세포 및 유전자 치료 시장 비즈니스 기회, 성장요인, 업계 동향 분석 및 예측(2026-2035년)

The Global Cell and Gene Therapy Market was valued at USD 12.2 billion in 2025 and is estimated to grow at a CAGR of 25.7% to reach USD 120.9 billion by 2035.

The cell and gene therapy industry is experiencing rapid expansion as advances in biotechnology, rising research investments, and increasing commercialization of innovative treatments continue to transform modern healthcare. These therapies utilize living cells, genetic materials, and advanced gene modification approaches to address complex diseases by targeting underlying biological causes rather than only managing symptoms. Growing demand for advanced treatment options is being supported by the increasing prevalence of chronic, inherited, and severe medical conditions worldwide. Continuous progress in regenerative medicine, expanding clinical development pipelines, and rising regulatory approvals are accelerating market growth. The industry is also benefiting from advancements in gene-editing platforms that improve precision and expand therapeutic possibilities across multiple disease categories. Increasing adoption of next-generation technologies is creating new opportunities for developers to introduce more effective and personalized treatment approaches. As research capabilities continue to evolve and commercialization efforts expand, the global cell and gene therapy market is expected to witness significant growth throughout the forecast period.

The cell and gene therapy market continues to gain momentum due to increasing investment in advanced biological treatments and the expansion of clinical-stage research programs. The industry includes a wide range of therapeutic approaches, including cell-based treatments, immune cell therapies, stem cell applications, and gene-based solutions designed to modify or replace faulty genetic functions. Rising demand for innovative therapies targeting serious health conditions is encouraging pharmaceutical and biotechnology companies to accelerate development activities. The growing use of advanced gene-editing technologies, including CRISPR-based platforms and other precision modification methods, is further broadening the potential applications of cell and gene therapies across healthcare.

The cell therapy segment reached USD 9 billion in 2025. This segment maintains its leading position due to the availability of a larger number of commercialized therapies, wider clinical acceptance, and increasing regulatory progress compared with gene therapy applications. Growing adoption of advanced cell-based treatments and continued expansion of approved therapy portfolios are strengthening segment growth. The increasing presence of innovative immune cell therapies has further contributed to the expansion of the cell therapy market by improving treatment options for patients with complex diseases.

The oncology segment held a 51.9% share in 2025. This segment continues to lead due to the rising global cancer burden and the increasing availability of advanced therapies designed to address various forms of cancer. Growing research activity and successful commercialization of innovative treatment approaches are supporting strong demand within oncology applications. Continued advancements in personalized medicine and targeted therapeutic development are expected to further strengthen the role of oncology in the cell and gene therapy market.

North America Cell and Gene Therapy Market captured a 61.8% share in 2025. The region benefits from a strong biotechnology ecosystem, extensive research capabilities, advanced healthcare infrastructure, and the presence of major cell and gene therapy developers. Significant investments from biotechnology companies, research organizations, and academic institutions continue to accelerate innovation and commercialization activities. The region's established clinical development environment and strong focus on advanced therapeutics further support its continued market leadership.

Prominent players operating in the global cell and gene therapy market include BioMarin Pharmaceutical, bluebird bio, Bristol Myers Squibb, CRISPR Therapeutics, Gilead Sciences, Johnson & Johnson, Krystal Biotech, Novartis, Orchard Therapeutics, Pfizer, Roche / Spark Therapeutics, Sarepta Therapeutics, uniQure, and Vertex Pharmaceuticals. Companies operating in the cell and gene therapy market are strengthening their market position by increasing research and development investments, expanding manufacturing capabilities, and accelerating the commercialization of advanced therapies. Market participants are focusing on strategic collaborations with research institutions, biotechnology firms, and healthcare organizations to enhance innovation and broaden therapeutic pipelines. Businesses are also investing in scalable manufacturing technologies, regulatory expertise, and advanced clinical development programs to improve market competitiveness. Expansion into emerging healthcare markets, strengthening intellectual property portfolios, and improving treatment accessibility remain key priorities for industry participants.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definition
• 1.2 Research approach
• 1.3 Quality commitments
  • 1.3.1 GMI AI policy and data integrity commitment
    • 1.3.1.1 Source consistency protocol
• 1.4 Research trail and confidence scoring
  • 1.4.1 Research trail components
  • 1.4.2 Scoring components
• 1.5 Data collection
  • 1.5.1 Partial list of primary sources
• 1.6 Data mining sources
  • 1.6.1 Paid sources
    • 1.6.1.1 Sources, by region
• 1.7 Base estimates and calculations
  • 1.7.1 Revenue share analysis
  • 1.7.2 Base year calculation
• 1.8 Forecast model
  • 1.8.1 Quantified market impact analysis
    • 1.8.1.1 Mathematical impact of growth parameters on forecast
• 1.9 Research transparency addendum
  • 1.9.1 Source attribution framework
  • 1.9.2 Quality assurance metrics
  • 1.9.3 Our commitment to trust

Chapter 2 Executive Summary

• 2.1 Industry 360° synopsis
• 2.2 Key market trends
  • 2.2.1 Regional trends
  • 2.2.2 Therapy type trends
  • 2.2.3 Indication trends
  • 2.2.4 End use trends
• 2.3 CXO perspectives: Strategic imperatives

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Increasing number of approved cell and gene therapies
    • 3.2.1.2 Rising prevalence of cancer and rare genetic disorders
    • 3.2.1.3 Expansion of manufacturing infrastructure and CDMO capabilities
    • 3.2.1.4 Advancements in gene editing and cell engineering technologies
    • 3.2.1.5 Increasing investments and strategic collaborations
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 High treatment and manufacturing costs
    • 3.2.2.2 Manufacturing and scalability limitations
    • 3.2.2.3 Regulatory and long-term safety concerns
  • 3.2.3 Market opportunities
    • 3.2.3.1 Expansion of allogeneic and off-the-shelf therapies
    • 3.2.3.2 Growing adoption in emerging markets
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
  • 3.4.1 North America
  • 3.4.2 Europe
  • 3.4.3 Asia Pacific
  • 3.4.4 Latin America
  • 3.4.5 MEA
• 3.5 Technology and innovation landscape
  • 3.5.1 Current technological trends
  • 3.5.2 Emerging technologies
• 3.6 Pricing analysis (Driven by Primary Research)
  • 3.6.1 Historical price trend analysis
  • 3.6.2 Pricing analysis, by therapy type
• 3.7 Porter’s analysis
• 3.8 PESTEL analysis
• 3.9 Investment & funding analysis
  • 3.9.1 Global CGT investment trends (2022–2026)
  • 3.9.2 Government, NIH & grant funding landscape
• 3.10 Approved & commercialized cell and gene therapy products registry
• 3.11 Pipeline and clinical trial landscape
• 3.12 Future market trends
• 3.13 Impact of AI & Generative AI on the market

Chapter 4 Competitive Landscape, 2025

• 4.1 Introduction
• 4.2 Company market share analysis
  • 4.2.1 North America
  • 4.2.2 Europe
  • 4.2.3 Asia Pacific
• 4.3 Company matrix analysis
• 4.4 Competitive analysis of major market players
• 4.5 Competitive positioning matrix
• 4.6 Key developments
  • 4.6.1 Merger and acquisition
  • 4.6.2 Partnership and collaboration
  • 4.6.3 New product launches
  • 4.6.4 Expansion plans

Chapter 5 Market Estimates and Forecast, By Therapy Type, 2022 - 2035 ($ Mn)

• 5.1 Key trends
• 5.2 Cell therapy
  • 5.2.1 CAR-T cell therapy
  • 5.2.2 TCR-T cell therapy
  • 5.2.3 TIL (Tumor-Infiltrating Lymphocyte) therapy
  • 5.2.4 Stem cell therapy
  • 5.2.5 Dendritic cell therapy
  • 5.2.6 Other cell-based therapies
• 5.3 Gene therapy
  • 5.3.1 By type
    • 5.3.1.1 In vivo gene therapy
    • 5.3.1.2 Ex vivo gene therapy
  • 5.3.2 By vector
    • 5.3.2.1 Viral vectors
    • 5.3.2.2 Non-viral vectors

Chapter 6 Market Estimates and Forecast, By Indication, 2022 - 2035 ($ Mn)

• 6.1 Key trends
• 6.2 Oncology
• 6.3 Hematological disorders
• 6.4 Rare genetic disorders
• 6.5 Neurological disorders
• 6.6 Ophthalmological disorders
• 6.7 Dermatological disorders
• 6.8 Immunological disorders
• 6.9 Other indications

Chapter 7 Market Estimates and Forecast, By End Use, 2022 - 2035 ($ Mn)

• 7.1 Key trends
• 7.2 Hospitals
• 7.3 Specialty clinics
• 7.4 Academic and research institutions
• 7.5 Other end users

Chapter 8 Market Estimates and Forecast, By Region, 2022 - 2035 ($ Mn)

• 8.1 Key trends
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 UK
  • 8.3.3 France
  • 8.3.4 Spain
  • 8.3.5 Italy
  • 8.3.6 Netherlands
• 8.4 Asia Pacific
  • 8.4.1 China
  • 8.4.2 India
  • 8.4.3 Japan
  • 8.4.4 Australia
  • 8.4.5 South Korea
• 8.5 Latin America
  • 8.5.1 Brazil
  • 8.5.2 Mexico
  • 8.5.3 Argentina
• 8.6 Middle East and Africa
  • 8.6.1 South Africa
  • 8.6.2 Saudi Arabia
  • 8.6.3 UAE

Chapter 9 Company Profiles

• 9.1 BioMarin Pharmaceutical
• 9.2 bluebird bio
• 9.3 Bristol Myers Squibb
• 9.4 CRISPR Therapeutics
• 9.5 Gilead Sciences
• 9.6 Johnson & Johnson
• 9.7 Krystal Biotech
• 9.8 Novartis
• 9.9 Orchard Therapeutics
• 9.10 Pfizer
• 9.11 Roche / Spark Therapeutics
• 9.12 Sarepta Therapeutics
• 9.13 uniQure
• 9.14 Vertex Pharmaceuticals