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Laboratory Developed Test-Global Market Insights and Sales Trends 2024
Synopsis
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 Released in 2016, the draft guidance sparked an intense debate over potential LDT regulation.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 global Laboratory Developed Test market size is expected to reach US$ 4376.7 million by 2029, growing at a CAGR of 3.1% from 2023 to 2029. The market is mainly driven by the significant applications of Laboratory Developed Test in various end use industries. The expanding demands from the Hospitals Laboratory, Clinical Research Organizations, Academic Institutes and Specialty Diagnostic Centers, are propelling Laboratory Developed Test market. Clinical Biochemistry, one of the segments analysed in this report, is projected to record % CAGR and reach US$ million by the end of the analysis period. Growth in the Hematology segment is estimated at % CAGR for the next seven-year period.
The global market for medical devices is estimated at US$ 603 billion in the year 2023, and will be growing at a CAGR of 5% during next six years. The global healthcare spending contributes to occupy 10% of the global GDP and is continuously rising in recent years due to the increasing health needs of the aging population, the growing prevalence of chronic and infectious diseases and the expansion of emerging markets. The medical devices market plays a significant role in the healthcare industry. The market is driven by several factors, including the increasing demand for advanced healthcare services globally, advancements in medical technology, growing geriatric population, rising healthcare expenditure, and increasing awareness about early disease diagnosis and treatment.
Report Objectives
This report provides market insight on the different segments, by players, by Type, by Application. Market size and forecast (2018-2029) has been provided in the report. The primary objectives of this report are to provide 1) global market size and forecasts, growth rates, market dynamics, industry structure and developments, market situation, trends; 2) global market share and ranking by company; 3) comprehensive presentation of the global market for Laboratory Developed Test, with both quantitative and qualitative analysis through detailed segmentation; 4) detailed value chain analysis and review of growth factors essential for the existing market players and new entrants; 5) emerging opportunities in the market and the future impact of major drivers and restraints of the market.
Key Features of The Study:
This report provides in-depth analysis of the global Laboratory Developed Test market, and provides market size (US$ million) and CAGR for the forecast period (2023-2029), considering 2022 as the base year.
This report profiles key players in the global Laboratory Developed Test market based on the following parameters - company details (found date, headquarters, manufacturing bases), products portfolio, Laboratory Developed Test sales data, market share and ranking.
This report elucidates potential market opportunities across different segments and explains attractive investment proposition matrices for this market.
This report illustrates key insights about market drivers, restraints, opportunities, market trends, regional outlook.
Key companies of Laboratory Developed Test covered in this report include Quest Diagnostics, Thermo Fisher, Waters, Roche, Illumina, Qiagen, 23andMe, Eurofins and Guardant Health, etc.
The global Laboratory Developed Test market report caters to various stakeholders in this industry including investors, suppliers, product players, distributors, new entrants, and financial analysts.
Market Segmentation
Company Profiles:
Quest Diagnostics
Thermo Fisher
Waters
Roche
Illumina
Qiagen
23andMe
Eurofins
Guardant Health
Biotheranostics
Adaptive Biotechnologies
Rosetta Genomics
Biodesix
Helix
Global Laboratory Developed Test market, by region:
North America (U.S., Canada, Mexico)
Europe (Germany, France, UK, Italy, etc.)
Asia Pacific (China, Japan, South Korea, Southeast Asia, India, etc.)
South America (Brazil, etc.)
Middle East and Africa (Turkey, GCC Countries, Africa, etc.)
Global Laboratory Developed Test market, Segment by Type:
Clinical Biochemistry
Hematology
Immunology
Molecular Diagnostics
Other
Global Laboratory Developed Test market, by Application
Hospitals Laboratory
Clinical Research Organizations
Academic Institutes
Specialty Diagnostic Centers
Other
Core Chapters
Chapter One: Introduces the report scope of the report, executive summary of global and regional market size and CAGR for the history and forecast period (2018-2023, 2024-2029). It offers a high-level view of the current state of the market and its likely evolution in the short to mid-term, and long term.
