IMARC Group, a leading market research company, has recently releases report titled “Mycoplasma Testing Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2024-2032,” The study provides a detailed analysis of the industry, including the global mycoplasma testing market size, share, trends, and growth forecast. The report also includes competitor and regional analysis and highlights the latest advancements in the market.
Report Highlights:
How big is the mycoplasma testing market?
The global mycoplasma testing market size reached US$ 914.9 Million in 2023. Looking forward, IMARC Group expects the market to reach US$ 2,388.2 Million by 2032, exhibiting a growth rate (CAGR) of 11.25% during 2024-2032.
Factors Affecting the Growth of the Mycoplasma Testing Industry:
- Technological advancements:
The development of advanced molecular and microbiological techniques has revolutionized mycoplasma detection methods, enabling faster, more sensitive, and more accurate testing procedures. Polymerase Chain Reaction (PCR), Deoxyribonucleic acid (DNA) sequencing, and fluorescence microscopy are among the cutting-edge technologies utilized for mycoplasma detection, allowing for rapid identification and quantification of mycoplasma contaminants in cell cultures and biopharmaceutical products. Moreover, the integration of automation and robotics into testing workflows has streamlined processes, improved efficiency, and reduced turnaround times, catering to the demand for biopharmaceutical manufacturing and quality control, creating a positive outlook for market expansion.
- Increasing prevalence of mycoplasma contamination:
The rising incidence of mycoplasma contamination in cell cultures and biopharmaceutical products is a significant driver of the mycoplasma testing market. Mycoplasma species are ubiquitous and can infect cell cultures through various sources, such as contaminated reagents, laboratory personnel, and airborne transmission. Mycoplasma contamination poses serious risks to cell-based research, bioproduction processes, and therapeutic development, compromising product quality, efficacy, and safety. As a result, stringent regulatory guidelines and quality standards mandate routine mycoplasma testing throughout the biopharmaceutical lifecycle, driving demand for reliable and comprehensive testing solutions to ensure product integrity and regulatory compliance is impelling the market growth.
- Regulatory requirements:
Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the International Council for Harmonization (ICH) have established stringent guidelines and standards for mycoplasma testing in biopharmaceutical manufacturing and cell-based therapies. These regulations mandate the implementation of validated testing methods, routine monitoring, and documentation of mycoplasma contamination to mitigate the risks associated with product adulteration and patient safety. Compliance with regulatory requirements is essential for obtaining product approvals, ensuring market access, and maintaining Good Manufacturing Practice (GMP) compliance among biopharmaceutical manufacturers, contract research organizations (CROs), and academic institutions is strengthening the demand for robust and reliable mycoplasma testing solutions.
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What are the growth prospects and trends in the mycoplasma testing industry?
The growing awareness among researchers and biopharmaceutical manufacturers about the potential risks associated with mycoplasma contamination is contributing to the growth of the mycoplasma testing market. In line with this, as the importance of maintaining cell culture integrity and product quality becomes increasingly evident, demand for reliable testing solutions to detect and prevent mycoplasma contamination continues to rise. Moreover, the expansion of biopharmaceutical research and development (R&D) activities, coupled with the increasing globalization of manufacturing processes, is supporting the growth of the mycoplasma testing market. Furthermore, as biopharmaceutical companies expand their operations globally, the need for comprehensive mycoplasma testing to ensure product safety and regulatory compliance is bolstering the market expansion.
What is included in market segmentation?
The report has segmented the market into the following categories:
Breakup by Product:
- Instruments
- Kits and Reagents
- Services
Kits and reagents represent the largest segment due to their convenience, reliability, and ease of use, catering to the diverse needs of laboratories and biopharmaceutical manufacturers for routine mycoplasma testing.
Breakup by Technology:
- NAAT (Nucleic Acid Amplification Technique)
- ELISA (Enzyme-linked Immunoassay)
- DNA Staining
- Others
On the basis of technology, the market is segmented into NAAT (Nucleic Acid Amplification Technique), ELISA (Enzyme-linked Immunoassay), DNA staining, and others.
Breakup by Application:
- Cell Line Testing
- Virus Testing
- End of Production Cells Testing
- Others
Cell line testing accounts for the majority of shares due to its critical role in ensuring the integrity and safety of cell-based research, bioproduction processes, and therapeutic development.
Breakup by End User:
- Academic Research Institutes
- Cell Banks
- Contract Research Organizations
- Pharmaceutical and Biotechnology Companies
- Others
Pharmaceutical and biotechnology companies dominate the market because of their extensive use of cell cultures in drug discovery, development, and manufacturing processes, necessitating rigorous mycoplasma testing to maintain product quality and regulatory compliance.
Market Breakup by Region:
- North America (United States, Canada)
- Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, Others)
- Europe (Germany, France, United Kingdom, Italy, Spain, Russia, Others)
- Latin America (Brazil, Mexico, Others)
- Middle East and Africa
North America enjoys the leading position due to its concentration of biopharmaceutical companies, research institutions, and stringent regulatory requirements to ensure product integrity and compliance with regulatory standards.
Who are the key players operating in the industry?
The report covers the major market players including:
- ATCC
- Bionique Testing Laboratories Inc. (Asahi Kasei Medical Co. Ltd.)
- Bio-Rad Laboratories Inc.
- Charles River Laboratories International Inc.
- Eurofins Scientific SE
- Invivogen
- Lonza Group
- Merck KGaA
- Roche Holding AG
- Sartorius AG
- Thermo Fisher Scientific Inc.
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