Mycoplasma Testing Market - By Product Type (Instruments, Kits & Reagents, Services), By Technique (PCR, ELISA, Microbial Culturing Techniques, Enzymatic Methods), By Application (Cell Line Testing, Virus Testing), By End-use & Forecast, 2024 – 2032

Mycoplasma Testing Market Size

Mycoplasma Testing Market was valued at around USD 909.5 million in 2023 and is estimated to register over 11.9% CAGR between 2024 and 2032. Mycoplasma testing involves a series of laboratory techniques designed to detect the presence of mycoplasma bacteria in various biological samples, particularly cell cultures used in research, biomanufacturing, and clinical applications. Mycoplasma is unique bacteria that lacks a cell wall, making them resistant to many antibiotics and difficult to detect using traditional staining methods.
 

Common testing methods include PCR, enzymatic assays, and direct culture. The increase in cell culture contamination, including mycoplasma contamination, poses significant challenges to research and biomanufacturing processes. For instance, as per estimates, over 10% of all cell cultures are believed to be tainted with mycoplasma species, underscoring the necessity of regular testing to guarantee the purity of cultures. Thus, as contamination rates rise, there's a corresponding need for robust mycoplasma testing methods to identify and mitigate contamination risks promptly.
 

Furthermore, increasing research and development activities are driving significant expansion within the mycoplasma testing market. With a rising demand for dependable and effective testing techniques such as nucleic acid tests, microbial culturing, and PCR technologies, underscores the importance of innovation in meeting evolving industry needs.
 

Mycoplasma Testing Market Trends

The growing advancements in cell line development technology are notably boosting mycoplasma testing, providing enhanced sensitivity, quicker detection, and fewer false positives. By refining cell culture techniques, cultures are becoming cleaner and more resilient, lowering the likelihood of mycoplasma contamination. Therefore, this is heightening the sensitivity of mycoplasma testing, enabling the detection of even minimal contamination levels.
 

• These advancements facilitate more reliable identification of mycoplasma contamination in cell cultures, ensuring the integrity of research and biopharmaceutical production processes.
   
• Furthermore, advanced cell culture systems often incorporate rapid detection methods for mycoplasma, such as PCR-based assays or automated microbial monitoring systems which include instruments such as automated cell counter which is estimated to reach USD 10.1 billion by 2032.
   
• These technologies can quickly identify mycoplasma contamination, allowing for prompt remediation measures to be taken.
   
• For instance, Thermo Fisher Scientific Inc.'s latest PCR-based mycoplasma detection kit, the Applied Biosystems MycoSEQ Mycoplasma Detection Kit Version 3.0, offers a rapid, sensitive, and accurate method for identifying mycoplasma contamination in cell cultures, fulfilling the criteria set forth by regulatory authorities.
   
• Thus, these progressions in cell culture technology contribute to more effective and efficient mycoplasma testing, thereby bolstering the integrity and safety of cell-based products.
   

Mycoplasma Testing Market Analysis

Based on product type, the mycoplasma testing industry is segmented into instruments, kits and reagents, and services. Kits and reagents are sub segmented into PCR assays, nucleic acid detection kits, stains, elimination kits, standards and controls, ELISA kits, and other kits and reagent. The kits and reagents segment is estimated to account for USD 1.4 billion by 2032.
 

• Kits and reagents play a pivotal role in mycoplasma testing, offering standardized protocols, streamlined workflows, and increased accuracy.
   
• Moreover, ready-to-use kits and reagents in mycoplasma testing are pre-measured and standardized, which significantly simplifies the testing process.
   
• They typically contain all the necessary components and protocols required for mycoplasma detection, eliminating the need for time-consuming preparation and optimization steps. Thus, aforementioned factors are anticipated to propel segmental growth.

 

Based on technique the mycoplasma testing market is segmented into PCR, ELISA, microbial culturing technique, enzymatic methods, and other techniques. The PCR segment accounted for USD 373.8 million in 2023.
 

• PCR offers high sensitivity and specificity, enabling accurate detection of mycoplasma DNA even at low concentrations. Its rapid and efficient nature allows for timely identification of contamination in cell cultures and biopharmaceutical products, crucial for maintaining product integrity.
   
• Furthermore, PCR's versatility allows for customized assays targeting specific regions of the mycoplasma genome, ensuring precise identification and differentiation from other contaminants.
   
• Moreover, regulatory compliance and widespread market adoption further contribute to PCR's dominance in mycoplasma testing, making it the preferred technique for many laboratories and industries worldwide.
   

Based on application, the market is segmented into cell line testing virus testing, end of production cells testing, and other applications. The cell line testing segment is estimated to account for USD 1.1 billion revenue size by 2032.
 

• The widespread use of cell lines in biopharmaceutical production, vaccine development, and basic research necessitates rigorous testing for mycoplasma contamination to ensure product safety and integrity.
   
• With the increasing demand for biologics and cell-based therapies, there is a growing emphasis on quality control measures, including mycoplasma testing, throughout the production process.
   
• Additionally, regulatory authorities require stringent testing protocols to mitigate the risk of mycoplasma contamination in cell-based products, further propelling the demand for cell line testing services.
   
• Thus, as the biopharmaceutical industry continues to expand and evolve, the demand for cell line testing services is expected to grow, stimulating the revenue size of the segment in the industry.
   

Based on end-use, the mycoplasma testing market is segmented into academic research institutes, cell banks & laboratories, contract research organizations, pharmaceutical & biotechnology companies, and other end-users. The pharmaceutical & biotechnology companies segment held the largest market share of 37.5% in 2023.
 

• Pharmaceutical and biotechnology companies are major contributors to the development and production of biologics, vaccines, and cell-based therapies, all of which require stringent mycoplasma testing to ensure product safety and compliance with regulatory standards.
   
• These companies invest heavily in quality control measures, including routine mycoplasma testing throughout the manufacturing process, to mitigate the risk of contamination and uphold product integrity.
   
• Additionally, the increasing demand for biopharmaceuticals and cell-based therapies, coupled with the growing emphasis on regulatory compliance, accelerates the adoption of advanced mycoplasma testing solutions by pharmaceutical and biotechnology companies.

 

In 2023, North America held a significant market share of 40.6% in the global mycoplasma testing market and is predicted to witness substantial market growth over the analysis timeline.
 

• The region's pharmaceutical and biotechnology industries extensively use cell cultures and biologics, necessitating rigorous mycoplasma testing to ensure product safety and compliance with FDA regulatory standards.
   
• Additionally, increasing government investment in the region to produce new active pharmaceutical ingredients (APIs) stimulates the demand for stringent quality control measures, including mycoplasma testing, to meet regulatory requirements and ensure product safety.
   
• For instance, in 2022, the U.S. Department of Health and Human Services announced an investment of USD 40 million with the goal of broadening the role of biomanufacturing in the development of active pharmaceutical ingredients (APIs) and antibiotics.
   
• With a robust healthcare infrastructure, strong focus on biopharmaceutical research and development, and the presence of key market players and research institutions, North America emerges as a pivotal contributor to the global market.
   

Mycoplasma Testing Market Share

The mycoplasma testing industry is competitive in nature, with several large multinationals and small and mid-sized companies competing in the industry. The development and launch of novel advanced products based on different technologies is among a key market strategy. Some of the leading industry players including Bio-Rad Laboratories, Inc., Charles River Laboratories International, Inc., Thermo Fisher Scientific Inc. among others have a notable presence in the market.
 

Mycoplasma Testing Market Companies

Some of the eminent market participants operating in the mycoplasma testing industry include:

• Becton, Dickinson, and Company (BD)
• Bio-Rad Laboratories, Inc.
• Charles River Laboratories International, Inc.
• Creative Bioarray
• Eurofins Scientific
• InvivoGen
• Lonza Group AG
• Merck KGaA
• Minerva Biolabs GmbH
• PromoCell GmbH
• QIAGEN N.V.
• Sartorius AG
• Thermo Fisher Scientific Inc.          
   

Mycoplasma Testing Industry News

• In April 2021, Bio-Rad Laboratories, Inc. unveiled two new products designed for the Droplet Digital PCR (ddPCR) platforms, namely the ddPCR Assays for AAV Viral Titer and the Vericheck ddPCR Mycoplasma Detection Kit. These launches aimed to support the development and production of safe and efficient cell and gene therapies. This product launch bolstered Bio-Rad's position as a leading provider of inventive solutions for researchers and biopharmaceutical firms, further enhancing its market presence and relevance in the industry.
   
• In January 2020, Charles River Laboratories International, Inc. acquired HemaCare Corporation, a leader in human-derived cellular products for the cell therapy market. This acquisition expanded Charles River's scientific capabilities in the emerging field of cell therapy, offering comprehensive research and manufacturing support solutions to developers and manufacturers across all stages of program advancement, from research to commercialization.
   

The mycoplasma testing market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 – 2032 for the following segments:

Market, By Product Type

• Instruments
• Kits and reagents 
  • PCR (Polymerase chain reaction) assays
  • Nucleic acid detection kits
  • Stains
  • Elimination kits
  • Standards & controls
  • ELISA (Enzyme-linked immunosorbent assay) kits
  • Other kits and reagents
• Services

Market, By Technique

• PCR (Polymerase chain reaction)
• ELISA (Enzyme-linked immunosorbent assay)
• Microbial culturing technique
• Enzymatic methods
• Other techniques

Market, By Application

• Cell line testing
• Virus testing
• End of production cells testing
• Other applications

Market, By End-use

• Academic research institutes
• Cell banks & laboratories
• Contract research organizations
• Pharmaceutical & biotechnology companies
• Other end-users

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of Middle East and Africa