세포 및 유전자 치료제 제조 QC(품질 관리) : 유럽 시장 분석 및 예측(2023-2033년)

The Europe Cell and Gene Therapy Manufacturing QC Market Expected to Reach $2,545.6 Million by 2033

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

How can this report add value to an 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.

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:

• bioMerieux SA
• F. Hoffmann-La Roche Ltd
• Lonza.
• Sartorius AG

Table of Contents

Executive Summary

1 Markets

• 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 Cell and Gene Therapy Manufacturing QC Market: Industry Analysis

• 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 Europe

• 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 Company Profiles

• 4.1 Overview
• 4.2 Manufacturers
  • 4.2.1 bioMerieux SA
    • 4.2.1.1 Company Overview
    • 4.2.1.2 Role of bioMerieux 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