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市場調査レポート
商品コード
1366583
CD19抗体の世界市場、臨床パイプラインの見通し(2028年)Global CD19 Antibody Market & Clinical Pipeline Outlook 2028 |
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CD19抗体の世界市場、臨床パイプラインの見通し(2028年) |
出版日: 2023年10月01日
発行: KuicK Research
ページ情報: 英文 420 Pages
納期: 即日から翌営業日
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世界のCD19抗体の市場規模は、2028年までに100億米ドルを超えると予測されています。
CD19標的療法は、過去10年間に免疫療法のもう一つの革命的なクラスとして出現しました。モノクローナル抗体、二特異性抗体、抗体薬物複合体、キメラ抗原受容体T細胞(CAR-T)療法からなるこれらの療法は、世界の製薬業界の臨床・商業の両分野から注目を集めています。これらの治療に対する患者や医師の反応も良好で、CD19標的治療薬の市場が2021年には50%近く、2022年には40%増加するという事実からもうかがい知ることができます。これは、規制当局の承認が急速に進んだことに起因しており、CD19標的治療薬の現在のパイプラインは、この市場規模がさらに急増する可能性を示しています。
CD19標的療法は、癌治療の臨床状況に大きな影響を与えています。CD19標的療法は、主に非ホジキンリンパ腫(NHL)や急性リンパ性白血病(ALL)、大細胞型B細胞リンパ腫(LBCL)などのB細胞性悪性腫瘍の治療に用いられています。これらの療法、特にKymriahやYescartaのようなCAR-T療法の臨床効果は目覚ましく、かなりの割合の患者で高い奏効率と寛解の延長をもたらし、有望な治療選択肢となっています。しかし、CAR-T療法に課題がないわけではありません。サイトカイン放出症候群(CRS)や神経毒性はCAR-T療法にしばしば関連しますが、研究者たちはこれらを管理する方法を見出しています。
いくつかの従来の治療法とは異なり、CD19を標的とする治療法は長期にわたる奏効の可能性を示しています。寛解に至った患者は長期間無病状態を維持することができ、QOLが大幅に改善します。さらに、CD19標的療法は個別化医療への大きな一歩でもあります。CD19標的療法は、各患者固有の免疫系と癌細胞の特徴に合わせて調整されるため、高度に個別化された治療法となります。
これらの治療薬の市場での継続的な成功は、医薬品市場の研究開発部門にとって励みとなり、その結果、いくつかの新しいCD19標的治療薬が開発および臨床試験パイプラインに入っています。これらの大半はCD19を標的とするCAR-T療法で、非ホジキンリンパ腫の中でも急性リンパ性白血病(ALL)や慢性リンパ性白血病(CLL)などの血液癌を対象に開発が進められています。さらに、全身性エリテマトーデス(SLE)、シェーグレン症候群、全身性強皮症などの自己免疫疾患など、免疫系の疾患もこれに続いています。
市場では最近、革新的なCD19標的治療薬の研究開発のための共同研究も行われており、承認済みCD19標的治療薬では前例のない特徴を有していることから、承認されれば市場での優位性が期待されます。これには、これらの治療法の開発に費やされるコストと時間を削減するのに役立つ独自のプラットフォームの使用も含まれます。
当レポートでは、世界のCD19抗体市場について調査し、市場の概要とともに、CD19抗体の作用機序、癌治療における役割、地域別動向、臨床試験動向、および市場に参入する企業の競合動向などを提供しています。
“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.