Published Year: 2023
Cell and Gene Therapy Manufacturing QC Market - A Global and Regional Analysis : Focus on Therapy T
The global cell and gene therapy manufacturing QC market was valued at $1.95 billion in 2022...
Market Research Report
A quick peek into the report
Table of Contents
1.1 Product Definition
1.1.1 Product Definition
1.1.2 Inclusion and Exclusion Criteria
1.2 Market Scope
1.2.1 Key Questions Answered in the Report
1.3 Research Methodology
1.3.1 Cell and Gene Therapy Manufacturing QC Market
1.3.2 Data Sources
1.3.2.1 Primary Data Sources
1.3.2.2 Secondary Data Sources
1.3.3 Market Estimation Model
1.3.4 Criteria for Company Profiling
1.4 Market Overview
1.4.1 Market Scenario
1.4.1.1 Realistic Growth Scenario
1.4.1.2 Optimistic Scenario
1.4.1.3 Pessimistic Scenario
1.4.2 Market Footprint and Growth Potential
1.4.3 Future Potential
1.4.4 COVID-19 Impact on Market
1.4.4.1 Impact on Research and Clinical Operations
1.4.4.2 COVID-19 Impact: Current Scenario of the Market
1.4.4.3 Pre- and Post-COVID-19 Impact Assessment
1.4.4.3.1 Pre-COVID-19 Phase
1.4.4.3.2 Post-COVID-19 Phase
2.1 Regulatory Framework
2.1.1 Chemistry, Manufacturing, and Control (CMC) Requirements by the Food and Drug Administration (FDA)
2.1.1.1 Product Testing
2.1.1.2 Microbial Testing
2.1.1.3 Identity
2.1.1.4 Purity
2.1.1.5 Potency
2.1.1.6 Viability
2.1.1.7 Cell Number or Dose
2.1.2 Quality Aspects of Cell and Gene Therapy Products by the European Medicines Agency (EMA)
2.1.2.1 Characterization
2.1.2.2 Identity Testing
2.1.2.3 Purity Testing
2.1.3 Current Good Manufacturing Practice (CGMP) Regulations
2.1.4 Regulatory Framework: Cell and Gene Therapy Manufacturing QC Market
3.1 Overview
3.2 Asia-Pacific
3.2.1.1 Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Offering)
3.2.1.2 Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Therapy Type)
3.2.1.3 Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Process)
3.2.1.4 Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Technology)
3.2.1.5 Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Application)
3.2.2 China
3.2.2.1 China Cell and Gene Therapy Manufacturing QC Market (by Offering)
3.2.2.2 China Cell and Gene Therapy Manufacturing QC Market (by Therapy Type)
3.2.2.3 China Cell and Gene Therapy Manufacturing QC Market (by Process)
3.2.2.4 China Cell and Gene Therapy Manufacturing QC Market (by Technology)
3.2.2.5 China Cell and Gene Therapy Manufacturing QC Market (by Application)
3.2.3 Japan
3.2.3.1 Japan Cell and Gene Therapy Manufacturing QC Market (by Offering)
3.2.3.2 Japan Cell and Gene Therapy Manufacturing QC Market (by Therapy Type)
3.2.3.3 Japan Cell and Gene Therapy Manufacturing QC Market (by Process)
3.2.3.4 Japan Cell and Gene Therapy Manufacturing QC Market (by Technology)
3.2.3.5 Japan Cell and Gene Therapy Manufacturing QC Market (by Application)
3.2.4 South Korea
3.2.4.1 South Korea Cell and Gene Therapy Manufacturing QC Market (by Offering)
3.2.4.2 South Korea Cell and Gene Therapy Manufacturing QC Market (by Therapy Type)
3.2.4.3 South Korea Cell and Gene Therapy Manufacturing QC Market (by Process)
3.2.4.4 South Korea Cell and Gene Therapy Manufacturing QC Market (by Technology)
3.2.4.5 South Korea Cell and Gene Therapy Manufacturing QC Market (by Application)
3.2.5 Australia
3.2.5.1 Australia Cell and Gene Therapy Manufacturing QC Market (by Offering)
3.2.5.2 Australia Cell and Gene Therapy Manufacturing QC Market (by Therapy Type)
3.2.5.3 Australia Cell and Gene Therapy Manufacturing QC Market (by Process)
3.2.5.4 Australia Cell and Gene Therapy Manufacturing QC Market (by Technology)
3.2.5.5 Australia Cell and Gene Therapy Manufacturing QC Market (by Application)
3.2.6 India
3.2.6.1 India Cell and Gene Therapy Manufacturing QC Market (by Offering)
3.2.6.2 India Cell and Gene Therapy Manufacturing QC Market (by Therapy Type)
3.2.6.3 India Cell and Gene Therapy Manufacturing QC Market (by Process)
3.2.6.4 India Cell and Gene Therapy Manufacturing QC Market (by Technology)
3.2.6.5 India Cell and Gene Therapy Manufacturing QC Market (by Application)
3.2.7 Rest-of-Asia-Pacific
3.2.7.1 Rest-of-Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Offering)
3.2.7.2 Rest-of-Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Therapy Type)
3.2.7.3 Rest-of-Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Process)
3.2.7.4 Rest-of-Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Technology)
3.2.7.5 Rest-of-Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Application)
4.1 Overview
4.2 Manufacturers
4.2.1 WuXi AppTec
4.2.1.1 Company Overview
4.2.1.2 Role of WuXi AppTec in the Cell and Gene Therapy Manufacturing QC Market
4.2.1.3 Key Competitors
4.2.1.4 Financials
4.2.1.5 Analyst Perspective
Table 1: Key Questions Answered in the Report
Table 2: Regulatory Scenario: Cell and Gene Therapy Manufacturing QC Market
Table 3: Asia-Pacific Cell and Gene Therapy Manufacturing QC Market Dynamics, Impact Analysis
Table 4: Approved Cell and Gene Therapies, Japan
Figure 1: Asia-Pacific Cell and Gene Therapy Manufacturing QC Market, $Billion, 2022-2033
Figure 2: Asia-Pacific Cell and Gene Therapy Manufacturing QC Market, Impact Analysis
Figure 3: Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Therapy Type), % Share, 2022 and 2033
Figure 4: Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Offering), % Share, 2022 and 2033
Figure 5: Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Process), % Share, 2022 and 2033
Figure 6: Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Technology), % Share, 2022 and 2033
Figure 7: Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Application), % Share, 2022 and 2033
Figure 8: Cell and Gene Therapy Manufacturing QC Market (by Region), Market Snapshot
Figure 9: Cell and Gene Therapy Manufacturing QC Market: Research Methodology
Figure 10: Primary Research Methodology
Figure 11: Bottom-Up Approach (Segment-Wise Analysis)
Figure 12: Top-Down Approach (Segment-Wise Analysis)
Figure 13: Asia-Pacific Cell and Gene Therapy Manufacturing QC Market Size and Growth Potential (Realistic Scenario), $Billion, 2022-2033
Figure 14: Asia-Pacific Cell and Gene Therapy Manufacturing QC Market Size and Growth Potential (Optimistic Scenario), $Billion, 2022-2033
Figure 15: Asia-Pacific Cell and Gene Therapy Manufacturing QC Market Size and Growth Potential (Pessimistic Scenario), $Billion, 2022-2033
Figure 16: Asia-Pacific Cell and Gene Therapy Manufacturing QC Market, $Billion, 2022-2033
Figure 17: Impact of COVID-19 on CGT Developmental Activities
Figure 18: Cell and Gene Therapy Manufacturing QC Market (by Region), Market Snapshot
Figure 19: Asia-Pacific Cell and Gene Therapy Manufacturing QC Market, $Million, 2022-2033
Figure 20: Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Country), % Share, 2022-2033
Figure 21: Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Offering), $Million, 2022-2033
Figure 22: Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Therapy Type), $Million, 2022-2033
Figure 23: Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Process), $Million, 2022-2033
Figure 24: Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Technology), $Million, 2022-2033
Figure 25: Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Application), $Million, 2022-2033
Figure 26: China Cell and Gene Therapy Manufacturing QC Market, $Million, 2022-2033
Figure 27: China Cell and Gene Therapy Manufacturing QC Market (by Offering), $Million, 2022-2033
Figure 28: China Cell and Gene Therapy Manufacturing QC Market (by Therapy Type), $Million, 2022-2033
Figure 29: China Cell and Gene Therapy Manufacturing QC Market (by Process), $Million, 2022-2033
Figure 30: China Cell and Gene Therapy Manufacturing QC Market (by Technology), $Million, 2022-2033
Figure 31: China Cell and Gene Therapy Manufacturing QC Market (by Application), $Million, 2022-2033
Figure 32: Japan Cell and Gene Therapy Manufacturing QC Market, $Million, 2022-2033
Figure 33: Japan Cell and Gene Therapy Manufacturing QC Market (by Offering), $Million, 2022-2033
