|
Forecast Period
|
2026-2030
|
|
Market Size (2024)
|
USD 4.41 Billion
|
|
Market Size (2030)
|
USD 5.98 Billion
|
|
CAGR (2025-2030)
|
5.17%
|
|
Fastest Growing Segment
|
Drug Development
|
|
Largest Market
|
North America
|
Market Overview
The Global Antimicrobial Susceptibility
Testing Market was valued at USD 4.41 Billion in 2024 and is expected to reach
USD 5.98 Billion by 2030 with a CAGR of 5.17%. The Global Antimicrobial
Susceptibility Testing (AST) Market is experiencing significant growth due to
increasing concerns regarding antibiotic resistance and the need for accurate
diagnostic tools. The rise in multi-drug-resistant infections has heightened
the demand for effective AST solutions to help clinicians make informed
decisions about appropriate treatment plans. As antibiotic resistance continues
to escalate, the ability to test pathogens’ susceptibility to various
antibiotics has become crucial in guiding therapy. This is driving healthcare
providers to adopt more reliable and efficient AST methods, reducing treatment
failure rates and improving patient outcomes. The growing awareness around
antimicrobial resistance (AMR) further amplifies the need for advanced AST
technologies, ensuring better management of infections and reducing unnecessary
use of antibiotics.
The market is witnessing several trends, including the
growing shift toward automated and rapid AST solutions. Traditional methods
such as culture-based techniques are gradually being replaced by molecular
diagnostics and automated testing systems. These methods provide faster and
more accurate results, reducing turnaround times significantly, which is
critical in the clinical setting. The focus on precision medicine is also
contributing to the market growth, as personalized treatment plans based on AST
results are gaining traction. Companies are investing in the development of
high-throughput and cost-effective AST systems, making it more accessible to
healthcare institutions worldwide. The integration of artificial intelligence
(AI) and machine learning to enhance AST accuracy is also gaining momentum,
positioning the market for innovative breakthroughs.
However, there are several challenges that need to be
addressed for the market to reach its full potential. One significant hurdle is
the high cost associated with advanced AST technologies, which may limit their
adoption, particularly in developing regions. Healthcare institutions may be
reluctant to invest in expensive diagnostic equipment if the cost-benefit ratio
is not favorable. Moreover, the lack of standardized protocols across different
regions may hinder the widespread adoption of AST methods. Regulatory barriers,
including stringent approval processes for new diagnostic technologies, also
pose challenges for companies looking to introduce innovative solutions.
Additionally, there is a need for training healthcare professionals to
understand and effectively use these advanced technologies, which can slow down
the pace of adoption in some regions.
Key Market Drivers
Increase
in Prevalence of Infectious Diseases
Infectious diseases are certain kind of
disorders caused by pathogenic microorganisms, such as bacteria, viruses,
fungi, parasites, and prions. These microorganisms can invade the human body,
multiply, and cause disease by damaging tissues, secreting toxins, or
triggering an immune response that results in inflammation. Influenza, malaria,
tuberculosis, dengue, and others are some of the most commonly prevailing
infectious diseases across the world. Antimicrobial susceptibility testing is a
critical tool for determining the appropriate antimicrobial therapy for
infectious diseases. When a patient gets affected with infectious disease,
sample of the bacteria is taken and is sent to the laboratory for antimicrobial
susceptibility testing. Results obtained from the test are used to guide the selection
of an appropriate antibiotic for treating the patient's infection. In recent
times, COVID-19 pandemic caused by the SARS-CoV-2 virus have emerged as the
leading infectious disease affecting many people across the world. According
to the report published by Worldometer in 2023, it has been observed that in
2021 around 106,771,290 cases of COVID-19 were reported in United States of
America causing 1,162,471 deaths, followed by 44,971,469 cases of COVID-19 in
India causing 531,692 deaths, 40,021,949 cases of COVID-19 in France leading to
166,811 deaths, and so on.
Pneumonia is the second most common
infectious diseases prevailing in various developing countries across the
world. As per the report presented by UNICEF in 2019, it has been
concluded that pneumonia kills more children than any other infectious disease,
claiming the lives of over 700,000 children under five every year, or around
2,000 every day. This includes over 200,000 newborns. Globally, there are over
1,400 cases of pneumonia per 100,000 children, or 1 case per 71 children every
year, with the greatest incidence occurring in South Asia (2,500 cases per
100,000 children) and West and Central Africa (1,620 cases per 100,000
children). Moreover, growing dependence of people on antimicrobial
susceptibility testing for prevention of these diseases is further expected to
register an impressive growth to global antimicrobial susceptibility testing
market in the forecast period.
