Hospital-Acquired Disease Testing Market Size (2025-2030)

The Hospital-Acquired Disease Testing Market was valued at USD 5.16 Billion in 2024 and is projected to reach a market size of USD 7.48 Billion by the end of 2030. Over the forecast period of 2025-2030, the market is projected to grow at a CAGR of 6.38%.

Increasing regulatory oversight, the broad integration of molecular diagnostic tools, and the growing need for swift pathogen detection are now driving investment strategies across acute-care environments. Healthcare institutions are transitioning from traditional culture-based methods to syndromic multiplex PCR systems, while advancements in point-of-care (POC) technologies are being combined with artificial intelligence (AI) analytics to mitigate antimicrobial resistance in real time. Industry players are accelerating mergers and acquisitions to acquire specialized technologies, and recent reimbursement updates—such as Medicare’s 2025 HCPCS codes—are incentivizing healthcare facilities to incorporate comprehensive infection-control diagnostics into routine clinical operations.

Key Market Insights:

Healthcare systems are increasingly seeking avenues to broaden their revenue streams and engage in high-growth, high-margin markets that align with their core capabilities and strategic value proposition. Significant investments in both capital and human resources, coupled with operational models that enable emerging business units to scale efficiently alongside established entities, characterize the organizations that are effectively and rapidly achieving diversification.

Market Drivers:

The increasing elderly population is a key factor contributing to the market’s.

The growing demand for hospital-acquired disease (HAD) testing is primarily fueled by the expanding geriatric population and the rising incidence of chronic health conditions. Individuals who are elderly or suffer from long-term illnesses such as diabetes, cardiovascular diseases, or respiratory disorders often require prolonged hospitalization due to their complex medical needs. Extended hospital stays heighten the risk of contracting infections such as pneumonia, surgical site infections, and urinary tract infections (UTIs) as a result of increased exposure to hospital environments.

The rising incidence of hospital-acquired infections (HAIs) serves as a major driver of market growth.

The increasing prevalence of bloodstream infections, surgical site infections, pneumonia, and urinary tract infections (UTIs) is contributing significantly to the growth of the hospital-acquired infection diagnostics market. The rising incidence of HAIs has compelled healthcare facilities to conduct more diagnostic tests to enable faster detection and treatment of infections. This not only improves patient outcomes but also supports effective infection control within hospital settings. Moreover, early detection through diagnostic testing helps reduce mortality rates, shorten hospitalization durations, and minimize associated complications.

Market Restraints and Challenges:

Insufficient reimbursement policies for hospital-acquired infection (HAI) screening in several regions act as a significant restraint on market growth.

While Medicare MolDX began covering syndromic panels in July 2024, private-payer adoption remains inconsistent across states, delaying return on investment (ROI) for hospital laboratories. In Vietnam, the absence of national policies for point-of-care (POC) testing compels healthcare providers to self-finance cardiac and coagulation assays despite evident clinical demand. These reimbursement and policy gaps lead administrators to prioritize selective screening approaches over universal testing strategies.

A stringent regulatory framework for the development of new diagnostic test kits poses a significant challenge to market growth.

Although the market presents substantial potential and emerging opportunities, several challenges are expected to impede its global growth. The continuous surge in COVID-19 cases worldwide has driven the demand for more advanced, reliable, and rapid diagnostic kits to ensure timely and effective patient care, creating significant pressure on the diagnostics sector. However, manufacturers face stringent regulatory barriers when introducing new test kits, despite the urgent need for innovative solutions. Each country operates under distinct regulatory frameworks and guidelines governing product approvals. In particular, agencies such as the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and other international regulatory bodies have strengthened their standards to ensure product safety and efficacy. Additionally, rising budgetary limitations are anticipated to further restrain the growth of the COVID-19 diagnostics market over the forecast period.

Market Opportunities:

The development and implementation of government guidelines present significant growth opportunities within the market.

Governments are actively implementing measures to lower the prevalence of hospital-acquired infections (HAIs) in order to alleviate the strain on healthcare facilities caused by extended patient hospitalizations. In developed nations, dedicated HAI prevention and control authorities have established comprehensive guidelines for infection detection and management. For example, the U.S. Centers for Disease Control and Prevention (CDC) recommends using nucleic acid amplification tests for C. difficile detection, while the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) advises a two-step process for identifying the same pathogen. Such regulatory guidelines directly stimulate demand for the recommended diagnostic tests, thereby driving market growth.

