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Evaluate:2026年孤儿药市场展望报告:销售、竞争与监管趋势(中译版)(32页).pdf

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1、Click here or press enter for the accessibility optimised version2026 OrphanDrugs ReportA safe(r)passage amidstormy waters?DraftClick here or press enter for the accessibility optimised versionPassage AmidStormy Waters?Orphan drug developers face atemperamental FDA and must battle forattention with

2、blockbusters in obesity andother common diseases.But orphan drug salestrajectories remain strong,buoyed byimportant policy wins.By Melanie Senior,with data analysis by Andreas HadjivasiliouDraftDespite policy and pricing turmoil across thepharma industry,sales of orphan drugs continueto rise steadil

3、y.They will account for over 21%ofall prescription pharmaceutical sales by 2032,according to Evaluate forecasts,up from 15%in2022.Drugs for rare diseases will generate over$400 billion of the almost$1.9 trillion inprojected global prescription drug sales in 2032 about the same as the entire prescrip

4、tionmedicines market twenty years ago.A safe(r)passage amid stormy waters?Orphan drug developers face a temperamental FDA and must battle for attention with blockbusters inobesity and other common diseases.But orphan drug sales trajectories remain strong,buoyed byimportant policy wins.Orphan drugs w

5、ill account forover 21%of all prescriptionpharmaceutical sales by 2032.Figure 1:Worldwide Orphan Drug Sales&Share of Prescription Drug Market(2022-32)The top eight orphans will each sell over$6billion worldwide in 2032.Category leaderDarzalex(daratumumab),for multiple myeloma,will reach almost twice

6、 that thanks in part to asub-cutaneous formulation,which doubles thefranchises effective lifespan.An orphan-friendlytweak to the Inflation Reduction Act(IRA)legislation in 2025 also helps.Darzalex secures sponsor Johnson&Johnsonsposition a-top the biggest companies byorphan drug sales,with almost$31

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1. **市场增长**:孤儿药销售额将持续增长,预计2032年占全球处方药销售额21%(约4000亿美元),高于2022年的15%。 2. **企业表现**:强生(Darzalex)领跑孤儿药销售(2032年预计309亿美元),Argenx(Vyvgart)增速最快(CAGR 22%)。 3. **政策支持**:2025年《通胀削减法案》修订扩大孤儿药豁免范围,罕见病儿科优先审查券(PRV)延期至2029年。 4. **研发趋势**:小分子药物在孤儿药管线中占比近半,中国生物技术公司崛起(FDA孤儿药指定占比从5%升至15%)。 5. **挑战**:FDA监管不确定性增加,部分基因疗法/罕见病药物遭拒;GLP-1等“重磅药”可能挤压孤儿药市场份额。
孤药市场如何? 政策影响几何? 未来趋势怎样?
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