漸進創新產品的發展策略—以不孕症藥品為例

Abstract

排卵輔助藥劑GnRH-agonist, Buserelin自1980年經行政院衛生署認可後，在台灣不孕症藥品市場上已行之有年。近年來出現一種新的排卵輔助藥劑GnRH-antagonist, Cetrorelix，有部份研究證實能較Buserelin有更短的療程，並可以減輕病患在治療上的痛苦；但是在懷孕成功率方面，有部分文獻是認為GnRH-antagonist高於Buserelin，但也有文獻指出這兩種藥物並沒有顯著的差異。 目前台灣對GnRH-antagonist在人工授孕方面的使用，似乎不能完全取代上市已久的GnRH-agonist，雖然我們不能完全了解是因為醫師的使用習慣或是其它因素所致。但在過去文獻的支持下，GnRH-antagonist療效似乎不會較GnRH-agonist來得低。 Cetrorelix在不孕症藥品市場中，可說是一種漸進創新的產品。有研究指出這類產品上市的風險會比全新產品的風險來得小。而對於新產品而言，在上市階段，產品的品質非常重要，尤其是藥品，療效與副作用更是所有醫師及病患考量的重點。 因此，我們以某試管嬰兒中心之60位病患之人體試驗之結果進行驗證(共分為三組，每組各20位病患，分別試用不同的排卵輔助藥劑)，並進一步發現在藥品療效與副作用皆無顯著之差異下，後進的類似廠商應該如何在產品品質及服務品質方面進行改善，以提升藥品銷售狀況。

After getting the approval from Department of Health in 1980, GnRH-agonist, Buserelin has been used for many years in Taiwan. Recently, here comes the new drug, GnRH-antagonist, Cetrorelix. Some researches suggested that GnRH-antagonist can make shorter cure duration, alleviate the patient’s pain during the cure duration and has the greater effectiveness on the pregnancy rate than that of GnRH-agonist. However, others suggested that there is no significant difference on cure effectiveness between these two drugs. In the past ten years, GnRH agonist played an important role in artificial reproductive technology (ART), it can control ovarian stimulation well, and help to get higher quality eggs to increase the pregnancy rate. But it also has high risks than that of GnRH antagonist. Recently, GnRH antagonist has been in the market. As to the usage rate of GnRH antagonist, it can not yet overtake that of GnRH agonist. Why can’t GnRH antagonist be used as the first line analogue for in-vitro fertilization (IVF) patients? Is it because of the cure effectiveness or the conservative attitude of doctor or because of other reason of clinical use? Cetrorelix is a kind of incrementally new product in infertility drug market. Some researches indicated that incrementally new product has the small risk than really new product do. Otherwise, the product quality is quite important in the early stage of launching, especially for pharmaceuticals. The curative effect and side effect is the relevant factors to doctors and patients. Therefore, this study was conducted on one cycle in 60 patients undergoing IVF programs to find the cure effectiveness and side effects by taking different treatment. And we found there is no significant difference on cure effectiveness and side effects between these two treatments. Under this situation, we give some market entry suggestions on product quality and service quality strategy for late entrant.