Figure 34: Japan Cell and Gene Therapy Manufacturing QC Market (by Therapy Type), $Million, 2022-2033
Figure 35: Japan Cell and Gene Therapy Manufacturing QC Market (by Process), $Million, 2022-2033
Figure 36: Japan Cell and Gene Therapy Manufacturing QC Market (by Technology), $Million, 2022-2033
Figure 37: Japan Cell and Gene Therapy Manufacturing QC Market (by Application), $Million, 2022-2033
Figure 38: South Korea Cell and Gene Therapy Manufacturing QC Market, $Million, 2022-2033
Figure 39: South Korea Cell and Gene Therapy Manufacturing QC Market (by Offering), $Million, 2022-2033
Figure 40: South Korea Cell and Gene Therapy Manufacturing QC Market (by Therapy Type), $Million, 2022-2033
Figure 41: South Korea Cell and Gene Therapy Manufacturing QC Market (by Process), $Million, 2022-2033
Figure 42: South Korea Cell and Gene Therapy Manufacturing QC Market (by Technology), $Million, 2022-2033
Figure 43: South Korea Cell and Gene Therapy Manufacturing QC Market (by Application), $Million, 2022-2033
Figure 44: Australia Cell and Gene Therapy Manufacturing QC Market, $Million, 2022-2033
Figure 45: Australia Cell and Gene Therapy Manufacturing QC Market (by Offering), $Million, 2022-2033
Figure 46: Australia Cell and Gene Therapy Manufacturing QC Market (by Therapy Type), $Million, 2022-2033
Figure 47: Australia Cell and Gene Therapy Manufacturing QC Market (by Process), $Million, 2022-2033
Figure 48: Australia Cell and Gene Therapy Manufacturing QC Market (by Technology), $Million, 2022-2033
Figure 49: Australia Cell and Gene Therapy Manufacturing QC Market (by Application), $Million, 2022-2033
Figure 50: India Cell and Gene Therapy Manufacturing QC Market, $Million, 2022-2033
Figure 51: India Cell and Gene Therapy Manufacturing QC Market (by Offering), $Million, 2022-2033
Figure 52: India Cell and Gene Therapy Manufacturing QC Market (by Therapy Type), $Million, 2022-2033
Figure 53: India Cell and Gene Therapy Manufacturing QC Market (by Process), $Million, 2022-2033
Figure 54: India Cell and Gene Therapy Manufacturing QC Market (by Technology), $Million, 2022-2033
Figure 55: India Cell and Gene Therapy Manufacturing QC Market (by Application), $Million, 2022-2033
Figure 56: Rest-of-Asia-Pacific Cell and Gene Therapy Manufacturing QC Market, $Million, 2022-2033
Figure 57: Rest-of-Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Offering), $Million, 2022-2033
Figure 58: Rest-of-Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Therapy Type), $Million, 2022-2033
Figure 59: Rest-of-Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Process), $Million, 2022-2033
Figure 60: Rest-of-Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Technology), $Million, 2022-2033
Figure 61: Rest-of-Asia-Pacific Cell and Gene Therapy Manufacturing QC Market (by Application), $Million, 2022-2033
Figure 62: Total Number of Companies Profiled
Figure 63: WuXi AppTec: Product Portfolio
Figure 64: WuXi AppTec: Overall Financials, $Million, 2020-2022
Figure 65: WuXi AppTec: Revenue (by Segment), $Million, 2021 and 2022
Asia-Pacific Cell and Gene Therapy Manufacturing QC Market Report Coverage
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Asia-Pacific Cell and Gene Therapy Manufacturing QC Market |
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|
Base Year |
2022 |
Market Size in 2023 |
$426.3 Million |
|
Forecast Period |
2023-2033 |
Value Projection and Estimation by 2033 |
$2,233.6 Million |
|
CAGR During Forecast Period |
18.01% |
|
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How can this report add value to an organization?
Workflow/Innovation Strategy: The APAC cell and gene therapy manufacturing QC market (by offering) has been segmented into products and services. Moreover, the study provides the reader with a detailed understanding of the different applications of cell and gene therapy manufacturing QC in raw material preparation, upstream processing, downstream processing, and packaging.
