LDT(Laboratory Developed Tests) 시장 규모, 점유율, 동향 분석 리포트 : 기술별, 용도별, 지역별, 부문별 예측(2024-2030년)

Laboratory Developed Tests Market Growth & Trends:

The global laboratory developed tests market size is expected to reach USD 19.85 billion by 2030, expanding at a CAGR of 7.05% from 2024 to 2030, according to a new report by Grand View Research, Inc. The growth of the industry is attributed to the increasing prevalence of chronic and genetic diseases, infectious & autoimmune diseases, and rising awareness among the population about healthy living. The laboratory-developed tests (LDTs) are generated and utilized in the laboratories, and LDTs are released into the market without FDA approval or any other independent regulatory assessment. LDTs are most typically employed in molecular diagnostics, which includes tests that target a variety of different chemicals in addition to genetics.

For instance, in July 2022, Quest Diagnostics launched a lab-based molecular diagnostic test for the diagnosis of monkeypox virus infections. Moreover, immunoassay is gaining immense adoption and acceptability with the development of novel tests. For instance, in December 2021, OPKO Health, Inc., announced the FDA approval of the 4Kscore test, an LDT in which, four immunoassays are combined into a single numerical score that takes into account the patient's age, biopsy history, and the results of a digital rectal exam. Although LDTs do not require FDA approval as they are not marketed to others, they need to go through rigorous validation procedures. However, the increasing global prevalence of cancer is a key factor driving the industry's growth.

According to GLOBOCAN, in 2020, there were an estimated 19.3 million new cancer cases globally, out of which, 2.3 million were breast cancer cases. Lung cancer was the most common cause of death among cancer patients, representing an unmet need for faster and more accurate diagnostic tools in the segment. In January 2021, the British In Vitro Diagnostics Association urged NHS England for the development of a commissioning framework for molecular diagnostics in oncology. Key players focus on product launches and geographical expansion to gain a higher industry share. For instance, in May 2022, Guardant Health launched Shield, a blood test that is available as an LDT for the detection of early signs of colorectal cancer in the adult population aged above 45 years

Laboratory Developed Tests Market Report Highlights:

• The molecular diagnostic technology segment dominated the industry and accounted for the largest share of the overall revenue in 2023
• The segment growth was attributed to the increased need to provide diagnostics tests for a number of diseases
• The oncology application segment is expected to grow lucratively over the forecast period due to the increasing prevalence of cancer
• The market is expected to grow significantly owing to the introduction of innovative services that can address the growing demands of the target audience
• North America dominated the industry in 2023 owing to the introduction of novel LDT products and the high demand for diagnostics tools with the increasing geriatric population

Table of Contents

Chapter 1. Laboratory Developed Tests Market: Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Technology
  • 1.2.2. Application
  • 1.2.3. Regional scope
  • 1.2.4. Estimates and forecasts timeline
• 1.3. Research Methodology
• 1.4. Information Procurement
  • 1.4.1. Purchased database
  • 1.4.2. GVR's internal database
  • 1.4.3. Secondary sources
  • 1.4.4. Primary research
  • 1.4.5. Details of primary research
    • 1.4.5.1. Data for primary interviews in North America
    • 1.4.5.2. Data for primary interviews in Europe
    • 1.4.5.3. Data for primary interviews in Asia Pacific
    • 1.4.5.4. Data for primary interviews in Latin America
    • 1.4.5.5. Data for Primary interviews in MEA
• 1.5. Information or Data Analysis
  • 1.5.1. Data analysis models
• 1.6. Market Formulation & Validation
• 1.7. Model Details
  • 1.7.1. Commodity flow analysis (Model 1)
  • 1.7.2. Approach 1: Commodity flow approach
  • 1.7.3. Volume price analysis (Model 2)
  • 1.7.4. Approach 2: Volume price analysis
• 1.8. List of Secondary Sources
• 1.9. List of Primary Sources
• 1.10. Objectives

Chapter 2. Laboratory Developed Tests Market: Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
  • 2.2.1. Technology outlook
  • 2.2.2. Application outlook
  • 2.2.3. Regional outlook
• 2.3. Competitive Insights

Chapter 3. Laboratory Developed Tests Market: Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent market outlook
  • 3.1.2. Related/ancillary market outlook
• 3.2. Market Dynamics
  • 3.2.1. Market driver analysis
    • 3.2.1.1. Increasing demand for in vitro diagnostic tests that are currently unavailable in the market
    • 3.2.1.2. Increasing demand for development of personalized medicine
    • 3.2.1.3. No requirement for any regulatory approval
  • 3.2.2. Market restraint analysis
    • 3.2.2.1. High cost associated with the laboratory-developed test
    • 3.2.2.2. Efficacy and safety issues related to LDT
• 3.3. Laboratory Developed Tests (LDT) Market Analysis Tools
  • 3.3.1. Industry Analysis - Porter's
    • 3.3.1.1. Supplier power
    • 3.3.1.2. Buyer power
    • 3.3.1.3. Substitution threat
    • 3.3.1.4. Threat of new entrant
    • 3.3.1.5. Competitive rivalry
  • 3.3.2. PESTEL Analysis
    • 3.3.2.1. Political landscape
    • 3.3.2.2. Technological landscape
    • 3.3.2.3. Economic landscape

