진균 검사 키트 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the fungal testing kits market size is expected to grow from USD 3.08 billion in 2025 to USD 3.33 billion in 2026 and is forecast to reach USD 4.95 billion by 2031 at 8.23% CAGR over 2026-2031.

This report is Segmented by Application (Clinical Diagnostics, Food & Agriculture, and More), Technology (Molecular Diagnostics, Immunoassays, and More), Test Type (Molecular Test, Chromogenic Test, and More), Sample Type (Skin, Urine, and More), End User (Diagnostic Laboratories and More), and Geography (North America, Europe, Asia-Pacific, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Fungal Testing Kits Market Trends and Insights

Rising Burden of Invasive Fungal Infections

The growing burden of invasive fungal infections is a core demand driver for the fungal testing kits market. A 2024 review estimated 6.5 million life-threatening invasive fungal infections each year and 3.8 million related deaths. Critically ill populations carry a particularly high risk, and a 2025 review reported more than 1.66 million deaths in critical-care settings. Untreated invasive candidiasis can have a 30-day mortality of 35% to 45%, making delayed diagnosis difficult to accept in acute care. Traditional culture methods can require 3 to 7 days, so hospitals increasingly favor molecular and antigen-based testing. This shift supports higher-value testing workflows and limits the need for vendors to use large price concessions to build volume.

Mycotoxin Compliance and Climate-Related Contamination Risk

Food safety rules are creating recurring demand for fungal testing kits across agricultural supply chains. EU Implementing Regulation 2023/2782 sets sampling and analysis methods for mycotoxin controls, and later amendments extended its coverage to additional food matrices. ISO 23719:2025 established a validated UHPLC-MS/MS method for measuring 17 mycotoxins in cereals and cereal products. These rules encourage laboratories to replace single-toxin testing with systems that can assess several analytes in one run. Climate-related changes in aflatoxin and fumonisin contamination add pressure in maize- and wheat-dependent supply chains across Southern and Eastern Europe. The result is a clearer divide between lower-cost rapid tests and laboratory-grade methods for high-throughput inspection.

Cost and Standardization Barriers for Advanced Workflows

MALDI-TOF mass spectrometry, whole-genome sequencing, and metagenomic sequencing provide details that conventional culture methods cannot match. Their instrument, reagent, and operating costs still limit uptake in many settings. The World Health Organization stated in 2025 that available diagnostics are often slow, inaccurate, expensive, and limited in scope, especially in low- and middle-income countries. This cost gap creates a two-tier pattern, with advanced systems adopted by high-income hospitals while other facilities rely on immunoassays or culture. Incomplete standards for pan-fungal and metagenomic assays also make multisite validation and regulatory review harder. Multiplexed tests that lower the cost per result may ease both barriers by combining species detection and resistance markers in a single run.

Other drivers and restraints analyzed in the detailed report include:

1. Faster Culture-Independent Diagnostics and Resistance Surveillance
2. Decentralized and Near-Patient Testing
3. Infrastructure Gaps and Clinical Interpretation Limits

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

Segment Analysis

Clinical diagnostics held 46.37% of the fungal testing kits market share in 2025. The segment is supported by use in intensive care, oncology, and transplant settings, where fast identification influences antifungal treatment decisions. The WHO identified clinical settings as a primary destination for diagnostic investment because of the mortality associated with critical-priority pathogens such as Candida auris and Aspergillus fumigatus. Food and agriculture is the second-largest application areas. Its demand is supported by the required mycotoxin surveillance under EU rules and FDA action-level enforcement. These obligations make testing a recurring operational need rather than a discretionary purchase.

Environmental monitoring is forecast to grow at a 8.98% CAGR through 2031. The fungal testing kits market size for this application is supported by monitoring needs in pharmaceutical cleanrooms, water systems, and air-handling units. Mold risk in built environments is also receiving greater attention as contamination conditions change. ISO/IEC 17025 accreditation requirements and USP <797> standards are pushing facilities beyond periodic culture plates toward methods with quantitative outputs. Veterinary and cosmetic safety uses remain smaller applications. They are attracting early innovation activity, including testing in food-producing animals where antifungal resistance is emerging as a regulatory concern.

Molecular diagnostics held 38.74% of technology revenue in 2025. PCR-based systems offer results within hours and species-level resolution that culture cannot usually deliver at the same speed. The fungal testing kits market includes qPCR, LAMP, digital droplet PCR, and CRISPR-based assays. A 2025 review described portable molecular tools that support near-real-time fungal identification and resistance prediction. QIAGEN launched its CE-IVDR-certified QIAstat-Dx BCID GPF Plus AMR Panel in April 2026, detecting 20 fungal and gram-positive targets and 10 resistance markers in 1 hour from positive blood cultures. Such panels combine identification and resistance information in one workflow.

Immunoassays are forecast to grow at a 9.23% CAGR through 2031. Their demand reflects the use of beta-D-glucan and galactomannan assays, which can provide infection signals earlier than culture. They can also avoid invasive specimen collection in some settings. The fungal testing kits market growth in immunoassays is supported by their fit with routine clinical screening and decentralized testing. The fungal testing kits market retains substantial culture-kit and consumable volumes in food and environmental testing. Their low cost and simple operation remain appropriate for routine monitoring work.

Complete Report Scope:

• By Application
  • Clinical Diagnostics
  • Food & Agriculture
  • Environmental Monitoring
  • Others
• By Technology
  • Molecular Diagnostics
  • Immunoassays
  • Culture-based Kits & Consumables
• By Test Type
  • Molecular Test
  • Chromogenic Test
  • Immunoassay Test
  • Culture-Based Test
  • Antifungal Susceptibility Test
  • Others
• By Sample Type
  • Skin
  • Urine
  • Vaginal Secretion
  • Blood
  • Others
• By End User
  • Diagnostic Laboratories
  • Hospitals and Clinics
  • Research Institutes
  • Others
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 36.72% of the fungal testing kits market share in 2025. The region has established clinical laboratory networks, reimbursement mechanisms for molecular tests, and active surveillance through the CDC and the Antimicrobial Resistance Laboratory Network. Candida auris clinical cases in the United States exceeded 6,197 in 2024, prompting faster screening and species-specific testing in healthcare settings. The United States accounts for most regional demand, while Canada and Mexico are increasing investment in tertiary-hospital diagnostics. The July 2025 transaction involving Waters and BD's Biosciences and Diagnostic Solutions business was valued at USD 17.5 billion and is expected to focus the combined business on regulated, high-volume diagnostic workflows.

Europe held the second-largest regional position in 2025. Germany is an anchor market, and the EU IVDR transition favors manufacturers that can meet Notified Body compliance requirements. The transition raises the quality threshold for fungal kits, while creating barriers for smaller companies with products subject to revised classification. EU mycotoxin rules provide a legally enforceable base of recurring food-safety testing across Germany, France, Italy, and Spain. QIAGEN launched the QIAstat-Dx BCID GN Plus AMR Panel in Europe in July 2026, extending bloodstream testing coverage to 33 pathogen targets and 28 resistance markers across its panels. This regulatory setting makes certification a key condition for fungal testing kits market commercialization of broad syndromic panels.

Asia-Pacific is forecast to grow at a 13.67% CAGR through 2031. China has established national laboratory requirements for invasive fungal disease through WS/T 497-2026, creating a clearer pathway for commercial procurement. India offers substantial potential because of healthcare expansion and a large population vulnerable to cryptococcal meningitis. Japan, South Korea, and Australia add demand through advanced diagnostics and food safety systems. The Middle East and Africa are supported by healthcare modernization in GCC states, but laboratory infrastructure and cold-chain gaps remain. South America also offers growth through Brazil's agricultural sector and its need for mycotoxin compliance testing.

1. ADT Biotech
2. Agilent Technologies
3. Beckton Dickinson
4. bioMerieux
5. Bio-Rad Laboratories
6. Bruker
7. Charm Sciences Inc.
8. Elitech Group
9. EnviroLogix Inc.
10. Eurofins
11. Roche
12. Gold Standard Diagnostics
13. HiMedia Laboratories Pvt. Ltd.
14. Hygiena LLC
15. Merck
16. Neogen
17. Norgen Biotek
18. QIAGEN
19. Romer Labs Division Holding GmbH
20. Siemens Healthineers
21. Thermo Fisher Scientific
22. VICAM
23. Zymo Research

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 Invasive Fungal Infections
  • 4.2.2 Expansion of Mycotoxin Compliance Testing
  • 4.2.3 Demand for Faster Culture-Independent Diagnostics
  • 4.2.4 Growth of Decentralized and Near-Patient Testing
  • 4.2.5 Antifungal Resistance Surveillance Requirements
  • 4.2.6 Climate-Linked Expansion of Fungal Contamination Risk
• 4.3 Market Restraints
  • 4.3.1 High Cost of Advanced Molecular and Mass Spectrometry Workflows
  • 4.3.2 Limited Diagnostic Infrastructure in Low- and Middle-Income Countries
  • 4.3.3 Incomplete Standardization of Pan-Fungal and Metagenomic Assays
  • 4.3.4 Difficulties Differentiating Colonization from Active Infection
• 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 Buyers
  • 4.7.3 Bargaining Power of Suppliers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Application
  • 5.1.1 Clinical Diagnostics
  • 5.1.2 Food & Agriculture
  • 5.1.3 Environmental Monitoring
  • 5.1.4 Others
• 5.2 By Technology
  • 5.2.1 Molecular Diagnostics
  • 5.2.2 Immunoassays
  • 5.2.3 Culture-based Kits & Consumables
• 5.3 By Test Type
  • 5.3.1 Molecular Test
  • 5.3.2 Chromogenic Test
  • 5.3.3 Immunoassay Test
  • 5.3.4 Culture-Based Test
  • 5.3.5 Antifungal Susceptibility Test
  • 5.3.6 Others
• 5.4 By Sample Type
  • 5.4.1 Skin
  • 5.4.2 Urine
  • 5.4.3 Vaginal Secretion
  • 5.4.4 Blood
  • 5.4.5 Others
• 5.5 By End User
  • 5.5.1 Diagnostic Laboratories
  • 5.5.2 Hospitals and Clinics
  • 5.5.3 Research Institutes
  • 5.5.4 Others
• 5.6 By Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 India
    • 5.6.3.3 Japan
    • 5.6.3.4 Australia
    • 5.6.3.5 South Korea
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East and Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East and Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 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 as Available, Strategic Information, Market Rank/Share for Key Companies, Products & Services, and Recent Developments)
  • 6.3.1 ADT Biotech
  • 6.3.2 Agilent Technologies, Inc.
  • 6.3.3 Becton, Dickinson and Company
  • 6.3.4 bioMerieux SA
  • 6.3.5 Bio-Rad Laboratories, Inc.
  • 6.3.6 Bruker Corporation
  • 6.3.7 Charm Sciences Inc.
  • 6.3.8 ELITechGroup
  • 6.3.9 EnviroLogix Inc.
  • 6.3.10 Eurofins Scientific SE
  • 6.3.11 F. Hoffmann-La Roche Ltd
  • 6.3.12 Gold Standard Diagnostics
  • 6.3.13 HiMedia Laboratories Pvt. Ltd.
  • 6.3.14 Hygiena LLC
  • 6.3.15 Merck KGaA
  • 6.3.16 Neogen Corporation
  • 6.3.17 Norgen Biotek Corp.
  • 6.3.18 QIAGEN N.V.
  • 6.3.19 Romer Labs Division Holding GmbH
  • 6.3.20 Siemens Healthineers AG
  • 6.3.21 Thermo Fisher Scientific Inc.
  • 6.3.22 VICAM
  • 6.3.23 Zymo Research Corporation

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment