Chinese- REPORT SUMMARY
- TABLE OF CONTENTS
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Twenty-five years ago, the Food and Drug Administration (FDA) asserted in a draft document that "home brew" tests-now commonly referred to as laboratory-developed tests (LDTs)-are subject to the same regulatory oversight as other in vitro diagnostics (IVDs)4. In 2010, the FDA began work on developing a proposed framework for future LDT oversight. Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation. While the proposed guidance has not been implemented, many questions regarding LDT oversight remain unresolved.
A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory.LDTs can be used to measure or detect a wide variety of analytes (substances such as proteins, chemical compounds like glucose or cholesterol, or DNA), in a sample taken from a human body. Some LDTs are relatively simple tests that measure single analytes, such as a test that measures the level of sodium. Other LDTs are complex and may measure or detect one or more analytes. For example, some tests can detect many DNA variations from a single blood sample, which can be used to help diagnose a genetic disease. Various levels of chemicals can be measured to help diagnose a patient’s state of health, such as levels of cholesterol or sodium.While the uses of an LDT are often the same as the uses of FDA-cleared or approved in vitro diagnostic tests, some labs may choose to offer their own test. For example, a hospital lab may run its own vitamin D assay, even though there is an FDA-cleared test for vitamin D currently on the market.The leading manufactures mainly are Biotheranostics, Rosetta Genomics, Biodesix, Roche, Illumina. Biotheranostics is the largest manufacturer; its revenue of global market exceeds 5% in 2016. The next is Rosetta Genomics and Biodesix.There are mainly two type product of Laboratory-developed Testing market: Commercial Service and R&D. Commercial Service accounts the largest proportion; however, R&D still have high growth rate.Geographically, the global Laboratory-developed Testing market has been segmented into North America, Europe, China, Japan, Southeast Asia, India and Other Regions. The North America held the largest share in the global Laboratory-developed Testing products market, its revenue of global market exceeds 68% in 2017. The next is Europe and Japan
This report offers an overview of the market trends, drivers, and barriers with respect to the USA Laboratory-developed Testing market. It also provides a detailed overview of the market of different regions across West USA, South USA, Middle West USA, Northeast USA. The report deeply analyzes type and application in the USA Laboratory-developed Testing market. Detailed analysis of key players, along with key growth strategies adopted by Laboratory-developed Testing industry, the PEST and SWOT analysis are also included. In short, the report will provide a comprehensive view of the industry's development and features.
By Player:
Adaptive Biotechnologies
Biotheranostics
Rosetta Genomics
Biodesix
Roche
Illumina
Guardant Health
Helix
Eurofins
Adaptive Biotechnologies Corporation
Qiagen
Quest Diagnostics
By Type:
Clinical Biochemistry
Critical Care
Haematology
Immunology
Microbiology
Molecular Diagnostics
Other Test Types
By End-User:
Academic Institutes
Clinical Research organizations
Hospitals laboratory
Specialty Diagnostic Centers
Other Type of Facilities
By Region:
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West USA
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South USA
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Middle West USA
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Northeast USA
TABLE OF CONTENT
1 Report Overview
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1.1 Product Definition and Scope
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1.2 PEST (Political, Economic, Social and Technological) Analysis of Laboratory-developed Testing Market
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1.3 Market Segment by Type
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1.3.1 USA Laboratory-developed Testing Market Size and Growth Rate of Clinical Biochemistry from 2016 to 2027
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1.3.2 USA Laboratory-developed Testing Market Size and Growth Rate of Critical Care from 2016 to 2027
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1.3.3 USA Laboratory-developed Testing Market Size and Growth Rate of Haematology from 2016 to 2027
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1.3.4 USA Laboratory-developed Testing Market Size and Growth Rate of Immunology from 2016 to 2027
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1.3.5 USA Laboratory-developed Testing Market Size and Growth Rate of Microbiology from 2016 to 2027
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1.3.6 USA Laboratory-developed Testing Market Size and Growth Rate of Molecular Diagnostics from 2016 to 2027
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1.3.7 USA Laboratory-developed Testing Market Size and Growth Rate of Other Test Types from 2016 to 2027
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1.4 Market Segment by Application
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1.4.1 USA Laboratory-developed Testing Market Size and Growth Rate of Academic Institutes from 2016 to 2027
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1.4.2 USA Laboratory-developed Testing Market Size and Growth Rate of Clinical Research organizations from 2016 to 2027
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1.4.3 USA Laboratory-developed Testing Market Size and Growth Rate of Hospitals laboratory from 2016 to 2027
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1.4.4 USA Laboratory-developed Testing Market Size and Growth Rate of Specialty Diagnostic Centers from 2016 to 2027
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1.4.5 USA Laboratory-developed Testing Market Size and Growth Rate of Other Type of Facilities from 2016 to 2027
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1.5 Market Segment by Regions
