CAR-T Cell Therapy Market

The CAR-T Cell Therapy Market is Expected to Reach US$ 11.80 Billion by 2031, Up from US$ 3.85 Billion in 2024, with a Projected CAGR of 17.5% from 2031 to 2031.

Market Insights and Analyst Perspective:

Chimeric antigen receptor (CAR) T cell therapy is emerging as one of the most effective cancer treatment strategies, with numerous pre-clinical and clinical trials conducted annually to broaden its applications. Following decades of research, the expansion of CAR-T cell therapy is inevitable. Future developments will explore not only autologous and allogeneic products but also new in-vivo CAR-T cell gene therapies and their effectiveness in conditions beyond hematologic malignancies. However, challenges in commercialization are hindering the growth of the CAR-T cell therapy market.

Growth Drivers:

Increasing Cancer Incidence Fuels CAR-T Cell Therapy Demand

CAR-T cell therapy represents a novel approach to cancer treatment, where T cells are engineered in a laboratory and reintroduced into the body to target cancer cells. This therapy is currently used to treat adult and pediatric leukemia, as well as certain types of lymphoma, and is being investigated for potential use against other cancers, including some solid tumors in the chest area.

Factors such as genetic predisposition, consumption of processed foods, environmental pollution, and lifestyle changes are contributing to the rising incidence of cancer. The American Cancer Society reported approximately 19.3 million new cancer cases worldwide in 2020. Consequently, the growing number of cancer patients is driving the demand for CAR-T cell therapies.

Strategic Insights

Report Segmentation and Scope:

The analysis of the "CAR-T cell therapy market" has been conducted based on the following segments: targeted antigen, indication, and end user.

Segmental Analysis:

In terms of targeted antigen, the CAR-T cell therapy market is divided into CD19 and BCMA segments. The CD19 segment accounted for a larger share of the CAR-T cell therapy market in 2022 and is expected to achieve a higher CAGR of 17.9% during the forecast period.

CAR-T cells have proven effective in treating relapsed/refractory diffuse large B cell lymphoma. Patient-derived T cells are genetically modified to create CD19 CAR T cells, which express receptors that bind to the CD19 protein, commonly found in leukemia and lymphoma cells.

The growth of this segment is expected to be driven by the availability of CD19 CAR-T cell therapy products. Below is a list of products approved by the US Food and Drug Administration and the European Union:

Manufacturer

Brand Product

Target Antigen

Disease Indication

Approval Year

Novartis

KYMRIAH

CD19

Leukemia

2017

Gilead Sciences, Inc

YESCARTA

CD19

Lymphoma

2017

Gilead Sciences, Inc

TECARTUS

CD19

Lymphoma and Leukemia

2020

Bristol Myers Squibb

BREYANZI

CD19

Lymphoma

2021

The CAR-T cell therapy market is categorized by indication into lymphomas, leukemia, and multiple myeloma. The lymphomas segment held the largest market share in 2022 and is projected to grow at a higher CAGR of 18.1% during the forecast period. Hematological malignancies, including acute lymphoblastic leukemia, chronic lymphocytic leukemia, lymphoma, and multiple myeloma, are the primary indications for CAR-T cell therapy.

By end user, the CAR-T cell therapy market is divided into hospitals and specialty clinics, ambulatory surgical centers, and others. The hospitals and specialty clinics segment dominated the market in 2022 and is expected to register the highest CAGR of 17.9% during the forecast period.

Technological Innovations to Propel CAR-T Cell Therapy Market Growth

The development and implementation of CAR-T therapy, which utilizes a patient's white blood cells to target specific blood cancer types, is among the most significant medical breakthroughs in recent years. CAR-T cell therapy offers hope for some cancer patients as a potential cure. Since the first CAR-T therapy was approved in 2017, five additional therapies have received FDA approval for specific adult and pediatric leukemia, lymphoma, and multiple myeloma types. Research is also underway to develop similar therapies for solid tumors.

Allogeneic CAR-T cell therapy has been the focus of numerous global pre-clinical and clinical trials, primarily targeting hematological malignancies, with CD19 being the most common target, alongside traditional targets like CD20, CD22, and BCMA. New targets such as CD70, CD7, and CD5 are also being explored. Emerging therapies for solid tumors are targeting mesothelin, GD2, and NKG2DL.

