July_New Drugs|Alzheimer's Disease Diagnostics and New Drug Opportunities Ready for Development

Published On: 2025/07/05|Categories: 大健康(Healthcare)|

Commentator: Shin Chung-chul, Director of Health Center, Ji-Pu Industrial Trend Research Institute

Dementia is one of the greatest challenges in our aging society, and the fight against dementia is one of the most urgent and unmet medical needs of human beings around the world. Alzheimer Disease (AD) accounts for about 60% of all cases of dementia, and new diagnostics and therapies are breaking through the dilemma of treating AD, and are shedding light on the development of solutions to the problem of Alzheimer's Disease. It is currently believed that Alzheimer's disease has a slow course and continues to deteriorate over time. Although the exact onset of the disease is still debated, the brain of the patient is obviously shrinking, and the culprit may be the accumulation of abnormal proteins such as β-Amyloid and Tau proteins in the patient's brain, resulting in the death of nerve cells, which leads to neurodegeneration of the brain tissue atrophy and the β-Amyloid is a major cause of the early onset of Alzheimer's disease. Beta amyloid is an early pathological feature of Alzheimer's disease, which may appear as early as 10-15 years before the onset of the disease, and the removal of beta amyloid will undoubtedly have a certain effect on the course of the disease. Although there is no new cure for Alzheimer's disease, the development of new drugs has moved from treating the symptoms to treating the root cause, from the past to the removal of amyloid plaques by using symptomatic drugs such as acetyl cholinesterase and glutamate receptor inhibitors to slowing down the deterioration of the disease. Although the development of new drugs for Alzheimer's disease is still slow, with the approval of the marketing of the anti-beta amyloid antibodies, the approval of the new tau proteins, neuroinflammatory or GLP-1, etc., new treatment options are emerging. Although the development of new drugs for Alzheimer's disease is still slow, with the approval of anti-beta amyloid antibodies, new tau protein, neuroinflammatory or GLP-1 therapeutic options, etc., which are gradually revealing a new dawn, bringing new hope to patients and promoting the development of the Alzheimer's disease market, the development of new drugs for Alzheimer's disease treatment has become one of the trends of the hotspots of the new drug development.

此外,新生物標記、醫學影像、診斷和臨床試驗方案也為近年來阿茲海默症診斷和治療研究取得顯著性的進展,生物標記(Biomaker)是降低新藥開發風險和提高治療成功率的實用手段,目前阿茲海默症檢測常用的生物標記仍以β類澱粉蛋白和Tau蛋白為主,而黃金診斷標準是類澱粉腦部正子斷層掃描,除基因檢測(APOE)、腰椎穿刺抽腦脊髓液、或MRI核磁共振等診斷檢查外,許多新型診斷工具陸續被開發和應用,正朝向操作更簡便快速、更準確(準確率>90%)、降低檢測成本,以及早期篩檢診斷的轉變,如表一,精準偵測腦部異常蛋白變化如pTau217或β類澱粉濃度比率(β類澱粉蛋白1-42 、β類澱粉蛋白1-40或β類澱粉蛋白寡聚體)等血液測試,準確可靠地檢測出阿茲海默症大腦變化特徵,除可幫助醫師精準診斷,降低因診斷不足,所造成約25-35%的誤診率,以及搭配藥物精準投藥外,更幫助患者在症狀出現的前幾年,檢測罹病風險,並作為阿茲海默症的認知分級,由於不同類型的失智症,疾病進程及治療也會有所差異,而早期準確的診斷可幫助患者和照護者制定治療計劃,也可為病患安排最適合的個人化醫療。

表一、阿茲海默症檢測方案

Source: Organized by Ji-Pu Industrial Trend Research Institute.

抗阿茲海默症商機正在快速崛起,新型診斷和新藥蓄勢待發
據market.us(2024)報告指出,2024 年全球阿茲海默症藥物市場規模65億美元,預估到2026 年可成長約1.42倍,達到 92億美元,年複合成長率為18.97%。阿茲海默症耗費鉅額社會成本,負擔不僅是醫療費用,更涵蓋病患照護成本,根據世界衛生組織(WHO)數據,全球約超過5千萬名阿茲海默症患者,2050年預計增至1.5億人。目前全球唯二核准上市的抗β類澱粉蛋白抗體新藥,分別為衛材(Eisai)/百健(Biogen)於2023年7月獲美國FDA完全核准的Lecanemab (商品名Leqembi®),以及禮來(Eli Lilly)於2024年7月獲美國FDA完全核准的Donanemab (商品名Kisunla®),新藥使用前,須進行基因檢測、腦脊髓液、類澱粉正子攝影等診斷檢查,從Leqembi®初步的銷售數據來看,2024年全年銷售額約達2億美元的營收,預期隨著各國核准上市,醫療保險覆蓋率增加,以及精準早篩檢測,將帶動新藥用藥市場前景看好,預期阿茲海默症治療新藥和檢測需求將持續攀高,有望在2-4年內整體市場規模突破100億美元。
在阿茲海默症新藥龐大商機的驅使下,國際大藥廠長期以來一直在尋找阿茲海默症治療方案,即使過去20年阿茲海默症新藥開發幾乎全軍覆沒,隨著抗β類澱粉蛋白抗體新藥上市,此僵局有望持續突破,雖然新藥在臨床應用仍面臨患者選擇、腦水腫發生率或腦出血等副作用的挑戰,但新藥治療18個月,可延緩退化5~7個月,也有機會停止退化,因此阿茲海默症新藥開發提高安全性,改善腦腫脹和腦出血等副作用、優異跨血腦屏障(BBB)遞送藥量技術,更好的異常蛋白結合,以及新作用標靶的開發就被各路人馬視為競爭搶奪市場的契機,除核准兩強外,尚有艾伯維 (AbbVie)、施貴寶(BMS)、羅氏(Roche)、或諾和諾德(Novo Nordisk)探索GLP-1治療阿茲海默症的潛力。

阿茲海默症仍待攻克,台廠佈局精準檢測和新藥,後勢搶分一杯羹
隨著阿茲海默症新藥國際獲准上市,2025年台灣在阿茲海默症用藥也將有新選擇,並開啟阿茲海默症檢測和治療的新商機。吉晟生技為台灣首家衛福部及原能會雙重認證的核子醫學藥廠,建立完整核醫藥品供應鏈,隨國際新藥在台上市,將帶動腦立晰NeuraCeq®注射劑(Florbetaben F18)檢測需求提升; 磁量生技以專利磁減量免疫檢測技術,開發Tau 蛋白免疫磁減量/β類澱粉蛋白的血液檢測新方案,搶攻阿茲海默症血液早篩檢測商機; 而旭富製藥鎖定高附加值創新藥物研發的高端原料藥市場,為TauRx新藥公司的阿茲海默症臨床3期新藥的原料中間體獨家供應商,隨著臨床試驗用藥持續出貨,或後續該藥物核准,後勢可期,以及或新旭(APRINOIA Therapeutics)聚焦以tau蛋白和α-突觸核蛋白(α-Syn)的正子顯影劑檢測和泛素蛋白酶降解藥物開發,將有望帶動台廠新成長動能。

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