Cell and Gene Therapy Manufacturing QC Market Size, Share & Trends Analysis Report By Therapy Type (Cell Therapy, Gene Therapy), 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 Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2024-2032

Cell and Gene Therapy Manufacturing QC Market Size & Insights

The global cell and gene therapy manufacturing QC market size was valued at USD 1.78 billion in 2023. It is estimated to reach from USD 2.23 billion to USD 13.77 billion by 2032, growing at a CAGR of 25.5% during the forecast period (2024–2032). Due to the increasing demand for these new treatments, the market for quality control in the manufacture of cell and gene therapy products is booming. Robust quality control procedures are needed to ensure safety and efficacy in the face of stringent regulations and complex treatments. Advances in analysis techniques and automation have led to market growth, but challenges such as costs and lack of standardisation continue to be a problem. To exploit future opportunities in this promising market, cooperation and innovation are key. 

The market for QC production of cell and gene therapy is increasing as a result of the great potential these treatments have to cure previously untreated diseases. As R&D grows in this area, accompanied by public and private investment, the need for strong quality control measures at all stages of production is becoming increasingly relevant. Cell and gene therapy can be highly complex and personalized for each patient, unlike traditional medicines. In order to ensure the safety, purity and efficiency of each treatment it is therefore necessary to install reliable quality control systems. Rapid advances in analytical techniques such as mass spectrometry and automation, leading to faster and more precise quality control procedures, are being seen on the market. Nevertheless, the challenges are still there. It can be expensive to implement such sophisticated technologies and the lack of standardization in quality control protocols across all sectors makes it difficult. Key players are increasingly focused on collaboration and innovation in order to solve these barriers. The industry can streamline production, improve product quality and pave the way for successfully commercialising these life enhancing therapies through shared best practices and development of new technology.

Highlights

• Cell therapies dominate the therapy type
• Pre commercial/ R&D manufacturing dominates theby scale
• In-house manufacturing dominates the by mode segment.
• Vector production dominates the workflow segment.
• Upstream Processes dominates the by process segment.
• Biopharmaceutical / Biotechnological Companies dominates the end user segment.
• Polymerase Chain Reaction (PCR) dominates the technology type segment.
• North America is the highest shareholder in the global market

Cell and Gene Therapy Manufacturing QC Market Growth Factors

Rapid Expansion of the Cell and Gene Therapy Industry

In parallel with the growth of cell and gene therapy as a whole, the market for QC production is experiencing an explosive development. A combination of factors that demand strong quality control measures is behind the increase:

Clinical Trial Boom: The cell and gene manufacturing quality control (QC) market is rapidly expanding due to the increasing number of clinical trials performed in the cell and gene therapy field. As more clinical trials are performed, there is a growing demand for QC technologies and services to ensure the safety, quality, and efficacy of investigational products. For example, as per report published by IQVIA in March 2024, 3,285 number of clinical trials for cell and gene therapies were started over last five years, along with 631 trials in 2023 across the globe. In addition, QC plays an important role in monitoring manufacturing processes to ensure critical parameters are maintained within acceptable limits, thus ensuring product consistency and repeatability across clinical trial sites (CTIs) and batches.

Product Pipeline: The rapidly growing pipeline of cell and gene therapy products is a major driving force behind the growth of the cell and gene therapy manufacturing quality control (QC) market. The demand for comprehensive QC testing and validation is increasing as more and more cell and gene therapy candidates progress through the development phase and move closer to commercialisation.

Scaling Up Manufacturing Capabilities: Manufacturers are increasing their production capacity to meet patient demand as more cell and gene therapies move into the Commercialisation Stage. In order to ensure the consistency of product quality, sterility and compliance with regulatory requirements this rise requires robust Quality Control procedures.

Diversity of Cell and Gene Therapy Products: Unique QC measures and specialized QC technology and expertise are needed for a wide range of cell and gene therapies, such as CART cell therapy. For example, in the case of cell therapy, specific QC measures for cellular viability, potency and function tests are required whereas gene therapies require a vector characterisation test. Such a diverse product range requires a wide range of QC solutions, driving growth and innovation in the QC market to address these varied needs.

