Mycoplasma Testing Market Set to Grow at a 11.5% CAGR, Crossing the US$ 4.52 Billion Mark by 2032

The mycoplasma testing market plays a vital role in ensuring the safety, reliability, and quality of biopharmaceutical products, vaccines, and cell-based research. Mycoplasma contamination is a major concern in cell cultures and biologics production, as it can compromise research accuracy, reduce product efficacy, and pose regulatory challenges. Testing methods such as PCR, ELISA, direct assays, and indirect culture techniques are widely adopted across pharmaceutical manufacturing, academic research, and clinical laboratories.

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According to the latest study by Persistence Market Research, the global mycoplasma testing market size is projected to rise from US$ 1.89 Bn in 2025 to US$ 4.52 Bn by 2032. The market is further anticipated to register a CAGR of 11.5% during the forecast period from 2025 to 2032. Growth is mainly fueled by the rising demand for biologics, cell and gene therapies, and stringent regulatory requirements for contamination-free production in the life sciences industry.

Market expansion is further supported by increasing R&D investments in biopharmaceuticals, coupled with rising adoption of contract research and manufacturing services (CROs/CMOs). Among the testing methods, PCR-based assays emerge as the leading segment, due to their high sensitivity, rapid turnaround time, and ability to detect multiple mycoplasma species simultaneously. Geographically, North America dominates the global market, attributed to its strong biopharmaceutical pipeline, advanced research infrastructure, and regulatory compliance standards. Meanwhile, Asia Pacific is expected to witness the fastest growth, driven by expanding biologics manufacturing, clinical trials, and investments in healthcare infrastructure across countries such as China, India, and South Korea.

Key Market Insights

The market is further anticipated to register a CAGR of 11.5% during the forecast period from 2025 to 2032.

PCR-based assays remain the leading testing method due to their speed, accuracy, and reliability.

North America leads the market, driven by regulatory standards and biologics development.

Increasing demand for cell & gene therapies and biologics is fueling the adoption of mycoplasma testing.

Outsourcing of testing services to CROs and CMOs is shaping market opportunities.

What are the main drivers of the mycoplasma testing market?

The primary drivers include the growing biopharmaceutical industry, rising adoption of cell and gene therapies, and increasing emphasis on regulatory compliance for contamination-free production. The demand for biologics and vaccines is boosting the need for reliable quality control processes, where mycoplasma testing plays a critical role. Additionally, outsourcing of testing to specialized service providers and growing R&D in academic and clinical laboratories are expanding market opportunities.

Market Dynamics

Drivers:

Increasing demand for biologics, vaccines, and cell therapies.

Rising regulatory emphasis on contamination-free production.

Growing investments in pharmaceutical R&D and biomanufacturing.

Market Restraining Factor:

High cost of advanced testing kits and instruments.

Lack of skilled professionals for complex molecular assays.

Limited adoption in low-resource settings due to cost constraints.

Key Market Opportunity:

Development of automated, rapid testing platforms integrated with digital analytics.

Expansion of mycoplasma testing services in emerging markets through CROs/CMOs.

Innovation in next-generation sequencing (NGS)-based assays for high-accuracy detection.

Market Segmentation

By Technology

PCR
ELISA
Direct Assay
Microbial Culture

By End-user

Biopharmaceutical
CROs
Cell Banks

By Product & Service

Assays
Kits
Reagents

By Region

North America
Europe
Asia Pacific
South Asia and Oceania
Latin America
Middle East and Africa

Regional Insights

North America remains the largest market, supported by robust biopharma pipelines, strong regulatory oversight, and advanced laboratory infrastructure.

Europe follows, benefiting from a well-established pharmaceutical industry and growing adoption of cell-based therapies.

Asia Pacific is projected to grow the fastest, driven by increasing investments in biomanufacturing, expansion of clinical trials, and government support for biotechnology.

Latin America and the Middle East & Africa are emerging markets, where rising pharmaceutical production and healthcare modernization are fueling testing demand.

Competitive Landscape

The mycoplasma testing market is competitive, with players focusing on advanced testing technologies, service expansion, and automation solutions to strengthen their presence.

Company Insights
✦ Lonza Group AG
✦ Merck KGaA
✦ Charles River Laboratories
✦ Thermo Fisher Scientific Inc.
✦ Agilent Technologies
✦ PromoCell GmbH
✦ Bio-Rad Laboratories Inc.
✦ Roche Diagnostics
✦ InvivoGen
✦ American Type Culture Collection (ATCC)

Key Industry Developments

Companies are investing in rapid PCR and digital PCR-based assays to enhance testing accuracy and shorten turnaround times.

Strategic partnerships between testing kit developers and CROs/CMOs are strengthening service-based revenue models.

Expansion into Asia Pacific with localized facilities is a key growth strategy for multinational players.

Innovation and Future Trends

The future of the mycoplasma testing market lies in automation, digitalization, and integration with advanced molecular diagnostics. Innovations in next-generation sequencing (NGS), microfluidics, and AI-driven data analysis are expected to improve detection accuracy and efficiency. The shift toward cell and gene therapies will further accelerate demand for rapid, high-sensitivity testing methods. Sustainable, cost-effective kits designed for emerging markets are also likely to create significant opportunities, positioning the industry for robust long-term growth.

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