The company’s performance improved significantly as it began full-scale supply of its combo diagnostic kit, which simultaneously detects COVID-19 and influenza A and B, to the US market. Osang Healthcare received formal approval (510K) for this product from the US Food and Drug Administration (FDA) in January. The company signed an exclusive supply contract with a global medical device company and began supplying the product from the first quarter. To date, only three companies have successfully obtained formal FDA approval for this product, with Osang Healthcare being the only Korean company among them.
By segment, the immunodiagnostics division, which produces diagnostic kits, accounted for the largest share with sales of 16.4 billion KRW. Given the long-term supply contracts secured over several years and the steady annual patient trends, performance in the immunodiagnostics division is expected to continue growing. Unlike the common cold, influenza requires specialized treatment, and its treatment method differs from that of COVID-19, resulting in consistent annual demand.
The biochemical diagnostics division, which manufactures blood glucose meters and glycated hemoglobin analyzers, recorded sales of 14.7 billion KRW. In the first quarter, performance decreased somewhat compared to the same period last year due to the replacement of some outdated equipment and emergency production support for the immunodiagnostics division. From the second quarter of this year, the company expects steady performance at or above last year’s level.
A representative from Osang Healthcare stated, “Our first-quarter results demonstrate the potential for significant performance improvement this year,” and added, “In the second quarter, we will continue strong growth through expanded supply of diagnostic kits and recovery of sales in existing diagnostic divisions.”
The representative further emphasized, “This year will mark the first year that Osang Healthcare demonstrates its ability to achieve external growth and high profitability even without temporary factors such as the COVID-19 pandemic. Once our new products under development are launched, we will be able to build an even more stable business portfolio.”
To enter the rapidly growing continuous glucose monitoring (CGM) market, Osang Healthcare invested $40 million (approximately 54 billion KRW) in Allez Health, a US company, in 2024. The company is currently preparing for FDA pivotal clinical trials, aiming for approval in 2026 and product launch in 2027.
According to global market research firm Mordor Intelligence, the global CGM market is expected to grow at a compound annual growth rate of 12.89%, from $13.13 billion (approximately 18 trillion KRW) in 2025 to $24.07 billion (approximately 33 trillion KRW) in 2030.
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