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Global Laboratory-developed Testing Market Insights, Forecast to 2025

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Table of Contents

    1 Study Coverage

    • 1.1 Laboratory-developed Testing Product
    • 1.2 Market Segments
    • 1.3 Key Manufacturers Covered
    • 1.4 Market by Type
      • 1.4.1 Global Laboratory-developed Testing Market Size Growth Rate by Product
      • 1.4.2 Clinical Biochemistry
      • 1.4.3 Critical Care
      • 1.4.4 Haematology
      • 1.4.5 Immunology
      • 1.4.6 Microbiology
      • 1.4.7 Molecular Diagnostics
      • 1.4.8 Other Test Types
    • 1.5 Market by End User
      • 1.5.1 Global Laboratory-developed Testing Market Size Growth Rate by End User
      • 1.5.2 Academic Institutes
      • 1.5.3 Clinical Research organizations
      • 1.5.4 Hospitals laboratory
      • 1.5.5 Specialty Diagnostic Centers
      • 1.5.6 Other Type of Facilities
    • 1.6 Study Objectives
    • 1.7 Years Considered

    2 Executive Summary

    • 2.1 Global Laboratory-developed Testing Market Size
      • 2.1.1 Global Laboratory-developed Testing Revenue 2014-2025
      • 2.1.2 Global Laboratory-developed Testing Sales 2014-2025
    • 2.2 Laboratory-developed Testing Growth Rate by Regions
      • 2.2.1 Global Laboratory-developed Testing Sales by Regions
      • 2.2.2 Global Laboratory-developed Testing Revenue by Regions

    3 Breakdown Data by Manufacturers

    • 3.1 Laboratory-developed Testing Sales by Manufacturers
      • 3.1.1 Laboratory-developed Testing Sales by Manufacturers
      • 3.1.2 Laboratory-developed Testing Sales Market Share by Manufacturers
      • 3.1.3 Global Laboratory-developed Testing Market Concentration Ratio (CR5 and HHI)
    • 3.2 Laboratory-developed Testing Revenue by Manufacturers
      • 3.2.1 Laboratory-developed Testing Revenue by Manufacturers (2014-2019)
      • 3.2.2 Laboratory-developed Testing Revenue Share by Manufacturers (2014-2019)
    • 3.3 Laboratory-developed Testing Price by Manufacturers
    • 3.4 Laboratory-developed Testing Manufacturing Base Distribution, Product Types
      • 3.4.1 Laboratory-developed Testing Manufacturers Manufacturing Base Distribution, Headquarters
      • 3.4.2 Manufacturers Laboratory-developed Testing Product Type
      • 3.4.3 Date of International Manufacturers Enter into Laboratory-developed Testing Market
    • 3.5 Manufacturers Mergers & Acquisitions, Expansion Plans

    4 Breakdown Data by Product

    • 4.1 Global Laboratory-developed Testing Sales by Product
    • 4.2 Global Laboratory-developed Testing Revenue by Product
    • 4.3 Laboratory-developed Testing Price by Product

    5 Breakdown Data by End User

    • 5.1 Overview
    • 5.2 Global Laboratory-developed Testing Breakdown Data by End User

    6 North America

    • 6.1 North America Laboratory-developed Testing by Countries
      • 6.1.1 North America Laboratory-developed Testing Sales by Countries
      • 6.1.2 North America Laboratory-developed Testing Revenue by Countries
      • 6.1.3 United States
      • 6.1.4 Canada
      • 6.1.5 Mexico
    • 6.2 North America Laboratory-developed Testing by Product
    • 6.3 North America Laboratory-developed Testing by End User

    7 Europe

    • 7.1 Europe Laboratory-developed Testing by Countries
      • 7.1.1 Europe Laboratory-developed Testing Sales by Countries
      • 7.1.2 Europe Laboratory-developed Testing Revenue by Countries
      • 7.1.3 Germany
      • 7.1.4 France
      • 7.1.5 UK
      • 7.1.6 Italy
      • 7.1.7 Russia
    • 7.2 Europe Laboratory-developed Testing by Product
    • 7.3 Europe Laboratory-developed Testing by End User

    8 Asia Pacific

    • 8.1 Asia Pacific Laboratory-developed Testing by Countries
      • 8.1.1 Asia Pacific Laboratory-developed Testing Sales by Countries
      • 8.1.2 Asia Pacific Laboratory-developed Testing Revenue by Countries
      • 8.1.3 China
      • 8.1.4 Japan
      • 8.1.5 Korea
      • 8.1.6 India
      • 8.1.7 Australia
      • 8.1.8 Indonesia
      • 8.1.9 Malaysia
      • 8.1.10 Philippines
      • 8.1.11 Thailand
      • 8.1.12 Vietnam
      • 8.1.13 Singapore
    • 8.2 Asia Pacific Laboratory-developed Testing by Product
    • 8.3 Asia Pacific Laboratory-developed Testing by End User

    9 Central & South America

    • 9.1 Central & South America Laboratory-developed Testing by Countries
      • 9.1.1 Central & South America Laboratory-developed Testing Sales by Countries
      • 9.1.2 Central & South America Laboratory-developed Testing Revenue by Countries
      • 9.1.3 Brazil
    • 9.2 Central & South America Laboratory-developed Testing by Product
    • 9.3 Central & South America Laboratory-developed Testing by End User

    10 Middle East and Africa

    • 10.1 Middle East and Africa Laboratory-developed Testing by Countries
      • 10.1.1 Middle East and Africa Laboratory-developed Testing Sales by Countries
      • 10.1.2 Middle East and Africa Laboratory-developed Testing Revenue by Countries
      • 10.1.3 GCC Countries
      • 10.1.4 Turkey
      • 10.1.5 Egypt
      • 10.1.6 South Africa
    • 10.2 Middle East and Africa Laboratory-developed Testing by Product
    • 10.3 Middle East and Africa Laboratory-developed Testing by End User

    11 Company Profiles

    • 11.1 Adaptive Biotechnologies Corporation
      • 11.1.1 Adaptive Biotechnologies Corporation Company Details
      • 11.1.2 Company Business Overview
      • 11.1.3 Adaptive Biotechnologies Corporation Laboratory-developed Testing Sales, Revenue and Gross Margin (2014-2019)
      • 11.1.4 Adaptive Biotechnologies Corporation Laboratory-developed Testing Products Offered
      • 11.1.5 Adaptive Biotechnologies Corporation Recent Development
    • 11.2 Quest Diagnostics
      • 11.2.1 Quest Diagnostics Company Details
      • 11.2.2 Company Business Overview
      • 11.2.3 Quest Diagnostics Laboratory-developed Testing Sales, Revenue and Gross Margin (2014-2019)
      • 11.2.4 Quest Diagnostics Laboratory-developed Testing Products Offered
      • 11.2.5 Quest Diagnostics Recent Development
    • 11.3 Roche
      • 11.3.1 Roche Company Details
      • 11.3.2 Company Business Overview
      • 11.3.3 Roche Laboratory-developed Testing Sales, Revenue and Gross Margin (2014-2019)
      • 11.3.4 Roche Laboratory-developed Testing Products Offered
      • 11.3.5 Roche Recent Development
    • 11.4 Illumina
      • 11.4.1 Illumina Company Details
      • 11.4.2 Company Business Overview
      • 11.4.3 Illumina Laboratory-developed Testing Sales, Revenue and Gross Margin (2014-2019)
      • 11.4.4 Illumina Laboratory-developed Testing Products Offered
      • 11.4.5 Illumina Recent Development
    • 11.5 Qiagen
      • 11.5.1 Qiagen Company Details
      • 11.5.2 Company Business Overview
      • 11.5.3 Qiagen Laboratory-developed Testing Sales, Revenue and Gross Margin (2014-2019)
      • 11.5.4 Qiagen Laboratory-developed Testing Products Offered
      • 11.5.5 Qiagen Recent Development
    • 11.6 Eurofins
      • 11.6.1 Eurofins Company Details
      • 11.6.2 Company Business Overview
      • 11.6.3 Eurofins Laboratory-developed Testing Sales, Revenue and Gross Margin (2014-2019)
      • 11.6.4 Eurofins Laboratory-developed Testing Products Offered
      • 11.6.5 Eurofins Recent Development
    • 11.7 Guardant Health
      • 11.7.1 Guardant Health Company Details
      • 11.7.2 Company Business Overview
      • 11.7.3 Guardant Health Laboratory-developed Testing Sales, Revenue and Gross Margin (2014-2019)
      • 11.7.4 Guardant Health Laboratory-developed Testing Products Offered
      • 11.7.5 Guardant Health Recent Development
    • 11.8 Biotheranostics
      • 11.8.1 Biotheranostics Company Details
      • 11.8.2 Company Business Overview
      • 11.8.3 Biotheranostics Laboratory-developed Testing Sales, Revenue and Gross Margin (2014-2019)
      • 11.8.4 Biotheranostics Laboratory-developed Testing Products Offered
      • 11.8.5 Biotheranostics Recent Development
    • 11.9 Adaptive Biotechnologies
      • 11.9.1 Adaptive Biotechnologies Company Details
      • 11.9.2 Company Business Overview
      • 11.9.3 Adaptive Biotechnologies Laboratory-developed Testing Sales, Revenue and Gross Margin (2014-2019)
      • 11.9.4 Adaptive Biotechnologies Laboratory-developed Testing Products Offered
      • 11.9.5 Adaptive Biotechnologies Recent Development
    • 11.10 Rosetta Genomics
      • 11.10.1 Rosetta Genomics Company Details
      • 11.10.2 Company Business Overview
      • 11.10.3 Rosetta Genomics Laboratory-developed Testing Sales, Revenue and Gross Margin (2014-2019)
      • 11.10.4 Rosetta Genomics Laboratory-developed Testing Products Offered
      • 11.10.5 Rosetta Genomics Recent Development
    • 11.11 Biodesix
    • 11.12 Helix

    12 Future Forecast

    • 12.1 Laboratory-developed Testing Market Forecast by Regions
      • 12.1.1 Global Laboratory-developed Testing Sales Forecast by Regions 2019-2025
      • 12.1.2 Global Laboratory-developed Testing Revenue Forecast by Regions 2019-2025
    • 12.2 Laboratory-developed Testing Market Forecast by Product
      • 12.2.1 Global Laboratory-developed Testing Sales Forecast by Product 2019-2025
      • 12.2.2 Global Laboratory-developed Testing Revenue Forecast by Product 2019-2025
    • 12.3 Laboratory-developed Testing Market Forecast by End User
    • 12.4 North America Laboratory-developed Testing Forecast
    • 12.5 Europe Laboratory-developed Testing Forecast
    • 12.6 Asia Pacific Laboratory-developed Testing Forecast
    • 12.7 Central & South America Laboratory-developed Testing Forecast
    • 12.8 Middle East and Africa Laboratory-developed Testing Forecast

    13 Market Opportunities, Challenges, Risks and Influences Factors Analysis

    • 13.1 Market Opportunities and Drivers
    • 13.2 Market Challenges
    • 13.3 Market Risks/Restraints
    • 13.4 Macroscopic Indicators

    14 Value Chain and Sales Channels Analysis

    • 14.1 Value Chain Analysis
    • 14.2 Laboratory-developed Testing Customers
    • 14.3 Sales Channels Analysis
      • 14.3.1 Sales Channels
      • 14.3.2 Distributors

    15 Research Findings and Conclusion

      16 Appendix

      • 16.1 Research Methodology
        • 16.1.1 Methodology/Research Approach
        • 16.1.2 Data Source
      • 16.2 Author Details

      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 Quest Diagnostics, Roche, Illumina, Qiagen,
      Eurofins. Quest Diagnostics is the largest manufacturer; its revenue of global market exceeds 5% in 2016. The next is Roche and Illumina.
      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
      The global Laboratory-developed Testing market is valued at 3010 million US$ in 2018 and will reach 4060 million US$ by the end of 2025, growing at a CAGR of 3.8% during 2019-2025. The objectives of this study are to define, segment, and project the size of the Laboratory-developed Testing market based on company, product type, end user and key regions.

      This report studies the global market size of Laboratory-developed Testing in key regions like North America, Europe, Asia Pacific, Central & South America and Middle East & Africa, focuses on the consumption of Laboratory-developed Testing in these regions.
      This research report categorizes the global Laboratory-developed Testing market by top players/brands, region, type and end user. This report also studies the global Laboratory-developed Testing market status, competition landscape, market share, growth rate, future trends, market drivers, opportunities and challenges, sales channels and distributors.

      The following manufacturers are covered in this report, with sales, revenue, market share for each company:
      Adaptive Biotechnologies Corporation
      Quest Diagnostics
      Roche
      Illumina
      Qiagen
      Eurofins
      Guardant Health
      Biotheranostics
      Adaptive Biotechnologies
      Rosetta Genomics
      Biodesix
      Helix

      Market size by Product
      Clinical Biochemistry
      Critical Care
      Haematology
      Immunology
      Microbiology
      Molecular Diagnostics
      Other Test Types
      Market size by End User
      Academic Institutes
      Clinical Research organizations
      Hospitals laboratory
      Specialty Diagnostic Centers
      Other Type of Facilities

      Market size by Region
      North America
      United States
      Canada
      Mexico
      Asia-Pacific
      China
      India
      Japan
      South Korea
      Australia
      Indonesia
      Singapore
      Malaysia
      Philippines
      Thailand
      Vietnam
      Europe
      Germany
      France
      UK
      Italy
      Spain
      Russia
      Central & South America
      Brazil
      Rest of Central & South America
      Middle East & Africa
      GCC Countries
      Turkey
      Egypt
      South Africa

      The study objectives of this report are:
      To study and analyze the global Laboratory-developed Testing market size (value & volume) by company, key regions, products and end user, breakdown data from 2014 to 2018, and forecast to 2025.
      To understand the structure of Laboratory-developed Testing market by identifying its various subsegments.
      To share detailed information about the key factors influencing the growth of the market (growth potential, opportunities, drivers, industry-specific challenges and risks).
      Focuses on the key global Laboratory-developed Testing companies, to define, describe and analyze the sales volume, value, market share, market competition landscape and recent development.
      To project the value and sales volume of Laboratory-developed Testing submarkets, with respect to key regions.
      To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market.

      In this study, the years considered to estimate the market size of Laboratory-developed Testing are as follows:
      History Year: 2014-2018
      Base Year: 2018
      Estimated Year: 2019
      Forecast Year 2019 to 2025

      This report includes the estimation of market size for value (million US$) and volume (K Units). Both top-down and bottom-up approaches have been used to estimate and validate the market size of Laboratory-developed Testing market, to estimate the size of various other dependent submarkets in the overall market. Key players in the market have been identified through secondary research, and their market shares have been determined through primary and secondary research. All percentage shares, splits, and breakdowns have been determined using secondary sources and verified primary sources.

      For the data information by region, company, type and application, 2018 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.

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