세포 및 유전자 치료 시장 - 규모, 점유율, 성장률, 산업 분석 : 유형별, 용도별, 지역별 인사이트 및 예측(2026-2034년)

Growth Factors of cell and gene therapy Market

The global cell and gene therapy market is poised for exceptional growth in the coming decade, driven by advancements in biotechnology, genomics, and molecular biology. According to Fortune Business Insights, the market was valued at USD 13.17 billion in 2025, with projections indicating growth to USD 17.54 billion in 2026 and a remarkable surge to USD 200.54 billion by 2034, reflecting a CAGR of 35.60% during the forecast period. In 2025, North America dominated the market with a 40.10% share, driven by cutting-edge research, established healthcare infrastructure, and strong regulatory support.

Cell and gene therapy focuses on personalized treatments for non-drug treatable diseases, including cancers, rare genetic disorders, and neurological conditions. These therapies involve modifying or replacing defective cells and genes, offering long-term and potentially curative benefits. Collaborations among industry leaders are accelerating product development, with companies such as Bayer AG and GSK plc investing heavily in R&D to expand their pipeline of therapies. For instance, in September 2024, Evotec SE partnered with Novo Nordisk A/s to develop off-the-shelf cell therapy products, highlighting the emphasis on innovation and global collaboration.

Market Dynamics

Drivers

The rising prevalence of cancer and rare genetic disorders is a major market driver. Cell and gene therapies correct genetic mutations or restore cell function in patients with limited treatment options. Advancements in genomic research and personalized medicine further enhance the development of targeted therapies. As per the World Health Organization (August 2025), approximately 7.74 million people globally were living with sickle cell disease in 2021, emphasizing the urgent need for innovative therapies.

Restraints

High manufacturing complexities and costs limit adoption. Personalized therapies require intricate production processes, specialized clinical studies, and rigorous quality control, which increase costs and reduce scalability. For example, Luxturna, a gene therapy for vision loss, costs approximately USD 425,000 per eye, creating financial barriers for patients and healthcare systems.

Opportunities

The development of new therapies for neurodegenerative disorders such as Alzheimer's, Parkinson's, and ALS represents significant growth potential. Companies are leveraging gene editing techniques to address underlying disease causes. In January 2025, Bayer AG and BlueRock Therapeutics LP initiated the bemdaneprocel Phase III trial, an investigational cell therapy for Parkinson's disease, signaling transformative opportunities in neurodegenerative treatment.

Challenges

The market faces a shortage of skilled professionals, including scientists, clinicians, and technical staff, required to develop and manufacture therapies. As per the International Society for Cell & Gene Therapy (ISCT, September 2025), only 35% of technical positions were adequately staffed, indicating a workforce gap that may impede growth.

Market Trends

A key trend is the increasing focus on CRISPR-based precision medicine. CRISPR enables precise gene editing, improving therapy efficacy and safety for genetic disorders. In May 2024, NIH-supported researchers developed a CRISPR-based therapy for carbamoyl phosphate synthetase 1 (CPS1) deficiency, demonstrating the technology's versatility for rare genetic diseases.

Segmentation Analysis

By Type

• Cell therapy dominated the market in 2026 with a 70.35% share, driven by targeted therapies for cancers and increased regulatory approvals. For example, Tecelra, a T-cell receptor therapy, received FDA approval in August 2024 for metastatic synovial sarcoma.
• Gene therapy held the second-leading share in 2024, focusing on various product types, vector types, and indications.

By End User

• Hospitals & clinics led with a 55.59% share in 2026, as these specialized therapies require skilled administration and are often part of collaborative development programs.
• Specialty clinics are projected to grow at a CAGR of 36.99%, reflecting increased access and adoption.

Regional Outlook

• North America: USD 5.27 billion in 2025, USD 7 billion in 2026, driven by advanced research and healthcare infrastructure; the U.S. accounted for USD 6.52 billion in 2026.
• Europe: Expected to reach USD 6.15 billion in 2026, with the U.K., Germany, and France valued at USD 1 billion, USD 1.5 billion, and USD 0.79 billion, respectively.
• Asia Pacific: Projected at USD 2.67 billion in 2026, with India and China at USD 0.22 billion and USD 0.96 billion.
• Latin America: USD 1.12 billion in 2026.
• Middle East & Africa (GCC): USD 0.26 billion in 2025.