Growth
in Geriatric Population
Growth in geriatric population across various parts of
the world is also one of the significant drivers of global antimicrobial
susceptibility testing market in the forecast period. This is because the
elderly population is more vulnerable to infectious diseases, and their
weakened immune systems make them more susceptible to bacterial infections.
Improvement in healthcare and medical technology have led to longer life
expectancies among geriatric people which is thereby growing the demand of
antimicrobial susceptibility testing among them to stop the development of
infection in their body at early stage. Influenza, shingles, tuberculosis,
gastrointestinal infections, and urinary tract infections are some of the
diseases which effects most of the people after 65 years of age. According
to the report published by Population Reference Bureau (PRB) based on countries
with the oldest populations in the world, it has been concluded that Japan is
the foremost country in the world accounting for around 28.2% of geriatric
people out of total population, followed by Italy with 22.8% of geriatric
population, Greece, and Portugal with 21.8 %, and Germany with 21.4% of
geriatric people out of the total population. Henceforth, growing
ratio of geriatric population in various developing countries across the globe
and growing prevalence of diseases associated with people during their elder
age is also expected to bolster the growth of global antimicrobial susceptibility
testing market in upcoming years.
Technological
Advancements in AST Systems
Technological advancements in antimicrobial
susceptibility testing (AST) systems are significantly driving the growth of
the Global AST Market. In September 2023, the U.S. Food and Drug
Administration (FDA) issued guidance to update susceptibility test interpretive
criteria (STIC) and associated performance data in device labeling for AST
systems. This initiative aims to enhance the accuracy and relevance of
AST results, ensuring that healthcare providers have the most current
information to make informed treatment decisions.
The Centers for Disease Control and Prevention (CDC)
continues to monitor antimicrobial resistance (AMR) through various
surveillance systems, including the National Antimicrobial Resistance
Monitoring System (NARMS). These efforts underscore the importance of advanced
AST technologies in detecting and responding to emerging resistant
pathogens.
In response to the growing threat of AMR, the CDC's
Antimicrobial Resistance Solutions Initiative invests in national
infrastructure to detect, respond, contain, and prevent resistant infections
across healthcare settings, communities, the food supply, and the environment.
This initiative highlights the critical role of innovative AST technologies in
combating AMR.
The FDA's Antimicrobial Resistance
Isolate Bank, as of December 1, 2023, has shipped more than 7,900 isolate
panels, providing researchers with access to a vast collection of bacterial and
fungal isolates. This resource supports the development and validation
of new AST methods, facilitating the introduction of more rapid and accurate
diagnostic tools.
These initiatives and resources reflect a concerted
effort by U.S. health agencies to advance AST technologies, thereby enhancing
the detection and management of antimicrobial-resistant infections. Such
advancements are expected to continue driving the growth and evolution of the
AST market in the coming years.
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Key Market Challenges
Lack
of Standardization and Validation
One of the significant challenges faced by the Global
Antimicrobial Susceptibility Testing (AST) Market is the lack of
standardization and validation across different testing methods and platforms.
AST is critical for determining the most effective antimicrobial agents against
bacterial infections. However, the absence of universally accepted guidelines
for testing procedures and interpretation of results can lead to
inconsistencies in outcomes. Different laboratories may employ various AST
techniques, which can yield different susceptibility profiles for the same
bacterial strain, thus making it challenging to compare results across
facilities. This lack of uniformity undermines the reliability and
reproducibility of AST results, which can directly impact patient treatment and
clinical decisions.
In addition, the validation of new AST technologies is
a complex process, often involving extensive clinical trials to prove their
efficacy and accuracy in real-world settings. As new methods and diagnostic
tools enter the market, they must undergo rigorous validation procedures to
meet regulatory standards. However, the validation process can be slow, and not
all new AST technologies receive the same level of scrutiny. This disparity can
lead to the introduction of unvalidated or insufficiently tested solutions into
clinical practice, potentially compromising the effectiveness of treatments.
