세계의 세포 및 유전자 치료 시장 : 치료 유형별, 벡터별, 제조 방법별, 최종사용자별, 지역별 - 시장 규모, 산업 역학, 기회 분석, 예측(2025-2035년)

The cell and gene therapy market is demonstrating a robust and accelerating growth trajectory, with its value reaching an estimated US$ 36.5 billion in 2024. This impressive market size reflects the rapid adoption and expanding applications of these advanced therapies across a range of medical conditions. Looking ahead, projections indicate that the market will soar to an estimated valuation of US$ 183.1 billion by 2035, representing a compound annual growth rate (CAGR) of 17.5% during the forecast period from 2026 to 2035.

Several key factors are driving this upward curve. Technological innovation remains at the forefront, with ongoing advances in gene editing, vector development, and manufacturing processes enabling more effective, safer, and scalable therapies. These breakthroughs are expanding the range of treatable diseases and improving clinical outcomes, thereby enhancing both patient access and market potential. Additionally, the persistent unmet medical needs in chronic and rare diseases continue to fuel demand for novel treatment options.

Noteworthy Market Developments

The cell and gene therapy market is led by major players such as Novartis, Gilead (through its Kite subsidiary), Pfizer, Bluebird Bio, and Amgen. Although the market is semi-consolidated, it remains highly competitive, with companies actively engaging in strategic partnerships and exploring innovative financing models to manage the high costs associated with advanced therapies. One notable example is the use of outcomes-based agreements (OBAs), which link payment to the real-world performance of therapies like CAR-T treatments, including well-known products such as Yescarta and Zolgensma.

In December 2025, the industry witnessed a significant collaboration as SCTbio and Fortrea announced a strategic partnership aimed at accelerating the development and delivery of cell and gene therapies. This collaboration highlights the growing trend of alliances designed to combine expertise, expand manufacturing capabilities, and streamline the path from research to patient access.

Meanwhile, Thermo Fisher Scientific Inc., a global leader in scientific innovation, marked a major milestone in November 2025 by officially opening its East Coast flagship Advanced Therapies Collaboration Center (ATxCC) in Philadelphia. This facility represents the company's second ATxCC in the United States, complementing its existing center in Carlsbad, California.

In October 2025, Lonza further strengthened its position in the market by launching two new TheraPEAK(R) products: AmpliCell(R) Cytokines and TheraPEAK(R) 293-GT(R) Medium. These GMP-compliant tools are designed to enhance consistency and biological relevance across the entire research and manufacturing continuum.

Core Growth Drivers

The rapid and tremendous growth of the cell and gene therapy market is fueling a substantial expansion in manufacturing capabilities, alongside the development of a robust Contract Development and Manufacturing Organization (CDMO) ecosystem. As an increasing number of therapies advance through clinical trials and move closer to commercialization, the demand for specialized production facilities that comply with Good Manufacturing Practices (GMP) has become critically important. Ensuring that manufacturing processes meet stringent quality and safety standards is essential for the successful delivery of these complex therapies to patients.

Emerging Opportunity Trends

In vivo gene editing has emerged as a transformative trend in the field of genetic medicine, fundamentally changing how therapeutic interventions are delivered. Unlike traditional approaches that involve removing cells from a patient's body, modifying them externally, and then reintroducing them, in vivo gene editing allows for direct alterations to a patient's DNA within their body. This method simplifies the treatment process by eliminating the need for complex cell extraction and reinfusion procedures, thereby making therapy administration more straightforward and accessible. The logistical advantages of in vivo gene editing are significant. Treatments can be delivered more efficiently, reducing the time and resources required to prepare and administer therapy.

Barriers to Optimization

A decline in global private funding for cell and gene therapy presents a significant challenge to the market's growth trajectory. Private investment plays a critical role in driving innovation and progression within this sector, particularly because many advancements rely heavily on early-stage research and development. When capital inflows from venture capitalists, private equity firms, and other private sources diminish, companies face substantial obstacles in securing the necessary resources to fund their research pipelines, conduct clinical trials, and bring new therapies to market. This reduction in funding can slow down the pace of scientific discovery and delay the transition of promising therapies from the laboratory to commercial availability.

Detailed Market Segmentation

By Therapy Type, the cell therapy segment captured a significant portion of the revenue share in the cell and gene therapy market in 2024, solidifying its leadership position within the industry. This dominance is largely attributable to a surge of regulatory approvals and increased investment fueling the rapid development and commercialization of cell-based treatments. The approval of new therapies by regulatory agencies not only validates the safety and efficacy of these innovative products but also encourages further research and confidence among investors, healthcare providers, and patients.

By Indication / Therapeutic Area, the infectious disease segment is projected to command the largest market share within the cell and gene therapy industry, reflecting the expanding application of these advanced therapeutic approaches in combating a wide array of infectious conditions. The increasing burden of infectious diseases worldwide, including viral, bacterial, and parasitic infections, has driven a surge in demand for innovative treatments that can effectively target pathogens and enhance immune responses. Cell and gene therapies offer promising solutions by enabling precise interventions at the molecular and cellular levels, which traditional treatments often cannot achieve.

By Vector Type (Gene Delivery Method), the in vivo delivery method dominated in 2024 by capturing the largest revenue share. This prominence is primarily attributed to its high efficiency and versatility, which make it suitable for a broad range of therapeutic applications. Unlike ex vivo methods, where cells are modified outside the body and then reintroduced, in vivo delivery involves directly administering genetic material into the patient's body. This approach simplifies the treatment process, reduces logistical challenges, and holds promise for treating a wider variety of diseases, including those affecting tissues and organs that are difficult to access externally.

By end-users, the cancer care centers hold the lion's share of the cell and gene therapy market, reflecting the high concentration of cancer treatments within this specialized healthcare segment. These centers are at the forefront of adopting advanced therapies as oncologists increasingly integrate cell and gene therapies into their treatment protocols. The growing prevalence of cancer worldwide, coupled with advancements in personalized medicine, has made these therapies a cornerstone for addressing complex and aggressive malignancies that were previously difficult to treat effectively.

Segment Breakdown

By Therapy Type

• Cell Therapy
• Stem Cell Therapy
• T-Cells
• Dendritic Cells
• NK Cells
• Gene Therapy
• In-vivGene Therapy
• Ex-vivGene Therapy
• Gene Editing Therapies
• RNA-Based Therapies
• Others

By Indication / Therapeutic Area

• Oncology
• Solid Tumors
• Genetic Disorders
• Neurological Disorders
• Cardiovascular Diseases
• Ophthalmology
• Musculoskeletal / Orthopedic Disorders
• Infectious Diseases
• Metabolic Disorders
• Others

By Vector Type (Gene Delivery Method)

• Viral Vectors
• Adeno-Associated Virus (AAV)
• Lentivirus
• Retrovirus
• Herpes Simplex Virus (HSV)
• Adenovirus
• Others
• Non-Viral Vectors
• Lipid Nanoparticles (LNPs)
• Naked DNA/RNA Plasmids
• Electroporation
• Gene gun/microinjection
• CRISPR-Cas Delivery Systems (non-viral)
• Others

By Manufacturing Type

• In-house
• Contract Development & Manufacturing Organizations (CDMOs)
• Hybrid Models (e.g., early stage in-house, scale-up outsourced)
• Others

By End User

• Hospitals and Specialty Clinics
• Academic and Research Institutes
• Biopharma and Biotech Companies
• CDMOs and CROS
• Government/Public Health Bodies
• Others

By Region

• North America
• The US
• Canada
• Mexico
• Europe
• Western Europe
• The UK
• Germany
• France
• Italy
• Spain
• Rest of Western Europe
• Eastern Europe
• Poland
• Russia
• Rest of Eastern Europe
• Asia Pacific
• China
• India
• Japan
• Australia and New Zealand
• South Korea
• ASEAN
• Rest of Asia Pacific
• Middle East and Africa
• Saudi Arabia
• South Africa
• UAE
• Rest of MEA
• South America
• Argentina
• Brazil
• Rest of South America

Geography Breakdown

• North America commands a dominant position in the global market, holding over 39.50% of the total share. This leadership is largely driven by the region's strong and unparalleled innovation ecosystem, which fosters cutting-edge research and rapid development across various advanced fields. The region's regulatory environment, particularly in the United States, plays a crucial role in sustaining this momentum. In 2024, the U.S. Food and Drug Administration (FDA) approved nine new cell and gene therapy products, demonstrating a forward-looking and supportive stance toward emerging biotechnologies.
• This positive regulatory climate has spurred an expansive research pipeline, with more than 2,500 active Investigational New Drug (IND) applications for cell and gene therapies currently filed with the FDA. Such a high volume of ongoing research initiatives reflects both the scientific community's enthusiasm and the regulatory agency's willingness to facilitate innovation. The robust pipeline not only signals future market growth but also attracts significant investment and talent to the region.

Leading Market Participants

• ALLOGENE THERAPEUTICS
• Amgen Inc.
• Astellas Pharma Inc.
• Atara Biotherapeutics, Inc.
• Bayer AG
• Biomarin
• Bluebird Bio, Inc.
• Bristol-Myers Squibb Company
• Celgene Corporation
• Cellectis
• Gilead Sciences, Inc.
• Hoffmann-La Roche Ltd
• ImmunoACT
• Johnson & Johnson
• Krystal Biotech, Inc
• Novartis AG
• Orchard Therapeutics plc
• Sana Biotechnology
• uniQure NV.
• Vericel Corporation
• Other Prominent Players

Table of Content

Chapter 1. Executive Summary: Global Cell And Gene Therapy Market

Chapter 2. Report Description

• 2.1. Research Framework
  • 2.1.1. Research Objective
  • 2.1.2. Market Definitions
  • 2.1.3. Market Segmentation
• 2.2. Research Methodology
  • 2.2.1. Market Size Estimation
  • 2.2.2. Qualitative Research
    • 2.2.2.1. Primary & Secondary Sources
  • 2.2.3. Quantitative Research
    • 2.2.3.1. Primary & Secondary Sources
  • 2.2.4. Breakdown of Primary Research Respondents, By Region
  • 2.2.5. Data Triangulation
  • 2.2.6. Assumption for Study

Chapter 3. Global Cell And Gene Therapy Market Overview

• 3.1. Industry Value Chain Analysis
  • 3.1.1. Material Provider
  • 3.1.2. Manufacturer
  • 3.1.3. Distributor
  • 3.1.4. End User
• 3.2. Industry Outlook
  • 3.2.1. Global Cell And Gene Therapy Market, 2020-2035 (in US$ Mn)
  • 3.2.2. Overview of Cell and Gene Therapy: Market and Regional Developments
• 3.3. PESTLE Analysis
• 3.4. Porter's Five Forces Analysis
  • 3.4.1. Bargaining Power of Suppliers
  • 3.4.2. Bargaining Power of Buyers
  • 3.4.3. Threat of Substitutes
  • 3.4.4. Threat of New Entrants
  • 3.4.5. Degree of Competition
• 3.5. Market Growth and Outlook
  • 3.5.1. Market Revenue Estimates and Forecast (US$ Mn), 2020-2035
  • 3.5.2. Price Trend Analysis, By Therapy Type
• 3.6. Market Attractiveness Analysis
  • 3.6.1. By Therapy Type
  • 3.6.2. By Region
  • 3.6.3. Actionable Insights (Analyst's Recommendations)

Chapter 4. Competition Dashboard

• 4.1. Market Concentration Rate
• 4.2. Company Market Share Analysis (Value %), 2025
• 4.3. Competitor Mapping & Benchmarking
  • 4.3.1. Key players - By Region

