Mycoplasma Testing Market Analysis, Size, and Forecast 2024-2028:
North America (US and Canada), Europe (France, Germany, Italy, and UK), Middle East and Africa (Egypt, KSA, Oman, and UAE), APAC (China, India, and Japan), South America (Argentina and Brazil), and Rest of World (ROW)

Mycoplasma Testing Market Size 2024-2028

The mycoplasma testing market size is valued to increase USD 743.4 million, at a CAGR of 12.68% from 2023 to 2028. Increasing focus on R and D of biopharmaceuticals will drive the mycoplasma testing market.

Major Market Trends & Insights

• North America dominated the market and accounted for a 40% growth during the forecast period.
• By End-user - Pharmaceutical and biotechnology companies segment was valued at USD 212.20 million in 2022
• By Product - Consumables segment accounted for the largest market revenue share in 2022

Market Size & Forecast

• Market Opportunities: USD 173.13 million
• Market Future Opportunities: USD 743.40 million
• CAGR : 12.68%
• North America: Largest market in 2022

Market Summary

• The market encompasses the global industry dedicated to detecting and identifying Mycoplasma infections in various sectors, including biopharmaceuticals, food, and water. Core technologies, such as Polymerase Chain Reaction (PCR) and Enzyme Immunoassay (EIA), dominate the testing landscape, offering high sensitivity and specificity. Applications span from research and development in biopharmaceuticals to food safety and water quality testing. The market is driven by the increasing focus on R&D in biopharmaceuticals and rising strategic alliances among companies. However, the high cost of mycoplasma testing products poses a significant challenge.
• According to a global report, the market is projected to reach a market share of 3.3% in the global in vitro diagnostics market by 2025. This underscores the ongoing importance and growth potential of this market.

What will be the Size of the Mycoplasma Testing Market during the forecast period?

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How is the Mycoplasma Testing Market Segmented and what are the key trends of market segmentation?

The mycoplasma testing industry research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD million" for the period 2024-2028, as well as historical data from 2018-2022 for the following segments.

• End-user
  • Pharmaceutical and biotechnology companies
  • Cell banks
  • Academic research institutes
  • CROs
  • Others
• Product
  • Consumables
  • Systems
• Technology
  • PCR (Polymerase Chain Reaction)
  • ELISA (Enzyme-Linked Immunosorbent Assay)
  • Microbial Culture Techniques
  • Enzymatic Methods
  • Direct Assay
  • Indirect Assay
  • DNA Staining
• Application
  • Cell Line Testing
  • Virus Testing
  • End-of-Production Cell Testing
  • Other Applications (Raw Material Testing)
• Geography
  • North America
    • US
    • Canada
  • Europe
    • France
    • Germany
    • Italy
    • UK
  • Middle East and Africa
    • Egypt
    • KSA
    • Oman
    • UAE
  • APAC
    • China
    • India
    • Japan
  • South America
    • Argentina
    • Brazil
  • Rest of World (ROW)

By End-user Insights

The pharmaceutical and biotechnology companies segment is estimated to witness significant growth during the forecast period.

Mycoplasma testing plays a crucial role in preventing contamination in various industries, including clinical microbiology, veterinary diagnostics, and biopharmaceutical production. According to recent studies, approximately 30% of microbial contaminations in biopharmaceutical manufacturing are attributed to mycoplasma. This issue can lead to substantial losses for companies due to wasted time, materials, and revenue. To mitigate these risks, several testing methods are employed. Result reporting and data interpretation are essential components of these tests, ensuring accurate and timely identification of mycoplasma contamination. Quality control and test validation are crucial for maintaining the reliability and accuracy of these tests. Specimen collection and sample preparation techniques are also vital in the testing process.

Microbial identification, colony forming units, and immunofluorescence assays are commonly used methods for mycoplasma detection. Contamination monitoring and regulatory compliance are ongoing concerns, with real-time PCR, ELISA techniques, and hybridoma technology being popular choices for continuous monitoring. In the veterinary diagnostics sector, mycoplasma testing is essential for infection prevention and animal health. Laboratory procedures, such as PCR amplification, DNA sequencing, and culture methods, are used to diagnose mycoplasma infections in animals. Pharmaceutical testing also relies on mycoplasma detection for ensuring the purity and safety of drugs. Sensitivity and specificity testing are crucial for determining the effectiveness and accuracy of mycoplasma testing products.

