Microbiology Testing Market Experiencing Rapid Growth

The global microbiology testing market size was valued at USD 5.33 billion in 2023 and it is expected to surpass around USD 12.72 billion by 2033 with a CAGR of 9.12% from 2024 to 2033 due to the increasing demand for genetic testing services.

Market Overview

The microbiology testing market is experiencing rapid growth driven by advancements in technology. This growth is particularly evident in industries such as pharmaceuticals, cosmetics, municipal water, and food and beverage, where microbiological testing plays a critical role in ensuring product safety and regulatory compliance. Various techniques, ranging from bioburden testing to mycoplasma detection, are routinely employed across these sectors. Microbiological testing serves to detect pathogenic microorganisms present in diverse samples collected from humans, animals, living environments, tools, and food products, among others. These tests are crucial for identifying the causative agents of diseases and ensuring the safety of the tested materials.

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Microbiological tests can be classified into four main categories: direct sigmoidoscopy, culture tests, immunoassays, and molecular biology tests. Each type of test holds distinct value, and the quality of testing outcomes is influenced by various factors, including the laboratory’s protocols and procedures. As such, ensuring consistent and reliable testing results necessitates adherence to established standards and best practices within the laboratory setting.

• In June 2023, Solvay announced its intention to construct a multipurpose microbiology laboratory in Europe
• In April 2022, DCN Dx acquired Biomed Diagnostics, a company specializing in microbiological testing products

Key Insights

• North America has held largest market share of around 44.40% in 2023.
• By product, the instruments segment has captured market share of around 75.40% in 2023.
• By product, the reagents segment is expanding at a CAGR of 10.7% from 2024 to 2033.
• By test type, the bacterial segment has garnered market share of around 34% in 2023.
• By application, the gastrointestinal diseases segment has held 25% of market share in 2023.
• By end user, the hospitals segment has captured market share of around 34% in 2023.
• The academic and research institutes segment is growing at a CAGR of 9.9% from 2024 to 2033.

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Regional Stance

In 2023, North America retained its position as the dominant market for microbiology testing, commanding a significant market share of 44.40%. However, as of March 2024, concerns have arisen within the American Society for Microbiology (ASM) regarding the FDA’s proposed rule, which is feared to potentially curtail patient access to high-quality and timely infectious disease testing. This apprehension extends to the possibility of increased health inequities and a stifling of innovation in the development of new Laboratory Developed Tests (LDTs) for infectious disease testing.

ASM, a leading professional society comprising 36,000 scientists and health practitioners, holds a mission to promote and advance the microbial sciences. Their concerns stem from the perceived lack of recognition by the FDA of the unique aspects inherent in infectious disease testing. The broad regulatory approach adopted by the FDA is believed to be counterproductive, potentially yielding outcomes contrary to the agency’s intended goals.

Within the United States, the American Board of Medical Microbiology (ABMM), approved by the U.S. Department of Health and Human Services (HHS), plays a crucial role in certifying doctoral-level microbiologists to oversee medical and public health microbiology laboratories and conduct high-complexity testing. This certification ensures adherence to rigorous standards and maintains the quality of microbiology testing practices.

In Canada, the Canadian Society of Microbiologists (CSM) strives to advance microbiology across all its facets and facilitate the exchange of ideas among microbiologists. Their efforts contribute to the ongoing development and enhancement of microbiology testing methodologies and practices in the region.

Among these dynamics, stakeholders in the North American microbiology testing market must navigate regulatory challenges while upholding standards of excellence in testing procedures. Collaboration between industry, regulatory bodies, and professional societies remains essential to address concerns and foster innovation in infectious disease testing, ensuring continued access to high-quality diagnostic solutions for patients across the region.

• In November 2023, the ADM North America Microbiology Laboratory attained accreditation
• In August 2023, Eurofins announced the completion of the acquisition of EAG Laboratories

Asia-Pacific is poised for rapid expansion in the microbiology testing market, driven by various factors including the strength and efficiency demonstrated by laboratories in India during crisis situations. Particularly noteworthy is India’s adeptness in setting up new assays swiftly, even amidst challenging circumstances. In China, robust microbiological surveillance practices are being implemented to ensure food safety. The Chinese government has undertaken significant efforts to establish a comprehensive national microbiological surveillance system, reflecting a commitment to safeguarding public health and consumer interests.

Characterizing pharmaceutical ingredients is paramount for maintaining final product quality and preventing harm to patients, and SGS employs microbiologists with extensive technical knowledge and expertise to develop and apply methods outlined by authoritative bodies such as the USP and Ph. Eur. These professionals assist in ensuring product quality and safety across various biologics, traditional pharmaceuticals, and medical devices, from development stages through to post-market support.

