The cell and gene therapy quality control and analytics market is
rapidly accelerating as
AI-driven tools, advanced testing technologies, and global industry
partnerships enhance accuracy, speed, and scalability in next-generation
therapeutics. With rising demand for precision medicine and complex CGT
treatments, AI-powered analytics, PCR innovations, and strong biopharma–CDMO
collaborations are reshaping quality control standards and driving robust
market growth.
The market has grown in recent periods due to the rising
prevalence of chronic and infectious diseases, driving high demand for
precision medicine, and targeted therapies.
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Key Highlights of Cell and Gene Therapy Quality Control
and Analytics Market
🔹 North America dominated the cell and gene therapy quality
control and analytics market in 2024.
🔹 The Asia
Pacific is expected to grow at a notable CAGR between 2025 and 2034.
🔹 By testing
type, the sterility testing segment led the cell and gene therapy quality
control and analytics market in 2024, whereas the potency testing segment is
expected to grow between 2025 and 2034.
🔹 By
analytical method, the PCR segment led the cell and gene therapy quality
control and analytics market in 2024, whereas the mass spectrometry segment is
expected to grow in between 2025 and 2034.
🔹 By
application area, the oncology segment led the market in 2024, whereas the
genetic disorders segment is expected to grow between 2025 and 2034.
🔹 By
end-user, the pharmaceutical and biotechnology companies segment led the market
in 2024, whereas the CDMOs segment is expected to grow between 2025 and 2034.
Advanced Technologies Helpful for the Growth of the Cell
and Gene Therapy Quality Control and Analytics Market
The cell and gene therapy
quality control and analytics market is expected to
grow due to advances in cell and gene therapies, the growing prevalence of
infectious and chronic diseases, and rising investments in research and
development. The market focuses on ensuring the safety, accuracy, and efficacy
of products, further fueling its growth.
Advanced technologies such as AI, ML, and NGS, which aid drug development and
enhance product safety, also fuel the market's growth. Advanced technologies
such as PCR, qPCR, and droplet digital PCR, which are useful for gene
integration and vector copy number quantification, are another factor driving
the market’s growth.
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New Trends of Cell and Gene Therapy Quality Control and
Analytics Market
🔹 Use of AI
for tasks such as data analysis, real-time monitoring, and predictive modeling
to improve efficiency is one of the major factors for the growth of the market.
🔹 Use of
sophisticated tools such as high-throughput sequencing, mass spectrometry, and
flow cytometry to handle the complexity of such therapies also helps to fuel
the growth of the market
🔹 Automation
to lower errors, improve efficiency, and improve product quality also helps to
enhance the growth of the market.
Impact
of AI in Cell and Gene Therapy Quality Control and Analysis Market:
Artificial
Intelligence (AI) is
revolutionizing quality control and analytics in the cell
and gene therapy market by
enabling faster, more accurate, and scalable evaluation of complex therapies.
AI-powered systems automate critical QC tasks such as identity, purity,
potency, and safety testing, while reducing human error and accelerating batch
release. By integrating and analyzing large, multi-modal datasets, including
sequencing, flow cytometry, and functional assays AI supports real-time
monitoring, predictive analysis, and regulatory compliance.
Additionally, AI facilitates the scalability of
manufacturing workflows, allowing rapid development and commercialization of
therapies like CAR-T and gene-editing products, while ensuring consistent
quality and safety across batches.
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Market Dynamics
Drivers
What Are the Growth Drivers of Cell and Gene Therapy
Quality Control and Analytics Market?
The rising prevalence of chronic and infectious diseases,
the high demand for personalized medications and treatments, and the high demand for clinical trials due to advanced gene and cell therapies are
major factors driving market growth.
Growing cases of cancer and other chronic diseases, leading to a high demand
for advanced cell and gene therapies, are another major factor driving market
growth. Stringent regulatory restrictions followed by the FDA and EMA to ensure
quality control and efficacy are among the major factors for the market’s
growth.
Challenge
How Do High Costs Affect the Growth of the Cell and Gene
Therapy Quality Control and Analytics Market?
High costs associated with advanced cell and gene therapy
technologies, maintaining quality control, and stringent regulatory demands are
among the major restrictions on the growth of the cell and gene therapy quality
control and analytics market. Costs associated with managing the intricate,
complex procedures for developing new cell and gene therapies also restrict the
market's growth.
Costs associated with tailoring and manufacturing personalized medications and
treatments are another major factor restraining the growth of the cell and gene
therapy quality control and analytics market.
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Opportunit
How Does the Partnership Between Stakeholders Create an
Opportunity for the Growth of the Cell and Gene Therapy Quality Control and
Analytics Market?
Partnerships between biopharma companies, CDMOs, tech
firms, and academic institutions are essential to validate emerging cell and
gene therapies, which is helpful for the market's growth. Such collaborations
aid the successful development and adoption of advanced tools, including
AI-driven analytics, rapid sterility testing, and real-time monitoring systems,
thereby fueling market growth.
