Volume 30, Issue 2 (June 2026)
Physiol Pharmacol 2026, 30(2): 125-147 |
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Kalidindi V R, Penamacha A, Nori L P. Biomarkers: tracing their evolution, development,
market trends, patentability, and current regulatory
landscape. Physiol Pharmacol 2026; 30 (2) :125-147
URL: http://ppj.phypha.ir/article-1-2224-en.html
URL: http://ppj.phypha.ir/article-1-2224-en.html
Abstract: (3906 Views)
Biomarkers are crucial tools in clinical research, precision medicine, and drug development. Throughout the drug development process, they play an important role in disease diagnosis, patient stratification, safety monitoring, therapeutic response assessment, and clinical decision-making. This review provides a comprehensive overview of biomarker definitions, classification, and development, with a major focus on biomarker validation and qualification. The article also examines current market trends, key industry developments, and patentable biomarker technologies used in the diagnosis and management of various diseases. In addition, the commercialization process of biomarker-based diagnostic technologies and the evolving regulatory frameworks governing biomarker qualification are discussed, with particular emphasis on the pathways established by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Furthermore, the review highlights the challenges, opportunities, and future prospects associated with biomarker development and implementation. This review provides valuable insights into the growing role of biomarkers in advancing medical research, drug development, and personalized healthcare.
Type of Manuscript: Review |
Subject:
Pharmacokinetics/Dynamics
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