Description
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
- Market for LDT Services in Cancer Screening
- Market for LDT Services for Inherited Disorders
- 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,
- 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There has been considerable discussion in recent years about regulation of this market, and the FDA proposed a draft guidance calling for more FDA oversight of these tests.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.
Table of Contents
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:
