The market faces hurdles due to lack of specificity and the need for more sensitive analysis systems. Point-of-care testing (POCT) requires highly sensitive diagnostic tools to detect minute levels of cardiac biomarkers like troponin, delaying rapid decision-making. Additionally, strict FDA validation and technical issues in sample collection and storage impact the market growth. The FDA's Biomarker Qualification Program aims to address these challenges, but the list of qualified biomarkers remains limited. Furthermore, issues in handling, labeling, and transporting samples may affect research and diagnostic accuracy, posing further obstacles to market expansion.
Market Opportunities: Development of novel cardiac biomarkers
The development of novel cardiac biomarkers holds tremendous potential and opportunity in the global cardiac biomarkers market. Currently available cardiac biomarkers like Troponin and CK-MB are indicative of cardiac injury only after onset of symptoms. However, novel biomarkers which can predict cardiac events before onset of symptoms can facilitate early clinical intervention and prevent adverse outcomes. For example, recent studies have shown biomarkers like ST2, Galectin-3 and others may serve as prognostic indicators, providing crucial information on predicting heart failure exacerbations days in advance. Such predictive biomarkers addressing unmet needs could transform cardiac treatment pathways globally. As per WHO, cardiovascular diseases remain the leading cause of death worldwide with an estimated 17.9 million lives lost each year. Nearly half of these deaths are premature in people under 70 years of age.
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