- 學位論文
新興醫療藥品之發展策略與商業模式_以視網膜再生醫療產品為例
Developmental Strategy and Business Model of Emerging Medical Medicine - A Case of Retinal Regeneration
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摘要
台灣生技產業經歷發展期、停滯期、轉型期，直至近年開始開花結果，授權案接連成功，為沉寂已久生技產業帶來數道光輝。然而，居安必須思維。台灣生技產業之獲利狀況與國際藥廠之收購意願息息相關，藥物授權與上市之市場特性亦受美國藥物定價政策牽引。 為優化新興醫療藥品之發展策略與商業模式，本論文收集歐美各大藥廠近年的投資與收購策略進行評估，並追蹤後新冠時期國際資金之變化。由其國際各大藥廠之前五年的收購模式與獲利必較分析，可預見其收購模式與標的將產生變化，而台灣生技產業也須因應進行調整。 藥物開發的策略是一個動態的優化過程。新藥研發期程長，為因應市場與競爭者的變化並維持自身的競爭力，其發展策略與商業模式除了需要有既定的方向外，亦需要給予彈性變動的空間。本研究以視網膜再生醫療產品為例，以市場導向的思維進行策略布局，透過多種商業模型進行策略面的優劣與相適性分析，建立一個以產品市場媒合度（Product market fit）為導向，商業模式適合度（Business model fit）為輔助之新興醫療藥品之發展策略與商業模式。 本研究之目標為建立一個優勢企業，以支持新興之再生醫療產品之發展，為相關病友提供更優渥的醫療方針，同時為企業獲取最大利益。有別於過去生技產業進行產品授權的銷售模式，本研究將配合近年之市場趨勢與顧客需求，為企業提供更廣泛與優渥的獲利選擇。 本研究的範圍涵蓋環境分析、市場分析、產品分析、顧客價值主張分析、價值鏈分析、商業模式分析與動態競爭分析，以了解政治、經濟、社會、科技、環境與法律等總體環境對該產業與產品發展、生產與銷售之影響。釐清本產品之特色與優缺點，並以此設定目標客群、探討目標客群之需求與痛點，並以此建立產品發展方針。隨後以SWOT分析、商業模式九宮格以及策略鑽石模型等設立適合該發展方針之商業模型，並檢查內外部環境與資源是否的以支持本商業模型之運營。 為加速產品發展與獲取最大利益，本研究分析過去二十年之再生醫療產業發展狀況、近年新興醫療相關公司之運營與發展策略、以及生技新創產業之資金流動特性，並依此制定利基市場、目標客群與發展策略。 因本新興醫療藥品之發展涉及研發面、生產面、法規面與物流鏈等，因此本研究之分析在選定利基市場後亦依本產品之特色，規劃營運地點、生產地點與物流鏈之最佳配置。將運營特色納入發展優勢中，以跳脫過去台灣生技醫療產品之價值評估模式，建立並優化專利以外之無形資產，增加公司價值與競爭優勢。以拓展公司發展彈性與策略競合之談判空間。 隨後本研究以動態競爭分析，評估未來之競爭與應對策略。同時以國外創新醫藥企業之發展史將新興醫療產業之發展歷程分為：探索期、成長期、高原期與衰退期，並以此概念探討世界兩大細胞療法公司（Kite Pharma和Juno Therapeutics）之發展與競合策略，以驗證本研究之論點，並推估資金投入之時機做為企業後續發展之建議。
並列摘要
Taiwan's biotechnology industry has gone through a period of development, stagnation, and transformation until it has begun to bear fruit in recent years, and the success of licensing cases has brought several flashes of brilliance to the long-silent biotechnology industry. However, we should always be prepared for danger in times of peace. The profitability of Taiwan's biotechnology industry is closely related to the acquisition intentions of major international pharmaceutical companies. The market of drug authorization and sale are also driven by the drug pricing policy of the USA. In order to optimize the development strategy and business model of emerging medical medicines, this paper collects and evaluates the investment and acquisition strategies of major European and American pharmaceutical companies in recent years, and tracks the changes in international funds in the post-COVID-19 period. Based on the analysis of the acquisition patterns and profits of major international pharmaceutical companies in the past five years, it is foreseeable that their acquisition patterns and targets will change, and Taiwan's biotechnology industry must also adjust accordingly. Drug development strategies involve a dynamic optimization process. The research and development of new drugs take long periods. To address market and competitor changes and maintain independent competitiveness, drug developers must set directions in strategy development and business models while enabling flexible changes. This study uses retina regenerative medical products as an example, layout with market-oriented thinking. Through strength and weakness analysis and fitness analysis on strategies based on business models, this study establishes a new drug development strategy and business model centering on product market fit and using business model fit as an assistive tool. The goal of the present study is to establish a dominant enterprise to support development of new regenerative medical products, provide patients with resourceful medical directions, and maximize the profits of the enterprise. Instead of adopting the selling mode of product authorization in the traditional biotechnology industry, this study provides enterprises with broader and more profitable options than before according to recent market trends and customer needs. The scope of this study encompasses environmental analysis, market analysis, product analysis, customer value proposition analysis, value chain analysis, business model analysis, and dynamic competition analysis to understand the effects of the macro environment including politics, economy, society, technology, environment, and law on the development of the industry and the production and sales of products. The features, advantages, and disadvantages of the product of interest are clarified and used as the basis for targeting customers, exploring needs and pain points of target customers, and establishing product development principles. Subsequently, strength, weakness, opportunity, and threat analysis, business model canvas, and the diamond model will be applied to develop a suitable business model for the established development principles. Internal and external environments and resources will also be examined to identify whether they can support operations of the proposed business model. To expedite product development and maximize profits, this study analyzes regenerative medical industry development statuses over the past 20 years, operations and development strategies of emerging companies related to medical products, and cash flow characteristics of biotechnology startups. The analysis results will be used as the basis for identifying the niche market, target customers, and development strategies. Development of the new medical product of interest involves multiple aspects including research and development, production, laws and regulations, and logistics chains. Thus, after a niche market is determined based on said analyses, this study will plan the site of operation, location of production, and optimal arrangement of the logistics chain according to the features of the product. Featured operations are integrated with development advantages to transcend the traditional evaluation model of biotechnology medical products in Taiwan. The proposed method can establish and optimize intangible assets in addition to patents and increase the company’s value and competitive advantages, thereby enhancing the development flexibility and negotiation level for strategic competition. This study will use dynamic competition analysis to evaluate the future competition and coping strategies. Development history of foreign startups related to medical products divides the development process of emerging medical businesses into exploration, growth, plateau, and decline stages. The concept is used to explore the development and coopetition strategies of two leading companies in cellular therapy (Kite Pharma and Juno Therapeutics) worldwide to verify the arguments of the present study. The timing of capital investment is also projected based on the same concept to suggest the developmental strategy of an emerging regenerative medicine company.
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