Mycoplasma Testing Market

Market Overview:

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. The rising prevalence of mycoplasma infections, considerable growth in the biotechnology industry, stringent guidelines for mycoplasma testing implemented by regulatory bodies and inflating disposable income levels in developing nations are some of the major factors propelling the market.

Mycoplasma testing refers to the process of detecting the presence of mycoplasma bacteria in biological samples. The testing consists of multiple techniques, such as polymerase chain reaction (PCR), DNA staining, enzymatic assays, and growth-based culture methods on agar media. The testing assists in amplifying specific DNA sequences, utilizes fluorescent dyes for visualization, and facilitates the growth of mycoplasma colonies. Mycoplasma testing serves the functions of quality control, contamination detection, and validation in biotechnology applications. It is essential for ensuring the integrity and reliability of cell cultures and related products.

The increasing emphasis on product safety and quality is resulting in numerous end-use industries prioritizing mycoplasma testing as part of their quality control processes. In addition to this, continual technological advancements, such as polymerase chain reaction (PCR), nucleic acid amplification techniques (NAT), and DNA hybridization procedures, are providing an impetus to the market. Moreover, the growing trend of outsourcing manufacturing processes by large organizations to contract research organizations and contract manufacturing organizations is creating a positive market outlook. Furthermore, extensive research and development (R&D) activities focusing on cell culture integrity is creating lucrative opportunities in the market.

Mycoplasma Testing Market Trends/Drivers:

Rise in the cases of mycoplasma infections 

The increasing incidence of mycoplasma infections is a significant driver for the growth of the global mycoplasma testing market. The increasing prevalence of a wide range of infections, including respiratory infections, urogenital infections, and systemic infections among individuals caused by mycoplasma infection, is fueling the demand for mycoplasma testing among the masses. In line with this, mycoplasma contamination in drug formulations and manufacturing processes leading to compromised product efficacy is also resulting in a higher uptake of mycoplasma testing procedures.

Implementation of stringent regulatory standards

Stringent guidelines and standards for mycoplasma testing implemented by regulatory bodies to ensure compliance for product approval and maintaining quality control are driving the market. This is leading to an enhanced adoption of mycoplasma testing methods and technologies in industries requiring rigorous quality assurance. Continual advancements in mycoplasma testing techniques, including the adoption of PCR-based assays with improved sensitivity and specificity, have resulted in accurate and efficient detection of mycoplasma contamination, which are driving the market for mycoplasma testing.

The rapid expansion of biopharmaceutical and biotechnology industries

The expansion of the biopharmaceutical and biotechnology industries, involving the large-scale use of cell cultures for large-scale manufacturing, is a factor driving the market. Regular mycoplasma testing helps maintain the health and quality of cell cultures, ensuring consistent and reliable manufacturing outcomes, thereby resulting in an augmented demand for mycoplasma testing solutions. Moreover, several ccompanies are increasingly investing in advanced mycoplasma testing technologies as well as partnering with specialized testing laboratories to meet the augmenting demand for comprehensive and reliable mycoplasma testing services, which is providing an impetus to the market.

Mycoplasma Testing Industry Segmentation: 

IMARC Group provides an analysis of the key trends in each segment of the global mycoplasma testing market report, along with forecasts at the global, regional, and country levels for 2024-2032. Our report has categorized the market based on product, technology, application, and end user. 

Breakup by Product: 

• Instruments
• Kits and Reagents
• Services
   

Kits and reagents dominate the mycoplasma testing market

The report has provided a detailed breakup and analysis of the mycoplasma testing market based on the product. This includes instruments, kits and reagents, and services. According to the report, kits and reagents represented the largest segment.

There has been an increased demand for ready-to-use kits and reagents with pre-optimized protocols and ready-to-use components as they assist in simplifying the testing process, thereby making them an attractive option for laboratories requiring efficient testing methods.