• In January 2024, the Beijing Institute of Technology (BIT) announced advancements in microbiological research aboard the Chinese Space Station, with its latest research project now onboard the Mengtian experimental module.
• In January 2023, BD introduced a fully automated robotic track system for microbiology labs. Alongside, in February 2024, Prime Minister Modi inaugurated a microbiology lab and 17 food testing vehicles for Assam.

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Report Highlights

By Product

In 2023, the instruments segment dominated the microbiology equipment market, holding a substantial revenue share of 75.40%. Microbiology equipment encompasses a wide array of tools essential for laboratory operations, including microscopes, slides, test tubes, petri dishes, growth mediums (both solid and liquid), inoculation loops, pipettes and tips, incubators, autoclaves, and laminar flow hoods. While some equipment, like microscopes and hoods, are permanent fixtures, others, such as pipette tips, are disposable. The presence of autoclaves enables the sterilization and reuse of equipment, contributing to cost efficiency and sustainability efforts.

Microbiological testing plays a pivotal role in quality control and regulatory compliance across industries, aiding in the mitigation of microbial contamination risks. By facilitating the determination of appropriate manufacturing processes, sterilization methods, and maintenance procedures, microbiological testing ensures product integrity and safety. Moreover, in the medical field, microbiological testing is instrumental in diagnosing, monitoring, and treating various conditions, helping to identify and mitigate potential sources of microbial contamination to safeguard patient health.

The reagents segment is poised for significant growth, with an anticipated Compound Annual Growth Rate (CAGR) of 10.7% during the projected period. Biochemical, immunological, and molecular biological tests form the cornerstone of microbial identification and differentiation. These tests are indispensable for microbiological quality control in production facilities and academic research settings. Reagents utilized in microbial identification tests target specific proteins, biochemical activities (such as enzyme activity), or gene sequences characteristic of microorganisms. Liquid biochemical tests, often requiring only a small amount of reagent applied on agar plates or in liquid mediums, facilitate efficient microbial detection and identification processes.

By Test

In 2023, the bacterial segment emerged as the dominant market player, capturing the highest market share of 34% based on application. Clinical microbiological laboratories traditionally rely on isolating pure cultures and conducting phenotypic tests to identify microorganisms. These tests often revolve around specific biochemical reactions, growth characteristics, colony morphology, and other physiological traits. Notably, features utilized for identification in clinical settings are highly conserved and specific to particular groups of microbes.

The respiratory diseases segment is anticipated to exhibit the fastest expansion over the projected period. Microscopic examination and culture of respiratory secretions are crucial for effectively treating respiratory infections. Adequate sampling is essential, particularly since the lower respiratory tract is typically sterile under normal conditions. Respiratory infections pose significant health challenges, particularly in children, with a wide range of potential pathogens. Identifying these pathogens aids in directing treatment and contributes to disease surveillance efforts.

By Application

In 2023, the gastrointestinal diseases segment emerged as the top revenue generator, commanding a significant market share of 25%. Rapid syndromic diagnostic testing for gastrointestinal pathogens has become increasingly prevalent as a clinical decision support tool, especially in pediatric emergency departments (EDs). This approach facilitates prompt clinical decisions and enhances patient outcomes by swiftly identifying disease-causing microbes.

Acute gastrointestinal tract infections are prevalent, with stool culture being the primary method for diagnosing bacterial intestinal infections. However, certain pathogens, such as Clostridium difficile and diarrheagenic Escherichia coli, require alternative diagnostic approaches, such as toxin detection and PCR assays targeting specific virulence factors. Gastrointestinal pathogen panels offer a comprehensive solution by simultaneously testing for multiple disease-causing microbes in a single stool sample, expediting diagnosis and treatment decisions.

The respiratory diseases segment is poised for rapid expansion in the coming years. Advancements in molecular diagnostic techniques have revolutionized respiratory pathogen detection, enabling faster identification of viruses and other microorganisms previously challenging to detect. The recognition of the lung microbiome has reshaped traditional views on pneumonia pathogenesis, opening avenues for novel diagnostic tools beyond specific pathogen detection. Clinical microbiology laboratories play a crucial role in determining the microbial causes of respiratory infections in children, with particular emphasis on diseases like tuberculosis and pertussis.

By End use

In 2023, the hospitals segment emerged as the dominant market contributor, holding a substantial market share of 34%. Within hospitals, microbiological methods are integral in conjunction with clinical symptoms, additional laboratory tests, and imaging techniques to differentiate true disease-associated infections from other conditions like colonization with normal flora or various disorders such as malignancies, inflammatory disorders, or autoimmune disorders. This comprehensive approach is essential for tailoring appropriate therapies and prognoses for patients.

