Global Laboratory-developed Testing Market 2019 by Manufacturers, Regions, Type and Application, Forecast to 2024

  • receipt Report ID : 199697
  • calendar_today Published On: Sep, 2019
  • file_copy Pages: 115
  • list Pharmaceuticals and 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 Released in 2014, the draft guidance sparked an intense debate over potential LDT regulation.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.

Scope of the Report:

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 worldwide market for Laboratory-developed Testing is expected to grow at a CAGR of roughly 5.0% over the next five years, will reach 4030 million US$ in 2024, from 3010 million US$ in 2019, according to a new study.

This report focuses on the Laboratory-developed Testing in global market, especially in North America, Europe and Asia-Pacific, South America, Middle East and Africa. This report categorizes the market based on manufacturers, regions, type and application.

Market Segment by Manufacturers, this report covers

Adaptive Biotechnologies Corporation

Quest Diagnostics

Roche

Illumina

Qiagen

Eurofins

Guardant Health

Biotheranostics

Adaptive Biotechnologies

Rosetta Genomics

Biodesix

Helix

Market Segment by Regions, regional analysis covers

North America (United States, Canada and Mexico)

Europe (Germany, France, UK, Russia and Italy)

Asia-Pacific (China, Japan, Korea, India and Southeast Asia)

South America (Brazil, Argentina, Colombia etc.)

Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

Market Segment by Type, covers

Clinical Biochemistry

Critical Care

Haematology

Immunology

Microbiology

Molecular Diagnostics

Other Test Types

Market Segment by Applications, can be divided into

Academic Institutes

Clinical Research organizations

Hospitals laboratory

Specialty Diagnostic Centers

Other Type of Facilities

The content of the study subjects, includes a total of 15 chapters:

Chapter 1, to describe Laboratory-developed Testing product scope, market overview, market opportunities, market driving force and market risks.

Chapter 2, to profile the top manufacturers of Laboratory-developed Testing, with price, sales, revenue and global market share of Laboratory-developed Testing in 2017 and 2018.

Chapter 3, the Laboratory-developed Testing competitive situation, sales, revenue and global market share of top manufacturers are analyzed emphatically by landscape contrast.

Chapter 4, the Laboratory-developed Testing breakdown data are shown at the regional level, to show the sales, revenue and growth by regions, from 2014 to 2019.

Chapter 5, 6, 7, 8 and 9, to break the sales data at the country level, with sales, revenue and market share for key countries in the world, from 2014 to 2019.

Chapter 10 and 11, to segment the sales by type and application, with sales market share and growth rate by type, application, from 2014 to 2019.

Chapter 12, Laboratory-developed Testing market forecast, by regions, type and application, with sales and revenue, from 2019 to 2024.

Chapter 13, 14 and 15, to describe Laboratory-developed Testing sales channel, distributors, customers, research findings and conclusion, appendix and data source.

Frequently Asked Questions

The base year for the study has been considered 2019, historic year 2014 and 2018, the forecast period considered is from 2020 to 2027. The regions analyzed for the market include North America, Europe, South America, Asia Pacific, and Middle East and Africa. These regions are further analyzed at the country-level. The study also includes attractiveness analysis of type, application and regions which are benchmarked based on their market size, growth rate and attractiveness in terms of present and future opportunity for understanding the future growth of the market.

Market is segmented on the basis:

  • By Type
  • By Application
  • By Region
  • By Country
  • By Manufacturer

The report offers in-depth analysis of driving factors, opportunities, restraints, and challenges for gaining the key insight of the market. The report emphasizes on all the key trends that play a vital role in the enlargement of the market from 2019 to 2026.

The report provides company profile of the key players operating in the market and a comparative analysis based on their business overviews industry offering, segment market share, regional presence, business strategies, innovations, mergers & acquisitions, recent developments, joint venture, collaborations, partnerships, SWOT analysis, and key financial information.

Table of Contents

1 Market Overview

1.1 Laboratory-developed Testing Introduction

1.2 Market Analysis by Type

1.2.1 Clinical Biochemistry

1.2.2 Critical Care

1.2.3 Haematology

1.2.4 Immunology

1.2.5 Microbiology

1.2.6 Molecular Diagnostics

1.2.7 Other Test Types

1.3 Market Analysis by Applications

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 Market Analysis by Regions

1.4.1 North America (United States, Canada and Mexico)

1.4.1.1 United States Market States and Outlook (2014-2024)

1.4.1.2 Canada Market States and Outlook (2014-2024)

1.4.1.3 Mexico Market States and Outlook (2014-2024)

1.4.2 Europe (Germany, France, UK, Russia and Italy)

1.4.2.1 Germany Market States and Outlook (2014-2024)

1.4.2.2 France Market States and Outlook (2014-2024)

1.4.2.3 UK Market States and Outlook (2014-2024)

1.4.2.4 Russia Market States and Outlook (2014-2024)

1.4.2.5 Italy Market States and Outlook (2014-2024)

1.4.3 Asia-Pacific (China, Japan, Korea, India and Southeast Asia)

1.4.3.1 China Market States and Outlook (2014-2024)

1.4.3.2 Japan Market States and Outlook (2014-2024)

1.4.3.3 Korea Market States and Outlook (2014-2024)

1.4.3.4 India Market States and Outlook (2014-2024)

1.4.3.5 Southeast Asia Market States and Outlook (2014-2024)

1.4.4 South America, Middle East and Africa

1.4.4.1 Brazil Market States and Outlook (2014-2024)

1.4.4.2 Egypt Market States and Outlook (2014-2024)

1.4.4.3 Saudi Arabia Market States and Outlook (2014-2024)

1.4.4.4 South Africa Market States and Outlook (2014-2024)

1.4.4.5 Turkey Market States and Outlook (2014-2024)

1.5 Market Dynamics

1.5.1 Market Opportunities

1.5.2 Market Risk

1.5.3 Market Driving Force

2 Manufacturers Profiles

2.1 Adaptive Biotechnologies Corporation

2.1.1 Business Overview

2.1.2 Laboratory-developed Testing Type and Applications

2.1.2.1 Product A

2.1.2.2 Product B

2.1.3 Adaptive Biotechnologies Corporation Laboratory-developed Testing Sales, Price, Revenue, Gross Margin and Market Share (2017-2018)

2.2 Quest Diagnostics

2.2.1 Business Overview

2.2.2 Laboratory-developed Testing Type and Applications

2.2.2.1 Product A

2.2.2.2 Product B

2.2.3 Quest Diagnostics Laboratory-developed Testing Sales, Price, Revenue, Gross Margin and Market Share (2017-2018)

2.3 Roche

2.3.1 Business Overview

2.3.2 Laboratory-developed Testing Type and Applications

2.3.2.1 Product A

2.3.2.2 Product B

2.3.3 Roche Laboratory-developed Testing Sales, Price, Revenue, Gross Margin and Market Share (2017-2018)

2.4 Illumina

2.4.1 Business Overview

2.4.2 Laboratory-developed Testing Type and Applications

2.4.2.1 Product A

2.4.2.2 Product B

2.4.3 Illumina Laboratory-developed Testing Sales, Price, Revenue, Gross Margin and Market Share (2017-2018)

2.5 Qiagen

2.5.1 Business Overview

2.5.2 Laboratory-developed Testing Type and Applications

2.5.2.1 Product A

2.5.2.2 Product B

2.5.3 Qiagen Laboratory-developed Testing Sales, Price, Revenue, Gross Margin and Market Share (2017-2018)

2.6 Eurofins

2.6.1 Business Overview

2.6.2 Laboratory-developed Testing Type and Applications

2.6.2.1 Product A

2.6.2.2 Product B

2.6.3 Eurofins Laboratory-developed Testing Sales, Price, Revenue, Gross Margin and Market Share (2017-2018)

2.7 Guardant Health

2.7.1 Business Overview

2.7.2 Laboratory-developed Testing Type and Applications

2.7.2.1 Product A

2.7.2.2 Product B

2.7.3 Guardant Health Laboratory-developed Testing Sales, Price, Revenue, Gross Margin and Market Share (2017-2018)

2.8 Biotheranostics

2.8.1 Business Overview

2.8.2 Laboratory-developed Testing Type and Applications

2.8.2.1 Product A

2.8.2.2 Product B

2.8.3 Biotheranostics Laboratory-developed Testing Sales, Price, Revenue, Gross Margin and Market Share (2017-2018)

2.9 Adaptive Biotechnologies

2.9.1 Business Overview

2.9.2 Laboratory-developed Testing Type and Applications

2.9.2.1 Product A

2.9.2.2 Product B

2.9.3 Adaptive Biotechnologies Laboratory-developed Testing Sales, Price, Revenue, Gross Margin and Market Share (2017-2018)

2.10 Rosetta Genomics

2.10.1 Business Overview

2.10.2 Laboratory-developed Testing Type and Applications

2.10.2.1 Product A

2.10.2.2 Product B

2.10.3 Rosetta Genomics Laboratory-developed Testing Sales, Price, Revenue, Gross Margin and Market Share (2017-2018)

2.11 Biodesix

2.11.1 Business Overview

2.11.2 Laboratory-developed Testing Type and Applications

2.11.2.1 Product A

2.11.2.2 Product B

2.11.3 Biodesix Laboratory-developed Testing Sales, Price, Revenue, Gross Margin and Market Share (2017-2018)

2.12 Helix

2.12.1 Business Overview

2.12.2 Laboratory-developed Testing Type and Applications

2.12.2.1 Product A

2.12.2.2 Product B

2.12.3 Helix Laboratory-developed Testing Sales, Price, Revenue, Gross Margin and Market Share (2017-2018)

3 Global Laboratory-developed Testing Sales, Revenue, Market Share and Competition by Manufacturer (2017-2018)

3.1 Global Laboratory-developed Testing Sales and Market Share by Manufacturer (2017-2018)

3.2 Global Laboratory-developed Testing Revenue and Market Share by Manufacturer (2017-2018)

3.3 Market Concentration Rate

3.3.1 Top 3 Laboratory-developed Testing Manufacturer Market Share in 2018

3.3.2 Top 6 Laboratory-developed Testing Manufacturer Market Share in 2018

3.4 Market Competition Trend

4 Global Laboratory-developed Testing Market Analysis by Regions

4.1 Global Laboratory-developed Testing Sales, Revenue and Market Share by Regions

4.1.1 Global Laboratory-developed Testing Sales and Market Share by Regions (2014-2019)

4.1.2 Global Laboratory-developed Testing Revenue and Market Share by Regions (2014-2019)

4.2 North America Laboratory-developed Testing Sales and Growth Rate (2014-2019)

4.3 Europe Laboratory-developed Testing Sales and Growth Rate (2014-2019)

4.4 Asia-Pacific Laboratory-developed Testing Sales and Growth Rate (2014-2019)

4.5 South America Laboratory-developed Testing Sales and Growth Rate (2014-2019)

4.6 Middle East and Africa Laboratory-developed Testing Sales and Growth Rate (2014-2019)

5 North America Laboratory-developed Testing by Country

5.1 North America Laboratory-developed Testing Sales, Revenue and Market Share by Country

5.1.1 North America Laboratory-developed Testing Sales and Market Share by Country (2014-2019)

5.1.2 North America Laboratory-developed Testing Revenue and Market Share by Country (2014-2019)

5.2 United States Laboratory-developed Testing Sales and Growth Rate (2014-2019)

5.3 Canada Laboratory-developed Testing Sales and Growth Rate (2014-2019)

5.4 Mexico Laboratory-developed Testing Sales and Growth Rate (2014-2019)

6 Europe Laboratory-developed Testing by Country

6.1 Europe Laboratory-developed Testing Sales, Revenue and Market Share by Country

6.1.1 Europe Laboratory-developed Testing Sales and Market Share by Country (2014-2019)

6.1.2 Europe Laboratory-developed Testing Revenue and Market Share by Country (2014-2019)

6.2 Germany Laboratory-developed Testing Sales and Growth Rate (2014-2019)

6.3 UK Laboratory-developed Testing Sales and Growth Rate (2014-2019)

6.4 France Laboratory-developed Testing Sales and Growth Rate (2014-2019)

6.5 Russia Laboratory-developed Testing Sales and Growth Rate (2014-2019)

6.6 Italy Laboratory-developed Testing Sales and Growth Rate (2014-2019)

7 Asia-Pacific Laboratory-developed Testing by Country

7.1 Asia-Pacific Laboratory-developed Testing Sales, Revenue and Market Share by Country

7.1.1 Asia-Pacific Laboratory-developed Testing Sales and Market Share by Country (2014-2019)

7.1.2 Asia-Pacific Laboratory-developed Testing Revenue and Market Share by Country (2014-2019)

7.2 China Laboratory-developed Testing Sales and Growth Rate (2014-2019)

7.3 Japan Laboratory-developed Testing Sales and Growth Rate (2014-2019)

7.4 Korea Laboratory-developed Testing Sales and Growth Rate (2014-2019)

7.5 India Laboratory-developed Testing Sales and Growth Rate (2014-2019)

7.6 Southeast Asia Laboratory-developed Testing Sales and Growth Rate (2014-2019)

8 South America Laboratory-developed Testing by Country

8.1 South America Laboratory-developed Testing Sales, Revenue and Market Share by Country

8.1.1 South America Laboratory-developed Testing Sales and Market Share by Country (2014-2019)

8.1.2 South America Laboratory-developed Testing Revenue and Market Share by Country (2014-2019)

8.2 Brazil Laboratory-developed Testing Sales and Growth Rate (2014-2019)

8.3 Argentina Laboratory-developed Testing Sales and Growth Rate (2014-2019)

8.4 Colombia Laboratory-developed Testing Sales and Growth Rate (2014-2019)

9 Middle East and Africa Laboratory-developed Testing by Countries

9.1 Middle East and Africa Laboratory-developed Testing Sales, Revenue and Market Share by Country

9.1.1 Middle East and Africa Laboratory-developed Testing Sales and Market Share by Country (2014-2019)

9.1.2 Middle East and Africa Laboratory-developed Testing Revenue and Market Share by Country (2014-2019)

9.2 Saudi Arabia Laboratory-developed Testing Sales and Growth Rate (2014-2019)

9.3 Turkey Laboratory-developed Testing Sales and Growth Rate (2014-2019)

9.4 Egypt Laboratory-developed Testing Sales and Growth Rate (2014-2019)

9.5 Nigeria Laboratory-developed Testing Sales and Growth Rate (2014-2019)

9.6 South Africa Laboratory-developed Testing Sales and Growth Rate (2014-2019)

10 Global Laboratory-developed Testing Market Segment by Type

10.1 Global Laboratory-developed Testing Sales, Revenue and Market Share by Type (2014-2019)

10.1.1 Global Laboratory-developed Testing Sales and Market Share by Type (2014-2019)

10.1.2 Global Laboratory-developed Testing Revenue and Market Share by Type (2014-2019)

10.2 Clinical Biochemistry Sales Growth and Price

10.2.1 Global Clinical Biochemistry Sales Growth (2014-2019)

10.2.2 Global Clinical Biochemistry Price (2014-2019)

10.3 Critical Care Sales Growth and Price

10.3.1 Global Critical Care Sales Growth (2014-2019)

10.3.2 Global Critical Care Price (2014-2019)

10.4 Haematology Sales Growth and Price

10.4.1 Global Haematology Sales Growth (2014-2019)

10.4.2 Global Haematology Price (2014-2019)

10.5 Immunology Sales Growth and Price

10.5.1 Global Immunology Sales Growth (2014-2019)

10.5.2 Global Immunology Price (2014-2019)

10.6 Microbiology Sales Growth and Price

10.6.1 Global Microbiology Sales Growth (2014-2019)

10.6.2 Global Microbiology Price (2014-2019)

10.7 Molecular Diagnostics Sales Growth and Price

10.7.1 Global Molecular Diagnostics Sales Growth (2014-2019)

10.7.2 Global Molecular Diagnostics Price (2014-2019)

10.8 Other Test Types Sales Growth and Price

10.8.1 Global Other Test Types Sales Growth (2014-2019)

10.8.2 Global Other Test Types Price (2014-2019)

11 Global Laboratory-developed Testing Market Segment by Application

11.1 Global Laboratory-developed Testing Sales Market Share by Application (2014-2019)

11.2 Academic Institutes Sales Growth (2014-2019)

11.3 Clinical Research organizations Sales Growth (2014-2019)

11.4 Hospitals laboratory Sales Growth (2014-2019)

11.5 Specialty Diagnostic Centers Sales Growth (2014-2019)

11.6 Other Type of Facilities Sales Growth (2014-2019)

12 Laboratory-developed Testing Market Forecast (2019-2024)

12.1 Global Laboratory-developed Testing Sales, Revenue and Growth Rate (2019-2024)

12.2 Laboratory-developed Testing Market Forecast by Regions (2019-2024)

12.2.1 North America Laboratory-developed Testing Market Forecast (2019-2024)

12.2.2 Europe Laboratory-developed Testing Market Forecast (2019-2024)

12.2.3 Asia-Pacific Laboratory-developed Testing Market Forecast (2019-2024)

12.2.4 South America Laboratory-developed Testing Market Forecast (2019-2024)

12.2.5 Middle East and Africa Laboratory-developed Testing Market Forecast (2019-2024)

12.3 Laboratory-developed Testing Market Forecast by Type (2019-2024)

12.3.1 Global Laboratory-developed Testing Sales Forecast by Type (2019-2024)

12.3.2 Global Laboratory-developed Testing Market Share Forecast by Type (2019-2024)

12.4 Laboratory-developed Testing Market Forecast by Application (2019-2024)

12.4.1 Global Laboratory-developed Testing Sales Forecast by Application (2019-2024)

12.4.2 Global Laboratory-developed Testing Market Share Forecast by Application (2019-2024)

13 Sales Channel, Distributors, Traders and Dealers

13.1 Sales Channel

13.1.1 Direct Marketing

13.1.2 Indirect Marketing

13.1.3 Marketing Channel Future Trend

13.2 Distributors, Traders and Dealers

14 Research Findings and Conclusion

15 Appendix

15.1 Methodology

15.2 Data Source

List of Tables and Figures

Figure Laboratory-developed Testing Picture

Table Product Specifications of Laboratory-developed Testing

Figure Global Sales Market Share of Laboratory-developed Testing by

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