Diagnostic kit companies, once symbols of the COVID-19 boom, are now evolving. They are expanding their scope from quickly detecting viral infections to precision medicine technologies capable of diagnosing serious diseases such as lung cancer and Alzheimer's disease.
According to industry sources on May 23, Japanese in vitro diagnostics company Fujirebio recently received approval from the U.S. Food and Drug Administration (FDA) for a blood-based Alzheimer's diagnostic kit. Until now, Alzheimer's disease has mainly been diagnosed using expensive imaging equipment such as MRI (magnetic resonance imaging) or PET (positron emission tomography) scans, as well as neuropsychological tests. However, with this approval, it is now possible to conduct early diagnosis with a simple blood test. Fujirebio's kit analyzes the concentration ratio of 'beta-amyloid,' a representative protein that accumulates in the brains of Alzheimer's patients, to determine whether there are pathological changes in the brain. Commercialization in the United States is expected as early as next month.
Korean companies are also actively seeking new growth engines by advancing their technologies. Aptamer Science is working with a major hospital in India to commercialize an early lung cancer diagnostic kit. This kit analyzes whether specific biomarkers in the blood are present to predict the likelihood of lung cancer and to identify high-risk groups at an early stage.
The evolution of diagnostic kits has turned the COVID-19 crisis into an opportunity. The pandemic created enormous demand for testing, which rapidly advanced mass production and fast, accurate testing technologies. As a result, diagnostic companies were able to dramatically improve their technological capabilities. Research on detecting disease-related biomarkers in blood has progressed rapidly, making it possible to diagnose diseases with a simple blood test instead of expensive imaging equipment.
Leading Korean companies that experienced a sharp drop in sales?the so-called "diagnostic kit cliff"?after COVID-19 are now making a comeback. SD Biosensor is expanding its product lineup to cover infectious and chronic diseases, including AIDS (HIV), respiratory syncytial virus (RSV), malaria, and blood glucose measurement. Seegene is also broadening its portfolio beyond molecular diagnostics to include products for sexually transmitted diseases, tuberculosis, and HPV (the virus that causes cervical cancer), moving into non-COVID areas.
This trend has led to visible results this year. SD Biosensor and Seegene, Korea's leading diagnostic kit companies, both achieved increased sales and improved profitability in the first quarter compared to the same period last year. SD Biosensor reported first-quarter sales of 185.3 billion won, a 5.1% increase year-on-year. Seegene's first-quarter sales reached 116 billion won, up 29% from a year earlier, and the company posted a profit of 14.8 billion won, achieving a double-digit operating margin (12.8%) for the first time in nine quarters.
An industry official said, "Diagnostic companies that grew rapidly during COVID-19 faced a crisis after the end of the pandemic boom due to inventory accumulation and increased fixed costs. However, they are now transforming into key players in the precision medicine field through technological advancement and diversification of diseases. Kit-based diagnostics, which combine accuracy, accessibility, and cost-effectiveness, will be at the core of future medical innovation."
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