Biological Safety Testing Market Size and Share
Market Overview
| Study Period | 2019 - 2030 |
|---|---|
| Market Size (2025) | USD 4.54 Billion |
| Market Size (2030) | USD 7.88 Billion |
| Growth Rate (2025 - 2030) | 11.63% 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. |
|
Biological Safety Testing Market Analysis by Mordor Intelligence
The Biological Safety Testing Market size is estimated at USD 4.54 billion in 2025, and is expected to reach USD 7.88 billion by 2030, at a CAGR of 11.63% during the forecast period (2025-2030).
Regulatory agencies now demand richer viral- and mycoplasma-safety datasets, while manufacturers scale up advanced therapy medicinal products (ATMPs) that require intensive contamination control. AI-enabled in-silico biosafety modelling is increasingly embedded in quality-control workflows, reducing batch-failure rates and trimming release times. Biothreat-preparedness spending from BARDA and EU-HERA has broadened demand beyond the traditional biopharma customer base. Outsourced quality control to Asia-based CDMOs, especially in China, is reshaping supply chains as laboratories there gain international accreditation.
Key Report Takeaways
- By product & service, reagents and kits led with 45.12% revenue share in 2024; instruments are poised to register the fastest 12.12% CAGR through 2030.
- By test type, sterility testing held 32.69% of the biological safety testing market share in 2024, whereas mycoplasma detection is projected to expand at an 11.71% CAGR.
- By application, recombinant proteins and monoclonal antibodies accounted for 64.28% of the biological safety testing market size in 2024 and continue to grow at 11.98% CAGR.
- By end user, pharmaceutical and biotechnology companies represented 52.38% revenue in 2024, while CDMOs recorded the highest 13.99% CAGR to 2030.
- By geography, North America held 46.25% revenue in 2024; Asia-Pacific is the fastest-growing region with a 17.24% CAGR to 2030.
Global Biological Safety Testing Market Trends and Insights
Drivers Impact Analysis
| Driver | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| Growth in global pharma–biotech pipeline & venture funding | +2.1% | Global, with concentration in North America & EU | Medium term (2-4 years) |
| Scale-up of ATMP manufacturing | +2.8% | Global, led by North America, expanding to EU & APAC | Long term (≥ 4 years) |
| Regulatory tightening on viral & mycoplasma contamination | +1.9% | Global, harmonized across FDA, EMA, PMDA jurisdictions | Short term (≤ 2 years) |
| Outsourcing surge to Asia-based CDMOs for cost-effective QC | +2.4% | APAC core, with spill-over effects to global supply chains | Medium term (2-4 years) |
| AI-enabled in-silico biosafety modelling | +1.2% | North America & EU early adoption, APAC following | Long term (≥ 4 years) |
| Biothreat-preparedness programs (BARDA, EU-HERA) | +1.1% | North America & EU, with strategic partnerships globally | Short term (≤ 2 years) |
| Source: Mordor Intelligence | |||
Growth in Global Pharma–Biotech Pipeline & Venture Funding
Deal flow across oncology, immunology, and gene therapy is setting record highs. Larger round sizes fund richer pre-clinical datasets, which in turn require extended biosafety test panels. Several start-ups, such as Aclid, raise seed capital earmarked for DNA-synthesis screening platforms that ease contamination risk, pushing volumes toward contract testing firms. The pipeline expansion particularly benefits contract testing organizations, as pharmaceutical companies increasingly outsource safety testing to specialized providers rather than maintaining in-house capabilities.
Scale-Up of Advanced Therapy Medicinal Products (ATMPs) Manufacturing
Guidance updates from the European Medicines Agency in 2024 and parallel FDA drafts are drawing ATMP producers toward expanded adventitious virus and cell-line authentication assays.[1]U.S. Food and Drug Administration, “Q5A(R2) Viral Safety Evaluation of Biotechnology Products,” fda.gov Lonza’s USD 1.2 billion site acquisition in Vacaville exemplifies the capital intensity needed to house such high-grade QC suites.[2]Lonza Group AG, “Lonza Completes Acquisition of Vacaville Facility,” lonza.com The unique testing requirements for ATMPs, including adventitious virus detection and cellular characterization, create specialized market segments with higher margins and technical barriers to entry.
