Cell and Gene Therapy Manufacturing QC Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Cell and Gene Therapy Manufacturing QC Market is projected to expand from USD 1.35 Billion in 2025 to USD 2.01 Billion by 2031, reflecting a compound annual growth rate of 6.87%. This sector focuses on stringent analytical testing and regulatory adherence processes designed to verify the safety, potency, purity, and identity of advanced medicinal products. The market is primarily underpinned by a surge in clinical trial volumes and an increasing rate of regulatory approvals for therapies targeting oncology and rare genetic disorders. These drivers necessitate the implementation of comprehensive quality assurance frameworks to manage the natural variability of biologic materials while ensuring rigorous safety standards are met during commercial scale-up.

Data from the American Society of Gene and Cell Therapy indicates that in 2024, the global development pipeline contained more than 4,000 therapeutic candidates, generating substantial demand for specialized testing protocols. Despite this robust growth trajectory, the market faces a significant obstacle regarding the technical complexity and high costs associated with creating standardized potency assays. These challenges often prolong production timelines and inflate the overall cost of goods sold, acting as a constraint on broader market expansion.

Market Drivers

Significant capital inflows 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 strive to commercialize complex therapies, vast financial resources are being allocated to clinical progression as well as the establishment of robust, scalable manufacturing and testing infrastructures. This financial strength enables companies to acquire high-end analytical instruments and validate the rapid testing methods required for regulatory compliance. According to the Alliance for Regenerative Medicine, the sector saw a resurgence in financing in October 2024, with global investments reaching $10.9 billion in the first half of the year alone, funding that is crucial for overcoming manufacturing bottlenecks and aligning quality control evolution with the increasing number of late-stage candidates.

A second critical driver is the integration of automation and digitalization into quality control workflows, which directly addresses the industry's need for precision and error reduction. By replacing labor-intensive manual assays with automated platforms, manufacturers are enhancing data integrity and reducing turnaround times for sterility and potency results. This shift is exemplified by major pharmaceutical collaborations aiming to secure automated production capacities; for instance, Fierce Pharma reported in April 2024 that Bristol Myers Squibb signed a $380 million deal to reserve exclusive capacity on Cellares' fully automated platform. This trend is further reinforced by regulatory successes, such as the record seven new FDA approvals for cell and gene therapies in 2023 noted by PharmaBoardroom in April 2024, underscoring the urgency for automated, compliant QC solutions to meet commercial demand.

Market Challenges

The intricate technical requirements and high costs involved in developing standardized potency assays constitute a formidable barrier to the growth of the Global Cell and Gene Therapy Manufacturing QC Market. Due to the significant biological variability inherent in advanced therapies, manufacturers are often compelled to design bespoke testing protocols to verify product potency rather than utilizing off-the-shelf standards. This lack of standardization requires expensive, labor-intensive development cycles that significantly increase the overall cost of goods sold (COGS) and extend production timelines. These issues frequently lead to regulatory delays, as deficiencies in Chemistry, Manufacturing, and Controls (CMC) can prevent products from advancing to the commercial stage where high-volume quality control testing generates revenue.

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

Market Trends

A dominant trend in the industry is the increasing reliance on outsourcing specialized QC assays to Contract Development and Manufacturing Organizations (CDMOs), driven by the technical demands of characterizing complex viral vectors and cell therapies. Rather than constructing 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 illustrated by significant market movements, such as Novo Holdings' pivotal $16.5 billion acquisition of Catalent in December 2024, as reported by BioPharma Dive, which underscores the sector's strategic reliance on external 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 both upstream and downstream processes. Manufacturers are utilizing machine learning algorithms to analyze vast datasets from bioreactors, allowing for the identification of critical quality deviations and metabolic shifts before they result in batch failure, thereby protecting expensive inventory. This predictive capability is becoming financially imperative given the high costs associated with manufacturing autologous treatments; according to IT Brief Australia in September 2025, the substantial financial risk of production errors - where a single cell therapy batch can cost upwards of $500,000 - is driving the adoption of AI-driven real-time monitoring for commercial viability.

Key Players Profiled in the Cell and Gene Therapy Manufacturing QC Market

• 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

Report Scope

In this report, the Global Cell and Gene Therapy Manufacturing QC Market has been segmented into the following categories:

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
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Cell and Gene Therapy Manufacturing QC Market.

Available Customization

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• Detailed analysis and profiling of additional market players (up to five).

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