台灣臨床試驗委託研究服務業之發展策略探討

Abstract

隨著全球人口快速攀升、人口老化和疾病種類增加，全球醫藥市場需求不斷增加且逐年成長，因此國際知名藥廠對新藥研發的投資皆是不遺餘力，然而在競爭激烈的產業環境驅使下，藥廠為了縮短新藥研發時程和減少支出成本，逐漸將研發、臨床試驗、製造和銷售等業務活動尋求專業性委外分工，促使臨床試驗委託研究服務業（Contract Research Organization, CRO）快速的成長。近年全球CRO企業將發展重心逐漸轉移至成本較低且人才資源豐富的亞太地區，同時台灣政府積極推動產業升級轉型，而生醫產業是政策重點發展產業之一；在全球新藥研發製造產業鏈中，CRO產業已是不可或缺的一環且其重要性與日俱增，台灣本土公司面對國際大型CRO企業和鄰近國家強烈的競爭下，需要不斷強化和擴展企業之核心能耐才能生存和增加競爭力。本研究透過文獻之收集和彙整探討CRO產業概況、商業流程委外之因素、知識密集服務業之特性以及CRO產業併購活動對於新藥研發流程之影響，並針對市場、政策、法規、人才培育和企業發展策略等面向，提出本研究對於台灣CRO產業發展策略之建議。

A combination of rapid global population growth, population ageing and the increasing variety of diseases has spurred the global pharmaceutical market growth and expanding. The pharmaceutical companies have increased their investment in new drug research and development. In order to reduce R D costs and speeding up the time-to-market process, pharmaceutical companies tend to outsource projects such as R D, clinical trials, manufacturing and sales to other industries, and promote the high growth of the Contract Research Organization (CRO) industry. In recent years, international CRO companies focus on the development of the market because of the talent resources and low cost of Asia-Pacific region. Meanwhile Taiwan government also actively promotes industrial upgrading and transformation. The biomedical industry is one of the key policy development industries. CRO has become important partner to pharmaceutical and biotechnology companies in the development of new drugs. As fierce competition between CRO companies and neighboring countries, Taiwan's CRO companies necessary to continuously strengthen and expand the core competence of the corporate in order to increase their competitiveness and survival. In this study explores the CRO industry overview, the factors of business process outsourcing (BPO), the characteristics of knowledge-intensive business service (KIBS) industries, and the impact of M A activities of the CRO industry on the R D process of new drugs through the collection and compilation of the literature. Also aiming at the market analysis, policies, regulations, talent cultivation, and corporate development strategy, this study puts forward suggestions for the development strategy of Taiwan's CRO industry.