체외진단(IVD) 동향과 시장 업데이트(2025년)

Kalorama Information's In Vitro Diagnostic (IVD) Trends and Market Update, 2025 delivers critical insights into the evolving IVD market amid global economic uncertainties. Published twice annually-in April and in December following the release of Kalorama's flagship study, The Worldwide Market for In Vitro Diagnostics (IVD), 18th Edition-this report serves as both a standalone resource and a strategic companion for decision-makers in the diagnostics industry.

The 2025 IVD market continues its growth trajectory, fueled by technological breakthroughs and rising healthcare demands. Innovations in next-generation sequencing (NGS), microfluidics, and precision medicine are transforming diagnostics, enabling highly accurate, sensitive, and personalized testing for complex conditions such as cancer and genetic disorders. The surge in companion diagnostics and multiplex testing underscores a shift toward patient-centric care and deeper disease insights.

Key growth segments attracting industry attention include Point-of-Care testing, cancer diagnostics, companion diagnostics technologies, immunochemistry, and mass spectrometry. Nucleic acid assays, gene testing, and HPV molecular diagnostics are poised for significant expansion, shaping the future of IVD.

This report provides actionable intelligence on:

• Market drivers and major industry trends
• New product developments shaping innovation
• Competitive landscape and key player strategies
• Emerging opportunities and high-growth segments

With expert analysis and up-to-date data, Kalorama equips executives, industry leaders, and investors with the tools to navigate regulatory challenges, capitalize on technological advancements, and identify profitable opportunities in the dynamic IVD sector.

Table of Contents

Chapter 1: Worldwide IVD Market - December 2025 Update

• About Kalorama Information
• IVD Market Demand and Growth
  • Figure 1-1: Q1-Q3 IVD Segment Performance Commentary, 2025 [Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay, Microbiology (Molecular), Point-of-Care (POC)]
  • Table 1-1: Global In Vitro Diagnostic Sales by Product Market, 2025 ($ million) [Blood Bank Molecular - NAT Screens; Blood Grouping/Typing; Circulating Tumor Cells; Clinical Chemistry; Coagulation (PT/INR); Coagulation, Molecular; D-dimer; Diabetes HbA1c, lab; Drugs of Abuse; Hematology - Core Lab; Histology/Cytology; HPV, Molecular; Immuno - Blood Bank Screening; Immuno-Infectious Disease; Immunoassays - Non-isotopic; Mass Spectrometry; Microbiology (ID/AST); Microbiology (Molecular); Microbiology - Mass Spectrometry; NAAT - Oncology; Nucleic Acid Assays - Genetic/Inherited; Other Immunos; POC, OTC Diabetes; POC, OTC Other; POC, Professional/Hospital]
  • Figure 1-2: IVD Segment Performance, Q1 2025-Q4 2025 estimated ($ million) [Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay, Microbiology, Point-of-Care (POC), Other]
  • Figure 1-3: IVD Segment Performance, Total Market Value, 2025 estimated ($ million) [Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay, Microbiology, Point-of-Care (POC), Other]
  • COVID-19 Diagnostic Markets
    • Table 1-2: COVID-19 Product Sales, 2025 ($ million) [Immunoassay (Antigen, Serology), Molecular, Rapid]
• Effect of COVID-19 on Market Segments
  • Table 1-3: IVD Market excluding and including COVID-19, 2025 ($ million)
  • Figure 1-4: IVD Market Distribution, by Segment, 2025 (%) [COVID-19 Assays and Instruments, IVD Market excluding COVID-19 Assays and Instruments]
  • Figure 1-5: IVD Market by COVID-19 and non-COVID markets, Quarterly Performance, 2025 estimated ($ million)
  • Table 1-4: Global In Vitro Diagnostic Market - YoY Growth, 2024-2025 (%) [Blood Bank Molecular - NAT Screens, Blood Grouping/Typing, Circulating Tumor Cells, Clinical Chemistry, Coagulation (PT/INR), Coagulation, Molecular, D-dimer, Diabetes HbA1c, Lab, Drugs of Abuse, Hematology - Core Lab, Histology/Cytology, HPV, Molecular, Immuno - Blood Bank Screening, Immuno - Infectious Disease, Immunoassays- non-isotopic, Microbiology (ID/AST), Microbiology (Molecular), Microbiology - Mass Spectrometry, NAAT - Oncology, Nucleic Acid Assays - Genetic/Inherited, Other Immunos, POC, OTC Diabetes, POC, OTC Other, POC, Professional/Hospital]
  • Figure 1-6: Global In Vitro Diagnostic Market - YoY Growth 2024-2025 (%) [Blood Bank Molecular - NAT Screens, Blood Grouping/Typing, Circulating Tumor Cells, Clinical Chemistry, Coagulation (PT/INR), Coagulation, Molecular, D-dimer, Diabetes HbA1c, Lab, Drugs of Abuse, Hematology - Core Lab, Histology/Cytology, HPV, Molecular, Immuno - Blood Bank Screening, Immuno - Infectious Disease, Immunoassays- non-isotopic, Microbiology (ID/AST), Microbiology (Molecular), Microbiology - Mass Spectrometry, NAAT - Oncology, Nucleic Acid Assays - Genetic/Inherited, Other Immunos, POC, OTC Diabetes, POC, OTC Other, POC, Professional/Hospital

Chapter 2: Product Trends and New Developments

• Selected New - Q3 2025 - Core IVD Product Launches, Developments and Trends
  • Immunoassay
  • Mass Spectrometry
  • Molecular
  • Personalized Medicine
  • POC
  • Coagulation
  • Flow Cytometry
  • Sequencing
• Selected COVID-19 Developments - Q3 2025
  • Antigen/Antibody
  • Molecular

Chapter 3: Top IVD Market Participant Results

• Selected Competitive Leader Updates
  • Figure 3-1: IVD Segment Growth by Leading Competitors, Change in Sales 2024-2025 (%)
  • Figure 3-2: Changes in Market Distribution for IVD Sales, 2022-2025 estimated (%)
  • Figure 3-3: Comparison of Total Diagnostic Sales for Abbott vs Roche, 2023-2025 estimated ($ million)
• Q3 2025 M&A Activity
  • Table 3-1: Q3 2025 Merger and Acquisition Activity
• Abbott Laboratories
  • Table 3-2: Abbott Corporate Summary
• Becton Dickinson and Co
  • Table 3-3: Becton Dickinson Corporate Summary
• bioMerieux SA
  • Table 3-4: bioMerieux Corporate Summary
• Danaher Corporation
  • Table 3-5: Danaher Corporation Summary
• Dexcom, Inc
  • Table 3-6: Dexcom Corporate Summary
• Exact Sciences
  • Table 3-7: Exact Sciences Corporate Summary
• Roche Diagnostic
  • Table 3-8: Roche Diagnostic Corporate Summary
• Siemens Healthineers
  • Table 3-9: Siemens Healthineers Corporate Summary
• Sysmex Corporation
  • Table 3-10: Sysmex Corporate Summary
• Thermo Fisher Scientific
  • Table 3-11: Thermo Fisher Scientific Corporate Summary

Chapter 4: New Opportunities

• Personalized Medicine
• Genetic Testing in Disease
• Microbiome
• IVD Digital Diagnostics
• Tariffs