国际重组蛋白药物的市场和研发趋势分析.docxVIP

最新 精品 Word 欢迎下载 可修改 国际重组蛋白药物的市场和研发趋势分析 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?2022,?which?is?66%?of?the?total?saleof?41?billion?for?the?whole?sector.?Year?2022?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?markettrend?and?for?the?strategic?planning?of?innovation.?Key?words:??recombinant?proteins?therapeutic,?market,?RD?trend本文中的重组蛋白药物也称rDNA药物，不包括重组疫苗、单克隆抗体药物（抗体药物的市场和研发趋势另有文章详述[1]）、检测用重组蛋白和生化提取的天然蛋白，也不包括仿制药物。重组蛋白药物虽然仅占全球处方药市场的7-8%左右，但是发展非常迅速，尤其到了21世纪其发展更是进入黄金时节，1989年的销售额为47亿美元，2022年为285亿美元，2021年达到347亿美元[2]，2022年约410亿美元，是1989年的9倍。相对小分子药物，重组蛋白药物生产条件苛刻、服用复杂和价格昂贵，但对于有些疾病的治疗是不可替代的。绝大部分重组蛋白药物是人体蛋白或其突变体，以弥补某些体内功能蛋白的缺陷或增加人体内蛋白功能为主要作用机理，其安全性显著大于小分子药物，因而具有较高的批准率，同时，重组蛋白药物的临床试验期要短于小分子药物，专利保护相对延长，给制药公司更长的独家销售时间[3]。这些特