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
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
This text is related
to segments covered.
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
This text is related
to country scope.
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
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- 3.1 Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- 3.2 Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- 3.3 Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- 3.4 Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
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