The Worldwide Market for Laboratory-Developed Tests: Services (Labs Performing LDTs) and Equipment (Instruments and Reagents Used in LDTs)

Sep 27, 2017
375 Pages - Pub ID: KLI15485878
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The Worldwide Market for Laboratory-Developed Tests: Services (Labs Performing LDTs) and Equipment (Instruments and Reagents Used in LDTs) 

Laboratory-developed tests, or LDTs, have been attracting a lot of attention in recent years, but they are not a new or recent phenomenon.  Historically, these tests were called “home-brew tests” or “in-house tests.”  Also historically, these tests were low-volume, simple and well characterized tests for low-risk diagnostic applications.  Today, high-risk, complex tests have been developed as LDTs, and are being used to provide clinical results to physicians and their patients.  This market has been elusive for industry watchers seeking a resource to inform business planning and competitive activity.    Kalorama Information has put its expertise in the in vitro diagnostics market to work with this volume which estimates market sizing and forecasts for two key areas of lab-developed tests.


The Market for Lab-Developed Test Services and the Market for Instruments and Reagents Sold to Labs

This is a unique report with a unique segmentation to help customers find the right segment for their needs.   Two separate but related markets are discussed in this report:  the market for clinical laboratory services using laboratory developed tests, and the market for products (platforms and consumables) sold to clinical laboratories who uses these products to make LDTs.  Both are large and rapidly growing markets.    As part of the market analysis, the report offers the following data:
Market for LDT Services in Infectious Disease, 2017 to 2022
Market for LDT Services in Cancer Screening, 2017 to 2022
Market for LDT Services for Inherited Disorders, 2017 to 2022
Investment in LDT Companies, 2016 and 2017
Status of FDA Regulation of LDT
 Selected Companies/Clinical Laboratories Offering Infectious Disease Test Services Based on LDTs
Companies/Clinical Laboratories Offering Cancer Screening Test Services Based on LDTs  
Companies/Clinical Laboratories Offering Genetic Testing for Inherited Disorders 
Market for Products and Reagents Sold to Labs for Use in LDTs, 2017 to 2022
Market for Products and Reagents Used in LDTs by Type
Market for Products and Reagents  Used in LDTs by Region.
M&A Activity: Acquisitions of or by Companies/Laboratories with LDTs 
Agreements Between Diagnostic Companies with LDTs and Pharmaceutical Companies 
Direct to Consumer (DTC) Offerings
Important Conclusions About the Market
Company Profiles

A Rapidly Moving, Highly Dynamic Market.

Chemistry Tests, Immunoassays  Histology Stains, Flow Cytometry, Karyotyping, ISH, Gene Signatures, Microarrays are among the technologies used in lab develop tests.  This report examines each technology category.  

There are great number of companies in the LDT market.  New LDTs are being developed and introduced, and some segments of this market (especially the market for cancer diagnosis, prognosis, personalized medicine, and monitoring patients) have become very competitive.   Some companies will not survive, but there are also examples of successful companies.  This field has attracted considerable interest from investors and from companies making acquisitions. 

Tracking FDA Actions and Statements and Industry Reaction

There has been considerable discussion in recent years about regulation of this market, and the FDA proposed a draft guidance calling for more FDA oversight of these tests.  However, at this time, the likely outcome of this discussion is not clear.  However, some LDTs available today have already been FDA cleared or approved, and others are likely to be developed into in vitro diagnostic (IVD) tests that a company can ship widely to clinical laboratories.  Early examples of this are discussed in the report.

Comprehensive Research 

There is no other resource that tackles this subject as comprehenisve as Kalorama Information's.  The report is a global report and includes forecast breakouts both in the service and product segments for; The United States, Europe, Asia, Japan, Latin America, China, Rest of World.

Companies Profiled Include:
    
