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Laboratory Developed Tests Market by Technology, by Application, and by Region - Global Forecast to 2023-2033

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    Report

  • 200 Pages
  • January 2023
  • Region: Global
  • Quintana Research and Consulting
  • ID: 5717230
The laboratory developed tests market size is estimated to be USD 10,252.4 million in 2022 and is expected to witness a CAGR of 6.81% during the forecast period 2023-2033. Escalating demand for personalized medicine, increasing the use of modern technology and expanding the healthcare infrastructure are projected to drive the market growth in near future. Furthermore, rising approval and product launch and surge in demand for in vitro diagnostic tests are other factors supporting the market growth. However, fluctuating regulatory landscapes is predicted to limit market growth.

Rising approval and product launch is expected to fuel the market growth during the forecast period. For instance, Bionano Genomics launched its first OGM-based LDT for facioscapulohumeral muscular dystrophy in September 2022. The Clinical Laboratory Improvement Amendments (CLIA) focus more emphasis on analytical performance and limit the Centers for Medicare & Medicaid Services' control over the usefulness or quality of LDTs, including whether or not patients have been harmed as a result of their use.

Increasing the use of modern technology and expanding the healthcare infrastructure is predicted to spur the market growth during the projected period. The laboratory-developed tests (LDTs) market also offers a thorough market analysis for each nation, which covers such factors as the rise in healthcare capital expenditure, the installed base of various types of products for the laboratory-developed tests market, the influence of technology using lifeline curves, and modifications to healthcare regulatory scenarios and their effects on the laboratory-developed test market.

Segmentation

By Technology

The market is categorized into hematology & coagulation, immunoassays, microbiology, molecular diagnostics, histology/cytology, clinical chemistry, flow cytometry, and others. In 2022, the molecular diagnostics segment accounted for the highest revenue share due to the ageing population and the growing demand for early disease detection. The demand for early disease detection & routine monitoring is predicted to increase due to the increasing number of chronic diseases and the growing need to control healthcare costs. The segment for genetic/inherited diseases is anticipated to develop at the second-fastest rate during the projected period. The rising incidence of genetic and inherited disorders and the high demand for prenatal diagnostic tests are both responsible for the segment's expansion. There has been an increase in screening tests used to find abnormalities in infants. More than 40 noninvasive prenatal tests are reportedly on the market, but none of them have received FDA approval. These tests boost the market for LDTs and contribute to the expansion of the entire industry.

By Application

The market is categorized into endocrine, immunology, oncology, hematology/general blood testing, infectious & parasitic diseases, toxicology, nutritional & metabolic disease, cardiology, mental/behavioral disorder, bodily fluid analysis, genetic disorders/inherited disease, pediatrics-specific testing, and other diseases. In the global market, the oncology segment accounted for the largest revenue share in 2022 owing to the fact that numerous other applications, including toxicology or blood coagulation, and oncology and hereditary diseases are also widely used. In September 2022, for instance, Allelica introduced ancestry-specific Polygenic Risk Score (PRS) analysis as an LDT for prostate cancer, coronary artery disease, breast cancer, Alzheimer's disease, and type 2 diabetes. The market is also experiencing significant expansion as a result of the rising incidence of cancer and the accelerating pace of cancer diagnosis. Neogenomics, for instance, released data on its LDT RaDaR assay in June 2022 with the purpose of helping its subsidiary Inivata Ltd. diagnose MRD. The immunoassay segment is anticipated to grow at the fastest CAGR over the forecast period due to longer lifespans, which enhance product demand as these tests continue to be the major form of diagnosis.

Regional Markets

In 2022, North America region accounted for the highest revenue in the laboratory developed tests market and is expected to maintain its dominance during the forecast period. This is attributed to higher healthcare costs, surge in the incidence of chronic diseases, increase in the number of elderly people, and rising funding. For instance, the U.S. Census Bureau estimates that there are 56 million seniors in the country, or 16.9% of the overall population. The region's market for molecular diagnostics is anticipated to expand at the fastest rate throughout the forecast period, propelling the expansion of the LDT industry. Additionally, major players are focusing on the development of novel products and obtaining regulatory approvals, which in turn fuels the expansion of LDT. For instance, Biomerica, Inc. introduced InFoods, an LDT for an IBS test, in August 2022. The region of Asia Pacific is anticipated to grow at the fastest rate throughout the projection period. This is due to the region's unmet medical requirements, increasing scientific research, and robust economic expansion. There is a significant demand for the development of novel products.

Competitor Insights

Some of the key players operating in the laboratory developed tests market are NeoGenomics Laboratories, 23andme, Inc., Guardant Health, Siemens Healthcare Pvt. Ltd., Illumina, Inc., Abbott, Quest Diagnostics Inc., QIAGEN, and F. Hoffmann-La Roche Ltd.

To achieve a competitive edge, these companies are implementing a variety of growth strategies. Strategic partnerships, alliances, and agreements with different businesses and research institutions are seen to be the main strategies used by companies in this sector.

For instance, Quanterix Corp. launched the first TDTs for the diagnostic test of Alzheimer's disease in July 2022 to assist clinical diagnostics and research applications in the United States.

This comprehensive research report focuses on the global and regional market size and forecasts of diverse segments including technology and application from 2022 to 2033.

Segmentation: Laboratory Developed Tests Market Report 2022 - 2033

Technology (Revenue, USD Million), 2022 - 2033

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

Application (Revenue, USD Million), 2022 - 2033

  • Endocrine
  • Immunology
  • Oncology
  • Hematology/General Blood Testing
  • Infectious & Parasitic Diseases
  • Toxicology
  • Nutritional & Metabolic Disease
  • Cardiology
  • Mental/Behavioral Disorder
  • Bodily Fluid Analysis
  • Genetic Disorders/Inherited Disease
  • Pediatrics-specific Testing
  • Other Diseases

By Region (Revenue, USD Million), 2022 - 2033

North America

  • U.S.
  • Canada

Europe

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

Asia Pacific

  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of APAC

Latin America

  • Brazil
  • Mexico
  • Argentina
  • Rest of LATAM

Middle East & Africa

  • South Africa
  • GCC
  • Rest of MEA

Table of Contents

1. Research Methodology
1.1. Study Objectives
1.2. Study Scope
1.3. Research Framework
1.3.1. Research Models
1.3.1.1. Bottom-up Approach
1.3.1.2. Top-down Approach
1.3.1.3. Data Triangulation
1.3.2. Data Analysis
1.3.2.1. Data Validation
1.3.2.2. Market Size Estimation
1.3.2.3. Market Forecast Model

2. Introduction: Laboratory Developed Tests

3. Executive Summary

4. Market Dynamics
4.1. Market Drivers
4.1.1. Driver 1
4.1.2. Driver 2
4.1.3. Driver 3
4.1.4. Driver 4
4.1.5. Driver 5
4.2. Market Restraint
4.2.1. Restraint 1
4.2.2. Restraint 2
4.2.3. Restraint 3
4.2.4. Restraint 4
4.3. Market Opportunities
4.3.1. Opportunity 1
4.3.2. Opportunity 2
4.3.3. Opportunity 3
4.3.4. Opportunity 4
4.4. Market Trends
4.4.1. Trend 1
4.4.2. Trend 2
4.4.3. Trend 3
4.4.4. Trend 4
4.5. Market Challenges
4.5.1. Challenge 1
4.5.2. Challenge 2
4.5.3. Challenge 3
4.5.4. Challenge 4

5. Market Environment Analysis
5.1. Porter’s 5 Forces Analysis
5.2. PESTEL Analysis
5.3. SWOT Analysis

6. COVID-19 Impact Analysis: Laboratory Developed Tests Market

7. Market Analysis by Technology
7.1. Hematology & Coagulation
7.1.1. Hematology & Coagulation Market Forecast, 2022-2033 (USD Million)
7.2. Immunoassays
7.2.1. Immunoassays Market Forecast, 2022-2033 (USD Million)
7.3. Microbiology
7.3.1. Microbiology Market Forecast, 2022-2033 (USD Million)
7.4. Molecular Diagnostics
7.4.1. Molecular Diagnostics Market Forecast, 2022-2033 (USD Million)
7.5. Histology/Cytology
7.5.1. Histology/Cytology Market Forecast, 2022-2033 (USD Million)
7.6. Clinical Chemistry
7.6.1. Clinical Chemistry Market Forecast, 2022-2033 (USD Million)
7.7. Flow Cytometry
7.7.1. Flow Cytometry Market Forecast, 2022-2033 (USD Million)
7.8. Others
7.8.1. Others Market Forecast, 2022-2033 (USD Million)

8. Market Analysis by Application
8.1. Endocrine
8.1.1. Endocrine Market Forecast, 2022-2033 (USD Million)
8.2. Immunology
8.2.1. Immunology Market Forecast, 2022-2033 (USD Million)
8.3. Oncology
8.3.1. Oncology Market Forecast, 2022-2033 (USD Million)
8.4. Hematology/General Blood Testing
8.4.1. Hematology/General Blood Testing Market Forecast, 2022-2033 (USD Million)
8.5. Infectious & Parasitic Diseases
8.5.1. Infectious & Parasitic Diseases Market Forecast, 2022-2033 (USD Million)
8.6. Toxicology
8.6.1. Toxicology Market Forecast, 2022-2033 (USD Million)
8.7. Nutritional & Metabolic Disease
8.7.1. Nutritional & Metabolic Disease Market Forecast, 2022-2033 (USD Million)
8.8. Cardiology
8.8.1. Cardiology Market Forecast, 2022-2033 (USD Million)
8.9. Mental/Behavioral Disorder
8.9.1. Mental/Behavioral Disorder Market Forecast, 2022-2033 (USD Million)
8.10. Bodily Fluid Analysis
8.10.1. Bodily Fluid Analysis Market Forecast, 2022-2033 (USD Million)
8.11. Genetic Disorders/Inherited Disease
8.11.1. Genetic Disorders/Inherited Disease Market Forecast, 2022-2033 (USD Million)
8.12. Pediatrics-specific Testing
8.12.1. Pediatrics-specific Testing Market Forecast, 2022-2033 (USD Million)
8.13. Other Diseases
8.13.1. Other Diseases Market Forecast, 2022-2033 (USD Million)
8.14.
8.14.1. Environment Testing Market Forecast, 2022-2033 (USD Million)
8.1. Pharmaceutical Companies & Biopharmaceutical
8.1.1. Pharmaceutical Companies & Biopharmaceutical Market Forecast, 2022-2033 (USD Million)
8.2. Food & Beverage
8.2.1. Food & Beverage Market Forecast, 2022-2033 (USD Million)
8.3. Oil & Gas
8.3.1. Oil & Gas Market Forecast, 2022-2033 (USD Million)
8.4. Others
8.4.1. Others Market Forecast, 2022-2033 (USD Million)

9. Regional Market Analysis
9.1. Regional Market Trends

10. North America Laboratory Developed Tests Market
10.1. North America Laboratory Developed Tests Market
10.1.1. North America Market Size and Forecast, 2022-2033 (USD Million)
10.1.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
10.1.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)
10.2. U.S. Laboratory Developed Tests Market
10.2.1. U.S. Market Size and Forecast, 2022-2033 (USD Million)
10.2.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
10.2.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)
10.3. Canada Laboratory Developed Tests Market
10.3.1. Canada Market Size and Forecast, 2022-2033 (USD Million)
10.3.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
10.3.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)

