- Laboratory-Developed Tests (LDTs), which are in vitro diagnostics designed, manufactured, and used within a single laboratory, are becoming increasingly vital in the landscape of personalized medicine, oncology, and rare disease diagnostics due to their flexibility, faster turnaround times, and ability to address unmet clinical needs not served by FDA-approved tests
- The escalating demand for LDTs is primarily fueled by the growing prevalence of complex diseases such as cancer and genetic disorders, the rapid advancement in molecular diagnostics and genomic technologies, and increased demand for tailored testing solutions across clinical and research laboratories
- North America dominated the laboratory-developed tests (LDTs) market with the largest revenue share of 36.9% in 2024, characterized by robust healthcare infrastructure, high adoption of precision medicine, favourable regulatory frameworks, and strong presence of leading diagnostic laboratories and research institutions across the U.S. and Canada
- Asia-Pacific is expected to be the fastest-growing region in the laboratory-developed tests (LDTs) market, with a projected CAGR of 23.8% from 2025 to 2032, driven by expanding healthcare access, increasing investments in genomics and clinical diagnostics, and growing awareness regarding early disease detection across countries such as China, India, and Japan
- The oncology/Cancer segment dominated the laboratory-developed tests (LDTs) market with a market share of 43.2% in 2024, driven by the increasing demand for cancer biomarker testing, companion diagnostics, and personalized treatment planning. The rise of liquid biopsies and NGS-based panels in oncology care has significantly boosted the adoption of LDTs in this segment