Regulatory Requirements for Cell and Gene Therapy Manufacturing

The main driver of the QC market for cell and gene therapy manufacturing is strict regulations. Regulatory authorities such as the FDA set strict development, production and commercialization guidelines to deal with these complicated medicinal products that present special safety risks. Clear guidelines such as those concerning CART cell therapy and gene editing, which contribute to ensuring product safety and compliance, are encouraging companies to invest in state-of-the-art QC technology. Additionally, adherence to Good Manufacturing Practices (GMPs) necessitates robust QC procedures throughout production. The implementation of these Regulations will not only help to gain market acceptance, but also strengthen the trust between patients and health care providers. Therefore, there is a growing demand for quality management solutions and expertise. Regulatory authorities are also increasing their envelope by encouraging continuous improvement of quality control procedures in accordance with inspections and guidance.

Cell and Gene Therapy Manufacturing QC Market Restraining Factors

Expanding Skills Gap and Labor Shortage

The rapid growth of cell and gene therapy manufacturing is creating a major challenge: a lack of qualified workers in quality control (QC). This is restricting the market's potential. For one reason, there's a shortage of them:

Demand exceeds supply: There simply isn't enough qualified QC professionals, in particular those with expertise in areas such as flow cytometry or gene sequencing.

Regulatory knowledge shortage: There is a high level of complexity and constant change in the regulation landscape, but there is not sufficient expertise to cope with it.

Training challenges: New technologies require the upskilling of the workforce, which can be costly and time consuming.

Limited Educational Programs: Universities and colleges haven't kept pace with the industry's needs, leading to a talent pipeline shortage.

The sector must work with educational institutions, set up training programmes and promote lifelong learning in order to overcome the skills gap and support further growth of the cell and gene QC market.

Cell and Gene Therapy Manufacturing QC Market Opportunities

Substantial Funding in the Cell and Gene Therapy Industry

As a result of the increase in funding for cell and gene therapy, there are exciting opportunities for QC players on this market. Here's how:

Increased quality assurance capabilities: by increasing funding, manufacturers are able to increase their investment in advanced quality assurance technologies that allow rapid and accurate testing of these complicated therapies.

Novel quality control methods: new quality control methods tailored to specific treatments may be developed as a result of higher research and development efforts supported by funding, overcoming the existing technical obstacles.

High technology infrastructure: Funding allows for the construction of specialised quality control laboratories and controlled environments in order to guarantee a stable product quality at production level.

Automation and digitization: Increased funding will facilitate automated quality control processes, improve efficiency, reduce errors as well as ensure consistency in testing.

Overall, in this emerging market for cell and gene therapy, the financial boom has created a favourable environment for companies that offer cutting edge QC technologies, technical expertise or streamlined production processes.

Cell and Gene Therapy Manufacturing QC Market Regional Analysis

North America Dominates the Global Market

Based on region, the global market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. 

North America is the most significant global market shareholder and is expected to expand substantially during the forecast period. The North American market for cellular and gene therapy QC is dominated by the dominance of a combination of multiple advantages. First of all, the region offers a robust healthcare system with modern facilities and experienced professionals that makes it an ideal platform for research, development and production. Secondly, hefty investments in R&D fuel innovation in QC methods and attract top talent. Supportive regulations create a climate that fosters groundbreaking therapies while prioritizing patient safety. This is the result of a flourishing clinical trial landscape in North America, where rigorous quality control measures are needed at all times during testing. The market is being driven by investors who are increasingly enthusiastic about cell and gene therapy and are pouring money into it. Finally, the region is home to cutting edge technologies, with state-of-the-art research facilities and a highly skilled workforce developing and implementing advanced quality control methods. The US, which leads the pack in clinical trials and therapy approvals, demonstrates that advantage.

