한글목차

유럽의 세포 및 유전자 치료제 제조 QC(품질 관리) 시장 규모는 2023년 5억 3,430만 달러에서 예측 기간 동안 16.90%의 연평균 복합 성장률(CAGR)을 나타내고, 2033년에는 25억 4,560만 달러 규모로 성장할 것으로 예상됩니다.

유럽 세포 및 유전자 치료제 제조 QC(품질관리) 시장 : 소개

유럽의 세포 및 유전자 치료제 제조 QC(품질 관리) 시장은 승인된 치료법 증가와 인프라 확충의 필요성으로 인해 확대될 것으로 예상됩니다. 또한, 세포 및 유전자 치료제의 대상 질환이 광범위하기 때문에 대규모 제조 및 QC 프로세스가 필요하며, 이는 시장 성장에 기여하고 있습니다.

유럽의 세포 및 유전자 치료제 제조 QC 시장은 몇 가지 요인으로 인해 괄목할 만한 성장세를 보이고 있습니다. 다양한 질병을 치료하기 위해 세포 및 유전자 치료법이 채택됨에 따라 이러한 첨단 치료법의 안전성, 유효성 및 일관성을 보장하기 위한 엄격한 품질 관리 조치에 대한 수요가 증가하고 있습니다. 유럽 규제 기관은 높은 제조 기준의 유지를 강조하고 있으며, 이는 시장 확대에 더욱 박차를 가하고 있습니다. 또한, 분석 기술 및 자동화의 발전은 QC 프로세스를 강화하여 효율적이고 신뢰할 수 있는 제조를 촉진하고 있습니다. 또한, 학계, 바이오 제약사, 위탁생산업체(CMO)의 협력은 혁신적인 QC 솔루션 개발에 기여하고 있습니다. 유럽이 세포치료 및 유전자치료 분야에서 선도적인 역할을 지속하고 있는 가운데, QC 시장은 지속적인 성장과 혁신을 위한 준비가 되어 있습니다.

유럽의 세포 및 유전자 치료 제조 QC(품질관리) 시장을 조사했으며, 시장 개요, 시장 성장에 영향을 미치는 각종 영향요인 분석, 규제 환경, 시장 규모 추이 및 예측, 각 부문별-주요 국가별 상세 분석, 주요 기업 분석 등의 정보를 정리하여 전해드립니다.

시장 분류

세분화 1: 치료 유형별

• 세포 치료
• 유전자 치료

세분화 2 : 제품별

• 제품
• 서비스

세분화 3: 프로세스별 세분화

• 원료 준비
• 업스트림 공정
• 다운스트림 공정
• 포장

세분화 4: 용도별 세분화

• 안전성 테스트
• 역가 시험
• 신원 확인 테스트
• 안정성 및 유전적 충실도 테스트
• 기타

세분화 5: 기술별 세분화

• 중합효소 연쇄반응(PCR)
• 유세포 분석
• Limulus Amebocyte Lysate (LAL)
• 효소 결합 면역 흡착 측정법(ELISA)
• 크로마토그래피
• 질량 분석
• 웨스턴 블로팅
• 차세대 시퀀싱(NGS)
• 전기영동
• 기타 기술

세분화 6: 국가별

• 영국
• 독일
• 프랑스
• 이탈리아
• 스페인
• 기타

주요 진출 기업 :

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

목차

주요 요약

제1장 시장

• 제품 정의
• 시장 범위
• 조사 방법
• 시장 개요
  • 세계 시장 시나리오
  • 시장 실적과 성장 가능성
  • 장래성
  • 시장에 대한 COVID-19의 영향

제2장 세포 및 유전자 치료 제조 QC(품질관리) 시장 : 업계 분석

• 규제 프레임워크

제3장 유럽

• 개요
• 유럽
• 영국
• 독일
• 프랑스
• 이탈리아
• 스페인
• 기타 지역
  • 제공 구분별 시장
  • 치료 유형별 시장
  • 프로세스별 시장
  • 기술별 시장
  • 용도별 시장

제4장 기업 개요

• 제조업체
• 서비스

영문목차

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