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In Vitro Diagnostics Business Outlook, 2026
Publication Date: April 21, 2026
Tags: Cardiovascular Disease, Coagulation, COVID-19, Genetic Diseases, Hematology, Histology and Cytology, Immunoassay, In Vitro Diagnostics (IVD), Infectious Diseases, Molecular Diagnostics, Oncology and Cancer, Point-of-Care (POC) Testing, Veterinary Diagnostics
Pages: Varies (average 30 pages)
SKU: 26-014KA
The in vitro diagnostics (IVD) industry is a cornerstone of modern healthcare, empowering clinicians to detect disease, monitor health conditions, and guide treatment decisions with precision. As healthcare continues to evolve—driven by rising rates of chronic conditions such as diabetes and cardiovascular disease, along with ongoing and emerging infectious threats—the IVD market is undergoing constant change and growth.
In Vitro Diagnostics Business Outlook is a monthly intelligence publication designed to help industry professionals stay current in this fast-moving environment. Delivered in 12 issues annually, each issue focuses on a different segment of the IVD industry, providing timely insights, exclusive data, and in-depth analysis.
Featured Content
Each monthly issue provides:
-
Market Data and Forecasts
Detailed growth rates, market size, and market share to help identify emerging opportunities. -
Comprehensive Market View
Coverage of key test categories and profiles of active companies across the IVD landscape. -
M&A Activity Tracking
Updates on mergers, acquisitions, partnerships, and collaborations shaping the market. -
Industry & Region Watch
Analysis of regional and segment-specific trends to support tailored strategic planning. -
In-Depth News Analysis
Reporting on significant developments and events, including exclusive information not readily available elsewhere.
2026 Editorial Focus
Topics vary month to month, reflecting evolving industry priorities. In 2026, subscribers can expect issues dedicated to:
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Reimbursement trends
-
Quality control reagents
-
Cardiac markers
-
STI point-of-care testing
-
Non-respiratory infectious diseases
-
An overall IVD market trend analysis
-
A forward-looking forecast of the respiratory testing market through 2027
- And more!
By delivering focused, actionable intelligence directly to subscribers’ each month, In Vitro Diagnostics Business Outlook helps decision-makers anticipate market shifts, identify growth opportunities, and navigate the complexities of the global IVD industry with confidence.
Table: Global Lab-Based Immunoassay Market, by Segment, 2026-2031 ($ million)
| Segment | 2026 | % Mkt | 2031 | % Mkt | CAGR |
| Allergy | $XX Million | $XX Million | $XX Million | XX% | XX% |
| Anemia | $XX Million | $XX Million | $XX Million | XX% | XX% |
| Autoimmune | $XX Million | $XX Million | $XX Million | XX% | XX% |
| Blood Bank Screening | $XX Million | $XX Million | $XX Million | XX% | XX% |
| Cardiac Markers | $XX Million | $XX Million | $XX Million | XX% | XX% |
| COVID-19 | $XX Million | $XX Million | $XX Million | XX% | XX% |
| Diabetes/HbA1c | $XX Million | $XX Million | $XX Million | XX% | XX% |
| Fertility | $XX Million | $XX Million | $XX Million | XX% | XX% |
| HAIs/Sepsis | $XX Million | $XX Million | $XX Million | XX% | XX% |
| Hepatitis | $XX Million | $XX Million | $XX Million | XX% | XX% |
| HIV | $XX Million | $XX Million | $XX Million | XX% | XX% |
| Lyme disease | $XX Million | $XX Million | $XX Million | XX% | XX% |
| Mycology | $XX Million | $XX Million | $XX Million | XX% | XX% |
| Parasitology | $XX Million | $XX Million | $XX Million | XX% | XX% |
