생물학적 안전성 시험 : 시장 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the biological safety testing market size is expected to grow from USD 4.54 billion in 2025 to USD 5.07 billion in 2026 and is forecast to reach USD 8.78 billion by 2031 at 11.63% CAGR over 2026-2031.

This report is Segmented by Product & Service (Products and Services), Test Type (Sterility Tests, Bioburden Tests, and More), Application (Recombinant Protein/Monoclonal Antibodies, and More), End User (Biopharma & Biotech Companies, Cdmos, and More), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). Market Forecasts are Provided in Terms of Value (USD).

Global Biological Safety Testing Market Trends and Insights

Expansion of Global Biopharma R&D and Venture Financing

Venture investors deployed USD 23 billion into biopharma in 2024, channeling 42% of capital toward immunology and gene-editing platforms that require extensive safety testing before investigational new drug filings. European Medicines Agency data show a 19% increase in biologics submissions during the first half of 2025, with each submission requiring sterility, endotoxin, and mycoplasma panels. Series B-stage sponsors are locking in three-year master service agreements that hedge reagent inflation of 8-12% seen in 2024-2025, concentrating spend among the five largest global laboratories. Pfizer reported a 14% increase in outsourced quality-control spending in 2025, as its mRNA vaccine portfolio expanded, underscoring the trend's durability. These trends collectively raise baseline testing volumes and translate venture funding into predictable service revenues.

Accelerated Commercialization of Cell & Gene Therapies

The U.S. FDA approved eight cell and gene therapy products in 2024, bringing the cumulative number of authorizations to 37 since 2017. Each autologous launch multiplies safety-testing demand, as batches cannot be pooled. Novartis processed more than 12,000 sterility tests in 2024 for its CAR-T network, illustrating the one-patient-one-batch paradigm. The EMA guidance issued in 2025 doubled viral testing for lentiviral vectors by mandating both in vitro and in vivo assays, while Japan shortened sterility holds from 28 days to seven, spurring the uptake of rapid methods across the Asia-Pacific region. Bluebird Bio reduced its release cycle time by 30% after installing automated mycoplasma detection at its Seattle site, confirming that in-house rapid platforms can quickly pay back when throughput is high. Geographic clusters are now co-locating manufacturing and testing to keep autologous products within a 48-hour cold-chain window.

Prolonged Validation Timelines for Novel Rapid Microbiology Methods

Rapid sterility platforms promise three-day results versus the 14-day compendial benchmark; however, U.S. FDA guidance issued in 2024 requires side-by-side equivalence studies over at least 30 production batches, which pushes validation timelines to 18-24 months for low-volume biologics. Charles River Laboratories noted a sub-forecast adoption of its Celsis system due to this burden, and the European Pharmacopoeia's 2025 framework grants full equivalence only to technologies detecting under 10 colony-forming units, a threshold that many ATP and cytometry platforms miss. Contract labs cannot amortize single-product validations across clients, choking mid-tier investment appetite. Consequently, fewer than 12% of Lonza's biologics customers had migrated to rapid sterility testing by mid-2025. Widespread adoption is therefore unlikely before 2028, which will limit the benefits of cycle-time compression in the intermediate term.

Other drivers and restraints analyzed in the detailed report include:

1. Stringent Global Regulatory Standards for Contamination Control
2. Growing Outsourcing of Quality Control to Cost-Efficient CDMOs
3. Volatile Supply of Horseshoe Crab Lysate and Alternate Reagent Uncertainty

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Services are rising at a 13.54% CAGR through 2031, even though products commanded 62.45% of the biological safety testing market in 2025. The high upfront price of automated microbiology platforms-often above USD 500,000 per unit-pushes early-stage sponsors toward variable-cost outsourcing. Suppliers of reagents are bundling LAL kits with rFC alternatives to mitigate lysate shortages, while single-use containers now require extractables- and leachables assays under ISO 13485:2024. Eurofins grew biopharma services revenue 16% year-over-year in 2024 as clients avoided 12- to 18-month in-house validation lead times.

Structural shifts favor services because CDMOs can amortize capital across multiple clients and offer faster turnaround times. Laboratories, such as Pacific BioLabs, have trimmed sterility cycles to 10 days by implementing staggered incubation, whereas product vendors face margin pressure due to competitive pricing per test. The services segment also captures value from new viral-safety requirements that many sponsors cannot support internally without BSL-2 or BSL-3 facilities. Consequently, outsourcing continues to gain momentum as complexity and regulatory expectations escalate.

Sterility tests held 28.54% of revenue in 2025, but face commoditization as automated liquid handlers cut labor input. Adventitious virus detection is the fastest-growing segment, with a 13.76% CAGR, driven by concerns about replication-competent lentivirus in gene therapy. Endotoxin assays remain high-margin because reagent scarcity inflates prices, yet widespread rFC approval could trim costs by 20% within three years. Mycoplasma detection is pivoting to PCR-based kits that provide four-hour results and comply with European Pharmacopoeia chapter 2.6.7.

Segment dynamism hinges on regulatory incentives. Charles River saw viral-safety revenue increase by 21% in 2024, as more clients required both pre-clinical and commercial testing. Rapid technology adoption is uneven; BioMerieux launched a multiplex assay that detects eight Mycoplasma species in a single run, while USP (71) revisions forced sponsors to revalidate sterility filters, temporarily boosting demand for contract labs. The biological safety testing market size for adventitious virus panels is set to expand as allogeneic therapies push master-cell-bank testing upstream.

Complete Report Scope:

• By Product & Service
  • Products
    • Reagents & Kits
    • Instruments
    • Single-Use Consumables
  • Services
    • Sterility Testing Services
    • Endotoxin & Pyrogen Testing Services
    • Cell Line Authentication & Characterisation
• 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
• 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 And Africa
    • GCC
    • South Africa
    • Rest Of Middle East And Africa
  • South America
    • Brazil
    • Argentina
    • Rest Of South America

Geography Analysis

North America contributed a 41.67% revenue share in 2025, anchored by venture-backed biotech clusters and the FDA's enforcement of revised sterility rules that link environmental monitoring with batch release. Thermo Fisher completed a USD 150 million expansion in Rockville to add capacity for 2,000 in vivo viral assays, while Canada harmonized mycoplasma PCR requirements with USP (63). Mexico's Grupo PiSA gained FDA recognition as a foreign testing site, shortening batch-release timelines for U.S. sponsors.

Europe benefits from a centralized EMA pathway, concentrating the biological safety testing market share in Germany, Switzerland, and Ireland. Lonza's EU labs operated at 87% utilization during the second half of 2024. Rapid-method interest is rising following the European Pharmacopoeia's alternative methods chapter; however, the U.K.'s divergent viral-safety rules require dual testing for pan-European launches. France and Italy are scaling CAR-T testing through public-private partnerships, boosting regional capacity.

The Asia-Pacific region is expected to post the fastest growth at a 12.54% CAGR from 2026 to 2031, following the NMPA's alignment with ICH standards and rising CDMO investment. WuXi's Shanghai lab secured EMA release-site status, and Japan reduced sterility holds to seven days, facilitating rapid method adoption. Samsung Biologics' three QC suites in Incheon illustrate capital intensity that smaller regional CDMOs cannot match. India's Biocon won EMA approval for its Bengaluru lab, while Australia reduced the review time for investigational testing to 30 days, attracting early-phase sponsors.

Emerging regions, such as South America and the Middle East, are adding capacity to meet WHO prequalification standards. Brazil now mandates Mycoplasma PCR for cell-culture products, and the UAE is building a USD 25 million testing center in Dubai Science Park. South Africa partnered with SGS to reduce sample shipping delays, signaling a greater level of regional self-sufficiency.

1. Alcami
2. Avance Biosciences
3. bioMerieux
4. Charles River
5. Creative BioLabs
6. Cytovance Biologics
7. Eurofins
8. Lonza Group
9. Merck KGaA (MilliporeSigma)
10. Microbac Laboratories
11. Nelson Labs
12. Pall Corporation (Danaher)
13. Pacific BioLabs
14. Promega
15. Sartorius
16. SGS
17. STERIS
18. Thermo Fisher Scientific
19. Toxikon (Labcorp)
20. WuXi App Tec

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope Of The Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Expansion of Global Biopharma R&D and Venture Financing
  • 4.2.2 Accelerated Commercialization of Cell & Gene Therapies
  • 4.2.3 Stringent Global Regulatory Standards for Contamination Control
  • 4.2.4 Growing Outsourcing of Quality Control to Cost-Efficient CDMOs
  • 4.2.5 Adoption of Digital Twins and Predictive Analytics for Batch Release
  • 4.2.6 Government Biodefense Stockpile Initiatives Boosting Validation Demand
• 4.3 Market Restraints
  • 4.3.1 Prolonged Validation Timelines for Novel Rapid Microbiology Methods
  • 4.3.2 Limited Skilled Workforce and Rising Training Expenditure
  • 4.3.3 Margin Compression from Vendor Consolidation in Testing Supply Chain
  • 4.3.4 Volatile Supply of Horseshoe Crab Lysate and Alternate Reagent Uncertainty
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat Of New Entrants
  • 4.7.2 Bargaining Power Of Buyers
  • 4.7.3 Bargaining Power Of Suppliers
  • 4.7.4 Threat Of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Product & Service
  • 5.1.1 Products
    • 5.1.1.1 Reagents & Kits
    • 5.1.1.2 Instruments
    • 5.1.1.3 Single-Use Consumables
  • 5.1.2 Services
    • 5.1.2.1 Sterility Testing Services
    • 5.1.2.2 Endotoxin & Pyrogen Testing Services
    • 5.1.2.3 Cell Line Authentication & Characterisation
• 5.2 By Test Type
  • 5.2.1 Sterility Tests
  • 5.2.2 Bioburden Tests
  • 5.2.3 Endotoxin/LAL Tests
  • 5.2.4 Mycoplasma Detection
  • 5.2.5 Adventitious Virus Detection
• 5.3 By Application
  • 5.3.1 Recombinant Protein / Monoclonal Antibodies
  • 5.3.2 Vaccine And Therapeutics
  • 5.3.3 Cellular And Gene Therapy
  • 5.3.4 Blood And Blood-Based Therapy
  • 5.3.5 Other Application
• 5.4 By End User
  • 5.4.1 Biopharma & Biotech Companies
  • 5.4.2 Contract Development & Manufacturing Organisations
  • 5.4.3 Academic & Research Institutes
  • 5.4.4 Medical Device Manufacturers
• 5.5 Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest Of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest Of Asia-Pacific
  • 5.5.4 Middle East And Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest Of Middle East And Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest Of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles {(Includes Global Level Overview, Market Level Overview, Core Segments, Financials as Available, Strategic Information, Market Rank/Share for Key Companies, Products & Services, and Recent Developments)}
  • 6.3.1 Alcami Corporation
  • 6.3.2 Avance Biosciences
  • 6.3.3 BioMerieux SA
  • 6.3.4 Charles River Laboratories
  • 6.3.5 Creative BioLabs
  • 6.3.6 Cytovance Biologics
  • 6.3.7 Eurofins Scientific
  • 6.3.8 Lonza Group
  • 6.3.9 Merck KGaA (MilliporeSigma)
  • 6.3.10 Microbac Laboratories
  • 6.3.11 Nelson Labs
  • 6.3.12 Pall Corporation (Danaher)
  • 6.3.13 Pacific BioLabs
  • 6.3.14 Promega Corporation
  • 6.3.15 Sartorius AG
  • 6.3.16 SGS SA
  • 6.3.17 Steris PLC
  • 6.3.18 Thermo Fisher Scientific
  • 6.3.19 Toxikon (Labcorp)
  • 6.3.20 WuXi AppTec

7 Market Opportunities & Future Outlook

• 7.1 White-Space & Unmet-Need Assessment