Mycoplasmas are the smallest known free-living microorganisms and are frequent contaminants of mammalian cell cultures. For the safety and purity of vaccines and other biological cell-derived products, it is important that the cell substrates and unprocessed bulk materials are free of adventitious agents, including mycoplasma. In many cases, mycoplasmas differ from other types of bacteria, making them difficult to culture and detect. Testing is done to detect mycoplasma like Mycoplasma hominis, Mycoplasma genitalium, Mycoplasma pneumoniae, and Ureaplasma urealyticum, which can cause nongonococcal urethritis (NGU), prostate inflammation (prostatitis), vaginal discharge, and pelvic inflammatory disease (PID) in men and women both.

Growing number of concerns of cell culture contamination to propel Mycoplasma Testing market demand
Mycoplasmas frequently contaminate the fluids used in bioprocessing and cell culture. It is widely accepted that initial cell cultures have a contamination rate of 1%, while continuous cell cultures have a contamination rate of 15% to 35% due to mycoplasma. Inefficient culturing techniques or malfunctioning laboratory apparatus can both result in mycoplasma contamination. Reusing pipet tips is an example of poor culture technique that might spread the contaminant by transferring mycoplasma-infected media into otherwise sterile media. Further, a faulty laminar flow might spread mycoplasma-carrying dust and aerosols throughout a biosafety cabinet, contaminating all the medium and cells within.

Mycoplasmas infiltrate cell cultures via a variety of difficult-to-trace ways. These include workers in the lab, serum, material used in cell culture, water baths, incubators, etc. Among the aforementioned sources, contamination by humans’ accounts for the largest share. The contaminants can be transmitted through dirty clothing, lab gear, human speaking close to a laminar airflow, the scalp, sneezing, coughing, etc. Also, wherever the cell cultures are kept, a continual influx of individuals raises the risk of contamination. Out of over 190 total species of mycoplasma, only 20 distinct mycoplasma species of human, bovine, and porcine origin have been found in cell culture. Eight of the species account for almost 95% of all mycoplasma contamination in cell culture. These include 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 is the best protection against mycoplasma contamination that can rapidly identify contaminated cultures and reagents. In the case of batch adulteration or a product recall, contamination of cell substrates used in the development of biopharmaceuticals constitutes a serious economic risk for manufacturers as well as a potential safety concern for patients. Regular mycoplasma testing is needed to be performed during the product manufacturing and development phase to decrease these risks.

Key strategies adopted by players and laboratories in Mycoplasma Testing market
Continuous advances in mycoplasma detection have enabled market players to develop innovative, rapid, and easy-to-use tests. Such advancements tend to provide competitive edge to manufacturers and therefore, major players are continuously focusing on investments for new product development and expanding their geographic reach to strengthen their positions in the high growth 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

Regardless of the 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 projected to garner even further momentum in the upcoming years due to a strong emphasis on innovation, greater acceptance in biopharmaceutical manufacturers across the globe, and development of rapid mycoplasma testing by market players, among others. For instance, assays based on nucleic-acid amplification techniques (NAT), such as polymerase chain reaction (PCR), have potential to address the challenges associated with mycoplasma testing 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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