세포 및 유전자 치료 임상시험 시장 : 유형, 단계, 용도, 최종사용자별 - 세계 예측(2025-2030년)

The Cell & Gene Therapy Clinical Trials Market was valued at USD 9.20 billion in 2023, expected to reach USD 10.48 billion in 2024, and is projected to grow at a CAGR of 14.61%, to USD 23.91 billion by 2030.

Cell and gene therapies represent cutting-edge developments in clinical trials focused on treating, preventing, or potentially curing condition-drivers at the genetic level. The scope of these therapies extends from oncology to rare genetic disorders, offering transformative potential in disease treatment protocols. These therapies are necessary due to their unique mechanisms that address root causes of diseases rather than merely alleviating symptoms, paving the way for sustainable, long-term management or cure of complex and chronic conditions. Application of these therapies spans multiple sectors, including healthcare and biotechnology, with end-use in hospitals, specialized treatment centers, and research institutions. Market insights highlight a surge in investment and collaborations between pharmaceutical companies, biotech firms, and academic institutions driven by technological advancements and supportive regulatory environments, which act as key growth influencers. Opportunities are abundant with increasing incidences of chronic diseases and an aging population, driving the demand for innovative treatments. However, challenges persist, such as high R&D costs, complex regulatory landscapes, and manufacturing and logistical hurdles, which can impede market growth. Additionally, the lack of appropriate reimbursement frameworks and the need for skilled workforce pose significant limitations. Focus on continuous innovation is essential, with ample scope for improvements in vector design, gene editing technologies like CRISPR, and scalable production methods to enhance therapy efficacy and reduce costs. The nature of the market leans towards consolidation, as larger pharmaceutical entities acquire smaller biotechs to bolster pipelines and capability portfolios. To thrive, businesses should focus on strategic partnerships for R&D, invest in cutting-edge manufacturing technologies, and champion personalized medicine approaches. Engaging with regulatory bodies early for optimizing trial designs and seeking versatile regulatory pathways could ease market entry and expansion, while targeting niche markets with high unmet needs would provide a competitive edge.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Cell & Gene Therapy Clinical Trials Market

The Cell & Gene Therapy Clinical Trials Market is undergoing transformative changes driven by a dynamic interplay of supply and demand factors. Understanding these evolving market dynamics prepares business organizations to make informed investment decisions, refine strategic decisions, and seize new opportunities. By gaining a comprehensive view of these trends, business organizations can mitigate various risks across political, geographic, technical, social, and economic domains while also gaining a clearer understanding of consumer behavior and its impact on manufacturing costs and purchasing trends.

• Market Drivers
  • Growing application of cell & gene therapy in cancer research
  • Rising prevalence of chronic disease across the globe
  • Increasing investment activities by biopharmaceutical companies for cell-based research
• Market Restraints
  • Technological complexity of delivering genes into the human body safely and effectively
• Market Opportunities
  • Growing regulatory approvals from the government for cell & gene therapies
  • Increasing adoption of advanced technologies for cell & gene therapy clinical trials
• Market Challenges
  • Issues associated with variability in patient responses to therapies

Porter's Five Forces: A Strategic Tool for Navigating the Cell & Gene Therapy Clinical Trials Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Cell & Gene Therapy Clinical Trials Market. It offers business organizations with a clear methodology for evaluating their competitive positioning and exploring strategic opportunities. This framework helps businesses assess the power dynamics within the market and determine the profitability of new ventures. With these insights, business organizations can leverage their strengths, address weaknesses, and avoid potential challenges, ensuring a more resilient market positioning.

PESTLE Analysis: Navigating External Influences in the Cell & Gene Therapy Clinical Trials Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Cell & Gene Therapy Clinical Trials Market. Political, Economic, Social, Technological, Legal, and Environmental factors analysis provides the necessary information to navigate these influences. By examining PESTLE factors, businesses can better understand potential risks and opportunities. This analysis enables business organizations to anticipate changes in regulations, consumer preferences, and economic trends, ensuring they are prepared to make proactive, forward-thinking decisions.