Regulatory Tightening on Viral & Mycoplasma Contamination
FDA’s Q5A(R2) viral-safety revision now recognises next-generation sequencing and recombinant Factor C reagents, demanding simultaneous legacy and alternative tests during transition periods. Europe’s pharmacopeia adopted rFC for endotoxin limits in chapter 2.6.32, cementing global convergence.[3]bioMérieux, “ENDONEXT Recombinant Factor C Assays,” biomerieux.com The regulatory tightening particularly impacts mycoplasma detection, where traditional culture methods are being supplemented with molecular techniques offering faster, more sensitive detection. These enhanced requirements drive testing volume growth while simultaneously pushing technological innovation in detection methodologies.
Outsourcing Surge To Asia-Based CDMOs for Cost-Effective QC Services
Chinese and Singaporean facilities attract multinational sponsors by cutting QC costs up to 60% while passing regular FDA and EMA audits. Western providers respond with domestic capacity upgrades, such as SGS’s 2024 biologics testing expansion in New Jersey. The geographic shift creates supply chain dependencies that pharmaceutical companies must carefully manage, particularly given potential geopolitical risks and the BIOSECURE Act's implications for Chinese service providers. Contract Development and Manufacturing Organizations represent the fastest-growing end-user segment at 13.99% CAGR, reflecting this outsourcing acceleration and the increasing sophistication of Asian testing capabilities.
Restraints Impact Analysis
| Restraint | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| Lengthy validation cycles for novel rapid-micro methods | -0.9% | Global, particularly acute in regulated markets | Medium term (2-4 years) |
| Shortage of qualified biosafety personnel & high training costs | -0.6% | APAC core, expanding to MEA & Latin America | Long term (≥ 4 years) |
| Price pressure from large pharma driving margin compression for CROs | -1.1% | Global, concentrated in North America & EU | Short term (≤ 2 years) |
| Supply-chain fragility for single-use reagents (HEPA, LAL) | -0.8% | Global, with acute impacts in APAC manufacturing | Medium term (2-4 years) |
| Source: Mordor Intelligence | |||
Lengthy Validation Cycles for Novel Rapid-Micro Methods
Despite FDA encouragement under its Process Analytical Technology framework, global validation still demands 18-24 months of side-by-side testing against compendial methods. Suppliers such as Rapid Micro Biosystems demonstrate 1- to 3-day sterility reads, yet sponsors maintain parallel legacy assays until regulatory comfort is proven.
Shortage of Qualified Biosafety Personnel & High Training Costs
Competency gaps widen as next-generation sequencing and AI analytics enter mainstream QC. Certification programmes exceed USD 50,000 per scientist, and turnover hovers at 20% annually in key markets. The European Network for Highly Infectious Diseases calls for harmonised curricula to stabilise workforce quality.
Segment Analysis
By Product & Service: Reagents Hold the Revenue Core While Instruments Accelerate
Reagents and kits captured 45.12% revenue in 2024, reflecting their consumable pull-through as test volumes expand across sterile injectables and ATMP release lots. The biological safety testing market size attributed to reagents grows in tandem with heightened contamination-screening frequency. Single-use filters and recombinant Factor C endotoxin vials dominate purchase orders, although PFAS-driven PVDF-filter phase-outs are spurring redesigns. Instrument sales advance at a 12.12% CAGR, powered by automated plate-reading systems, ddPCR analytics, and real-time incubation chambers. Vendors integrate AI modules that flag anomalies and pre-empt false positives, shrinking deviation investigations. Service revenues climb as pharma sponsors outsource sterility, endotoxin, and cell-line authentication to specialist labs, using bundled contracts that include sample logistics and data-integrity auditing. Rising ATMP pipelines further tilt spending toward bespoke adventitious-virus panels, which carry premium pricing.
Note: Segment shares of all individual segments available upon report purchase
By Test Type: Sterility Remains Foundational, Mycoplasma Races Ahead
Sterility assays accounted for a 32.69% biological safety testing market share in 2024, remaining a release-critical step for every parenteral batch. Incubation-based protocols still dominate submissions, yet continuous-monitoring systems such as BACT/ALERT shorten final approval windows. Mycoplasma detection logs the highest 11.71% CAGR as PCR-based kits and combined RNA-sequencing workflows replace 28-day culture waits. Regulatory convergence around PCR acceptance accelerates adoption, especially for cell-therapy intermediates. Endotoxin testing is migrating to recombinant Factor C, decoupling supply from horseshoe-crab lysate shortages and enhancing sustainability. Adventitious-virus detection relies increasingly on next-generation sequencing, allowing sponsors to widen pathogen panels without extending timelines.
By Application: Recombinant Proteins Dominate Revenue, Cell & Gene Therapy Provides the Lift
Recombinant proteins and monoclonal antibodies contributed 64.28% to the 2024 revenue base while still expanding at 11.98% CAGR, keeping them the bedrock of the biological safety testing market. High-volume commercial antibodies demand predictable, high-throughput QC, prompting investment in dual-lane sterility suites that pair legacy culture with rapid-micro methods. Vaccine programmes remain steady beneficiaries of BARDA and EU-HERA funding, yet cell- and gene-therapy developers deliver the steepest incremental test volume per batch due to stringent viral-vector scrutiny. Blood-based therapies add complexity; pathogen-inactivation technologies adopted in Europe are not yet universal elsewhere, so QC labs must run multiple method combinations to satisfy divergent regulations.
Note: Segment shares of all individual segments available upon report purchase
By End User: Pharma & Biotech Still Largest, CDMOs Expand Fastest
Pharmaceutical and biotechnology firms commanded 52.38% of 2024 spending, as they retain core biosafety competencies for late-stage and commercial drugs. Nevertheless, the CDMO cohort records a 13.99% CAGR as cost-conscious sponsors externalise QC to integrated service providers. Avid Bioservices’ USD 1.1 billion acquisition by private-equity investors underscores the strategic value ascribed to bundled manufacturing-and-testing footprints. Academic institutes fill early-stage assay gaps, often leveraging grant-funded sequencing platforms to characterise novel vectors. Medical-device manufacturers remain a niche yet essential customer set, guided by the FDA’s risk-based ISO 10993 expectations that rely on biocompatibility and endotoxin evidence for clearance.
Geography Analysis
North America generated 46.25% of global revenue in 2024, supported by FDA regulatory rigor, BARDA procurement, and the presence of major monoclonal-antibody producers. Sponsors in the region increasingly pilot AI-driven contamination-risk algorithms, propelling demand for software-integrated incubators. Europe follows, benefitting from ATMP science clusters across Germany and the United Kingdom and from pharmacopoeial acceptance of rFC, which accelerates endotoxin-method shifts. Supply-chain stress does arise, as PFAS-regulated consumables face looming phase-outs that compel EU labs to re-qualify alternatives.
Asia-Pacific posts the highest 17.24% CAGR to 2030, propelled by China’s vast CDMO build-out, Singapore’s cell-therapy innovation hubs, and Japan’s ISO-aligned PMDA rules that ease export barriers. Local labs secure FDA multi-regional inspections, validating reliability at lower cost points. Still, geopolitical tensions and the pending BIOSECURE Act introduce uncertainty, pushing some sponsors to split QC placement between Asia and domestic sites for redundancy.
Middle East & Africa and South America remain nascent but strategic. National vaccine institutes in Brazil and Saudi Arabia invest in GMP-grade sterility and mycoplasma suites, supported by World Bank health-security grants. Limited skilled-personnel pools and intermittent power supply constrain pace, yet long-term commitments to regional manufacturing autonomy sustain incremental QC demand.
Competitive Landscape
Competitive intensity is moderate. Charles River Laboratories, Lonza, and Thermo Fisher Scientific anchor the high-end, leveraging global regulatory familiarity and full-service portfolios. They deploy M&A to absorb niche rapid-testing innovators; Lonza’s Vacaville buy bolsters large-scale antibody capacity and co-located biosafety suites. Meanwhile, Asian CDMOs such as WuXi Advanced Therapies market 40%-60 % cost savings for sterility and viral-vector assays, capturing small and mid-cap biotech contracts. Western rivals reply with domestic automation upgrades and data-integrity certifications that justify premium pricing.
Technology replaces price as a differentiator. Recombinant Factor C (rFC) reagents open the endotoxin segment to new suppliers, while next-generation sequencing vendors partner with QC labs to insert their pipelines into regulatory filings. AI-enabled risk prediction invites software entrants that collaborate with incubator OEMs to embed analytics at the equipment level. Sustainability is a budding battleground; suppliers offer PFAS-free single-use filtration and LAL-free endotoxin kits to align with pending environmental rules.
White-space opportunities persist in ATMP-specific contamination models and rapid adventitious-virus panels. Market leaders invest in joint development agreements with academic gene-therapy centers, securing early-access pipelines that later feed commercial contracts. Fragmentation is most pronounced among regional test-only laboratories that serve local generics makers; consolidation is likely as capital requirements escalate.
Biological Safety Testing Industry Leaders
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Eurofins Scientific
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Merck KGaA
-
Promega Corporation
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Thermo Fisher Scientific
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Lonza Group
- *Disclaimer: Major Players sorted in no particular order
Recent Industry Developments
- February 2025: FDA finalised guidance on the Advanced Manufacturing Technologies Designation Program, smoothing adoption of QC automation platforms.
- November 2024: Avid Bioservices entered a USD 1.1 billion merger with GHO Capital Partners and Ampersand Capital Partners, highlighting QC-service consolidation.
- October 2024: Lonza completed the USD 1.2 billion acquisition of Genentech’s Vacaville site, expanding biologics capacity and co-located QC infrastructure.
- October 2024: Bio-Rad launched the Vericheck ddPCR Kit for precise AAV-vector assessment, improving gene-therapy QC accuracy.
- October 2024: Lonza extended a partnership to supply antibody-drug conjugates, including a new bioconjugation suite in Visp, Switzerland, operational in 2027
Research Methodology Framework and Report Scope
Market Definitions and Key Coverage
Mordor Intelligence defines the biological safety testing market as the value generated by reagents, kits, instruments, and outsourced laboratory services applied to sterility, mycoplasma, bioburden, endotoxin, adventitious-agent, and residual host contaminant assays that certify biopharmaceuticals, vaccines, and advanced therapies as contamination-free before batch release. Scope touches every regulated stage from cell-bank establishment to commercial fill-finish while tracking revenues earned by in-house quality groups and external contract testing organizations.
Scope Exclusion: Routine environmental monitoring devices and biosafety cabinets fall outside this study.
Segmentation Overview
- By Product & Service
- Products
- Reagents & Kits
- Instruments
- Single-use Consumables
- Services
- Sterility Testing Services
- Endotoxin & Pyrogen Testing Services
- Cell Line Authentication & Characterisation
- Products
- By Test Type
- Sterility Tests
- Bioburden Tests
- Endotoxin/LAL Tests
- Mycoplasma Detection
- Adventitious Virus Detection
- By Application
- Recombinant Protein/Monoclonal Antibodies
- Vaccine and Therapeutics
- Cellular and Gene Therapy
- Blood and Blood-based Therapy
- Other Application
- By End User
- Biopharma & Biotech Companies
- Contract Development & Manufacturing Organisations
- Academic & Research Institutes
- Medical Device Manufacturers
- 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
Interviews with quality-assurance managers at large pharmas, CDMO commercial directors, and regulatory assessors across North America, Europe, and Asia helped us validate typical test volumes, outsourcing ratios, pricing corridors, and adoption of rapid-microbiological methods, filling gaps left by desk work.
Desk Research
Our analysts began with publicly available regulatory dossiers such as FDA's BLA approvals database, EMA's EudraGMDP listings, and WHO TRS annexes, which detail mandatory assay panels, thereby anchoring the universe of tests. We next sampled import-export codes for sterility test kits from UN Comtrade, cross-checked the bill-of-materials pricing trends on US ITC DataWeb, and reviewed industry association white papers from BioProcess International and PDA that quantify average quality-control spend per liter of biologic bulk. Paid repositories, D&B Hoovers for company financial splits, Questel for biosafety-related patent activity, and Dow Jones Factiva for contract award news, supplemented share and growth signals. These sources are illustrative; many other dependable publications and datasets were consulted for triangulation.
Market-Sizing & Forecasting
We first applied a top-down "biologic production volume × mandatory test intensity × average selling price" construct, rebuilt for five regions using batch filings and IND pipeline counts, then calibrated results with selective bottom-up vendor revenue roll-ups and channel checks. Key variables tracked included: 1) marketed biologic stock-keeping units, 2) new cell and gene therapy trials, 3) median assays per batch, 4) outsourcing penetration, and 5) assay ASP drift linked to rapid-method uptake. Multivariate regression, informed by expert consensus, projected each driver through 2030 and produced a defensible CAGR, while scenario analysis flagged upside demand from pandemic-preparedness funding. Data gaps in vendor splits were bridged by applying validated ASP benchmarks to disclosed sample volumes.
Data Validation & Update Cycle
Outputs pass a two-layer analyst review, variance tests against historical quality-control ratios, and anomaly checks versus quarterly earnings calls. Reports refresh yearly, with interim revisions triggered by material facility expansions, regulatory rewrites, or novel therapy approvals.
Why Mordor's Biological Safety Testing Baseline Commands Reliability
Published estimates often diverge because firms mix services with adjacent lab supplies, choose different base years, or refresh at uneven intervals.
Key gap drivers include narrower geographic cut-offs, omission of in-house testing revenue, one-time COVID windfalls embedded in some models, and currency conversion held constant by others despite recent dollar swings. Mordor's disciplined scope, annual refresh, and dual-approach modeling limit such distortions.
Benchmark comparison
| Market Size | Anonymized source | Primary gap driver |
|---|---|---|
| USD 4.54 B (2025) | Mordor Intelligence | |
| USD 5.51 B (2025) | Global Consultancy A | Includes PPE consumables and viral clearance services beyond mandated assays |
| USD 5.38 B (2025) | Regional Consultancy B | Uses supplier revenue booked in 2024 converted at constant 2022 FX rates |
| USD 4.20 B (2024) | Trade Journal C | Excludes captive in-house testing and applies conservative ASP decline assumption |
In sum, our balanced, transparently sourced baseline gives decision-makers a dependable starting point, one that is repeatedly stress-tested against real production data and expert judgment so surprises stay minimal while confidence stays high.
Key Questions Answered in the Report
What is the current size of the biological safety testing market?
The market is valued at USD 4.54 billion in 2025 and is projected to reach USD 7.88 billion by 2030.
Which region grows fastest in biological safety testing?
Asia-Pacific leads with a 17.24% CAGR, driven by China’s CDMO build-out and expanding regulatory alignment.
Why are recombinant proteins significant for biosafety testing demand?
Recombinant proteins and monoclonal antibodies hold 64.28% revenue in 2024, requiring high-volume sterility and endotoxin assays to maintain global supply.
How is AI influencing biological safety testing workflows?
AI-enabled in-silico modelling predicts contamination risks, supports real-time release, and can reduce batch failures, especially in viral-vector production lines.
What is replacing traditional LAL endotoxin testing?
Recombinant Factor C reagents gain regulatory acceptance, remove horseshoe-crab dependency, and provide 100% endotoxin specificity.
Which end-user group is expanding fastest?
Contract Development and Manufacturing Organizations post a 13.99% CAGR as sponsors outsource QC to integrated service providers.
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