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 Global 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
2.1.3.1 Europe
2.1.4 Regulatory Framework: Cell and Gene Therapy Manufacturing QC Market
3.1 Overview
3.2 Europe
3.2.1 Europe Cell and Gene Therapy Manufacturing QC Market (by Offering)
3.2.2 Europe Cell and Gene Therapy Manufacturing QC Market (by Therapy Type)
3.2.3 Europe Cell and Gene Therapy Manufacturing QC Market (by Process)
3.2.4 Europe Cell and Gene Therapy Manufacturing QC Market (by Technology)
3.2.5 Europe Cell and Gene Therapy Manufacturing QC Market (by Application)
3.3 U.K.
3.3.1 U.K. Cell and Gene Therapy Manufacturing QC Market (by Offering)
3.3.2 U.K. Cell and Gene Therapy Manufacturing QC Market (by Therapy Type)
3.3.3 U.K. Cell and Gene Therapy Manufacturing QC Market (by Process)
3.3.4 U.K. Cell and Gene Therapy Manufacturing QC Market (by Technology)
3.3.5 U.K. Cell and Gene Therapy Manufacturing QC Market (by Application)
3.4 Germany
3.4.1 Germany Cell and Gene Therapy Manufacturing QC Market (by Offering)
3.4.2 Germany Cell and Gene Therapy Manufacturing QC Market (by Therapy Type)
3.4.3 Germany Cell and Gene Therapy Manufacturing QC Market (by Process)
3.4.4 Germany Cell and Gene Therapy Manufacturing QC Market (by Technology)
3.4.5 Germany Cell and Gene Therapy Manufacturing QC Market (by Application)
3.5 France
3.5.1 France Cell and Gene Therapy Manufacturing QC Market (by Offering)
3.5.2 France Cell and Gene Therapy Manufacturing QC Market (by Therapy Type)
3.5.3 France Cell and Gene Therapy Manufacturing QC Market (by Process)
3.5.4 France Cell and Gene Therapy Manufacturing QC Market (by Technology)
3.5.5 France Cell and Gene Therapy Manufacturing QC Market (by Application)
3.6 Italy
3.6.1 Italy Cell and Gene Therapy Manufacturing QC Market (by Offering)
3.6.2 Italy Cell and Gene Therapy Manufacturing QC Market (by Therapy Type)
3.6.3 Italy Cell and Gene Therapy Manufacturing QC Market (by Process)
3.6.4 Italy Cell and Gene Therapy Manufacturing QC Market (by Technology)
3.6.5 Italy Cell and Gene Therapy Manufacturing QC Market (by Application)
3.7 Spain
3.7.1 Spain Cell and Gene Therapy Manufacturing QC Market (by Offering)
3.7.2 Spain Cell and Gene Therapy Manufacturing QC Market (by Therapy Type)
3.7.3 Spain Cell and Gene Therapy Manufacturing QC Market (by Process)
3.7.4 Spain Cell and Gene Therapy Manufacturing QC Market (by Technology)
3.7.5 Spain Cell and Gene Therapy Manufacturing QC Market (by Application)
3.8 Rest-of-Europe
3.8.1 Rest-of-Europe Cell and Gene Therapy Manufacturing QC Market (by Offering)
3.8.2 Rest-of-Europe Cell and Gene Therapy Manufacturing QC Market (by Therapy Type)
3.8.3 Rest-of-Europe Cell and Gene Therapy Manufacturing QC Market (by Process)
3.8.4 Rest-of-Europe Cell and Gene Therapy Manufacturing QC Market (by Technology)
3.8.5 Rest-of-Europe Cell and Gene Therapy Manufacturing QC Market (by Application)
4.1 Overview
4.2 Manufacturers
4.2.1 bioMérieux SA
4.2.1.1 Company Overview
4.2.1.2 Role of bioMérieux SA 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
4.2.2 F. Hoffmann-La Roche Ltd
4.2.2.1 Company Overview
4.2.2.2 Role of F. Hoffmann-La Roche Ltd in the Cell and Gene Therapy Manufacturing QC Market
4.2.2.3 Key Competitors
4.2.2.4 Financials
4.2.2.5 Key Insights about the Financial Health of the Company
4.2.2.6 Analyst Perspective
4.2.3 Lonza.
4.2.3.1 Company Overview
4.2.3.2 Role of Lonza. in the Cell and Gene Therapy Manufacturing QC Market
4.2.3.3 Key Competitors
4.2.3.4 Financials
4.2.3.5 Analyst Perspective
4.2.4 Miltenyi Biotec B.V. & Co. KG
4.2.4.1 Company Overview
4.2.4.2 Role of Miltenyi Biotec B.V. & Co. KG in the Cell and Gene Therapy Manufacturing QC Market
4.2.4.3 Key Competitors
4.2.4.4 Analyst Perspective
4.2.5 Sartorius AG
4.2.5.1 Company Overview
4.2.5.2 Role of Sartorius AG in the Cell and Gene Therapy Manufacturing QC Market
4.2.5.3 Key Competitors
4.2.5.4 Financials
4.2.5.5 Analyst Perspective
