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North America Laboratory Developed Test Market

2021

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)

Publication Month: Oct 2021 | Report Code: TIPRE00025237 | No. of Pages: 120 | Category: Biotechnology | Status: Published

Market Insights

North America Laboratory Developed Test Market Market to Grow at a CAGR of 6.8% to reach US$ 8,988.78 million from 2021 to 2028

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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).

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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

  1. Quest Diagnostics Incorporated
  2. F. HOFFMANN-LA ROCHE LTD
  3. QIAGEN
  4. Illumina, Inc.
  5. Eurofins Scientific

Save and reduce time carrying out entry-level research by identifying the growth, size, leading players and segments in the North America laboratory developed test market.

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- The key findings and recommendations highlight crucial progressive industry trends in the North America laboratory developed test market, thereby allowing players across the value chain to develop effective long-term strategies.

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- Scrutinize in-depth market trends and outlook coupled with the factors driving the market, as well as those hindering it.

- Enhance the decision-making process by understanding the strategies that underpin security interest with respect to client products, segmentation, pricing and distribution.

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