샘플 요청 목록에 추가
세계의 체외진단 검사 시장에 대해 조사했으며, 시장의 개요와 업계 동향, 부문별 동향 및 시장에 참여하는 기업의 개요 등을 제공하고 있습니다.
목차 제1장 개요
제2장 서론
제3장 체외진단 시장의 세계 상황
제4장 기업과 업계의 동향
제5장 POC(Point of Care) 검사
제6장 코어 시험기관
제7장 면역측정
제8장 분자 어세이
제9장 혈액학
제10장 응고
제11장 미생물학과 바이러스학
제12장 혈액은행 서비스
제13장 조직학과 세포학
제14장 기업 개요 : 탑티어
Abbott Diagnostics
i-STAT Business
Agilent Technologies
Beckman Coulter / Danaher
Becton, Dickinson and Company(BD)
bioMerieux Inc
Bio-Rad Laboratories, Inc.
Bruker Corporation
Cepheid / Danaher
Danaher Corporation
Dexcom
DiaSorin S.p.A
Hologic, Inc.
PANTHER Molecular System
Instrumentation Laboratory(IL) / Werfen
Leica Biosystems/Danaher
Natera
QuidelOrtho Corporation
Radiometer A/S / Danaher
HemoCue
Roche Diagnostics
cobas Liat System
Roche Tissue Diagnostics
Siemens Healthineers
Sysmex Inostics
Thermo Fisher Scientific Inc.
Werfen
제15장 기업 개요 : 제2층
BGI Genomics
MGI Tech Co., Limited
Diagnostica Stago S.A.S
Eiken Chemical Co., Ltd
Fujirebio Diagnostics, Inc.
Grifols S.A
Guardant Health, Inc.
Horiba Medical
Menarini Diagnostics
Meridian Bioscience, Inc.
Shenzhen Mindray Bio-medical Electronics Co., Ltd.
Myriad Genetics, Inc.
Nihon Kohden
OraSure Technologies, Inc.
QIAGEN
Randox Laboratories Ltd
Sekisui Diagnostics LLC
Veracyte, Inc.
제16장 기업 개요 : 혈액은행 스페셜리스트
AliveDx
Cerus Corporation
제17장 기업 개요 : 코어랩과 기타 기업
AB SCIEX Pte Ltd.
ARKRAY
EKF Diagnostics Holdings Plc
ELITech Group S.A.S.
Shimadzu Scientific Instruments
Snibe Co. Ltd.
Tosoh Bioscience
Trinity Biotech Plc
제18장 기업 개요 : CTC 및 액체생검 검사 프로바이더
Biocept, Inc.
Biodesix
Epic Sciences
Epigenomics AG
Foundation Medicine, Inc.
Menarini-Silicon Biosystems
NeoGenomics
제19장 기업 개요 : 스페셜리스트
Ascensia Diabetes Care Holdings AG
Bigfoot Biomedical Inc.(Abbott)
Debiotech SA
Glooko Inc.
Insulet Corporation
Lifescan Inc.
Medtronic plc
Nemaura Medical Inc.
Verily Life Sciences LLC
제20장 기업 개요 : 혈액학(세포 분석) 및 응고 스페셜리스트
CellaVision AB
Masimo Corporation
Nova Biomedical Corporation
제21장 기업 개요 : 조직 병리학 스페셜리스트
Amoy Diagnostics Co. Ltd.
Applied Spectral Imaging Inc.(ASI)
BioGenex Laboratories, Inc.
BioView Ltd.
Visiopharm
제22장 기업 개요 : 면역측정 스페셜리스트
Biohit Healthcare
Biomerica Inc.
Bio-Techne Corporation
Eurobio Scientific
EUROIMMUN AG(Revvity)
Immunodiagnostic Systems(IDS)
INOVA Diagnostics, Inc.
One Lambda, Inc
Response Biomedical Corp.
Theradiag
VolitionRx Limited
제23장 기업 개요 : 미생물학 스페셜리스트
Accelerate Diagnostics, Inc.
Advanced Biological Laboratories, S.A.(ABL)
altona Diagnostics
ArcDia International Oy Ltd.
BIOFIRE Diagnostics, LLC.(Acquired by bioMerieux)
COPAN ITALIA S.p.A. and COPAN Diagnostics, Inc.
Curetis
Genetic Analysis AS
Greiner Bio-One International GmbH
Mast Group
Mobidiag
Q-linea AB
OpGen, Inc.
Seegene, Inc.
T2 Biosystems
제24장 기업 개요 : 분자 검사 스페셜리스트
Enzo Biochem Inc.
NanoString Technologies, Inc.(Bruker)
Pacific Biosciences of California, Inc.(PacBio)
Standard BioTools
Takara Bio Inc.
Vela Diagnostics
제25장 기업 개요 : POC(Point of Care) 검사 스페셜리스트
Abingdon Health Ltd.
binx Health
Biomeme, Inc.
Chembio Diagnostic Systems, Inc.
Co-Diagnostics, Inc.
Cue Health
Diazyme
DNA Electronics Ltd(DNAe)
DxGen Corp
Genedrive plc(formerly Epistem Holdings)
Immunostics, Inc.
MedMira, Inc.
QuantuMDx Group, Ltd.
Rheonix, Inc.
COVID-19
제26장 기업 개요 : 출생전 검사 서비스 프로바이더
Berry Genomics Co. ltd.
CooperGenomics(Division of CooperSurgical)
INEX Innovate
Oxford Gene Technology
Yourgene Health
제27장 기업 개요 : 품질관리와 샘플 사전 처리 스페셜리스트
10x Genomics
Agena Bioscience, Inc.
Biotype Diagnostic GmbH
DxTerity Diagnostics Inc.
Horizon Discovery Group plc
IncellDx
LGC SeraCare Life Sciences, Inc.
PreAnalytiX GmbH
Precipio, Inc.
Quanterix Corporation
Streck Inc.
제28장 테스트 서비스 프로바이더
23andMe
Agendia BV
Ambry Genetics
ARUP Laboratories
Aspira Women's Health
BioReference Laboratories
Biotheranostics
BluePrint Genetics Oy
Boston Heart Diagnostics
CareDx, Inc.
Predictive Oncology
Labcorp, Laboratory Corporation of America
Mayo Clinic Laboratories
MDxHealth SA
OPKO Diagnostics
Quest Diagnostics
Diagnostic Services
Prenatal and Women's Health
Sonic Healthcare
KSA
Kalorama Information's "The Worldwide Market for In Vitro Diagnostic (IVD) Tests" , now in its 17th edition, is the essential resource for anyone interested in or involved in the IVD industry. This comprehensive report provides reliable estimates, real-world forecasts from 2024 to 2029, and essential insights needed to understand the IVD market in its entirety. With every significant test category covered in detail, it's like having ten market research reports in one comprehensive volume .
Key Features:
Extensive Coverage: Detailed estimates and forecasts for every significant IVD test category, with chapters on Clinical Chemistry, Hematology, Histology, Molecular, Immunoassay, Infectious Disease, Coagulation, Blood Bank IVD, Point of Care (POC), and more.
In-Depth Analysis: Based on vendor reporting, interviews, and global activities, this 1,700 page report offers a full assessment of the IVD market.
Trusted Source: Published since 1999, it's the most trusted report by top companies in the IVD industry.
Growth Projections: Market size, future projections, and compound annual growth rates for all test segments through 2029.
Company Profiles: In-depth profiles of hundreds of companies, including the top 40, covering financial results, product launches, and strategic plans.
Global Scope: Analysis includes market size for every significant country and major market segments globally.
Essential Insights for Business Planning:
Market Size and Trends: Understand the size and breakdown of IVD market segments.
Future Projections: Forecasts for where these markets will be in five years.
Industry Changes: Track the evolution of the IVD market over time.
Competitive Landscape: Identify key players, mergers, and groundbreaking product launches.
Strategic Opportunities: Discover growth markets for potential entry or investment.
Country-Level Coverage:
This report reflects the global scope of the IVD market, covering:
Regions: US, Europe, Asia Pacific, Latin America, Eastern Europe, Emerging Markets, Rest of World.
Countries: Germany, UK, France, Spain, Italy, Russia, Netherlands, Turkey, Poland, Canada, China, Japan, Malaysia, Singapore, South Korea, Australia, Saudi Arabia, Brazil, Argentina, Colombia, Chile, Peru, South Africa, and more.
Table of Contents Chapter 1: Executive Summary
Figure 1-1: The Worldwide IVD Market, 2019, 2024, and 2029 ($ billions)
Figure 1-2: COVID-19 IVD Market, Share by Segment (Immunoassay Lab-Based, Molecular Dx Lab-Based, Point-of-Care), 2024 (%)
Scope and Methodology
Size and Growth of the Market
Table 1-1: Global In Vitro Diagnostic (IVD) Sales, by Product Segment, 2024-2029 ($ million) (Blood Bank Molecular; Blood Bank Screening; Drugs of Abuse; Blood Grouping/Typing; Circulating Tumor Cells; Clinical Chemistry; Coagulation; Histology/Cytology; Continuous Glucose; COVID-19 Dx; Diabetes HbA1c Immunoassays, Lab-Based; Hematology; HPV, Molecular; Immunoassays - Infectious Disease; Immunoassays - Other Immunoassays; Mass Spectrometry; Microbiology (ID/AST); Molecular Microbiology; Nucleic Acid Assays; POC, OTC Diabetes; POC, OTC Other; POC, Professional; Other)
Market Highlights
Competitive Picture in IVD
Finding What You Are Looking For in the 17th Edition
Table 1-2: Finding What You Are Looking For in the 17th Edition
Chapter 2: Introduction
IVD Landscape
Report Design
Changes Between 16th and 17th Editions
PAMA and CMS
Market Analysis of IVD Market Segments
Table 2-1: Global In Vitro Diagnostic (IVD) Sales, by Product Segment, 2024-2029 ($ million) (%) (Blood Bank Molecular; Blood Bank Screening; Drugs of Abuse; Blood Grouping/Typing; Circulating Tumor Cells; Clinical Chemistry; Coagulation; Histology/Cytology; Continuous Glucose; COVID-19 Dx; Diabetes HbA1c Immunoassays, Lab-Based; Hematology; HPV, Molecular; Immunoassays - Infectious Disease; Immunoassays - Other Immunoassays; Mass Spectrometry; Microbiology (ID/AST); Molecular Microbiology; Nucleic Acid Assays; POC, OTC Diabetes; POC, OTC Other; POC, Professional; Other)
Table 2-2: Additional Global In Vitro Diagnostic (IVD) Markets of Interest (Not in Totals), Sales by Product Segment, 2024-2029 ($ million) (%) (Clinical Sequencing; Drugs of Abuse, Criminal; Drugs of Abuse, Employment [non IVD]; DTC Genetic Testing; Flow Cytometry; Prenatal Test Services)
Figure 2-1: Top 10 Global In Vitro Diagnostic (IVD) Product Segments, by Sales, 2024-2029 ($ billion)
Figure 2-2: Top 10 Global In Vitro Diagnostic (IVD) Product Segments, by CAGR, 2024-2029 (%)
Figure 2-3: Developed vs. Developing IVD Market Shares, 2024 and Projected 2029 (%)
Top Suppliers and Niche Players
Introduction
Overview of the Top Tier Companies
Table 2-3: Clinical Diagnostic Revenues of Selected Top 20 IVD Companies* Figure 2-4: Top 10 IVD Companies* Figure 2-5: Top 10 IVD Companies* Roche Diagnostics
* Abbott Diagnostics
Danaher Corporation
* * * Siemens Healthineers
Thermo Fisher Scientific
Dexcom
Illumina
Becton Dickinson & Co
bioMerieux
Exact Sciences
Sysmex Corporation
QuidelOrtho Corporation
Werfen
* * Hologic
Agilent
Natera
Bio-Rad Laboratories
Revvity
DiaSorin Group
Bruker/CALID Group
Overview of Selected Second Tier Companies
Table 2-4: Revenues of Selected Top 20 Niche IVD Players, 2023 and estimated 2024 ($ million)* Figure 2-6: Top Tier Market Distribution, 2023 and estimated 2024 (%)
Mindray
QIAGEN N.V.
Myriad Genetics
Grifols S.A.
Guardant Health
Randox
BGI Genomics
Sekisui Diagnostics
Invitae
Diagnostica Stago
Fujirebio
Fulgent Genetics
Meridian
Eiken Chemical Co
Nihon Kohden
Horiba/ABX
Veracyte
OraSure Technologies
Menarini Diagnostics
Biocartis
IVD Companies Mergers & Acquisitions
Table 2-5: Selected IVD Mergers and Acquisitions, 2020-2024 (first half)
Collaboration, Partnership, Alliance Agreements
Test Services
Table 2-6: Selected Test Services, Sales 2019-2024 ($ million, estimated where applicable)
Table 2-7: Global Lab Market Segmentation, 2023 ($ billion)
Table 2-8: Clinical Laboratory Revenues for Selected of U.S.-based Reference Labs, 2019-2024 ($ million, estimated)
Historical IVD Market vs Today
In the Beginning to Now
Figure 2-7: Share of IVD Market, by Segment, 2000 and 2024 Compared (%) (Blood Banking [imm & typing]; Clinical Chemistry; Coagulation; Hematology; Immunoassays; Microbiology [ID/AST]; Molecular; POC - Other; Histology/Cytology; POC Diabetes; Others)
Future
Next-Generation Sequencing
Cancer Testing (Liquid Biopsy)
Companion Diagnostics
Point of View
Figure 2-8: IVD Market, by Segment, 2023 Compared to 2024 ($ million) (%)
COVID-19 Impact and Summary
Figure 2-9: Combined Performance in COVID-19 and non-COVID-19 IVD Market Segments, 2020-2029 ($ million)
COVID-19 Market Value
Table 2-9: COVID-19 Market Estimates, by Segment (Immunoassay, Molecular, Rapid - POC), 2024 (%)
Chapter 3: The Global Picture for In Vitro Diagnostic Markets
Background
Simultaneous Threats: Chronic and Acute
Expected World IVD Market Developments
Global Population and Aging
Figure 3-1: Global Fertility Rate vs. Population Size, 1950-2050 (billion)
Figure 3-2: Global Population Distribution, 2022
Table 3-1: Elderly Support Ratio in Various Countries, 2010 and 2050
(Australia; Brazil; Canada; China; China, Hong Kong SAR; France; Germany; India; Italy; Japan; Mexico; Saudi Arabia; Singapore; South Africa; Spain; Turkey; United Kingdom; United States; World)
Workforce Reduction
WHO Essential IVD List
Table 3-2: WHO Model List of Essential In Vitro Diagnostics (EDL)
Increase in Chronic Diseases
Figure 3-3: Leading Causes of Death Globally, 2021 (number of deaths in millions)
COVID-19
Table 3-3: Selected Molecular EUA Tests for COVID-19, 2020-July 2024
Table 3-4: Selected Antigen Immunoassay Tests for SARS-CoV-2, 2020-2023
Table 3-5: Individual EUAs for Serology Tests for SARS-CoV-2, 2020-2023
Table 3-6 Individual EUAs For IVDs for Management of COVID-19 Patients
Emerging and Emerged Markets
Table 3-7: Market Potential by Total Population and Percent Urban, 2023 (Brazil; Canada; Chile; China; Colombia; Egypt; India; Malaysia; Mexico; Peru; Poland; Russia; Saudi Arabia; South Africa; South Korea; Turkey; Ukraine; United States; Vietnam)
Size and Forecast for the Global IVD Market
Table 3-8: Global In Vitro Diagnostic Market, Major Country/Region Markets, 2024 and 2029 ($ million) (Australia; Brazil; Canada; China; Eastern Europe; EU 15/W. Europe; India; Japan; Mexico; Peru; Russia; Saudi Arabia; South Africa; South Korea; Turkey; UAE; United States; Vietnam; ROW)
Table 3-9: Global In Vitro Diagnostic Market, Regional Markets, 2024 and 2029 ($ million) (Africa, Asia Pacific, Europe, Latin America, Middle East, North America)
Figure 3-4: Global In Vitro Diagnostic Market, Regional Markets, 2024 and 2029 ($ billion) (Africa, Asia Pacific, Europe, Latin America, Middle East, North America)
Figure 3-5: Global In Vitro Diagnostic Market, Share by Regional Markets, 2024 (%) (Africa, Asia Pacific, Europe, Latin America, Middle East, North America)
Table 3-10: Global In Vitro Diagnostic Market, YOY Growth, by Segment, 2023-2024 (%) (Blood Bank Molecular - NAT Screens; Blood Bank Screening - Immunoassays; Blood Grouping/Typing; Clinical Chemistry; Coagulation [PT/INR]; Coagulation, Molecular; D-dimer; Diabetes HbA1c, Lab; Drugs of Abuse; Hematology - Core Lab; Histology/Cytology; Immunoassays - Infectious Disease; Immunoassays - Other Immunos; Microbiology [ID/AST]; Microbiology [Molecular]; Nucleic Acid Assays; POC, OTC Diabetes; POC, OTC Other; POC, Professional/Hospital)
