Hospital Acquired Infections Diagnostics Market
Overview
The Hospital Acquired Infections
Diagnostics Market is projected to witness significant growth between 2025 and
2035, driven by number of surgical operations performed annually has been
rising gradually all over the world. Valued at approximately USD 4.2 billion in
2025, the market is expected to soar to USD 7.3 billion by 2035, reflecting a
strong compound annual growth rate (CAGR) of 7.1% over the ten-year period.
Hospital Acquired Infections, also
referred to as nosocomial infections, are infections acquired by patients
during treatment in a healthcare center, e.g., a hospital, that were neither
present upon, nor incubating at, admission. They usually appear 48 hours or
more following admission but may also appear after discharge. They are a
serious threat to health, extend hospitalization time, drive up healthcare
expenditure, and are a factor in increased morbidity and mortality rates.
Common categories of HAI include
bloodstream infections (BSI), urinary tract infection (UTI), surgical site
infection (SSI), pneumonia, particularly ventilator-associated, and
gastrointestinal infections like Clostridioides difficile infection. HAI infections
are frequently a result of antibiotic-resistant bacteria, such as
Staphylococcus aureus (MRSA), Pseudomonas aeruginosa, Escherichia coli, and
Klebsiella pneumoniae.
Diagnosis of HAIs occurs through a
mixture of clinical evaluation and laboratory testing. Molecular tests, such as
PCR and NAATs, are used extensively because of high sensitivity coupled with
quick results. Conventional microbiology tests like culture tests continue to
find utility in determining susceptibility to antibiotics as well as
identifying pathogens. Immunoassay and serology tests identify infections by
focusing specifically on antigens or antibodies. Techniques such as mass
spectrometry and next-generation sequencing are being adopted more frequently
in advanced environments to conduct an overall profiling of pathogens. Early,
precise diagnosis of HAIs is instrumental in starting targeted therapy,
preventing outbreaks, and curbing transmission in a healthcare facility
setting. Anti-microbial stewardship, surveillance, and regular screening are
vital to controlling HAIs effectively.
Hospital Acquired Infections Diagnostics Market
Drivers and Opportunities
Rising prevalence of
antibiotic-resistant pathogens driving the Hospital Acquired Infections
Diagnostics Market during the forecast period
One of the key drivers of Hospital
Acquired Infections (HAIs) diagnostics market growth is the increased incidence
of antibiotic-resistant infections. Misuse and overprescription of antibiotics
have contributed to the development of multidrug-resistant organisms (MDROs),
which are more difficult to treat and need more sophisticated diagnostic
equipment to identify early on. Healthcare settings are also under immense
pressure to identify these infections promptly to contain their spread and
choose optimal treatment methods. Such has boosted demand for fast, precise
diagnostic technology in the form of molecular diagnostics and point-of-care
technology products, capable of identifying resistance genes and pathogens with
enhanced sensitivity. Regulatory agencies, along with international health
agencies, are actively encouraging infection surveillance programs, further
fueling market growth.
growing awareness and
emphasis on patient safety and infection control in healthcare settings drives
global Hospital Acquired Infections Diagnostics Market
Another key driving force is increased
awareness and focus on infection control and patient safety in healthcare
environments. Governments, together with healthcare agencies, have implemented
rigorous guidelines, as well as reimbursement schemes, that encourage hospitals
to lower infection levels. The monetary penalties linked to high HAI rates in
most healthcare systems, particularly in developed nations, are driving
hospitals to invest in enhanced diagnosis infrastructure. Diagnostic testing is
increasingly being adopted as a part of day-to-day hospital practice, from
admission through to follow-up, driving increased uptake of enhanced HAI
diagnostic equipment across healthcare centres of all types.
Opportunity for the Hospital Acquired Infections
Diagnostics Market
Adoption of advanced
technologies in emerging economies is significant opportunities in the global Hospital
Acquired Infections Diagnostics Market
One of the prime opportunities in the
HAIs diagnosis marketplace exists in the uptake of newer technologies across
emerging economies. Asia-Pacific, Latin America, and parts of Middle East and
Africa are experiencing healthcare infrastructure improvements, coupled with
increasing healthcare spends and infection control practice awareness, creating
untapped potential in these geographies to be seized by diagnostic companies
through offering affordable, scalable diagnostic solutions. Access to more
skilled healthcare professionals, as well as enhanced lab capabilities, also
supports incorporating molecular diagnostics, as well as automated testing
platforms, into these geographies. Additionally, public-private partnerships
and global health projects are financially supporting HAI prevention and
control programs, which are frequently accompanied by diagnosis tools and
equipment. Diagnostic companies that are able to adjust products to fit
budgets, as well as regulatory environments, of these opening-up markets—while
providing fast, reliable diagnoses—have a competitive edge in these
geographies. By making solutions more affordable, as well as accessible,
diagnostic companies can dramatically increase their addressable markets, as
well as help drive better patient outcomes across regions where historically
infection rates have been high, as well as infection control budgets are low.
Hospital Acquired Infections Diagnostics Market
Scope
Report Attributes
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Description
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Market Size in 2025
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USD 4.2 Billion
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Market Forecast in
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USD
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CAGR % 2025-2035
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7.1%
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Base Year
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2024
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Historic Data
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2020-2024
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Forecast Period
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2025-2035
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Report USP
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Production, Consumption, company
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Segments Covered
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Regional Scope
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Country Scope
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1) U.S.
2) Canada
3) U.K.
4) Germany
5) France
6) Italy
7) Spain
8) Benelux
9) Nordic Countries
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Hospital Acquired Infections Diagnostics Market Report
Segmentation Analysis
The reagents and
consumables product type segment is anticipated to hold the highest share of
the global hospital acquired infections diagnostics market during the projected
timeframe.
The reagent and consumables segment is
anticipated to command the highest share of the Hospital Acquired Infections
(HAIs) diagnostics market throughout the forecast period, owing to its
recurring as well as essential nature in diagnostic testing. Such products
consist of test kits, detection reagents, culture media, and other disposable
products used across most diagnostic platforms, especially in molecular as well
as immunoassay-based tests. As against diagnostic equipment, where reagent
replenishment involves periodic replacement, reagent and consumable products
are employed in each diagnostic analysis, resulting in steady demand. As
healthcare professionals move towards high-throughput as well as automated
diagnosis platforms, utilization of standardized reagents of higher quality
also becomes essential to improve accuracy as well as efficiency. Rising
awareness about infection prevention, increased rates of multidrug-resistant
infections, as well as more common routine screening in hospitals, also help drive
this segment. In turn, companies are focusing on developing sophisticated
reagents, allowing faster turn-around, along with greater sensitivity,
especially in point-of-care, as well as in molecular diagnosis.
The Urinary Tract
Infections (UTIs) type segment dominated the market in 2024 and is predicted to
grow at the highest CAGR over the forecast period.
The Urinary
Tract Infections (UTIs) segment led the Hospital Acquired Infections
diagnostics segment in 2024 and has been anticipated to register the highest
Compound Annual Growth Rate (CAGR) through the forecast period. UTIs are among
the most prevalent hospital-acquired infections, especially in patients with
indwelling catheters, urological procedure recipients, and individuals with
compromised immunity. The infections are found in multiple healthcare settings
owing to factors such as excessive hospitalization, unhygienic catheter
management, and compliance failures in hygiene practices. The rise in
catheter-associated urinary tract infections (CAUTIs) has increased pressure to
implement early detection and intervention, propelling the need for quickening
diagnostic tools without compromising accuracy. The growth of the segment also
derives traction from advances in diagnostic methods, such as molecular tests
that can identify targeted germs and antibiotic resistance in a urine specimen
in a quick turnaround time. Additionally, regulatory requirements and hospital
accreditation standards now emphasize monitoring and reporting UTI, compelling
hospitals to invest in enhanced diagnostic tools.
Molecular Diagnostics
Technology Segment hold significant share for HAI Diagnostics Market
The share of
the Hospital Acquired Infections (HAIs) diagnostic market by the molecular
diagnostic sector is significant owing to its accuracy, speed, and increased
usage in clinical practices. Molecular methods, i.e., PCR, NAATs, and next
generation sequencing (NGS), enable immediate identification of pathogens along
with resistance genes straight from clinical specimens. In contrast to culture
methods, where results are received after days, molecular diagnosis provides
results in hours, facilitating targeted therapeutic decisions at appropriate
time.
It is
especially important in hospital settings where timely interventions can avert
infection transmission and enhance patient prognosis. Additionally, the
emergence of drug resistance has put more emphasis on diagnostic tools that can
not only detect infection but also detect resistance genetic markers.
Technological innovation has also contributed to an array of user-friendly,
point-of-care molecular platforms that are finding applications both in central
labs, as well as at the bedside.
