Hospital Acquired Infections Diagnostics Market Size, Share & Trends Analysis Report By Test (Molecular, Conventional), By Infection (UTI, Pneumonia), By Product, By Type, By Region, And Segment Forecasts, 2025 - 2030

Market Size & Trends

The global hospital acquired infections diagnostics market size was estimated at USD 4.29 billion in 2024 and is projected to grow at a CAGR of 1.49% from 2025 to 2030. Market growth can be attributed to the rising prevalence of Hospital-acquired Infections (HAIs), such as bloodstream infections, surgical-site infections, and ventilator-associated pneumonia, coupled with the increasing antimicrobial resistance among pathogens. Factors such as inadequate infection control practices, the growing number of surgical procedures, and the expanding geriatric population, who are more susceptible to HAIs, have further intensified the demand for advanced diagnostic solutions.

HAIs can be termed as the infections patients acquire while receiving treatment for other conditions within a healthcare setting, and they can lead to severe complications, prolonged hospital stays, and even death. According to the World Health Organization (WHO), approximately 1 in 10 patients worldwide will experience a healthcare-associated infection during their hospital stay. This translates to millions of people annually, with the most common types of HAIs, including urinary tract infections (UTIs), surgical site infections (SSIs), pneumonia, and bloodstream infections.

In the U.S. alone, the Centers for Disease Control and Prevention (CDC) estimates that 1 in 31 hospitalized patients has at least one HAI on any given day. This equates to around 700,000 cases of HAIs annually, leading to approximately 75,000 deaths. The economic burden of HAIs is substantial, with direct healthcare costs in the U.S. alone exceeding USD 28 billion each year. These infections are often caused by multidrug-resistant organisms (MDROs), such as methicillin-resistant Staphylococcus aureus (MRSA) and Clostridioides difficile (C. difficile), which complicate treatment and require more advanced diagnostic and therapeutic measures.

One of the most transformative advancements in HAI diagnostics is the development of molecular diagnostic technologies, particularly Polymerase Chain Reaction (PCR). PCR-based methods, including real-time PCR and multiplex PCR, allow for the rapid detection of pathogens, even those that are difficult to culture. These technologies enable healthcare providers to identify the causative agents of infections in a matter of hours rather than days, significantly reducing the time to appropriate treatment.

Test Insights

The convention tests segment dominated the HAI market in 2024, driven by its established reliability and affordability in clinical settings. Conventional diagnostic methods, such as culture-based techniques, biochemical tests, and microscopy, witness significant demand for identifying pathogens causing HAIs. Another factor contributing to the demand for conventional HAI diagnostic methods is their adaptability to various types of infections, including bloodstream infections, urinary tract infections, and ventilator-associated pneumonia.

The molecular tests segment is expected to expand at the fastest CAGR of 1.71% during the forecast period. The development of advanced molecular diagnostics significantly improves the speed and accuracy of pathogen detection, thereby contributing to segment growth. For instance, in April 2023, Llusern Scientific launched the Lodestar DX analyzer and UTI panel test, designed for rapid diagnosis of urinary tract infections (UTIs).

Infection Insights

UTIs dominated the HAIs market in 2024 with a revenue share of 26.8% and are expected to grow at the fastest CAGR over the forecast period. According to a report published by the Centers for Disease Control and Prevention (CDC) and the National Health Safety Network in January 2024, approximately 12% to 16% of adults hospitalized can have an indwelling urinary catheter (IUC) at some point during their stay.

The pneumonia segment held the second largest share in 2024 owing to the increasing incidence of ventilator-associated pneumonia (VAP) and other respiratory infections in healthcare settings. Patients requiring mechanical ventilation are at increased risk of pneumonia, increasing the importance of rapid and accurate critical diagnostics. Advanced diagnostic technologies, including molecular assays and biomarker-based tests, are being adopted to identify pathogens causing pneumonia more precisely. This enables specialized treatments that can improve patient outcomes and help combat the growing issue of antimicrobial resistance.

Product Insights

The consumables segment held the largest revenue share in 2024 and is expected to grow at the fastest CAGR of 1.55% over the forecast period, which is driven by their increasing contribution to streamlining diagnostic workflows. Innovations in consumables have enabled rapid identification of pathogens, significantly reducing the time to result in diagnostic procedures. For instance, in July 2022, Hologic launched two new respiratory assays for detecting COVID-19, influenza A, influenza B, and RSV in the EU.

The instrument segment is expected to witness significant growth owing to the advancements in diagnostic technologies and the rising demand for rapid and accurate detection of HAIs. The development of advanced point-of-care diagnostic instruments is also contributing to the segment growth, reshaping the HAI diagnostics landscape. For instance, in July 2024, Bosch Healthcare Solutions introduced a PCR test for C. difficile, norovirus, and rotavirus, enhancing the Vivalytic platform's diagnostic capabilities.

Type Insights

The blood tests segment held the largest revenue share in 2024 and is expected to grow at the fastest CAGR of 1.55% during the forecast period. The adoption of molecular diagnostics has significantly enhanced the sensitivity and accuracy of blood tests, allowing for early pathogen identification and resistance profiling, which supports targeted therapy. Similarly, the increasing focus on the development of advanced blood tests can lead to the development of more effective solutions. For instance, in December 2023, a new 45-minute blood test for sepsis was trialed in the UK, aiming to enhance early detection of this life-threatening condition.

Urinalysis held the second largest share in 2024 as hospitals and other healthcare settings significantly rely on advanced urinalysis techniques to diagnose hospital-acquired infections, such as catheter-associated urinary tract infections (CAUTIs). Furthermore, urinalysis has emerged as a preferred method for routine infection screening in both inpatient and outpatient settings, owing to its non-invasive nature and cost-effectiveness. Lastly, the increasing awareness of antibiotic resistance is encouraging healthcare facilities to prioritize accurate urinalysis as part of their infection control strategies.