HOSPITAL-ACQUIRED DISEASE TESTING MARKET REPORT COVERAGE:

Hospital-Acquired Disease Testing Market Segmentation:

Hospital-Acquired Disease Testing Market Segmentation By Product Type:

• Consumables
• Instruments
• Software

Instruments within the hospital-acquired disease (HAD) testing market include a broad spectrum of diagnostic devices such as automated analyzers, PCR systems, and immunoassay platforms, which serve as the foundation for laboratory-based testing. Demand for these advanced instruments is rising due to the need for high-throughput screening and faster turnaround times. Hospitals and diagnostic laboratories are increasingly investing in cutting-edge instruments that provide greater sensitivity and automation. Additionally, the integration of artificial intelligence (AI) and machine learning (ML) into diagnostic platforms enhances workflow efficiency and minimizes human error, further driving adoption.

Consumables, encompassing test kits, reagents, and assay cartridges, account for a substantial share of the HAD testing market. Their recurring use ensures a consistent revenue stream for manufacturers. The increasing prevalence of HAIs and the necessity for frequent testing have spurred demand for high-quality, reliable consumables. Manufacturers are prioritizing the development of multiplexed assays and ready-to-use reagent kits that streamline testing and reduce turnaround times. Furthermore, the growing adoption of point-of-care (POC) testing solutions supports the expansion of the consumables segment, as these systems require specialized cartridges and reagents for operation.

Hospital-Acquired Disease Testing Market Segmentation By Test Type:

• Molecular Diagnostics
• Microbiology Testing
• Immunoassays
• Others

Molecular Diagnostics has become the benchmark for the rapid and precise detection of pathogens responsible for hospital-acquired infections (HAIs). Methods such as nucleic acid amplification tests (NAATs), polymerase chain reaction (PCR), and next-generation sequencing (NGS) provide exceptional sensitivity and specificity, allowing for the identification of even low-abundance microorganisms. The increasing adoption of molecular diagnostics is driven by the need for timely clinical intervention and the rising challenge of antimicrobial resistance. Hospitals are progressively utilizing these technologies to enhance patient management and minimize the risk of healthcare-associated outbreaks.

Immunoassays constitute another essential segment of the hospital-acquired disease testing market, offering a cost-effective and scalable approach for routine screening and surveillance. These assays detect specific antigens or antibodies linked to infectious agents, delivering critical information for diagnosis and monitoring. Advances in high-throughput, automated immunoassay platforms have significantly improved laboratory efficiency and processing capacity. Furthermore, the emergence of rapid immunochromatographic tests and lateral flow assays has enabled point-of-care testing, allowing healthcare providers to make timely, informed decisions at the bedside. The adaptability and user-friendliness of immunoassays underscore their vital role in combating HAIs.

Hospital-Acquired Disease Testing Market Segmentation By Disease Type:

• Urinary Tract Infections
• Bloodstream Infections
• Surgical Site Infections
• Gastrointestinal Infections
• Pneumonia
• Others

Urinary Tract Infections (UTIs) are among the most prevalent hospital-acquired infections, particularly in patients with indwelling catheters. The high frequency of catheter-associated UTIs has led hospitals to establish rigorous screening and monitoring protocols. Advances in diagnostics, including rapid molecular assays and automated urine analyzers, have enhanced the detection and management of UTIs, thereby lowering the risk of complications and reducing hospital readmissions.

Surgical Site Infections (SSIs) represent another critical concern in hospital settings, contributing significantly to postoperative complications. Many healthcare facilities now follow standardized practices, including preoperative screening, intraoperative infection control, and postoperative surveillance. Diagnostic approaches for SSIs typically combine molecular assays, microbiological cultures, and imaging studies. The increasing adoption of rapid diagnostic tools facilitates earlier detection and intervention, improving patient outcomes and reducing healthcare costs associated with extended hospital stays.