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1.5.1 West USA Laboratory-developed Testing Consumption Market Size and Growth Rate from 2016 to 2027
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1.5.2 South USA Laboratory-developed Testing Consumption Market Size and Growth Rate from 2016 to 2027
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1.5.3 Middle West USA Laboratory-developed Testing Consumption Market Size and Growth Rate from 2016 to 2027
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1.5.4 Northeast USA Laboratory-developed Testing Consumption Market Size and Growth Rate from 2016 to 2027
2 Market Trends and Competitive Landscape
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2.1 Market Trends and Dynamics
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2.1.1 Market Challenges and Restraints
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2.1.2 Market Opportunities and Potentials
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2.1.3 Mergers and Acquisitions
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2.2 Competitive Landscape Analysis
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2.2.1 Industrial Concentration Analysis
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2.2.2 Porter's Five Forces Analysis of the Industry
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2.2.3 SWOT Analysis for New Entrants
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2.3 Coronavirus (COVID-19) Distribution and its Impact on the Industry
3 Segmentation of Laboratory-developed Testing Market by Types
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3.1 Products Development Trends of Different Types
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3.2 Products Types of Major Vendors
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3.3 Competitive Landscape Analysis of Different Types
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3.4 Market Size of Laboratory-developed Testing by Major Types
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3.4.1 Market Size and Growth Rate of Clinical Biochemistry
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3.4.2 Market Size and Growth Rate of Critical Care
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3.4.3 Market Size and Growth Rate of Haematology
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3.4.4 Market Size and Growth Rate of Immunology
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3.4.5 Market Size and Growth Rate of Microbiology
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3.4.6 Market Size and Growth Rate of Molecular Diagnostics
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3.4.7 Market Size and Growth Rate of Other Test Types
4 Segmentation of Laboratory-developed Testing Market by End-Users
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4.1 Downstream Client Analysis by End-Users
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4.2 Competitive Landscape Analysis of Different End-Users
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4.3 Market Potential Analysis of Different End-Users
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4.4 Market Size of Laboratory-developed Testing by Major End-Users
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4.4.1 Market Size and Growth Rate of Laboratory-developed Testing in Academic Institutes
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4.4.2 Market Size and Growth Rate of Laboratory-developed Testing in Clinical Research organizations
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4.4.3 Market Size and Growth Rate of Laboratory-developed Testing in Hospitals laboratory
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4.4.4 Market Size and Growth Rate of Laboratory-developed Testing in Specialty Diagnostic Centers
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4.4.5 Market Size and Growth Rate of Laboratory-developed Testing in Other Type of Facilities
5 Market Analysis by Regions
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5.1 USA Laboratory-developed Testing Production Analysis by Regions
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5.2 USA Laboratory-developed Testing Consumption Analysis by Regions
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5.3 Coronavirus (COVID-19) Impact on USA Economy
6 West USA Laboratory-developed Testing Landscape Analysis
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6.1 West USA Laboratory-developed Testing Landscape Analysis by Major Types
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6.2 West USA Laboratory-developed Testing Landscape Analysis by Major End-Users
7 South USA Laboratory-developed Testing Landscape Analysis
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7.1 South USA Laboratory-developed Testing Landscape Analysis by Major Types
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7.2 South USA Laboratory-developed Testing Landscape Analysis by Major End-Users
8 Middle West USA Laboratory-developed Testing Landscape Analysis
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8.1 Middle West USA Laboratory-developed Testing Landscape Analysis by Major Types
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8.2 Middle West USA Laboratory-developed Testing Landscape Analysis by Major End-Users
9 Northeast USA Laboratory-developed Testing Landscape Analysis
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9.1 Northeast USA Laboratory-developed Testing Landscape Analysis by Major Types
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9.2 Northeast USA Laboratory-developed Testing Landscape Analysis by Major End-Users
10 Major Players Profiles
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10.1 Adaptive Biotechnologies
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10.1.1 Adaptive Biotechnologies Company Profile and Recent Development
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10.1.2 Market Performance
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10.1.3 Product and Service Introduction
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10.2 Biotheranostics
