Table of Contents
Volume 3, Issue 1 – Focus on Molecular HLA Testing
Market Analysis: Molecular HLA/Transplant Testing
Overview of Molecular HLA/Transplant Testing
Market Outlook
Regional Market
Top Company Briefs
Immucor
Luminex/DiaSorin
CareDx
Thermo Fisher Scientific
Executive News Briefing
DEKFI Diagnostics Appoint New CEO
Onera Raises $32 Million in Funding
Cleveland Diagnostics Completes $75 Million in Funding
Financial Highlights: Agilent and Hologic
Agilent Full Year Fiscal 2023 Sales up 1.5% in Core Business YOY
- Figure: Agilent Sales, by Business (Agilent CrossLab Group, Diagnostics and Genomics Group, Life Sciences and Applied Markets Group), FY 2022 and FY 2023
- Figure: Agilent Sales, by Business (Agilent CrossLab Group, Diagnostics and Genomics Group, Life Sciences and Applied Markets Group), FY 2023 Quarterly Performance
- Table: Agilent Revenue Mix, by Type (Consumables/Services/Informatics and Instruments), FY 2023 (%)
- Figure: Agilent FY 2023 Regional Sales Breakdown Distribution, by Region (Americas, Asia Pacific, Europe) (%)
Hologic Supports Strong Financial Performance in Full-Year Fiscal Year Guidance
- Table: Hologic Diagnostic Sales Performance, by Product Group (Blood Screening, Cytology & Perinatal, Molecular Diagnostics), FY 2023 ($ millions)
- Figure: Hologic Revenue, by Product Group (Blood Screening, Cytology & Perinatal, Molecular Diagnostics), FY 2022 and FY 2023 ($ millions)
- Figure: Hologic Geographic Revenue Distribution, by Region (Asia Pacific, Europe, United States, All Others), FY 2023 (%)
Diagnostic Market Mergers, Acquisitions and Partnership Deals
Mergers and Acquisitions
- Table: Selected Diagnostic Market Mergers and Acquisitions Deals
Partnerships and Collaborations
Industry Watch
COVID-19 Update
Region Watch
India
- Figure: India Real GDP Growth, Inflation Rate (consumer prices), 2017-2024
- Figure: India IVD Market Distribution of Sales, by Broad IVD Segment (Chemistry/Hematology/Coagulation, Histology/Cytology, Immunoassays, Microbiology/Virology, Point-of-Care Glucose, Other Segments), 2023 (%)
Saudi Arabia
- Figure: Saudi Arabia Population Pyramid, 2023 and 2053
- Figure: Saudi Arabia Total Annual Liquid Fuels Production and Consumption, 2013-2022 (millions of barrels)
- Figure: Saudi Arabia IVD Market Share, by Broad IVD Segment (Chemistry/Hematology/Coagulation, Histology/Cytology, Immunoassays, Microbiology/Virology, Point-of-Care Glucose, Other Segments), 2023
Broad-based Company Announcements
QuidelOrtho Obtains FDA Nod
Illumina Plans to Divest Grail
Roche to Acquire LumiraDx
QIAGEN Expands Footprint with New Regional Headquarters in Middle East
Volume 3, Issue 2 – Focus on Immunoassay Overview
Market Analysis
Overview of IVD Immunoassay
Market Outlook
- Table: Global Lab-Based Immunoassay Market by Segment, 2023-2028 ($ millions)
- Figure: Global Lab-Based Immunoassay Market, by Segment, 2023-2028 ($ millions)
Regional Market
- Table: Global Immunoassay Market (Lab-Based) Sales Distribution, by Region, 2023 (%) (North America, Europe, Asia Pacific, Latin America, Middle East, Africa)
- Figure: Global Immunoassay Market Sales Distribution, Top 10 Country Markets, 2023 (%)
Top Company Briefs
Roche
Abbott Diagnostics
Siemens Healthineers
Other Selected Immunoassay News
