臨床試驗委託服務機構（CRO）之產業角色演化： 網絡結構、價值鏈及商業模式探討

Abstract

隨著全球人口的急劇增長、老年人口比例的提高以及各類疾病發病率的上升，全球醫療市場的需求日益增加，推動了新藥研發的投入。然而，藥廠和生物技術公司面臨著縮短新藥研發時程和降低研發成本的巨大壓力，逐漸將研發、臨床試驗、製造和銷售等業務活動委託給專業的外部機構進行分工合作。臨床試驗委託研究服務機構（Contract Research Organization, CRO）因此迅速崛起，成為新藥研發過程中的重要合作夥伴。CRO公司提供包括試驗設計、臨床試驗數據管理與分析、法規合規性支持等全方位的委託服務，並運用大數據分析、電子化智慧型平板、手機等數位工具和遠端執行的虛擬服務（Virtual Services）等先進技術手段，提升臨床試驗的效率和準確性。 本研究主要探討臨床試驗委託服務機構（CRO）在新藥開發生態系中的產業角色演化，並著重於合作網絡結構與聯結、價值鏈及商業模式的探討。研究問題包括現行CRO價值鏈之服務類型及分工模式、CRO在新藥開發生態系的多重角色及演化分析樣態、CRO與藥廠和生物技術公司的合作策略與商業模式，以及未來CRO在新藥開發生態系中的演化方向。 本研究採用質性研究方法，透過文獻回顧、實務經驗分享及深度訪談，分析CRO產業的合作模式及演化樣態。研究結果顯示，功能性服務模式（Functional Service Provider, FSP）在CRO產業中佔有重要地位，提供專業的服務和成本效益，有助於提高臨床試驗的效率和品質。除此之外，CRO公司在高度分工和快速成長的過程中，逐漸向水平領域擴展，特別是在特定治療領域中進行專門化的分工，以提升服務的專業化水平。CRO公司與藥廠和生物技術公司之間的合作模式包括全方位服務模式（Full-Service, FS）、合作服務模式（Partnership Service, PS）和功能性服務模式（FSP），這些多元商業模式的出現反映了市場需求的多樣化和專業化趨勢。 未來，CRO產業將朝向高度專業化和多元化的服務發展，成為新藥開發過程中的重要戰略合作夥伴。CRO公司需不斷提升技術能力和專業知識，通過創新和合作保持市場競爭力，提供包括策略諮詢、法規合規性支持、數據管理與分析等多元化的綜合服務，以應對不斷變化的市場需求和挑戰。

With the rapid increase in the global population, the rising proportion of the elderly, and the increasing incidence of various diseases, the demand for the global healthcare market has been growing. This has driven significant investment in new drug development. However, pharmaceutical and biotechnology companies face immense pressure to shorten the development time and reduce the costs of new drugs. Consequently, they have increasingly outsourced R&D, clinical trials, manufacturing, and sales activities to specialized external organizations. Contract Research Organizations (CROs) have thus rapidly emerged as crucial partners in the new drug development process. CROs provide comprehensive services, including trial design, clinical trial data management and analysis, regulatory compliance support, and utilize advanced technologies such as big data analytics, digital tools like smart tablets and smartphones, and remote execution through virtual services to enhance the efficiency and accuracy of clinical trials. This study primarily explores the evolving industrial role of CROs in the new drug development ecosystem, focusing on network structure and connections, value chain, and business models. The research questions include the current service types and division of labor in the CRO value chain, the multiple roles and evolutionary patterns of CROs in the new drug development ecosystem, the cooperation strategies and business models between CROs and pharmaceutical and biotechnology companies, and the anticipated evolution of CROs in the new drug development ecosystem. Using qualitative research methods, this study analyzes the cooperation models and evolutionary patterns of the CRO industry through literature review, practical experience sharing, and in-depth interviews. The results indicate that the Functional Service Provider (FSP) model holds a significant position in the CRO industry, providing professional services and cost-efficiency that help improve the efficiency and quality of clinical trials. Additionally, as CROs undergo high degrees of specialization and rapid growth, they are expanding horizontally, particularly by specializing in specific therapeutic areas to enhance the level of professional services. The cooperation models between CROs and pharmaceutical and biotechnology companies include Full-Service (FS), Partnership Service (PS), and Functional Service Provider (FSP) models, reflecting the diverse and specialized demands of the market. In the future, the CRO industry will develop towards highly specialized and diversified services, becoming essential strategic partners in the new drug development process. CROs need to continuously improve their technical capabilities and professional knowledge, maintain market competitiveness through innovation and collaboration, and provide diversified comprehensive services, including strategic consulting, regulatory compliance support, and data management and analysis, to meet the ever-changing market demands and challenges.