台灣製藥廠以新劑量劑型、新使用途徑、新複方或國際學名藥為開發新產品模式之可行性

Abstract

台灣當前藥品產業市場因為總額預算的實施而成長受限，但出口國 外市場前，必須先能在台灣本地成功上市，本土製藥公司有志於發展製藥事業與技術的公司面臨產品開發的困境，除了在台灣上市第一個無專利的國際學名藥之外，新劑量劑型、新使用途徑、新複方類型的新藥是大家認為是一個相當不錯的機會，不僅可建立相當的專利技術門檻，也可針對病患需求創造產品差異化，避免單純的價格競爭，所以國際型大藥廠在創新型新藥開發困難的情形之下也積極推出此類型產品，延長產品生命週期。 但單獨在台灣開發這類型產品的回收可行性如何？以目前台灣產 業價值鏈的參數調整，透過NPV 與rNPV 報酬的計算來判斷專案是否 可行，不考慮風險的NPV 當然比較單純，但是開發專案的起始應更審慎評估，尤其是採用比較嚴格保守的rNPV 計算發現，從二、三期臨床試驗開始發展新劑量劑型、新使用途徑、新複方藥時，產品未來淨營收規模需要達新台幣七億一千萬以上才有開發的價值，目前在台灣單一市場上很難找到這樣的產品；若透過產品組合的優勢下降行銷費用或臨床試驗設計下降病人數時，仍無法在三億淨營收預估下達成開發可行性。而台灣無專利的第一個國際學名藥產品上市時通常只要求執行一定病人數的三期臨床，被認為是目前單考慮台灣本地市場規模較小之下，最可行的方案，但是經rNPV 的計算發現，預估淨營收規模達一億五千萬以上才具有開發價值；若透過產品組合的優勢下降行銷費用或臨床試驗設計下降病人數時，也要一億零五百萬以上才有回收開發的可行性。但是開發公司必須謹慎的是，若開發期延長或病人數增加之下，很容易使原本具開發價值的專案轉變為虧損狀態。 而且我們在產業競爭分析中也了解到，除了製藥公司本身的競爭策略與形成之外，政策整合對於已聚焦的製藥公司具有高度影響，以適當的標準審理新劑量劑型、新使用途徑、新複方或國際學名藥產品，縮短開發期，使得原本就極少數具開發價值的產品能把握市場機會。

The Growth rate of Taiwan pharmaceutical market is limited since the global budget conducted. Products will be developed and launched successfully in Taiwan market before exported to foreign market. Not only new strength、new formulation、new application route and new combination but also first launched global generics are good opportunities for Taiwan pharmaceutical companies which intent to develop the tech. and business. They can build up patent barrier, create product differentiation and prolong product life cycle. Big Pharma also launch these kinds of products when first-in class products are rare to develop successfully. What about the payoff of these new strength、new formulation、new application route、new combination and 1st launched global generics drugs in Taiwan? According to the reference of Taiwan pharmaceutical, we evaluate them by risk-adjusted net present value (rNPV) and NPV calculation. In new strength、new formulation、new application route and new combination products strategy, the product net revenue has to be over NTD710million to achieve developmental value from initial phase 2 and 3. Such kind of candidates is hard to find out in Taiwan single market. If we reduce the marketing cost or patient numbers in clinical trial, it still not to be valuable when net revenue is NTD300million. 1st launched Global generic products are considered as available candidates in single and smaller Taiwan market because global generics only need one phase 3 generally. After rNPV calculation, the project is valuable when revenues will achieve NTD150million. If we reduce the marketing cost or patient numbers in clinical trial, it will be valuable when net revenue is over NTD 105million. Pharmaceutical companies shall be careful to check the value when developing stage prolonged and patients enrollment increased. In competition model analysis, we find out the integration between governments or policy is critical rather than the individual competition strategy. The projects will turned into un-valuable and lose the opportunities of market when governments evaluate the documents in globally highest benchmarking regulation and delay the launching schedules.