In Vitro Diagnostics Business Outlook, 2024 (6 Updates)

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
  • Allenz 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, Womens 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
• Revvitys Euroimmun Announces Groundbreaking Launch in the EU

Volume 3, Issue 6 – Glucose Testing

MARKET ANALYSIS: IVD GLUCOSE TESTING

OVERVIEW OF IVD GLUCOSE TESTING

• MARKET OUTLOOK
  • Table: Global Diabetes Sales, by Test Category, 2024-2029 ($ million) (Glucose OTC; Glucose Professional; Glucose, Continuous; HbA1c POC; HbA1c Lab)
  • Figure: Global Diabetes Testing Market, by Segment with CAGR 2024-2029 ($ million) (Glucose OTC; Glucose Professional; Glucose, Continuous; HbA1c POC; HbA1c Lab)
• REGIONAL MARKET
  • Figure: Global Diabetes Prevalence, 20-79y, 2021 Estimates (per 1,000s)
  • Figure: Global Distribution, Diabetes Test Market, 2024 (%) (Glucose, HbA1c)
• COMPANY BRIEFS
• Abbott Diagnostics
• Dexcom
• Roche

EXECUTIVE NEWS BRIEFING

• BRIEFS
• Agilent Reorganizes Business Units
• Natera Co-Founder Named R&D Leader of the Year
• QIAGEN Moves QIAstat-Dx to Drive Growth
• OraSure Receives Funding
• AmplifiDx Captures Additional Funding
• 52North Closes $6 Million in Funding

FINANCIAL HIGHLIGHTS: ABBOTT LABORATORIES, QIAGEN

• ABBOTT CONTINUES STEADY PERFORMANCE IN 2024; 9M SALES INCREASE 3.7%
  • Figure: Abbott Sales by Business, 9M 2023 and 9M 2024 ($ million)
  • Table: Diagnostic Sales, Abbott Laboratories, 9M 2023 and 2024 ($ million)
  • Figure: Diagnostic Sales, Abbott Laboratories, 9M 2023 and 2024 ($ million)
  • Table: COVID-19 Test Sales, Abbott Laboratories, 9M 2023 and 2024 ($ million)
  • Figure: Diabetes Care, Abbott Laboratories, 9M 2023 and 9M 2024 ($ million)
• QIAGEN REPORTS STRONG PERFORMANCE IN Q3 2024; RAISES GUIDANCE
  • Figure: QIAGEN Revenue Mix by Business Segment, 9M 2024 ($ million) (Molecular Diagnostics, Life Sciences)
  • Figure: QIAGEN Sales by Product Group, 9M 2024 ($ million) (Sample Technologies, Diagnostic Solutions, PCR/Nucleic Acid Amplification, Genomics/NGS, Other)
  • Table: QIAGEN Sales, by Product Type, 9M 2023 and 9M 2024 ($ million) (CAGR %) (Consumables and Related Revenues, Instruments)
  • Figure: QIAGEN Diagnostic Solutions Sales, by Segment, 9M 2023 and 9M 2024 ($ million) (QuantiFERON, QIAstat-Dx, NeuMoDx, Other)
  • Figure: QIAGEN Sales, by Geographic Region, 9M 2023 and 9M 2024 ($ million) (Americas, EMEA, Asia Pacific/Japan)

DIAGNOSTIC MARKET MERGERS, ACQUISITIONS AND PARTNERSHIP DEALS

• PARTNERSHIPS AND COLLABORATIONS
• MERGERS AND ACQUISITIONS
  • Table: Recent Diagnostic Market Mergers, Acquisitions and Partnership Deals, Dec. 2023-Nov. 2024

INDUSTRY WATCH

• INDUSTRY WATCH COVID-19/FLU UPDATE

REGION WATCH

• VIETNAM
  • Figure: Vietnam GDP, Composition by Sector, 2023 (%) (Agriculture, Forestry, Fishery; Industry, Construction; Services)
  • Figure: Vietnam GDP Value and Growth by Year, 2015-2023 ($ billion)

BROAD-BASED COMPANY ANNOUNCEMENTS

• ANNOUNCEMENTS
• Roche Receives FDA Expanded Approval
• Foundation Medicine Received FDA Companion Diagnostic Approval
• Deepull Receives FDA Breakthrough Device Designation
• bioMérieux Snags Clearance for Tropical Fever Panel
• Roche Receives CE Mark for New Cobas Systems 2.0
• Agilent Received Certification for Companion Diagnostic