Mycoplasma testing market seen reaching $3.52 billion by 2035

Market Research Future forecasts the global mycoplasma testing market will grow from $1.35 billion in 2026 to $3.52 billion by 2035, driven by tighter regulatory requirements, expanding cell and gene therapy pipelines, and wider use of rapid molecular testing. The market’s shift from culture-based methods to PCR and outsourcing to CDMOs is reshaping demand across biopharma and manufacturing.

Why it matters: - Mycoplasma testing is becoming a required compliance cost for biomanufacturers shipping cell-based products, not an optional quality upgrade. - Faster testing methods are replacing 28-day culture-based workflows, which changes how biopharma quality control teams operate. - Growth in cell and gene therapies is multiplying testing volume at cell bank, in-process and final release stages.

What happened: - Market Research Future projected the global mycoplasma testing market will rise from USD 1.35 billion in 2026 to USD 3.52 billion by 2035. - The forecast implies a 10.2% compound annual growth rate from 2026 to 2035. - The market base was estimated at USD 1.21 billion in 2025. - The forecast points to regulatory enforcement, cell and gene therapy expansion and rapid molecular platform adoption as the main growth drivers. - The report also cited rising outsourcing to contract manufacturing organizations and contract development and manufacturing organizations. - A free sample and detailed report were offered by Market Research Future.

The details: - FDA and EMA requirements have tightened across the biologics manufacturing lifecycle. - Updated EMA Annex 1, effective August 2023, increased mycoplasma detection expectations in aseptic manufacturing suites. - New biologic, biosimilar and advanced therapy medicinal product submissions now require documented mycoplasma clearance at cell bank, in-process and final product stages. - More than 2,800 cell and gene therapy candidates were in active clinical development globally as of Q4 2024. - That was a 42% increase from 2021 levels. - Global cell and gene therapy revenues are forecast to exceed USD 50 billion by 2032. - The global biopharmaceutical CDMO sector surpassed USD 22 billion in revenue in 2024. - About 40% of outsourced manufacturing contracts now include in vitro mycoplasma screening as a standard service. - Kits and reagents held about 42.3% of revenue in 2025. - qPCR held about 59.1% of revenue in 2025. - Digital PCR was the fastest-growing technology segment, with a 14.55% CAGR from 2026 to 2035. - Cell-line quality control held about 38.2% of revenue in 2025. - Gene and cell therapy manufacturing was the fastest-growing application segment, at 15.8% CAGR. - Biopharma and biotechnology companies accounted for about 60.15% of revenue in 2025. - Contract manufacturing organizations were the fastest-growing end-user segment, at 13.85% CAGR. - North America led the market with about 43.1% share in 2025. - Europe was the second-largest region with about 27.8% share in 2025. - Asia-Pacific was the fastest-growing region, at 16.5% CAGR. - The Middle East and Africa region was forecast to grow at 8.9% CAGR. - South America reached USD 0.04 billion in 2025.

Between the lines: - The market’s growth is being driven more by regulation and manufacturing scale than by broad discretionary healthcare spending. - CDMO outsourcing is shifting testing demand away from in-house labs and toward centralized service providers. - The move toward rapid PCR and digital PCR reflects pressure for faster release decisions and lower contamination risk. - Regional growth is strongest where biologics manufacturing infrastructure and regulatory alignment are expanding. - The report expects precision molecular diagnostics and AI-driven contamination prediction to shape the market through the end of the decade.

What's next: - The report expects the market to keep expanding through 2035 as biologics pipelines grow and compliance demands increase. - It forecasts that by 2030, 45% of large biomanufacturing QC laboratories will integrate AI-powered contamination prediction with automated testing workflows. - The ICH Q5A(R2) revision process is expected to establish globally harmonized acceptance criteria for rapid mycoplasma detection methods by 2027. - That could lower method-transfer costs and speed adoption of advanced molecular platforms. - More related research covers adjacent diagnostics and testing markets.

The bottom line: - Mycoplasma testing is moving from a niche QC function to a core, recurring requirement across biologics manufacturing, and that is expanding the market fast.