Europe Laboratory Developed Tests Market Size $7.59 Billion By 2032, CAGR: 7.7%

Europe Laboratory Developed Tests Market Size Worth $7.59 Billion By 2032 | CAGR: 7.7%

The europe laboratory developed tests market size is expected to reach USD 7.59 billion by 2032, according to a new study by Polaris Market Research. The report “Europe Laboratory Developed Tests Market Share, Size, Trends, Industry Analysis Report, By Technology (Immunoassays, Hematology and Coagulation, Molecular Diagnostics, and Others); By Application; By Region; Segment Forecast, 2024 - 2032” gives a detailed insight into current market dynamics and provides analysis on future market growth.

The increasing prevalence of various chronic diseases, the drastic shift towards personalized medicine, and the development of new laboratory-developed tests offering greater flexibility and customization compared to conventional commercial tests are prominent factors driving the global market growth. Increasing investments in research & development activities by leading healthcare organizations and academic institutions focused on improving performance and applications of these tests are further likely to have a positive impact on the market’s growth.

For instance, in November 2023, SPT Labtech announced its latest developments in Firefly, a genomics liquid handling platform. The new platform is targeted to address concerns in the preparation of laboratory-developed tests.

Furthermore, the presence of favorable regulatory frameworks that provide clear pathways for the development, validation, and use of laboratory-developed tests and the increased focus of leading government healthcare agencies towards providing complete guidance and ensuring the safety or effectiveness of these tests could further boost market growth. For instance, in September 2023, the FDA (Food and Drug Administration) announced a new proposed rule that mainly aimed at helping to ensure the effectiveness and safety of laboratory-developed tests. Also, the FDA will provide oversight of the tests through a phaseout of its general approach.

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Advancements in next-generation sequencing have revolutionized the field of genetic testing and enabled rapid and cost-efficient methods of analysis of DNA and RNA, which are widely used in applications like genetic screening, cancer profiling, and infectious disease detection and are positively impacting the market. Also, AI algorithms are being incorporated into laboratory-developed tests to improve the accuracy of diagnostic tests and analyze disease outcomes, leading to significant improvements in product demand. For instance, In February 2023, Cardio Diagnostics unveiled PrecisionCHD, a groundbreaking integrated epigenetic-genetic blood test tailored for early coronary heart disease detection. This marks the second clinical test leveraging an artificial intelligence-integrated epigenetic-genetic engine.

In addition, with the growing demand for point-of-care testing, especially in developed countries due to the growing preference for fast and convenient diagnostic tests across various healthcare settings, the manufacturers of laboratory-developed tests have the opportunity to develop point-of-care solutions offering better results with convenience.

Europe Laboratory Developed Tests Market Report Highlights

  • The molecular diagnostics segment accounted for a notable share due to its widespread use in the detection of various viral, bacterial, and genetic diseases
  • The oncology segment held the majority share on account of rising advancements in precision medicine and proliferation for early detection of diseases
  • France dominated the market, which is attributed to the prevalence of chronic and other diseases and the significant presence of an aging population
  • The key market players include Abbott, Roche Diagnostics, Eurofins Scientific, Siemens Healthcare, Cerba Healthcare, TDL Pathology, and Qiagen

Polaris Market Research has segmented the Europe laboratory developed tests market report based on technology, application, and region:

Europe Laboratory Developed Tests, Technology Outlook (Revenue - USD Billion, 2019 - 2032)

  • Immunoassays
  • Hematology and Coagulation
  • Molecular Diagnostics
  • Microbiology
  • Clinical Chemistry
  • Histology/Cytology
  • Flow Cytometry
  • Mass Spectroscopy
  • Others

Europe Laboratory Developed Tests, Application Outlook (Revenue - USD Billion, 2019 - 2032)

  • Oncology
  • Genetic Disorders/Inherited Diseases
  • Immunology
  • Nutritional and Metabolic Diseases
  • Cardiology
  • Mental/Behavioral Disorder
  • Toxicology
  • Others

Europe Laboratory Developed Tests, Regional Outlook (Revenue - USD Billion, 2019 - 2032)

  • Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Netherlands
  • Rest of Europe

Europe Laboratory Developed Tests Market Report Scope

Report Attributes


Market size value in 2024

USD 4.18 billion

Revenue forecast in 2032

USD 7.59 billion


7.7% from 2024 – 2032

Base year


Historical data

2019 – 2022

Forecast period

2024 – 2032

Quantitative units

Revenue in USD billion and CAGR from 2024 to 2032

Segments covered

  • By Technology
  • By Application
  • By Country

Regional scope

  • Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Netherlands
  • Russia
  • Rest of Europe

Competitive Landscape

  • Europe Laboratory Developed Tests Market Share Analysis (2023)
  • Company Profiles/Industry participants profiling includes company overview, financial information, product/service benchmarking, and recent developments

Report Format

  • PDF + Excel


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