3% |
| Medical devices | 125 | 120 | 20 | 117 | 94.2% |
| Biotech & drug discovery | 112 | 110 | 79 | 50 | 44.5% |
| Healthcare infrastructure | 22 | 21 | 5 | 7 | 33.3% |
| Medical AI | 16 | 16 | 6 | 13 | 81.2% |
Biotech's lower rate is development in progress, not failure — 78 of the sector's 112 companies are in the clinical stage.
9. New entrants
First-ever Korean trial authorisation in the past twelve months: Aprogen · BIONEER · INGENIA Therapeutics · Keeps Biopharma · ORGANOIDSCIENCES. First-ever product approval: Curocell · IMGT.
Trial data begins in 2012. Records predating corporate mergers may not carry over to the present entity.
Method and limits
Population — the complete census of 403 KOSPI/KOSDAQ-listed medical AI, biotech and medical device companies (the MAA index). A census, not a sample. 19 index constituents whose main business is not healthcare (oil refining, food, security software and the like) are excluded from these tallies.
Sources — Korea MFDS (data.go.kr), US FDA openFDA, PubMed, KIPRIS and ClinicalTrials.gov. Records are matched by business registration number or exact corporate-name match after stripping legal suffixes; similarity matching is never used.
Subsidiaries — records filed by subsidiaries are counted under the listed parent only where control is confirmed in DART filings, and are labelled as subsidiary filings. Coverage is a floor.
Direction of error — filings under US-subsidiary names and CRO-sponsored trials are not captured. Every known error is conservative; there is no overcounting path.
Verification — figures naming companies were re-queried against the source agency through an independent path; exclusions are disclosed in the text. Errors reported to us are recomputed and corrected with a visible history. Underlying records for any company are available on request.