臺灣特管法監管下的液態活檢診斷市場評估策略: 以次世代定序技術平台為例

Abstract

癌症長期以來是國人十大死因中的頭號殺手，發病率逐漸上升。液體活檢技術的出現，為精準醫療提供了新的可能性。液體活檢通過檢測血液中的腫瘤標誌物或癌細胞DNA，確定治療方向並追踪癌症進展。相比傳統的組織活檢，液體活檢具有多次採樣和持續追踪的優勢，提高了臨床管理效率和患者生存期。在台灣，精準醫療得到了政策支持，食品藥物管理署和衛生福利部發布了相關指引和管理辦法，加速精準醫療和基因治療的發展。然而，液體活檢技術在臨床應用中的敏感度有待提高，並面臨法規和市場競爭的不確定性。對液體活檢技術在市場中的定位、產品優劣勢及法規政策進行研究具有重要意義。本研究旨在評估液體活檢技術在分子診斷市場中的定位及未來發展方向。 首先，本研究分析美國FDA資料庫與台灣實驗室自行研發檢驗技術(LDTs)產品，以非小細胞肺癌（NSCLC）為例，通過美國體外診斷(In Vitro Diagnostic, IVD)認證的產品包括Cobas EGFR Mutation Test v2（羅氏分子系統公司）、FoundationOne Liquid CDx（Foundation Medicine公司）和Guardant360 CDx（Guardant Health公司）。另外透過查詢台灣特管辦法LDTs認證之廠商名單，發現台灣目前尚未有廣泛型液態切片產品獲得LDTs認證。因此，本研究特別關注正在申請認證的液體活檢技術公司A。該公司代理的廣泛型液態切片產品雖然尚未獲得認證，但已在臨床上使用。為深入了解該產品在台灣市場的定位及銷售策略，本文進行了SWOT分析。此外，透過臨床問卷調查，收集了胸腔科與血液腫瘤科主任及主治醫師的使用經驗，探討其在臨床使用的趨勢。 結果顯示，液態切片檢測結果是否可申請健保用藥及檢測本身是否有法規認證，均為目前影響臨床醫師使用程度的主要因素，且不同科別和年資的醫師在使用液體活檢技術上的趨勢和需求亦有所差異。此外，胸腔科醫師特別重視報告完成時間及臨床用藥實證；相比之下，腫瘤科醫師對報告時間的要求較為寬鬆，普遍能接受目前產品的報告速度。為深入了解技術開發的市場利基點。透過業界專家訪談，進一步強調了液體活檢技術在臨床敏感度和法規政策方面所面臨的挑戰。針對特定癌別設計不同品項產品，並通過代理服務滿足市場需求，皆為未來市場對應策略。這些策略為未來技術開發提供了重要參考。液體活檢技術有望在癌症診斷和治療的精準度作出重要貢獻。

Cancer has long been the leading cause of death among the top ten causes in Taiwan, with its incidence rate gradually increasing. The emergence of liquid biopsy technology offers new possibilities for precision medicine. Liquid biopsy determines treatment direction and monitors cancer progression by detecting tumor markers or cancer cell DNA in the blood. Compared to traditional tissue biopsy, liquid biopsy has the advantages of multiple sampling and continuous monitoring, improving clinical management efficiency and patient survival rates. In Taiwan, precision medicine has received policy support, with the Food and Drug Administration (FDA) and the Ministry of Health and Welfare issuing relevant guidelines and management measures to accelerate the development of precision medicine and gene therapy. However, the sensitivity of liquid biopsy technology in clinical applications needs improvement, and it faces uncertainties in regulations and market competition. Studying the market positioning, product strengths and weaknesses, and regulatory policies of liquid biopsy technology is of great significance. This research aims to assess the market positioning and future development direction of liquid biopsy technology in the molecular diagnostics market. This study analyzes the US FDA database and Taiwanese LDT products, using non-small cell lung cancer (NSCLC) as a case study. Products that have received US IVD certification include the Cobas EGFR Mutation Test v2 (Roche Molecular Systems), FoundationOne Liquid CDx (Foundation Medicine), and Guardant360 CDx (Guardant Health). By consulting the list of companies certified under Taiwan's special regulations for LDT, it was found that there are currently no broad-spectrum liquid biopsy products with LDT certification in Taiwan. Therefore, this study particularly focuses on Company A, which is in the process of applying for certification for its liquid biopsy technology. Although their broad-spectrum liquid biopsy product has not yet been certified, it is already being used clinically. To gain a deeper understanding of this product's market positioning and sales strategy in Taiwan, this paper conducts a SWOT analysis. Additionally, a clinical survey was conducted to gather usage experiences from the heads and attending physicians in thoracic surgery and hematology-oncology departments. The survey explored the clinical usage trends. The results indicate that whether the liquid biopsy test results can be used to apply for insurance coverage and whether the test itself is regulatory certified are the primary factors influencing clinical usage by physicians. Furthermore, there are variations in the trends and needs for liquid biopsy technology usage among physicians of different specialties and years of experience. Thoracic surgeons particularly emphasize the importance of report turnaround time and clinical drug efficacy evidence. In contrast, oncologists are more lenient regarding report turnaround times and generally accept the current product's report speed. To further understand the market niche for technology development, industry expert interviews were conducted, highlighting the challenges in clinical sensitivity and regulatory policies faced by liquid biopsy technology. Designing different product items for specific cancer types and meeting market demands through agency services are future market response strategies. These strategies provide important references for future technology development. Liquid biopsy technology is poised to make significant contributions to the precision of cancer diagnosis and treatment.