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In Vitro Diagnostics Business Outlook, 2025
Publication Date: December 23, 2025
Tags: 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
Pages: Varies (average 30 pages)
SKU: 25-014KA
The in vitro diagnostics (IVD) sector stands as a cornerstone of modern healthcare, empowering clinicians with the tools to detect diseases, monitor health conditions, and guide precise treatment decisions.
As healthcare evolves, the IVD market is poised for transformative growth. With the rising prevalence of chronic conditions such as diabetes and cardiovascular diseases, as well as ongoing threats from infectious diseases like COVID-19 and emerging variants, the demand for innovative diagnostic solutions has never been greater.
In Vitro Diagnostics Business Outlook is a monthly publication, delivering 12 issues annually, each dedicated to a different segment of the IVD industry. It provides exclusive insights and data, including:
- Market Data and Forecasts: Detailed growth rates, market size, and market share to identify new opportunities.
- Comprehensive Market View: Coverage of test categories and company profiles.
- M&A Activities: Updates on mergers, acquisitions, partnerships, and collaborations.
- Industry & Region Watch: Tailored strategies based on regional and industry-specific trends.
- News Analysis: In-depth reporting on significant news and events, including exclusive information not readily available elsewhere.
Table: Global Lab-Based Immunoassay Market, by Segment, 2025-2030 ($ million)
| Segment | 2025 | % Mkt | 2030 | % 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 | $XX Million | XX% | XX% |
Source: Kalorama Information
For further details and to purchase directly, please contact us.
Table of Contents
Volume 4, Issue 1 – Focus on Cardiac Biomarkers
Market Analysis: Cardiac Biomarker Testing
Overview of Cardiac Biomarkers
Market Outlook
- Figure: Cardiac Marker Testing Market by End User, 2024-2029 ($ million) (Lab-based, POC-based)
- Table: Cardiac Marker Diagnostic Sales by End User, 2024-2029 ($ million) (Lab-based, POC-based)
- Figure: Cardiac Marker Testing Market by End User and Total Value Over Time, 2019-2029 ($ million) (Lab-based, PoC-based)
- Figure: Cardiac Marker Testing Market, by Marker, 2024 (% Share) (Troponin, BNP, CK-MB, Myoglobin, Other)
Regional Market
- Table: Cardiac Marker Test Sales Distribution by Global Region, 2024 (%) (Asia Pacific, Europe, North America, RoW)
Company Briefs
Abbott Diagnostics
Beckman Coulter
Siemens
Vendor Market Share
- Figure: Market Share of Leading Vendors in the Cardiac Marker Segment, by Company, 2024 (%) (Abbott, Danaher, QuidelOrtho, Roche, Siemens, Others)
Executive News Briefing
Briefs
Senseera Closes $7.1 Million in Funding Round
Geneoscopy Closes Series C Funding
Oxford Cancer Analytics Raises $11 Million in Series A Funding
MiRXES Nabs $40 Million in Financing
Tethis Nabs €15 Million Funding
Financial Highlights: Becton Dickinson, Natera
Becton Dickinson Reports 4% Revenue Growth in Fiscal 2024
- Table: Becton Dickinson Financial Review, by Business Segment, FY 2022-FY 2024 ($ million) (BD Medical, BD Life Sciences, BD Interventional)
- Figure: Becton Dickinson Business Division Performance, by Business Segment, FY 2022-FY 2024 ($ million) (BD Medical, BD Life Sciences, BD Interventional)
