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    Mycoplasma Testing Market

    ID: MRFR/LS/5312-HCR
    100 Pages
    Rahul Gotadki
    October 2025

    Mycoplasma Testing Market Research Report By Test Type (PCR Testing, ELISA Testing, Culture Testing, Nucleic Acid Hybridization), By Application (Quality Control, Research and Development, Diagnostic Testing), By End Use (Pharmaceutical Companies, Biotechnology Companies, Academic Research Institutes), By Region (North America, Europe, Asia Pacific) and By Regional (North America, Europe, South America, Asia Pacific, Middle East and Africa) - Forecast to 2035

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    Mycoplasma Testing Market Summary

    As per MRFR analysis, the Mycoplasma Testing Market Size was estimated at 1.895 USD Billion in 2024. The Mycoplasma Testing industry is projected to grow from 2.112 USD Billion in 2025 to 6.243 USD Billion by 2035, exhibiting a compound annual growth rate (CAGR) of 11.45 during the forecast period 2025 - 2035.

    Key Market Trends & Highlights

    The Mycoplasma Testing Market is experiencing robust growth driven by technological advancements and increasing demand from the biopharmaceutical sector.

    • Technological advancements in testing methods are enhancing the accuracy and efficiency of mycoplasma detection.
    • North America remains the largest market, while the Asia-Pacific region is emerging as the fastest-growing market for mycoplasma testing.
    • PCR testing holds the largest market share, whereas ELISA testing is witnessing the fastest growth in adoption.
    • The rising incidence of mycoplasma contamination and increased focus on quality control in biopharmaceuticals are key drivers propelling market expansion.

    Market Size & Forecast

    2024 Market Size 1.895 (USD Billion)
    2035 Market Size 6.243 (USD Billion)
    CAGR (2025 - 2035) 11.45%

    Major Players

    Thermo Fisher Scientific (US), Merck KGaA (DE), Bio-Rad Laboratories (US), F. Hoffmann-La Roche AG (CH), Genetic Technologies Limited (AU), Lonza Group AG (CH), Charles River Laboratories (US), Boehringer Ingelheim (DE), Abcam plc (GB)

    Mycoplasma Testing Market Trends

    The Mycoplasma Testing Market is currently experiencing a notable evolution, driven by the increasing demand for accurate and reliable testing methods across various sectors, including pharmaceuticals, biotechnology, and clinical diagnostics. The growing awareness of mycoplasma contamination in cell cultures and its potential impact on research and production processes has led to heightened scrutiny and regulatory requirements. Consequently, organizations are investing in advanced testing technologies to ensure compliance and maintain the integrity of their products. This trend appears to be fostering innovation in testing methodologies, with a focus on enhancing sensitivity and specificity. Moreover, the Mycoplasma Testing Market is likely to benefit from the rising prevalence of infectious diseases and the expanding biopharmaceutical industry. As the need for effective quality control measures intensifies, companies are increasingly adopting automated and high-throughput testing solutions. This shift not only streamlines the testing process but also reduces the risk of human error, thereby improving overall efficiency. Additionally, collaborations between key stakeholders, including research institutions and technology providers, may further propel advancements in testing capabilities, ensuring that the market remains responsive to evolving challenges and opportunities.

    Technological Advancements in Testing Methods

    The Mycoplasma Testing Market is witnessing a surge in technological innovations aimed at improving testing accuracy and efficiency. New methodologies, such as PCR and next-generation sequencing, are being integrated into testing protocols, enhancing the detection of mycoplasma contamination. These advancements not only facilitate faster results but also increase the reliability of testing outcomes, which is crucial for industries reliant on cell cultures.

    Regulatory Compliance and Quality Assurance

    As regulatory bodies continue to emphasize stringent quality control measures, the Mycoplasma Testing Market is adapting to meet these requirements. Companies are increasingly prioritizing compliance with international standards, leading to a rise in demand for comprehensive testing solutions. This trend underscores the importance of maintaining product integrity and safety, particularly in the biopharmaceutical sector.

    Growing Demand from Biopharmaceutical Sector

    The biopharmaceutical industry is a significant driver of growth within the Mycoplasma Testing Market. With the expansion of biologics and advanced therapies, there is an escalating need for rigorous testing to prevent contamination. This demand is prompting companies to invest in robust testing frameworks, ensuring that their products meet the highest quality standards.

