세계의 LDT(Laboratory Developed Tests) 시장 : 규모, 점유율, 동향 분석 보고서 - 용도별, 기술별, 지역별 전망 및 예측(2024-2031년)

The Global Laboratory Developed Tests Market size is expected to reach $20.3 billion by 2031, rising at a market growth of 6.9% CAGR during the forecast period.

LDTs encompass a wide range of genetic tests designed to diagnose various types of inherited diseases, including single-gene disorders, chromosomal abnormalities, mitochondrial disorders, and complex genetic conditions. Consequently, the genetic disorders/ inherited disease segment would acquire nearly 10% of the total market share by 2031. These tests can identify disease-causing mutations in genes associated with conditions such as cystic fibrosis, muscular dystrophy, inherited cancers, and rare genetic syndromes.

As healthcare expenditure rises, there is often a corresponding increase in demand for advanced diagnostic tests. In addition, with greater investment in healthcare, there's usually more funding available for research and development of new diagnostic technologies. Hence, increasing healthcare expenditure is driving the growth of the market. Additionally, POCT enables rapid testing and decision-making at or near the point of patient care, leading to quicker diagnosis and treatment initiation. Moreover, POCT facilitates rapid and on-demand testing, which aligns with personalized medicine principles. Hence, the expansion of point-of-care testing drives the market's growth.

The pandemic disrupted global supply chains, affecting the availability of reagents, consumables, and equipment necessary for LDT development and testing. Laboratories faced challenges in sourcing essential materials, leading to test development and implementation delays. However, the pandemic accelerated the development and deployment of COVID-19 tests, including LDTs, to meet the urgent need for diagnostic testing. Thus, the COVID-19 pandemic had a moderate impact on the market.

However, Multimodal testing often involves integrating multiple testing modalities, such as genomics, proteomics, metabolomics, and imaging, to provide comprehensive diagnostic information. Furthermore, multimodal testing generates large volumes of heterogeneous data from multiple sources, including genomic sequences, protein expression profiles, metabolic pathways, and imaging scans. Therefore, the complexity of multimodal testing is hampering the market's growth.

Application Outlook

On the basis of application, the market is segmented into oncology, genetic disorders/inherited disease, infectious & parasitic diseases, immunology, endocrine, nutritional & metabolic disease, cardiology, mental/behavioral disorder, pediatrics-specific testing, and others. The infectious & parasitic diseases segment attained a 14% revenue share in the market in 2023. LDTs for infectious and parasitic diseases encompass a wide range of tests designed to detect and identify various pathogens, including bacteria, viruses, fungi, and parasites.

Technology Outlook

Based on technology, the market is divided into immunoassays, hematology & coagulation, molecular diagnostics, microbiology, clinical chemistry, histology/cytology, flow cytometry, mass spectroscopy, and others. The immunoassays segment attained 19.9% revenue share in the market in 2023. Immunoassays offer high sensitivity and specificity, allowing for accurate detection and quantification of biomarkers even at low concentrations. This capability is crucial for diagnosing conditions early, monitoring disease progression, evaluating treatment efficacy, and detecting relapse or recurrence.

Regional Outlook

Region-wise, the market is analyzed across North America, Europe, Asia Pacific, and LAMEA. In 2023, the North America region witnessed 38% revenue share in the market. The region is a global leader in technological innovation, particularly in the fields of molecular diagnostics, genomics, and personalized medicine. Technological advancements enable the development of sophisticated LDTs that utilize next-generation sequencing, PCR-based assays, microarray technologies, and digital pathology systems.

Recent Strategies Deployed in the Market

• May-2024: Quest Diagnostics Incorporated took over PathAI Diagnostics, a leading laboratory services company based in Memphis, TN. Through this acquisition, Quest Diagnostics would expedite the uptake of digital and AI pathology advancements for enhancing the quality, speed, and efficiency of diagnosing cancer and other illnesses.
• Feb-2024: Abbott Laboratories came into partnership with Fujirebio, a Japanese multinational biotechnology company. Through this partnership, Abbott Laboratories would create a research-only neurofilament-light chain (Nf-L) neurology biomarker assay for use with Abbott's Alinity(R) i.
• Jan-2024: Neogenomics, Inc. came into partnership with ConcertAI LLC, a biotechnology research company. Through this partnership, Neogenomics, Inc. would advance broad-scale hematological research solutions for exploring real-world clinical practices and outcomes in hematological malignancies.
• Jan-2023: Qiagen N.V introduced "EZ2 Connect MDx" for use in diagnostic laboratories. EZ2 Connect MDx brings standardized and efficient nucleic acid purification within reach of any clinical laboratory, paired with the QIAsphere digital system enabling remote instrument management.
• Jul-2022: Guardant Health, Inc. came into partnership with Adicon Holdings Limited, a leading independent clinical laboratory company based in China. Through this partnership, Guardant Health, Inc. would provide biopharmaceutical companies conducting clinical trials in China with Guardant Health's comprehensive genomic profiling (CGP) tests.

List of Key Companies Profiled

• Neogenomics, Inc.
• Guardant Health, Inc.
• Qiagen N.V
• Quest Diagnostics Incorporated
• Abbott Laboratories
• Siemens Healthineers AG (Siemens AG)
• Illumina, Inc.
• Bio-Rad Laboratories, Inc.
• F. Hoffmann-La Roche Ltd.
• Eurofins Scientific SE

Global Laboratory Developed Tests Market Report Segmentation

By Application

• Oncology
• Genetic Disorders/Inherited Disease
• Infectious & Parasitic Diseases
• Endocrine
• Immunology
• Nutritional & Metabolic Disease
• Cardiology
• Mental/Behavioral Disorder
• Pediatrics-specific Testing
• Others

By Technology

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

By Geography

• North America
  • US
  • Canada
  • Mexico
  • Rest of North America
• Europe
  • Germany
  • UK
  • France
  • Russia
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Singapore
  • Malaysia
  • Rest of Asia Pacific
• LAMEA
  • Brazil
  • Argentina
  • UAE
  • Saudi Arabia
  • South Africa
  • Nigeria
  • Rest of LAMEA

Table of Contents

Chapter 1. Market Scope & Methodology

• 1.1 Market Definition
• 1.2 Objectives
• 1.3 Market Scope
• 1.4 Segmentation
  • 1.4.1 Global Laboratory Developed Tests Market, by Application
  • 1.4.2 Global Laboratory Developed Tests Market, by Technology
  • 1.4.3 Global Laboratory Developed Tests Market, by Geography
• 1.5 Methodology for the research

Chapter 2. Market at a Glance

• 2.1 Key Highlights

Chapter 3. Market Overview

• 3.1 Introduction
  • 3.1.1 Overview
    • 3.1.1.1 Market Composition and Scenario
• 3.2 Key Factors Impacting the Market
  • 3.2.1 Market Drivers
  • 3.2.2 Market Restraints
  • 3.2.3 Market Opportunities
  • 3.2.4 Market Challenges
• 3.3 Porter Five Forces Analysis

Chapter 4. Strategies Deployed in Laboratory Developed Tests Market.

Chapter 5. Global Laboratory Developed Tests Market by Application

• 5.1 Global Oncology Market by Region
• 5.2 Global Genetic Disorders/Inherited Disease Market by Region
• 5.3 Global Infectious & Parasitic Diseases Market by Region
• 5.4 Global Endocrine Market by Region
• 5.5 Global Immunology Market by Region
• 5.6 Global Nutritional & Metabolic Disease Market by Region
• 5.7 Global Cardiology Market by Region
• 5.8 Global Mental/Behavioral Disorder Market by Region
• 5.9 Global Pediatrics-specific Testing Market by Region
• 5.1 Global Others Market by Region

Chapter 6. Global Laboratory Developed Tests Market by Technology

• 6.1 Global Molecular Diagnostics Market by Region
• 6.2 Global Immunoassays Market by Region
• 6.3 Global Hematology & Coagulation Market by Region
• 6.4 Global Microbiology Market by Region
• 6.5 Global Clinical Chemistry Market by Region
• 6.6 Global Histology/Cytology Market by Region
• 6.7 Global Flow Cytometry Market by Region
• 6.8 Global Mass Spectroscopy Market by Region
• 6.9 Global Others Market by Region

