市場調查報告書
商品編碼
1464782
雙特異性抗體市場:按作用機制、治療領域和最終用戶 - 2024-2030 年全球預測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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雙特異性抗體市場規模預計2023年為43.6億美元,2024年達到61.4億美元,預計2030年將達到514.7億美元,複合年成長率為42.24%。
雙特異性抗體 (BsAb) 是一種工程蛋白,可同時結合兩種不同類型的抗原或同一抗原上的兩個不同表位。這種雙標靶能力使它們有別於傳統的單株抗體,傳統的單株抗體是為了結合單一抗原而開發的。雙特異性抗體的主要用途是在治療領域,特別是針對和中和癌細胞。其獨特的能力使效應細胞更接近癌細胞,從而增強免疫系統對抗癌症的能力。此外,它在研究中了解疾病機制的用途與其在開發更有效的自體免疫和發炎疾病治療方法中的應用進一步一致。全球癌症和其他慢性疾病發病率的上升、基因和蛋白質工程技術的進步以及開發和核准新型雙特異性抗體的創新推動了雙特異性抗體市場的成長,其中包括對治療方法的監管支持不斷增加。然而,雙特異性抗體的擴展受到開發雙特異性抗體的高成本和生產雙特異性抗體的複雜性的阻礙。同時,擴大使用雙特異性抗體來治療罕見疾病,以及製藥公司對醫療基礎設施和研發活動的投資增加,正在為雙特異性抗體市場開闢新的途徑。
主要市場統計 | |
---|---|
基準年[2023] | 43.6億美元 |
預測年份 [2024] | 61.4億美元 |
預測年份 [2030] | 514.7億美元 |
複合年成長率(%) | 42.24% |
作用機轉:增加對雙抗原標靶的偏好,以盡量減少脫靶效應
雙抗原靶向雙特異性抗體旨在同時結合細胞表面上的兩種不同抗原。該機制透過確保標靶必須存在才能結合來提高選擇性和功效,從而最大限度地減少脫靶效應並改善治療結果。它是癌症等複雜疾病所必需的,其中多種途徑驅動疾病進展。雙重阻斷抗體同時抑制兩種不同訊號傳導途徑的作用。透過抑制兩種不同的配體或受體,這些抗體可以更有效地阻斷病理過程,特別是在癌症和自體免疫疾病等疾病中。在訊號途徑冗餘損害單一標靶藥物功效的情況下,基於需求的雙阻斷抗體偏好變得明顯。 T 細胞接合劑是雙特異性抗體的一個子集,旨在使細胞毒性 T 細胞靠近癌細胞,促進腫瘤的靶向殺傷。在腫瘤學領域,基於需求的 T 細胞參與者偏好尤其強烈,利用患者的免疫系統來對抗癌症的能力可顯著改善治療結果。與這些機制相比,針對雙抗原的雙特異性抗體具有選擇性增加的優點,特別適合具有明確特徵和特異性病理標記的疾病。透過靶向多種途徑,雙抗原阻斷抗體有望改善以途徑冗餘和補償疾病進展機制為特徵的疾病的治療結果。 T 細胞接合劑提供了一種獨特的方法,透過招募免疫系統來對抗腫瘤,並在腫瘤學方面顯示出巨大的潛力,但潛在的免疫介導的毒性需要仔細管理。
治療領域:擴大雙特異性抗體在癌症領域的應用,旨在接觸和破壞癌細胞
