Mycoplasma Testing Market Size and Share
Market Overview
| Study Period | 2019 - 2030 |
|---|---|
| Market Size (2025) | USD 1.13 Billion |
| Market Size (2030) | USD 1.93 Billion |
| Growth Rate (2025 - 2030) | 11.27% CAGR |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0. |
|
Mycoplasma Testing Market Analysis by Mordor Intelligence
The Mycoplasma Testing Market size is estimated at USD 1.13 billion in 2025, and is expected to reach USD 1.93 billion by 2030, at a CAGR of 11.27% during the forecast period (2025-2030).
Heightened regulatory scrutiny on biologics manufacturing, expanding cell- and gene-therapy production, and growing preference for rapid nucleic-acid methods underpin this trajectory. Regulatory agencies, led by the FDA and EMA, require validated mycoplasma detection at multiple points in the product lifecycle, turning compliance into a non-discretionary spend for biomanufacturers fda.gov. Digital PCR and automated sample-to-answer platforms accelerate lot-release timelines, while the outsourcing trend transfers testing workloads to contract organizations that can scale capacity quickly. Regional manufacturing expansions in China, India, and Singapore combine with tax incentives to spur laboratory build-outs, yet shortages of skilled molecular QA personnel and high automation costs temper adoption rates in smaller facilities. Competitive dynamics favor vendors able to bundle instruments, kits, and services, boosting cross-selling potential and consolidating customer relationships.
Key Report Takeaways
- By product and service, kits and reagents held a 46.17% revenue share in 2024, whereas services are projected to expand at a 14.68% CAGR to 2030.
- By technology, qPCR led with 64.39% of the mycoplasma testing market share in 2024, while digital PCR is forecast to grow at 16.26% through 2030.
- By application, cell-line quality control accounted for 41.62% of the mycoplasma testing market size in 2024; gene and cell therapy manufacturing will rise at a 17.82% CAGR between 2025 and 2030.
- By end user, biopharma & biotechnology companies accounted for 65.29% of the mycoplasma testing market size in 2024; contract manufacturing organizations recorded the fastest growth, progressing at 15.45% CAGR to 2030.
- By geography, North America commanded 40.81% share of the mycoplasma testing market in 2024, yet Asia-Pacific is advancing at an 18.62% CAGR through 2030.
Global Mycoplasma Testing Market Trends and Insights
Drivers Impact Analysis
| Driver | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| Expansion of biopharma and cell & gene therapy facilities | +2.8% | Global, concentrated in North America & EU | Medium term (2-4 years) |
| Regulatory mandates require mycoplasma release testing | +2.1% | Global, led by FDA/EMA jurisdictions | Short term (≤ 2 years) |
| Increasing incidents of cell-culture contamination | +1.9% | Global, high-volume manufacturing hubs | Short term (≤ 2 years) |
| Rising demand for rapid, high-sensitivity PCR assays | +1.7% | North America & EU, expanding to APAC | Medium term (2-4 years) |
| Decentralised QC labs in emerging biotech hubs | +1.2% | APAC core, spill-over to MEA | Long term (≥ 4 years) |
| VC-backed growth of synthetic biology start-ups | +0.9% | North America & EU, emerging in APAC | Long term (≥ 4 years) |
| Source: Mordor Intelligence | |||
Expansion of Biopharma and Cell & Gene Therapy Manufacturing Facilities
Capacity ramp-ups in autologous and allogeneic therapy plants have multiplied sample volumes that require 100% batch testing. Contamination prevalence in cell cultures ranges between 15% and 35%, and FDA guidance now mandates mycoplasma testing after pooling and prior to washing, increasing sampling frequency.[1]American Type Culture Collection, “Cell Culture Contamination Studies,” atcc.org Continuous perfusion bioreactors raise real-time monitoring needs, pushing demand for automated analyzers that handle higher throughputs with minimal human intervention. Facility roll-outs in emerging markets must complete qualification studies, creating greenfield demand for third-party test services. Together, these trends add 2.8 percentage points to the forecast CAGR.