Chapter 7. Global Laboratory Developed Tests Market by Region

• 7.1 North America Laboratory Developed Tests Market
  • 7.1.1 North America Laboratory Developed Tests Market by Application
    • 7.1.1.1 North America Oncology Market by Country
    • 7.1.1.2 North America Genetic Disorders/Inherited Disease Market by Country
    • 7.1.1.3 North America Infectious & Parasitic Diseases Market by Country
    • 7.1.1.4 North America Endocrine Market by Country
    • 7.1.1.5 North America Immunology Market by Country
    • 7.1.1.6 North America Nutritional & Metabolic Disease Market by Country
    • 7.1.1.7 North America Cardiology Market by Country
    • 7.1.1.8 North America Mental/Behavioral Disorder Market by Country
    • 7.1.1.9 North America Pediatrics-specific Testing Market by Country
    • 7.1.1.10 North America Others Market by Country
  • 7.1.2 North America Laboratory Developed Tests Market by Technology
    • 7.1.2.1 North America Molecular Diagnostics Market by Country
    • 7.1.2.2 North America Immunoassays Market by Country
    • 7.1.2.3 North America Hematology & Coagulation Market by Country
    • 7.1.2.4 North America Microbiology Market by Country
    • 7.1.2.5 North America Clinical Chemistry Market by Country
    • 7.1.2.6 North America Histology/Cytology Market by Country
    • 7.1.2.7 North America Flow Cytometry Market by Country
    • 7.1.2.8 North America Mass Spectroscopy Market by Country
    • 7.1.2.9 North America Others Market by Country
  • 7.1.3 North America Laboratory Developed Tests Market by Country
    • 7.1.3.1 US Laboratory Developed Tests Market
      • 7.1.3.1.1 US Laboratory Developed Tests Market by Application
      • 7.1.3.1.2 US Laboratory Developed Tests Market by Technology
    • 7.1.3.2 Canada Laboratory Developed Tests Market
      • 7.1.3.2.1 Canada Laboratory Developed Tests Market by Application
      • 7.1.3.2.2 Canada Laboratory Developed Tests Market by Technology
    • 7.1.3.3 Mexico Laboratory Developed Tests Market
      • 7.1.3.3.1 Mexico Laboratory Developed Tests Market by Application
      • 7.1.3.3.2 Mexico Laboratory Developed Tests Market by Technology
    • 7.1.3.4 Rest of North America Laboratory Developed Tests Market
      • 7.1.3.4.1 Rest of North America Laboratory Developed Tests Market by Application
      • 7.1.3.4.2 Rest of North America Laboratory Developed Tests Market by Technology
• 7.2 Europe Laboratory Developed Tests Market
  • 7.2.1 Europe Laboratory Developed Tests Market by Application
    • 7.2.1.1 Europe Oncology Market by Country
    • 7.2.1.2 Europe Genetic Disorders/Inherited Disease Market by Country
    • 7.2.1.3 Europe Infectious & Parasitic Diseases Market by Country
    • 7.2.1.4 Europe Endocrine Market by Country
    • 7.2.1.5 Europe Immunology Market by Country
    • 7.2.1.6 Europe Nutritional & Metabolic Disease Market by Country
    • 7.2.1.7 Europe Cardiology Market by Country
    • 7.2.1.8 Europe Mental/Behavioral Disorder Market by Country
    • 7.2.1.9 Europe Pediatrics-specific Testing Market by Country
    • 7.2.1.10 Europe Others Market by Country
  • 7.2.2 Europe Laboratory Developed Tests Market by Technology
    • 7.2.2.1 Europe Molecular Diagnostics Market by Country
    • 7.2.2.2 Europe Immunoassays Market by Country
    • 7.2.2.3 Europe Hematology & Coagulation Market by Country
    • 7.2.2.4 Europe Microbiology Market by Country
    • 7.2.2.5 Europe Clinical Chemistry Market by Country
    • 7.2.2.6 Europe Histology/Cytology Market by Country
    • 7.2.2.7 Europe Flow Cytometry Market by Country
    • 7.2.2.8 Europe Mass Spectroscopy Market by Country
