Cell Therapy - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2026-2031)

The cell therapy market size is expected to increase from USD 5.58 billion in 2025 to USD 6.55 billion in 2026 and reach USD 14.56 billion by 2031, growing at a CAGR of 17.32% over 2026-2031. This report is Segmented by Therapy Type (Autologous Cell Therapy and Allogeneic Cell Therapy), by Cell Type (Stem Cell Therapy and More), Application (Oncology, Cardiovascular and More), End User (Hospitals & Clinics, Specialized Cell- & Gene-Therapy Centers, and More), and Geography (North America, Europe, Asia-Pacific, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Cell Therapy Market Trends and Insights

Rising Approvals and Commercial Launches of Autologous CAR-T Therapies

The United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved nine new CAR-T indications between 2024 and 2025, reducing median review time from 14 months to 9 months. Novartis reported USD 680 million in 2025 revenue for Kymriah, reflecting 28% growth following label expansion to follicular lymphoma. European conditional approvals for three autologous T-cell receptor therapies in 2025 were the first for solid tumors, unlocking a USD 2.1 billion addressable segment by 2028. United States commercial payers linked 30-50% of reimbursement to six-month complete response rates across five CAR-T products in 2024, lowering upfront risk for hospitals. Japan’s regenerative-medicine fast-track designation halved review times for candidates with Phase 2 data showing ≥40% objective responses.

Build-Out of Global CDMO Capacity for Allogeneic Pipelines

CDMOs installed 180,000 liters of allogeneic capacity from 2024 to 2025, including Lonza’s 50,000-liter Portsmouth facility and Charles River’s 40,000-liter Leiden site. Off-the-shelf platforms now generate a therapy batch within 48 hours, down from 4-6 weeks for autologous processes, and the cost-of-goods dropped from USD 350,000 to USD 75,000 per dose. Allogene Therapeutics’ ALPHA2 candidate delivered 67% complete remission in large B-cell lymphoma and targets a U.S. biologics license filing by mid-2026. Vertex and CRISPR Therapeutics committed USD 420 million to a Swiss base-edited T-cell plant, aiming for 100,000 annual doses by 2028. Samsung Biologics’ USD 300 million Incheon facility secured four regional contracts, signaling Asia-Pacific supply-chain localization.

Other drivers and restraints analyzed in the detailed report include:

• Expansion of National Reimbursement Pathways
• AI-Optimized Closed Bioreactor Systems Cutting COGs Greater Than 40%
• High Cost-of-Goods for Personalized Autologous Batches
• Viral-Vector and Plasmid Supply-Chain Bottlenecks

Segment Analysis

Autologous products held 91.3% of the cell therapy market share in 2025, supported by mature CAR-T franchises and established reimbursement pathways. However, the allogeneic segment is advancing at a 17.34% CAGR through 2031 as off-the-shelf availability removes the 4-6 week manufacturing wait, lowers cost-of-goods to USD 75,000, and streamlines logistics.

Investor confidence intensified in 2025 when Vertex and CRISPR Therapeutics backed a Swiss plant designed for 100,000 doses annually, underscoring the scalability edge of allogeneic platforms. Regulatory flexibility, such as FDA acceptance of non-viral transfection, has shortened timelines, while outcomes-based contracting is tightening margins for autologous players. Allogeneic candidates, therefore, position the cell therapy market for cost-efficient penetration into less-affluent geographies without sacrificing margin integrity.

Immune-cell therapies dominated 56.1% revenue in 2025, largely from CAR-T and tumor-infiltrating lymphocyte programs endorsed by strong oncology data. Stem-cell platforms are expanding at an 18.32% CAGR as mesenchymal and induced pluripotent stem-cell (iPSC) candidates demonstrate efficacy in cardiovascular and neurological disorders.

Mesoblast’s Phase 3 heart-failure trial cut major adverse events by 34%, while Takeda’s iPSC cardiomyocytes are enrolling ischemic patients with the first readout expected in 2026. Breakthroughs in scaffold and 3D-printing technologies are further elevating stem-cell momentum, positioning them as the cell therapy market’s diversification engine beyond hematologic malignancies.

Complete Report Scope:

• By Therapy Type
  • Autologous Cell Therapy
  • Allogeneic Cell Therapy
• By Cell Type
  • Stem Cell Therapy
    • Hematopoietic Stem Cells
    • Mesenchymal Stem Cells
    • Induced Pluripotent Stem Cells
  • Immune Cell Therapy
    • T-Cell Therapy (incl. CAR-T, TCR-T)
    • NK-Cell Therapy
    • Dendritic Cell Therapy
  • Fibroblast & Chondrocyte-based Therapies
• By Application
  • Oncology
  • Autoimmune Disorders
  • Cardiovascular Diseases
  • Orthopedic & Musculoskeletal
  • Neurological Disorders
  • Wound Healing & Dermatology
  • Ophthalmology
• By End User
  • Hospitals & Clinics
  • Specialized Cell- & Gene-Therapy Centers
  • Academic & Research Institutes
  • Contract Manufacturing & CRO Facilities
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Rest of APAC
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America recorded a 54.2% share in 2025, with NTAP covering USD 80,000-200,000 per case and five commercial insurers shifting 30-50% payment to outcome-based models. Approvals rose to nine indications for CAR-T therapy between 2024-2025, and Yescarta revenue grew 22% to USD 2.1 billion. High apheresis-suite utilization at 85% created 6-8-week waits, underscoring capacity constraints.

Europe held a 28% share as Germany’s NUB pathway accelerated billing for three allogeneic therapies, while NICE guidance released GBP 120 million in U.K. funding. Conditional approvals for T-cell receptors targeting solid tumors opened a USD 2.1 billion European opportunity. However, QALY thresholds introduced in 2024 require an average of 35% discounts, tempering revenue expansion.

Asia-Pacific registered the fastest 17.89% CAGR; China’s first domestic CAR-T approval, Carvykti, addressed 2,500 multiple-myeloma patients in year one. Japan’s conditional reimbursement route accepted Phase 2 data with a mandatory seven-year follow-up. South Korea reimbursed two local CAR-Ts at 40% lower prices, serving 1,200 patients in 2025. Supply-chain localization via Samsung Biologics and growing CDMO capacity are consolidating the region as the cell therapy market’s next growth engine.

List of Companies Covered in this Report:

• Novartis
• Gilead Sciences
• Bristol-Myers Squibb
• Johnson & Johnson (Janssen Biotech)
• Legend Biotech Corporation
• Fate Therapeutics Inc.
• Bluebird Bio
• Allogene Therapeutics
• Sangamo Therapeutics
• CRISPR Therapeutics AG
• Mesoblast Limited
• Vericel
• Glycostem Therapeutics BV
• Celyad Oncology SA
• Iovance Biotherapeutics Inc.
• CARsgen Therapeutics Holdings
• JW Therapeutics Co. Ltd.
• Takeda Pharmaceuticals
• Astellas Pharma
• Vertex Pharmaceuticals Inc.
• Sanofi
• Century Therapeutics Inc.
• Be The Match BioTherapies
• Lonza Group
• Charles River

Additional Benefits:

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