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Cell and Gene Therapy Manufacturing Quality Control (QC) Market Size is valued at USD 2.71 Bn in 2024 and is predicted to reach USD 16.32 Bn by the year 2034 at a 19.8% CAGR during the forecast period for 2025-2034.
A crucial element in the production of cell and gene therapies, quality control (QC) guarantees the advanced therapeutic products' safety, potency, integrity, and efficacy prior to their administration to patients. Considering the intricate characteristics and individualized approach of cell and gene therapies, quality control procedures are rigorous and specialized, incorporating an extensive array of analytical methodologies and regulatory benchmarks.
Additionally, the broader spectrum of medical conditions targeted by cell and gene therapies necessitates extensive manufacturing and QC processes, further contributing to market expansion. Moreover, the escalating pipeline of cell and gene therapy candidates, addressing a wide array of diseases ranging from genetic disorders to cancers and rare diseases, is amplifying the requirement for cell and gene therapy manufacturing quality control (QC).
Furthermore, the rising incidents of chronic diseases and genetic disorders are an additional catalyst for market growth. Moreover, continuous advancements in cell and gene therapy technologies have spurred the development of innovative therapeutic approaches for various diseases, consequently increasing the demand for quality control measures. As the field continues to progress, an escalating need emerges for stringent quality control processes to ensure the safety, efficacy, and consistency of therapeutic products.
The Cell & Gene Therapy Manufacturing Quality Control (QC) the market is segmented on the basis of component, process, application and end-user. As per the Component, the market is categorised into Equipment & Accessories, Consumables, and Others. The Application comprises Sterility Testing, Purity Testing, Potency Testing, Identity Testing, and Others (stability, viability, etc.). As per the Process segment, the market has Upstream Processing, Downstream Processing, and Packaging. At last, the End-User segment consists of Pharmaceutical & Biotechnology Companies, and Contract Manufacturing Organizations.
The Downstream processing category is expected to hold a major share of the global Cell and Gene Therapy Manufacturing Quality Control (QC) market. Firstly, as the field of cell and gene therapy continues to advance, there is an increasing focus on optimizing downstream processing techniques to purify and isolate therapeutic products efficiently. Downstream processing plays a significant and important role in the manufacturing workflow by separating and purifying the desired therapeutic molecules from cell cultures or genetic material, ensuring the production of high-quality and potent therapies.
Moreover, with the expanding pipeline of cell and gene therapy candidates targeting a wide range of diseases, there is a growing need for robust downstream processing methodologies to scale up production and meet the rising demand for these therapies. Downstream processing enables the isolation of therapeutic products in sufficient quantities while maintaining their purity and biological activity, thereby facilitating large-scale manufacturing and commercialization efforts. Furthermore, advancements in downstream processing technologies and techniques are driving innovation in this segment. Novel purification methods, chromatography systems, and filtration technologies are being developed to enhance the efficiency, yield, and cost-effectiveness of downstream processing, addressing the specific requirements of cell and gene therapy manufacturing.
The Potency testing segment is projected to grow rapidly in the global Cell and Gene Therapy Manufacturing Quality Control (QC) market. This surge can be because of several factors driving demand and adoption. Firstly, as the field of cell and gene therapy expands, there is a growing emphasis on ensuring the efficacy and potency of these therapies. Potency testing plays a crucial role in assessing the therapeutic effectiveness of cell and gene therapy products, thus becoming increasingly vital for quality control purposes. Moreover, with the increasing number of approved cell and gene therapies targeting a diverse range of diseases, there is a heightened need for accurate and reliable potency testing methods to validate the therapeutic potency of these products.
The North American Cell and Gene Therapy Manufacturing Quality Control (QC) market is expected to register a tremendous market share. Expansion is fueled by multiple elements, such as the increasing uptake of advanced therapies, rising investments in the biotechnology and pharmaceutical sectors, and the availability of a proficient workforce. Consequently, the Europe market for quality control in cell and gene therapy manufacturing is primed for significant expansion in the foreseeable future, playing a crucial role in advancing healthcare solutions across the region. Additionally, the escalating prevalence of chronic diseases in the area has hastened the need for cutting-edge cell and gene therapies, prompting the implementation of rigorous quality control measures. Europe nations are vigorously engaged in research and development endeavours, facilitating partnerships with biotech firms.
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Report Attribute |
Specifications |
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Market Size Value In 2024 |
USD 2.71 Bn |
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Revenue Forecast In 2034 |
USD 16.32 Bn |
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Growth Rate CAGR |
CAGR of 23.89% from 2025 to 2034 |
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Quantitative Units |
Representation of revenue in US$ Million and CAGR from 2025 to 2034 |
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Historic Year |
2021 to 2024 |
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Forecast Year |
2025-2034 |
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Report Coverage |
The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
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Segments Covered |
By Component, Process, Application And End-User. |
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Regional Scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
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Country Scope |
U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico; France; Italy; Spain; South East Asia; South Korea |
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Competitive Landscape |
bioMérieux SA, Bio-Rad Laboratories, Inc., Bio-Techne Corporation, QIAGEN, Charles River Laboratories International, Inc., Lonza Group AG, Merck KGaA, Intertek Group pl, Thermo Fisher Scientific, Inc., Eurofins Scientific S.E. and F. Hoffmann-La Roche Ltd., Catalent, Wuxi AppTec, Takara Bio Inc, Oxford Biomedica plc, Cell and Gene Therapy Catapult, FUJIFILM Holdings Corporation, Danaher (Cytiva), Sartorius AG, AGC Biologics, Eurofins Scientific |
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Customization Scope |
Free customization report with the procurement of the report and modifications to the regional and segment scope. Particular Geographic competitive landscape. |
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Pricing And Available Payment Methods |
Explore pricing alternatives that are customized to your particular study requirements. |
Chapter 1. Methodology and Scope
1.1. Research Methodology
1.2. Research Scope & Assumptions
Chapter 2. Executive Summary
Chapter 3. Global Cell and Gene Therapy Manufacturing Quality Control (QC) Market Snapshot
Chapter 4. Global Cell and Gene Therapy Manufacturing Quality Control (QC) Market Variables, Trends & Scope
4.1. Market Segmentation & Scope
4.2. Drivers
4.3. Challenges
4.4. Trends
4.5. Investment and Funding Analysis
4.6. Industry Analysis – Porter’s Five Forces Analysis
4.7. Competitive Landscape & Market Share Analysis
4.8. Impact of Covid-19 Analysis
Chapter 5. Market Segmentation 1: by Component Estimates & Trend Analysis
5.1. by Component & Market Share, 2024 & 2034
5.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2021 to 2034 for the following by Component:
5.2.1. Equipment & Accessories
5.2.2. Consumables
5.2.3. Others
Chapter 6. Market Segmentation 2: by Analytical Method Estimates & Trend Analysis
6.1. by Analytical Method & Market Share, 2024 & 2034
6.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2021 to 2034 for the following by Analytical Method:
