The Cell and Gene Therapy Manufacturing Quality Control (QC) Market is on an upward growth curve. 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. 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.\n\nList 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, and Other Market Players.\n\nMarket Dynamics: Drivers include 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. The growing prevalence of chronic diseases and genetic disorders is also contributing to market expansion. As these technologies evolve, the need for robust quality control systems has become critical to ensure that therapeutic products meet safety, efficacy, and consistency standards.\n\nChallenges 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. Ensuring the consistency and reproducibility of cell and gene therapy products remains a continuous challenge due to the complex biological processes involved.\n\nRegional Trends: North America is expected to dominate the global market, driven by its well-established healthcare infrastructure, strong R&D investments, and the presence of leading market players. The region benefits from a supportive regulatory environment. Europe holds a significant share, bolstered by 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 market growth.\n\nRecent Developments: In February 2024, Thermo Fisher Scientific established a novel sterile drug facility in Singapore, enhancing its capacity to serve the Asia-Pacific region with pharmaceuticals and vaccines, signaling a significant milestone for Singapore as a biomedical hub. In April 2020, Merck announced the creation of a second facility in Carlsbad, California, USA, specifically for its BioReliance® viral and gene therapy services, with a €100 million budget and an anticipated inauguration in 2021-2022.\n\nSegmentation of the Market:\n- By Component: Equipment & Accessories, Consumables, Others\n- By Application: Sterility Testing, Purity Testing, Potency Testing, Identity Testing, Others (stability, viability, etc.)\n- By Process: Upstream Processing, Downstream Processing, Packaging\n- By End-User: Pharmaceutical & Biotechnology Companies, Contract Manufacturing Organizations\n- By Region: North America, Europe, Asia-Pacific, Latin America, Middle East & Africa\n\nInsightAce Analytic is a market research and consulting firm that enables clients to make strategic decisions through qualitative and quantitative market intelligence solutions. The firm helps clients gain a competitive advantage by identifying untapped markets, exploring new technologies, segmenting potential markets, and repositioning products. It provides syndicated and custom market intelligence reports with in-depth analysis and key market insights in a timely and cost-effective manner.

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

The global cell and gene therapy manufacturing quality control (QC) market is projected to grow from USD 2.71 billion in 2024 to USD 16.32 billion by 2034, at a compound annual growth rate (CAGR) of 19.8% from 2025 to 2034. This growth is driven by rising demand for personalized medicine, advancements in therapy technologies, increased R&D investment, and expanding regulatory approvals. Key players include 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, FUJIFILM Holdings Corporation, Danaher (Cytiva), Sartorius AG, AGC Biologics, and others. North America is expected to dominate the market due to strong healthcare infrastructure and R&D investment, while Europe holds a significant share through favorable policies and industry collaboration. Challenges include complex manufacturing processes, high costs, and difficulties in scaling production. Recent developments include Thermo Fisher Scientific establishing a sterile drug facility in Singapore in February 2024 and Merck creating a second facility in Carlsbad, California, in April 2020 for its BioReliance® viral and gene therapy services.