盘点2021:近10年世界新药研发与药品供求关系发展

Review 2021:Development of World′s Innovative Drugs R&D and Drug Supply-Demand Relationship in Recent Ten Years

目的回顾分析2021年世界创新药物发展情况并展望未来。方法梳理总结2021年美国、欧盟和日本三大医药板块的新药成绩和研发特点,比较近10年批准上市的新分子实体和生物大分子药物的数量;从世界“创新药-仿制药-非处方药-特殊药”结构格局分析仿制药、临床需求与快速通道审批新药的发展现状与挑战。结果与结论近两年,新冠肺炎疫情的持续,给世界经济带来重大影响,全球医药市场竞争愈加激烈,企业对新药研发投入不断增加,创新药研发将出现新的市场机会。近10年,批准上市的新分子实体药物的数量明显高于生物大分子药物。仿制药发展是世界合理的药物结构格局未发生变化,虽然创新药是体现国家创新能力的主体,但仿制药仍是世界民生需求的主体。展望医药创新发展,未来5年发展的基本格局不会发生明显改变,创新投入居高不下与回报率逐年降低的现象难以改变;必须重视药物研发路径的创新发展;必须认识新药研发复杂而漫长的过程中,需要引入商业市场机制,而商业市场发展的实现需要遵从临床需求;必须下大力气重视创新临床路径,降低临床投资成本,迫切需要使用人工智能(AI)等创新技术来改进新药研发过程;为满足民生需求,各国政府要从国际战略高度提高认识,推进仿制药健康发展。

Objective To review and analyze the development of the world's innovative drugs in 2021 and to look forward to the future.Methods The achievements and research and development(R&D)characteristics of new drugs in the three pharmaceutical sectors in the USA,the European Union and Japan in 2021 were summarized,and the number of new molecular entities(NMEs)and biological macromolecular drugs approved for listing in recent ten years were compared.The development status and challenges of generic drugs,clinical needs,and fast track for approving new drugs were analyzed based on the world structural pattern of"innovative drugs-generic drugs-OTC drugs-special drugs".Results and Conclusion In the past two years,the continuous development of the coronavirus disease 2019(COVID-19)epidemic has had a major impact on the world economy,which led to increasingly fierce competition in the global pharmaceutical market.With the increasing investment of enterprises in new drug R&D,new market opportunities will appear in innovative drug R&D.In recent ten years,the NMEs approved for listing is significantly more than biological macromolecular drugs.The development of generic drugs is a reasonable drug structure pattern in the world,and it has not changed.Although innovative drugs are the main body of national innovation ability,generic drugs are still the main body of people's livelihood needs in the world.Looking forward to the development of pharmaceutical innovation,the basic pattern of development will not change significantly in the next five years,and the phenomenon of high investment in innovation and decreasing rate of return year by year is difficult to change.We must pay attention to the innovative development of drug R&D pathways,recognize that commercial market mechanism needs to be introduced during the complex and long process of new drug R&D while the realization of commercial market development needs to comply with clinical needs.We must also pay attention to innovative clinical pathways and reduce clinical investment costs,and urgently need to use innovative technologies such as artificial intelligence(AI)to improve the new drug R&D process.Governments should raise awareness from the height of international strategy and promote the healthy development of generic drugs to meet the people's livelihood needs.