6.2.1. Sterility Testing
6.2.2. Purity Testing
6.2.3. Potency Testing
6.2.4. Identity Testing
6.2.5. Others (Stability, Viability, Etc.)
Chapter 7. Market Segmentation 3: by Process Estimates & Trend Analysis
7.1. by Process & Market Share, 2024 & 2034
7.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2021 to 2034 for the following by Process:
7.2.1. Upstream Processes
7.2.2. Downstream Processes
7.2.3. Process Development
Chapter 8. Market Segmentation 4: by End-User Estimates & Trend Analysis
8.1. by End-User & Market Share, 2024 & 2034
8.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2021 to 2034 for the following by End-User:
8.2.1. Pharmaceutical & Biotechnology Companies
8.2.2. Contract Manufacturing Organizations
Chapter 9. Cell and Gene Therapy Manufacturing Quality Control (QC) Market Segmentation 5: Regional Estimates & Trend Analysis
9.1. North America
9.1.1. North America Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Component, 2021-2034
9.1.2. North America Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Analytical Method, 2021-2034
9.1.3. North America Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Process, 2021-2034
9.1.4. North America Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2021-2034
9.1.5. North America Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
9.2. Europe
9.2.1. Europe Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Component, 2021-2034
9.2.2. Europe Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Analytical Method, 2021-2034
9.2.3. Europe Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Process, 2021-2034
9.2.4. Europe Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2021-2034
9.2.5. Europe Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
9.3. Asia Pacific
9.3.1. Asia Pacific Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Component, 2021-2034
9.3.2. Asia Pacific Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Analytical Method, 2021-2034
9.3.3. Asia-Pacific Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Process, 2021-2034
9.3.4. Asia Pacific Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2021-2034
9.3.5. Asia Pacific Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
9.4. Latin America
9.4.1. Latin America Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Component, 2021-2034
9.4.2. Latin America Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Analytical Method, 2021-2034
9.4.3. Latin America Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Process, 2021-2034
9.4.4. Latin America Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2021-2034
9.4.5. Latin America Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
9.5. Middle East & Africa
9.5.1. Middle East & Africa Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Component, 2021-2034
9.5.2. Middle East & Africa Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Analytical Method, 2021-2034
9.5.3. Middle East & Africa Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by Process, 2021-2034
9.5.4. Middle East & Africa Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2021-2034
9.5.5. Middle East & Africa Cell and Gene Therapy Manufacturing Quality Control (QC) Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
Chapter 10. Competitive Landscape
10.1. Major Mergers and Acquisitions/Strategic Alliances
10.2. Company Profiles
10.2.1. bioMérieux SA
10.2.2. Bio-Rad Laboratories, Inc.
10.2.3. Bio-Techne Corporation
10.2.4. QIAGEN
10.2.5. Charles River Laboratories International, Inc.
10.2.6. Lonza Group AG
10.2.7. Merck KGaA
10.2.8. Intertek Group plc
10.2.9. Thermo Fisher Scientific, Inc.
10.2.10. Eurofins Scientific S.E.
10.2.11. F. Hoffmann-La Roche Ltd.
10.2.12. Catalent
10.2.13. Wuxi AppTec
10.2.14. Takara Bio Inc
10.2.15. Oxford Biomedica plc
10.2.16. Cell and Gene Therapy Catapult
10.2.17. FUJIFILM Holdings Corporation
10.2.18. Danaher (Cytiva)
10.2.19. Sartorius AG
10.2.20. AGC Biologics.
10.2.21. Eurofins Scientific
10.2.22. Other Prominent Players
Cell and Gene Therapy Manufacturing Quality Control (QC) Market By Component
Cell and Gene Therapy Manufacturing Quality Control (QC) Market By Application
Cell and Gene Therapy Manufacturing Quality Control (QC) Market By Process-
Cell and Gene Therapy Manufacturing Quality Control (QC) Market By End-User-
Cell and Gene Therapy Manufacturing Quality Control (QC) Market By Region-
North America-
Europe-
Asia-Pacific-
Latin America-
InsightAce Analytic follows a standard and comprehensive market research methodology focused on offering the most accurate and precise market insights. The methods followed for all our market research studies include three significant steps – primary research, secondary research, and data modeling and analysis - to derive the current market size and forecast it over the forecast period. In this study, these three steps were used iteratively to generate valid data points (minimum deviation), which were cross-validated through multiple approaches mentioned below in the data modeling section.
Through secondary research methods, information on the market under study, its peer, and the parent market was collected. This information was then entered into data models. The resulted data points and insights were then validated by primary participants.
Based on additional insights from these primary participants, more directional efforts were put into doing secondary research and optimize data models. This process was repeated till all data models used in the study produced similar results (with minimum deviation). This way, this iterative process was able to generate the most accurate market numbers and qualitative insights.
Secondary research
The secondary research sources that are typically mentioned to include, but are not limited to:
The paid sources for secondary research like Factiva, OneSource, Hoovers, and Statista
Primary Research:
Primary research involves telephonic interviews, e-mail interactions, as well as face-to-face interviews for each market, category, segment, and subsegment across geographies
The contributors who typically take part in such a course include, but are not limited to:
Data Modeling and Analysis:
In the iterative process (mentioned above), data models received inputs from primary as well as secondary sources. But analysts working on these models were the key. They used their extensive knowledge and experience about industry and topic to make changes and fine-tuning these models as per the product/service under study.
The standard data models used while studying this market were the top-down and bottom-up approaches and the company shares analysis model. However, other methods were also used along with these – which were specific to the industry and product/service under study.
To know more about the research methodology used for this study, kindly contact us/click here.
