市场调查报告书
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1464782
双特异性抗体市场:按作用机制、治疗领域和最终用户 - 2024-2030 年全球预测Bispecific Antibodies Market by Mechanism of Action (Dual Antigen Targeting, Dual-Blocking Antibodies, T-cell Engagers), Therapeutic Area (Autoimmune Diseases, Infectious Diseases, Neurological Disorders), End-user - Global Forecast 2024-2030 |
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双特异性抗体市场规模预计2023年为43.6亿美元,2024年达到61.4亿美元,预计2030年将达到514.7亿美元,复合年增长率为42.24%。
双特异性抗体 (BsAb) 是一种工程蛋白,可同时结合两种不同类型的抗原或同一抗原上的两个不同表位。这种双标靶能力使它们有别于传统的单株抗体,传统的单株抗体是为了结合单一抗原而开发的。双特异性抗体的主要用途是在治疗领域,特别是针对和中和癌细胞。其独特的能力使效应细胞更接近癌细胞,从而增强免疫系统对抗癌症的能力。此外,它在研究中了解疾病机制的用途与其在开发更有效的自体免疫和发炎疾病治疗方法中的应用进一步一致。全球癌症和其他慢性疾病发病率的上升、基因和蛋白质工程技术的进步以及开发和核准新型双特异性抗体的创新推动了双特异性抗体市场的增长,其中包括对治疗方法的监管支持不断增加。然而,双特异性抗体的扩展受到开发双特异性抗体的高成本和生产双特异性抗体的复杂性的阻碍。同时,越来越多地使用双特异性抗体来治疗罕见疾病,以及製药公司对医疗基础设施和研发活动的投资增加,正在为双特异性抗体市场开闢新的途径。
主要市场统计 | |
---|---|
基准年[2023] | 43.6亿美元 |
预测年份 [2024] | 61.4亿美元 |
预测年份 [2030] | 514.7亿美元 |
复合年增长率(%) | 42.24% |
作用机转:增加对双抗原标靶的偏好,以尽量减少脱靶效应
双抗原靶向双特异性抗体旨在同时结合细胞表面上的两种不同抗原。该机制透过确保标靶必须存在才能结合来提高选择性和功效,从而最大限度地减少脱靶效应并改善治疗结果。它是癌症等复杂疾病所必需的,其中多种途径驱动疾病进展。双重阻断抗体同时抑制两种不同讯号传导途径的作用。透过抑制两种不同的配体或受体,这些抗体可以更有效地阻断病理过程,特别是在癌症和自体免疫疾病等疾病中。在讯号途径冗余损害单一标靶药物功效的情况下,基于需求的双阻断抗体偏好变得明显。 T 细胞接合剂是双特异性抗体的一个子集,旨在使细胞毒性 T 细胞靠近癌细胞,促进肿瘤的靶向杀伤。在肿瘤学领域,基于需求的 T 细胞参与者偏好尤其强烈,利用患者的免疫系统来对抗癌症的能力可显着改善治疗结果。与这些机制相比,针对双抗原的双特异性抗体具有选择性增加的优点,特别适合具有明确特征和特异性病理标记的疾病。透过靶向多种途径,双抗原阻断抗体有望改善以途径冗余和补偿疾病进展机制为特征的疾病的治疗结果。 T 细胞接合剂提供了一种独特的方法,透过招募免疫系统来对抗肿瘤,并在肿瘤学方面显示出巨大的潜力,但潜在的免疫介导的毒性需要仔细管理。
治疗领域:扩大双特异性抗体在癌症领域的应用,旨在接触和破坏癌细胞
双特异性抗体的双靶向能力提供了一种强大的机制来攻击和破坏癌细胞,同时保护健康组织。双特异性抗体在肿瘤学中的应用范围广泛,从标靶化肿瘤抗原到让免疫效应细胞参与更定向的针对癌症的免疫反应。在自体免疫疾病中,双特异性抗体(bsAb)代表了一种有前途的标靶免疫治疗方法。这些分子经过定制,可同时结合两种不同的抗原或表位,精确调节免疫反应。需要实现选择性免疫抑製而不具有广泛的免疫抑製作用并降低感染疾病和恶性的风险。双特异性抗体作用于多个标靶的独特能力有可能对抗感染疾病,特别是包括爱滋病毒在内的病毒感染疾病,其中逃避免疫系统是一个关键挑战。这些治疗方法可以透过同时针对病毒表位和招募免疫细胞来增强抗病毒反应。双特异性抗体能够精确靶向神经抗原并促进穿过血脑障壁(BBB),这是神经治疗的关键挑战,为神经疾病的治疗提供了新途径。在癌症领域,临床开发的双特异性抗体应用最为先进,种类繁多。这是由于对标靶癌症治疗的高需求以及该领域的大量投资。与传统治疗方法相比,双特异性抗体可在自体免疫和神经系统疾病领域提供新颖的作用机制。目前针对感染疾病开发的双特异性抗体很少,它们代表了一种潜在的突破性治疗方法,特别是对于对标准治疗有抵抗力的慢性病毒感染疾病。
区域洞察
在强大的研发基础设施、大量的医疗保健支出和强大的专利组合的支持下,美国处于市场需求和双特异性抗体开发的前沿。 FDA 的支持性法律规范加速了创新治疗方法的核准,并鼓励对专门从事双特异性抗体的生物技术公司进行大量投资。在加拿大,人们对双特异性抗体疗法的兴趣日益浓厚,研究机构和生物技术新兴企业获得了政府和私人资助。儘管南美双特异性抗体市场仍处于发展阶段,但医疗保健支出的增加、创新癌症治疗意识的增强以及医疗基础设施的改善正在推动该地区的市场扩张,显示出巨大的成长潜力。在欧盟,重点放在引进先进的治疗解决方案,包括双特异性抗体。新治疗方法的核准、高昂的医疗费用以及欧洲药品管理局 (EMA) 提高患者意识的积极措施正在为 BsAb 创造有利的环境。双特异性抗体在中东和非洲的采用进展缓慢,主要是由于卫生基础设施有限和卫生支出较低。然而,阿联酋和沙乌地阿拉伯等中东国家正在医疗保健领域取得长足进步,这可能为双特异性抗体市场提供动力。亚太地区双特异性抗体市场正在显着成长。这是由于医疗费用飙升、癌症发病率上升以及人们对先进治疗的认识不断增强。中国和日本处于双特异性抗体研发的前沿。监管改革、医疗基础设施的扩张以及本地生物技术公司与国际製药巨头之间的联盟是推动亚太市场的关键因素。
FPNV定位矩阵
FPNV定位矩阵对于评估双特异性抗体市场至关重要。我们检视与业务策略和产品满意度相关的关键指标,以对供应商进行全面评估。这种深入的分析使用户能够根据自己的要求做出明智的决策。根据评估,供应商被分为四个成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市场占有率分析
市场占有率分析是一种综合工具,可以对双特异性抗体市场供应商的现状进行深入而详细的研究。全面比较和分析供应商在整体收益、基本客群和其他关键指标方面的贡献,以便更好地了解公司的绩效及其在争夺市场占有率时面临的挑战。此外,该分析还提供了对该行业竞争特征的宝贵见解,包括在研究基准年观察到的累积、分散主导地位和合併特征等因素。这种详细程度的提高使供应商能够做出更明智的决策并制定有效的策略,从而在市场上获得竞争优势。
1. 市场渗透率:提供有关主要企业所服务的市场的全面资讯。
2. 市场开拓:我们深入研究利润丰厚的新兴市场,并分析其在成熟细分市场的渗透率。
3. 市场多元化:提供有关新产品发布、开拓地区、最新发展和投资的详细资讯。
4.竞争评估与资讯:对主要企业的市场占有率、策略、产品、认证、监管状况、专利状况、製造能力等进行全面评估。
5. 产品开发与创新:提供对未来技术、研发活动和突破性产品开发的见解。
1. 双特异性抗体市场规模及预测如何?
2.双特异性抗体市场预测期间需要考虑投资的产品、细分市场、应用和领域有哪些?
3. 双特异性抗体市场的技术趋势和法规结构是什么?
4.双特异性抗体市场主要厂商的市场占有率为何?
5. 进入双特异性抗体市场的合适型态和策略手段是什么?
[192 Pages Report] The Bispecific Antibodies Market size was estimated at USD 4.36 billion in 2023 and expected to reach USD 6.14 billion in 2024, at a CAGR 42.24% to reach USD 51.47 billion by 2030.
Bispecific antibodies (BsAbs) are engineered proteins that can simultaneously attach to two different types of antigens or two different epitopes on the same antigen. This dual-targeting ability distinguishes them from traditional monoclonal antibodies developed to bind to a single antigen. The primary applications of bispecific antibodies reside in the therapeutic domain, particularly in targeting and neutralizing cancer cells. Their unique capability allows them to bring effector cells in close proximity to cancer cells, enhancing the immune system's ability to combat cancer. Additionally, their use in research to understand disease mechanisms further aligns with their application in creating more effective treatments for autoimmune and inflammatory diseases. Several factors contribute to the growth of the bispecific antibodies market, including rising incidences of cancer and other chronic illnesses globally, advancements in genetic engineering and protein engineering technologies, and growing regulatory support for innovative therapies for developing and approving novel bispecific antibodies. However, the expansion of bispecific antibodies is hindered by the high costs of the development of bispecific antibodies and the manufacturing complexities associated with bispecific antibodies. On the other hand, expanding usage of bispecific antibodies in the treatment of rare diseases and rising investments in healthcare infrastructure and research & development activities by pharmaceutical companies opens new avenues for the bispecific antibodies market.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 4.36 billion |
Estimated Year [2024] | USD 6.14 billion |
Forecast Year [2030] | USD 51.47 billion |
CAGR (%) | 42.24% |
Mechanism of Action: Increasing preference for dual antigen targeting for minimizing off-target effects
Dual antigen-targeting bispecific antibodies are designed to bind to two distinct antigens on the surface of cells simultaneously. This mechanism enhances selectivity and efficacy by ensuring that targets must be present for binding, thereby minimizing off-target effects and improving therapeutic outcomes. It is needed in complex diseases, including cancer, where multiple pathways drive disease progression. Dual-blocking antibodies inhibit the action of two separate signaling pathways simultaneously. By blocking two different ligands or receptors, these antibodies can more effectively shut down pathological processes, especially in diseases such as cancer and autoimmune disorders. Need-based preference for dual-blocking antibodies becomes apparent in conditions where redundancy in signaling pathways can undermine the efficacy of single-target agents. T-cell engagers represent a subset of bispecific antibodies designed to bring cytotoxic T-cells into close proximity with tumor cells, thereby promoting the targeted killing of the tumor. Need-based preference for T-cell engagers is particularly strong in oncology, where the ability to harness the patient's immune system to fight cancer can significantly improve outcomes. In comparing these mechanisms, dual antigen-targeting bsAbs offer the advantage of enhanced selectivity, making them particularly suitable for diseases with well-characterized and specific pathological markers. Dual-blocking antibodies, by targeting multiple pathways, promise improved therapeutic outcomes in diseases characterized by pathway redundancy or compensatory mechanisms of disease progression. T-cell engagers offer a unique approach by mobilizing the immune system against tumors, showing great promise in oncology but requiring careful management of potential immune-mediated toxicities.
Therapeutic Area: Expanding application of bispecific antibodies in oncology for engaging and destroying cancer cells
Oncology remains the most prolific area for the application of bispecific antibodies, with their dual-targeting ability offering a potent mechanism for engaging and destroying cancer cells while sparing healthy tissue. The use of bsAbs in oncology spans targeting tumor antigens to engaging immune effector cells for a more directed immune response against cancer. In autoimmune diseases, bispecific antibodies (bsAbs) pose a promising approach for targeted immunotherapy. These molecules are tailored to bind two different antigens or epitopes simultaneously, allowing precision in modulating immune responses. The need lies in achieving selective immunosuppression without broad immunosuppressive effects, thus reducing the risk of infections and malignancies. The unique capability of bispecific antibodies to engage multiple targets holds potential in combating infectious diseases, particularly viral infections, including HIV, where evasion of the immune system is a significant challenge. These therapies can simultaneously target viral epitopes and recruit immune cells, thereby enhancing the antiviral response. Bispecific antibodies offer a novel pathway in treating neurological disorders by enabling precise targeting of neural antigens and facilitating the cross of the blood-brain barrier (BBB), a significant challenge in neurotherapeutics. The oncology sector exhibits the most advanced application and diverse range of bsAbs under clinical development, which is attributed to the high need for targeted cancer therapies and the significant investment in this area. Autoimmune diseases and neurological disorders represent growing segments where bsAbs can offer novel mechanisms of action compared to traditional therapies. Infectious diseases currently have fewer bsAbs under development and show potential for groundbreaking therapies, especially in chronic viral infections resistant to standard treatment.
Regional Insights
The United States is at the forefront of the market demand and the development of bispecific antibodies, backed by robust R&D infrastructure, significant healthcare spending, and a strong patent portfolio. The FDA's supportive regulatory framework accelerates the approval of innovative therapies, encouraging substantial investments in biotechnology firms focused on BsAbs. Canada showcases a growing interest in bispecific antibody therapies, with research institutions and biotech startups receiving government and private funding. The South American market for bispecific antibodies is in a nascent stage; however, it exhibits potential for significant growth due to increasing healthcare expenditure, rising awareness about innovative cancer treatments, and improving healthcare infrastructure, contributing to the market expansion in this region. In the European Union, there's a strong emphasis on the adoption of advanced therapeutic solutions, including bispecific antibodies. The EMA's (European Medicines Agency) proactive approach to approving novel treatments and high healthcare expenditure and patient awareness fosters a favorable environment for BsAbs. The Middle East and Africa show a slower adoption of bispecific antibodies, primarily due to limited healthcare infrastructure and lower healthcare spending. However, certain countries in the Middle East, such as UAE and Saudi Arabia, are making strides in the healthcare sector, which could provide an impetus to the bispecific antibodies market. The APAC region is witnessing remarkable growth in the bispecific antibodies market, driven by escalating healthcare expenditure, rising cancer incidence, and growing awareness about advanced therapies. China and Japan are at the forefront, spearheading research and development in the bispecific antibodies. Regulatory reforms, expanding healthcare infrastructures, and partnerships between local biotech firms and international pharmaceutical giants are key factors propelling the market in APAC.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Bispecific Antibodies Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Bispecific Antibodies Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Bispecific Antibodies Market, highlighting leading vendors and their innovative profiles. These include AbbVie Inc., Adimab, LLC, Affimed GmbH, Amgen Inc., Astellas Pharma Inc., AstraZeneca PLC, Eli Lilly and Company, Emergent BioSolutions Inc., F. Hoffmann-La Roche Ltd., Genmab A/S, Gilead Sciences, Inc., Innovent Biologics, Janssen Global Services, LLC by Johnson & Johnson Pte. Ltd., MacroGenics, Inc., Merck KGaA, Mereo Biopharma Group PLC, Merus N.V., Novartis AG, Pfizer Inc., Pieris Pharmaceuticals, Inc., Regeneron Pharmaceuticals Inc., Sanofi S.A., TG Therapeutics, Inc., and Xencor, Inc..
Market Segmentation & Coverage
1. Market Penetration: It presents comprehensive information on the market provided by key players.
2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
1. What is the market size and forecast of the Bispecific Antibodies Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Bispecific Antibodies Market?
3. What are the technology trends and regulatory frameworks in the Bispecific Antibodies Market?
4. What is the market share of the leading vendors in the Bispecific Antibodies Market?
5. Which modes and strategic moves are suitable for entering the Bispecific Antibodies Market?