Europe Laboratory Developed Tests Market - By Test Type (Clinical Biochemistry, Immunology, Haematology, Microbiology, Molecular Diagnostics), Application (Oncology, Genetics, Infectious Diseases, Neurology), End Use & Forecast, 2024 - 2032

Europe Laboratory Developed Tests Market - By Test Type (Clinical Biochemistry, Immunology, Haematology, Microbiology, Molecular Diagnostics), Application (Oncology, Genetics, Infectious Diseases, Neurology), End Use & Forecast, 2024 - 2032

Europe Laboratory Developed Tests Market Size

Europe Laboratory Developed Tests Market size was valued at around USD 2.1 billion in 2023 and is estimated to grow at 6.1% CAGR from 2024 to 2032. Rising demand for infectious disease testing, increasing healthcare expenditure and focus on early disease detection and prevention are among the key attributes driving the laboratory developed tests (LDTs) market growth in the region. For instance, according to data released by the European Respiratory Virus Surveillance Summary in 2023, around half of the regional countries are experiencing increased levels of fever and cough and there is a sharp rise in the recorded numbers.

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Similarly, a rise in the number of patients suffering from respiratory syncytial virus (RSV) is being observed each year in Europe. Thus, LDTs have played a critical role in detecting infections, monitoring transmission dynamics, and guiding public health responses in Europe for different infectious diseases.

Further, increasing adoption of next-generation sequencing (NGS) have revolutionized genomic analysis and enabled high-throughput sequencing of DNA and RNA. Europe has witnessed widespread adoption of NGS platforms in research, clinical diagnostics, and personalized medicine applications, driving the demand for LDTs based on sequencing technologies.

Laboratory developed tests (LDTs) refer to diagnostic tests that are developed, validated, and performed within a single laboratory. These tests are designed to detect a wide range of conditions, from infectious diseases to genetic disorders, and they are often used when commercial tests are not available or do not meet the specific needs of a patient population.
 

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Europe Laboratory Developed Tests Market Trends

Europe is at the forefront for personalized medicine initiatives, which rely heavily on molecular diagnostics and genetic testing. LDTs play a crucial role in tailoring treatments to individual patients based on their genetic makeup and disease characteristics.

• Precision medicine relies on the identification of specific biomarkers, genetic mutations, or molecular signatures associated with disease pathology. Diagnostic tests, including laboratory developed tests (LDTs), play a crucial role in identifying these biomarkers, enabling the development of targeted therapies designed to act on specific molecular targets. For example, in 2021 an initiative was launched, aimed at identifying the barriers to biomarker testing and develop policy landscape for the EU27 countries and the UK. This initiative also focused on unlocking the potential of precision medicine to improve cancer care in the region.
• Additionally, next-generation sequencing (NGS), PCR-based assays, microarray analysis, and other molecular diagnostic techniques enable comprehensive profiling of genetic variations, gene expression patterns, and epigenetic modifications. These technological advancements facilitate the development of innovative diagnostic tests that support precision medicine initiatives.

Europe Laboratory Developed Tests Market Analysis

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Based on test type, the market is categorized into clinical biochemistry, immunology, haematology, microbiology, molecular diagnostics, flow cytometry, histology/cytology, and other test types. The molecular diagnostics segment held leading market share and was valued at USD 576.8 million in 2023.

• Molecular diagnostics are widely used for the diagnosis, prognosis, and monitoring of various diseases, including cancer, infectious diseases, genetic disorders, and autoimmune conditions. LDTs that leverage molecular techniques are essential for detecting genetic mutations, viral RNA/DNA, gene expression patterns, and other molecular alterations indicative of disease states.
• Additionally, the development of targeted therapies and personalized treatments often relies on companion diagnostics to identify patients who are most likely to benefit from specific therapeutic interventions. Laboratory developed tests play a critical role in companion diagnostics development by providing laboratories with the flexibility to develop and validate assays that correlate with therapeutic response markers.
• Furthermore, molecular diagnostics are essential tools in research and translational medicine for biomarker discovery, drug development, and clinical trials. The laboratory developed tests allows them to perform exploratory research and validate novel biomarkers for clinical utility, paving the way for the development of diagnostic assays with diagnostic, prognostic, or predictive values.

Based on application, the Europe laboratory developed tests market is categorized into oncology, genetics, infectious diseases, autoimmune disorders, neurology, mental/behavioural disorder, nutritional & metabolic disease, and other applications. The oncology segment dominated the market, with a revenue share of over 28% in 2023.

• Laboratory developed tests aid in the diagnosis and subtyping of cancer by identifying characteristic genetic mutations, gene expression patterns, and protein markers associated with different cancer types and subtypes. These tests help oncologists accurately classify tumors, differentiate between benign and malignant lesions, and guide treatment decisions based on tumor histology and molecular characteristics.
• Further, LDTs are used for genetic testing and comprehensive tumor profiling to identify specific genetic mutations, biomarkers, and molecular alterations associated with cancer. Next-generation sequencing (NGS) and other molecular techniques allow laboratories to analyze tumor DNA, RNA, and proteins, providing insights into tumor biology, heterogeneity, and potential therapeutic targets.
• Moreover, these tests also provide prognostic information by assessing tumor-specific biomarkers associated with disease prognosis, recurrence risk, and patient survival outcomes.

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Based on end-use, the Europe laboratory developed tests market is categorized into hospital laboratories, diagnostic centers, clinical research organizations, academic and research institutes, and other end-users. The hospital laboratories segment dominated the market, with a revenue of around USD 802.4 million in 2023.

• Hospital laboratories perform a wide range of diagnostic tests to support clinical decision-making and patient care across various medical specialties. LDTs enable hospitals to offer specialized and customized testing services tailored to the specific needs of their patient population.
• Hospital laboratories seek cost-effective testing solutions that balance clinical utility with economic considerations. LDTs offer hospitals the opportunity to develop in-house testing capabilities that are cost-effective compared to outsourcing testing to commercial reference laboratories.

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Germany laboratory developed tests market accounted for USD 362.7 million revenue in 2023 and is predicted to witness robust market growth over the forecast timeline.

• Germany has a vibrant biomedical research ecosystem characterized by leading academic institutions, research organizations, and biotechnology companies. LDTs are instrumental in supporting translational research efforts by facilitating biomarker discovery, preclinical studies, and clinical validation of novel diagnostic assays and therapeutic targets.
• Advances in laboratory technologies, molecular diagnostics, and bioinformatics drive innovation in LDT development and implementation. The country is home to key manufacturers of diagnostic instruments, reagents, and consumables, which contribute to the availability of state-of-the-art equipment and assay platforms for performing LDTs in laboratories across the country, thereby, driving the market growth.

France laboratory developed tests market is expected to grow significantly during the forecast period.

• France has implemented a national cancer control program aimed at reducing the burden of cancer through prevention, early detection, and improved treatment outcomes. The demand for LDTs in oncology is driven by the need for accurate and timely diagnosis, prognostication, and personalized treatment approaches to manage different types of cancer effectively.
• For instance, in September 2023, Roche France and Foundation Medicine announced the partnership with Institute Gustave Roussy to transfer the FoundationOne Liquid CDx technology to the institute. This strategic development is aimed to provide in-house liquid biopsy genomic testing to cancer patients in France. Such developments enable the industry players to push precision medicine in cancer treatments, fueling the industry growth.

UK laboratory developed tests market is anticipated to witness high growth rate from 2024-2032, due to several factors.

• The National Health Service (NHS) provides comprehensive healthcare services in the UK, including diagnostic testing, disease monitoring, and treatment. NHS laboratories and private diagnostic providers play a central role in delivering diagnostic services, creating a significant demand for LDTs to support patient care, clinical decision-making, and disease management.
• Cancer is among the leading cause of morbidity and mortality in the UK, driving demand for accurate and timely cancer diagnosis, prognosis, and treatment monitoring. The laboratory developed tests play a critical role in oncology by enabling the detection of tumor-specific biomarkers, genetic mutations, and molecular alterations, guiding treatment decisions, and assessing treatment response in cancer patients.

Europe Laboratory Developed Tests Market Share

Collaboration is key for key players to expand their reach, access new markets, and drive innovation. They form strategic partnerships and collaborations with healthcare institutions, research organizations, diagnostic manufacturers, and technology providers to leverage complementary expertise, resources, and capabilities. Partnerships facilitate the development, validation, and commercialization of new LDTs and foster collaboration across the healthcare ecosystem.

Europe Laboratory Developed Tests Market Companies

Some of the eminent market participants operating in the Europe laboratory developed tests industry include

• 23andMe, Inc.
• Abbott
• Bio-Rad Laboratories, Inc.
• Eurofins Scientific
• F. Hoffmann-La Roche Ltd.
• Illumina, Inc.
• OPKO Health, Inc.
• QIAGEN
• Quest Diagnostics Incorporated
• SVAR Lifesciences

Europe Laboratory Developed Tests Industry News

• In April 2024, PeploBio, a clinical laboratory focused on precision medicine and diagnostic solutions, in collaboration with IncellDX, is ready to launch the first test designed to help diagnose Long COVID in the EU and UK. Long COVID is a condition developed by persistent symptoms following a COVID-19 infection that is expected to affect around 65 million people worldwide. This product launch will allow the company to improve its industry position in the coming years.

Europe laboratory developed tests market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 to 2032 for the following segments

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Market, By Test Type

• Clinical biochemistry
• Immunology
• Haematology
• Microbiology
• Molecular diagnostics
• Flow cytometry
• Histology/Cytology
• Other test types

By Application

• Oncology
• Genetics
• Infectious diseases
• Autoimmune disorders
• Neurology
• Mental/behavioral disorder
• Nutritional & metabolic disease
• Other applications

By End-use

• Hospital laboratories
• Diagnostic centers
• Clinical research organizations
• Academic and research institutes
• Other end-users

The above information is provided for the following countries

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