毕业设计-委托加工(cmo)方式在国内药企制剂产品进入国际规范市场中的角色定位.docVIP

摘 要 大量‘重磅炸弹药物’专利过期以及全球金融危机和巨额医疗支出给各国财政带来的巨大压力可以说是仿制药得以快速发展的根本原因。接下来5年，美欧日等发达国家医药市场增速将放缓至1%～4%，这很大程度上与大量高价专利药专利过期转而由平价仿制药替代，而新药上市速度明显放缓分不开的，预计2011年至2015年的五年间约1200亿美元的专利药销售额将由220亿美元的仿制药代替，净损失980亿美元。 过去的20年里，委托加工业务一直维持着两位数的增长，而这在接下来的5年里预计仍将持续一趋势。到2017年，全球药品委托加工业务预计将达到630亿美元，其中固体制剂的委托加工业务占比最大，预计将维持12.5％的年增长率，至2017年达550亿美元。 ‘医药企业通过国际认证，制剂产品取得美国或欧盟国家的上市资格，真正进入国际主流医药市场’被明确写在医药行业十一五和十二五发展规划中，而规范市场上市许可制度也为国内药企经济快捷的走出国门提供了一条相对低风险的道路。本文通过对国内药企现状的介绍，结合对两个国内药企实现制剂产品出口欧美市场典型实例的分析，论证了委托加工方式在现阶段国内药企制剂出口业务中所应起的重要作用。 关键词：制剂出口；委托加工；药事法规；通用名药 The Important role for CMO in the Current Finished Dosage Products Export Business of Domestic Pharmaceutical Companies Patent expire for a large number of ‘blockbuster drug’, as well as the global financial crisis and enormous financial pressure from huge medical spending, are considered as the major facotors to drive the generic drugs industry develop rapidly. Over the next five years, patent expiries will save payers in Developed markets $120Bn, offset by $22Bn of expected generic spending for these medicines, resulting in a $98Bn patent ‘dividend’in these years. Meanwhile, the launching speed of new drugs is also slowing down.The pharmaceutical industy growth rate for regulated market, such as US, western Europe and Japan will decrease to 1-4%. The CMO industry has experienced double-digit growth in the past two decades and that trend is expected to continue for the next five years. By 2017, the size of the global contract manufacturing market is expected to grow to about $63 billion，and solid dosage formulation remains the largest segment of the CMO industry by revenue. The solid dosage market is expected to expand over the next five years at an annual rate of 12.5% and as much as $55 billion will be spent by 2017 on CMO-based solid dosage manufacturing. ‘The pharmaceutical industry eleventh/twelveth five-year development planning’, issued by NDRC, clearly indicate the positive national policy for the Internationaliz