Chapter Two: Provides the analysis of various market segments by Type, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different market segments.
Chapter Three: Provides the analysis of various market segments by Application, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different downstream markets.
Chapter Four: Detailed analysis of Laboratory Developed Test companies’ competitive landscape, revenue, market share and ranking, latest development plan, merger, and acquisition information, etc.
Chapter Five: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product introduction, revenue, recent development, etc.
Chapter Six, Seven, Eight, Nine and Ten: North America, Europe, Asia Pacific, Latin America, Middle East & Africa, revenue by country.
Chapter Eleven: this section also introduces the market dynamics, latest developments of the market, the driving factors and restrictive factors of the market, the challenges and risks faced by companies in the industry, and the analysis of relevant policies in the industry.
Chapter Twelve: Research Finding/Conclusion
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 2016, 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 global Laboratory Developed Test market size is expected to reach US$ 4376.7 million by 2029, growing at a CAGR of 3.1% from 2023 to 2029. The market is mainly driven by the significant applications of Laboratory Developed Test in various end use industries. The expanding demands from the Hospitals Laboratory, Clinical Research Organizations, Academic Institutes and Specialty Diagnostic Centers, are propelling Laboratory Developed Test market. Clinical Biochemistry, one of the segments analysed in this report, is projected to record % CAGR and reach US$ million by the end of the analysis period. Growth in the Hematology segment is estimated at % CAGR for the next seven-year period.
The global market for medical devices is estimated at US$ 603 billion in the year 2023, and will be growing at a CAGR of 5% during next six years. The global healthcare spending contributes to occupy 10% of the global GDP and is continuously rising in recent years due to the increasing health needs of the aging population, the growing prevalence of chronic and infectious diseases and the expansion of emerging markets. The medical devices market plays a significant role in the healthcare industry. The market is driven by several factors, including the increasing demand for advanced healthcare services globally, advancements in medical technology, growing geriatric population, rising healthcare expenditure, and increasing awareness about early disease diagnosis and treatment.
Report Objectives
This report provides market insight on the different segments, by players, by Type, by Application. Market size and forecast (2018-2029) has been provided in the report. The primary objectives of this report are to provide 1) global market size and forecasts, growth rates, market dynamics, industry structure and developments, market situation, trends; 2) global market share and ranking by company; 3) comprehensive presentation of the global market for Laboratory Developed Test, with both quantitative and qualitative analysis through detailed segmentation; 4) detailed value chain analysis and review of growth factors essential for the existing market players and new entrants; 5) emerging opportunities in the market and the future impact of major drivers and restraints of the market.
Key Features of The Study:
This report provides in-depth analysis of the global Laboratory Developed Test market, and provides market size (US$ million) and CAGR for the forecast period (2023-2029), considering 2022 as the base year.
This report profiles key players in the global Laboratory Developed Test market based on the following parameters - company details (found date, headquarters, manufacturing bases), products portfolio, Laboratory Developed Test sales data, market share and ranking.
This report elucidates potential market opportunities across different segments and explains attractive investment proposition matrices for this market.
This report illustrates key insights about market drivers, restraints, opportunities, market trends, regional outlook.
Key companies of Laboratory Developed Test covered in this report include Quest Diagnostics, Thermo Fisher, Waters, Roche, Illumina, Qiagen, 23andMe, Eurofins and Guardant Health, etc.
The global Laboratory Developed Test market report caters to various stakeholders in this industry including investors, suppliers, product players, distributors, new entrants, and financial analysts.
Market Segmentation
Company Profiles:
Quest Diagnostics
Thermo Fisher
Waters
Roche
Illumina
Qiagen
23andMe
Eurofins
Guardant Health
Biotheranostics
Adaptive Biotechnologies
Rosetta Genomics
Biodesix
Helix
Global Laboratory Developed Test market, by region:
North America (U.S., Canada, Mexico)
Europe (Germany, France, UK, Italy, etc.)
Asia Pacific (China, Japan, South Korea, Southeast Asia, India, etc.)
