USD 832.4 million
Report ID:
SQMIG35I2219 |
Region:
Global |
Published Date: May, 2025
Pages:
219
|Tables:
66
|Figures:
75
Global Mycoplasma Testing Market size was valued at USD 832.4 million in 2023 and is poised to grow from USD 897.33 million in 2024 to USD 1636.44 million by 2032, growing at a CAGR of 7.8% during the forecast period (2025-2032).
Growth and innovations in the diagnostic sector have created an opportunity for mycoplasma testing market size because of the rising contaminations of mycoplasma within the pharmaceutical and biotechnology industry producing mycoplasma testing products. Main mycoplasma testing market growth drivers include rising research initiatives in the biotechnology and the biopharmaceutical industries, and the higher demand of the mycoplasma testing kits by the biopharmaceutical industry.
The mycoplasma testing market share will increase due to emerging markets because of the better infrastructure for healthcare, an increased unmet healthcare demands, and the rising incidence of mycoplasma contamination. As a matter of fact, rules and regulations mandating testing for biologics and vaccines for mycoplasma contamination have been published by regulatory bodies, including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Due to this, a heightened demand for mycoplasma testing has been witnessed in the biopharmaceutical sector. Also, technical innovations are inclined to lead to the mycoplasma testing market share, including faster and more accurate procedures and equipment for mycoplasma testing. The latest instance is Minerva Biolabs GmbH's VenorGeM Advance assay, highly sensitive and specific, which targets mycoplasma contamination in biological matrices of cell cultures.
US Mycoplasma Testing Market is poised to grow at a sustainable CAGR for the next forecast year.
Market snapshot - 2025-2032
Global Market Size
USD 832.4 million
Largest Segment
Cell Line Testing
Fastest Growth
End of Production Cells Testing
Growth Rate
7.8% CAGR
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Global Mycoplasma Testing Market is segmented by Product, Technology, Application, End-User and region. Based on Product, the market is segmented into Instruments, Kits & Reagents and Services. Based on Technology, the market is segmented into PCR, ELISA, Direct Assay, Indirect Assay, Microbial Culture Techniques and Enzymatic Methods. Based on Application, the market is segmented into Cell Line Testing, Virus Testing, End of Production Cells Testing and Others. Based on End-User, the market is segmented into Academic Research Institutes, Cell Banks, Contract Research Organizations, Pharmaceutical & Biotechnology Companies and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.
Mycoplasma testing industry growth and R&D spending were stimulated by growth in demand in the research initiatives of cell culture. In 2023, the cell line testing segment experienced the highest growth rate and highest mycoplasma testing market share at 41.65%. Testing is a necessity for identifying Mycoplasma, which, if done, would boost mycoplasma testing industry growth and more R&D spending. Almost USD 981 million was spent by the Canadian Institutes of Health Research (CIHR) for funding various health research projects across the country. Furthermore, NRC-IRAP offers technical support to the cell companies in Canada that are small and medium-sized. This kind of support stimulates innovation and development of new products in the cell industry.
The end-of-production cells testing segment ranked the second mycoplasma testing market share position in 2023. Critical stability and contamination assessments are a few of the tests crucial for proving the product's safety. This procedure ensures that products comply with safety requirements through evaluation of the genetic stability of recombinant cells post-manufacturing, and it addresses possible contamination problems in the production system. The importance of end-of-product cell testing is predicted to drive further mycoplasma testing market growth as the demand for quality assurance grows, emphasizing the need to determine product stability and ensure the absence of contamination in biopharmaceutical manufacturing.
The pharmaceutical and biotechnology companies segment led the highest CAGR in the period forecast with a 35.56% mycoplasma testing market share in 2023. It is being driven by considerable advancements in drug development that are being propelled by such corporations making notable investments in R&D. They assure biological safety of their products by subjecting raw materials to stringent quality testing, meeting legal requirements, and thereby improve product reliability. At the same time, as companies seek solutions to these pressing issues affecting healthcare, the incidence of chronic diseases such as psoriasis and rheumatoid arthritis will rise further, pushing demand for new treatments and into the biopharmaceutical sector through 2023.
However, the contract research organizations (CROs) segment is expected to grow profitably in the mycoplasma testing industry. This is mainly because of the increasingly broad scope of research services offered to pharmaceutical and biotechnology companies. Such CROs provided critical services that are needed to be able to ensure the launch of a new therapy. They have to provide commercialization support for biologic assays and also biopharmaceutical development. Of these organizations, specialist tests, including mycoplasma testing, are undertaken to ensure the integrity and sterility of the cultures used in preclinical research and biopharmaceutical development. With an increasing number of CROs, the quality and accessibility of outsourced testing services enhance, driving the market growth and increasing the overall efficiency of the drug development process.
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According to the global mycoplasma testing market forecast, North America led the market in 2023 with a revenue share of 39.04%. A combination of several factors leads to a high mycoplasma testing market share. Prevalence of respiratory disorders is also at a high level and the rising investment in biotechnology by major companies since its wide application in cancer research and developing novel biologics, vaccines, and drugs. Besides, through the development and integration of strict regulatory requirements, companies such as the FDA and the U.S. Department of Health and Human Services, in collaboration with the Centers for Disease Control and Prevention and the National Institutes of Health, continually advance standards on the testing of biological and microbiological safety of biomedical laboratories.
Asia-Pacific is predicted to grow at the highest CAGR during the forecast period. It is expected that the future development prospects would be spurred by the implementation of biosafety quality improvement-friendly regulatory mandates adopted by the health care organizations. It is with better infrastructures in place and better maintenance at higher levels of product safety that it would be anticipated to have a positive effect on the adoption of mycoplasma testing under the National Biotechnology Development Strategy-through government-led initiatives toward becoming a prime industrial power. Moreover, these developments were expected to ensure the continued industrial growth in the pharmaceutical and biologics industries and to bring long-term health benefits to humans. Further scope for development is perceived with the fact that there exist biological safety specific guidelines for the given research areas which include cell culture and recombinant DNA research.
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Expanding Research & Development Activities
Rising Awareness of Contamination Risks
Lack of Availability of Trained Personnel
Market Fragmentation
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Established and emerging companies compete with each other in the mycoplasma testing industry, introducing competition. Companies often depend on strategic alliances and innovative testing methods to firmly position themselves within the market. Regional companies are also becoming more aggressive as they expand their ranges to suit local customers.
SkyQuest's ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
As per SkyQuest analysis, the mycoplasma testing market report forecasts that due to increased regulatory vigilance and quality assurance concerns in the biopharmaceutical market, the mycoplasma testing market is predicted to be highly growth oriented. With enhanced R&D activity, there will be increased demand for complex techniques for testing and ensuring efficacy and safety of medicinal goods. However, high-cost testing and lack of skilled people could be the major undermining factors toward the growth of the industry. In this respect, stakeholders would predict to concentrate on automation and strategic alliances also to successfully overcome the challenges. Thus, strategic models of this type in a dynamic environment can improve operational efficacy, promote innovation, and eventually help create safer and more efficient biopharmaceuticals.
Report Metric | Details |
---|---|
Market size value in 2023 | USD 832.4 million |
Market size value in 2032 | USD 1636.44 million |
Growth Rate | 7.8% |
Base year | 2024 |
Forecast period | 2025-2032 |
Forecast Unit (Value) | USD Million |
Segments covered |
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Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
Companies covered |
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Customization scope | Free report customization with purchase. Customization includes:-
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Table Of Content
Executive Summary
Market overview
Parent Market Analysis
Market overview
Market size
KEY MARKET INSIGHTS
COVID IMPACT
MARKET DYNAMICS & OUTLOOK
Market Size by Region
KEY COMPANY PROFILES
Methodology
For the Mycoplasma Testing Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Mycoplasma Testing Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Mycoplasma Testing Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Mycoplasma Testing Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
Mycoplasma Testing Market size was valued at USD 790.2 Million in 2023 and is poised to grow from USD 867.72 Million in 2024 to USD 1834.48 Million by 2032, growing at a CAGR of 9.81% during the forecast period (2025-2032).
Established and emerging companies compete with each other in the mycoplasma testing industry, introducing competition. Companies often depend on strategic alliances and innovative testing methods to firmly position themselves within the market. Regional companies are also becoming more aggressive as they expand their ranges to suit local customers. 'Merck KGaA', 'Roche Diagnostics (A Division of F. Hoffmann-La Roche Ltd.) ', 'Charles River Laboratories International, Inc. ', 'Lonza Group Ltd. ', 'Thermo Fisher Scientific, Inc. ', 'Eurofins Scientific Group ', 'Sartorius Stedim Biotech S.A. ', 'Agilent Technologies, Inc. ', 'Meridian Bioscience, Inc. ', 'American Type Culture Collection ', 'Bionique Testing Laboratories, Inc. ', 'InvivoGen ', 'PromoCell GmbH ', 'Biological Industries Israel Beit Haemek Ltd. ', 'Clongen Laboratories, LLC ', 'Creative Bioarray ', 'Nelson Laboratories Fairfield, Inc. (A Part of Sotera Health) ', 'Norgen Biotek Corporation ', 'Biotools B & M Labs, S.A. ', 'GenBio (A Part of ExonHit Therapeutics SA) ', 'GeneCopoeia, Inc. ', 'Minerva Biolabs GmbH ', 'Mycoplasma Experience ', 'Savyon Diagnostics', 'ScienceCell Research Laboratories'
Demand for mycoplasma testing is increasing, driven by an upsurge in the research and development of biological products in biotechnology and pharmaceuticals, including cell-based medicines and vaccines. As more and more researchers increasingly rely on cell lines for manufacturing, the requirement for a mycoplasma infection-free cell line stream has become necessary. As businesses grow through giving increased priority to quality assurance during their research operations, mycoplasma testing market demand is rising along with the need for rigorous testing methodologies.
Integration of Automation in Testing: Automation in the operations of laboratories and testing operations such as mycoplasma testing is now quite a routine affair. Automated systems ensure reduction of testing time to a level that is significantly lower, productivity increases sharply, and human errors are considerably minimized. The expanding interest of biopharmaceutical companies in enhancing process efficiency with uniform quality will keep on boosting their demand for mycoplasma testing technology companies.
According to the global mycoplasma testing market forecast, North America led the market in 2023 with a revenue share of 39.04%. A combination of several factors leads to a high mycoplasma testing market share. Prevalence of respiratory disorders is also at a high level and the rising investment in biotechnology by major companies since its wide application in cancer research and developing novel biologics, vaccines, and drugs. Besides, through the development and integration of strict regulatory requirements, companies such as the FDA and the U.S. Department of Health and Human Services, in collaboration with the Centers for Disease Control and Prevention and the National Institutes of Health, continually advance standards on the testing of biological and microbiological safety of biomedical laboratories.
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