    • 7.2.2.9 Europe Others Market by Country
  • 7.2.3 Europe Laboratory Developed Tests Market by Country
    • 7.2.3.1 Germany Laboratory Developed Tests Market
      • 7.2.3.1.1 Germany Laboratory Developed Tests Market by Application
      • 7.2.3.1.2 Germany Laboratory Developed Tests Market by Technology
    • 7.2.3.2 UK Laboratory Developed Tests Market
      • 7.2.3.2.1 UK Laboratory Developed Tests Market by Application
      • 7.2.3.2.2 UK Laboratory Developed Tests Market by Technology
    • 7.2.3.3 France Laboratory Developed Tests Market
      • 7.2.3.3.1 France Laboratory Developed Tests Market by Application
      • 7.2.3.3.2 France Laboratory Developed Tests Market by Technology
    • 7.2.3.4 Russia Laboratory Developed Tests Market
      • 7.2.3.4.1 Russia Laboratory Developed Tests Market by Application
      • 7.2.3.4.2 Russia Laboratory Developed Tests Market by Technology
    • 7.2.3.5 Spain Laboratory Developed Tests Market
      • 7.2.3.5.1 Spain Laboratory Developed Tests Market by Application
      • 7.2.3.5.2 Spain Laboratory Developed Tests Market by Technology
    • 7.2.3.6 Italy Laboratory Developed Tests Market
      • 7.2.3.6.1 Italy Laboratory Developed Tests Market by Application
      • 7.2.3.6.2 Italy Laboratory Developed Tests Market by Technology
    • 7.2.3.7 Rest of Europe Laboratory Developed Tests Market
      • 7.2.3.7.1 Rest of Europe Laboratory Developed Tests Market by Application
      • 7.2.3.7.2 Rest of Europe Laboratory Developed Tests Market by Technology
• 7.3 Asia Pacific Laboratory Developed Tests Market
  • 7.3.1 Asia Pacific Laboratory Developed Tests Market by Application
    • 7.3.1.1 Asia Pacific Oncology Market by Country
    • 7.3.1.2 Asia Pacific Genetic Disorders/Inherited Disease Market by Country
    • 7.3.1.3 Asia Pacific Infectious & Parasitic Diseases Market by Country
    • 7.3.1.4 Asia Pacific Endocrine Market by Country
    • 7.3.1.5 Asia Pacific Immunology Market by Country
    • 7.3.1.6 Asia Pacific Nutritional & Metabolic Disease Market by Country
    • 7.3.1.7 Asia Pacific Cardiology Market by Country
    • 7.3.1.8 Asia Pacific Mental/Behavioral Disorder Market by Country
    • 7.3.1.9 Asia Pacific Pediatrics-specific Testing Market by Country
    • 7.3.1.10 Asia Pacific Others Market by Country
  • 7.3.2 Asia Pacific Laboratory Developed Tests Market by Technology
    • 7.3.2.1 Asia Pacific Molecular Diagnostics Market by Country
    • 7.3.2.2 Asia Pacific Immunoassays Market by Country
    • 7.3.2.3 Asia Pacific Hematology & Coagulation Market by Country
    • 7.3.2.4 Asia Pacific Microbiology Market by Country
    • 7.3.2.5 Asia Pacific Clinical Chemistry Market by Country
    • 7.3.2.6 Asia Pacific Histology/Cytology Market by Country
    • 7.3.2.7 Asia Pacific Flow Cytometry Market by Country
    • 7.3.2.8 Asia Pacific Mass Spectroscopy Market by Country
    • 7.3.2.9 Asia Pacific Others Market by Country
  • 7.3.3 Asia Pacific Laboratory Developed Tests Market by Country
    • 7.3.3.1 China Laboratory Developed Tests Market
      • 7.3.3.1.1 China Laboratory Developed Tests Market by Application
      • 7.3.3.1.2 China Laboratory Developed Tests Market by Technology
    • 7.3.3.2 Japan Laboratory Developed Tests Market
      • 7.3.3.2.1 Japan Laboratory Developed Tests Market by Application
      • 7.3.3.2.2 Japan Laboratory Developed Tests Market by Technology
    • 7.3.3.3 India Laboratory Developed Tests Market
      • 7.3.3.3.1 India Laboratory Developed Tests Market by Application
      • 7.3.3.3.2 India Laboratory Developed Tests Market by Technology
    • 7.3.3.4 South Korea Laboratory Developed Tests Market
