Mycoplasma Testing Market Set to Expand at 11.5% CAGR Through 2032, Reveals Persistence Market Research

Market Overview and Growth Drivers

The global mycoplasma testing market is poised for remarkable growth, with its size projected to rise from US$ 1.89 billion in 2025 to US$ 4.52 billion by 2032. This expansion represents a robust compound annual growth rate (CAGR) of 11.5% during the forecast period. Mycoplasma, known for lacking cell walls and being resistant to many antibiotics, are a significant contaminant in cell cultures and biomanufacturing environments. The testing of these microorganisms is critical to ensure the quality and safety of biologics, vaccines, and other cell-based products.

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Several key drivers are fueling this market's growth. The increase in global mycoplasma infections, rising contamination concerns in biopharmaceutical production, and supportive government initiatives in emerging markets are among the most influential. North America currently leads the market with a 46% revenue share due to its advanced biotechnology sector and stringent regulatory standards. The PCR (Polymerase Chain Reaction) segment dominates the market due to its unmatched sensitivity and speed, while the biopharmaceutical end-user segment remains the leading contributor due to its heavy reliance on contamination-free manufacturing environments.

✦ Key Highlights from the Report

✦ The global mycoplasma testing market is projected to grow at a CAGR of 11.5% through 2032.
✦ The PCR segment holds the largest share due to its high sensitivity, specificity, and rapid detection.
✦ ELISA is the fastest-growing segment owing to its simplicity and low equipment requirements.
✦ North America leads the market with a 46% revenue share due to strong regulatory frameworks and biopharma growth.
✦ AI-powered testing methods are revolutionizing mycoplasma detection with higher speed and accuracy.
✦ Rising investments in biotech and life sciences research are boosting the demand for mycoplasma testing globally.

Market Segmentation 📋

The mycoplasma testing market is segmented based on product type and end-user categories.

On the basis of product type, the market is divided into PCR assays, ELISA kits, culture methods, and other detection technologies. Among these, PCR assays dominate due to their ability to detect low levels of contamination with high accuracy and speed. ELISA kits are gaining popularity owing to their user-friendly design and affordability, especially in smaller laboratories and developing regions.

By end-user, the market includes biopharmaceutical companies, contract research organizations (CROs), academic research institutions, and others. Biopharmaceutical companies hold the largest market share because of their stringent regulatory compliance requirements and extensive usage of cell cultures. CROs are the fastest-growing segment, driven by increased outsourcing of R&D and quality assurance activities.

🌍 Regional Insights

North America holds the largest share of the global mycoplasma testing market, primarily driven by its advanced healthcare and biotechnology sectors. The region is home to major pharmaceutical companies and research institutes that strictly follow FDA and other regulatory body guidelines. Canada is expected to show the fastest growth, backed by rising biomedical investments and increasing mycoplasma pneumonia infections.

Asia Pacific is projected to grow at the highest CAGR during the forecast period. The presence of key pharmaceutical players, rising investments in biotech infrastructure, and supportive government policies like India's National Biotechnology Development Strategy are major contributors. Japan is a significant market within the region due to increasing contamination cases and its strong focus on quality control.

Europe remains a robust market with increasing demand for quality biopharmaceuticals. The EMA's regulatory standards and investments through Horizon Europe are enhancing testing capabilities and encouraging the adoption of advanced technologies such as qPCR and NGS for accurate and timely detection.

📊 Market Drivers

The surge in contamination cases and the demand for quality control in biotechnology and pharmaceutical industries are major market drivers. Rising infections, especially post-COVID-19, have led to a heightened awareness and need for efficient mycoplasma detection. Furthermore, innovations in diagnostic technologies, including the development of the MycoSEQPlus Detection System and real-time PCR-based assays, are propelling the market. These solutions offer faster and more reliable results, reducing the risk of product recalls and ensuring patient safety.

❌ Market Restraints

Despite strong growth prospects, the high cost of mycoplasma testing equipment and reagents remains a significant barrier. Many emerging economies face financial constraints that limit access to advanced diagnostic technologies. Kits such as the Eagle Biosciences qPCR kit, priced at over US$ 3,300, are out of reach for many smaller labs. This economic barrier restricts market expansion, particularly in developing nations, and challenges universal access to contamination-free biologics.

✨ Market Opportunities

AI-driven diagnostic technologies represent a transformative opportunity for the mycoplasma testing market. Tools using convolutional neural networks and machine learning models are enabling ultra-sensitive detection and reducing the need for manual intervention. The adoption of such technologies in regenerative medicine, animal health, and even egg distribution underscores their wide-ranging applicability. With global emphasis on faster, cost-effective, and accurate testing, AI and automation are poised to revolutionize this industry.

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Frequently Asked Questions (FAQs)

How Big is the Mycoplasma Testing Market?
Who are the Key Players in the Global Market for Mycoplasma Testing?
What is the Projected Growth Rate of the Mycoplasma Testing Market?
What is the Market Forecast for Mycoplasma Testing through 2032?
Which Region is Estimated to Dominate the Industry through the Forecast Period?

💼 Company Insights

Key players operating in the mycoplasma testing market include:

• Charles River Laboratories
• Merck KGaA
• Lonza Group
• Thermo Fisher Scientific
• Eurofins Scientific
• Bionique Testing Laboratories
• Roche Diagnostics
• ATCC
• Takara Bio Inc.
• Sigma-Aldrich Corporation

Recent Developments:

In 2024, Lonza Group launched a next-generation mycoplasma detection kit integrated with AI analytics to enhance speed and precision.

Charles River Laboratories expanded its testing services in Canada with a new GMP-compliant facility focusing on mycoplasma and viral contamination.

Conclusion

The mycoplasma testing market is set to witness significant growth over the next decade, fueled by increasing contamination risks, technological advancements, and regulatory mandates. As biologics and advanced therapeutics continue to gain momentum, ensuring the sterility and safety of these products becomes crucial. With North America leading in market share and Asia Pacific demonstrating promising growth potential, the global landscape offers ample opportunities for investment and innovation. Stakeholders must leverage emerging technologies like AI and expand testing accessibility to unlock the full potential of this vital healthcare segment.

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About Persistence Market Research:

At Persistence Market Research, we specialize in creating research studies that serve as strategic tools for driving business growth. Established as a proprietary firm in 2012, we have evolved into a registered company in England and Wales in 2023 under the name Persistence Research & Consultancy Services Ltd. With a solid foundation, we have completed over 3600 custom and syndicate market research projects, and delivered more than 2700 projects for other leading market research companies' clients.

Our approach combines traditional market research methods with modern tools to offer comprehensive research solutions. With a decade of experience, we pride ourselves on deriving actionable insights from data to help businesses stay ahead of the competition. Our client base spans multinational corporations, leading consulting firms, investment funds, and government departments. A significant portion of our sales comes from repeat clients, a testament to the value and trust we've built over the years.

This release was published on openPR.