Laboratory-developed Testing Market Report

Global and Region Laboratory-developed Testing Market Demand & Opportunity Outlook 2022-2028

  • POSTDATE：Jul 30, 2022
  • PAGES：183
  • REPORT CODE：GMM917838
  • REPORT SUMMARY
  • TABLE OF CONTENTS

  • 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 Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation.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 Adaptive Biotechnologies, Roche, Adaptive Biotechnologies Corporation, Rosetta Genomics, Guardant Health. Adaptive Biotechnologies is the largest manufacturer; its revenue of global market exceeds 5% in 2016. The next is Roche and Adaptive Biotechnologies Corporation.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 report details the trend, potential and market size of Laboratory-developed Testing market, and analyzes the current situation and prospects of the market from both qualitative and quantitative aspects, which can be roughly divided into three parts.

    The first part (Chapter1-7) mainly covers the qualitative analysis of Laboratory-developed Testingmarket, defines the market attractiveness level of Laboratory-developed Testing market through Porter's Five Forces Analysis, and summarizes the different factors in the overall environment through PEST analysis. Understand the distribution of industrial chain value in each link of industrial chain through the analysis of industrial chain structure. Thus estimate the market space of each link.

    The second part (Chapter8-12), based on the segmentation of Laboratory-developed Testing industry, describes the types of Laboratory-developed Testing market, the applications of major players and the market size, and deeply analyzes the current situation of the global Laboratory-developed Testing market and the development prospects and opportunities of Laboratory-developed Testing industry.

    The third part (Chapter14-15) includes the market positions of the major players and information on the market participants, which will help you gain a comprehensive understanding of the current competitive situation and potential growth opportunities in the market.

    As COVID-19 continues to impact the global economy in 2022, the report also considers the short - and long-term impacts of COVID-19 on the global Laboratory-developed Testing market in Chapter 13.

    By Player:

    • Eurofins

    • Adaptive Biotechnologies

    • Roche

    • Adaptive Biotechnologies Corporation

    • Rosetta Genomics

    • Guardant Health

    • Quest Diagnostics

    • Biodesix

    • Qiagen

    • Helix

    • Illumina

    • Biotheranostics

    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 Geography:

    • United States

    • Europe

    • China

    • Japan

    • India

    • South Korea

  • TABLE OF CONTENT

    1 Introduction

    • 1.1 Market Definition

    • 1.2 Market Segment Analysis

    • 1.3 Market Size 2022

    • 1.4 Laboratory-developed Testing Market Outlook: Forecast for 2022 - 2028

    • 1.5 Pricing Analysis

    2 Executive Summary

    3 Laboratory-developed Testing Market Lineage Outlook

    • 3.1 Parent Market Outlook

    • 3.2 Related/Ancillary Market Outlook

    • 3.3 Penetration & Growth Prospect Mapping, 2022

    4 Market Analysis Tools: Porter's Five Forces

    • 4.1 Supplier Power

    • 4.2 Buyer Power

    • 4.3 Substitution Threat

    • 4.4 Threat of New Entrants

    • 4.5 Competitive Rivalry

    5 Laboratory-developed Testing Industry Analysis - PEST (Political & Legal, Economic, Social, and Technological)

    • 5.1 Political/Legal Landscape

    • 5.2 Economic Landscape

    • 5.3 Social Landscape

    • 5.4 Technology Landscape

    6 Laboratory-developed Testing Market - Value Chain Analysis

    • 6.1 Industry's Value Chain Analysis

    • 6.2 Product Life Cycle

    • 6.3 User Perspective Analysis

    7 Region and Country-wise Laboratory-developed Testing Market Analysis and Outlook to 2022

    • 7.1 Global Laboratory-developed Testing Consumption (2017-2022)

    • 7.2 United States Laboratory-developed Testing Consumption (2017-2022)

    • 7.3 Europe Laboratory-developed Testing Consumption (2017-2022)

    • 7.4 China Laboratory-developed Testing Consumption (2017-2022)

    • 7.5 Japan Laboratory-developed Testing Consumption (2017-2022)

    • 7.6 India Laboratory-developed Testing Consumption (2017-2022)

    • 7.7 South Korea Laboratory-developed Testing Consumption (2017-2022)

    8 Region and Country-wise Laboratory-developed Testing Market Analysis and Outlook to 2028

    • 8.1 Global Laboratory-developed Testing Consumption Forecast (2022-2028)

    • 8.2 United States Laboratory-developed Testing Consumption Forecast (2022-2028)

    • 8.3 Europe Laboratory-developed Testing Consumption Forecast (2022-2028)

    • 8.4 China Laboratory-developed Testing Consumption Forecast (2022-2028)

    • 8.5 Japan Laboratory-developed Testing Consumption Forecast (2022-2028)

    • 8.6 India Laboratory-developed Testing Consumption Forecast (2022-2028)

    • 8.7 South Korea Laboratory-developed Testing Consumption Forecast (2022-2028)

    9 Global Laboratory-developed Testing Market Outlook by Types and Applications to 2022

    • 9.1 Global Laboratory-developed Testing Consumption and Growth Rate by Type (2017-2022)

      • 9.1.1 Global Clinical Biochemistry Consumption and Growth Rate (2017-2022)

      • 9.1.2 Global Critical Care Consumption and Growth Rate (2017-2022)

      • 9.1.3 Global Haematology Consumption and Growth Rate (2017-2022)

      • 9.1.4 Global Immunology Consumption and Growth Rate (2017-2022)

      • 9.1.5 Global Microbiology Consumption and Growth Rate (2017-2022)

      • 9.1.6 Global Molecular Diagnostics Consumption and Growth Rate (2017-2022)

      • 9.1.7 Global Other Test Types Consumption and Growth Rate (2017-2022)

    • 9.2 Global Laboratory-developed Testing Consumption and Growth Rate by Application (2017-2022)

      • 9.2.1 Global Academic Institutes Consumption and Growth Rate (2017-2022)

      • 9.2.2 Global Clinical Research organizations Consumption and Growth Rate (2017-2022)

      • 9.2.3 Global Hospitals laboratory Consumption and Growth Rate (2017-2022)

      • 9.2.4 Global Specialty Diagnostic Centers Consumption and Growth Rate (2017-2022)

      • 9.2.5 Global Other Type of Facilities Consumption and Growth Rate (2017-2022)

    10 Global Laboratory-developed Testing Market Outlook by Types and Applications to 2028

    • 10.1 Global Laboratory-developed Testing Consumption Forecast and Growth Rate by Type (2022-2028)

      • 10.1.1 Global Clinical Biochemistry Consumption Forecast and Growth Rate (2022-2028)

      • 10.1.2 Global Critical Care Consumption Forecast and Growth Rate (2022-2028)

      • 10.1.3 Global Haematology Consumption Forecast and Growth Rate (2022-2028)

      • 10.1.4 Global Immunology Consumption Forecast and Growth Rate (2022-2028)

      • 10.1.5 Global Microbiology Consumption Forecast and Growth Rate (2022-2028)

      • 10.1.6 Global Molecular Diagnostics Consumption Forecast and Growth Rate (2022-2028)

      • 10.1.7 Global Other Test Types Consumption Forecast and Growth Rate (2022-2028)

    • 10.2 Global Laboratory-developed Testing Consumption Forecast and Growth Rate by Application (2022-2028)

      • 10.2.1 Global Academic Institutes Consumption Forecast and Growth Rate (2022-2028)

      • 10.2.2 Global Clinical Research organizations Consumption Forecast and Growth Rate (2022-2028)

      • 10.2.3 Global Hospitals laboratory Consumption Forecast and Growth Rate (2022-2028)

      • 10.2.4 Global Specialty Diagnostic Centers Consumption Forecast and Growth Rate (2022-2028)

      • 10.2.5 Global Other Type of Facilities Consumption Forecast and Growth Rate (2022-2028)

    11 Global Laboratory-developed Testing Import and Export Analysis (Top 5 Countries)

    • 11.1 Global Laboratory-developed Testing Import by Region (Top 5 Countries) (2017-2028)

    • 11.2 Global Laboratory-developed Testing Export by Region (Top 5 Countries) (2017-2028)

    12 Coronavirus Disease (COVID-19) Impact

    • 12.1 Industry Impact Analysis

    • 12.2 Laboratory-developed Testing Market Outlook to 2028 - COVID-19 Affected Forecasts

    13 Competition Matrix

    • 13.1 Target Markets

    • 13.2 Comprehensive Analysis of Products in Competitive Markets

    14 Global Laboratory-developed Testing Market Competitive Analysis

    • 14.1 Eurofins

      • 14.1.1 Eurofins Company Details

      • 14.1.2 Eurofins Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

      • 14.1.3 Eurofins Laboratory-developed Testing Product and Service

    • 14.2 Adaptive Biotechnologies

      • 14.2.1 Adaptive Biotechnologies Company Details

      • 14.2.2 Adaptive Biotechnologies Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

      • 14.2.3 Adaptive Biotechnologies Laboratory-developed Testing Product and Service

    • 14.3 Roche

      • 14.3.1 Roche Company Details

      • 14.3.2 Roche Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

      • 14.3.3 Roche Laboratory-developed Testing Product and Service

    • 14.4 Adaptive Biotechnologies Corporation

      • 14.4.1 Adaptive Biotechnologies Corporation Company Details

      • 14.4.2 Adaptive Biotechnologies Corporation Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

      • 14.4.3 Adaptive Biotechnologies Corporation Laboratory-developed Testing Product and Service

    • 14.5 Rosetta Genomics

      • 14.5.1 Rosetta Genomics Company Details

      • 14.5.2 Rosetta Genomics Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

      • 14.5.3 Rosetta Genomics Laboratory-developed Testing Product and Service

    • 14.6 Guardant Health

      • 14.6.1 Guardant Health Company Details

      • 14.6.2 Guardant Health Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

      • 14.6.3 Guardant Health Laboratory-developed Testing Product and Service

    • 14.7 Quest Diagnostics

      • 14.7.1 Quest Diagnostics Company Details

      • 14.7.2 Quest Diagnostics Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

      • 14.7.3 Quest Diagnostics Laboratory-developed Testing Product and Service

    • 14.8 Biodesix

      • 14.8.1 Biodesix Company Details

      • 14.8.2 Biodesix Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

      • 14.8.3 Biodesix Laboratory-developed Testing Product and Service

    • 14.9 Qiagen

      • 14.9.1 Qiagen Company Details

      • 14.9.2 Qiagen Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

      • 14.9.3 Qiagen Laboratory-developed Testing Product and Service

    • 14.10 Helix

      • 14.10.1 Helix Company Details

      • 14.10.2 Helix Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

      • 14.10.3 Helix Laboratory-developed Testing Product and Service

    • 14.11 Illumina

      • 14.11.1 Illumina Company Details

      • 14.11.2 Illumina Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

      • 14.11.3 Illumina Laboratory-developed Testing Product and Service

    • 14.12 Biotheranostics

      • 14.12.1 Biotheranostics Company Details

      • 14.12.2 Biotheranostics Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

      • 14.12.3 Biotheranostics Laboratory-developed Testing Product and Service

    15 Appendix


    TABLE OF CHARTS

    • Table Definition of Laboratory-developed Testing

    • Figure Laboratory-developed Testing Picture

    • Table Global Laboratory-developed Testing Market Size and Forecast 2022 - 2028 (USD million)

    • Figure Global Laboratory-developed Testing Market Size and Forecast 2022 - 2028 (USD million)

    • Figure Global Laboratory-developed Testing Market: Year-over-year Growth 2022 - 2028 (%)

    • Table Parent Market Analysis

    • Figure Parent Market Price

    • Table Related/Ancillary Market Outlook Analysis

    • Table Supplier Power Analysis

    • Table Buyer Power Analysis

    • Table Substitution Threat Analysis

    • Table Threat of New Entrants Analysis

    • Table Competitive Rivalry Analysis

    • Figure Global Laboratory-developed Testing Consumption by Country (2017-2022)

    • Figure United States Laboratory-developed Testing Consumption and Growth Rate (2017-2022)

    • Table Europe Laboratory-developed Testing Consumption and Growth Rate (2017-2022)

    • Figure China Laboratory-developed Testing Consumption and Growth Rate (2017-2022)

    • Figure Japan Laboratory-developed Testing Consumption and Growth Rate (2017-2022)

    • Figure India Laboratory-developed Testing Consumption and Growth Rate (2017-2022)

    • Figure South Korea Laboratory-developed Testing Consumption and Growth Rate (2017-2022)

    • Figure Global Laboratory-developed Testing Consumption Forecast by Country (2022-2028)

    • Figure United States Laboratory-developed Testing Consumption Forecast and Growth Rate (2022-2028)

    • Table Europe Laboratory-developed Testing Consumption Forecast and Growth Rate (2022-2028)

    • Figure China Laboratory-developed Testing Consumption Forecast and Growth Rate (2022-2028)

    • Figure Japan Laboratory-developed Testing Consumption Forecast and Growth Rate (2022-2028)

    • Figure India Laboratory-developed Testing Consumption Forecast and Growth Rate (2022-2028)

    • Figure South Korea Laboratory-developed Testing Consumption Forecast and Growth Rate (2022-2028)

    • Figure Global Clinical Biochemistry Consumption and Growth Rate (2017-2022)

    • Figure Global Critical Care Consumption and Growth Rate (2017-2022)

    • Figure Global Haematology Consumption and Growth Rate (2017-2022)

    • Figure Global Immunology Consumption and Growth Rate (2017-2022)

    • Figure Global Microbiology Consumption and Growth Rate (2017-2022)

    • Figure Global Molecular Diagnostics Consumption and Growth Rate (2017-2022)

    • Figure Global Other Test Types Consumption and Growth Rate (2017-2022)

    • Figure Global Academic Institutes Consumption and Growth Rate (2017-2022)

    • Figure Global Clinical Research organizations Consumption and Growth Rate (2017-2022)

    • Figure Global Hospitals laboratory Consumption and Growth Rate (2017-2022)

    • Figure Global Specialty Diagnostic Centers Consumption and Growth Rate (2017-2022)

    • Figure Global Other Type of Facilities Consumption and Growth Rate (2017-2022)

    • Figure Global Clinical Biochemistry Consumption Forecast and Growth Rate (2022-2028)

    • Figure Global Critical Care Consumption Forecast and Growth Rate (2022-2028)

    • Figure Global Haematology Consumption Forecast and Growth Rate (2022-2028)

    • Figure Global Immunology Consumption Forecast and Growth Rate (2022-2028)

    • Figure Global Microbiology Consumption Forecast and Growth Rate (2022-2028)

    • Figure Global Molecular Diagnostics Consumption Forecast and Growth Rate (2022-2028)

    • Figure Global Other Test Types Consumption Forecast and Growth Rate (2022-2028)

    • Figure Global Academic Institutes Consumption Forecast and Growth Rate (2022-2028)

    • Figure Global Clinical Research organizations Consumption Forecast and Growth Rate (2022-2028)

    • Figure Global Hospitals laboratory Consumption Forecast and Growth Rate (2022-2028)

    • Figure Global Specialty Diagnostic Centers Consumption Forecast and Growth Rate (2022-2028)

    • Figure Global Other Type of Facilities Consumption Forecast and Growth Rate (2022-2028)

    • Table Global Laboratory-developed Testing Import by Region (Top 5 Countries) (2017-2028)

    • Table Global Laboratory-developed Testing Export by Region (Top 5 Countries) (2017-2028)

    • Table Eurofins (Foundation Year, Company Profile and etc.)

    • Table Eurofins Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

    • Table Eurofins Laboratory-developed Testing Product and Service

    • Table Adaptive Biotechnologies (Foundation Year, Company Profile and etc.)

    • Table Adaptive Biotechnologies Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

    • Table Adaptive Biotechnologies Laboratory-developed Testing Product and Service

    • Table Roche (Foundation Year, Company Profile and etc.)

    • Table Roche Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

    • Table Roche Laboratory-developed Testing Product and Service

    • Table Adaptive Biotechnologies Corporation (Foundation Year, Company Profile and etc.)

    • Table Adaptive Biotechnologies Corporation Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

    • Table Adaptive Biotechnologies Corporation Laboratory-developed Testing Product and Service

    • Table Rosetta Genomics (Foundation Year, Company Profile and etc.)

    • Table Rosetta Genomics Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

    • Table Rosetta Genomics Laboratory-developed Testing Product and Service

    • Table Guardant Health (Foundation Year, Company Profile and etc.)

    • Table Guardant Health Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

    • Table Guardant Health Laboratory-developed Testing Product and Service

    • Table Quest Diagnostics (Foundation Year, Company Profile and etc.)

    • Table Quest Diagnostics Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

    • Table Quest Diagnostics Laboratory-developed Testing Product and Service

    • Table Biodesix (Foundation Year, Company Profile and etc.)

    • Table Biodesix Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

    • Table Biodesix Laboratory-developed Testing Product and Service

    • Table Qiagen (Foundation Year, Company Profile and etc.)

    • Table Qiagen Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

    • Table Qiagen Laboratory-developed Testing Product and Service

    • Table Helix (Foundation Year, Company Profile and etc.)

    • Table Helix Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

    • Table Helix Laboratory-developed Testing Product and Service

    • Table Illumina (Foundation Year, Company Profile and etc.)

    • Table Illumina Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

    • Table Illumina Laboratory-developed Testing Product and Service

    • Table Biotheranostics (Foundation Year, Company Profile and etc.)

    • Table Biotheranostics Laboratory-developed Testing Sales, Price, Value and Gross Profit (2017-2022)

    • Table Biotheranostics Laboratory-developed Testing Product and Service


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