      • 7.3.3.4.1 South Korea Laboratory Developed Tests Market by Application
      • 7.3.3.4.2 South Korea Laboratory Developed Tests Market by Technology
    • 7.3.3.5 Singapore Laboratory Developed Tests Market
      • 7.3.3.5.1 Singapore Laboratory Developed Tests Market by Application
      • 7.3.3.5.2 Singapore Laboratory Developed Tests Market by Technology
    • 7.3.3.6 Malaysia Laboratory Developed Tests Market
      • 7.3.3.6.1 Malaysia Laboratory Developed Tests Market by Application
      • 7.3.3.6.2 Malaysia Laboratory Developed Tests Market by Technology
    • 7.3.3.7 Rest of Asia Pacific Laboratory Developed Tests Market
      • 7.3.3.7.1 Rest of Asia Pacific Laboratory Developed Tests Market by Application
      • 7.3.3.7.2 Rest of Asia Pacific Laboratory Developed Tests Market by Technology
• 7.4 LAMEA Laboratory Developed Tests Market
  • 7.4.1 LAMEA Laboratory Developed Tests Market by Application
    • 7.4.1.1 LAMEA Oncology Market by Country
    • 7.4.1.2 LAMEA Genetic Disorders/Inherited Disease Market by Country
    • 7.4.1.3 LAMEA Infectious & Parasitic Diseases Market by Country
    • 7.4.1.4 LAMEA Endocrine Market by Country
    • 7.4.1.5 LAMEA Immunology Market by Country
    • 7.4.1.6 LAMEA Nutritional & Metabolic Disease Market by Country
    • 7.4.1.7 LAMEA Cardiology Market by Country
    • 7.4.1.8 LAMEA Mental/Behavioral Disorder Market by Country
    • 7.4.1.9 LAMEA Pediatrics-specific Testing Market by Country
    • 7.4.1.10 LAMEA Others Market by Country
  • 7.4.2 LAMEA Laboratory Developed Tests Market by Technology
    • 7.4.2.1 LAMEA Molecular Diagnostics Market by Country
    • 7.4.2.2 LAMEA Immunoassays Market by Country
    • 7.4.2.3 LAMEA Hematology & Coagulation Market by Country
    • 7.4.2.4 LAMEA Microbiology Market by Country
    • 7.4.2.5 LAMEA Clinical Chemistry Market by Country
    • 7.4.2.6 LAMEA Histology/Cytology Market by Country
    • 7.4.2.7 LAMEA Flow Cytometry Market by Country
    • 7.4.2.8 LAMEA Mass Spectroscopy Market by Country
    • 7.4.2.9 LAMEA Others Market by Country
  • 7.4.3 LAMEA Laboratory Developed Tests Market by Country
    • 7.4.3.1 Brazil Laboratory Developed Tests Market
      • 7.4.3.1.1 Brazil Laboratory Developed Tests Market by Application
      • 7.4.3.1.2 Brazil Laboratory Developed Tests Market by Technology
    • 7.4.3.2 Argentina Laboratory Developed Tests Market
      • 7.4.3.2.1 Argentina Laboratory Developed Tests Market by Application
      • 7.4.3.2.2 Argentina Laboratory Developed Tests Market by Technology
    • 7.4.3.3 UAE Laboratory Developed Tests Market
      • 7.4.3.3.1 UAE Laboratory Developed Tests Market by Application
      • 7.4.3.3.2 UAE Laboratory Developed Tests Market by Technology
    • 7.4.3.4 Saudi Arabia Laboratory Developed Tests Market
      • 7.4.3.4.1 Saudi Arabia Laboratory Developed Tests Market by Application
      • 7.4.3.4.2 Saudi Arabia Laboratory Developed Tests Market by Technology
    • 7.4.3.5 South Africa Laboratory Developed Tests Market
      • 7.4.3.5.1 South Africa Laboratory Developed Tests Market by Application
      • 7.4.3.5.2 South Africa Laboratory Developed Tests Market by Technology
    • 7.4.3.6 Nigeria Laboratory Developed Tests Market
      • 7.4.3.6.1 Nigeria Laboratory Developed Tests Market by Application
      • 7.4.3.6.2 Nigeria Laboratory Developed Tests Market by Technology
    • 7.4.3.7 Rest of LAMEA Laboratory Developed Tests Market
      • 7.4.3.7.1 Rest of LAMEA Laboratory Developed Tests Market by Application
      • 7.4.3.7.2 Rest of LAMEA Laboratory Developed Tests Market by Technology

