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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 Infographic
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    Mycoplasma Testing Market Summary

    The Global Mycoplasma Testing Market is projected to grow from 1.91 USD Billion in 2024 to 6.23 USD Billion by 2032.

    Key Market Trends & Highlights

    Mycoplasma Testing Key Trends and Highlights

    • The market is expected to experience a compound annual growth rate (CAGR) of 11.37% from 2025 to 2032.
    • By 2035, the market valuation is anticipated to reach 6.23 USD Billion, indicating robust growth potential.
    • In 2024, the market is valued at 1.91 USD Billion, reflecting a strong foundation for future expansion.
    • Growing adoption of advanced diagnostic techniques due to increasing awareness of mycoplasma infections is a major market driver.

    Market Size & Forecast

    2024 Market Size 1.91 (USD Billion)
    2035 Market Size 6.23 (USD Billion)
    CAGR (2025-2035) 11.37%

    Major Players

    Abcam, ATCC, Qiagen, BioRad Laboratories, Thermo Fisher Scientific, Boehringer Ingelheim, Genetic Technologies, Sartorius, HoffmannLa Roche, Merck KGaA, Lonza, Charles River Laboratories, Norgen Biotek, PCR Biosystems, Eurofins Scientific

    Mycoplasma Testing Market Trends

    The Mycoplasma Testing Market is experiencing significant growth driven by the increasing prevalence of mycoplasma contamination in cell cultures, which poses risks in biopharmaceutical production and diagnostics. The rising awareness of regulatory standards and quality control in the biotechnology and pharmaceutical sectors further fuels this demand. Additionally, technological advancements in testing methods, such as improved PCR techniques and real-time monitoring systems, are expanding the market's potential. 

    The focus on ensuring the safety and efficacy of biological products and vaccines continues to propel the adoption of mycoplasma testing solutions.Opportunities abound in the sector of mycoplasma testing. More funding in research and development by pharmaceutical and biotech companies brings about and good atmosphere for the introduction of new and innovative testing techniques. Besides, the personalization of medicine suggests the prospects for the development of more individualized mycoplasma testing procedures that target particular clients.

    The current trends in the healthcare industry have also illustrated the need for more efficient and dependable methods of testing in order to maximize the quality of the products. The collaboration between the industrial players and the regulatory bodies aimed at bettering and homogenizing the testing procedures might additionally support the growth of this market. Automation of testing procedures seems to be a recent trend, thus enabling laboratories to be more productive and reduce mistakes caused by humans.

    The integration of advanced analytics and data management tools in mycoplasma testing is rising, enabling laboratories to process large volumes of samples quickly. Additionally, there is a growing trend toward outsourcing testing services as companies seek to optimize operations and focus on core competencies. This trend presents a significant opportunity for specialized testing service providers to expand their market reach and cater to diverse customer segments.

    The increasing prevalence of mycoplasma contamination in cell cultures and the growing demand for accurate testing methodologies are driving advancements in the mycoplasma testing market, highlighting the necessity for stringent quality control measures in biopharmaceutical production.

    U.S. Food and Drug Administration (FDA)

    Mycoplasma Testing Market Drivers

    Market Growth Projections

    The Global Mycoplasma Testing Market Industry is poised for substantial growth, with projections indicating a market size of 1.91 USD Billion in 2024 and an anticipated increase to 6.23 USD Billion by 2035. This growth trajectory suggests a compound annual growth rate (CAGR) of 11.37% from 2025 to 2035. Such projections reflect the increasing recognition of the importance of mycoplasma testing in various sectors, including pharmaceuticals, biotechnology, and academic research. The rising demand for high-quality biopharmaceutical products and the need for compliance with regulatory standards are likely to drive this growth, positioning the mycoplasma testing market as a vital component of the broader life sciences industry.

    Stringent Regulatory Frameworks

    The Global Mycoplasma Testing Market Industry is significantly influenced by stringent regulatory frameworks imposed by health authorities. Regulatory bodies, such as the FDA and EMA, mandate rigorous testing for mycoplasma contamination in cell cultures and biopharmaceutical products. These regulations are designed to protect public health and ensure product safety. As a result, companies are compelled to adopt comprehensive mycoplasma testing protocols to comply with these standards. The increasing emphasis on regulatory compliance is likely to drive market growth, as organizations seek to avoid costly penalties and product recalls. This regulatory landscape is expected to remain a crucial factor in shaping the future of the mycoplasma testing market.

    Rising Demand for Biopharmaceuticals

    The increasing demand for biopharmaceuticals is a significant driver of the Global Mycoplasma Testing Market Industry. As the biopharmaceutical sector expands, the need for stringent quality control measures becomes paramount. Mycoplasma contamination poses a serious risk to the safety and efficacy of biopharmaceutical products. Consequently, manufacturers are investing in advanced mycoplasma testing solutions to ensure compliance with regulatory standards. In 2024, the market is projected to reach 1.91 USD Billion, reflecting the urgency for reliable testing methods to safeguard product integrity. This trend is expected to continue as the industry grows, further propelling the demand for mycoplasma testing solutions.

    Technological Advancements in Testing Methods

    Technological advancements in mycoplasma testing methods are reshaping the Global Mycoplasma Testing Market Industry. Innovations such as PCR-based assays and next-generation sequencing are enhancing the sensitivity and specificity of mycoplasma detection. These advanced techniques enable rapid and accurate identification of mycoplasma species, which is essential for maintaining the quality of biopharmaceutical products. As the market evolves, the adoption of these cutting-edge technologies is anticipated to increase, driving growth. The projected compound annual growth rate (CAGR) of 11.37% from 2025 to 2035 underscores the potential for technological innovations to transform the landscape of mycoplasma testing.

    Expansion of Research and Development Activities

    The expansion of research and development activities in the life sciences sector is a crucial driver of the Global Mycoplasma Testing Market Industry. As research institutions and pharmaceutical companies invest in innovative therapies and vaccines, the need for reliable mycoplasma testing becomes increasingly important. R&D activities often involve cell cultures that are susceptible to mycoplasma contamination, necessitating robust testing protocols. This trend is expected to fuel demand for mycoplasma testing solutions, as organizations strive to ensure the integrity of their research outcomes. The growth in R&D spending is likely to have a lasting impact on the mycoplasma testing market, fostering advancements in testing methodologies.

    Growing Awareness of Mycoplasma Contamination Risks

    The growing awareness of mycoplasma contamination risks among manufacturers and researchers is a pivotal driver of the Global Mycoplasma Testing Market Industry. As stakeholders recognize the detrimental effects of mycoplasma on cell cultures and biopharmaceutical products, there is an increasing demand for effective testing solutions. Educational initiatives and industry collaborations are fostering a better understanding of contamination risks, leading to heightened vigilance in quality control practices. This awareness is likely to result in a surge in mycoplasma testing adoption, contributing to market growth. The anticipated increase in market size to 6.23 USD Billion by 2035 reflects this rising consciousness within the industry.

    Market Segment Insights

    Mycoplasma Testing Market Test Type Insights

    The Mycoplasma Testing Market is experiencing notable growth, particularly across various test types, which are pivotal for effective diagnosis and research in various industries, including pharmaceuticals and biotechnology. In 2023, the market value is recognized at 1.7 USD Billion, and by 2032, it aims to reach approximately 4.5 USD Billion, showcasing considerable market growth driven by advancements in technology and increasing awareness regarding mycoplasma contamination in cell cultures and biological products. 

    Among the different test types, PCR Testing holds a significant position, valued at 0.85 USD Billion in 2023 and expected to rise to 2.2 USD Billion by 2032, representing a majority holding in the market due to its rapid, sensitive and specific detection capabilities.

    This is critical, especially in research laboratories and clinics where prompt diagnostics are essential. ELISA Testing also plays an important role in the global landscape, with a valuation of 0.45 USD Billion in 2023 and a forecasted growth of 1.2 USD Billion by 2032, making it significant for quantifying proteins related to mycoplasma infections and proving valuable in both research and clinical settings. 

    Culture Testing is valued lower than the others, at 0.3 USD Billion in 2023, with expectations to grow to 0.8 USD Billion in 2032, and although it is less dominant, it remains essential for isolating and identifying mycoplasma species, thus still maintaining its relevance in specific applications.

    Lastly, Nucleic Acid Hybridization, valued at 0.1 USD Billion in 2023 and projected to reach 0.3 USD Billion by 2032, is the least dominant among the test types but is considered important for its role in identifying specific mycoplasma sequences in samples, indicating opportunities for improvement and niche applications. 

    Mycoplasma Testing Market Application Insights

    The Mycoplasma Testing Market is poised for notable growth in the Application segment, prominently driven by the rising need for quality assurance in pharmaceutical and biopharmaceutical sectors. In 2023, the overall market was valued at 1.7 billion USD, reflecting the increasing focus on quality control measures, particularly in the manufacture of cell-based products, which are critical for vaccine and drug production. 

    The demand for accurate diagnostic testing also plays a significant role in the market, as healthcare providers aim to detect mycoplasma contamination that can compromise patient safety and product efficacy.Research and development applications are equally essential in advancing new methodologies and technologies for mycoplasma detection. 

    As the market evolves, innovation and compliance with regulatory standards will further drive growth across these applications, ensuring the integrity and safety of various biological products. The diverse applications reflect the segment's vitality in sustaining market momentum, highlighting the importance of both quality control and extensive research in maintaining industry standards.

    Mycoplasma Testing Market End Use Insights

    The Mycoplasma Testing Market is expected to see significant revenue growth, driven by increasing demand across various end-use segments, including Pharmaceutical Companies, Biotechnology Companies, and Academic Research Institutes. In 2023, the overall market is valued at 1.7 billion USD, reflecting a robust demand for mycoplasma testing solutions. 

    Pharmaceutical Companies play a pivotal role in this market as the need for contamination-free products is essential for drug development and manufacturing, ensuring product safety and compliance with regulatory frameworks.Biotechnology Companies contribute significantly to market growth due to their focus on developing innovative therapies and bioprocesses, where mycoplasma testing ensures quality control and reliability in production. 

    Academic Research Institutes also hold a crucial position by conducting extensive research, which necessitates the use of mycoplasma testing for accurate results in projects involving cell cultures. The combination of these sectors not only drives market demand but also opens avenues for advanced testing technologies, enhancing overall market growth.As safety regulations become more stringent, the importance of mycoplasma testing becomes even more pronounced in the Mycoplasma Testing Market.

    Mycoplasma Testing Market Region Insights

    The Mycoplasma Testing Market revenue in 2023 stood at approximately 1.7 billion USD, with significant contributions from various regions, including North America, Europe, and Asia Pacific. North America dominates the market due to advanced healthcare infrastructure, increased funding for research, and a high prevalence of mycoplasma-related diseases. 

    In Europe, robust regulatory frameworks and an increasing focus on pharmaceutical innovation drive growth, enabling market players to capitalize on mycoplasma testing solutions. Asia Pacific shows promising growth potential due to a rise in healthcare expenditures and growing awareness of mycoplasma infections, positioning it as a rapidly evolving region in the Mycoplasma Testing Market industry.

    Overall, the market is shaped by trends such as technological advancements in testing methods, increasing demand for biologics, and the expanding biotechnology sector. However, challenges like the high costs of testing and a shortage of skilled professionals could hinder market growth. Market statistics suggest that the continued investment in research and development presents ample opportunities for advancements within the industry, ensuring a competitive landscape among key players in this growing domain.

    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 Global Mycoplasma Testing Market is projected to grow at 11.37% CAGR from 2024 to 2032, driven by advancements in diagnostic technologies and increasing demand for quality control in pharmaceuticals.

    New opportunities lie in:

    • Develop rapid testing kits for mycoplasma detection in cell cultures.
    • Invest in automation technologies for high-throughput mycoplasma testing.
    • Expand services to include mycoplasma testing in veterinary diagnostics.

    By 2035, the market is expected to demonstrate robust growth, reflecting heightened awareness and technological advancements.

    Market Segmentation

    Mycoplasma Testing Market Region Outlook

    • North America
    • Europe
    • Asia Pacific

    Mycoplasma Testing Market End Use Outlook

    • Pharmaceutical Companies
    • Biotechnology Companies
    • Academic Research Institutes

    Mycoplasma Testing Market Regional Outlook

    • North America
    • Europe
    • South America
    • Asia Pacific
    • Middle East and Africa

    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

    Report Attribute/Metric Details
    Market Size 2022 1.52 (USD Billion)
    Market Size 2023 1.7 (USD Billion)
    Market Size 2032 4.5 (USD Billion)
    Compound Annual Growth Rate (CAGR) 11.45% (2024 - 2032)
    Report Coverage Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
    Base Year 2023
    Market Forecast Period 2024 - 2032
    Historical Data 2018-2022
    Market Forecast Units USD Billion
    Key Companies Profiled Abcam, ATCC, Qiagen, BioRad Laboratories, Thermo Fisher Scientific, Boehringer Ingelheim, Genetic Technologies, Sartorius, F. HoffmannLa Roche, Merck KGaA, Lonza, Charles River Laboratories, Norgen Biotek, PCR Biosystems, Eurofins Scientific
    Segments Covered Test Type, Application, End Use, Region, Regional
    Key Market Opportunities Increased demand for quality control, Rising biopharmaceutical market growth, Advancements in diagnostic technologies, Expanding research and development activities, Growing awareness of mycoplasma contamination
    Key Market Dynamics Increasing biopharmaceutical production, Rising prevalence of mycoplasma contamination, Stringent regulatory guidelines, Advancements in testing technologies, Growing demand for quality assurance
    Countries Covered North 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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