MYCOPLASMA TESTING MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2025-2032)

Global Mycoplasma Testing Market Size and Trends Forecast: 2025 - 2032

The global mycoplasma testing market is estimated to be valued at USD 999.8 Mn in 2025 and is expected to reach USD 1,935.9 Mn by 2032, exhibiting a compound annual growth rate (CAGR) of 9.9% from 2025 to 2032.

Key Takeaways of the Global Mycoplasma Testing Market

• By product type, the kits & reagents segment is expected to contribute the highest share of the global mycoplasma testing market with 52. 3% in 2025.
• North America is expected to be the largest market for mycoplasma testing during the forecast period, accounting for over 35. 7% of the market share in 2025.
• Asia Pacific is expected to be the second-largest market for the mycoplasma testing market, accounting for over 25.2% of the market share in 2025.

Market Overview

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Global mycoplasma testing market is experiencing steady growth driven by factors such as increasing R&D investments by market players and increasing funding by the government. Moreover market players are focusing on inorganic strategies, such as mergers and acquisitions, which is expected to aid in market growth over the forecast period. Mycoplasma testing is essential in the field of biotechnology and pharmaceuticals. There are different types of products available in the market for mycoplasma testing. The major products can be categorized into two types, kits and services.

However, the high cost of instruments required for mycoplasma testing is a significant barrier impacting the expansion of the global mycoplasma testing market.

Market Concentration and Competitive Landscape

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Current Events and their Impact on the Global Mycoplasma Testing Market

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Market Trends

• The Increasing Prevalence of Mycoplasma Infections and Respiratory Diseases

The increasing prevalence of mycoplasma infections and respiratory diseases has emerged as a primary catalyst driving the expansion of the global mycoplasma testing market. Mycoplasma pneumoniae, one of the most clinically significant species, has demonstrated concerning epidemiological patterns in recent years, particularly affecting pediatric and young adult populations.

For instance, according to the Gov.UK, between October 2023 and March 2024, there were 2,592 Mycoplasma pneumoniae detections cases, a substantial increase compared to 364 in the 2022 to 2023 winter season.

Segmental Insights

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Global Mycoplasma Testing Market Insights, By Product Type: Kits & Reagents Dominates Owing to their Fundamental Role as Consumable Components

In terms of product type, the kits & reagents segment is estimated to contribute the highest market share of 52.3% in 2025, owing to their fundamental role as consumable components that drive recurring revenue streams and widespread adoption across diverse laboratory settings.

The dominance of kits and reagents stems from their essential nature in mycoplasma detection workflows, where these consumable materials are required for every single test performed, creating a continuous demand cycle that far exceeds the one-time purchase pattern associated with instruments.

This segment's leadership position is reinforced by the expanding biopharmaceutical industry's stringent quality control requirements, as outlined by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), which mandate regular mycoplasma testing throughout the manufacturing process of biological products, vaccines, and cell-based therapies. For example, regulators require testing at points such as master and working cell banks, seed lots, harvest, and final product stages

Emerging Innovations in the Global Mycoplasma Testing Market

• The Integration of Molecular Diagnostic Techniques
  • The integration of molecular diagnostic techniques such as real-time polymerase chain reaction (qPCR) is gaining traction in the market. This technology allows for quicker identification of mycoplasma contamination compared to traditional culture-based methods, which often require several days to weeks for results. Real-time PCR enhances sensitivity and specificity significantly, detecting mycoplasma DNA at very low levels, which is integral for ensuring sterile conditions before product release or research continuation. The increasing adoption of qPCR kits optimized for mycoplasma detection in cell cultures and biopharmaceutical environments underscores this trend.
• The Development of Automated and High-Throughput Testing Platforms
  • The development of automated, high-throughput testing platforms tailored for routine, large‑scale screening needs is enabling laboratories to process vast numbers of samples quickly, accurately, and consistently—meeting rising demand in diagnostic and research environments with enhanced efficiency and minimal manual intervention. Automated systems reduce the dependency on manual handling, thereby minimizing the risk of human error and contamination during sample preparation and analysis. These platforms often combine sample processing, amplification, and detection steps into a unified workflow, accelerating result turnaround times. This automation is particularly valuable in biomanufacturing environments where hundreds of batch samples may need to be tested regularly to comply with stringent regulatory requirements.

