The global cell & gene therapy quality control market is on a rapid growth trajectory, expected to rise from USD 2.28 billion in 2024 to around USD 22.81 billion by 2034, reflecting a robust CAGR of 25.74% during the forecast period (2025–2034). This surge is driven by increasing approvals of cell and gene therapies, stringent regulatory requirements, and the rising demand for advanced testing processes.

In this article, we explore the market size, growth drivers, and provide a brief overview of the top companies shaping the cell & gene therapy quality control landscape.

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📊 Cell & Gene Therapy Quality Control Market Overview

• Market Size (2024): USD 2.28 billion

• Market Size (2025): USD 2.87 billion

• Projected Size (2034): USD 22.81 billion

• CAGR (2025–2034): 25.74%

🌎 Regional Insights

• North America dominates with a 40–45% share in 2024 due to strong R&D infrastructure and government support.

• Asia Pacific is the fastest-growing region, driven by rising healthcare investments and increased awareness.

🔬 Testing Type Insights

• Sterility Testing accounted for the largest revenue share in 2024 (20–25%).

• Potency Testing is expected to be the fastest-growing segment through 2035.

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🚀 Key Drivers Fueling Market Growth

1. Rising Approvals of Advanced Therapies: Increased FDA and EMA approvals for gene and cell therapies.

2. Stringent Regulatory Norms: Need for rigorous testing to ensure safety and efficacy.

3. Innovation in QC Technologies: Automation and AI-driven testing platforms gaining traction.

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🏆 Top Companies in the Cell & Gene Therapy Quality Control Market

Here’s a snapshot of the leading players shaping this dynamic industry:

🔹 Charles River Laboratories

• About: A global leader in laboratory services supporting drug discovery and development.

• Products: Endotoxin testing, sterility assurance, viral clearance studies.

• Market Cap: Approx. USD 12 billion.

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🔹 Eurofins Scientific

• About: Specializes in analytical testing for genomics, pharmaceuticals, and environment.

• Products: Cell-based assays, microbiology QC services, analytical support for CGT.

• Market Cap: Approx. USD 17 billion.

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🔹 Thermo Fisher Scientific

• About: A multinational providing innovative solutions for scientific research and diagnostics.

• Products: PCR reagents, sterility testing kits, QC instrumentation.

• Market Cap: Approx. USD 200 billion.

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🔹 Merck KGaA (MilliporeSigma)

• About: Known for life science tools and solutions under MilliporeSigma in the U.S.

• Products: Sterility testing systems, viral filtration solutions, analytics platforms.

• Market Cap: Approx. USD 85 billion.

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🔹 Sartorius AG

• About: German-based company focused on laboratory and bioprocess solutions.

• Products: QC systems for gene therapy, bioanalytics tools, bioprocess control systems.

• Market Cap: Approx. USD 25 billion.

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🔹 Bio-Rad Laboratories

• About: Provides life science research and clinical diagnostic products worldwide.

• Products: PCR instruments, QC assays for gene therapy validation.

• Market Cap: Approx. USD 12 billion.

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🔹 QIAGEN N.V.

• About: Dutch-German provider of sample and assay technologies.

• Products: Viral vector QC, nucleic acid purification kits, PCR reagents.

• Market Cap: Approx. USD 10 billion.

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🔹 Danaher Corporation (Cytiva)

• About: Through Cytiva, Danaher delivers bioprocess solutions for cell & gene therapies.

• Products: QC testing platforms, viral clearance services, analytics solutions.

• Market Cap: Approx. USD 185 billion.

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🔹 Promega Corporation

• About: Privately held company offering genomic and proteomic solutions.

• Products: Luminescent assay kits, QC reagents for gene therapies.

• Market Cap: Estimated revenue over USD 750 million annually.

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🔹 WuXi AppTec

• About: Leading China-based CRO offering comprehensive cell & gene therapy services.

• Products: GMP QC testing, viral safety testing, analytical development services.

• Market Cap: Approx. USD 22 billion.

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🔹 Lonza Group AG

• About: Swiss biotech giant providing end-to-end manufacturing for CGT.

• Products: QC analytics, sterility testing, viral vector services.

• Market Cap: Approx. USD 40 billion.

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🔹 Agilent Technologies

• About: Develops instruments and software for laboratories globally.

• Products: Analytical instruments for QC, bioanalyzers.

• Market Cap: Approx. USD 35 billion.

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🔹 Illumina, Inc.

• About: Genomics pioneer, providing sequencing solutions.

• Products: NGS platforms for QC in gene therapy, sequencing reagents.

• Market Cap: Approx. USD 30 billion.

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🔹 Bio-Techne Corporation

• About: Supplies life sciences tools, particularly for CGT applications.

• Products: QC reagents, analytical assays for cell characterization.

• Market Cap: Approx. USD 12 billion.

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🔹 Samsung Biologics

• About: South Korea’s leading CDMO with QC capabilities for advanced therapies.

• Products: Sterility testing, viral vector analytics, manufacturing QC support.

• Market Cap: Approx. USD 55 billion.

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🔹 Labcorp Drug Development

• About: Formerly Covance, provides comprehensive QC solutions for clinical trials.

• Products: Bioanalytical testing, viral clearance studies, sterility assurance.

• Market Cap: Approx. USD 17 billion.

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🔹 BlueBird Bio QC Labs

• About: Specialized in gene therapy development with integrated QC labs.

• Products: Potency testing, viral vector quality assessments.

• Market Cap: Approx. USD 500 million.

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❓ Frequently Asked Questions (FAQs)

1. What is driving the growth of the cell & gene therapy quality control market?

The growth is driven by increased approvals of CGTs, regulatory compliance needs, and innovations in QC technologies.

2. Which region dominates the market?

North America leads due to robust infrastructure and high R&D investments.

3. Which testing type holds the largest market share?

Sterility testing currently holds the largest share, while potency testing is the fastest-growing segment.

4. Who are the leading players in this market?

Top players include Thermo Fisher Scientific, Charles River Laboratories, Merck KGaA, Lonza Group, and WuXi AppTec.

5. What is the expected CAGR of the market between 2025 and 2034?

The market is projected to grow at a CAGR of 25.74% during this period.

Source : https://www.towardshealthcare.com/insights/cell-and-gene-therapy-quality-control-market-sizing

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