Mycoplasma Testing Market size was valued at USD 1.09 billion in 2024 and is expected to cross USD 4.09 billion by the end of 2037, registering more than 12.3% CAGR during the forecast period i.e., between 2025-2037. In the year 2025, the industry size of mycoplasma testing is estimated at USD 1.2 billion. The market is growing owing to rising demand for biosimilars and biologics. The production of biologics and biosimilars requires the use of various raw materials, including cell culture media, growth factors, and additives. These materials are the potential source of mycoplasma contamination. In correspondence, mycoplasma testing becomes crucial to ensure the safer use of these raw materials.
Moreover, the rising globalization of clinical trials brings new opportunities for the mycoplasma testing market growth. The world is fostering research initiatives through international collaboration. This leads to the exchange of cell lines, samples, and reagents among countries and increases the risk of mycoplasma contamination. Thus, the test is used to preserve the integrity of shared material.
Growth Drivers
Challenges
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Base Year |
2024 |
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Forecast Year |
2025-2037 |
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CAGR |
12.3% |
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Base Year Market Size (2024) |
USD 1.09 billion |
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Forecast Year Market Size (2037) |
USD 4.09 billion |
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Regional Scope |
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Application (Cell Line, Virus Testing, End of Production Testing)
The cell line segment is estimated to gain the largest market share of about 55% in the year 2037. The growth of the segment is expected due to the rising demand for monoclonal antibodies. For instance, monoclonal antibodies have been proven efficient in constraining COVID-19. Anti-SARS-CoV-2 monoclonal antibodies, such as REGEN-COV, have gained success to prevent infection in domestic contacts and to reduce the risk of hospitalization or death associated with COVID-19. Testing cell lines used for monoclonal antibod production ensures the prevention of mycoplasma contamination and interference with cell growth and antibody expression.
Technique (PCR, ELISA, Microbial Culture, Enzymatic Methods)
The PCR segment is expected to garner a tremendous share of around 40% in the year 2037. The PCR technique recognizes the various species of mycoplasma by isolating the additional contaminated DNA. The results gained by the PCR (polymerase chain reaction) technique are highly reliant, moreover, the results are quick to achieve and the technique is easy to use.
Our in-depth analysis of the market includes the following segments:
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Application |
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Technique |
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Product & Services |
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End User |
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North American Market Statistics
The North America mycoplasma testing market is poised to be the largest with a share of about 37% by the end of 2037. The presence of various biotech and pharmaceutical companies and increased investment in R&D will push the formation of new drugs and antibodies, recombinant proteins, and cell-based therapies. The need for mycoplasma testing increases correspondingly to ensure the safety and quality of these products. The Department of Health and Human Services in the United States will put USD 40 million to broaden the role of biomanufacturing in the development of active pharmaceutical ingredients (APIs), antibiotics, and essential pharmaceuticals.
APAC Market Analysis
The Asia Pacific mycoplasma testing market is estimated to be the second largest, registering a share of about 26% over the forecast period. The increased knowledge of the effects of infectious substances, as well as regulatory restrictions enforced by healthcare organizations to improve biosafety quality, are driving the demand for mycoplasma testing. WHO's Regional Office for South East Asia (SEARO) arranged two regional trainings to assist biosafety, concentrating on infectious material shipping, and bio-risk assessment.
European Market Forecast
Further, the mycoplasma testing market in Europe is projected to hold a notable share between 2023 and 2037. The market growth in the region is due to strict adherence to good laboratory practices (GLP), and good manufacturing practices (GMP) by all the biotech and pharma companies. Hence, mycoplasma testing is considered an essential component of these practices to ensure product safety.
Author Credits: Abhishek Verma
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