- Figure: BD Life Sciences Division, Segment Mix, FY 2020 vs. FY 2024 (%) (Integrated Diagnostic Solutions, Biosciences)
- Figure: Becton Dickinson U.S./International Revenue Distribution, FY 2022-FY 2024 ($ million)
- Figure: Becton Dickinson Revenue Distribution, by Region, FY 2024 (%) (EMEA, Greater Asia, United States, Other)
Natera Continues Overall Growth Trend with Preliminary 2024 Results, Expecting a 56% Increase over 2023
- Figure: Natera Financial Overview by Quarter, Q1 2023-Q4 2024* ($ million)
Diagnostic Market Mergers, Acquisitions, and Partnership Deals
Partnerships and Collaborations
Mergers and Acquisitions
- Table: Recent Diagnostic Market Mergers, Acquisitions, and Partnership Deals, Dec. 2023-Jan. 2025
Industry Watch
Industry Watch COVID-19/Flu Update
Region Watch
Mexico
- Figure: Mexico GDP, GDP (PPP), and Health Spending, 1990-2020, estimated 2025 ($ billion)
- Figure: Mexico IVD Market Sales Trends, by Broad IVD Segment, 2016-2024 ($ million) (Clinical Chemistry, Hematology, and Coagulation; Histology; Immunoassays; Microbiology; POC; Others)
Broad-based Company Announcements
Announcements
Roche Secures CE Marking for Mass Spec System
QIAGEN Receives FDA Clearance for Five-Target Syndromic Panel
Revvity Secures FDA Clearance for Free Testosterone Test
Spear Bio Secures FDA Breakthrough Device Designation
Roche Announces Clearance of First ISH Test B-cell Lymphoma
Roche Receives Additional FDA Clearance
Volume 4, Issue 2 – Focus on Infectious Disease Testing
Market Analysis: Infectious Disease Testing
Overview of Infectious Disease Testing
Market Outlook
- Table 1: Global Infectious Disease Testing Market Revenue, by Segment, 2024-2029 ($ million) [Lab-based Immunoassays, Lab-based Molecular, Point-of-Care Tests]
- Figure 1: Global Infectious Disease Testing Market, by Segment, 2019-2029 ($ million) [Lab-based Immunoassays, Lab-based Molecular, Point-of-Care Tests]
- Figure 2: Global Infectious Disease Testing Market, Change in Market Performance by Segment, 2023-2024 [Blood Bank Screening, COVID-19, HAIs/Sepsis, Hepatitis, HIV, Respiratory (excl. COVID), Others]
- Figure 3: Global Infectious Disease Testing Market, by Analyte Target, Distribution of Sales, 2024 [Blood Bank Screening, COVID-19, HAIs/Sepsis, Hepatitis, HIV, Respiratory (excl. COVID), Others]
Regional Market
- Table 2: Infectious Disease Testing, Distribution by Global Region, 2024 [North America, Europe, Asia Pacific, RoW]
Company Briefs
Roche
Abbott
Danaher
Other Participants
Executive News Briefing
Briefings
Dxcover Limited Raises New Capital
Cubit Diagnostics Awarded NIH Funding
CARB-X Funds AstraDx’s Neonatal Sepsis Rapid Test
Freenome Raises Additional $254 Million
Renovaro Secures $15 Million in New Capital
Ataraxis AI Secures $20.4 Million in Funding
MSInsight Nabs €1.6 Million Seed Funding
C2N Diagnostics Receives $10 Million Investment
Financial Highlights: Guardant Health, Roche
Guardant Reports Strong Demand – Increasing Revenues +31% Over Previous Year
- Figure 4: Guardant Health Test Volume, by Segment and Total, Quarterly Q1 2023 through Q4 2024 [Biopharmaceutical Customers, Clinical Customers]
- Table 3: Guardant Health, by Group Business Revenue, FY 2023 vs FY 2024 ($ million) [Clinical Precision Oncology Testing, Development Services and Other]
- Figure 5: Guardant Health, by Group Business, FY 2023 vs FY 2024 ($ million) [Clinical Precision Oncology Testing, Development Services and Other]
- Figure 6: Guardant Health Revenue Performance, by Geographic Region, FY 2023 vs FY 2024 ($ million) [United States, International]
Roche Diagnostic Sales Grow 4% CER in 2024 – Supported by Demand for Immunodiagnostics, Pathology, and Molecular Solutions
- Table 4: Roche, by Group Business, 2024 (CHF MN) [Diagnostic Division, Pharmaceutical Division]
- Figure 7: Roche Diagnostics, 2024 Product Sales Breakdown, 2024 (CHF MN) [Core Lab, Molecular, Pathology Lab, Point-of-Care]
- Figure 8: Roche Diagnostic, Segment Distribution, 2024 (%) [Core Lab, Molecular, Pathology Lab, Point-of-Care]
- Table 5: Roche Diagnostics Division Sales, by Region, 2024 (CHF MN)
Diagnostic Market Mergers, Acquisitions, and Partnership Deals
Mergers and Acquisitions
- Table 6: Recent Diagnostic Market Mergers, Acquisitions, and Partnership Deals, Dec. 2024-March 2025
Partnerships and Collaborations
Industry Watch
Industry Watch COVID-19/Flu Update
Region Watch
Brazil
- Figure 9: Brazil Short-Term GDP Growth and Inflation Change, 2022-2024, 2025-2026 Projected (%)
- Figure 10: Brazil General Government Gross Debt as a Percent of GDP, 2000-2020 and 2025 projected (%)
- Figure 11: Brazil IVD Market Distribution of Sales, by IVD Segment, 2024 (%)
Broad-based Company Announcements
Announcements
AliveDx Nabs CE Mark for Expanded Autoimmune Menu
Beckman Coulter Received FDA Breakthrough Device Designation
Beckton Dickinson to Spin Off Bioscience and Diagnostic Business
GRAIL Provides Galleri Multi-Cancer Early Detection Test Through Quest
Molecular Instruments RNA-ISH Enables Breakthrough LDT
Roche Snags FDA Clearance for Preeclampsia Test
CytoChip Receives FDA Clearance and CLIA Waiver
Cicero Diagnostics Unveiled Endometriosis Detection LDT
bioMérieux Secures FDA Clearance for BIOFIRE FILMARRAY GI Panel
Beckman Coulter Gains Clearance for its DxC 500i
Volume 4, Issue 3 – Focus on Blood Grouping/Typing Testing
About Kalorama Information
Market Analysis: Blood Grouping/Typing Testing
Overview of Blood Grouping/Typing Testing
Molecular Methods in Blood Typing
Discovery of a New Blood Group System
Market Outlook: Blood Grouping and Typing
Overview of Blood Grouping and Typing
Regional Market
- Figure: Blood Grouping/Typing Market, Estimated Revenues, by Global Region, 2019-2029 [Asia Pacific, Europe, North America, Rest of World]
Company Briefs
Bio-Rad
Grifols
QuidelOrtho
- Figure: Global Blood Grouping/Typing Market Share, by Vendor, 2024 (%) [Bio-Rad, Grifols, QuidelOrtho, Others]
Werfen/Immucor
AliveRx/Quotient
Executive News Briefing
Briefs
Craif Raises $22 Million in Series C Funding
Deepull Closes Series C Financing Round
Upfront Diagnostics Raises $4.3 million in Funding Round
Cizzle Biotechnology Raises £150,000 in Additional Funding
Hedera Dx Lands €15 Million in Funding
32 Biosciences Secures $6 Million in Funding
Financial Highlights: bioMérieux & Trinity Biotech
bioMérieux Reports Full-Year 2024 Sales of €3,980 Million, Representing 10.3% Organic Growth and Exceeding Expectations
- Figure: Trinity Biotech Sales, by Business Segment, FY 2023 and FY 2024 ($ thousands) [Clinical Laboratory, Point-of-Care]
Diagnostic Market Mergers, Acquisitions, and Partnership Deals
Partnerships and Collaborations
Recent Mergers and Acquisitions
- Table: Recent Diagnostic Market Mergers, Acquisitions, and Partnership Deals, December 2024-June 2025
Industry Watch
Industry Watch COVID-19/Flu Update
Region Watch
China
- Figure: China Total Health Expenditures, $ Billion and Total Population, 2010-2023
- Figure: China IVD Market Distribution of Sales, by IVD Segment, 2024 (%)
Broad-based Company Announcements
Company Announcements
Guardant Health Launches New Hereditary Cancer Test
EDX Medical Launches Test for Early Testicular Cancer Detection
Lumipulse G pTau 217 β-Amyloid 1-42 Plasma Ratio Receives FDA Clearance
Boditech and SphingoTec Launch AFIAS Sphingotest penKid Assay
Roche Plans Investment of $550 Million for Indianapolis Diagnostic Site
Roche Receives FDA Breakthrough Device Designation
DiaSorin Captures FDA Clearance for Multiplex Molecular Panel
Nordic Bioscience Launches nordicEndotrophin Assay
genedrive Certification of Rapid CYP2C19 ID Kit
Predicta Biosciences Launches GenoPredicta Marrow and GenoPredicta Blood
Baebies Received FDA Breakthrough Device Designation
New Day Diagnostics Launches ColoHealth
Randox Received FDA Go-Ahead for ConcizuTrace ELISA
LifeLabs Introduces Three Blood-Based Alzheimer’s Disease Tests
Volume 4, Issue 4 – Focus on Histology/Cytology IVD Testing
Market Analysis: Histology/Cytology Testing
Overview of Histology/Cytology Testing
Market Outlook: Histology/Cytology
Overview of Histology/Cytology
- Table: Histology/Cytology Diagnostic Sales, by Broad Test Category, 2025 ($ million) [Pap Tests, in situ Hybridization, Immunohistochemistry, Traditional Non-Pap Stains, HPV – Amplification/Genome]
- Figure: Histology/Cytology Diagnostic Market Distribution, by Broad Test Category, 2025 (%) [Pap Tests, in situ Hybridization, Immunohistochemistry, Traditional Non-Pap Stains, HPV – Amplification/Genome]
- Figure: Evolution of the Histology/Cytology Diagnostic Market, 2020-2030 ($ million) [Pap Tests, in situ Hybridization, Immunohistochemistry, Traditional Non-Pap Stains, HPV – Amplification/Genome]
Regional Market
- Table: Global Histology/Cytology Sales Distribution, by Region, 2025 (%) [North America, Europe, Asia Pacific, RoW]
Company Briefs
Agilent
Danaher
Hologic
Roche
Executive News Briefing
Briefings
Visby Medical Raises $55 Million
GeneCentric Raises $8 Million in Series C Round
Aptitude Medical Systems Secures $9 Million in BARDA Funding
Aptitude Medical Systems Secures $8.25 Million in BARDA Funding
South Korea’s QuantaMatrix Awarded $2.9 Million
Cyted Health Raises $44 Million in Series B Financing Round
Monod Bio Reaps $1.5 Million Gates Foundation Grant
Octave Bioscience Closes $35 Million in Series C Financing
Financial Highlights: Abbott, Horiba
Abbott Leans on Diabetes Care Segment for Growth in 2025
Diabetes Care – U.S. Market Performance
Diabetes Care – International Market Performance
Diagnostic Snapshot
- Table: Diagnostic Sales, Abbott Laboratories, H1 2024 and 2025 ($ million)
Abbott: Total Company Performance
- Table: Total Sales, Abbott Laboratories, H1 2024 and 2025 ($ million)
Horiba Reported Year-over-Year Growth in H1 ’25 of 4.4%, Increasing by 6.2 Billion Yen; Expects 5.6% Growth Full Year
- Figure: Horiba Sales by Business Segment, H1 2024 vs H1 2025 (million Yen) [Energy & Environment, Bio & Healthcare, Materials & Semiconductor]
- Figure: Horiba H1 2024 & H1 2025 Net Sales, Operating Income, Operating Income Ratio (million Yen)
- Table: Horiba H1 2024 & H1 2025 Geographic Market Performance (million Yen) [Japan, Asia, Americas, Europe, Total]
- Figure: Horiba H1 2024/2025 Bio & Healthcare Division, Geographic Market Performance (million Yen) [Japan, Asia, Americas, Europe]
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
Poland
- Figure: Poland Population Distribution, 2000 through 2100
Poland: Healthcare Investment and IVD Market Overview
IVD Market in Poland
- Figure: Poland – Market Distribution of Broad IVD Segments, 2025 (%) [Immunoassays, Microbiology/Virology, Point-of-Care, Histology/Cytology, Chemistry/Hematology/Coagulation, Other Segments]
Broad-based Company Announcements
Announcements
Roche Secures CE-IVDR for its HER2 CDx Assay
QIAGEN Launches QIAstat -Dx Rise
Agilent Receives FDA Approval
Pearl Diagnostics Receives FDA Clearance for New Assay
Thermo Fisher Captures FDA Approval for NGS-based Companion Diagnostic
Hardy Diagnostics Captures FDA Clearance for NG Test
Diasorin Captures FDA Clearance for Multiplex Molecular Panel
Waters and BD Biosciences & Diagnostics Combine
Thermo Fisher Gains NGS Assay Approval
EpiCypher Launches Single-Molecule Genomics Assay
BioMérieux Secures FDA and CLIA-waiver Clearance
Biocartis Captures FDA Approval for CDx
Volume 4, Issue 5 – Focus on Continuous Glucose Monitoring (CGM)
Market Analysis: Continuous Glucose Monitoring
Overview of Continuous Glucose Monitoring
Market Outlook: Continuous Glucose Monitoring
Overview of Continuous Glucose Monitoring
- Table: Glucose Testing Market, Sales by Broad Category, 2025 and 2030 ($ million) [Glucose Continuous, Glucose OTC, Glucose Professional]
- Figure: Glucose Testing Market, Continuous Glucose Monitor Distribution of Total Sales, 2025 and 2030 [Glucose Continuous and Remaining Glucose Testing Market]
- Figure: Glucose Testing Market, Continuous Glucose Monitor, Estimated Distribution of Total Sales by Modality [rtCGM, isCGM, implantable CGM], 2025 (%)
Regional Market
- Figure: Global Continuous Glucose Testing Market, Estimated Market Value by Region, 2025 ($ million) [Europe, Japan, United States, RoW]
Company Briefs
Abbott Diagnostics
Medtronic
Dexcom
Senseonics
Executive News Briefing
Rapidemic Secures €2.3 Million Grant
StratifAI Secures €12.5 Million for Precision Oncology
Predicta Biosciences Raises $23.4 Million in Series A Funding
Predicta Biosciences Welcomes New CEO
Owlstone Medical Scores $49.1 million
Financial Highlights: Fulgent Genetics, Thermo Fisher Scientific
Fulgent Genetics Posts Strong Performance in Core Revenue
- Figure: Fulgent Genetics’ Financial Results by Q1 2024 Through Q2 2025 ($ million)
- Figure: Fulgent Genetics Distribution of Revenues by Payor, H1 2025
- Figure: Fulgent Genetics Revenue Performance by Geographic Region, H1 2025
Thermo Fisher Maintains Steady Performance in H1 2025
- Table: Thermo Fisher Scientific Sales by Division, 6M 2024 and 6M 2025 ($ million)
- Figure: Thermo Fisher Scientific, Sales by Division, 6M 2024 and 6M 2025 ($ million)
- Table: Thermo Fisher Scientific 2025 Highlights by Quarter, Q1 2025 vs. Q2 2025
Diagnostic Market Mergers, Acquisitions, and Partnership Deals
Partnerships and Collaborations
Mergers and Acquisitions
- Table: Recent Diagnostic Market Mergers, Acquisitions, and Partnership Deals, Dec. 2024-Oct. 2025
Industry Watch
Industry Watch COVID-19/Flu Update