The market for mycoplasma testing is expected to grow significantly in the coming years, with an estimated 25% of clinical microbiology laboratories adopting molecular diagnostics for mycoplasma detection. Additionally, the increasing demand for diagnostic kits and the growing focus on contamination control are driving market growth. These trends reflect the ongoing efforts to improve the accuracy, reliability, and efficiency of mycoplasma testing methods across various industries. By staying informed of the latest developments and advancements in mycoplasma testing, companies can better protect their operations from the negative impacts of microbial contamination.

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The Pharmaceutical and biotechnology companies segment was valued at USD 212.20 million in 2018 and showed a gradual increase during the forecast period.

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Regional Analysis

North America is estimated to contribute 40% to the growth of the global market during the forecast period.Technavio's analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.

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In 2023, North America led The market due to the significant presence of life science researchers and research institutions. Companies like Charles River Laboratories and ScienCell Research Laboratories Inc. Contribute substantially to this region's revenue. Biotechnology, biological, and pharmaceutical firms prioritize mycoplasma testing to prevent contamination, driving market growth. The PCR methodology is commonly used for detection. North America's market expansion is fueled by the increasing number of tests performed and the industry's growing awareness of mycoplasma's potential impact on research and product development.

The region's market size reflects this trend, with approximately 25% of global tests originating from North America. Additionally, over 30% of all mycoplasma testing laboratories are located in this region.

Market Dynamics

Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.

The market encompasses various techniques and technologies employed to detect and manage mycoplasma contamination in cell cultures, particularly in the biopharmaceutical industry. Mycoplasma contamination can significantly impact product quality and safety, necessitating rigorous testing to ensure regulatory compliance and maintain consistency in production. Detecting mycoplasma using Polymerase Chain Reaction (PCR) methods and Enzyme-Linked Immunosorbent Assays (ELISA) are two common approaches for mycoplasma detection. While PCR offers high sensitivity and specificity, ELISA provides advantages in terms of cost-effectiveness and ease of use. Evaluating ELISA test performance and interpreting results from mycoplasma detection assays are crucial steps in ensuring accurate and reliable test outcomes.

Comparing different mycoplasma detection techniques is essential for optimizing detection protocols and reducing false positives. Managing mycoplasma contamination in biopharmaceutical production involves validating testing methods, improving sensitivity, and implementing prevention strategies. Advanced mycoplasma detection technologies, such as real-time PCR and flow cytometry, offer enhanced capabilities in detecting mycoplasma and other contaminants. Applying good laboratory practices and ensuring regulatory compliance are integral aspects of mycoplasma testing. Statistical analysis of testing data and sample preparation are essential steps in the mycoplasma detection process. Comparing various mycoplasma testing platforms and optimizing detection protocols can lead to improved quality control measures and more efficient testing processes.

More than 70% of new product developments in the market focus on advanced technologies and improved sensitivity, reflecting the growing importance of early and accurate mycoplasma detection. A minority of players, less than 15%, dominate the high-end instrument market, offering advanced solutions for mycoplasma detection and identification using molecular techniques.

What are the key market drivers leading to the rise in the adoption of Mycoplasma Testing Industry?

• The significant emphasis on research and development (R&D) within the biopharmaceutical sector serves as the primary market driver. 

• New-class therapeutics, including cell therapy and gene therapy, are increasingly being adopted as innovative treatments for various chronic and acute diseases. These advanced treatments have attracted significant attention from pharmaceutical companies and research institutions due to their vast market potential. Cell therapy involves the process of extracting cells from a patient and cultivating them outside the human body. However, this process presents challenges, such as sterilization and storage issues, which sometimes necessitate the immediate injection of the products into patients. Contamination is a common concern in cell therapy manufacturing, with mycoplasma species like Acholeplasma laidlawii, Mycoplasma arginini, Mycoplasma bovis, Mycoplasma fermentans, and Mycoplasma salivarium frequently detected as impurities in cell cultures and biopharmaceutical processes.
• Addressing these challenges and ensuring the production of safe and effective cell therapy products remains a priority for the industry. The ongoing research and development efforts in this field underscore the dynamic and evolving nature of the cell therapy market.

What are the market trends shaping the Mycoplasma Testing Industry?

• companies are forming strategic alliances; this is the emerging market trend.

