The global cell and gene therapy manufacturing QC market size was valued at USD 2.24 billion in 2024 and is projected to grow from USD 2.79 billion in 2025 to USD 17.44 billion by 2033, exhibiting a CAGR of 25.7% during the forecast period (2025-2033).
The major factors driving the market are growing pipeline of cell & gene therapy (CGT), increasing investments in advanced therapy medicinal products (ATMPs) sector including cell & gene therapy, and increasing number of CAR-T cell therapy trials. Further, regulatory requirements for CGT products drive the demand robust QC services to ensure safety and efficacy of CGT therapies. Furthermore, the growing number of therapeutic developers is also propelling the adoption of outsourced QC services, automation, and AI-driven analytics, streamlining compliance and improving efficiency.
Moreover, investments in next-generation sequencing (NGS), multi-attribute methods (MAM), and biosafety testing are further shaping the future of QC in this sector. As the industry scales up production to meet rising global demand, the market will continue to expand, ensuring the safety, efficacy, and regulatory compliance of innovative therapies. The graph illustrates the distribution of gene therapy, GMCT & CBIO, and cell therapy developers across North America, Europe, Asia-Pacific, and other regions. It highlights North America's dominance in gene therapy and Europe’s strong presence in GMCT & CBIO and cell therapy development.
Source: Alliance for Regenerative Medicine, and Straits Research
As CGT manufacturers focus on accelerating production and commercialization, outsourcing QC activities to specialized contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) is becoming a key trend.
Source: Cell and Gene Therapy Catapult Review Reports, and Straits Research
Thus, this trend reflects a strategic shift towards external partnerships to enhance efficiency, ensure compliance, and streamline CGT manufacturing.
The integration of real-time analytics and AI-driven insights is transforming quality control in cell and gene therapy manufacturing by enhancing decision-making, improving process efficiency, and ensuring regulatory compliance.
Thus, this trend is driving a shift from reactive to proactive QC strategies, improving product safety and accelerating time-to-market.
Rising investments in cell and gene therapy manufacturing are driving advancements in QC infrastructure, technologies, and workforce development to meet regulatory and industry demands.
Source: Alliance for Regenerative Medicine, and Straits Research
Thus, growing investments in CGT manufacturing are accelerating advancements in QC infrastructure, ensuring robust quality standards, regulatory compliance, and scalable production.
Stringent regulatory requirements drive the growth of the cell and gene therapy manufacturing QC sector by ensuring strict compliance and safety standards. Advanced therapeutic products are highly complex and represent health risks and safety concerns to patients, which is why they require strict control and compliance for therapeutic use. Regulatory authorities worldwide, including the FDA and the EMA, have developed comprehensive frameworks and guidelines that regulate cell and gene therapy development, production, and commercialization.
Thus, regulatory policies and stricter guidelines are accelerating the demand for robust QC measures, driving growth in the cell and gene therapy manufacturing industry.
The expanding skills gap and labor shortage is the major factor restraining the growth of the market. As industry continues to evolve rapidly, the demand for highly skilled and experienced QC professionals is outpacing the supply, creating a critical workforce challenge, thereby restraining the market's growth.
Thus, the skills gap and labor shortage pose a significant challenge, limiting the market's growth and scalability.
The rapidly growing pipeline of CGT products presents a significant opportunity for the market, driving the demand for advanced testing solutions to ensure compliance, safety, and efficacy. As more and more cell and gene therapy candidates advance through the development stages and move closer to commercialization, the demand for comprehensive QC testing and validation increases substantially, propelling the demand for QC services.
Gene Therapy Pipeline, 2024
Global | Q1, 2024 | Q2, 2024 | Q3, 2024 | Q4, 2024 |
Preclinical | 1,471 | 1,436 | 1,393 | 1,424 |
Phase I | 301 | 314 | 318 | 341 |
Phase II | 282 | 279 | 289 | 306 |
Phase III | 35 | 34 | 35 | 35 |
Preregistration | 4 | 5 | 6 | 11 |
Total | 2,093 | 2,068 | 2,041 | 2,117 |
Source: American Society of Gene & Cell Therapy (ASGCT), and Straits Research
Thus, the expanding CGT pipeline is driving the need for advanced QC testing to ensure regulatory compliance, safety, and efficacy.