Region Watch
Belgium
- Figure: Belgium: Overall Share of Health Spending (Government/Compulsory Schemes, Out-of-Pocket [OOP], Voluntary Health Insurance [VHI]), 2023
- Figure: Belgium: Market Distribution of Broad IVD Segments, 2025 (%)
Broad-based Company Announcements
Guardant Health Secures FDA Nod for CDx
ClearNote Health Receives UKCA Approval for Two Early Detection Cancer Tests
Xpedite Dx Launches One-Step Viral DNA/RNA Extraction Kit
NeuroKaire Launches Unique Test for MDD
Mirxes Gains NMPA Approval
CND Life Sciences Scores FDA Breakthrough Device Designation
Hologic Gains FDA and CE Mark for Molecular Tests
J&J Intends to Spin Off Orthopedic Business
Roche Receives Go-Ahead From FDA
Volume 4, Issue 6 – Focus on Hematology
Market Analysis: Hematology
Overview of Hematology
Market Outlook: Hematology
- Table: Global Hematology Testing Market, by Product Segment, 2025-2030 ($ million) [Decentralized (POC) Hematology, Laboratory-based Hematology]
- Figure: Global Hematology Testing Market, by Product Segment, 2025-2030 ($ million) [Decentralized (POC) Hematology, Laboratory-based Hematology]
- Table: Lab-Based and Decentralized Hematology Market Summary, 2025
- Figure: Global Hematology Testing Market, Vendor Share, 2025 (%)
Regional Market
- Table: Hematology Analyzer/Reagent Market, by Region, 2025-2030 ($ million) [Asia Pacific, Europe, North America, Rest of World]
- Figure: Hematology Analyzer/Reagent Market, by Setting and Region, 2025 ($ million) [Decentralized (POC) Hematology, Laboratory-based Hematology]
Company Briefs
Danaher
Roche
Sysmex
Executive News Briefing
Detact Diagnostics Awarded $1.6 Million
Hepta Bio Receives $6.7 Million in Seed Funding
arcoris bio Advances NGS Biomarker Technology with CHF 6.3 Million Funding
Circular Genomics Lands $15 Million Series A Financing
Bruker Adds New Board Member
BillionToOne Onboards Chair of Audit Committee
Amplifold Raises €5 Million
Financial Highlights: Exact Sciences
Exact Sciences Highlights Continued Growth Across Cancer Screening and Oncology Testing in Q3 2025
- Figure: Exact Sciences Revenue Mix, by Product Segment, Q3 2024 vs Q3 2025 ($ million) [Precision Oncology, Screening]
- Figure: Exact Sciences Revenue Mix, by Product Segment, by Quarter 2020–Q3 2025 ($ million) [COVID-19 Testing, Fecal Occult Screening, Precision Oncology]
Acquisition Pending – Abbott Laboratories to Acquire Exact Sciences
- Figure: Abbott-Exact Sciences Transaction: Exact Sciences Impact and Business Strategy Outlook
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
Turkey
- Figure: Turkey IVD Market Strength and Challenges Profile
- Turkey IVD Market, Estimated Value by Segment, 2025
Broad-based Company Announcements
Scanogen Granted FDA Breakthrough Device Designation
Beckton Dickinson Receives FDA Clearance and CE Marking
QuidelOrtho Captures FDA Clearance or VITROS Immunodiagnostic
Tosoh Bioscience Snags FDA Clearance
QIAGEN Set to Acquire Parse Biosciences
Thermo Fisher Gains Clearance for the EXENT Analyzer and Assay
Promega OncoMate Wins FDA Approval
PrognomiQ Launches LDT
Roche Lands FDA Clearance with CLIA Waiver for New POC Test
Co-Diagnostics Forms New AI Business Unit
FDA Proposes Reclassification of Companion Diagnostic Assays
Astrin Biosciences Prepares to Launch Certitude Breast
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