| Proteins | $XX Million | $XX Million | $XX Million | XX% | XX% |
| Respiratory (excl. COVID) | $XX Million | $XX Million | $XX Million | XX% | XX% |
| STD | $XX Million | $XX Million | $XX Million | XX% | XX% |
| Therapeutic Drugs | $XX Million | $XX Million | $XX Million | XX% | XX% |
| Thyroid | $XX Million | $XX Million | $XX Million | XX% | XX% |
| ToRCH | $XX Million | $XX Million | $XX Million | XX% | XX% |
| Tox/Drug of Abuse | $XX Million | $XX Million | $XX Million | XX% | XX% |
| Tumor Markers | $XX Million | $XX Million | $XX Million | XX% | XX% |
| Vitamin D | $XX Million | $XX Million | $XX Million | XX% | XX% |
| Other Infectious Disease | $XX Million | $XX Million | $XX Million | XX% | XX% |
| Others Non-Infectious Disease | $XX Million | $XX Million | $XX Million | XX% | XX% |
Source: Kalorama Information
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Volume 5, Issue 1 – Focus on Reimbursement
Market Analysis: Reimbursement
Overview of IVD Reimbursement
Outlook: Reimbursement
- Figure: CMS Average Reimbursement Trend: 40+ High-Frequency Clinical Laboratory Test Codes
- Table: CMS Reimbursement Limit by Clinical Laboratory Test Code, 2010, 2015, 2020, and 2025
- Table: Select Companies/Products Expected 2026 Reimbursement Impact
- Table: Summary of Key Reimbursement Drivers
Executive News Briefing
Briefings
Kiffik Biomedical Closes Series A Financing
NeoGenomics Appoints Jack Kenny to Board of Directors
Cardio Diagnostics Launches Precision CHD Test in India
Cyclomics Closes €2.5 Million Investment Round
Truvian Appoints New Chief Medical and Strategy Officer
Alamar Biosciences Closes $50 Million in New Capital
Alamar Biosciences Welcomes New CSO
Hummingbird Diagnostics Appoints New CEO
Precede Biosciences Nabs $83.5 Million in Total Financing
Financial Highlights
Agilent Full Year Fiscal 2025 Sales up 7% in Business YOY
- Figure: Agilent Sales by Business, FY 2024 and 2025 ($)
- Figure: Agilent Sales by Business, FY 2025 Quarterly Performance ($)
- Table: Agilent Revenue Mix, by Type, FY 2025 (%)
- Figure: Agilent FY 2025 Regional Sales Breakdown Distribution (%)
Diagnostic Market Mergers, Acquisitions, and Partnership Deals
Mergers and Acquisitions
- Table: Recent Diagnostic Market Mergers, Acquisitions, and Partnership Deals
Partnerships and Collaborations
Industry Watch
Industry Watch COVID-19/Flu Update
Region Watch
Australia
- Figure: Australia Exports, Distribution by Industry Segment, 2023 ($ billion)
- Figure: Australia IVD Market Sales Trend, 2020-2025 ($ million)
Broad-based Company Announcements
Announcements
Mira Precision Health Launches ToxNav in U.S.
Beckton Dickinson Receives FDA Clearance and CE Marking
QuidelOrtho Captures FDA Clearance or VITROS Immunodiagnostic
FDA Proposes Reclassification of Companion Diagnostic Assays
Congress Discusses PAMA
MeMed Accelerates AI-enabled Acute-Care Diagnostics
Truvian Health Snags Clearance for Nine Additional Analytes
Volume 5, Issue 2 – Focus on Quality Control
Market Analysis: IVD Quality Control
Overview of IVD Quality Control
Market Outlook: IVD Quality Control
- Figure: IVD Quality Control Market, by Concentration, 2025 (%) [Immunoassay, Molecular]
- Figure: IVD Quality Control Market, 2020-2025, 2030 Est. ($ million)
Company Briefs
Bio‑Rad
Thermo Fisher
Executive News Briefing
Biomakers Closes Additional Funding
Cleveland Diagnostic Appoints New CEO
Cleveland Diagnostics Appoints New Board
Waters Announced Appointment of New Board Member
Hologic Total Revenues Remain Steady but Changes on the Horizon
- Table: Hologic Product Revenues Performance, by Product Group, FY2025 ($ million)
- Figure: Hologic Geographic Revenue Distribution, FY2025 (%)
