The global mycoplasma testing market size was valued at USD 627.16 million in 2019 and is expected to witness attractive growth over the forecast period. Increasing investments in R&D activities have contributed toward huge revenue for the market. Rising introduction of novel technologies by key players is expected to further boost the growth. Rise in cell culture contamination is also another factor driving the growth.
Due to the limitation of culture methods, researchers are involved in the identification and development of more rapid and accurate mycoplasma tests in recent years. The primary advantages of such rapid tests would be high sensitivity, capability of identifying a wide range of mycoplasma species, and cycle time reduction, thus, reducing the production time. These rapid methods would also facilitate faster decision making to minimize the spread of contamination. One such example of alternative method for culture-based testing is Nucleic Acid-based Technology (NAT) that allows rapid detection of mycoplasma in cell culture. In 2018, American Type Culture Collection announced the launch of its new Polymerase Chain Reaction (PCR) based service that helps detect contaminants in mycoplasma cell cultures.
Increasing research activities conducted by pharmaceutical and biotechnology companies are resulting in the adoption of new technologies for drug discovery and development. In 2018, Boehringer Ingelheim announced its plans to invest around USD 259 million for its new Biologicals Development Center (BDC), to be located at its R&D site in Germany. Merck is also planning to invest USD 16 billion in R&D over the next five years, in addition to its annual investment of USD 7 billion. Thus, a huge amount of spending in R&D activities is expected to drive developments in this field, thereby boosting the demand for mycoplasma testing products.
Research activities in 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 order to facilitate research-based activities for new drug development. In April 2019, the U.S. Food and Drug Administration (FDA) announced their 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 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, increase in government funding for pharmaceutical and biotechnology research has stimulated R&D activities, thereby, fostering huge application of mycoplasma testing products.
More than 190 mycoplasma species are known, out of which only eight are responsible for more than 95% of cell culture contaminations. Poor cultural practices, dust, aerosols, and cross-contamination due to faulty or broken laminar flow are some of the factors due to which there is an increase in the number of cell culture contamination events. Additionally, mycoplasma contamination adversely affects the research work of scientists in laboratories. Human mycoplasma is a key source of cell culture contamination that occurs due to the laboratory technicians who are infected with M. orale or M. fermentans. Hence, testing of such bacteria is considered as a significant requirement to generate a robust data in the field of biomedical research.
On the basis of products, the mycoplasma testing market is segmented into instruments, kits and reagents, and services. Kits and reagents accounted for the largest market share in 2019 owing to repeated purchase of consumables for detection of mycoplasma in cell culture research work and other applications. Kit and reagents is further segmented into PCR assays, nucleic acid detection kits, stains, elimination kits, and standards and controls.
PCR assays aid in accurate mycoplasma identification and provide results within few hours. Detection of mycoplasma can be done easily by verifying bands of DNA fragments using electrophoresis, which is mostly used by PCR assays that do not need preparation of labeled probes. For instance, Takara Bio Inc. developed a PCR mycoplasma detection set that does not allow further amplification of DNA originating from other sources, such as cultured cells that majorly affect detection results.
Instruments are expected to showcase significant growth over the forecast period, due to the growing availability of automated instruments for the detection of mycoplasma. PCR systems offer a better approach that enables rapid detection and provides results in a short amount of time. For instance, Bio-Rad developed PCR-based CFX96 Touch Real-Time PCR Detection System. It is a flexible and precise PCR detection, with six channels that combine advanced and effective optical technology, with precise control in temperature. This helps deliver a reliable and sensitive detection method for both multiplex and singleplex reactions.
On the basis of technology, the PCR segment held the largest market share in 2019. This technology enables the detection of multiple species of mycoplasma while separating other contaminating DNA. It provides test results with high specificity and efficiency. Ease of procedure and rapid detection are some of the major advantages offered by this technique. For instance, LookOut Mycoplasma PCR Detection Kit developed by Merck KGaA, facilitates detection of Ureaplasma, Mycoplasma, and Acholeplasma contamination in cell-derived biologicals and cell culture lines.
Direct assays are expected to showcase lucrative growth over the forecast period. High level of certainty provided by these tests has been one of the key reasons for its significant market growth. However, some disadvantages associated with direct assays include low sensitivity and requirement of prolonged incubation period prior to detection. Microbial culture techniques are also highly demanded due increasing applications in mycoplasma contamination testing and rising number of research activities conducted in the field of biopharmaceutical industry.
Cell line testing held the largest market share in terms of revenue in 2019 owing to 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.
End of production cells testing segment is anticipated to exhibit significant growth over the forecast period owing to huge amount of cell harvest and 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 is majorly triggering growth of this segment.
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 check of raw materials, thus, ensuring biological safety management. Moreover, the biopharmaceutical industry is also growing due to increase in incidence of diseases such as rheumatoid arthritis and psoriasis.
Contract Research Organizations (CROs) is expected to showcase lucrative growth over the forecast period owing to rising research services made available by these organizations. They require the use of mycoplasma tests needed to maintain the sterility of cultures in preclinical research and biopharmaceutical development, thus, ensuring the quality of the outsourced testing services.
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 U.S. showed a prominent growth, which is expected to positively influence the regional growth.
Asia Pacific is projected to display lucrative growth over the forecast period. This is due to the significant awareness and funding initiatives generated by the 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 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.
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 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 development, characterization, and release of biosimilar and biologics.
Base year for estimation
Actual estimates/Historical data
2016 - 2018
2020 - 2027
Revenue in USD Million & CAGR from 2020 to 2027
North America, Europe, Asia Pacific, Latin America, Middle East & Africa
U.S., Canada, U.K., Germany, Spain, France, Italy, Russia, Japan, India, China, South Korea, Singapore, Australia, Brazil, Mexico, Argentina, South Africa, Saudi Arabia, UAE
Revenue forecast, company share, competitive landscape, growth factors and trends
15% free customization scope (equivalent to 5 analysts working days)
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This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2016 to 2027. For the purpose of this study, Grand View Research has segmented the global mycoplasma testing market report on the basis of product, technology, application, end use, and region:
Mycoplasma Testing Product Outlook (Revenue, USD Million, 2016 - 2027)
Kits & Reagents
Nucleic Acid Detection Kits
Standards & Controls
Mycoplasma Testing Technology Outlook (Revenue, USD Million, 2016 - 2027)
Microbial Culture Techniques
Mycoplasma Testing Application Outlook (Revenue, USD Million, 2016 - 2027)
Cell Line Testing
End of Production Cells Testing
Mycoplasma Testing End-use Outlook (Revenue, USD Million, 2016 - 2027)
Academic Research Institutes
Contract Research Organizations
Pharmaceutical & Biotechnology Companies
Mycoplasma Testing Regional Outlook (Revenue, USD Million, 2016 - 2027)
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