Product Code: 20-033
Now more than ever, molecular diagnostics are the most important part of in vitro diagnostics. Kalorama Information has, for many years, estimated the size of and forecasted the growth of the worldwide market for molecular diagnostics in all major segments, and does so in this edition as a pandemic has reached developed markets including the United States.
2020 was set to be a year of growth and innovations in molecular diagnostics under any circumstances. New products, higher growth than other in vitro diagnostic categories, continued acceptance of next-generation sequencing methods were driving. Liquid biopsy technologies and the increased use of predictive genetic tests were and still are areas of anticipated revenue growth. The sudden onsent of SARS-CoV-2 and the resulting disease COVID-19 put the world's focus on molecular diagnostics in an unexpected way.
This will not be universally the case. In non-COVID-19 testing areas, such as cancer and inherited diseases, molecular diagnostics vendors need to continue to persuade. Here volumes may be reduced by social distancing measures. But they are expected to continue to make progress converting laboratory customers. New technologies such as molecular near-patient and next-generation sequencing are increasingly part of the mix. The report details these trends.
This report provides 2020 market sizing and expected growth to 2025 for the following segments:
- COVID-19 Molecular IVD Test Market (Full Year 2020 Projected and Market 2H 2020)
- COVID-19 Molecular IVD Test Market North America
- COVID-19 Molecular IVD Test Market Europe
- COVID-19 Molecular IVD Test Market Asia Pacific
- COVID-19 Molecular IVD Test Market Rest of World
- Infectious Disease Markets, including:
- Hepatitis
- HIV
- Respiratory
- HAIs and Sepsis Tests
- TB
- Sexually Transmitted Diseases
- NAT Blood Testing
- Molecular Histology
- Molecular Cancer Testing
- Molecular Transplantation Testing
- Inherited Disease Testing
- NIPT
- Inherited
- Thrombophilia
- Pharmacogenomics
There has also been a huge influx of product introductions from small, obscure companies. These have mostly targeted the low end of the price range and often had poor performance, while a small number of high-end automated systems are mostly limited to certain segments of the market, such as independent reference laboratories and centralized hospital laboratories. Low-quality products from fly-by-night companies are the predictable result of the shortages and the relatively basic resources needed to produce mediocre antibody test kits with a low level of quality control. A few major companies are seeing the most test runs, particularly in the United States.
COVID-19 testing has also been a bit of a double-edged sword for labs generally, for in vitro diagnostics and for molecular tests. Boosting volumes in infectious disease have been notably paired with drops due to social distancing measures and hospital surgical postponements. What is the result? Kalorama Information's report helps to sort out the array of news and reports about the current state of molecular diagnostics, reasonable global estimates for COVID, and the impact of COVID-19 on the rest of molecular testing.
Kalorama covers the global markets. For All Markets, Kalorama Information provides the following:
- Impacts of COVID-19 on Market Segments
- Regional Market Distribution
- Profiles of Top Companies
- Major Companies with COVID-19 Tests
- Other Companies with COVID-19 Tests
- HIV Products on the Market
- Transplantation Products on the Market
- The Increasing Role of Next-Generation Sequencing
- Trends - Lab Automation and Molecular Diagnostics
- Trends - CRISPR
- Trends - Artificial Intelligence
- Company Profiles
Kalorama Information has monitored 2020 secondary sources, trade publications, medical journals, government websites and policy documents, as well as financial statements from vendors to assess the market impact of COVID-19. In addition, Kalorama has been tracking lab volumes with a survey since mid-April, and Kalorama's U.S. MasterFile product was used to keep track of instrument trends.
Companies Profiled in the Report Include:
- Abbott Diagnostics
- Agena Bioscience
- Agendia BV
- ARUP Laboratories
- Asuragen
- Advanced Cell Diagnostics
- Agilent
- Amoy Diagnostics
- Applied Spectral Imaging
- Becton, Dickinson & Co.
