精準醫(yī)療是一種基于病人特定分子標(biāo)志物的醫(yī)療模式,不同于目前針對一般病人的循證醫(yī)學(xué)模式.簡要介紹了精準醫(yī)療的發(fā)展歷史和美國的精準醫(yī)療計劃,提出對制藥行業(yè)的挑戰(zhàn)主要在于:新藥產(chǎn)品研發(fā)的復(fù)雜程度加大、較小的市場容量下研發(fā)投入難以回報、配套政策的滯后,給制藥行業(yè)帶來的機會在于:疾病細分導(dǎo)致藥物創(chuàng)新需求增加、老藥和失敗藥物面臨重生的機遇、中小企業(yè)競爭的優(yōu)勢上升、延伸產(chǎn)業(yè)發(fā)展空間巨大,并針對性地提出了發(fā)展策略和建議.

Precision medicine is a medical model based on the specific molecular markers of the patients, and it is different from the evidence-based medicine for “average patient”. The histories of precision medicine and “precision medicine initiative” of USA were introduced briefly. It is suggested that the possible challenges for pharmaceutical industry including the complexity of the new product development, the investment return bottleneck because of market capacity, and the constraints from related policies. The opportunities for the pharmaceutical industry will be the large number of diseases for drug innovation, rebirth chance for failure or older drugs, more competitive advantages for the small and medium sized enterprises, and further space for industrial development. Several suggestions are targeted given.