Table 3-11: Global In Vitro Diagnostic Market, Regional Markets, 2023-2024 YOY Change (%) (Africa, Asia Pacific, Europe, Latin America, Middle East, North America)
The IVD Market in the United States
Table 3-12: United States IVD Market Share, by Segment, 2024 (%) (Blood Grouping; Clinical Chemistry; Coagulation; Hematology; Histology; Immunoassay Infectious Disease; Immunoassay Other; Microbiology ID/AST; Microbiology Molecular; Nucleic Acid Assays; POC Diabetes; POC Other; Others)
PAMA and Reimbursement Changes
Impact of CARES Act on PAMA
Table 3-13: Proposed Clinical Diagnostic Laboratory Test (CDLT) Rates, 2020-2027
Saving Access to Laboratory Service Act (SALSA)
LDT Update
Changes Resulting from COVID-19 Pandemic
Table 3-14: FDA Enforcement Discretion of New Regulation Phaseout Stage, by IVD Category, 2024
Bundled Insurance Payments for ESRD Patients
Table 3-15: Laboratory Tests Subject to ESRD Consolidated Billing
Advanced Laboratory Tests (ADLT)
Table 3-16: List of Approved ADLTs, March 2024
Precision Medicine and NGS
IVD Market in Europe: Growing Markets
Table 3-17: Economic Indicators (GDP Growth, Inflation Growth), by Select European Country, 2020-2024 (%) (France, Germany, Italy, Spain)
Figure 3-6: International Monetary Fund Inflation Map, Global 2024
Table 3-18: Western European IVD Market, by Country, 2024 ($ million, estimated) (Austria; Belgium; Denmark; Finland; France; Germany; Greece; Ireland; Italy; Luxembourg; Netherlands; Norway; Portugal; Spain; Sweden; Switzerland; UK)
EU Regulation
Table 3-19: IVD Market Per Capita, Europe, 2023 Estimates (Bulgaria; Croatia; Czech Republic; France; Germany; Greece; Hungary; Italy; Lithuania; Netherlands; Poland; Romania; Russia; Serbia; Slovakia; Slovenia; Spain; Sweden; Switzerland; Ukraine; UK)
Precision Medicine in Europe
Brexit
Japan
Table 3-20: Japan IVD Market, Share by Segment, 2024 (%) (Clinical Chemistry; Coagulation; Hematology; Histology; Immunoassay Infectious Disease; Immunoassay Other; Microbiology ID/AST; Microbiology Molecular; POC Diabetes; POC Other; Others)
Eastern Europe: Growth Region
Table 3-21: Eastern European IVD Market, by Country, 2024 ($ million) (Bulgaria; Croatia; Czech Republic; Hungary; Poland; Romania; Slovakia; Slovenia; Ukraine; Other)
Figure 3-7: Eastern Europe IVD Market, by Country, 2024 ($ million) (Bulgaria; Croatia; Czech Republic; Hungary; Poland; Romania; Slovakia; Slovenia; Ukraine)
China: Current IVD Market
Table 3-22: China IVD Market, Share by Segment, 2024 (%) (Blood Bank Screening; Clinical Chemistry; Coagulation; Hematology; Histology; Immunoassay Infectious Disease; Immunoassay Other; Microbiology ID/AST; Microbiology Molecular; POC Diabetes; POC Other; Others)
Table 3-23: Total Midyear Population, by Broad Age Group: China, 2010-2050 (million persons)
Clinical Laboratory Market in China
IVD Distribution in China
India: Population and Opportunity
Table 3-24: India IVD Market, Share by Segment, 2024 (%) (Clinical Chemistry, Hematology, Coagulation; Histology; Immunoassay; Microbiology; POC Glucose; POC Other; Others)
Clinical Laboratory Market in India
IVD Regulation
Rest of Asia
Table 3-25: Asia Pacific IVD Market, by Country, 2024 ($ million) (Australia; India; Indonesia; Malaysia; Philippines; Singapore; South Korea; Thailand; Vietnam)
Brazil
Table 3-26: Brazil IVD Market, by Broad Segment, 2024 (%) (Clinical Chemistry, Hematology, Coagulation; Histology; Immunoassays; Microbiology; POC Glucose; POC Other; Others)
Disease Trends
Clinical Laboratory Market in Brazil
IVD Regulation
Mexico
Table 3-27: Mexico IVD Market, by Broad Segment, 2024 (%) (Clinical Chemistry, Histology, Immunoassay, Microbiology, POC Diabetes, POC Other, Others)
The Russian Federation
Canada
Emerging Markets
Saudi Arabia IVD Market
South Africa IVD Market
South Korea IVD Market
Turkey IVD Market
United Arab Emirates (UAE) IVD Market
Other Markets to Watch
IVD Market Opportunity by Country
Table 3-28: IVD Market Opportunity, by Country (2023 Market Rank, Country CAGR 2024-2029) (%) (Argentina; Australia; Austria; Belarus; Belgium; Brazil; Bulgaria; Canada; Chile; China; Colombia; Croatia; Czech Republic; Denmark; Egypt; Finland; France; Germany; Greece; Hungary; India; Indonesia; Iran; Iraq; Ireland; Israel; Italy; Japan; Jordan; Luxembourg; Malaysia; Mexico; Netherlands; Norway; Peru; Philippines; Poland; Portugal; Romania; Russia; Saudi Arabia; Singapore; Slovakia; Slovenia; South Africa; South Korea; Spain; Sweden; Switzerland; Thailand; Turkey; U.S.; Ukraine; United Arab Emirates; United Kingdom; Venezuela; Vietnam)
Figure 3-8: IVD Market Opportunity, Top 20 Markets, by Country Market Value and Country CAGR, 2024 and 2029 ($ million) (%)
Chapter 4: Company and Industry Trends
Introduction
Advanced Medicine Without Borders
Table 4-1: Key Emerging IVD Markets, 2019-2024 ($ million) (Brazil; China; Mexico; Russia; South Korea; Turkey; Vietnam)
China Market Information
Direct to Consumer Genetic Test Services
Future Trends
Gene Editing
Table 4-2: Selected Gene Editing / CRISPR Innovations
CRISPR as a Diagnostic Tool
CRISPR and the Food Industry
Microbiome
Table 4-3: Selected Microbiome Test Innovations
Next Generation Sequencing
Table 4-4: Selected Clinical NGS Platforms on the Market
Liquid Biopsy
Quality Assurance
Product News
Market Cleared Products
Liquid Biopsy in Microbiology
Liquid Biopsy Companies in 2021-2024
The Future for Liquid Biopsy
Information Technology Advances and Artificial Intelligence
AI in Clinical Practice
Table 4-5: Selected AI Market Cleared Tests
The Regulatory Pathway
Product Initiatives
Table 4-6: Selected AI Product Initiatives in Development and Collaborations
AI in Liquid Biopsy
Table 4-7: Selected AI/Liquid Biopsy Initiatives
Future Trends
Exosome Sequencing
Biotin Interference in Immunoassay Detection Errors
Table 4-8: Biotin-free Offerings Currently on the Market
Table 4-9: Biotin Interference with Troponin Lab Tests - Assays Subject to Biotin Interference
Traumatic Brain Injury and IVD
Personalized Medicine
Companion Diagnostics
Table 4-10: FDA Approved Companion Diagnostics 2024
Telehealth
Telehealth eMed to Implement Home Test to Treat Program
Blockchain
Substance Abuse
Opioid Epidemic
COVID-19 and Substance Abuse
Biomarkers and Substance Abuse
Clinical Laboratory Testing for Drugs of Abuse
Table 4-11: Global Drug Abuse Statistics
Urine
Blood
Oral
Hair
Table 4-12: Selected Opioid Test FDA Approvals
Saliva Testing
Breath Test Advances
Table 4-13: Selected Disease Markers in Exhaled Breath
Micro-Hospital Opportunities
Climate Change and Infectious Disease
Kickback Schemes
Early Sepsis Detection
Staffing Shortages
Chapter 5: Point-of-Care (POC) Tests
Overview and Trends
POC Industry Drivers
Patient focused drivers
Medical/Healthcare related drivers
Technology drivers
Economic drivers
Other drivers
POC Industry Challenges
Regulatory Challenges
Professional POC
Table 5-1: Worldwide Professional POC Test Sales, by Category, 2024 -2029 ($ million) (Cardiac Markers; Cholesterol; Coagulation; Critical Care POC; Drugs of Abuse; Fecal Occult Blood; Fertility; Glucose; HbA1c POC; Hematology; Infectious Diseases; Urinalysis; Others)
Table 5-2: Selected Professional POC Test Innovations (excluding COVID-19 testing)
OTC Self Testing
Table 5-3: Worldwide POC Self-Test Sales, by Category, 2024-2029 ($ million) (Cholesterol; Coagulation; Drugs of Abuse; Fecal Occult Blood; Glucose, Continuous; Glucose, Self; H. pylori; HIV; Other [TSH, Allergy, Autoimmune, etc.]; Other Infectious Disease [inc. COVID-19]; Pregnancy; Urinalysis)
Home Collection Trend
Table 5-4: Worldwide Home Collection Test Kit Market, by Category, 2022* Table 5-5: Selected Molecular Tests EUAs for Home Collection SARS-CoV-2 Tests
Pregnancy/Fertility Tests
Table 5-6: POC Pregnancy and Fertility Test Market Distribution, by End User, 2024 (%) (OTC, PRO)
Table 5-7: Pregnancy/Fertility POC Test Sales Distribution, by Global Region, 2024 (%) (Europe; Japan; United States; RoW)
Colon Cancer Screening
Table 5-8: Selected POC Colon Cancer Tests
Table 5-9: Colon Cancer POC Test Sales Distribution, by Global Region, 2024 (%) (Europe; Japan; United States; RoW)
Lipid Testing
Table 5-10: Lipid POC Test Sales Distribution, by Global Region, 2024 (%) (Europe; Japan; United States; RoW)
Drugs of Abuse Testing
Table 5-11: POC Drugs of Abuse Test Sales Distribution, by Setting, 2024 (%) (Criminal Justice; Critical Care - Traditional POC; Employment Screening)
Products
Table 5-12: Drugs of Abuse Tests on the Market
Rapid and POC Infectious Disease Testing
Table 5-13: Innovations in Molecular POC Infectious Disease Diagnostics
Products
HIV and Hepatitis Testing and Monitoring
Tuberculosis
Tropical and Neglected Diseases
Respiratory Diseases
Sepsis and Nosocomial Disease
Sexual Health
Lyme Disease
Table 5-14: Innovations in Molecular POC Infectious Disease Diagnostics
COVID-19
Table 5-15: Selected Antigen POC Home Immunoassay Tests for SARS-CoV-2
Market Size and Growth
Table 5-16: Infectious Disease POC Test Demand, by Type, 2024 (C.difficile; COVID-19; E.coli; H.pylori; Hepatitis; HIV; Home Test/OTC; Influenza; Malaria; Other respiratory; STD; Others)
Table 5-17: Infectious Disease POC Test Sales Distribution, by Global Region, 2024 (%) (Europe; Japan; United States; RoW)
Diabetes Testing - Blood Glucose Monitoring
Table 5-18: Glucose POC Test Sales Distribution, by Global Region, 2024 (%) (Europe; Japan; United States; RoW)
Figure 5-1: POC Glucose Testing Market Growth, by Category, 2024-2029 (%)
IT to Aid Diabetes Management
Table 5-19: Selected Apps and Glucose Management IT
Diabetes Market Analysis
Table 5-20: Global Diabetes Sales, by Test Category, 2024-2029 ($ million) (Glucose OTC; Glucose, continuous; HbA1c Lab; HbA1c POC)
POC Glucose Competitors
Table 5-21: POC Test Revenues of Selected IVD Glucose Companies, 2024 ($ million, estimated)
Blood Glucose Self-Testing
Table 5-22: Selected Glucose Self-Test Meter Innovations
Noninvasive Testing Devices
Table 5-23: Selected Noninvasive Glucose Monitoring Devices
Continuous Glucose Monitoring
Table 5-24: Selected Continuous Blood Glucose System Developments
Blood Glucose Testing by Professionals
Table 5-25: Selected Innovations in Hospital-based Glucose Monitoring
Diabetes Testing - Glycated Hemoglobin
Table 5-26: Global HbA1c Test Sales Market and Distribution, by Setting, 2024-2029 ($ million) (HbA1c Lab; HbA1c POC)
Table 5-27: Selected POC HbA1c Devices
Genes and Other Markers of Diabetes
Table 5-28: Selected POC Diabetes Monitoring Tests
The Major POC Test Players
Table 5-29: POC Test Revenues of Selected IVD Companies, 2024 ($ million, estimated)
Chapter 6: The Core Lab
Core Lab Overview and Trends
Table 6-1: Selected Analytes for the Core Lab
Connectivity
Overview of Chemistry Tests
Lab Automation
Market Analysis
Table 6-2: Global Clinical Chemistry Sales, by Test Category, 2024-2029 ($ million) (Blood Gases, General Chemistries, Urinalysis)
Table 6-3: Global Clinical Chemistry Sales Distribution, by Region, 2024 (Asia Pacific; Europe; North America; RoW)
Table 6-4: Selected Major Clinical Chemistry Companies, by Sales, 2024 ($ million, estimated) (Blood gas/electrolyte, general chemistries, UA)
Table 6-5: Selected Clinical Chemistry Innovations
Rapid Response Systems
Table 6-6: Selected Major Whole Blood Chemistry Analyzers
Critical Care Analysis
Table 6-7: Blood Gas, Electrolyte and Critical Care Instrument Market, by End User, 2024 and 2029 ($ million) (Lab-based; POC-based)
Table 6-8: Blood Gas, Electrolyte, and Critical Care Market Leaders including POC, 2024 (percent distribution of total sales)
Urinalysis
Table 6-9: UA Market by End User, 2024 and 2029 ($ million) (Lab-based, POC-based)
Table 6-10: Urinalysis Systems (including POC) Market Leaders, 2023 (percent distribution of total sales) estimated
Table 6-11: Selected Urinalysis Innovations
The Commercial Outlook for Chemistry Tests
Chapter 7: Immunoassays
Overview and Trends
Immunoassay Technology Continues to Evolve
Table 7-1: Selected Immunoassay Technologies
Mass Spectrometry
Table 7-2: Selected Innovation in Mass Spectrometry for Routine Analyses
Radioimmunoassays
Market Analysis
Leading Suppliers and Growth Potential
Table 7-3: Global Lab-based Immunoassay (excluding infectious disease and blood screening) Sales, by Analyte Type, 2024-2029 ($ million) (Allergy; Anemia; Autoimmune; Cardiac Markers; Diabetes/HbA1c; Drug of Abuse; Fertility; Proteins; Therapeutic Drugs; Thyroid; Tumor Markers; Vitamin D; Others)
Table 7-4: Global Immunoassay (excluding infectious disease and blood screening) Sales Distribution, by Region, 2024 (%) (Asia Pacific, Europe, Japan, North America, RoW)
Table 7-5: IVD Quality Control Market, 2024 ($ million, estimated)
Table 7-6: Selected Immunoassay Quality Control Products
Table 7-7: Revenues of Leading Lab-based Immunoassay Vendors, 2023-2024 ($ million, estimated)
Mature Assay Segment
Thyroid Function
Therapeutic Drug Monitoring
Vitamin D
Table 7-8: Selected Vitamin D Immunoassays
Anemia
Toxicology/DAU
Allergy
Maturing Immunoassays
Proteins
Growth Immunoassays
Tumor Markers
Table 7-9: Selected Tumor Marker Innovations
Cardiac Markers
Table 7-10: Selected Cardiac Marker Innovations
Autoimmune
Table 7-11: Selected Autoimmune Test Innovations
Rheumatoid Arthritis
Table 7-12: Selected Arthritis Immunoassay Innovations
Gastrointestinal Disorders
Table 7-13: Selected Inflammatory Bowel Disease Test Innovations
Transplant Management
Table 7-14: Selected Immunoassays for Transplant Medicine
Women's Health
Table 7-15: Selected Women's Health Innovations
Alzheimer's Disease
Table 7-16: Selected Innovations for Alzheimer's Disease Immunoassays
Traumatic Brain Injury
Sleep Apnea
Miscellaneous
Table 7-17: Selected Immunoassay Innovations
Point-of-Care OTC and Professional Use Immunoassays
Table 7-18: Global POC Immunoassay Sales Distribution, by Region, 2024 (%) (Europe; Japan; United States; RoW)
Table 7-19: Global POC Immunoassay Test Sales, by Test Category, 2024-2029 ($ million) (OTC/Self Tests [Pregnancy/Ovulation; Drugs of Abuse; HIV; H. pylori; Infectious Disease/COVID-19; Other] and Professional POC [Cardiac Markers; Drugs of Abuse; HbA1c; Pregnancy; Infectious Disease/COVID-19; Other])
