en Pharmacokinetics/Dynamics Pharmacokinetics/Dynamics Review Review <p style="text-align: justify;"><span style="font-family:Arial;"><span style="font-size:12px;">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.</span></span></p> Biomarkers ,Biomarker development ,Regulatory landscape ,Patentability ,Market trends 125 147 http://ppj.phypha.ir/browse.php?a_code=A-10-2176-1&slc_lang=en&sid=1 Venkateswara Raju Kalidindi venkateswararaju.k@svcp.edu.in 3200319475328460039421 0000000262794710 No Department of Regulatory Affairs, Shri Vishnu College of Pharmacy, Bhimavaram, West Godavari (Dt.), Andhra Pradesh, India Anusha Penamacha anuvarma2468@gmail.com 3200319475328460039422 0009000803976355 No Department of Regulatory Affairs, Shri Vishnu College of Pharmacy, Bhimavaram, West Godavari (Dt.), Andhra Pradesh, India Lakshmi Prasanthi Nori lakshmi.n@svcp.edu.in 3200319475328460039423 0000000207842484 Yes Department of Regulatory Affairs, Shri Vishnu College of Pharmacy, Bhimavaram, West Godavari (Dt.), Andhra Pradesh, India