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10.2.1 Biotheranostics Company Profile and Recent Development
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10.2.2 Market Performance
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10.2.3 Product and Service Introduction
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10.3 Rosetta Genomics
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10.3.1 Rosetta Genomics Company Profile and Recent Development
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10.3.2 Market Performance
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10.3.3 Product and Service Introduction
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10.4 Biodesix
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10.4.1 Biodesix Company Profile and Recent Development
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10.4.2 Market Performance
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10.4.3 Product and Service Introduction
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10.5 Roche
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10.5.1 Roche Company Profile and Recent Development
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10.5.2 Market Performance
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10.5.3 Product and Service Introduction
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10.6 Illumina
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10.6.1 Illumina Company Profile and Recent Development
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10.6.2 Market Performance
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10.6.3 Product and Service Introduction
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10.7 Guardant Health
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10.7.1 Guardant Health Company Profile and Recent Development
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10.7.2 Market Performance
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10.7.3 Product and Service Introduction
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10.8 Helix
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10.8.1 Helix Company Profile and Recent Development
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10.8.2 Market Performance
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10.8.3 Product and Service Introduction
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10.9 Eurofins
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10.9.1 Eurofins Company Profile and Recent Development
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10.9.2 Market Performance
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10.9.3 Product and Service Introduction
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10.10 Adaptive Biotechnologies Corporation
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10.10.1 Adaptive Biotechnologies Corporation Company Profile and Recent Development
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10.10.2 Market Performance
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10.10.3 Product and Service Introduction
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10.11 Qiagen
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10.11.1 Qiagen Company Profile and Recent Development
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10.11.2 Market Performance
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10.11.3 Product and Service Introduction
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10.12 Quest Diagnostics
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10.12.1 Quest Diagnostics Company Profile and Recent Development
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10.12.2 Market Performance
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10.12.3 Product and Service Introduction
The List of Tables and Figures
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Figure Product Picture
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Figure USA Laboratory-developed Testing Market Size and Growth Rate of Clinical Biochemistry from 2016 to 2027
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Figure USA Laboratory-developed Testing Market Size and Growth Rate of Critical Care from 2016 to 2027
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Figure USA Laboratory-developed Testing Market Size and Growth Rate of Haematology from 2016 to 2027
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Figure USA Laboratory-developed Testing Market Size and Growth Rate of Immunology from 2016 to 2027
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Figure USA Laboratory-developed Testing Market Size and Growth Rate of Microbiology from 2016 to 2027
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Figure USA Laboratory-developed Testing Market Size and Growth Rate of Molecular Diagnostics from 2016 to 2027
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Figure USA Laboratory-developed Testing Market Size and Growth Rate of Other Test Types from 2016 to 2027
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Figure Market Share by Type in 2016
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Figure Market Share by Type in 2020
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Figure Market Share by Type in 2027
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Figure USA Laboratory-developed Testing Market Size and Growth Rate of Academic Institutes from 2016 to 2027
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Figure USA Laboratory-developed Testing Market Size and Growth Rate of Clinical Research organizations from 2016 to 2027
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Figure USA Laboratory-developed Testing Market Size and Growth Rate of Hospitals laboratory from 2016 to 2027
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Figure USA Laboratory-developed Testing Market Size and Growth Rate of Specialty Diagnostic Centers from 2016 to 2027
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Figure USA Laboratory-developed Testing Market Size and Growth Rate of Other Type of Facilities from 2016 to 2027
