国际重组蛋白药物与市场和研发趋势分析.docVIP

国际重组蛋白药物的市场和研发趋势分析 吴卫星1?张???毓2?王小宁3??詹启敏11、分子肿瘤学国家重点实验室?北京1007302、北京大学医学部免疫系?北京?1000833、华南理工大学生物科学与工程学院?广州510640摘要 从1982年美国批准第一个重组蛋白药物（重组人胰岛素Humulin）上市，至今已经整整四分之一个世纪了。重组蛋白药物虽仅占全球处方药市场的7-8%左右，但却是增长最快的一类。目前，共有82个重组蛋白药物用于临床，其中“重磅炸弹”15个，占总数的18%;2005年重组蛋白药物销售总额约410亿美元，“重磅炸弹”销售额合计约270亿美元，占总额的66%。2006年，美国和欧洲批准了第一个肺吸入型胰岛素上市；欧洲批准了第一个由转基因羊生产的重组人抗凝血酶用于临床，并批准了第一个重组蛋白仿制药物上市。重组蛋白药物市场已经从蛹发育为美丽的蝴蝶，但是，这只蝴蝶能够美丽多久，还受到多种因素的制约。本文以美国和欧洲重组蛋白药物市场为主，采用市场细分的方法，从重组蛋白药物种类的销售额入手，分析了市场及研发趋势，将对我们判断市场走向、提供创新思维和制定创新战略有着实际的参考价值。关键词：重组药物??市场?研发趋势作者简介：吴卫星，男，博士，合作研究教授?wuweixing@Market?Analysis?and?the?RD?Trend?for?Recombinant?Protein?TherapeuticsWU?Wei-xing1,?ZHANG?Yu2,?WANG?Xiao-ning3?ZHAN?Qi-min11、State?Key?Laboratory?of?Molecular?Oncology??Beijing?100730,?China2、Department?of?Immunology,?Peking?University?Health?Science?Center?Beijing?1000833、School?of?Bioscience?and?Bioengineering,?South?China?University?of?Technology?Guangzhou?510640The?first?of?its?kind?drug,?recombinant?human?insulin?(Humulin)?received?administrative?approval?in?America?in?1982.?A?quarter?of?a?century?later,recombinant?protein?drug?represents?a?sector?undergoing?the?fastest?growth,?accounting?for?7-8%?of?today’s?market?of?prescription?drugs.?Among?the?82recombinant?proteins?therapeutics?licensed?so?far,?18?are?block-busters?withthe?annual?sale?of?27?billion?dollars?in?2005,?which?is?66%?of?the?total?saleof?41?billion?for?the?whole?sector.?Year?2006?observed?several?landmark?eventsin?this?field,?including?the?approval?of?the?first?inhalational?insulin?by?USand?EU,?and?the?marketing?of?the?first?recombinant?drug?produced?in?transgenicanimals?and?the?first?generic?recombinant?drug?in?EU.?While?it?is?blooming,how?long?will?the?blossom?last??In?this?article,?we?dissected?the?market?ofthe?recombinant?protein?therapeutics?launched?in?US?and?EU?by?their?group?sale.In?addition,?we?reviewed?the?ongoing?research?and?development?efforts?in?thisfield.?Such?information?should?be?of?help?for?better?judgment?of?the?