  • 23andMe, Inc.    
  • Adaptive Biotechnologies Corporation    
  • Admera Health    
  • Agendia Nv    
  • Agilenttechnologies Inc.    
  • Altheadx, Inc.    
  • Ambry Genetics Corp.  
  • Applied Proteomics, Inc.  
  • Athena Diagnostics, Inc. (A Quest Diagnostics Business)    
  • BGI 
  • Biodesix, Inc.    
  • Biotheranostics, Inc.    
  • Bruker Corporation    
  • Cancer Genetics, Inc.    
  • Cardiodx, Inc.    
  • Caredx, Inc.    
  • Caris Life Sciences    
  • Castle Biosciences, Inc.    
  • Centogene Ag 
  • Color Genomics, Inc. 
  • Cynvenio Biosystems, Inc. 
  • Epic Sciences, Inc. 
  • Eurofins 
  • Exact Sciences Corporation 
  • Foundation Medicine, Inc. 
  • Genomic Health, Inc. 
  • Genoptix, Inc. Good Start Genetics, Inc. (Acquired By Invitae Corporation) 
  • Grail, Inc. 
  • Guardant Health, Inc. 
  • Helix 
  • Illumina, Inc. 
  • Integrated Diagnostics, Inc. 
  • Invitae Corporation 
  • Laboratory Corporation Of America (Labcorp) 
  • Mdxhealth 
  • Multiplicom Nv (Part Of Agilent Technologies) 
  • Myriad Genetics, Inc. 
  •  Nantomics (Member Of The Nantworks Ecosystem Of Companies) 
  • Natera, Inc. 
  •  Neogenomics, Inc./Neogenomics Laboratories 
  •  Opko Health, Inc./Opko Diagnostics 
  • Pacific Biosciences Of California, Inc. 
  • Perkin Elmer, Inc. 
  •  Qiagen N.V. 
  • Quest Diagnostics 
  •  Roche 
  •  Rosetta Genomics Ltd. 
  •  Sciex 
  • Sera Prognostics, Inc. 
  • Thermo Fisher Scientific, Inc. 
  •  Waters Corporation 

In this report, laboratory developed tests (LDTs) include all clinical tests developed by laboratories for their own use, in contrast to in vitro diagnostic (IVD) kits that are manufactured and sold by diagnostic companies for use by many different clinical labs.  For LDTs, clinical labs do have to purchase instruments and reagents, but these products are not FDA approved/cleared or CE-IVD marked kits (or other kits approved by regulatory authorities of a specific company) that contain everything required to do a test that was developed by the diagnostic company.  The clinical lab uses these reagents to develop and validate the LDT before the test can be used for diagnostic purposes.   The information presented in this report is derived from publicly available information sources such as company reports and announcements, government reports and databases, medical organization reports, medical associations, and other publications.  The analysis is based on the author's industry knowledge combined with literature searches and discussions with industry professionals and experts in the areas of point-of-care tests, decentralized healthcare and healthcare economics.

CHAPTER 1: EXECUTIVE SUMMARY

OVERVIEW

SCOPE AND METHODOLOGY
Two Markets: Market for Services and For Test Products Sold to Labs (for use in LDTs)
MARKET OVERVIEW

Kalorama’s Analysis of the LDT Market

LDT Services Market by Segment (Infectious Disease, Oncology LDT, Genetic Testing, Other LDT)
Table 1-1: Laboratory Developed Test Services Market; Major Clinical (Disease) Segments (2016 – 2021) (in millions USD)
LDT Services Market by Segment (Infectious Disease, Oncology LDT, Genetic Testing, Other LDT)

Table 1-2:Worldwide Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs (2016-2021) (in millions 
USD)
FUTURE PROSPECTS IN THE LABORATORY DEVELOPMENT TEST MARKET
Status of FDA Regulation 
CHAPTER 2: INTRODUCTION

LABORATORY DEVELOP TESTS VERSUS IN VITRO DIAGNOSTIC TESTS

IVD

LDTs

WHY DO LABORATORIES USE LABORATORY DEVELOPED TESTS?

LABORATORY DEVELOPED TEST MARKETS – CLINICAL LABORATORIES PERFORMING LABORATORY DEVELOPED TESTS VERSUS 

INSTRUMENT AND REAGENT MANUFACTURERS

POINT-OF-VIEW AND METHODOLOGY
Uniqueness of the LDT Market
CHAPTER 3: LABORATORY DEVELOPED TESTS - OVERVIEW

WHAT IS A LABORATORY DEVELOPED TEST?
Kalorama Definition - LDT

Regulatory Approval and LDTs
OTHER IMPORTANT TERMINOLOGY
General purpose reagent:

Analyte specific reagent (ASR):
USE OF DIAGNOSTIC TECHNOLOGIES AS LABORATORY DEVELOPED TESTS
Chemistry Tests

Immunoassays

Histology Stains
Table 3-1: Selected Companies Marketing Histology Stains

Table 3-2: Selected Companies Marketing Microscopes
Immunohistochemistry

Flow Cytometry
Table 3-3: Selected Companies Marketing Antibodies for Immunohistochemistry and/or Flow Cytometry Testing in Clinical Laboratories

