세포 기반 면역치료 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the cell based immunotherapy market size is expected to increase from USD 4.86 billion in 2025 to USD 5.64 billion in 2026 and reach USD 10.78 billion by 2031, growing at a CAGR of 13.83% over 2026-2031.

This report is Segmented by Cell Source (Autologous, Allogeneic), Cell Type (CAR-T Cells, TCR-T Cells, CAR-NK Cells, Tumor-Infiltrating Lymphocytes), Primary Indication (B-Cell Malignancies, Prostate Cancer, and More), End User (Hospitals, and More), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, South America). Market Forecasts are Provided in Terms of Value (USD).

Global Cell Based Immunotherapy Market Trends and Insights

Surging Cancer Prevalence and Earlier-Line Use Approvals

Global cancer incidence reached 20 million new cases in 2024, and regulators responded by green-lighting the use of second-line CAR-T therapy in diffuse large B-cell lymphoma, shifting a sizable share of fitter patients into the cell-based immunotherapy market. The U.S. FDA's expanded label for Yescarta moved 40% of eligible patients forward by one therapy line. At the same time, the European Medicines Agency followed with conditional approval for Kymriah in second-line follicular lymphoma. Real-world evidence now shows a 24-month progression-free survival rate of 52% in second-line CAR-T cohorts, compared to 31% in third-line cohorts. Sponsors are redesigning registrational trials around earlier-line endpoints, anticipating that this regulatory momentum will hold through 2027.

Rapid Advances in Gene-Editing and Viral-Vector Engineering

CRISPR, base-editing, and optimized lentiviral systems are enhancing cell potency and reducing the cost of goods by 35% per dose. Caribou's TRAC-edited allogeneic CAR-T therapy delivered a 68% complete response rate with no graft-versus-host disease in Phase 1, highlighting the feasibility of single-step edits to enhance persistence. Parallel innovations in adeno-associated virus serotype engineering enabled Sana Biotechnology's in vivo CAR approach, which transduced 80% of T cells in non-human primates without ex vivo manipulation. These advances are lowering technical barriers for smaller entrants and intensifying competition for first-generation autologous incumbents.

Complex, Fragile Supply Chain & Specialized Talent Shortages

Cold-chain mishaps and workforce gaps continue to trigger batch failures. A global survey found that 68% of contract manufacturers had unfilled process development roles, with a median hiring time of over 9 months. Cryopreservation excursions caused 12% of 2024 batch rejections. Academic programs are scaling slowly; only 14 universities offer lentiviral-production curricula. Vertical integration efforts such as Gilead internalizing vector production and Novartis co-running a technician academy with the University of Pennsylvania will take several years to close the gap.

Other drivers and restraints analyzed in the detailed report include:

1. Expanding Reimbursement Frameworks for Commercial CAR-T Launches
2. Big-Pharma M&A, Licensing Deals, and Capacity Build-Outs
3. Cytokine-Release-Syndrome (CRS) Risk & Associated Liability Costs

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Autologous therapies accounted for 72.31% of the cell-based immunotherapy market share in 2025, driven by four commercial CAR-T brands that collectively treated over 18,000 patients in 2024. Patient-specific products carry zero graft-versus-host risk and have commanded list prices above USD 400,000. Yet they rely on 14-28 day manufacturing windows, during which 15-20% of patients progress. The allogeneic segment, projected to expand at a 14.14% CAGR, circumvents these delays. Donor cells edited at the TRAC, B2M, and CIITA loci can be banked for off-the-shelf dosing as soon as the disease is confirmed.

Allogeneic programs are already infusing patients within 3 days of leukapheresis and are demonstrating an overall response rate of 75% in early lymphoma trials. Regulators now permit sponsors to extrapolate specific autologous safety endpoints, thereby streamlining the development process. Persistence beyond 24 months remains a crucial unknown, and payers are aware of the higher cumulative cost associated with repeat dosing. Even so, the operational simplicity of inventory models is incentivizing contract manufacturers to carve out allogeneic-dedicated suites.

CAR-T platforms accounted for 64.73% of 2025 revenue, driven by six FDA-approved products for hematologic malignancies. Manufacturing infrastructure is established, and vein-to-vein times have almost halved since 2020. Nonetheless, low trafficking and antigen heterogeneity cap solid-tumor response rates at single digits. CAR-NK programs, forecast for a 15.07% CAGR, sidestep HLA matching and have yet to register any CRS or neurotoxicity signals, making them attractive as off-the-shelf candidates.

Induced-pluripotent-stem-cell-derived CAR-NK products achieved a 63% objective response in advanced ovarian cancer without severe toxicities, validating their innate cytotoxicity. Tumor-infiltrating lymphocyte (TIL) therapy occupies a smaller niche but won its first U.S. approval in 2024 for metastatic melanoma, providing an option for neoantigen-rich tumors. TCR-T products gained traction in synovial sarcoma and could eventually target intracellular antigens inaccessible to CARs, although HLA restriction limits addressable populations.

Complete Report Scope:

• By Cell Source
  • Autologous
  • Allogeneic
• By Cell Type
  • CAR-T Cells
  • TCR-T Cells
  • CAR-NK Cells
  • Tumor-Infiltrating Lymphocytes (TIL)
• By Primary Indication
  • B-cell Malignancies
  • Prostate Cancer
  • Renal Cell Carcinoma
  • Liver Cancer
  • Other Indications
• By End User
  • Hospitals
  • Specialty Cancer Centers
  • Academic & Research Institutes
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America generated 44.26% of global revenue in 2025, supported by six FDA-approved products, 180 active trials, and outcomes-based reimbursement that underwrites high list prices. In 2024, the United States treated 9,500 patients, 60% of whom received therapy at 15 high-volume centers that now operate automated on-site manufacturing facilities. Canada lags with only three approved products and third-line coverage limits, while Mexico's access remains confined to medical tourists traveling to U.S. sites.

The Asia-Pacific region is the fastest-growing, with a 16.21% CAGR forecast. In 2024, China's regulator cleared eight domestic CAR-T products, priced at CNY 1.2 million (approximately USD 165,000), to undercut imports. Japan's conditional pathway cuts 18 months off review timelines, fueling trial starts. India and Australia are still in their early stages but have earmarked public funds for domestic manufacturing by 2027, indicating longer-term upside.

Germany embraced value-based pricing, whereas the United Kingdom rejected one leading product for cost-effectiveness, pending confidential rebates. Italy and Spain face regional budget allocations that can delay reimbursement up to two years after an EMA green light. Middle East & Africa and South America represent just 6% of demand, though Dubai's center-of-excellence model and Brazil's priority reviews hint at incremental growth as local capacity emerges.

1. Adaptimmune Therapeutics plc
2. Allogene Therapeutics
3. Atara Biotherapeutics Inc.
4. Autolus Therapeutics plc
5. Bluebird Bio
6. Bristol-Myers Squibb
7. Cabaletta Bio Inc.
8. Caribou Biosciences Inc.
9. Celyad Oncology SA
10. Roche
11. Gamida Cell Ltd
12. Gilead Sciences
13. Johnson & Johnson
14. JW Therapeutics Co. Ltd
15. Legend Biotech Corp.
16. Lonza Group
17. Miltenyi Biotec B.V. & Co. KG
18. Mustang Bio Inc.
19. Novartis
20. Orca Bio Inc.
21. Pfizer
22. Precision BioSciences Inc.
23. Sorrento Therapeutics
24. Tessa Therapeutics Ltd

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Surging Cancer Prevalence and Earlier-Line Use Approvals
  • 4.2.2 Rapid Advances in Gene-Editing & Viral-Vector Engineering
  • 4.2.3 Expanding Reimbursement Frameworks for Commercial CAR-T Launches
  • 4.2.4 Big-Pharma M&A, Licensing Deals, and Capacity Build-Outs
  • 4.2.5 Point-Of-Care Micro-Factories Slashing Vein-To-Vein Cycle-Time
  • 4.2.6 In-Vivo CAR Payload Delivery Platforms Eliminating Lymphodepletion
• 4.3 Market Restraints
  • 4.3.1 Complex, Fragile Supply Chain & Specialized Talent Shortages
  • 4.3.2 Cytokine-Release-Syndrome (CRS) Risk & Associated Liability Costs
  • 4.3.3 Viral-Vector Raw-Material Bottlenecks Constraining Scale-Up
  • 4.3.4 Regulatory Uncertainty Around In-Vivo Gene-Delivery Vectors
• 4.4 Regulatory Landscape
• 4.5 Technological Outlook
• 4.6 Porter's Five Forces Analysis
  • 4.6.1 Threat of New Entrants
  • 4.6.2 Bargaining Power of Buyers
  • 4.6.3 Bargaining Power of Suppliers
  • 4.6.4 Threat of Substitutes
  • 4.6.5 Competitive Rivalry

5 Market Size & Growth Forecasts

• 5.1 By Cell Source
  • 5.1.1 Autologous
  • 5.1.2 Allogeneic
• 5.2 By Cell Type
  • 5.2.1 CAR-T Cells
  • 5.2.2 TCR-T Cells
  • 5.2.3 CAR-NK Cells
  • 5.2.4 Tumor-Infiltrating Lymphocytes (TIL)
• 5.3 By Primary Indication
  • 5.3.1 B-cell Malignancies
  • 5.3.2 Prostate Cancer
  • 5.3.3 Renal Cell Carcinoma
  • 5.3.4 Liver Cancer
  • 5.3.5 Other Indications
• 5.4 By End User
  • 5.4.1 Hospitals
  • 5.4.2 Specialty Cancer Centers
  • 5.4.3 Academic & Research Institutes
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East & Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East & Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market-level Overview, Core Segments, Financials, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
  • 6.3.1 Adaptimmune Therapeutics plc
  • 6.3.2 Allogene Therapeutics Inc.
  • 6.3.3 Atara Biotherapeutics Inc.
  • 6.3.4 Autolus Therapeutics plc
  • 6.3.5 Bluebird Bio Inc.
  • 6.3.6 Bristol Myers Squibb Co.
  • 6.3.7 Cabaletta Bio Inc.
  • 6.3.8 Caribou Biosciences Inc.
  • 6.3.9 Celyad Oncology SA
  • 6.3.10 F. Hoffmann-La Roche Ltd
  • 6.3.11 Gamida Cell Ltd
  • 6.3.12 Gilead Sciences Inc.
  • 6.3.13 Johnson & Johnson
  • 6.3.14 JW Therapeutics Co. Ltd
  • 6.3.15 Legend Biotech Corp.
  • 6.3.16 Lonza Group Ltd
  • 6.3.17 Miltenyi Biotec B.V. & Co. KG
  • 6.3.18 Mustang Bio Inc.
  • 6.3.19 Novartis AG
  • 6.3.20 Orca Bio Inc.
  • 6.3.21 Pfizer Inc.
  • 6.3.22 Precision BioSciences Inc.
  • 6.3.23 Sorrento Therapeutics Inc.
  • 6.3.24 Tessa Therapeutics Ltd

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment