Cell and Gene Therapy Manufacturing QC Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Therapy Type (Cell Therapy, Gene Therapy), By Offering (Instruments, Consumables, Others), By Process (Raw Material Preparation, Upstream Processing, Downstream Processing, Packaging), By Technology (Polymerase Chain Reaction (PCR), Flow Cytometry, Limulus Amebocyte Lysate (LAL), Enzyme-Linked Immunosorbent Assay (ELISA), Chromatography, Mass Spectrometry, Western Blotting, Next-Generation Sequencing (NGS), Electrophoresis, Others), By Application (Safety Testing, Potency Testing, Identity Testing, Stability and Genetic Fidelity Testing, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 1.35 Billion
CAGR (2026-2031)	6.87%
Fastest Growing Segment	Gene Therapy
Largest Market	North America
Market Size (2031)	USD 2.01 Billion

Market Overview

The Global Cell and Gene Therapy Manufacturing QC Market will grow from USD 1.35 Billion in 2025 to USD 2.01 Billion by 2031 at a 6.87% CAGR. Cell and gene therapy manufacturing quality control comprises the rigorous analytical testing and regulatory compliance processes employed to verify the safety, potency, purity, and identity of advanced therapy medicinal products. The market is primarily supported by the escalating volume of clinical trials and the increasing frequency of regulatory approvals for treatments targeting rare genetic disorders and oncology. These factors compel manufacturers to implement extensive quality assurance frameworks to manage the inherent variability of biologic materials and meet stringent safety standards during commercial scaling.

According to the American Society of Gene and Cell Therapy, in 2024, the global development pipeline included over 4,000 therapeutic candidates, creating a substantial demand for specialized testing protocols. Despite this robust growth, one significant challenge impeding market expansion is the technical complexity and high cost associated with developing standardized potency assays, which often extends production timelines and increases the overall cost of goods sold.

Key Market Drivers

Substantial capital influx and investments in biopharmaceutical R&D are fundamentally accelerating the adoption of advanced quality control measures within the cell and gene therapy (CGT) sector. As developers race to commercialize complex therapies, significant financial resources are being allocated not only to clinical progression but also to the establishment of robust, scalable manufacturing and testing infrastructure. This financial buoyancy enables companies to procure high-end analytical instruments and validate rapid testing methods essential for regulatory compliance. According to the Alliance for Regenerative Medicine, in October 2024, the sector witnessed a resurgence in financing, with global investments reaching $10.9 billion in the first half of the year alone. Such funding is critical for overcoming manufacturing bottlenecks, ensuring that quality control processes evolve in tandem with the increasing number of therapeutic candidates entering late-stage development.

The integration of automation and digitalization in quality control workflows represents the second pivotal driver, directly addressing the industry's need for precision and error reduction. Automated platforms are increasingly replacing manual, labor-intensive assays, thereby enhancing data integrity and reducing the turnaround time for sterility and potency results. This shift is exemplified by major pharmaceutical collaborations seeking to secure automated production capacities. For instance, Fierce Pharma reported in April 2024 that Bristol Myers Squibb signed a deal worth $380 million to reserve exclusive capacity on Cellares' fully automated manufacturing and quality control platform. This trend is further underscored by the broader regulatory success of the field; according to PharmaBoardroom, in April 2024, the industry celebrated a record year with seven new cell and gene therapies receiving FDA approval in 2023, a milestone that reinforces the urgency for automated, compliant QC solutions to meet commercial demand.

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Key Market Challenges

The technical complexity and high cost associated with developing standardized potency assays constitute a formidable barrier to the growth of the Global Cell and Gene Therapy Manufacturing QC Market. Because advanced therapies exhibit significant biological variability, manufacturers are often forced to create bespoke testing protocols to verify product potency rather than relying on off-the-shelf standards. This lack of standardization necessitates labor-intensive, expensive development cycles that significantly inflate the overall cost of goods sold (COGS) and extend production timelines. These challenges frequently result in regulatory delays, as Chemistry, Manufacturing, and Controls (CMC) deficiencies prevent products from progressing to the commercial stage where high-volume quality control testing revenue is generated.

According to the Alliance for Regenerative Medicine, in 2024, the industry anticipated up to 17 regulatory approvals for new cell and gene therapies globally. This projected influx of commercial products highlights the acute pressure on quality control systems; however, the inefficiency of current potency assays creates a bottleneck that stifles this potential throughput. Consequently, the market’s expansion is directly impeded as high testing costs and technical hurdles slow the transition of therapeutic candidates into scalable commercial production.

Key Market Trends

The increasing outsourcing of specialized QC assays to Contract Development and Manufacturing Organizations (CDMOs) has become a dominant trend as developers grapple with the technical demands of characterizing complex viral vectors and cell therapies. Rather than building expensive in-house testing capabilities for every modality, biopharmaceutical companies are leveraging the established regulatory expertise and scalable infrastructure of CDMOs to accelerate batch release. This consolidation of manufacturing and testing resources is best exemplified by major market movements where large entities secure external capacity to mitigate supply chain risks. According to BioPharma Dive, December 2024, Novo Holdings finalized its pivotal acquisition of Catalent for $16.5 billion, a transaction that underscores the industry's strategic reliance on outsourced partners to manage the growing volume and complexity of advanced therapeutic production.

Simultaneously, the application of artificial intelligence for predictive quality analytics is emerging as a transformative force, moving beyond simple digitization to optimize upstream and downstream processes. By utilizing machine learning algorithms to analyze vast datasets from bioreactors, manufacturers can identify critical quality deviations and metabolic shifts before they result in batch failure, thereby safeguarding expensive inventory. This predictive capability is becoming financially imperative given the exorbitant costs associated with manufacturing autologous treatments. According to IT Brief Australia, September 2025, the substantial financial risk of production errors is driving this adoption, as a single cell therapy batch can cost upwards of $500,000 to produce, making AI-driven real-time monitoring essential for commercial viability.

Segmental Insights

The Gene Therapy segment represents the fastest-growing category within the Global Cell and Gene Therapy Manufacturing QC Market. This rapid expansion is driven by the increasing volume of therapeutics progressing through clinical pipelines and receiving commercial approval from regulatory authorities such as the US FDA and the European Medicines Agency. As production scales, these institutions enforce strict safety standards regarding product purity and potency, necessitating extensive quality control measures. Consequently, manufacturers are prioritizing validated testing protocols to ensure regulatory compliance, fueling the sustained demand for gene therapy quality assurance services.

Regional Insights

North America leads the Global Cell and Gene Therapy Manufacturing QC Market, primarily due to its advanced biotechnology infrastructure and substantial investments in research and development. The region hosts a dense concentration of major pharmaceutical companies and specialized contract manufacturers that consistently drive technological advancements in production. This market dominance is further strengthened by the U.S. Food and Drug Administration (FDA), which supports the industry through comprehensive regulatory frameworks and expedited approval programs like the Regenerative Medicine Advanced Therapy designation. These factors create a cohesive ecosystem that accelerates innovation and ensures rigorous quality compliance, securing North America’s premier status.

