Table of Contents
Overview
New York, NY – Sep 08, 2025 – The Global Mycoplasma Testing Market was valued at USD 951 Million in 2024 and is expected to grow to USD 2338 Million in 2032. Between 2025 and 2032, this market is estimated to register a CAGR of 12.11%.
Mycoplasma testing has emerged as a critical component in ensuring the safety, reliability, and compliance of biopharmaceutical products. Mycoplasmas, a group of bacteria lacking cell walls, can cause severe contamination in cell cultures used for research, biologics manufacturing, and vaccine development. Their presence compromises product integrity, reduces yield, and poses significant risks to patient safety.
To address these concerns, mycoplasma testing has been widely adopted as an essential quality control measure across the biopharma and life sciences industries. Testing methods include culture-based assays, enzymatic techniques, DNA staining, and advanced polymerase chain reaction (PCR)-based approaches. Among these, PCR testing is increasingly preferred due to its rapid turnaround, high sensitivity, and ability to detect a wide range of mycoplasma species.
Regulatory agencies, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), mandate rigorous mycoplasma testing in biologics production. Compliance with these guidelines assures product safety and enhances trust in therapeutic solutions.
The growing demand for biologics, cell therapies, and vaccines is driving the expansion of mycoplasma testing services. Market growth is further supported by technological advancements that reduce testing time and improve detection accuracy.
Through reliable mycoplasma testing, organizations reinforce their commitment to patient safety, product quality, and global regulatory compliance. As the life sciences sector continues to expand, mycoplasma testing will remain a cornerstone of biologics manufacturing and research integrity.
Key Takeaways
- The global mycoplasma testing market was valued at US$ 951 million in 2024 and is projected to expand at a CAGR of 12.11%, reaching US$ 2,338 million by 2032.
- In 2022, the kits and reagents segment dominated the market, accounting for 55.6% of total revenue, supported by the increasing availability of automated testing equipment.
- The polymerase chain reaction (PCR) segment led the technology landscape in 2022, holding a 36.1% revenue share due to its high accuracy and rapid results.
- North America emerged as the leading regional market in 2022, contributing 40.7% of global revenue, driven by advanced healthcare infrastructure and strong regulatory frameworks.
- By end-user, the biotechnology and pharmaceutical sector accounted for the largest revenue share, representing 36.8% of the market in 2022, reflecting the rising demand for biologics and cell-based therapies.
Regional Analysis
The global mycoplasma testing market is experiencing significant growth, supported by rising demand for advanced testing products and services across regions. In 2022, North America accounted for 40.7% of total revenue, maintaining its dominance due to well-established healthcare infrastructure, strict regulatory standards, and the strong presence of leading biopharmaceutical companies.
Europe represented the second-largest market, with growth largely attributed to the expansion of the regional biopharmaceutical sector and increased emphasis on quality control and regulatory compliance.
Meanwhile, the Asia-Pacific region has emerged as the fastest-growing market, propelled by the rapid adoption of biologics, the expansion of local biopharmaceutical industries, and the increasing trend of outsourcing manufacturing activities to cost-efficient hubs such as China and India. This strong regional momentum is expected to position Asia-Pacific as a key driver of global market expansion over the forecast period.
Frequently Asked Questions on Mycoplasma Testing
- What is mycoplasma testing?
Mycoplasma testing is a laboratory procedure used to detect contamination in cell cultures, biological products, and biopharmaceuticals. Mycoplasmas are small bacteria lacking cell walls, making them difficult to detect without specialized methods such as PCR, ELISA, or culture-based assays. - Why is mycoplasma testing important in laboratories?
Mycoplasma testing is critical because contamination can compromise research accuracy, alter cell behavior, and reduce product quality. It ensures reliability in experimental results, compliance with regulatory standards, and safety in biologics manufacturing and pharmaceutical production processes. - What methods are commonly used for mycoplasma detection?
The most widely used methods include polymerase chain reaction (PCR) assays, culture techniques, and enzymatic detection kits. PCR is highly sensitive and rapid, while culture methods remain the reference standard for confirming mycoplasma contamination. - Which industries require mycoplasma testing?
Mycoplasma testing is essential in pharmaceutical manufacturing, biotechnology, academic research, and vaccine production. Regulatory authorities mandate its use in biologics and biosimilars manufacturing to maintain product integrity, patient safety, and compliance with international quality guidelines. - How often should cell cultures be tested for mycoplasma?
Testing frequency varies by application but is typically recommended on a monthly basis in research laboratories. In biopharmaceutical production, more frequent monitoring is mandated to comply with Good Manufacturing Practices (GMP) and international regulatory standards. - Which regions hold the largest share in the mycoplasma testing market?
North America dominates the market due to advanced healthcare infrastructure, strict FDA regulations, and extensive biopharmaceutical research. Europe follows closely, while Asia-Pacific is expected to show the fastest growth due to expanding biotech industries and government support. - Who are the key players in the mycoplasma testing market?
Major players include Thermo Fisher Scientific, Lonza Group, Merck KGaA, Charles River Laboratories, and Agilent Technologies. These companies offer a wide range of PCR kits, culture media, and enzymatic detection assays to serve global markets.
Conclusion
The mycoplasma testing market is witnessing strong growth, driven by the rising demand for biologics, vaccines, and cell-based therapies, alongside strict global regulatory requirements. PCR-based methods are increasingly favored due to their rapid, accurate, and comprehensive detection capabilities. North America currently dominates the market, while Asia-Pacific is emerging as the fastest-growing region, supported by expanding biopharmaceutical manufacturing and outsourcing activities.
With key players focusing on innovation and automation, the industry is positioned for significant advancements. Overall, mycoplasma testing remains vital for ensuring product quality, safeguarding patient safety, and reinforcing compliance in the evolving global biopharmaceutical landscape.
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