The global mycoplasma testing market size was valued at USD 761.51 million in 2021 and it is predicted to surpass around USD 2.32 billion by 2030 with a CAGR of 13.18% from 2022 to 2030.
The global mycoplasma testing market size was valued at USD 761.51 million in 2021 and it is predicted to surpass around USD 2.32 billion by 2030 with a CAGR of 13.18% from 2022 to 2030.
Report Highlights
- The kits and reagents segment captured the highest revenue share of 50.75% in 2021.
- The PCR segment dominated the mycoplasma testing market with a revenue share of 32.3% in 2021 and exhibits the fastest growth rate during the projected period.
- The cell line testing segment accounted for the largest share of 41.34% in 2021, as well as the fastest growth rate throughout the forecast period.
- The pharmaceutical and biotechnology companies segment received highest revenue shares of 35.24% in 2021, as well as the fastest CAGR throughout the forecast period.
- North America dominated the market and accounted for revenue share of 39.08% in 2021.
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The major factors driving the expansion of market includes growing demand for mycoplasma testing in biomanufacturing, emerging economies, and growing pharmaceutical outsourcing. Additionally, the market’s overall growth is driven by rising cell-line contamination and innovation & research in biological sciences.
Growing number of government initiatives to support pharmaceutical and biotechnology companies is also driving the market growth. The U.S. FDA proposed to remove a test for detecting mycoplasma within in vitro living cell cultures, as it can help identify only a single test method. These changes in biologics regulations are anticipated to improve specificity and sensitivity in mycoplasma detection tests, leading to introduction of new technologies in the industry. This is expected to create immense opportunities for key players in new product development.
The rates of M. pneumoniae positivity sharply decreased during the COVID-19 pandemic outbreak at the end of 2019. This was a result of the COVID-19 pandemic’s stringent regulations, which successfully stopped the spread of M. pneumonia. However, it is anticipated that M. pneumonia will expand even more throughout the research period following the relaxation of COVID-19 limits, which will have a positive impact on the mycoplasma testing market’s growth.
Increasing investments in R&D have contributed significantly to the market’s revenue growth. With rising healthcare expenditure, research activities in the life sciences industry are increasing significantly. The adoption of new technologies for drug discovery & development and innovations in cell culture technologies are driving the demand for mycoplasma tests. The high risk of cell culture contamination remains the primary factor expected to drive the mycoplasma testing market over the forecast period
Mycoplasma is estimated to contaminate around 15%-35% of all continuous cell cultures around the world. Out of over 190 known species of mycoplasma, only eight species are responsible for more than 95% of cell culture contamination. Poor cultural practices, aerosols, dust, and cross-contamination as a result of faulty or broken laminar flow are some of the factors responsible for an increase in the number of cell culture contamination events. Such factors are likely to drive the market demand for mycoplasma testing solutions.
Scope of The Report
| Report Coverage | Details |
| Market Size in 2021 | USD 761.51 million |
| Revenue Forecast by 2030 | USD 2.32 billion |
| Growth rate from 2022 to 2030 | CAGR of 13.18% |
| Base Year | 2021 |
| Forecast Period | 2022 to 2030 |
| Segmentation | Product, Technology, Application, End-use, Region |
| Companies Covered | Thermo Fisher Scientific, Inc.; Merck KGaA; Lonza Group AG; Charles River Laboratories International, Inc.; PromoCell GmbH; American Type Culture Collection; Asahi Kasei Medical Co. Ltd.; Sartorius AG; InvivoGen; Eurofins Scientific. |
Trends and Opportunities
Increasing efforts in research and development activities have resulted in securing higher revenue in the global mycoplasma testing market. Some of the key players in the market are also investing huge sum of money in this market to come with advanced and better solutions to provide their customers. Moreover, rising expenditure in the healthcare sector and increasing life science research are expected to create lucrative growth opportunities in this market. Adoption of new technologies for drug development and discovery will also benefit the market’s growth in the coming years.
Key Market Trends
Polymerase Chain Reaction (PCR) is Expected to Hold a Significant Market Share Over the Forecast Period
North America currently dominates the mycoplasma testing market, and it is expected to continue its stronghold for a few more years. This region is expected to increase its market share in the future due to its well-established healthcare industry and the rising prevalence of respiratory diseases in the area. Other factors driving the growth of this region are the presence of global biotech companies and pharmaceutical players and higher investment in R&D activities in the region. The United States holds the majority of the market share in North America. This is due to the rising healthcare expenditure, along with the rapid adoption of point-of-care testing.
The launch of products in the country will also increase the mycoplasma testing procedures contributing to the market growth. For instance, in July 2020, bioMérieux launched BIOFIRE MYCOPLASMA, an innovative test for mycoplasma detection in the United States for pharmaceutical products used for biotherapeutics (antibodies, hormones, cell and gene therapies, etc.), the most vibrant sector in the pharmaceutical industry. Furthermore, in April 2020, Infinity Laboratories expanded its capabilities by launching Mycoplasma testing. Such adoption of critical strategies like expansion, partnerships, acquisitions, and others will expand the capabilities of the key market players, thereby driving the market growth.
Moreover, rising research and development studies proving the efficacies of diagnostic techniques in the United States are expected to drive market growth during the study period. For instance, in January 2021, Fujifilm and the Center for Advanced Biological Innovation and Manufacturing are investing about USD 76 million in Massachusetts for advanced research and development in cell and gene therapy, gene editing, immunotherapy, and biotechnology. Thus, owing to the above-mentioned factors, the studied market is expected to grow significantly in the region during the study period.