South America (Brazil, etc.)
Middle East and Africa (Turkey, GCC Countries, Africa, etc.)
Global Laboratory Developed Test market, Segment by Type:
Clinical Biochemistry
Hematology
Immunology
Molecular Diagnostics
Other
Global Laboratory Developed Test market, by Application
Hospitals Laboratory
Clinical Research Organizations
Academic Institutes
Specialty Diagnostic Centers
Other
Core Chapters
Chapter One: Introduces the report scope of the report, executive summary of global and regional market size and CAGR for the history and forecast period (2018-2023, 2024-2029). It offers a high-level view of the current state of the market and its likely evolution in the short to mid-term, and long term.
Chapter Two: Provides the analysis of various market segments by Type, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different market segments.
Chapter Three: Provides the analysis of various market segments by Application, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different downstream markets.
Chapter Four: Detailed analysis of Laboratory Developed Test companies’ competitive landscape, revenue, market share and ranking, latest development plan, merger, and acquisition information, etc.
Chapter Five: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product introduction, revenue, recent development, etc.
Chapter Six, Seven, Eight, Nine and Ten: North America, Europe, Asia Pacific, Latin America, Middle East & Africa, revenue by country.
Chapter Eleven: this section also introduces the market dynamics, latest developments of the market, the driving factors and restrictive factors of the market, the challenges and risks faced by companies in the industry, and the analysis of relevant policies in the industry.
Chapter Twelve: Research Finding/Conclusion
Index1 Market Overview of Laboratory Developed Test
1.1 Laboratory Developed Test Market Overview
1.1.1 Laboratory Developed Test Product Scope
1.1.2 Laboratory Developed Test Market Status and Outlook
1.2 Global Laboratory Developed Test Market Size Overview by Region 2018 VS 2022 VS 2029
1.3 Global Laboratory Developed Test Market Size by Region (2018-2029)
1.4 Global Laboratory Developed Test Historic Market Size by Region (2018-2023)
1.5 Global Laboratory Developed Test Market Size Forecast by Region (2024-2029)
1.6 Key Regions, Laboratory Developed Test Market Size (2018-2029)
1.6.1 North America Laboratory Developed Test Market Size (2018-2029)
1.6.2 Europe Laboratory Developed Test Market Size (2018-2029)
1.6.3 Asia-Pacific Laboratory Developed Test Market Size (2018-2029)
1.6.4 Latin America Laboratory Developed Test Market Size (2018-2029)
1.6.5 Middle East & Africa Laboratory Developed Test Market Size (2018-2029)
2 Laboratory Developed Test Market by Type
2.1 Introduction
2.1.1 Clinical Biochemistry
2.1.2 Hematology
2.1.3 Immunology
2.1.4 Molecular Diagnostics
2.1.5 Other
2.2 Global Laboratory Developed Test Market Size by Type: 2018 VS 2022 VS 2029
2.2.1 Global Laboratory Developed Test Historic Market Size by Type (2018-2023)
2.2.2 Global Laboratory Developed Test Forecasted Market Size by Type (2024-2029)
2.3 Key Regions Market Size by Type
2.3.1 North America Laboratory Developed Test Revenue Breakdown by Type (2018-2029)
2.3.2 Europe Laboratory Developed Test Revenue Breakdown by Type (2018-2029)
2.3.3 Asia-Pacific Laboratory Developed Test Revenue Breakdown by Type (2018-2029)
2.3.4 Latin America Laboratory Developed Test Revenue Breakdown by Type (2018-2029)
