Cell and Gene Therapy Manufacturing Quality Control (QC) Market is on an Upward Growth Curve

InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the "Global Cell and Gene Therapy Manufacturing Quality Control (QC) Market - (By Component (Equipment & Accessories, Consumables, Others), By Application (Sterility Testing, Purity Testing, Potency Testing, Identity Testing, Others (stability, viability, etc.)), By Process (Upstream Processing, Downstream Processing, Packaging), By End-User (Pharmaceutical & Biotechnology Companies, Contract Manufacturing Organizations)), Trends, Industry Competition Analysis, Revenue and Forecast To 2031."

According to the latest research by InsightAce Analytic, the Global 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.

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The quality control (QC) market within cell and gene therapy manufacturing plays a critical role in ensuring the safety, efficacy, and consistency of these advanced therapeutic modalities. As cell and gene therapy technologies rapidly advance, there is an increasing emphasis on implementing robust QC protocols that comply with evolving regulatory requirements and guarantee the delivery of high-quality treatments to patients worldwide. The growing number of regulatory approvals for cell and gene therapies has significantly heightened the demand for specialized manufacturing and quality control services. Each new approval necessitates rigorous quality assessments to ensure compliance with international safety standards and uphold patient well-being.

Pharmaceutical companies, biotechnology organizations, and academic research institutions are dedicating substantial investments toward the development of cell and gene therapies. These efforts focus on innovation in treatment approaches, optimization of manufacturing workflows, and the strengthening of QC systems to meet both regulatory mandates and market expectations.

List of Major Players in the Cell and Gene Therapy Manufacturing Quality Control (QC):
• 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.
• 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
• Other Market Players

Market Dynamics:
Drivers-
The Cell & Gene Therapy Manufacturing Quality Control (QC) market is being driven by several key factors, including the rising demand for personalized medicine, advancements in cell and gene therapy technologies, increased investment in research and development, and broader regulatory approvals for gene and cell therapies. Furthermore, the growing prevalence of chronic diseases and genetic disorders is contributing to market expansion. As cell and gene therapy technologies continue to evolve, the need for robust quality control systems has become critical to ensure that therapeutic products meet safety, efficacy, and consistency standards.

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Challenges:
The Cell & Gene Therapy Manufacturing Quality Control (QC) market faces several significant challenges. These include complex and intricate manufacturing processes, stringent regulatory requirements, high production costs, and technical and logistical obstacles related to scaling production to meet market demand. Additionally, ensuring the consistency and reproducibility of cell and gene therapy products remains a continuous challenge for manufacturers, as these therapies often involve complex biological processes that require precise control.

Regional Trends:
North America is expected to dominate the global market for Cell and Gene Therapy Manufacturing Quality Control (QC), driven by its well-established healthcare infrastructure, strong research and development investments, and the presence of leading market players. The region benefits from a supportive regulatory environment that promotes innovation and growth in the sector. Europe holds a significant share of the market as well, bolstered by the increasing adoption of cutting-edge therapies, favorable government initiatives, and a thriving pharmaceutical industry. Collaborative efforts between industry players and academic institutions in Europe are fostering innovation and contributing to the region's market growth.

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.

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Segmentation of Cell and Gene Therapy Manufacturing Quality Control (QC)-
By Component
• Equipment & Accessories
• Consumables
• Others
By Application
• Sterility Testing
• Purity Testing
• Potency Testing
• Identity Testing
• Others (stability, viability, etc.)
By Process-
• Upstream Processing
• Downstream Processing
• Packaging
By End-User-
• Pharmaceutical & Biotechnology Companies
• Contract Manufacturing Organizations
By Region-
North America-
• The US
• Canada
• Mexico
Europe-
• Germany
• The UK
• France
• Italy
• Spain
• Rest of Europe
Asia-Pacific-
• China
• Japan
• India
• South Korea
• Southeast Asia
• Rest of Asia Pacific
Latin America-
• Brazil
• Argentina
• Rest of Latin America
Middle East & Africa-
• GCC Countries
• South Africa
• Rest of Middle East and Africa

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