감염증 체외진단 시장 : 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the infectious disease in vitro diagnostics market size is projected to be USD 2.45 billion in 2025, USD 2.63 billion in 2026, and reach USD 3.87 billion by 2031, growing at a CAGR of 6.46% from 2026 to 2031.

This report is Segmented by Product (Reagents, Instruments, Software), Testing Type (Lab, POC), Sample (Blood/Serum, Urine, Other), Disease (Hepatitis, and More), Technology (Immunodiagnostics, PCR, NGS, INAAT, Other), Application (Diagnostics, Screening), End User (Diagnostic Laboratories, and More), and Geography (North America, Europe, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Infectious Disease In Vitro Diagnostics Market Trends and Insights

Rising Burden of Respiratory and Bloodstream Infections

The infectious disease in vitro diagnostics market continues to draw its strongest base demand from the persistence of respiratory, bloodstream, urinary, and gastrointestinal infections across both hospital and community settings. The WHO GLASS 2025 report analyzed more than 23 million bacteriologically confirmed cases reported by 110 countries from 2016 through 2023, and it showed that drug-resistant pathogen proportions were stable or rising across several major infection categories. This pattern matters for the infectious disease in vitro diagnostics market because high-confirmation settings are concentrated in countries with better laboratory infrastructure, while regions with heavier disease burden still remain underdiagnosed. That gap keeps demand tied not only to immediate test volumes but also to future laboratory build-out across South Asia, sub-Saharan Africa, and parts of Latin America. Hospital-acquired infections add a second layer of demand because bloodstream infections require rapid organism identification and earlier antimicrobial selection to guide the first 48 hours of treatment. The infectious disease in vitro diagnostics market, therefore, benefits from both higher infection incidence and a widening clinical need for faster and more reliable laboratory decision support.

Shift Toward Syndromic Multiplex Testing Platforms

The infectious disease in vitro diagnostics market is seeing a clear shift toward syndromic multiplex testing as hospitals try to combine faster diagnosis with tighter use of staff and instrument time. QIAGEN received FDA clearance in March 2026 for gastrointestinal panels on the QIAstat-Dx Rise system, and the broader QIAstat-Dx platform had more than 5,200 instruments installed across over 100 countries. That installed base matters because a platform that supports respiratory, gastrointestinal, and emerging pathogen panels allows hospitals to consolidate menu purchases and commit to repeat reagent spending over multi-year periods. bioMerieux received IVDR CE marking in March 2026 for its BIOFIRE SPOTFIRE R/STplus Panel, which can detect 15 pathogens in 15 minutes at the point of care. Faster multiplex testing also supports antibiotic stewardship because clinicians can reduce broad empirical prescribing when pathogen identification arrives earlier in the care cycle. The infectious disease in vitro diagnostics market is therefore gaining from a buying logic that now links these platforms to cost control, throughput, and treatment quality rather than to test menu expansion alone.

High Cost of Molecular Platforms and Assay Consumables

The infectious disease in vitro diagnostics market still faces a major access barrier from the cost of molecular systems and the consumables needed to run them. Multiplex syndromic panels often cost 5 to 10 times more per test than single-target lateral flow formats, which keeps many primary care and community settings in lower-income regions outside the practical buyer pool. A 2026 study indexed on ScienceDirect described a portable microfluidic nucleic acid amplification system with sample-to-answer results in under 30 minutes at a per-test cost of USD 1.5. That contrast shows how far much of the infectious disease in vitro diagnostics market still is from price points that can scale across high-burden low-resource settings. When hospitals cannot afford broad panel testing, they often substitute cheaper single-target methods that can miss co-infections and weaken treatment choice. Reagent rental and volume-linked pricing help at the margin, but they have not yet solved the affordability gap that limits wider market penetration.

Other drivers and restraints analyzed in the detailed report include:

1. Expansion of Decentralized and Point-of-Care Testing Networks
2. Rising Adoption of Automated Molecular and Immunoassay Workflows
3. Stringent Regulatory Review and Local Validation Requirements

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Reagents, kits, and consumables held 48.31% of revenue in 2025, which made them the largest product category in the infectious disease in vitro diagnostics market. Their position reflects a business model in which instruments are frequently placed under subsidized terms while long-term consumable purchasing drives the revenue stream. Once a laboratory validates a cartridge or reagent format, the switching burden becomes high because revalidation, retraining, and contract changes all raise replacement costs. That dynamic gives the infectious disease in vitro diagnostics market a stable, recurring layer that is less volatile than one-time capital equipment purchases. Instruments remained the second major category and covered high-throughput immunoanalyzers, PCR systems, MALDI-TOF platforms, and automated sample processors. These systems still shape laboratory buying decisions because installed hardware determines which menus and workflow formats a site can support over time.