Chapter 4. Laboratory Developed Tests (LDT) Market: Technology Estimates & Trend Analysis

• 4.1. Technology Market Share, 2023 & 2030
• 4.2. Segment Dashboard
• 4.3. Global Laboratory Developed Tests (LDT) Market by Technology Outlook
• 4.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
  • 4.4.1. Immunoassays
    • 4.4.1.1. Immunoassays market estimates and forecasts, 2018 to 2030 (USD Million)
  • 4.4.2. Hematology and Coagulation
    • 4.4.2.1. Hematology and coagulation market estimates and forecasts, 2018 to 2030 (USD Million)
  • 4.4.3. Molecular Diagnostics
    • 4.4.3.1. Molecular diagnostics market estimates and forecasts, 2018 to 2030 (USD Million)
  • 4.4.4. Microbiology
    • 4.4.4.1. Microbiology market estimates and forecasts, 2018 to 2030 (USD Million)
  • 4.4.5. Clinical Chemistry
    • 4.4.5.1. Clinical chemistry market estimates and forecasts, 2018 to 2030 (USD Million)
  • 4.4.6. Histology/Cytology
    • 4.4.6.1. Histology/Cytology market estimates and forecasts, 2018 to 2030 (USD Million)
  • 4.4.7. Flow Cytometry
    • 4.4.7.1. Flow Cytometry market estimates and forecasts, 2018 to 2030 (USD Million)
  • 4.4.8. Mass Spectroscopy
    • 4.4.8.1. Mass spectroscopy market estimates and forecasts, 2018 to 2030 (USD Million)
  • 4.4.9. Others
    • 4.4.9.1. Others market estimates and forecasts, 2018 to 2030 (USD Million)

Chapter 5. Laboratory Developed Tests (LDT) Market: Application Estimates & Trend Analysis

• 5.1. Application Market Share, 2023 & 2030
• 5.2. Segment Dashboard
• 5.3. Global Laboratory Developed Tests (LDT) Market by Application Outlook
• 5.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
  • 5.4.1. Oncology
    • 5.4.1.1. Oncology market estimates and forecasts, 2018 to 2030 (USD Million)
  • 5.4.2. Genetic Disorders/Inherited Disease
    • 5.4.2.1. Genetic disorders/Inherited disease market estimates and forecasts, 2018 to 2030 (USD Million)
  • 5.4.3. Infectious & Parasitic Diseases
    • 5.4.3.1. Infectious & parasitic diseases market estimates and forecasts, 2018 to 2030 (USD Million)
  • 5.4.4. Immunology
    • 5.4.4.1. Immunology market estimates and forecasts, 2018 to 2030 (USD Million)
  • 5.4.5. Endocrine
    • 5.4.5.1. Endocrine market estimates and forecasts, 2018 to 2030 (USD Million)
  • 5.4.6. Nutritional & Metabolic Disease
    • 5.4.6.1. Nutritional & metabolic disease market estimates and forecasts, 2018 to 2030 (USD Million)
  • 5.4.7. Cardiology
    • 5.4.7.1. Cardiology market estimates and forecasts, 2018 to 2030 (USD Million)
  • 5.4.8. Mental/Behavioral Disorder
    • 5.4.8.1. Mental/Behavioral disorder market estimates and forecasts, 2018 to 2030 (USD Million)
  • 5.4.9. Pediatrics-specific Testing
    • 5.4.9.1. Pediatrics-specific testing market estimates and forecasts, 2018 to 2030 (USD Million)
  • 5.4.10. Hematology/General Blood Testing
    • 5.4.10.1. Hematology/General blood testing market estimates and forecasts, 2018 to 2030 (USD Million)
  • 5.4.11. Bodily Fluid Analysis
    • 5.4.11.1. Bodily fluid analysis market estimates and forecasts, 2018 to 2030 (USD Million)
  • 5.4.12. Toxicology
    • 5.4.12.1. Toxicology market estimates and forecasts, 2018 to 2030 (USD Million)
  • 5.4.13. Other Diseases
    • 5.4.13.1. Other diseases market estimates and forecasts, 2018 to 2030 (USD Million)

Chapter 6. Laboratory Developed Tests (LDT) Market: Regional Estimates & Trend Analysis

