市场调查报告书
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1366583
全球CD19抗体市场及临床管线展望(2028)Global CD19 Antibody Market & Clinical Pipeline Outlook 2028 |
预计2028年,全球CD19抗体市场规模将超过100亿美元。
过去十年来,CD19 标靶疗法已成为另一类革命性的免疫疗法。 这些疗法包括单株抗体、双特异性抗体、抗体药物偶联物和嵌合抗原受体T细胞(CAR-T)疗法,吸引了全球製药业临床和商业部门的关注。 患者和医生对这些治疗的反应也是正面的,CD19 标靶疗法的市场预计在 2021 年将成长近 50%,在 2022 年将成长近 50%,到 2022 年将成长 40%。 这是由于监管部门批准的速度很快,而且目前 CD19 标靶治疗药物的研发管线表明该市场规模有进一步激增的潜力。
CD19 标靶治疗对癌症治疗的临床前景产生了重大影响。 CD19标靶疗法主要用于治疗B细胞恶性肿瘤,如非何杰金氏淋巴瘤(NHL)、急性淋巴性白血病(ALL)和大B细胞淋巴瘤(LBCL)。 这些疗法,特别是 Kymriah 和 Yescarta 等 CAR-T 疗法的临床疗效令人印象深刻,在相当一部分患者中产生了高缓解率和长期缓解,使它们成为一种有前途的治疗选择。 然而,CAR-T疗法并非没有挑战。 细胞激素释放症候群 (CRS) 和神经毒性通常与 CAR-T 疗法相关,但研究人员正在寻找管理它们的方法。
与一些传统治疗不同,CD19 标靶疗法已显示出持久反应的潜力。 获得缓解的患者可以长期保持无病状态,并且生活品质显着改善。 此外,CD19标靶治疗也是迈向个人化医疗的重要一步。 CD19标靶治疗根据每位患者独特的免疫系统和癌细胞特征量身定制,使其成为高度个人化的治疗。
这些疗法在市场上的持续成功对于医药市场的研发部门来说是令人鼓舞的,导致几种新的 CD19 标靶疗法进入开发和临床试验管道。 其中大多数是针对 CD19 的 CAR-T 疗法,正在开发用于非何杰金氏淋巴瘤中的急性淋巴细胞白血病 (ALL) 和慢性淋巴细胞白血病 (CLL) 等血癌。 其次是免疫系统疾病,包括自体免疫疾病,如係统性红斑狼疮 (SLE)、干燥症和系统性硬皮症。
市场最近出现了针对CD19标靶创新疗法研发的合作研究。这预计将为我们带来市场优势。 这包括使用专有平台来帮助降低开发这些治疗方法的成本和时间。
本报告调查了全球CD19抗体市场,并提供了市场概况,以及CD19抗体的作用机制、其在癌症治疗中的作用、区域趋势、临床试验趋势以及进入该市场的公司的竞争趋势。市场.等等。
“Global CD19 Antibody Market & Clinical Pipeline Outlook 2028” Report Highlights:
CD19 targeting therapies have emerged as another revolutionary class of immunotherapies in the past decade. These therapies, which consist of monoclonal antibodies, a bispecific antibody, an antibody-drug conjugate and chimeric antigen receptor T-cell (CAR-T) therapies, have captured the attention of both the clinical and commercial spheres in the global pharmaceutical industry. The patient and physician response to these therapies has been favorable as well, which can be gathered from the fact that the market of CD19-targeting therapies increased by almost 50% in 2021, and 40% in 2022. This can be attributed to the rapid regulatory approvals, and the current pipeline of investigational CD19-targeting therapies shows potential for a further surge of this market cap.
CD19-targeting therapies have made a significant impact on the clinical landscape of cancer treatment. They are primarily used for treating B-cell malignancies such as non-Hodgkin lymphoma (NHL) like acute lymphocytic leukemia (ALL), and large B-cell lymphoma (LBCL). The clinical efficacy of these therapies, especially CAR-T therapies like Kymriah and Yescarta, has been remarkable, leading to high response rates and prolonged remissions in a substantial proportion of patients, making them a promising treatment options. However, CAR-T therapies are not without challenges. Cytokine release syndrome (CRS) and neurotoxicity are often associated with CAR-T therapies; however, researchers have found ways to manage these.
Unlike some traditional therapies, CD19-targeting therapies have shown the potential for long-lasting responses. Patients who achieve remission can remain disease-free for extended periods, significantly improving their quality of life. Moreover, CD19-targeting therapies also represent a big step towards personalized medicine. They are tailored to each patient's unique immune system and the characteristics of their cancer cells, making them a highly individualized treatment.
CD19-targeting therapies have also become a focal point for pharmaceutical companies. The pharmaceutical industry has seen intense competition in the development and commercialization of CD19-targeting therapies. Established giants like Novartis, Amgen, and Gilead have played a significant role but smaller biotech firms are also entering the market now, bringing with them innovative treatments. An example of this is Uplizna, which was developed by Viela Bio, though now a part of Amgen.
At present, nine CD19-targeting therapies have received approval from the regulatory bodies. These are the bispecific antibody Blincyto, the monoclonal antibodies Uplizna and Monjuvi, the antibody-drug conjugate Zynlonta, and the CAR-T therapies Kymriah, Yescarta, Tecartus, Breyanzi, and Carteyva. While the first eight have FDA approvals, Carteyva only has a regional approval in China, where JW Therapeutics markets it.
The continued success of these therapies in the market has been encouraging for the research and development sector of the pharmaceutical market, and as a result, several new CD19-targeting therapies have entered the development and clinical trial pipelines. A majority of these are CD19-targeting CAR-T therapies, which are being developed for hematological cancers such as acute lymphocytic leukemia (ALL) and chronic lymphocytic leukemia (CLL) among other non-Hodgkin lymphomas. This is closely followed by disorders of the immune system, such as autoimmune diseases like systemic lupus erythematosus (SLE) Sjogren's syndrome and systemic scleroderma.
The regulatory bodies have also been instrumental in encouraging the development of CD19-targeting therapies by granting several of them special drug designations. The FDA, for instance, granted the Fast Track designation to KYV-101, IMPT-314 and CABA-201, which have been developed by Kyverna Therapeutics, ImmPACT Bio' and Cabaletta Bio, respectively. In addition, the FDA also accepted the IND applications of many candidates recently, with the newest being Kyverna's KYV-101 for the treatment of diffuse cutaneous systemic sclerosis in October 2023.
The market has also seen some collaborations happening lately for the research and development of innovative CD19-targeting therapies, having characteristics unprecedented by the approved CD19-targeting therapies, which are anticipated to give these an edge in the market upon approval. This includes the use of proprietary platforms to help cut down on the cost and time spent in the development of these therapies.
Thus, the market of CD19-targeting therapies is quite vibrant and dynamic, and is currently being driven by several factors. Moreover, as research finds use of CD19-targeting therapies in newer indications, it is obvious that the therapeutic potential of the CD19 protein remains to be fully uncovered. New market entrants have been increasing the competition within the market, which is expected to be one of the major factors driving innovation at present.