Cell and Gene Therapy Manufacturing Quality Control Market Driven by Regulatory Pressures and Innovation in Bioprocess Validation and Compliance

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 procedures designed to ensure the safety, efficacy, and consistency of advanced therapeutic products. As cell and gene therapy technologies continue to evolve rapidly, there is a growing emphasis on implementing stringent quality control protocols aligned with regulatory standards to support the global delivery of high-quality treatments. Regulatory authorities across the globe are increasingly granting approvals for clinical use of these therapies, thereby fueling demand for robust manufacturing and quality control solutions.

This expanding regulatory acceptance underscores the need for reliable QC practices to ensure therapeutic compliance and safeguard patient well-being. In response, pharmaceutical and biotechnology companies, as well as academic research institutions, are significantly increasing investments in the development of novel therapies, process optimization, and the advancement of quality assurance systems. Furthermore, supportive government initiatives-including grants, tax incentives, and dedicated funding programs-are actively encouraging the development and commercialization of cell and gene therapies. These policy-driven incentives are catalyzing investments in manufacturing infrastructure and quality control capabilities, thereby driving 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 primarily driven by the increasing demand for personalized medicine, rapid advancements in therapeutic technologies, rising investments in research and development, and the expanding number of regulatory approvals for cell and gene therapy products. Additionally, the growing prevalence of chronic illnesses and genetic disorders is further propelling market growth. As innovation in cell and gene therapies continues, the need for rigorous quality control measures becomes increasingly critical to ensure the safety, efficacy, and consistency of therapeutic products.

Challenges:
Despite its growth potential, the Cell and Gene Therapy Manufacturing QC market faces several key challenges. These include complex manufacturing processes, stringent regulatory requirements, high production costs, and operational difficulties associated with scaling manufacturing to meet growing demand. Ensuring the reproducibility and uniformity of cell and gene therapy products across different batches remains a persistent concern for manufacturers, requiring continuous process optimization and innovation.

Regional Trends:
North America is anticipated to lead the global Cell and Gene Therapy Manufacturing QC market in terms of revenue, supported by a well-developed healthcare infrastructure, substantial R&D investments, the presence of leading industry players, and a favorable regulatory landscape. Europe also represents a significant share of the market, driven by the adoption of advanced therapeutic technologies, strong government support, and a robust pharmaceutical ecosystem. Strategic collaborations between academic institutions and commercial entities in the region are further enhancing innovation and market development.

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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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This release was published on openPR.