11. Europe Laboratory Developed Tests Market
11.1. Europe Laboratory Developed Tests Market
11.1.1. Europe Market Size and Forecast, 2022-2033 (USD Million)
11.1.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
11.1.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)
11.2. Germany Laboratory Developed Tests Market
11.2.1. Germany Market Size and Forecast, 2022-2033 (USD Million)
11.2.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
11.2.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)
11.3. UK Laboratory Developed Tests Market
11.3.1. UK Market Size and Forecast, 2022-2033 (USD Million)
11.3.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
11.3.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)
11.4. France Laboratory Developed Tests Market
11.4.1. France Market Size and Forecast, 2022-2033 (USD Million)
11.4.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
11.4.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)
11.5. Spain Laboratory Developed Tests Market
11.5.1. Spain Market Size and Forecast, 2022-2033 (USD Million)
11.5.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
11.5.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)
11.6. Italy Laboratory Developed Tests Market
11.6.1. Italy Market Size and Forecast, 2022-2033 (USD Million)
11.6.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
11.6.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)
11.7. Rest of Europe Laboratory Developed Tests Market
11.7.1. Rest of Europe Market Size and Forecast, 2022-2033 (USD Million)
11.7.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
11.7.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)

12. Asia Pacific Laboratory Developed Tests Market
12.1. Asia Pacific Laboratory Developed Tests Market
12.1.1. Asia Pacific Market Size and Forecast, 2022-2033 (USD Million)
12.1.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
12.1.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)
12.2. Japan Laboratory Developed Tests Market
12.2.1. Japan Market Size and Forecast, 2022-2033 (USD Million)
12.2.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
12.2.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)
12.3. China Laboratory Developed Tests Market
12.3.1. China Market Size and Forecast, 2022-2033 (USD Million)
12.3.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
12.3.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)
12.4. India Laboratory Developed Tests Market
12.4.1. India Market Size and Forecast, 2022-2033 (USD Million)
12.4.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
12.4.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)
12.5. South Korea Laboratory Developed Tests Market
12.5.1. South Korea Market Size and Forecast, 2022-2033 (USD Million)
12.5.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
12.5.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)
12.5.1.3. Market Size and Forecast by Device, 2022-2033 (USD Million)
12.6. Australia Laboratory Developed Tests Market
12.6.1. Australia Market Size and Forecast, 2022-2033 (USD Million)
12.6.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
12.6.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)
12.7. Rest of Asia Pacific Laboratory Developed Tests Market
12.7.1. Rest of Asia Pacific Market Size and Forecast, 2022-2033 (USD Million)
12.7.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
12.7.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)

13. Latin America Laboratory Developed Tests Market
13.1. Latin America Laboratory Developed Tests Market
13.1.1. Latin America Market Size and Forecast, 2022-2033 (USD Million)
13.1.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
13.1.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)
13.2. Brazil Laboratory Developed Tests Market
13.2.1. Brazil Market Size and Forecast, 2022-2033 (USD Million)
13.2.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
13.2.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)
13.3. Mexico Laboratory Developed Tests Market
13.3.1. Mexico Market Size and Forecast, 2022-2033 (USD Million)
13.3.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
13.3.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)
13.4. Argentina Laboratory Developed Tests Market
13.4.1. Argentina Market Size and Forecast, 2022-2033 (USD Million)
13.4.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
13.4.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)
13.5. Rest of Latin America Laboratory Developed Tests Market
13.5.1. Rest of Latin America Market Size and Forecast, 2022-2033 (USD Million)
13.5.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
13.5.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)

14. MEA Laboratory Developed Tests Market
14.1. MEA Laboratory Developed Tests Market
14.1.1. MEA Market Size and Forecast, 2022-2033 (USD Million)
14.1.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
14.1.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)
14.2. GCC Laboratory Developed Tests Market
14.2.1. GCC Market Size and Forecast, 2022-2033 (USD Million)
14.2.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
14.2.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)
14.3. South Africa Laboratory Developed Tests Market
14.3.1. South Africa Market Size and Forecast, 2022-2033 (USD Million)
14.3.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
14.3.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)
14.4. Rest of MEA Laboratory Developed Tests Market
14.4.1. Rest of MEA Market Size and Forecast, 2022-2033 (USD Million)
14.4.1.1. Market Size and Forecast by Technology, 2022-2033 (USD Million)
14.4.1.2. Market Size and Forecast by Application, 2022-2033 (USD Million)