Chapter 5. Global Cell And Gene Therapy Market Analysis

• 5.1. Market Dynamics and Trends
  • 5.1.1. Growth Drivers
  • 5.1.2. Restraints
  • 5.1.3. Opportunity
  • 5.1.4. Key Trends
• 5.2. Market Opportunity Snapshot
• 5.3. By Therapy Type
  • 5.3.1. Key Insights
  • 5.3.2. Market Size and Forecast, 2020-2035 (US$ Mn)
    • 5.3.2.1. Cell Therapy
      • 5.3.2.1.1. Stem Cell Therapy
      • 5.3.2.1.2. T-Cells
      • 5.3.2.1.3. Dendritic Cells
      • 5.3.2.1.4. NK Cells
    • 5.3.2.2. Gene Therapy
      • 5.3.2.2.1. In-vivGene Therapy
      • 5.3.2.2.2. Ex-vivGene Therapy
      • 5.3.2.2.3. Gene Editing Therapies
      • 5.3.2.2.4. RNA-Based Therapies
      • 5.3.2.2.5. Others
• 5.4. By Indication / Therapeutic Area
  • 5.4.1. Key Insights
  • 5.4.2. Market Size and Forecast, 2020-2035 (US$ Mn)
    • 5.4.2.1. Oncology
    • 5.4.2.2. Solid Tumors
    • 5.4.2.3. Genetic Disorders
    • 5.4.2.4. Neurological Disorders
    • 5.4.2.5. Cardiovascular Diseases
    • 5.4.2.6. Ophthalmology
    • 5.4.2.7. Musculoskeletal / Orthopedic Disorders
    • 5.4.2.8. Infectious Diseases
    • 5.4.2.9. Metabolic Disorders
    • 5.4.2.10. Others
• 5.5. By Vector Type (Gene Delivery Method)
  • 5.5.1. Key Insights
  • 5.5.2. Market Size and Forecast, 2020-2035 (US$ Mn)
    • 5.5.2.1. Viral Vectors
      • 5.5.2.1.1. Adeno-Associated Virus (AAV)
      • 5.5.2.1.2. Lentivirus
      • 5.5.2.1.3. Retrovirus
      • 5.5.2.1.4. Herpes Simplex Virus (HSV)
      • 5.5.2.1.5. Adenovirus
      • 5.5.2.1.6. Others
    • 5.5.2.2. Non-Viral Vectors
      • 5.5.2.2.1. Lipid Nanoparticles (LNPs)
      • 5.5.2.2.2. Naked DNA/RNA Plasmids
      • 5.5.2.2.3. Electroporation
      • 5.5.2.2.4. Gene gun / microinjection
      • 5.5.2.2.5. CRISPR-Cas Delivery Systems (non-viral)
      • 5.5.2.2.6. Others
• 5.6. By Manufacturing Type
  • 5.6.1. Key Insights
  • 5.6.2. Market Size and Forecast, 2020-2035 (US$ Mn)
    • 5.6.2.1. In-house
    • 5.6.2.2. Contract Development & Manufacturing Organizations (CDMOs)
    • 5.6.2.3. Hybrid Models (e.g., early stage in-house, scale-up outsourced)
    • 5.6.2.4. Others
• 5.7. By End User
  • 5.7.1. Key Insights
  • 5.7.2. Market Size and Forecast, 2020-2035 (US$ Mn)
    • 5.7.2.1. Hospitals and Specialty Clinics
    • 5.7.2.2. Academic and Research Institutes
    • 5.7.2.3. Biopharma and Biotech Companies
    • 5.7.2.4. CDMOs and CROS
    • 5.7.2.5. Government/Public Health Bodies
    • 5.7.2.6. Others
• 5.8. By Region
  • 5.8.1. Key Insights
  • 5.8.2. Market Size and Forecast, 2020-2035 (US$ Mn)
    • 5.8.2.1. North America
      • 5.8.2.1.1. The U.S.
      • 5.8.2.1.2. Canada
      • 5.8.2.1.3. Mexico
    • 5.8.2.2. Europe
      • 5.8.2.2.1. Western Europe
        • 5.8.2.2.1.1. The UK
        • 5.8.2.2.1.2. Germany
        • 5.8.2.2.1.3. France
        • 5.8.2.2.1.4. Italy
        • 5.8.2.2.1.5. Spain
        • 5.8.2.2.1.6. Rest of Western Europe
      • 5.8.2.2.2. Eastern Europe
        • 5.8.2.2.2.1. Poland
        • 5.8.2.2.2.2. Russia
        • 5.8.2.2.2.3. Rest of Eastern Europe
    • 5.8.2.3. Asia Pacific
      • 5.8.2.3.1. China
      • 5.8.2.3.2. India
      • 5.8.2.3.3. Japan
      • 5.8.2.3.4. South Korea
      • 5.8.2.3.5. Australia & New Zealand
      • 5.8.2.3.6. ASEAN
        • 5.8.2.3.6.1.1. Indonesia
        • 5.8.2.3.6.1.2. Malaysia
        • 5.8.2.3.6.1.3. Thailand
        • 5.8.2.3.6.1.4. Singapore
        • 5.8.2.3.6.1.5. Rest of ASEAN
      • 5.8.2.3.7. Rest of Asia Pacific
    • 5.8.2.4. Middle East & Africa
      • 5.8.2.4.1. UAE
      • 5.8.2.4.2. Saudi Arabia
      • 5.8.2.4.3. South Africa
      • 5.8.2.4.4. Rest of MEA
    • 5.8.2.5. South America
      • 5.8.2.5.1. Argentina
      • 5.8.2.5.2. Brazil
      • 5.8.2.5.3. Rest of South America

Chapter 6. North America Cell And Gene Therapy Market Analysis

• 6.1. Market Dynamics and Trends
  • 6.1.1. Growth Drivers
  • 6.1.2. Restraints
  • 6.1.3. Opportunity
  • 6.1.4. Key Trends
• 6.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 6.2.1. By Therapy Type
  • 6.2.2. By Indication / Therapeutic Area
  • 6.2.3. By Vector Type (Gene Delivery Method)
  • 6.2.4. By Manufacturing Type
  • 6.2.5. By End User
  • 6.2.6. By Region

Chapter 7. Europe Cell And Gene Therapy Market Analysis

• 7.1. Market Dynamics and Trends
  • 7.1.1. Growth Drivers
  • 7.1.2. Restraints
  • 7.1.3. Opportunity
  • 7.1.4. Key Trends
• 7.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 7.2.1. By Therapy Type
  • 7.2.2. By Indication / Therapeutic Area
  • 7.2.3. By Vector Type (Gene Delivery Method)
  • 7.2.4. By Manufacturing Type
  • 7.2.5. By End User
  • 7.2.6. By Region

Chapter 8. Asia Pacific Cell And Gene Therapy Market Analysis

• 8.1. Market Dynamics and Trends
  • 8.1.1. Growth Drivers
  • 8.1.2. Restraints
  • 8.1.3. Opportunity
  • 8.1.4. Key Trends
• 8.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 8.2.1. By Therapy Type
  • 8.2.2. By Indication / Therapeutic Area
  • 8.2.3. By Vector Type (Gene Delivery Method)
  • 8.2.4. By Manufacturing Type
  • 8.2.5. By End User
  • 8.2.6. By Region

Chapter 9. Middle East & Africa Cell And Gene Therapy Market Analysis

• 9.1. Market Dynamics and Trends
  • 9.1.1. Growth Drivers
  • 9.1.2. Restraints
  • 9.1.3. Opportunity
  • 9.1.4. Key Trends
• 9.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 9.2.1. By Therapy Type
  • 9.2.2. By Indication / Therapeutic Area
  • 9.2.3. By Vector Type (Gene Delivery Method)
  • 9.2.4. By Manufacturing Type
  • 9.2.5. By End User
  • 9.2.6. By Region

Chapter 10. South America Cell And Gene Therapy Market Analysis

• 10.1. Market Dynamics and Trends
  • 10.1.1. Growth Drivers
  • 10.1.2. Restraints
  • 10.1.3. Opportunity
  • 10.1.4. Key Trends
• 10.2. Market Size and Forecast, 2020-2035 (US$ Mn)
  • 10.2.1. By Therapy Type
  • 10.2.2. By Indication / Therapeutic Area
  • 10.2.3. By Vector Type (Gene Delivery Method)
  • 10.2.4. By Manufacturing Type
  • 10.2.5. By End User
  • 10.2.6. By Region

Chapter 11. Company Profile (Company Overview, Financial Matrix, Key Product landscape, Key Personnel, Key Competitors, Contact Address, and Business Strategy Outlook)

• 11.1. ALLOGENE THERAPEUTICS
• 11.2. Amgen Inc.
• 11.3. Astellas Pharma Inc.
• 11.4. Atara Biotherapeutics, Inc.
• 11.5. Bayer AG
• 11.6. Biomarin
• 11.7. Bluebird Bio, Inc.
• 11.8. Bristol-Myers Squibb Company
• 11.9. Celgene Corporation
• 11.10. Cellectis
• 11.11. Gilead Sciences, Inc.
• 11.12. Hoffmann-La Roche Ltd
• 11.13. ImmunoACT
• 11.14. Johnson & Johnson
• 11.15. Krystal Biotech, Inc
• 11.16. Novartis AG
• 11.17. Orchard Therapeutics plc
• 11.18. Sana Biotechnology
• 11.19. uniQure NV.
• 11.20. Vericel Corporation
• 11.21. Other Prominent Players

Chapter 12. Annexure

• 12.1. List of Secondary Sources
• 12.2. Key Country Markets- Macro Economic Outlook/Indicators