Diagnostic Market Mergers, Acquisitions, and Partnership Deals
Mergers and Acquisitions
- Table: Recent Diagnostic Market Mergers, Acquisitions, and Partnership Deals
Partnerships and Collaborations
Industry Watch
Industry Watch COVID-19/Flu Update
Region Watch
Saudi Arabia
- Figure: Saudi Arabia Population Pyramid, 2025 and 2050
- Figure: Saudi Arabia – Total Annual Liquid Fuels Production and Consumption, 2013-2023 (millions of barrels)
- Figure: Saudi Arabia IVD Market Share, by Broad IVD Segment, 2025 (%)
Broad-based Company Announcements
Cepheid Lands FDA Clearance for Xpert GI Panel
Truvian Health Scores Another FDA Clearance for CBC
Guardant Health Received FDA Approval for Companion Diagnostic
Diasorin Secures De Novo FDA Authorization
Quest Diagnostics Launches New Test
Biophysical Marker Test for Autism
Randox Secures FDA Clearance for New Clinical Testing Panel
Hologic Nabs FDA Approval for Aptima HPV Assay
OraSure Launches OraQuick HIV Self-Test in Canada
BillionToOne Expands Leadership in Hemolytic Disease
Athelas Receives FDA Clearance
New England Biolabs Launches New Product
LEX Diagnostics Scores FDA Clearance for VELO System
Promega Announces Approval of MSI Detection Kit in China
Volume 5, Issue 3 – Focus on Veterinary Diagnostics
Market Analysis: Veterinary Diagnostics
Overview of Veterinary Diagnostics
Veterinary Diagnostics Market Outlook
- Figure 1: Veterinary Diagnostics Market, by Segment, 2025 and 2030 ($ million) [Companion, Food]
Company Briefs: Veterinary Diagnostics
IDEXX Laboratories
Mars Petcare
Zoetis
Vendor Market Share: Veterinary Diagnostics
- Figure 2: Competitive Market Share Global Veterinary Diagnostics, by Leading Vendors, Estimated 2025 (%)
Regional Market: Veterinary Diagnostics
- Figure 3: Veterinary Diagnostic Market, Geographic Distribution of Sales, 2020-2030 ($ million) [Asia Pacific, Europe, Latin America, United States Rest of World]
Executive News Briefing
Briefings
Mainz Biomed Strengthens Cancer Detection Financing
Reacta Healthcare Appoints New Chairman of the Board
Trinity Biotech Secures $25 Million Financing
Abram Scientific Closes $11.75 Million Series A Funding
Quest Diagnostics Appoints New Senior Vice President, Chief Strategy and M&A Officer
Dexcom Appoints New Member to Board of Directors
Babson Diagnostics Names News CEO
Castle Biosciences Opens New Corporate Headquarters
Owkin Spinout Waiv Secures $33 Million for AI
Bruker Delivered Overall Revenue Growth in 2025
- Table 1: Bruker Product Revenues Performance, by Business Product Group, FY2025 ($ million)
- Figure 4: Bruker Corporation Sales, by Business Product Group, 2024 vs. 2025 ($ million)
- Figure 5: Bruker Corporation 2024 and 2025 Regional Sales Breakdown Distribution, 2024 vs. 2025 [Asia Pacific, Europe, United States, Other)
Diagnostic Market Mergers, Acquisitions, and Partnership Deals
Partnerships and Collaborations
Mergers and Acquisitions
- Table 2: Recent Diagnostic Market Mergers, Acquisitions, and Partnership Deals
Industry Watch
Industry Watch COVID-19/Flu Update
Region Watch
South Africa
- Figure 6: South Africa Population Pyramid, 2025 and 2055 Estimates
- Figure 7: South Africa GDP, Composition by Sector (Agriculture, Industry, Services) – Range (%)
- Figure 8: South Africa IVD Market Share, by Broad IVD Segment, 2025 (%) [Core Lab, Histology/Cytology, Immunoassays, Microbiology/Virology, Point-of-Care, Other Segments]
Broad-based Company Announcements
Announcements
Bio-Techne Gains CE-IVD Marking for Its Ella Platform
Breath Diagnostics Receives FDA Breakthrough Device Designation
Biomerica Lands Approval in Vietnam for EZ Detect
NG Biotech and Hardy Diagnostics Granted FDA Breakthrough Device Designation
Diasorin Secures FDA Approval of LIAISON QuantiFERON-TB Gold Plus II
Meridian Bioscience Lands IVDR Certification for Alethia Molecular Assay Portfolio
NeoGenomics Launches RaDaR ST
Bruker Launches CellScape XR
MiraDx Launches PROSTOX Standard Genetic Test
Techcyte Gains CE Marking for Fusion AP Platform
PathAI Granted Breakthrough Device Designation for PathAssist Derm
MeMed Secures Breakthrough Device Designation
Natera Launches Zenith Genomics
Roche Nets CE Marking for First Immunoassay Test for Alzheimer’s Disease
Volume 5, Issue 4 – Focus on Cardiac Markers
Market Analysis: Cardiac Markers
Overview of Cardiac Markers
Market Outlook: Cardiac Markers
- Table: Global Cardiac Marker Diagnostic Sales, by Setting, 2025-2030 ($ million) [Lab-based, POC-based]
- Figure: Global Cardiac Marker Testing Market, by Setting, 2025-2030 ($ million) [Lab-based, POC-based]
- Figure: Global Cardiac Marker Testing Market, by Setting and Total Value Over Time, 2020-2030 ($ million) [Lab-based, POC-based]
- Figure: Global Cardiac Marker Testing Market Share, by Marker Type, 2025 (%) [BNP, CK-MB, Myoglobin, Troponin, Other]
Company Briefs
Danaher
Roche
Siemens Healthineers
Vendor Market Share
- Figure: Leading Vendors in the Cardiac Marker Segment, Market Share by Company, 2025 (%)
Regional Market
- Table: Cardiac Marker Test Sales Distribution, by Global Region, 2025 (%) [Asia Pacific, Europe, North America, RoW)
Executive News Briefing
Briefings
Personalis Appoints New President
ClearNote Health Appoints New Chief Medical Officer
Virchow Raises $4 Million to Advance Biopsy Specimen Access in Precision Oncology
Plus Therapeutics Welcomes Ron Andrews to Board of Directors
BillionToOne Appoints VP of Medical Affairs and Clinical Development
Blackstone and TPG Complete Acquisition of Hologic
Hologic Announces Appointment of New CEO
BD Announces Retirement of its Executive Vice President
Caristo Diagnostics Welcomes New CEO
Financial Highlights: bioMérieux
bioMérieux Full Year 2025 Sales Reach €4,070 million, Representing +6.2% Organic Growth
- Figure: bioMérieux Sales Distribution, by Business Segment, 2025 (%) [Clinical Applications, Industrial Applications]
- Table: bioMérieux Financial Review, by Clinical Applications Product Segments, FY 2024-FY 2025 (€M)
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
India
- Figure: India Real GDP Growth vs. Inflation Rate (consumer prices) Estimated, 2018-2025
- Figure: India IVD Market Distribution of Sales, by Broad IVD Segment, Estimated 2025 (%) [Core Lab, Histology/Cytology, Immunoassays, Microbiology/Virology, Point-of-Care – Glucose, Point-of-Care – Other, Other Segments]
Broad-based Company Announcements
Announcements
Roche Launches CE Marked MPX-E Assay
Spear Bio Launches New Ultra-Sensitive Neurodegenerative Assays
Integrated DNA Technologies Launches Archer FUSIONPlex HT Dx and VARIANTPlex-HT Dx
Myriad Genetics Snags FDA Approval for MyChoice CDx Test
Fujirebio Gains CE Marking for Fully Automated Lumipulse G Nfl Assay
FDA Categorizes Roche’s Ionify Steroid Assays for Mass Spectrometry as Moderate Complexity
Lumos Diagnostics Secures FDA Clearance with CLIA Waiver
Agilent Nabs FDA Approval for PD-L1 HIC 22C3 PharmDx
Darwin AG Launches Multi-Cancer Check
Caris Life Sciences Launches ChromoSeq
Waters Snags FDA Clearance for Onclarity HPV Self-Collection Kit
bioMérieux Launches Mycoplasma QC Testing
Roche Secures CE Marking for its MS Test
Beckman Coulter Acquires CE Marking for New Assay
QIAGEN Launches Rapid QIAstat-Dx Panel
Labcorp Launches Fentanyl Test
Myriad Genetics Announces myChoice Test Approval in Japan
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