Ecker Dawn M, Jones Susan Dana, Levine Howard L
a BioProcess Technology Consultants, Inc. ; Woburn , MA USA.
MAbs. 2015;7(1):9-14. doi: 10.4161/19420862.2015.989042.
Since the commercialization of the first therapeutic monoclonal antibody product in 1986, this class of biopharmaceutical products has grown significantly so that, as of November 10, 2014, forty-seven monoclonal antibody products have been approved in the US or Europe for the treatment of a variety of diseases, and many of these products have also been approved for other global markets. At the current approval rate of ∼ four new products per year, ∼ 70 monoclonal antibody products will be on the market by 2020, and combined world-wide sales will be nearly $125 billion.
自1986年首个治疗性单克隆抗体产品商业化以来,这类生物制药产品有了显著增长。截至2014年11月10日,已有47种单克隆抗体产品在美国或欧洲获批用于治疗多种疾病,其中许多产品也已在其他全球市场获批。按照目前每年约四种新产品的获批速度,到2020年将有大约70种单克隆抗体产品上市,全球总销售额将接近1250亿美元。