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Figure Market Share by End-User in 2016
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Figure Market Share by End-User in 2020
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Figure Market Share by End-User in 2027
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Figure West USA Laboratory-developed Testing Consumption Market Size and Growth Rate from 2016 to 2027
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Figure South USA Laboratory-developed Testing Consumption Market Size and Growth Rate from 2016 to 2027
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Figure Middle West USA Laboratory-developed Testing Consumption Market Size and Growth Rate from 2016 to 2027
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Figure Northeast USA Laboratory-developed Testing Consumption Market Size and Growth Rate from 2016 to 2027
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Figure Development Trends and Industry Dynamics of Laboratory-developed Testing Industry
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Figure Market Challenges and Restraints
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Figure Market Opportunities and Potentials
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Table Mergers and Acquisition
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Figure Market Share of TOP 3 Players in 2019
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Figure Market Share of TOP 5 Players in 2019
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Figure Market Share of TOP 6 Players from 2016 to 2020
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Figure Porter's Five Forces Analysis
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Figure New Entrant SWOT Analysis
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Figure Coronavirus (COVID-19) Distribution Map of USA
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Table Coronavirus (COVID-19) Impact on the Industry
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Figure Specifications of Different Types of Laboratory-developed Testing
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Figure Development Trends of Different Types
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Table Products Types of Major Vendors
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Figure Competitive Landscape Analysis of Different Types
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Table Consumption of Laboratory-developed Testing by Different Types from 2016 to 2027
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Table Consumption Share of Laboratory-developed Testing by Different Types from 2016 to 2027
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Figure Market Size and Growth Rate of Clinical Biochemistry
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Figure Market Size and Growth Rate of Critical Care
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Figure Market Size and Growth Rate of Haematology
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Figure Market Size and Growth Rate of Immunology
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Figure Market Size and Growth Rate of Microbiology
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Figure Market Size and Growth Rate of Molecular Diagnostics
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Figure Market Size and Growth Rate of Other Test Types
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Table Downstream Client Analysis by End-Users
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Figure Competitive Landscape Analysis of Different End-Users
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Table Market Potential Analysis of Different End-Users
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Figure Consumption of Laboratory-developed Testing by Different End-Users from 2016 to 2027
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Table Consumption Share of Laboratory-developed Testing by Different End-Users from 2016 to 2027
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Figure Market Size and Growth Rate of Academic Institutes
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Figure Market Size and Growth Rate of Clinical Research organizations
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Figure Market Size and Growth Rate of Hospitals laboratory
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Figure Market Size and Growth Rate of Specialty Diagnostic Centers
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Figure Market Size and Growth Rate of Other Type of Facilities
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Table USA Laboratory-developed Testing Production by Regions
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Table USA Laboratory-developed Testing Production Share by Regions
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Figure USA Laboratory-developed Testing Production Share by Regions in 2016
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Figure USA Laboratory-developed Testing Production Share by Regions in 2021
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Figure USA Laboratory-developed Testing Production Share by Regions in 2027
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Table USA Laboratory-developed Testing Consumption by Regions
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Table USA Laboratory-developed Testing Consumption Share by Regions
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Figure USA Laboratory-developed Testing Consumption Share by Regions in 2016
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Figure USA Laboratory-developed Testing Consumption Share by Regions in 2021
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Figure USA Laboratory-developed Testing Consumption Share by Regions in 2027
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Table West USA Laboratory-developed Testing Consumption by Types from 2016 to 2027
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Table West USA Laboratory-developed Testing Consumption Share by Types from 2016 to 2027