- Biocartis
- BGI
- Berry Genomics
- BioMerieux
- Bio-Rad
- Care DX
- Danaher
- Cepheid
- Beckman Coulter
- Leica Biosystems
- Eiken Chemical
- Fluidigm
- GenMark
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- Genotypic Technology PVT
- Greiner Bio-One GMBH
- Grifols
- Hologic
- Illumina
- Immucor
- Meridian
- Molbio
- Myriad Genetics
- Nanostring
- Neogenomics
- NeuromoDX
- Perkin Elmer
- Oxford Nanopore
- Promega
- Prescient Medicine
- Qiagen
- Quidel
- Roche
- Thermo
- Vela
- Veracyte
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TABLE OF CONTENTS
CHAPTER ONE: EXECUTIVE SUMMARY
- MOLECULAR DIAGNOSTICS IN THE SPOTLIGHT
- Figure 1-1: Molecular Diagnostics Market (w COVID-19 and without COVID-19, 2020) $BN
- Hundreds of PCR Tests on the Market, U.S. Labs Settle on a Few
- COVID-19 Market
- Table 1-1: COVID-19 Molecular Testing Market, First Half-Year 2020 and Full Year 2020 ($M)
- EMERGING TRENDS
- Automation
- Molecular Point of Care
- Table 1-2: Market-Available Molecular POC Diagnostic Platforms
- Next-Generation Sequencing on the Rise
- LDT Regulation and COVID-19
- Reimbursement Environment
- Thermo and Qiagen Merger
- Table 1-3: Complementary diagnostic products offered by Thermo Fisher, Qiagen
- CRISPR, Sequencing and COVID-19
- THE GLOBAL MOLECULAR DIAGNOSTICS MARKET IN THE ERA OF COVID-19
- Table 1-4: Non-COVID-19 Molecular Diagnostics Market ($M)
CHAPTER TWO: COVID-19 MOLECULAR DIAGNOSTIC MARKET ANALYSIS
- Major IVD Players See Brisk COVID-19 Test Sales
- Table 2-1: COVD-19 Molecular Detection Tests from Major Suppliers
- Table 2-2: COVID-19 test market by Region Second Half of 2020 and Full Year 2020 Estimated: North
- America, Europe, APAC, ROW, LATAM, World
- NORTH AMERICA
- Table 2-3: COVID-19 Tests, North America
- EUROPE
- Table 2-4: COVID Tests, Europe
- APAC
- Table 2-6: COVID Tests APAC Region
- LATIN AMERICA
- Table 2-7: Latin America COVID Testing
- REST-OF-WORLD
- Table 2-8: Rest of World Testing
- COVID TESTING MARKET COMPUTATION METHODOLOGY
- TEST VENDORS
- Table 2-9: Other PCR Tests Products on the Market
- TESTING TRENDS, RECOMMENDATIONS, CONSENSUS TAKING SHAPE
CHAPTER THREE: MARKETS FOR OTHER MOLECULAR DIAGNOSTIC TESTS
- Table 3-1: Molecular Diagnostic Market, 2020 and 2025 by Category $M
- Figure 3-1: Market by Regions: US, Europe, Asia, ROW
- INFECTIOUS DISEASES
- Repiratory Diseases: COVID-19 Impact
- Mycobacteria/Tuberculosis: Market and COVID-19 Impact
- Hospital-Acquired Infections (HAIs) : Market and COVID-19 Impact
- Sexually Transmitted Infections: Market and COVID-19 Impact
- Hepatitis: COVID-19 Impact
- Table 3-2: Selected Molecular Hepatitis Tests
- HIV Market and COVID-19 Impact
- Table 3-3: Selected Molecular Test Products for HIV
- MOLECULAR HISTOLOGY AND CYTOLOGY DIAGNOSTICS
- COVID-19 Impact
- HPV
- COVID-19 Impact
- Product Developments
- MARKETS FOR MOLECULAR CANCER DIAGNOSTICS
- Cancer Molecular Blood Markers - COVID-19 Impact
- MOLECULAR TRANSPLANT DIAGNOSTICS
- COVID-19
- Table 3-4: Selected Innovations in the Field of Molecular Transplant Diagnostics
- MOLECULAR INHERITED DISEASES DIAGNOSTICS
- Inherited Diseases - COVID-19 Impact
- Thrombophilia and Coagulation Markers
- Non-Invasive Prenatal Testing (NIPT)
- Inherited Disease Tests
CHAPTER FOUR: TRENDS TO WATCH - SEQUENCING, CRISPR, AUTOMATION
- SEQUENCING
- COVID and NGS
- NGS and Inherited Disease
- NGS and Companion Diagnostics
- Table 4-1: Selected Clinical NGS Platforms in the Market
- Outlook For NGS in Molecular Diagnostics
