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*, 2023 and estimated 2024 ($ million)
- Figure 2-4: Top 10 IVD Companies*, Clinical Diagnostic Revenues, 2023 ($ billion)
- Figure 2-5: Top 10 IVD Companies*, Clinical Diagnostic Revenues, Estimated 2024 ($ billion)
- Roche Diagnostics
- *Roche Tissue Diagnostics
- Abbott Diagnostics
- Danaher Corporation
- *Cepheid
- *Radiometer
- *Beckman Coulter
- Siemens Healthineers
- Thermo Fisher Scientific
- Dexcom
- Illumina
- Becton Dickinson & Co
- bioMerieux
- Exact Sciences
- Sysmex Corporation
- QuidelOrtho Corporation
- Werfen
- *Instrumentation Laboratory
- *Inova Diagnostics
- 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* (% Estimated Share)
- 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