Table 3-4: Selected Companies Marketing Flow Cytometry Platforms
Karyotyping

In Situ Hybridization
Table 3-5: Selected Companies Marketing Probes for FISH Based Tests in Clinical Laboratories
Polymerase Chain Reaction and Other Nucleic Acid Amplification Technologies
Table 3-6: Selected Companies Marketing Open PCR Platforms That Can be Used by Clinical Laboratories for LDTs
Analysis of Gene Expression Patterns (Gene Signatures)

Microarrays

Protein Microarrays

DNA Microarrays

Chromosomal Microarrays

Tissue Microarrays

Mass Spectrometry

Table 3-7: Selected Companies Marketing Mass Spectrometers

Sequencing

Table 3-8: Selected Companies Marketing Next Generation Sequencing Platforms to Clinical Laboratories 45

CHAPTER 4: CLINICAL APPLICATIONS WHERE LABORATORY DEVELOPED TESTS ARE USED

INFECTIOUS DISEASE
Table 4-1: Selected Companies/Clinical Laboratories Offering Infectious Disease Test Services Based on LDTs [Excluding microbial 
identification testing by culture]
ONCOLOGY
Hereditary Risk of Cancer
Table 4-2: Selected Companies/Clinical Laboratories Offering Laboratory Developed Tests for Hereditary Risk of Cancer
Cancer Screening
Table 4-3: Selected Companies/Clinical Laboratories Offering Cancer Screening Test Services Based on LDTs
Diagnosis, Prognosis, Treatment Decisions (Personalized Medicine) in Cancer Care
Table 4-4: Selected Companies/Clinical Laboratories Offering Cancer Diagnosis/Prognosis/Personalized Medicine Test Services Based on 
LDTs
GENETIC TESTING

Testing for Risk of Disease – Moving Beyond Cancer
Table 4-5: Selected Companies/Clinical Laboratories Offering Laboratory Developed Tests for Risk of Disease – Cancer and Beyond
Chromosome Analysis and Non-Invasive Prenatal Testing (NIPT)
Table 4-6: Selected Companies/Clinical Laboratories Offering Non-Invasive Prenatal Testing (NIPT)/Chromosome Analysis Based on LDTs
Testing for Inherited Disorders (Prenatal Testing, Postnatal Testing, Carrier Screening)
Table 4-7: Selected Companies/Clinical Laboratories Offering Genetic Testing for Inherited Disorders (Prenatal Testing, Postnatal Testing, 
Carrier Screening) Based on LDTs
Newborn Screening

Other Genetic Testing
Table 4-8: Selected Companies/Clinical Laboratories Offering Newborn Screening or Other Genetic Tests Based on LDTs
Direct-to-Consumer Genetic Testing
Table 4-9: Selected Examples of Companies Offering Direct-to-Consumer Genetic Testing Services Based on LDTs
PHARMACOGENOMICS
Table 4-10: Selected Companies/Clinical Laboratories Offering Pharmacogenomic Test Services Based on LDTs
MASS SPECTROMETRY-BASED TESTS FOR SMALL MOLECULES

OTHER LABORATORY DEVELOPED TEST APPLICATIONS
Table 4-11: Selected Companies/Clinical Laboratories Offering Autoimmune/Inflammatory Test Services Based on LDTs

Table 4-12: Selected Companies/Clinical Laboratories Offering Cardiovascular Test Services Based on LDTs

Table 4-13: Selected Companies/Clinical Laboratories Offering Neurological Test Services Based on LDTs 107

Table 4-14: Selected Companies Offering Other Test Services Based on LDTs
CHAPTER 5: DEALS – COMPANIES AND LABORATORIES, LABORATORY DEVELOPED TESTS

INVESTMENTS/FINANCINGS – COMPANIES/CLINICAL LABORATORIES WITH LDTS
2016 and 2017 Investment in LDTs

Table 5-1: Selected Investments and Financing Agreements, Companies/Laboratories with LDTs and Selected Companies Providing 
Products to Laboratories with LDTs (2014 through August 2017)
MERGERS AND ACQUISITIONS
Table 5-2: Selected Acquisitions of or by Companies/Laboratories with LDTs (2014 through August 2017)
CORPORATE COLLABORATIONS
Table 5-3: Selected Agreements Between Diagnostic Companies and Other Diagnostic Companies or Clinical Laboratories Relating to 
LDTs [Includes IVD Companies and Diagnostic Companies Operating CLIA Laboratories] (2014 through August 2017)

Table 5-4: Selected Agreements Between Diagnostic Companies/Laboratories with LDTs and Pharmaceutical or Biopharmaceutical 
Companies(Includes Agreements with Selected CROs) (2014 through August 2017)
CHAPTER 6: MARKET DRIVERS AND CHALLENGES – LABORATORY DEVELOPED TESTS

TECHNOLOGY
Status of FDA-approved and CE-marked Tests
CLINICAL MARKET DRIVERS

COMPETITION
A Large Amount of Companies
PERSONALIZED MEDICINE AND COMPANION DIAGNOSTICS
Foundation Medicine

Thermo Fisher Oncomine
REGULATION OF LABORATORY DEVELOPED TESTS – US AND OUTSIDE THE US

FDA

Directive 98/79/EC

REIMBURSEMENT

CMTP and Greek Park Collaborative

Association for Molecular Pathology

FUTURE PROSPECTS

Conversion from CLIA Lab Services Offerings to IVD Kits
Table 6-1: Selected FDA Approved/Cleared Laboratory Developed Tests

CHAPTER 7: LABORATORY DEVELOPED TEST MARKET ANALYSIS – CLINICAL LABORATORIES PERFORMING LDTS

WORLDWIDE LABORATORY DEVELOPED TESTING SERVICE MARKET

The Number of LDTs on the Market

Small versus Large Volume

LDT SERVICES MARKET BY SEGMENT
Table 7-1: Laboratory Developed Test Services Market; Major Clinical (Disease) Segments (2016 – 2021)151(in millions USD)
LDT Services Market by Geography
Table 7-2: Laboratory Developed Test Services Market by Geographical Distribution (2016-2021) (in millions USD)
INFECTIOUS DISEASE LABORATORY DEVELOPED TESTING SERVICES MARKET

Markets for LDTs for Infectious Disease Detection and Microbiology
Table 7-3: Infectious Disease Laboratory Developed Test Service Market, (2016-2021)(in millions USD) . 155
LDT Infectious Disease Services Market by Geography
Table 7-4: Geographical Distribution of the Infectious Disease Laboratory Developed Test Service Market (2016-2021) [Excluding 
microbial identification by culture](in millions USD)

Table 7-5:Geographical Distribution of the Infectious Disease Laboratory Microbial Identification Market (Culture) (2016-2021) (in 
millions USD)
ONCOLOGY LABORATORY DEVELOPED TESTING SERVICES MARKET

LDT Services Market for Oncology by Segment
Table 7-6: Oncology Laboratory Developed Test Services Market, Segmented by Clinical Application (2016-2021) (in millions USD)

Hereditary Risk of CancerTesting ServicesMarket

Cancer Screening Services Market

Diagnosis, Prognosis, Treatment Decisions (Personalized Medicine) in Cancer Care

Geographical Distribution of the Oncology Laboratory Developed Test Service Market

Table 7-7: Geographical Distribution of the Oncology Laboratory Developed Test Services Market {Cancer Screening plus 
Diagnosis/Prognosis/Monitoring] (2016-2021) (in millions USD)
GENETIC TESTING LABORATORY DEVELOPED TESTING SERVICES MARKET

LDT Genetic Test Market by Segment
Table 7-8: Genetic Testing Laboratory Developed Test Service Market, Segmented by Clinical Application (2016-2021) (in millions USD)
LDT Market by Geography
Table 7-9: Geographical Distribution of the Genetic Testing Laboratory Developed Test Service Market (2016-2021) (millions USD)
MARKET FOR OTHER LABORATORY DEVELOPED TESTS

CHAPTER 8: LABORATORY DEVELOPED TEST MARKET ANALYSIS – INSTRUMENT AND REAGENT MANUFACTURERS

UNIQUNESS OF MARKET ANALYSIS ON LDT PRODUCT AND REAGENTS

LDT PRODUCTS AND REAGENTS BY SEGMENT (PCR, MASS SPECTROMETRY, NGS. MICROARRAYS AND OTHER)

Table 8-1:Worldwide Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs (2016-2021) (in millions 
USD)
Geographic Distribution of Product and Reagants Used for LDT Market

Table 8-2: Geographical Distribution of the Market for Products (Instruments and Consumables) Used by Clinical Laboratories for LDTs 
(2016-2021) (in millions USD)
CHAPTER 9: COMPANY PROFILES

23ANDME, INC.

ADAPTIVE BIOTECHNOLOGIES CORPORATION

ADMERA HEALTH

AGENDIA NV

AGILENT TECHNOLOGIES INC.
Recent Revenue History

Agilent Technologies Revenues (2014, 2015, 2016)

Company Overview
ALTHEADX, INC.

AMBRY GENETICS CORP.

APPLIED PROTEOMICS, INC.

ATHENA DIAGNOSTICS, INC. (A QUEST DIAGNOSTICS BUSINESS)

BGI

BIODESIX, INC.

BIOTHERANOSTICS, INC.

BRUKER CORPORATION
Recent Revenue History:
Bruker Corporation Revenues (2013 - 2016)
Company Overview:
CANCER GENETICS, INC.
Recent Revenue History
Cancer Genetics Revenues (2014, 2015, 2016)
Company Overview
Collaborations with Universities or Other Non-Profit Organizations
Collaborations with Other Companies
CARDIODX, INC.

CAREDX, INC.
Recent Revenue History
CareDx Revenues (2014, 2015, 2016)
Company Overview
CARIS LIFE SCIENCES

CASTLE BIOSCIENCES, INC.

CENTOGENE AG

COLOR GENOMICS, INC.

CYNVENIO BIOSYSTEMS, INC.

EPIC SCIENCES, INC.

EUROFINS
Recent Revenue History
Eurofins Health Revenues (2014 to 2016)
Company Overview
EXACT SCIENCES CORPORATION
Recent Revenue History
Exact sciences Revenues (2014, 2015, 2016)
Company Overview
FOUNDATION MEDICINE, INC.
Recent Revenue History
Foundation Medicine Revenues (2014, 2015, 2016)
Company Overview
GENOMIC HEALTH, INC.
Recent Revenue History
Genomic Health Revenues (2014 to 2016)
Company Overview
GENOPTIX, INC.

GOOD START GENETICS, INC. (ACQUIRED BY INVITAE CORPORATION)

GRAIL, INC.

GUARDANT HEALTH, INC.

HELIX

ILLUMINA, INC.
Recent Revenue History
Illumina (2014, 2015, 2016)
Company Overview
INTEGRATED DIAGNOSTICS, INC.

INVITAE CORPORATION
Recent Revenue History
Invitae Corporation Revenues (2014, 2015, 2016)
Company Overview
LABORATORY CORPORATION OF AMERICA (LABCORP)
Recent Revenue History
Laboratory Corporation of America (LabCorp) Revenues (2014, 2015, 2016)
Company Overview
MDXHEALTH
Recent Revenue History:
MDxHealth Revenues (2014, 2015, 2016)
Company Overview
MULTIPLICOM NV (PART OF AGILENT TECHNOLOGIES)

MYRIAD GENETICS, INC.
Recent Revenue History
Myriad Genetics Revenues (2015, 2016, 2017)
Company Overview
NANTOMICS (MEMBER OF THE NANTWORKS ECOSYSTEM OF COMPANIES)

NATERA, INC.
Recent Revenue History:
Natera Revenues (2014, 2015, 2016)
Company Overview
NEOGENOMICS, INC./NEOGENOMICS LABORATORIES
Recent Revenue History
NeoGenomics Revenues (2014, 2015, 2106)
Company Overview
OPKO HEALTH, INC./OPKO DIAGNOSTICS
Recent Revenue History
OPKO Health (2014, 2015, 2106)
Company Overview
PACIFIC BIOSCIENCES OF CALIFORNIA, INC.
Recent Revenue History
Pacific Biosciences Revenues (2014, 2105, 2016)
Company Overview
PERKINELMER, INC.
Recent Revenue History:
PerkinElmer Revenues (2015 through 2017)
Company Overview:
QIAGEN N.V.
Recent Revenue History
QIAGEN (2014, 2015, 2106)
Company Overview
QUEST DIAGNOSTICS
Recent Revenue History
Quest Diagnostics Revenues (2014, 2015, 2016)
Company Overview
ROCHE
Recent Revenue History
Roche Revenues (2015 - 2016) (mCHF)
Roche Revenues (2015 - 2016) (mUSD)
Company Overview
ROSETTA GENOMICS LTD.
Recent Revenue History:
Rosetta Genomics Revenues (2014 to 2016)
Company Overview:
SCIEX

SERA PROGNOSTICS, INC.

THERMO FISHER SCIENTIFIC, INC.
Recent Revenue History
Thermo Fisher Scientific Revenues (2014-2016)
Company Overview
WATERS CORPORATION
Recent Revenue History:
Waters Corporation Revenues (2014, 2015, 2016)
Company Overview:

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