Executive News Briefing
NOWDiagnostics Selects New Science Officer
Freenome Raises $254 Million in New Funding
QuidelOrtho Axes CEO
Agilent CEO to Retire
Financial Highlights: Bio-Rad Laboratories and Veracyte
Bio-Rad Laboratories Reports Full-Year 2023 Clinical Diagnostics Revenues up 3.2% over previous year
- Table: Bio-Rad Laboratories Net Sales, 2021-2023 ($M)
- Figure: Bio-Rad Laboratories’ Sales by Business, 2022 vs. 2023, $M
- Figure: Bio-Rad Laboratories Quarterly Performance by Business, 2022 vs. 2023 ($M)
- Figure: Bio-Rad Laboratories 2022 and 2023 Regional Sales Breakdown Distribution
Veracyte Reported Strong Performance in 2023
- Figure: Veracyte 12-Month (FY22 and FY23) Sales by Division (Testing, Product, Biopharmaceutical and Other), Thousands USD
Diagnostic Market Mergers, Acquisitions and Partnership Deals
Mergers and Acquisitions
- Table: Selected Diagnostic Market Mergers and Acquisitions Deals
Partnerships and Collaborations
Industry Watch
Virus Testing Update
Region Watch
Peru
- Figure: Peru Population Distribution by Broad Age Group, 2023 and 2040 Estimates
- Figure: Peru GDP Value and Growth by Year, 2010-2022
- Figure: Peru COVID-19 Lab Samples Tested and Positivity by Region, Cumulative 2020-2023
South Africa
- Figure: South Africa Population Pyramid, 2023 and 2033 Estimates
- Figure: South Africa GDP, Composition by Sector (Agriculture, Industry, Services)
Broad-based Company Announcements
Werfen Receives CE Mark for Aptiva Antiphospholipid Syndrome
DiaSorin Nabs FDA Clearance for New LIAISON PLEX System
T2 Biosystems Offers Expanded Panel
Cepheid Received FDA Clearance for Xpert Xpress GBS
DiaCarta Collaboration to Launch Prostate Cancer LDT
Volume 3, Issue 3 – Clinical Chemistry
Market Analysis: Clinical Chemistry
Overview of Clinical Chemistry Market
Market Outlook
- Table: Clinical Chemistry Diagnostic Sales, by Broad Test Category, 2023 ($ millions)
- Figure: Clinical Chemistry Diagnostic Market Distribution, by Broad Test Category, 2023 (%)
Major Product Activity
- Lab-based Clinical Chemistry
- Table: Market Summary: Lab-based Clinical Chemistry Market, by Segment, 2023 and 2028 ($ millions)
- Point-of-Care Clinical Chemistry
- Table: Market Summary: POC-based Clinical Chemistry Market, 2023 and 2028 ($ millions)
Regional Market
- Figure: Global Clinical Chemistry Sales Estimates and Projection, by Region, 2023 and 2028 ($ millions)
- Table: Global Clinical Chemistry Sales Distribution, by Region, 2023 (%)
Top Company Briefs
Roche
Abbott
Danaher
Executive News Briefing
Cue Health Calls It Quits
Allez Health Secures $60 Million in Funding
Next Gen Diagnostics Welcomes New Scientific Advisory Board Member
Next Gen Diagnostics Opens First U.S. Laboratory
Financial Highlights: bioMérieux & Sekisui Diagnostics
- Figure: bioMérieux Sales Distribution, by Business Segment, 2023 (%)
- Table: bioMérieux Financial Review, by Business Segment, FY 2022 – FY 2-23 (€M)
- Figure: bioMérieux FY 2022 vs FY 2023 Regional Sales Breakdown (€M)
- Table: Sekisui Chemical Financial Results, FY 2022 and FY 2023 (Billions of Yen)
- Table: Sekisui Chemical Annual Overview and Focus, FY 2023 and FY 2024 (Billions of Yen)
- Table: Sekisui Chemical Net Sales, by Segment, FY22 and FY23 (Billions of Yen)
- Figure: Sekisui Chemical Medical Division, Revenue Mix, by Type, by Quarter, Q1 FY22 – Q4FY23 (Millions of Yen)
Diagnostic Market Mergers, Acquisitions and Partnership Deals
Mergers and Acquisitions
- Table: Selected Diagnostic Market Mergers and Acquisitions Deals
Partnerships and Collaborations
Industry Watch
COVID-19/Flu Update
Region Watch
Japan
- Figure: Japan National Health Expenditures, Year-on-Year Growth Rate, 1985-2019 (Yen trillion, %)
- Figure: Japan: Changes in Number of Hospitals, by Hospital Type, 2015-2019
- Figure: Japan: Changes in Number of Beds, by Bed Type and Number of Beds per Hospital, 2015-2019
- Figure: Japan: Changes in Average Length of Stay, by Bed Type, 2015-2019
- Figure: Japan IVD Market, by Segment, 2023 (%)
Broad-based Company Announcements
Announcements
QIAGEN Launches Gastrointestinal Molecular Panel in the United States
Illumina Spins Off Grail
QIAGEN Discontinues NeuMoDx System
DiaSorin Nabs Clearance for LIAISON PLEX Blood Culture Yeast Assay
Genetic Signatures Granted FDA Clearance for GI Kit
Volume 3, Issue 4 – Blood Screening
Overview of Blood Screening
Market Outlook
- Figure: Blood Screening Market, 2019-2029 ($ billion)
- Figure: Blood Screening Sales, by Test Method, 2024 and 2029 ($ billion) (Immunoassay Screen, NAT Screens)
- Figure: Blood Donation Screening Market Distribution, by Analyte, 2024 (%) (Hepatitis, HIV, Other)
Regional Market
- Table: Estimated Blood Donations, by WHO Region, 2018
- Figure: Whole Blood Donations per 1000 Population, 2018
- Table: Blood Screening Market Distribution, by Global Region, 2024 (%) (Asia Pacific, Europe, North America, RoW)
- Figure: Blood Screening Market Distribution of Sales, by Global Region (%) (Asia Pacific, Europe, North America, RoW)
Segment Activity by Region
- Immunoassays
- Figure: Market Summary: Immunoassay Blood Screening Market, Distribution of Sales, by Region, 2024 (%) (Asia Pacific, Europe, North America, RoW)
- Molecular
- Figure: Market Summary: NAT Blood Screening Market, Distribution of Sales by Region (North America, Europe, Asia Pacific, RoW), 2024
Top Company Briefs
Roche
Grifols
Abbott
Executive News Briefing
Briefs
Trinity Biotech Engages New CCO
BillionToOne Closes Financing Deal
OraSure Technologies Elects New Board Member
Viome Life Sciences Secures $25 Million in Financing
Syantra Raises $3.6 Million in A-1 Round Financing
Financial Highlights: Dexcom and Exact Sciences
Dexcom Revenues Increase 15% (+$133 million) in Q2 2024
- Figure: Dexcom Revenue Mix, by Product Segment, Q2 2023 and Q2 2024
- Figure: Dexcom Revenue Mix by Product Segment, By Quarter 2022 – Q2 2024
- Table: Dexcom Geographic Revenues, by Region, Q2 2023 and Q2 2024 ($ million)
Exact Sciences Reports it “Tested a Record Number of Cancer Patients with Oncotype DX”
- Figure: Exact Sciences Revenue Mix, by Product Segment, Q2 2023 vs Q2 2024 ($ million)
- Figure: Exact Sciences Revenue Mix, by Product Segment, by Quarter 2022-Q2 2024 ($ million)
Diagnostic Market Mergers, Acquisitions and Partnership Deals
Partnerships and Collaborations
Mergers and Acquisitions
- Table: Selected Diagnostic Market Mergers and Acquisitions Deals
Region Watch
- Figure: South Korea GDP, GDP (PPP), and Health Spending, CAGR 2005-2010, 2010-2015, 2015-2020 and 2020-2023 (%)
- Figure: South Korea Medical Tourism Visits Reported, 2009-2023 (# of patients)
- Figure: South Korea Old-Age Dependency Ratio and Aging Index, 1980-2065
Broad-based Company Announcements
Announcements
Foundation Medicine Gets the Nod for Its Companion Diagnostics
QuidelOrtho Proud to Announce Clearance for VITROS Syphilis Assay
AliveDx Receives IVDR-CE Mark for Multiplexed Assay
T2 Biosystems Scores FDA Pediatric Clearance
ID-FISH Technology Announces FDA Nod for its Lyme ImmunoBlot
Volume 3, Issue 5 – Point-of-Care (POC)
Market Analysis: IVD POC Testing
Overview of IVD POC Testing
Market Outlook
- Table: Global POC Diagnostic Market, by Broad Segment, 2024 and 2029 ($ million) (professional testing, self-testing)
- Figure: Point-of-Care Diagnostics (COVID-19 vs. non-COVID testing), 2020-2024 ($ million)
- Figure: Global POC Diagnostic Market Distribution, by Segment, 2024 (%) (Cardiac Care; Coagulation; Critical Care; Drug of Abuse; Fecal Occult Blood; Glucose; Hematology; Infectious Disease Lipid [Cholesterol]; Pregnancy/Fertility; Urinalysis; Others)
Selected Product Activity
Regional Market
- Figure: POC Diagnostics Market Value, by Global Region, 2024 ($ million) (North America, Europe, Asia Pacific, Latin America, Middle East, Africa)
Company Briefs
Abbott Diagnostics
Dexcom
Roche
Executive News Briefing
Briefs
Quanterix Appoints New Member to Board of Directors
Beckman Coulter Appoints New President
MARAbio Raises $19 Million in Series A Funding
Amprion Makes Advances in Series B Financing
Sunbird Bio Closes $14 Million Financing Round
Bruker Reported 17% Growth in Second Quarter 2024 and 11% Growth for the First Six Months
- Figure: Bruker Corporation Sales, by Business, H1 2023 Compared to H1 2024 (Bruker BioSpin, Bruker CALID, Bruker Nano, BEST, Eliminations)
- Figure: Bruker CALID Quarterly Performance, Sales by Quarter, Q1 2022 – Q2 2024
- Figure: Bruker Corporation H1 2023 and H1 2024 Regional Sales Breakdown Distribution (Asia Pacific, Japan; Europe; United States; Other)
Myriad Genetics Reports 13% Revenue Growth in First Half 2024
- Table: Myriad Genetics Revenue Mix, by Product, H1 2023 vs H1 2024 ($ million) (Hereditary Cancer; Pharmacogenomics; Prenatal; Tumor Profiling)
- Figure: Myriad Genetics Revenue Mix, by Business Unit, Quarterly Performance Q1 2023 through Q2 2024 ($ million) (Mental Health, Oncology, Women’s Health)
Diagnostic Market Mergers, Acquisitions and Partnership Deals
Partnerships and Collaborations
Mergers and Acquisitions
- Table: Recent Diagnostic Market Mergers, Acquisitions and Partnership Deals
Industry Watch
Industry Watch COVID-19/Flu Update
Region Watch
Finland
- Figure: Finland GDP Value and Growth, by Year, 2013-2023 ($ billion)
- Figure: Finland Social Protection Expenditure by Function, 1995-2022 in 2022 Prices (€ billion)
- Figure: Finland IVD Market, 2019-2024 ($ million)
Broad-based Company Announcements
Announcements
Roche Launches TAGS Technology Test
Exact Sciences Welcomes New Cologuard Plus Test
PreAnalytiX Launches PAXgene Urine Liquid Biopsy Set
Abionic Launches Early Sepsis Test
QIAGEN Expands Liquid Biopsy Portfolio
FoundationOne Gains Liquid CDx Approval
Revvity’s Euroimmun Announces Groundbreaking Launch in the EU