Software and services are projected to grow at a 8.35% CAGR through 2031, but they moved into a more strategic role within the infectious disease in vitro diagnostics market as a result of connectivity and surveillance integration becoming more important. Laboratories are increasingly valuing LIS connectivity modules, antimicrobial resistance data links, and interpretation support services as part of broader contracts instead of stand-alone purchases. This shift gives large suppliers another way to deepen account retention after the initial instrument sale. It also strengthens the position of companies that can offer a multi-layer package of hardware, assays, and workflow software instead of a single test format. Within the infectious disease in vitro diagnostics industry, suppliers that pair menu breadth with service integration are better placed to defend margins when instrument pricing becomes more competitive. Quality system demands under ISO 13485 and FDA manufacturing rules also reinforce the advantage of established suppliers that can absorb compliance costs without disrupting supply continuity.

Laboratory testing accounted for 61.68% of revenue in 2025, which kept centralized laboratories at the core of the infectious disease in vitro diagnostics market. High-complexity workups such as HIV viral load monitoring, hepatitis C genotyping, tuberculosis resistance profiling, and STI confirmation still rely heavily on hospital core labs and independent reference facilities. These settings retain an advantage because they operate with validated quality controls, specialist staff, and deep information system integration. At the same time, point-of-care testing is projected to grow at a 9.73% CAGR through 2031, making it the fastest-growing testing type in the infectious disease in vitro diagnostics market. The demand shift is less about replacing central labs and more about moving selected use cases into faster and more accessible care settings.

A 2025 article in Diagnostics described AI-enhanced point-of-care systems that reduced time-to-result from 15 minutes to as little as 2 minutes in prototype settings. WHO support for near-point-of-care tuberculosis molecular diagnostics in 2026 further widened the case for decentralized testing in endemic regions. DiaSorin's CLIA-waived LIAISON NES platform also showed how regulatory progress can move molecular testing into urgent care clinics and physician offices that do not operate under high-complexity laboratory structures. These changes improve speed and convenience, but they do not remove the role of central laboratories for confirmatory and high-volume testing. Within the infectious disease in vitro diagnostics market, the strongest suppliers are those that can serve both near-patient and centralized settings with connected menu strategies. This also reduces the risk that point-of-care growth simply cannibalizes laboratory revenue rather than expanding the total testing base.

Blood, serum, and plasma represented 52.42% of revenue in 2025, which kept this sample group at the center of the infectious disease in vitro diagnostics market size. The category remains strong because bloodstream infection diagnosis, HIV monitoring, hepatitis serology, and syphilis screening are deeply embedded in blood-based clinical pathways. Many of these tests also sit inside mandatory antenatal, transfusion, and pre-procedure screening frameworks, which makes demand less sensitive to short-term budget changes. Urine remained the second meaningful sample type because it supports urinary tract infection diagnosis, STI confirmation, and newer tuberculosis detection approaches. This sample mix shows that the infectious disease in vitro diagnostics market still depends on specimen types that fit established clinical practice and standardized processing routes.

Other sample types are projected to grow at a 8.98% CAGR through 2031, making them the fastest-expanding category in the infectious disease in vitro diagnostics market. WHO guidance on HPV DNA genotyping endorsed self-collected cervical samples and home collection in appropriate screening pathways, which expands testing outside the clinic visit model. bioMerieux also validated its BIOFIRE SPOTFIRE R/STplus panels for nasopharyngeal, throat, and anterior nasal swabs, which improves access in near-patient respiratory testing. Flexible sampling helps widen utilization because it aligns better with self-collection, outpatient use, and low-infrastructure testing workflows. It also allows suppliers in the infectious disease in vitro diagnostics market to target screening programs and community channels that are less dependent on phlebotomy and hospital-based specimen handling. Over time, broader specimen acceptance should support both access and repeat testing frequency in selected disease areas.

Complete Report Scope:

• By Product and Service
  • Reagents, Kits, and Consumables
  • Instruments
  • Software and Services
• By Type of Testing
  • Laboratory Testing
  • Point-of-Care Testing
• By Sample Type
  • Blood, Serum, and Plasma
  • Urine
  • Other Sample Types
• By Disease Type
  • Hepatitis
  • HIV
  • Hospital-Acquired Infections
  • Mosquito-Borne Diseases
  • HPV
  • Chlamydia trachomatis
  • Neisseria gonorrhea
  • Tuberculosis
  • Influenza
  • Syphilis
  • Other Infectious Diseases
• By Technology
  • Immunodiagnostics
  • Clinical Microbiology
  • Polymerase Chain Reaction
  • Isothermal Nucleic Acid Amplification Technology
  • DNA Sequencing and Next-Generation Sequencing
  • DNA Microarray
  • Other Technologies
• By Clinical Application
  • Diagnostics
  • Screening
• By End User
  • Diagnostic Laboratories
  • Hospitals and Clinics
  • Academic and Research Institutions
  • Other End Users
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 40.86% of revenue in 2025, which made it the largest regional segment in the infectious disease in vitro diagnostics market. The region benefits from deep reimbursement coverage, a large installed base of automated molecular systems, and hospital structures that can absorb complex testing workflows. CMS updated the Clinical Laboratory Fee Schedule under the Consolidated Appropriations Act of 2026, delaying payment reductions through the end of 2026 and capping annual cuts at 15% starting in 2027. That policy gives laboratories near-term visibility even though future reimbursement pressure remains part of the operating outlook. CMS MolDX guidance effective April 2026 also tightened ICD-10 documentation requirements for syndromic respiratory and gastrointestinal panel claims. This favors suppliers that can support strong clinical evidence and coding discipline across customer accounts. Canada and Mexico remain smaller in value terms, but both continue to build demand through HIV, tuberculosis, and HPV testing pathways that align with broader regional public health priorities.

Europe remained the second-largest region in the infectious disease in vitro diagnostics market and continued to rely heavily on centralized hospital laboratory networks. Germany, the United Kingdom, France, Italy, and Spain anchor most of the region's structured testing volume through established hospital procurement systems and broad clinical adoption of molecular and immunoassay menus. IVDR remains the single strongest policy force shaping commercialization in the region because it raises the burden of evidence and re-registration across assay portfolios. bioMerieux's March 2026 CE marking for BIOFIRE SPOTFIRE respiratory and sore throat panels showed how companies with scale are moving to preserve and extend their menu positions under the new framework.

Asia-Pacific is projected to grow at a 9.58% CAGR through 2031, making it the fastest-growing regional segment in the infectious disease in vitro diagnostics market. The region combines a high infectious disease burden with expanding laboratory infrastructure and maturing regulatory pathways for localized diagnostics. India recorded 26.2 lakh tuberculosis cases in 2024, which keeps demand strong for molecular TB testing, drug resistance profiling, and near-patient workflows aligned with 2026 WHO guidance. China also remains important because infectious disease testing accounted for 41.8% of the country's IVD revenue in 2025, supported by mandatory screening for HIV, hepatitis B and C, syphilis, and tuberculosis in several care pathways. Government-supported tender programs and hospital digitization are helping the shift from manual methods to automated platforms in Tier-2 and Tier-3 city hospitals. The Middle East and Africa remain split between high-throughput investment in GCC states and donor-backed testing networks across sub-Saharan Africa. South America continues to gain from STI, dengue, and hepatitis screening expansion, although procurement fragmentation and currency volatility still moderate capital investment speed.

1. Abbott Laboratories
2. Beckton Dickinson
3. Bio-Rad Laboratories
4. bioMerieux
5. Co-Diagnostics
6. Danaher
7. DiaSorin
8. Roche
9. Grifols
10. Hologic
11. Meril Life Science
12. Molbio Diagnostics Limited
13. Orasure Technologies
14. QIAGEN
15. QuidelOrtho
16. SD Biosensor, Inc.
17. Seegene
18. Siemens Healthineers
19. Sysmex
20. Thermo Fisher Scientific
21. Trinity Biotech plc

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Burden of Respiratory and Bloodstream Infections
  • 4.2.2 Shift Toward Syndromic Multiplex Testing Platforms
  • 4.2.3 Expansion of Decentralized and Point-of-Care Testing Networks
  • 4.2.4 Rising Adoption of Automated Molecular and Immunoassay Workflows
  • 4.2.5 Integration of AI-Enabled Interpretation and Workflow Software
  • 4.2.6 Increased Hospital Preparedness for Outbreak Surveillance and AMR Monitoring
• 4.3 Market Restraints
  • 4.3.1 High Cost of Molecular Platforms and Assay Consumables
  • 4.3.2 Stringent Regulatory Review and Local Validation Requirements
  • 4.3.3 Reimbursement Pressure on Non-Urgent and Low-Volume Testing
  • 4.3.4 Skilled Labor Shortages for Complex Diagnostics and Data Interpretation
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Industry Rivalry

5 Market Size & Growth Forecasts

• 5.1 By Product and Service
  • 5.1.1 Reagents, Kits, and Consumables
  • 5.1.2 Instruments
  • 5.1.3 Software and Services
• 5.2 By Type of Testing
  • 5.2.1 Laboratory Testing
  • 5.2.2 Point-of-Care Testing
• 5.3 By Sample Type
  • 5.3.1 Blood, Serum, and Plasma
  • 5.3.2 Urine
  • 5.3.3 Other Sample Types
• 5.4 By Disease Type
  • 5.4.1 Hepatitis
  • 5.4.2 HIV
  • 5.4.3 Hospital-Acquired Infections
  • 5.4.4 Mosquito-Borne Diseases
  • 5.4.5 HPV
  • 5.4.6 Chlamydia trachomatis
  • 5.4.7 Neisseria gonorrhea
  • 5.4.8 Tuberculosis
  • 5.4.9 Influenza
  • 5.4.10 Syphilis
  • 5.4.11 Other Infectious Diseases
• 5.5 By Technology
  • 5.5.1 Immunodiagnostics
  • 5.5.2 Clinical Microbiology
  • 5.5.3 Polymerase Chain Reaction
  • 5.5.4 Isothermal Nucleic Acid Amplification Technology
  • 5.5.5 DNA Sequencing and Next-Generation Sequencing
  • 5.5.6 DNA Microarray
  • 5.5.7 Other Technologies
• 5.6 By Clinical Application
  • 5.6.1 Diagnostics
  • 5.6.2 Screening
• 5.7 By End User
  • 5.7.1 Diagnostic Laboratories
  • 5.7.2 Hospitals and Clinics
  • 5.7.3 Academic and Research Institutions
  • 5.7.4 Other End Users
• 5.8 By Geography
  • 5.8.1 North America
    • 5.8.1.1 United States
    • 5.8.1.2 Canada
    • 5.8.1.3 Mexico
  • 5.8.2 Europe
    • 5.8.2.1 Germany
    • 5.8.2.2 United Kingdom
    • 5.8.2.3 France
    • 5.8.2.4 Italy
    • 5.8.2.5 Spain
    • 5.8.2.6 Rest of Europe
  • 5.8.3 Asia-Pacific
    • 5.8.3.1 China
    • 5.8.3.2 Japan
    • 5.8.3.3 India
    • 5.8.3.4 Australia
    • 5.8.3.5 South Korea
    • 5.8.3.6 Rest of Asia-Pacific
  • 5.8.4 Middle East & Africa
    • 5.8.4.1 GCC
    • 5.8.4.2 South Africa
    • 5.8.4.3 Rest of Middle East & Africa
  • 5.8.5 South America
    • 5.8.5.1 Brazil
    • 5.8.5.2 Argentina
    • 5.8.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market-level Overview, Core Segments, Financials, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
  • 6.3.1 Abbott Laboratories
  • 6.3.2 Becton, Dickinson and Company
  • 6.3.3 Bio-Rad Laboratories, Inc.
  • 6.3.4 bioMerieux SA
  • 6.3.5 Co-Diagnostics, Inc.
  • 6.3.6 Danaher Corporation
  • 6.3.7 DiaSorin S.p.A.
  • 6.3.8 F. Hoffmann-La Roche Ltd.
  • 6.3.9 Grifols, S.A.
  • 6.3.10 Hologic, Inc.
  • 6.3.11 Meril Life Sciences Pvt. Ltd.
  • 6.3.12 Molbio Diagnostics Limited
  • 6.3.13 OraSure Technologies, Inc.
  • 6.3.14 QIAGEN N.V.
  • 6.3.15 QuidelOrtho Corporation
  • 6.3.16 SD Biosensor, Inc.
  • 6.3.17 Seegene Inc.
  • 6.3.18 Siemens Healthineers AG
  • 6.3.19 Sysmex Corporation
  • 6.3.20 Thermo Fisher Scientific Inc.
  • 6.3.21 Trinity Biotech plc

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment