Mycoplasma Testing Market – Global Industry Size, Share, Trends, Opportunity, & Forecast, Segmented By Product (Instruments, Kits and Reagents), By Technology (PCR, ELISA, Enzymatic Methods, DNA Staining, Other), By Application (Cell Line Testing, Bioproduction Testing, Other), By End-User (Academic Research Institutes, Cell Banks, Contract Research Organizations, Pharmaceutical & Biotechnology Companies, Others), By Region, Competition, 2020-2030F

Market Overview

Global Mycoplasma Testing Market was valued at USD 1090.70 Million in 2024 and is anticipated to project robust growth in the forecast period with a CAGR of 13.45% through 2030. The Global Mycoplasma Testing Market is a dynamic and rapidly evolving sector within the broader field of diagnostics and infectious disease management. Mycoplasma, a genus of bacteria known for their lack of a cell wall, can infect various host organisms, including humans, animals, and cell cultures. Mycoplasma contamination poses a significant threat to research, biopharmaceutical manufacturing, and clinical diagnostics, making mycoplasma testing an essential component of quality control and safety assurance.

Key Market Drivers

Rising Biopharmaceutical and Biotechnology Industries

The rapid expansion of the biopharmaceutical and biotechnology industries is a key driver of the Global Mycoplasma Testing Market. Over the past few years, the number of FDA-registered manufacturing facilities in the U.S. producing human-use medicines, along with their associated testing, labeling, and packaging operations, has surged by more than 50%. Biopharmaceutical companies are actively investing in new construction, facility expansions, and technology upgrades to support the production of next-generation therapies, ensuring a robust and scalable supply chain for advanced treatments across the country. These industries rely heavily on cell culture-based production processes, where contamination can compromise product integrity, regulatory compliance, and patient safety. Mycoplasma, a frequent and insidious contaminant, necessitates stringent testing protocols to ensure the purity and efficacy of biopharmaceutical products. The rising investments, increasing adoption of biologics, and growing need for quality control in biotech processes directly fuel the demand for mycoplasma testing. Biopharmaceuticals, including monoclonal antibodies, recombinant proteins, and biosimilars, are revolutionizing modern medicine. These products rely on mammalian cell cultures for production, making them highly susceptible to mycoplasma contamination. The growing adoption of biologics for treating chronic diseases, including cancer, autoimmune disorders, and infectious diseases, necessitates stringent contamination control measures. As patents for biologic drugs expire, biosimilar manufacturers must comply with regulatory guidelines for mycoplasma testing to ensure their products meet the same safety and efficacy standards as originator biologics. With global sales of biologics projected to surpass traditional pharmaceuticals, mycoplasma testing has become an integral part of quality assurance in drug development and production.

The increasing focus on cell and gene therapy (CGT) is another key factor boosting mycoplasma testing demand. These advanced therapies involve the use of living cells and genetic modifications, making them particularly vulnerable to microbial contamination. Currently, over 4,000 gene, cell, and RNA therapies are in development, reflecting a rapid expansion in advanced treatment innovation. The clinical pipeline has seen a sharp rise in therapies across all three development phases, with Phase I programs experiencing an 11% increase, signaling strong early-stage investment and a growing pipeline of next-generation therapeutics. The FDA and EMA mandate strict mycoplasma testing for cell-based therapies to ensure safety and prevent risks associated with live cell infusions in patients. The rise of gene editing technologies, such as CRISPR-Cas9, requires contaminant-free cell cultures, increasing the necessity for highly sensitive mycoplasma detection methods. As CGT continues to gain traction, companies are prioritizing contamination control, leading to increased investment in automated, high-throughput mycoplasma testing technologies.

The global push for vaccine development and large-scale biologics manufacturing has significantly increased the adoption of mycoplasma testing. Vaccines, particularly those based on mRNA, viral vectors, and recombinant proteins, are produced using cell cultures, requiring strict quality control to prevent microbial contamination. East Asia accounts for approximately 55% of global vaccine manufacturing capacity, while Europe and North America collectively hold 40%. In contrast, Africa and South America together represent less than 5% of worldwide production capacity, highlighting a significant regional disparity in vaccine manufacturing infrastructure. The pandemic highlighted the need for rapid vaccine production, reinforcing the role of rigorous sterility testing, including mycoplasma screening. Emerging markets are scaling up local vaccine production, necessitating investment in advanced mycoplasma detection methods. The increasing demand for safe and effective vaccines will sustain the long-term growth of mycoplasma testing in pharmaceutical and biotech facilities.