Recent Developments

• In May 2025, Bio-Techne Corporation entered into a partnership with Kytopen to integrate their respective technologies for improved cell therapy manufacturing. The collaboration focuses on combining a non-viral genome engineering system with a continuous flow cellular engineering platform to streamline the gene delivery process. This joint effort aims to enhance the efficiency and scalability of manufacturing workflows, ensuring the production of high-quality therapeutic cells. By merging these advanced solutions, the companies seek to address major bottlenecks in the production of non-viral cell therapies, ultimately supporting developers in bringing more effective and consistent treatments to the market faster.
• In June 2024, Thermo Fisher Scientific opened a new GMP-certified facility in Bleiswijk, Netherlands, designed to accelerate the development and commercialization of advanced therapies. This state-of-the-art site expands the company’s clinical trial network in Europe and provides comprehensive supply chain services, including clinical Qualified Person (QP) release services which are essential for regulatory quality control. The facility supports the increasing demand for cell and gene therapies by offering end-to-end capabilities that range from ultra-cold storage to specific packaging and labeling. By integrating these critical quality and logistics functions, the company aims to facilitate the timely delivery of high-value therapeutics to patients across the region.
• In April 2024, Charles River Laboratories announced a strategic collaboration with Axovia Therapeutics to support the development of gene therapies for ciliopathies. Under this agreement, the company committed to manufacturing High Quality plasmid DNA, a critical starting material that combines key features of Good Manufacturing Practice compliance with rapid turnaround times. This partnership utilizes an established plasmid platform to produce the gene of interest, facilitating the progression of therapeutic programs into clinical trials. The initiative highlights the company's expanding capabilities in the cell and gene therapy manufacturing market, specifically addressing the need for specialized, high-purity components to ensure the safety and efficacy of advanced treatments.
• In March 2024, Beckman Coulter Life Sciences launched the CytoFLEX nano Flow Cytometer, a purpose-built nanoscale instrument designed to revolutionize the detection and characterization of extracellular vesicles in the global cell and gene therapy market. This new solution enables the simultaneous detection of multiple parameters with high sensitivity, allowing researchers to count and characterize nanoparticles as small as 40 nanometers. The platform incorporates extensive automated quality control processes to ensure consistent instrument performance and reproducible results. By offering enhanced sensitivity and resolution, this technology addresses critical challenges in analyzing lower abundance targets within heterogeneous populations, thereby supporting the advancement of quality assurance in therapeutic development.

Key Market Players

• Bio-Techne Corporation
• Biomerieux SA
• F. Hoffmann-La Roche Ltd
• Lonza Group Ltd.
• Miltenyi Biotec India Pvt Ltd.
• Sartorius AG
• Thermo Fisher Scientific Inc.
• AGC Inc.
• Charles River Laboratories International, Inc.
• Merck KGaA

By Therapy Type	By Offering	By Process	By Technology	By Application	By Region
Cell Therapy Gene Therapy	Instruments Consumables Others	Raw Material Preparation Upstream Processing Downstream Processing Packaging	Polymerase Chain Reaction (PCR) Flow Cytometry Limulus Amebocyte Lysate (LAL) Enzyme-Linked Immunosorbent Assay (ELISA) Chromatography Mass Spectrometry Western Blotting Next-Generation Sequencing (NGS) Electrophoresis Others	Safety Testing Potency Testing Identity Testing Stability and Genetic Fidelity Testing Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Cell and Gene Therapy Manufacturing QC Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Cell and Gene Therapy Manufacturing QC Market, By Therapy Type:

• Cell Therapy
• Gene Therapy

• Cell and Gene Therapy Manufacturing QC Market, By Offering:

• Instruments
• Consumables
• Others

• Cell and Gene Therapy Manufacturing QC Market, By Process:

• Raw Material Preparation
• Upstream Processing
• Downstream Processing
• Packaging

• Cell and Gene Therapy Manufacturing QC Market, By Technology:

• Polymerase Chain Reaction (PCR)
• Flow Cytometry
• Limulus Amebocyte Lysate (LAL)
• Enzyme-Linked Immunosorbent Assay (ELISA)
• Chromatography
• Mass Spectrometry
• Western Blotting
• Next-Generation Sequencing (NGS)
• Electrophoresis
• Others

• Cell and Gene Therapy Manufacturing QC Market, By Application:

• Safety Testing
• Potency Testing
• Identity Testing
• Stability and Genetic Fidelity Testing
• Others

• Cell and Gene Therapy Manufacturing QC Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE