Overview of  Mycoplasma Testing

Mycoplasma is a group of bacteria that lack cell walls around their cell membranes. This feature differentiates them from other bacteria and allows them to enter human and animal cells, making them pathogens. As they can persist unseen inside cell cultures, mycoplasma contamination is a serious issue for industries involved in cell-based research, biologics manufacturing and therapeutic development like biopharmaceuticals. Even at very low levels, mycoplasma contamination can alter the physiology of cells and affect research outcomes. Thus, reliable mycoplasma testing is crucial at various stages of bioprocessing to deliver safe and effective biotherapeutics.

Regulatory Standards for Mycoplasma Testing

Stringent regulations mandate mycoplasma testing of cell substrates, cellular products, and purified therapeutics. International bodies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO) have comprehensively addressed mycoplasma testing. The FDA regulations require testing of all cell banks, bulk harvests, and final drug product. The EMA specifies regular testing during research, development, manufacture, and distribution of biological medicinal products. Similarly, the WHO provides detailed guidance on establishing an in-house mycoplasma testing laboratory and using certified external testing services. Compliance with regulatory standards ensures consumer safety while supporting a robust global biopharma industry.

Available Mycoplasma Testing Techniques

Traditional Mycoplasma Testing methods rely on labor-intensive culture and microscopy techniques with long turnaround times. However, modern techniques like polymerase chain reaction (PCR) and luminescent ATP determination assays provide rapid, sensitive, and accurate mycoplasma detection.

PCR-based techniques are highly sensitive and specific for mycoplasma detection. Real-time PCR is commonly used as it provides quantitative data and automated analysis. Mycoplasma universal PCR kits detect all pathogenic species with no special culture requirements.

Non-isotopic mycoplasma detection assays measure the adenosine triphosphate (ATP) produced by viable mycoplasmas via bioluminescence. Tests based on this principle can directly detect ATP in cell culture samples in less than two days with a detection limit of 10 CFU/mL.

Hybridization probes that bind directly to mycoplasma ribosomal RNA provide a different detection approach. Newer techniques like genetic sequence analysis are also being studied for mycoplasma testing.

Growing Biopharmaceutical Industry Drives Demand

With rising demand for biologics and cell/gene therapies, investments into modern biomanufacturing are surging worldwide. The global biopharma market was valued at ~$270 billion in 2020 and is projected to reach $400 billion by 2026. This rapid growth has heightened regulatory oversight and increased need for reliable upstream/downstream bioprocess monitoring including mycoplasma testing.

Asia Pacific and Latin America Emerge as Lucrative Regions

Asia Pacific and Latin America have emerged as thriving biomanufacturing hubs, attracted by opportunities for investment and business expansion. The biopharma industries in India, China, Japan, Brazil and Mexico are expanding aggressively. This has propelled regional authorities to strengthen regulatory compliances and bolstered demand for analytical testing services including mycoplasma screening of bioproducts.

Automation and Multiplexing Accelerate

Automated platforms for mycoplasma DNA extraction and PCR-based amplification/detection have sped up workflow while lowering the hands-on time. Availability of ready-to-use multiplex testing kits that combine primers for detecting several mycoplasma genera further augment testing convenience. These technical upgrades, combined with competitive pricing, are fueling wider adoption of high-throughput mycoplasma screening protocols.

Contract Testing Services Grab Major Revenue

Given time and resource requirements for establishing an in-house mycoplasma testing facility, most biopharma companies rely on external testing services. Prominent contract testing laboratories offer a diverse service portfolio for turnkey mycoplasma screening via culture, PCR and ATP assays. Their global footprint and round-the-clock sample analysis support caters well to product developers worldwide. As a result, the contract testing segment captures over 65% of the global mycoplasma testing market revenue.

Key Players

Leading providers of mycoplasma detection technologies and services include Thermo Fisher Scientific, Merck, Lonza, Charles River Laboratories, Bionique Testing Laboratories, Biological Industries Israel Beit Haemek, and InvivoGen. These established brands provide a complete suite of solutions from validated PCR-based research use test kits to GMP-compliant screening of biomanufacturing samples. Growing collaborations between technology innovators and service giants are helping augment market reach and competitiveness.

Stringent regulations and the exponential growth of cell-based biotherapeutics have elevated mycoplasma testing to a critical quality control process. Rapid, sensitive and automated detection techniques now enable high-throughput screening and timely product release. As the biopharma sector continues its pace of expansion globally, especially in emerging economies, the mycoplasma testing market is primed to progress steadily in the coming years. Reliance on experienced external testing services will remain paramount to facilitate seamless bioprocessing.

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Money Singh is a seasoned content writer with over four years of experience in the market research sector. Her expertise spans various industries, including food and beverages, biotechnology, chemical and materials, defense and aerospace, consumer goods, etc. (https://www.linkedin.com/in/money-singh-590844163)