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首页> 外文期刊>BioProcess International >Using Technology to Overcome Bioprocessing Complexity:Advanced Concentration and Analytical Technologies Accelerate Development and Manufacture of mAbs, Vaccines, and Biosimilars
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Using Technology to Overcome Bioprocessing Complexity:Advanced Concentration and Analytical Technologies Accelerate Development and Manufacture of mAbs, Vaccines, and Biosimilars

机译：使用技术克服生物加工的复杂性：先进的浓度和分析技术可加速单克隆抗体，疫苗和生物仿制药的开发和生产

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摘要

Unlike chemically synthesized drugs, whose structure is known and reproducible, biological drugs are derived from living cells and are sensitive, complex mixtures requiring cutting-edge biological technologies for their production. The growing importance of biosimilars in recent years is reflected in a corresponding rise in market value. The value of the global biologic therapeutic drug market reached approximately US$230 billion in 2014 and, according to BCC Research, will increase to nearly $390 billion by the end of 2019. This corresponds to a compound annual growth rate (CAGR) of just over 10%. BCC Research also estimates that biosimilars accounted for nearly $2.0 billion of the biologic therapeutic drug market in 2014 and that this segment is growing at a CAGR of 15%. Key drivers for the growth of biologic therapeutic drugs include the aging of the global population and the worldwide increase in chronic diseases; biologic drugs are very effective for treating arthritis, diabetes and heart diseases. Rising wealth and improving healthcare systems in emerging regions are also having a positive impact on the demand for biopharmaceuticals. The higher growth rate for biosimilars is due to the fact that numerous blockbuster monoclonal antibody (mAb)-based drugs will be off patent by 2020.
机译：与化学合成药物（其结构已知且可重现）不同，生物药物源自活细胞，并且是敏感，复杂的混合物，需要尖端的生物技术来生产。近年来，生物仿制药的重要性日益提高，这反映在市场价值的相应提高上。根据BCC Research的数据，2014年全球生物治疗药物市场的价值约为2300亿美元，到2019年底将增长到近3900亿美元。这相当于10余倍的复合年增长率（CAGR） ％。 BCC Research还估计，2014年生物仿制药将占生物治疗药物市场的近20亿美元，并且这一细分市场的复合年增长率为15％。生物治疗药物增长的主要驱动力包括全球人口的老龄化和全球慢性病的增加;生物药物对于治疗关节炎，糖尿病和心脏病非常有效。新兴地区财富的增加和医疗体系的改善也对生物制药的需求产生了积极的影响。生物仿制药的较高增长率是由于以下事实：到2020年，许多基于重磅炸弹单克隆抗体（mAb）的药物将不再获得专利。

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