U.S. Legionella Testing Market Size, Share & COVID-19 Impact Analysis, By Type (Culture Media, Urine Antigen Testing (UAT), Polymerase Chain Reaction (PCR), Serology, and Direct Fluorescent Antibody (DFA) Test), By End User (Hospitals & Clinics, Clinical Laboratories, and Others), and Country Forecast, 2023-2030

The U.S. legionella testing market size was worth USD 103.6 million in 2022 and is projected to grow at a CAGR of 9.2% during the forecast period. 

The significant rise in the cases of legionnaire infection or Pontiac fever cases in the country is increasing the demand for legionella testing. According to the World Health Organization (WHO) 2022 data, in the U.S., around 10-15 cases of legionnaire infection are detected per million population per year. In addition, there is a rising awareness among the population regarding the proper management of the disease.

The symptoms of the disease are similar to other types of pneumonia, which makes testing an essential step for its proper treatment and management. Furthermore, the rising emphasis on proper sanitization, advancements in bacterial testing, and growing efforts by the government to increase legionella testing in the country, among others, are a few factors contributing to the U.S. legionella testing market growth.

The market witnessed slow growth during the COVID-19 pandemic due to disruptions in the demand and supply chain, a temporary halt in manufacturing testing kits, and the shift of healthcare facilities toward managing the pandemic.

LATEST TRENDS

Rising Adoption of Rapid Testing Methods is the Latest Trend

Conventional culture methods to detect legionella bacteria are tedious and time-consuming. Hence, in order to facilitate the proper detection of legionnaire disease, manufacturers are continuously trying to develop efficient molecular testing products with high sensitivity and specificity.

There is an increasing shift among healthcare professionals toward utilizing fast and efficient test methods such as urine antigen tests and polymerase chain reaction (PCR) tests. According to various research articles, it has been demonstrated that polymerase chain reaction (PCR) is the fast and accurate testing method for detecting Legionella from environmental samples with sensitivity and specificity of 94.0% and 72.0%, respectively.

DRIVING FACTORS

Strict Guidelines for Regular Water Testing to Boost the Market Growth 

Legionella bacteria most commonly grow in water systems such as stagnant water, buildings’ water systems, and swimming pools, posing a health risk and concern to the public. The rising concern of the government regarding the management of sudden legionellosis outbreak and reducing the risk of mortality, is driving the adoption of these tests.  According to the Georgia Department of Public Health, in July 2019, there were 11 lab-confirmed cases of legionnaires infection and around 55 probable (positive antigen tests) cases related to the sudden outbreak of Legionella disease at the Sheraton Hotel located in Georgia.

In order to prevent such outbreaks, the U.S. government is continuously implementing stringent regulations for regular water testing.

• For instance, in the year 2017, the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) issued regulatory guidelines to reduce the risk of Legionella in healthcare facilities' water systems and prevent the outbreaks of legionnaires disease.

Furthermore, until April 2022, one city and four states in the country had established legionella testing regulations. In addition, five states had proposed the testing legislation.

The above-mentioned factors are likely to increase the demand for these products in the country, thereby propelling the growth of the market.

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According to the Legionnaires’ Disease Surveillance Summary Report, U.S., published by the CDC, the total number of legionnaires disease cases was about  8,890 in the year 2019 with the highest incidence rate in Ohio, followed by Michigan and New York, among others.

RESTRAINING FACTORS

Strict Regulatory Approvals of the Product Coupled with Product Recalls to Hamper the Market Growth 

The legionella testing products are classified under class II medical devices by the U.S. FDA. Class II medical devices are devices with special control in addition to general controls. Special controls are generally specific to devices and include various parameters such as performance standards, postmarket surveillance, pre-market data requirements, and others. The manufacturers of class II medical devices are required to submit documents related to the safety and effectiveness of the product. Thus, the strict regulatory approval process is leading to limited new product approvals in the country, thereby limiting market growth.

Furthermore, the recalls of a few products is likely to impede the market growth during the forecast period as it hampers the brand name and adoption of the product.

• For instance, in March 2017, the U.S. FDA recalled the Legionella IFA Substrate Slide developed by Focus Diagnostics (now a part of DiaSorin Molecular LLC) after the submission of the CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that Legionella IFA device was not 510(k) exempt.

SEGMENTATION

By Type Analysis

Based on type, the U.S. legionella testing market is segmented into urine antigen testing, polymerase chain reaction (PCR), serology tests, culture media, and direct antibody fluorescent methods.

The urine antigen testing type segment accounted for the dominant share in 2022. The dominance of the segment is attributed to various benefits over other tests including quick results and are non-invasive with high specificity, among others. In addition, these tests are cost-effective and preferred more among the population.

• For instance, according to various laboratories, the cost of urine antigen tests for Legionella in the U.S. is around USD 66 and for urine polymerase chain reaction tests, the cost is about USD 159.

By End User Analysis

Based on end user, the U.S. market is classified into hospitals and clinics, clinical laboratories, and others which comprises environmental testing sites.

The clinical laboratories segment accounted for the largest share in 2022. This was due to the growing incidence of legionnaire’s disease and the increase in laboratory testing.

• According to the Centers for Disease Control and Prevention data, approximately 70% of the medical decision in the U.S. depends on the laboratory test results. Also, in the U.S., an estimated 14 billion tests are ordered annually.

Furthermore, the increasing adoption of advanced technology by clinical laboratories, the growing integration of point-of-care testing, among others, is bolstering the growth of the market.

On the other hand, the others segment, comprising various environmental & public sites, is expected to grow at a significant CAGR during the forecast period. The increasing frequency of stagnant water in public buildings and the growing implementation of stringent guidelines for environment monitoring are contributing to the segment growth. Furthermore, the rising initiatives by the government to implement strict water testing to prevent the transmission of Legionella is one of the predominant factors driving the segment growth.

• For instance, according to an article published by the Centers for Disease Control and Prevention in 2021, facilities such as buildings and schools would test water storage systems for Legionella before returning to service.

KEY INDUSTRY PLAYERS

The market in the U.S. is consolidated with the presence of a few key players, such as Quidel Corporation, Abbott, Bio-Rad Laboratories, Inc., IDEXX Corporation, and others. The presence of a robust product portfolio, the strong distribution network of these companies are some factors contributing to the significant U.S. legionella testing market share of these companies. Further, various business strategic activities are being adopted by these companies in order to expand their business and also strengthen their market presence.

•  For instance, in November 2022, IDEXX Laboratories, Inc. acquired Tecta-PDS, a Canada based company focused on developing an automated microbiology testing platform. Through this acquisition, the company aimed to expand its water microbiology testing capabilities.

LIST OF KEY COMPANIES PROFILED:

• Quidel Corporation (U.S.)


• Abbott (Alere) (U.S.)


• Merck KGaA (Germany)


• Bio-Rad Laboratories, Inc. (U.S.)


• Thermo Fisher Scientific Inc. (U.S.)


• BD (U.S.)


• bioMérieux (France)


• IDEXX Corporation (U.S.)


• Eurofins Scientific (Luxembourg)

KEY INDUSTRY DEVELOPMENTS:

• October 2022- BioFire Diagnostics received the U.S. FDA clearance for its device, “FilmArray Pneumonia Panel plus”. The device is a multiplex panel to detect respiratory pathogens in human clinical specimens. The panel can detect organisms such as Legionella pneumophila, Chlamydia pneumonia, and others.


• December 2021 - Pace Analytical acquired Special Pathogens Laboratory, one of the prominent players in legionella testing and detection in the U.S. Through this acquisition, the company expanded its legionella testing product portfolio.

REPORT COVERAGE

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The U.S. market research report provides a detailed analysis of the market. It focuses on key aspects such as leading companies, product types, and leading applications of the product. Besides this, the report offers insights into the market, current global legionella testing market trends, competitive landscape, and highlights key industry developments. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth of the market over the recent years. 

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