CAR T-cell Therapy Market

Chimeric Antigen Receptor (CAR) T-cell therapy, an innovative cancer immunotherapy, begins with extracting T-cells from either patients (Autologous) or healthy donors (Allogeneic) via Leukapheresis. These extracted T-cells are then genetically modified using a viral vector to express synthetic receptors (CARs) on their surface, enabling them to selectively kill cancer cells while sparing healthy ones by targeting specific tumor cell surface proteins known as antigens. While CAR T-cell therapy has demonstrated remarkable efficacy in treating hematological malignancies like refractory/relapsed Acute Lymphoblastic Leukemia (ALL) and Diffuse Large B-cell Lymphoma (DLBCL), its success in treating solid tumors remains limited.

According to Biotech Forecasts, the global CAR T-cell therapy market was valued at USD 3,404 million in 2023 and is estimated to reach USD 12,832 million by 2030, registering a CAGR of 18% from 2023 to 2030.

Following Factors Driving the Market Growth:

(1)  Surge in Approved Products:

Since the landmark approvals of KYMRIAH and YESCARTA in 2017, there have been a total of 10 approved products globally. These include TECARTUS in 2020, followed by BREYANZI, ABECMA, and CARTEYVA in 2021. Continuing this trend, CARVYKTI obtained approval in 2022, with NexCAR19 (Actalycabtagene Autoleucel) and FUCASO (Equecabtagene Autoleucel) approved in India and China, respectively, in 2023. The most recently approved ZEVOR-CEL (Zevorcabtagene Autoleucel) in February 2024 by China NMPA for treating multiple myeloma further emphasizes this trend. 

Currently, there are 11 late-stage candidates slated for potential approval in 2024 or subsequent years, including Obecabtagene Autoleucel (Obe-cel), anticipated to undergo an FDA approval decision in 2024.

(2)  Increasing Public and Private Investment:

In 2022, the total global funding for the cell and gene therapy landscape amounted to USD 12.6 billion, which included venture financing of USD 5,106 million. Notable contributions came from cell therapy companies like Affini-T Therapeutics and ImmPACT Bio, raising $175 million and $111 million, respectively. 

Despite a pause in major M&A deals since Kite and Celgene's acquisition, AstraZeneca made significant moves in 2022, acquiring Neogene and TeneoTwo for USD 320 million and USD 1.3 billion, respectively. Moreover, in 2024, AstraZeneca finalized its acquisition of Gracell Biotechnology for USD 1.2 billion, securing its lead CAR T-cell therapy asset, CG012F.

(3)  The Rise in Prevalence of Cancer:

According to the World Health Organization (WHO), cancer was responsible for nearly 10 million deaths worldwide in 2022, making it the second leading cause of death globally after heart attacks. The American Cancer Society estimates that there will be around 2 million new cancer cases diagnosed in the United States in 2024.

Other factors that boost the market growth involve; (4) an increase in government support, (5) ethical acceptance of Cell and Gene therapy for cancer treatment, and (6) an increase in awareness regarding CAR T-cell therapy.

However, the high costs of treatment (with KYMRIAH and YESCARTA priced at $373,000, and the recently approved CARVYKTI at a staggering $465,000), along with extended production times (despite efforts by Novartis and Gilead to reduce manufacturing time by 2 days, autologous CAR T-cell therapy still requires 13 to 14 days), obstacles in solid tumor treatment, and concerns about unwanted immune responses and potential side effects may impede market growth.

These challenges, coupled with global economic difficulties, have led many cell therapy companies and startups to downsize or discontinue their CAR T-cell programs. Notably, Bellicum Pharmaceuticals and Celyad SA have taken such decisions, with Takeda being the latest to abandon its three CAR T-cell assets (TAK-102, TAK-103, and TAK-940). Moreover, Precision Biosciences strategically transferred the global rights of its PBCAR0191 to Imugene Limited.

Nevertheless, the long-term outlook for CAR T-cell therapy remains promising, with anticipated approvals of Allogeneic or "off-the-shelf" CAR T-cell therapies. Furthermore, the expanded application of CAR T-cell therapy beyond cancer, including in other immunology diseases, indicates sustained growth and innovation in the field.

The report also presents a detailed quantitative analysis of the current market trends and future estimations from 2028 to 2023. The forecasts cover 7 Product Types, 6 Disease Indication Types, 4 Regions, and 16 Countries. 

The report comes with an associated file covering quantitative data from all numeric forecasts presented in the report.

The report has the following key findings:

• The global CAR T-cell therapy market reached USD 3,404 million in 2023 and is anticipated to surge to USD 12,832 million by 2030, showcasing a robust CAGR of 18% from 2023 to 2030. 

• In 2023, YESCARTA® dominated the market with a 44% market share (USD 1,498 million) and is expected to maintain its dominance in the forecast period.

• The segment for Diffuse Large B-cell Lymphoma (DLBCL) emerged as the top revenue generator by disease indication, projected to sustain its market share, followed by the Acute Lymphocytic Leukemia (ALL) segment. 

• In 2023, North America dominated the global CAR T-cell therapy market with a 65.4% market share, poised to maintain its dominance in the forecast period.

• China is forecasted to exhibit the highest growth in the Asia-Pacific region during the forecast period, driven by the approval of three products, including Carteyva (2019), FUCASO (2023), and ZEVOR-CEL (2024). 

• India demonstrated a promising Compound Annual Growth Rate (CAGR) over the forecast period, notably highlighted by the introduction of its first domestically produced CAR T-cell therapy, NexCAR19 (Actalycabtagene Autoleucel), by ImmunoACT in 2023.

The report covers the following topics: 

• Market Drivers, Restraints, and Opportunities

• Porter's Five Forces Analysis

• Market Analysis by Product Type, Disease Indication, and Region 

• 30 Company Profiles, CAR T-Cell Pipeline, Financial Overview, and Key Strategies

• 10 Approved Product Profiles, Financial Overview, and Key Developments

• Clinical Trials Analysis from 2003 to Q1-2024

• Market analysis and forecast from 2018 to 2030

• Historical Timeline

• Key Market Developments from 2018 to 2023

• Expected Candidates Approval Analysis 

• Conclusion and Strategic Recommendations

• Others