Competitive Landscape

The market is consolidated, dominated by Novartis AG, Gilead Sciences, Inc., and Bayer AG, offering diverse CGT products and expanding globally through R&D and strategic collaborations. Other major players include Rocket Pharmaceuticals, Bristol-Myers Squibb, Krystal Biotech, Vertex Pharmaceuticals, and CRISPR Therapeutics. Key developments include FDA approvals for advanced therapies, new CAR-T cell therapies, and partnerships to strengthen onshore manufacturing.

Conclusion

The global cell and gene therapy market is projected to grow from USD 13.17 billion in 2025 to USD 200.54 billion by 2034, reflecting rapid adoption of targeted, personalized therapies for cancer, genetic, and neurodegenerative diseases. Despite challenges such as high costs and skilled workforce shortages, innovations in CRISPR-based therapies, cell engineering, and collaborative R&D are expected to drive unprecedented market expansion.

Segmentation By Type

• Cell Therapy
  • Therapy Type
• CAR-T Cell Therapy
• TCR-T Cell Therapy
• Natural Killer (NK) Cells
• Others
  • Product Type
• Kymriah
• Yescarta
• Tecartus
• Breyanzi
• Abecma
• Carvykti
• Others
  • Indication
• Oncology
• Others
• Gene Therapy
  • Product Type
• Zolgensma
• Luxturna
• Roctavian
• Others
  • Vector Type
• Viral Vectors
• Non-Viral Vectors
  • Indication
• Genetic Disorders
• Ophthalmology
• Hematology
• Others

By End User

• Hospitals & Clinics
• Specialty Clinics
• Others

By Geography

• North America (By Type, End User, and Country)
  • U.S.
  • Canada
• Europe (By Type, End User, and Country/Sub-region)
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • Scandinavia
  • Rest of Europe
• Asia Pacific (By Type, End User, and Country/Sub-region)
  • China
  • Japan
  • India
  • Australia
  • Southeast Asia
  • Rest of Asia Pacific
• Latin America (By Type, End User, and Country/Sub-region)
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East & Africa (By Type, End User, and Country/Sub-region)
  • GCC
  • South Africa
  • Rest of the Middle East & Africa

Table of Content

1. Introduction

• 1.1. Research Scope
• 1.2. Market Segmentation
• 1.3. Research Methodology
• 1.4. Definitions and Assumptions

2. Executive Summary

3. Market Dynamics

• 3.1. Market Drivers
• 3.2. Market Restraints
• 3.3. Market Opportunities
• 3.4. Market Trends

4. Key Insights

• 4.1. Development of Cell and Gene Therapy for New Disease Indications
• 4.2. Regulatory Scenarios, By Key Countries/Regions
• 4.3. Technological Advancements in the Market
• 4.4. New Product Launches, By Key Players
• 4.5. Pipeline Analysis, By Key Companies
• 4.6. Key Industry Developments (Mergers, Acquisitions, Partnerships, Launches, and Others)
• 4.7. Pricing & Reimbursement Landscape in the Market
• 4.8. Manufacturing & Supply Chain Insights
• 4.9. Investment & Funding Trends in the Market
• 4.10. Overview: Patient Access to the Therapy & Ethical Considerations