Increasing Contamination Risks in Cell Culture and Bioprocessing

The Global Mycoplasma Testing Market is expanding significantly, driven by the growing risks of contamination in cell culture and bioprocessing. Studies by the FDA, ATCC, and other organizations estimate that 5% to 30% of all cell cultures are contaminated with mycoplasma species. In one study, over 25% of common cell lines showed evidence of viral contamination. Non-cytopathic viruses pose an even greater detection challenge, as they can persist undetected without visibly compromising cell culture health. Mycoplasma, a genus of bacteria lacking a cell wall, is one of the most persistent and difficult-to-detect contaminants in biotechnology, pharmaceuticals, and life sciences research. Its ability to evade standard antibiotics and pass through filtration systems poses serious risks to biological products, drug development, and vaccine manufacturing. As contamination rates increase, companies and research institutions are investing heavily in mycoplasma testing solutions to maintain product integrity, regulatory compliance, and operational efficiency.  

Mycoplasma contamination is a widespread and chronic issue in laboratories, bioprocessing plants, and pharmaceutical manufacturing facilities. It is estimated that: Mycoplasma contamination affects an estimated 15% to 35% of continuous cell cultures worldwide. Since their initial isolation in 1956, over 180 species have been identified, yet just six species account for 95% of all cell culture infections, posing a persistent challenge in research and biopharmaceutical production. Unlike bacterial or fungal contaminants, mycoplasma does not cause visible turbidity, making it difficult to detect without specialized testing. Once introduced, mycoplasma alters cell metabolism, gene expression, and experimental outcomes, leading to compromised research and faulty drug production. This high contamination frequency is forcing laboratories and biopharmaceutical companies to implement stringent routine mycoplasma testing protocols, boosting demand for rapid, sensitive, and automated detection methods.

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Key Market Challenges

Cost Constraints in Developing Regions

One of the significant challenges in expanding the mycoplasma testing market is the cost associated with acquiring and implementing testing solutions. In developing regions with limited healthcare budgets, investing in expensive mycoplasma testing equipment and reagents can be prohibitive.

Many developing countries allocate a substantial portion of their healthcare budgets to basic healthcare needs like vaccinations and infectious disease control. This leaves limited resources for advanced diagnostic technologies, including mycoplasma testing. Establishing a mycoplasma testing infrastructure, including purchasing specialized equipment and training personnel, requires a considerable initial investment that some regions may struggle to afford. Continuous testing relies on a steady supply of costly reagents and consumables, which can be a financial burden for healthcare facilities in resource-constrained areas.

Regulatory Hurdles and Compliance Challenges

Mycoplasma testing is subject to stringent regulatory standards, particularly in the pharmaceutical and biotechnology sectors. Navigating these regulations and ensuring compliance can be a complex and time-consuming process.

Different regions and countries often have varying regulatory frameworks for mycoplasma testing. Complying with these diverse standards can be challenging for manufacturers, potentially slowing down market growth. Regulatory agencies require extensive documentation, validation data, and quality control procedures, which can increase the time and resources required to bring mycoplasma testing products to market. Regulatory requirements for diagnostic tests can change over time, necessitating continuous updates and modifications to testing procedures and products. Adapting to these changes can be a significant challenge for manufacturers.

Limited Awareness and Education

Despite the growing awareness of mycoplasma-related infections, there is still a need for increased education and awareness about the importance of mycoplasma testing in various sectors.

In some regions and industries, there may be a lack of awareness about mycoplasma infections and their potential impact on research, healthcare, and biopharmaceutical production. Misconceptions about mycoplasma testing, its relevance, and the consequences of contamination can hinder its adoption. Educating stakeholders is crucial to dispel myths and foster understanding. Proper mycoplasma testing requires skilled personnel who understand the intricacies of testing procedures. A shortage of trained professionals can slow down testing efforts.

Key Market Trends

Rapid Adoption of Molecular Diagnostics

One significant trend in the Global Mycoplasma Testing Market is the rapid adoption of molecular diagnostics, particularly Polymerase Chain Reaction (PCR)-based methods.

Molecular diagnostic techniques, such as PCR, offer unparalleled sensitivity and specificity in detecting mycoplasma DNA. They can identify even low levels of contamination quickly and accurately. Molecular tests provide rapid results, often within hours, compared to traditional culture-based methods that can take days or even weeks. This speed is crucial in maintaining the efficiency of biopharmaceutical production and research. Automated molecular testing platforms allow for high throughput, making them suitable for large-scale testing in biopharmaceutical manufacturing facilities.

PCR-based methods reduce the risk of false positives associated with traditional culture-based techniques, as they do not rely on the growth of mycoplasma cells.

