Mycoplasma Testing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Mycoplasma Testing Market is projected to expand from USD 1.09 billion in 2025 to USD 2.34 billion by 2031, reflecting a compound annual growth rate (CAGR) of 13.51%. Mycoplasma testing involves analytical protocols designed to identify Mollicutes contamination within cell banks, raw materials, and finished biopharmaceutical goods to guarantee patient safety.

This market is chiefly bolstered by the rising quantity of biopharmaceutical production and strict regulatory requirements mandating that products remain free of adventitious agents before release. Additionally, the commercial introduction of advanced therapeutic medicinal products, which necessitate stringent quality assurance, serves as a key growth engine. As reported by the Alliance for Regenerative Medicine in 2025, 35% of global revenue derived from cell and gene therapies originated outside the United States, highlighting the broadening international scope of the biologics industry that demands extensive testing frameworks.

Despite strong market demand, growth is hindered by the regulatory difficulties involved in validating rapid alternative methods intended to supersede traditional 28-day culture assays. Manufacturers frequently encounter significant obstacles in proving that faster, automated technologies offer detection limits equivalent to established compendial standards. These validation challenges often postpone the integration of efficient testing solutions for therapies with short shelf lives.

Market Drivers

The escalating global requirement for biologics and biosimilars serves as a primary propellant for the mycoplasma testing market, fundamentally altering quality control standards. As pharmaceutical developers hasten the commercial launch of complex molecules, the necessity for mandatory lot release testing for adventitious agents increases proportionally to safeguard patient health. This pattern is confirmed by persistent regulatory momentum; for instance, Fierce Pharma reported in January 2026 that the U.S. FDA's Center for Drug Evaluation and Research authorized 46 novel drugs in 2025. This continuous arrival of new therapies necessitates rigorous sterility verification and expanded testing protocols to minimize contamination risks throughout the product's life cycle.

Concurrently, the substantial enlargement of biopharmaceutical manufacturing capabilities drives market growth, as corporations upgrade infrastructure to satisfy global supply demands. New production sites mandate comprehensive validation, encompassing utility monitoring and raw material analysis, which markedly boosts the usage of mycoplasma detection assays. To demonstrate this investment trend, Amgen announced in a September 2025 press release that it had dedicated $650 million to extending its U.S. manufacturing network, thereby establishing new operational hubs that require biosafety oversight. Moreover, the outsourcing industry reflects this expansion; according to Samsung Biologics' 'Second Quarter 2025 Financial Results' released in July 2025, the firm obtained sales contracts amounting to $2.4 billion in the first half of the year, emphasizing the massive scale of manufacturing operations dependent on robust testing strategies.

Market Challenges

The regulatory intricacies tied to validating rapid alternative techniques notably obstruct the growth of the Global Mycoplasma Testing Market. While manufacturers aim to supersede traditional 28-day culture assays with accelerated automated technologies to speed up the release of short-shelf-life treatments, regulatory bodies impose rigorous comparability requirements. Companies must demonstrate that these rapid methods attain detection limits indistinguishable from established compendial protocols. This stipulation leads to costly and prolonged validation studies, which often postpone the deployment of faster testing systems and curtail recurring sales of high-value rapid testing consumables.

This operational impediment hinders the market from fully leveraging the broader expansion of the biopharmaceutical industry. Data from the Alliance for Regenerative Medicine indicates that the global count of therapeutic developers rose by 6% in 2025. While this suggests a growing client base for testing solutions, the onerous validation procedure deters these developers from transitioning to advanced methodologies. As a result, the market undergoes retarded revenue accumulation because manufacturers are compelled to depend on slower, legacy testing processes instead of embracing premium rapid solutions that would enhance market value.

Market Trends

The shift from culture-based techniques to Nucleic Acid Amplification Techniques (NAT) is gaining momentum, fueled by the urgent necessity for rapid lot release in biomanufacturing. Since traditional 28-day culture assays generate bottlenecks for therapeutics with limited shelf lives, manufacturers are turning to molecular alternatives that provide equivalent sensitivity with drastically shortened turnaround times. This operational transition is highlighted by the performance of contemporary assays; as noted in Eurofins' 'BioPharma Services News - Summer 2025' report from June 2025, validated NAT platforms like MycoSEQ are capable of delivering confirmed mycoplasma detection results in fewer than five days. This significant decrease in testing time enables biopharmaceutical developers to accelerate product release schedules while adhering to rigorous safety regulations.

At the same time, the rising reliance on outsourcing to Contract Research Organizations (CROs) is restructuring the market environment, as companies pursue specialized infrastructure for intricate commercial-stage testing. Biopharmaceutical developers are streamlining their supply chains by engaging external partners who provide unified manufacturing and quality control services, thereby circumventing the steep capital expenditures associated with internal lab expansion. This movement toward strategic consolidation is exemplified by recent industry developments; according to a May 2025 press release by Minaris Advanced Therapies regarding the 'New company unveiled at the annual ISCT conference,' the firm merged Minaris Regenerative Medicine with the U.S. and U.K. divisions of WuXi Advanced Therapies. This union created a global entity managing testing services for more than 27 commercial products, underscoring the sector's increasing dependence on large-scale, integrated testing providers.

Key Players Profiled in the Mycoplasma Testing Market

• 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

Report Scope

In this report, the Global Mycoplasma Testing Market has been segmented into the following categories:

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
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Mycoplasma Testing Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

This product will be delivered within 1-3 business days.