聚焦糖尿病治疗药物

Spotlight on Antidiabetic Drugs

糖尿病药物市场是当前制药行业最具价值和发展最快的市场之一,拥有大量需要药物干预的糖尿病患者。自从胰岛素被发现以来,制药公司研发了一大批具有数十亿美元销售额的药物。由于人们更倾向于久坐的生活习惯,世界卫生组织预测糖尿病患者数量将呈爆炸性增加,也极大地提高了大批新型重磅炸弹级抗糖尿病药物问世的几率。在新型药物(包括传统的胰岛素类似物)稳固地位的驱动下,糖尿病药物市场被预测将在未来5年内翻倍。本综述分析了当前市场动态,以及越来越不利于市场发展的管理环境对产品发展的影响。当创新药物面临着国家监管部门越来越多的审查,胰岛素类生物仿制药的法规也即将颁布,从长远来看,将在无形中削弱糖尿病市场。此外,还讨论了胰岛素仿制药进入市场带来的重要挑战,并对其治疗作用进行了评价。

The diabetes market is currently one of the biggest value and fastest growing in the pharma industry,fueled by the vast number of patients needing pharmaceutical intervention to control their disease. Since the discovery of insulin,the industry has developed a raft of multibillion dollar-selling drugs to treat the disease. The future explosion in patient number predicted by the World Health Organization（WHO）,as the global population leads a more sedentary lifestyle,offers ample opportunity for the development of new blockbuster antidiabetic agents. Driven by these new products,as well as entrenched insulin analogs,the value of the market is forecast to almost double in the next fi ve years.This review looks at current market dynamics and the effect that an increasingly hostile regulatory environment is having on product development. While novel drugs face increased scrutiny by the national regulatory agencies,legislation allowing the development of insulin biosimilars is just around the corner and may shape the diabetes market beyond recognition in the long term. In this review,we discuss the key challenges in bringing insulin generics to the market,and evaluate the magnitude of the threat.