Laboratory-developed Testing: Technologies and Markets

  • ID: 4315512
  • Report
  • Region: Global
  • 84 Pages
  • BCC Research
10 % OFF
until Apr 30th 2018
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The Global Market for Laboratory-Developed is Expected to Increase from Nearly $11.0 Billion in 2016 to $14.9 Billion in 2021 at a CAGR of 6.3% for 2016-2021

FEATURED COMPANIES

  • 23Andme
  • Asuragen
  • Biotheranostics
  • Genecentric Diagnostics
  • Illumina
  • Merck KGAA
  • MORE

Report Includes

  • An overview of the global market for laboratory-developed testing.
  • Analyses of global market trends, with data from 2014, 2015 and 2016, and projections of CAGRs through 2021.
  • Coverage of different types of tests, including esoteric, public health, anatomic technology, genomic testing, mass spectrophotometry, and other new technologies.
  • Information on the industry's structure, with focuses on reagent manufacturers, reference laboratrories, academic medical centers, and trends in pricing and performance.
  • Relevant patent analysis, including key patents, new patents, and pending patents.
  • Analysis of the market's dynamics, specifically growth drivers, restraints, and opportunities.
  • Profiles of major players in the industry.

Report Scope

This report will focus on companies that rely on laboratory-developed testing for at least 10% of their revenue. This is meant to avoid focusing on companies and laboratories that occasionally offer laboratory-developed tests to deal with unique patient needs. This report will also focus on the suppliers of the analyte-specific reagents used within these laboratory-developed tests, as their contract manufacturing is key to the successful development of these tests. While various technologies will be highlighted with relation to their use in laboratory-developed testing, we will not explore the markets for these different technologies in depth.

Note: Product cover images may vary from those shown
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FEATURED COMPANIES

  • 23Andme
  • Asuragen
  • Biotheranostics
  • Genecentric Diagnostics
  • Illumina
  • Merck KGAA
  • MORE

1: Introduction

  • Study Goals and Objectives
  • Reasons for Doing This Study
  • Scope of Report
  • Information Sources
  • Methodology

2: Summary and Highlights

  • Key Trends
  • Table 1 : Global Market for Laboratory-developed Tests, by Laboratory Type, Through 2021
  • Figure 1 : Summary Figure: Global Market for Laboratory-developed Tests, by Lab Type, 2014-2021

3: Description of Laboratory-developed Tests

  • Life Cycle of Clinical Diagnostic Tests
  • Why Use an LDT?
  • Common Technologies Used
  • Clinical Indications
  • Differences between LDTs and FDA-approved Tests

4: Uses of Laboratory Diagnostic Tests

  • Esoteric Testing
  • Anatomic Pathology
  • Public Health
  • New Technology
  • Molecular Diagnostics
  • Mass Spectrophotometry
  • Genomics and Next-generation Sequencing
  • Table 3 : Uses of Laboratory-developed Tests

5: Segments of Laboratory Diagnostic Tests

  • Clinical Diagnostics
  • Specialty Laboratories
  • Reference Laboratories
  • Academic Medical Centers
  • Analyte-specific Reagents

6: Market Breakdown by LDT Type

  • Anatomic Pathology
  • Genomic Testing
  • Mass Spectrophotometry
  • Serology
  • Molecular Diagnostics

7: Market Breakdown by Analyte-specific Reagent Use

  • Contract Manufacturers
  • Specialty Manufacturers
  • Table 11 : Global Analyte-specific Reagent Market, by Type, Through 2021

8: Patent Review/New Developments

  • Patent Review
  • Research and Development

9: Industry Structure

  • Reagent Manufacturers
  • Reference Laboratories
  • Academic Medical Centers
  • Specialty Laboratories
  • Regulatory
  • Trends in Price/Performance
  • Industrial Changes

10: Government Regulations

  • Clinical Diagnostics
  • CLIA versus FDA
  • The Impact of the FDA's Guidance on LDTs
  • 2017 Regulatory Review
  • What is an LDT?

11: Industry Issues

  • Industry Analysis
  • Reimbursement and Payer Markets
  • Potential Solutions
  • Industry Recommendations
  • Case Studies
  • Clinical Laboratory Improvement Amendments (CLIA): State Survey Agency Contacts

12: Company Profiles

  • 23Andme
  • Arup Laboratories
  • Access Genetics
  • Asuragen
  • BD
  • Bioreference
  • Biotheranostics
  • Empire Genomics
  • Enzo Biochem
  • Genecentric Diagnostics
  • Genomic Health
  • IDT
  • Illumina
  • Labcorp
  • Luminex
  • Merck KGAA
  • Molecularhealth
  • Myriad Genetics
  • Neogenomics
  • Oxford Gene Technology
  • Quest Diagnostics
  • Rosetta Genomics
  • Thermo Fisher
  • Ventana Medical Systems Inc.

List of Tables

Table 1 : Global Market for Laboratory-developed Tests, by Laboratory Type, Through 2021
Table 2 : Life Cycle of Clinical Diagnostic Tests
Table 3 : Uses of Laboratory-developed Tests
Table 4 : Uses of Laboratory-developed Tests
Table 5 : Summary of Laboratory-developed Test Market Segments
Table 6 : Global Anatomic Pathology LDT Market, by Type, through 2021
Table 7 : Global Genomic Testing LDT Market, by Type, Through 2021
Table 8 : Global Mass Spectrophotometry LDT Market, by Type, through 2021
Table 9 : Global Serology LDT Market, by Type, Through 2021
Table 10 : Global Molecular Diagnostics LDT Market, by Type, through 2021
Table 11 : Global Analyte-specific Reagent Market, by Type, Through 2021
Table 12 : Global Analyte-specific Reagent Market from Contract Manufacturers, by Type, Through 2021
Table 13 : Global Analyte-specific Reagent Market from Specialty Manufacturers, by Type, Through 2021

List of Figures

Figure 1 : Summary Figure: Global Market for Laboratory-developed Tests, by Lab Type, 2014-2021

Note: Product cover images may vary from those shown
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FEATURED COMPANIES

  • 23Andme
  • Asuragen
  • Biotheranostics
  • Genecentric Diagnostics
  • Illumina
  • Merck KGAA
  • MORE

Analyst's Credentials:

Todd Graham is an experienced scientist who has worked in a variety of settings throughout the biotechnology industry for more than 10 years as a key technical resource for a variety of businesses. Among his accomplishments are coordinating the roll out of a new test for a major clinical laboratory services provider, developing pre-clinical and clinical assays in support of pharmaceuticals and medical devices, and being a key team member in developing novel technologies for molecular diagnostics.

Note: Product cover images may vary from those shown
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  • 23Andme
  • Arup Laboratories
  • Access Genetics
  • Asuragen
  • BD
  • Bioreference
  • Biotheranostics
  • Empire Genomics
  • Enzo Biochem
  • Genecentric Diagnostics
  • Genomic Health
  • IDT
  • Illumina
  • Labcorp
  • Luminex
  • Merck KGAA
  • Molecularhealth
  • Myriad Genetics
  • Neogenomics
  • Oxford Gene Technology
  • Quest Diagnostics
  • Rosetta Genomics
  • Thermo Fisher
  • Ventana Medical Systems Inc.
Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown
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