Asia-Pacific is the most rapidly growing market

Asia-Pacific is the fastest-growing region during the forecast period. The explosive growth in the market for cell and gene therapy manufacturing QC is set to take place in Asia Pacific, fueled by a powerful combination of factors. In particular in China, government investment is pouring money for R&D and promotion of innovation. This revolution is led by some of the biggest companies in China, Japan and South Korea, which are developing groundbreaking treatments. In addition, APAC is attracting global players with significantly reduced clinical trial costs compared to other regions. This advantage, in combination with the huge population base of this region, is a goldmine for research. APAC is well placed to become a major consumer of cell and gene therapies, as well as an important contributor to the development of this revolutionary area of medicine, owing to robust government support, a growing ecosystem of companies and research institutes, and cost-effective trials.

Cell and Gene Therapy Manufacturing QC Market Segmental Analysis

The global market is bifurcated into therapy type, scale, mode, workflow, process, end user, and technology type.

By Therapy

Based on therapy type, the market is segmented into cell therapy (CAR-T (Autologous CAR-T, Allogeneic CAR-T), CAR-NK, B-Cell, & Other) and gene therapy (Viral (AAV, Lenti, and Other), Non-Viral).

Cell therapy dominates the therapy type segment. Cell therapy is the use of living cells to treat a disease. To ensure these therapies are safe and effective, they undergo rigorous quality control throughout production. It also involves verifying the identity, potency, purity and stability of cells. The growth of the QC cell therapy market is driven by stringent regulations and advances in QC technology. However, the complexity of cell therapy and the cost of quality control procedures are a challenge. Despite these obstacles, the future of this market promises to be brighter thanks to continuing innovation and investment that paves the way for better cell therapy.

By Scale

Based on scale, the market is segmented into pre-commercial/ R&D manufacturing and commercial scale manufacturing

Pre commercial/ R&D manufacturing dominates the scale segment. New treatments are laid down in the pre commercial or R&D phase of cell and gene therapy production. This is where small batches of experimental treatments are produced for clinical trials. In order to ensure patient safety and to ensure that the medicinal products comply with regulatory standards, rigorous quality control is essential at this stage. This QC focus throughout pre-commercial manufacturing is a major driver for the cell and gene therapy manufacturing QC market's growth.

By Mode

Based on mode, the market is bifurcated into contract manufacturing and in-house manufacturing.

In-house manufacturing dominates the mode segment. In the case of cell and gene therapy, inhouse manufacturing allows companies to handle everything themselves from building facilities or hiring experts to performing all quality control procedures. It enables them to gain greater control over production secrets, the ability to adapt rapidly and ultimately manage a whole process. However, substantial initial investment and continued costs are needed to achieve this. Major companies like Samsung Biologics and Thermo Fisher Scientific are increasingly setting up production facilities thanks to these advantages. This trend is driving growth in the QC market for cell and gene therapy, as these companies require equipment and expertise to do their work at home.

By Workflow

Based on workflow, the market is segmented into cell processing, cell banking, process development, fill & finish operations, raw material testing, vector production, and other workflows.

Vector production dominates the workflow segment. A fundamental step in the development of cell and gene therapy is vector production, which makes it possible to develop delivery vehicles for specific genes. At this stage, strict quality control measures are needed because the safety or effectiveness of vectors may be affected by a few tiny variations. Due to the increased focus on inhouse vector production by large players, the market for cell and gene therapy QC has grown. In order to guarantee the quality and consistency of their vectors, these companies demand high quality control solutions which will lead to increased use of modern testing methods and qualified personnel on the market. 

By Process

Based on process, the market is segmented into upstream processes and downstream processes.

Upstream processes dominate the process segment. Quality control during cell and gene therapy production should be carefully monitored. Monitoring of the identity, purity and potency of cells at different points during their life cycle from collection to harvesting shall also be part of this process. Companies such as Oxford Biomedica or Cytiva provide solutions and expertise in this field with a view to ensuring the safety and efficacy of these treatments. This focus on strict quality control measures has been instrumental in supporting the growth of the QC market for cell and gene therapy.

