細胞及基因治療市場商機、成長要素、產業趨勢分析及2026-2035年預測。

2025年全球細胞和基因治療市場價值為122億美元，預計到2035年將以25.7%的複合年成長率成長至1209億美元。

隨著生物技術的進步、研發投入的增加以及創新療法商業化程度的提高，現代醫療保健持續轉型，細胞和基因治療產業正經歷快速成長。這些療法利用活細胞、遺傳物質和先進的基因工程技術，不僅透過控制症狀，更著力於潛在的生物學因素，來應對複雜的疾病。全球範圍內慢性病、遺傳性疾病和嚴重的日益普遍，推動了對先進療法的需求成長。再生醫學的持續進步、臨床開發平臺的不斷拓展以及法規核准的增加，都在加速市場成長。基因編輯平台的進步也為該行業帶來了益處，提高了治療的精準度，並擴展了多種疾病的治療可能性。下一代技術的日益普及，為研發人員提供了新的機遇，使其能夠推出更有效、更個人化的治療方法。隨著研究能力的不斷提升和商業化力度的加大，預計全球細胞和基因治療市場在預測期內將保持顯著成長。

在對先進生物療法的投資不斷增加以及臨床階段研究計畫不斷擴展的推動下，細胞和基因治療市場持續成長。該行業涵蓋多種治療方法，包括細胞療法、免疫療法、幹細胞應用以及旨在糾正或替代缺陷基因功能的基因解決方案。針對嚴重的創新療法需求日益成長，正在加速製藥和生技公司的研發活動。包括基於 CRISPR 的平台和其他精準基因編輯方法在內的先進基因編輯技術的日益普及，進一步拓展了細胞和基因療法在醫療保健領域的潛在應用。

預計到2025年，細胞治療市場規模將達90億美元。與基因治療相比，細胞治療市場保持主導商業化療法數量更多、臨床接受度更高以及法規核准進展更快。先進細胞療法的日益普及和已通過核准療法組合的持續擴大是推動該市場成長的主要動力。此外，創新免疫療法的日益普及也為複雜疾病患者提供了更多治療選擇，從而促進了細胞治療市場的擴張。

預計到2025年，腫瘤治療領域將佔據51.9%的市場。由於全球癌症負擔日益加重，以及針對多種癌症類型的先進療法的日益普及，該領域將繼續保持主導地位。活性化的研究活動和創新療法的成功商業化，支撐了腫瘤治療領域的強勁需求。個人化醫療和標靶治療的持續發展，有望進一步鞏固腫瘤治療在細胞和基因治療市場的地位。

到2025年，北美將佔據細胞和基因治療市場61.8%的佔有率。該地區受益於強大的生物技術生態系統、雄厚的研發實力、先進的醫療基礎設施以及許多領先的細胞和基因治療研發公司。生技公司、研究機構和學術機構的大量投資持續加速創新和商業化進程。該地區完善的臨床開發環境和對先進療法的重視進一步鞏固了其市場領先地位。

目錄

第1章：調查方法和範圍

第2章執行摘要

第3章 行業洞察

• 產業生態系分析
• 影響產業的因素
  • 促進因素
    • 核准的細胞和基因療法數量增加
    • 癌症和罕見遺傳疾病的發生率不斷上升
    • 擴大製造基礎設施和CDMO能力
    • 基因編輯與細胞工程技術的進步
    • 擴大投資和策略夥伴關係
  • 產業潛在風險與挑戰
    • 高昂的治療成本和製造成本
    • 製造和擴充性限制
    • 對法規和長期安全性的擔憂
  • 市場機遇
    • 擴大異基因移植和既有療法
    • 新興市場採用率的擴大
• 成長潛力分析
• 監理情勢
• 技術與創新展望
  • 最新科技趨勢
  • 新興技術
• 價格分析
  • 對過去價格趨勢的分析
  • 價格分析：依療法類型
• 波特的分析
• PESTLE分析
• 投資與資金籌措分析
  • 全球資本利得稅投資趨勢（2022-2026）
  • 政府、美國國立衛生研究院和津貼資金籌措趨勢
• 已批准且市售的細胞和基因治療產品登記冊
• 研發管線和臨床試驗趨勢
• 未來市場趨勢
• 人工智慧和生成式人工智慧對市場的影響

第4章 競爭情勢

• 介紹
• 企業市佔率分析
  • 北美洲
  • 歐洲
  • 亞太地區
• 企業矩陣分析
• 主要市場公司的競爭分析
• 競爭定位矩陣
• 主要進展
  • 併購
  • 夥伴關係和聯盟
  • 新產品發布
  • 業務拓展計劃

第5章 市場估計與預測：依治療類型分類，2022-2035年

• 細胞療法
  • CAR-T細胞療法
  • TCR-T細胞療法
  • 腫瘤浸潤淋巴細胞（TIL）療法
  • 幹細胞療法
  • 樹突細胞療法
  • 其他細胞療法
• 基因治療
  • 按類型
    • 體內基因治療
    • 體外基因治療
  • 透過向量
    • 病毒載體
    • 非病毒載體

第6章 市場估計與預測：依適應症分類，2022-2035年

• 腫瘤學
• 血液疾病
• 罕見遺傳疾病
• 神經病變
• 眼科疾病
• 皮膚病
• 免疫系統疾病
• 其他改編

第7章 市場估計與預測：依最終用途分類，2022-2035年

• 醫院
• 專科診所
• 學術和研究機構
• 其他最終用戶

第8章 市場估計與預測：依地區分類，2022-2035年

• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 英國
  • 法國
  • 西班牙
  • 義大利
  • 荷蘭
• 亞太地區
  • 中國
  • 印度
  • 日本
  • 澳洲
  • 韓國
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 阿根廷
• 中東和非洲
  • 南非
  • 沙烏地阿拉伯
  • UAE

第9章：公司簡介

• 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
• Vertex Pharmaceuticals

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