市場調查報告書
商品編碼
1366583
全球CD19抗體市場及臨床管線展望(2028)Global CD19 Antibody Market & Clinical Pipeline Outlook 2028 |
預計2028年,全球CD19抗體市場規模將超過100億美元。
過去十年來,CD19 標靶療法已成為另一類革命性的免疫療法。 這些療法包括單株抗體、雙特異性抗體、抗體藥物偶聯物和嵌合抗原受體T細胞(CAR-T)療法,吸引了全球製藥業臨床和商業部門的關注。 患者和醫生對這些治療的反應也是正面的,CD19 標靶療法的市場預計在 2021 年將成長近 50%,在 2022 年將成長近 50%,到 2022 年將成長 40%。 這是由於監管部門批准的速度很快,而且目前 CD19 標靶治療藥物的研發管線表明該市場規模有進一步激增的潛力。
CD19 標靶治療對癌症治療的臨床前景產生了重大影響。 CD19標靶療法主要用於治療B細胞惡性腫瘤,如非何傑金氏淋巴瘤(NHL)、急性淋巴性白血病(ALL)和大B細胞淋巴瘤(LBCL)。 這些療法,特別是 Kymriah 和 Yescarta 等 CAR-T 療法的臨床療效令人印象深刻,在相當一部分患者中產生了高緩解率和長期緩解,使它們成為一種有前途的治療選擇。 然而,CAR-T療法並非沒有挑戰。 細胞激素釋放症候群 (CRS) 和神經毒性通常與 CAR-T 療法相關,但研究人員正在尋找管理它們的方法。
與一些傳統治療不同,CD19 標靶療法已顯示出持久反應的潛力。 獲得緩解的患者可以長期保持無病狀態,並且生活品質顯著改善。 此外,CD19標靶治療也是邁向個人化醫療的重要一步。 CD19標靶治療根據每位患者獨特的免疫系統和癌細胞特徵量身定制,使其成為高度個人化的治療。
這些療法在市場上的持續成功對於醫藥市場的研發部門來說是令人鼓舞的,導致幾種新的 CD19 標靶療法進入開發和臨床試驗管道。 其中大多數是針對 CD19 的 CAR-T 療法,正在開發用於非何傑金氏淋巴瘤中的急性淋巴細胞白血病 (ALL) 和慢性淋巴細胞白血病 (CLL) 等血癌。 其次是免疫系統疾病,包括自體免疫疾病,如係統性紅斑狼瘡 (SLE)、乾燥症和系統性硬皮症。
市場最近出現了針對CD19標靶創新療法研發的合作研究。這預計將為我們帶來市場優勢。 這包括使用專有平台來幫助降低開發這些治療方法的成本和時間。
本報告調查了全球CD19抗體市場,並提供了市場概況,以及CD19抗體的作用機制、其在癌症治療中的作用、區域趨勢、臨床試驗趨勢以及進入該市場的公司的競爭趨勢。市場.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.