5. Global Cell and Gene Therapy Market Analysis, Insights and Forecast, 2021-2034

• 5.1. Market Analysis, Insights and Forecast - By Type
  • 5.1.1. Cell Therapy
    • 5.1.1.1. Therapy Type
      • 5.1.1.1.1. CAR-T Cell Therapy
      • 5.1.1.1.2. TCR-T Cell Therapy
      • 5.1.1.1.3. Natural Killer (NK) Cells
      • 5.1.1.1.4. Others
    • 5.1.1.2. Product Type
      • 5.1.1.2.1. Kymriah
      • 5.1.1.2.2. Yescarta
      • 5.1.1.2.3. Tecartus
      • 5.1.1.2.4. Breyanzi
      • 5.1.1.2.5. Abecma
      • 5.1.1.2.6. Carvykti
      • 5.1.1.2.7. Others
    • 5.1.1.3. Indication
      • 5.1.1.3.1. Oncology
      • 5.1.1.3.2. Others
  • 5.1.2. Gene Therapy
    • 5.1.2.1. Product Type
      • 5.1.2.1.1. Zolgensma
      • 5.1.2.1.2. Luxturna
      • 5.1.2.1.3. Roctavian
      • 5.1.2.1.4. Others
    • 5.1.2.2. Vector Type
      • 5.1.2.2.1. Viral Vectors
      • 5.1.2.2.2. Non-Viral Vectors
    • 5.1.2.3. Indication
      • 5.1.2.3.1. Genetic Disorders
      • 5.1.2.3.2. Ophthalmology
      • 5.1.2.3.3. Hematology
      • 5.1.2.3.4. Others
• 5.2. Market Analysis, Insights and Forecast - By End User
  • 5.2.1. Hospitals & Clinics
  • 5.2.2. Specialty Clinics
  • 5.2.3. Others
• 5.3. Market Analysis, Insights and Forecast - Region
  • 5.3.1. North America
  • 5.3.2. Europe
  • 5.3.3. Asia Pacific
  • 5.3.4. Latin America
  • 5.3.5. Middle East & Africa

6. North America Cell and Gene Therapy Market Analysis, Insights and Forecast, 2021-2034

• 6.1. Market Analysis, Insights and Forecast - By Type
  • 6.1.1. Cell Therapy
    • 6.1.1.1. Therapy Type
      • 6.1.1.1.1. CAR-T Cell Therapy
      • 6.1.1.1.2. TCR-T Cell Therapy
      • 6.1.1.1.3. Natural Killer (NK) Cells
      • 6.1.1.1.4. Others
    • 6.1.1.2. Product Type
      • 6.1.1.2.1. Kymriah
      • 6.1.1.2.2. Yescarta
      • 6.1.1.2.3. Tecartus
      • 6.1.1.2.4. Breyanzi
      • 6.1.1.2.5. Abecma
      • 6.1.1.2.6. Carvykti
      • 6.1.1.2.7. Others
    • 6.1.1.3. Indication
      • 6.1.1.3.1. Oncology
      • 6.1.1.3.2. Others
  • 6.1.2. Gene Therapy
    • 6.1.2.1. Product Type
      • 6.1.2.1.1. Zolgensma
      • 6.1.2.1.2. Luxturna
      • 6.1.2.1.3. Roctavian
      • 6.1.2.1.4. Others
    • 6.1.2.2. Vector Type
      • 6.1.2.2.1. Viral Vectors
      • 6.1.2.2.2. Non-Viral Vectors
    • 6.1.2.3. Indication
      • 6.1.2.3.1. Genetic Disorders
      • 6.1.2.3.2. Ophthalmology
      • 6.1.2.3.3. Hematology
      • 6.1.2.3.4. Others
• 6.2. Market Analysis, Insights and Forecast - By End User
  • 6.2.1. Hospitals & Clinics
  • 6.2.2. Specialty Clinics
  • 6.2.3. Others
• 6.3. Market Analysis, Insights and Forecast - By Country
  • 6.3.1. U.S.
  • 6.3.2. Canada

7. Europe Cell and Gene Therapy Market Analysis, Insights and Forecast, 2021-2034

• 7.1. Market Analysis, Insights and Forecast - By Type
  • 7.1.1. Cell Therapy
    • 7.1.1.1. Therapy Type
      • 7.1.1.1.1. CAR-T Cell Therapy
      • 7.1.1.1.2. TCR-T Cell Therapy
      • 7.1.1.1.3. Natural Killer (NK) Cells
      • 7.1.1.1.4. Others
    • 7.1.1.2. Product Type
      • 7.1.1.2.1. Kymriah
      • 7.1.1.2.2. Yescarta
      • 7.1.1.2.3. Tecartus
      • 7.1.1.2.4. Breyanzi
      • 7.1.1.2.5. Abecma
      • 7.1.1.2.6. Carvykti
      • 7.1.1.2.7. Others
    • 7.1.1.3. Indication
      • 7.1.1.3.1. Oncology
      • 7.1.1.3.2. Others
  • 7.1.2. Gene Therapy
    • 7.1.2.1. Product Type
      • 7.1.2.1.1. Zolgensma
      • 7.1.2.1.2. Luxturna
      • 7.1.2.1.3. Roctavian
      • 7.1.2.1.4. Others
    • 7.1.2.2. Vector Type
      • 7.1.2.2.1. Viral Vectors
      • 7.1.2.2.2. Non-Viral Vectors
    • 7.1.2.3. Indication
      • 7.1.2.3.1. Genetic Disorders
      • 7.1.2.3.2. Ophthalmology
      • 7.1.2.3.3. Hematology
      • 7.1.2.3.4. Others
• 7.2. Market Analysis, Insights and Forecast - By End User
  • 7.2.1. Hospitals & Clinics
  • 7.2.2. Specialty Clinics
  • 7.2.3. Others
• 7.3. Market Analysis, Insights and Forecast - By Country/ Sub-Region
  • 7.3.1. Germany
  • 7.3.2. U.K.
  • 7.3.3. France
  • 7.3.4. Italy
  • 7.3.5. Spain
  • 7.3.6. Scandinavia
  • 7.3.7. Rest of Europe

8. Asia Pacific Cell and Gene Therapy Market Analysis, Insights and Forecast, 2021-2034

• 8.1. Market Analysis, Insights and Forecast - By Type
  • 8.1.1. Cell Therapy
    • 8.1.1.1. Therapy Type
      • 8.1.1.1.1. CAR-T Cell Therapy
      • 8.1.1.1.2. TCR-T Cell Therapy
      • 8.1.1.1.3. Natural Killer (NK) Cells
      • 8.1.1.1.4. Others
    • 8.1.1.2. Product Type
      • 8.1.1.2.1. Kymriah
      • 8.1.1.2.2. Yescarta
      • 8.1.1.2.3. Tecartus
      • 8.1.1.2.4. Breyanzi
      • 8.1.1.2.5. Abecma
      • 8.1.1.2.6. Carvykti
      • 8.1.1.2.7. Others
    • 8.1.1.3. Indication
      • 8.1.1.3.1. Oncology
      • 8.1.1.3.2. Others
  • 8.1.2. Gene Therapy
    • 8.1.2.1. Product Type
      • 8.1.2.1.1. Zolgensma
      • 8.1.2.1.2. Luxturna
      • 8.1.2.1.3. Roctavian
      • 8.1.2.1.4. Others
    • 8.1.2.2. Vector Type
      • 8.1.2.2.1. Viral Vectors
      • 8.1.2.2.2. Non-Viral Vectors
    • 8.1.2.3. Indication
      • 8.1.2.3.1. Genetic Disorders
      • 8.1.2.3.2. Ophthalmology
      • 8.1.2.3.3. Hematology
      • 8.1.2.3.4. Others
• 8.2. Market Analysis, Insights and Forecast - By End User
  • 8.2.1. Hospitals & Clinics
  • 8.2.2. Specialty Clinics
  • 8.2.3. Others
• 8.3. Market Analysis, Insights and Forecast - By Country/ Sub-Region
  • 8.3.1. China
  • 8.3.2. Japan
  • 8.3.3. India
  • 8.3.4. Australia
  • 8.3.5. Southeast Asia
  • 8.3.6. Rest of Asia Pacific

9. Latin America Cell and Gene Therapy Market Analysis, Insights and Forecast, 2021-2034

• 9.1. Market Analysis, Insights and Forecast - By Type
  • 9.1.1. Cell Therapy
    • 9.1.1.1. Therapy Type
      • 9.1.1.1.1. CAR-T Cell Therapy
      • 9.1.1.1.2. TCR-T Cell Therapy
      • 9.1.1.1.3. Natural Killer (NK) Cells
      • 9.1.1.1.4. Others
    • 9.1.1.2. Product Type
      • 9.1.1.2.1. Kymriah
      • 9.1.1.2.2. Yescarta
      • 9.1.1.2.3. Tecartus
      • 9.1.1.2.4. Breyanzi
      • 9.1.1.2.5. Abecma
      • 9.1.1.2.6. Carvykti
      • 9.1.1.2.7. Others
    • 9.1.1.3. Indication
      • 9.1.1.3.1. Oncology
      • 9.1.1.3.2. Others
  • 9.1.2. Gene Therapy
    • 9.1.2.1. Product Type
      • 9.1.2.1.1. Zolgensma
      • 9.1.2.1.2. Luxturna
      • 9.1.2.1.3. Roctavian
      • 9.1.2.1.4. Others
    • 9.1.2.2. Vector Type
      • 9.1.2.2.1. Viral Vectors
      • 9.1.2.2.2. Non-Viral Vectors
    • 9.1.2.3. Indication
      • 9.1.2.3.1. Genetic Disorders
      • 9.1.2.3.2. Ophthalmology
      • 9.1.2.3.3. Hematology
      • 9.1.2.3.4. Others
• 9.2. Market Analysis, Insights and Forecast - By End User
  • 9.2.1. Hospitals & Clinics
  • 9.2.2. Specialty Clinics
  • 9.2.3. Others
• 9.3. Market Analysis, Insights and Forecast - By Country/ Sub-Region
  • 9.3.1. Brazil
  • 9.3.2. Mexico
  • 9.3.3. Rest of Latin America

10. Middle East & Africa Cell and Gene Therapy Market Analysis, Insights and Forecast, 2021-2034

• 10.1. Market Analysis, Insights and Forecast - By Type
  • 10.1.1. Cell Therapy
    • 10.1.1.1. Therapy Type
      • 10.1.1.1.1. CAR-T Cell Therapy
      • 10.1.1.1.2. TCR-T Cell Therapy
      • 10.1.1.1.3. Natural Killer (NK) Cells
      • 10.1.1.1.4. Others
    • 10.1.1.2. Product Type
      • 10.1.1.2.1. Kymriah
      • 10.1.1.2.2. Yescarta
      • 10.1.1.2.3. Tecartus
      • 10.1.1.2.4. Breyanzi
      • 10.1.1.2.5. Abecma
      • 10.1.1.2.6. Carvykti
      • 10.1.1.2.7. Others
    • 10.1.1.3. Indication
      • 10.1.1.3.1. Oncology
      • 10.1.1.3.2. Others
  • 10.1.2. Gene Therapy
    • 10.1.2.1. Product Type
      • 10.1.2.1.1. Zolgensma
      • 10.1.2.1.2. Luxturna
      • 10.1.2.1.3. Roctavian
      • 10.1.2.1.4. Others
    • 10.1.2.2. Vector Type
      • 10.1.2.2.1. Viral Vectors
      • 10.1.2.2.2. Non-Viral Vectors
    • 10.1.2.3. Indication
      • 10.1.2.3.1. Genetic Disorders
      • 10.1.2.3.2. Ophthalmology
      • 10.1.2.3.3. Hematology
      • 10.1.2.3.4. Others
• 10.2. Market Analysis, Insights and Forecast - By End User
  • 10.2.1. Hospitals & Clinics
  • 10.2.2. Specialty Clinics
  • 10.2.3. Others
• 10.3. Market Analysis, Insights and Forecast - By Country/ Sub-Region
  • 10.3.1. GCC
  • 10.3.2. South Africa
  • 10.3.3. Rest of Middle East & Africa

11. Competitive Analysis

• 11.1. Global Market Share Analysis (2025)
• 11.2. Company Profiles (Overview, Products, SWOT analysis, Recent developments, strategies, financials (based on availability))
  • 11.2.1. Vertex Pharmaceuticals Incorporated
  • 11.2.2. Krystal Biotech, Inc.
  • 11.2.3. Rocket Pharmaceuticals
  • 11.2.4. CRISPR Therapeutics
  • 11.2.5. Bayer AG
  • 11.2.6. Novartis AG
  • 11.2.7. Gilead Sciences, Inc.
  • 11.2.8. F. Hoffmann-La Roche Ltd (Spark Therapeutics)
  • 11.2.9. Bristol-Myers Squibb Company
  • 11.2.10. Adaptimmune