市场调查报告书
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1355048
全球 T 细胞治疗市场评估:按方式、治疗类型、适应症、最终用户、地区、机会、预测(2016-2030)T-Cells therapy Market Assessment, By Modality, By Therapy Type, By Indication, By End-user, By Region, Opportunities and Forecast, 2016-2030F |
全球T细胞治疗市场规模预计将从2022年的33.3亿美元增加到2030年的129.8亿美元,2023-2030年预测期间复合年增长率为18.54%。
Tecartus、Yescarta 和 Kymriah 获得批准后,一些组织将其商业模式从小规模化疗和基于蛋白质的疗法开发转变为工程疗法。这一因素正在推动私人和公共机构的策略性投资并促进市场成长。由于产品核准的增加和生产能力的提高,预计未来几年 T 细胞治疗实体的市场竞争将会扩大。
例如,2022 年 2 月,美国 FDA 批准了 Yescarta,这是第一个用于治疗復发或难治性大 B 细胞淋巴瘤 (LBCL) 的嵌合抗原受体 (CAR) T 细胞疗法。Yescarta 获得 NCCN 治疗指南 1 类推荐,是第一个获得此殊荣的 CAR-T 细胞疗法。同样,2022年2月,FDA宣布siltakabutagene autoleucel(siltakabutagene autoreucel Carvykti)获得批准。
2023 年 1 月,California Institute for Regenerative Medicine(CIRM)承诺投入 400 万美元来开发和测试 CAR-T 细胞疗法,以治疗多种 B 细胞恶性肿瘤,包括淋巴瘤和白血病。
在 CAR-T 细胞疗法中,从患者身上收集的 T 细胞经过人工生物工程改造以表达 CAR。CAR-T细胞领域的公司正在寻求与其他公司的策略联盟,包括联盟、业务扩张、协议、联合研究和新产品推出,这些正在推动T细胞治疗市场的成长。
例如,Janssen Biotech, Inc.生产的CARVYKTI于2022年获得FDA批准。嵌合抗原受体 T 细胞 (CAR-T) 是一种称为 CARVYKTI 的疗法的缩写。患有多发性骨髓瘤(一种骨髓恶性肿瘤)的成年患者可以使用 CARVYKTI (Ciltakabutagene Autoleucel) 进行治疗。CARVYKTI 治疗在四次或多次先前治疗后復发或变得难治的多发性骨髓瘤成年患者。该药物由蛋白□体抑制剂、免疫调节剂和抗 CD38 单株抗体组成。
近年来,全球T细胞治疗市场取得了显着进展。CAR-T疗法等创新技术正在彻底改变癌症治疗,研究人员正在探索TCR疗法等下一代T细胞疗法,扩大可治疗疾病的范围。此外,源自健康捐赠者的同种异体 T 细胞疗法的发展使治疗变得更加容易。这些突破代表了个人化和现成 T 细胞疗法的光明前景,扩大了全球市场治疗选择的范围。
COVID-19的爆发阻碍了全球医疗产业的活动,特别是T细胞治疗市场。由于大多数国家实施了封锁政策,疫情对全球 T 细胞治疗市场造成了打击。供应链中断导致一些公司 T 细胞疗法的生产和供应延误。这场大流行对多项 T 细胞疗法临床试验造成了重大干扰,其中一些试验被推迟或完全取消。
但值得注意的是,疫情发生后,癌症病患增多,医疗产业创新需求凸显,不少企业加强研发。因此,鼓励资助旨在了解如何应用 T 细胞疗法治疗病毒感染的研究。例如,Tevogen Bio 于 2022 年 11 月宣布打算探讨 TVGN-489 的潜在治疗用途,TVGN-489 是一种针对 COVID-19 的研究性 T 细胞疗法。
本报告研究分析了全球T细胞治疗市场,提供市场规模和预测、市场动态、主要参与者的现状和前景等。
Global T-Cells therapy market size was valued at USD 3.33 billion in 2022, and is expected to reach USD 12.98 billion in 2030, with a CAGR of 18.54% for the forecast period between 2023 and 2030F. The market for T-cell treatment is constantly evolving and expanding, largely due to ongoing research and development initiatives. To improve efficacy and widen the applications of T-cell therapies, scientists and researchers are constantly investigating new methods, tools, and therapeutic targets. The key factors driving the expansion of the T-cell therapy market size are the rise in cancer prevalence, elderly population, and the usage of various cell therapy technologies to treat cancer symptoms. The prevalence of certain cancers such as leukemia, myeloma, lymphoma, and cancer relapse increase the need for efficient therapeutic interventions and fuels market growth. Also, multiple medications that are currently in the clinical development stage are fueling the market's expansion. For instance, Caribou Biosciences, Inc.'s CB-010 and CB-011 are undergoing phase I clinical studies. Similarly, Cartesian Therapeutics, Inc.'s DESCARTES-17 and DESCARTES-25 are now undergoing preclinical and Phase I trials, respectively. Thus, it is further projected that key companies' attention to developments may possibly fuel the market for T-cell treatment growth.
After tecartus, Yescarta, and Kymriah were approved, several organizations changed their business models from developing small chemical and protein-based treatments to adoptive therapy. This element has encouraged strategic investments by both private and public organizations, which has helped the market grow. The market rivalry for T-cell therapy entities is anticipated to expand in the coming years due to increasing product approval and rising production capacities.
