雙特異性抗體市場：現況分析與預測（2023-2030）

Bispecific Antibody Market: Current Analysis and Forecast (2023-2030)

出版日期: 2024年03月01日 | 出版商:

UnivDatos Market Insights Pvt Ltd | 英文 136 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

由於核准數量的增加，雙特異性抗體市場預計將穩定成長在 11.2% 左右。例如，2022年10月，針對B細胞成熟抗原和CD3的雙特異性抗體治療藥物Tecvayli將獲得美國食品藥物管理局的批准，作為治療四線或以上治療後持續存在的骨髓瘤的治療方法。來自（FDA）。在預測期內，有幾個因素正在推動市場成長，例如增加對醫療保健產業的投資。除此之外，雙特異性抗體的加速上市增加了對有效治療藥物的需求，也穩定地推動了雙特異性抗體市場的發展。

依藥物類型劃分，市場分為 blinatumomab、emicizumab、amivantamab 等。由於產品批准增加，博納吐單抗在 2022 年佔據市場主導地位。例如，2023年6月，Amgen向美國食品藥物管理局提交了BLINCYTOR（blinatumomab）的補充生物製劑許可申請（sBLA），用於治療患有CD19陽性B細胞前體急性淋巴細胞白血病的成人和兒童患者。 Blinatumomab 是一種新型免疫治療藥物，用於治療某些類型的白血病。 Blinatumomab 是一種雙特異性 T 細胞接合器 (BiTE) 抗體構建體。 Blinatumomab 透過同時結合 CD19（一種 B 細胞表面的蛋白質）和 CD3（一種 T 細胞表面的蛋白質）來發揮作用。透過使 T 細胞與癌性 B 細胞緊密接觸，blinatumomab 可以活化 T 細胞並靶向破壞它們。因此，在藥物類型中，blinatumomab在2022年佔據了較大的市場佔有率。

依適應症，市場分為癌症、血友病、黃斑部病變等。由於血友病治療的臨床研究不斷增加，預計血友病領域將在預測期內佔據重要佔有率。例如，2021年7月，JW Pharmaceuticals在韓國A型血友病患者中評估了皮下注射Hemlibra的安全性、有效性和藥物動力學，無論是否使用FVIII抑制劑。雙特異性抗體市場的血友病部分專注於開發治療血友病的新治療方法，血友病是一種以凝血因子缺乏或缺乏為特徵的遺傳性出血性疾病。血友病傳統上採用替代療法治療，即透過靜脈注射缺乏凝血因子來預防或控制出血事件。雙特異性抗體有可能成為血友病患者的替代或補充療法，解決其中一些尚未找到治療方法的疾病。因此，在預測期內，血友病在最終用戶中將表現出更高的複合年增長率。

為了更瞭解市場，市場分為北美（美國、加拿大等北美地區）、歐洲（德國、英國、法國、西班牙、義大利等歐洲地區）、亞洲太平洋地區（中國、日本、印度、其他亞太地區）和世界其他地區是根據其在世界其他地區的存在進行分析的。由於癌症患者的快速增加、醫療保健成本的增加以及引入創新進步的舉措和投資的增加，北美在 2022 年目前的情況下將主導市場。例如，2023年5月，美國公司艾伯維宣佈EPKINLYTM是第一個也是唯一一個獲得美國食品藥物管理局批准用於治療復發或難治性（R/R）瀰漫性大B細胞淋巴瘤（ DLBCL）成年患者的T細胞療法。由於該地區病例的增加，政府機構啟動了有關慢性病的認識計畫。因此，在這些地區中，北美將在2022年佔據很大的市場佔有率。

市場上營運的主要公司包括 Akeso Biopharma Co., Ltd.、Alexion Pharmaceuticals, Inc.、Amgen Inc.、Genmab A/S、Immunocore Ltd.、Janssen Global Services, LLC、Linton Pharm、Merck KGaA、Genentech, Inc.、Pfizer Inc.

Bispecific antibodies are engineered molecules that can bind to two different targets simultaneously. They're designed to redirect immune cells to target specific cells, such as cancer cells, enhancing the body's ability to fight diseases. These antibodies have gained attention in cancer therapy and other fields due to their potential to improve treatment efficacy and reduce side effects. A rising number of clinical trials and technological advancements to find effective treatments are leading to the market's growth. Several other factors, such as rising research & development activities, rising healthcare expenditure, rising regulatory support, and a surge in government collaborations & partnerships are driving the bispecific antibody market globally.

The Bispecific Antibody Market is expected to grow at a steady rate of around 11.2% owing to the rising drug approvals. For instance, in October 2022, Tecvayli, a bispecific antibody therapy targeting B-cell maturation antigen and CD3, received accelerated approval from the U.S. Food and Drug Administration (FDA) to treat myeloma that persisted after four or more lines of prior therapy. Several factors, including rising investments in healthcare departments, are driving the market's growth during the forecast period. Apart from this, the accelerated launch of bispecific antibodies has resulted in higher demand for effective treatment procedures which are also driving this market of bispecific antibodies at a steady rate.

