Cell and Gene Therapy Manufacturing Quality Control (QC) Market

Cell and Gene Therapy Manufacturing Quality Control (QC) Market Size is valued at USD 446.2 Mn in 2023 and is predicted to reach USD 2,434.4 Mn by the year 2031 at a 23.89% CAGR during the forecast period for 2024-2031.

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.

Competitive Landscape

Some Major Key Players In The Cell and Gene Therapy Manufacturing Quality Control (QC) Market:

bioMérieux SA
Bio-Rad Laboratories, Inc.
Bio-Techne Corporation
QIAGEN
Charles River Laboratories International, Inc.
Lonza Group AG
Merck KGaA
Intertek Group plc
Thermo Fisher Scientific, Inc.
Eurofins Scientific S.E.
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
Other Prominent Players

Market Segmentation:

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.

Based On The Process, The Downstream Processing Category Accounts For A Major Contributor To The Market.

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 Witnessed Growth At A Rapid Rate.

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.

In The Region, The North American Cell And Gene Therapy Manufacturing Quality Control (QC) Market Holds A Significant Revenue Share

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.

Recent Developments

In Feb 2024, Thermo Fisher Scientific has established a novel sterile drug facility in Singapore, which will enhance the company's capacity to supply clients in the Asia-Pacific region with novel pharmaceuticals and vaccines. In addition to being an investment in pandemic preparedness, the new facility signifies a significant achievement and milestone for Singapore, which is rapidly becoming a biomedical centre in the Asia-Pacific region.

In Apr 2020, Merck, a prominent scientific and technological business, has declared the creation of a second establishment in Carlsbad, California, USA, specifically for its BioReliance® viral and gene therapy services. The anticipated inauguration of the state-of-the-art commercial establishment, with a budget of €100 million, is scheduled for the fiscal year 2021-2022.