세포 및 유전자 치료 임상시험 서비스 시장 : 서비스별, 단계별, 적응증별, 치료 유형별, 최종 용도별 - 세계 예측(2024-2032년)

Global Cell & Gene Therapy Clinical Trial Services Market size will expand at a 10.8 CAGR from 2024 to 2032, attributed to technological upgrades, such as CRISPR-Cas9 and viral vectors, in line with supportive regulatory environments. These innovations enhance therapeutic potential and streamline approval processes, stimulating increased research and trial activities. With regulatory agencies like the FDA facilitating faster approvals for groundbreaking therapies, there is a growing momentum among biotech firms and pharmaceutical companies to invest in and accelerate the development of novel treatments, fueling market growth.

For instance, in June 2023, the FDA launched a new office to handle a surge in cell and gene therapy submissions, including potential approvals for the first CRISPR therapy and gene therapy for Duchenne muscular dystrophy. This development signifies heightened regulatory activity and industry momentum, stimulating growth opportunities for service providers supporting these trials, ranging from patient recruitment to regulatory compliance and data management.

The cell & gene therapy clinical trial services industry is fragmented based on service, phase, indication, therapy type, end-use, and region.

The neurology segment will garner remarkable gains through 2032, spurred by the pressing need for effective treatments for neurological disorders. With conditions like Parkinson's, Alzheimer's, and ALS driving research, there is a substantial investment in therapies targeting these areas. Clinical trials in neurology benefit from specialized expertise, robust patient recruitment networks, and regulatory support, making it a focal point for innovation. Advances in gene editing and cell therapies offer promising avenues for addressing unmet medical needs, further bolstering this segment's prominence.

The academic and research institutions segment will see a considerable surge by 2032, owing to their pivotal role in pioneering innovative therapies and conducting early-stage trials. These institutions possess extensive expertise, infrastructure, and access to patient populations critical for advancing research. Collaborations with biotech firms and government funding bolster their capabilities. As demand grows for cutting-edge therapies, academic and research institutions will conduct essential clinical trials that validate the safety and efficacy of cell and gene therapies.

Asia Pacific cell & gene therapy clinical trial services market share will experience a notable CAGR between 2024 and 2032 due to increasing investments in healthcare infrastructure, rising prevalence of genetic disorders, and supportive regulatory environments. The region's diverse patient population and lower operational costs attract global biotech and pharmaceutical firms to conduct clinical trials. As countries like China, Japan, and South Korea advance in biotechnology and genetic research, Asia Pacific will stand as a key contributor to the expansion of the global cell & gene therapy clinical trial services industry.

Table of Contents

Chapter 1 Methodology & Scope

• 1.1 Market scope & definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates & calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360° synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Rising incidence of chronic and genetic disease
    • 3.2.1.2 Technological advancement in cell and gene therapy
    • 3.2.1.3 Increasing investment in research & development activities
    • 3.2.1.4 Expanded application in oncology and rare disease
  • 3.2.2 Industry pitfalls & challenges
    • 3.2.2.1 Stringent regulatory challenges
    • 3.2.2.2 High development cost
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
• 3.5 Porter's analysis
• 3.6 PESTEL analysis

Chapter 4 Competitive Landscape, 2023

• 4.1 Introduction
• 4.2 Company matrix analysis
• 4.3 Competitive analysis of major market players
• 4.4 Competitive positioning matrix
• 4.5 Strategic dashboard

Chapter 5 Market Estimates and Forecast, By Service, 2021-2032 ($ Million)

• 5.1 Key trends
• 5.2 Clinical trial design & planning
• 5.3 Supply & logistics services
• 5.4 Regulatory affairs & compliance
• 5.5 Data management & biostatistics
• 5.6 Site management & monitoring
• 5.7 Other services

Chapter 6 Market Estimates and Forecast, By Phase, 2021-2032 ($ Million)

• 6.1 Key trends
• 6.2 Phase I
• 6.3 Phase II
• 6.4 Phase III
• 6.5 Phase IV

Chapter 7 Market Estimates and Forecast, By Indication, 2021-2032 ($ Million)

• 7.1 Key trends
• 7.2 Oncology
• 7.3 Hematology
• 7.4 Endocrine/metabolic disorders
• 7.5 Infectious diseases
• 7.6 Neurology
• 7.7 Cardiovascular diseases
• 7.8 Musculoskeletal disorders
• 7.9 Other indications

Chapter 8 Market Estimates and Forecast, By Therapy Type, 2021-2032 ($ Million)

• 8.1 Key trends
• 8.2 Gene therapy
• 8.3 Cell therapy
• 8.4 Gene modified cell therapy

Chapter 9 Market Estimates and Forecast, By End-Use, 2021-2032 ($ Million)

• 9.1 Key trends
• 9.2 Pharmaceutical & biotechnology companies
• 9.3 Contract research organizations
• 9.4 Academic & research institutes
• 9.5 Other end-users

Chapter 10 Market Estimates and Forecast, By Region, 2021-2032 ($ Million)

• 10.1 Key trends
• 10.2 North America
  • 10.2.1 U.S.
  • 10.2.2 Canada
• 10.3 Europe
  • 10.3.1 Germany
  • 10.3.2 UK
  • 10.3.3 France
  • 10.3.4 Spain
  • 10.3.5 Italy
  • 10.3.6 Netherlands
  • 10.3.7 Rest of Europe
• 10.4 Asia Pacific
  • 10.4.1 Japan
  • 10.4.2 China
  • 10.4.3 India
  • 10.4.4 Australia
  • 10.4.5 South Korea
  • 10.4.6 Rest of Asia Pacific
• 10.5 Latin America
  • 10.5.1 Brazil
  • 10.5.2 Mexico
  • 10.5.3 Rest of Latin America
• 10.6 Middle East and Africa
  • 10.6.1 South Africa
  • 10.6.2 Saudi Arabia
  • 10.6.3 UAE
  • 10.6.4 Rest of Middle East and Africa

Chapter 11 Company Profiles

• 11.1 ADVARRA
• 11.2 Charles River Laboratories International Inc.
• 11.3 Catalent Pharma
• 11.4 ICON PLC
• 11.5 IQVIA
• 11.6 Medpace, Inc.
• 11.7 Novotech
• 11.8 Precision Medicine Group, LLC
• 11.9 Parexel International
• 11.10 Syneos Health
• 11.11 Sharp Services, LLC
• 11.12 Thermo Fisher Scientific Inc.
• 11.13 Worldwide Clinical Trials