Laboratory Developed Tests Market

Laboratory Developed Tests Market Size

Laboratory Developed Tests Market size was valued at around USD 8.9 billion in 2023 and is estimated to grow at 6.4% CAGR from 2024 to 2032. The increasing incidence of cancer and genetic disorders, coupled with the rising prevalence of infectious and chronic diseases, is driving significant growth in the laboratory developed tests (LDTs) market.

As more people are diagnosed with these conditions, there is a growing demand for specialized diagnostic tests that can accurately detect and monitor them. For instance, according to World Health Organization, cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020. The most common cancers are breast, lung, colon and rectum and prostate cancers. As per the WHO, around 2.26 million deaths were due to breast cancer worldwide in 2020.

Additionally, the prevalence of genetic disorders is a significant public health issue, affecting a substantial proportion of the population worldwide. For instance, the CDC highlights that about 65% of people experience health issues due to congenital genetic mutations. These increase in the prevalence underscore the substantial impact of genetic disorders on individuals globally and emphasize the importance of understanding, diagnosing, and managing these conditions effectively.

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.

Laboratory Developed Tests Market Trends

Growing awareness and focus on early disease detection is a significant trend driving the growth of the laboratory developed tests (LDTs) market. With increased emphasis on preventive healthcare, individuals are seeking ways to detect diseases at their earliest stages, prompting greater demand for diagnostic tests capable of early detection.

• Technological advancements have revolutionized early disease detection, such as the development of high-sensitivity assays and advanced imaging techniques, enabling the identification of diseases before symptoms appear.
  
• For example, the advent of next-generation sequencing (NGS) has revolutionized genetic testing, allowing for comprehensive analysis of an individual's DNA to identify genetic mutations associated with various diseases, including cancer and rare genetic disorders. NGS-based LDTs enable clinicians to detect these mutations early, facilitating personalized treatment plans and potentially improving patient outcomes.
  
• Additionally, the integration of artificial intelligence (AI) and machine learning algorithms into diagnostic testing platforms has enhanced the accuracy and efficiency of early disease detection.
  

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 dominated the market, generating approximately USD 2.4 billion in revenue in 2023.

• Molecular diagnostics offer highly sensitive and specific methods for detecting pathogens and identifying genetic mutations associated with cancer, driving their adoption in clinical settings.
  
• Additionally, there is a growing demand for molecular diagnostic tests that can be performed at the point of care, enabling rapid diagnosis and treatment decisions. This is particularly important in settings where timely intervention is critical, such as emergency departments, clinics, and remote healthcare facilities.
  

Based on application, the 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, accounting significant share of 28.8 % in 2023.

• Molecular diagnostic tests in oncology, such as genetic sequencing and mutation analysis, provide critical information about tumor characteristics, enabling oncologists to select the most effective treatments and therapies for each patient.
  
• Additionally, laboratory developed tests play a crucial role in early cancer detection and screening programs. Tests for cancer biomarkers, circulating tumor cells, and genetic mutations allow for the detection of cancer at its earliest stages, improving patient outcomes through early intervention and treatment, driving the demand for molecular tests in oncology.

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Based on end-use, the 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 3.3 billion in 2023.

• Hospitals serve as primary centers for the diagnosis and treatment of a broad spectrum of diseases and conditions. Given the rising prevalence of infectious diseases, chronic illnesses, and cancer, hospital laboratories are witnessing an escalating demand for diagnostic testing to facilitate patient care.
  
• Additionally, hospital laboratories are closely integrated with clinical care teams, allowing for seamless coordination between diagnostic testing and patient management. LDTs enable hospitals to provide comprehensive diagnostic services that support clinicians in diagnosing diseases, monitoring treatment responses, and managing patient care effectively, hence contributing to the segmental growth.

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North America laboratory developed tests market accounted for USD 3.7 billion in revenue in 2023 and is predicted to witness substantial market growth over the analysis timeline.

• The region faces a growing burden of chronic diseases such as diabetes, cardiovascular diseases, and cancer, as well as infectious diseases like COVID-19. This has led to a higher demand for diagnostic tests across various medical specialties, fueling the growth of the LDTs market.
  
• For instance, according to the CDC, in the U.S. in 2021, a total of 38.4 million people (11.6% of the US population) had diabetes, both diagnosed and undiagnosed.
  

U.S. laboratory developed tests market holds a dominant position with the market share of 93.3% in 2023.  

• U.S. government allocated significant funding to support research and development for laboratory developed tests, particularly in response to public health emergencies like the COVID-19 pandemic.
  
• For example, the funding allocated through the Coronavirus Aid, Relief, and Economic Security (CARES) Act serves as a prime example. Enacted in March 2020, the CARES Act designated billions of dollars for a multitude of initiatives aimed at mitigating the impacts of COVID-19, including substantial funding for the advancement, and broadening of diagnostic testing capabilities. This governmental backing is propelling the market expansion for laboratory-developed tests across the country.
  

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

• Germany has been at the forefront of precision medicine initiatives, aiming to tailor treatments to individual patients based on their genetic makeup and other factors. LDTs play a crucial role in providing the molecular information needed for precision medicine approaches, driving their demand in the market.
  
• Additionally, Germany boasts a robust network of research institutions, academic centers, and industry collaborations, driving innovation in diagnostics. Collaborations between academia, research institutes, and industry players contribute to the development of new LDTs and advancements in diagnostic technologies.
  

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

• China is facing a growing burden of chronic diseases such as cardiovascular diseases, diabetes, and cancer, as well as infectious diseases like COVID-19. The rising prevalence of these diseases is driving demand for diagnostic tests, including LDTs, to support early detection, monitoring, and treatment.
  
• Additionally, China has made significant strides in medical technology and innovation, leading to the development of advanced diagnostic tools and platforms. This advancement in areas such as molecular diagnostics, next-generation sequencing (NGS), and point-of-care testing (POCT) drives the demand for LDTs and contributes to market growth.
  

Laboratory Developed Tests Market Share

The laboratory developed tests industry is competitive in nature, with various large multinationals and small and mid-sized companies competing in the industry. The development and launch of novel technologies with improved efficiency and cost-effectiveness are key market strategies for laboratory developed tests manufacturers, driving competition and innovation in the industry. This emphasis on innovation aims to address evolving clinical needs and enhance patient outcomes, positioning companies to gain market share and meet the growing demand for advanced laboratory developed tests.

Laboratory Developed Tests Market Companies

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

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

Laboratory Developed Tests Industry News:

• In August 2023, Abbott received FDA clearance for its Alinity h-series lab instruments, allowing for advanced testing of patients' complete blood counts (CBC). This approval enhanced the company’s reputation in the market and enabled them with more customer base.
  
• In March 2023, Bio-Rad Laboratories, Inc. received the MicroVals approval for its iQ-Check STEC VirX Kit for the real-time PCR detection of virulence genes in Shiga toxin-producing Escherichia coli (STEC) in flour products and raw dough products. This approval improved the company’s product portfolio for microbiology testing and enhanced its competitiveness in the market.
  

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 diseases
• 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 regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Netherlands
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of Middle East and Africa