Laboratory-developed Testing: Technologies and Markets
The global market for laboratory-developed tests reached nearly $9.7 billion in 2015. This market is expected to increase from nearly $11.0 billion in 2016 to $14.9 billion in 2021 at a compound annual growth rate (CAGR) of 6.3% for 2016-2021.
The specialty lab market isegment s expected to grow from $1.6 billion in 2016 to nearly $2.1 billion at a CAGR of 5.9% from 2016 through 2021.
The reference lab market segment is expected to grow from nearly $9.4 billion in 2016 to $12.7 billion in 2021 at a CAGR of 6.3% from 2016 through 2021.
The specialty lab market isegment s expected to grow from $1.6 billion in 2016 to nearly $2.1 billion at a CAGR of 5.9% from 2016 through 2021.
The reference lab market segment is expected to grow from nearly $9.4 billion in 2016 to $12.7 billion in 2021 at a CAGR of 6.3% from 2016 through 2021.
CHAPTER 1 INTRODUCTION
Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Information Sources
Methodology
Analyst's Credentials
Related BCC Research Reports
CHAPTER 2 SUMMARY AND HIGHLIGHTS
Key Trends
CHAPTER 3 DESCRIPTION OF LABORATORY-DEVELOPED TESTS
CHAPTER 4 USES OF LABORATORY DIAGNOSTIC TESTS
CHAPTER 5 SEGMENTS OF LABORATORY DIAGNOSTIC TESTS
CHAPTER 6 MARKET BREAKDOWN BY LDT TYPE
CHAPTER 7 MARKET BREAKDOWN BY ANALYTE-SPECIFIC REAGENT USE
CHAPTER 8 PATENT REVIEW/NEW DEVELOPMENTS
CHAPTER 9 INDUSTRY STRUCTURE
CHAPTER 10 GOVERNMENT REGULATIONS
CHAPTER 11 INDUSTRY ISSUES
CHAPTER 12 COMPANY PROFILES
PAMA Is Taking a Hammer to Laboratory Test Prices
Regulatory Discretion Impacts Certain LDTs
Genomics Testing Comes of Age
Testing Mix Shifts within LDTs
Consolidation of the LDT Marketplace
The Understated Importance of Mass Spectrophotometry LDTs
Life Cycle of Clinical Diagnostic Tests
Why Use an LDT?
Common Technologies Used
Clinical Indications
Differences between LDTs and FDA-approved Tests
Polymerase Chain Reaction (PCR)
Next-generation Sequencing
Other Molecular Technologies
Mass Spectrometry
Immunoassays
Oncology
Infectious Disease
Rare Diseases
Maternity
Chronic Disease
How PCR Works in an LDT
How NGS Works in LDTs
Sequencing by Synthesis
SOLiD Sequencing
Semiconductor Sequencing
How Mass Spectrophotometry Works in LDTs
HPLC-MS
MALDI-TOF
How an Immunoassay Works in an LDT
Esoteric Testing
Anatomic Pathology
Public Health
New Technology
Molecular Diagnostics
Mass Spectrophotometry
Genomics and Next-generation Sequencing
Clinical Diagnostics
Specialty Laboratories
Reference Laboratories
Academic Medical Centers
Analyte-specific Reagents
Anatomic Pathology
Genomic Testing
Mass Spectrophotometry
Serology
Molecular Diagnostics
Contract Manufacturers
Specialty Manufacturers
Patent Review
Research and Development
Quantitation of Tamoxifen and Metabolites Thereof by Mass Spectrometry
Companion Diagnostics in LDTs
Standardization of LDTs
LC-MS test for Urinary 8-iso-prostaglandin F2?
Expression Profiling in Cancer Diagnostics
Summary of the Patent Application
Implications of the Patent
Quest Diagnostics
Competitive Analysis
Reagent Manufacturers
Reference Laboratories
Academic Medical Centers
Specialty Laboratories
Regulatory
Trends in Price/Performance
Industrial Changes
Clinical Diagnostics
CLIA versus FDA
The Impact of the FDA's Guidance on LDTs
2017 REGULATORY REVIEW
What is an LDT?
Summary of the FDA's Draft Guidance
Computational Analysis
External Organizations
Direct-to-consumer Testing
Industry Analysis
Reimbursement and Payer Markets
Potential Solutions
Industry Recommendations
Case Studies
Clinical Laboratory Improvement Amendments (CLIA): State Survey Agency Contacts
FDA versus the LDT Industry
Two-tier Business
Coding a Test
Valuing the LDT
Sell Off Intellectual Property
Encourage One-stop Shopping within Specialties for Laboratory-developed Tests
Proove BioSciences
The Rise of the Chinese Genomic Testing Market
FDA's Perspective
LDT Industry's Perspective
Points of Contention
Potential Paths Forward
Evolution of Genomic Tests
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.
Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Information Sources
Methodology
Analyst's Credentials
Related BCC Research Reports
CHAPTER 2 SUMMARY AND HIGHLIGHTS
Key Trends
CHAPTER 3 DESCRIPTION OF LABORATORY-DEVELOPED TESTS
CHAPTER 4 USES OF LABORATORY DIAGNOSTIC TESTS
CHAPTER 5 SEGMENTS OF LABORATORY DIAGNOSTIC TESTS
CHAPTER 6 MARKET BREAKDOWN BY LDT TYPE
CHAPTER 7 MARKET BREAKDOWN BY ANALYTE-SPECIFIC REAGENT USE
CHAPTER 8 PATENT REVIEW/NEW DEVELOPMENTS
CHAPTER 9 INDUSTRY STRUCTURE
CHAPTER 10 GOVERNMENT REGULATIONS
CHAPTER 11 INDUSTRY ISSUES
CHAPTER 12 COMPANY PROFILES
PAMA Is Taking a Hammer to Laboratory Test Prices
Regulatory Discretion Impacts Certain LDTs
Genomics Testing Comes of Age
Testing Mix Shifts within LDTs
Consolidation of the LDT Marketplace
The Understated Importance of Mass Spectrophotometry LDTs
Life Cycle of Clinical Diagnostic Tests
Why Use an LDT?
Common Technologies Used
Clinical Indications
Differences between LDTs and FDA-approved Tests
Polymerase Chain Reaction (PCR)
Next-generation Sequencing
Other Molecular Technologies
Mass Spectrometry
Immunoassays
Oncology
Infectious Disease
Rare Diseases
Maternity
Chronic Disease
How PCR Works in an LDT
How NGS Works in LDTs
Sequencing by Synthesis
SOLiD Sequencing
Semiconductor Sequencing
How Mass Spectrophotometry Works in LDTs
HPLC-MS
MALDI-TOF
How an Immunoassay Works in an LDT
Esoteric Testing
Anatomic Pathology
Public Health
New Technology
Molecular Diagnostics
Mass Spectrophotometry
Genomics and Next-generation Sequencing
Clinical Diagnostics
Specialty Laboratories
Reference Laboratories
Academic Medical Centers
Analyte-specific Reagents
Anatomic Pathology
Genomic Testing
Mass Spectrophotometry
Serology
Molecular Diagnostics
Contract Manufacturers
Specialty Manufacturers
Patent Review
Research and Development
Quantitation of Tamoxifen and Metabolites Thereof by Mass Spectrometry
Companion Diagnostics in LDTs
Standardization of LDTs
LC-MS test for Urinary 8-iso-prostaglandin F2?
Expression Profiling in Cancer Diagnostics
Summary of the Patent Application
Implications of the Patent
Quest Diagnostics
Competitive Analysis
Reagent Manufacturers
Reference Laboratories
Academic Medical Centers
Specialty Laboratories
Regulatory
Trends in Price/Performance
Industrial Changes
Clinical Diagnostics
CLIA versus FDA
The Impact of the FDA's Guidance on LDTs
2017 REGULATORY REVIEW
What is an LDT?
Summary of the FDA's Draft Guidance
Computational Analysis
External Organizations
Direct-to-consumer Testing
Industry Analysis
Reimbursement and Payer Markets
Potential Solutions
Industry Recommendations
Case Studies
Clinical Laboratory Improvement Amendments (CLIA): State Survey Agency Contacts
FDA versus the LDT Industry
Two-tier Business
Coding a Test
Valuing the LDT
Sell Off Intellectual Property
Encourage One-stop Shopping within Specialties for Laboratory-developed Tests
Proove BioSciences
The Rise of the Chinese Genomic Testing Market
FDA's Perspective
LDT Industry's Perspective
Points of Contention
Potential Paths Forward
Evolution of Genomic Tests
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
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
Figure 1 Summary Figure: Global Market for Laboratory-developed Tests, by Lab Type, 2014-2021
