Laboratory Developed Tests Market Size, Growth, Trends | Report 2022-2030
The global laboratory developed tests market was valued at USD 4.54 billion in 2021 and it is predicted to surpass around USD 8.49 billion by 2030 with a CAGR of 7.2% from 2022 to 2030.
The growth of laboratory developed tests market is attributed to the increasing prevalence of chronic and genetic diseases, infectious and autoimmune diseases, and increasing awareness among the population for healthy living. For the simple reason that they are generated and utilized in laboratories, lab-developed tests (LDTs) are released into the market without FDA approval or any other independent regulatory assessment. Although it oversees labs, the Centers for Medicare & Medicaid Services (CMS) has little knowledge of the usefulness, dependability, or quality of LDTs, particularly whether patients have been harmed as a result of their use.
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.
Oncology and hereditary illnesses are frequent applications, but broad use is also seen in a variety of other applications, such as toxicology or blood coagulation. For instance, in September 2022, Allelica launched ancestry-specific polygenic risk score (PRS) analysis as a laboratory-developed test (LDT) for prostate cancer, coronary artery disease, breast cancer, Alzheimer's disease, and type 2 diabetes.
North America dominated the LDTs market in 2021 which can be attributed to rising healthcare expenditure, increasing prevalence of chronic diseases, growing geriatric population, and increasing government funding. For instance, according to the U.S. Census Bureau, the geriatric population is around 56 million accounting for 16.9% of the total country’s population. The molecular diagnostic market in the region is expected to grow at the fastest growth rate over the forecast period subsequently driving the overall market growth. Moreover, key players in the LDT market are focusing on developing novel products and achieving regulatory approvals which in turn drive the market growth. For instance, in July 2022 Quanterix Corporation launched the first pTau-181 plasma laboratory-developed test for research applications and clinical diagnostics in the U.S.
Scope of The Report
| Report Coverage | Details |
| Market Size in 2021 | USD 4.54 billion |
| Revenue Forecast by 2030 | USD 8.49 billion |
| Growth rate from 2022 to 2030 | CAGR of 7.2% |
| Base Year | 2021 |
| Forecast Period | 2022 to 2030 |
| Segmentation | Technology, Application, Region |
| Companies Covered |
Quest Diagnostics Incorporated., Abbott; Guardant Health; Siemens Healthcare Private Limited.; QIAGEN; Eurofins Scientific, Illumina, Inc.; F. Hoffmann-La Roche Ltd. |
Key Players
Market Segmentation
Chapter 1. Introduction
1.1. Research Objective
1.2. Scope of the Study
1.3. Definition
Chapter 2. Research Methodology
2.1. Research Approach
2.2. Data Sources
2.3. Assumptions & Limitations
Chapter 3. Executive Summary
3.1. Market Snapshot
Chapter 4. Market Variables and Scope
4.1. Introduction
4.2. Market Classification and Scope
4.3. Industry Value Chain Analysis
4.3.1. Raw Material Procurement Analysis
4.3.2. Sales and Distribution Channel Analysis
4.3.3. Downstream Buyer Analysis
Chapter 5. COVID 19 Impact on Laboratory Developed Tests Market
5.1. COVID-19 Landscape: Laboratory Developed Tests Industry Impact
5.2. COVID 19 - Impact Assessment for the Industry
5.3. COVID 19 Impact: Global Major Government Policy
5.4. Market Trends and Opportunities in the COVID-19 Landscape
Chapter 6. Market Dynamics Analysis and Trends
6.1. Market Dynamics
6.1.1. Market Drivers
6.1.2. Market Restraints
6.1.3. Market Opportunities
6.2. Porter’s Five Forces Analysis
6.2.1. Bargaining power of suppliers
6.2.2. Bargaining power of buyers
6.2.3. Threat of substitute
6.2.4. Threat of new entrants
6.2.5. Degree of competition
Chapter 7. Competitive Landscape
7.1.1. Company Market Share/Positioning Analysis
7.1.2. Key Strategies Adopted by Players
7.1.3. Vendor Landscape
7.1.3.1. List of Suppliers
7.1.3.2. List of Buyers
Chapter 8. Global Laboratory Developed Tests Market, By Technology
8.1. Laboratory Developed Tests Market, by Technology, 2022-2030
8.1.1. Immunoassays
8.1.1.1. Market Revenue and Forecast (2017-2030)
8.1.2. Hematology and coagulation
8.1.2.1. Market Revenue and Forecast (2017-2030)
8.1.3. Molecular diagnostics
8.1.3.1. Market Revenue and Forecast (2017-2030)
8.1.4. Microbiology
8.1.4.1. Market Revenue and Forecast (2017-2030)
8.1.5. Clinical Chemistry
8.1.5.1. Market Revenue and Forecast (2017-2030)
8.1.6. Histology/cytology
8.1.6.1. Market Revenue and Forecast (2017-2030)
8.1.7. Flow cytometry
8.1.7.1. Market Revenue and Forecast (2017-2030)
8.1.8. Mass spectroscopy
8.1.8.1. Market Revenue and Forecast (2017-2030)
8.1.9. Others
8.1.9.1. Market Revenue and Forecast (2017-2030)
Chapter 9. Global Laboratory Developed Tests Market, By Application
9.1. Laboratory Developed Tests Market, by Application, 2022-2030
9.1.1. Oncology
9.1.1.1. Market Revenue and Forecast (2017-2030)
9.1.2. Genetic disorders/inherited disease
9.1.2.1. Market Revenue and Forecast (2017-2030)
9.1.3. Infectious and parasitic diseases
9.1.3.1. Market Revenue and Forecast (2017-2030)
9.1.4. Immunology
9.1.4.1. Market Revenue and Forecast (2017-2030)
9.1.5. Endocrine
9.1.5.1. Market Revenue and Forecast (2017-2030)
9.1.6. nutritional and metabolic disease
9.1.6.1. Market Revenue and Forecast (2017-2030)
9.1.7. Cardiology
9.1.7.1. Market Revenue and Forecast (2017-2030)
9.1.8. Mental/behavioral disorder
9.1.8.1. Market Revenue and Forecast (2017-2030)
9.1.9. Pediatrics-specific testing
9.1.9.1. Market Revenue and Forecast (2017-2030)
9.1.10. Hematology/general blood testing
9.1.10.1. Market Revenue and Forecast (2017-2030)
9.1.11. Bodily fluid analysis
9.1.11.1. Market Revenue and Forecast (2017-2030)
9.1.12. Toxicology
9.1.12.1. Market Revenue and Forecast (2017-2030)
9.1.13. Other Diseases
9.1.13.1. Market Revenue and Forecast (2017-2030)
Chapter 10. Global Laboratory Developed Tests Market, Regional Estimates and Trend Forecast
10.1. North America
10.1.1. Market Revenue and Forecast, by Technology (2017-2030)
10.1.2. Market Revenue and Forecast, by Application (2017-2030)
10.1.3. U.S.
10.1.3.1. Market Revenue and Forecast, by Technology (2017-2030)
10.1.3.2. Market Revenue and Forecast, by Application (2017-2030)
10.1.4. Rest of North America
10.1.4.1. Market Revenue and Forecast, by Technology (2017-2030)
10.1.4.2. Market Revenue and Forecast, by Application (2017-2030)
10.2. Europe
10.2.1. Market Revenue and Forecast, by Technology (2017-2030)
10.2.2. Market Revenue and Forecast, by Application (2017-2030)
10.2.3. UK
10.2.3.1. Market Revenue and Forecast, by Technology (2017-2030)
10.2.3.2. Market Revenue and Forecast, by Application (2017-2030)
10.2.4. Germany
10.2.4.1. Market Revenue and Forecast, by Technology (2017-2030)
10.2.4.2. Market Revenue and Forecast, by Application (2017-2030)
10.2.5. France
10.2.5.1. Market Revenue and Forecast, by Technology (2017-2030)
10.2.5.2. Market Revenue and Forecast, by Application (2017-2030)
10.2.6. Rest of Europe
10.2.6.1. Market Revenue and Forecast, by Technology (2017-2030)
10.2.6.2. Market Revenue and Forecast, by Application (2017-2030)
10.3. APAC
10.3.1. Market Revenue and Forecast, by Technology (2017-2030)
10.3.2. Market Revenue and Forecast, by Application (2017-2030)
10.3.3. India
10.3.3.1. Market Revenue and Forecast, by Technology (2017-2030)
10.3.3.2. Market Revenue and Forecast, by Application (2017-2030)
10.3.4. China
10.3.4.1. Market Revenue and Forecast, by Technology (2017-2030)
10.3.4.2. Market Revenue and Forecast, by Application (2017-2030)
10.3.5. Japan
10.3.5.1. Market Revenue and Forecast, by Technology (2017-2030)
10.3.5.2. Market Revenue and Forecast, by Application (2017-2030)
10.3.6. Rest of APAC
10.3.6.1. Market Revenue and Forecast, by Technology (2017-2030)
10.3.6.2. Market Revenue and Forecast, by Application (2017-2030)
10.4. MEA
10.4.1. Market Revenue and Forecast, by Technology (2017-2030)
10.4.2. Market Revenue and Forecast, by Application (2017-2030)
10.4.3. GCC
10.4.3.1. Market Revenue and Forecast, by Technology (2017-2030)
10.4.3.2. Market Revenue and Forecast, by Application (2017-2030)
10.4.4. North Africa
10.4.4.1. Market Revenue and Forecast, by Technology (2017-2030)
10.4.4.2. Market Revenue and Forecast, by Application (2017-2030)
10.4.5. South Africa
10.4.5.1. Market Revenue and Forecast, by Technology (2017-2030)
10.4.5.2. Market Revenue and Forecast, by Application (2017-2030)
10.4.6. Rest of MEA
10.4.6.1. Market Revenue and Forecast, by Technology (2017-2030)
10.4.6.2. Market Revenue and Forecast, by Application (2017-2030)
10.5. Latin America
10.5.1. Market Revenue and Forecast, by Technology (2017-2030)
10.5.2. Market Revenue and Forecast, by Application (2017-2030)
10.5.3. Brazil
10.5.3.1. Market Revenue and Forecast, by Technology (2017-2030)
10.5.3.2. Market Revenue and Forecast, by Application (2017-2030)
10.5.4. Rest of LATAM
10.5.4.1. Market Revenue and Forecast, by Technology (2017-2030)
10.5.4.2. Market Revenue and Forecast, by Application (2017-2030)
Chapter 11. Company Profiles
11.1. Quest Diagnostics Incorporated.
11.1.1. Company Overview
11.1.2. Product Offerings
11.1.3. Financial Performance
11.1.4. Recent Initiatives
11.2. Abbott
11.2.1. Company Overview
11.2.2. Product Offerings
11.2.3. Financial Performance
11.2.4. Recent Initiatives
11.3. Guardant Health
11.3.1. Company Overview
11.3.2. Product Offerings
11.3.3. Financial Performance
11.3.4. Recent Initiatives
11.4. Siemens Healthcare Private Limited.
11.4.1. Company Overview
11.4.2. Product Offerings
11.4.3. Financial Performance
11.4.4. LTE Scientific
11.5. QIAGEN
11.5.1. Company Overview
11.5.2. Product Offerings
11.5.3. Financial Performance
11.5.4. Recent Initiatives
11.6. Eurofins Scientific
11.6.1. Company Overview
11.6.2. Product Offerings
11.6.3. Financial Performance
11.6.4. Recent Initiatives
11.7. Illumina, Inc.
11.7.1. Company Overview
11.7.2. Product Offerings
11.7.3. Financial Performance
11.7.4. Recent Initiatives
11.8. F. Hoffmann-La Roche Ltd.
11.8.1. Company Overview
11.8.2. Product Offerings
11.8.3. Financial Performance
11.8.4. Recent Initiatives
Chapter 12. Research Methodology
12.1. Primary Research
12.2. Secondary Research
12.3. Assumptions
Chapter 13. Appendix
13.1. About Us
13.2. Glossary of Terms
Cross-segment Market Size and Analysis for
Mentioned Segments
Additional Company Profiles (Upto 5 With No Cost)
Additional Countries (Apart From Mentioned Countries)
Country/Region-specific Report
Go To Market Strategy
Region Specific Market DynamicsRegion Level Market Share Import Export AnalysisProduction AnalysisOthers