製藥產業專業分工與新興經營模式探討

Abstract

面對日益競爭的全球藥物市場，各大藥廠莫不投入大量的研發資源，但卻未能顯示在每年的創新藥物數量上，在內部創新藥物研發產生創新缺口，而大量暢銷藥物又面臨專利到期的雙重壓力下，為了分散研發風險、對暢銷藥物的過度依賴以及維持成長率，愈來愈多的製藥大廠積極的尋找合作夥伴，促進了產業價值鏈的分工，出現了專業的生技公司、臨床試驗公司等提供藥物開發過程中特定階段的產品加值工作，透過共同承擔風險與分享利潤的分工體制已逐漸成型。 本研究運用產業分析、商業模式的理論邏輯歸納近年來製藥產業市場的動向，以質化的分析加上交易成本理論輔助強化推論的邏輯性，深入探討以下問題： 1. 製藥產業專業分工與新興經營模式出現的原因以及如何運作？ 2. 製藥產業進行專業分工的同時，產生的效益及可能面對的問題為何？ 3. 製藥產業專業分工模式對於整個製藥產業的影響為何？ 本研究由當今製藥產業經營趨勢著手，以晶圓代工模式的概念應用於製藥產業經營上，探討製藥產業經營所面臨的問題與挑戰。依市場上所得資訊分析透過製藥產業專業分工的好處以及執行上其他相關問題，並以製藥專業代工模式和晶圓專業代工比較，比較兩者在營運上的異同。。而後以Anchen Pharmaceutical Co.為例，說明現今市場上進行市場專業化的廠商的經營模式。最後，本研究提出以下結論： 製藥產業的成本壓力和風險分攤考量促進了專業代工模式如CRO、CMO的興起，而製藥公司為了降低風險而釋出產品的過程，讓專業藥廠的經營模式興起。市場專業化公司如專業藥廠模式趨向整合，與整合型藥廠的界線愈來愈模糊；而活動專業化公司則趨向分工，但逐漸發展至提供One-Stop Shopping的完整服務以降低交易成本。CRO與CMO提供了大型製藥廠高成本、高風險以及產能不足的解決方案，但同時成為專業藥廠與生技公司夥伴而增加了競爭對手，產業之間形成彼此既競爭又合作的新產業生態。製藥產業專業分工已逐漸形成，不過涉及智慧財產權、專利權與產業特性發展速度較電子產業緩慢。

For many decades, pharmaceutical R&D has been a fully integrated process where the pharmaceutical company owned and conducted almost every single step of the R&D value chain. Over the recent past, however, the productivity in pharmaceutical research and development faces intense pressure. R&D expenditures of the companies have almost tripled for a decade ago. At the same time, the number of new drug approvals has droped. To share R&D risks and decrease the cost, pharmaceutical companies start to collaborate with external partners and outsouce activities during the innovation process. These partners include contract research organization(CROs)、contract manufacturing organizations(CMOs), or any other organization that provides pharmaceutical company then reimburses the service provider with a fee in return for the services received. It accelerates the vertical distegration in the pharmaceutical industry. Specifically, the present study tries to answer the following three questions: 1. What are the reasons of vertical distegration of the pharmaceutical industry and how it works? 2. What is the vaules of vertical distegration in the pharmaceutical industry? 3. What effects will the vertical distegration ito the pharmaceutical industry? This research concludes that the vertical specialization emerged in ther pharmaceutical industry dues to traditional large pharmaceutical companies seeks external partners tohare R&D risks and cost. During this process, specialty pharma emerged by “out-licensing product” from large pharmaceutical companies. The pharmaceutical industry shifts from vertical integration to distegration gradually, but, due to industrial characters, the shift process is relatively slow. Besides, the CROs and CMOs provide the opportunities to biotechnology companies to market their drugs. Result in collaborated and competive situation in the pharmaceutical industry.