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Laboratory-developed Testing: Technologies and Markets

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. 

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.


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
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
Chapter 3: Description of Laboratory-developed Tests
Life Cycle of Clinical Diagnostic Tests
Why Use an LDT?
Common Technologies Used
Polymerase Chain Reaction (PCR)
Next-generation Sequencing
Other Molecular Technologies
Mass Spectrometry
Immunoassays
Clinical Indications
Oncology
Infectious Disease
Rare Diseases
Maternity
Chronic Disease
Differences between LDTs and FDA-approved Tests
Chapter 4: Uses of Laboratory Diagnostic Tests
Esoteric Testing
Anatomic Pathology
Public Health
New Technology
Molecular Diagnostics
Mass Spectrophotometry
Genomics and Next-generation Sequencing
Chapter 5: Segments of Laboratory Diagnostic Tests
Clinical Diagnostics
Specialty Laboratories
Reference Laboratories
Academic Medical Centers
Analyte-specific Reagents
Chapter 6: Market Breakdown by LDT Type
Anatomic Pathology
Genomic Testing
Mass Spectrophotometry
Serology
Molecular Diagnostics
Chapter 7: Market Breakdown by Analyte-specific Reagent Use
Contract Manufacturers
Specialty Manufacturers
Chapter 8: Patent Review/New Developments
Patent Review
Quantitation of Tamoxifen and Metabolites Thereof by Mass Spectrometry
Research and Development
Companion Diagnostics in LDTs
Standardization of LDTs
LC-MS test for Urinary 8-iso-prostaglandin F2α
Expression Profiling in Cancer Diagnostics
Chapter 9: Industry Structure
Reagent Manufacturers
Reference Laboratories
Academic Medical Centers
Specialty Laboratories
Regulatory
Trends in Price/Performance
Industrial Changes
Chapter 10: Government Regulations
Clinical Diagnostics
CLIA versus FDA
The Impact of the FDA’s Guidance on LDTs
Summary of the FDA’s Draft Guidance
2017 Regulatory Review
What is an LDT?
Computational Analysis
External Organizations
Direct-to-consumer Testing
Chapter 11: Industry Issues
Industry Analysis
FDA versus the LDT Industry
Two-tier Business
Reimbursement and Payer Markets
Coding a Test
Valuing the LDT
Potential Solutions
Industry Recommendations
Sell Off Intellectual Property
Encourage One-stop Shopping within Specialties for Laboratory-developed Tests
Case Studies
Proove BioSciences
The Rise of the Chinese Genomic Testing Market
Clinical Laboratory Improvement Amendments (CLIA): State Survey Agency Contacts
Chapter 12: Company Profiles
About BCC Research
About BCC Research
BCC Membership
BCC Custom Research
List of Tables
Table 1 Summary Table: Global Market for Laboratory-developed Tests, by Laboratory Type, Through 2021 ($ Millions)
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 ($Millions)
Table 7 Global Genomic Testing LDT Market, by Type, Through 2021 ($ Millions)
Table 8 Global Mass Spectrophotometry LDT Market, by Type, through 2021 ($Millions)
Table 9 Global Serology LDT Market, by Type, Through 2021 ($ Millions)
Table 10 Global Molecular Diagnostics LDT Market, by Type, through 2021 ($millions)
Table 11 Global Analyte-specific Reagent Market, by Type, Through 2021 ($ Millions)
Table 12 Global Analyte-specific Reagent Market from Contract Manufacturers, by Type, Through 2021 ($ Millions)
table 13 Global Analyte-specific Reagent Market from Specialty Manufacturers, by Type, Through 2021 ($ Millions)
List of Figures
FIGURE 1 Summary Figure: Global Market for Laboratory-developed Tests, by Lab Type, 2014-2021 ($ Millions)

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