Numerous innovations in instruments, such as the development of automated systems and high-throughput screening platforms, are also resulting in higher efficiency and accuracy of mycoplasma testing. Additionally, research laboratories and biotechnology companies are preferring mycoplasma testing in-house, thereby driving the demand for instruments capable of performing molecular tests efficiently and with high throughput.

On the other hand, the services segment is driven by the rising trend of outsourcing of mycoplasma testing by large companies to specialized service providers to benefit from their expertise and infrastructure. Service providers offering specialized mycoplasma testing services ensure compliance with stringent government standards, thereby fueling the segment growth.

Breakup by Technology: 

• NAAT (Nucleic Acid Amplification Technique)
• ELISA (Enzyme-linked Immunoassay)
• DNA Staining
• Others
   

The report has provided a detailed breakup and analysis of the mycoplasma testing market based on the technology. This includes NAAT (Nucleic Acid Amplification Technique), ELISA (Enzyme-linked Immunoassay), DNA staining, and others.

NAAT methods, such as polymerase chain reaction (PCR), offer high sensitivity and specificity in detecting mycoplasma DNA, which is a crucial factor driving the adoption of NAAT in mycoplasma testing. NAAT techniques provide relatively quick results compared to traditional culture-based methods, which is also propelling the segment growth.

ELISA is a well-established and widely adopted immunoassay technique that is also very easy to use, which is resulting in a higher product uptake. Also, the broad availability, high throughput and cost-effectiveness of ELISA kits for mycoplasma testing is fueling the demand for ELISA in mycoplasma testing. ELISA can also detect specific Mycoplasma antigens present in the sample, and can be used with various sample types, including cell culture supernatants, cell lysates, and biologics, hence driving the segment’s popularity.

On the other hand, DNA staining methods, such as fluorescent dyes, offer a simple and cost-effective approach to mycoplasma testing. It can also be used as a complementary method alongside other mycoplasma testing methods, such as NAAT or ELISA, which is creating a positive outlook for the segment.

Breakup by Application:

• Cell Line Testing
• Virus Testing
• End of Production Cells Testing
• Others
   

Cell line testing dominates the mycoplasma testing market 

The report has provided a detailed breakup and analysis of the mycoplasma testing market based on the application. This includes cell line testing, virus testing, end of production cells testing, and others. According to the report, cell line testing represented the largest segment. 

Cell line testing is essential for verifying that the cell lines are free from contaminants, including mycoplasma, and ensuring the integrity of cell lines used in biotechnology, thereby driving the segment growth. Additionally, cell line testing helps prevent cross-contamination between different cell lines, thereby is widely adopted in as part of the approval process for biological products by regulatory authorities.

On the contrary, the rapid utilization of virus testing in detecting and preventing viral contamination in vaccines, therapeutic proteins, and gene therapy vectors essential for patient safety is propelling the segment growth. Also, regulatory authorities mandating virus testing for certain biological products is creating a positive outlook for the market segment.

The rising adoption of end of production cells testing for quality and purity verification of the cells before they are used in downstream processes is creating lucrative opportunities for the market segment.

Breakup by End User:

• Academic Research Institutes
• Cell Banks
• Contract Research Organizations
• Pharmaceutical and Biotechnology Companies
• Others
   

Pharmaceutical and biotechnology companies hold a larger share in mycoplasma testing

A detailed breakup and analysis of the mycoplasma testing market based on the end user has also been provided in the report. This includes academic research institutes, cell banks, contract research organizations, pharmaceutical and biotechnology companies, and others. According to the report, pharmaceutical and biotechnology companies accounted for the largest market share.

The expansion of cell banks as repositories for valuable and diverse cell lines used in research, manufacturing, and clinical applications, as well as a reliable supplier of cells to pharmaceutical and biotechnology companies support the growth of the segment. 

Contract Research Organizations (CROs), on the other hand, provide research and development services with high-quality data and reliable results, work with various clients and receive different biological samples and cell lines for research, primarily pharmaceutical and biotechnology companies, thereby resulting in the growth of both segments.