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Product Insights
The kits and reagents segment captured the highest revenue share of 50.75% in 2021, due to the high demand for these products in mycoplasma detection, as well as their high cost. Various market players have developed mycoplasma detection kits catering specifically to the needs of researchers and biologic manufacturers, which is fueling segment growth. Due to the growing availability of automated equipment for the detection of mycoplasma, instruments are predicted to experience substantial growth during the projected period.
A better method that enables quick detection and produces results quickly is provided by PCR systems. For instance, the CFX96 Touch Real-Time PCR Detection System from Bio-Rad Laboratories is based on PCR. It is a versatile and accurate PCR detection system with six channels that combines cutting-edge optical technique with exact temperature control. As a result, both multiplex as well as singleplex reactions can be detected using a method that is trustworthy and sensitive. Thus, propelling the mycoplasma testing market growth.
Technology Insights
The PCR segment dominated the mycoplasma testing market with a revenue share of 32.3% in 2021 and exhibits the fastest growth rate during the projected period. This approach allows the separation of other contaminating DNA while allowing the detection of various mycoplasma species. It offers test findings that are highly efficient and specific. Some of the key benefits provided by this technology includes ease of use and quick detection. For instance, the Merck KGaA-developed LookOut Mycoplasma PCR Detection Kit that makes it easier to detect contamination with Ureaplasma, Mycoplasma, and Acholeplasma in cell-derived biologicals and cell culture lines.
ELISA technology is expected to gain considerable market share during the forecast period as it facilitates easy detection with the use of labeled probes or antibodies for mycoplasma detection. In some instances, PCR and ELISA tests are combined to form PCR-ELISA, a photometric enzyme-based immunoassay that facilitates the detection of PCR-amplified mycoplasma DNA in samples. Functional advantages, cost-effectiveness, and ability to detect a wide range of strains are few factors propelling segment growth during the forecast period.
Application Insights
The cell line testing segment accounted for the largest share of 41.34% in 2021, as well as the fastest growth rate throughout the forecast period, owing to the increase in research projects being done in the field of cell culture. For instance, the federal funding agency in Canada for health research, Canadian Institutes of Health Research (CIHR), has supported many health researchers in Canada with around USD 981 million in investments. The National Research Council’s Industrial Research and Assistance Program (NRC-IRAP) is also offering technical support to several Canadian life science companies including small and medium-scale involved in product development and innovation.
A surge in mycoplasma contamination in cell culture is also anticipated to cause it to see the largest growth during the projection period. Toxin development and changes in metabolite production in cell culture can be caused by mycoplasma contamination. As a result, cell line testing and authentication are given the utmost significance in the biopharmaceutical and pharmaceutical industries.
End-use Insights
The pharmaceutical and biotechnology companies segment received highest revenue shares of 35.24% in 2021, as well as the fastest CAGR throughout the forecast period. Because these firms have made significant investments in R&D efforts, which have fostered advancements in the field of drug development research. These businesses carry out quality tests on raw materials to manage biological safety. Furthermore, the prevalence of disorders like rheumatoid arthritis and psoriasis is rising, which is contributing to the growth of the biopharmaceutical industry.
Due to the expanding research services offered by these firms, contract research organizations (CROs) are predicted to grow profitably over the projected period. In order to ensure the sterility of cultures used in preclinical research and biopharmaceutical development, they mandate the use of mycoplasma tests, ensuring the caliber of the outsourced testing services.
Regional Insights
North America dominated the market and accounted for revenue share of 39.08% in 2021. Due to its established healthcare sector and the increased incidence of respiratory disorders, this area is predicted to enhance its market share. The existence of multinational pharmaceutical and biotech companies as well as increased investment in R&D activities in the region are additional factors promoting the expansion of this region.
Asia Pacific is estimated to witness an exponential CAGR during the projected timeframe, which can be attributed to increase in healthcare spending and rise in the demand for better infrastructure in laboratory & clinical research. Furthermore, regulatory policies imposed by healthcare organizations favoring improvements in biosafety quality are likely to surge growth opportunities in the future.
In addition, emerging markets such as India are also witnessing lucrative opportunities in this sector. the Indian government is implementing a variety of strategic efforts to encourage more Research and innovation for the development of new medication, propels the market growth.
Key Players
- Thermo Fisher Scientific, Inc.
- Merck KGaA
- Lonza Group AG
- Charles River Laboratories International, Inc.
- PromoCell GmbH
- American Type Culture Collection
- Asahi Kasei Medical Co., Ltd.
- Sartorius AG
- InvivoGen
- Eurofins Scientific
Market Segmentation
- By Product Outlook
- Instruments
- Kits & Reagents
- PCR Assays
- Nucleic Acid Detection Kits
- Stains
- Elimination Kits
- Standards & Controls
- Others
- Services
- By Technology Outlook
- PCR
- ELISA
- Direct Assay
- Indirect Assay
- Microbial Culture Techniques
- Enzymatic Methods
- By Application Outlook
- Cell Line Testing
- Virus Testing
- End of Production Cells Testing
- Others
- By End-use Outlook
- Academic Research Institutes
- Cell Banks
- Contract Research Organizations
- Pharmaceutical & Biotechnology Companies
- Others
- By Regional Outlook
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
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