세계의 세포 및 유전자 치료 시장 : 치료 유형, 전달 방법, 치료 영역, 용도, 최종사용자별 - 예측(2025-2030년)

The Cell & Gene Therapy Market was valued at USD 14.33 billion in 2023 and is projected to grow to USD 16.65 billion in 2024, with a CAGR of 18.98%, reaching USD 48.39 billion by 2030.

The cell and gene therapy industry stands at the forefront of modern medicine, representing a paradigm shift in our approach to treating life-threatening and chronic diseases. Over recent years, innovative breakthroughs and regulatory advancements have propelled this field into a new era of therapeutic promise. The market has experienced robust growth due to rapid scientific discoveries, increased investments in biotechnology, and an enhanced understanding of disease pathophysiology at the molecular level. These therapies not only offer the possibility of durable remissions and cures but also provide hope to millions of patients who previously had limited or no treatment options. With a strong emphasis on personalized medicine, the sector continues to bridge the gap between research and clinical application, establishing integrated platforms that foster both clinical and academic collaborations. Stakeholders across the board-from researchers and clinicians to investors and policy makers-have recognized the immense potential embedded within the cell and gene therapy landscape, transforming it into a fertile ground for scientific rigor and commercial opportunity.

As the market maturing further, innovation becomes increasingly interwoven with patient-centric outcomes. The convergence of advanced genomic technologies, refined cell manipulation techniques, and improved delivery methodologies has paved the way for therapies that are not only highly effective but also increasingly accessible. This transformation signals a strategic pivot in drug development, influencing the investment strategies and operational frameworks of industry leaders. The industry is evolving rapidly, driven by a combination of demand for curative treatment options and a renewed optimism among professionals that stand at the threshold of a new era in therapeutic development.

Transformative Shifts in the Cell & Gene Therapy Landscape

Recent years have witnessed a multitude of transformative shifts within the cell and gene therapy industry that have redefined both the market dynamics and the operational strategies of key players. One pivotal change has been the development and integration of state-of-the-art biotechnological platforms, which have enabled more precise and effective therapies. As scientific advances continue to unravel the complexities of cellular functions and genetic expressions, breakthrough treatments have moved quickly from proof-of-concept to clinical application. Regulatory agencies have also updated approval pathways, shortening the developmental timeline and making way for more agile market entries. These regulatory reforms are coupled with increased public and private funding, which has further catalyzed innovation and accelerated the pace at which therapies are being brought to market.

In parallel, the adoption of digital analytical tools and real-time data collection has revolutionized the clinical trial landscape, leading to more robust and adaptive study designs. Innovation is now driven by a combination of data analytics and an in-depth understanding of molecular biology, resulting in therapies that cater not only to the typical patient profile but also to diverse genetic backgrounds and disease subtypes. The ability to integrate advanced manufacturing techniques with scalable research methodologies has also played a crucial role in mitigating production challenges and cost constraints. These trends indicate that both the scientific and commercial aspects of cell and gene therapy are undergoing rapid evolution, underscoring the need for continuous adaptation, collaborative research, and increased investment in novel technologies that are transforming the landscape once dominated by traditional therapeutic approaches.

Key Segmentation Insights in the Cell & Gene Therapy Market

Understanding the market segmentation provides valuable insights into the multifaceted structure of the cell and gene therapy domain. The market is primarily categorized based on therapy type, where the two main domains are cell therapy and gene therapy. In the realm of cell therapy, detailed analyses extend to subdivisions such as stem cell therapies and T cell therapy. Within stem cell therapies, a distinction is made between hematopoietic stem cell therapies and mesenchymal stem cell therapies, while T cell therapy is examined through the lenses of CAR T cell therapy and T cell receptor-based approaches. Conversely, gene therapy is dissected into ex vivo gene therapy and in vivo gene therapy, representing distinct approaches to modifying genetic function and expression.

