PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1927707
PUBLISHER: AnalystView Market Insights | PRODUCT CODE: 1927707
Mycoplasma Testing Market size was valued at US$ 1,452.54 Million in 2024, expanding at a CAGR of 12.01% from 2025 to 2032.
Mycoplasma testing involves detecting and quantifying Mycoplasma contamination in cell cultures, biologics, and pharmaceutical products to ensure product safety and compliance with regulatory standards. The growing demand for biologics, vaccines, and cell-based therapies is driving the adoption of Mycoplasma testing solutions across research and manufacturing laboratories. Opportunities exist in developing rapid, high-sensitivity assays and automated testing platforms that reduce turnaround times and enhance detection accuracy, which is critical for maintaining quality in large-scale biopharmaceutical production. A prominent trend is the integration of molecular and PCR-based techniques with traditional culture methods to improve reliability while minimizing false negatives. However, the complexity of Mycoplasma detection and variability in test sensitivity pose challenges, limiting adoption in small-scale laboratories and in applications requiring ultra-rapid or high-throughput testing.
Mycoplasma Testing Market- Market Dynamics
Rising demand for contamination control in biopharmaceutical and cell therapy production
The growing adoption of biopharmaceuticals, vaccines, and cell-based therapies is significantly driving the demand for Mycoplasma testing solutions, which play a critical role in ensuring the safety, quality, and regulatory compliance of these products. As manufacturers increasingly scale up production of biologics and therapeutic cell lines, there is a pressing need for rapid and reliable Mycoplasma detection methods to prevent contamination that can compromise product efficacy and patient safety. The trend toward high-throughput and automated testing platforms is further increasing demand, as these solutions enable faster results, consistent accuracy, and integration into modern bio manufacturing workflows. Moreover, the continuous growth in global biologics production, particularly in regions such as North America and Europe, is significantly driving the requirement for sensitive and standardized Mycoplasma testing. For instance, recent data from 2024 indicates that over 75 percent of biopharmaceutical manufacturers perform routine Mycoplasma testing across all cell-based production lines. The expanding use of gene and cell therapies is also intensifying the need for robust contamination monitoring to maintain stringent quality standards.
The Global Mycoplasma Testing Market is segmented on the basis of Product Type, Technology, Test Type, Application, and Region.
The market is segmented into three categories based on product type: Mycoplasma detection kits, reagents & assays, and reference standards. These kits offer rapid, standardized, and validated solutions, reducing time and labor in testing workflows. Reagents & Assays rank second, as they are essential for customizing detection protocols, supporting both manual and automated testing platforms, and enabling higher sensitivity and specificity in molecular and culture-based detection methods. Reference Standards follow, providing critical quality controls and calibration materials to ensure assay accuracy, regulatory compliance, and reproducibility across laboratories. Overall, the market prioritization reflects the need for reliable, efficient, and validated testing solutions that safeguard product quality and meet stringent regulatory standards.
The market is categorized into four segments based on technology: PCR-based testing, ELISA, DNA staining, and microbial culture methods. The PCR-based testing segment leads the market, driven by its high sensitivity, rapid turnaround, and broad adoption in quality control and contamination monitoring workflows. ELISA ranks second, valued for its robust antigen-antibody detection capabilities and applicability in high-throughput screening and quality control processes. DNA Staining follows, used primarily in research and specialized laboratory applications to detect mycoplasma contamination visually, though it is less sensitive and labor-intensive compared to molecular methods. Microbial Culture Methods rank last, as they remain the traditional standard for mycoplasma detection but are slower, require specialized expertise, and have lower throughput, limiting their use in modern, time-sensitive production environments. Overall, prioritization reflects accuracy, speed, and integration with automated workflow.
Mycoplasma Testing Market- Geographical Insights
The Mycoplasma Testing Market shows distinct regional dynamics, with North America leading global demand due to its robust biopharmaceutical industry, advanced laboratory infrastructure, and strict regulatory requirements for contamination control, accounting for about 38-40% of the market share. The United States drives this dominance as major therapeutic and vaccine manufacturers routinely implement mycoplasma testing in quality control protocols. Europe holds the second-largest share, supported by harmonized regulations and expanded biotechnology research in countries such as Germany, the UK, and France, which boosts the adoption of rapid detection solutions. The Asia-Pacific region is the fastest-growing market, propelled by expanding pharmaceutical production in China, India, and Japan and increasing investments in automated testing systems. Strategic developments reinforce regional momentum; for example, bioMerieux partnered with AnaBioTec in May 2024 to advance innovative mycoplasma testing methodologies, and global expansion initiatives by major players are increasing accessibility of kits and services.
Mycoplasma Testing Market- Country Insights
At the country level, the United States is the foremost market for mycoplasma testing, driven by its substantial biopharmaceutical industry, stringent regulatory contamination standards, and extensive R&D activity, which collectively lead to high adoption of advanced testing solutions. North America overall accounted for nearly half of the global market in 2024, with the U.S. as the primary contributor. In Europe, countries such as Germany, the United Kingdom, and France are significant contributors, supported by strong research infrastructure and widespread contamination control initiatives in biologics manufacturing. The Asia-Pacific region, led by China, Japan, and India, is expanding rapidly as pharmaceutical production increases and investment in quality control rises, with China's market projected to grow strongly due to robust domestic biotech activity. Strategic collaborations, such as bioMerieux's 2024 partnership with AnaBioTec to enhance mycoplasma detection methods, further advance country-level capabilities and innovation.
The competitive landscape of the Mycoplasma Testing Market is shaped by a mix of established life science firms and specialized diagnostics providers focused on contamination detection solutions. Key players such as Merck KGaA, bioMerieux SA, Thermo Fisher Scientific Inc., Agilent Technologies Inc., Lonza Group Ltd., and Charles River Laboratories International Inc. compete on the basis of test accuracy, speed, automation compatibility, and global distribution networks. Companies are investing in assay development, automation integration, and expanded service offerings to strengthen market positions. Strategic transactions are actively reshaping competition; for instance, bioMerieux's partnership with AnaBioTec in 2024 aims to co-develop enhanced mycoplasma detection technologies, while Thermo Fisher Scientific's acquisition of Qiagen's Cell Culture and Molecular Diagnostics Business (completed in 2023) expanded its infectious disease and contamination testing portfolio, including mycoplasma solutions. Ongoing collaborations with contract research organizations and genomic service providers further extend the reach of testing platforms, supporting broad adoption in biopharmaceutical manufacturing and research environments. Overall, competitive dynamics prioritize innovation, regulatory compliance, and comprehensive testing solutions.
In September 2025, Fuse Diagnostics launched its Flip Mycoplasma rapid mycoplasma contamination test across major European countries through a distribution agreement with CliniSciences, enabling ultra-rapid, simple cell culture quality screening without complex equipment.
Agathos Biologics stated in April 2023 that it would provide life science researchers with analytical testing services. Agathos only uses QIAGEN-developed QIAcuity equipment and assays. Additionally, Agathos and QIAGEN have partnered to test and validate mycoplasma and recombinant adeno-associated viral vector (rAAV) assays.