Cell and Gene Therapy Quality Control and Analytics Market Revenue by 2033

13 Oct 2025

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Table of Content

1. Cell and Gene Therapy Quality Control and Analytics Market Revenue and Trends 2025 to 2033 2. Market Growth and Key Propulsive Factors 3. Segmental Analysis 4. Regional Analysis 5. Cell & Gene Therapy Quality Control & Analytics Market Coverage 6. Key Players in Cell and Gene Therapy Quality Control and Analytics Market

Cell and Gene Therapy Quality Control and Analytics Market Revenue and Trends 2025 to 2033

The cell and gene therapy quality control and analytics market is driven by increasing therapeutic approvals, regulatory emphasis on safety, and advancements in molecular testing technologies. The Cell & Gene Therapy Quality Control & Analytics Market is witnessing robust growth driven by rising therapeutic approvals, regulatory focus on safety, and advances in molecular testing technologies.

Market Growth and Key Propulsive Factors

The cell and gene therapy quality control and analytics market is growing significantly due to increased clinical adoption of cutting-edge regenerative therapies and multi-agency regulatory focus on product safety and consistency. This market covers tools, technologies, and services that are part of evaluating cell and gene therapy products’ purity, potency, identity, and safety throughout development and manufacturing.

Additionally, demand for precision therapies, expansion of biopharmaceutical manufacturing facilities, and continued refinement of analytical methods like PCR, NGS, and flow cytometer provide growth impetus. Moreover, the introduction of automated quality systems and AI-based analytics facilitate quicker and more robust product validation and release.

Segmental Analysis

• By Testing Type - The sterility testing type leads the market due to its role in ensuring that there is no microbial contamination of advanced cell and gene therapy products, ensuring safety and efficacy in addition to compliance with increasing regulatory requirements.
• By Analytical Method - PCR leads the analytical method segment based on greater specificity, higher speed, and provenance of genetic contaminants while still supporting product consistency to be considered for gene and cell therapies.
• By Area of Application - Oncology is the leading area of application as the majority of the approved gene facilitated therapies and gene therapies in the pipeline target a variety of cancers and treatment paradigms in oncology which drives a higher demand for analytical and control solutions.
• By End User - The greater investment in advanced analytical platforms increases reliance on pharmaceutical and biotech companies as the end-user, as this industry class are the original end-users of therapeutic cell and gene products.

Regional Analysis

North America is the preeminent force in the cell & gene therapy quality assurance arena, buoyed by clarity of CMC and clinical insights from both regulators and innovators resulting in clear route to market for complex bespoke assays. The footprint of dense clusters of CDMOs, analytical laboratories and clinical trial infrastructure enable medic and biologic scale-up and industrial speed batch release testing.

Asia Pacific is rapidly growing as regulators streamline pathways, local biotechs grow, and goverments put resources into advanced therapies with funding, pilot manufacture, and funding. Total commercial clinical trial footprint in region has increased substantially and is driven by China, Japan and India implementing more streamlined approvals for larger trial populations all resulting in an increase in demand for analytics, release testing, and CRO services. Many local CDMOs and academic translational centers are establishing even faster uptakes of quality control platforms.

Cell & Gene Therapy Quality Control & Analytics Market Coverage

Recent Developments

• In April 2025, AGC Biologics launched new Cell and Gene Technologies Division that focus on increasing AGC Biologics capabilities and supporting developers in need of capacity, scientific capabilities, and technically qualified cell and gene CDMO operators. (Source: https://www.agcbio.com)

Key Players in Cell and Gene Therapy Quality Control and Analytics Market

• Lonza Group
• WuXi AppTec
• Charles River Laboratories
• MilliporeSigma
• Labcorp Drug Development
• Eurofins Scientific
• Catalent, Inc.
• BioReliance (Merck KGaA)
• Pharmalex
• Medpace, Inc.

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