Global Laboratory-developed Testing Sales Market Report 2018 : Quest Diagnostics, Roche, Illumina, Qiagen, Eurofins, Guardant Health,

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This report studies the global Laboratory-developed Testing market status and forecast, categorizes the global Laboratory-developed Testing market size (value & volume) by key players, type, application, and region. This report focuses on the top players in North America, Europe, China, Japan, Southeast Asia India and Other regions (Middle East & Africa, Central & South America).

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 Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation.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 patients 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 2017 and will reach 4060 million US$ by the end of 2025, growing at a CAGR of 3.8% during 2018-2025.

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The major players covered in this report
Adaptive Biotechnologies Corporation
Quest Diagnostics
Roche
Illumina
Qiagen
Eurofins
Guardant Health
Biotheranostics
Adaptive Biotechnologies
Rosetta Genomics
Biodesix
Helix

Geographically, this report studies the key regions, focuses on product sales, value, market share and growth opportunity in these regions, covering
United States
Europe
China
Japan
Southeast Asia
India

We can also provide the customized separate regional or country-level reports, for the following regions:
North America
United States
Canada
Mexico
Asia-Pacific
China
India
Japan
South Korea
Australia
Indonesia
Singapore
Rest of Asia-Pacific
Europe
Germany
France
UK
Italy
Spain
Russia
Rest of Europe
Central & South America
Brazil
Argentina
Rest of South America
Middle East & Africa
Saudi Arabia
Turkey
Rest of Middle East & Africa

On the basis of product, this report displays the production, revenue, price, market share and growth rate of each type, primarily split into
Clinical Biochemistry
Critical Care
Haematology
Immunology
Microbiology
Molecular Diagnostics
Other Test Types
On the basis on the end users/applications, this report focuses on the status and outlook for major applications/end users, sales volume, market share and growth rate for each application, including
Academic Institutes
Clinical Research organizations
Hospitals laboratory
Specialty Diagnostic Centers
Other Type of Facilities

The study objectives of this report are:
To analyze and study the global Laboratory-developed Testing sales, value, status (2013-2017) and forecast (2018-2025);
To analyze the top players in North America, Europe, China, Japan, Southeast Asia and India, to study the sales, value and market share of top players in these regions.
Focuses on the key Laboratory-developed Testing players, to study the sales, value, market share and development plans in future.
Focuses on the global key manufacturers, to define, describe and analyze the market competition landscape, SWOT analysis.
To define, describe and forecast the market by type, application and region.
To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
To identify significant trends and factors driving or inhibiting the market growth.
To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
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.

In this study, the years considered to estimate the market size of Laboratory-developed Testing are as follows:
History Year: 2013-2017
Base Year: 2017
Estimated Year: 2018
Forecast Year 2018 to 2025

For the data information by region, company, type and application, 2017 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.

Key Stakeholders
Laboratory-developed Testing Manufacturers
Laboratory-developed Testing Distributors/Traders/Wholesalers
Laboratory-developed Testing Subcomponent Manufacturers
Industry Association
Downstream Vendors

Table of Contents

Global Laboratory-developed Testing Sales Market Report 2018
1 Laboratory-developed Testing Market Overview
1.1 Product Overview and Scope of Laboratory-developed Testing
1.2 Classification of Laboratory-developed Testing by Product Category
1.2.1 Global Laboratory-developed Testing Market Size (Sales) Comparison by Type (2013-2025)
1.2.2 Global Laboratory-developed Testing Market Size (Sales) Market Share by Type (Product Category) in 2017
1.2.3 Clinical Biochemistry
1.2.4 Critical Care
1.2.5 Haematology
1.2.6 Immunology
1.2.7 Microbiology
1.2.8 Molecular Diagnostics
1.2.9 Other Test Types
1.3 Global Laboratory-developed Testing Market by Application/End Users
1.3.1 Global Laboratory-developed Testing Sales (Volume) and Market Share Comparison by Application (2013-2025)
1.3.1 Academic Institutes
1.3.2 Clinical Research organizations
1.3.3 Hospitals laboratory
1.3.4 Specialty Diagnostic Centers
1.3.5 Other Type of Facilities
1.4 Global Laboratory-developed Testing Market by Region
1.4.1 Global Laboratory-developed Testing Market Size (Value) Comparison by Region (2013-2025)
1.4.2 United States Laboratory-developed Testing Status and Prospect (2013-2025)
1.4.3 Europe Laboratory-developed Testing Status and Prospect (2013-2025)
1.4.4 China Laboratory-developed Testing Status and Prospect (2013-2025)
1.4.5 Japan Laboratory-developed Testing Status and Prospect (2013-2025)
1.4.6 Southeast Asia Laboratory-developed Testing Status and Prospect (2013-2025)
1.4.7 India Laboratory-developed Testing Status and Prospect (2013-2025)
1.5 Global Market Size (Value and Volume) of Laboratory-developed Testing (2013-2025)
1.5.1 Global Laboratory-developed Testing Sales and Growth Rate (2013-2025)
1.5.2 Global Laboratory-developed Testing Revenue and Growth Rate (2013-2025)

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2 Global Laboratory-developed Testing Competition by Players/Suppliers, Type and Application
2.1 Global Laboratory-developed Testing Market Competition by Players/Suppliers
2.1.1 Global Laboratory-developed Testing Sales and Market Share of Key Players/Suppliers (2013-2018)
2.1.2 Global Laboratory-developed Testing Revenue and Share by Players/Suppliers (2013-2018)
2.2 Global Laboratory-developed Testing (Volume and Value) by Type
2.2.1 Global Laboratory-developed Testing Sales and Market Share by Type (2013-2018)
2.2.2 Global Laboratory-developed Testing Revenue and Market Share by Type (2013-2018)
2.3 Global Laboratory-developed Testing (Volume and Value) by Region
2.3.1 Global Laboratory-developed Testing Sales and Market Share by Region (2013-2018)
2.3.2 Global Laboratory-developed Testing Revenue and Market Share by Region (2013-2018)
2.4 Global Laboratory-developed Testing (Volume) by Application

3 United States Laboratory-developed Testing (Volume, Value and Sales Price)
3.1 United States Laboratory-developed Testing Sales and Value (2013-2018)
3.1.1 United States Laboratory-developed Testing Sales and Growth Rate (2013-2018)
3.1.2 United States Laboratory-developed Testing Revenue and Growth Rate (2013-2018)
3.1.3 United States Laboratory-developed Testing Sales Price Trend (2013-2018)
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