The Hospitals &
Clinics segments dominated the Hospital Acquired Infections Diagnostics Market
The hospital
and clinics segment led the Hospital Acquired Infections diagnostics market and
is anticipated to continue its leadership position owing to its high patient
flow and enhanced infection transmission risks in these environments. ICUs, in
particular, are top spots where HAIs are common, owing to increased utilization
of invasive devices such as catheters, ventilators, and central lines. Early
diagnosis, along with its accuracy, plays a pivotal role in controlling
infection in such high-risk environments, hence fueling demand from diagnostic
tests.
Clinics also
make a substantial contribution to this sector, especially those that conduct
minor surgical interventions or have patients that are immunocompromised.
Regulation to ensure infection control, as well as surveillance, has also
driven hospitals and clinics to incorporate diagnostic testing into everyday
practice. Such establishments routinely have on-site laboratories or access to
diagnostic laboratories, allowing regular utilization of complex testing
platforms, encompassing molecular diagnosis, immunoassay, and culture methods.
The
following segments are part of an in-depth analysis of the global hospital
acquired infections diagnostics market:
Market
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By Product Type
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o PCR (Polymerase Chain Reaction) instruments
o Microarrays
o Immunoassay analysers
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By Infection Type
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By Technology
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By End-user
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Hospital Acquired Infections Diagnostics Market
Share Analysis by Region
North America is
projected to hold the largest share of the global Hospital Acquired Infections
Diagnostics Market over the forecast period.
North America has been expected to
account for the largest share of the worldwide Hospital Acquired Infections
Diagnostics Market because of its highly developed healthcare infrastructure,
infection control awareness, and prevalent usage of advanced diagnostic
technology. There is a high incidence of hospital-acquired infections,
especially in the United States, resulting in stringent regulatory requirements
and national infection surveillance programs.
Government bodies like Centers for
Disease Control and Prevention (CDC) and Centers for Medicare & Medicaid
Services (CMS) encourage infection surveillance as well as reporting actively,
further enhancing the utilization of diagnostic products. There is also strong
healthcare expenditure along with a well-equipped diagnostics sector in North
America, coupled with prominent players in the industry. Demand for fast,
precise molecular diagnostic assays also increases, given the issue of
antibiotic resistance across regions. All these factors combine to make North
America the leading region in the HAIs diagnostics market, where growth would
be steady.
Hospital Acquired Infections Diagnostics Market Competition
Landscape Analysis
The market
is competitive, with several established players and new entrants Product Type
a range of hospital acquired infection diagnostic products. Some of the key
players Becton, Dickinson and Company (BD), bioMérieux SA, F. Hoffmann-La Roche
Ltd, Thermo Fisher Scientific Inc., Abbott Laboratories, Siemens Healthineers,
Danaher Corporation and Others
Global Hospital
Acquired Infections Diagnostics Market Recent Developments News:
o
February 2024 saw
an exclusive agreement between PathAI and Roche Tissue Diagnostics (RTD) to
design companion diagnostic-enabled AI-powered digital pathology
algorithms. The agreement has been formed to improve cancer diagnosis as well
as infectious disease diagnosis accuracy by incorporating PathAI’s
sophisticated image analysis algorithms into Roche’s navify® Digital Pathology
platform.
o
In July 2024, Becton, Dickinson, and Company
(BD) entered into a worldwide partnership with Quest Diagnostics to develop,
produce, and commercialize flow cytometry-based companion diagnostics (CDx).
The purpose of these diagnostics is to help choose appropriate treatments for
cancer patients and patients afflicted by other ailments.
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HiMedia Laboratories introduced in April 2024
a portfolio of molecular solutions to detect antimicrobial resistance (AMR).
These solutions comprise state-of-the-art PCR kits as well as sequencing
services capable of detecting resistance genes across various pathogens.
The Global Hospital
Acquired Infections Diagnostics Market is dominated by a few large companies,
such as
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Becton, Dickinson and Company (BD)
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bioMérieux SA
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F. Hoffmann-La Roche Ltd
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Thermo Fisher Scientific
Inc.
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Abbott Laboratories
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Siemens Healthineers
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Danaher Corporation
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Qiagen N.V.
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Hologic, Inc.
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Luminex Corporation
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Bio-Rad Laboratories,
Inc.
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Cepheid (a Danaher
company)
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GenMark Diagnostics (part of Roche)
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Merck KGaA
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T2 Biosystems, Inc.
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Others
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Other Prominent Players