Hospital-Acquired Disease Testing Market Segmentation By End User:

• Hospitals
• Academic & Research Institutes
• Diagnostic Laboratories
• Others

Hospitals constitute the largest end-user segment in the hospital-acquired disease (HAD) testing market, representing the majority of testing volumes due to the high prevalence of HAIs in inpatient settings. The integration of infection control programs, routine surveillance, and outbreak management protocols has made hospital-based testing a cornerstone of patient care. Healthcare facilities are investing in advanced diagnostic platforms, automated analyzers, and integrated data management systems to optimize testing workflows and improve patient safety.

Diagnostic Laboratories, including both independent and hospital-affiliated facilities, play a pivotal role in the HAD testing market. These laboratories are equipped with specialized infrastructure and trained personnel capable of performing a wide array of diagnostic tests. The ongoing trend toward centralization and consolidation of laboratory services is accelerating the adoption of high-throughput, automated testing platforms. Furthermore, diagnostic laboratories are increasingly partnering with hospitals and healthcare networks to deliver comprehensive testing solutions, encompassing microbiology, molecular diagnostics, and immunoassays. Emphasis on quality assurance, accreditation, and adherence to regulatory standards continues to strengthen the capabilities and reliability of these laboratories.

Hospital-Acquired Disease Testing Market Segmentation: Regional Analysis:

• North America
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

North America remains the leading region in the hospital-acquired disease (HAD) testing market, supported by a well-established healthcare infrastructure, high awareness of infection prevention, and stringent regulatory oversight. The United States, in particular, has implemented comprehensive infection control programs and made substantial investments in research and development, driving the adoption of advanced diagnostic technologies. The presence of prominent market players, robust funding for healthcare innovation, and a favorable reimbursement environment further reinforce market growth in the region.

Asia Pacific is emerging as the fastest-growing market for HAD testing. Factors such as rapid urbanization, expanding hospital networks, and rising healthcare expenditures are driving demand for diagnostic solutions. Governments in countries including China, India, and Japan are emphasizing infection control and investing in laboratory modernization programs. The region also benefits from a large patient population, growing awareness of hospital-acquired infections, and increasing collaborations with international health organizations.

COVID-19 Impact Analysis:

The sudden onset of the COVID-19 pandemic has significantly accelerated diagnostic activities, treatment protocols, and research and development efforts aimed at creating diagnostic solutions, including molecular tests and point-of-care assays. The heightened demand for COVID-19 diagnostic procedures and products has generated substantial opportunities within the healthcare sector, thereby driving market growth. Market participants are increasingly leveraging technological innovations to deliver more efficient diagnostic solutions. For example, in November 2021, Siemens Healthcare GmbH introduced the Atellica COVID-19 Severity Algorithm, designed to predict disease progression and the risk of life-threatening multi-organ dysfunction in COVID-19 patients.

The emergence of new COVID-19 variants and the growing need for accurate diagnostics are expected to sustain momentum in the global market. While pandemic-related restrictions had some impact, the overall effect on the supply chain was relatively limited.

Latest Market News:

January 2025: bioMérieux completed its €138 million acquisition of SpinChip Diagnostics, acquiring rapid 10-minute immunoassays for myocardial infarction detection.

June 2024: bioMérieux received FDA 510(k) clearance and a CLIA waiver for the BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel, enabling detection of 15 respiratory pathogens in just 15 minutes.

Latest Trends and Developments:

Rising awareness of hospital-acquired infections (HAIs) and their clinical and economic implications has driven increased demand for effective diagnostic solutions among healthcare providers. This trend is reinforced by stringent regulations and guidelines that promote robust infection control practices, encouraging healthcare facilities to implement comprehensive testing protocols. Additionally, advancements in diagnostic technologies—such as molecular diagnostics and rapid testing methods—have strengthened the market by enabling faster and more accurate pathogen identification.

Key Players in the Market:

1. Becton, Dickinson and Company (BD)
2. F. Hoffmann-La Roche Ltd
3. bioMérieux SA
4. Thermo Fisher Scientific Inc.
5. Siemens Healthineers AG
6. Bio-Rad Laboratories, Inc.
7. QuidelOrtho Corporation
8. Danaher Corporation
9. Luminex Corporation
10. GenMark Diagnostics, Inc.