生物相似藥的合約代工製造商業模式探討

Abstract

隨著各國政府部門及法規單位的支持推動，生物相似藥產業近年來蓬勃發展、也帶動全球醫藥市場對於生物相似藥品需求量快速成長。為了補足全球生物相似藥品供給上的缺口，合約委託代工製造生物相似藥的商機正不斷的擴大。 台灣生技業者的現有規模和設備資源遠不及於國際間的大型製藥企業。在全球激烈的兢爭環境中，國內廠商如何於生物相似藥委託代工製造產業建立出穩固的獲利模式？在論文裡闡述相關的市場趨勢、產業結構分析，嘗試找出其中成功的關鍵要素並摘要整理如下供國內廠商參考。 1. 尋找具有開發價值的產品線和代工契約 2. 提供機動性的產能配置 3. 生產流程和產線設備的精進和改良 4. 發展合約研究開發和生產製造併行模式 5. 找尋新利基市場：生物相似藥物檢測分析和製程品質驗證 6. 跨領域的產業技術整合開拓更多的市場和商機

The growth of biosimilars is blooming under government instructions and the following health market demands are also increasing rapidly. Therefore, the contrast manufacturing organizations in biosimilars and other biologics become more popular in global industry for the increasing production capacity requirement. How to engage into the biosimilar developing tendency and set up ideal business model is the main concern in Taiwan under smaller company scale and current resource limitation. In the thesis, I would analyze the interaction between biologic/biosimilar pharmaceuticals and the related manufacturing suppliers. Try to seek the key success factors of contrast manufacturing organizations in biosimilar industry for Taiwan biotechnology companies as the following suggestions: 1. The selections of high-profit pipelines in manufacturing contrasts 2. Arrange the flexible and rapid-response production supply chains 3. Improve the synthesis processes and equipment steadily for the better performance and efficacy. 4. Explore contrast manufacturing organization into contrast manufacturing & developing organization. 5. Notice the unmet needs of analytical & quality control markets in biologic/biosimilar industry. 6. Seek the possible business cooperation: multi-technology integration might create blue-ocean strategy in higher market value.