Cellular Immunotherapy Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented By Therapy Type (CAR T Cell Therapy, Dendritic Cell Therapy, NK Cell Therapy, TIL Therapy, Others), By Indication (B-cell Malignancies, Prostate Cancer, Liver Cancer, Renal Cell Carcinoma, Others), By End-Use (Hospitals, Cancer Institutes, Others), By Region, By Competition 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 7.61 Billion
CAGR (2026-2031)	10.04%
Fastest Growing Segment	B-cell Malignancies
Largest Market	North America
Market Size (2031)	USD 13.51 Billion

Market Overview

The Global Cellular Immunotherapy Market will grow from USD 7.61 Billion in 2025 to USD 13.51 Billion by 2031 at a 10.04% CAGR. Cellular immunotherapy is a specialized therapeutic modality that harnesses the patient's immune system to identify and eliminate cancer cells, often by extracting, genetically modifying, and reinfusing immune cells such as T-cells to target specific tumor antigens. The Global Cellular Immunotherapy Market is primarily driven by the rising prevalence of oncological conditions and the accelerating pace of regulatory approvals for novel treatments, which have transitioned these therapies from experimental to mainstream clinical use. According to the Alliance for Regenerative Medicine, in 2024, investment in the cell and gene therapy sector increased by 30 percent, reflecting substantial capital inflow aimed at advancing these innovative pipelines.

Despite this robust growth trajectory, the market faces a significant challenge related to the complex and costly manufacturing processes required for autologous therapies. The logistical burden of maintaining a personalized, vein-to-vein supply chain creates scalability hurdles and high price points that could restrict patient access and impede broader market expansion.

Key Market Drivers

The escalating global incidence of cancer and autoimmune diseases serves as the primary catalyst for the expansion of the cellular immunotherapy market. As conventional standards of care often yield suboptimal outcomes for refractory malignancies, the demand for immune-modulating interventions like CAR-T therapy has intensified to meet the urgent need for durable biological treatments. This market momentum is fundamentally underpinned by the growing demographic burden of oncological conditions, which necessitates the rapid deployment of targeted cellular modalities. According to the American Cancer Society, January 2025, in the 'Cancer Facts & Figures 2025' report, it was projected that over 2,041,900 new cancer cases would be diagnosed in the United States alone. This surging patient population is driving biopharmaceutical developers to pivot towards scalable therapies capable of addressing high unmet medical needs across both hematological and solid tumor indications.

Rapid technological advancements in CAR-T and gene editing are concurrently transforming the commercial landscape, enabling the transition of these therapies from experimental pipelines to profitable, mainstream products. Improvements in genetic engineering and manufacturing consistency have streamlined the path to regulatory approval, fostering a favorable environment for market adoption and revenue growth. The economic impact of these innovations is evidenced by the robust financial performance of leading sector players. According to Gilead Sciences, February 2025, in the 'Fourth Quarter and Full Year 2024 Financial Results', Cell Therapy product sales increased by 6 percent year-over-year to 2.0 billion USD. Supporting this commercial progress is a proactive regulatory environment; according to the Regulatory Affairs Professionals Society, January 2025, in the 'CDER approved 50 novel drugs in 2024' article, the FDA's Center for Biologics Evaluation and Research granted approval for 10 new biological license applications in 2024, underscoring the agency's commitment to accelerating access to novel biological therapies.

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Key Market Challenges

The complex manufacturing framework required for autologous therapies constitutes a primary obstacle restricting the expansion of the Global Cellular Immunotherapy Market. Because these treatments involve a personalized, vein-to-vein supply chain, they demand labor-intensive processing and rigorous quality control that prevent traditional economies of scale. This logistical rigidity results in high costs of goods sold, translating into elevated market prices that many healthcare systems find difficult to sustain. Consequently, the high price point limits reimbursement coverage and narrows the patient population capable of accessing these interventions, effectively capping the potential market volume for new entrants.

This manufacturing bottleneck has led to a market environment where commercial success is heavily concentrated rather than broadly distributed. The inability to efficiently scale production forces the industry to rely on a small number of assets, stifling the diversification necessary for robust growth. According to the Alliance for Regenerative Medicine, in 2025, approximately 75 percent of global revenue in this sector is generated by fewer than ten commercialized products. This high degree of revenue concentration illustrates how scalability hurdles directly impede the broader market from maturing into a high-volume therapeutic landscape.

Key Market Trends

The utilization of artificial intelligence in cell therapy discovery is fundamentally altering the R&D landscape by streamlining the identification of optimal cellular constructs and predicting therapeutic efficacy with enhanced precision. Developers are increasingly deploying machine learning algorithms to analyze vast biological datasets, allowing for the rapid design of synthetic receptors that minimize off-target effects before wet-lab testing begins. This computational shift is significantly compressing development timelines; according to the International Institute for Management Development, November 2025, in the 'Future Readiness Indicator 2025' report, the integration of AI-driven workflows can cut the time required to reach preclinical candidates by up to 40 percent. By reducing trial-and-error experimentation, these technologies are lowering early-stage costs and enhancing the probability of clinical success.

A decided shift towards allogeneic off-the-shelf cell therapies is concurrently emerging to address the logistical limitations of first-generation autologous treatments. By utilizing healthy donor cells or induced pluripotent stem cells to create standardized master cell banks, manufacturers can produce therapeutic doses in advance, ensuring immediate availability and enabling true commercial scalability. This transition is gaining substantial regulatory momentum; according to Reprocell, September 2025, in the 'Current Landscape of FDA Stem Cell Approvals and Trials 2023-2025' article, Fate Therapeutics' off-the-shelf iPSC-derived CAR-T therapy for systemic lupus erythematosus was granted FDA RMAT designation in April 2025. As these platforms advance, they promise to democratize access by dismantling the complex supply chains that currently restrict market growth.

Segmental Insights

The B-cell Malignancies segment represents the fastest-growing area within the Global Cellular Immunotherapy Market, primarily driven by the demonstrated clinical efficacy of CAR-T cell therapies in treating hematological cancers. This rapid expansion is supported by a steady stream of product approvals from the U.S. Food and Drug Administration (FDA), which has authorized these targeted treatments for conditions such as diffuse large B-cell lymphoma and acute lymphoblastic leukemia. Additionally, regulatory decisions to approve these therapies for earlier lines of treatment have substantially increased the addressable patient population. Consequently, the rising adoption of these curative options for relapsed or refractory cases continues to fuel significant market growth.

Regional Insights

North America maintains a dominant position in the global cellular immunotherapy market, driven primarily by the high prevalence of chronic diseases and a robust healthcare infrastructure. The region benefits significantly from extensive research and development initiatives funded by established pharmaceutical organizations. Additionally, the U.S. Food and Drug Administration provides a favorable regulatory framework that expedites the approval and commercialization of new therapies. High healthcare expenditure and the early adoption of advanced treatment modalities further support market expansion, ensuring the region remains the primary contributor to global industry revenue.

Recent Developments

• In August 2024, Adaptimmune Therapeutics achieved a major breakthrough in the Global Cellular Immunotherapy Market with the U.S. FDA accelerated approval of Tecelra (afamitresgene autoleucel). This product became the first engineered cell therapy approved for a solid tumor indication in the United States, specifically for adults with unresectable or metastatic synovial sarcoma. The approval was grounded in positive results from the SPEARHEAD-1 trial, which highlighted the efficacy of the TCR T-cell therapy in targeting MAGE-A4 positive tumors. This advancement represented a critical step forward in extending the reach of cellular immunotherapies beyond hematological cancers and offered new hope for patients with rare soft tissue sarcomas.
• In April 2024, Johnson & Johnson announced that the U.S. FDA approved Carvykti (ciltacabtagene autoleucel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. This approval expanded the indication for the BCMA-targeted CAR-T cell therapy into earlier lines of treatment, significantly impacting the Global Cellular Immunotherapy Market. The decision was supported by data from the Phase 3 CARTITUDE-4 study, which showed that the therapy reduced the risk of disease progression or death compared to standard regimens. This development underscored the company's commitment to advancing immune-based treatments for blood cancers.
• In February 2024, AstraZeneca announced the successful completion of its acquisition of Gracell Biotechnologies, a global clinical-stage biopharmaceutical company dedicated to developing innovative cell therapies. This strategic transaction, valued at approximately $1.2 billion, integrated Gracell’s proprietary FasTCAR manufacturing platform into AstraZeneca’s expanding oncology portfolio. The acquisition significantly bolstered the company's capabilities in the Global Cellular Immunotherapy Market by adding GC012F, a potentially best-in-class dual-targeting autologous CAR-T therapy for multiple myeloma and autoimmune diseases. By finalizing this deal, the company aimed to accelerate its ambition to deliver transformative cell therapies and address unmet medical needs in hematologic malignancies.
• In February 2024, Iovance Biotherapeutics received accelerated approval from the U.S. FDA for Amtagvi (lifileucel), marking a historic milestone in the Global Cellular Immunotherapy Market. This regulatory decision established Amtagvi as the first tumor-derived autologous T cell immunotherapy authorized for adult patients with unresectable or metastatic melanoma. The approval was supported by clinical data demonstrating durable response rates in patients who had previously been treated with a PD-1 blocking antibody and other standard therapies. The commercial launch of this novel tumor-infiltrating lymphocyte (TIL) therapy introduced a pioneering personalized treatment modality for solid tumor cancers, addressing a significant therapeutic gap.

Key Market Players

• Bristol-Myers Squibb Company
• Novartis AG
• Gilead Sciences Inc.
• F. Hoffmann-La Roche Ltd.
• Merck KGaA
• GlaxoSmithKline plc
• AstraZeneca Plc
• Pfizer Inc.
• Johnson & Johnson
• Celyad

By Therapy Type	By Indication	By End-Use	By Region
CAR T Cell Therapy Dendritic Cell Therapy NK Cell Therapy TIL Therapy Others	B-cell Malignancies Prostate Cancer Liver Cancer Renal Cell Carcinoma Others	Hospitals Cancer Institutes Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Cellular Immunotherapy Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Cellular Immunotherapy Market, By Therapy Type:

• CAR T Cell Therapy
• Dendritic Cell Therapy
• NK Cell Therapy
• TIL Therapy
• Others

• Cellular Immunotherapy Market, By Indication:

• B-cell Malignancies
• Prostate Cancer
• Liver Cancer
• Renal Cell Carcinoma
• Others

• Cellular Immunotherapy Market, By End-Use:

• Hospitals
• Cancer Institutes
• Others

• Cellular Immunotherapy Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE