台灣臨床委託研究機構（CRO）進入中國市場的經營策略-以鈦翔公司為例

Abstract

新藥開發需要長周期及高資金的投入，是高風險，也是高獲利的產業，研發時程越短，專利的保護期就越長，獲利就愈大，因此，專業分工的委託研究機構（CRO）產業就應運而生，相對於全球委託研究機構產業發展進程，大陸委託研究機構產業仍處於萌芽階段。近幾年，大陸因為醫藥創新政策的催化、一致性評價的推進，以及全球委託研究機構市場的轉移等因素的影響下，使得大陸委託研究機構產業呈現爆發性的增長。 過去很少有對委託研究機構產業進行研究，而不同類型的委託研究機構產業想要能成功立足與成長，並不是簡單的一個因素就可以成功，尤其針對兩岸本土中小型的I期臨床試驗委託研究機構公司而言，更不是件容易的事，必須要發展出一種有效的經營模式（Business Model），才可以立足兩岸，放眼全球。 本研究係以台灣本土中小型的I期臨床試驗委託研究機構公司為個案研究對象，採用質性研究之描述性個案研究法（Descriptive Case Study），嘗試以Hamel（2000）之經營模式架構，從核心策略（Core Strategy）、策略性資源（Strategic Resources）、顧客介面（Customer Interface），以及價值網路（Value Network）四個構面，探討個案公司之經營模式。透過對個案公司經營模式的全面檢視，分別對兩岸本土中小型的I期臨床試驗委託研究機構產業及個案公司，提出經營上的建議。 經由本研究分析的結果，對兩岸本土中小型的I期臨床試驗委託研究機構產業而言，顯示出四個重要的結論： 1. 經營模式最重要的要素，首推策略性資源，同時結合核心策略與善用價值網路，以符合產業的關鍵性成功因素（key success factors）。 2. 有效的活動構造提升，能深化策略資源的能力，並支援核心策略的發展，才能區隔市場，提昇競爭力，建立競爭優勢。 3. 顧客利益的提供，有助於建立客戶滿意度與忠誠度，以及業務推廣，提升市場占有率。 4. 需透過持續的經驗及技術的累積，不斷的創新與善用資源配置，建立獨特性與差異性，以及動態管理的經營模式，才能建立企業長久的競爭優勢。 對個案公司提出之經營策略建議為： 1. 有效提升活動構造，以支援並深化核心策略及策略性資源的運用。 2. 善用國際化經驗能力的品牌與形象優勢，加強行銷業務活動。 3. 善用價值網路的支援與互補資源能力，共同開發業務與行銷，相互提升彼此的企業形象與聲譽。 4. 強化顧客介面與提供顧客利益的經營模式。 5. 強化經營模式各要素之效率與獨特性，以創造利潤，建立競爭優勢。 本研究對兩岸本土中小型的I期臨床試驗委託研究機構產業及個案公司，在其營運策略之擬定及調整上，具有一定的參考價值。

New drug development requires a long period and high capital investment. It is a high-risk and high-profit industry. The shorter the R D period, the longer the patent protection period and the greater the profit. Therefore, the Contract Research Organization (CRO) industry of professional division of labor emerged at the historic moment. Compared with the global Contract Research Organization industry development level, the Contract Research Organization industry is still in the embryonic stage. In recent years, due to the influence of factors such as the catalysis of pharmaceutical innovation policies, the promotion of consistency evaluation, and the transfer of the global market for commissioned research institutions, the industry of mainland the Contract Research Organization has shown explosive growth. In the past, there have been few studies on the Contract Research Organization industry, and different types of Contract Research Organization industry want to be able to successfully establish and grow, it is not a single factor that can be created, especially for the cross-strait local small and medium-sized phase I clinical trial (including the BE trial) Contract Research Organization company is not an easy task. It must develop an effective business model before it can stand on both sides of the strait and look at the world. This research is based on the Taiwan local small and medium-sized phase I clinical trials Contract Research Organization company as case study objects. This research adopts Descriptive Case Study method and takes system integration vendors as the object. Through theoretical and practical verification, it tries to describe how business strategies were made based on the structure of Hamel Business Model (2000). According to business model of Hamel, refine the business model of the studied company via the Core Strategy, Strategic Resources, Customer Interface and Value Network. Through the overview of the studied company’s business model, we try to provide the cross-strait local small and medium-sized phase I clinical trials Contract Research Organization industry and case company recommendations to the company strategy. Based on the analysis of this study, for the cross-strait local small and medium-sized phase I clinical trials Contract Research Organization industry, it shows four important conclusions: 1. The most important element of the business model, the first push strategic resources, combined with the core strategy and the best use of value network, in order to meet the industry's key success factors. 2. Effective activity construction enhances, deepens the ability of strategic resources, and supports the development of core strategies, in order to market segments, enhance competitiveness, and build competitive advantage. 3. The provision of customer benefits helps to build customer satisfaction and loyalty, as well as business promotion, to enhance market share. 4. Only through continuous accumulation of experience and technology, constant innovation and good use of resource allocation, the establishment of uniqueness and difference, and a dynamic management business model can we establish a long-term competitive advantage. The business strategy recommendations for the case company are: 1. Effectively enhance activity structure to support and deepen the use of core strategies and strategic resources. 2. Making good use of the brand and image advantages of international experience and capabilities to strengthen marketing business activities. 3. Make good use of the support of the value network and complementary resources, jointly develop business and marketing, and mutually enhance each other's corporate image and reputation. 4. Strengthen the customer interface and provide customer benefits business model. 5. Strengthen the efficiency and uniqueness of all the factor in the business model to make profit and establish a competitive advantage. This thesis has reference value to draft and adjust business strategy of cross-strait the local small and medium-sized phase I clinical trials Contract Research Organization industry and case company.