Cell and Gene Therapy Manufacturing Quality Control Market Trends Highlight Rising Applications in Sterility, Potency, and Identity Testing Across Pharmaceutical and Biotech Companies

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 2034."

According to the latest research by InsightAce Analytic, the Global Cell and Gene Therapy Manufacturing Quality Control (QC) Market is valued at USD 2.71 Bn in 2024, and it is expected to reach USD 16.32 Bn by the year 2034, with a CAGR of 19.8% during the forecast period of 2025-2034.

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The cell and gene therapy manufacturing quality control (QC) market encompasses a comprehensive set of protocols designed to ensure the safety, efficacy, and consistency of advanced therapeutic products. With rapid advancements in cell and gene therapy technologies, there is a growing emphasis on implementing stringent QC procedures that align with evolving regulatory standards, thereby facilitating the global delivery of high-quality treatments. Increasing regulatory approvals of these therapies for clinical use are driving the demand for reliable manufacturing and quality control solutions.

This heightened regulatory focus underscores the critical need for robust QC measures to ensure compliance and safeguard patient safety. In response, pharmaceutical and biotechnology companies, along with academic research institutions, are substantially investing in innovative therapy development, process optimization, and the enhancement of quality assurance systems. Furthermore, government initiatives-including grants, tax incentives, and targeted funding programs-are supporting the expansion and commercialization of cell and gene therapies. These policy-driven measures are stimulating investment in manufacturing infrastructure and QC capabilities, contributing to sustained growth in the market.

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

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Market Dynamics
Drivers:
The Cell and Gene Therapy Manufacturing Quality Control (QC) market is witnessing robust growth, driven by rising demand for personalized medicine, ongoing advancements in therapeutic technologies, and increasing investments in research and development. The expanding pipeline of regulatory approvals for cell and gene therapy products, coupled with the growing prevalence of chronic diseases and genetic disorders, further supports market expansion. As these therapies evolve, the adoption of stringent quality control measures becomes increasingly critical to ensure product safety, efficacy, and consistency.

Challenges:
Despite its strong growth potential, the market faces several challenges, including the complexity of manufacturing processes, stringent regulatory compliance requirements, high production costs, and operational difficulties associated with scaling production to meet rising demand. Ensuring batch-to-batch consistency and reproducibility remains a significant concern, necessitating continuous efforts in process optimization and technological innovation.

Regional Trends:
North America is projected to maintain a dominant position in the global Cell and Gene Therapy Manufacturing QC market, driven by its advanced healthcare infrastructure, substantial R&D investment, presence of leading industry players, and supportive regulatory framework. Europe also represents a significant share of the market, supported by the adoption of advanced therapeutic technologies, strong governmental support, and a well-established pharmaceutical ecosystem. Collaborative initiatives between academic institutions and commercial organizations are further promoting innovation and accelerating market growth across the region.

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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.

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

Read Overview Report- https://www.insightaceanalytic.com/report/cell-and-gene-therapy-manufacturing-quality-control-qc-market/2395

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InsightAce Analytic is a market research and consulting firm that enables clients to make strategic decisions. Our qualitative and quantitative market intelligence solutions inform the need for market and competitive intelligence to expand businesses. We help clients gain competitive advantage by identifying untapped markets, exploring new and competing technologies, segmenting potential markets and repositioning products. Our expertise is in providing syndicated and custom market intelligence reports with an in-depth analysis with key market insights in a timely and cost-effective manner.

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This release was published on openPR.