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July 2025
The global cell & gene therapy quality control market size is calculated at US$ 2.28 in 2024, grew to US$ 2.87 billion in 2025, and is projected to reach around US$ 22.81 billion by 2034. The market is projected to expand at a CAGR of 25.74% between 2025 and 2034.
The cell & gene therapy quality control market is expanding due to the increasing approval of cell and gene therapy, stringent regulatory requirements, and increasing need for modern testing processes. North America dominates the market due to strong R&D and government infrastructure, while Asia Pacific is the fastest growing due to increasing healthcare awareness and government spending.
| Metric | Details |
| Market Size in 2025 | USD 2.87 Billion |
| Projected Market Size in 2034 | USD 22.81 Billion |
| CAGR (2025 - 2034) | 25.74% |
| Leading Region | North America |
| Market Segmentation | By Testing Type, By Product & Service, By Therapy Type, By Stage, By End-User, By Region |
| Top Key Players | Charles River Laboratories, Eurofins Scientific, Thermo Fisher Scientific, Merck KGaA (MilliporeSigma), Sartorius AG, Bio-Rad Laboratories, QIAGEN N.V., Danaher Corporation (Cytiva), Promega Corporation, WuXi AppTec, Lonza Group AG, Agilent Technologies, Illumina, Inc., Bio-Techne Corporation, Samsung Biologics, Labcorp Drug Development, BlueBird Bio QC Labs, Paragon Bioservices (Catalent), GenScript Biotech Corporation, Avance Biosciences |
The cell and gene therapy quality control market includes products, services, and technologies used to ensure the identity, purity, potency, and safety of cell- and gene-based therapies throughout their development and manufacturing lifecycle. This encompasses analytical testing, release testing, in-process control, stability testing, and regulatory compliance checks as per GMP/GLP guidelines.
AI Integration in the cell and gene therapy quality control QC is driving the growth of the market, as the quality control testing of cell and gene therapy manufacturers adopts AI-driven bioprocessing technologies, particularly in areas such as QA/QC and batch release. AI-driven analytics enhance the detection of irregularities in production processes. It is also used to optimize and design CRISPR-based gene editing procedures to create cells that are improved and able to target cancer cells. AI-based technology delivers considerably huge efficacies in cell and gene therapy manufacturing and allows more patients to benefit from significant treatments.
Why Increasing Cell and Gene Therapy Approval?
The approval of cell and gene therapies, such as FDA approvals, has risen from 14% of all new drug approvals in 2004 to 48% in 2023. These therapies can offer transformative benefits to patients who often have no other options. In recent years, there has been record funding, clinical research, and new product launches in this sector. Cell and gene therapies encompass a wide range of medicines, including cell-based immunotherapies, cell therapies, gene therapies, and tissue-engineered products, but exclude RNA therapeutics. As more cellular therapies progress through clinical trials towards approval, the demand for robust, well-characterized production methods has increased, fueling growth in the cell and gene therapy quality control (QC) market.
Challenges of Cell and Gene Therapy Quality Control
The scale of cell and gene therapy production encounters a major barrier. Unlike traditional pharmaceutical methods, CGT manufacturing requires customized production systems, which restrict the growth of the cell & gene therapy quality control market.
What is Analytical Development in Cell Therapy?
Data analytics has become essential in cell and gene therapy manufacturing. As the industry advances, with therapies growing more complex and regulations tightening, data analytics plays a vital role in maintaining efficiency, quality, and compliance. It is equally important for quality control, allowing manufacturers to identify process anomalies that could threaten product quality. This capability opens up growth opportunities for the cell and gene therapy quality control (QC) market.
For Instance,
By testing type, the sterility testing segment led the cell & gene therapy quality control market, due to sterility testing is significant to ensure that the biological product is free of viable microbes. Verifying the product is sterile is particularly critical when treating immunocompromised patients. Sterility testing is an important component of quality control in the pharmaceutical, hospital pharmacy industries and compounding pharmacy industries. It confirms that products are safe for patient use.
On the other hand, the potency testing segment is projected to experience the fastest CAGR from 2025 to 2035, as potency testing is required to ensure the efficacy, safety, and quality of pharmaceutical products, as well as the validation of comparability between an innovator and biosimilar product. Potency testing is a crucial tool in the biotech and pharmaceutical sectors, assuring product quality. Potency testing assures the strength of a medication substance used while all clinical investigation phases remain reliable, and that only product lots that meet defined specifications or acceptance criteria are used.
By product & service, the kits & reagents segment dominated the cell & gene therapy quality control market in 2024, because reagents and kits are significant tools in the sector of microbiology, allowing the fast and precise detection of different conditions and pathogens. These are intended to simplify the diagnostic methods, creation it more effective and available for medical professionals. In point-of-care testing, which offers rapid results, is often used for infectious diseases such as HIV, influenza, and malaria. These kits and reagents allow early detection of diseases, enabling timely treatment initiation and enhancing patient outcomes.
The contract testing services segment is projected to grow at the highest CAGR from 2025 to 2035, as contract testing ensures correct interaction among microservices, identifies early issues, lowers the requirement for extensive end-to-end tests, and allows independent advancement, leading to rapid, more reliable deployments. It enhances testing effectiveness, improves application quality, quickens time-to-market, and increases test coverage.
By therapy type, the gene therapy segment led the cell & gene therapy quality control market in 2024, due to its offers a probable opportunity to manage diseases previously considered incurable. Genetic therapies are used to avoid, treat, or cure some inherited disorders, like cystic fibrosis, hemophilia, alpha-1 antitrypsin deficiency, sickle cell disease, and beta thalassemia. They are also used to treat cancers or infections, including HIV.
