PUBLISHER: Allied Market Research | PRODUCT CODE: 1298398
PUBLISHER: Allied Market Research | PRODUCT CODE: 1298398
The Mycoplasma Testing Market was valued at $0.7 billion in 2022 and is estimated to reach $2,243.10 million by 2032, exhibiting a CAGR of 11.7% from 2023 to 2032.
Mycoplasma testing is used to detect the presence of mycoplasma contamination in cell culture samples. Mycoplasma is a type of bacteria that lacks a cell wall and is difficult to detect and remove from cell cultures. Mycoplasma contamination can cause various problems in cell cultures, such as altered growth characteristics, changes in gene expression, and compromised experimental results. Therefore, it is essential to regularly test cell cultures for mycoplasma contamination to ensure the accuracy and reliability of experimental results. Mycoplasma testing is important in the process of testing vaccines, virus cultures, and other biopharmaceuticals.
The mycoplasma testing market growth is driven by an increase in demand for biologics & biosimilars, a surge in incidences of cell culture contamination, and a rise in the adoption of novel technologies for drug development. Biologics and biosimilars are complex drugs produced using living cells, and they can be contaminated by mycoplasma during the manufacturing process. Thus, regulatory bodies such as Food and Drug Administration (FDA) and European Medicines Agency (EMA) require biologics and biosimilars to be tested for mycoplasma contamination before they are approved for use. This has created a surge in demand for mycoplasma testing services. For instance, according to the IQVIA report on the Impact of Biosimilar Competition in Europe in 2021, about 9 biosimilars were approved in 2020 and 7 approved in 2021. Thus, the rise in the approval and demand for biologics & biosimilars has resulted in increased demand for mycoplasma testing.
Furthermore, the rise in incidences of cell culture contamination in the biopharmaceutical industry and the globalization of clinical trials are the key factors that boost market growth. As clinical trials are conducted across multiple countries and regions, there is a need for mycoplasma testing services that can ensure the safety of trial participants and the accuracy of trial data. This has led to an increasing demand for mycoplasma testing services and products that meet standardized testing requirements.
However, the high cost of mycoplasma testing products limits their adoption in biopharmaceutical companies, which, in turn, restrains the market growth. For instance, the cost of SouthernBiotech's Mycoplasma Detection Kit used for the detection of mycoplasma contamination in cell cultures is around $200-230. In addition, the price of culture-based mycoplasma testing service is about $250-300 per sample. Thus, the high cost of mycoplasma testing products and services negatively impacts market growth.
On the other hand, the increase in demand for mycoplasma testing in developed and developing countries such as U.S., Germany, and China is expected to create immense opportunities for the mycoplasma testing market during the forecast period.
The mycoplasma testing market is segmented on the basis of product, technology, application, end-user, and region. On the basis of product, the market is categorized into instruments, kits & reagents, and services. On the basis of technology, the market is divided into PCR, ELISA, microbial culture techniques, and enzymatic methods. On the basis of application, the market is classified into cell line testing, virus testing, end-of-production cell testing, and others. On the basis of end users, the market is segregated into academic research institutes, cell banks, contract research organizations, pharmaceutical & biotechnology companies, and others.
Region-wise, the market is analyzed across North America (U.S., Canada, and Mexico), Europe (Germany, France, UK, Italy, Spain, and the rest of Europe), Asia-Pacific (China, Japan, India, Australia, South Korea, and rest of Asia-Pacific), and LAMEA (Brazil, Saudi Arabia, South Africa, and rest of LAMEA).
Major key players that operate in the global mycoplasma testing market are: ATCC, Bionique Testing Laboratories LLC, Bio-Rad Laboratories, Inc., Charles River Laboratories, Eurofins Scientific, F. Hoffmann-La Roche Ltd., InvivoGen, Lonza, Norgen Biotek Corp., and Thermo Fisher Scientific Inc. Key players operating in the market have adopted product approval, acquisition, and product launch as their key strategies to expand their product portfolio.