Dublin, June 27, 2024 (GLOBE NEWSWIRE) -- The "Global Cell and Gene Therapy Manufacturing Quality Control (QC) Market Size, Market Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts, 2023-2031" report has been added to ResearchAndMarkets.com's offering.
The cell and gene therapy manufacturing quality control (QC) market is expected to grow at a CAGR of 25% during the forecast period of 2024 to 2032
This study report represents analysis of each segment from 2021 to 2031 considering 2022 as the base year. Compounded Annual Growth Rate (CAGR) for each of the respective segments estimated for the forecast period of 2023 to 2031.
Cell and gene therapy manufacturing quality control (QC) plays a pivotal role in ensuring the safety, efficacy, and consistency of cell and gene therapies. The cell and gene therapy manufacturing QC market is driven by regulatory requirements, personalized medicine trends, and advancements in analytical technologies.
Despite the complexity of product characterization, the market is poised for growth due to the increasing adoption of cell and gene therapies. Equipment and accessories and Process Development segments are expected to exhibit significant growth during the forecast period. Geographically, Asia-Pacific presents opportunities for expansion. Industry leaders' strategies focus on technology integration, capacity expansion, and comprehensive QC solutions to address the evolving demands of cell and gene therapy manufacturing quality control.
Market Competition to Intensify during the Forecast Period
Prominent players in the cell and gene therapy manufacturing QC market include Lonza Group, Charles River Laboratories, Eurofins Scientific, WuXiAppTec, bioMArieux SA, Bio-Rad Laboratories, Inc., Bio-Techne Corporation, QIAGEN, Merck KGaA, Intertek Group plc, Thermo Fisher Scientific, Inc., and F. Hoffmann-La Roche Ltd. These companies provide a wide array of QC services, analytical tools, and expertise tailored to the unique challenges of cell and gene therapies.
Key strategies involve investing in advanced analytical technologies, expanding testing capabilities, and offering comprehensive QC solutions that support product development, manufacturing, and regulatory compliance. The market is characterized by strategic collaborations and partnerships to address evolving QC needs.
North America Remains as the Global Leader
North America held the highest revenue share in 2023, driven by its established cell and gene therapy ecosystem, supportive regulatory environment, and significant research and development activities. However, the Asia-Pacific region is projected to witness the highest CAGR from 2024 to 2032. Increasing investments in healthcare infrastructure, rising research collaborations, and the emergence of contract manufacturing organizations (CMOs) are driving the growth of the QC market in this region.
Stringent Regulatory Requirements
The QC market for cell and gene therapy manufacturing is driven by stringent regulatory requirements imposed by health authorities such as the FDA and EMA. Regulatory agencies demand rigorous quality control measures to ensure that cell and gene therapies meet safety and efficacy standards. For example, the FDA's guidelines for chemistry, manufacturing, and controls (CMC) emphasize thorough testing, characterization, and validation to ensure the quality and consistency of therapies. The regulatory landscape serves as a significant driver for investments in QC infrastructure and technologies.
Growing Adoption of Personalized Medicine
The rise of personalized medicine, wherein therapies are tailored to individual patients, has amplified the demand for robust QC procedures. Cell and gene therapies are often customized for each patient, requiring precise characterization, identity confirmation, and potency testing. As cell and gene therapies become more mainstream, the QC market experiences a surge in demand for advanced analytical methods and technologies to ensure therapy-specific quality and patient safety.
Advancements in Analytical Technologies
Rapid advancements in analytical technologies, such as high-throughput sequencing, mass spectrometry, and flow cytometry, have revolutionized the QC landscape. These technologies enable comprehensive characterization and analysis of cell and gene therapies, including their genetic makeup, purity, and potency. The integration of cutting-edge analytics into QC processes not only enhances the quality and reliability of therapies but also expedites development and manufacturing timelines.
Complexity of Product Characterization
A key restraint in the cell and gene therapy manufacturing QC market is the complexity of product characterization. Cell and gene therapies are often multifaceted and involve various components, making their comprehensive characterization challenging. The heterogeneity of cell populations, genetic modifications, and therapeutic mechanisms necessitates advanced analytical techniques that can accurately assess product quality. This complexity can lead to prolonged QC timelines and increased costs.
Consumables Dominate the Market by Component
A The market is segmented by component into Equipment and accessories, Consumables, and Others. In 2023, Consumables accounted for the highest revenue share, primarily due to their continuous usage in cell and gene therapy QC processes. During the forecast period from 2024 to 2032, Equipment and accessories are projected to exhibit the highest CAGR. The adoption of advanced equipment and technologies, such as next-generation sequencers and high-performance liquid chromatography systems, is expected to drive this growth.
Downstream Processes Dominate the Market by Process
The market is further segmented by process into Upstream Processes, Downstream Processes, and Process Development. In 2023, Downstream Processes generated the highest revenue, attributed to the need for purification and isolation of therapeutic cells and genetic material. However, during the forecast period, Process Development is anticipated to achieve the highest CAGR. The focus on optimizing and scaling up manufacturing processes to ensure consistent product quality is driving investments in process development and associated QC strategies.
Key Questions Answered in This Report
- What are the key micro and macro environmental factors that are impacting the growth of Cell And Gene Therapy Manufacturing Quality Control (QC) market?
- What are the key investment pockets with respect to product segments and geographies currently and during the forecast period?
- Estimated forecast and market projections up to 2031.
- Which segment accounts for the fastest CAGR during the forecast period?
- Which market segment holds a larger market share and why?
- Are low and middle-income economies investing in the Cell And Gene Therapy Manufacturing Quality Control (QC) market?
- Which is the largest regional market for Cell And Gene Therapy Manufacturing Quality Control (QC) market?
- What are the market trends and dynamics in emerging markets such as Asia Pacific, Latin America, and Middle East & Africa?
- Which are the key trends driving Cell And Gene Therapy Manufacturing Quality Control (QC) market growth?
- Who are the key competitors and what are their key strategies to enhance their market presence in the Cell And Gene Therapy Manufacturing Quality Control (QC) market worldwide?
Companies Featured
- Lonza Group
- Charles River Laboratories
- Eurofins Scientific
- WuXiAppTec
- bioMerieux SA
- Bio-Rad Laboratories, Inc.
- Bio-Techne Corporation
- QIAGEN
- Merck KGaA
- Intertek Group plc
- Thermo Fisher Scientific, Inc.
- F. Hoffmann-La Roche Ltd.
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
For more information about this report visit https://www.researchandmarkets.com/r/3q2erx
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