체외진단약 사업 전망(2026년)

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:

• 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 of Contents

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 Euro-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

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

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