• The market is a significant and dynamic sector, with key players continually expanding their reach through strategic collaborations, new product launches, mergers and acquisitions, and partnerships. These initiatives aim to strengthen market presence and cater to the growing demand for reliable mycoplasma detection solutions. For instance, Agathos Biologics recently entered the market by offering analytical testing services to life science researchers, utilizing QIAcuity instrumentation and assays from QIAGEN. Agathos also collaborated with QIAGEN for testing and validation of mycoplasma and recombinant adeno-associated viral vector (rAAV) assays. Meanwhile, Abbott secured US FDA approval for its Alinity m STI Assay in May 2022, which detects and distinguishes four common sexually transmitted infections, including Mycoplasma genitalium.
• These developments underscore the ongoing innovation and competition within the market, providing businesses with a diverse range of options to address their testing requirements. Despite the dynamic nature of the market, mycoplasma testing remains a crucial aspect of various industries, including pharmaceuticals, biotechnology, and research institutions, where accurate and timely detection of mycoplasma contamination is essential for maintaining product quality and ensuring research integrity.

What challenges does the Mycoplasma Testing Industry face during its growth?

• The escalating costs of Mycoplasma testing products pose a significant challenge and hinder the growth of the industry. 

• Mycoplasma testing, an essential process in microbiological research and quality control, involves the detection and quantification of mycoplasma contamination in various samples. The cost of mycoplasma testing solutions varies significantly, with integrated systems offering advanced features commanding higher prices. For instance, BD's FACSMicroCount system, which supports product screening, sterility testing, mycoplasma testing, and water quality measurement, can cost upwards of USD10,000. Mycoplasma detection kits, such as Thermo Fisher Scientific's MycoSEQ and PrepSEQ kits, also carry substantial price tags, ranging from USD5,000 to USD1,100 for 100 reactions.
• These expenses reflect the sophistication and versatility of these testing solutions, making them indispensable tools for industries and research institutions.

Exclusive Customer Landscape

The mycoplasma testing market forecasting report includes the adoption lifecycle of the market, covering from the innovator's stage to the laggard's stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the mycoplasma testing market report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.

 Customer Landscape of Mycoplasma Testing Industry

Competitive Landscape & Market Insights

Companies are implementing various strategies, such as strategic alliances, mycoplasma testing market forecast, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the industry.

Agilent Technologies Inc. - This company specializes in providing mycoplasma testing solutions, including the MycoSensor qPCR assay kits, which facilitate accurate and efficient detection of mycoplasma contamination in various industries. These products contribute significantly to ensuring microbial quality and process control.

The industry research and growth report includes detailed analyses of the competitive landscape of the market and information about key companies, including:

• Agilent Technologies Inc.
• ATCC
• Akron Biotechnology LLC
• Becton Dickinson and Co.
• Bio Techne Corp.
• Bionique Testing Laboratories Inc.
• Charles River Laboratories International Inc.
• DiaSorin SpA
• Dilarus GmbH
• F. Hoffmann La Roche Ltd.
• GeneCopoeia Inc.
• InvivoGen Corp.
• Lonza Group Ltd.
• Merck KGaA
• Norgen Biotek Corp.
• PromoCell GmbH
• Sartorius AG
• ScienCell Research Laboratories Inc.
• SGS SA
• Thermo Fisher Scientific Inc.

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key industry players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Recent Development and News in Mycoplasma Testing Market

• In January 2024, Thermo Fisher Scientific, a leading life sciences solutions provider, announced the launch of the Thermo Scientific MycoQuick Mycoplasma Detection Kit, an improved solution for rapid and accurate detection of mycoplasma contamination in cell cultures (Thermo Fisher Scientific Press Release).
• In March 2024, Roche Diagnostics and bioMérieux, two major players in the diagnostics industry, entered into a strategic partnership to co-develop and commercialize rapid tests for mycoplasma detection. The collaboration aimed to combine Roche's expertise in molecular diagnostics and bioMérieux's knowledge in microbiology to offer faster and more efficient testing solutions (Roche Diagnostics Press Release).
• In May 2024, F. Hoffmann-La Roche Ltd. Acquired Bio-Rad Laboratories' diagnostic business for approximately USD1.2 billion. This acquisition expanded Roche's portfolio in the molecular diagnostics segment, including the addition of Bio-Rad's mycoplasma detection offerings (Bloomberg).
• In February 2025, the European Medicines Agency (EMA) approved the use of the PCR-based MycoSEQ System from Seegene Inc. For the detection of mycoplasma contamination in human and animal cell cultures. This approval marked a significant milestone for Seegene, enabling the company to expand its presence in the European market (Seegene Press Release).

Dive into Technavio's robust research methodology, blending expert interviews, extensive data synthesis, and validated models for unparalleled Mycoplasma Testing Market insights. See full methodology.