Chapter 8. Company Profiles

• 8.1 Neogenomics, Inc.
  • 8.1.1 Company Overview
  • 8.1.2 Financial Analysis
  • 8.1.3 Segmental Analysis
  • 8.1.4 Research & Development Expenses
  • 8.1.5 Recent strategies and developments:
    • 8.1.5.1 Partnerships, Collaborations, and Agreements:
  • 8.1.6 SWOT Analysis
• 8.2 Guardant Health, Inc.
  • 8.2.1 Company Overview
  • 8.2.2 Financial Analysis
  • 8.2.3 Regional Analysis
  • 8.2.4 Research & Development Expenses
  • 8.2.5 Recent strategies and developments:
    • 8.2.5.1 Partnerships, Collaborations, and Agreements:
  • 8.2.6 SWOT Analysis
• 8.3 Qiagen N.V.
  • 8.3.1 Company Overview
  • 8.3.2 Financial Analysis
  • 8.3.3 Regional Analysis
  • 8.3.4 Research & Development Expenses
  • 8.3.5 Recent strategies and developments:
    • 8.3.5.1 Partnerships, Collaborations, and Agreements:
    • 8.3.5.2 Product Launches and Product Expansions:
    • 8.3.5.3 Acquisition and Mergers:
  • 8.3.6 SWOT Analysis
• 8.4 Quest Diagnostics Incorporated
  • 8.4.1 Company Overview
  • 8.4.2 Financial Analysis
  • 8.4.3 Segmental Analysis
  • 8.4.4 Recent strategies and developments:
    • 8.4.4.1 Acquisition and Mergers:
  • 8.4.5 SWOT Analysis
• 8.5 Abbott Laboratories
  • 8.5.1 Company Overview
  • 8.5.2 Financial Analysis
  • 8.5.3 Segmental and Regional Analysis
  • 8.5.4 Research & Development Expense
  • 8.5.5 Recent strategies and developments:
    • 8.5.5.1 Partnerships, Collaborations, and Agreements:
  • 8.5.6 SWOT Analysis
• 8.6 Siemens Healthineers AG (Siemens AG)
  • 8.6.1 Company Overview
  • 8.6.2 Financial Analysis
  • 8.6.3 Segmental and Regional Analysis
  • 8.6.4 Research & Development Expense
  • 8.6.5 Recent strategies and developments:
    • 8.6.5.1 Partnerships, Collaborations, and Agreements:
  • 8.6.6 SWOT Analysis
• 8.7 Illumina, Inc.
  • 8.7.1 Company Overview
  • 8.7.2 Financial Analysis
  • 8.7.3 Segment and Regional Analysis
  • 8.7.4 Research & Development Expense
  • 8.7.5 SWOT Analysis
• 8.8 Bio-Rad laboratories, Inc.
  • 8.8.1 Company Overview
  • 8.8.2 Financial Analysis
  • 8.8.3 Segmental and Regional Analysis
  • 8.8.4 Research & Development Expenses
  • 8.8.5 Recent strategies and developments:
    • 8.8.5.1 Partnerships, Collaborations, and Agreements:
  • 8.8.6 SWOT Analysis
• 8.9 F. Hoffmann-La Roche Ltd.
  • 8.9.1 Company Overview
  • 8.9.2 Financial Analysis
  • 8.9.3 Segmental and Regional Analysis
  • 8.9.4 Research & Development Expense
  • 8.9.5 SWOT Analysis
• 8.10. Eurofins Scientific SE
  • 8.10.1 Company Overview
  • 8.10.2 Financial Analysis
  • 8.10.3 Regional Analysis
  • 8.10.4 SWOT Analysis

Chapter 9. Winning Imperatives of Laboratory Developed Tests Market