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Figure West USA Laboratory-developed Testing Consumption Share by Types in 2016
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Figure West USA Laboratory-developed Testing Consumption Share by Types in 2021
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Figure West USA Laboratory-developed Testing Consumption Share by Types in 2027
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Table West USA Laboratory-developed Testing Consumption by End-Users from 2016 to 2027
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Table West USA Laboratory-developed Testing Consumption Share by End-Users from 2016 to 2027
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Figure West USA Laboratory-developed Testing Consumption Share by End-Users in 2016
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Figure West USA Laboratory-developed Testing Consumption Share by End-Users in 2021
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Figure West USA Laboratory-developed Testing Consumption Share by End-Users in 2027
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Table South USA Laboratory-developed Testing Consumption by Types from 2016 to 2027
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Table South USA Laboratory-developed Testing Consumption Share by Types from 2016 to 2027
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Figure South USA Laboratory-developed Testing Consumption Share by Types in 2016
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Figure South USA Laboratory-developed Testing Consumption Share by Types in 2021
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Figure South USA Laboratory-developed Testing Consumption Share by Types in 2027
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Table South USA Laboratory-developed Testing Consumption by End-Users from 2016 to 2027
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Table South USA Laboratory-developed Testing Consumption Share by End-Users from 2016 to 2027
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Figure South USA Laboratory-developed Testing Consumption Share by End-Users in 2016
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Figure South USA Laboratory-developed Testing Consumption Share by End-Users in 2021
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Figure South USA Laboratory-developed Testing Consumption Share by End-Users in 2027
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Table Middle West USA Laboratory-developed Testing Consumption by Types from 2016 to 2027
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Table Middle West USA Laboratory-developed Testing Consumption Share by Types from 2016 to 2027
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Figure Middle West USA Laboratory-developed Testing Consumption Share by Types in 2016
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Figure Middle West USA Laboratory-developed Testing Consumption Share by Types in 2021
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Figure Middle West USA Laboratory-developed Testing Consumption Share by Types in 2027
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Table Middle West USA Laboratory-developed Testing Consumption by End-Users from 2016 to 2027
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Table Middle West USA Laboratory-developed Testing Consumption Share by End-Users from 2016 to 2027
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Figure Middle West USA Laboratory-developed Testing Consumption Share by End-Users in 2016
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Figure Middle West USA Laboratory-developed Testing Consumption Share by End-Users in 2021
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Figure Middle West USA Laboratory-developed Testing Consumption Share by End-Users in 2027
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Table Northeast USA Laboratory-developed Testing Consumption by Types from 2016 to 2027
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Table Northeast USA Laboratory-developed Testing Consumption Share by Types from 2016 to 2027
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Figure Northeast USA Laboratory-developed Testing Consumption Share by Types in 2016
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Figure Northeast USA Laboratory-developed Testing Consumption Share by Types in 2021
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Figure Northeast USA Laboratory-developed Testing Consumption Share by Types in 2027
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Table Northeast USA Laboratory-developed Testing Consumption by End-Users from 2016 to 2027
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Table Northeast USA Laboratory-developed Testing Consumption Share by End-Users from 2016 to 2027
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Figure Northeast USA Laboratory-developed Testing Consumption Share by End-Users in 2016
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Figure Northeast USA Laboratory-developed Testing Consumption Share by End-Users in 2021
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Figure Northeast USA Laboratory-developed Testing Consumption Share by End-Users in 2027
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Table Company Profile and Development Status of Adaptive Biotechnologies
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Table Sales, Revenue, Sales Price and Gross Margin Analysis of Adaptive Biotechnologies
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Figure Sales and Growth Rate Analysis of Adaptive Biotechnologies
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Figure Revenue and Market Share Analysis of Adaptive Biotechnologies
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Table Product and Service Introduction of Adaptive Biotechnologies
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Table Company Profile and Development Status of Biotheranostics