Growth/Marketing Strategy: Cell and gene therapy manufacturing QC is being used for raw material preparation, upstream processing, downstream processing, and packaging. Various companies are providing products and services to aid in the manufacturing and QC of various cell and gene therapies, which is also the key strategy for market players to excel in the current APAC cell and gene therapy manufacturing QC market.
Competitive Strategy: Key players in the APAC cell and gene therapy manufacturing QC market have been analyzed and profiled in the study, including manufacturers involved in new product launches, acquisitions, expansions, and strategic collaborations. Moreover, a detailed competitive benchmarking of the players operating in the APAC cell and gene therapy manufacturing QC market has been done to help the reader understand how players stack against each other, presenting a clear market landscape. Additionally, comprehensive competitive strategies such as partnerships, agreements, and collaborations will aid the reader in understanding the untapped revenue pockets in the market.
Introduction to Asia-Pacific Cell and Gene Therapy Manufacturing QC Market
The Asia-Pacific cell and gene therapy manufacturing QC market was valued at $426.3 million in 2023 and is expected to reach $2,233.6 million by 2033, growing at a CAGR of 18.01% during the forecast period 2023-2033. The cell and gene therapy manufacturing quality control (QC) market is projected to grow due to the rising number of approved therapies and the need for expanded infrastructure. Furthermore, the broader range of medical conditions targeted by cell and gene therapies necessitates large-scale manufacturing and QC processes, contributing to market growth.
Market Introduction
The Asia-Pacific (APAC) region is witnessing significant growth in the cell and gene therapy manufacturing quality control (QC) market. This expansion is driven by several factors, including the rising adoption of advanced therapies, increasing investments in biotechnology and pharmaceutical sectors, and the presence of a skilled workforce. Moreover, the growing prevalence of chronic diseases in the region has accelerated the demand for innovative cell and gene therapies, necessitating stringent QC measures. APAC countries are actively involved in research and development activities, fostering collaborations with biotech companies. As a result, the APAC cell and gene therapy manufacturing QC market is poised for substantial growth in the coming years, contributing to the advancement of healthcare solutions in the region.
Market Segmentation
Segmentation 1: by Therapy Type
• Cell Therapy
• Gene Therapy
Segmentation 2: by Offering
• Products
• Services
Segmentation 3: by Process
• Raw Material Preparation
• Upstream Processing
• Downstream Processing
• Packaging
Segmentation 4: by Application
• Safety Testing
• Potency Testing
• Identity Testing
• Stability and Genetic Fidelity Testing
• Others
Segmentation 5: by Technology
• Polymerase Chain Reaction (PCR)
• Flow Cytometry
• Limulus Amebocyte Lysate (LAL)
• Enzyme-Linked Immunosorbent Assay (ELISA)
• Chromatography
• Mass Spectrometry
• Western Blotting
• Next-Generation Sequencing (NGS)
• Electrophoresis
• Other Technologies
Segmentation 6: by Country
• China
• Japan
• South Korea
• Australia
• India
• Rest-of-Asia-Pacific and Japan
Asia-Pacific Cell and Gene Therapy Manufacturing QC Market
Analysis and Forecast, 2023-2033
Some Faq's
Frequently Asked Questions
Cell and gene therapy manufacturing QC involves applying quality control protocols and assessments during these therapies' production. It encompasses a range of checks and tests to guarantee the reliability, safety, and effectiveness of these advanced treatments. Quality control procedures are carried out at different manufacturing stages, such as testing raw materials, validating processes, monitoring ongoing production, and conducting final product assessments.
The global cell and gene therapy manufacturing QC market was valued at $1.95 billion in 2022 and is anticipated to reach $10.65 billion by 2033, witnessing a CAGR of 16.85% during the forecast period 2023-2033.
Key trends in the cell and gene therapy manufacturing QC market include a growing focus on automation, expansion of production capacity to meet rising demand, and the adoption of closed and variable manufacturing systems to reduce contamination risk and enhance efficiency. These trends reflect ongoing advancements in the industry, with more innovations expected to shape its future.
• Companies that manufacture and commercialize consumables and equipment required in the manufacturing QC of cell and gene therapy
• Any new entrant that wants to know where the opportunities lie in the cell and gene therapy manufacturing QC market
• Any established player that wants to expand its product portfolio or business in new geographies
Quality control in cell and gene therapy manufacturing is crucial to ensure the safety, efficacy, and consistency of these advanced treatments. It involves rigorous testing and monitoring throughout the production process to meet regulatory standards and deliver reliable therapies.
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