United States Legionella Testing Market is estimated to reach US$ 180.1 Million by 2032 | Top key players - Abbott, Becton, Dickinson and Company (BD), BioMérieux SA.

Market Overview:

The Legionella Testing Market is expected to grow at a CAGR of 9.7% during the forecasting period (2024-2031). The Market is growing due to rising global incidences of Legionella outbreaks and stricter water safety regulations across healthcare, commercial, and industrial facilities. According to DataM Intelligence

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The Legionella Testing Market refers to the industry focused on detecting Legionella bacteria in water systems through laboratory-based and rapid diagnostic methods. It includes testing solutions, equipment, and services used across healthcare facilities, industrial sites, commercial buildings, and municipal water systems to prevent outbreaks of Legionnaires' disease. The market supports regulatory compliance, risk assessment, and continuous monitoring of water quality.

Industry Recent Developments: United States

✅ September 2025: Rapid and non-invasive diagnostic technologies such as PCR and urine antigen tests are increasingly adopted in clinical settings, expanding the in vitro diagnostics (IVD) testing segment with faster and more reliable Legionella detection.

✅ October 2025: Stricter regulatory and public health standards drove rapid growth in diagnostic laboratories, with more outsourcing of Legionella testing services to meet infection control requirements.

✅ November 2025: Rising clinical trials focused on pneumonia patients are fueling innovations in rapid testing kits and molecular diagnostics to enhance patient safety, particularly in hospitals and corporate building settings.

Industry Recent Developments: Japan

✅ September 2025: The water testing segment leads market revenue growth, supported by mandatory water safety testing regulations and heightened awareness of Legionella risks in public and healthcare facilities.

✅ October 2025: Integration of AI and machine learning technologies in Legionella diagnostics improves environmental testing efficiency and accuracy in healthcare and industrial sectors.

✅ November 2025: The Japan Legionella Testing Kits Market is growing with projections indicating a CAGR around 9.3%, driven by rising demand for innovative and accessible testing solutions across healthcare and water safety monitoring applications.

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FDA Approvals / Clearances (2025):

✅ No major new FDA 510(k) clearances specifically for a novel Legionella IVD listed in 2025 were found in publicly available FDA 510(k) summaries during my search. Many routine 510(k) actions in 2025 were for respiratory or multiplex pathogen panels rather than Legionella-specific IVDs.

✅ FDA device actions (recall/notifications): Trinity Biotech issued an URGENT: MEDICAL DEVICE Notification / recall related to its Legionella urinary antigen ELISA in mid-2025 (classified as a Class II device action; customers were advised to inspect conjugate bottles and could request replacements). This is the clearest FDA-listed action specifically referencing a Legionella test in 2025.

Mergers & Acquisitions (Notable 2025 deals):

✅ 3M - acquisition of BioMonitor (Feb 2025): Market research summaries report that 3M completed the acquisition of BioMonitor (a rapid-Legionella detection provider) in February 2025, positioning 3M to expand its water-safety/rapid-detection portfolio. I could not locate a widely-indexed standalone 3M press release in open sources during the search (the deal is reported in industry market reports). Recommend checking 3M investor/press pages or the target company's site for the primary announcement.

✅ Ongoing sector consolidation: Multiple market reports note steady M&A activity (larger diagnostics/water-testing groups acquiring smaller rapid-test or molecular specialists) through 2024-2025 (examples of transactions reported by industry analysts).

Regulatory Validations / Approvals (Europe and standards bodies) in 2025:

✅ AFNOR validation (Bio-Rad): Bio-Rad received AFNOR third-party validation for new Legionella PCR extraction protocols (iQ-Check Legionella Aquadien short protocols, including a Free DNA Removal Solution) - a significant third-party validation relevant to laboratories using molecular Legionella assays.