Expansion of Point-of-Care Testing (POCT)

Point-of-care testing (POCT) for mycoplasma infections is gaining prominence, especially in clinical and veterinary settings. POCT devices are becoming more accessible and user-friendly, allowing healthcare providers to perform mycoplasma testing at the point of care, such as clinics, doctor's offices, and veterinary clinics. POCT enables rapid diagnosis, which is crucial for initiating timely treatment. This is particularly beneficial in cases of respiratory and urogenital infections in humans and animals. POCT eliminates the need for sample transportation to central laboratories, reducing turnaround time and facilitating quicker decision-making in patient care.

Emergence of Automation and Robotics

Automation and robotics are making inroads into mycoplasma testing processes, streamlining workflows and enhancing efficiency.

Automated systems ensure consistent and highly accurate testing results, reducing the risk of human error. This is especially critical in pharmaceutical and biotechnology industries. In facilities where mycoplasma testing is performed on a large scale, automation can significantly increase testing capacity and reduce labor costs. Robotic systems can handle complex sample processing tasks, such as DNA extraction and sample transfer, allowing for greater efficiency and precision.

Segmental Insights

Product Insights

Based on the category of Product, the kits and reagents segment emerged as the fastest growing segment in the global market for Mycoplasma Testing in 2024. Kits and reagents provide comprehensive mycoplasma testing solutions in a single package. These kits typically include all the necessary components, such as primers, probes, enzymes, and buffers, required for accurate mycoplasma detection. This comprehensive nature simplifies testing processes for laboratories and research facilities, reducing the need for piecemeal procurement of individual components. It streamlines workflows and ensures consistent and reliable results.

Mycoplasma testing kits are designed for accessibility and user-friendliness. They are accessible to a wide range of laboratories, including those with limited resources or expertise in molecular diagnostics. The user-friendly nature of these kits means that laboratories can quickly adopt mycoplasma testing as part of their routine protocols without the need for extensive training. This accessibility drives widespread adoption. Established manufacturers of mycoplasma testing kits and reagents adhere to stringent quality control measures during production. They ensure the consistent quality and performance of their products. Laboratories and biopharmaceutical companies rely on the consistent quality of kits and reagents to maintain the integrity of their testing processes. Consistency reduces the risk of false negatives or positives, crucial in critical applications like pharmaceutical manufacturing. Mycoplasma testing kits and reagents are versatile and can be applied to various sample types, including cell cultures, biopharmaceuticals, and clinical specimens. This versatility caters to the diverse needs of different industries and research areas. Laboratories and biotech companies can use the same kits for a range of applications, optimizing cost-effectiveness. Reputable manufacturers ensure that their mycoplasma testing kits and reagents comply with relevant regulatory standards, such as those set by the FDA and EMA. Regulatory compliance is paramount in industries like pharmaceuticals and biotechnology. Laboratories and companies can trust that these kits meet the necessary regulatory requirements, simplifying the validation and documentation processes. These factors are expected to drive the growth of this segment.

Technology Insight

Based on the category of Technology, the PCR segment emerged as the dominant player in the global market for Mycoplasma Testing in 2022. PCR technology offers exceptional sensitivity and specificity in detecting mycoplasma DNA. It can identify even trace amounts of mycoplasma contamination with a high degree of accuracy. In industries like biopharmaceutical manufacturing, where product safety is paramount, the ability to reliably detect low levels of mycoplasma contamination is crucial. PCR's sensitivity and specificity make it the preferred choice for such critical applications.

PCR-based mycoplasma testing provides rapid results, often within a few hours. This swift turnaround time is a significant advantage in maintaining production schedules and research timelines. Laboratories and biopharmaceutical companies can quickly assess the mycoplasma status of their samples, facilitating prompt decision-making and reducing the risk of contamination-related delays. PCR can be easily automated, allowing for high-throughput testing. Automated PCR systems can process a large number of samples simultaneously. In industries with high testing volumes, such as biopharmaceutical manufacturing, automation ensures efficiency and cost-effectiveness. It allows for comprehensive mycoplasma testing without significant increases in labor or time. PCR technology is versatile and can be applied to a wide range of sample types, including cell cultures, biopharmaceutical products, and clinical specimens. This versatility makes PCR suitable for various industries and research areas, reducing the need for multiple testing technologies. Laboratories can use PCR for different testing needs, simplifying their workflows.

PCR-based mycoplasma testing methods have undergone extensive validation and are widely accepted in regulated industries like pharmaceuticals and biotechnology. Regulatory agencies, such as the FDA and EMA, recognize the reliability of PCR for mycoplasma testing. Laboratories and companies can confidently use PCR methods, knowing they align with regulatory requirements. Ongoing investments in research and development have led to continuous improvements in PCR technology, enhancing its performance and reliability. The commitment to innovation ensures that PCR technology remains at the forefront of mycoplasma testing. Laboratories and companies benefit from access to advanced PCR solutions for their testing needs.

End-User Insights

The pharmaceutical and biotechnology companies’ segment is projected to experience rapid growth during the forecast period. Pharmaceutical and biotechnology companies operate in highly regulated environments, with stringent quality control standards enforced by regulatory agencies like the FDA and EMA. Compliance with regulatory requirements is non-negotiable for these companies. Mycoplasma testing is a vital component of ensuring product safety, and failure to meet regulatory standards can result in product recalls and regulatory penalties.

Mycoplasma contamination poses a significant threat to biopharmaceutical manufacturing processes. It can compromise product quality, safety, and efficacy. Pharmaceutical and biotechnology companies prioritize mycoplasma testing to safeguard the integrity of their biologic products, which often represent substantial investments in research and development. Preventing contamination is crucial in maintaining production schedules and minimizing financial losses. Pharmaceutical and biotechnology companies invest heavily in research and development to discover and produce innovative drugs and biologics. Mycoplasma contamination can derail research efforts and render experimental results invalid. As a result, these companies integrate mycoplasma testing into their research workflows to ensure the accuracy and reliability of their findings. Detecting mycoplasma contamination early is essential for risk mitigation. Early detection minimizes the risk of contamination spread and costly production disruptions. By conducting routine mycoplasma testing, pharmaceutical and biotechnology companies proactively identify and address contamination, reducing the risk of production delays, batch loss, and costly decontamination procedures. These factors collectively contribute to the growth of this segment.

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Regional Insights

North America emerged as the largest market in the global Mycoplasma Testing market in 2024, holding the largest market share in terms of value. This region is poised to further bolster its market presence, attributed to its well-established healthcare sector and a growing prevalence of respiratory disorders. Additionally, the presence of multinational pharmaceutical and biotechnology corporations, along with escalated investments in research and development endeavors, is driving the region's continued expansion.

Recent Developments

• In September 2024, Bionique Testing Laboratories LLC and bioMérieux have partnered to offer bioMérieux’s customers direct access to Bionique’s validation services for the BIOFIRE FILMARRAY 2.0 Industry system. This collaboration streamlines the validation and implementation of mycoplasma detection technology, supporting the clinical development of biologics, including cell and gene therapies.
• In August 2023, Charles River Laboratories has partnered with Fondazione Telethon to support HQ plasmid DNA manufacturing for lentivirus production in ex vivo cell and gene therapy. Leveraging Charles River’s CDMO expertise, the collaboration will provide both HQ and GMP-compliant plasmid DNA to advance Fondazione Telethon’s rare disease research and therapeutic development.
• In July 2023 - Agilent Technologies Inc. received three 2023 Scientists’ Choice Awards, including Best New Spectroscopy Product of 2022, Analytical Science Video of the Year, and Analytical Science Customer Service of the Year. Additionally, the company earned a Platinum Seal of Quality for its entire range of analytical HPLC systems, recognizing its excellence in scientific innovation and customer support.
• In December 2021, Bionique Testing Laboratories Inc. acquires Bio-Analytical Technologies, Inc. (BAT), a leading provider of bioanalytical testing services. The acquisition of BAT allows Bionique to expand its bioanalytical testing capabilities and to offer its clients a more comprehensive range of testing services.   

Key Market Players

• Agilent Technologies Inc
• ATCC
• Bionique Testing Laboratories Inc.
• Charles River Laboratories International Inc.
• Lonza Group Ltd
• Merck KGaA
• Bionique Testing Laboratories Inc.
• PromoCell GmbH
• Thermo Fisher Scientific Inc.
• Sartorius AG

Report Scope:

In this report, the Global Mycoplasma Testing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Mycoplasma Testing Market, By Product:

o   Instruments

o   Kits and Reagents

• Mycoplasma Testing Market, By Technology:

o   PCR

o   ELISA

o   Enzymatic Methods

o   DNA Staining

o   Other

• Mycoplasma Testing Market, By Application:

o   Cell Line Testing

o   Bioproduction Testing

o   Other

• Mycoplasma Testing Market, By End-User:

o   Academic Research Institutes

o   Cell Banks

o   Contract Research Organizations

o   Pharmaceutical & Biotechnology Companies

o   Others

• Mycoplasma Testing Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia-Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Mycoplasma Testing Market.

Available Customizations:

Global Mycoplasma Testing market report with the given market data, Tech Sci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).