隨著人口老化、疾病種類增加，藥品市場逐年增加，不斷研發安全有效的新藥是全人類之所期盼，然而新藥研發的過程冗長繁瑣，平均耗時十年，投資上億美元，而成功率大約僅有萬分之一。由於專利藥品陸續到期、FDA對新藥審核法規漸趨嚴厲等因素之下，使得近年來藥廠的利潤大幅下降。新藥研發委託外包服務業(CRO, Contract Research Organization) 因為可以減少藥廠人力及營運成本，並加速新藥研發，縮短新藥上市時間而逐漸興起。
2015年製藥研發外包市場規模預估CRO總產值將達332億美元，市場成長率約每年15％。近年來國際CRO公司需求及重心往成本低、人才優的亞太地區發展，尤其中國、印度已成為外包的主力國家。台灣政府也積極佈局CRO產業供應鏈，並整合上下游服務以搶得國際藥廠商機，此外惟有台灣CRO產業的成熟才能加速國內醫藥的開發。
本研究運用資源依賴理論(Resource Dependence Theory)觀點，透過中國CRO藥明康德(Wuxi AppTec)與台灣昌達生化(QPS Taiwan)兩個個案，來檢視環境生存資源不確定性與組織活動的關係，從個案比較中探討企業如何透過各種併購、合資、策略聯盟或法規管制的策略，以增加對重要資源的獨立性並降低競爭的不確定性，藉此取得企業競爭優勢。
分析結果發現，中國成功的CRO個案在服務整合過程的資源依賴管理主要著重在交易相依，以直接投入及併購策略為主，注重國際認證及智財權保護，倚重執行長人脈協調資源，固守小分子研發能力並向下游整合。參考藥明康德的成功經驗及台灣的人才優勢，建議台灣CRO產業的發展應著重研發人才的培養、服務品質的提升、產出效率的創新、立基市場的佈局。此外，建議成立CRO服務聯盟來培養台灣新藥研發人才，提升新藥研發動能，將學術界的發現快速落實轉換成新藥上市的可能。

With the aging population, the increasing variety of diseases, drug expenditure is increasing, which means that the drug market is also expanding. Developing safe and effective new drugs for all mankind is constantly what we look for. The drug development and the approval process are lengthy and cumbersome. It takes an average of 10 years, investing hundreds of millions of dollars, from the research labs to the patients. Only 0.001% of invented drug was ever approved for human usage. As patents on many blockbuster drugs are about to expire, the FDA regulations become more stringent therefore the profit of pharmaceutical companies in recent years has dropped significantly. In order to reduce manpower and operating costs, speeding up the time-to-market process, more and more pharmaceutical companies tend to outsource research projects to Contract Research Organizations (CROs).

CRO market size is estimated to reach $ 33.2 billion with 15% market growth rate per year in 2015. In recent years, international CRO companies focus on the development of branches especially in China and India because of the low cost, and superior talents of Asia-Pacific region. Taiwan government also actively laid out the CRO industry supply chain, integrating upstream and downstream services to grab the international pharmaceutical business opportunities. In addition, the complete CRO value chain will help accelerate the new drug development in Taiwan.

In this study, through the Wuxi AppTec and QPS Taiwan cases, various strategies of M&A, joint ventures, strategic alliances or regulatory control were evaluated with the perspective of Resource Dependency Theory to explore how CROs were used to obtain a competitive advantage. The results of case study show that Wuxi AppTec focus more on direct investment, M&A, certification and intellectual property protection, the CEO’s contacts coordinate resources to increase the independence of the important resources and reduce the uncertainty of the competition. Based on its core competency with integrated downstream services, they both provided a “whole package” service.

Combine with the successful factors of WuXi AppTec and the advantages of superior talents in Taiwan, CRO industry should spend their resources on the following tasks: cultivating R&D talents, improving the quality of service, enhancing innovation efficiency, and identifying niche markets. In addition, Taiwan CRO Center is proposed to cultivate drug discovery talents, to boost up R&D energy, and let the academic research found convert into a new drug more quickly than before.

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