North America Cell and Gene Therapy Manufacturing QC Market Size, Share & Trends Analysis Report By Therapy Type (Cell Therapy, CAR-T, CAR-NK, B-Cell, Others, Gene Therapy, Viral, Non-viral), By Scale (Pre-commercial/ R&D Manufacturing, Commercial Scale Manufacturing), By Mode (Contract Manufacturing, In-house Manufacturing), By Workflow (Cell Processing, Cell Banking, Fill & Finish Operations, Raw Material Testing, Vector Production, Other Workflows), By Process (Upstream Processes, Downstream Processes), By End-User (Pharmaceutical Companies, Biopharmaceutical / Biotechnological Companies, Contract Manufacturing Organizations), By Technology Type (Fluorescence-Activated Cell Sorting (FACS), Enzyme-Linked Immunosorbent Assay (ELISA), Chromatography, Next-Generation Sequencing (NGS), Polymerase Chain Reaction (PCR), Others) and By Country(U.S., Canada) Forecasts, 2025-2033

North America Cell and Gene Therapy Manufacturing QC Market Size

The North America Cell and Gene Therapy Manufacturing QC Market size was valued at USD 862.9 million in 2024 and is estimated to reach from USD 1,081.20 million in 2025 to USD 6,569.31 million by 2033, growing at a CAGR of 25.3% during the forecast period (2025–2033).

This market is experiencing rapid growth, driven by the increasing number of clinical trials and rising investments in advanced therapies. Additionally, the market is projected to witness significant growth due to the presence of cutting-edge biopharmaceutical companies and a well-established regulatory framework in North America.

North America Cell and Gene Therapy Manufacturing QC Market Growth Factors

Rise in cell and gene therapy approvals

The growing approval of innovative cell and gene therapies is one of the key drivers of demand for QC. As of 2023, the FDA has approved several cell and gene therapy products, including high-profile treatments like Luxturna (for inherited retinal disease) and Zolgensma (for spinal muscular atrophy). These approvals have led to a surge in the need for robust QC processes to ensure product safety and consistency.

Additionally, the increase in the number of therapies entering clinical trials also demands rigorous testing at various stages of development. This surge is also tied to government incentives and fast-track approval programs for breakthrough therapies, which expedite the clinical process but place greater emphasis on maintaining product safety standards. As the market continues to expand, the demand for QC in manufacturing processes is expected to grow alongside it. 

Market Restraint

High costs of QC infrastructure

One of the major restraints for the North American Market is the high cost of implementing and maintaining QC infrastructure. Establishing specialized QC laboratories and acquiring advanced tools such as NGS systems, digital PCR machines, and automated cell analyzers require significant capital investment.

Additionally, the cost of hiring skilled personnel to operate these technologies and interpret complex data further increases operational expenses. QC expenses may account for up to 40% of total manufacturing costs. These high costs can be particularly challenging for small and mid-sized biopharma companies, limiting their ability to scale up manufacturing operations or invest in the latest QC technologies. 

Market Opportunities

Expansion of contract QC services

As the complexity and cost of QC processes grow, many biopharmaceutical companies are turning to contract research organizations (CROs) that specialize in QC services. The market for contract QC services is expected to expand significantly in North America as smaller biotech firms seek to outsource QC processes to reduce costs. Leading CROs offer advanced analytical platforms and compliance expertise, allowing companies to focus on therapy development rather than QC infrastructure.

By 2023, nearly 50% of cell and gene therapy developers in North America had outsourced their QC needs. This trend is expected to create lucrative opportunities for CROs offering specialized QC services. Furthermore, regulatory agencies are increasingly endorsing the use of third-party QC service providers, further boosting market opportunities in this segment. 

Regional Analysis

The North American region, dominated by the United States, is the leading area for this industry. The U.S. holds the largest market share, driven by the advanced healthcare infrastructure and strong regulatory frameworks. Several factors contribute to the U.S. leadership in this space. The FDA's proactive regulatory approach, through initiatives like the "Breakthrough Therapy Designation," fast-tracks the approval of innovative therapies while ensuring rigorous QC standards are met. In 2022, the FDA approved 18 gene therapy investigational new drug (IND) applications, underscoring the critical role of stringent QC in the approval process.

Additionally, major biopharmaceutical companies, including Novartis, Pfizer, and Gilead, have established advanced QC laboratories in the U.S. to support their cell and gene therapy production facilities. These facilities are equipped with cutting-edge QC tools like Next-Generation Sequencing (NGS) and digital PCR, ensuring precise monitoring of product safety and efficacy. Novartis, for instance, invested $500 million in 2022 to expand its gene therapy manufacturing capabilities in North Carolina, which includes QC infrastructure development.

Furthermore, the key players in this market are introducing novel products in this segment to enhance their market share. For instance, in March 2024, Slingshot Bio launched a range of solutions to address quality control issues in cell therapy development and manufacturing. These controls are essential for validating the accuracy and consistency of analytical procedures employed to assess cell therapy products. Thus, such factors are estimated to augment the regional market growth.

Segmentation Analysis

The North America Cell and Gene Therapy Manufacturing QC Market is segmented by therapy type, scale, mode, workflow, process, end-user, and technology type.

By Type

Cell Therapy dominates the therapy type segment and is estimated to grow at a CAGR of 23.3%. This segment is growing rapidly in the North America Cell and Gene Therapy Manufacturing QC Market due to the increasing number of clinical applications, particularly in cancer treatment. Therapies like CAR-T are gaining approval, driving demand for stringent QC processes to ensure safety, efficacy, and regulatory compliance.

By Scale

Pre-commercial/ R&D Manufacturing is estimated to own the scale segment and is anticipated to expand at a CAGR of 24.8%. The pre-commercial/R&D manufacturing segment is expanding due to the increasing number of early-stage clinical trials for cell and gene therapies. Companies are investing in QC to meet regulatory standards during initial phases, ensuring product safety and efficacy, which is crucial for progressing to later clinical stages and eventual commercialization.

By Mode

In-house manufacturing dominates the mode segment and is expected to augment at a CAGR of 24.8%. In-house manufacturing is growing as biopharmaceutical companies seek greater control over production quality and regulatory compliance in cell and gene therapies. By establishing dedicated QC facilities, companies can streamline processes, reduce reliance on third-party manufacturers, and ensure more efficient oversight of product consistency and safety.

By Workflow

Vector Production dominates the workflow segment and is expected to augment at a CAGR of 26.4%. The vector production workflow segment is expanding as viral vectors, such as lentivirus and AAV, are critical for delivering gene therapies. Demand for efficient QC in vector production is rising due to the need to ensure purity, potency, and scalability, especially as gene therapy pipelines grow and regulatory scrutiny intensifies.

Analyst’s Perspective

As per our research analysts, the North America Cell and Gene Therapy Manufacturing QC Market is poised for strong growth, driven by the rising number of therapy approvals and advancements in QC technologies. However, high costs associated with QC infrastructure may limit market expansion for smaller companies. The increasing trend of outsourcing QC services presents a key growth opportunity, especially for CROs with specialized QC capabilities.

As the market evolves, investments in automation, AI-based tools, and next-generation QC technologies will be critical to ensuring regulatory compliance and product safety. Furthermore, companies that can streamline QC processes while managing costs are likely to gain a competitive edge in this dynamic market.