North America CAR T-Cell Therapy Market Outlook to 2028

North America CAR T-Cell Therapy Market Overview

The North America CAR T-Cell Therapy market reached a valuation of USD 1.7 billion based on the historical data of past five years. The market is primarily driven by advancements in immunotherapy and a rising prevalence of hematological cancers such as leukemia and lymphoma, which are primary targets for CAR T-Cell therapies. An increasing number of regulatory approvals for therapies in the region further stimulates market growth.

The North American CAR T-Cell therapy market is dominated by several key players including Kite Pharma (Gilead Sciences), Novartis, Juno Therapeutics (Bristol-Myers Squibb), Legend Biotech, and Autolus Therapeutics. These companies are pioneers in the field, with Kite Pharma and Novartis leading the commercial approval of CAR T-cell therapies like Yescarta and Kymriah, respectively, making them critical players in the development of next-generation therapies.

In May 2023, Gilead Sciences announced the expansion of its CAR T-cell therapy production facility in California to meet growing demand. The expansion is set to increase its production capacity by 25%, targeting more patients in North America. This development is seen as a strategic move to solidify Kite Pharmas position as a market leader, particularly as the demand for CAR T-cell therapies rises across the region.

California is emerging as the dominant state in the North American CAR T-cell therapy industry, driven by its concentration of biotechnology companies and world-class research institutions. In 2023, the state accounted for more than one-third of the total CAR T-cell therapy treatments in the U.S., largely due to the presence of major players like Gilead Sciences and the proximity to research hubs such as Stanford University.

North America CAR T-Cell Therapy Market Segmentation

The North America CAR T-cell therapy market is segmented into various factors product type, therapeutic application and region etc.

By Product Type: The market is segmented by product type into Autologous CAR T-cell Therapy and Allogeneic CAR T-cell Therapy. Autologous CAR T-cell Therapy held a dominant market share in 2023 due to its effectiveness in personalized treatment. The therapy uses the patient's own cells, reducing the risk of immune rejection and increasing therapeutic efficacy.

By Therapeutic Application: The market is segmented into Hematological Cancers, Solid Tumors, and Autoimmune Diseases. Hematological Cancers accounted dominated the market share, driven by the success of CAR T-cell therapies in treating conditions like B-cell lymphomas and multiple myeloma. The dominance of this segment is attributed to the high efficacy rates observed in hematological malignancies, which have seen a complete remission rate in relapsed or refractory patients.

By Region: The market is segmented regionally into USA and Canada. The USA dominates the North America CAR T-Cell Therapy market, accounting for a dominant part of the market. This is due to the presence of major biotechnology companies, advanced research facilities, and a robust regulatory framework that supports the rapid approval and commercialization of CAR T-cell therapies.

North America CAR T-Cell Therapy Market Competitive Landscape

Player Name

Establishment Year

Headquarters

Kite Pharma (Gilead)

2009

Santa Monica, CA

Novartis

1996

Basel, Switzerland

Juno Therapeutics (BMS)

2013

Seattle, WA

Legend Biotech

2014

Somerset, NJ

Autolus Therapeutics

2014

London, UK

Legend Biotechs License Agreement with Novartis: Legend Biotech recently announced an exclusive, global license agreement with Novartis for certain CAR-T therapies targeting DLL3.The deal grants Novartis the exclusive worldwide rights to develop, manufacture and commercialize these cell therapies, including Legend Biotech's autologous CAR-T cell therapy candidate LB2102

Novartis Partners with Major Research Institutions: Novartis has been actively developing its T-Charge platform, a next-generation CAR-T technology designed to enhance the efficacy and safety of CAR-T therapies. This platform aims to preserve T cell stemness, which is critical for maintaining the therapeutic potential of CAR-T cells. Early clinical trials using this platform, specifically with therapies YTB323 (targeting CD19) and PHE885 (targeting BCMA).

North America CAR T-Cell Therapy Industry Analysis

Growth Drivers

Increasing Cancer Incidence: In North America, the number of patients diagnosed with hematological cancers, such as lymphoma and leukemia, is significantly rising. In 2024, new cases of blood cancers are being reported, driving the demand for advanced treatment options like CAR T-cell therapy. This rising patient population has led to a surge in clinical trials, with trials actively investigating CAR T-cell therapies in 2024.

Advances in CAR T-Cell Therapy Manufacturing: CAR T-cell therapies are benefitting from improvements in manufacturing processes, reducing the time required to produce personalized treatments. In 2024, the average production time for autologous CAR T-cell therapies has decreased from 22 days to 15 days. This advancement is expected to allow an additional 1,500 patients in the U.S. to access treatment by the end of the year. Enhanced manufacturing capabilities, combined with increased investment, are pushing the availability of these therapies beyond their traditional use cases.

Rising Investment in Immuno-oncology: The biotechnology sector, including immuno-oncology, has seen record-setting investments, with the bio-pharma sector raising approximately USD 9.3 billion in 2023 alone. Leading biopharmaceutical companies are directing more capital toward expanding the application of CAR T-cell therapies beyond hematological cancers. This influx of funding supports the commercialization of new CAR T-cell therapies for solid tumors, a key area of development in North America.

Challenges

Complex Supply Chain and Manufacturing Bottlenecks: The process of manufacturing CAR T-cell therapies is highly complex, involving the harvesting, modification, and reinfusion of a patients own cells. In 2024, delays in cell processing caused by supply chain constraints and limited manufacturing capacity are expected to affect patients. The shortage of production facilities, combined with the need for specialized logistics, has led to long wait times.

Limited Healthcare Infrastructure: While CAR T-cell therapy has been approved in several regions across North America, not all healthcare facilities are equipped to handle the complexities of administering these therapies. In 2024, fewer than 250 certified centers across the U.S. and Canada can provide CAR T-cell treatments, limiting patient access in rural or underserved regions.

Government Initiatives

Expansion of the Cancer Moonshot Program: The Biden Cancer Moonshot aims to accelerate progress in cancer research and improve prevention, detection, and treatment. It emphasizes collaboration across various sectors, including federal agencies, healthcare providers, and private companies, focusing on the treatment of solid tumors.

State-Level Funding for CAR T-Cell Therapy Research: Several states, including California and New York, have announced their own initiatives to fund CAR T-cell therapy research. In 2024, California alone allocated USD 1.2 billion to cancer research, with a portion dedicated to CAR T-cell development. These state-level investments aim to accelerate clinical trials for new therapies, particularly those targeting solid tumors.

North America CAR T-Cell Therapy Market Future Outlook

The CAR T-cell therapy market in North America is expected to grow exponentially. Future growth is expected to be driven by the increasing number of indications approved for CAR T-cell therapies beyond hematological malignancies, potentially targeting solid tumors. Ongoing clinical trials and the potential for personalized medicine approaches will further bolster market expansion over the next five years.

Future Trends

Expansion of CAR T-Cell Applications to Solid Tumors: By 2028, CAR T-cell therapy will expand beyond hematological cancers to target solid tumors, which account for many new cases in North America. This shift will be driven by ongoing clinical trials, which are expected to receive approval in the next 3-4 years. These therapies will be specifically designed to target antigens found in solid tumors like pancreatic and lung cancer, opening new avenues for treatment.

Introduction of Multi-Targeting CAR T-Cell Therapies: Multi-targeting CAR T-cell therapies, capable of attacking multiple cancer antigens simultaneously, will become the standard of care for relapsed cancers. Early data from 2024 clinical trials show that these therapies could improve remission rates of traditional single-target therapies. The FDA is expected to grant approval for these therapies within the next five years, marking a significant advancement in cancer treatment.
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