Market Research Logo

Laboratory-Developed Testing: Technologies and Markets

Laboratory-Developed Testing: Technologies and Markets

The laboratory-developed test market within the U.S. was valued at $8.1 billion in 2013 and $9.7 billion in 2014. The market is expected to reach roughly $17.7 billion in 2019, a compound annual growth rate (CAGR) of 12.7% from 2014 to 2019.

This report provides:

Analyses of global market trends, with data from 2012, 2013 and 2014, and projections of CAGRs through 2019.

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, trends in pricing and performance, as well as other areas.

Relevant patent analysis, including key patents, new patents, and pending patents.

Analysis of the market's dynamics, specifically growth drivers, restraints, and opportunities.


SCOPE OF REPORT

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 only occasionally offer laboratory-developed tests to deal with unique patient needs. This report will also focus on suppliers of the analyte-specific reagents used within these laboratory-developed tests, as their contract manufacturing is a 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 THE STUDY
SCOPE OF REPORT
INTENDED AUDIENCE
INFORMATION SOURCES
ANALYST'S CREDENTIALS
RELATED BCC RESEARCH REPORTS
BCC RESEARCH WEBSITE
DISCLAIMER
CHAPTER 2 SUMMARY
SUMMARY TABLE MARKET FOR U.S. LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($ MILLIONS)
SUMMARY FIGURE MARKET FOR U.S. LABORATORY-DEVELOPED TESTS, 2012-2019 ($ MILLIONS)
KEY TRENDS
THE RISE OF FDA REGULATION
GENOMIC RAMP-UP
DECLINE OF THE ACADEMIC MEDICAL CENTER
EVOLUTION OF THE LABORATORY-DEVELOPED TEST (LDT)
MOLECULAR DIAGNOSTICS EXPLOSION
SHIFTS TOWARDS LICENSING AND STARTUP INVESTMENT
SLOW DECLINE OF SEROLOGY
CHAPTER 3 OVERVIEW: DESCRIPTION OF LABORATORY-DEVELOPED
TESTS
LIFE CYCLE OF CLINICAL DIAGNOSTIC TESTS
TABLE 1 LIFE CYCLE OF CLINICAL DIAGNOSTIC TESTS
WHY USE AN LDT
COMMON TECHNOLOGIES USED
POLYMERASE CHAIN REACTION (PCR)
How PCR Works in an LDT
NEXT-GENERATION SEQUENCING
How NGS Works in LDTs
Sequencing by Synthesis
SOLiD Sequencing
Semiconductor Sequencing
OTHER MOLECULAR TECHNOLOGIES
MASS SPECTROMETRY
How Mass Spectrophotometry Works in LDTs
HPLC-MS
MALDI-TOF
IMMUNOASSAYS
How an Immunoassay Works in an LDT
CLINICAL INDICATIONS
ONCOLOGY
INFECTIOUS DISEASE
RARE DISEASES
MATERNITY
CHRONIC DISEASE
DIFFERENCES BETWEEN LDTS AND FDA APPROVED TESTS
CHAPTER 4 USES OF LABORATORY-DEVELOPED TESTS
TABLE 2 USES OF LABORATORY-DEVELOPED TESTS
ESOTERIC TESTING
ANATOMIC PATHOLOGY
PUBLIC HEALTH
NEW TECHNOLOGY
MOLECULAR DIAGNOSTICS
MASS SPECTROPHOTOMETRY