4.3 Service
4.3.1 Eurofins Scientific
4.3.1.1 Company Overview
4.3.1.2 Role of Eurofins Scientific in the Cell and Gene Therapy Manufacturing QC Market
4.3.1.3 Key Competitors
4.3.1.4 Financials
4.3.1.5 Analyst Perspective
4.3.2 Merck KGaA
4.3.2.1 Company Overview
4.3.2.2 Role of Merck KGaA in the Cell and Gene Therapy Manufacturing QC Market
4.3.2.3 Key Competitors
4.3.2.4 Financials
4.3.2.5 Analyst Perspective
Table 1: Key Questions Answered in the Report
Table 2: Regulatory Scenario: Cell and Gene Therapy Manufacturing QC Market
Table 3: Europe Cell and Gene Therapy Manufacturing QC Market Dynamics, Impact Analysis
Figure 1: Europe Cell and Gene Therapy Manufacturing QC Market, $Billion, 2022-2033
Figure 2: Europe Cell and Gene Therapy Manufacturing QC Market, Impact Analysis
Figure 3: Europe Cell and Gene Therapy Manufacturing QC Market (by Therapy Type), % Share, 2022 and 2033
Figure 4: Europe Cell and Gene Therapy Manufacturing QC Market (by Offering), % Share, 2022 and 2033
Figure 5: Europe Cell and Gene Therapy Manufacturing QC Market (by Process), % Share, 2022 and 2033
Figure 6: Europe Cell and Gene Therapy Manufacturing QC Market (by Technology), % Share, 2022 and 2033
Figure 7: Europe 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: Cell and Gene Therapy Manufacturing QC Market Size and Growth Potential (Realistic Scenario), $Billion, 2022-2033
Figure 14: Cell and Gene Therapy Manufacturing QC Market Size and Growth Potential (Optimistic Scenario), $Billion, 2022-2033
Figure 15: Cell and Gene Therapy Manufacturing QC Market Size and Growth Potential (Pessimistic Scenario), $Billion, 2022-2033
Figure 16: Europe 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: Europe Cell and Gene Therapy Manufacturing QC Market, $Million, 2022-2033
Figure 20: Europe Cell and Gene Therapy Manufacturing QC Market (by Country), % Share, 2022-2033
Figure 21: Europe Cell and Gene Therapy Manufacturing QC Market (by Offering), $Million, 2022-2033
Figure 22: Europe Cell and Gene Therapy Manufacturing QC Market (by Therapy Type), $Million, 2022-2033
Figure 23: Europe Cell and Gene Therapy Manufacturing QC Market (by Process), $Million, 2022-2033
Figure 24: Europe Cell and Gene Therapy Manufacturing QC Market (by Technology), $Million, 2022-2033
Figure 25: Europe Cell and Gene Therapy Manufacturing QC Market (by Application), $Million, 2022-2033
Figure 26: U.K. Cell and Gene Therapy Manufacturing QC Market, $Million, 2022-2033
Figure 27: U.K. Cell and Gene Therapy Manufacturing QC Market (by Offering), $Million, 2022-2033
Figure 28: U.K. Cell and Gene Therapy Manufacturing QC Market (by Therapy Type), $Million, 2022-2033
Figure 29: U.K. Cell and Gene Therapy Manufacturing QC Market (by Process), $Million, 2022-2033
Figure 30: U.K. Cell and Gene Therapy Manufacturing QC Market (by Technology), $Million, 2022-2033
Figure 31: U.K. Cell and Gene Therapy Manufacturing QC Market (by Application), $Million, 2022-2033
Figure 32: Germany Cell and Gene Therapy Manufacturing QC Market, $Million, 2022-2033
Figure 33: Germany Cell and Gene Therapy Manufacturing QC Market (by Offering), $Million, 2022-2033
Figure 34: Germany Cell and Gene Therapy Manufacturing QC Market (by Therapy Type), $Million, 2022-2033
Figure 35: Germany Cell and Gene Therapy Manufacturing QC Market (by Process), $Million, 2022-2033
Figure 36: Germany Cell and Gene Therapy Manufacturing QC Market (by Technology), $Million, 2022-2033
Figure 37: Germany Cell and Gene Therapy Manufacturing QC Market (by Application), $Million, 2022-2033
Figure 38: France Cell and Gene Therapy Manufacturing QC Market, $Million, 2022-2033
Figure 39: France Cell and Gene Therapy Manufacturing QC Market (by Offering), $Million, 2022-2033
Figure 40: France Cell and Gene Therapy Manufacturing QC Market (by Therapy Type), $Million, 2022-2033
Figure 41: France Cell and Gene Therapy Manufacturing QC Market (by Process), $Million, 2022-2033
Figure 42: France Cell and Gene Therapy Manufacturing QC Market (by Technology), $Million, 2022-2033
Figure 43: France Cell and Gene Therapy Manufacturing QC Market (by Application), $Million, 2022-2033
Figure 44: Italy Cell and Gene Therapy Manufacturing QC Market, $Million, 2022-2033
Figure 45: Italy Cell and Gene Therapy Manufacturing QC Market (by Offering), $Million, 2022-2033
Figure 46: Italy Cell and Gene Therapy Manufacturing QC Market (by Therapy Type), $Million, 2022-2033
Figure 47: Italy Cell and Gene Therapy Manufacturing QC Market (by Process), $Million, 2022-2033
Figure 48: Italy Cell and Gene Therapy Manufacturing QC Market (by Technology), $Million, 2022-2033
Figure 49: Italy Cell and Gene Therapy Manufacturing QC Market (by Application), $Million, 2022-2033
Figure 50: Spain Cell and Gene Therapy Manufacturing QC Market, $Million, 2022-2033
Figure 51: Spain Cell and Gene Therapy Manufacturing QC Market (by Offering), $Million, 2022-2033
Figure 52: Spain Cell and Gene Therapy Manufacturing QC Market (by Therapy Type), $Million, 2022-2033
Figure 53: Spain Cell and Gene Therapy Manufacturing QC Market (by Process), $Million, 2022-2033
Figure 54: Spain Cell and Gene Therapy Manufacturing QC Market (by Technology), $Million, 2022-2033
Figure 55: Spain Cell and Gene Therapy Manufacturing QC Market (by Application), $Million, 2022-2033
Figure 56: Rest-of-Europe Cell and Gene Therapy Manufacturing QC Market, $Million, 2022-2033
Figure 57: Rest-of-Europe Cell and Gene Therapy Manufacturing QC Market (by Offering), $Million, 2022-2033
Figure 58: Rest-of-Europe Cell and Gene Therapy Manufacturing QC Market (by Therapy Type), $Million, 2022-2033
Figure 59: Rest-of-Europe Cell and Gene Therapy Manufacturing QC Market (by Process), $Million, 2022-2033
Figure 60: Rest-of-Europe Cell and Gene Therapy Manufacturing QC Market (by Technology), $Million, 2022-2033
Figure 61: Rest-of-Europe Cell and Gene Therapy Manufacturing QC Market (by Application), $Million, 2022-2033
Figure 62: Total Number of Companies Profiled
Figure 63: bioMérieux SA: Product Portfolio
Figure 64: bioMérieux SA: Overall Financials, $Million, 2020-2022
Figure 65: bioMérieux SA: Revenue (by Segment), $Million, 2020-2022
Figure 66: bioMérieux SA: Revenue (by Region), $Million, 2020-2022
Figure 67: F. Hoffmann-La Roche Ltd: Product Portfolio
Figure 68: F. Hoffmann-La Roche Ltd: Overall Financials, $Million, 2020-2022
Figure 69: F. Hoffmann-La Roche Ltd: Revenue (by Segment), $Million, 2020-2022
Figure 70: F. Hoffmann-La Roche Ltd: Revenue (by Region), $Million, 2020-2022
Figure 71: F. Hoffmann-La Roche Ltd: R&D Expenditure, $Million, 2020-2022
Figure 72: Lonza.: Product Portfolio
Figure 73: Lonza.: Overall Financials, $Million, 2020-2022
Figure 74: Lonza.: Revenue (by Segment), $Million, 2021and 2022
Figure 75: Miltenyi Biotec B.V. & Co. KG: Product Portfolio
Figure 76: Sartorius AG: Product Portfolio
Figure 77: Sartorius AG: Overall Financials, $Million, 2020-2022
Figure 78: Sartorius AG: Revenue (by Segment), $Million, 2020-2022
Figure 79: Sartorius AG: Revenue (by Region), $Million, 2020-2022
Figure 80: Eurofins Scientific: Product Portfolio
Figure 81: Eurofins Scientific.: Overall Financials, $Million, 2020-2022
Figure 82: Eurofins Scientific.: Revenue (by Segment), $Million, 2020-2022
Figure 83: Eurofins Scientific.: Revenue (by Region), $Million, 2020-2022
Figure 84: Merck KGaA: Product Portfolio
Figure 85: Merck KGaA: Overall Financials, $Million, 2020-2022
Figure 86: Merck KGaA: Revenue (by Segment), $Million, 2020-2022
Figure 87: Merck KGaA: Revenue (by Region), $Million, 2020-2022
Europe Cell and Gene Therapy Manufacturing QC Market Report Coverage
|
Europe Cell and Gene Therapy Manufacturing QC Market |
|||
|
Base Year |
2022 |
Market Size in 2023 |
$534.3 Million |
|
Forecast Period |
2023-2033 |
Value Projection and Estimation by 2033 |
$2,545.6 Million |
|
CAGR During Forecast Period |
16.90% |
||
Key Market Players and Competition Synopsis
The companies that are profiled have been selected based on inputs gathered from primary experts and analysing the company's coverage, product portfolio, its market penetration.
Some of the prominent names established in this market are:
• bioMérieux SA
• F. Hoffmann-La Roche Ltd
• Lonza.
• Sartorius AG
How can this report add value to the organization?
Workflow/Innovation Strategy: The Europe 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 Europe cell and gene therapy manufacturing QC market.
Competitive Strategy: Key players in the Europe 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 Europe 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 Europe Cell and Gene Therapy Manufacturing QC Market
The Europe cell and gene therapy manufacturing Quality Control (QC) market is expected to reach $2,545.6 million by 2033 from $534.3 million in 2023 at a CAGR of 16.90% 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 cell and gene therapy manufacturing Quality Control (QC) market in Europe is experiencing notable growth driven by several factors. With the increasing adoption of cell and gene therapies for treating various diseases, there's a rising demand for stringent quality control measures to ensure the safety, efficacy, and consistency of these advanced therapies. European regulatory bodies' emphasis on maintaining high manufacturing standards further propels market expansion. Additionally, advancements in analytical technologies and automation are enhancing QC processes, facilitating efficient and reliable manufacturing. Furthermore, collaborations between academic institutions, biopharmaceutical companies, and contract manufacturing organizations (CMOs) contribute to the development of innovative QC solutions. As Europe continues to play a leading role in the cell and gene therapy landscape, the QC market is poised for continued growth and innovation.
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
• U.K.
• Germany
• France
• Italy
• Spain
• Rest-of-Europe
Europe Cell and Gene Therapy Manufacturing QC Market
Analysis and Forecast, 2023-2033
Some Faq's
Frequently Asked Questions
Cell and gene therapy manufacturing quality control (QC) entails implementing protocols and evaluations throughout the production process of these therapies. It involves various checks and tests aimed at ensuring the dependability, safety, and efficacy of these advanced treatments. QC procedures are conducted at various manufacturing phases, including the examination of raw materials, validation of processes, continuous monitoring of production, and the completion of final product assessments.Cell and gene therapy manufacturing quality control (QC) entails implementing protocols and evaluations throughout the production process of these therapies. It involves various checks and tests aimed at ensuring the dependability, safety, and efficacy of these advanced treatments. QC procedures are conducted at various manufacturing phases, including the examination of raw materials, validation of processes, continuous monitoring of production, and the completion of 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
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
The QC market plays a crucial role in advancing cell and gene therapy manufacturing by providing essential testing services, analytical technologies, and expertise to ensure compliance with regulatory standards. This includes developing innovative QC solutions to address the unique challenges associated with these advanced therapies.
The manufacturing process for cell and gene therapy typically involves several key steps, including cell collection or gene modification, cell expansion or gene delivery, quality control testing, and final product formulation. These steps ensure the production of safe and effective therapies for patients undergoing treatment.
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