Based on the drug type, the market is segmented into blinatumomab, emicizumab, amivantamab, and others. The blinatumomab segment dominated the market in the year 2022 owing to the rising product approvals. For instance, in June 2023, Amgen received the U.S. Food and Drug Administration (FDA) for its supplemental Biologics License Application (sBLA) for BLINCYTO(R) (blinatumomab) for the treatment of adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia. Blinatumomab is a novel immunotherapy drug used in the treatment of certain types of leukemia. Blinatumomab is a bispecific T-cell engager (BiTE) antibody construct. It works by binding simultaneously to CD19, a protein found on the surface of B cells, and CD3, a protein found on the surface of T cells. By bringing T cells into proximity to cancerous B cells, blinatumomab activates the T cells, which then target and destroy the cancer cells. Thus, among the drug types, the blinatumomab segment held a significant market share in 2022.

Based on the indication, the market is categorized into cancer, hemophilia, macular degeneration, and others. The hemophilia segment is expected to hold a significant share of the market in the forecast period owing to the rising clinical studies for treating hemophilia. For instance, in July 2021, JW Pharmaceutical initiated a clinical trial to evaluate the safety, efficacy, and pharmacokinetics of FVIII Inhibitor titers of Hemlibra subcutaneous injection in Korean Hemophilia A patients with/without FVIII Inhibitors. The hemophilia segment in the bispecific antibody market focuses on developing novel therapeutic approaches to treat hemophilia, a genetic bleeding disorder characterized by deficiencies or defects in clotting factors. Hemophilia is traditionally treated with replacement therapy, where the deficient clotting factor is administered intravenously to prevent or control bleeding episodes. Bispecific antibodies offer a potential alternative or complementary therapy for hemophilia patients, addressing some of these unmet medical needs. Thus, the hemophilia category will witness a higher CAGR amongst end users during the forecast period.

For a better understanding, the market is analyzed based on its worldwide presence in countries such as North America (U.S., Canada, and the Rest of North America), Europe (Germany, U.K., France, Spain, Italy, Rest of Europe), Asia-Pacific (China, Japan, India, Rest of Asia-Pacific), Rest of World. North America is dominating the market in the current scenario of 2022 due to the surge in cases of cancer, rising healthcare expenditure, and rising initiatives and investments in introducing innovative advancements. For instance, in May 2023, U.S-based AbbVie received U.S. Food and Drug Administration (FDA) approval for its EPKINLYTM as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Government organizations are initiating awareness programs for chronic diseases for the sake of the growing cases in the region. Thus, amongst regions, North America held a significant share of the market in 2022.

Some of the major players operating in the market include Akeso Biopharma Co., Ltd.; Alexion Pharmaceuticals, Inc.; Amgen Inc.; Genmab A/S; Immunocore Ltd.; Janssen Global Services, LLC; Linton Pharm; Merck KGaA; Genentech, Inc.; Pfizer Inc.

1.MARKET INTRODUCTION

1.1.Market Definitions
1.2.Main Objective
1.3.Stakeholders
1.4.Limitation

2.RESEARCH METHODOLOGY OR ASSUMPTION

2.1.Research Process of the Bispecific Antibody Market
2.2.Research Methodology of the Bispecific Antibody Market
2.3.Respondent Profile

3.MARKET SYNOPSIS

4.EXECUTIVE SUMMARY

5.IMPACT OF COVID-19 ON THE BISPECIFIC ANTIBODY MARKET

6.BISPECIFIC ANTIBODY MARKET REVENUE (USD BN), 2020-2030F

7.MARKET INSIGHTS BY DRUG TYPE

7.1.Blinatumomab
7.2.Emicizumab
7.3.Amivantamab
7.4.Others

8.MARKET INSIGHTS BY INDICATION

8.1.Cancer
- 8.1.1.Multiple Myeloma
- 8.1.2.Lymphoma
- 8.1.3.Leukemia
- 8.1.4.Others
8.2.Hemophilia
8.3.Macular Degeneration
8.4.Others

9.MARKET INSIGHTS BY REGION

9.1.North America
- 9.1.1.U.S.
- 9.1.2.Canada
- 9.1.3.Rest of North America
9.2.Europe
- 9.2.1.Germany
- 9.2.2.U.K.
- 9.2.3.France
- 9.2.4.Italy
- 9.2.5.Spain
- 9.2.6.Rest of Europe
9.3.Asia-Pacific
- 9.3.1.China
- 9.3.2.Japan
- 9.3.3.India
- 9.3.4.Rest of Asia-Pacific
9.4.Rest of World