• 6.1. Regional Market Share Analysis, 2023 & 2030
• 6.2. Regional Market Dashboard
• 6.3. Global Regional Market Snapshot
• 6.4. Market Size, & Forecasts Trend Analysis, 2018 to 2030:
• 6.5. North America
  • 6.5.1. U.S.
    • 6.5.1.1. Key country dynamics
    • 6.5.1.2. Regulatory framework/ reimbursement structure
    • 6.5.1.3. Competitive scenario
    • 6.5.1.4. U.S. market estimates and forecasts, 2018 to 2030 (USD Million)
  • 6.5.2. Canada
    • 6.5.2.1. Key country dynamics
    • 6.5.2.2. Regulatory framework/ reimbursement structure
    • 6.5.2.3. Competitive scenario
    • 6.5.2.4. Canada market estimates and forecasts, 2018 to 2030 (USD Million)
• 6.6. Europe
  • 6.6.1. UK
    • 6.6.1.1. Key country dynamics
    • 6.6.1.2. Regulatory framework/ reimbursement structure
    • 6.6.1.3. Competitive scenario
    • 6.6.1.4. UK market estimates and forecasts, 2018 to 2030 (USD Million)
  • 6.6.2. Germany
    • 6.6.2.1. Key country dynamics
    • 6.6.2.2. Regulatory framework/ reimbursement structure
    • 6.6.2.3. Competitive scenario
    • 6.6.2.4. Germany market estimates and forecasts, 2018 to 2030 (USD Million)
  • 6.6.3. France
    • 6.6.3.1. Key country dynamics
    • 6.6.3.2. Regulatory framework/ reimbursement structure
    • 6.6.3.3. Competitive scenario
    • 6.6.3.4. France market estimates and forecasts, 2018 to 2030 (USD Million)
  • 6.6.4. Italy
    • 6.6.4.1. Key country dynamics
    • 6.6.4.2. Regulatory framework/ reimbursement structure
    • 6.6.4.3. Competitive scenario
    • 6.6.4.4. Italy market estimates and forecasts, 2018 to 2030 (USD Million)
  • 6.6.5. Spain
    • 6.6.5.1. Key country dynamics
    • 6.6.5.2. Regulatory framework/ reimbursement structure
    • 6.6.5.3. Competitive scenario
    • 6.6.5.4. Spain market estimates and forecasts, 2018 to 2030 (USD Million)
  • 6.6.6. Norway
    • 6.6.6.1. Key country dynamics
    • 6.6.6.2. Regulatory framework/ reimbursement structure
    • 6.6.6.3. Competitive scenario
    • 6.6.6.4. Norway market estimates and forecasts, 2018 to 2030 (USD Million)
  • 6.6.7. Sweden
    • 6.6.7.1. Key country dynamics
    • 6.6.7.2. Regulatory framework/ reimbursement structure
    • 6.6.7.3. Competitive scenario
    • 6.6.7.4. Sweden market estimates and forecasts, 2018 to 2030 (USD Million)
  • 6.6.8. Denmark
    • 6.6.8.1. Key country dynamics
    • 6.6.8.2. Regulatory framework/ reimbursement structure
    • 6.6.8.3. Competitive scenario
    • 6.6.8.4. Denmark market estimates and forecasts, 2018 to 2030 (USD Million)
• 6.7. Asia Pacific
  • 6.7.1. Japan
    • 6.7.1.1. Key country dynamics
    • 6.7.1.2. Regulatory framework/ reimbursement structure
    • 6.7.1.3. Competitive scenario
    • 6.7.1.4. Japan market estimates and forecasts, 2018 to 2030 (USD Million)
  • 6.7.2. China
    • 6.7.2.1. Key country dynamics
    • 6.7.2.2. Regulatory framework/ reimbursement structure
    • 6.7.2.3. Competitive scenario
    • 6.7.2.4. China market estimates and forecasts, 2018 to 2030 (USD Million)
  • 6.7.3. India
    • 6.7.3.1. Key country dynamics
    • 6.7.3.2. Regulatory framework/ reimbursement structure
    • 6.7.3.3. Competitive scenario
    • 6.7.3.4. India market estimates and forecasts, 2018 to 2030 (USD Million)
  • 6.7.4. Australia
    • 6.7.4.1. Key country dynamics
    • 6.7.4.2. Regulatory framework/ reimbursement structure
    • 6.7.4.3. Competitive scenario
    • 6.7.4.4. Australia market estimates and forecasts, 2018 to 2030 (USD Million)
  • 6.7.5. South Korea
    • 6.7.5.1. Key country dynamics
    • 6.7.5.2. Regulatory framework/ reimbursement structure
    • 6.7.5.3. Competitive scenario
    • 6.7.5.4. South Korea market estimates and forecasts, 2018 to 2030 (USD Million)
  • 6.7.6. Thailand
    • 6.7.6.1. Key country dynamics
    • 6.7.6.2. Regulatory framework/ reimbursement structure
    • 6.7.6.3. Competitive scenario
    • 6.7.6.4. Thailand market estimates and forecasts, 2018 to 2030 (USD Million)
• 6.8. Latin America
  • 6.8.1. Brazil
    • 6.8.1.1. Key country dynamics
    • 6.8.1.2. Regulatory framework/ reimbursement structure
    • 6.8.1.3. Competitive scenario
    • 6.8.1.4. Brazil market estimates and forecasts, 2018 to 2030 (USD Million)
  • 6.8.2. Mexico
    • 6.8.2.1. Key country dynamics
    • 6.8.2.2. Regulatory framework/ reimbursement structure
    • 6.8.2.3. Competitive scenario
    • 6.8.2.4. Mexico market estimates and forecasts, 2018 to 2030 (USD Million)
  • 6.8.3. Argentina
    • 6.8.3.1. Key country dynamics
    • 6.8.3.2. Regulatory framework/ reimbursement structure
    • 6.8.3.3. Competitive scenario
    • 6.8.3.4. Argentina market estimates and forecasts, 2018 to 2030 (USD Million)
• 6.9. MEA
  • 6.9.1. South Africa
    • 6.9.1.1. Key country dynamics
    • 6.9.1.2. Regulatory framework/ reimbursement structure
    • 6.9.1.3. Competitive scenario
    • 6.9.1.4. South Africa market estimates and forecasts, 2018 to 2030 (USD Million)
  • 6.9.2. Saudi Arabia
    • 6.9.2.1. Key country dynamics
    • 6.9.2.2. Regulatory framework/ reimbursement structure
    • 6.9.2.3. Competitive scenario
    • 6.9.2.4. Saudi Arabia market estimates and forecasts, 2018 to 2030 (USD Million)
  • 6.9.3. UAE
    • 6.9.3.1. Key country dynamics
    • 6.9.3.2. Regulatory framework/ reimbursement structure
    • 6.9.3.3. Competitive scenario
    • 6.9.3.4. UAE market estimates and forecasts, 2018 to 2030 (USD Million)
  • 6.9.4. Kuwait
    • 6.9.4.1. Key country dynamics
    • 6.9.4.2. Regulatory framework/ reimbursement structure
    • 6.9.4.3. Competitive scenario
    • 6.9.4.4. Kuwait market estimates and forecasts, 2018 to 2030 (USD Million)