2.3.5 Middle East and Africa Laboratory Developed Test Revenue Breakdown by Type (2018-2029)
3 Laboratory Developed Test Market Overview by Application
3.1 Introduction
3.1.1 Hospitals Laboratory
3.1.2 Clinical Research Organizations
3.1.3 Academic Institutes
3.1.4 Specialty Diagnostic Centers
3.1.5 Other
3.2 Global Laboratory Developed Test Market Size by Application: 2018 VS 2022 VS 2029
3.2.1 Global Laboratory Developed Test Historic Market Size by Application (2018-2023)
3.2.2 Global Laboratory Developed Test Forecasted Market Size by Application (2024-2029)
3.3 Key Regions Market Size by Application
3.3.1 North America Laboratory Developed Test Revenue Breakdown by Application (2018-2029)
3.3.2 Europe Laboratory Developed Test Revenue Breakdown by Application (2018-2029)
3.3.3 Asia-Pacific Laboratory Developed Test Revenue Breakdown by Application (2018-2029)
3.3.4 Latin America Laboratory Developed Test Revenue Breakdown by Application (2018-2029)
3.3.5 Middle East and Africa Laboratory Developed Test Revenue Breakdown by Application (2018-2029)
4 Laboratory Developed Test Competition Analysis by Players
4.1 Global Laboratory Developed Test Market Size by Players (2018-2023)
4.2 Global Top Players by Company Type (Tier 1, Tier 2 and Tier 3) & (based on the Revenue in Laboratory Developed Test as of 2022)
4.3 Date of Key Players Enter into Laboratory Developed Test Market
4.4 Global Top Players Laboratory Developed Test Headquarters and Area Served
4.5 Key Players Laboratory Developed Test Product Solution and Service
4.6 Competitive Status
4.6.1 Laboratory Developed Test Market Concentration Rate
4.6.2 Mergers & Acquisitions, Expansion Plans
5 Company (Top Players) Profiles
5.1 Quest Diagnostics
5.1.1 Quest Diagnostics Profile
5.1.2 Quest Diagnostics Main Business
5.1.3 Quest Diagnostics Laboratory Developed Test Products, Services and Solutions
5.1.4 Quest Diagnostics Laboratory Developed Test Revenue (US$ Million) & (2018-2023)
5.1.5 Quest Diagnostics Recent Developments
5.2 Thermo Fisher
5.2.1 Thermo Fisher Profile
5.2.2 Thermo Fisher Main Business
5.2.3 Thermo Fisher Laboratory Developed Test Products, Services and Solutions
5.2.4 Thermo Fisher Laboratory Developed Test Revenue (US$ Million) & (2018-2023)
5.2.5 Thermo Fisher Recent Developments
5.3 Waters
5.3.1 Waters Profile
5.3.2 Waters Main Business
5.3.3 Waters Laboratory Developed Test Products, Services and Solutions
5.3.4 Waters Laboratory Developed Test Revenue (US$ Million) & (2018-2023)
5.3.5 Roche Recent Developments
5.4 Roche
5.4.1 Roche Profile
5.4.2 Roche Main Business
5.4.3 Roche Laboratory Developed Test Products, Services and Solutions
5.4.4 Roche Laboratory Developed Test Revenue (US$ Million) & (2018-2023)
5.4.5 Roche Recent Developments
5.5 Illumina
5.5.1 Illumina Profile
5.5.2 Illumina Main Business
5.5.3 Illumina Laboratory Developed Test Products, Services and Solutions
5.5.4 Illumina Laboratory Developed Test Revenue (US$ Million) & (2018-2023)
5.5.5 Illumina Recent Developments
5.6 Qiagen
5.6.1 Qiagen Profile
5.6.2 Qiagen Main Business
5.6.3 Qiagen Laboratory Developed Test Products, Services and Solutions
5.6.4 Qiagen Laboratory Developed Test Revenue (US$ Million) & (2018-2023)
5.6.5 Qiagen Recent Developments
5.7 23andMe
5.7.1 23andMe Profile
5.7.2 23andMe Main Business
5.7.3 23andMe Laboratory Developed Test Products, Services and Solutions
5.7.4 23andMe Laboratory Developed Test Revenue (US$ Million) & (2018-2023)
5.7.5 23andMe Recent Developments
5.8 Eurofins
5.8.1 Eurofins Profile
5.8.2 Eurofins Main Business
5.8.3 Eurofins Laboratory Developed Test Products, Services and Solutions
5.8.4 Eurofins Laboratory Developed Test Revenue (US$ Million) & (2018-2023)
5.8.5 Eurofins Recent Developments
5.9 Guardant Health
5.9.1 Guardant Health Profile
5.9.2 Guardant Health Main Business
5.9.3 Guardant Health Laboratory Developed Test Products, Services and Solutions
5.9.4 Guardant Health Laboratory Developed Test Revenue (US$ Million) & (2018-2023)
5.9.5 Guardant Health Recent Developments
5.10 Biotheranostics
5.10.1 Biotheranostics Profile
5.10.2 Biotheranostics Main Business
5.10.3 Biotheranostics Laboratory Developed Test Products, Services and Solutions
5.10.4 Biotheranostics Laboratory Developed Test Revenue (US$ Million) & (2018-2023)
5.10.5 Biotheranostics Recent Developments
5.11 Adaptive Biotechnologies
5.11.1 Adaptive Biotechnologies Profile
5.11.2 Adaptive Biotechnologies Main Business
5.11.3 Adaptive Biotechnologies Laboratory Developed Test Products, Services and Solutions
5.11.4 Adaptive Biotechnologies Laboratory Developed Test Revenue (US$ Million) & (2018-2023)
5.11.5 Adaptive Biotechnologies Recent Developments
5.12 Rosetta Genomics
5.12.1 Rosetta Genomics Profile
5.12.2 Rosetta Genomics Main Business
5.12.3 Rosetta Genomics Laboratory Developed Test Products, Services and Solutions
5.12.4 Rosetta Genomics Laboratory Developed Test Revenue (US$ Million) & (2018-2023)
5.12.5 Rosetta Genomics Recent Developments
5.13 Biodesix
5.13.1 Biodesix Profile
5.13.2 Biodesix Main Business
5.13.3 Biodesix Laboratory Developed Test Products, Services and Solutions
5.13.4 Biodesix Laboratory Developed Test Revenue (US$ Million) & (2018-2023)
5.13.5 Biodesix Recent Developments
5.14 Helix
5.14.1 Helix Profile
5.14.2 Helix Main Business
5.14.3 Helix Laboratory Developed Test Products, Services and Solutions
5.14.4 Helix Laboratory Developed Test Revenue (US$ Million) & (2018-2023)
5.14.5 Helix Recent Developments
6 North America
6.1 North America Laboratory Developed Test Market Size by Country (2018-2029)
6.2 U.S.
6.3 Canada
7 Europe
7.1 Europe Laboratory Developed Test Market Size by Country (2018-2029)
7.2 Germany
7.3 France
7.4 U.K.
7.5 Italy
7.6 Russia
7.7 Nordic Countries
7.8 Rest of Europe
8 Asia-Pacific
8.1 Asia-Pacific Laboratory Developed Test Market Size by Region (2018-2029)
8.2 China
8.3 Japan
8.4 South Korea
8.5 Southeast Asia
8.6 India
8.7 Australia
8.8 Rest of Asia-Pacific
9 Latin America
9.1 Latin America Laboratory Developed Test Market Size by Country (2018-2029)
9.2 Mexico
9.3 Brazil
9.4 Rest of Latin America
10 Middle East & Africa
10.1 Middle East & Africa Laboratory Developed Test Market Size by Country (2018-2029)
10.2 Turkey
10.3 Saudi Arabia
10.4 UAE
10.5 Rest of Middle East & Africa
11 Laboratory Developed Test Market Dynamics
11.1 Laboratory Developed Test Industry Trends
11.2 Laboratory Developed Test Market Drivers
11.3 Laboratory Developed Test Market Challenges
11.4 Laboratory Developed Test Market Restraints
12 Research Finding /Conclusion
13 Methodology and Data Source
13.1 Methodology/Research Approach
13.1.1 Research Programs/Design
13.1.2 Market Size Estimation
13.1.3 Market Breakdown and Data Triangulation
13.2 Data Source
13.2.1 Secondary Sources
13.2.2 Primary Sources
13.3 Disclaimer
13.4 Author List
Published By : QY Research
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