台灣生物相似藥廠商之市場進入策略—以泰福生技為例

生物藥品不僅為許多癌症、自體免疫等慢性疾病或罕見疾病提供了良好的治療效果，也是製藥產業發展最快的環節，市場需求快速成長，2018年佔全球整體藥品的28%，銷售額超過2400億美元。生物相似藥指的是藥廠對專利過期的生物藥進行模仿並製造出跟原廠生物藥在品質、安全性與療效性上有高度相似的藥品。隨著許多暢銷的生物藥品專利於2015-2022陸續過期，生物相似藥產業市場空間大、進入門檻高、藥品價格降價幅度低三大特點，吸引全球製藥產業紛紛投入生物相似藥領域，已成為近年來醫藥市場中蓬勃發展的新興產業。面對生物藥品價格高居不下，各國醫療支出負擔日益增加，因此近年各國來促成生物相似藥品法規的頒布以及建立加速審查等政策，以支持生物相似藥品加入市場競爭。這麼一來，盼能促使生物藥品的產業「替代品威脅」升高，產業競爭張力提升以降低生物藥品的價格，惠及更多病患。本研究彙整生物相似藥產業最新的全球發展現況與產業競爭分析。美國是全球最大的藥品市場，約佔生物藥品市場的50%，然而生物相似藥法規建置起步晚，市場滲透率低，直至2017年以後生物相似藥品的審核才有突破性的成長。因此美國是最具潛力也最受矚目的市場，各家廠商已摩拳擦掌，生物相似藥業競爭的時代即將來臨。本研究分析個案公司泰福生技之發展歷程、經營方式、資源與能力，並分析其優劣勢、事業/產品組合，以BCG矩陣評估其產品之競爭地位，並探討其資源與價值活動佈局，以及美國市場進入策略分析。

關鍵字

生物相似藥；市場進入策略；泰福生技；產品事業組合； BCG矩陣

並列摘要

Biologics are providing significant treatment outcome for patients with cancer and autoimmune diseases. With a growing demand for biologics, it’s the fastest-growing sector in the pharmaceutical industry, with total revenues reaching up to $240 billion USD, 28% of global pharmaceutical market share in 2018. Biosimilars are highly similar to the reference product (biologic) in terms of safety, purity and potency, but may have minor differences in clinically inactive components. With several of the world’s best-known biologics continuing to face patent expiration during 2015-2022, the biosimilars market is set for continued growth. In addition, barriers to biosimilar entry is unique and high without significant pricing reduction compared to generic. These characteristics are also attracted to more and more players joined into biosimilar development, and it’s become a burgeoning market. Aim to reduce health care cost, there are many governments around the world developed the policies and regulations to accelerate approval of biosimilars medicines and encourage biosimilar competition to increase product options, provide more access and deliver more safe, effective and lower-cost biosimilar alternatives to patients. This study is also provided updated global biosimilar industry overview and market competition analysis. United States is the largest pharmaceutic market in the world with 50% market share of biologics. However, since compared to EU, FDA was comparatively slow to issue final regulations for an approval pathway for biosimilars, and therefore biosimilar market adoption is slow. Until 2017, FDA has recently announced several polices to streamline and accelerate regulatory process. US market with robust market potential and is expected to have highly increase in competition in the near future. This study analyze a biosimilar firm- Tanvex BioPharma by reviewing company stakeholder, business strategy, resource and capability, and identify US market entry strategy and resource/value activities by utilizing tool of SWOT and BCG matrix.