Study Period | 2021-2033 | CAGR | 25.7% |
Historical Period | 2021-2023 | Forecast Period | 2025-2033 |
Base Year | 2024 | Base Year Market Size | USD 2.24 billion |
Forecast Year | 2033 | Forecast Year Market Size | USD 17.44 billion |
Largest Market | North America | Fastest Growing Market | Asia Pacific |
North America holds a leading position in the cell and gene therapy manufacturing QC market owing to strong regulatory frameworks (FDA guidelines), high R&D investments, advanced QC infrastructure, and a robust pipeline of CGT products. The presence of key industry players, extensive clinical trials, and government funding initiatives further drives market growth, ensuring compliance and innovation in QC processes.
Asia Pacific region is anticipated to grow at fastest CAGR of 26.3% during the forecast period. This is attributed to governments and private entities in countries such as China, Japan, and South Korea actively investing in biotech infrastructure and accelerating the adoption of cell and gene therapy. Furthermore, growing demand for advanced therapies, expansion of contract development, and manufacturing organizations are driving the need for QC services in this region.
The cell and gene therapy manufacturing QC sector is experiencing dynamic growth and diversification across the globe, with each county contributing uniquely to the advancement of this transformative field.
Source: Clinical Trials.gov, and Straits Research
Source: Health Innovation Agency, and Straits Research
Source: Cell and Gene Therapy Catapult Review Reports, and Straits Research
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The market is segmented into cell therapy [CAR-T {Autologous CAR-T, Allogeneic CAR-T}, CAR-NK, B-Cell, & Others] and gene therapy [Viral {AAV, Lenti, and Other}, Non-Viral]. Gene therapy segment is expected to register fastest CAGR during the forecast period, owing to increasing number of FDA and EMA approvals for gene therapies, growing pipeline of gene therapy, and strict guidelines for purity and potency of gene therapies are driving the need for robust QC services.
The market is segmented into pre-commercial/ R&D manufacturing and commercial scale manufacturing. Pre commercial/ R&D Manufacturing segment dominated the market in 2024 and is expected to register a highest CAGR during the forecast period. This growth is driven by, increasing number of cell and gene therapy products under clinical trials, autologous and allogeneic cell therapy platforms, and a high failure rate in late-stage clinical trials has increased the activity in the pre-commercial phase.
The market is bifurcated into contract manufacturing and in-house manufacturing. Contract manufacturing segment is expected to register fastest CAGR during the forecast period, owing to surge in outsourcing of QC processes to CDMOs which are equipped with advanced analytical technologies and compliant with regulatory standards.
The market is segmented into cell processing, cell banking, process development, fill & finish operations, raw material testing, vector production, and other workflows. Vector production segment accounted for largest share in 2024, owing to increasing demand for gene replacement therapies, drives the need for ensuring quality and efficiency of vectors, which in turn, drives the demand for vector production QC service.
The market is segmented into upstream processes and downstream processes. Downstream processes segment is expected to register fastest CAGR of 25.3% during the forecast period, owing to advancement in bioprocessing technologies that has improved the downstream processing, rise in demand for high purity CGT products and expansion of contract manufacturing organizations are collectively driving the segment growth.
The market is segmented into, pharmaceutical companies, biopharmaceutical/biotechnological companies, and contract manufacturing organizations. Biopharmaceutical / Biotechnological Companies dominated the market in 2024, as major pharmaceutical companies such as Novartis and Gilead Sciences have increased their pipeline candidates with cell and gene therapies and growing collaborations between biopharma companies further drives the segment growth.
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) dominated the market owing to its high sensitivity, rapid turnaround, and regulatory compliance in detecting genetic modifications and contaminants. The adoption of qPCR and dPCR for precise quantification and the rising need for standardized potency and identity assays further contributes to the segment growth.
Key players in the industry are focus on adopting key business strategies, such as strategic collaborations, acquisitions, and expansions, to gain a strong foothold in the market.
Solvias is an emerging player in the market, specialized in method development, validation, stability testing, and regulatory compliance support for CGT.
The cell and gene therapy manufacturing QC market is witnessing significant growth, driven by stringent regulatory requirements for CGT manufacturing, increasing adoption of automated and AI-driven QC solutions, a growing pipeline of CGT products, and rising investments in advanced QC infrastructure. Additionally, the outsourcing of QC activities to specialized CROs and CDMOs is streamlining compliance and scalability, while real-time analytics and predictive quality control are enhancing manufacturing efficiency. Expanding global collaborations and government funding initiatives further accelerate the market by supporting innovation and standardization in QC processes.