2010 年全球藥品銷售額約8800 億美金，並預估未來五年內，全球藥品市場規模可再成長3000 億美元，龐大的市場吸引許多生技製藥公司積極投入新藥的開發，但是製藥與審批程序日趨複雜，因此新藥上市必須仰賴專業分工。本研究臨床試驗委託研究機構，由於其提供生技製藥業臨床試驗研究支援，可加速新藥上市時程，是新藥開發價值鏈重要環節。 台灣的臨床試驗委託研究機構自 1996 年至今，歷經產業環境從導入期進入成長期之外部環境變化快速，本研究採用個案研究法，以深入訪談、觀察等方式探討企業如何因應外部環境不斷調整策略方向，如何設計價值單元以及具備哪些內部及外部資源優勢，並據此提出未來實務建議。依據本研究提出的三個研究問題，經個案研究結果分析所得結論如下： 一、 台灣臨床試驗委託研究機構產業環境變化，主要來自兩大因素：各國競爭及科技發展、成本考量造成的全球位移趨勢，以及臨床試驗相關法規的變更。因此策略方向初期以國內學名藥業務作為主力，隨著亞太區、生技醫藥技術發展與政府輔導等因素，策略轉向新藥開發臨床試驗的國際案件，並以策略聯盟方式加快開發業務速度。長期策略方向則是持續佈局國際市場並建立新的技術平台。 二、 臨床試驗委託研究機構以九項價值單元組合完成嚴謹的臨床試驗經營流程，包括「業務開發」、「法規諮詢」、「專案管理」、「醫學撰寫」、「臨床監測」、「專業檢驗」、「資料管理」、「統計分析」、「結案報告」。不同階段的臨床試驗程序可能整合在同一價值單元，以創造最終價值。 三、 各項價值單元之內部、外部資源分析結果顯示，臨床試驗委託研究機構歷經產業環境變化與策略調整，累積資源形成現有實體設備、關係、人力與經驗，可提供國際新藥開發臨床試驗案件服務，為企業策略發展基礎。 / In 2010, global pharmaceutical sales is estimated to reach 880 billion US dollars and the market is expected to expand 300 billion US dollars further within 5 years. Such a huge market has attracted many bio-pharmaceutical companies to invest their assets in new drug research and development (ND R&D). However, the procedure of new drug production and application is getting more and more complicated, thus it depends on professional services to assist launching new drugs. A contract research organization, also called a clinical research organization (CRO), is an organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services to speed up launch timeline, and has played an important role in ND R&D value chain. Taiwan CRO industrial environment has went through from introduction period to growing period since 1996. External environment changes rapidly. This study adopts case study method, by in-depth interviews, observation etc. to explore how CRO companies continue to adjust strategy in response to the external environment, how to design value units and what internal and external resource advantages they have. The study also proposes future practice recommendations for CRO companies based on the results. To answer three research questions, the study result is concluded as follows: 1. Taiwan CRO industry environment changes mainly from two factors: one is global displacement trend attributed to international competition, technology and cost. The other is changes in laws and regulations related to clinical trials. Therefore, the initial strategic direction focused on the domestic generic drug business. With the Asia Pacific biotechnology development and government guidance etc., it shifted to new drug international cases and strategic alliances. Long-term strategic direction is to focus on international market and to establish new technology platforms. 2. Taiwan CRO uses 9 value units to constitute whole management process of clinical trials. These value units include: "sales development", "regulatory consulting", "project management", "medical writing", "clinical monitoring", "sample testing", "data management", "statistical analysis" and “final report". Different stages of clinical trial procedures may be integrated in the same value unit, in order to create the ultimate value. 3. All value units’ internal and external resource analysis shows that Taiwan CRO accumulated resources such as physical facilities, relationships, human resources and experiences through industrial environment changes and strategy adjustment. These resources enable Taiwan CRO to provide new drug development services for international cases and this ability eventually became the foundation of corporate strategy.

本研究主要透過一個全新的產業矩陣架構，細膩翔實地檢視造成好萊塢電影產業現有形態的產業特性，讓相關產業決策者能夠看到好萊塢電影產業每個環節的意義，繼而思索未來發展的種種可能性，也希望這個研究能給國片市場的經營管理帶來一些參考價值。 分析研究的結果主要如下： 一、好萊塢電影產業成功的關鍵之一，在於其產出部份所面對的不僅是夠大的國內市場，還有可以為其帶來更多淨利的全球市場。 二、好萊塢電影產業在一開始就將電影設定為一種商業性產品，因此幾乎所有的投入價值單元(成本、演員、導演、科技、特效或獲獎消息等)，一直到產出面的產品(戲院電影、電視電影、有線電視電影、錄影帶、授權商品)進入各種通路，和授權商品廠商間的異業結盟等，皆和「行銷」有所關聯。 三、各種環境前提，包括了美國文化意涵在全球透過各種不同媒介的高度湛入，和美國在國際政治、經濟、學術、商業地位上的重要角色，也助勢好萊塢電影產業的蓬勃發展。 四、反觀台灣電影產業，既然本身在有限的市場下無法形成像好萊塢電影產業這樣的規模，就應該用一個宏觀的角度去找出自身在全球電影產業中的位置，尋找自己可以扮演的角色；既然無法掌握所有的投入價值單元，就應該就本身的優勢，挑選有競爭力的投入價值單元，全心投入，成為全球電影產業價值鏈中能夠出色的一部份。

本研究以策略管理理論「策略形態分析」法與「策略矩陣分析」法為基礎，發展出新的分析架構–「價值單元展開分析」法，並與策略矩陣整合成為策略系統模型。藉由個案研究，驗證此策略系統模型如何使管理者能更精確地衡量未來策略規劃之選擇，最佳化公司未來競爭策略方向。 筆者以個案探討新創科技公司在持續變動與競爭之產業中，競爭策略分析與規劃之方法。以3D感測產業作為分析與研究之個案產業，並以其中一新創科技公司–L科技公司作為個案探討之對象，提出一以新創科技公司為出發點，在衡量現有與發展未來競爭策略時，可供利用與權衡的分析方法。 「價值單元展開分析」法追尋理性與系統化思考，為公司導入嚴謹明確、量化、及標準化的度量衡工具，使公司得以更加周詳完備與深入地分析其條件前提，將策略最佳化。且此架構具高度延展性，得充分配合公司進行各種思考面向之分析。此外，「價值單元展開分析」法亦可完全結合與相容於「策略矩陣分析」法之中，形成易於溝通與同步的策略系統模型，利用此特點解決公司在策略規劃時可能遭遇之混沌與困難，將效率、效益、及效能用在得當之處，使公司未來發展更符合目標。 / This study investigates the methods of analyzing and planning competitive strategies, with a case study of a technology startup company – “L Company” in the 3D sensor industry. Based on strategy analysis and Strategic Matrix Analysis, this study developed a new analytic framework – “Value Unit Expansion Analysis” which is a systematic model integrated into Strategic Matrix Analysis. By verifying the systematic model through the case, this study proposed a more precise and optimization–capable method to form a company’s future competitive strategies. Value Unit Expansion Analysis is a clarifying, quantifying, and standardizing method for the company to pave the path for factor condition analysis and strategic optimization. The structure was designed with a high flexibility in correspondence to different considerations and changing aspects; it is compatible and can be built within Strategic Matrix Analysis. The systematic model is liable for communication and synchronization during the process of strategy planning and, therefore, setting higher efficiency, benefit, and utility for pertinent strategies that fit into companies’ goals.