According to a new report published by Introspective Market Research, titled, “Mycoplasma Testing Market by Product, Technology, and End-User,” The Global Mycoplasma Testing Market Size Was Valued at USD 0.94 Billion in 2023 and is Projected to Reach USD 2.95 Billion by 2032, Growing at a CAGR of 13.58%.
The mycoplasma testing market has gained significant momentum as mycoplasma contamination remains one of the most common and serious challenges in cell culture and biopharmaceutical manufacturing. Mycoplasmas are small, cell wall–deficient bacteria that can cause undetected contamination in cell lines, leading to inaccurate research outcomes, compromised biopharmaceutical products, and substantial financial losses. Mycoplasma testing ensures the safety, reliability, and quality of biological products, making it a critical component in research, diagnostics, and drug development.
Compared to traditional microbial detection methods, mycoplasma testing offers faster results, greater sensitivity, and improved accuracy, helping laboratories and manufacturers comply with stringent regulatory requirements. The increasing use of cell-based therapies, rise in biologics production, and growing need for contamination-free biopharmaceutical products are driving strong adoption of these tests across pharmaceutical companies, academic research institutes, and clinical laboratories.
One of the major growth drivers of the mycoplasma testing market is the expanding biopharmaceutical industry and rising demand for biologics. Biologics, including monoclonal antibodies, vaccines, and cell-based therapies, require stringent contamination control to ensure product safety and efficacy. Mycoplasma contamination can alter cell physiology, affect product yield, and compromise clinical results, making routine testing essential. With regulatory agencies such as the FDA and EMA mandating mycoplasma testing during biologics production, pharmaceutical companies are increasingly adopting advanced and rapid testing solutions. This rising emphasis on quality assurance and compliance is significantly accelerating the demand for mycoplasma testing worldwide.
A significant market opportunity lies in the increasing adoption of cell and gene therapies worldwide. With hundreds of therapies under clinical trials and many expected to gain approvals in the coming years, the demand for reliable and efficient contamination testing will rise substantially. Mycoplasma testing plays a crucial role in ensuring the purity of cell-based products, thereby safeguarding patient outcomes. Moreover, the growing interest in personalized medicine and regenerative therapies presents a lucrative opportunity for testing solution providers. Companies investing in advanced molecular technologies, automation, and rapid detection systems are well-positioned to capture emerging opportunities in this fast-growing healthcare segment.
Mycoplasma Testing Market, Segmentation
The Mycoplasma Testing Market is segmented on the basis of Product, Technology, and End-User.
Product: The product segment is further classified into Assay Kits & Reagents, Instruments, and Services. Among these, the Assay Kits & Reagents sub-segment accounted for the highest market share in 2023. This dominance is attributed to their wide use in routine testing, cost-effectiveness, and convenience for laboratories. Assay kits are specifically designed for rapid and accurate detection of mycoplasma contamination in cell cultures, making them indispensable in research and manufacturing. The rising demand for biologics and cell-based therapies further drives the adoption of ready-to-use assay kits and reagents, strengthening their position as the leading product segment.
Technology: The technology segment is further classified into Polymerase Chain Reaction (PCR), Enzyme-Based Assays, Direct Assays, and Others. Among these, the PCR sub-segment accounted for the highest market share in 2023. PCR-based testing is preferred due to its high sensitivity, rapid turnaround, and ability to detect a wide variety of mycoplasma species. It has become the gold standard for contamination detection in research and clinical applications. Continuous advancements in real-time PCR platforms, coupled with regulatory compliance requirements, make PCR technology the most widely adopted and reliable method in the global mycoplasma testing market.
Some of The Leading/Active Market Players Are
- Lonza Group (Switzerland)
- Charles River Laboratories (United States)
- Thermo Fisher Scientific Inc. (United States)
- Merck KGaA (Germany)
- Agilent Technologies (United States)
- PromoCell GmbH (Germany)
- Sartorius AG (Germany)
- Bio-Rad Laboratories Inc. (United States)
- American Type Culture Collection (ATCC) (United States)
- Minerva Biolabs GmbH (Germany)
- InvivoGen (France)
- Abcam plc (United Kingdom)
- Roche Diagnostics (Switzerland)
- Creative Bioarray (United States) and other active players.
Key Industry Developments
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In May 2024, Lonza Group introduced a next-generation PCR-based mycoplasma detection kit designed to deliver faster and more reliable results for biopharmaceutical manufacturers. This innovation enhances quality control processes and enables manufacturers to comply more efficiently with international regulatory requirements, thereby improving product safety and accelerating the release of biologics and cell therapies.
- In January 2024, Charles River Laboratories expanded its cell and gene therapy testing services by opening a new state-of-the-art testing facility in Pennsylvania, USA. The facility will provide specialized mycoplasma testing, sterility testing, and viral safety services to support the growing demand for cell and gene therapies, strengthening the company’s global testing capabilities.
Key Findings of the Study
- Assay Kits & Reagents and PCR technology dominated the market in 2023.
- North America and Europe remain the leading regions for adoption.
- Rising biologics demand and regulatory mandates drive market growth.
- Cell and gene therapy adoption creates new opportunities for expansion.