From another perspective, market segmentation is also driven by the delivery method utilized in these therapies, predominantly focusing on intramuscular and intravenous techniques. In addition, the therapeutic application spectrum spans several key areas, including cardiovascular issues, metabolic disorders, neurological disorders, oncology, and ophthalmology. Each therapeutic area is subject to deeper investigation; for example, cardiovascular applications are further divided into conditions such as congestive heart failure and ischemic heart disease, whereas metabolic disorders focus on diabetes and obesity. Similarly, neurological disorders encompass a range of conditions spanning Alzheimer's disease, Huntington's disease, multiple sclerosis, Parkinson's disease, and spinal cord injuries, and oncology is studied with respect to hematological malignancies, lymphomas, and solid tumors.

Furthermore, the application of these therapies is split into those used for clinical applications and those intended for research and development, with the clinical category further delineated into disease prevention and treatment. Lastly, the end-user segmentation distinguishes between academic and research institutes, which include private research labs and universities, and hospitals and clinics that deliver direct patient care. These segmentation insights serve as the bedrock for strategic decision-making and enable stakeholders to hone in on precise market niches and growth opportunities.

Based on Therapy Type, market is studied across Cell Therapy and Gene Therapy. The Cell Therapy is further studied across Stem Cell Therapies and T Cell Therapy. The Stem Cell Therapies is further studied across Hematopoietic Stem Cell Therapies and Mesenchymal Stem Cell Therapies. The T Cell Therapy is further studied across CAR T Cell Therapy and T Cell Receptor (TCR)-based. The Gene Therapy is further studied across Ex Vivo Gene Therapy and In Vivo Gene Therapy.

Based on Delivery Method, market is studied across Intramuscular and Intravenous.

Based on Therapeutic Areas, market is studied across Cardiovascular, Metabolic Disorders, Neurological Disorders, Oncology, and Ophthalmology. The Cardiovascular is further studied across Congestive Heart Failure and Ischemic Heart Disease. The Metabolic Disorders is further studied across Diabetes and Obesity. The Neurological Disorders is further studied across Alzheimer's Disease, Huntington's Disease, Multiple Sclerosis, Parkinson's Disease, and Spinal Cord Injuries. The Oncology is further studied across Hematological Malignancies, Lymphomas, and Solid Tumors.

Based on Application, market is studied across Clinical Applications and Research & Development. The Clinical Applications is further studied across Disease Prevention and Disease Treatment.

Based on End User, market is studied across Academic & Research Institutes and Hospitals & Clinics. The Academic & Research Institutes is further studied across Private Research Labs and Universities.

Key Regional Insights Shaping the Global Market

Global trends in the cell and gene therapy market are not uniform, but vary substantially across key regions. The Americas continues to lead with a broad network of research and high levels of investment, bolstering national initiatives in biotechnology innovation and product commercialization. This region benefits from a well-developed reimbursement and regulatory environment that supports the rapid introduction of innovative therapies.

In regions grouped under Europe, Middle East & Africa, there is a significant focus on balancing innovation with strict regulatory oversight. These regions have been proactive in adopting global standards in clinical research while fostering local advancements through strategic public-private partnerships. Recent policy changes and increased research funding have enabled these markets to narrow the gap between traditional treatments and novel curative approaches. Finally, the Asia-Pacific region is emerging as a critical hub for both research and manufacturing. Rapid economic growth, coupled with large-scale governmental investments in science and technology, have positioned this region as an attractive destination for clinical trials and cost-efficient manufacturing of advanced therapies. In summary, while each region exhibits unique characteristics, there is a clear convergence in striving towards accelerated innovation and improved patient outcomes on a global scale.

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.

Key Companies Shaping the Cell & Gene Therapy Ecosystem

The competitive landscape in the cell and gene therapy market is marked by a diverse set of companies that are not only investing in innovative research but are also committed to scaling manufacturing processes and clinical execution. Industry pioneers such as AbbVie Inc., Amgen Inc., and Bristol-Myers Squibb Company have been instrumental in driving forward high-impact clinical programs. Other notable companies like Abeona Therapeutics Inc., Adaptimmune Therapeutics PLC, and AGC Inc. continue to push the envelope with novel therapeutic modalities.

This realm also includes outstanding contributions from companies like Alnylam Pharmaceuticals, Inc., American Gene Technologies Inc., and AnGes, Inc., each bringing unique expertise to the forefront of cell and gene therapies. The competitive field is further enriched by industry leaders such as Astellas Pharma Inc., Becton, Dickinson and Company, and Biogen Inc., who have consistently showcased innovations that translate laboratory research into effective clinical results. Bluebird Bio, Inc.? BridgeBio Pharma, Inc.? and C.H. Boehringer Sohn AG & Co. KG are also at the cutting edge, alongside emerging firms like Cellectis SA, CRISPR Therapeutics AG, and F. Hoffmann-La Roche AG. The dynamic interplay between these companies, including Gilead Sciences, Inc., Intellia Therapeutics, Inc., Ionis Pharmaceuticals, Inc., and Johnson & Johnson Services Inc., emphasizes the symbiotic relationship between rapid technological evolution and comprehensive market strategies. Further, key players such as Kyowa Kirin Co., Ltd., Merck KGaA, Moderna, Inc., Mustang Bio, Inc., Novartis AG, Novo Nordisk A/S, Pfizer, Inc., REGENXBIO Inc., Sangamo Therapeutics, Inc., Sarepta Therapeutics, Inc., Shoreline Biosciences, Sibiono GeneTech Co. Ltd., Syncona Limited, Thermo Fisher Scientific Inc., and Vertex Pharmaceuticals Incorporated help to illustrate the competitive dynamism and technical depth of the market, driving forward advancements that promise to reshape therapeutic landscapes worldwide.

The report delves into recent significant developments in the Cell & Gene Therapy Market, highlighting leading vendors and their innovative profiles. These include AbbVie Inc., Abeona Therapeutics Inc., Adaptimmune Therapeutics PLC, AGC Inc., Alnylam Pharmaceuticals, Inc., American Gene Technologies Inc., Amgen Inc., AnGes, Inc, Astellas Pharma Inc., Becton, Dickinson and Company, Biogen Inc., Bluebird Bio, Inc., BridgeBio Pharma, Inc., Bristol-Myers Squibb Company, C.H. Boehringer Sohn AG & Co. KG, Cellectis SA, CRISPR Therapeutics AG, F. Hoffmann-La Roche AG, Gilead Sciences, Inc., Intellia Therapeutics, Inc., Ionis Pharmaceuticals, Inc., Johnson & Johnson Services Inc., Kyowa Kirin Co., Ltd., Merck KGaA, Moderna, Inc., Mustang Bio, Inc., Novartis AG, Novo Nordisk A/S, Pfizer, Inc., REGENXBIO Inc., Sangamo Therapeutics, Inc., Sarepta Therapeutics, Inc., Shoreline Biosciences, Sibiono GeneTech Co. Ltd., Syncona Limited, Thermo Fisher Scientific Inc., and Vertex Pharmaceuticals Incorporated. Actionable Recommendations for Industry Leaders

Industry leaders are encouraged to embrace innovation by integrating advanced data analytics and digital health platforms to streamline research and development. Given the high complexity of therapeutic modalities, investing in scalable manufacturing and maintaining strong regulatory communications are essential. Leaders should focus on building strategic partnerships that leverage cross-functional expertise and promote shared risk in clinical advancements. An agile approach to commercialization and the incorporation of real-world evidence can greatly enhance market acceptance and patient outcomes. Fostering robust collaborations across academic, clinical, and industrial spectrums will pave the way to a sustainable and competitive future in the evolving therapeutic landscape.

Conclusion: Summarizing the Evolution and Future Prospects

The cell and gene therapy market is undergoing a transformative evolution propelled by significant scientific, regulatory, and technological advancements. A thorough analysis reveals that evolving segmentation strategies, insightful regional trends, and a competitive roster of innovative companies collectively underscore the growth potential of this field. The industry is well positioned to continue transforming the treatment landscape, delivering unprecedented outcomes for patients across diverse therapeutic areas. This report culminates in a clear message; that sustained innovation, strategic investment, and collaborative industry partnerships are essential to navigate the complexities and realize the promise of breakthrough therapies. The insights derived from market analysis not only elucidate current trends but also serve as a roadmap for sustained growth and commercial success in an ever-evolving industry.