Partnerships also help to develop regulatory confidence, reduce development
risk, and ensure that new solutions meet industry standards. Hence, these
factors collectively create a significant opportunity for market growth.
Cell and Gene Therapy Quality Control and
Analytics Market Report Scope
|
Report Attributes
|
Key Statistics
|
|
Dominating Region in 2025
|
North America
|
|
Fastest Growing Region
|
Asia Pacific
|
|
Base Year
|
2025
|
|
Forecast Period
|
2025 to 2034
|
|
Segments Covered
|
Testing Type, Analytical Method, Application
Area, End-User, and Region
|
|
Regions Covered
|
North America, Europe, Asia-Pacific, Latin
America, and Middle East & Africa
|
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Cell and Gene Therapy Quality Control and Analytics
Market Regional Analysis
North America Led the Cell and Gene Therapy Quality
Control and Analytics Market in 2024
North America led the market in 2024 due to its developed
healthcare framework, advanced technologies, and well-established healthcare
and research infrastructure,which fueled markete growtt. The rising prevalence
of chronic diseases such as cancer, neurological problems, and cardiovascular
issues, leading to high demand for personalized medications and treatments, is
another major factor for the market’s growth.
The US has made a major contribution to the market's growth through high
investment in research and development and regulatory approval of new and
innovative therapies.
Asia Pacific Is Observed to Be the Fastest-Growing Region
in the Foreseeable Period
Asia Pacific is expected to be the fastest-growing region
over the forecast period due to advancing healthcare infrastructure and higher
demand for new cell and gene therapies. Higher personal and government
investments in the advanced development of cell and gene therapies are another
major factor driving the market's growth in the foreseeable period. It also
helps to keep tabs on the quality, efficacy, and safety of new products to
achieve better results.
China has a major contribution to market growth due to its large population, a
growing geriatric population, and high demand for personalized treatments for
rising chronic diseases.
Europe Is Observed to Have a Notable Growth in the
Foreseeable Period
Europe is expected to show notable growth over the
forecast period due to a higher number of approved cell and gene therapies,
technological advancements in analytical methods, and stringent regulatory
requirements, thereby fueling market growth. The growing prevalence of
infectious and chronic diseases, leading to a high demand for personalized
medications and treatments, is another major factor driving market growth.
Segmental Analysis
By Testing Type
The sterility testing segment led the cell and gene
therapy quality control and analytics market in 2024 due to high demand for
quality assurance and allogenic products, as well as advancements in rapid
testing methods that support market growth. Heavy investments in quality
control infrastructure and specialized services to increase the volume of CGT
products further fuel the need for comprehensive sterile processing and release
testing, which is beneficial for market growth. The transition from traditional
to advanced techniques is another major factor driving the market's growth.
The potency testing segment is expected to grow over the
forecast period, as it involves measuring the biological activity and
therapeutic potential of products. It is an essential requirement under
regulatory frameworks, further fueling the market's growth. The rising
complexity of therapies due to technological innovations, leading to a high
demand for robust potency assays, is another major factor driving the market's
growth in the foreseeable future. The segment also focuses on the product’s
safety, efficacy, and consistent quality.
By Analytical Method
The Polymerase Chain Reaction (PCR) segment dominated the cell and gene therapy
quality control and analytics market in 2024, driven by its high sensitivity
and rapid turnaround, which helped drive market growth. The market also
observes growth, as the segment serves as the core technology for product
characterization, such as transgene expression analysis and vector copy number (VCN)
determination, which helps fuel the market's growth.
The cutting-edge technologies of PCR, such as qPCR and
digital PCR (dPCR), help detect low-abundance targets, further fueling market
growth. The segment also observes growth due to its ability to identify and
quantify specific genetic modifications in cell and gene therapy, which is
beneficial for the market.
The mass spectrometry
segment is expected to grow over the forecast period due to its cutting-edge
technology, which is useful for handling the analytical capabilities of cell
and gene therapy. The segment focuses on the necessary molecular-level
characterization to ensure product safety and efficacy, further fueling market
growth in the foreseeable future.
The segment also helps to detect impurities during drug development, further
fueling its growth. Detailed, structured information about the biomolecules
essential for drug development also fuels the market’s growth.
By Application Area
The oncology segment dominated the cell and gene therapy
quality control and analytics market in 2024, driven by the increasing global
prevalence of cancer, which in turn led to high demand for cell and gene
therapies. The complexity of oncology applications, such as CAR-T cell therapies,
drives higher demand for quality control and analytical services, further
fueling market growth. Such specialized services help to offer high
scalability, which is helpful for manufacturers to meet stringent regulations,
further fueling the growth of the market for new therapeutic processes.
The genetic disorders segment is expected to grow during
the forecast period due to the rising prevalence of genetic disorders, further
fueling demand for personalized medications, thereby driving market growth.