    Mycoplasma Testing Market Drivers

    Growing Awareness of Mycoplasma Risks

    The growing awareness of the risks associated with mycoplasma contamination among researchers and manufacturers is a crucial driver for the Mycoplasma Testing Market. Educational initiatives and industry conferences are increasingly highlighting the potential impact of mycoplasma on research outcomes and product quality. This awareness is leading to a proactive approach in testing, with more organizations prioritizing mycoplasma testing as part of their quality assurance processes. As a result, the market is expected to experience a surge in demand, with projections indicating a growth rate of approximately 8% annually. This trend reflects a shift towards a more vigilant stance on contamination risks, further solidifying the role of mycoplasma testing in laboratory and manufacturing settings.

    Rising Incidence of Mycoplasma Contamination

    The increasing incidence of mycoplasma contamination in cell cultures and biopharmaceutical products is a primary driver for the Mycoplasma Testing Market. Mycoplasma contamination can lead to significant financial losses and compromised product quality, prompting manufacturers to invest in robust testing solutions. Reports indicate that approximately 15-35% of cell cultures may be contaminated with mycoplasma, underscoring the necessity for effective testing. As the biopharmaceutical sector expands, the demand for reliable mycoplasma testing is expected to rise, with the market projected to grow at a compound annual growth rate of around 10% over the next few years. This trend highlights the critical role of mycoplasma testing in ensuring the safety and efficacy of biological products.

    Advancements in Molecular Testing Technologies

    Technological advancements in molecular testing methods are significantly influencing the Mycoplasma Testing Market. Innovations such as PCR (Polymerase Chain Reaction) and next-generation sequencing have enhanced the sensitivity and specificity of mycoplasma detection. These advanced techniques allow for rapid and accurate identification of mycoplasma species, which is crucial for maintaining the integrity of biopharmaceutical products. The market for molecular testing is expected to witness substantial growth, with estimates suggesting a market size increase to over USD 1 billion by 2026. As laboratories seek to adopt more efficient testing methodologies, the demand for advanced mycoplasma testing solutions is likely to escalate, further propelling market growth.

    Expansion of Biopharmaceutical Manufacturing Facilities

    The expansion of biopharmaceutical manufacturing facilities is driving the Mycoplasma Testing Market. As new production plants are established, the need for comprehensive testing protocols becomes paramount to ensure product safety and compliance with regulatory standards. The biopharmaceutical sector is experiencing rapid growth, with investments in new facilities projected to exceed USD 10 billion in the coming years. This expansion necessitates the implementation of rigorous mycoplasma testing to prevent contamination and ensure the integrity of biological products. Consequently, the demand for mycoplasma testing solutions is likely to increase, as manufacturers seek to safeguard their operations and maintain high-quality standards in their products.

    Increased Focus on Quality Control in Biopharmaceuticals

    The heightened focus on quality control and assurance in the biopharmaceutical industry serves as a significant driver for the Mycoplasma Testing Market. Regulatory bodies are imposing stringent guidelines to ensure that biopharmaceutical products are free from contaminants, including mycoplasma. This regulatory landscape compels manufacturers to implement comprehensive testing protocols, thereby increasing the demand for mycoplasma testing solutions. The market is projected to reach USD 500 million by 2025, driven by the need for compliance with these regulations. As companies strive to meet quality standards, the reliance on effective mycoplasma testing will likely intensify, reinforcing its importance in the biopharmaceutical manufacturing process.

    Market Segment Insights

    By Test Type: PCR Testing (Largest) vs. ELISA Testing (Fastest-Growing)

    In the mycoplasma testing market, the test type segment reveals distinct dynamics among PCR Testing, ELISA Testing, Culture Testing, and Nucleic Acid Hybridization. PCR Testing holds the largest market share, primarily due to its sensitivity and rapid results, gaining significant traction among healthcare providers. Meanwhile, ELISA Testing is swiftly capturing market presence, reflecting its growing acceptance in laboratory settings for its efficiency and cost-effectiveness, thus catering to diverse testing needs.

    PCR Testing (Dominant) vs. Culture Testing (Emerging)

    PCR Testing is recognized as the dominant force within the mycoplasma testing segment due to its unparalleled precision in detecting mycoplasma pathogens with quick turnaround times. Laboratories greatly appreciate its high sensitivity, leading to its widespread adoption in clinical diagnostics. On the other hand, Culture Testing represents an emerging alternative, favored for its ability to provide comprehensive data regarding organism viability. Although traditionally slower and more resource-intensive, advancements in culture techniques are fostering its resurgence in applications requiring quantitative analysis, thus positioning it as an important player within the testing landscape.

    By Application: Diagnostic Testing (Largest) vs. Quality Control (Fastest-Growing)

    The Mycoplasma Testing Market is predominantly driven by the Diagnostic Testing segment, which holds the largest market share among the applications. This segment's prominence can be attributed to the increasing prevalence of microbial infections and the need for precise identification and treatment. Regulatory requirements have also necessitated robust diagnostic measures, further solidifying its market position. Conversely, the Quality Control segment is witnessing rapid growth as industries become increasingly cognizant of the importance of maintaining high standards in product quality. Enhanced focus on preventing contamination in production processes is driving demand for mycoplasma testing in this area. This trend is expected to continue, with more industries adopting these tests to assure product integrity and safety.

    Diagnostic Testing (Dominant) vs. Quality Control (Emerging)

    The Diagnostic Testing segment is recognized as the dominant force in the Mycoplasma Testing Market. It encompasses methodologies utilized for identifying mycoplasmas in clinical samples, ensuring appropriate treatment interventions. The segment is pivotal in healthcare, driven by heightened awareness of mycoplasma-related infections. On the other hand, the Quality Control segment is emerging as a vital player, particularly in industries such as pharmaceuticals and biotechnology. Companies are increasingly implementing mycoplasma testing to meet stringent regulatory standards, enhance product quality, and ensure patient safety. This segment is marked by its proactive approach to preventing product contamination, showcasing its growing importance in the overall testing landscape.

    By End Use: Pharmaceutical Companies (Largest) vs. Biotechnology Companies (Fastest-Growing)

    In the Mycoplasma Testing Market, the distribution of market share among the key end-use segments highlights the pharmaceutical companies as the dominant force. These entities rely heavily on mycoplasma testing to ensure the safety and efficacy of their products. On the other hand, biotechnology companies are rapidly gaining ground, driven by the increasing focus on biopharmaceutical development. This competitive landscape showcases a clear hierarchy in market participation, where pharmaceutical companies hold a substantial share while biotechnology companies continue to expand their influence.

    End Use: Pharmaceutical Companies (Dominant) vs. Biotechnology Companies (Emerging)

    Pharmaceutical companies represent the dominant segment in the Mycoplasma Testing Market, owing to their extensive regulatory requirements and the critical need for high-quality assurance. Their established processes and resources enable them to implement rigorous testing protocols effectively. Conversely, biotechnology companies, classified as emerging players, are witnessing exponential growth fueled by advancements in research and technology. Their focus on developing novel therapies and biologics is propelling demand for mycoplasma testing, establishing them as a significant contributor to the market's dynamics. This duality highlights a transformative phase in the market, where traditional and innovative approaches coexist.

    Get more detailed insights about Mycoplasma Testing Market

    Regional Insights

    The Mycoplasma Testing Market is experiencing notable growth across various regions, with North America holding a significant market share valued at 0.8 USD Billion in 2023 and projected to grow to 2.2 USD Billion by 2032, thus dominating the market primarily due to increased research and regulatory requirements in the biopharmaceutical sector. Europe follows closely, with a valuation of 0.5 USD Billion in 2023 and expected to reach 1.4 USD Billion by 2032, reflecting a growing focus on stringent quality control measures in drug manufacturing.

    The APAC region, valued at 0.3 USD Billion in 2023, is anticipated to show rapid growth potential as pharmaceutical industries expand activities and regulations tighten, leading to an expected increase to 0.9 USD Billion by 2032. In South America, the market value stood at 0.05 USD Billion in 2023, projected to grow modestly to 0.15 USD Billion by 2032, indicating an emerging focus on laboratory testing services.

    Lastly, the MEA region is currently valued at 0.02 USD Billion in 2023 and is set to expand to 0.05 USD Billion by 2032, reflecting slow growth but gradual recognition of mycoplasma testing's importance.

    This segmentation underlines the Mycoplasma Testing Market revenue distribution and the varying developmental pace across regions, highlighting North America's majority holding while also signaling growth opportunities, particularly in APAC and MEA.

    Mycoplasma Testing Market Regional Insights

    Source: Primary Research, Secondary Research, Market Research Future Database and Analyst Review

    Key Players and Competitive Insights

    The Mycoplasma Testing Market has evolved as a critical sector within the broader landscape of biotechnology and medical diagnostics. Mycoplasma contamination in cell cultures can lead to substantial economic and scientific setbacks, making accurate and reliable testing methodologies essential. 

    Various players in the market are focused on addressing these challenges through innovative solutions, including robust detection kits and advanced analytical technologies. With an increasing emphasis on quality control, particularly in the pharmaceutical and biopharmaceutical sectors, the competitive landscape is marked by a blend of established entities and emerging companies striving to establish their markets by offering enhanced testing capabilities that meet regulatory requirements and industry standards.

    Abcam holds a significant presence in the Mycoplasma Testing Market, leveraging its strengths in antibody and protein production to develop reliable mycoplasma detection kits. The company is known for its commitment to high-quality research products and a diverse portfolio catering to the needs of researchers in various fields. Abcam's reputation for reliability and its focus on user-friendly products contribute to its competitive edge as researchers seek efficient and dependable solutions to mitigate contamination risks. 

    Furthermore, the company's strong customer service and technical support enhance its overall market presence, providing clients with valuable resources and insights throughout their research processes.In the competitive realm of the Mycoplasma Testing Market, ATCC stands out for its extensive catalog of authenticated biological materials and expertise in mycoplasma testing. The company is dedicated to offering comprehensive solutions that address contamination challenges faced in cell culture and microbiological testing. 

    ATCC's well-established brand recognition is synonymous with quality assurance, making it a preferred choice for laboratories and research facilities. Its innovative testing methods and commitment to continuous improvement in quality management systems reflect its focus on providing reliable and accurate mycoplasma testing solutions. By maintaining rigorous quality control and providing education and training resources, ATCC reinforces its position as a key player in this essential market segment.

    Key Companies in the Mycoplasma Testing Market market include

    Industry Developments

    • Q2 2024: Thermo Fisher Scientific Launches New MycoSEQ Mycoplasma Detection Assay for Cell and Gene Therapy Manufacturing Thermo Fisher Scientific announced the launch of its next-generation MycoSEQ Mycoplasma Detection Assay, designed to provide rapid and sensitive detection of mycoplasma contamination in cell and gene therapy manufacturing workflows.
    • Q1 2024: Lonza Expands Mycoplasma Testing Capabilities with New Facility in Switzerland Lonza announced the opening of a new dedicated mycoplasma testing laboratory at its Visp, Switzerland site, aimed at supporting increased demand for rapid and compliant mycoplasma testing services for biopharmaceutical clients.
    • Q2 2024: Charles River Laboratories Acquires Mycoplasma Testing Specialist BioOutsource Charles River Laboratories completed the acquisition of BioOutsource, a UK-based provider of mycoplasma and viral testing services, to strengthen its biologics testing portfolio and expand its global reach.
    • Q3 2024: MilliporeSigma Receives FDA Clearance for Updated Mycoplasma Detection Kit MilliporeSigma, the U.S. and Canada life science business of Merck KGaA, announced FDA clearance for its updated MycoAlert Mycoplasma Detection Kit, enabling faster and more reliable mycoplasma testing for biomanufacturers.
    • Q2 2024: BioMérieux Launches Automated Mycoplasma Testing Platform for Biopharma Industry BioMérieux introduced a fully automated mycoplasma testing platform designed to streamline and accelerate quality control processes in biopharmaceutical manufacturing.
    • Q1 2025: Eurofins Scientific Opens New Mycoplasma Testing Laboratory in Singapore Eurofins Scientific announced the inauguration of a new laboratory in Singapore dedicated to mycoplasma and sterility testing, expanding its global network of biopharmaceutical testing services.
    • Q2 2025: Sartorius Launches Rapid Mycoplasma Detection Solution for Cell Therapy Manufacturers Sartorius introduced a rapid mycoplasma detection solution tailored for cell therapy manufacturers, aiming to reduce testing turnaround times and support regulatory compliance.
    • Q1 2024: Takara Bio Launches PCR-Based Mycoplasma Detection Kit for Research and Clinical Use Takara Bio announced the commercial launch of a new PCR-based mycoplasma detection kit, designed for both research and clinical laboratory applications.
    • Q3 2024: Agilent Technologies Expands Mycoplasma Testing Portfolio with Acquisition of Microbial QC Startup Agilent Technologies acquired a microbial quality control startup specializing in rapid mycoplasma detection technologies, enhancing its offerings for the biopharmaceutical sector.
    • Q2 2024: FDA Approves New Mycoplasma Detection Method for Biologics Manufacturing The U.S. Food and Drug Administration approved a novel nucleic acid-based mycoplasma detection method for use in biologics manufacturing, providing an alternative to traditional culture-based assays.
    • Q4 2024: QIAGEN Launches Digital PCR Mycoplasma Detection Kit for Bioprocessing QIAGEN announced the launch of a digital PCR-based mycoplasma detection kit, offering enhanced sensitivity and quantification for bioprocessing applications.
    • Q1 2025: GenScript Biotech Expands Mycoplasma Testing Services with New U.S. Facility GenScript Biotech opened a new facility in the United States dedicated to providing mycoplasma testing services for cell and gene therapy developers.

    Future Outlook

    Mycoplasma Testing Market Future Outlook

    The Mycoplasma Testing Market is projected to grow at 11.45% CAGR from 2024 to 2035, driven by increasing demand for accurate diagnostics and advancements in testing technologies.

    New opportunities lie in:

    • Development of rapid testing kits for point-of-care diagnostics.
    • Expansion of mycoplasma testing services in emerging markets.
    • Integration of AI-driven analytics for enhanced test accuracy.

    By 2035, the Mycoplasma Testing Market is expected to achieve substantial growth and innovation.

    Market Segmentation

    Mycoplasma Testing Market End Use Outlook

    • Pharmaceutical Companies
    • Biotechnology Companies
    • Academic Research Institutes

    Mycoplasma Testing Market Test Type Outlook

    • PCR Testing
    • ELISA Testing
    • Culture Testing
    • Nucleic Acid Hybridization

    Mycoplasma Testing Market Application Outlook

    • Quality Control
    • Research and Development
    • Diagnostic Testing

    Report Scope

    MARKET SIZE 20241.895(USD Billion)
    MARKET SIZE 20252.112(USD Billion)
    MARKET SIZE 20356.243(USD Billion)
    COMPOUND ANNUAL GROWTH RATE (CAGR)11.45% (2024 - 2035)
    REPORT COVERAGERevenue Forecast, Competitive Landscape, Growth Factors, and Trends
    BASE YEAR2024
    Market Forecast Period2025 - 2035
    Historical Data2019 - 2024
    Market Forecast UnitsUSD Billion
    Key Companies ProfiledMarket analysis in progress
    Segments CoveredMarket segmentation analysis in progress
    Key Market OpportunitiesAdvancements in molecular diagnostics enhance accuracy and speed in the Mycoplasma Testing Market.
    Key Market DynamicsRising demand for accurate mycoplasma detection drives innovation and regulatory scrutiny in testing methodologies.
    Countries CoveredNorth America, Europe, APAC, South America, MEA

    Market Highlights

    Author
    Rahul Gotadki
    Assistant Manager

    He holds an experience of about 7+ years in Market Research and Business Consulting, working under the spectrum of Life Sciences and Healthcare domains. Rahul conceptualizes and implements a scalable business strategy and provides strategic leadership to the clients. His expertise lies in market estimation, competitive intelligence, pipeline analysis, customer assessment, etc. In addition to the above, his other responsibility includes strategic tracking of high growth markets & advising clients on the potential areas of focus they could direct their business initiatives

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    FAQs

    What is the expected market size of the Mycoplasma Testing Market in 2032?

    The Mycoplasma Testing Market is expected to reach a valuation of 4.5 billion USD by 2032.

    What is the projected CAGR for the Mycoplasma Testing Market from 2024 to 2032?

    The anticipated CAGR for the Mycoplasma Testing Market from 2024 to 2032 is 11.45%.

    Which region is expected to have the largest market share in the Mycoplasma Testing Market by 2032?

    North America is projected to hold the largest market share in the Mycoplasma Testing Market, expected to reach 2.2 billion USD by 2032.

    What is the market size for PCR Testing in the Mycoplasma Testing Market by 2032?

    PCR Testing within the Mycoplasma Testing Market is expected to reach a value of 2.2 billion USD by 2032.

    What is the market value for ELISA Testing in the Mycoplasma Testing Market in 2023?

    ELISA Testing in the Mycoplasma Testing Market is valued at 0.45 billion USD in 2023.

    Who are the key players in the Mycoplasma Testing Market?

    Major players in the market include Abcam, Qiagen, Thermo Fisher Scientific, and Lonza, among others.

    What is the expected market growth rate for the Asia-Pacific region in the Mycoplasma Testing Market by 2032?

    The Asia-Pacific region is expected to achieve a market value of 0.9 billion USD in the Mycoplasma Testing Market by 2032.

    What is the market size of the Culture Testing segment in the Mycoplasma Testing Market for 2032?

    The Culture Testing segment is projected to reach a size of 0.8 billion USD in the Mycoplasma Testing Market by 2032.

    What growth drivers are impacting the Mycoplasma Testing Market?

    The increasing prevalence of mycoplasma contamination in cell culture and advancements in testing technologies are key growth drivers.

    What is the value of the Mycoplasma Testing Market in South America by 2032?

    The market value for the Mycoplasma Testing Market in South America is expected to reach 0.15 billion USD by 2032.

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