- Figure 4-1: Percent of the MDX Market Revenues for Tests Using NGS 2020 and 2025
- Evolving Informatics Solutions in Clinical Sequencing
- Sample Preparation and Quality Control
- LAB AUTOMATION AND MOLECULAR DIAGNOSTICS
- Table 4-2: Selected Automated Molecular Test Instrument Platforms
- Table 4-3: Selected FDA Declared EUA Tests
- CRISPR AND MOLECULAR DIAGNOSTICS
- CRISPR and COVID-19
- Table 4-4: CRISPR Innovations
CHAPTER FIVE: COMPANY PROFILES
- ABBOTT DIAGNOSTICS
- Company Overview
- Financial Review
- Table 5-1: Abbott Diagnostics' Recent Revenue History ($ millions)
- COVID-19
- FDA approval of ALK Break Apart FISH Probe Kit
- Alinity s System
- WHO prequalification (PQ) approval of viral load test
- ARUP LABORATORIES
- Table 5-2: ARUP Labs' Recent Revenue History ($ millions)
- ADVANCED CELL DIAGNOSTICS (BIOTECHNE)
- AGILENT TECHNOLOGIES INC./DAKO
- Company Overview
- Financial Review
- Table 5-3: Agilent Technologies' Recent Revenue History ($ millions)
- BECTON, DICKINSON & CO. (BD)
- Business Segments
- Recent Acquisitions
- Recent Divestitures
- Leading Position in the Flow Cytometry Market
- Revenue and Growth
- Molecular Diagnostics Focus
- BEIJING GENOMICS INSTITUTE (BGI)
- Complete Genomics
- Sanger Sequencing
- BIOCARTIS
- Company Overview
- Financial Review
- Table 5-4: Biocartis' Recent Revenue History ($ millions)
- Table 5-5: Biocartis' Recent Revenue History ($ millions)
- BIONEER
- AccuPower COVID-19 Real-Time RT-PCR Kit
- BIOM
- Table 5-6 BioMerieux Revenue History
- Molecular
- BIO-RAD LABORATORIES, INC
- Key Comment
- Recent Revenue History
- Table 5-7: Bio-Rad Revenue History
- CAREDX, INC.
- Products Offered by CareDx
- DANAHER (CEPHEID AND LEICA BIOSYSTEMS)
- Life Sciences Business
- Diagnostics Business
- Cepheid
- Leica Biosystems
- Danaher's 2019 Performance and 2020 Expectations
- GENOTYPIC TECHNOLOGY PVT. LTD.
- GRIFOLS, S. A
- Molecular Immunohematology and Specialty Testing Products
- NAT Blood Screening
- HOLOGIC, INC.
- Table 5-8: Hologic's Recent Revenue History ($ millions)
- ILLUMINA, INC.
- Company Overview
- Table 5-9: Illumina's Recent Revenue History ($ millions)
- Table 5-10: llumina's Technology Platforms and Targeted Applications
- MOLBIO DIAGNOSTICS PVT. LTD.
- MYRIAD GENETICS, INC.
- Company Overview
- Financial Review
- Table 5-11: Myriad Genetics' Recent Revenue History ($ millions)
- NANOSTRING TECHNOLOGIES, INC.
- NEUROMODX
- PERKINELMER INC.
- OXFORD NANOPORE TECHNOLOGIES LTD
- PROMEGA COPRORATION
- PRESCIENT MEDICINE HOLDINGS (AUTOGENOMICS)
- QIAGEN
- Company Overview
- Thermo Fisher Purchase
- Table 5-12: Complementary diagnostic products offered by Thermo Fisher, Qiagen
- Table 5-13: QIAGEN's Recent Revenue History ($ millions)
- ROCHE DIAGNOSTICS
- Company Overview
- COVID-19
- Financial Review
- Table 5-14: Roche Diagnostics' Recent Revenue History ($ millions)
- Cobas Liat System - POC
- Approval for cobas EZH2 Mutation Test
- June 2020 - partnership with SpeeDX
- Stratos Genomics
- HPV
- PLUS Cytoogy
- ASPiRATION study
- Cobas Zika test for blood screening
- FDA approval of Babesia test
- FDA 510(k) clearance for cobas TV/MG test
- Release of NAVIFY Guidelines app
- EBV and BKV Tests on the cobas 6800/8800 Systems
- Expanded use of VENTANA PD-L1 (SP142) Assay in triple-negative breast cancer (TNBC)
- THERMO FISHER SCIENTIFIC INC.
- Company Overview
- Table 5-15: Thermo Fisher's Recent Revenue History ($ millions)
- Transplant Diagnostics
- qPCR
- Sequencing
- Qiagen
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