Table 7-20: Selected Self-Test Immunoassay Innovations
Pregnancy Testing
Cardiovascular Diagnostics
Drugs of Abuse/Therapeutic Drug Monitoring
Innovating POC
Table 7-21: Selected POC Test Innovations
Table 7-22: Selected POC Immunoassay Test Platforms
The Commercial Outlook for Immunoassays
Chapter 8: Molecular Assays
Overview
Table 8-1: Common Next Generation Molecular Test Traits
Sample Preparation and Quality Control
Table 8-2: Selected Molecular Test Sample Preparation and QC Innovations
Molecular Evolution
Exosome Sequencing
Table 8-3: Selected Exosome Test Innovations
Liquid Biopsy
Table 8-4: Selected Liquid Biopsy Innovations
Metabolomic Profiling
Information Technology
Table 8-5: Selected IT Innovations in Molecular Diagnostics
Artificial Intelligence (AI)
Forensic Studies - An Emerging Opportunity
Table 8-6: Selected Innovations in Forensic DNA Testing
Test Platforms
Table 8-7: Key Molecular Technologies and Major Players
Table 8-8: Selected Molecular Test Platform Innovations
Major Players
Table 8-9: Molecular Test Revenues of Selected IVD Vendors, 2019-2023, 2024 estimated ($ million)
Market Analysis
Table 8-10: Global Genomic, HLA and Oncology Molecular Test Sales, by Type with NIPT, 2024-2029 ($ million)
Oncology
Table 8-11: Global Molecular Cancer Test Sales Distribution, by Region, 2024 (%) (Asia Pacific, Europe, North America, RoW)
Table 8-12: Selected Molecular Tumor Marker Test Innovations
Inherited Diseases and Thrombophilia SNPs
Table 8-13: Most Frequently Requested Genetic Tests
Table 8-14: Global Molecular Thrombophilia Assay Sales Distribution, by Region, 2024 (%) (Asia Pacific; Europe; North America; RoW)
Table 8-15: Selected Genomic Tests for Inherited Diseases
Depression and Psychiatric Disorders
Prenatal and Newborn Testing
Table 8-16: Global Prenatal Test Sales Distribution, by Region, 2024 (%) (Asia Pacific; Europe; North America; RoW)
Table 8-17: Selected Prenatal Services Provided
Table 8-18: Selected Molecular Tests for Prenatal Analysis
Transplant Diagnostics
Table 8-19: Global Molecular HLA Testing Sales Distribution, by Region, 2024 (%) (Asia Pacific; Europe; North America; RoW)
Table 8-20: Selected Innovations of Molecular Transplant Diagnostics
The Commercial Outlook for Molecular Tests
Chapter 9: Hematology
Overview of Hematology and Trends
Table 9-1: Hematology Analyzer Distribution of Sales by Menu Capability, 2024 estimated
Table 9-2: Lab-based Hematology Sales by Analyte Average Annual Distribution (%)
Digital Image Analysis
Table 9-3: Selected Hematology Image Analysis Innovations
Digital Evolution
Quality Control Measurement Programs
Table 9-4: Selected Quality Control Hematology FDA Registrations, 2024
Laboratory-based Hematology Testing
Table 9-5: Selected Hematology Innovations
Table 9-6: Global Laboratory-based Hematology Test and Instrument Market, 2024 and 2029 ($ million)
Regional Laboratory-based Hematology Test and Instrument Market
Table 9-7: Global Laboratory-based Hematology Test and Instrument Market, by Region, 2024 (Asia Pacific; Europe; North America; RoW)
Decentralized Hematology Testing
Hemoglobin/Hematocrit at the POC
Table 9-8: POC Hematology Distribution, by Specialty, 2024 (%) (Hematocrit/Hemoglobin vs. Other Routine Hematology (WBC, Erythrocyte, Platelet)
Table 9-9: Selected POC Hemoglobin and Hematocrit Systems
Table 9-10: Selected POC Hematology Analyzer Systems
Table 9-11: Decentralized Hematology Test and Instrument Market, by Type, 2024 and 2029 ($ million) (Instruments, Lab-Style; Handheld Devices)
Market Analysis: Leading Suppliers
Table 9-12: Top Hematology Company Revenues (Laboratory and POC), 2024 ($ million)
Table 9-13: Global Hematology (Laboratory-based and POC) Sales Distribution, by Region, 2024 (Asia Pacific; Europe; North America; RoW)
The Commercial Outlook for Hematology Tests
Chapter 10: Coagulation
Overview and Trends of Coagulation and Immunohematology Tests
Special Topics
COVID-19
Direct Oral Anticoagulants (DOACs)
Table 10-1: Select Major Anticoagulant Sales ($ billion)
D-dimer
Table 10-2: Global D-dimer Sales Distribution, by Region, 2024 (%) (Asia Pacific; Europe; North America; RoW)
Market Analysis
Table 10-3: Global Coagulation Sales, by Segment, 2024-2029 ($ million) (D-dimer; Molecular; Professional POC; Professional Self; PT/INR Labs)
Table 10-4: Global Coagulation Test and Instrument Market, by Region, 2024 (%) (Asia Pacific; Europe; North America; RoW)
Lab-based Testing
Table 10-5: Selected Lab-based Coagulation Innovations
Genetic Markers of Hypercoagulopathies
Table 10-6: Related CMS Codes for Reimbursement National Limits, Molecular, 2023
Table 10-7: Global Molecular - Thrombophilia SNP Sales Distribution, by Region, 2024 (%) (Asia Pacific; Europe; North America; RoW)
Table 10-8: Selected Molecular Coagulation Test Innovations
Leading Suppliers: Laboratory Systems
Table 10-9: Top Coagulation Company Revenues, Laboratory-based, 2024 ($ million, estimated)
Decentralized Coagulation Testing - Professional Use
Decentralized Coagulation Testing - OTC
Table 10-10: Selected POC Coagulation Test Innovations
Platelet Testing
Table 10-11: Selected Platelet Activity Test Innovations
Leading Suppliers: POC Systems
Table 10-12: Top Coagulation Company Revenues, POC, 2024 ($ million, estimated)
The Commercial Market for Coagulation Tests
Table 10-13: Major Anticoagulants Uses and Tests
Chapter 11: Microbiology and Virology
The Real Impact of Infections
Herpes and Alzheimer's Disease
Ebola and Cancer
HIV and Cancer
H pylori and Cancer
Bacteria and Parkinson's
HPV and Cancer
Microbial Antibiotic Resistance - The Role of Clinical Tests
Fast Identification
Table 11-1: Selected Companies Developing Faster Identification, Some Also with Antimicrobial Susceptibility/Resistance Tests
Traditional Microbiology and Its Limits
The New Microbiology - Innovations
Liquid Based Microbiology and Automation Innovations
Post-Blood Culture Microbial ID
PCR and Other NAAT-Based Tests for Infectious Diseases
Table 11-2: Selected Nucleic Acid Amplification Test and Other Molecular Companies in Microbiology
Microbiome-Related Microbiology Tests
Illumina
Bio-Rad
QIAGEN
Luminex (DiaSorin)
inBiome BV
DNA Genotek
Abbott
Thermo Fisher Scientific
Table 11-3: Selected Microbiome-Based Tests
Next Generation Sequencing-Based Microbiology Approaches
Table 11-4: Selected Companies Applying DNA/RNA Sequencing to Microbiology
Syndromic/Multiplex Testing
New Infectious Disease Threats
Table 11-5: Selected Companies Marketing Products Addressing Emerging Infectious Disease Threats
Tickborne Diseases (TBDs)
Zika
Chagas
Dengue
Ebola
Chikungunya
Middle East Respiratory Syndrome-Coronavirus (MERS-CoV)
Marburg
SARS-CoV-2 (COVID-19)
Monkeypox
Market Analysis
Table 11-6: Global Microbiology Sales Distribution, by Region, 2024 (%) (Asia Pacific; Europe; North America; RoW)
Market Analysis - Traditional Microbiology ID/AST
Table 11-7: Global Microbiology ID/AST Market, by Segment, 2024-2029 ($ million) (Blood Culture; Chromogenic Media; ID/AST Auto; ID/AST Panels; Rapid Microbiology)
