Biogen and Eisai's 'Lecanemab' and Other Dementia Treatments
For Patients with Mild Cognitive Impairment or Early Alzheimer's
Rapid Diagnosis Essential for Effective Treatment
Current PET and Cerebrospinal Fluid Tests Pose High Patient Costs
Blood Tests and Brain MRI AI Diagnostic Support Gain Attention
[Asia Economy Reporter Lee Chun-hee] Expectations for conquering dementia are growing as the results of the Phase 3 clinical trial of Biogen and Eisai's Alzheimer's dementia treatment 'Lecanemab' were released on the 29th (local time). Since accurate early diagnosis is essential to enhance the efficacy of the treatment, attempts to diagnose dementia through blood and genetic testing are also ongoing.
According to related industries, Biogen and Eisai plan to disclose detailed information about the Phase 3 clinical trial of Lecanemab at the International Conference on Alzheimer's Disease Clinical Trials (CTAD) held in San Francisco, USA, from today until December 2nd (local time). In the topline results released last September, a 27% improvement effect was confirmed compared to the placebo group in the Clinical Dementia Rating-Sum of Boxes (CDR-SOB) after 18 months of administration. Expectations for Lecanemab have increased further as Biogen-Eisai's 'Aduhelm' (active ingredient Aducanumab), which succeeded in obtaining approval from the U.S. Food and Drug Administration (FDA), practically failed in commercialization, and Roche's Gantenerumab also failed in Phase 3 clinical trials.
Most of the Alzheimer's treatments currently under development, including Lecanemab, target patients with mild cognitive impairment (MCI) or early Alzheimer's, which are pre-dementia stages. Rapid diagnosis is inevitably essential for smooth treatment. Additionally, the World Health Organization (WHO) predicts that the global dementia population will reach 139 million by 2050, and domestically, the dementia population is expected to exceed 2 million by 2040, indicating that the dementia diagnosis market will expand further. Global market research firm Inkwood Research forecasts that the Alzheimer's diagnosis market will grow from $1.598 billion in 2020 at an average annual growth rate of 4.5%, reaching $1.989 billion (approximately 2.6384 trillion KRW) by 2025.
Currently, positron emission tomography (PET) scanning is considered the most accurate dementia diagnostic method. However, since it is a non-reimbursed item, patients must bear costs exceeding 1 million KRW. Cerebrospinal fluid testing costs about 500,000 KRW, roughly half the price, but obtaining samples is difficult and causes significant discomfort to patients.
Therefore, techniques for diagnosing Alzheimer's through blood tests are gaining significant attention. Domestically, PeopleBio and Medipron have succeeded in developing Alzheimer's diagnostic technology using blood. This method measures amyloid beta (Aβ), a major biomarker of Alzheimer's dementia, from collected blood samples. The price is approximately 100,000 KRW, making it significantly more affordable.
PeopleBio recently launched the Alzheimer's blood test brand 'AlzOn' and is accelerating its business. It received approval from the Ministry of Food and Drug Safety in 2018 and obtained new medical technology certification last year. It is explained that sensitivity of 100% and specificity of 92% were confirmed in clinical trials. Currently, diagnostic kits are supplied to 120 medical institutions nationwide, including tertiary general hospitals, health screening centers, and clinics. Medipron also developed the Alzheimer's diagnostic kit 'QFlex Alz Plus' by measuring multiple biomarkers including Aβ in blood and received approval from the Ministry of Food and Drug Safety in 2020.
Efforts to refine brain MRI interpretation are also ongoing. Although relatively less expensive than PET, the diagnosis of dementia by doctors' visual inspection has the drawback of variability depending on clinical experience. In response, Vuno developed 'VunoMed-DeepBrain AD,' which automatically analyzes brain MRI to quantify the possibility of Alzheimer's disease, and it has been recognized for nursing care benefits and supplied to institutions such as Gangdong Kyung Hee University Hospital.
Technologies that predict the risk of dementia occurrence in advance through genetic analysis are also attracting attention. Macrogen launched the 'MyGenomeStory SeniorCare' service in 2017, which analyzes the risk of elderly diseases such as Alzheimer's, vascular dementia, and Parkinson's disease. Clinomics is developing 'Xeno Senior,' which tests degenerative brain diseases like dementia and age-related diseases such as macular degeneration based on multi-omics, with plans to commercialize it next year.
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