Mycoplasma Testing Market to Reach USD 2.94 Billion by 2032, Driven by Biopharma Growth | SNS Insider

Increasing Biopharmaceutical Production and Stringent Regulations Propel Market Expansion at a CAGR of 13.53%

AUSTIN, TX, UNITED STATES, February 24, 2025 /EINPresswire.com/ -- According to Research by SNS Insider, The Mycoplasma Testing Market was estimated at USD 941.56 million in 2023 and is expected to reach USD 2943.09 million by 2032, at a CAGR of 13.53% during the forecast period of 2024-2032.

The Mycoplasma Testing Market is growing fast, which is being led by mounting regulatory concerns, surging biopharmaceutical production, and increased cell-based research. Improvements in PCR-based analysis, enhanced interest in monoclonal antibodies, and increased concern regarding contamination of cell culture-based applications are powering market growth within research and pharma segments. Moreover, the utilization of automated test solutions and tough quality control programs in the process of manufacturing biologics is also driving the development of the market on the global front.

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Key Players in Mycoplasma Testing Market
• Thermo Fisher Scientific Inc. (MycoSEQ Mycoplasma Detection Kit, MycoAlert Mycoplasma Detection Kit)
• Lonza Group Ltd. (MycoAlert PLUS Mycoplasma Detection Kit, Nucleofector Technology)
• Merck KGaA (PlasmoTest Mycoplasma Detection Kit, Mycoplasma Removal Agent)
• Charles River Laboratories International, Inc. (Endosafe-PTS System, Accugenix Mycoplasma Testing Services)
• Roche Diagnostics (MycoTOOL Mycoplasma Real-Time PCR Kit, LightCycler 480 System)
• bioMérieux SA (VIDAS Mycoplasma Assay, NucliSENS EasyQ Mycoplasma)
• Agilent Technologies, Inc. (AriaMx Real-Time PCR System, Mycoplasma Detection Assays)
• Becton, Dickinson and Company (BD MAX Mycoplasma Detection Kit, BD Phoenix M50)
• InvivoGen (PlasmoTest Mycoplasma Detection Kit, Normocin Antimicrobial Reagent)
• PromoCell GmbH (Mycoplasma Detection Kit, Antibiotic-Antimycotic Solution)
• Sartorius AG (Microsart ATMP Mycoplasma Kit, Microsart RESEARCH Mycoplasma Kit)
• Takara Bio Inc. (PCR Mycoplasma Detection Set, Mycoplasma Elimination Cocktail)
• Minerva Biolabs GmbH (VenorGeM Mycoplasma Detection Kit, Mycoplasma Off Kit)
• ATCC (American Type Culture Collection) (Universal Mycoplasma Detection Kit, Genuine Cultures for Mycoplasma Testing)
• Biological Industries Israel Beit Haemek Ltd. (Mycoplasma Detection Kit, Mycoplasma Prevention Reagent)
• MP Biomedicals, LLC (Mycoplasma PCR Detection Kit, Mycoplasma Removal Agent)
• Clongen Laboratories, LLC (Mycoplasma Testing Services, PCR Detection Kits)
• GenBio (ImmunoWELL Mycoplasma IgG/IgM Test, Mycoplasma Pneumoniae IgM ELISA)
• ScienCell Research Laboratories, Inc. (Mycoplasma Detection Kit, Mycoplasma Removal Reagent)
• Eurofins Scientific (Mycoplasma Testing Services, Mycoplasma Real-Time PCR Assay)

By Product, the kits & reagents segment dominated the mycoplasma testing market with around 52% market share in 2023

The dominance is because of their critical role in routine contamination screening in biopharmaceutical manufacturing, cell culture research, and vaccine production. The segment's leadership is fueled by the extensive use of PCR-based and ELISA-based mycoplasma detection kits, which are highly sensitive, provide quick results, and are easy to use. Further, regulatory protocols requiring stringent contamination testing in cell-based therapies and biologics have driven the need for ready-to-use kits. The growing dependence on contract research organizations (CROs) and biopharmaceutical companies for bulk biologics production has also increased segment growth. Ongoing improvements in molecular detection technologies and automation of test workflows also underpin continued market leadership.

By Technology, PCR segmented the mycoplasma testing market with around 34.12% market share in 2023.

The dominance is because of its high sensitivity, speed, and accuracy in mycoplasma contamination detection. PCR-based testing allows for rapid amplification of mycoplasma DNA so that early detection at very low levels of contamination can be achieved, which is important for the integrity of biopharmaceutical products and cell cultures. Regulatory bodies like the FDA and EMA require stringent mycoplasma testing for biologics and cell therapy production, yet another reason why PCR has found increasing adoption. Technological progress, such as real-time PCR (qPCR) and multiplex PCR, has also boosted efficiency by making it possible to conduct high-throughput testing with little sample preparation. The trend towards laboratory and CRO automation has further established PCR's position of dominance in the market.

By Application, the Cell Line Testing segment dominated the mycoplasma testing market and contributed to 41% market share in 2023.

The segment's dominance is owing to the absolute necessity for contamination-free cell cultures in vaccine production, biopharmaceutical manufacturing, and research at educational institutions. Contamination with mycoplasma can critically affect cell viability, modify experimental results, and invalidate the quality of biologics, calling for rigorous routine testing. Regulatory bodies like the FDA and EMA require stringent mycoplasma testing of cell-based products, which further contributes to the demand for cell line testing. Also, the increased application of cell lines in regenerative medicine, monoclonal antibody manufacturing, and gene therapy has increased the demand for accurate and reliable means of detecting mycoplasma. Higher R&D spending and the use of sophisticated testing methods like PCR and ELISA further consolidated this segment's leadership position.

By End-use, The Pharmaceutical & Biotechnology Companies segment dominated the market with a 36% market share of the mycoplasma testing market in 2023.

The segment’s dominance is because of the rigorous regulatory standards for biologics, cell-based therapies, and vaccine manufacturing. Regulatory agencies such as the FDA and EMA require the regular mycoplasma testing of products to help guarantee product safety and efficacy, which results in fast adoption among biopharma firms. Increased demand for gene therapies, personalized medicine, and monoclonal antibodies further intensified the need for cell cultures that are contamination-free. Biopharmaceutical plant expansion, in addition to heightened R&D investment in pharmaceutical development, further increased the demand for mycoplasma testing. Further entrenching market dominance were major pharmaceutical companies embracing high-throughput testing platforms and automation.

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North America dominated the mycoplasma testing market with around 40% market share in 2023.

The region is dominated because of its well-developed biopharmaceutical sector, strict regulatory environments, and high R&D investments. The location of major pharmaceutical and biotechnology firms and strict FDA and other regulatory guidelines have fueled the extensive use of mycoplasma testing in drug production and cell therapy. Besides, the rapid demand for vaccines, monoclonal antibodies, and gene therapy products has also driven market domination, with adequate laboratory infrastructures and government support for biopharma research.

The Asia-Pacific region is the fastest-growing mycoplasma testing market due to the growth in biopharmaceutical manufacturing, increasing healthcare investments, and increasing clinical research. These nations are investing heavily in biologics, cell-based research, and vaccine production, generating a high demand for mycoplasma testing solutions. Government efforts to enhance biotech innovation, combined with the rising presence of CROs and CDMOs, further fuel market growth.

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