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

Growth Factors of Cell and Gene Therapy Market

The global Cell and Gene Therapy Market was valued at USD 12.21 billion in 2025 and is projected to grow from USD 16.45 billion in 2026 to USD 143.55 billion by 2034, registering a remarkable CAGR of 31.10% during the forecast period. North America dominated the market with a 52.58% market share in 2025, supported by strong biotechnology infrastructure, favorable regulatory frameworks, and increasing commercialization of advanced therapies.

Cell and gene therapies represent a transformative approach to treating cancer, rare genetic disorders, and chronic diseases by targeting the underlying causes of disease rather than merely managing symptoms. The market is entering a more mature growth phase as approved products continue to increase and companies focus on manufacturing scalability, patient access, reimbursement strategies, and commercialization.

Major companies such as Vertex Pharmaceuticals, Novartis, Bristol Myers Squibb, Gilead Sciences, Krystal Biotech, CRISPR Therapeutics, and Roche are investing heavily in research, strategic partnerships, acquisitions, and manufacturing expansion to strengthen their market presence.

Market Drivers

The growing prevalence of rare genetic diseases, cancer, and chronic conditions is a major factor driving market growth. Traditional treatment options often fail to address the root causes of these diseases, creating strong demand for innovative gene-editing and cell-based therapies.

Increasing success of CAR-T therapies, gene replacement technologies, CRISPR-based treatments, and regenerative medicine solutions is accelerating adoption globally. Furthermore, rising investments in manufacturing infrastructure and clinical development activities are supporting long-term market expansion.

Market Trends

A major trend shaping the industry is the transition toward allogeneic and off-the-shelf therapies. Unlike autologous therapies that use a patient's own cells, allogeneic therapies can be manufactured in advance and supplied on demand.

This approach offers several advantages:

• Improved treatment availability
• Reduced manufacturing timelines
• Better scalability
• Lower production costs
• Simplified distribution networks

As a result, pharmaceutical companies are increasingly investing in next-generation allogeneic platforms and automated manufacturing technologies.

Market Restraints

Despite strong growth prospects, high treatment costs and reimbursement challenges remain significant barriers. Cell and gene therapies often require highly specialized manufacturing processes, complex logistics, and extensive patient monitoring, leading to exceptionally high treatment costs.

Many healthcare providers and insurance companies continue to evaluate long-term efficacy before approving broad reimbursement coverage, limiting patient access in some regions.

Market Opportunities

Growing investments in manufacturing facilities and automation systems are creating substantial growth opportunities. Expansion of large-scale production capacity will help reduce bottlenecks, improve supply chain efficiency, and support broader commercialization of advanced therapies.

Several leading pharmaceutical companies are investing billions of dollars in next-generation manufacturing facilities to support future demand.

Market Challenges

One of the biggest challenges facing the industry is scaling autologous therapies. Since each therapy is produced using cells collected from individual patients, manufacturing remains complex, time-sensitive, and expensive.

Ensuring consistent quality, timely delivery, and commercial-scale production remains a critical challenge that companies must overcome to expand patient access globally.

Segmentation Analysis

By Type

The Cell Therapy segment dominated the market in 2025 due to the strong commercial success of CAR-T therapies and growing physician confidence in cell-based treatments.

Several approved products have already established a significant market presence in oncology and hematologic cancers, driving segment leadership.

The Gene Therapy segment is expected to grow at a CAGR of 21.97% during the forecast period as gene-editing technologies continue to advance and gain regulatory approvals.

By End User

The Hospitals & Clinics segment accounted for the largest market share in 2025. These facilities possess the specialized infrastructure, trained personnel, and patient monitoring capabilities required for administering complex cell and gene therapies.

The Specialty Clinics segment is projected to grow at the fastest CAGR of 32.79% through 2034 due to increasing specialization in regenerative medicine and advanced therapeutic delivery.

Regional Insights

North America

North America remained the largest regional market with a value of USD 6.42 billion in 2025.

Key growth factors include:

• Strong biotechnology ecosystem
• High healthcare spending
• Robust clinical trial activity
• Favorable regulatory support

U.S. Market (2026): USD 7.95 billion

Europe

Europe is projected to reach USD 4.47 billion in 2026, supported by rising chronic disease prevalence, an aging population, and increasing adoption of advanced therapies.

• Germany: USD 1.09 billion (2026)
• U.K.: USD 0.72 billion (2026)

Asia Pacific

Asia Pacific is expected to reach USD 2.18 billion in 2026, driven by expanding healthcare infrastructure, increasing research investments, and growing adoption of regenerative medicine.

• China: USD 0.79 billion (2026)
• Japan: USD 0.44 billion (2026)
• India: USD 0.18 billion (2026)

Competitive Landscape

The market is highly consolidated, with leading players focusing on product development, strategic collaborations, acquisitions, and manufacturing expansion.

Key companies include:

• Vertex Pharmaceuticals
• Novartis
• Bristol Myers Squibb
• Gilead Sciences
• Roche
• Bayer
• CRISPR Therapeutics
• Adaptimmune

Recent industry developments include strategic collaborations, CAR-T therapy advancements, manufacturing investments, and acquisitions aimed at accelerating commercialization and expanding treatment accessibility.

Conclusion

The Cell and Gene Therapy Market is entering a period of unprecedented expansion, driven by rapid technological innovation, increasing regulatory approvals, and growing demand for curative treatments. The market is forecast to grow from USD 12.21 billion in 2025 to USD 143.55 billion by 2034, making it one of the fastest-growing segments within the global biopharmaceutical industry. As manufacturing capabilities improve, reimbursement frameworks evolve, and allogeneic therapies gain traction, the market is expected to unlock significant opportunities across oncology, rare diseases, regenerative medicine, and personalized healthcare.

Segmentation By Type, End User, and Region

By Type * Cell Therapy

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

By End User * Hospitals & Clinics

• Specialty Clinics
• Others

By Region * 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 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
      • 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 Diseases
      • 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
      • 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 Diseases
      • 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
      • 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 Diseases
      • 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
      • 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 Diseases
      • 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
      • 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 Diseases
      • 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
      • 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 Diseases
      • 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
  • 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