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艾昆纬(IQVIA):2026欧洲生物类似药竞争的影响白皮书(中译版)(42页).pdf

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1、White PaperThe Impact of Biosimilar Competition in Europe January 2026MAX NEWTON,Principal,Global Strategic Partners,IQVIA KELSEY STODDART,Senior Consultant,Global Supplier&Association Relations,IQVIAAURELIO ARIAS,Director,Global Thought Leadership,IQVIATable of contentsIntroduction 1IQVIA observati

2、ons 21.Pipeline 42.Commercial attractiveness 63.International competitiveness 94.Access inequality 105.Advanced planning 14Methodology 16Country and product segment KPIs 18Granulocyte-Colony Stimulating Factor(GCSF)18Anti-Tumour Necrosis Factor(Anti-TNF)20Insulins 22Oncology 24Parathyroid hormone(te

3、riparatide)26Ophthalmology 28Appendix 30EMA list of approved biosimilars 30List of biosimilars under review by EMA 36References 37About the authors 38Find out more 39 |1The 11th edition of the Impact of Biosimilar Competition in Europe report builds upon the perspectives from last years publication

4、and provides a forward-looking view on the upcoming opportunities and challenges for biosimilar competition in Europe.Biosimilars continue to play a critical role in the European healthcare system by generating savings for payers,creating headroom for innovation,and expanding access to biologic ther

5、apy for patients.Since the first biosimilar was launched in 2006,biosimilar medicines have become a core component of an effective healthcare system.However,the biosimilar pipeline signals future headwinds,which have been highlighted in previous reports and remain relevant today.The report consists

6、of novel observations on market conditions for 2025,and a streamlined set of Key Performance Indicators(KPIs)to monitor the impact of biosimilars in 23 European markets.Previous observations remain relevant and have been refined or referenced to align with the reports approach of sharing novel obser

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1. **生物类似物市场现状**:欧洲生物药占药品市场44%(2025Q3),生物类似物占5%,年增长率11%,趋于成熟。 2. **生物类似物缺口**:2032年前欧洲100种生物药将失去专利保护,79%无生物类似物在研,仅10%可能面临竞争,潜在错失1430亿美元(55%)全球销售额机会。 3. **监管简化影响**:EMA等机构拟取消生物类似物III期临床,或降低50%研发成本,但难以填补缺口,且国际监管不统一限制效益。 4. **区域竞争与准入不平等**:欧洲生物类似物市场比美国大55%,但西欧与中东欧患者治疗日差距达35%,后者需180亿欧元投资才能缩小差距。 5. **未来规划建议**:需通过早期指标(如专利到期跟踪、竞争预测)及生命周期规划(如价格监测、患者准入)优化生物类似物市场可持续性。
生物药竞争如何? 欧洲仿制药趋势? 药品市场缺口大吗?
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