评估单克隆抗体创新市场中的度:基于专利的研究
André Soares Motta-Santos1,2, Leonardo Costa Ribeiro1, Jeff Gow2
1Center for Development and Regional Planning (CEDEPLAR), Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Minas Gerais, Brazil.
PloS one
|March 27, 2025
概括
单克隆抗体 (mAb) 创新市场显示中等度,超过化学药物的度. 主要参与者和高收入国家主导了 mAb 开发和专利战略.
科学领域:
- 生物技术和制药创新 生物技术和制药创新
- 知识产权分析知识产权分析
- 医疗保健市场动态 医疗保健市场动态
背景情况:
- 单克隆抗体 (mAbs) 在医疗保健治疗中具有很高的疗效和安全性,自20世纪80年代末以来推动了市场的大幅增长.
- 尽管成本高昂,mAbs的治疗潜力导致了全球市场的快速扩张.
- 了解市场度对于评估生物制药领域的创新环境至关重要.
研究的目的:
- 通过使用专利数据,对单克隆抗体 (mAb) 创新的市场度进行定量分析.
- 评估全球技术传播战略和mAb行业的创新趋势.
- 为了比较mAb市场的度与化学药物创新的度.
主要方法:
- 使用赫芬达尔-希尔施曼指数和度比率进行定量专利分析.
- 线性回归和核心密度图的应用,用于创新和传播分析.
- 数据来源于FDA注册的mAb专利 (IQVIA数据库),抗体学会,紫色书和色书到2019年的数据.
主要成果:
- mAb创新市场对一般专利的集中度适度,对优先专利的集中度低.
- 许多专利家族产生了更多的后代专利,但与化学药物相比,它们在更少的国家被申请.
- 关键的创新者包括罗氏,PDL,希望之城,Celltech,AbbVie,阿姆根,诺华,GSK,Biogen,BMS,Regeneron,J&J和AstraZeneca,他们的专利通常集中在mAb生产方法上.
结论:
- 单克隆抗体 (mAb) 创新市场比化学药品市场更加集中.
- 在mAb开发领域的专业知识和创新集中在少数国家内,并由来自高收入国家的关键参与者主导.
- 对于mAbs的专利策略,强调后代代代而不是广泛的国际申请,与化学药物专利趋势形成鲜明对比.
更多相关视频
07:25In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
10:50Purification and Analytics of a Monoclonal Antibody from Chinese Hamster Ovary Cells Using an Automated Microbioreactor System
Published on: May 1, 2019
相关概念视频
01:31Hybridoma Technology
Hybridoma technology is used for the large-scale production of monoclonal antibodies. Monoclonal antibodies bind to only a single antigenic determinant or epitope. Such antibodies are used in research, diagnostics, and disease therapy. The hybridoma technology established in 1975 by Georges Köhler and Cesar Milstein was awarded the Nobel Prize in Medicine in 1984 for revolutionizing research and therapy.
Hybridoma Selection
Commonly used fusion techniques — electroporation, polyethylene glycol...
Hybridoma Selection
Commonly used fusion techniques — electroporation, polyethylene glycol...
01:28Drug Products: Biologics, Biosimilars and Interchangeables
Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...