The non-viral gene therapy segment is projected to experience the fastest CAGR from 2025 to 2035, as it uses non-viral vectors, which provide bio-safety. Due to their demonstrated lower pathogenicity, affordability, and ease of production, non-viral vectors have an important safety advantage over viral approaches.
By stages, the clinical trial QC segment dominated in the cell & gene therapy quality control market in 2024, as Quality control (QC) in clinical trials is the procedure that ensures protection of human subjects from research challenges, consistency of the data, and therefore assures internal stability. Quality Control (QC) in the context of clinical trials is applied to a systematic process of monitoring and assessing different features of a clinical trial. It confirms that the data collected is correct, consistent, and by established protocols and standards. It prevents the inclusion of flawed data and maintains the complete quality and integrity of the trial.
On the other hand, the commercial production QC segment is expected to grow at the fastest CAGR over the forecast period, 2025 to 2035, as it offers many advantages, such as improving patient safety, treatment outcomes, and overall operational efficiency. By applying robust QC processes, healthcare providers lower errors, reduce costs associated with recalls and rework, and ensure compliance with healthcare sector regulations.
By end user, the pharmaceutical & biotechnology companies segment dominated in the cell & gene therapy quality control market in 2024, as gene and cell therapy are significant to the pharmaceutical & biotechnology sector. Gene therapy provides advanced therapy and treatments than traditional pharma and small-molecule drugs. Pharmaceutical companies are attaching cell & gene therapy to address complex medical conditions and advance therapeutic options.
On the other hand, the CDMOs segment is expected to grow at the fastest CAGR over the forecast period, 2025 to 2035, as CDMOs effectively manage labor, materials, operations, and quality, resulting in better cost control for gene and cell therapy developers. CDMO offers drug developers the required resources and expertise to manufacture their cell and gene therapies in a safe, rapid, and affordable manner.
North America dominated the cell & gene therapy quality control market in 2024, as North America is home to 85% of the world’s small, research-intensive biopharma companies. These companies are significant to drug development and U.S. competitiveness. A strong nationwide revolution ecosystem that includes helpful policies is significant for enabling a diverse community of actors in the drug development to innovate and thrive. Advances in pharmaceutical and biotechnology firms are contributing to the R&D of novel drug development, contributing to the growth of the market.
For Instance,
The U.S. is an innovative sector of the world because the presence of government researchers, academic institutions, and biopharmaceutical companies works together for the patients' needs. Also, it has a well-working R&D ecosystem and helps foreign competitors by penalizing companies that partner with the U.S. government. With more than 8,000 medicines in clinical development globally, of which nearly 70% have the potential to be first-in-class disease management in the U.S., which drives the growth of the market
Growing government support for medical services, such as Health Canada, can monitor and track precise environmental biotechnology products and byproducts by integrating, collecting, analyzing, and interpreting data, and broadcasting the data. The Canadian government not only regulates genetic engineering but also regulates biotechnology products under a wider category, such as “novel foods” and “plants with novel traits,” which contains products of genetic engineering as well as organisms produced by different technologies, contributing to the growth of the market.
Asia Pacific is estimated to be the fastest-growing market during the forecast period, as it has the potential to enhance healthcare results, predominantly for chronic diseases and cancer, by tailoring treatments to individual patient characteristics, with cell and gene therapies often custom-made to specific patients. The presence of major key players such as Catalent Inc., FUJIFILM Holdings Corp., Charles River Laboratories International Inc., Lonza Group AG, Merck KgaA, Nikon Corp., Takara Bio Inc., Thermo Fisher Scientific Inc., drives the growth of the market.
For Instance,
China has greater regulatory support and industry regulation on quality standards of cell and gene therapy. The presence of advanced infrastructure for clinical studies is driven by an increase in global multicenter clinical studies. A thriving healthcare ecosystem with government-industry collaboration growing basic biomedical research to highly advanced IPs in CGT, which drives the market growth.
India's healthcare sector is rapidly increasing, driven by increasing demand for quality care. Increasing healthcare partnership which aims to expand translational research efforts through co-development of multi-center studies and academia, focusing on advanced therapies to solve India’s challenging medical requirements in malignancies, autoimmune diseases.
Europe is expected to grow significantly in the Cell & gene therapy quality control market during the forecast period, as cell and gene therapy sector in Europe has expressively grown from early scientific breakthroughs, like viral technology and gene editing, to government frameworks like European Medicines Agency’s (EMA) Advanced Therapy Medicinal Products (ATMP). Recent advancements in platform technologies (such as mRNA), manufacturing scalability and robotics, as well as AI, have broadened therapeutic applications beyond rare diseases and oncology into solid tumors and autoimmune diseases, which drives the growth of the market.
Germany is a momentous player in stem cell research and regenerative medicine. The modern developments in the field of stem cells in Germany have provided an efficient approach to medicine, providing hope to patients struggling with autoimmune, degenerative, and lifestyle disorders. This cell and gene therapy quality control QC market.
The UK is experiencing an increase in approved cell and gene therapies because of a variety of factors, including noteworthy government investment, a huge NHS infrastructure, and developments in manufacturing capabilities, which drive the growth of the market.
In March 2025, Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, Stated, “We are excited about the acquisition of EsoBiotec and the opportunity to rapidly advance their promising in vivo platform. We believe it has the probable to revolutionize cell therapy and will allow us to scale these innovative treatments so that many more patients around the world can access them. EsoBiotec accelerates and expands the impact of our recent investments and marks a major step forward in realising our ambition to harness the full potential of cell therapy.” (Source - Astrazeneca)
By Testing Type
By Product & Service
By Therapy Type
By Stage
By End-User
By Region
July 2025
July 2025
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July 2025