Mycoplasma Testing Market – Global Industry Size, Share, Trends, Opportunity, & Forecast, Segmented By Product (Instruments, Kits and Reagents), By Technology (PCR, ELISA, Enzymatic Methods, DNA Staining, Other), By Application (Cell Line Testing, Bioproduction Testing, Other), By End-User (Academic Research Institutes, Cell Banks, Contract Research Organizations, Pharmaceutical & Biotechnology Companies, Others), By Region, Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 1097.92 Million
CAGR (2026-2031)	13.51%
Fastest Growing Segment	Kits and Reagents
Largest Market	North America
Market Size (2031)	USD 2348.42 Million

Market Overview

The Global Mycoplasma Testing Market will grow from USD 1097.92 Million in 2025 to USD 2348.42 Million by 2031 at a 13.51% CAGR. Mycoplasma testing encompasses the analytical procedures utilized to detect Mollicutes contamination in cell banks, raw materials, and finished biopharmaceutical products to ensure patient safety. The market is primarily supported by the escalating volume of biopharmaceutical manufacturing and stringent regulatory mandates requiring the absence of adventitious agents in product release protocols. Furthermore, the commercialization of advanced therapeutic medicinal products, which demand rigorous quality control, is a fundamental driver. According to the Alliance for Regenerative Medicine, in 2025, 35% of worldwide revenue from cell and gene therapies originated outside the United States, underscoring the expanding international scale of the biologics sector that necessitates comprehensive testing strategies.

Despite this robust demand, a significant challenge impeding market expansion is the regulatory complexity associated with validating rapid alternative methods to replace traditional 28-day culture assays. Manufacturers often face substantial hurdles in demonstrating that faster, automated technologies possess detection limits comparable to established compendial standards, which can delay the adoption of these efficient testing solutions for short-shelf-life therapies.

Key Market Drivers

The growing global demand for biologics and biosimilars acts as a primary catalyst for the mycoplasma testing market, fundamentally reshaping quality control requirements. As pharmaceutical developers accelerate the commercialization of complex molecules, the volume of mandatory lot release testing for adventitious agents rises proportionately to ensure patient safety. This trend is evidenced by sustained regulatory activity; according to Fierce Pharma, January 2026, in the '2025 approvals' report, the U.S. FDA's Center for Drug Evaluation and Research approved 46 novel drugs in 2025, representing a continued influx of new therapies requiring rigorous sterility confirmation. Such a steady stream of approved biological entities directly necessitates expanded testing protocols to mitigate contamination risks throughout the product lifecycle.

Simultaneously, the significant expansion of biopharmaceutical manufacturing capacities is a critical driver, as companies scale infrastructure to meet global supply needs. New production facilities require extensive validation, including utility monitoring and raw material testing, which significantly increases the consumption of mycoplasma detection assays. Illustrating this investment wave, according to Amgen, September 2025, in the 'Amgen Announces $650M Expansion' press release, the company committed $650 million to expand its U.S. manufacturing network, directly creating new operational nodes requiring biosafety oversight. Furthermore, the outsourcing sector mirrors this growth; according to Samsung Biologics, July 2025, in the 'Second Quarter 2025 Financial Results', the company secured sales contracts totaling $2.4 billion in the first half of the year, underscoring the substantial scale of manufacturing activities that rely on comprehensive testing strategies.

Download Free Sample Report

Key Market Challenges

The regulatory complexity associated with validating rapid alternative methods significantly hampers the expansion of the Global Mycoplasma Testing Market. Manufacturers seek to replace traditional 28-day culture assays with faster automated technologies to expedite the release of short-shelf-life therapies. However, regulatory agencies enforce stringent comparability standards, requiring companies to prove that these rapid methods achieve detection limits identical to established compendial protocols. This demand necessitates expensive and protracted validation studies, which frequently delays the implementation of faster testing systems and restricts the recurring sales of higher-value rapid testing consumables.

This operational bottleneck prevents the market from fully capitalizing on the broader growth of the biopharmaceutical sector. According to the Alliance for Regenerative Medicine, in 2025, the number of therapeutic developers globally increased by 6%. Although this statistic indicates a rising customer base for testing products, the burdensome validation process discourages these developers from switching to advanced methods. Consequently, the market experiences slower revenue growth as manufacturers are forced to rely on slower, legacy testing procedures rather than adopting premium rapid solutions that would drive market value.

Key Market Trends

The transition from culture-based methods to Nucleic Acid Amplification Techniques (NAT) is accelerating, driven by the critical need for rapid lot release in biomanufacturing. As traditional 28-day culture assays create bottlenecks for short-shelf-life therapeutics, manufacturers are adopting molecular alternatives that offer comparable sensitivity with significantly reduced turnaround times. This operational shift is evidenced by the capabilities of modern assays; according to Eurofins, June 2025, in the 'BioPharma Services News - Summer 2025' report, validated NAT platforms such as MycoSEQ can now deliver confirmed mycoplasma detection results in under five days. This drastic reduction in testing duration allows biopharmaceutical developers to expedite product release cycles while maintaining compliance with stringent safety standards.

