市場調查報告書
商品編碼
1441148
雙特異性抗體的全球市場:藥物銷售、專利、價格和臨床試驗見解 (2029)Global Bispecific Antibody Market, Drugs Sales, Patent, Price & Clinical Trials Insight 2029 |
雙特異性抗體是一種令人興奮的新治療方法,在過去十年中勢頭強勁。 這些精心設計的分子提供了獨特的作用機制,可利用免疫系統精確靶向惡性和其他患病細胞和組織,從而提供一種有針對性的方法,最大限度地降低副作用的風險。 過去三年,雙特異性抗體市場的研發和商業活動迅速升溫,預計未來幾年該市場將快速成長。
雙特異性抗體是設計用於同時結合兩種不同抗原(通常在不同細胞類型上)的蛋白質。 其雙重標靶能力提供了多種利用免疫系統對抗疾病的方法。 對抗癌症的常見方法是引導 T 細胞和自然殺手細胞攻擊惡性細胞。 它還可以交聯免疫細胞和腫瘤細胞以增強免疫反應。 此外,它還可以阻斷兩種不同的訊號路徑並將免疫細胞招募到腫瘤微環境中。
對於癌症以外的適應症,雙特異性抗體可以雙重靶向不同的疾病介質或細胞類型。 這提供了中和或消除與發炎、自體免疫和其他疾病有關的致病蛋白、細胞因子和細胞的機會。 然而,根據適應症,雙特異性抗體的作用機轉可能會有所不同。
與傳統的單株抗體相比,雙特異性抗體的多功能性具有多種優勢,包括更高的特異性、效力和同時靶向多個途徑的靈活性。Masu。 這在癌症治療中具有特殊的意義,其中單株抗體被大量用於抑制各種與癌症相關的途徑。 透過將免疫細胞引導至腫瘤,雙特異性抗體可以克服腫瘤的免疫逃脫機制,與傳統化療相比,有可能提高療效並降低毒性。
美國FDA於2014年批准了Blinatumomab(商品名Blincyto),標誌著雙特異性抗體治療復發或難治性B細胞前體急性淋巴細胞白血病領域的一個重要里程碑,從根本上改變了這一法律。 繼這一成功之後,幾種新的雙特異性抗體正在臨床開發中,涵蓋多種疾病,重點是癌症。 然而,除了癌症之外,還有越來越多的雙特異性候選抗體旨在解決病毒和細菌感染以及自體免疫疾病等新興適應症。 這種多樣化凸顯了此類藥物治療應用範圍的不斷擴大。
雙特異性抗體已取得足夠的臨床成功,足以驗證其作為主要新藥類別的潛力。 它們利用多種疾病途徑的獨特能力開闢了單株抗體以外的新治療可能性。 雖然腫瘤學處於領先地位,但向其他疾病領域的擴張也在加速。 分子設計和工程的持續創新使雙特異性抗體成為一種令人興奮的多功能方法,可以改變各種未滿足的醫療需求的治療方法,並且正在越來越多地探索。
本報告調查了全球雙特異性抗體市場,並提供了市場概況,包括藥物趨勢、臨床試驗趨勢、區域趨勢以及進入市場的公司競爭格局。
Global Bispecific Antibody Market, Drugs Sales, Patent, Price & Clinical Trials Insight 2029 Report Highlights:
Bispecific antibodies represent an exciting new therapeutic approach that has been gaining momentum since the last decade. These meticulously designed molecules offer a unique mechanism of action that harnesses the immune system to target malignant and other diseased cells and tissues with precision, offering a targeted approach that minimizes the risk of adverse effects. In the last three years, the market of bispecific antibodies has experienced a rapid surge in research and development, and commercial activities, setting the market for a speedy growth in the coming years.
Bispecific antibodies are engineered proteins intended to simultaneously bind two different antigens, typically found on distinct cell types. Their dual targeting ability provides multiple ways to exploit the immune systems against diseases. For cancer, common approaches include redirecting T cells or natural killer cells to attack malignant cells. They can also crosslink immune cells with tumor cells to enhance the immune response. Additionally, they can block two different signaling pathways or recruit immune cells to the tumor microenvironment.
For indications apart from cancer, bispecific antibodies enable dual targeting of different disease mediators or cell types. This provides opportunities to neutralize or clear pathogenic proteins, cytokines or cells involved in inflammation, autoimmunity and other diseases. However, depending on the indications, the mechanism by which bispecific antibodies work can change.
The versatility of bispecific antibodies offers several advantages over their predecessors, traditional monoclonal antibodies, including enhanced specificity, potency and flexibility in targeting multiple pathways at the same time. This become especially relevant in cancer treatment, where monoclonal antibodies are utilized heavily to interfere with different cancer-associated pathways. By directly redirecting immune cells to tumors, bispecific antibodies can overcome tumor immune evasion mechanisms, leading to improved efficacy and potentially lower toxicity compared to conventional chemotherapy.
The US FDA approved Blinatumomab (commercially known as Blincyto) in 2014, marking a key milestone in the field of bispecific antibodies and fundamentally changing how relapsed or refractory precursor B-cell acute lymphoblastic leukemia is treated. Following this success, multiple new bispecific antibodies have arisen in clinical development, covering a wide range of medical disorders, with a focus on cancer. Nonetheless, in addition to cancer, there has been an increase in the number of bispecific candidates designed to address emerging indications such as viral and bacterial infections, as well as autoimmune diseases. This diversification highlights the growing range of therapeutic applications for this class of medicines.
Currently, there are over 800 bispecific candidates in active clinical development. Phase 3 trials are underway across a spectrum of solid cancers like triple negative breast cancer, small cell lung cancer, bladder cancer among others, in addition to hematological cancers, including myeloma and leukemia. Further, a few other phase 3 candidates are also being investigated in indications beyond cancer, like hemophilia A and diabetic macular edema, displaying the diversity in indications.
The heightened attention on the development of this novel therapeutic class has been greatly supported by the increasing global value of the bispecific antibodies market. At present, 12 bispecific antibodies have received approvals in different markets around the globe, which together, generated revenue of over US$ 8.5 Billion in the year 2023. This was an increase of over 47% as compared to the total sales of 2022, which was approximately over US$ 5.8 Billion. A bulk of this value comes from the global sales of Hemlibra, a bispecific antibody indicated for the treatment of Hemophilia A, which is the highest selling member of this drug class.
Since bispecific antibodies were introduced in the market, the US has been a major contributor to the overall sales of these drugs. In 2023, the US market alone generated a revenue of US$ 5.6 Billion, with the international market contributing US$ 2.8 Billion to the total sales. This was an increase of 34% compared to the sales recorded in 2022, showing the growing interest of patients and physicians in novel therapeutics, such as bispecific antibodies.
Therefore, bispecific antibodies have demonstrated enough clinical success to validate their potential as a major new drug class. Their unique ability to tap into multiple disease pathways is unlocking new therapeutic possibilities beyond monoclonal antibodies. While oncology has led the way, expansion into other disease areas is accelerating. With continued innovation in molecular designs and engineering, bispecific antibodies represent an exciting versatile approach to transform treatment across a wide range of unmet medical needs, which researchers are slowly progressing to.