By End User

Based on end user, the market is segmented into, pharmaceutical companies, biopharmaceutical/biotechnological companies, and contract manufacturing organizations.

Biopharmaceutical/biotechnological companies dominate the segment. The cell and gene therapy QC market is segmented by company size: small, medium, and large biopharmaceutical/biotech companies. Small enterprises are creative and have low resources. They may collaborate with other companies for the development of new medicines, such as Neurocrine Biosciences' partnership with Voyager Therapeutics to develop gene therapies. Compared to small companies, medium enterprises have a broader product range and reach on the market. For example, Sarepta Therapeutics, a small biotechnology company, recently received FDA approval for gene therapy to treat Duchenne Muscular Dystrophy. There are substantial resources and a worldwide reach for large companies. They're investing heavily in research and development, which means they can be expanded through acquisitions or partnerships. A new large scale manufacturing facility for cell therapy has recently been opened by Catalent, one of the largest companies in the world.

By Technology

Based on technology type, the market is segmented into fluorescence-activated cell sorting (FACS), enzyme-linked immunosorbent assay (ELISA), chromatography, next-generation sequencing (NGS), polymerase chain reaction (PCR), and others.

Polymerase chain reaction (PCR) dominates the technology type segment. In order to ensure that the therapeutic gene is present and potent, as well as detection of contaminants, PCR a common DNA analysis technique is essential for cell and gene therapy QC. However, the development of ddPCR, a more reliable and precise alternative, has been driven by restrictions such as reference standard dependency. ddPCR's growing adoption in AAV vector quantification, contaminant detection, and beyond (cell counting, DNA quality control) highlights its increasing importance as a QC tool across scientific research.

Impact of covid-19

COVID-19 has positive and negative market consequences, as carbon emissions have decreased globally due to the lockout. COVID-19's reduction in emissions is a short-term benefit. Still, when industries and enterprises attempt to recoup some of their financial losses in the first quarter of the year, carbon emissions will rise dramatically. COVID-19 had a negative impact on global recycling efforts. Countries, notably the United States, have halted or decreased recycling programs to focus on collecting additional domestic waste or because services have been disrupted by the virus.

Also, with industries slowly returning to normalcy following the COVID-19 outbreak, this shift in workplace health and safety is expected to increase due to mandatory social distancing and continuous personal care through sanitization to eliminate even the tiniest possibility of COVID-19 spread. COVID-19 has impacted various companies' revenues, and if the lockdown is lifted, companies will turn their attention to operations to make up for their losses.

Recent Developments

• In January 2024, Galapagos NV and Thermo Fisher Scientific, Inc. announced they had entered into a strategic collaboration agreement for the decentralized manufacturing of Galapagos’ point-of-care CAR-T product candidate in the San Francisco area.
• In November 2023,Lonza announced the launch of its new GS Effex cell line for the development of therapeutic antibodies with enhanced potency. The GS Effex cell line was developed to meet pressing market needs originating from the shift towards more sophisticated therapeutic antibodies.
• In September 2023, Charles River Laboratories announced the launch of its lentiviral vector (LVV) manufacturing platform, Lentivation. This platform is designed to streamline LVV manufacturing processes for gene and gene-modified cell therapies, potentially cutting down manufacturing timelines by as much as 60%, resulting in fewer than seven months compared to conventional methods.

Analyst’s Perspective

The cell and gene therapy manufacturing QC market is experiencing significant growth, driven by the rapid advancement of personalized medicine and increasing regulatory requirements. As these therapies evolve, the complexity of quality control processes intensifies, necessitating more sophisticated and robust testing methods. Key factors influencing the market include the need for stringent validation to ensure safety and efficacy, as well as the rising adoption of automation and advanced analytics to enhance precision and efficiency. Companies are investing in cutting-edge technologies and expanding their QC capabilities to meet these demands, positioning themselves competitively in this dynamic and high-growth sector. With ongoing innovations and regulatory pressures, the QC market for cell and gene therapies is poised for continued expansion and evolution.