Hospital laboratories play a pivotal role in identifying the organisms responsible for common infections, with diagnostic microbiology being a vital component within the clinical pathology or laboratory medicine departments. Microbiology laboratories, whether part of hospital facilities or independent reference laboratories serving large geographic areas, offer a wide range of tests, including esoteric tests for less common infections, to support clinical decision-making and patient care.

The academic and research institutes segment is poised for robust growth, with an anticipated Compound Annual Growth Rate (CAGR) of 9.9% over the projected period. These institutes are at the forefront of biological and biotechnological research concerning microorganisms, boasting state-of-the-art facilities. In these settings, diagnostic microbiology plays a crucial role in identifying pathogenic microbes, distinguishing them from normal flora and environmental organisms, and facilitating research into infectious diseases.

Market Dynamics

Driver

Technological advancements

Advancements in technology, such as real-time PCR (RT-PCR), quantitative PCR (qPCR), and automation, including sample-to-result instrumentation, are pivotal drivers propelling the microbiology testing market forward. These innovations have addressed challenges by streamlining processes and enhancing efficiency. FDA-cleared assays categorized as “moderate complexity” due to automation and simplification have widened accessibility, particularly for smaller or understaffed laboratories. Furthermore, the advent of multiplex tests allows for the simultaneous detection of multiple pathogens from a single specimen, simplifying diagnostic procedures.

Digital PCR and next-generation sequencing (NGS) have further revolutionized molecular diagnostics, enabling the analysis of complex, polymicrobial specimens with unparalleled accuracy, even detecting organisms present in minute quantities as low as <0.01% of the microbial consortium. Collectively, these technological breakthroughs have fueled the expansion of the microbiology testing market, catering to the growing demand for precise and comprehensive diagnostic solutions across diverse clinical scenarios.

Restraint

Laboratory limitations

Clinical microbiology laboratories encounter significant hurdles, including infrastructure limitations, equipment constraints, logistical challenges, quality assurance issues, and human resource shortages. One prevalent obstacle is the need for equipment that is “tropicalized” to withstand harsh climatic conditions characterized by high humidity, temperature, and/or sand exposure. While such equipment must endure adverse environments, it also must maintain consistent performance standards, ideally with low energy consumption and minimal maintenance requirements. Addressing these challenges is crucial to unlocking the full potential of the microbiology testing market, as they currently impede the scalability and efficiency of laboratory operations.

Opportunity

Automation in the industry

The integration of laboratory robotics and automation systems presents a significant opportunity for the microbiology testing market. By automating repetitive and labor-intensive tasks, such as sample handling and testing procedures, technicians can allocate their time to higher-value tasks, enhancing overall productivity. These systems operate tirelessly with precision, reducing handling errors and cross-contamination, thus improving test robustness and minimizing the risk of false positives.

Consequently, investigation times and costs are lowered, and batch losses are reduced, driving operational efficiency. Moreover, automated data recording ensures full data integrity and traceability throughout the testing workflow, from sample collection to result reporting, further enhancing reliability and compliance. Embracing automation in microbiology laboratories not only streamlines processes but also creates opportunities for market expansion by delivering enhanced efficiency, accuracy, and quality in testing services.

Recent Developments

• In October 2022, NAMSA, a prominent MedTech Contract Research Organization, completed its acquisition of Perfectus Biomed Group, a UK-based laboratory offering tailored microbiological services
• In February 2024, Bruker revealed a Share Purchase Agreement to acquire ELITechGroup, an innovator in molecular diagnostics
• In July 2022, LANXESS finalized its acquisition of IFF’s microbial control business In January 2024, Samsung Biologics chose Rapid Micro Biosystems’ Growth Direct® platform to automate critical microbiology quality control testing

Key Players in the Clinical Trials Market

• Bio-Rad Laboratories Inc.
• Abbott Laboratories
• Becton Dickinson and Company
• F. Hoffmann-La Roche Ltd
• Bruker Corporation
• Hologic Corporation
• Danaher Corporation (Cepheid Inc.)
• Biomerieux SA
• Thermo Fisher Scientific Inc.
• Agilent Technologies Inc.
• Merck KGaA
• Shimadzu Corporation
• NEOGEN Corporation

MARKET SEGMENTATION

By Product

• Instruments
• Reagents

By Test Type

• Bacterial
• Viral
• Fungal

By Application

• Respiratory Diseases
• Bloodstream Infection
• Gastrointestinal Diseases
• Sexually Transmitted Diseases
• Urinary Tract Infections
• Periodontal Diseases
• Others

By End User

• Hospitals
• Diagnostic Centers
• Academic and Research Institutes
• Others

By Geography

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa

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