Cell and Gene Therapy Manufacturing Quality Control (QC) Market to Reach USD 2.8 billion by 2031, Expanding at a CAGR of 24.6 % Says, Transparency Market Research

Increasing development & adoption of cell & gene therapy and rapid expansion of biotechnology & pharmaceutical industry to drive the market growth.


Wilmington, Delaware, United States, Aug. 28, 2023 (GLOBE NEWSWIRE) -- Transparency Market Research Inc. - The global cell and gene therapy manufacturing quality control (QC) market is projected to flourish at a CAGR of 24.6% from 2023 to 2031. As per the report published by TMR, a valuation of US$ 2.8 billion is anticipated for the market in 2031. As of 2023, the market for cell and gene therapy manufacturing quality control (QC) is expected to close at US$ 463.1 million.

The growing pipeline of cell and gene therapy candidates, targeting a range of diseases including genetic disorders, cancers, and rare diseases, is increasing the demand for cell and gene therapy manufacturing quality control (QC)

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Competitive Landscape

The global cell and gene therapy manufacturing QC market is fragmented, with the presence of large number of players. Merger & acquisition and collaborations are the key strategies adopted by market players to increase market share.

  • 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.

Key Developments

  • In February 2022 – Cell and gene therapy innovators can now leverage new integrated commercial packaging and distribution services from Thermo Fisher Scientific, designed to seamlessly transition therapies from clinic to commercial launch for patients across the U.S. and Europe.
  • QIAGEN - dPCR CGT Assay GFP (FAM) , Cell and Gene Therapy assay for GFP to be used with the QIAcuity dPCR system.
  • Novartis is involved in gene therapy development and manufacturing. The company emphasizes rigorous quality control to ensure the safety and efficacy of its products.
  • BioMarin is a biotechnology company that develops and commercializes innovative therapies, including gene therapies, with a focus on quality control.

Increasing research and development in the cell and gene therapy field, due to the increased needs and challenges related to rare diseases, oncology, and other medical conditions leads increasing the demand for cell and gene therapy manufacturing quality control (QC) to ensure the safety, efficacy, and quality of therapies.

The advancements in analytical technologies and integration of innovative technologies such as automation, robotics, and artificial intelligence into QC processes significantly enhanced the capacity to analyze, characterize, and guarantee the quality of cell and gene therapy products.

Key Takeaways from the Market Study

  • As of 2022, the cell and gene therapy manufacturing quality control (QC) market was valued at US$ 371.7 million
  • Based on component, the global consumables segment accounted for the largest global cell and gene therapy manufacturing QC market share during the forecast period,
  • In terms of end-user, the pharmaceutical & biotechnology companies segment held the leading share of the global cell and gene therapy manufacturing QC market demand in 2022. 
  • Based on the analytical method, the potency testing segment dominated the global cell and gene therapy manufacturing QC industry   during the forecast period.

Cell and Gene Therapy Manufacturing Quality Control (QC) Market: Key Trends and Opportunistic Frontiers

  • Increasing demand for cell & gene therapies and growing trend of personalized medicines, driving the demand for quality control measures.
  • The growing number of government initiatives and regulatory agencies to promote the development and safe implementation of cell and gene therapies contributes to the growth of the QC market.
  • Increasing technological advances in analytical techniques, automation, and data analytics are enhancing the efficiency, accuracy, and speed of QC testing, making it more feasible to perform comprehensive quality assessments, expected to boost the market demand
  • increased investments from biopharmaceutical companies, venture capitalists, and collaborations with contract testing organizations are driving the growth of the QC market.

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Cell and Gene Therapy Manufacturing Quality Control (QC) Market- Regional Analysis

  • North America is anticipated to hold the largest cell and gene therapy manufacturing quality control (QC) market share during the forecast period owing to the strong presence of research, biotechnology, and pharmaceutical industries, driving demand for advanced cell and gene therapy manufacturing quality control (QC) technologies in the region. The increasing government funding for life sciences research and biotechnology contributes to the growth of the market in the region.
  • Asia Pacific is expected to account for a significant market share in the cell and gene therapy manufacturing quality control (QC) market. Increase in demand for innovative treatment options has spurred the development and manufacturing of cell and gene therapies in the region.  The growing healthcare expenditure, increased population and growing focus on personalized medicine drives the demand for precise cell and gene therapy manufacturing quality control solutions.

Cell and Gene Therapy Manufacturing Quality Control (QC) Market- Key Segments

Component

  • Equipment & Accessories
  • Consumables
  • Others

Analytical Method

  • Sterility Testing
  • Purity Testing
  • Potency Testing
  • Identity Testing
  • Others (stability, viability, etc.)

Process

  • Upstream Processes
  • Downstream Processes
  • Process Development

End-user

  • Pharmaceutical & Biotechnology Companies
  • Contract Manufacturing Organizations

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