Regulatory Mandates Require Mycoplasma Release Testing for Biologics
The FDA’s laboratory developed tests rule and EMA guidance for advanced therapy medicinal Products require validated assays from a master cell bank to a finished drug.[2]Federal Register Editorial Team, “Laboratory Developed Tests; Final Rule,” federalregister.gov The European Medicines Agency's guidelines for Advanced Therapy Medicinal Products mandate comprehensive mycoplasma testing throughout the manufacturing process, from master cell banks to final product release. These regulatory changes create non-discretionary demand for testing services, as manufacturers cannot release products without demonstrating mycoplasma absence through validated methods. Compliance spending accelerates through 2027 as phased LDT oversight takes effect.The phased implementation of new LDT regulations over four years creates predictable demand growth as laboratories upgrade their testing capabilities to maintain compliance.
Increasing Incidents of Cell-Culture Contamination
Industry case studies document filtration bypass, DNA persistence, and charge-variant shifts in monoclonal antibodies following undetected contamination.[3]Wiley Editors, “Charge Variants in Contaminated mAbs,” onlinelibrary.wiley.com Economic fallout includes batch destruction, facility shutdowns, and regulatory inspections, prompting proactive screening policies. High-density cultures and longer residence times in intensified processes further elevate risk, translating into more frequent interim tests.
Rising Demand for Rapid, High-Sensitivity PCR-Based Assays
Digital PCR detects ≤10 CFU/mL without reference curves, providing absolute quantification that meets release-testing precision needs. Platforms such as the BIOFIRE Mycoplasma system report results in 60 minutes, condensing lot-release cycles. AI-driven analytics streamline interpretation and cut false positives. Regulatory nods, e.g., Health Canada’s clearance of Roche MycoTOOL, validate these technologies for commercial adoption.
Restraints Impact Analysis
| Restraint | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| High capital expenditure for automated systems | -1.8% | Global, smaller labs affected | Short term (≤ 2 years) |
| False-positive/-negative retest delays | -1.4% | Global, high-volume sites | Medium term (2-4 years) |
| Skilled molecular-QA workforce shortages | -1.1% | North America & EU, rising in APAC | Long term (≥ 4 years) |
| Regulatory lag on microfluidic and next-gen assays | -0.8% | Global, jurisdiction-specific | Medium term (2-4 years) |
| Source: Mordor Intelligence | |||
High Capital Expenditure for Implementing Automated Detection Systems
Entry-level automated analyzers cost USD 100,000–500,000, with annual service contracts topping USD 50,000. Smaller CTLs and academic labs struggle to justify such outlays, prolonging reliance on manual culture methods. FDA LDT compliance adds validation costs and strains capital budgets, curbing near-term uptake. Smaller contract testing laboratories face particular challenges in justifying automation investments given their limited sample volumes and diverse testing requirements. The complexity of validating automated systems for regulatory compliance adds significant time and cost burdens, with validation studies typically requiring 6-12 months and specialized expertise.
False-Positive/-Negative Retest Delays
DNA carry-over and cross-contamination trigger confirmatory workflows that erode the speed advantage of PCR, while false negatives threaten patient safety and invite regulatory scrutiny. Discordant results between culture and molecular assays extend release timelines by weeks, especially when investigation protocols lack standardisation. Regulatory agencies' requirements for investigation of atypical results can delay product releases by weeks or months, particularly when multiple testing methods yield conflicting outcomes. The industry's transition from culture-based to molecular methods introduces new sources of variability that require extensive method validation and comparison studies to establish confidence in results.
Segment Analysis
By Product & Service: Outsourced Services Gain Momentum
Kits and reagents maintained a 46.17% share in 2024, underlining their consumable nature within the Mycoplasma testing market. The Services segment is set to expand at 14.68% CAGR as biomanufacturers delegate method validation and routine screening to accredited laboratories. High regulatory hurdles and evolving assay formats encourage companies to buy expert capacity instead of building it. Eurofins’ network of 45+ global sites illustrates how scale produces cost-efficiencies that individual firms cannot replicate.
Automation-ready instruments show steady but slower growth because purchasers often tie them to long-term reagent contracts. The BIOFIRE platform and Rapid Micro Biosystems’ vial-reader appeal by blending speed with pharmacopeial compliance. As services grow, kit vendors align with third-party labs under reagent-rental models that lock in supply revenues. This synergy consolidates buyer–supplier dependencies and drives volume in both categories.
Note: Segment shares of all individual segments available upon report purchase
By Technology: Digital PCR Disrupts Legacy Workflows
qPCR holds 64.39% of the 2024 Mycoplasma testing market share thanks to entrenched protocols and broad instrument availability. Digital PCR, with a 16.26% growth rate, mitigates standard-curve errors and detects rare events vital for gene-therapy lots. Sensitivity gains resonate with regulatory auditors seeking robust quantification. Conventional PCR remains a budget choice for legacy facilities, while ELISA and DNA staining stay relevant in niche academic applications. Next-generation sequencing promises multiplex pathogen screens but awaits regulatory consensus.
Regulatory bodies now accept nucleic-acid methods equivalent to culture for release testing, catalysing digital PCR uptake. Instrument makers invest in microfluidic chip formats that slice reaction mixes into thousands of partitions, lowering detection thresholds. AI augmentation further lessens operator skill barriers, unlocking broader lab adoption.
By Application: Gene Therapy Drives Highest Upside
Cell-line quality control dominated the mycoplasma testing market in 2024, with a 41.62% share. Yet gene and cell therapy manufacturing will outpace all other uses at a 17.82% CAGR. Extended culture durations, autologous workflows, and multi-step manipulations amplify contamination risk, compelling frequent in-process checks. Regulatory guidance treats each manufacturing step as a potential contamination window, swelling sample numbers.
Bioproduction batch-release testing remains a staple, while raw-material & media testing gains share as firms recognise upstream vectors such as animal-origin components. Vaccine and virus manufacturers broaden surveillance alongside rising viral-vector therapeutics pipelines. Academic discovery work sits outside stringent release rules but still demands periodic screening to protect research integrity.
Note: Segment shares of all individual segments available upon report purchase
By End User: CMOs Capture Outsourcing Wave
Biopharma and biotechnology Companies accounted for 65.29% of the end-user segment in 2024, yet CMOs will grow the fastest at 15.45% CAGR as virtual biotech firms rely on third parties from plasmid prep through fill-finish. The Mycoplasma testing market size for contract labs widens when projects scale from pre-clinical to commercial runs.
Diagnostic and reference labs diversify into biologics support, chasing higher-margin industry work. Cell banks guard against line cross-contamination because a single tainted master cell bank can invalidate years of submissions. Workforce shortages push even large pharma to outsource surge testing during tech-transfer or facility shutdown periods, reinforcing the CMO growth curve.
Geography Analysis
North America led with 40.81% of 2024 revenue as FDA oversight, mature bioprocessing infrastructure, and early technology adoption underpin stable demand. The region’s biocluster density and capital availability encourage rapid replacement of culture methods with automated PCR systems. Service providers leverage proximity to innovators, enabling just-in-time sample logistics and compliance audits.
Europe follows with a cohesive regulatory framework from the EMA and harmonised pharmacopoeias that facilitate multi-country lot release. The Mycoplasma testing market size tied to EU gene-therapy trials rises as Germany, Spain, and the United Kingdom host GMP facilities. Vendors cater to multi-language documentation and serialization demands, spurring informatics-enabled assay platforms.
Asia-Pacific represents the fastest-growing arena, expanding at 18.62% CAGR. China’s cell-therapy sector benefits from government priority listings, while India’s production-linked incentive schemes attract vaccine exporters. Singapore’s decentralized QC labs shorten turnaround times for regional biologics plants. Fragmented regulations necessitate local validation, favouring global companies that co-locate service hubs.
South America and the Middle East & Africa trail in absolute revenue but offer untapped upside as domestic vaccine programs and biosimilar plants proliferate. Logistics hurdles and limited cold-chain infrastructure slow penetration of rapid PCR devices, yet public-health investments could unlock future orders once training and service networks mature.
Competitive Landscape
The mycoplasma testing market is moderately fragmented. Thermo Fisher Scientific, Charles River Laboratories, and Merck KGaA combine broad reagent portfolios with global technical-service teams, anchoring them atop instrument and kit sales. Danaher’s 2024 merger of Cytiva and Pall created a USD 7.5 billion bioprocess powerhouse that unifies filtration, culture media, and testing under one umbrella.
Specialised laboratories such as Eurofins Scientific and SGS scale through multi-site GMP accreditations, capturing outsourced workloads that require geographic proximity to filling lines. Their competitive edge lies in turnkey validation packages that compress client timelines. Smaller innovators like Minerva Biolabs focus on reagent-only niches, while Rapid Micro Biosystems targets high-throughput QC labs with automated reader systems.
