市場調查報告書
商品編碼
1355048
全球 T 細胞治療市場評估:按方式、治療類型、適應症、最終用戶、地區、機會、預測(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細胞治療市場規模預計將從2022年的33.3億美元增加到2030年的129.8億美元,2023-2030年預測期間複合年增長率為18.54%。
Tecartus、Yescarta 和 Kymriah 獲得批准後,一些組織將其商業模式從小規模化療和基於蛋白質的療法開發轉變為工程療法。這一因素正在推動私人和公共機構的策略性投資並促進市場成長。由於產品核准的增加和生產能力的提高,預計未來幾年 T 細胞治療實體的市場競爭將會擴大。
例如,2022 年 2 月,美國 FDA 批准了 Yescarta,這是第一個用於治療復發或難治性大 B 細胞淋巴瘤 (LBCL) 的嵌合抗原受體 (CAR) T 細胞療法。Yescarta 獲得 NCCN 治療指南 1 類推薦,是第一個獲得此殊榮的 CAR-T 細胞療法。同樣,2022年2月,FDA宣布siltakabutagene autoleucel(siltakabutagene autoreucel Carvykti)獲得批准。
2023 年 1 月,California Institute for Regenerative Medicine(CIRM)承諾投入 400 萬美元來開發和測試 CAR-T 細胞療法,以治療多種 B 細胞惡性腫瘤,包括淋巴瘤和白血病。
在 CAR-T 細胞療法中,從患者身上收集的 T 細胞經過人工生物工程改造以表達 CAR。CAR-T細胞領域的公司正在尋求與其他公司的策略聯盟,包括聯盟、業務擴張、協議、聯合研究和新產品推出,這些正在推動T細胞治療市場的成長。
例如,Janssen Biotech, Inc.生產的CARVYKTI於2022年獲得FDA批准。嵌合抗原受體 T 細胞 (CAR-T) 是一種稱為 CARVYKTI 的療法的縮寫。患有多發性骨髓瘤(一種骨髓惡性腫瘤)的成年患者可以使用 CARVYKTI (Ciltakabutagene Autoleucel) 進行治療。CARVYKTI 治療在四次或多次先前治療後復發或變得難治的多發性骨髓瘤成年患者。該藥物由蛋白□體抑制劑、免疫調節劑和抗 CD38 單株抗體組成。
近年來,全球T細胞治療市場取得了顯著進展。CAR-T療法等創新技術正在徹底改變癌症治療,研究人員正在探索TCR療法等下一代T細胞療法,擴大可治療疾病的範圍。此外,源自健康捐贈者的同種異體 T 細胞療法的發展使治療變得更加容易。這些突破代表了個人化和現成 T 細胞療法的光明前景,擴大了全球市場治療選擇的範圍。
COVID-19的爆發阻礙了全球醫療產業的活動,特別是T細胞治療市場。由於大多數國家實施了封鎖政策,疫情對全球 T 細胞治療市場造成了打擊。供應鏈中斷導致一些公司 T 細胞療法的生產和供應延誤。這場大流行對多項 T 細胞療法臨床試驗造成了重大干擾,其中一些試驗被推遲或完全取消。
但值得注意的是,疫情發生後,癌症病患增多,醫療產業創新需求凸顯,不少企業加強研發。因此,鼓勵資助旨在了解如何應用 T 細胞療法治療病毒感染的研究。例如,Tevogen Bio 於 2022 年 11 月宣布打算探討 TVGN-489 的潛在治療用途,TVGN-489 是一種針對 COVID-19 的研究性 T 細胞療法。
本報告研究分析了全球T細胞治療市場,提供市場規模和預測、市場動態、主要參與者的現狀和前景等。
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.