市场调查报告书
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1441148
双特异性抗体的全球市场:药物销售、专利、价格和临床试验见解 (2029)Global Bispecific Antibody Market, Drugs Sales, Patent, Price & Clinical Trials Insight 2029 |
双特异性抗体是一种令人兴奋的新治疗方法,在过去十年中势头强劲。 这些精心设计的分子提供了独特的作用机制,可利用免疫系统精确靶向恶性和其他患病细胞和组织,从而提供一种有针对性的方法,最大限度地降低副作用的风险。 过去三年,双特异性抗体市场的研发和商业活动迅速升温,预计未来几年该市场将快速成长。
双特异性抗体是设计用于同时结合两种不同抗原(通常在不同细胞类型上)的蛋白质。 其双重标靶能力提供了多种利用免疫系统对抗疾病的方法。 对抗癌症的常见方法是引导 T 细胞和自然杀手细胞攻击恶性细胞。 它还可以交联免疫细胞和肿瘤细胞以增强免疫反应。 此外,它还可以阻断两种不同的讯号路径并将免疫细胞招募到肿瘤微环境中。
对于癌症以外的适应症,双特异性抗体可以双重靶向不同的疾病介质或细胞类型。 这提供了中和或消除与发炎、自体免疫和其他疾病有关的致病蛋白、细胞因子和细胞的机会。 然而,根据适应症,双特异性抗体的作用机转可能会有所不同。
与传统的单株抗体相比,双特异性抗体的多功能性具有多种优势,包括更高的特异性、效力和同时靶向多个途径的灵活性。Masu。 这在癌症治疗中具有特殊的意义,其中单株抗体被大量用于抑制各种与癌症相关的途径。 透过将免疫细胞引导至肿瘤,双特异性抗体可以克服肿瘤的免疫逃脱机制,与传统化疗相比,有可能提高疗效并降低毒性。
美国FDA于2014年批准了Blinatumomab(商品名Blincyto),标誌着双特异性抗体治疗復发或难治性B细胞前体急性淋巴细胞白血病领域的一个重要里程碑,从根本上改变了这一法律。 继这一成功之后,几种新的双特异性抗体正在临床开发中,涵盖多种疾病,重点是癌症。 然而,除了癌症之外,还有越来越多的双特异性候选抗体旨在解决病毒和细菌感染以及自体免疫疾病等新兴适应症。 这种多样化凸显了此类药物治疗应用范围的不断扩大。
双特异性抗体已取得足够的临床成功,足以验证其作为主要新药类别的潜力。 它们利用多种疾病途径的独特能力开闢了单株抗体以外的新治疗可能性。 虽然肿瘤学处于领先地位,但向其他疾病领域的扩张也在加速。 分子设计和工程的持续创新使双特异性抗体成为一种令人兴奋的多功能方法,可以改变各种未满足的医疗需求的治疗方法,并且正在越来越多地探索。
本报告调查了全球双特异性抗体市场,并提供了市场概况,包括药物趋势、临床试验趋势、区域趋势以及进入市场的公司竞争格局。
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.