세포 및 유전자 치료 임상시험 시장 규모, 점유율, 동향 분석 보고서 : 단계별, 적응증별, 지역별, 부문 예측(2025-2033년)

Cell And Gene Therapy Clinical Trials Market Size, Share & Trends Analysis Report By Phase (Phase I, Phase II, Phase III), By Indication (Oncology, Cardiology, CNS, Musculoskeletal, Infectious Diseases), By Region, And Segment Forecasts, 2025 - 2033

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한글목차

세포 및 유전자 치료 임상시험 시장 개요

이 시장은 주로 유전자 치료 분야의 기술 혁신이 가속화되는 속도와 첨단 치료에 대한 규제 당국의 지원 증가에 의해 주도되고 있습니다. CRISPR과 같은 유전체 편집 기술의 발전과 바이러스 및 비바이러스 벡터 전달 시스템의 획기적인 발전으로 연구자들은 희귀 유전질환, 암, 자가면역질환에 대한 고도로 표적화된 치료제 후보물질을 개발할 수 있게 되었습니다. FDA와 EMA 등 규제기관은 CGT 개발을 지원하기 위해 조기 승인 경로, 희귀질환 치료제 지정, RMAT(재생의료 첨단치료제) 지정 등을 도입했습니다. 이러한 특혜는 신규 CGT 제품 개발 기업의 시간 및 비용 부담을 크게 줄여 초기 단계의 테스트 시작을 촉진하고 있습니다.

또한 CGT 개발에 주력하는 바이오텍 기업, 대형 제약사, 학술연구센터 간의 자금 유입과 전략적 제휴가 시장 개척을 촉진하고 있습니다. 특히 벤처캐피털과 민관협력을 통한 이러한 재정적 모멘텀은 임상시험 스폰서들이 파일럿 시험에서 다기관 국제 임상시험으로 규모를 확대할 수 있도록 하고 있습니다. Bluebird Bio, CRISPR Therapeutics, Beam Therapeutics 등의 기업들은 겸상적혈구증, CAR-T 치료, 유전자 편집 기반 종양학 파이프라인 등의 분야에서 다수의 I/II상 임상을 시작했습니다. 또한, 이러한 치료법의 안전성, 용량, 장기적 유효성 검증의 필요성으로 인해 CGT 시험에 특화된 전문 CRO 및 시험 인프라에 대한 수요가 증가하고 있습니다.

목차

제1장 조사 방법과 범위

제2장 주요 요약

제3장 세포 및 유전자 치료 임상시험 시장 : 변수, 동향, 범위

• 시장 계통 전망
• 세포 및 유전자 치료 임상시험 시장 역학
• 기술적 상황
• 가격 모델 분석
• 세포 및 유전자 치료 임상시험 시장 : 분석 툴

제4장 세포 및 유전자 치료 임상시험 시장 : 단계별 추정 및 동향 분석

• 부문 대시보드
• 세계의 세포 및 유전자 치료 임상시험 시장 단계별 변동 분석
• 세계의 세포 및 유전자 치료 임상시험 시장 규모와 동향 분석(단계별, 2021-2033년)
• 단계 I
• 단계 II
• 단계 III
• 단계 IV

제5장 세포 및 유전자 치료 임상시험 시장 : 적응증별 추정 및 동향 분석

• 부문 대시보드
• 세계의 세포 및 유전자 치료 임상시험 시장 적응 별 변동 분석
• 세계의 세포 및 유전자 치료 임상시험 시장 규모와 동향 분석(적응증별, 2021-2033년)
• 종양학
• 심장병학
• 중추신경계
• 근골격
• 감염증
• 피부과
• 내분비, 대사 및 유전
• 면역학 및 염증
• 안과
• 혈액학
• 소화기내과
• 기타

제6장 세포 및 유전자 치료 임상시험 시장 : 유형, 제품, 시험, 샘플, 최종 용도별 지역 추정·동향 분석

• 지역별 시장 대시보드
• 세계 지역 시장 스냅숏
• 시장 규모, 예측 동향 분석, 2021-2033년 :
• 북미
  • 미국
  • 캐나다
  • 멕시코
• 유럽
  • 영국
  • 독일
  • 프랑스
  • 이탈리아
  • 스페인
  • 덴마크
  • 스웨덴
  • 노르웨이
• 아시아태평양
  • 일본
  • 중국
  • 인도
  • 호주
  • 한국
  • 태국
• 라틴아메리카
  • 브라질
  • 아르헨티나
• 중동 및 아프리카
  • 남아프리카공화국
  • 사우디아라비아
  • 아랍에미리트(UAE)
  • 쿠웨이트

제7장 경쟁 구도

• 기업 분류
• 세포 및 유전자 치료 임상시험 시장 점유율 분석(2024년)
• 기업 개요
  • IQVIA
  • ICON Plc
  • LabCorp
  • Charles River Laboratories
  • PAREXEL International Corp.
  • Syneos Health
  • Medpace
  • Thermo Fisher Scientific, Inc.
  • Novotech
  • Veristat, LLC

LSH

영문 목차

영문목차

Cell And Gene Therapy Clinical Trials Market Summary

The market is primarily driven by the accelerating pace of innovation in genetic medicine and increasing regulatory support for advanced therapies. Advancements in genome editing technologies such as CRISPR, as well as breakthroughs in viral and non-viral vector delivery systems, have enabled researchers to develop highly targeted therapeutic candidates for rare genetic disorders, cancers, and autoimmune diseases. Regulatory bodies, including the FDA and EMA, have introduced accelerated approval pathways, orphan drug designations, and RMAT (Regenerative Medicine Advanced Therapy) designations to support CGT development. These incentives have significantly reduced the time and cost burden for companies developing novel CGT products, encouraging the launch of early-phase trials.

Furthermore, the influx of funding and strategic partnerships between biotech firms, large pharmaceutical companies, and academic research centers focused on CGT development is driving the market growth. This financial momentum, especially from venture capital and public-private collaborations, is enabling clinical trial sponsors to scale up from pilot studies to multi-site international trials. Companies like Bluebird Bio, CRISPR Therapeutics, and Beam Therapeutics, numerous Phase I/II trials are being initiated in areas such as sickle cell disease, CAR-T therapies, and gene editing-based oncology pipelines.Moreover, the need to validate safety, dosing, and long-term efficacy of these therapies has increased demand for specialized CROs and trial infrastructure tailored to CGT studies.

Global Cell And Gene Therapy Clinical Trials Market Report Segmentation

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global cell and gene therapy clinical trials market report based on phase, indication, and region:

• Phase Outlook (Revenue, USD Million, 2021 - 2033)
• Phase I
• Phase II
• Phase III
• Phase IV
• Indication Outlook (Revenue, USD Million, 2021 - 2033)
• Oncology
• Cardiology
• CNS
• Musculoskeletal
• Infectious diseases
• Dermatology
• Endocrine, metabolic, genetic
• Immunology & inflammation
• Ophthalmology
• Hematology
• Gastroenterology
• Others
• Regional Outlook (Revenue, USD Million, 2021 - 2033)
• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Denmark
  • Norway
  • Sweden
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Thailand
• Latin America
  • Brazil
  • Argentina
• Middle East and Africa (MEA)
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation and Scope
• 1.2. Market Definitions
• 1.3. Research Methodology
• 1.4. Information Procurement
  • 1.4.1. Purchased database
  • 1.4.2. GVR's internal database
  • 1.4.3. Secondary sources
  • 1.4.4. Primary research
• 1.5. Information or Data Analysis
  • 1.5.1. Data analysis models
• 1.6. Market Formulation & Validation
• 1.7. Model Details
  • 1.7.1. Commodity flow analysis (Model 1)
  • 1.7.2. Value chain based analysis (Model 2)
  • 1.7.3. Multivariate Analysis (Model 3)
• 1.8. List of Secondary Sources
• 1.9. List of Primary Sources
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Snapshot
• 2.3. Competitive Landscape Snapshot

Chapter 3. Cell And Gene Therapy Clinical Trials Market: Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent Market Outlook
  • 3.1.2. Ancillary Market Outlook
• 3.2. Cell And Gene Therapy Clinical Trials Market Dynamics
  • 3.2.1. Market Driver Impact Analysis
    • 3.2.1.1. Growing Interest in Cell and Gene Therapy
    • 3.2.1.2. Adoption Of New Technology in Clinical Research
    • 3.2.1.3. Increasing Investments And R&D Funding
  • 3.2.2. Market Restraint Analysis
    • 3.2.2.1. Recruitment Obstacles
• 3.3. Technological Landscape
• 3.4. Pricing Model Analysis
• 3.5. Cell And Gene Therapy Clinical Trials Market: Analysis Tools
  • 3.5.1. Porter's Five Forces Analysis
  • 3.5.2. PESTEL Analysis

Chapter 4. Cell And Gene Therapy Clinical Trials Market: Phase Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. Global Cell and Gene Therapy Clinical Trials Market Phase Movement Analysis
• 4.3. Global Cell and Gene Therapy Clinical Trials Market Size & Trend Analysis, by Phase, 2021 to 2033 (USD Million)
• 4.4. Phase I
  • 4.4.1. Phase I Market Estimates and Forecasts, 2021 - 2033 (USD million)
• 4.5. Phase II
  • 4.5.1. Phase II Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.6. Phase III
  • 4.6.1. Phase III Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.7. Phase IV
  • 4.7.1. Phase IV Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. Cell And Gene Therapy Clinical Trials Market: Indication Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. Global Cell and Gene Therapy Clinical Trials Market Indication Movement Analysis
• 5.3. Global Cell and Gene Therapy Clinical Trials Market Size & Trend Analysis, by Indication, 2021 to 2033 (USD Million)
• 5.4. Oncology
  • 5.4.1. Oncology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Cardiology
  • 5.5.1. Cardiology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.6. CNS
  • 5.6.1. CNS Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.7. Musculoskeletal
  • 5.7.1. Musculoskeletal Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.8. Infectious diseases
  • 5.8.1. Infectious diseases Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.9. Dermatology
  • 5.9.1. Dermatology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.10. Endocrine, metabolic, genetic
  • 5.10.1. Endocrine, metabolic, genetic Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.11. Immunology & inflammation
  • 5.11.1. Immunology & inflammation Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.12. Ophthalmology
  • 5.12.1. Ophthalmology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.13. Hematology
  • 5.13.1. Hematology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.14. Gastroenterology
  • 5.14.1. Gastroenterology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.15. Others
  • 5.15.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. Cell And Gene Therapy Clinical Trials Market: Regional Estimates & Trend Analysis by Type, Product, Test, Sample, End Use

• 6.1. Regional Market Dashboard
• 6.2. Global Regional Market Snapshot
• 6.3. Market Size, & Forecasts Trend Analysis, 2021 to 2033:
• 6.4. North America
  • 6.4.1. North America Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.4.2. U.S.
    • 6.4.2.1. Key Country Dynamics
    • 6.4.2.2. Competitive Scenario
    • 6.4.2.3. Regulatory Framework
    • 6.4.2.4. U.S. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.4.3. Canada
    • 6.4.3.1. Key Country Dynamics
    • 6.4.3.2. Competitive Scenario
    • 6.4.3.3. Regulatory Framework
    • 6.4.3.4. Canada Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.4.4. Mexico
    • 6.4.4.1. Key Country Dynamics
    • 6.4.4.2. Competitive Scenario
    • 6.4.4.3. Regulatory Framework
    • 6.4.4.4. Mexico Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.5. Europe
  • 6.5.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5.2. UK
    • 6.5.2.1. Key Country Dynamics
    • 6.5.2.2. Competitive Scenario
    • 6.5.2.3. Regulatory Framework
    • 6.5.2.4. Europe Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5.3. Germany
    • 6.5.3.1. Key Country Dynamics
    • 6.5.3.2. Competitive Scenario
    • 6.5.3.3. Regulatory Framework
    • 6.5.3.4. Germany Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5.4. France
    • 6.5.4.1. Key Country Dynamics
    • 6.5.4.2. Competitive Scenario
    • 6.5.4.3. Regulatory Framework
    • 6.5.4.4. France Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5.5. Italy
    • 6.5.5.1. Key Country Dynamics
    • 6.5.5.2. Competitive Scenario
    • 6.5.5.3. Regulatory Framework
    • 6.5.5.4. Italy Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5.6. Spain
    • 6.5.6.1. Key Country Dynamics
    • 6.5.6.2. Competitive Scenario
    • 6.5.6.3. Regulatory Framework
    • 6.5.6.4. Spain Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5.7. Denmark
    • 6.5.7.1. Key Country Dynamics
    • 6.5.7.2. Competitive Scenario
    • 6.5.7.3. Regulatory Framework
    • 6.5.7.4. Denmark Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5.8. Sweden
    • 6.5.8.1. Key Country Dynamics
    • 6.5.8.2. Competitive Scenario
    • 6.5.8.3. Regulatory Framework
    • 6.5.8.4. Sweden Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.5.9. Norway
    • 6.5.9.1. Key Country Dynamics
    • 6.5.9.2. Competitive Scenario
    • 6.5.9.3. Regulatory Framework
    • 6.5.9.4. Norway Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.6. Asia Pacific
  • 6.6.1. Asia Pacific Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.6.2. Japan
    • 6.6.2.1. Key Country Dynamics
    • 6.6.2.2. Competitive Scenario
    • 6.6.2.3. Regulatory Framework
    • 6.6.2.4. Japan Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.6.3. China
    • 6.6.3.1. Key Country Dynamics
    • 6.6.3.2. Competitive Scenario
    • 6.6.3.3. Regulatory Framework
    • 6.6.3.4. China Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.6.4. India
    • 6.6.4.1. Key Country Dynamics
    • 6.6.4.2. Competitive Scenario
    • 6.6.4.3. Regulatory Framework
    • 6.6.4.4. India Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.6.5. Australia
    • 6.6.5.1. Key Country Dynamics
    • 6.6.5.2. Competitive Scenario
    • 6.6.5.3. Regulatory Framework
    • 6.6.5.4. Australia Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.6.6. South Korea
    • 6.6.6.1. Key Country Dynamics
    • 6.6.6.2. Competitive Scenario
    • 6.6.6.3. Regulatory Framework
    • 6.6.6.4. South Korea Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.6.7. Thailand
    • 6.6.7.1. Key Country Dynamics
    • 6.6.7.2. Competitive Scenario
    • 6.6.7.3. Regulatory Framework
    • 6.6.7.4. Thailand Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.7. Latin America
  • 6.7.1. Latin America Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.7.2. Brazil
    • 6.7.2.1. Key Country Dynamics
    • 6.7.2.2. Competitive Scenario
    • 6.7.2.3. Regulatory Framework
    • 6.7.2.4. Brazil Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.7.3. Argentina
    • 6.7.3.1. Key Country Dynamics
    • 6.7.3.2. Competitive Scenario
    • 6.7.3.3. Regulatory Framework
    • 6.7.3.4. Argentina Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.8. MEA
  • 6.8.1. MEA Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.8.2. South Africa
    • 6.8.2.1. Key Country Dynamics
    • 6.8.2.2. Competitive Scenario
    • 6.8.2.3. Regulatory Framework
    • 6.8.2.4. South Africa Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.8.3. Saudi Arabia
    • 6.8.3.1. Key Country Dynamics
    • 6.8.3.2. Competitive Scenario
    • 6.8.3.3. Regulatory Framework
    • 6.8.3.4. Saudi Arabia Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.8.4. UAE
    • 6.8.4.1. Key Country Dynamics
    • 6.8.4.2. Competitive Scenario
    • 6.8.4.3. Regulatory Framework
    • 6.8.4.4. UAE Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 6.8.5. Kuwait
    • 6.8.5.1. Key Country Dynamics
    • 6.8.5.2. Competitive Scenario
    • 6.8.5.3. Regulatory Framework
    • 6.8.5.4. Kuwait Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. Competitive Landscape

• 7.1. Company Categorization
• 7.2. Cell And Gene Therapy Clinical Trials Market Share Analysis, 2024
• 7.3. Company Profiles
  • 7.3.1. IQVIA
    • 7.3.1.1. Company overview
    • 7.3.1.2. Financial performance
    • 7.3.1.3. Product benchmarking
    • 7.3.1.4. Strategic initiatives
  • 7.3.2. ICON Plc
    • 7.3.2.1. Company overview
    • 7.3.2.2. Financial performance
    • 7.3.2.3. Product benchmarking
    • 7.3.2.4. Strategic initiatives
  • 7.3.3. LabCorp
    • 7.3.3.1. Company overview
    • 7.3.3.2. Financial performance
    • 7.3.3.3. Product benchmarking
    • 7.3.3.4. Strategic initiatives
  • 7.3.4. Charles River Laboratories
    • 7.3.4.1. Company overview
    • 7.3.4.2. Financial performance
    • 7.3.4.3. Product benchmarking
    • 7.3.4.4. Strategic initiatives
  • 7.3.5. PAREXEL International Corp.
    • 7.3.5.1. Company overview
    • 7.3.5.2. Financial performance
    • 7.3.5.3. Product benchmarking
    • 7.3.5.4. Strategic initiatives
  • 7.3.6. Syneos Health
    • 7.3.6.1. Company overview
    • 7.3.6.2. Financial performance
    • 7.3.6.3. Product benchmarking
    • 7.3.6.4. Strategic initiatives
  • 7.3.7. Medpace
    • 7.3.7.1. Company overview
    • 7.3.7.2. Financial performance
    • 7.3.7.3. Product benchmarking
    • 7.3.7.4. Strategic initiatives
  • 7.3.8. Thermo Fisher Scientific, Inc.
    • 7.3.8.1. Company overview
    • 7.3.8.2. Financial performance
    • 7.3.8.3. Product benchmarking
    • 7.3.8.4. Strategic initiatives
  • 7.3.9. Novotech
    • 7.3.9.1. Company overview
    • 7.3.9.2. Financial performance
    • 7.3.9.3. Product benchmarking
    • 7.3.9.4. Strategic initiatives
  • 7.3.10. Veristat, LLC
    • 7.3.10.1. Company overview
    • 7.3.10.2. Financial performance
    • 7.3.10.3. Product benchmarking
    • 7.3.10.4. Strategic initiatives

관련자료