Kalorama Information’s latest report, The Worldwide Market for Laboratory-Developed Tests (LDTs), 2023-2028, is now available for purchase. This comprehensive study delves into the dynamic landscape of LDTs, exploring both the services market and the market for test products sold to clinical laboratories.

The Worldwide Market for Laboratory-Developed Tests includes comprehensive analysis of the effects of the FDA's new "Medical Devices: Laboratory Developed Tests" rule, passed in April 2024, which subjects LDTs to significantly greater regulatory oversight.

Inclusion Criteria for LDTs:

• 2023-2024: LDTs are defined as tests developed by laboratories for their own use, distinct from regulated in vitro diagnostic (IVD) kits manufactured by diagnostic companies.
• From 2025: LDTs are considered IVDs in the U.S. market, subject to phased-in regulations.

Key Points:

• Scope and Methodology:
  • Market data is provided in U.S. dollars for 2023-2028.
  • Revenues of key market players (where available) are analyzed for the preceding three years.
• Two Interrelated Markets:
  • Clinical laboratory services utilizing LDTs.
  • Products (platforms and consumables) sold to clinical laboratories for LDT development.
• Global Coverage with Regional Focus:
  • Developed regions (United States, Japan, Western Europe) dominate LDT performance.
• Focus on Major Clinical Disease Segments
  • Infectious Disease  
  • Oncology LDT Services Market
  • Genetic Testing
• Product Sales Approach:
  • Market data reflects factory sales to end users, considering instrumentation costs embedded in per-test prices.
• LDTs: Transforming Healthcare:
  • Exciting assays with potential to revolutionize healthcare delivery.
• AI in LDT Development
  • Discussion of the pivotal role AI could in revolutionizing the way LDT tests are developed, validated, and utilized in clinical settings, particularly in data analysis, assay design, quality control, result interpretation, and regulatory considerations
• Impact of the COVID-19 Pandemic:
  • Historical “home-brew” or “in-house” LDTs have evolved into high-risk, complex tests.
  • SARS-CoV-2 testing highlights their critical role.
• Defining LDTs:
  • Broader definition includes all clinical tests developed by laboratories for their own use, beyond the FDA’s narrower view.

For further details and to purchase directly, please contact us.

Sample Report: A sample is available as a PDF upon request.