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. Increasing prevalence of genetic disorder and rare disease globally
    • 5.1.1.2. Growing awareness and rising demand for personalised medicine
  • 5.1.2. Restraints
    • 5.1.2.1. Complex production processes and quality control issues associated with cell & gene therapy
  • 5.1.3. Opportunities
    • 5.1.3.1. Development of off-the-shelf cell therapies offers scalable solutions for large patient populations
    • 5.1.3.2. Rising collaboration between biotechnology and pharmaceutical companies for enhanced research & development
  • 5.1.4. Challenges
    • 5.1.4.1. Stringent governmental regulation & approval procedures for new gene therapies
• 5.2. Market Segmentation Analysis
  • 5.2.1. Therapy Type: Preference for T cell therapy to target and destroy cancer cells
  • 5.2.2. Delivery Method: Utilization of intramuscular delivery system to reduced invasiveness
  • 5.2.3. Therapeutic Areas: Rising demand of cell & gene therapy in cardiovascular therapeutics for long lasting solutions
  • 5.2.4. Application: Usage of cell & gene therapy in clinical applications to directly treat and prevent diseases by altering genetic makeup
  • 5.2.5. End User: Adoption of cell & gene therapy in hospital & clinics to enhance treatment outcomes and patient satisfaction
• 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 Market, by Therapy Type

• 6.1. Introduction
• 6.2. Cell Therapy
  • 6.2.1. Stem Cell Therapies
    • 6.2.1.1. Hematopoietic Stem Cell Therapies
    • 6.2.1.2. Mesenchymal Stem Cell Therapies
  • 6.2.2. T Cell Therapy
    • 6.2.2.1. CAR T Cell Therapy
    • 6.2.2.2. T Cell Receptor (TCR)-based
• 6.3. Gene Therapy
  • 6.3.1. Ex Vivo Gene Therapy
  • 6.3.2. In Vivo Gene Therapy

7. Cell & Gene Therapy Market, by Delivery Method

• 7.1. Introduction
• 7.2. Intramuscular
• 7.3. Intravenous

8. Cell & Gene Therapy Market, by Therapeutic Areas

• 8.1. Introduction
• 8.2. Cardiovascular
  • 8.2.1. Congestive Heart Failure
  • 8.2.2. Ischemic Heart Disease
• 8.3. Metabolic Disorders
  • 8.3.1. Diabetes
  • 8.3.2. Obesity
• 8.4. Neurological Disorders
  • 8.4.1. Alzheimer's Disease
  • 8.4.2. Huntington's Disease
  • 8.4.3. Multiple Sclerosis
  • 8.4.4. Parkinson's Disease
  • 8.4.5. Spinal Cord Injuries
• 8.5. Oncology
  • 8.5.1. Hematological Malignancies
  • 8.5.2. Lymphomas
  • 8.5.3. Solid Tumors
• 8.6. Ophthalmology

9. Cell & Gene Therapy Market, by Application

• 9.1. Introduction
• 9.2. Clinical Applications
  • 9.2.1. Disease Prevention
  • 9.2.2. Disease Treatment
• 9.3. Research & Development

10. Cell & Gene Therapy Market, by End User

• 10.1. Introduction
• 10.2. Academic & Research Institutes
  • 10.2.1. Private Research Labs
  • 10.2.2. Universities
• 10.3. Hospitals & Clinics

11. Americas Cell & Gene Therapy Market

• 11.1. Introduction
• 11.2. Argentina
• 11.3. Brazil
• 11.4. Canada
• 11.5. Mexico
• 11.6. United States

12. Asia-Pacific Cell & Gene Therapy Market

• 12.1. Introduction
• 12.2. Australia
• 12.3. China
• 12.4. India
• 12.5. Indonesia
• 12.6. Japan
• 12.7. Malaysia
• 12.8. Philippines
• 12.9. Singapore
• 12.10. South Korea
• 12.11. Taiwan
• 12.12. Thailand
• 12.13. Vietnam

13. Europe, Middle East & Africa Cell & Gene Therapy Market

• 13.1. Introduction
• 13.2. Denmark
• 13.3. Egypt
• 13.4. Finland
• 13.5. France
• 13.6. Germany
• 13.7. Israel
• 13.8. Italy
• 13.9. Netherlands
• 13.10. Nigeria
• 13.11. Norway
• 13.12. Poland
• 13.13. Qatar
• 13.14. Russia
• 13.15. Saudi Arabia
• 13.16. South Africa
• 13.17. Spain
• 13.18. Sweden
• 13.19. Switzerland
• 13.20. Turkey
• 13.21. United Arab Emirates
• 13.22. United Kingdom

14. Competitive Landscape

• 14.1. Market Share Analysis, 2023
• 14.2. FPNV Positioning Matrix, 2023
• 14.3. Competitive Scenario Analysis
  • 14.3.1. Novartis acquires Kate Therapeutics to advance gene therapies for neuromuscular diseases
  • 14.3.2. Cellular Origins and Fresenius Kabi sign agreement for automated cell and gene therapy manufacturing
  • 14.3.3. Astellas and AviadoBio exclusive license agreement for AVB-101 gene therapy targeting frontotemporal dementia
  • 14.3.4. Virica Biotech and Ginkgo Bioworks partner to enhance AAV gene therapy production
  • 14.3.5. McKesson launches InspiroGene to enhance cell and gene therapy commercialization
  • 14.3.6. ArsenalBio secures USD 325m for advanced CRISPR T cell therapies targeting solid tumors
  • 14.3.7. Genezen acquires uniQure's Lexington facility to enhance gene therapy manufacturing capabilities
  • 14.3.8. Charles River expands gene therapy collaboration with NUS Medicine to enhance engineered stem cell cancer treatments
  • 14.3.9. AstraZeneca completes acquisition of Gracell Biotechnologies to enhance cell therapy portfolio
  • 14.3.10. AbbVie and Umoja Biopharma collaborate to innovate in-situ CAR-T cell therapies
• 14.4. Strategy Analysis & Recommendation
  • 14.4.1. Amgen Inc.
  • 14.4.2. F. Hoffmann-La Roche AG
  • 14.4.3. Astellas Pharma Inc.
  • 14.4.4. Bristol-Myers Squibb Company

Companies Mentioned

• 1. AbbVie Inc.
• 2. Abeona Therapeutics Inc.
• 3. Adaptimmune Therapeutics PLC
• 4. AGC Inc.
• 5. Alnylam Pharmaceuticals, Inc.
• 6. American Gene Technologies Inc.
• 7. Amgen Inc.
• 8. AnGes, Inc
• 9. Astellas Pharma Inc.
• 10. Becton, Dickinson and Company
• 11. Biogen Inc.
• 12. Bluebird Bio, Inc.
• 13. BridgeBio Pharma, Inc.
• 14. Bristol-Myers Squibb Company
• 15. C.H. Boehringer Sohn AG & Co. KG
• 16. Cellectis SA
• 17. CRISPR Therapeutics AG
• 18. F. Hoffmann-La Roche AG
• 19. Gilead Sciences, Inc.
• 20. Intellia Therapeutics, Inc.
• 21. Ionis Pharmaceuticals, Inc.
• 22. Johnson & Johnson Services Inc.
• 23. Kyowa Kirin Co., Ltd.
• 24. Merck KGaA
• 25. Moderna, Inc.
• 26. Mustang Bio, Inc.
• 27. Novartis AG
• 28. Novo Nordisk A/S
• 29. Pfizer, Inc.
• 30. REGENXBIO Inc.
• 31. Sangamo Therapeutics, Inc.
• 32. Sarepta Therapeutics, Inc.
• 33. Shoreline Biosciences
• 34. Sibiono GeneTech Co. Ltd.
• 35. Syncona Limited
• 36. Thermo Fisher Scientific Inc.
• 37. Vertex Pharmaceuticals Incorporated