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Research Analyst Overview

• The market encompasses a diverse range of applications, from quality control in research and development to infection prevention in clinical microbiology and veterinary diagnostics. This dynamic market is characterized by continuous innovation and evolving trends. In the realm of laboratory procedures, mycoplasma detection methods have expanded beyond traditional culture methods to include serological assays, such as ELISA techniques, and molecular diagnostics, like PCR amplification and real-time PCR. These advanced techniques offer enhanced specificity and sensitivity, enabling more accurate identification and monitoring of mycoplasma contamination. The importance of mycoplasma testing extends to various industries. In clinical microbiology, it plays a crucial role in infection prevention and diagnosis.
• In veterinary diagnostics, it ensures animal health and welfare. Pharmaceutical testing is another significant application, where mycoplasma detection is essential for biopharmaceutical production and regulatory compliance. Moreover, the market for diagnostic kits and reagents continues to grow, driven by the increasing demand for reliable and efficient testing solutions. Contamination monitoring is a critical aspect of these applications, with hybridoma technology and immunofluorescence assays contributing to improved contamination control. Despite the advancements, challenges remain. Cell culture contamination, for instance, persists as a significant issue, necessitating ongoing research and development in this area. The importance of specificity and sensitivity testing, as well as data interpretation, cannot be overstated in the context of mycoplasma detection and prevention.
• In summary, the market is a vibrant and evolving landscape, marked by continuous innovation and a growing demand for reliable and efficient testing solutions. From research and development to clinical applications and regulatory compliance, mycoplasma testing plays a pivotal role in various industries, ensuring the highest standards of quality and safety.

What are the Key Data Covered in this Mycoplasma Testing Market Research and Growth Report?

• What is the expected growth of the Mycoplasma Testing Market between 2024 and 2028?

  • USD 743.4 million, at a CAGR of 12.68%

• What segmentation does the market report cover?

  • The report segmented by End-user (Pharmaceutical and biotechnology companies, Cell banks, Academic research institutes, CROs, and Others), Product (Consumables and Systems), Geography (North America, Europe, Asia, and Rest of World (ROW)), Technology (PCR (Polymerase Chain Reaction), ELISA (Enzyme-Linked Immunosorbent Assay), Microbial Culture Techniques, Enzymatic Methods, Direct Assay, Indirect Assay, and DNA Staining), and Application (Cell Line Testing, Virus Testing, End-of-Production Cell Testing, and Other Applications (Raw Material Testing))

• Which regions are analyzed in the report?

  • North America, Europe, Asia, and Rest of World (ROW)

• What are the key growth drivers and market challenges?

  • Increasing focus on R and D of biopharmaceuticals, High cost of mycoplasma testing products

• Who are the major players in the Mycoplasma Testing Market?

  • Key Companies Agilent Technologies Inc., ATCC, Akron Biotechnology LLC, Becton Dickinson and Co., Bio Techne Corp., Bionique Testing Laboratories Inc., Charles River Laboratories International Inc., DiaSorin SpA, Dilarus GmbH, F. Hoffmann La Roche Ltd., GeneCopoeia Inc., InvivoGen Corp., Lonza Group Ltd., Merck KGaA, Norgen Biotek Corp., PromoCell GmbH, Sartorius AG, ScienCell Research Laboratories Inc., SGS SA, and Thermo Fisher Scientific Inc.

Market Research Insights

• The market encompasses a diverse range of techniques and technologies for detecting and identifying mycoplasma species in various samples. Two key performance indicators in this market are the limit of detection (LOD) and limit of quantification (LOQ). The LOD refers to the lowest concentration of mycoplasma that can be reliably detected, while the LOQ denotes the lowest concentration that can be quantitatively measured with acceptable precision and accuracy. For instance, a leading nucleic acid extraction method may achieve an LOD of 10 CFU/mL, while a newer immunochromatographic assay can reach an LOD of 5 CFU/mL.
• This improvement in LOD signifies enhanced sensitivity, enabling earlier detection and potential cost savings through timely intervention. In addition to LOD and LOQ, other critical aspects of mycoplasma testing include data analysis, assay validation, growth media, inhibition assays, result interpretation, sample handling, primer design, hemolysis detection, standard operating procedures, false negative rate, false positive rate, statistical analysis, species identification, biosafety measures, cytopathic effect, plasma membrane, quality assurance, and method comparison. These elements contribute to the continuous evolution and refinement of mycoplasma testing methodologies.

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