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

The Global Gene Therapy Market was valued at USD 3.3 billion in 2025 and is estimated to grow at a CAGR of 26.2% to reach USD 33.6 billion by 2035.

Strong market growth is supported by continuous advancements in gene delivery technologies, expanding development of gene vectors, rising investments in gene therapy research, increasing incidence of cancer and other target diseases, broader availability of cell and gene therapy manufacturing services, and the growing number of product approvals and commercial launches. The gene therapy market is also benefiting from the increasing demand for innovative treatment options capable of addressing diseases with limited therapeutic alternatives. Growing awareness of precision medicine, improvements in genetic testing, and advances in manufacturing capabilities are encouraging wider adoption of gene-based therapies across healthcare systems. Gene therapy involves modifying, replacing, or introducing genetic material within a patient's cells to prevent, manage, or treat disease. The technology offers the potential for long-lasting therapeutic outcomes by addressing the underlying genetic cause of disease rather than simply controlling symptoms. As research activities continue to expand and commercialization accelerates, the market is expected to experience sustained growth throughout the forecast period.

The rising burden of genetic and rare diseases continues to create significant opportunities for the gene therapy market. Many inherited disorders have historically offered limited treatment options, making gene therapy an increasingly attractive solution for healthcare providers and patients seeking durable therapeutic outcomes. In many cases, a single treatment has the potential to deliver long-term clinical benefits, reducing the need for continuous medication and ongoing disease management. Improvements in disease awareness, genetic screening, and diagnostic technologies are identifying a larger patient population eligible for gene therapy treatments and clinical research programs. At the same time, ongoing progress in gene delivery platforms is improving treatment precision, manufacturing efficiency, and overall therapeutic performance, further supporting market expansion.

The in vivo gene therapy segment generated USD 2.7 billion in 2025. This segment maintains its leadership because in vivo therapies allow therapeutic genes to be delivered directly into the patient's body, enabling treatment across multiple organs and tissues through a systemic approach. Such capabilities are particularly valuable for diseases affecting several body systems. Continuous innovation in delivery technologies has also enhanced the accuracy, efficiency, and safety of genetic material delivery, contributing to improved therapeutic outcomes and accelerating adoption of in vivo gene therapy across clinical applications.

The oncology segment accounted for 46.5% share in 2025 and is anticipated to grow at a CAGR of 24.2% between 2026 and 2035. The segment continues to lead the market because gene therapy enables targeted delivery of therapeutic genes directly to cancer cells while minimizing the impact on surrounding healthy tissues. This precision-based treatment approach helps improve therapeutic effectiveness while reducing unwanted side effects commonly associated with conventional treatment methods. In addition, gene therapy is increasingly being evaluated alongside existing treatment strategies to improve overall clinical outcomes. The growing global prevalence of cancer continues to support strong demand for innovative gene-based therapeutic solutions.

North America Gene Therapy Market held a 62.5% share in 2025. Regional growth is supported by a favorable regulatory framework, substantial public and private investment, advanced healthcare infrastructure, and a highly developed research environment. The region also benefits from a strong concentration of biotechnology companies, research organizations, and healthcare institutions that continue to accelerate innovation and commercialization within the gene therapy industry. Ongoing investments in scientific research, manufacturing capabilities, and clinical development continue to reinforce North America's leadership position and support long-term market expansion.

Leading participants operating in the global gene therapy market include Novartis, BioMarin, Vertex Pharmaceuticals, Orchard Therapeutics, Pfizer, UniQure, Amgen, Bayer, Ferring Pharmaceuticals, Gilead Sciences, CRISPR Therapeutics, Bristol Myers Squibb, Krystal Biotech, bluebird bio, Sarepta Therapeutics, and Spark Therapeutics (Roche). Companies operating in the gene therapy market are strengthening their competitive position through continuous investment in research and development, expansion of manufacturing capacity, and advancement of proprietary gene delivery technologies. Strategic collaborations with biotechnology firms, research institutions, and contract manufacturing organizations are helping accelerate product development and commercialization. Many companies are broadening their clinical pipelines by targeting multiple therapeutic areas while enhancing manufacturing scalability and process efficiency to support growing commercial demand. Organizations are also pursuing regulatory approvals across additional markets, expanding geographic presence, and investing in advanced production facilities to improve supply capabilities.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Research approach
• 1.2 Quality commitments
  • 1.2.1 GMI AI policy & data integrity commitment
    • 1.2.1.1 Source consistency protocol
• 1.3 Research trail & confidence scoring
  • 1.3.1 Research trail components
  • 1.3.2 Scoring components
• 1.4 Data collection
  • 1.4.1 Partial list of primary sources
• 1.5 Data mining sources
  • 1.5.1 Paid sources
    • 1.5.1.1 Sources, by region
• 1.6 Base estimates and calculations
  • 1.6.1 Base year calculation for any one approach
• 1.7 Market estimates & forecasts parameters
• 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 Vector type trends
  • 2.2.4 Indication trends
  • 2.2.5 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 Advancements in gene editing technologies
    • 3.2.1.2 Increasing prevalence of rare genetic and inherited diseases
    • 3.2.1.3 Rising investments and collaborations
    • 3.2.1.4 Growing awareness and improved genetic diagnostics
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 High development and manufacturing costs
    • 3.2.2.2 Complexity of gene therapy delivery and potential side effects
  • 3.2.3 Market opportunities
    • 3.2.3.1 Development of personalized and precision gene therapies
    • 3.2.3.2 Expansion in emerging markets with growing healthcare infrastructure
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
  • 3.4.1 North America
    • 3.4.1.1 U.S.
    • 3.4.1.2 Canada
  • 3.4.2 Europe
  • 3.4.3 Asia Pacific
  • 3.4.4 Latin America
  • 3.4.5 Middle East and Africa
• 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 gene therapy investment trends (2022–2026)
  • 3.9.2 Government, NIH & grant funding landscape
• 3.10 Approved & commercialized gene therapy products
• 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 In vivo gene therapy
• 5.3 Ex vivo gene therapy

Chapter 6 Market Estimates and Forecast, By Delivery Method, 2022 – 2035 ($ Mn)

• 6.1 Key trends
• 6.2 Viral vectors
  • 6.2.1 Adeno-associated virus vectors
  • 6.2.2 Lentiviral vectors
  • 6.2.3 Retrovirus & γ-Retrovirus
  • 6.2.4 Other viral vectors
• 6.3 Non-viral vectors

Chapter 7 Market Estimates and Forecast, By Indication, 2022 – 2035 ($ Mn)

• 7.1 Key trends
• 7.2 Oncology
• 7.3 Rare and genetic disorders
• 7.4 Hematology
• 7.5 Ophthalmology
• 7.6 Other indications

Chapter 8 Market Estimates and Forecast, By End Use, 2022 – 2035 ($ Mn)

• 8.1 Key trends
• 8.2 Hospitals
• 8.3 Specialty clinics and gene therapy centers
• 8.4 Academic and research institutions
• 8.5 Other end users

Chapter 9 Market Estimates and Forecast, By Region, 2022 – 2035 ($ Mn)

• 9.1 Key trends
• 9.2 North America
  • 9.2.1 U.S.
  • 9.2.2 Canada
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 France
  • 9.3.4 Spain
  • 9.3.5 Italy
  • 9.3.6 Netherlands
• 9.4 Asia Pacific
  • 9.4.1 China
  • 9.4.2 India
  • 9.4.3 Japan
  • 9.4.4 Australia
  • 9.4.5 South Korea
• 9.5 Latin America
  • 9.5.1 Brazil
  • 9.5.2 Mexico
  • 9.5.3 Argentina
• 9.6 Middle East and Africa
  • 9.6.1 South Africa
  • 9.6.2 Saudi Arabia
  • 9.6.3 UAE

Chapter 10 Company Profiles

• 10.1 Amgen
• 10.2 Bayer
• 10.3 BioMarin
• 10.4 bluebird bio
• 10.5 Bristol Myers Squibb
• 10.6 CRISPR Therapeutics
• 10.7 Ferring Pharmaceuticals
• 10.8 Gilead Sciences
• 10.9 Krystal Biotech
• 10.10 Novartis
• 10.11 Orchard Therapeutics
• 10.12 Pfizer
• 10.13 Sarepta Therapeutics
• 10.14 Spark Therapeutics (Roche)
• 10.15 UniQure
• 10.16 Vertex Pharmaceuticals