Mycoplasma detection assays help ensure products like cell cultures or biologics are free from contamination prior to their use in research or clinical applications. These assays help deliver safe, effective and high-quality biotherapeutic products to patients.
Mycoplasma testing helps detect and eliminate potentially hazardous microbiological contaminants from cell cultures. It finds widespread application in testing biological products like vaccines, blood components, cell therapies and other medical supplies. Rising pressure to meet stringent quality standards has boosted demand from industries engaged in new drug development, biosimilar production and manufacturing of biologics.
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 are Charles River Laboratories International, Merck KGaA, Lonza Group Ltd, Roche Diagnostics, Thermo Fisher Scientific, Merck.
Increasing cell culture contamination and stringent regulatory mandates have opened lucrative growth opportunities for market players. Global Mycoplasma Testing Market Size Growing prevalence of chronic diseases is propelling research on advanced therapies like gene and cell therapies, driving demand.
North America dominated the market in 2020 owing to presence of major players and availability of technologically advanced diagnostic products and services. However, Asia Pacific is anticipated to witness highest growth on back of increasing healthcare investments, rising affordability and growing biotech industry in countries like China and India.
Market Drivers
Stringent regulatory guidelines mandating mycoplasma testing of cell substrates: Stringent regulations by FDA, EMA and others have made mycoplasma testing mandatory at various stages of research and development as well as manufacturing of biological products. This is a key factor driving market growth.
Increasing investments in cell-based research: Rising expenditure on cell-based research for development of novel biologics, vaccines and other cellular products is fueling demand for reliable mycoplasma detection testing services and kits.
Market Restrains
High instrument costs: Significant capital investments required for advanced mycoplasma detection platforms like PCR, bioassays and microfluidics may limit adoption among small labs and companies.
Lack of skilled professionals: Scarcity of skilled technicians and scientists trained to perform precise mycoplasma testing techniques continues to hamper market growth to a certain extent.
Segment Analysis
The global mycoplasma testing market is dominated by kits and reagents segment as it accounts for the largest market share. This is because kits and reagents form the basic requirements for any mycoplasma testing process. The mycoplasma testing kits are used to detect mycoplasma contamination in cell culture samples. The reagents are the solution or substances required for specific chemical reactions involved in various mycoplasma testing techniques. Some of the commonly used reagents for testing include staining reagents, culture media, antibiotics, and enzymes.
Global Analysis
The North America region holds the major share in the global mycoplasma testing market and is expected to maintain its dominance during the forecast period. This is due to the large presence of pharmaceutical and biotechnology companies in the region conducting research activities. The growing biosimilars and biologics industry in countries like the US and Canada is also driving the demand for mycoplasma testing in this region. The Asia Pacific region is projected to witness the highest growth rate during the forecast period. This is attributed to increasing investments by market players, rising biopharmaceutical industry, and growing acceptance of advanced technologies in countries like China, India, and South Korea.
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