Chapter 7. Competitive Landscape

• 7.1. Recent Developments & Impact Analysis, By Key Market Participants
• 7.2. Company/Competition Categorization
• 7.3. Vendor Landscape
  • 7.3.1. List of key distributors and channel partners
  • 7.3.2. Key customers
  • 7.3.3. Key company market share analysis, 2023
  • 7.3.4. Quest Diagnostics Incorporated.
    • 7.3.4.1. Company overview
    • 7.3.4.2. Financial performance
    • 7.3.4.3. Product benchmarking
    • 7.3.4.4. Strategic initiatives
  • 7.3.5. 23andMe, Inc.
    • 7.3.5.1. Company overview
    • 7.3.5.2. Financial performance
    • 7.3.5.3. Product benchmarking
    • 7.3.5.4. Strategic initiatives
  • 7.3.6. Abbott
    • 7.3.6.1. Company overview
    • 7.3.6.2. Financial performance
    • 7.3.6.3. Product benchmarking
    • 7.3.6.4. Strategic initiatives
  • 7.3.7. Guardant Health
    • 7.3.7.1. Company overview
    • 7.3.7.2. Product benchmarking
    • 7.3.7.3. Strategic initiatives
  • 7.3.8. NeoGenomics Laboratories.
    • 7.3.8.1. Company overview
    • 7.3.8.2. Financial performance
    • 7.3.8.3. Product benchmarking
    • 7.3.8.4. Strategic initiatives
  • 7.3.9. QIAGEN
    • 7.3.9.1. Company overview
    • 7.3.9.2. Financial performance
    • 7.3.9.3. Product benchmarking
    • 7.3.9.4. Strategic initiatives
  • 7.3.10. Siemens Healthineers AG
    • 7.3.10.1. Company overview
    • 7.3.10.2. Product benchmarking
    • 7.3.10.3. Strategic initiatives
  • 7.3.11. Illumina, Inc.
    • 7.3.11.1. Company overview
    • 7.3.11.2. Product benchmarking
    • 7.3.11.3. Strategic initiatives
  • 7.3.12. F. Hoffmann-La Roche Ltd.
    • 7.3.12.1. Company overview
    • 7.3.12.2. Product benchmarking
    • 7.3.12.3. Strategic initiatives