The absence of a standardized approach is particularly
problematic for emerging markets, where resources for comprehensive validation
and training are often limited. Without proper standardization and validation
of AST methods, healthcare providers may struggle to accurately determine
antimicrobial susceptibility, which could contribute to the further spread of
antimicrobial resistance (AMR). Addressing this challenge will require the
development of international standards, improved regulatory frameworks, and
enhanced collaboration among stakeholders to ensure consistent, reliable, and
validated AST practices worldwide.
Regulatory
Hurdles
Regulatory hurdles pose a significant challenge to the
growth and expansion of the Global Antimicrobial Susceptibility Testing (AST)
Market. Regulatory bodies in different regions have stringent requirements for
the approval and commercialization of new AST technologies, which can delay the
introduction of innovative solutions to the market. These regulatory
requirements are essential for ensuring the safety, efficacy, and accuracy of
AST products, but they also create barriers for manufacturers, particularly
smaller companies or startups with limited resources. In some cases, the
process of obtaining approval from agencies like the U.S. Food and Drug
Administration (FDA) or the European Medicines Agency (EMA) can take several
years, during which the development and commercialization costs continue to
rise.
The complexity and variability of regulatory standards
across different regions can also pose challenges for companies seeking to
expand their reach globally. Companies must navigate a fragmented regulatory
landscape, where the criteria for approval and market entry differ
substantially. In addition to traditional product testing and clinical trials,
companies are often required to meet specific post-market surveillance
obligations, making the regulatory pathway more cumbersome. These regulatory
delays can hinder the timely adoption of new AST solutions that could address
critical needs in combating antimicrobial resistance (AMR).
Regulatory bodies are also cautious in approving new
diagnostic technologies due to the potential risks associated with inaccurate
results. Misidentifying antimicrobial resistance could lead to inappropriate
treatments, contributing to the worsening of AMR. This risk factor makes
regulators particularly stringent in their assessment of new AST solutions,
adding another layer of complexity to the approval process. As a result,
navigating regulatory hurdles remains one of the key challenges for companies operating
in the antimicrobial susceptibility testing market.
Key Market Trends
Shift
Towards Automated and High-Throughput Systems
The shift towards automated and high-throughput
systems is a significant trend driving the Global Antimicrobial Susceptibility
Testing (AST) Market. Laboratories and healthcare providers are increasingly
adopting automated systems to enhance efficiency, reduce human error, and
improve consistency in testing. Automated AST systems streamline workflows by
handling large volumes of samples, enabling faster and more accurate results.
These systems are particularly valuable in settings with high patient turnover,
such as hospitals and large diagnostic laboratories, where the demand for quick
results is paramount.
High-throughput systems allow for the simultaneous
processing of multiple samples, significantly increasing productivity. This is
especially important as the global healthcare industry faces rising diagnostic
demands due to the increasing prevalence of infectious diseases and
antimicrobial resistance (AMR). By incorporating automation, laboratories can
reduce the turnaround time for AST results, ensuring timely initiation of
effective treatments and minimizing the risk of AMR spread. Additionally, automation
minimizes the need for extensive manual labor, reducing the possibility of
human error and ensuring reproducible results, which is essential in accurate
susceptibility testing.
These automated systems also offer improved data
management capabilities, integrating with laboratory information systems (LIS)
and enabling seamless reporting and tracking of results. The trend towards
automation is driven by the growing need for precision, efficiency, and
scalability in diagnostic testing. As healthcare systems increasingly adopt
digital health technologies and seek ways to handle larger patient volumes,
automated AST systems are poised to become a core component in the fight
against AMR. The continued development of these systems is expected to further
enhance diagnostic capabilities and provide more rapid and accurate
antimicrobial susceptibility data in the years ahead.
Rise
of Point-of-Care Testing
The rise of point-of-care (POC) testing is a
significant market trend in the Global Antimicrobial Susceptibility Testing
(AST) market, driven by the growing need for rapid, accurate, and accessible
diagnostics in healthcare settings. POC testing enables healthcare providers to
perform antimicrobial susceptibility testing directly at the patient’s
location, such as in a hospital room, clinic, or even in remote or
resource-limited areas, without needing to send samples to a central
laboratory. This shift is primarily fueled by the desire to shorten the time
between diagnosis and treatment initiation, which is critical for improving
patient outcomes and managing antimicrobial resistance (AMR).
The traditional AST methods, which can take up to 48
hours or longer to yield results, create delays in prescribing the appropriate
antibiotics, leading to suboptimal treatment. With POC AST technologies, test
results are available in a matter of hours or even minutes, enabling clinicians
to select the most effective treatment promptly. This reduction in turnaround
time helps reduce unnecessary antibiotic use, thus supporting efforts to combat
AMR. The growing adoption of rapid diagnostics in settings where timely
decisions are critical, such as intensive care units or emergency departments,
is contributing to the rise of POC testing.
In addition to improving patient care, POC AST systems
are becoming more portable, user-friendly, and cost-effective, making them
suitable for a wide range of healthcare environments. The increasing need for
real-time diagnostics in both developed and emerging markets is expanding the
application of POC testing. This trend is particularly vital in low-resource
settings, where access to centralized laboratories may be limited. As
healthcare systems continue to prioritize quick and accurate antimicrobial susceptibility
testing, the rise of POC technologies will play a pivotal role in shaping the
future of the AST market.
Segmental Insights
Product
Insights
Based
on the Product, Manual Tests emerged as the dominant segment in the Global
Antimicrobial Susceptibility Testing Market in 2024. This is due to their
widespread adoption and established effectiveness in clinical settings. These
tests, such as the disk diffusion method and broth dilution technique, continue
to be the gold standard in many laboratories due to their simplicity,
reliability, and relatively low cost. Manual testing provides accurate and
reproducible results, making it the preferred choice in healthcare facilities,
especially in resource-limited settings. Moreover, manual methods require
minimal technological infrastructure, which contributes to their sustained
popularity in developing regions.
Technique
Insights
Based on the Technique, Disk Diffusion emerged as the
dominant segment in the
Global Antimicrobial Susceptibility Testing Market in 2024. This
is primarily
due to its simplicity, reliability, and widespread use in microbiology
laboratories. The method, commonly referred to as the Kirby-Bauer test,
involves placing antibiotic-impregnated paper discs on an agar plate inoculated
with the microorganism in question. The zone of inhibition around each disc
indicates the microorganism's susceptibility to the antibiotic, making it a
straightforward and effective way to assess antimicrobial resistance. This
technique's dominance is attributed to its low cost and ease of implementation,
making it suitable for both large-scale laboratories and smaller,
resource-constrained settings. Furthermore, the disk diffusion method has been
extensively validated, with well-established guidelines from organizations such
as the Clinical and Laboratory Standards Institute (CLSI) ensuring consistent
and accurate results.
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Regional Insights
North America emerged
as the dominant region in the Global Antimicrobial Susceptibility Testing
Market in 2024. This is driven by a
combination of advanced healthcare infrastructure, high adoption of diagnostic
technologies, and a growing focus on combating antimicrobial resistance (AMR).
The region benefits from a robust healthcare system, well-established
regulatory frameworks, and high funding for research and development, which
collectively foster the widespread use of AST methods across hospitals, laboratories,
and research institutions. In the U.S. and Canada, the presence of leading
diagnostic companies and advanced medical technology providers has also
accelerated the adoption of cutting-edge AST solutions, including both manual
and automated testing methods. These countries have stringent antimicrobial
stewardship programs and public health policies aimed at monitoring and
controlling the spread of AMR, further driving the demand for AST.
Asia-Pacific emerged as
the fastest growing region in the Global Antimicrobial Susceptibility Testing
Market during the forecast period. This is due to a combination of increasing
healthcare investments, rising awareness about antimicrobial resistance (AMR),
and growing demand for advanced diagnostic solutions. Several countries in the
region, including China, India, Japan, and South Korea, have been making
substantial improvements in their healthcare infrastructure, which has
positively impacted the adoption of AST methods. This growth is supported by a
surge in government initiatives, such as antimicrobial resistance action plans,
aimed at tackling the rising threat of drug-resistant infections. Furthermore,
the region is experiencing a notable increase in hospital and laboratory
facilities, which require reliable diagnostic tools to assess the effectiveness
of antimicrobial treatments.
Recent Developments
- In October 2024, Hardy Diagnostics
announced an exclusive partnership with Gradientech to distribute its
FDA-approved QuickMIC system in the U.S. and Canada. The QuickMIC system aids
in the rapid management of sepsis by helping clinicians make faster antibiotic
treatment decisions, significantly improving outcomes for sepsis patients.
Sepsis is a leading cause of death in hospitals, with over 1.7 million adults
in the U.S. diagnosed annually, resulting in at least 250,000 deaths, according
to the CDC.
- In August 2024, Merck, a leading science
and technology company, completed its acquisition of Mirus Bio for
approximately USD 600 Million, following regulatory approvals and other
customary conditions. This acquisition aligns with Merck's strategy to expand
its viral vector manufacturing capabilities and supports its commitment to
advancing cell and gene therapies from preclinical to commercial production.
Merck acquired Mirus Bio from Gamma Biosciences, a life sciences platform
backed by global investment firm KKR.
- In May 2024, Bruker Corporation (US)
expanded its footprint in the molecular diagnostics market with the acquisition
of ELITechGroup (Italy), focusing on its molecular diagnostics portfolio, while
excluding the clinical chemistry segment. This strategic acquisition enhances
Bruker's ability to offer cutting-edge solutions, especially in microbiology
and infection diagnostics, reinforcing its position as a leader in the
molecular diagnostics space.
- In February 2024, Avails Medical, Inc.
announced that it received 510(k) clearance from the U.S. FDA for its eQUANT
system, a breakthrough in rapid, automated antibiotic susceptibility testing
(AST). The system offers a standardized inoculum directly from positive blood
cultures, marking a significant advancement in addressing antibiotic
resistance. Clinical data submitted to the FDA shows that eQUANT™ can reduce
routine AST turnaround times by up to one day, with over 95% correlation to
standard care methods.
- In April 2023, bioMérieux (France) and
Oxford Nanopore Technologies (UK) formed a strategic partnership aimed at
developing groundbreaking solutions in the field of infectious disease
diagnostics. This collaboration combines bioMérieux’s expertise in microbiological
diagnostics with Oxford Nanopore's cutting-edge sequencing technology. The
partnership is expected to accelerate the development of innovative diagnostic
tools that enhance the speed, accuracy, and cost-effectiveness of identifying
infectious diseases, with potential applications in clinical settings, public
health, and pathogen surveillance.
Key Market Players
- Bio-Rad
Laboratories Inc.
- Merck
& Co., Inc.
- Thermo
Fisher Scientific Inc.
- Danaher
Corporation
- bioMérieux
SA
- Becton,
Dickinson and Company
- ELITech
Group SAS
- F.
Hoffmann-La Roche Ltd.
- Accelerate
Diagnostics, Inc.
- HiMedia
Laboratories Private Limited
|
By Product
|
By Technique
|
By Application
|
By End User
|
By Region
|
- Manual Tests
- Automated Instruments
- Consumables & Media
|
- Automated AST
- Etest Method
- Dilution
- Disk Diffusion
- Others
|
- Drug Development
- Susceptibility Testing
- Others
|
- Hospitals
- Diagnostic Laboratories
- Biotechnology & Pharmaceutical Companies
- Others
|
- North America
- Europe
- Asia Pacific
- South America
- Middle East & Africa
|
Report Scope:
In this report, the Global Antimicrobial
Susceptibility Testing Market has been segmented into the following categories,
in addition to the industry trends which have also been detailed below:
- Antimicrobial
Susceptibility Testing Market, By Product:
o
Manual
Tests
§
MIC
Strips
§
Susceptibility
Testing Disks
§
Susceptibility
Plates
o
Automated
Instruments
o
Consumables
& Media
- Antimicrobial
Susceptibility Testing Market, By Technique:
o
Automated
AST
o
Etest
Method
o
Dilution
o
Disk
Diffusion
o
Others
- Antimicrobial
Susceptibility Testing Market, By Application:
o
Drug
Development
o
Susceptibility
Testing
o
Others
- Antimicrobial
Susceptibility Testing Market, By End User:
o
Hospitals
o
Diagnostic
Laboratories
o
Biotechnology
& Pharmaceutical Companies
o
Others
- Antimicrobial
Susceptibility Testing Market, By Region:
o
North
America
§
United
States
§
Canada
§
Mexico
o
Europe
§
France
§
United
Kingdom
§
Italy
§
Germany
§
Spain
o
Asia-Pacific
§
China
§
India
§
Japan
§
Australia
§
South
Korea
o
South
America
§
Brazil
§
Argentina
§
Colombia
o
Middle
East & Africa
§
South
Africa
§
Saudi
Arabia
§
UAE
Competitive Landscape
Company
Profiles: Detailed
analysis of the major companies present in the Global Antimicrobial
Susceptibility Testing Market.
Available Customizations:
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TechSci Research offers customizations according to a company's specific needs.
The following customization options are available for the report:
Company Information
- Detailed analysis and profiling of additional market players (up to
five).
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