✅ CE / IVDR transition context (Europe): The landscape for CE-marked IVDs changed in 2024-2025 because of IVDR implementation and CE-mark validity issues; industry notices flagged CE-marked IVDs having limited validity windows through 26 May 2025 as the new regulations phased in. This affected how vendors placed Legionella IVD kits on EU markets in 2025.

✅ General: growth of PCR-based / molecular approvals: Industry research notes several CE or national approvals for PCR-based Legionella kits in 2024-2025 (market launches and regulatory clearances at national/CE levels), reflecting a shift from culture/UAT toward molecular methods in routine water testing. For specific CE registrations, check the individual vendor announcements.

Major Key Players:

1. Abbott
A global healthcare leader offering advanced water testing and diagnostic solutions. Its technologies support rapid detection and monitoring of microbial contaminants.

2. Becton, Dickinson and Company (BD)
BD provides high-precision diagnostic instruments and microbiological testing kits. Its solutions enhance accuracy and efficiency in waterborne pathogen detection.

3. BioMérieux SA
A major player in in-vitro diagnostics specializing in microbial identification systems. The company delivers robust Legionella and water quality testing platforms.

4. Idexx Laboratories Inc.
IDEXX is widely recognized for innovative water testing products, including rapid microbial detection kits. Its solutions are trusted for regulatory compliance and routine monitoring.

5. Merck Millipore
Merck offers advanced filtration, culture media, and water testing technologies. Its products support reliable microbial analysis and quality control across industries.

6. Thermo Fisher Scientific Inc.
Thermo Fisher provides comprehensive water testing instruments and molecular diagnostic tools. Its broad portfolio enables high-sensitivity detection of waterborne pathogens.

Segments Covered in the Legionella Testing Market:

By Test Type: Urinary Antigen Test (UAT), Culture Methods, Direct Fluorescent Antibody Test (DFA), Polymerase Chain Reaction (PCR), Others.

By Application: Clinical Testing Methods, Environmental Testing Methods.

By Antibiotics: Azithromycin, Rifampin, Quinolones, Others.

By End-user: Hospitals, Diagnostic centers, Others.

Regional Analysis for Legionella Testing Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Chapter Outline:

⏩ Market Overview: It contains five chapters, as well as information about the research scope, major manufacturers covered, market segments, Legionella Testing market segments, study objectives, and years considered.

⏩ Market Landscape: The competition in the Global Legionella Testing Market is evaluated here in terms of value, turnover, revenues, and market share by organization, as well as market rate, competitive landscape, and recent developments, transaction, growth, sale, and market shares of top companies.

⏩ Companies Profiles: The global Legionella Testing market's leading players are studied based on sales, main products, gross profit margin, revenue, price, and growth production.

⏩ Market Outlook by Region: The report goes through gross margin, sales, income, supply, market share, CAGR, and market size by region in this segment. North America, Europe, Asia Pacific, Middle East & Africa, and South America are among the regions and countries studied in depth in this study.

⏩ Market Segments: It contains the deep research study which interprets how different end-user/application/type segments contribute to the Legionella Testing Market.

⏩ Market Forecast: Production Side: In this part of the report, the authors have focused on production and production value forecast, key producers forecast, and production and production value forecast by type.

⏩ Research Findings: This section of the report showcases the findings and analysis of the report.

⏩ Conclusion: This portion of the report is the last section of the report where the conclusion of the research study is provided.

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Frequently asked questions:

➠ What is the global sales value, production value, consumption value, import and export of Legionella Testing market?

➠ Who are the global key manufacturers of the Legionella Testing Industry? How is their operating situation (capacity, production, sales, price, cost, gross, and revenue)?

➠ What are the Legionella Testing market opportunities and threats faced by the vendors in the global Legionella Testing Industry?

➠ Which application/end-user or product type may seek incremental growth prospects? What is the market share of each type and application?

➠ What focused approach and constraints are holding the Legionella Testing market?

➠ What are the different sales, marketing, and distribution channels in the global industry?

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