North America Laboratory Developed Test Market Forecast to 2028 - COVID-19 Impact and Regional Analysis By Type (Clinical Biochemistry, Critical Care, Haematology, Microbiology, Molecular Diagnostics, Immunology, and Other Test Types) and Application (Academic Institutes, Clinical Research Organizations, Hospitals Laboratory, Specialty Diagnostic Centers, and Others)
Market Introduction
A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed and used within a single laboratory. These tests can be utilized to estimate or distinguish an extensive assortment of analytes materials such as proteins, chemical compounds like glucose or cholesterol, or DNA, from a specimen received from human anatomy. The expansion of automated in vitro diagnostics (IVD) methods for labs and dispensaries to render precise, and error-free analysis is anticipated to fuel the increment.
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Market Overview and Dynamics
The North America laboratory developed test market is expected to reach US$ 8,988.78 million by 2028 from an estimated value of US$ 5,664.43 million in 2021; it is likely to register a CAGR of 6.8% from 2021 to 2028. The key factors driving the growth of market are increasing incidence of cancer and genetic disorders and a large number of product launches for laboratory developed tests. However, the changing regulatory landscape may hamper the growth of the North America laboratory development test market during the forecast period.
Cancer is one of the leading causes of death worldwide. As per the WHO estimates, cancer was a cause of ~9.6 million deaths in 2018. Clinical diagnostics helps in detecting early signs and risk factors, paving way for early intervention. The laboratory developed tests (LDTs) have a decisive impact on each step of diagnosis, from screening to the prevention of certain diseases and early diagnosis at the onset of illness. For instance, the Oncotype DX lab test is used to determine if chemotherapy would benefit patients with early-stage breast cancer. It also helps evaluate the likelihood of disease recurrence; for this, the test is performed on a small tissue sample removed during breast cancer surgery. In addition, the increasing incidence of genetic disorders is also driving the demand for LDTs. A large number of LDTs are available for genetic testing owing to a lack of availability of genetic tests in the market. As per the Association for Molecular Pathology 2018 assessment, ~70,000 genetic tests are available in the medical market, and most of these are LDTs. Therefore, the rising incidence of cancer and growing awareness regarding the importance of early diagnostics are boosting the adoption of LDTs. Also, LDTs are developed and used within laboratories and are not distributed or sold to other laboratories or healthcare facilities. These tests are developed to overcome the challenge of the unavailability of commercial tests. Many LDTs are genetic tests developed for rare diseases. Thus, the frequency of development and introduction of new LDTs is high. Also, the increasing emergence of SARS-CoV-2 variants has highlighted the need to identify, trace, and track mutations across the complete viral genome. Hence, increasing research on the development of LDTs to detect cancer and autoimmune diseases is driving the market growth.
The COVID-19 pandemic has emphasized a need for widespread diagnostic testing. The commercially available test kits have proved insufficient to meet the demand owing to manufacturing, supply chain limitations, and the timeline required for Food and Drug Administration (FDA) review and authorization of test products. In contrast, laboratory developed tests (LDTs) are internally developed and validated at the performing laboratory allowed laboratories to fill the testing gaps during the pandemic and in other clinical scenarios where commercial tests are scarce. The government regulation efforts have also bolstered the laboratory developed tests growth since the pandemic. In August 2020, to address the COVID-19 testing shortage, the US Department of Health and Human Services (HHS) made a brief statement that effectively rescinded the FDA guidance requiring clinical labs to seek an emergency use authorization (EUA) or submit data to the FDA in conjunction with offering laboratory-developed tests (LDTs).A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed and used within a single laboratory. These tests can be utilized to estimate or distinguish an extensive assortment of analytes materials such as proteins, chemical compounds like glucose or cholesterol, or DNA, from a specimen received from human anatomy. The expansion of automated in vitro diagnostics (IVD) methods for labs and dispensaries to render precise, and error-free analysis is anticipated to fuel the increment.
Key Market Segments
The North America laboratory developed test market, by type, is segmented into clinical biochemistry, critical care, haematology, microbiology, molecular diagnostics, immunology, and other test types. The haematology segment is subsegmented into coagulation and hemostasis, hemoglobin testing, blood count testing, and others. The molecular diagnostics segment held the largest share of the market in 2021. However, the haematology segment is anticipated to register the highest CAGR during the forecast period.
The North America laboratory developed test market, by application, is segmented into academic institutes, clinical research organizations, hospitals laboratory, specialty diagnostic centers, and others. The hospitals laboratory segment held the largest share of the market in 2021. However, the specialty diagnostic centers segment is anticipated to register the highest CAGR during the forecast period.
Major Sources and Companies Listed
A few of the primary and secondary sources associated with this report on the North America laboratory developed test market are the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and American Cancer Society (ACS).
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NORTH AMERICA LABORATORY DEVELOPED TEST MARKET SEGMENTATION
By Type
- Clinical Biochemistry
- Critical Care
- Haematology
- Coagulation and Hemostasis,
- Hemoglobin Testing
- Blood Count Testing
- Others
- Immunology
- Microbiology
- Molecular Diagnostics
- Other Test Types
By Application
- Academic Institutes
- Clinical Research organizations
- Hospitals laboratory
- Specialty Diagnostic Centers
- Others
By Country
- US
- Canada
- Mexico
Company Profiles
- Quest Diagnostics Incorporated
- F. HOFFMANN-LA ROCHE LTD
- QIAGEN
- Illumina, Inc.
- Eurofins Scientific
1. Introduction
1.1 Scope of the Study
1.2 The Insight Partners Research Report Guidance
1.3 Market Segmentation
1.3.1 North America Laboratory Developed Test Market – By Type
1.3.2 North America Laboratory Developed Test Market – By Application
1.3.3 North America Laboratory Developed Test Market – By Country
2. Laboratory Developed Test Market – Key Takeaways
3. Research Methodology
3.1 Coverage
3.2 Secondary Research
3.3 Primary Research
4. Laboratory Developed Test Market – Market Landscape
4.1 Overview
4.2 PEST Analysis
4.2.1 North America – PEST Analysis
4.3 Experts Opinion
5. Laboratory Developed Test Market –North America Analysis
5.1 North America Laboratory Developed Test Market Revenue Forecast and Analysis
6. Laboratory Developed Test Market Analysis – By Type
6.1 Overview
6.2 Laboratory Developed Test Market Revenue Share, by Type (2021 and 2028)
6.3 Clinical Biochemistry
6.3.1 Overview
6.3.2 Clinical Biochemistry: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
6.4 Haematology
6.4.1 Overview
6.4.2 Haematology: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
6.4.3 Coagulation and Hemostasis
6.4.3.1 Overview
6.4.3.2 Coagulation and Hemostasis: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
6.4.4 Hemoglobin Testing
6.4.4.1 Overview
6.4.4.2 Hemoglobin Testing: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
6.4.5 Blood Count Testing
6.4.5.1 Overview
6.4.5.2 Blood Count Testing: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
6.4.6 Others
6.4.6.1 Overview
6.4.6.2 Others: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
6.5 Immunology
6.5.1 Overview
6.5.2 Immunology: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
6.6 Critical Care
6.6.1 Overview
6.6.2 Critical Care: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
6.7 Microbiology
6.7.1 Overview
6.7.2 Microbiology: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
6.8 Molecular Diagnostics
6.8.1 Overview
6.8.2 Molecular Diagnostics: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
6.9 Other Test Types
6.9.1 Overview
6.9.2 Other Test Types: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
7. Laboratory Developed Test Market Analysis – By Application
7.1 Overview
7.2 Laboratory Developed Test Market Revenue Share, by Application (2021 and 2028)
7.3 Academic Institutes
7.3.1 Overview
7.3.2 Academic Institutes: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
7.4 Clinical Research organizations
7.4.1 Overview
7.4.2 Clinical Research organizations: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
7.5 Hospital laboratory
7.5.1 Overview
7.5.2 Hospital laboratory: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
7.6 Specialty Diagnostic Centers