Acquisition activity intensifies as firms chase end-to-end platform breadth. bioMérieux’s 2025 buyout of SpinChip Diagnostics adds ultra-fast immunoassay capability to complement its BIOFIRE molecular suite, positioning the company for sample-to-answer dominance. AI partnerships aim to trim interpretation errors and reduce retest frequency, providing another lever for differentiation.
Mycoplasma Testing Industry Leaders
-
Bionique Testing Laboratories Inc.
-
Thermo Fisher Scientific Inc.
-
Eurofins Scientific
-
Merck KGaA
-
ATCC
- *Disclaimer: Major Players sorted in no particular order
Recent Industry Developments
- January 2025: bioMérieux completed the acquisition of SpinChip Diagnostics ASA for EUR 111 (USD 127.3) million, enhancing its point-of-care diagnostics capabilities with rapid immunoassay technology that delivers results from whole blood samples in 10 minutes. The acquisition strengthens bioMérieux's position in the mycoplasma testing market by expanding its diagnostic platform portfolio and accelerating development of rapid testing solutions for biopharmaceutical applications.
- July 2024: SGS North America expanded its biologics testing capabilities at the Lincolnshire Center of Excellence, enhancing instrumentation and expertise to support growing biopharmaceutical market demand. The expansion includes advanced mycoplasma testing capabilities and positions SGS to capture increased demand from both small and large molecule testing applications.
- February 2024: Standard BioTools Inc. partnered with Next Gen Diagnostics to automate pathogen whole genome sequencing, reducing bacterial sequencing costs to under USD 10 per sample. The partnership addresses bottlenecks in sample preparation and bioinformatics that impact mycoplasma testing efficiency and scalability.
- March 2024: – US BioTek Laboratories acquired RealTime Laboratories, a pioneer in mycotoxin testing, expanding its diagnostic testing portfolio and geographic reach. The acquisition enhances US BioTek's capabilities in contamination testing and provides access to advanced testing technologies relevant to mycoplasma detection applications.
Research Methodology Framework and Report Scope
Market Definitions and Key Coverage
Our study defines the global mycoplasma testing market as all commercial instruments, kits, reagents, and outsourced services used to detect or monitor mycoplasma contamination in biopharmaceutical production and research cell cultures. Testing technologies embraced range from conventional culture-based assays to rapid nucleic-acid amplification platforms and fluorescent staining.
Scope exclusion: clinical respiratory or urogenital mycoplasma diagnostics performed in hospital laboratories are not counted in this market.
Segmentation Overview
- By Product & Service
- Instruments
- Real-time PCR Systems
- Rapid Microfluidic Analyzers
- Automated Detection Platforms
- Other Instruments
- Kits & Reagents
- PCR Assay Kits
- ELISA Kits
- Enzymatic Assay Kits
- Fluorescent‐Staining Reagents
- Others
- Services
- Instruments
- By Technology
- Conventional PCR
- qPCR
- Digital PCR
- ELISA
- Enzymatic Methods
- DNA Staining
- Next-Generation Sequencing
- Other NAATs
- By Application
- Cell-Line Quality Control
- Bioproduction Batch-Release Testing
- Raw-Material & Media Testing
- Gene & Cell Therapy Manufacturing
- Vaccine & Virus Testing
- Other Applications
- By End User
- Biopharma & Biotechnology Companies
- Contract Manufacturing Organizations (CMOs)
- Academic & Research Institutes
- Cell Banks & Repositories
- Diagnostic & Reference Laboratories
- By Geography
- North America
- United States
- Canada
- Mexico
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Rest of Europe
- Asia-Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of Asia-Pacific
- Middle East & Africa
- GCC
- South Africa
- Rest of Middle East & Africa
- South America
- Brazil
- Argentina
- Rest of South America
- North America
Detailed Research Methodology and Data Validation
Primary Research
Mordor analysts interviewed quality-assurance heads at biopharma manufacturers, procurement managers at contract manufacturing organizations, and directors of academic cell banks across North America, Europe, and high-growth Asia. These conversations validated usage rates, kit pricing tiers, and typical test frequency per 1,000 L bioreactor run, while short online surveys with lab managers helped us benchmark service outsourcing tendencies.