Simultaneously, increasing outsourcing to Contract Research Organizations (CROs) is reshaping the market landscape, as companies seek specialized infrastructure for complex commercial-stage testing. Biopharmaceutical developers are consolidating their supply chains by leveraging external partners who offer integrated manufacturing and quality control solutions, thereby avoiding the high capital costs of internal lab expansion. This trend towards strategic consolidation is illustrated by recent industry movements; according to Minaris Advanced Therapies, May 2025, in the 'New company unveiled at the annual ISCT conference' press release, the firm combined Minaris Regenerative Medicine with the U.S. and U.K. operations of WuXi Advanced Therapies to create a global entity providing testing services for over 27 commercial products. This merger highlights the growing sector reliance on large-scale, integrated testing providers.

Segmental Insights

The Kits and Reagents segment is currently experiencing the most rapid expansion within the Global Mycoplasma Testing Market, primarily due to the recurring nature of consumable procurement compared to capital-intensive instruments. This growth is significantly accelerated by the biopharmaceutical industry’s transition toward rapid detection methods, such as nucleic acid amplification techniques, which rely heavily on specific validated assays. Stringent regulatory frameworks established by agencies like the European Medicines Agency and the United States Pharmacopeia mandate frequent contamination screening throughout the drug manufacturing process. Consequently, the continuous need to ensure product safety and regulatory compliance sustains the high-volume demand for these testing consumables.

Regional Insights

North America maintains a dominant position in the mycoplasma testing market, driven by a robust pharmaceutical and biotechnology sector. The region operates under strict regulatory frameworks, with the U.S. Food and Drug Administration and United States Pharmacopeia mandating rigorous contamination controls for biological products. These requirements ensure safety in cell banking and vaccine production, fostering high adoption rates for testing protocols. Additionally, strong funding for life sciences research and the concentration of key market players in the United States further support the sustained demand for sterility assurance measures.

Recent Developments

• In October 2024, Merck opened a new biosafety testing facility in Rockville, Maryland, representing an investment of €290 million to meet the growing global demand for these services. The facility features advanced testing capabilities, including a new rapid methods package that integrates the Blazar® CHO Animal Origin Free panel. This molecular method enables the rapid detection of virus families and, when combined with assays for mycoplasma, sterility, and retrovirus-like particles, significantly reduces turnaround times. The integrated testing approach allows for results to be obtained in as little as 14 days, compared to the traditional timeline of 35 days, thus accelerating the release of bulk harvest materials.
• In September 2024, BioMérieux announced a strategic collaboration with Bionique Testing Laboratories to offer method validation services for the BIOFIRE® Mycoplasma test. This partnership was established to help customers expedite the implementation and validation of the rapid mycoplasma testing system within their pharmaceutical quality control workflows. Through this agreement, the company aims to provide standardized and tailored validation packages that support compliance with current good manufacturing practice (cGMP) regulations. The service allows biopharmaceutical manufacturers to leverage external expertise, thereby saving internal laboratory resources and reducing the risks associated with in-lab contamination during validation studies.
• In February 2024, Thermo Fisher Scientific announced the expansion of its good manufacturing practices (GMP) laboratory in Middleton, Wisconsin, to include mycoplasma and additional biosafety testing capabilities. This service expansion was designed to provide a comprehensive solution for biopharmaceutical customers, ensuring that their products are free of contaminants and helping to deliver safe medicines to patients more quickly. The new offerings at the Middleton facility enable the company to support customers with a single-location solution for the full panel of necessary tests, thereby accelerating the development and release of life-changing therapies.
• In January 2024, Minerva Biolabs introduced a next-generation solution for mycoplasma detection, the Venor®GeM dScreen. This new assay was developed for the direct testing of cell cultures, media, and other biological matrices in research and development environments. The product is a ready-to-use digital PCR assay that utilizes TaqMan probes and is compatible with the QIAcuity® platform from Qiagen. It offers a rapid time-to-result of approximately three hours and does not require sample preparation. The assay is capable of detecting over 100 relevant mycoplasma species and includes an internal control to identify potential false-negative results caused by PCR inhibitors.

Key Market Players

• Agilent Technologies Inc
• ATCC
• Bionique Testing Laboratories Inc.
• Charles River Laboratories International Inc.
• Lonza Group Ltd
• Merck KGaA
• Bionique Testing Laboratories Inc.
• PromoCell GmbH
• Thermo Fisher Scientific Inc.
• Sartorius AG

By Product	By Technology	By Application	By End-User	By Region
Instruments Kits and Reagents	PCR ELISA Enzymatic Methods DNA Staining Other	Cell Line Testing Bioproduction Testing Other	Academic Research Institutes Cell Banks Contract Research Organizations Pharmaceutical & Biotechnology Companies Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Mycoplasma Testing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Mycoplasma Testing Market, By Product:

• Instruments
• Kits and Reagents

• Mycoplasma Testing Market, By Technology:

• PCR
• ELISA
• Enzymatic Methods
• DNA Staining
• Other

• Mycoplasma Testing Market, By Application:

• Cell Line Testing
• Bioproduction Testing
• Other

• Mycoplasma Testing Market, By End-User:

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

• Mycoplasma Testing Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE