Report Detail

Pharma & Healthcare Global Laboratory-developed Testing Market Growth 2019-2024

  • RnM3065050
  • |
  • 06 March, 2019
  • |
  • Global
  • |
  • 165 Pages
  • |
  • LPI(LP Information)
  • |
  • Pharma & Healthcare

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 Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation.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

According to this study, over the next five years the Laboratory-developed Testing market will register a 5.0% CAGR in terms of revenue, the global market size will reach US$ 4030 million by 2024, from US$ 3010 million in 2019. In particular, this report presents the global market share (sales and revenue) of key companies in Laboratory-developed Testing business, shared in Chapter 3.

This report presents a comprehensive overview, market shares, and growth opportunities of Laboratory-developed Testing market by product type, application, key manufacturers and key regions and countries.

This study considers the Laboratory-developed Testing value and volume generated from the sales of the following segments:

Segmentation by product type: breakdown data from 2014 to 2019, in Section 2.3; and forecast to 2024 in section 11.7.
Clinical Biochemistry
Critical Care
Haematology
Immunology
Microbiology
Molecular Diagnostics
Other Test Types
Segmentation by application: breakdown data from 2014 to 2019, in Section 2.4; and forecast to 2024 in section 11.8.
Academic Institutes
Clinical Research organizations
Hospitals laboratory
Specialty Diagnostic Centers
Other Type of Facilities

This report also splits the market by region: Breakdown data in Chapter 4, 5, 6, 7 and 8.
Americas
United States
Canada
Mexico
Brazil
APAC
China
Japan
Korea
Southeast Asia
India
Australia
Europe
Germany
France
UK
Italy
Russia
Spain
Middle East & Africa
Egypt
South Africa
Israel
Turkey
GCC Countries

The report also presents the market competition landscape and a corresponding detailed analysis of the major vendor/manufacturers in the market. The key manufacturers covered in this report: Breakdown data in in Chapter 3.
Adaptive Biotechnologies Corporation
Quest Diagnostics
Roche
Illumina
Qiagen
Eurofins
Guardant Health
Biotheranostics
Adaptive Biotechnologies
Rosetta Genomics
Biodesix
Helix

In addition, this report discusses the key drivers influencing market growth, opportunities, the challenges and the risks faced by key manufacturers and the market as a whole. It also analyzes key emerging trends and their impact on present and future development.

Research objectives
To study and analyze the global Laboratory-developed Testing consumption (value & volume) by key regions/countries, product type and application, history data from 2014 to 2018, and forecast to 2024.
To understand the structure of Laboratory-developed Testing market by identifying its various subsegments.
Focuses on the key global Laboratory-developed Testing manufacturers, to define, describe and analyze the sales volume, value, market share, market competition landscape, SWOT analysis and development plans in next few years.
To analyze the Laboratory-developed Testing with respect to individual growth trends, future prospects, and their contribution to the total market.
To share detailed information about the key factors influencing the growth of the market (growth potential, opportunities, drivers, industry-specific challenges and risks).
To project the consumption of Laboratory-developed Testing submarkets, with respect to key regions (along with their respective key countries).
To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market.
To strategically profile the key players and comprehensively analyze their growth strategies.


Table of Contents

    2019-2024 Global Laboratory-developed Testing Consumption Market Report

      1 Scope of the Report

      • 1.1 Market Introduction
      • 1.2 Research Objectives
      • 1.3 Years Considered
      • 1.4 Market Research Methodology
      • 1.5 Economic Indicators
      • 1.6 Currency Considered

      2 Executive Summary

      • 2.1 World Market Overview
        • 2.1.1 Global Laboratory-developed Testing Consumption 2014-2024
        • 2.1.2 Laboratory-developed Testing Consumption CAGR by Region
      • 2.2 Laboratory-developed Testing Segment by Type
        • 2.2.1 Clinical Biochemistry
        • 2.2.2 Critical Care
        • 2.2.3 Haematology
        • 2.2.4 Immunology
        • 2.2.5 Microbiology
        • 2.2.6 Molecular Diagnostics
        • 2.2.7 Other Test Types
      • 2.3 Laboratory-developed Testing Consumption by Type
        • 2.3.1 Global Laboratory-developed Testing Consumption Market Share by Type (2014-2019)
        • 2.3.2 Global Laboratory-developed Testing Revenue and Market Share by Type (2014-2019)
        • 2.3.3 Global Laboratory-developed Testing Sale Price by Type (2014-2019)
      • 2.4 Laboratory-developed Testing Segment by Application
        • 2.4.1 Academic Institutes
        • 2.4.2 Clinical Research organizations
        • 2.4.3 Hospitals laboratory
        • 2.4.4 Specialty Diagnostic Centers
        • 2.4.5 Other Type of Facilities
      • 2.5 Laboratory-developed Testing Consumption by Application
        • 2.5.1 Global Laboratory-developed Testing Consumption Market Share by Application (2014-2019)
        • 2.5.2 Global Laboratory-developed Testing Value and Market Share by Application (2014-2019)
        • 2.5.3 Global Laboratory-developed Testing Sale Price by Application (2014-2019)

      3 Global Laboratory-developed Testing by Players

      • 3.1 Global Laboratory-developed Testing Sales Market Share by Players
        • 3.1.1 Global Laboratory-developed Testing Sales by Players (2017-2019)
        • 3.1.2 Global Laboratory-developed Testing Sales Market Share by Players (2017-2019)
      • 3.2 Global Laboratory-developed Testing Revenue Market Share by Players
        • 3.2.1 Global Laboratory-developed Testing Revenue by Players (2017-2019)
        • 3.2.2 Global Laboratory-developed Testing Revenue Market Share by Players (2017-2019)
      • 3.3 Global Laboratory-developed Testing Sale Price by Players
      • 3.4 Global Laboratory-developed Testing Manufacturing Base Distribution, Sales Area, Product Types by Players
        • 3.4.1 Global Laboratory-developed Testing Manufacturing Base Distribution and Sales Area by Players
        • 3.4.2 Players Laboratory-developed Testing Products Offered
      • 3.5 Market Concentration Rate Analysis
        • 3.5.1 Competition Landscape Analysis
        • 3.5.2 Concentration Ratio (CR3, CR5 and CR10) (2017-2019)
      • 3.6 New Products and Potential Entrants
      • 3.7 Mergers & Acquisitions, Expansion

      4 Laboratory-developed Testing by Regions

      • 4.1 Laboratory-developed Testing by Regions
        • 4.1.1 Global Laboratory-developed Testing Consumption by Regions
        • 4.1.2 Global Laboratory-developed Testing Value by Regions
      • 4.2 Americas Laboratory-developed Testing Consumption Growth
      • 4.3 APAC Laboratory-developed Testing Consumption Growth
      • 4.4 Europe Laboratory-developed Testing Consumption Growth
      • 4.5 Middle East & Africa Laboratory-developed Testing Consumption Growth

      5 Americas

      • 5.1 Americas Laboratory-developed Testing Consumption by Countries
        • 5.1.1 Americas Laboratory-developed Testing Consumption by Countries (2014-2019)
        • 5.1.2 Americas Laboratory-developed Testing Value by Countries (2014-2019)
      • 5.2 Americas Laboratory-developed Testing Consumption by Type
      • 5.3 Americas Laboratory-developed Testing Consumption by Application
      • 5.4 United States
      • 5.5 Canada
      • 5.6 Mexico
      • 5.7 Key Economic Indicators of Few Americas Countries

      6 APAC

      • 6.1 APAC Laboratory-developed Testing Consumption by Countries
        • 6.1.1 APAC Laboratory-developed Testing Consumption by Countries (2014-2019)
        • 6.1.2 APAC Laboratory-developed Testing Value by Countries (2014-2019)
      • 6.2 APAC Laboratory-developed Testing Consumption by Type
      • 6.3 APAC Laboratory-developed Testing Consumption by Application
      • 6.4 China
      • 6.5 Japan
      • 6.6 Korea
      • 6.7 Southeast Asia
      • 6.8 India
      • 6.9 Australia
      • 6.10 Key Economic Indicators of Few APAC Countries

      7 Europe

      • 7.1 Europe Laboratory-developed Testing by Countries
        • 7.1.1 Europe Laboratory-developed Testing Consumption by Countries (2014-2019)
        • 7.1.2 Europe Laboratory-developed Testing Value by Countries (2014-2019)
      • 7.2 Europe Laboratory-developed Testing Consumption by Type
      • 7.3 Europe Laboratory-developed Testing Consumption by Application
      • 7.4 Germany
      • 7.5 France
      • 7.6 UK
      • 7.7 Italy
      • 7.8 Russia
      • 7.9 Spain
      • 7.10 Key Economic Indicators of Few Europe Countries

      8 Middle East & Africa

      • 8.1 Middle East & Africa Laboratory-developed Testing by Countries
        • 8.1.1 Middle East & Africa Laboratory-developed Testing Consumption by Countries (2014-2019)
        • 8.1.2 Middle East & Africa Laboratory-developed Testing Value by Countries (2014-2019)
      • 8.2 Middle East & Africa Laboratory-developed Testing Consumption by Type
      • 8.3 Middle East & Africa Laboratory-developed Testing Consumption by Application
      • 8.4 Egypt
      • 8.5 South Africa
      • 8.6 Israel
      • 8.7 Turkey
      • 8.8 GCC Countries

      9 Market Drivers, Challenges and Trends

      • 9.1 Market Drivers and Impact
        • 9.1.1 Growing Demand from Key Regions
        • 9.1.2 Growing Demand from Key Applications and Potential Industries
      • 9.2 Market Challenges and Impact
      • 9.3 Market Trends

      10 Marketing, Distributors and Customer

      • 10.1 Sales Channel
        • 10.1.1 Direct Channels
        • 10.1.2 Indirect Channels
      • 10.2 Laboratory-developed Testing Distributors
      • 10.3 Laboratory-developed Testing Customer

      11 Global Laboratory-developed Testing Market Forecast

      • 11.1 Global Laboratory-developed Testing Consumption Forecast (2019-2024)
      • 11.2 Global Laboratory-developed Testing Forecast by Regions
        • 11.2.1 Global Laboratory-developed Testing Forecast by Regions (2019-2024)
        • 11.2.2 Global Laboratory-developed Testing Value Forecast by Regions (2019-2024)
        • 11.2.3 Americas Consumption Forecast
        • 11.2.4 APAC Consumption Forecast
        • 11.2.5 Europe Consumption Forecast
        • 11.2.6 Middle East & Africa Consumption Forecast
      • 11.3 Americas Forecast by Countries
        • 11.3.1 United States Market Forecast
        • 11.3.2 Canada Market Forecast
        • 11.3.3 Mexico Market Forecast
        • 11.3.4 Brazil Market Forecast
      • 11.4 APAC Forecast by Countries
        • 11.4.1 China Market Forecast
        • 11.4.2 Japan Market Forecast
        • 11.4.3 Korea Market Forecast
        • 11.4.4 Southeast Asia Market Forecast
        • 11.4.5 India Market Forecast
        • 11.4.6 Australia Market Forecast
      • 11.5 Europe Forecast by Countries
        • 11.5.1 Germany Market Forecast
        • 11.5.2 France Market Forecast
        • 11.5.3 UK Market Forecast
        • 11.5.4 Italy Market Forecast
        • 11.5.5 Russia Market Forecast
        • 11.5.6 Spain Market Forecast
      • 11.6 Middle East & Africa Forecast by Countries
        • 11.6.1 Egypt Market Forecast
        • 11.6.2 South Africa Market Forecast
        • 11.6.3 Israel Market Forecast
        • 11.6.4 Turkey Market Forecast
        • 11.6.5 GCC Countries Market Forecast
      • 11.7 Global Laboratory-developed Testing Forecast by Type
      • 11.8 Global Laboratory-developed Testing Forecast by Application