GENOMICS AND NEXT-GENERATION SEQUENCING
CHAPTER 5 SEGMENTS
CLINICAL DIAGNOSTICS
TABLE 3 SEGMENTS OF THE CLINICAL DIAGNOSTIC INDUSTRY
SPECIALTY LABORATORIES
REFERENCE LABORATORIES
ACADEMIC MEDICAL CENTERS
ANALYTE-SPECIFIC REAGENTS
TABLE 4 SUMMARY OF LABORATORY-DEVELOPED TEST MARKET SEGMENTS
CHAPTER 6 LABORATORY-DEVELOPED CLINICAL ASSAYS
TABLE 5 U.S. MARKET FOR LABORATORY-DEVELOPED CLINICAL ASSAYS, THROUGH 2019 ($ MILLIONS)
ANATOMIC PATHOLOGY
TABLE 6 U.S. MARKET FOR ANATOMIC PATHOLOGY LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($MILLIONS)
GENOMIC TESTING
TABLE 7 U.S. MARKET FOR GENOMIC LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($ MILLIONS)
MASS SPECTROPHOTOMETRY
TABLE 8 U.S. MARKET FOR MASS SPECTROPHOTOMETRY LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($MILLIONS)
SEROLOGY
TABLE 9 U.S. MARKET FOR SEROLOGY LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($ MILLIONS)
MOLECULAR DIAGNOSTICS
TABLE 10 U.S. MARKET FOR MOLECULAR DIAGNOSTICS LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($MILLIONS)
CHAPTER 7 ANALYTE-SPECIFIC REAGENTS
ANALYTE-SPECIFIC REAGENT MARKET
TABLE 11 U.S. MARKET FOR ANALYTE-SPECIFIC REAGENTS FOR LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($ MILLIONS)
CONTRACT MANUFACTURERS
TABLE 12 U.S. MARKET FOR ANALYTE-SPECIFIC REAGENTS FROM CONTRACT MANUFACTURERS FOR LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($MILLIONS)
SPECIALTY MANUFACTURERS
TABLE 13 U.S. MARKET FOR ANALYTE-SPECIFIC REAGENTS FROM SPECIALTY MANUFACTURERS FOR LABORATORY-DEVELOPED TESTS, THROUGH 2019 ($MILLIONS)
CHAPTER 8 TECHNOLOGY AND PATENTS
AUTISM ASSOCIATED GENETIC MARKERS-LINEAGEN
SUMMARY OF THE PATENT
IMPLICATIONS OF THE PATENT
LINEAGEN
COMPETITIVE ANALYSIS
DIAGNOSTIC PROCESSES THAT FACTOR EXPERIMENTAL
CONDITIONS-SEQUENOM
SUMMARY OF THE PATENT
IMPLICATIONS OF THE PATENT
SEQUENOM
COMPETITIVE ANALYSIS
METHODS FOR IMPROVING INFLAMMATORY BOWEL DISEASE
DIAGNOSIS-NESTLE/PROMETHEUS DIAGNOSTICS
SUMMARY OF THE PATENT
IMPLICATIONS OF THE PATENT
PROMETHEUS DIAGNOSTICS
COMPETITIVE ANALYSIS
METHODS AND COMPOSITIONS FOR UNIVERSAL DETECTION OF NUCLEIC
ACIDS-UNITAQ BIO
SUMMARY OF THE PATENT
IMPLICATIONS OF THE PATENT
UNITAQ BIO
COMPETITIVE ANALYSIS
GENETIC POLYMORPHISMS ASSOCIATED WITH ALZHEIMER'S DISEASE, METHODS OF DETECTION AND USES THEREOF-CELERA/ QUEST
DIAGNOSTICS
SUMMARY OF THE PATENT
IMPLICATIONS OF THE PATENT
QUEST DIAGNOSTICS
COMPETITIVE ANALYSIS
MATERIALS AND METHODS FOR DETERMINING DIAGNOSIS AND PROGNOSIS OF PROSTATE CANCER-THE REGENTS OF THE UNIVERSITY OF CALIFORNIA/PROVERI
SUMMARY OF THE PATENT
IMPLICATIONS OF THE PATENT
PROVERI
COMPETITIVE ANALYSIS
METHOD AND KIT FOR CHARACTERIZING MICROORGANISMS-FRY
LABORATORIES
SUMMARY OF THE PATENT
IMPLICATIONS OF THE PATENT
FRY LABORATORIES
COMPETITIVE ANALYSIS
BIOMARKERS FOR MONITORING TREATMENT OF NEUROPSYCHIATRIC
DISEASES-RIDGE DIAGNOSTICS
SUMMARY OF THE PATENT
IMPLICATIONS OF THE PATENT
RIDGE DIAGNOSTICS
COMPETITIVE ANALYSIS
TABLE 14 PATENT APPLICATIONS FOR LABORATORY-DEVELOPED
TESTING
CHAPTER 9 LABORATORY-DEVELOPED TEST R&D
RAPID DETECTION OF INFECTIOUS DISEASE
APPLICATION OF GENOMIC LDTS
USE OF CIRCULATING TUMOR CELLS IN DIAGNOSTICS
CHAPTER 10 INDUSTRY STRUCTURE
REAGENT MANUFACTURERS
REFERENCE LABORATORIES
ACADEMIC MEDICAL CENTERS
SPECIALTY LABORATORIES
REGULATORY
TRENDS IN PRICE AND PERFORMANCE
INDUSTRIAL CHANGES
CHAPTER 11 GOVERNMENT REGULATIONS
CLINICAL DIAGNOSTICS
CLIA VS. FDA
TABLE 15 DIVISION OF LABORATORY SERVICE CENTERS FOR MEDICARE AND MEDICAID SERVICES, LABORATORIES BY TYPE OF FACILITY (EXEMPT/NON-EXEMPT COMBINED), CLIA UPDATE, THROUGH JUNE 2014
IMPACT OF THE FDA'S GUIDANCE ON LDTS
SUMMARY OF FDA'S DRAFT GUIDANCE
IMPLICATIONS
CASE STUDY: GOOGLE'S 23ANDME
REGULATIONS OUTSIDE OF THE UNITED STATES
REGULATIONS WITHIN ASIA
AUSTRALIAN LDT REGULATIONS
STATUS OF LDTS WITHIN EUROPE
HEALTH CANADA AND LDTS
CHAPTER 12 INDUSTRY ISSUES
INDUSTRY ANALYSIS
FDA VERSUS THE LDT INDUSTRY
FDA's Perspective
LDT Industry's Perspective
Points of Contention
Potential Paths Forward
Evolution of Genomic Tests
TWO-TIER BUSINESS
REIMBURSEMENT AND PAYER MARKETS
CODING A TEST
VALUING THE LDT
POTENTIAL SOLUTIONS
INDUSTRY RECOMMENDATIONS
INVEST IN INFORMATION TECHNOLOGY PARTICULARLY DATABASE
MANAGEMENT
ENCOURAGE TIE-INS WITH EXISTING ELECTRONIC HEALTH RECORD
SYSTEMS
SUPPORT EFFORTS TO REGULATE LDTS FOR ROUTINE ANALYTES
SELL OFF INTELLECTUAL PROPERTY
ENCOURAGE ONE-STOP SHOPPING WITHIN SPECIALTIES FOR LABORATORY-DEVELOPED TESTS
CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA): STATE SURVEY
AGENCY CONTACTS
CHAPTER 13 COMPANY PROFILES
23ANDME
ACCESS GENETICS
ARUP LABORATORIES
ASURAGEN
BD
BIOREFERENCE
BIOTHERANOSTICS
CYTOCELL
EMPIRE GENOMICS
ENZO BIOCHEM
EUROFINS
FRY LABORATORIES
GENECENTRIC DIAGNOSTICS
GENOMIC HEALTH
IDT
ILLUMINA
LABCORP
LUMINEX
MERCK KGAA
MOLECULARHEALTH
MYRIAD GENETICS
NEOGENOMICS
OLIGOS ETC.
PROVERI INC.
QUEST DIAGNOSTICS
RIDGE DIAGNOSTICS
ROSETTA GENOMICS
SELAH GENOMICS
SEQUENOM
SIEMENS
SIGNAL GENETICS
THERMO FISHER
UNITAQ BIO
VENTANA MEDICAL SYSTEMS INC.

Download our eBook: How to Succeed Using Market Research

Learn how to effectively navigate the market research process to help guide your organization on the journey to success.

Download eBook

Share this report