Market Overview
Global Mycoplasma Testing Market size and share is currently valued at USD 1,064 million in 2024 and is anticipated to generate an estimated revenue of USD 2,909 million by 2032, according to the latest study by Polaris Market Research. Besides, the report notes that the market exhibits a robust 13.4% Compound Annual Growth Rate (CAGR) over the forecasted timeframe, 2023 - 2032
The global mycoplasma testing market is witnessing robust growth, owing to the rising use of cell cultures in biologics manufacturing and research applications. Biopharmaceuticals such as monoclonal antibodies, recombinant proteins, and cell-based therapies require stringent contamination control to meet global regulatory standards. Mycoplasma contamination, often undetectable without specialized assays, presents a significant risk to product quality and patient safety. As a result, regulatory bodies including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and World Health Organization (WHO) mandate comprehensive mycoplasma testing for biopharmaceutical products.
Traditionally, mycoplasma detection was performed using culture-based techniques, which, although reliable, were time-consuming and required specialized expertise. Modern advancements have introduced PCR-based methods, ELISA kits, and nucleic acid amplification technologies that allow for rapid and highly sensitive detection. Automation and integration with digital systems are also transforming mycoplasma testing workflows, enabling more efficient quality control processes in both research and commercial environments.
Market Segmentation
The mycoplasma testing market can be segmented based on product type, technique, application, and end-user.
By Product Type:
- Kits and Reagents: These are the most commonly used products for mycoplasma detection and are widely adopted due to their convenience, reliability, and ease of integration into lab protocols. Kits include ready-to-use PCR reagents, ELISA kits, and luminescence-based detection tools.
- Instruments: This segment includes PCR machines, biosafety cabinets, and other laboratory equipment essential for conducting mycoplasma testing. These tools are especially important in high-throughput laboratories and commercial manufacturing settings.
- Services: Testing services offered by CROs and CMOs are gaining popularity due to the high cost of setting up in-house capabilities. These services provide comprehensive testing using standardized protocols to ensure regulatory compliance.
By Technique:
- PCR-Based Assays: Polymerase chain reaction (PCR) techniques are widely used due to their high sensitivity and rapid turnaround times. These assays can detect low levels of contamination and are suitable for routine monitoring in both clinical and commercial labs.
- ELISA: Enzyme-linked immunosorbent assay methods are used to detect mycoplasma antigens and provide a quantitative readout. ELISA is typically used in confirmatory testing and is valued for its specificity.
- Direct and Indirect Culture Methods: Despite their longer turnaround time, culture-based methods are considered a gold standard by regulatory bodies. They are typically used to confirm PCR-based results or in low-throughput settings.
- DNA Staining: This technique involves staining cell cultures to detect the presence of mycoplasma DNA under a microscope. Although less sensitive than molecular methods, DNA staining is still used in certain academic research and screening applications.
By Application:
- Cell Line Testing: This is the most common application of mycoplasma testing, especially in research and development labs involved in cell biology, oncology, and regenerative medicine.
- Virus Testing: Mycoplasma contamination can interfere with virus propagation and analysis. Testing ensures the integrity of viral stocks used in vaccine production and research.
- End-of-Production Cell Testing: Regulatory agencies require mycoplasma testing at the end of biopharmaceutical production to certify that the final product is free from contamination.
- Others: This includes applications in biosimilars development, tissue engineering, and personalized medicine where cell-based processes are essential.
By End User:
- Pharmaceutical and Biotechnology Companies: These companies form the largest end-user segment, driven by the need to maintain product safety and comply with regulatory standards.
- Academic and Research Institutes: With increased funding for biomedical research, academic laboratories are investing in routine contamination screening to ensure the validity of experimental data.
- Contract Research and Manufacturing Organizations: These organizations provide outsourced testing services, helping biopharma firms meet compliance without investing in internal testing capabilities.
- Others: This category includes hospitals, diagnostic labs, and forensic labs where contamination control is critical for reliable diagnostics.
???????????????????????????? ???????????? ???????????????????????????????? ???????????????????????????????????????????????????? ???????????????????????? ????????????????:
https://www.polarismarketresearch.com/industry-analysis/mycoplasma-testing-market
Regional Analysis
The mycoplasma testing market exhibits strong regional variation, driven by differences in healthcare infrastructure, regulatory frameworks, research activity, and industrial development.
North America:
North America, particularly the United States, dominates the global mycoplasma testing market due to its advanced biotechnology sector, stringent regulatory guidelines, and strong investments in pharmaceutical research. The presence of leading market players and well-established CROs contributes to market maturity. Additionally, continuous innovation in biologics and cell-based therapies fuels the need for reliable contamination testing across the country.
Europe:
Europe is another significant contributor to market growth, led by countries like Germany, the United Kingdom, and France. The region’s focus on sustainable pharmaceutical manufacturing and adherence to EMA guidelines make contamination testing a critical aspect of drug development. European laboratories are also early adopters of novel PCR and automation technologies, boosting demand for mycoplasma testing kits and systems.
Asia-Pacific:
The Asia-Pacific region is expected to witness the fastest growth due to increasing investments in biotechnology and pharmaceuticals across emerging economies such as China, India, and South Korea. These countries are experiencing a boom in biosimilar production and clinical research, leading to a greater emphasis on regulatory compliance and quality assurance. Government support for life sciences innovation and the rise of domestic pharmaceutical manufacturing further contribute to market expansion.
Latin America:
Latin America is gradually emerging as a growing market for mycoplasma testing, with countries such as Brazil and Mexico showing increased research activity and pharmaceutical production. Although infrastructure limitations persist, expanding healthcare investments and growing awareness of contamination risks are creating new opportunities for testing technologies and services.
Middle East and Africa:
The mycoplasma testing market in the Middle East and Africa is still in the nascent stage but shows potential for future growth. Increasing research initiatives, partnerships with global biotechnology firms, and a gradual shift toward local biologics production are expected to drive demand for contamination control solutions.
Key Companies
Several key players are at the forefront of the global mycoplasma testing market, offering advanced solutions for contamination detection, regulatory compliance, and laboratory efficiency.
- Agilent Technologies (US)
- American Type Culture Collection (US)
- Biological Industries Israel Beit Haemek Ltd. (Israel)
- Bionique Testing Laboratories, Inc. (US)
- Biotools B & M Labs, S.A. (Spain)
- Charles River Laboratories International, Inc. (US)
- Creative Bioarray (US)
- Eurofins Scientific (Luxembourg)
- GeneCopoeia, Inc. (US)
- GenBio (copyright)
- InvivoGen (US)
- Lonza Group Ltd. (Switzerland)
- Merck KGaA (Germany)
- Meridian Bioscience, Inc. (US)
- Minerva Biolabs GmbH (Germany)
Outlook and Future Trends
The future of the mycoplasma testing market lies in the adoption of rapid, automated, and highly sensitive detection methods that align with the demands of modern biopharmaceutical production. As biologics continue to transform healthcare, ensuring product safety through contamination monitoring will remain a top priority. The integration of digital systems, artificial intelligence, and next-generation sequencing in contamination control is likely to further enhance detection accuracy and efficiency.
More Trending Latest Reports By Polaris Market Research:
Building Automation Systems Market
Medical Imaging Equipment Market
Comments on “Mycoplasma Testing Market Overview: Size, Share, and Competitive Landscape”