Mycoplasma Testing Market Outlook 2027 | Key Developments and Future Scope

 

The global mycoplasma testing market is projected to grow at a robust 11% CAGR from 2022 to 2027. Key drivers include expanding R&D activities and investments, increased government funding initiatives, rapid growth in the pharmaceutical and biotechnology sectors, heightened concerns about cell culture contamination, advances in cell culture technologies, rising demand for fast and accurate testing, and a growing incidence of respiratory tract infections.

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Mycoplasmas are the smallest known free-living microorganisms and are common contaminants in mammalian cell cultures. To ensure the safety and purity of vaccines and other biologically derived products, it is essential that cell substrates and unprocessed bulk materials remain free of adventitious agents—mycoplasmas included. Because these organisms differ significantly from typical bacteria, they are often difficult to culture and detect. Testing typically targets species such as Mycoplasma hominis, Mycoplasma genitalium, Mycoplasma pneumoniae, and Ureaplasma urealyticum, which are associated with conditions like nongonococcal urethritis (NGU), prostatitis, vaginal discharge, and pelvic inflammatory disease (PID) in both men and women.

Competitive Landscape Analysis: Mycoplasma Testing Market

The global mycoplasma testing market is marked by the presence of key and well-established market players such as listed below:-

·        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)

Rising Concern Over Cell Culture Contamination Driving the Demand for Mycoplasma Testing

Mycoplasmas often infiltrate bioprocessing and cell-culture systems. Primary cell cultures are estimated to have at least a 1% contamination rate, while continuous cultures may exhibit contamination levels between 15% and 35%. Such contamination can stem from poor culturing practices or malfunctioning laboratory equipment. For example, reusing pipette tips can transfer mycoplasma-infected media into otherwise sterile cultures, while faulty laminar-flow systems can spread contaminated dust or aerosols throughout biosafety cabinets.

These organisms can enter cell cultures through multiple, often hard-to-trace sources, including laboratory personnel, serum, culture materials, water baths, and incubators. Human-related contamination is believed to be the most common, with transmission occurring through unclean clothing or gear, talking near airflow systems, and routine actions such as coughing or sneezing. Increased movement of people around culture areas further elevates the risk.

Out of more than 190 known mycoplasma species, only around 20 of human, bovine, or porcine origin have been detected in cell culture. Eight species are responsible for roughly 95% of all contamination cases: 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 remains the most effective safeguard against mycoplasma contamination, enabling early identification of compromised cultures and reagents. Because contaminated cell substrates can trigger costly batch failures or product recalls—and pose potential risks to patients—regular mycoplasma testing throughout product development and manufacturing is essential for reducing both economic and safety-related impacts.

Key Business Strategies adopted by the Leading Market Players and Laboratories

Continuous advancements and developments in mycoplasma detection have enabled market players to develop innovative, rapid, and easy-to-use tests. Such advancements tend to provide a competitive edge to all manufacturers and therefore, all major players are continuously focusing on investments for new product development and expanding their geographic reach to strengthen their position in this 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 for the detection of mycoplasma contamination offering a faster and more convenient solution. The kit uses adapted PCR method and provides accurate results within minutes, making it a valuable tool across laboratories.

·        In April 2022, AlphaBiolabs launched sexually-transmitted infection (STI) testing for public and healthcare partners. The complete panel (7 STIs) detect 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. This acquisition is intended at expanding its biosafety contract testing business.

·        In July 2020, bioMérieux launched BIOFIRE MYCOPLASMA, an innovative test for the detection of mycoplasma in pharmaceutical products used for biotherapeutics such as antibodies, hormones, and cell & gene therapies. BIOFIRE MYCOPLASMA is a rapid and easy-to-use molecular biology test featuring an automated workflow for DNA extraction, amplification and detection.

·        In April 2020, Infinity Laboratories announced the launch of Mycoplasma testing in response to the high demand within the biological, therapeutics, and pharmaceutical industries. The launch results into a significant capital investment for the company further providing manufacturers the edge to bring products to market faster.

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North America is Expected to hold a Larger Share in the Mycoplasma Testing Market

From a geographical perspective, North America holds a larger market share of the global mycoplasma testing market. This can be mainly attributed to the increased adoption of novel technologies, growing number of clinical studies in the region, well-established healthcare infrastructure, presence of multinational pharma & biotech companies supporting high R&D investments, and increased incidence of respiratory disorders. According to Centers for Disease Control and Prevention (CDC), the chronic lower respiratory diseases (including asthma) accounted for 142,342 deaths in 2021 in the US. Additionally, launch of mycoplasma testing capabilities and expanding customer reach by laboratories has further resulted in the high adoption of mycoplasma testing in the region.

Irrespective of the upcoming challenges such as lengthy turnaround time, quality control concerns, long analytical and lead time, among others, the global mycoplasma testing market has a high potential to grow at a significant rate and is expected to gain further momentum in the upcoming years due to a strong emphasis on innovation, greater acceptance in biopharmaceutical manufacturers across the world, and development of rapid mycoplasma testing by top 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. NAT-based tests are very sensitive and quick to perform as they detect the presence of nucleic acid sequence unique to the microorganisms of interest that potentially contaminate the culture.

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