Cell and Gene Therapy QC & Analytics Market 2026-2034 | Size & Trends
Coverage: Cell and Gene Therapy Quality Control and Analytics Market covers analysis By Testing Type (Sterility Testing, Identity Testing, Potency Testing, Mycoplasma Testing, Endotoxin Testing, Others); Analytical Method (Flow Cytometry, Polymerase Chain Reaction (PCR)/digital PCR (dPCR), High-Performance Liquid Chromatography (HPLC), Mass Spectrometry, Enzyme-Linked Immunosorbent Assay (ELISA), Others); Application Area (Oncology, Genetic Disorders, Cardiovascular Diseases, Infectious Diseases, Others); End-User (Pharmaceutical & Biotechnology Companies, Contract Development and Manufacturing Organizations (CDMOs), Academic & Research Institutes, Others); and Geography
- Report Date : Feb 2026
- Report Code : TIPRE00042196
- Category : Life Sciences
- Status : Upcoming
- Available Report Formats :
- No. of Pages : 150
The global cell and gene therapy quality control and analytics market is estimated to be valued at approximately US$ 1.88 billion in 2025. It is projected to reach around US$ 5.38 billion by 2034, representing a compound annual growth rate (CAGR) of 12.40% during 2026–2034.
Cell and Gene Therapy Quality Control and Analytics Market AnalysisThe market for quality control (QC) and analytics in the cell and gene therapy (CGT) space is poised for rapid growth. This expansion is driven by the rising number of CGT approvals, increasingly complex therapy modalities (e.g., CAR-T, gene editing, AAV vectors), and stringent regulatory frameworks demanding thorough testing of identity, purity, potency, and stability. Real-time analytics, AI-powered data interpretation, and advanced assay platforms (flow cytometry, PCR/dPCR, mass spectrometry) are increasingly adopted to manage this complexity.
The growth is also fuelled by the outsourcing of QC/analytics services to contract development and manufacturing organizations (CDMOs) and specialized testing labs, as biopharma players focus on core therapy development. The shift from R&D to commercial-scale manufacture intensifies demand for scalable QC analytics infrastructure.
Cell and Gene Therapy Quality Control and Analytics Market OverviewQC and analytics in the CGT domain refer to the suite of processes, technologies, and services used to ensure that cell- and gene-based therapeutic products meet required quality specifications before administration to patients. These include sterility, identity, and potency assays, vector copy number analysis, multi-parameter flow cytometry, immunophenotyping, residual impurity testing, and stability monitoring. QC & analytics systems enable faster batch release, improved manufacturing yield, regulatory compliance, and superior patient safety.
These solutions are integral to CGT workflows, supporting clinical trial progression, commercial manufacturing, and lifecycle management of advanced therapies.
Strategic Insights
Cell and Gene Therapy Quality Control and Analytics Market Drivers and OpportunitiesMarket Drivers:
- Rising volume of cell and gene therapy approvals and pipelines: More advanced therapies mean higher demand for sophisticated QC & analytics platforms.
- Stringent regulatory demands for safety, potency, and comparability of CGT products: QC & analytics become a mandatory tool for market entry and post-approval monitoring.
- Increasing outsourcing to specialized labs/CDMOs: As developers scale, QC/analytics services are often externalized, fuelling service-segment growth.
Market Opportunities:
- Integration of AI/ML for predictive analytics and real-time monitoring: Enables smarter analytics and faster batch release decisions.
- Expansion in emerging markets with growing CGT manufacturing footprints (e.g., China, India): Cost-effective analytics platforms and cloud-based solutions will gain traction.
- Development of novel assay platforms (single-cell analysis, multi-omics, digital PCR) tailored for complex CGT products: Offers high-value differentiation for providers.
By Testing Type:
- Sterility Testing
- Identity Testing
- Potency Testing
- Mycoplasma Testing
- Endotoxin Testing
- Others
By Analytical Method:
- Flow Cytometry
- Polymerase Chain Reaction (PCR) / digital PCR (dPCR)
- High-Performance Liquid Chromatography (HPLC)
- Mass Spectrometry
- Enzyme-Linked Immunosorbent Assay (ELISA)
- Others
By Application Area:
- Oncology
- Genetic Disorders
- Cardiovascular Diseases
- Infectious Diseases
- Others
By End-User:
- Pharmaceutical & Biotechnology Companies
- Contract Development and Manufacturing Organizations (CDMOs)
- Academic & Research Institutes
- Others
By Geography:
- North America
- Europe
- Asia Pacific
- South & Central America
- Middle East & Africa
Market Report Scope
Cell and Gene Therapy Quality Control and Analytics Market Share Analysis by GeographyNorth America
- Market Share: Holds the largest share globally, driven by advanced CGT infrastructure and regulatory maturity.
- Key Drivers: Strong R&D investment, large number of CGT approvals, well-established CDMO/QC service providers.
- Trends: Increased adoption of integrated analytics platforms, cloud-based QC solutions, and real-time batch release testing.
Europe
- Market Share: Significant share owing to strong regulatory frameworks and public-private initiatives in cell and gene therapies.
- Key Drivers: EU-wide harmonization of advanced therapy medicinal product regulation (ATMP), rising demand in clinical trials.
- Trends: Growing interoperability of analytics systems, pan-European QC service networks, and focus on cross-border manufacturing compliance.
Asia Pacific
- Market Share: Fastest-growing region during the forecast period.
- Key Drivers: Rapid healthcare and biotech infrastructure expansion, growing CGT manufacturing hubs, and supportive government initiatives.
- Trends: Adoption of cost-effective cloud-based QC/analytics, localization of service providers, and regional partnerships with global CDMOs.
- South & Central America
- Market Share: Emerging contributor with growth potential.
- Key Drivers: Expansion of biotech/CGT manufacturing, increasing outsourcing of analytics services to cost-advantage regions.
- Trends: Cloud-based QC services, regional collaborations, and regulatory enhancements to support advanced therapies.
Middle East & Africa
- Market Share: Developing but high-potential region.
- Key Drivers: National e-health and biotech strategies, investments in advanced manufacturing infrastructure.
- Trends: Adoption of cloud & analytics platforms, growing need for QC/analytics in regional CGT initiatives, partnership models with global providers.
The QC & analytics market for cell and gene therapies is becoming increasingly competitive due to the presence of global analytics service providers, CDMOs with in-house QC capabilities, and niche analytics platform specialists. This competition drives differentiation through:
- Seamless integration of analytics and QC platforms with CGT manufacturing workflows.
- Scalable cloud-based QC/analytics solutions tailored for small & large therapy developers.
- AI-enabled automation for assay interpretation, batch release decisions, and trend monitoring.
- Interoperability with manufacturing, CRO, CDMO, and regulatory systems (e.g., LIMS, ELN, regulatory submission platforms).
Opportunities and Strategic Moves:
- Form alliances with CGT developers and CDMOs to provide comprehensive QC & analytics packages.
- Embed AI/ML and automation into QC workflows for faster turnaround and cost-efficiency.
- Expand presence in emerging markets (Asia-Pacific, Latin America) with regional analytics hubs.
- Invest in next-generation assay platforms (e.g., single-cell sequencing, multi-omics) to stay ahead of the competition.
- Thermo Fisher Scientific Inc.
- Merck KGaA
- Sartorius AG
- Danaher Corporation
- Eurofins Scientific
- Charles River Laboratories International, Inc.
- Labcorp Drug Development
- Catalent, Inc.
- Bio‑Rad Laboratories, Inc.
- WuXi AppTec
- AGC Biologics
- Pharmalex
- Medpace, Inc.
- MilliporeSigma
- QIAGEN N.V.
- BioReliance
- In April 2025, AGC Biologics launched its dedicated Cell & Gene Technologies Division aimed at supporting developers with enhanced QC & analytics capabilities for advanced therapies.
- Growing use of AI‐driven robotics platforms in CGT manufacturing and QC; for example, a collaboration in 2025 validated a fully automated cell therapy production and QC platform, enabling decentralized manufacturing.
- Biopharma and CDMO investment in regional analytics hubs is increasing to meet cost and regulatory pressures, particularly in the Asia-Pacific.
- Rising regulatory scrutiny of CGT products requiring advanced analytics (single-cell, multi-omics) and real‐time release testing is driving service demand.
The "Cell and Gene Therapy Quality Control and Analytics Market Size and Forecast (2024–2034)" report provides a detailed analysis covering the following:
- Market size and forecast at global, regional, and country levels for all key market segments covered under the scope
- Market trends, including market dynamics such as drivers, restraints, and key opportunities
- Detailed PEST and SWOT analysis
- Market analysis covering key market trends, global and regional frameworks, major players, regulations, and recent market developments
- Industry landscape and competition analysis covering market concentration, heat-map analysis, prominent players, and recent developments in the QC & analytics segment of the CGT market
- Detailed company profiles
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Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
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to segments covered.
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
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to country scope.
Frequently Asked Questions
1. Rising approvals and pipelines of cell and gene therapies.
2. Increasing regulatory stringency on QC, potency, and analytics for advanced therapies.
3. Growing outsourcing of QC/analytics to CDMOs and specialist labs.
The analytical methods segment (e.g., PCR/dPCR, mass spectrometry, flow cytometry) and the services segment (outsourced analytics) are gaining traction, driven by complex therapy modalities and the need for advanced characterization.
1. Pharmaceutical & biotechnology companies developing cell & gene therapies.
2. Contract development and manufacturing organizations (CDMOs) offering QC/analytics support.
3. Academic & research institutes involved in translational CGT work.
Major players include Thermo Fisher Scientific, Merck KGaA, Sartorius, Danaher, Eurofins Scientific, Charles River Laboratories, Catalent, Bio-Rad, Labcorp Drug Development, and WuXi AppTec.
Key challenges include high cost and complexity of analytics platforms, the requirement for highly skilled talent, and regulatory variability across geographies affecting global scalability.
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