Mycoplasma Testing Industry

According to a recent report by Grand View Research, Inc., the global mycoplasma testing market is projected to reach a value of USD 2.26 billion by 2030. The market is expected to grow at a robust Compound Annual Growth Rate (CAGR) of 13.58% during the forecast period. Several key factors are contributing to this rapid expansion, including the increasing demand for mycoplasma testing within the biomanufacturing sector, the rise of pharmaceutical outsourcing, and growing activity in emerging markets. Additionally, the growing frequency of cell-line contamination, coupled with ongoing innovation and research in the field of biological sciences, is playing a pivotal role in driving market growth.

One of the notable contributors to market expansion is the increasing number of government initiatives aimed at supporting pharmaceutical and biotechnology industries. For instance, the U.S. Food and Drug Administration (FDA) has proposed eliminating a specific test used for detecting mycoplasma in in vitro living cell cultures, as it currently supports only a single test method. By revising biologics regulations to encourage more accurate and versatile testing approaches, the FDA is expected to improve the specificity and sensitivity of mycoplasma detection. This regulatory evolution is likely to pave the way for new technologies, creating substantial opportunities for market players to innovate and launch advanced testing products.

The COVID-19 pandemic had a notable, albeit temporary, impact on the market. At the onset of the pandemic in late 2019, the positivity rates of Mycoplasma pneumoniae infections significantly declined due to strict global containment measures. These measures not only curbed the spread of COVID-19 but also inadvertently reduced the transmission of other respiratory pathogens, including M. pneumoniae. However, as restrictions are gradually lifted, a resurgence in M. pneumoniae infections is anticipated, which is expected to contribute positively to the demand for mycoplasma testing throughout the forecast period.

Moreover, the market is being propelled by increasing investments in research and development across the life sciences sector. Rising healthcare expenditures are fueling extensive R&D initiatives, particularly in drug discovery, biologics development, and cell culture innovation. The adoption of advanced technologies in these fields is boosting the need for reliable and accurate mycoplasma testing methods. Among the key concerns for researchers and manufacturers is the high risk of cell culture contamination—a persistent and costly issue that mycoplasma testing aims to address.

It is estimated that mycoplasma contaminates approximately 15% to 35% of all continuous cell cultures globally. Out of over 190 identified mycoplasma species, just eight are responsible for over 95% of all reported contamination cases. Contributing factors include poor aseptic techniques, contaminated lab equipment, aerosol exposure, dust, and cross-contamination due to malfunctioning or improperly maintained laminar flow hoods. These risks underscore the need for robust mycoplasma detection protocols, thereby driving market demand for reliable testing solutions.

In summary, with the convergence of supportive regulatory changes, technological advancement, increased R&D activity, and rising awareness of contamination risks, the global mycoplasma testing market is poised for significant and sustained growth through 2030.

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Mycoplasma Testing Market Segments Highlights:

  • By product, kits and reagents dominated the market, and are anticipated to exhibit the fastest CAGR throughout the forecast period, due to their widespread use in mycoplasma testing
  • Ease of conducting the procedure and rapid detection are some of the major advantages offered by the PCR method
  • By application, the cell line testing segment held a largest share of 41.65% in 2023, owing to the increase in research projects being done in the field of cell culture
  • Mycoplasma contamination can cause alterations in cell culture metabolites and lead to development of toxins. This increases the importance of cell line testing and authentication in the pharmaceutical and biopharmaceutical industries
  • North America held the largest share of 39.04% in 2023. This is mostly attributed to the presence of significant market participants, as well as rising R&D spending and federal assistance
  • In Asia Pacific, the market is expected to grow at the highest rate in a projected time period driven by factors such as the rising prevalence of target diseases with an aging population, rising awareness and others

Mycoplasma Testing Market Report Segmentation

Grand View Research has segmented the global mycoplasma testing market on the basis of product, technology, application, end-use, and region:

Mycoplasma Testing Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Instruments
  • Kits & Reagents
    • PCR Assays
    • Nucleic Acid Detection Kits
    • Stains
    • Elimination Kits
    • Standards & Controls
    • Others
  • Services

Mycoplasma Testing Technology Outlook (Revenue, USD Million, 2018 - 2030)

  • PCR
  • ELISA
  • Direct Assay
  • Indirect Assay
  • Microbial Culture Techniques
  • Enzymatic Methods

Mycoplasma Testing Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Cell Line Testing
  • Virus Testing
  • End of Production Cells Testing
  • Others

Mycoplasma Testing End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Academic Research Institutes
  • Cell Banks
  • Contract Research Organizations
  • Pharmaceutical & Biotechnology Companies
  • Others

Mycoplasma Testing Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America
    • US
    • Canada
  • Europe
    • Germany
    • UK
    • Spain
    • France
    • Italy
    • Denmark
    • Sweden
    • Norway
    • Russia
  • Asia Pacific
    • Japan
    • China
    • India
    • South Korea
    • Thailand
    • Australia
    • Singapore
  • Latin America
    • Brazil
    • Mexico
    • Argentina
  • MEA
    • South Africa
    • Saudi Arabia
    • UAE
    • Kuwait

Key Mycoplasma Testing Company Insights

  • Thermo Fisher Scientific, Inc.
  • Merck KGaA
  • Lonza Group AG
  • Charles River Laboratories International, Inc.
  • PromoCell GmbH
  • American Type Culture Collection
  • Asahi Kasei Medical Co., Ltd.
  • Sartorius AG
  • InvivoGen
  • Eurofins Scientific

Order a free sample PDF of the Mycoplasma Testing Market Intelligence Study, published by Grand View Research.