by The global mycoplasma testing market is primarily driven by the growing biopharmaceutical industry and stringent regulations for cell line authentication. Mycoplasma testing helps identify and remove possible microbial contamination in cell cultures intended for research and therapeutic applications. The conventional methods for mycoplasma testing include microbial culture, direct DNA staining, and enzyme-linked immunesorbent assay (ELISA). However, polymerase chain reaction (PCR)-based mycoplasma testing methods are gaining traction due to their higher sensitivity and specificity.
The Global Mycoplasma Testing Market is estimated to be valued at US$ 997.8 Mn in 2024 and is expected to exhibit a CAGR of 9.7% over the forecast period 2024 To 2031.
Key Takeaways
– Key players operating in the Global Mycoplasma Testing Market Size are Charles River Laboratories International, Merck KGaA, Lonza Group Ltd, Roche Diagnostics, Thermo Fisher Scientific, Merck, InvivoGen, Creative Bioarray.
– Significant opportunities exist in developing economies due to rising biotechnology research and growing pharmaceutical industry.
– Advancements in PCR and ELISA methods allow for higher throughput screening, easier automation, and faster turnaround times boosting their adoption in the mycoplasma testing market.
Market Drivers
– Increasing R&D expenditures of biopharmaceutical companies is a key factor driving the demand for mycoplasma testing to minimize costly contamination issues during drug development and manufacturing. Stringent regulations regarding sterility and safety of cell lines and biologics are further boosting compliance with mycoplasma screening mandates.
Current Challenges in Global Mycoplasma Testing Market
The global mycoplasma testing market is facing various challenges that are hindering its growth. The high cost of instruments and lack of skilled professionals for performing tests are major issues. Mycoplasma testing includes cultivation, direct detection assays, and indirect detection assays which require expensive equipment and reagents. Developing countries have limited resources to invest in advanced testing technologies. Further, significant training is needed to perform the complex testing procedures properly and accurately interpret the results which leads to shortages of trained technicians. Non-standardized testing methods and protocols add to the challenges. There is a need for universal guidelines and regulations regarding mycoplasma screening of cell lines and biologics. This will help harmonize quality control practices.
SWOT Analysis
Strength: Sensitivity and accuracy of PCR and DNA-based detection methods; Growing outsourcing of testing to specialized labs.
Weakness: High costs of instruments and reagents; Requirement of skilled professionals.
Opportunity: Increasing R&D in pharmaceutical and biotechnology sectors; Emerging economies providing lucrative growth prospects.
Threats: Lack of common standards and regulations; Shortage of trained technicians.
Geographical Regions – Value Concentration and Fastest Growing
North America accounts for the largest share of the global mycoplasma testing market, both in terms of value and volume. This is attributed to well-established pharmaceutical and biotechnology industries in the region coupled with rising research activities. Asia Pacific is expected to be the fastest growing regional market during the forecast period owing to increasing government support for life sciences sector, rising healthcare expenditure, and growing outsourcing of clinical trials and manufacturing to countries like China and India.
*Note:
1.Source: Coherent Market Insights, Public sources, Desk research
2.We have leveraged AI tools to mine information and compile it
