Mycoplasmas are the smallest free-living microbes known to man, and they commonly contaminate mammalian cell cultures. To ensure the safety and integrity of vaccines and other biological cell-derived products, cell substrates and unprocessed bulk materials must be free of adventitious organisms such as mycoplasma. Mycoplasmas vary from other forms of bacteria in numerous ways, making them difficult to culture and identify. Mycoplasmas such as Mycoplasma hominis, Mycoplasma genitalium, Mycoplasma pneumoniae, and Ureaplasma urealyticum are tested for because they can cause nongonococcal urethritis (NGU), prostate inflammation (prostatitis), vaginal discharge, and pelvic inflammatory disease (PID) in both men and women.

Concerns about Mycoplasma contamination in cell culture are increasing. Putting market demand to the test
Mycoplasmas routinely contaminate bioprocessing and cell culture fluids. It is commonly known that beginning cell cultures have a 1% contamination rate, but continuing cell cultures have a 15% to 35% contamination rate due to mycoplasma. Mycoplasma contamination can occur as a result of inefficient culture procedures or faulty laboratory equipment. Reusing pipet tips is an example of poor culture technique that might disseminate mycoplasma-infected media into otherwise sterile media. Furthermore, improper laminar flow might disperse mycoplasma-carrying dust and aerosols throughout a biosafety cabinet, infecting all medium and cells Mycoplasmas enter cell cultures in a number of obscure ways. These include lab employees, serum, cell culture materials, water baths, incubators, and so forth. Human contamination accounts for the majority of the aforementioned sources. Contaminants can be conveyed by unclean clothing, lab equipment, human speech near a laminar airflow, the scalp, sneezing, coughing, and so on. Furthermore, wherever the cell cultures are stored, a constant stream of people increases the potential of contamination. Only 20 unique mycoplasma species of human, bovine, and porcine origin have been discovered in cell culture, out of approximately 190 total species. Eight species are responsible for over 95% of all mycoplasma contamination in cell culture. M. arginini (bovine), M. fermentans (human), M. hominis (human), M. hyorhinis (porcine), M. orale (human), M. pirum (human), M. salivarium (human), and Acholeplasma laidlawii (bovine).
Routine testing, which can quickly identify contaminated cultures and chemicals, is the greatest defense against mycoplasma contamination. Contamination of cell substrates used in the development of biopharmaceuticals poses a substantial economic risk for producers as well as a possible safety problem for patients in the event of batch adulteration or a product recall. To reduce these hazards, regular mycoplasma testing must be undertaken during the product production and development phases.

Key Strategies Employed by Companies and laboratories in Mycoplasma Testing market
Continuous advancements in mycoplasma detection have enabled market participants to create new, quick, and simple-to-use diagnostics. Such innovations tend to provide manufacturers a competitive advantage, therefore key companies are always focusing on investments for new product development and increasing their geographic reach to reinforce their positions in the rapidly growing Mycoplasma Testing market. Some of the recent developments are listed below-

• In February 2023, SwiftDx announced the launch of its mycoplasma detection kit. The SwiftDx Mycoplasma Detection Kit is a new lateral flow test to detect mycoplasma contamination offering a quicker and more convenient solution

• In April 2022, AlphaBiolabs launched sexually-transmitted infection (STI) testing for the detection of chlamydia, gonorrhoea, mycoplasma genitalium, mycoplasma hominis, trichomoniasis, ureaplasma parvum (UTI), and ureaplasma urealyticum (UTI)

• In December 2021, Asahi Kasei Medical Co., Ltd. completely acquired Bionique Testing Laboratories LLC, one of the providers of mycoplasma testing services for the biotherapeutics and life-sciences industries in the US

Despite challenges such as lengthy turnaround time, quality control concerns, long analytical and lead time, among others, the global mycoplasma testing market has high potential to grow at a significant rate and is expected to gain even more momentum in the coming years due to a strong emphasis on innovation, greater acceptance in biopharmaceutical manufacturers around the world, and market players' development of rapid mycoplasma testing, among others. For example, assays based on nucleic-acid amplification methods (NAT), such as polymerase chain reaction (PCR), offer the potential to solve mycoplasma testing difficulties such as turnaround time and quality control.

Competitive Landscape Analysis: Mycoplasma Testing Market
The global mycoplasma testing market is marked by the presence of well-established market players such as Thermo Fisher Scientific, Inc. (US); Charles River Laboratories International, Inc. (US); Merck KGaA (Germany); Lonza Group (Switzerland); PromoCell GmbH (Germany); American Type Culture Collection (US); and others.

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