The rising number of extensive studies involving cell cultures and biological samples in academic research institutes are providing a thrust to the market growth across academic research institutes.

Breakup by Region: 

• North America
  • United States
  • Canada
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Others
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others
• Middle East and Africa
   

North America exhibits a clear dominance, accounting for the largest mycoplasma testing market share

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa.

North America holds a significant market share since the region has a well-developed biotechnology and life science research infrastructure and is actively present in the development of new drugs, vaccines, and biologics. Additionally, the region is also fostering the establishment of numerous pharmaceutical, biotechnology, and research organizations.

The key players across North America, including research institutions and biotechnology companies, are increasingly adopting mycoplasma testing a critical aspect of their quality control processes.

In addition to this, continual technological advancements in biotech and biomedical applications and extensive research and development (R&D) activities resulting in the use of large-scale testing methods by regulatory authorities of the USA is contributing to the overall market growth in this region.

Competitive Landscape:

The top players in the global mycoplasma testing market are investing in extensive research and development (R&D) activities to introduce innovative and advanced testing solutions. They are focusing on rapid testing kits, automated systems, and improved detection technologies with improved sensitivity and accuracy to cater to evolving consumer needs. The major players are also entering into strategic partnerships and collaborations with academic institutions and research organizations and leverage their expertise to make joint research projects and broaden their customer base. Furthermore, the key players are investing in marketing and promotional activities using digital marketing, conferences, exhibitions, and scientific publications to create awareness about mycoplasma testing products and services.

The report has provided a comprehensive analysis of the competitive landscape in the global mycoplasma testing market. Detailed profiles of all major companies have also been provided. Some of the key players in the global mycoplasma testing market include:

• 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.

Recent Developments: 

• In July 2018, ATCC introduced its PCR-based mycoplasma detection service (ATCC 136-XV), which combines Whatman FTA sample collection cards with the Universal Mycoplasma Detection Kit to enable easy and reliable detection of over 60 species of mycoplasma, including common contaminants in cell culture. 
• In December 15, 2021, Asahi Kasei Medical acquired Bionique, a US-based mycoplasma testing services provider, as part of its global biosafety testing services unit, combining the expertise of Bionique and ViruSure to offer clients comprehensive and reliable biosafety testing and facilitating expansion of its mycoplasma testing services.
• In April 2021, Bio-rad launched ddPCR Assays for AAV Viral Titer and the Vericheck ddPCR Mycoplasma Detection Kit in the Droplet Digital PCR (ddPCR) platforms to support the development and manufacture of safe and effective cell and gene therapies.

Mycoplasma Testing Market Report Scope:

Key Questions Answered in This Report: 

• How has the global mycoplasma testing market performed so far, and how will it perform in the coming years? 
• What are the drivers, restraints, and opportunities in the global mycoplasma testing market? 
• What is the impact of each driver, restraint, and opportunity on the global mycoplasma testing market? 
• What are the key regional markets? 
• Which countries represent the most attractive mycoplasma testing market? 
• What is the breakup of the market based on the product? 
• Which is the most attractive product in the mycoplasma testing market? 
• What is the breakup of the market based on the technology? 
• Which is the most attractive technology in the mycoplasma testing market? 
• What is the breakup of the market based on the application? 
• Which is the most attractive application in the mycoplasma testing market? 
• What is the breakup of the market based on the end user? 
• Which is the most attractive end user in the mycoplasma testing market? 
• What is the competitive structure of the global mycoplasma testing market? 
• Who are the key players/companies in the global mycoplasma testing market? 

Key Benefits for Stakeholders 

• IMARC’s report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the mycoplasma testing market from 2018-2032. 
• The research study provides the latest information on the market drivers, challenges, and opportunities in the global mycoplasma testing market. 
• The study maps the leading, as well as the fastest-growing, regional markets. It further enables stakeholders to identify the key country-level markets within each region. 
• Porter's five forces analysis assist stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the mycoplasma testing industry and its attractiveness. 
• Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.