Mycoplasma Testing In Clinical Market is expected to reach at 3.4 billion by 2032, Upcoming Trends, Segmented by Type, Application, End-User and Region -Sartorius AG, Clongen Laboratories, Bio-Rad Laboratories, Inc., MERCK KGAA, Charles River, ELITechGROU

The global mycoplasma testing market size was valued at USD 767.16 million in 2021 and is expected to reach at 3.4 billion by 2032, attractive growth over the forecast period. Increasing investments in R&D activities have contributed to huge revenue for the market. The rising introduction of novel technologies by key players is expected to further boost growth. The rise in cell culture contamination is also another factor driving growth.Research activities in the pharmaceutical and biotechnology sectors are increasingly supported by various government authorities. For instance, the U.S. government is providing financial support to the global pharmaceutical companies in order to facilitate research-based activities for new drug development. In April 2019, the U.S. Food and Drug Administration (FDA) announced its plan to amend the regulations pertaining to the only testing method used for the detection of mycoplasma. According to the agency, the regulation is restrictive in nature and thus, prevents the use of other testing methods which may have the potential to accurately detect mycoplasma. Such changes in biologics regulation are expected to improve sensitivity and specificity in mycoplasma detection tests, evolving new technologies. Thus, an increase in government funding for pharmaceutical and biotechnology research has stimulated R&D activities, thereby, fostering the huge application of mycoplasma testing products.

Key Players in the Mycoplasma Testing In Clinical market:

Sartorius AG, Clongen Laboratories, Bio-Rad Laboratories, Inc., MERCK KGAA, Charles River, ELITechGROUP, PromoCell GmbH, Minerva Biolabs, Eurofins Scientific, BioFire Diagnostics, ZEAKON Diagnostics, Lonza, Liofilchem Srl, Roche, Agilent Technologies, Inc.

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Application Insights
Cell line testing held the largest market share in terms of revenue in 2019 owing to the growing number of research activities undertaken in the field of cell culture. It is also expected to witness the highest growth over the forecast period due to the rise in mycoplasma contamination in cell culture. Mycoplasma contamination can lead to alterations in cell culture metabolite formations and develop toxins. This gives cell line testing and authentication prime importance in the pharmaceutical and biopharmaceutical industries.

The end of the production cell testing segment is anticipated to exhibit significant growth over the forecast period owing to the huge amount of cell harvest and a growing number of clinical trials for drug discovery and development. This application segment includes genetic analysis of the transgenes using techniques, such as Southern Blotting, transgene copy number, and mRNA sequencing. Thus, quality control measures taking place in the process of drug discovery are majorly triggering the growth of this segment.

End-use Insights
Pharmaceutical and biotechnology companies held the largest market share in 2019 due to huge investments in R&D activities by these companies, which has led to progressive research related to drug discovery. These companies are engaged in quality checks of raw materials, thus, ensuring biological safety management. Moreover, the biopharmaceutical industry is also growing due to an increase in the incidence of diseases such as rheumatoid arthritis and psoriasis.

Mycoplasma Testing In Clinical Market Types:

PCR, ELSA, Enzymatic Methods, DNA Staining.

Mycoplasma Testing In Clinical Market Applications:

Cell Line Testing, Virus Testing, Others

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Regional Insights
In 2019, North America dominated the market for mycoplasma testing owing to rising healthcare spending and investments by the U.S. government to promote research-based activities in biopharmaceutical industries. The production of biopharmaceuticals in North America is also growing, which requires highly purified cultures to produce therapeutics. As per the National Science Foundation, in 2019, the R&D sector in the U.S. showed a prominent growth, which is expected to positively influence regional growth.

The Asia Pacific is projected to display lucrative growth over the forecast period. This is due to the significant awareness and funding initiatives generated by countries such as India. The Indian government is undertaking various strategic initiatives to facilitate additional R&D activities for the introduction of new drugs. Moreover, regulatory policies enforced by healthcare organizations favoring improvements in biosafety quality are expected to increase growth opportunities in the near future. For instance, China has a number of regulatory bodies, such as the Ministry of Health, overseeing laboratory and experiment approval, and biosafety oversight.

Challenges: High degree of consolidation acts as an entry barrier for new entrants
The top players in this market are large and well-established and enjoy a high degree of brand loyalty. New entrants in this market compete with existing players and set themselves apart by developing innovative product offerings. The high degree of consolidation acts as a major entry barrier for new entrants, which in turn, is expected to restrict investments and thus slow down the growth potential of this market.

"Assays, Kits, & Reagents products segment accounted for the largest share of the mycoplasma testing market, by product & service, in 2019"
The mycoplasma testing market is segmented into assays, kits, & reagents; instruments; and services based on product & service. In 2019, the assays, kits, & reagents segment accounted for this market's largest share. The frequent purchase of these consumables as compared to instruments and the increasing use of kit-based techniques for mycoplasma testing are the important factors driving the growth of this market segment.

"Cell line testing segment accounted for the largest share in the market, by application, in 2019"
Based on application, the mycoplasma testing market is segmented into cell line testing, virus testing, and end-of-production cell testing. In 2019, the cell line testing segment accounted for the largest share of this market. Factors such as the rapid growth in the biopharmaceutical industry and the increasing demand for monoclonal antibodies drive this market segment's growth.

"North America is the largest regional market for mycoplasma testing market"
The global mycoplasma testing market is segmented into North America, Europe, the Asia Pacific, and the Rest of the World. In 2019, North America accounted for the largest share of the global mycoplasma testing market. The large share of this regional segment can primarily be attributed to the growth in biotechnology and pharmaceutical industries, the high adoption rate of novel technologies, and the large number of life science research studies conducted in this region.

Mycoplasma Testing Market Share Insights
Key market players include Bionique Testing Laboratories, Inc.; Lonza Group Ltd.; Merck KGaA; PromoCell GmbH; ATCC (American Type Culture Collection); Biological Industries Israel Beit Haemek Ltd.; Charles River Laboratories International, Inc.; Thermo Fisher Scientific; and InvivoGen.

The major strategies adopted by these companies include mergers and acquisitions, new product development, and geographical expansions. For instance, in 2019, Lonza expanded its mycoplasma detection portfolio by launching the new luminometer Lucetta 2-a product used to accelerate and simplify the detection of mycoplasma in cell cultures. Additionally, in March 2018, Charles River Laboratories International, Inc. announced key expansions to its biologics testing solutions infrastructure to support the development, characterization, and release of biosimilar and biologics.

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