7.6.1 Overview
7.6.2 Specialty Diagnostic Centers: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
7.7 Others
7.7.1 Overview
7.7.2 Others: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
8. Laboratory Developed Test Market –North America Analysis
8.1 North America: Laboratory Developed Test Market
8.1.1 Overview
8.1.3 North America: Laboratory Developed Test Market, by Country, 2021 & 2028 (%)
8.1.3.1 US: Laboratory Developed Test Market– Revenue and Forecast to 2028 (USD Million)
8.1.3.1.1 US: Laboratory Developed Test Market – Revenue and Forecast to 2028 (USD Million)
8.1.3.1.2 US: Laboratory Developed Test Market, by Type, 2019–2028 (USD Million)
8.1.3.1.2.1 US: Laboratory Developed Test Market, by Haematology, 2019–2028 (USD Million)
8.1.3.1.3 US: Laboratory Developed Test Market, by Application, 2019–2028 (USD Million)
8.1.3.2 Canada: Laboratory Developed Test Market – Revenue and Forecast to 2028 (USD Million)
8.1.3.2.1 Canada: Laboratory Developed Test Market – Revenue and Forecast to 2028 (USD Million)
8.1.3.2.2 Canada: Laboratory Developed Test Market, by Type, 2019–2028 (USD Million)
8.1.3.2.2.1 Canada: Laboratory Developed Test Market, by Haematology, 2019–2028 (USD Million)
8.1.3.2.3 Canada: Laboratory Developed Test Market, by Application, 2019–2028 (USD Million)
8.1.3.3 Mexico: Laboratory Developed Test Market – Revenue and Forecast to 2028 (USD Million)
8.1.3.3.1 Mexico: Laboratory Developed Test Market – Revenue and Forecast to 2028 (USD Million)
8.1.3.3.2 Mexico: Laboratory Developed Test Market, by Type – 2019–2028 (USD Million)
8.1.3.3.2.1 Mexico: Laboratory Developed Test Market, by Haematology, 2019–2028 (USD Million)
8.1.3.3.3 Mexico: Laboratory Developed Test Market, by Application, 2019–2028 (USD Million)
9. Impact Of COVID-19 Pandemic on North America Laboratory Developed Test Market
9.1 North America: Impact Assessment of COVID-19 Pandemic
10. Laboratory Developed Test Market–Industry Landscape
10.1 Overview
10.2 Inorganic Growth Strategies
10.2.1 Overview
10.3 Organic Growth Strategies
10.3.1 Overview
11. Company Profiles
11.1 Quest Diagnostics Incorporated
11.1.1 Key Facts
11.1.2 Business Description
11.1.3 Products and Services
11.1.4 Financial Overview
11.1.5 SWOT Analysis
11.1.6 Key Developments
11.2 F.HOFFMANN-LA ROCHE LTD.
11.2.1 Key Facts
11.2.2 Business Description
11.2.3 Products and Services
11.2.4 Financial Overview
11.2.5 SWOT Analysis
11.2.6 Key Developments
11.3 QIAGEN
11.3.1 Key Facts
11.3.2 Business Description
11.3.3 Products and Services
11.3.4 Financial Overview
11.3.5 SWOT Analysis
11.3.6 Key Developments
11.4 Illumina, Inc.
11.4.1 Key Facts
11.4.2 Business Description
11.4.3 Products and Services
11.4.4 Financial Overview
11.4.5 SWOT Analysis
11.4.6 Key Developments
11.5 Eurofins Scientific
11.5.1 Key Facts
11.5.2 Business Description
11.5.3 Products and Services
11.5.4 Financial Overview
11.5.5 SWOT Analysis
11.5.6 Key Developments
11.6 Biodesix
11.6.1 Key Facts
11.6.2 Business Description
11.6.3 Products and Services
11.6.4 Financial Overview
11.6.5 SWOT Analysis
11.6.6 Key Developments
11.7 Adaptive Biotechnologies
11.7.1 Key Facts
11.7.2 Business Description
11.7.3 Products and Services
11.7.4 Financial Overview
11.7.5 SWOT Analysis
11.7.6 Key Developments
11.8 Biotheranostics
11.8.1 Key Facts
11.8.2 Business Description
11.8.3 Products and Services
11.8.4 Financial Overview
11.8.5 SWOT Analysis
11.8.6 Key Developments
11.9 Rosetta Genomics Ltd.
11.9.1 Key Facts
11.9.2 Business Description
11.9.3 Products and Services
11.9.4 Financial Overview
11.9.5 The company’s financial information is not available in the public domain.
11.9.6 SWOT Analysis
11.9.7 Key Developments
11.10 Guardant Health
11.10.1 Key Facts
11.10.2 Business Description
11.10.3 Products and Services
11.10.4 Financial Overview
11.10.5 SWOT Analysis
11.10.6 Key Developments
12. Appendix
12.1 About The Insight Partners
12.2 Glossary of Terms
LIST OF TABLES
Table 1. US Laboratory Developed Test Market, by Type – Revenue and Forecast to 2028 (USD Million)
Table 2. US Laboratory Developed Test Market, by Haematology – Revenue and Forecast to 2028 (USD Million)
Table 3. US Laboratory Developed Test Market, by Application – Revenue and Forecast to 2028 (USD Million)
Table 4. Canada Laboratory Developed Test Market, by Type – Revenue and Forecast to 2028 (USD Million)
Table 5. Canada Laboratory Developed Test Market, by Haematology – Revenue and Forecast to 2028 (USD Million)
Table 6. Canada Laboratory Developed Test Market, by Application – Revenue and Forecast to 2028 (USD Million)
Table 7. Mexico Laboratory Developed Test Market, by Type – Revenue and Forecast to 2028 (USD Million)
Table 8. Mexico Laboratory Developed Test Market, by Haematology – Revenue and Forecast to 2028 (USD Million)
Table 9. Mexico Laboratory Developed Test Market, by Application – Revenue and Forecast to 2028 (USD Million)
Table 10. Recent Inorganic Growth Strategies in the Laboratory Developed Test Market
Table 11. Recent Organic Growth Strategies in the Laboratory Developed Test Market
Table 12. Glossary of Terms, Laboratory Developed Test Market
LIST OF FIGURES
Figure 1. Laboratory Developed Test Market Segmentation
Figure 2. Laboratory Developed Test Market Segmentation, By Country
Figure 3. Laboratory Developed Test Market Overview
Figure 4. Molecular Diagnostics Segment Held the Largest Share of the Type Segment in Laboratory Developed Test Market
Figure 5. North America Laboratory Developed Test Market – Leading Country Markets (US$ Million)
Figure 6. North America PEST Analysis
Figure 7. North America Laboratory Developed Test Market – Revenue Forecast and Analysis – 2020- 2028
Figure 8. Laboratory Developed Test Market Revenue Share, by Type (2021 and 2028)
Figure 9. Clinical Biochemistry: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
Figure 10. Haematology: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
Figure 11. Coagulation and Hemostasis: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
Figure 12. Hemoglobin Testing: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
Figure 13. Blood Count Testing: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
Figure 14. Others: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
Figure 15. Immunology: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
Figure 16. Critical Care: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
Figure 17. Microbiology: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
Figure 18. Molecular Diagnostics: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
Figure 19. Other Test Types: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
Figure 20. Laboratory Developed Test Market Revenue Share, by Application (2021 and 2028)
Figure 21. Academic Institutes: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
Figure 22. Clinical Research organizations: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
Figure 23. Hospital laboratory: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
Figure 24. Specialty Diagnostic Centers: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
Figure 25. Others: Laboratory Developed Test Market – Revenue and Forecast to 2028 (US$ Million)
Figure 26. North America: Laboratory Developed Test Market, by Key Country – Revenue (2021) (USD Million)
Figure 27. North America: Laboratory Developed Test Market, by Country, 2021 & 2028 (%)
Figure 28. US: Laboratory Developed Test Market – Revenue and Forecast to 2028 (USD Million)
Figure 29. Canada: Laboratory Developed Test Market – Revenue and Forecast to 2028 (USD Million)
Figure 30. Mexico: Laboratory Developed Test Market – Revenue and Forecast to 2028 (USD Million)
Figure 31. Impact of COVID-19 Pandemic in North American Country Markets
- Quest Diagnostics Incorporated
- F. HOFFMANN-LA ROCHE LTD
- QIAGEN
- Illumina, Inc.
- Eurofins Scientific
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