      12 Key Players Analysis

      • 12.1 Adaptive Biotechnologies Corporation
        • 12.1.1 Company Details
        • 12.1.2 Laboratory-developed Testing Product Offered
        • 12.1.3 Adaptive Biotechnologies Corporation Laboratory-developed Testing Sales, Revenue, Price and Gross Margin (2017-2019)
        • 12.1.4 Main Business Overview
        • 12.1.5 Adaptive Biotechnologies Corporation News
      • 12.2 Quest Diagnostics
        • 12.2.1 Company Details
        • 12.2.2 Laboratory-developed Testing Product Offered
        • 12.2.3 Quest Diagnostics Laboratory-developed Testing Sales, Revenue, Price and Gross Margin (2017-2019)
        • 12.2.4 Main Business Overview
        • 12.2.5 Quest Diagnostics News
      • 12.3 Roche
        • 12.3.1 Company Details
        • 12.3.2 Laboratory-developed Testing Product Offered
        • 12.3.3 Roche Laboratory-developed Testing Sales, Revenue, Price and Gross Margin (2017-2019)
        • 12.3.4 Main Business Overview
        • 12.3.5 Roche News
      • 12.4 Illumina
        • 12.4.1 Company Details
        • 12.4.2 Laboratory-developed Testing Product Offered
        • 12.4.3 Illumina Laboratory-developed Testing Sales, Revenue, Price and Gross Margin (2017-2019)
        • 12.4.4 Main Business Overview
        • 12.4.5 Illumina News
      • 12.5 Qiagen
        • 12.5.1 Company Details
        • 12.5.2 Laboratory-developed Testing Product Offered
        • 12.5.3 Qiagen Laboratory-developed Testing Sales, Revenue, Price and Gross Margin (2017-2019)
        • 12.5.4 Main Business Overview
        • 12.5.5 Qiagen News
      • 12.6 Eurofins
        • 12.6.1 Company Details
        • 12.6.2 Laboratory-developed Testing Product Offered
        • 12.6.3 Eurofins Laboratory-developed Testing Sales, Revenue, Price and Gross Margin (2017-2019)
        • 12.6.4 Main Business Overview
        • 12.6.5 Eurofins News
      • 12.7 Guardant Health
        • 12.7.1 Company Details
        • 12.7.2 Laboratory-developed Testing Product Offered
        • 12.7.3 Guardant Health Laboratory-developed Testing Sales, Revenue, Price and Gross Margin (2017-2019)
        • 12.7.4 Main Business Overview
        • 12.7.5 Guardant Health News
      • 12.8 Biotheranostics
        • 12.8.1 Company Details
        • 12.8.2 Laboratory-developed Testing Product Offered
        • 12.8.3 Biotheranostics Laboratory-developed Testing Sales, Revenue, Price and Gross Margin (2017-2019)
        • 12.8.4 Main Business Overview
        • 12.8.5 Biotheranostics News
      • 12.9 Adaptive Biotechnologies
        • 12.9.1 Company Details
        • 12.9.2 Laboratory-developed Testing Product Offered
        • 12.9.3 Adaptive Biotechnologies Laboratory-developed Testing Sales, Revenue, Price and Gross Margin (2017-2019)
        • 12.9.4 Main Business Overview
        • 12.9.5 Adaptive Biotechnologies News
      • 12.10 Rosetta Genomics
        • 12.10.1 Company Details
        • 12.10.2 Laboratory-developed Testing Product Offered
        • 12.10.3 Rosetta Genomics Laboratory-developed Testing Sales, Revenue, Price and Gross Margin (2017-2019)
        • 12.10.4 Main Business Overview
        • 12.10.5 Rosetta Genomics News
      • 12.11 Biodesix
      • 12.12 Helix

      13 Research Findings and Conclusion

      Summary:
      Get latest Market Research Reports on Laboratory-developed Testing . Industry analysis & Market Report on Laboratory-developed Testing is a syndicated market report, published as Global Laboratory-developed Testing Market Growth 2019-2024. It is complete Research Study and Industry Analysis of Laboratory-developed Testing market, to understand, Market Demand, Growth, trends analysis and Factor Influencing market.

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