Specialized medications and treatments help identify the root cause of the
disease, enabling effective treatment and fueling market growth in the
foreseeable period.
Curative treatments and solutions to effectively manage genetic disorders are
another major factor driving the market's growth. Technological advancements in
gene editing, such as CRISPR-Cas9, also help to enhance the market’s growth in
the foreseeable period.
By End User
The pharmaceutical and biotechnology companies segment
led the cell and gene therapy quality control and analytics market in 2024,
driven by significant investments in cell and gene therapy. Higher demand for
the effectiveness, safety, and quality of products is another major factor
driving market growth. High demand for precision medicine, personalized
treatments, and the expansion of clinical trials at pharmaceutical and
biotechnology
companies also help fuel the market's growth. Higher demand for clinical trials
for oncology and chronic disease management is another major factor for the
market’s growth.
The contract development and manufacturing organizations
(CDMO) segment is expected to grow in the foreseeable period due to high demand
for specialized services. The segment focuses on providing specialized
manufacturing expertise, scalability, technical support, and assistance with
regulatory compliance, which also helps fuel the market’s growth in the
foreseeable period. The rising number of clinical trials due to the
introduction of new, technologically advanced cell and gene therapies also
helps to increase the market’s demand in the foreseeable period.
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Cell And Gene Therapy Quality Control and
Analytics Market Leading Companies
Tier I: Market Leaders
These companies are dominant in the market, offering
comprehensive quality control and analytical solutions across various stages of
cell and gene therapy development.
|
Company
|
Key Offerings
|
|
Thermo Fisher Scientific
|
Broad portfolio including next-generation sequencing,
PCR/qPCR, and AI-driven analytics platforms.
|
|
Lonza Group
|
Extensive services in cell and gene therapy
manufacturing, including quality control and analytics.
|
|
Merck KGaA
|
Offers a range of analytical solutions and consumables
for cell and gene therapy applications.
|
|
Bio-Rad Laboratories
|
Provides analytical instruments and reagents for gene
therapy quality control.
|
|
QIAGEN
|
Specializes in molecular testing and analytical
solutions for gene therapy.
|
Tier II: Established Players
These companies have a significant presence in the
market, offering specialized services and products that support cell and gene
therapy quality control and analytics.
|
Company
|
Key Offerings
|
|
Charles River Laboratories
|
Provides comprehensive services including quality
control testing for gene therapies
|
|
Bio-Techne Corporation
|
Offers tools and reagents for cell and gene therapy
research and development.
|
|
WuXi AppTec
|
Provides integrated services including quality control
testing for gene therapies.
|
|
Catalent, Inc
|
Specializes in gene therapy manufacturing and quality
control services.
|
|
Eurofins Scientific
|
Offers analytical testing services for gene therapy
products.
|
Tier III: Emerging and Niche Players
These companies are emerging players or niche providers
that contribute to specific aspects of cell and gene therapy quality control
and analytics.
|
Company
|
Key Offerings
|
|
IQVIA
|
Provides data analytics and technology solutions for
gene therapy development.
|
|
F. Hoffmann-La Roche Ltd.
|
Offers diagnostic solutions supporting gene therapy
applications
|
|
Samsung Biologics
|
Provides contract development and manufacturing
services with quality control capabilities.
|
|
Sangamo Therapeutics
|
Focuses on gene therapy development with integrated
quality control processes.
|
|
Galapagos NV
|
Engages in cell therapy development with an emphasis on
quality control.
|
Recent Developments in Cell and Gene Therapy Quality
Control and Analytics Market
🔹 In
November 2025, BRIC-Translational Health Science and Technology Institute
(BRIC-THSTI), in collaboration with Miltenyi Biotec and the Biotechnology
Industry Research Assistance Council (BIRAC), announced the launch of India’s
first Hands-on training programme on the Foundations of Cell and Gene Therapy
(CGT) Manufacturing, with a special focus on CAR-T cell therapy. The main aim
of the launch is to bridge the gap between the research and clinical parts. Source
- Healthcare Radius
🔹 In
September 2025, Solvias announced that William Mauck, Team Lead Manager,
Molecular Biology Lab at Solvias, and an expert in cell and gene therapy (CGT)
quality and analytics, will present at the upcoming Cell & Gene Therapy
International (CGTI) 2025, co-located with BioProcess International in Boston,
Massachusetts. The annual conference involved cutting-edge insights by global
experts. Source – PR Newswire
Segment Covered in the Report
By Testing Type
🔹 Sterility
Testing
🔹 Identity
Testing
🔹 Potency
Testing
🔹 Mycoplasma
Testing
🔹 Endotoxin
Testing
🔹 Others>
By Analytical Method
🔹 Flow
Cytometry
🔹 Polymerase
Chain Reaction (PCR)
🔹 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 Region
🔹 North America
🔹 Europe
🔹 Asia Pacific
🔹Latin America
🔹Middle East & Africa (MEA)
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