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Table Sales, Revenue, Sales Price and Gross Margin Analysis of Biotheranostics
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Figure Sales and Growth Rate Analysis of Biotheranostics
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Figure Revenue and Market Share Analysis of Biotheranostics
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Table Product and Service Introduction of Biotheranostics
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Table Company Profile and Development Status of Rosetta Genomics
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Table Sales, Revenue, Sales Price and Gross Margin Analysis of Rosetta Genomics
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Figure Sales and Growth Rate Analysis of Rosetta Genomics
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Figure Revenue and Market Share Analysis of Rosetta Genomics
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Table Product and Service Introduction of Rosetta Genomics
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Table Company Profile and Development Status of Biodesix
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Table Sales, Revenue, Sales Price and Gross Margin Analysis of Biodesix
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Figure Sales and Growth Rate Analysis of Biodesix
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Figure Revenue and Market Share Analysis of Biodesix
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Table Product and Service Introduction of Biodesix
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Table Company Profile and Development Status of Roche
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Table Sales, Revenue, Sales Price and Gross Margin Analysis of Roche
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Figure Sales and Growth Rate Analysis of Roche
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Figure Revenue and Market Share Analysis of Roche
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Table Product and Service Introduction of Roche
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Table Company Profile and Development Status of Illumina
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Table Sales, Revenue, Sales Price and Gross Margin Analysis of Illumina
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Figure Sales and Growth Rate Analysis of Illumina
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Figure Revenue and Market Share Analysis of Illumina
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Table Product and Service Introduction of Illumina
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Table Company Profile and Development Status of Guardant Health
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Table Sales, Revenue, Sales Price and Gross Margin Analysis of Guardant Health
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Figure Sales and Growth Rate Analysis of Guardant Health
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Figure Revenue and Market Share Analysis of Guardant Health
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Table Product and Service Introduction of Guardant Health
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Table Company Profile and Development Status of Helix
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Table Sales, Revenue, Sales Price and Gross Margin Analysis of Helix
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Figure Sales and Growth Rate Analysis of Helix
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Figure Revenue and Market Share Analysis of Helix
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Table Product and Service Introduction of Helix
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Table Company Profile and Development Status of Eurofins
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Table Sales, Revenue, Sales Price and Gross Margin Analysis of Eurofins
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Figure Sales and Growth Rate Analysis of Eurofins
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Figure Revenue and Market Share Analysis of Eurofins
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Table Product and Service Introduction of Eurofins
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Table Company Profile and Development Status of Adaptive Biotechnologies Corporation
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Table Sales, Revenue, Sales Price and Gross Margin Analysis of Adaptive Biotechnologies Corporation
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Figure Sales and Growth Rate Analysis of Adaptive Biotechnologies Corporation
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Figure Revenue and Market Share Analysis of Adaptive Biotechnologies Corporation
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Table Product and Service Introduction of Adaptive Biotechnologies Corporation
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Table Company Profile and Development Status of Qiagen
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Table Sales, Revenue, Sales Price and Gross Margin Analysis of Qiagen
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Figure Sales and Growth Rate Analysis of Qiagen
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Figure Revenue and Market Share Analysis of Qiagen
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Table Product and Service Introduction of Qiagen
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Table Company Profile and Development Status of Quest Diagnostics
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Table Sales, Revenue, Sales Price and Gross Margin Analysis of Quest Diagnostics
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Figure Sales and Growth Rate Analysis of Quest Diagnostics
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Figure Revenue and Market Share Analysis of Quest Diagnostics
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Table Product and Service Introduction of Quest Diagnostics
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