U.S. Laboratory Developed Tests Markets, 2023-2024 & 2029: Ensuring High Standards in LDT Practices, Vendor Landscape Dynamics


Dublin, May 21, 2024 (GLOBE NEWSWIRE) -- The "U.S. Laboratory Developed Tests (LDTs) Market - Focused Insights 2024-2029" report has been added to ResearchAndMarkets.com's offering.

In alignment with the ever-evolving landscape of the healthcare industry, recent analysis showcases a marked growth in the market for laboratory-developed tests (LDTs) within the United States. Innovations and advancements in the field are anticipated to fuel a steady growth rate of 3.40% from 2023 to 2029. Key contributions to this expansion include the upsurge of chronic and infectious diseases, advancements in genetic health assessments, and the precision of molecular diagnostics.



Gracing the forefront of this growth spectrum is the molecular diagnostics test segment which is burgeoning at an expeditious pace with indications of the fastest growth within the market. The uptick is buoyed by favorable reimbursement policies and governmental backing. Moreover, the oncology application segment assertively holds the majority of the market share, markedly spurred by the pressing need to manage the increasing incidence of cancer and the consequent healthcare expenditures.

Ensuring High Standards in LDT Practices

Despite the inherent lack of FDA approval for the direct marketing of LDTs, the industry harnesses FDA-approved components such as Analyte Specific Reagents in their development. The market is characterized by stringent quality control measures and regulatory oversight, underscoring a commitment to maintaining the integrity and precision of LDT results. Laboratories nationwide adhere to rigorous and regular evaluations to uphold these standards.

Vendor Landscape Dynamics

The U.S. LDT market is rich with investment and innovation, featuring prominent vendors such as LabCorp and Quest Diagnostics. Recognized for their significant market share, these independent laboratories, along with an array of domestic and international competitors, drive forward the development of LDTs, distinguishing the U.S. clinical laboratory tests market with robust competition and continual advancement.

Segmentation Insights

Segmentation analysis reveals diversity within the LDT market, with test categories extending across clinical & immunochemistry, molecular diagnostics, microbiology, and more. Applications range from oncology and rare genetic disorders to infectious diseases, demonstrating the wide-reaching impact of LDTs.

Questions Addressing Market Size and Trends

The quest for comprehensive market insights propels a series of pivotal questions, among them the size of the U.S. laboratory-developed tests market, its anticipated growth trajectory, and the trends steering its expansion. These inquiries fuel the exploration of a market that stands crucial in the landscape of modern healthcare and diagnostics.

Consumer demand and healthcare industry’s requisite for precision and early diagnosis are instrumental in the progressive climb of the U.S. LDT market. This growth embodies the commitment to healthcare innovation and the steadfast pursuit of increased diagnostic accuracy in the service of improved patient outcomes.

Key Attributes:

Report AttributeDetails
No. of Pages66
Forecast Period2023 - 2029
Estimated Market Value (USD) in 2023$2.52 Billion
Forecasted Market Value (USD) by 2029$3.08 Billion
Compound Annual Growth Rate3.4%



A selection of companies mentioned in this report includes, but is not limited to:

  • LabCorp
  • Eurofins
  • Mayo Clinic
  • OPKO Health Inc
  • Quest Diagnostics
  • Siemens Healthineers
  • Sonic Healthcare
  • Accu Reference Medical Lab
  • ARUP Laboratories
  • Clinical Reference Laboratory
  • DaVita
  • Empire City Laboratories
  • Fresenius Medical Care
  • Laboratory of Florida LLC
  • HealthTrackRx
  • Millennium Health
  • U.S. Specialty Labs
  • NeoGenomics
  • Charles River Laboratories
  • Centers Laboratory
  • Qiagen
  • Fuller Laboratories
  • Unilab Corp
  • Bionano Laboratories
  • Cooper Clinics
  • U.R. Medicine Laboratories
  • Vista Clinical Laboratory



For more information about this report visit https://www.researchandmarkets.com/r/g2mfq8

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U.S. Laboratory Developed Tests (LDTs) Market

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