15. Competitor Analysis
15.1. Market Share Analysis, 2022
15.2. Major Recent Developments, 2019-2022

16. Company Profiles
16.1. NeoGenomics Laboratories
16.1.1. Company Snapshot
16.1.2. Company Overview
16.1.3. Financials
16.1.4. Product Benchmarking
16.1.5. Recent Developments
16.2.23andme, Inc.
16.2.1. Company Snapshot
16.2.2. Company Overview
16.2.3. Financials
16.2.4. Product Benchmarking
16.2.5. Recent Developments
16.3. Guardant Health
16.3.1. Company Snapshot
16.3.2. Company Overview
16.3.3. Financials
16.3.4. Product Benchmarking
16.3.5. Recent Developments
16.4. Siemens Healthcare Pvt. Ltd
16.4.1. Company Snapshot
16.4.2. Company Overview
16.4.3. Financials
16.4.4. Product Benchmarking
16.4.5. Recent Developments
16.5. Illumina, Inc.
16.5.1. Company Snapshot
16.5.2. Company Overview
16.5.3. Financials
16.5.4. Product Benchmarking
16.5.5. Recent Developments
16.6. Abbott
16.6.1. Company Snapshot
16.6.2. Company Overview
16.6.3. Financials
16.6.4. Product Benchmarking
16.6.5. Recent Developments
16.7. Quest Diagnostics Inc
16.7.1. Company Snapshot
16.7.2. Company Overview
16.7.3. Financials
16.7.4. Product Benchmarking
16.7.5. Recent Developments
16.8. QIAGEN
16.8.1. Company Snapshot
16.8.2. Company Overview
16.8.3. Financials
16.8.4. Product Benchmarking
16.8.5. Recent Developments
16.9. F. Hoffmann-La Roche Ltd.
16.9.1. Company Snapshot
16.9.2. Company Overview
16.9.3. Financials
16.9.4. Product Benchmarking
16.9.5. Recent Developments
16.10. Company 10
16.10.1. Company Snapshot
16.10.2. Company Overview
16.10.3. Financials
16.10.4. Product Benchmarking
16.10.5. Recent Developments
16.11. Company 11
16.11.1. Company Snapshot
16.11.2. Company Overview
16.11.3. Financials
16.11.4. Product Benchmarking
16.11.5. Recent Developments
16.12. Company 12
16.12.1. Company Snapshot
16.12.2. Company Overview
16.12.3. Financials
16.12.4. Product Benchmarking
16.12.5. Recent Developments
16.13. Company 13
16.13.1. Company Snapshot
16.13.2. Company Overview
16.13.3. Financials
16.13.4. Product Benchmarking
16.13.5. Recent Developments
16.14. Company 14
16.14.1. Company Snapshot
16.14.2. Company Overview
16.14.3. Financials
16.14.4. Product Benchmarking
16.14.5. Recent Developments
16.15. Company 15
16.15.1. Company Snapshot
16.15.2. Company Overview
16.15.3. Financials
16.15.4. Product Benchmarking
16.15.5. Recent Developments
16.16. Others Prominent Players

17. Conclusion & Recommendations

Companies Mentioned

A selection of companies mentioned in this report includes:

  • NeoGenomics Laboratories
  • 23andme Inc.
  • Guardant Health
  • Siemens Healthcare Pvt. Ltd.
  • Illumina Inc.
  • Abbott
  • Quest Diagnostics Inc.
  • QIAGEN
  • F. Hoffmann-La Roche Ltd.