只差一步,生物药将完胜化学药
根据在研药物来源的不同,可将全球在研药物分为化学合成药物、生物制品和天然来源药物三类,也可将这些类别进一步细分。
毫无疑问,化学合成药物仍是候选药物的最主要来源,历年来该类药物占比均超过50%。但是,目前其增长速度却在逐年降低,2017年化学合成类小分子药物的数量为7855种,增幅仅为4.2%,远低于全球在研药物数量的整体增幅(8.4%)。
排名居第二位的药物类别为抗体蛋白类生物药,2017年其增幅高达15.1%。其他生物类药物同样表现不俗,2017年蛋白类、细胞疗法类和肽类生物药物的增幅分别为24.1%、67.1%和27.0%。在生物类药物更为具体的细分类别中,同样观察到了类似明显的增幅。
天平向生物药倾斜
对于制药行业在宏观层面是倾向于化学小分子药物还是生物药物发展这一问题,业内已经讨论多年。正如我们所看到的,化学小分子药物依然占据主导地位,但生物制品的增速亦不能小觑。
将在研药物分为生物技术药物和非生物技术药物两大类,通过对1995~2017年相关研究数据进行分析后发现,非生物技术药物,尤其是传统的新化学实体药物的地位正在动摇。生物技术药物自20世纪90年代出现,之后一直保持稳定增长,自2010年以来,生物制品的发展在一定程度上得到了推动,但增长仍较为缓慢。2016年以来,生物技术药物出现了较为迅猛的加速发展势头。
截至目前,生物技术药物在全球在研药物整体中的比例已增至37.8%,而2016年该比例为33%。
生物技术药物近两年来的跳跃式增长尤为引人注意,这些数据变化也表明,整个药物研发产业的天平似乎正在向生物技术药物倾斜。
克服给药方式,生物药将完胜化学药
物制品虽然具有更好的疗效和特异性,但其给药方式相对不便,且成本相对更高。所以,在未来生物技术药物和化学小分子药物竞争中,化学小分子药物仍将占有一席之地。
目前国外已有在研的植物细胞表达的口服生物药物,相信不久的将来,随着生物技术的发展及制剂技术的发展,低成本口服生物药的上市将成为可能,到那时,生物药将完胜化学药。
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