我國學名藥外銷美國市場關鍵成功因素與競爭策略之探討

Abstract

本文挑選美國學名藥市場為研究啟始，以我國學名藥製藥產業發展為研究核心，嘗試探索下述問題： 美國學名藥市場發展趨勢，其產業價值鏈近十年發生何種變革？此變革對於台灣製藥企業的機會與挑戰。 面對美國學名藥產業鏈的變革，台灣製藥企業在美國學名藥市場的關鍵成功因素與競爭策略之探討。 採用之研究方法係以專家業者訪談、次級資料與文獻搜集，以及研究者在學名藥產業服務的觀察結果而來。應用之理論文獻聚焦於外部環境之中的總體環境分析、五力分析與國家環境分析，以及內部環境中的價值鏈分析、SWOT分析、事業競爭策略與商業模式分析。據以彙整爬梳美國學名藥市場發展變革、市場現況與價值鏈系統，分別聚焦於探索台灣學名藥市場在外部環境中，產業發展現狀況與國家競爭力，分析我國學名藥製藥產業內部環境在美國學名藥市場有何競爭優勢。訪談國內三家具指標性的上市櫃藥廠之管理階層，分別探討其在美國外銷市場的競爭策略與戰略地圖，嘗試分析整理其鍵成功因素為何。並嘗試將整理前述章節的分析結果，將美國學名藥市場產業價值鏈與台灣製藥廠商之發展現狀疊合分析，聚焦於外銷美國市場的整體策略。嘗試探索台灣學名藥產業在美國市場的利基點與競爭優勢所在。 綜合評析台灣學名藥產業整體競爭優勢與核心競爭力，分析在美國學名藥市場產業價值鏈的關鍵成功因素所在。 本文的研究發現如下： ㄧ、藥廠的轉型合併與整合係全球醫藥業產業鏈所面臨的最大改變。 二、由於政府政策積極降低藥品給付，加速審批學名藥上市，競爭更加激烈。 三、藥品零售通路商整併後市佔率日趨集中，學名藥廠不斷透過併購以擴大規模，市場集中度逐步提高。 綜觀本文研究，台灣學名藥製藥商在美國市場的關鍵成功因素與競爭策略如下： 本土、區域性或全球市場拓展，應採外部併購策略。 未來學名藥廠將面臨競爭加劇、獲利率降低的市場，各藥廠間的併購趨勢也將持續進行。無論是取代或收購競爭對手，獲取新的製藥能力與市場，亦或者是整併與收購上游原料藥供應鏈都是可行的方向。 產品面應採取內部商品集中差異化策略，生產利基型藥品。 大型學名藥廠也開始在產品發展策略上逐漸轉型，朝向高附加價值產品發展，如技術門檻較高的特色學名藥(Specialty generics)、生技學名藥(Biosimiliar)及超級學名藥(Super generics)等，以成為具有專業劑型開發技術的開發型藥廠。 積極推動利基型的學名藥品之開發，才能夠在高度競爭的市場中展現競爭優勢。

This study is centered around the development of Taiwan’s generics manufacturing, with the U.S. generics market as a starting point. Major research questions are the following: 1. Trends occurred in the development of U.S. generics market: What changes have taken place within the industry’s value chain over the past decade? What opportunities and challenges have been brought about by these changes for Taiwan’s pharmaceuticals? 2. Given the changes in U.S. generics industry chain, what are the keys to success and competitive strategies for Taiwanese pharmaceuticals in the U.S. generics market? Methods adopted by this study include experts and industry interviews, secondary data and literature review, and the author’s observation working in the generics industry. The foci of scholarship engaged revolves around PEST, Porter’s five forces and national environment analyses of the external environment, as well as value chain, SWOT, corporate competitive strategy and business model analyses of the internal environment. Through this process, this study maps out changes throughout the development of the U.S. generics market, its status quo and its value chain system, explores the state of the industry and national competitiveness of Taiwan’s generics market in the external environment, and analyzes the competitive advantages that exist within the internal environment of the Taiwanese generics industry in the U.S. generics market. This study also interviews executives of three iconic, publicly listed Taiwanese pharmaceuticals, and explores their respective competitive strategies and strategy maps in the U.S. export market, in an attempt to analyze the key factors of their success. This study also attempts to use such analysis in a further overlay analysis of the U.S. generics market value chain and the state of Taiwanese pharmaceuticals, in order to explore the niches and competitive advantages of Taiwanese generics industry in the U.S. market with a focus on the overall strategy of exporting to the U.S. Furthermore, this study provides an overall commentary on the competitive advantages and core competitiveness of Taiwanese generics industry, as well as an analysis of the key factors of success in the U.S. generics market value chain. Findings made by this study are as follows: 1. The greatest change for the global pharmaceutical value chain has been the transition, merger and integration of individual pharmaceutical companies. 2. Competition has intensified as a result of policies aiming to lower reimbursement and speed up generics approvals. 3. Market concentration has increased, as a result of mergers and acquisitions, both between retail distributors and between generics companies. Overall, this study suggests the key factors of success and competitive strategies for Taiwanese generics industry in the U.S. market are the following: 1. External acquisition should be the approach in expanding local, regional or global market. The generics industry will be confronted by a market with increased competition and decreased profit margin, and the trend of M&As between individual companies will also continue. Thus, replacing or acquiring competitions, either by acquiring new manufacture capacity and market or by integrating with and acquiring API supply chains, is a viable approach. 2. Internal focus and differentiation strategies should be employed in term of product development to produce niche drugs. Major generics companies have now begun to change their strategies toward products of greater added value, such as specialty generics, biosimilar and super generics with greater technological requirement, in a bid to become research-based pharmaceuticals with technologies to develop patented dosage forms. To conclude, for Taiwanese generics, competitive advantages may be acquired only through active efforts in the development of niche generics.