For instance, the U.S. FDA approved Yescarta, the first chimeric antigen receptor (CAR) T-cell treatment in February 2022 to manage relapsed or refractory large B-cell lymphoma (LBCL). The NCCN Treatment Guideline's Category 1 recommendation for Yescarta makes it the first CAR T-cell treatment to receive this distinction. The FDA similarly approved ciltacabtagene autoleucel (Carvykti) in February 2022 for patients with multiple myeloma that is refractory, which did not respond to treatment, or has reappeared after treatment (relapsed).
The California Institute for Regenerative Medicine (CIRM) committed $4 million in January 2023 to develop and test a CAR T-cell therapy for treating diverse B-cell malignancies, including lymphomas and leukemias.
Following the closure of the transaction in May 2023 , Laurus Labs' share in ImmunoACT will rise to 33.86% on a fully diluted basis. In November 2021, the corporation had already purchased 26.62% of ImmunoACT. The CAR T-cell therapy assets in ImmunoACT's portfolio are in various stages of development and are used to treat various cancers and autoimmune illnesses. With this funding, Laurus Labs is more committed to offering patients revolutionary Cell and Gene Therapy technology at an affordable price. This funding will aid ImmunoACT in preparing to produce more medications.
In CAR T-cell therapy, T-cells taken from patients are artificially bioengineered to express CARS, which can recognize and attach to the cancer cells. Companies in the CAR T-cell segment are engaging in strategic developments with other companies, such as partnerships, expansions, agreements, collaborations, and the introduction of new products, which is promoting the growth of the T-cell treatment market.
For instance, the FDA authorized CARVYKTI produced by Janssen Biotech, Inc. in 2022. Chimeric antigen receptor T-cell, or CAR-T, is the abbreviation for the therapy known as CARVYKTI. Adult patients with multiple myeloma, a bone marrow malignancy, can receive treatment with CARVYKTI (ciltacabtagene autoleucel). After four or more prior lines of therapy, CARVYKTI treats adult patients with multiple myeloma that have relapsed or become resistant to treatment. It comprises a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.
Astellas committed USD 50 million to Poseida's CAR T-cell therapy in August 2023. Astellas will have exclusive negotiating rights and first choice for licensing P-MUC1C-ALLO1 in solid tumors as part of the agreement.
The development, testing, and marketing of cell therapies and other biologics used in T-cell therapy treatments, such as adoptive cell transfer (ACT), are governed by the U.S. Food and Drug Administration (FDA).
Cell therapy evaluation standards and guidelines have been published by the European Medicines Agency (EMA) for use in clinical and human trials.
The safety, effectiveness, and quality of biological products used in T-cell therapy treatments are overseen by the FDA's Center for Biologic Evaluation and Research (CBER).
Best practices have been established by the National Institutes of Health (NIH ) for carrying out clinical trials utilizing cell therapies, particularly for T-cell therapy. Guidelines for patient selection criteria, risk assessment techniques, and monitoring procedures are included.
To guarantee that cell therapies are produced safely and ethically, the International Society for Cellular Therapy (ISCT) offers rules and criteria.
The global T-cell therapy market has witnessed significant advancements in recent years. Innovative technologies like CAR-T therapy have revolutionized cancer treatment, researchers are exploring next-generation T-cell therapies, such as TCR (T-cell Receptor) therapies, which broadens the scope of treatable diseases. Furthermore, the development of allogeneic T-cell therapies, derived from healthy donors, is making treatments more accessible. These breakthroughs signify a promising future for personalized and off-the-shelf T-cell therapies, expanding the horizon of therapeutic options in the global market.
The U.S. Food and Drug Administration (FDA) granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Autolus Therapeutics plc, a clinical-stage biopharmaceutical firm, to its lead gene therapy obecabatagene autoleucel (obe-cel) in April 2022. In the ongoing FELIX Phase 2 study in adult relapsed/refractory B-Acute Lymphocytic Leukemia, a CD19-directed autologous chimeric antigen receptor (CAR) T treatment is being examined.
In 2022, Novartis International AG introduced a novel T-Cell Therapy known as Kymriah, specifically designed for addressing relapsed or refractory follicular lymphoma. This innovative therapy, classified as a CD19-targeted CAR-T-cell therapy, received FDA approval.
The COVID-19 outbreak hampered operations in the global health care industry, especially the T-cell treatment market. The pandemic hurt the global T-cell treatment market since most nations implemented lockdown policies. Due to supply chain interruptions, certain businesses encountered delays in producing and delivering T-cell therapies. The pandemic caused significant disruptions to several clinical trials of T-cell treatments, with some trials being postponed or discontinued entirely.
However, it was noted that post-pandemic, the prevalence of cancer cases has brought attention to the need for innovation in the healthcare industry, and many businesses are boosting their efforts in R&D. It has encouraged funding for research aimed at figuring out how T-cell treatments might be applied to treat viral infections. For instance, Tevogen Bio announced, in November 2022, it intended to examine the potential therapeutic uses of TVGN-489, an investigational COVID-19 T-cell therapy, in Long COVID. The highly purified cytotoxic CD8+ T lymphocytes (CTLs) TVGN-489 are designed to locate and eradicate SARS-CoV-2 infected cells.
The increasing number of businesses engaging in CAR-T therapy development is projected to boost market competition. Novartis AG and Kite Pharma currently dominate the T-cell therapy market through innovative and novel product introductions. In addition, numerous prominent corporations are launching significant initiatives to strengthen their market presence. For instance, in June 2022, Immunocore Ltd., a commercial-stage biotechnology startup, engaged into a clinical trial collaboration and supply deal with Sanofi. Sanofi can use KIMMTRAK to analyze their precisely PEGylated, tailored form of IL-2, SAR444245 in this collaboration. The agreement will help the company's expansion by improving cell therapy manufacturing operations.
All segments will be provided for all regions and countries covered:
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.