Impacts of Artificial Intelligence (AI) on the Global Mycoplasma Testing Market

The integration and application of AI technologies within mycoplasma testing are shaping the future of contamination control, ensuring higher safety standards and operational efficiency.

• Eurofins Scientific, a leading global bioanalytical testing company, has integrated AI-driven data analysis tools into its microbial testing services. By embedding machine learning algorithms into their platforms, Eurofins has enhanced its ability to quickly interpret complex biological datasets, reducing human error and accelerating test results. This strategic integration of AI not only bolsters the company’s operational efficiency but also elevates its capacity to deliver highly reliable contamination detection for pharmaceutical and biopharmaceutical clients globally.
• Cytena GmbH is a biotech firm that leverages AI algorithms for cell line quality control, including mycoplasma detection. Its AI-driven imaging technology scans cell cultures for subtle signs of contamination that might otherwise go unnoticed, significantly reducing false negatives. This improved accuracy not only saves time but also prevents costly setbacks in drug development pipelines.

Regional Insights

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North America Mycoplasma Testing Market Analysis and Trends

North America is expected to be the largest market for mycoplasma testing during the forecast period, accounting for over 35.7% of the market share in 2025. North America has established itself as the dominant regional market for mycoplasma testing. The region is home to several leading life sciences companies that are pioneering innovation in sequencing technology. Strong government funding for biomedical research has encouraged rapid technological advancements in the field.

For instance, as per an article published in June 2025 by the International Journal of Infectious Diseases, in the U.S., M. pneumoniae accounts for about 2%-18% of Community‑Acquired Pneumonia (CAP) cases in adults with higher prevalence in old ages and up to 40% in children. These infections exhibit periodic peaks every 3-7 years, largely influenced by strain variations due to mutations.

Asia Pacific Mycoplasma Testing Market Analysis and Trends

Asia Pacific is expected to be the second-largest market for mycoplasma testing, accounting for over 25.2% of the market share in 2025. Asia Pacific is the fastest growing regional market for mycoplasma testing. Several factors contribute to the region's burgeoning growth rate. Countries like China and India are making vast public investments to build out their genomics capabilities as part of ambitious national bioscience development agendas.

For instance, according to data released by the Japanese NIID, in November 2024, between 20% and 30% of infections of Mycoplasma pneumonia are of antibiotic-resistant varieties.

Global Mycoplasma Testing Market Outlook for Key Countries

U.S. Mycoplasma Testing Market Analysis and Trends

The U.S. is a dominant force in the global mycoplasma testing market, driven by stringent regulatory frameworks enforced by the U.S. Food and Drug Administration (FDA). The U.S. FDA mandates routine mycoplasma testing in biologics manufacturing, particularly for vaccines, monoclonal antibodies, and cell therapies. Additionally, the country’s rapidly expanding biopharmaceutical industry, coupled with strong R&D investments and government support, creates consistent demand for advanced testing kits and reagents. This regulatory rigor and industrial maturity solidify the U.S. position as a global market leader.

China Mycoplasma Testing Market Analysis and Trends

China is emerging as a major driver in the global mycoplasma testing market due to its aggressive investments in biotechnology under national initiatives such as “Made in China 2025” and the “Healthy China” strategy. These programs prioritize self-sufficiency in high-tech biosciences and emphasize the development of pharmaceutical manufacturing infrastructure. As Chinese biotech firms scale up production of biologics and vaccines, compliance with international quality standards, including routine mycoplasma testing, becomes essential — fueling rapid growth in testing demand across the country.

India Mycoplasma Testing Market Analysis and Trends

India plays a critical role in driving the global mycoplasma testing market due to its fast-growing biosimilars industry and strong position in Contract Development and Manufacturing (CDMO). Indian pharmaceutical companies are increasingly exporting biologics to regulated markets like the U.S. and EU, where compliance with mycoplasma testing standards is mandatory. Furthermore, the Indian government’s support for biotechnology innovation through initiatives such as “Biotech Parks” and the Department of Biotechnology’s (DBT) funding programs continues to boost infrastructure for biologics testing and development.

Japan Mycoplasma Testing Market Analysis and Trends

Japan’s contribution to the global mycoplasma testing market is propelled by its growing focus on infectious disease surveillance and diagnostic innovation. Japan’s technologically advanced healthcare system, strong government support for infectious disease control, and a growing focus on precision diagnostics make it a key player in the Asia Pacific mycoplasma testing landscape.

Pricing Analysis of the Global Mycoplasma Testing Market

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Market Report Scope

Global Mycoplasma Testing Industry News

• In January 2025, Roche announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver for its cobas liat sexually transmitted infection (STI) multiplex assay panels. These panels, including tests for chlamydia and gonorrhea (CT/NG) and chlamydia, gonorrhea and Mycoplasma genitalium (CT/NG/MG), enable clinicians to diagnose and differentiate between multiple STIs with a single sample. These tests will be exclusively available in the U.S. mycoplasma market in the coming months, with commercialization under CE mark expected to follow shortly.
• In October 2024, Merck opened its new USD 319 million biosafety testing facility in Maryland, U.S. Biosafety testing and analytical development are fundamental components of drug development and commercialization for traditional and novel modalities.
• In July 2024, ThermoFisher Scientific introduced MycoSEQ Mycoplasma Detection Kits which offer a fully integrated solution for real-time PCR–based mycoplasma detection.

Analyst View

• The global mycoplasma testing market is witnessing substantial momentum, driven primarily by the increasing adoption of biopharmaceuticals and stringent regulatory requirements for product safety. Mycoplasma contamination poses significant risks in biotechnological and pharmaceutical manufacturing, prompting companies to invest heavily in advanced testing methodologies.
• The surge in R&D activities, especially in biologics and vaccine development, is further propelling the demand for reliable mycoplasma testing solutions.
• However, the market faces challenges due to the high cost and complexity of certain testing techniques, which can limit accessibility for smaller laboratories and emerging market players. Additionally, the lack of standardized protocols across regions sometimes hampers seamless testing processes, creating a need for harmonized regulations.
• Amid these challenges, technological advancements such as the integration of PCR-based techniques and automation are opening new avenues for faster and more accurate mycoplasma detection. These innovations are not only reducing turnaround times but also enhance sensitivity and specificity, fostering broader adoption.
• Geographically, North America continues to dominate the market due to its established pharmaceutical industry and robust regulatory framework.
• Overall, the mycoplasma testing market is poised for continued growth, with opportunities arising from evolving technologies and expanding biopharmaceutical production worldwide. Stakeholders focusing on innovation and regulatory compliance will likely maintain a competitive edge in this dynamic landscape.

Market Segmentation

• By Product Type Insights (Revenue, USD Mn, 2020 - 2032)
• Kits & Reagents
• Instruments
• By Application Insights (Revenue, USD Mn, 2020 - 2032)
• Cell Line Testing
• Virus Testing
• End of Production Testing
• Others (Raw Material Testing, etc.)
• By End User Insights (Revenue, USD Mn, 2020 - 2032)
• Pharmaceutical & Biotechnology Companies
• Contract Research Organizations
• Academic Research Institutes
• Regional Insights (Revenue, USD Mn, 2020 - 2032)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
• Charles River Laboratories International
• Merck KGaA
• Lonza Group Ltd.
• Roche Diagnostics
• Thermo Fisher Scientific
• Merck
• InvivoGen
• Creative Bioarray

Sources

Primary Research Interviews

• Mycoplasma testing laboratory heads
• Clinical diagnostics experts
• Biopharmaceutical quality control managers
• Regulatory affairs specialists
• Others

Magazines

• Clinical Lab News
• Genetic Engineering & Biotechnology News
• BioPharm International
• Others

Journals

• Journal of Clinical Microbiology
• Journal of Biotechnology
• Diagnostic Microbiology and Infectious Disease
• Others

Newspapers

• The Wall Street Journal Health Section
• The New York Times Science Section
• Financial Times Health & Pharma News
• Others

Associations

• American Society for Microbiology (ASM)
• International Society for Pharmaceutical Engineering (ISPE)
• Association of Clinical Scientists (ACS)
• Others

Public Domain Sources

• World Health Organization (WHO)
• U.S. Food and Drug Administration (FDA)
• Centers for Disease Control and Prevention (CDC)
• National Institutes of Health (NIH)
• Others

Proprietary Elements

• CMI Data Analytics Tool – Global Mycoplasma Testing Market
• CMI Existing Repository of Information for the Last 8 Years

*Definition: Mycoplasma testing is essential in the field of biotechnology and pharmaceuticals. There are different types of products available in the market for mycoplasma testing. The major products can be categorized into two types - kits and services.