Market Share Analysis: Understanding the Competitive Landscape in the Cell & Gene Therapy Clinical Trials Market

A detailed market share analysis in the Cell & Gene Therapy Clinical Trials Market provides a comprehensive assessment of vendors' performance. Companies can identify their competitive positioning by comparing key metrics, including revenue, customer base, and growth rates. This analysis highlights market concentration, fragmentation, and trends in consolidation, offering vendors the insights required to make strategic decisions that enhance their position in an increasingly competitive landscape.

FPNV Positioning Matrix: Evaluating Vendors' Performance in the Cell & Gene Therapy Clinical Trials Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the Cell & Gene Therapy Clinical Trials Market. This matrix enables business organizations to make well-informed decisions that align with their goals by assessing vendors based on their business strategy and product satisfaction. The four quadrants provide a clear and precise segmentation of vendors, helping users identify the right partners and solutions that best fit their strategic objectives.

Strategy Analysis & Recommendation: Charting a Path to Success in the Cell & Gene Therapy Clinical Trials Market

A strategic analysis of the Cell & Gene Therapy Clinical Trials Market is essential for businesses looking to strengthen their global market presence. By reviewing key resources, capabilities, and performance indicators, business organizations can identify growth opportunities and work toward improvement. This approach helps businesses navigate challenges in the competitive landscape and ensures they are well-positioned to capitalize on newer opportunities and drive long-term success.

Key Company Profiles

The report delves into recent significant developments in the Cell & Gene Therapy Clinical Trials Market, highlighting leading vendors and their innovative profiles. These include Accell Clinical Research, LLC, Alnylam Pharmaceuticals, Inc., Amgen Inc., Atlant Clinical Ltd., Biogen Inc., Charles River Laboratories International, Inc., CORESTEM, Inc., CTI Clinical Trial and Consulting Services, Inc., Dendreon Pharmaceuticals LLC, HELIXMITH Co., Ltd., ICON PLC, IQVIA Inc., Kolon TissueGene, Inc., Laboratory Corporation of America Holdings, Medpace Holdings, Inc., Novartis AG, Novotech Pty Limited, Parexel International Corporation, Ppd, Inc., ProPharma Group Holdings, LLC, PSI CRO, SGS S.A., Syneos Health, Inc., Veristat, LLC, and Wuxi AppTec Inc..

Market Segmentation & Coverage

This research report categorizes the Cell & Gene Therapy Clinical Trials Market to forecast the revenues and analyze trends in each of the following sub-markets:

• Based on Type, market is studied across Cell Therapy Clinical Trials and Gene Therapy Clinical Trials. The Cell Therapy Clinical Trials is further studied across Allogeneic Cell Therapy, Autologous Cell Therapy, CAR-T Cell Therapy, and Mesenchymal Stem Cell Therapy. The Gene Therapy Clinical Trials is further studied across Antisense Oligonucleotide-Based Gene Therapy, CRISPR-Based Gene Therapy, Non-Viral Vector Gene Therapy, and Viral Vector Gene Therapy.
• Based on Phase, market is studied across Phase I, Phase II, Phase III, and Phase IV.
• Based on Application, market is studied across Cardiology, Dermatology, Endocrine, Metabolic, & Genetic, Gastroenterology, Hematology, Immunology & Inflammation, Infectious Diseases, Musculoskeletal, Neurology, Oncology, and Ophthalmology.
• Based on End-User, market is studied across Academic & Research Institutes, Contract Research Organizations (CROs), Hospitals and Clinics, and Pharmaceutical Companies.
• Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

The report offers a comprehensive analysis of the market, covering key focus areas:

1. Market Penetration: A detailed review of the current market environment, including extensive data from top industry players, evaluating their market reach and overall influence.

2. Market Development: Identifies growth opportunities in emerging markets and assesses expansion potential in established sectors, providing a strategic roadmap for future growth.

3. Market Diversification: Analyzes recent product launches, untapped geographic regions, major industry advancements, and strategic investments reshaping the market.

4. Competitive Assessment & Intelligence: Provides a thorough analysis of the competitive landscape, examining market share, business strategies, product portfolios, certifications, regulatory approvals, patent trends, and technological advancements of key players.

5. Product Development & Innovation: Highlights cutting-edge technologies, R&D activities, and product innovations expected to drive future market growth.

The report also answers critical questions to aid stakeholders in making informed decisions:

1. What is the current market size, and what is the forecasted growth?

2. Which products, segments, and regions offer the best investment opportunities?

3. What are the key technology trends and regulatory influences shaping the market?

4. How do leading vendors rank in terms of market share and competitive positioning?

5. What revenue sources and strategic opportunities drive vendors' market entry or exit strategies?

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Segmentation & Coverage
• 1.3. Years Considered for the Study
• 1.4. Currency & Pricing
• 1.5. Language
• 1.6. Stakeholders

2. Research Methodology

• 2.1. Define: Research Objective
• 2.2. Determine: Research Design
• 2.3. Prepare: Research Instrument
• 2.4. Collect: Data Source
• 2.5. Analyze: Data Interpretation
• 2.6. Formulate: Data Verification
• 2.7. Publish: Research Report
• 2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Market Dynamics
  • 5.1.1. Drivers
    • 5.1.1.1. Growing application of cell & gene therapy in cancer research
    • 5.1.1.2. Rising prevalence of chronic disease across the globe
    • 5.1.1.3. Increasing investment activities by biopharmaceutical companies for cell-based research
  • 5.1.2. Restraints
    • 5.1.2.1. Technological complexity of delivering genes into the human body safely and effectively
  • 5.1.3. Opportunities
    • 5.1.3.1. Growing regulatory approvals from the government for cell & gene therapies
    • 5.1.3.2. Increasing adoption of advanced technologies for cell & gene therapy clinical trials
  • 5.1.4. Challenges
    • 5.1.4.1. Issues associated with variability in patient responses to therapies
• 5.2. Market Segmentation Analysis
  • 5.2.1. Type: Rising significance of allogeneic cell therapy in the treatment of cancers and genetic disorders

• 5.2.2. End-User: Increasing application of cell & gene therapy clinical trials in contract research organizations due to their efficiency and scalability

• 5.3. Porter's Five Forces Analysis
  • 5.3.1. Threat of New Entrants
  • 5.3.2. Threat of Substitutes
  • 5.3.3. Bargaining Power of Customers
  • 5.3.4. Bargaining Power of Suppliers
  • 5.3.5. Industry Rivalry
• 5.4. PESTLE Analysis
  • 5.4.1. Political
  • 5.4.2. Economic
  • 5.4.3. Social
  • 5.4.4. Technological
  • 5.4.5. Legal
  • 5.4.6. Environmental

6. Cell & Gene Therapy Clinical Trials Market, by Type

• 6.1. Introduction
• 6.2. Cell Therapy Clinical Trials
  • 6.2.1. Allogeneic Cell Therapy
  • 6.2.2. Autologous Cell Therapy
  • 6.2.3. CAR-T Cell Therapy
  • 6.2.4. Mesenchymal Stem Cell Therapy
• 6.3. Gene Therapy Clinical Trials
  • 6.3.1. Antisense Oligonucleotide-Based Gene Therapy
  • 6.3.2. CRISPR-Based Gene Therapy
  • 6.3.3. Non-Viral Vector Gene Therapy
  • 6.3.4. Viral Vector Gene Therapy

7. Cell & Gene Therapy Clinical Trials Market, by Phase

• 7.1. Introduction
• 7.2. Phase I
• 7.3. Phase II
• 7.4. Phase III
• 7.5. Phase IV

8. Cell & Gene Therapy Clinical Trials Market, by Application

• 8.1. Introduction
• 8.2. Cardiology
• 8.3. Dermatology
• 8.4. Endocrine, Metabolic, & Genetic
• 8.5. Gastroenterology
• 8.6. Hematology
• 8.7. Immunology & Inflammation
• 8.8. Infectious Diseases
• 8.9. Musculoskeletal
• 8.10. Neurology
• 8.11. Oncology
• 8.12. Ophthalmology

9. Cell & Gene Therapy Clinical Trials Market, by End-User

• 9.1. Introduction
• 9.2. Academic & Research Institutes
• 9.3. Contract Research Organizations (CROs)
• 9.4. Hospitals and Clinics
• 9.5. Pharmaceutical Companies

10. Americas Cell & Gene Therapy Clinical Trials Market

• 10.1. Introduction
• 10.2. Argentina
• 10.3. Brazil
• 10.4. Canada
• 10.5. Mexico
• 10.6. United States

11. Asia-Pacific Cell & Gene Therapy Clinical Trials Market

• 11.1. Introduction
• 11.2. Australia
• 11.3. China
• 11.4. India
• 11.5. Indonesia
• 11.6. Japan
• 11.7. Malaysia
• 11.8. Philippines
• 11.9. Singapore
• 11.10. South Korea
• 11.11. Taiwan
• 11.12. Thailand
• 11.13. Vietnam

12. Europe, Middle East & Africa Cell & Gene Therapy Clinical Trials Market

• 12.1. Introduction
• 12.2. Denmark
• 12.3. Egypt
• 12.4. Finland
• 12.5. France
• 12.6. Germany
• 12.7. Israel
• 12.8. Italy
• 12.9. Netherlands
• 12.10. Nigeria
• 12.11. Norway
• 12.12. Poland
• 12.13. Qatar
• 12.14. Russia
• 12.15. Saudi Arabia
• 12.16. South Africa
• 12.17. Spain
• 12.18. Sweden
• 12.19. Switzerland
• 12.20. Turkey
• 12.21. United Arab Emirates
• 12.22. United Kingdom

13. Competitive Landscape

• 13.1. Market Share Analysis, 2023
• 13.2. FPNV Positioning Matrix, 2023
• 13.3. Competitive Scenario Analysis
  • 13.3.1. Cincinnati Children's launches USD 60 million Applied Gene and Cell Therapy Center in Sharonville
  • 13.3.2. Strategic partnership between Premier Research and BioCentriq accelerates pre-IND timelines and clinical translation of innovative cell therapies
  • 13.3.3. Astellas Pharma invests USD 50 million in Poseida Therapeutics for exclusive licensing and cancer cell therapy development
• 13.4. Strategy Analysis & Recommendation

Companies Mentioned

• 1. Accell Clinical Research, LLC
• 2. Alnylam Pharmaceuticals, Inc.
• 3. Amgen Inc.
• 4. Atlant Clinical Ltd.
• 5. Biogen Inc.
• 6. Charles River Laboratories International, Inc.
• 7. CORESTEM, Inc.
• 8. CTI Clinical Trial and Consulting Services, Inc.
• 9. Dendreon Pharmaceuticals LLC
• 10. HELIXMITH Co., Ltd.
• 11. ICON PLC
• 12. IQVIA Inc.
• 13. Kolon TissueGene, Inc.
• 14. Laboratory Corporation of America Holdings
• 15. Medpace Holdings, Inc.
• 16. Novartis AG
• 17. Novotech Pty Limited
• 18. Parexel International Corporation
• 19. Ppd, Inc.
• 20. ProPharma Group Holdings, LLC
• 21. PSI CRO
• 22. SGS S.A.
• 23. Syneos Health, Inc.
• 24. Veristat, LLC
• 25. Wuxi AppTec Inc.