Regional Insights

North America hospital-acquired infections diagnostics industry held the second-largest global share in 2024. This large revenue share is attributed to the increasing prevalence of HAIs, which are a leading cause of morbidity and mortality in healthcare settings. For instance, in March 2023, the Centers for Disease Control and Prevention (CDC) reported that Candida auris (C. auris) has emerged as a significant antimicrobial resistance threat in U.S. healthcare facilities, spreading rapidly between 2020 and 2021, with clinical infections rising from 476 in 2019 to 1,471 in 2021.

U.S. Hospital Acquired Infections Diagnostics Market Trends

The hospital-acquired infections diagnostics industry in the U.S. is expected to grow over the forecast period. Common types of HAIs include surgical site infections, central line-associated bloodstream infections, catheter-associated urinary tract infections, and ventilator-associated pneumonia. In July 2024, a study by the National Institutes of Health revealed an increase in both hospital-acquired infections and antibiotic resistance.

Europe Hospital Acquired Infections Diagnostics Market Trends

Europe hospital-acquired infections diagnostics industry dominated the global market with the largest revenue share of 34.57% in 2024. The market is driven by the high disease burden, availability of infrastructure, increased healthcare expenditure, rapid technological advancements, proactive government initiatives, rise in patient awareness, and the presence of major players. Furthermore, in June 2024, QIAGEN launched 35 new digital PCR assays for microbial applications, enhancing the detection of pathogens causing tropical diseases, STIs, and UTIs, expanding its portfolio to over 680 targets for improved infectious disease research.

The hospital-acquired infection diagnostics industry in the UK has a highly competitive landscape, with several companies competing to increase their market share. Key players in the UK market include major global companies such as Abbott Laboratories and Becton Dickinson, which are at the forefront of developing innovative diagnostic solutions.

The hospital-acquired infection (HAI) diagnostics industry in Germany is experiencing significant growth, driven by an increasing presence of international market players and enhanced access to advanced testing solutions and services. Companies such as Siemens Healthineers and bioMérieux are prominent players, focusing on innovation and quality to capture market share.

Asia Pacific Hospital Acquired Infections Diagnostics Market Trends

Asia Pacific hospital-acquired infections diagnostics industry is expected to witness the fastest CAGR of 2.29% during the forecast period. The high growth rate can be attributed to the rising disease incidence rate and the high geriatric population. Increasing demand for cost-effective diagnostics and a growing population are among the factors significantly contributing to market growth. The rising incidence of HAI in countries such as India and China is expected to boost the industry in the near future further.

The hospital-acquired infections diagnostics industry in China is characterized by intense competition between global giants such as Roche and Abbott, and local manufacturers such as Mindray and Wondfo Biotech. In January 2024, China's National Health Commission announced the implementation of a new standard for monitoring hospital-acquired infections (HAIs), effective February 1st.

The hospital-acquired infections diagnostics industry in Japan is dominated by established players such as Thermo Fisher Scientific, QIAGEN, and bioMérieux. These companies leverage cutting-edge molecular diagnostic technologies, particularly in bloodstream infections and urinary tract infections (UTIs). In October 2024, a study published in Infection Control & Hospital Epidemiology reported that healthcare-associated infections (HAIs) were present in 6.6% of patients across multiple hospitals in Aichi, Japan.

Key Hospital Acquired Infections Diagnostics Company Insights

Some of the key players operating in the market include BIOMÉRIEUX, Abbott; and F. Hoffmann-La Roche Ltd. Product launches, approvals, strategic acquisitions, and innovations are just a few of the important business strategies used by market participants to maintain and grow their global reach:

Recent Developments

• In November 2024, QIAGEN announced the establishment of a new facility in Esplugues de Llobregat, Barcelona, to enhance its QIAstat-Dx operations. The site will focus on infectious disease testing and precision medicine, supporting partnerships with Eli Lilly and AstraZeneca.

• In June 2024, QIAGEN launched the QIAstat-Dx Gastrointestinal Panel 2 in the U.S., enabling rapid detection of up to 16 pathogens causing gastrointestinal infections. This FDA-cleared test improves diagnostic accuracy and efficiency, addressing common challenges in gastrointestinal care.

• In June 2024, QIAGEN launched 35 new digital PCR assays for microbial applications, enhancing the detection of pathogens causing tropical diseases, STIs, and UTIs, expanding its portfolio to over 680 targets for improved infectious disease research.

• In January 2024, bioMérieux acquired LUMED, a Canadian software company, to enhance its antimicrobial stewardship and infection prevention efforts. This acquisition allows bioMérieux to fully integrate LUMED’s clinical decision support system, improving hospital antimicrobial prescriptions and monitoring healthcare-associated infections to combat antimicrobial resistance effectively.

• In November 2023, Oxford University and Danaher partnered to advance precision medicine for sepsis through rapid molecular testing. Utilizing Cepheid's diagnostic technology, the collaboration aims to identify specific sepsis subtypes, enabling advanced treatments.

Hospital Acquired Infections Diagnostics Market Report Scope

Global Hospital Acquired Infections Diagnostics Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global hospital acquired infections diagnostics market based on test, infection, product, type, and region:

• Test Outlook (Revenue, USD Million, 2018 - 2030)

  • Molecular

  • Conventional

• Infection Outlook (Revenue, USD Million, 2018 - 2030)

  • UTI

  • Pneumonia

  • Surgical site infection

  • Bloodstream infections

  • Others

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Consumables

  • Instruments

• Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Blood tests

  • Urinalysis

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • Thailand

    • South Korea

  • Latin America

    • Brazil

    • Argentina

  • Middle East and Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait