면역치료 및 CAR-T 세포치료 시장 예측(-2034년) - 치료법별, 적응증별, 투여 경로별, 기술별, 최종사용자별 및 지역별 분석

According to Stratistics MRC, the Global Immunotherapy & CAR-T Cell Therapy Market is accounted for $6.8 billion in 2026 and is expected to reach $20.7 billion by 2034 growing at a CAGR of 14.9% during the forecast period. Immunotherapy and CAR-T cell therapy represent innovative approaches that activate or engineer the immune system to target cancer cells. Immunotherapy encompasses checkpoint inhibitors, monoclonal antibodies, therapeutic vaccines, and related technologies designed to enhance antitumor immunity. CAR-T treatment involves collecting T cells, genetically engineering them to recognize selected tumor antigens, and returning them to the patient. Their adoption is growing across blood cancers and emerging solid-tumor applications, driven by advances in precision medicine, biomarker identification, cell manufacturing, clinical research, and efforts to improve therapeutic safety and effectiveness.

According to the FDA, its Oncology Center of Excellence facilitated 89 oncology drug and biologic product approvals in 2024, including 19 new molecular entities or biologics license applications and 34 new indications for previously approved products. This demonstrates continued regulatory activity supporting cancer-treatment innovation.

Market Dynamics:

Driver:

Rising cancer incidence and unmet treatment needs

The growing prevalence of cancer is strengthening the need for innovative immunotherapy and CAR-T cell treatments. Rising diagnoses across blood cancers and challenging tumor types are encouraging clinicians to consider therapies that can deliver more targeted and lasting responses. Limitations associated with conventional cancer treatments, including treatment resistance, relapse, and adverse systemic effects, are increasing interest in immune-based technologies. Advances in clinical evidence, broader therapeutic applications, and deeper knowledge of tumor biology are also accelerating the development and adoption of personalized cellular therapies.

Restraint:

High treatment costs and complex manufacturing

Expensive treatment and complicated manufacturing requirements can restrict the expansion of immunotherapy and CAR-T cell therapy. CAR-T therapy involves personalized cell collection, genetic engineering, cellular expansion, quality assessment, and reinfusion, requiring substantial resources. Dedicated manufacturing facilities, specialized staff, sophisticated technologies, and patient monitoring add further costs. Limited reimbursement and healthcare budgets can make these therapies difficult to access in many settings. As a result, high overall expenses may constrain adoption and prevent eligible patients and healthcare institutions from widely utilizing advanced cellular treatment options.

Opportunity:

Expansion into solid tumor treatment

Growing research into solid tumors offers considerable opportunities for immunotherapy and CAR-T cell therapy. CAR-T treatments have achieved notable progress in selected hematological cancers, while researchers are now working to address barriers that limit effectiveness against solid tumors. Innovations involving tumor antigens, engineered receptors, combination treatment strategies, and targeted delivery could expand therapeutic applications. If these approaches demonstrate consistent clinical benefits, they could significantly enlarge the potential patient pool and support new commercial opportunities for pharmaceutical, biotechnology, and cell-therapy companies.

Threat:

Regulatory and approval challenges

Stringent regulatory standards pose a significant challenge to immunotherapy and CAR-T cell therapy development. Their complex biological mechanisms, genetic engineering processes, individualized production, and safety considerations require extensive clinical and regulatory assessment. Delays involving trials, manufacturing validation, or approvals can raise development expenses and extend commercialization schedules. Evolving regulatory frameworks may introduce further compliance obligations for companies. These uncertainties can reduce investment attractiveness, delay product launches, and slow the availability of innovative cellular and immune-based treatments to eligible patients.

Covid-19 Impact:

The COVID-19 outbreak temporarily affected immunotherapy and CAR-T cell therapy activities through postponed clinical studies, disrupted patient enrollment, delayed treatments, and reduced hospital capacity. Resource allocation toward COVID-19 care, transportation restrictions, and supply-chain difficulties created additional challenges for cell collection, production, logistics, and treatment delivery. Cancer patients experienced limited access to specialized services during the pandemic. Nevertheless, COVID-19 encouraged greater use of remote monitoring, decentralized trials, digital healthcare solutions, and stronger manufacturing strategies, helping the sector recover as oncology services and research programs resumed.

The monoclonal antibodies segment is expected to be the largest during the forecast period

The monoclonal antibodies segment is expected to account for the largest market share during the forecast period due to their ability to selectively target cancer-associated antigens. They can interfere with harmful signaling pathways, activate immune mechanisms, or directly support the elimination of malignant cells. Their widespread use across different cancers, established clinical foundation, and compatibility with combination therapies contribute to their strong market presence. Ongoing advances in antibody engineering, targeting precision, and treatment development are expanding their applications and reinforcing their leading role in modern immunotherapy.

The cancer research institutes segment is expected to have the highest CAGR during the forecast period

Over the forecast period, the cancer research institutes segment is predicted to witness the highest growth rate as they contribute significantly to the advancement and assessment of innovative cancer therapies. Their activities include translational research, early clinical investigations, biomarker studies, and development of cellular treatments. Concentration on emerging immunotherapy approaches enables researchers to investigate novel targets, combination therapies, and engineered immune-cell technologies more effectively. Growing partnerships with pharmaceutical and biotechnology organizations are enhancing research infrastructure and helping accelerate the progression of promising immunotherapy and CAR-T cell therapy candidates into clinical development.

Region with largest share:

During the forecast period, the North America region is expected to hold the largest market share, supported by sophisticated healthcare systems, extensive cancer research capabilities, and numerous specialized treatment facilities. Its strong biotechnology sector and active clinical research environment encourage the development and adoption of advanced cancer treatments. Partnerships between pharmaceutical firms, academic organizations, and healthcare institutions further facilitate innovation and commercialization. In addition, supportive reimbursement environments, increasing acceptance of personalized medicine, and expanding access to specialized cellular therapy centers reinforce the region's dominant position.

Region with highest CAGR:

Over the forecast period, the Asia Pacific region is anticipated to exhibit the highest CAGR, driven by developing healthcare systems, rising demand for advanced cancer treatments, and stronger oncology research activity. Growing biotechnology capabilities and specialized cell-therapy facilities are improving regional treatment availability. Pharmaceutical and biotechnology organizations are also expanding partnerships and clinical programs throughout key Asian countries. Increasing awareness of personalized therapies, better access to innovative treatments, and expanding research infrastructure are collectively establishing a favorable environment for accelerated regional market growth.

Key players in the market

Some of the key players in Immunotherapy & CAR-T Cell Therapy Market include Gilead Sciences, Inc., Bristol-Myers Squibb Company, Johnson & Johnson, Novartis AG, Legend Biotech, Autolus Therapeutics, Galapagos NV, Fate Therapeutics, AstraZeneca, Mustang Bio, Fosun Pharma, JW Therapeutics, IASO Biotherapeutics, Juventas Cell Therapy, CARsgen Therapeutics, Cellectis, Sorrento Therapeutics and Pfizer, Inc.

Key Developments:

In December 2025, Pfizer Inc. announced it has entered into an exclusive global collaboration and license agreement with YaoPharma, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Limited, a leading innovation-driven global healthcare company, for the development, manufacturing and commercialization of YP05002, a small molecule glucagon-like peptide 1 (GLP-1) receptor agonist currently in Phase 1 development for chronic weight management.

In May 2025, Novartis has signed a strategic agreement with Shanghai Pharma to help sell the Swiss company's mature ophthalmic products in China. Novartis will leverage Shanghai Pharma's omni-channel integrated marketing services and broad market coverage capabilities to accelerate the reach of some Novartis drugs for ocular infections and glaucoma in smaller territories not currently targeted by Novartis.

Therapy Types Covered:

• Monoclonal Antibodies
• Immune Checkpoint Inhibitors
• Cancer Vaccines
• Cytokines & Interleukins
• CAR-T Cell Therapy
• Other Cell-Based Immunotherapies

Indications Covered:

• Hematologic Malignancies
• Solid Tumors
• Autoimmune Disorders
• Infectious Diseases

Administration Routes Covered:

• Intravenous
• Intratumoral
• Oral

Technologies Covered:

• Gene-Modified Cell Therapy
• Non-Gene Modified Cell Therapy
• Oncolytic Virus Therapy
• Bispecific Antibodies

End Users Covered:

• Hospitals
• Cancer Research Institutes
• Specialty Clinics
• Academic & Research Organizations

Regions Covered:

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • United Kingdom
  • Germany
  • France
  • Italy
  • Spain
  • Netherlands
  • Belgium
  • Sweden
  • Switzerland
  • Poland
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Thailand
  • Malaysia
  • Singapore
  • Vietnam
  • Rest of Asia Pacific
• South America
  • Brazil
  • Argentina
  • Colombia
  • Chile
  • Peru
  • Rest of South America
• Rest of the World (RoW)
  • Middle East
• Saudi Arabia
• United Arab Emirates
• Qatar
• Israel
• Rest of Middle East
  • Africa
• South Africa
• Egypt
• Morocco
• Rest of Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2023, 2024, 2025, 2026, 2027, 2028, 2030, 2032 and 2034
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

• Company Profiling
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

• 1.1 Market Snapshot and Key Highlights
• 1.2 Growth Drivers, Challenges, and Opportunities
• 1.3 Competitive Landscape Overview
• 1.4 Strategic Insights and Recommendations

2 Research Framework

• 2.1 Study Objectives and Scope
• 2.2 Stakeholder Analysis
• 2.3 Research Assumptions and Limitations
• 2.4 Research Methodology
  • 2.4.1 Data Collection (Primary and Secondary)
  • 2.4.2 Data Modeling and Estimation Techniques
  • 2.4.3 Data Validation and Triangulation
  • 2.4.4 Analytical and Forecasting Approach

3 Market Dynamics and Trend Analysis

• 3.1 Market Definition and Structure
• 3.2 Key Market Drivers
• 3.3 Market Restraints and Challenges
• 3.4 Growth Opportunities and Investment Hotspots
• 3.5 Industry Threats and Risk Assessment
• 3.6 Technology and Innovation Landscape
• 3.7 Emerging and High-Growth Markets
• 3.8 Regulatory and Policy Environment
• 3.9 Impact of COVID-19 and Recovery Outlook

4 Competitive and Strategic Assessment

• 4.1 Porter's Five Forces Analysis
  • 4.1.1 Supplier Bargaining Power
  • 4.1.2 Buyer Bargaining Power
  • 4.1.3 Threat of Substitutes
  • 4.1.4 Threat of New Entrants
  • 4.1.5 Competitive Rivalry
• 4.2 Market Share Analysis of Key Players
• 4.3 Product Benchmarking and Performance Comparison

5 Global Immunotherapy & CAR-T Cell Therapy Market, By Therapy Type

• 5.1 Monoclonal Antibodies
• 5.2 Immune Checkpoint Inhibitors
• 5.3 Cancer Vaccines
• 5.4 Cytokines & Interleukins
• 5.5 CAR-T Cell Therapy
• 5.6 Other Cell-Based Immunotherapies

6 Global Immunotherapy & CAR-T Cell Therapy Market, By Indication

• 6.1 Hematologic Malignancies
• 6.2 Solid Tumors
• 6.3 Autoimmune Disorders
• 6.4 Infectious Diseases

7 Global Immunotherapy & CAR-T Cell Therapy Market, By Administration Route

• 7.1 Intravenous
• 7.2 Intratumoral
• 7.3 Oral

8 Global Immunotherapy & CAR-T Cell Therapy Market, By Technology

• 8.1 Gene-Modified Cell Therapy
• 8.2 Non-Gene Modified Cell Therapy
• 8.3 Oncolytic Virus Therapy
• 8.4 Bispecific Antibodies

9 Global Immunotherapy & CAR-T Cell Therapy Market, By End User

• 9.1 Hospitals
• 9.2 Cancer Research Institutes
• 9.3 Specialty Clinics
• 9.4 Academic & Research Organizations

10 Global Immunotherapy & CAR-T Cell Therapy Market, By Geography

• 10.1 North America
  • 10.1.1 United States
  • 10.1.2 Canada
  • 10.1.3 Mexico
• 10.2 Europe
  • 10.2.1 United Kingdom
  • 10.2.2 Germany
  • 10.2.3 France
  • 10.2.4 Italy
  • 10.2.5 Spain
  • 10.2.6 Netherlands
  • 10.2.7 Belgium
  • 10.2.8 Sweden
  • 10.2.9 Switzerland
  • 10.2.10 Poland
  • 10.2.11 Rest of Europe
• 10.3 Asia Pacific
  • 10.3.1 China
  • 10.3.2 Japan
  • 10.3.3 India
  • 10.3.4 South Korea
  • 10.3.5 Australia
  • 10.3.6 Indonesia
  • 10.3.7 Thailand
  • 10.3.8 Malaysia
  • 10.3.9 Singapore
  • 10.3.10 Vietnam
  • 10.3.11 Rest of Asia Pacific
• 10.4 South America
  • 10.4.1 Brazil
  • 10.4.2 Argentina
  • 10.4.3 Colombia
  • 10.4.4 Chile
  • 10.4.5 Peru
  • 10.4.6 Rest of South America
• 10.5 Rest of the World (RoW)
  • 10.5.1 Middle East
    • 10.5.1.1 Saudi Arabia
    • 10.5.1.2 United Arab Emirates
    • 10.5.1.3 Qatar
    • 10.5.1.4 Israel
    • 10.5.1.5 Rest of Middle East
  • 10.5.2 Africa
    • 10.5.2.1 South Africa
    • 10.5.2.2 Egypt
    • 10.5.2.3 Morocco
    • 10.5.2.4 Rest of Africa

11 Strategic Market Intelligence

• 11.1 Industry Value Network and Supply Chain Assessment
• 11.2 White-Space and Opportunity Mapping
• 11.3 Product Evolution and Market Life Cycle Analysis
• 11.4 Channel, Distributor, and Go-to-Market Assessment

12 Industry Developments and Strategic Initiatives

• 12.1 Mergers and Acquisitions
• 12.2 Partnerships, Alliances, and Joint Ventures
• 12.3 New Product Launches and Certifications
• 12.4 Capacity Expansion and Investments
• 12.5 Other Strategic Initiatives

13 Company Profiles

• 13.1 Gilead Sciences, Inc.
• 13.2 Bristol-Myers Squibb Company
• 13.3 Johnson & Johnson
• 13.4 Novartis AG
• 13.5 Legend Biotech
• 13.6 Autolus Therapeutics
• 13.7 Galapagos NV
• 13.8 Fate Therapeutics
• 13.9 AstraZeneca
• 13.10 Mustang Bio
• 13.11 Fosun Pharma
• 13.12 JW Therapeutics
• 13.13 IASO Biotherapeutics
• 13.14 Juventas Cell Therapy
• 13.15 CARsgen Therapeutics
• 13.16 Cellectis
• 13.17 Sorrento Therapeutics
• 13.18 Pfizer, Inc.