外泌體產業專利分析

Abstract

本研究旨在透過文獻回顧及專利分析兩種方法，相輔相成共同揭示外泌體技術在改善公共衛生、推動農業永續與環境保護方面的跨領域潛力與全球趨勢，文獻回顧提供機制理解與科學論據，專利分析則建立創新應用與產業化證據，同時提供臺灣生技公司做為外泌體產品開發之參考依據，並以真實案例顯現外泌體（Exosome）作為由細胞分泌、攜載多樣化生物分子的細胞外囊泡，廣泛參與細胞間訊息傳遞，影響著動植物生理機制與人類疾病發展，從專利技術分類與區域專利布局分析外泌體在醫療研究、美妝原料、農業永續及環境保護等跨領域應用。 隨著外泌體研究由基礎學術領域逐漸跨入臨床及產業應用，近年來相關技術發展和專利布局日益受到關注。新興產業的趨勢經常由技術的突破帶動該領域的產業發展，本研究以專利檢索為核心操作，輔以文獻分析、政府科研計畫資料整合與真實世界案例調查，掌握全球外泌體技術的發展現況。從外泌體的生物功能與異質性影響生產技術等學術文獻，建立專利技術功效矩陣分析出外泌體的重要技術類別，同時佐以近十年全球的外泌體技術分類與時間趨勢關係圖顯現外泌體技術的專利布局態勢。 本研究著重分析外泌體特性所帶動的專利布局及其優勢技術分類，探討外泌體本身的獨特性質如何影響生產製造流程，不同細胞來源以及同一細胞來源但不同培養條件所製造的外泌體無法保持品質一致性的痛點，而取得專利權保護的三要件為新穎性、進步性、產業利用性，由專利申請的公開資訊上探查技術突破點與潛在優勢。本研究也以全球視角剖析外泌體產業的專利發展態勢，由專利分類分析瞭解外泌體技術在國際的布局情形。並且統計分析全球外泌體產業之主要專利申請國家及其申請的重要技術分類分布，比較其研發投入與技術佈局掌握各類技術領域的專利分布和重點，再從專利申請數量分析出全球外泌體技術領導者。 最後本研究深入比較美國、歐盟、亞洲及最後回歸臺灣的外泌體專利技術分布差異，探討各地理區域在外泌體研發上的著力點與競爭態勢，從而描繪出全球外泌體技術創新的競爭版圖，提供臺灣生技新創在全球外泌體產業專利攻防上切實可行的見解和策略定位參考。

This study aims to reveal the interdisciplinary potential and global trends of exosome technology in enhancing public health, promoting sustainable agriculture, and supporting environmental protection through a dual-method approach: literature review and patent analysis. The literature review provides mechanistic understanding and scientific rationale, while the patent analysis establishes evidence of innovation and commercialization. It also offers a practical reference for Taiwanese biotech companies in developing exosome-related products. Real-world case studies demonstrate that exosomes—extracellular vesicles secreted by cells and capable of carrying diverse biomolecules—are widely involved in intercellular communication, influencing the physiological mechanisms of both plants and animals, as well as the progression of human diseases. Through patent classification and global regional distribution analysis, this study identifies technological trends in exosome applications across medical research, cosmetic ingredients, sustainable agriculture, and environmental protection. As exosome research transitions from academic foundations to clinical and industrial applications, there has been increasing attention to the technological development and formation of patent portfolios in recent years. Emerging industries often evolve from technological breakthroughs that catalyze sector-wide transformation. This research places patent search at its core, supplemented by literature analysis, integration of government-funded project data, and real-world case investigations to grasp the current status of global exosome technology development. Drawing from scientific literature on exosome biological functionality and heterogeneity in production, the study constructs a Technology-Efficacy Matrix to identify key technology categories. It is further supported by a ten-year global trend analysis of exosome patent classification to visualize the evolution of the exosome patent portfolio. This study particularly emphasizes how the biological characteristics of exosomes drive the development of Patent Portfolios and influence advantageous technical classifications. It explores a key production challenge: the inability to maintain consistent exosome quality due to variability among different cell sources or even among batches from the same cell line under different culture conditions. Based on the three criteria for patent protection—novelty, non-obviousness, and industrial applicability—the study utilizes publicly available patent disclosures to uncover potential breakthrough points and competitive advantages. From a global perspective, the study examines the exosome industry's patent development landscape through classification-based analysis to understand the international deployment of exosome technologies. It also statistically analyzes the major patent-filing countries and the distribution of key technical categories, comparing their R&D investment levels and Patent Portfolios to identify global leaders in exosome technology. Finally, the study conducts an in-depth comparative analysis of exosome patent portfolios in the United States, European Union, Asia, and Taiwan. It identifies key strategic focus areas and the competitive dynamics of each region in R&D, ultimately depicting the global innovation landscape of exosome technology. These findings offer actionable insights and strategic positioning references for Taiwanese biotech startups seeking to establish a foothold in the global exosome patent arena.