inThought Research, Wolters Kluwer Pharma Solutions, Yardley, Pennsylvania 19067, USA.
Mol Diagn Ther. 2011 Feb 1;15(1):53-5. doi: 10.2165/11534880-000000000-00000.
Companion diagnostics and stratified medicines will be increasingly used over the next ten years. Current market leaders who have created diagnostic divisions with a focus on biomarker identification will benefit, notably Abbott, AstraZeneca, Novartis, and GlaxoSmithKline. Pricing incentives and improvement in efficacy will drive this market. The US FDA is not likely to mandate stratification of medications, but cost containment for clinical trials will be sufficient incentive for companies to pursue this approach. The next area expected to produce stratified medicines is infectious disease, expanding from HIV to hepatitis C and hepatitis B. Celera is likely to be first to market with diagnostics for genetic variations in hepatitis C and hepatitis B. Metabolic disorders, especially diabetes, are also fertile ground for stratified medicine, likely to catch up to oncology and infectious disease over the next decade.
在未来十年内,伴随诊断和分层药物将越来越多地被使用。目前,已经创建了专注于生物标志物识别的诊断部门的市场领导者将从中受益,特别是雅培、阿斯利康、诺华和葛兰素史克。定价激励和疗效的提高将推动这一市场的发展。美国食品和药物管理局(FDA)不太可能强制要求药物分层,但临床试验的成本控制将足以促使公司采用这种方法。预计下一个产生分层药物的领域是传染病,从艾滋病毒扩展到丙型肝炎和乙型肝炎。塞莱拉公司可能会率先推出丙型肝炎和乙型肝炎基因变异的诊断产品。代谢紊乱,特别是糖尿病,也是分层药物的肥沃土壤,在未来十年内,它可能会赶上肿瘤学和传染病。