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市場調査レポート
商品コード
1737200
CAR-T細胞療法市場(標的抗原別、治療用途別、地域別):将来予測(2026~2032年)Car T Cell Therapy Market By Targeted Antigen (CD 19, HER1, BCMA, CD33), Therapeutic Application (Acute Lymphocytic Leukemia, Colorectal Cancer, Chronic Lymphocytic Leukemia, Hepatocellular Carcinoma) & Region for 2026-2032 |
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CAR-T細胞療法市場(標的抗原別、治療用途別、地域別):将来予測(2026~2032年) |
出版日: 2025年05月09日
発行: Verified Market Research
ページ情報: 英文 202 Pages
納期: 2~3営業日
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がん、特に白血病やリンパ腫などの血液悪性腫瘍の罹患率の増加は、CAR-T細胞療法が効率的に標的とするものです。さらに、遺伝子編集技術やカスタマイズ医療の進歩により、より精密で効果的な治療が可能になり、2024年には369億米ドル、2032年には1,916億米ドルに達します。
腫瘍学研究のための資金が増加し、規制当局の承認も良好なことから、これらの治療法の開発と商業化が加速しています。革新的な治療に対する患者の需要や、KymriahやYescartaなどの初期のCAR-T細胞療法の成功が、市場の拡大をさらに後押ししており、2026年から2032年までのCAGRは約63.82%で成長しています。
CAR-T細胞療法市場の定義/概要
CAR-T細胞療法は免疫療法の一種であり、患者のT細胞がキメラ抗原受容体(CAR)を発現するように遺伝子改変され、より効果的にがん細胞を標的として攻撃できるようになります。主な用途は、白血病、リンパ腫、多発性骨髄腫などの血液悪性腫瘍の治療です。この治療法は、特にこれまでの治療法に反応しなかった人に有望な結果をもたらしています。CAR-T細胞療法の将来には、固形がんへの適用拡大、安全性と有効性の向上、治療コストの削減、新しい製造・送達システムによるアクセシビリティの向上が含まれます。
がんの罹患率の上昇は、CAR-T細胞療法市場を牽引する重要な要素です。世界中でがん罹患率が上昇するにつれ、革新的で効果的な治療法に対する要望が高まっています。世界保健機関(WHO)によると、がんの診断数は2040年までに2,950万人に達すると予測されており、白血病やリンパ腫などの血液悪性腫瘍が重要な役割を果たしています。このような負担の増大は、個別化治療の選択肢を提供し、臨床試験で有望な結果を示しているCAR-T細胞療法への関心と投資を高めています。
政府や医療機関は、新規のがん治療薬に対する重要な必要性を認識しており、CAR-T細胞療法の研究と承認を推進しています。2024年3月、FDAはいくつかのがん種を対象とした新規CAR-T細胞療法の承認プロセスを早め、こうした革新的治療への患者アクセスの拡大へのコミットメントを示しました。さらに、研究開発への多額の投資、バイオテクノロジー企業と研究機関の共同努力により、CAR-T細胞療法産業は劇的に拡大すると予測されています。がんの発生頻度が増加し、より良い治療法が求められ続けていることから、世界のCAR-T細胞療法市場は2030年までに380億米ドルに達すると予想されています。
CAR-T細胞療法の一般的で重篤な副作用であるサイトカイン放出症候群(CRS)の発生率の上昇は、市場拡大を阻害する可能性があります。CRSは、CAR-T細胞が注入中に過剰に活性化され、炎症性サイトカインが大量に放出されることで生じ、高熱、血圧低下、呼吸器障害、重症の場合は臓器不全を引き起こす可能性があります。CRSの予測不可能性と重症度は、医療従事者、患者、規制当局の間に懸念を生み、CAR-T細胞療法に対する一般の認識や取り込みに影響を及ぼしています。CRSの治療には、トシリズマブやコルチコステロイドのような免疫抑制薬の使用を含む慎重なケアが必要であり、すでに高額となっている治療費をさらに増加させ、患者へのアクセスをさらに制限する可能性があります。
CRSの早期発見と管理技術の進歩は、危険性の軽減に役立っています。研究開発は、より安全でCRSを引き起こしにくい次世代CAR-T細胞療法を開発しています。さらに、CRSのモニタリングと対応に関する臨床ガイドラインも進化しており、いくつかの懸念は払拭されつつあります。しかし、重篤な副作用の継続的な可能性は、特に医療インフラが未発達な地域や集中治療が高額な地域において、より広範な市場成長の障壁となっています。
The increasing incidence of cancer, particularly hematologic malignancies such as leukemia and lymphoma, which CAR T-cell treatments efficiently target. Furthermore, advances in gene-editing technology and customized medicine are allowing for more precise and effective therapies is fuelling the USD 36.9 Billion in 2024 and reaching USD 191.6 Billion by 2032.
Rising funding for oncology research, along with favorable regulatory approvals, is accelerating the development and commercialization of these therapies. Patient demand for innovative treatments and the success of early CAR T therapies, such as Kymriah and Yescarta, are further fueling market expansion is grow at a CAGR of about 63.82% from 2026 to 2032.
Car T Cell Therapy Market: Definition/ Overview
CAR T-cell treatment is a type of immunotherapy in which a patient's T-cells are genetically modified to express chimeric antigen receptors (CARs), allowing them to more effectively target and attack cancer cells. Its main applications are to treat blood malignancies such as leukemia, lymphoma, and multiple myeloma. The therapy has produced promising outcomes, particularly in individuals who have not responded to previous therapies. The future of CAR T-cell therapy includes expanding its application to solid tumors, improving safety and efficacy, lowering treatment costs, and increasing accessibility through novel manufacturing and delivery systems.
The rising incidence of cancer is a crucial element driving the CAR T-cell treatment market. As cancer rates climb around the world, there is an increased desire for innovative and effective therapies. According to the World Health Organization (WHO), cancer diagnoses are anticipated to reach 29.5 million by 2040, with hematologic malignancies like leukemia and lymphoma playing a significant role. This growing burden has sparked increased interest and investment in CAR T-cell treatments, which provide individualized therapy choices and have demonstrated encouraging results in clinical trials.
Governments and healthcare organizations recognize the critical need for novel cancer medicines and are thus promoting the research and approval of CAR T-cell treatments. In March 2024, the FDA hastened the clearance process for new CAR T therapies targeting several cancer types, demonstrating a commitment to expanding patient access to these innovative treatments. Furthermore, with large investments in research and development, as well as joint efforts between biotech businesses and research institutes, the CAR T-cell treatment industry is predicted to expand dramatically. The global CAR T-cell therapy market is expected to reach $38 billion by 2030, owing to the increasing frequency of cancer and the continued need for better treatments.
Rising incidence of cytokine release syndrome (CRS), a common and serious side effect of CAR T-cell therapy, may impede market expansion. CRS arises when CAR T-cells become over-activated during infusion, resulting in a huge release of inflammatory cytokines that can induce high fevers, low blood pressure, respiratory problems, and, in severe cases, organ failure. The unpredictability and severity of CRS have created concerns among healthcare practitioners, patients, and regulatory agencies, influencing public perception and uptake of CAR T-cell therapy. Managing CRS necessitates careful care, including the use of immunosuppressive medicines such as tocilizumab and corticosteroids, which might increase the already high treatment expenses, further limiting patient accessibility.
Advances in CRS early identification and management techniques are helping to reduce dangers. Researchers are developing next-generation CAR T-cell therapies that are designed to be safer and less likely to cause CRS. Furthermore, clinical guidelines for monitoring and responding to CRS are evolving, which may allay some concerns. However, the continuous potential of severe side effects remains a barrier to broader market growth, particularly in places with underdeveloped healthcare infrastructure or where intensive care is too expensive.
The growing demand for CD19-targeted CAR T-cell treatments is likely to greatly boost the market. CD19 is a well-known antigen for treating B-cell malignancies, specifically acute lymphocytic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL). The success of CD19-targeted therapies such as Kymriah (Novartis) and Yescarta (Gilead/Kite) has led to widespread acceptance, with the CD19 sector dominating the market. In June 2023,Gilead Sciences announced substantial rise in Yescarta sales, citing increased demand in the United States and Europe as more treatment centers accept the drug. The continuous success of these medicines has confirmed CD19 as a key market growth driver.
For instance, in April 2024, the US FDA granted Kymriah expedited permission to treat a broader group of patients with relapsed or refractory ALL, increasing access to the medication. This regulatory support demonstrates the increasing awareness of CD19 treatments' efficacy. Furthermore, continued research to increase safety and efficacy, combined with excellent clinical outcomes, ensures that the increasing demand for CD19-targeted medicines will continue to drive the CAR T-cell therapy industry.
The fastest-growing segment, is BCMA (B-cell maturation antigen), which is gaining popularity due to its efficacy in treating multiple myeloma. With novel BCMA-targeted medicines such as Abecma entering the market, this segment is projected to expand rapidly in the future years.
The increasing use of CAR T-cell treatments for acute lymphatic leukemia (ALL) is likely to drive market expansion. Kymriah (Novartis), a CAR T-cell therapy licensed for pediatric and young adult patients with relapsed or refractory ALL, has demonstrated extraordinary success in attaining remission in many situations when previous treatments have failed. In May 2023, Novartis reported a surge in demand for Kymriah due to its success in treating ALL, particularly among younger patients. As the first FDA-approved CAR T-cell therapy, Kymriah has established a strong precedent, encouraging additional investment and research into ALL-targeted medicines, which is likely to drive market growth.
In March 2024, the European Medicines Agency (EMA) upgraded Kymriah's permission to treat a broader range of ALL patients, making it more accessible throughout Europe. This regulatory support, combined with continued advances in ALL treatments, sets the sector for rapid expansion. With greater patient awareness, better clinical outcomes, and regulatory support, the adoption of CAR T-cell treatments for ALL will continue to drive the overall CAR T-cell therapy market.
Chronic lymphocytic leukemia (CLL) is the fastest-growing segment, owing to increased research and clinical studies involving CAR T-cell therapy. As treatment options for CLL improve, this market is likely to rise substantially, reflecting increased demand and the development of more effective medicines.
Country/Region-wise
The increasing use of improved therapeutic alternatives and a supportive regulatory framework. The American Cancer Society estimates that 1.9 million new cancer cases would be diagnosed in 2023, offering a large potential patient pool for CAR T cell therapy. In March 2024, the United States Food and Drug Administration (FDA) authorized two additional CAR T cell therapies for treating certain types of blood malignancies, increasing the total number of CAR T cell products approved in the United States to nine. In January 2024, Bristol Myers Squibb announced a 45% year-over-year rise in sales of its CAR T cell therapy medicines, totaling USD 1.2 Billion in revenue. The National Cancer Institute has also in 2024, it will increase its financing for cell therapy research by 25%, with USD 500 Million set aside particularly for CAR T cell therapy development and clinical trials.
According to a Cell & Gene Therapy Catapult analysis, the number of CAR T cell therapy clinical studies in North America grew by 35% in 2023 compared to 2022, with over 500 trials currently underway. Furthermore, the Centers for Medicare & Medicaid Services reported that insurance coverage for CAR T cell therapies expanded by 30% in 2023, improving access to these treatments. These developments, coupled with increasing success rates in clinical trials and growing physician acceptance, indicate that North America will continue to lead the global CAR T cell therapy market growth.
The growing healthcare infrastructure in Asia-Pacific is expected to boost the CAR T-cell treatment market significantly. Many countries, including China and India, are investing considerably in improving their healthcare systems, which includes the construction of advanced treatment facilities and increased access to cutting-edge therapies. For instance, in April 2024, the Chinese government announced a significant financial commitment to support oncology research and increase access to CAR T-cell therapy in rural areas. This investment is likely to increase the availability of novel treatments, making them more accessible to a larger patient population and boosting the growth of the CAR T-cell therapy market in the area.
Furthermore, the Asia-Pacific market is seeing greater collaboration between local biotech businesses and multinational pharmaceutical corporations, which is helping to improve the development and marketing of CAR T cell therapies. Gilead Sciences established a partnership with a top Chinese biotech firm in February 2024 to develop and commercialize CAR T-cell medicines specifically for the Asian market. The goal of this collaboration is to speed the commercialization of CAR T-cell therapeutics by using the region's developing healthcare infrastructure and expertise. According to Verified Market Research, the CAR T-cell therapy market is expected to grow at a compound annual growth rate (CAGR) of more than 63.82% between 2024 and 2031, owing to infrastructure improvements and strategic partnerships, highlighting the region's potential in this rapidly evolving market.
The competitive landscape of the CAR T-cell therapy market is characterized by the presence of emerging biotechnology firms and smaller pharmaceutical companies focusing on innovative therapies. These players often collaborate with academic institutions and research organizations to develop novel treatments. They also benefit from partnerships with larger companies for funding and commercialization. With advancements in gene editing and manufacturing processes, these smaller firms are gaining traction by addressing unmet clinical needs, targeting diverse cancer types, and optimizing the safety and efficacy of CAR T-cell therapies.
Some of the prominent players operating in the CAR T cell therapy market Include:
CARsgen Therapeutics, Ltd.
Novartis International AG
Pfizer, Inc.
Kite Pharma, Inc.
Legend Biotech
Juno Therapeutics.
In March 2024, Bristol Myers Squibb announced positive clinical trial findings for Abecma, a CAR T-cell treatment targeting multiple myeloma. According to the business, the medication displayed significant efficacy in patients with relapsed and refractory disease, indicating that it has the potential to gain broader market acceptability.
In January 2024, Celgene reported positive findings from a Phase II clinical trial of their CAR T-cell treatment for ALL. The trial demonstrated a high overall remission rate, highlighting the potential of CAR T treatments in both juvenile and adult populations.