Thus, advancements in cell-based therapies are likely to introduce new trends in the CAR-T cell therapy market in the coming years.

Regional Analysis:

The global CAR-T cell therapy market report encompasses North America, Europe, Asia Pacific, South and Central America, and the Rest of the World. In 2022, North America held the largest share of the CAR-T cell therapy market. The growth in this region is fueled by the increasing number of product launches by leading manufacturers and the presence of key market players. Additionally, extensive research and development by various pharmaceutical and biotechnology companies, as well as academic and research institutions, are expected to drive market growth in North America. For example, in June 2022, Bristol Myers Squibb announced the FDA approval of Breyanzi (lisocabtagene maraleucel), a CD19-directed CAR-T cell therapy for adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL).

In the US, the growth of the CAR-T cell therapy market is primarily driven by the expanding pharmaceutical and biopharmaceutical sectors, characterized by technological advancements and increasing adaptability. Furthermore, rising R&D investments by US-based pharmaceutical and biotechnology companies aimed at improving clinical trial outcomes and ensuring patient safety are propelling market growth. For instance, in July 2021, BioNTech SE signed a purchase agreement with Kite, a Gilead Company, to acquire Kite's clinical manufacturing facility in Gaithersburg, MD, along with its solid tumor neoantigen T cell receptor (TCR) R&D platform. This new facility will enhance BioNTech's existing cell therapy manufacturing capabilities in Idar-Oberstein, Germany, and provide additional capacity to support clinical trials in the US, advancing the company's innovative cell therapy pipeline, which includes candidates for cancer based on NEOSTIM and CAR-T Cell Amplifying mRNA Vaccine (CARVac) and the recently acquired Individualized Neoantigen TCR program.

Future Opportunities and Research Developments:

While CAR-T cell therapies have demonstrated promising results in cancer treatment, their application is currently limited to patients with specific liquid tumors that are relapsed and resistant. In the coming years, several CAR-T cell therapies for regenerative medicine in the US and advanced therapy medicinal products in Europe are expected to gain market authorization. Numerous key players are developing innovative techniques for a wide array of indications. In the long term, these therapies may significantly enhance patient outcomes by providing substantial, potentially curative health benefits from a single dose.

The future of CAR-T cell therapy appears bright, given the number of ongoing clinical trials and the development of new CAR-T cell products for various indications. Researchers are motivated to explore ways to improve the efficacy of CAR-T cells, as evidenced by the complete response rates and progression-free survival seen in patients with relapsed/refractory malignancies who have undergone extensive prior treatments.

Investigations are underway into factors such as antigen loss that may lead to immune escape, with strategies being developed to address these challenges. One approach involves creating CAR-T cell therapies that target multiple antigens simultaneously. New therapies are being developed to target antigens like CD138 and GPRC5D, while CAR-T cell therapies for ALL and NHL focus on the CD19 antigen, and therapies for multiple myeloma target the BCMA antigen.

The CAR-T cell therapy market forecast can assist stakeholders in this sector in planning their growth strategies. Below are some research and development initiatives by leading players in the CAR-T cell therapy market:

• In November 2023, Vittoria Biotherapeutics announced the completion of a private financing round, raising over US$15 million to fund clinical trials for VIPER-101, an autologous dual population CD5-knockout CAR-T cell therapy for T cell lymphoma.
• In December 2023, AstraZeneca revealed its acquisition of Gracell Biotechnologies Inc. to enhance AstraZeneca's existing capabilities and previous investments in cell therapy.
• In December 2021, researchers at the University of California San Diego School of Medicine received a US$4.1 million grant to support the advancement of their innovative CAR-T cell therapy, funded by the governing board of the California Institute for Regenerative Medicine, which may facilitate the transition of novel cancer treatments from the lab to patients.

CAR-T Cell Therapy Market Report Scope

Competitive Landscape and Key Companies:

Prominent companies profiled in the CAR-T cell therapy market report include Bristol-Myers Squibb Company, Novartis AG, Gilead Sciences, Inc., Johnson and Johnson Services, Inc., CARsgen Therapeutics Co., Ltd, Aurora Biopharma, Legend Biotech, Pfizer Inc., bluebird bio, Inc., Mustang Bio, Sorrento Therapeutics, Inc., and Fate Therapeutics. These companies are focused on developing new technologies, enhancing existing products, and expanding their geographic reach to meet the growing global demand.