Table 11-8: Global ID/AST Testing Sales Distribution, by Region, 2024 (%) (Asia Pacific; Europe; North America; RoW)
Traditional ID/AST
Table 11-9: Global ID/AST Testing, Distribution by Systems, (%) (Panel, Auto)
Blood Culture
Table 11-10: Selected Advanced Techniques in Positive Blood Culture
Chromogenic Media
Rapid Tests Performed on Colonies from Culture Media
Supplies
Market Analysis - Microbiology Immunoassays
Improvements in Microbiology Immunoassays
Table 11-11: Selected Infectious Disease Immunoassay Innovations
Table 11-12: Global Clinical Laboratory-Based Microbiology/Infectious Disease Immunoassay Market, by Pathogen, 2024 ($ million, estimated) (COVID-19; HAIs/Sepsis; Hepatitis; HIV; Lyme Disease; Mycology; Parasitology; Respiratory; STDs; ToRCH; Other)
Table 11-13: Global Laboratory-Based Microbiology/Infectious Disease Immunoassay Market Distribution, by Region, 2024 (%) (Asia Pacific; Europe; North America; RoW)
Hepatitis Testing
Sepsis
Figure 11-1: Global Lab-based Microbiology Immunoassay Sepsis Market Distribution, by Type, 2024 (PCT, Traditional)
HIV Immunoassay Testing
Table 11-15: Selected HIV Assays
Sexually Transmitted Diseases (STDs)
ToRCH
Lyme Disease
TBD-Serochip (Roche associated)
Rapid Immunoassay Tests
Table 11-16: Global Rapid Immunoassay Testing Market, Sales Distribution by Pathogen, 2024 (%) (C.Difficile; COVID-19; E.coli; H.pylori; Hepatitis; HIV; Influenza; Malaria; Other respiratory; STD; Other)
Market Analysis - Molecular Microbiology
Table 11-17: Global Molecular Microbiology Sales Distribution by Region, 2024 (%) (North America, Europe, Asia Pacific, RoW)
Table 11-18: Global Molecular Microbiology Market, by Pathogen/Disease Indication, 2024-2029 ($ million) (COVID-19; GC/Chlamydia; HAI; Hepatitis; HIV; Mycobacteria/TB; Organism ID; Respiratory; Others)
Lab Automation and Molecular Diagnostics
Table 11-19: Selected Automated Molecular Test Instrument Platforms
Molecular Respiratory Infection Testing
The Respiratory Trio - Flu, Strep, RSV
Table 11-20: Selected COVID-19, Flu, RSV Tests
Molecular Testing for Sexually Transmitted Diseases
Molecular Hepatitis Testing
Molecular HIV Testing
Table 11-21: Innovations in Molecular POC Diagnostics for HIV
Molecular Tests for Hospital-Acquired Infections (HAIs)
Table 11-22: Frequency of the Most Common Nosocomial Infections
Assessing the Problem: Nosocomial Infection Statistics
Clostridium Difficile
MRSA
Molecular TB Testing
Limitations of Molecular Microbiology Testing
Mass Spectrometry
Table 11-23: Selected Companies Marketing Mass Spectrometers and/or Assays for the Clinical Laboratory [CE-Marked and/or 510(k) cleared]
The Future Outlook for Microbiology
Chapter 12: Blood Banking Services
Overview
The Current Status of Global Blood Collection
Global Blood Safety
Table 12-1: Laboratory Screening of Blood Donations for Transfusion-Transmissible Infections, Number of Countries (Chagas; HBV; HCV; HIV; HTLV I/II1; Malaria; Syphilis)
Table 12-2: Prevalence of TTIs in Blood Donations [Median (Interquartile range)], by Income Group
Zika Virus
Blood and Component Collection
Table 12-3: Blood Component Usage for Selected Conditions
Reevaluating Blood Transfusions
Table 12-4: Impact of Alloimmunization (% of Patients Screening Positive for One or More Antibodies)
Blood Typing and Grouping Market
Manual Blood Typing Methods
Automated Blood Typing and Screening Methods
Molecular Methods
Table 12-5: Selected Blood Typing and Grouping Innovations
Size and Growth of Typing Markets
Table 12-6: Global Blood Typing Market, 2024-2029 ($ million)
Blood Typing Market by Geography
Table 12-7: Global Blood Typing Sales Distribution, by Region, 2024 (%) (Asia Pacific; Europe; North America; RoW)
Blood Testing Market
Table 12-8: Selected Blood Testing Innovations
Preventing Bacterial Infections
Immunoassays
Nucleic Acid Testing (NAT)
Size and Growth of the Market
Table 12-9: Global Blood Banking Diagnostics Market, 2024-2029 ($ million) (Immunoassay Screen; NAT Screens)
Blood Testing Market by Geography
Table 12-10: Global Blood Testing Market, by Geography, 2024 (%) (Asia Pacific; Europe; North America; RoW)
The Commercial Outlook for Blood Banking Testing
Chapter 13: Histology and Cytology
Overview
Special Topics
Histology Automation
Table 13-1: Selected Histology Lab Automation
Table 13-2: Histology Information Technology Tools
Advanced Analysis Solutions
Table 13-3: Selected Advanced Histology Techniques
HPV meets Core Lab
Table 13-4: Global HPV Test Sales Distribution, by Region, 2024 (%) (Asia Pacific; Europe; North America; RoW)
Table 13-5: Selected HPV Test Innovations
Market Analysis
Total Market
Table 13-6: Global Histology/Cytology Sales by Type, 2024-2029 ($ million) (HPV; Immunohistochemistry; in situ hybridization; Pap Tests; traditional non-Pap stains)
Regional Market Analysis
Table 13-7: Global Histology/Cytology Sales Distribution, by Region, 2024 (%) (Asia Pacific; Europe; North America; RoW)
Table 13-8: Revenues of the Major Histology Companies, 2018-2024 ($ million, estimated)
Traditional Stains
Table 13-9: Selected Vendors of Traditional Histology Stains
Pap Testing
Table 13-10: Primary and Secondary Prevention of Cervical Cancer, Screening Responses, by Country, 2021
Immunohistochemistry and In Situ Hybridization
Table 13-11: Selected In Situ Hybridization-based Tests
Table 13-12: Selected IHC Test Innovations
Pharmacodiagnostic Histology
Table 13-13: Major Pharmacodiagnostic Markers
Table 13-14: Selected Pharmacodiagnostic Histology Tests
Digital Imaging and Computational Pathology
Table 13-15: Selected Digital Pathology Image Capture and Viewing Solutions
COVID-19 and Digital Pathology
Table 13-16: Selected Digital Imaging Innovations
Circulating Tumor Cells
Table 13-17: Selected Innovations in CTC Technology
Flow Cytometry
The Commercial Outlook for Histology and Cytology Tests
Chapter 14: Company Profiles: The Top Tier
Abbott Diagnostics
Table 14-1: Abbott Diagnostics Revenue History, 2017-2023 ($ million)
Table 14-2: Abbott Diagnostic Revenues, by Segment, 2017-2023 ($ million, estimated)
Core Lab
Hematology
Blood Banking
Infectious Diseases - Molecular
Diabetes
HIV Point of Care
i-STAT Business
Companion Diagnostic Testing
Liquid Biopsy
COVID-19
Agilent Technologies
Table 14-3: Agilent Revenue History Diagnostics and Genomics, 2017-2023 ($ million)
Genomics
Cytogenetic Analysis
Sequencing
CRISPR
Flow Cytometry
Companion Diagnostics - Dako
COVID-19
Beckman Coulter / Danaher
Table 14-4: Beckman Coulter Revenue History, 2017-2023 ($ million, estimated)
Table 14-5: Beckman Coulter Diagnostic Revenues, by Segment, 2019-2023 ($ million, estimated)
Hematology
Hematology IT
Clinical Chemistry
Immunoassays
Microbiology
IT Clinical
Flow Cytometry
Blood Banking
Beckman Coulter Life Sciences
COVID-19
Becton, Dickinson and Company (BD)
Table 14-6: BD Clinical Diagnostic Systems Revenue History, 2017-2023 ($ million, estimated) FYE Sept 30
Table 14-7: BD Clinical Flow Cytometry Revenues, 2017-2023 ($ million, estimated)
Cytology
Molecular Microbiology
Traditional Microbiology - ID/AST
Blood Culture
Hospital Acquired Infections
Blood Collection
Mass Spectrometry
Flow Cytometry
COVID-19
bioMerieux Inc.
Table 14-8: bioMerieux Revenue History, 2017-2023 ($ million)
Table 14-9: bioMerieux Diagnostic Revenues, by Segment, 2017-2023 ($ million)
Traditional Microbiology
Blood Culture
Immunoassays
Mass Spectrometry
BIOFIRE Diagnostics Business
Expansion
COVID-19
Bio-Rad Laboratories, Inc.
Table 14-10: Bio-Rad Revenue History, 2017-2023 ($ million, estimated)
Table 14-11: Bio-Rad Diagnostic Revenues, by Segment, 2017-2023 ($ million, estimated)
Quality Control
Blood Bank
Diabetes
Immunoassays
Liquid Biopsy
Droplet Digital PCR
Sequencing
COVID-19
Bruker Corporation
Table 14-12: Bruker Revenue History Product Revenue, 2017-2023 ($ million)
Acquisitions and Collaborations
Mass Spectrometry
Microbiology
Molecular PCR
COVID-19
Cepheid / Danaher
Table 14-13: Cepheid Revenue History, Clinical Product Sales, 2017-2023 ($ million)
GeneXpert/ Xpress Line
Tuberculosis
Microbiology
POC Testing
Cancer
COVID-19
Danaher Corporation
Table 14-14: Danaher Revenue History, Diagnostics Segment, 2017-2023 ($ million, estimated)
Acquisitions
Dexcom
Table 14-15: Dexcom Revenue History, 2017-2023 ($ million)
DiaSorin S.p.A
Table 14-16: DiaSorin Revenue History, 2017-2023 ($ million)
Development Plan
Expansion
Immunoassays
Molecular
Molecular Oncology
COVID-19
Exact Sciences
Table 14-17: Exact Sciences Revenue History, 2017-2023 ($ million)
COVID-19
Hologic, Inc.
Table 14-18: Hologic Revenue History, Diagnostic Product Revenue, 2017-2023 ($ million, estimated)
Table 14-19: Hologic Diagnostic Revenues, by Segment, 2017-2023 ($ million)
Acquisitions
PANTHER Molecular System
HIV Testing
Sexually Transmitted Infections
Infectious Diseases
Panther Fusion
Cytology
COVID-19
Illumina
Table 14-20: Illumina Revenue History, 2017-2023 ($ million, not all revenues are for clinical products and services; estimated)
Table 14-21: Illumina Diagnostic Revenues, by Segment ($ million, estimated)
China
COVID-19
Instrumentation Laboratory (IL) / Werfen
Expansion
Coagulation
Acute Care
Information Technology
Leica Biosystems/Danaher
Table 14-22: Leica Revenue History, 2017-2023 ($ million, estimated)
Digital Pathology
Companion Diagnostics
Stain Reagents
Lab Systems
Sample Handling
Circulating Tumor Cells (CTCs)
Artificial Intelligence
COVID-19
Natera
Table 14-23: Natera Revenue History, 2017-2023 ($ million)
QuidelOrtho Corporation
Table 14-24: QuidelOrtho Revenue History, 2018-2023 ($ million)
Table 14-25: QuidelOrtho Diagnostic Revenues, by Segment, 2020-2023 ($ million, estimated)
Immunoassays
Rapid Immunoassays
The Solana Business
Molecular - Savanna
Blood Bank
COVID-19
Radiometer A/S / Danaher
Table 14-26: Radiometer A/S Revenue History, 2017-2023 (estimated, $ million)
Critical Care
Immunoassays
HemoCue
Transcutaneous Monitoring
Revvity
Table 14-27: Revvity Revenue History, 2021-2023 ($ million, estimated)
Table 14-28: Revvity Diagnostic Revenues, by Segment, 2021-2023 ($ million, estimated)
COVID-19
Roche Diagnostics
Table 14-29: Roche Revenue History, 2017-2023 ($ million)
Table 14-30: Roche Diagnostic Revenues, by Segment ($ million, estimated)
Hematology
Immunoassays
HIV
Molecular Expansion
Core Molecular
Digital PCR
Diabetes Care
Coagulation
cobas Liat System - POC
HPV
Blood Bank
Transplant Medicine
Cancer Companion Testing
IT in Anatomical Pathology
Information Technology
Digital Pathology
COVID-19
Roche Tissue Diagnostics
Table 14-31: Ventana Medical Systems Revenue History, 2017-2023 ($ million)
Immunohistochemistry - IHC
Cervical Cancer Screening
Companion Diagnostics
Siemens Healthineers (Siemens)
Table 14-32: Siemens Healthineers Revenue History, 2017-2023 ($ million), estimated)
Table 14-33: Siemens Healthineers Diagnostic Revenues, by Segment, 2021-2023 ($ million)
Core Lab
Lab Automation
Immunoassays
Hematology
Urinalysis
Molecular
Expansion to Support Molecular Diagnostics - Fast Track Diagnostics
Sequencing with Artificial Intelligence
Acute Care - POC
POC Connectivity
Business Expansion
COVID-19
Sysmex Corporation
Table 14-34: Sysmex Revenue History, 2018-2023 ($ million) FYE March 31
Table 14-35: Sysmex Diagnostic Revenues by Segment ($ million, estimated)
Hematology
Coagulation
Urinalysis and Infectious Disease
Immunoassays
Lab Information System
Information Technology
Flow Cytometry
Precision Medicine / Companion Test Diagnostics
Liquid Biopsy
Oncology
Sysmex Inostics
Forging New Markets
COVID-19
Thermo Fisher Scientific Inc.
Table 14-36: Thermo Fisher Revenue History, Clinical Diagnostics, 2017-2023 ($ million)
Table 14-37: Thermo Fisher Scientific Diagnostic Revenues, by Segment, 2017-2023 ($ million)
Immunoassays
Microbiology
Molecular Test Business
Next Generation Sequencing
qPCR
Oncology Companion Diagnostics
Transplant Medicine
Microbiome
Mass Spectrometry
Collaborations
Gene Editing and Cell Therapy
China
COVID-19
Werfen
Table 14-38: Werfen Recent Revenue History, 2017-2023 ($ million) estimated)
Chapter 15: Company Profiles: The Second Tier
BGI Genomics (formerly Beijing Genome Institute)
Table 15-1: BGI Genomics Revenue History, 2017-2023 ($ million)
PCR and Fluorescence
MGI Tech Co., Limited, China
Prenatal Testing
Test Services
Whole Genome Sequencing (WGS)
NGS Sequencing
Collaborations
COVID-19
Biocartis
Table 15-2: Biocartis Revenue History, 2017-2023 ($ million)
COVID-19
Diagnostica Stago S.A.S.
Eiken Chemical Co., Ltd
Table 15-3: Eiken Chemical Revenue History, 2017-2023, FYE March 31 ($ million)
Product News
COVID-19
Fujirebio Diagnostics, Inc.
Table 15-4: Fujirebio Diagnostics Revenue History, 2017-2023, FYE March 31 ($ million)
Fulgent Genetics, Inc
Table 15-5: Fulgent Revenue History, 2017-2023 ($ million)
COVID-19
Grifols S.A.
Table 15-6: Grifols Revenue History, 2017-2023 ($ million)
Table 15-7: Grifols Diagnostic Revenues, by Segment, 2017-2023 ($ million)
Blood Transfusion Business
ABO Blood Typing
Molecular ABO Blood Typing
Immunoassays
Market Expansion
Self-Testing
Guardant Health, Inc.
Table 15-8: Guardant Health Revenue History, 2019-2023 ($ million)
Horiba Medical
Table 15-9: Horiba Medical Revenue History, Medical Diagnostic Sales, 2017-2023 ($ millions)
Invitae
Menarini Diagnostics
COVID-19
Meridian Bioscience, Inc.
Table 15-10: Meridian Bioscience Revenue History, 2017-2023 ($ million, estimated) FYE Sept 30
Immunoassays
Molecular Tests
COVID-19
Mindray - Shenzhen Mindray Bio-medical Electronics Co., Ltd.
Myriad Genetics, Inc.
Table 15-11: Myriad Genetics Revenue History, 2017-2023 ($ million) FYE June 30
Nihon Kohden
Table 15-12: Nihon Kohden Revenues History, 2017-2023 ($ million)
OraSure Technologies, Inc.
Table 15-13: OraSure Technologies Revenue History, 2017-2023 ($ million)
Table 15-14: OraSure Technologies Product Revenue History, by Segment, 2020-2023 ($ thousands)
COVID-19
QIAGEN
Table 15-15: QIAGEN Revenue History, 2017-2023 ($ million)
Table 15-16: QIAGEN Diagnostic Revenues, by Segment, 2017-2023 ($ million, estimated)
Tuberculosis
Molecular Expansion
Precision Medicine / Companion Diagnostics
Molecular Microbiology
Prenatal Testing
Next Generation Sequencing
Sample Prep, Informatics
Digital PCR
Liquid Biopsy
Cervical Cancer
Expansion
COVID-19
Randox Laboratories Ltd.
Clinical Chemistries
POC
Controls
Evidence Series - Multistat Biochip Analyzers
Molecular
COVID-19
Sekisui Diagnostics LLC
COVID-19
Veracyte, Inc.
Table 15-17: Veracyte Revenue History, 2017-2023 ($ million)
Chapter 16: Company Profiles: Blood Bank Specialists
AliveDx
COVID-19
Cerus Corporation
Table 16-1: Cerus Revenue History, 2017-2023 ($ million)
COVID-19
Chapter 17: Company Profiles: Core Lab and Other Companies
AB SCIEX Pte Ltd.
ARKRAY
Dry Chemistry / Immunoassays
Urinalysis
Diabetes
Molecular
EKF Diagnostics Holdings Plc
COVID-19
ELITech Group S.A.S.
COVID-19
Shimadzu Scientific Instruments
Snibe Co. Ltd., (Shenzhen New Industries Biomedical Engineering Co. Ltd.)
COVID-19
Tosoh Bioscience
COVID-19
Trinity Biotech Plc
Table 17-1: Trinity Biotech Revenue History, 2017-2023 ($ million)
COVID-19
Chapter 18: Company Profiles: CTC & Liquid Biopsy Test Providers
Biocept, Inc.
COVID-19
Biodesix
COVID-19
Epic Sciences
Epigenomics AG
Foundation Medicine, Inc.
Menarini-Silicon Biosystems
COVID-19
NeoGenomics
Chapter 19: Company Profiles: Specialists
Ascensia Diabetes Care Holdings AG
Bigfoot Biomedical Inc. (Abbott)
Debiotech SA
COVID-19
Glooko Inc.
Insulet Corporation
Table 19-1: Insulet Corp Revenue History, 2017-2023 ($ million)
Lifescan Inc.
Medtronic plc
Nemaura Medical Inc.
COVID-19
Verily Life Sciences LLC
COVID-19
Chapter 20: Company Profiles: Hematology (Cell Analysis) and Coagulation Specialists
CellaVision AB
Masimo Corporation
Table 20-1: Masimo Revenues History, 2017-2023 ($ million)
Nova Biomedical Corporation (Nova)
Chapter 21: Company Profiles: Histopathology Specialists
Amoy Diagnostics Co. Ltd.
Applied Spectral Imaging Inc. (ASI)
BioGenex Laboratories, Inc.
BioView Ltd.
Visiopharm
Chapter 22: Company Profiles: Immunoassay Specialists
Biohit Healthcare
Biomerica Inc.
Table 22-1: Biomerica Revenue History, 2017-2023 ($ million)
COVID-19
Bio-Techne Corporation
Table 22-2: Bio-Techne Revenue History, 2017-2023 ($ million)
COVID-19
Eurobio Scientific
COVID-19
EUROIMMUN AG (Revvity)
COVID-19
Immunodiagnostic Systems (IDS)
INOVA Diagnostics, Inc.
One Lambda, Inc
Response Biomedical Corp.
COVID-19
Theradiag
COVID-19
VolitionRx Limited
COVID-19
Chapter 23: Company Profiles: Microbiology Specialists
Accelerate Diagnostics, Inc.
Table 23-1: Accelerate Diagnostics Revenue History, 2017-2023 ($ thousands)
COVID-19
Advanced Biological Laboratories, S.A. (ABL)
COVID-19
altona Diagnostics
COVID-19
ArcDia International Oy Ltd.
COVID-19
BIOFIRE Diagnostics, LLC. (Acquired by bioMerieux)
COPAN ITALIA S.p.A. and COPAN Diagnostics, Inc.
COVID-19
Curetis
COVID-19
Genetic Analysis AS
COVID-19
Greiner Bio-One International GmbH
Mast Group
COVID-19
Mobidiag
COVID-19
Q-linea AB
OpGen, Inc.
COVID-19
Seegene, Inc.
COVID-19
T2 Biosystems
COVID-19
Chapter 24: Company Profiles: Molecular Test Specialists
Enzo Biochem Inc.
COVID-19
NanoString Technologies, Inc. (Bruker)
COVID-19
Pacific Biosciences of California, Inc. (PacBio)
Table 24-1: PacBio Revenue History, 2017-2023 ($ million)
COVID-19
Standard BioTools
COVID-19
Takara Bio Inc.
COVID-19
Vela Diagnostics
COVID-19
Chapter 25: Company Profiles: Point of Care Test Specialists
Abingdon Health Ltd.
COVID-19
binx Health
COVID-19
Biomeme, Inc.
COVID-19
Chembio Diagnostic Systems, Inc.
COVID-19
Co-Diagnostics, Inc.
Table 25-1: Co-diagnostics Revenue History, 2020-2023 ($ million)
Cue Health
Test to Treat
Diazyme
COVID-19
DNA Electronics Ltd (DNAe)
DxGen Corp
Genedrive plc (formerly Epistem Holdings)
COVID-19
Immunostics, Inc.
COVID-19
MedMira, Inc.
COVID-19
QuantuMDx Group, Ltd.
COVID-19
Rheonix, Inc.
COVID-19
Chapter 26: Company Profiles: Prenatal Test Service Providers
Berry Genomics Co. ltd.
CooperGenomics (Division of CooperSurgical)
INEX Innovate
COVID-19
Oxford Gene Technology
Yourgene Health
COVID-19
Chapter 27: Company Profiles: Quality Control & Sample Pretreatment Specialists
10x Genomics
Agena Bioscience, Inc.
COVID-19
Biotype Diagnostic GmbH
COVID-19
DxTerity Diagnostics Inc.
COVID-19
Horizon Discovery Group plc
IncellDx
LGC SeraCare Life Sciences, Inc.
COVID-19
PreAnalytiX GmbH
Precipio, Inc.
COVID-19
Quanterix Corporation
COVID-19
Streck Inc.
Chapter 28: Test Service Providers
23andMe
Agendia BV
Ambry Genetics
COVID-19
ARUP Laboratories
COVID-19
Aspira Women's Health
Table 28-1: Aspira Women's Health Revenue History, 2017-2023 ($ million)
BioReference Laboratories
COVID-19
Biotheranostics
BluePrint Genetics Oy
Boston Heart Diagnostics
CareDx, Inc.
Table 28-2: CareDx Revenue History, 2017-2023 ($ in thousands)
Predictive Oncology
Labcorp, Laboratory Corporation of America
Table 28-3: Labcorp Revenue History, 2017-2023 ($ million)
COVID-19
Mayo Clinic Laboratories
MDxHealth SA
Table 28-4: MDxHealth Revenue History, 2017-2023 ($ million)
OPKO Diagnostics
Table 28-5: OPKO Diagnostics Revenue History, 2017-2023 ($ million)
COVID-19
Quest Diagnostics
Table 28-6: Quest Diagnostics Revenue History, 2017-2023 ($ million)
Diagnostic Services
Oncology
Infectious Diseases
Prenatal and Women's Health
Retail / Consumer Health
Expansion
COVID-19
Sonic Healthcare