Desk Research
We began with open-access regulators, such as the US Food and Drug Administration's guidance on sterility for biologics, European Medicines Agency cell-based product dossiers, and WHO TRS reports, which clarify compulsory testing frequencies. Trade associations, including the International Society for Cell & Gene Therapy, BioProcess International, and the International Cell Line Authentication Committee, offer contamination incidence statistics and adoption benchmarks that our team filtered for global relevance.
Company 10-Ks, investor decks, patent filings indexed on Questel, shipment records from Volza, plus peer-reviewed papers in PubMed supplied shipment volumes, average selling prices, and technology diffusion clues. D&B Hoovers and Dow Jones Factiva provided financial splits for publicly listed kit suppliers. This list is illustrative; many additional public and proprietary sources supported data collection and cross-checks.
Market-Sizing & Forecasting
A top-down construct anchored on global biologics production capacity and average contamination monitoring frequency produced the initial demand pool, which was subsequently pressure tested through bottom-up spot checks of key supplier revenues and channel ASP × volume splits. Variables driving the model include cumulative biologics batch capacity (L), regulated batch-release test quotas, penetration of rapid PCR methods, kit ASP deflation, workforce availability, and regional CapEx incentives. Multivariate regression gauges the influence of these indicators, and scenario analysis frames upside or downside around regulatory stringency shifts. Where supplier roll-ups under or overshot the macro build, gap ratios were evenly distributed across segments before final sign-off.
Data Validation & Update Cycle
Every dataset passes variance screens, peer review by a second analyst, and senior approval. Annual refreshes are standard; mid-cycle updates trigger when the FDA, EMA, or major economies issue new biologics guidance or a top-five supplier restates revenues. A last-mile sense check occurs just before release so clients receive the freshest view.
Why Our Mycoplasma Testing Baseline Commands Reliability
Published figures often differ because firms apply unique scope boundaries, currency assumptions, and forecast cadences. Our team openly discloses variables and refresh timing so buyers grasp the levers behind every number.
Key gap drivers include whether diagnostics are bundled with bioprocess testing, the aggressiveness of kit price erosion curves, and how frequently capacity expansions are folded into models. Our base year, 2025, reflects full inclusion of gene-therapy dedicated facilities and a balanced ASP glide path, whereas some publishers adopt conservative expansion lags or exclude service revenues.
Benchmark comparison
| Market Size | Anonymized source | Primary gap driver |
|---|---|---|
| USD 1.13 billion (2025) | Mordor Intelligence | - |
| USD 926.5 million (2024) | Global Consultancy A | Omits outsourced testing services and assumes slower PCR adoption |
| USD 909.5 million (2023) | Regional Consultancy B | Excludes Asia-Pacific capacity additions and uses 2023 currency averages |
| USD 1.08 billion (2024) | Industry Association C | Applies flat ASPs and a narrower kit portfolio definition |
The comparison shows that differing inclusions around services, geography, and pricing mechanics explain most numeric gaps. By grounding estimates in verifiable capacity metrics and regularly refreshed primary cues, we believe Mordor Intelligence provides the most transparent, decision-ready baseline for stakeholders planning investments or regulatory strategy.
Key Questions Answered in the Report
What is the current size of the mycoplasma testing market?
The market is valued at USD 1.13 billion in 2025 and is forecast to reach USD 1.93 billion by 2030.
Which segment is growing the fastest?
Gene & Cell Therapy Manufacturing is projected to grow at 17.82% CAGR due to strict contamination-control requirements.
Why are CMOs gaining share in mycoplasma testing?
Biotech firms are outsourcing manufacturing and quality control to CMOs to access validated laboratories without large capital outlays, pushing CMO demand up at 15.45% CAGR.
How do regulatory mandates influence market growth?
FDA and EMA rules make mycoplasma testing mandatory before product release, creating non-discretionary spending that raises overall market CAGR.
Which technology is disrupting traditional methods?
Digital PCR offers absolute quantification with detection limits around 10 CFU/mL, expanding at 16.26% CAGR as labs replace culture-based assays.
What restrains rapid adoption of automated platforms?
High upfront costs of USD 100,000–500,000 and shortages of trained molecular-QA staff delay automation, particularly in smaller labs.
Page last updated on:
