藥物基因體學對生技醫藥產業生態影響之探討

Abstract

科技的創新常是造成產業生態改變的重要因素，而創新科技的管理更是企業是否能夠成功掌握新市場脈動的關鍵。無論是從企業內部建立創新能耐，或是從外部借重創新資源，皆考驗著高階經理人之遠見與經營策略。尤其是當新市場正在發展初期，企業如何運用競合策略來開拓市場機會，更是產業發展與企業成長之關鍵考量。 藥物基因體學（簡稱PGx）是研究人體基因如何影響個人對藥物反應之差異性的新興科學。Genentech用於治療乳癌藥物Herceptin的成功，顯示出應用PGx有助於新藥開發經濟效益的提升與個人化醫療之發展。然而，PGx營運模式仍處於發展階段，無論是在市場規模或產品最終應用上，皆充滿高度不確定性與挑戰。 本論文係以生技醫藥產業為研究範圍，探討PGx的應用對於生技醫藥產業之發展產生哪些潛在效益；並希望透過產業結構分析與競合策略等理論架構，來進一步解析PGx應用如何影響生技醫藥產業結構與競合動態。本研究係以產業層次分析為主，以理論輔助強化推論的邏輯性，並據以提出競合結構下攸關廠商的營運策略、以及相關產業發展政策之建議。 本研究首先從新藥開發價值鏈出發，就技術面、市場面、與法規面建立推論模型，並輔以文獻資料作為佐證，歸納得知PGx應用可產生「提升新藥開發之經濟效益」與「發展個人化醫療」等兩項潛在效益。接著，藉由PGx成功個案歸納出，PGx應用改變「產品開發模式」與「廠商競合模式」，並透過新藥開發價值鏈分析PGx商品化之成功關鍵與市場機會。最後，本研究透過Roche、Affymetrix、與ParAllele三個案之價值網分析，探討PGx賽局中各參賽者之策略考量。本研究發現，業內領導廠商對於PGx應用應以委外策略為主，而新進廠商積極採取PGx策略將具有先佔優勢。最後，本文分別針對實務面以及後續研究提出策略性建議。

Techology innovation is one of the critical factors triggering the emergence of new market opportunities, which results in the changes of industry landscape. Facing potential industry changes, a firm has to figure out how to strategically manage technological innovation in order to capture opportunities of value creation. Pharmacogenomics (PGx) is a field of knowledge dealing with how genes affect the way individuals respond to drugs. Genentech's Herceptin is the successful example of applying PGx-based approaches to drug development. The drug was approved around eight years sooner than the average blockbuster, with estimated US$35 million saving on the costs of clinical trials and an estimated US$2.5 billion on revenue generation during that eight-year period. Despite its promise to both the improvement of the efficiency of new drug development and the facilitatation of personalized medicine, PGx faces significantly technical, financial, and commercial challenges before it can be broadly applied to clinical practices. A final hurdle will be overcoming industry doubts that a business model exists for PGx. Overall, given the situation that pharmaceutical companies still have a dominant thinking on blockbuster drugs, the idea of creating a nitch market for a new therapeutic would be not so attractive. The purpose of this thesis is to explore what and how the potential impact of applying PGx in biomedical industry is, with a special emphasis on its impact on the co-opetition dynamics among various value-net players. First, we analyze what kinds of potential benefits result from PGx applications along the value chain of drug discovery. We found that PGx applications not only improve the efficiency of new drug development but also facilitate personalized medicine. Next, based on several successful cases, we further indicate that PGx applications could change both product development model and companies’ co-optition structure. To further discuss effective strategies responding to the development of PGx applications, we provide rather detailed analysis on the collaborations among Roche, Affymetrix, and ParAllele. Based on the case study, we propose that it would be an win-win collaboration between incumbents and PGx specialists in capturing value creation based on PGx applications. Strategic implications and policy suggestions are also discussed.