雙特異性抗體的雙靶向能力提供了一種強大的機制來攻擊和破壞癌細胞,同時保護健康組織。雙特異性抗體在腫瘤學中的應用範圍廣泛,從標靶化腫瘤抗原到讓免疫效應細胞參與更定向的針對癌症的免疫反應。在自體免疫疾病中,雙特異性抗體(bsAb)代表了一種有前途的標靶免疫治療方法。這些分子經過客製化,可同時結合兩種不同的抗原或表位,精確調節免疫反應。需要實現選擇性免疫抑製而不具有廣泛的免疫抑製作用並降低感染疾病和惡性的風險。雙特異性抗體作用於多個標靶的獨特能力有可能對抗感染疾病,特別是包括愛滋病毒在內的病毒感染疾病,其中逃避免疫系統是一個關鍵挑戰。這些治療方法可以透過同時針對病毒表位和招募免疫細胞來增強抗病毒反應。雙特異性抗體能夠精確靶向神經抗原並促進穿過血腦障壁(BBB),這是神經治療的關鍵挑戰,為神經疾病的治療提供了新途徑。在癌症領域,臨床開發的雙特異性抗體應用最為先進,種類繁多。這是由於對標靶癌症治療的高需求以及該領域的大量投資。與傳統治療方法相比,雙特異性抗體可在自體免疫和神經系統疾病領域提供新穎的作用機制。目前針對感染疾病開發的雙特異性抗體很少,它們代表了一種潛在的突破性治療方法,特別是對於對標準治療有抵抗力的慢性病毒感染疾病。
區域洞察
在強大的研發基礎設施、大量的醫療保健支出和強大的專利組合的支持下,美國處於市場需求和雙特異性抗體開發的前沿。 FDA 的支持性法律規範加速了創新治療方法的核准,並鼓勵對專門從事雙特異性抗體的生物技術公司進行大量投資。在加拿大,人們對雙特異性抗體療法的興趣日益濃厚,研究機構和生物技術新興企業獲得了政府和私人資助。儘管南美雙特異性抗體市場仍處於發展階段,但醫療保健支出的增加、創新癌症治療意識的增強以及醫療基礎設施的改善正在推動該地區的市場擴張,顯示出巨大的成長潛力。在歐盟,重點放在引進先進的治療解決方案,包括雙特異性抗體。新治療方法的核准、高昂的醫療費用以及歐洲藥品管理局 (EMA) 提高患者意識的積極措施正在為 BsAb 創造有利的環境。雙特異性抗體在中東和非洲的採用進展緩慢,主要是由於衛生基礎設施有限和衛生支出較低。然而,阿拉伯聯合大公國和沙烏地阿拉伯等中東國家正在醫療保健領域取得長足進步,這可能為雙特異性抗體市場提供動力。亞太地區雙特異性抗體市場正在顯著成長。這是由於醫療費用飆升、癌症發病率上升以及人們對先進治療的認知不斷增強。中國和日本處於雙特異性抗體研發的前沿。監管改革、醫療基礎設施的擴張以及本地生物技術公司與國際製藥巨頭之間的聯盟是推動亞太市場的關鍵因素。
FPNV定位矩陣
FPNV定位矩陣對於評估雙特異性抗體市場至關重要。我們檢視與業務策略和產品滿意度相關的關鍵指標,以對供應商進行全面評估。這種深入的分析使用戶能夠根據自己的要求做出明智的決策。根據評估,供應商被分為四個成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市場佔有率分析
市場佔有率分析是一種綜合工具,可以對雙特異性抗體市場供應商的現狀進行深入而詳細的研究。全面比較和分析供應商在整體收益、基本客群和其他關鍵指標方面的貢獻,以便更好地了解公司的績效及其在爭奪市場佔有率時面臨的挑戰。此外,該分析還提供了對該行業競爭特徵的寶貴見解,包括在研究基準年觀察到的累積、分散主導地位和合併特徵等因素。這種詳細程度的提高使供應商能夠做出更明智的決策並制定有效的策略,從而在市場上獲得競爭優勢。
1. 市場滲透率:提供有關主要企業所服務的市場的全面資訊。
2. 市場開拓:我們深入研究利潤豐厚的新興市場,並分析其在成熟細分市場的滲透率。
3. 市場多元化:提供有關新產品發布、開拓地區、最新發展和投資的詳細資訊。
4.競爭評估與資訊:對主要企業的市場佔有率、策略、產品、認證、監管狀況、專利狀況、製造能力等進行全面評估。
5. 產品開發與創新:提供對未來技術、研發活動和突破性產品開發的見解。
1. 雙特異性抗體市場規模及預測如何?
2.雙特異性抗體市場預測期間需要考慮投資的產品、細分市場、應用和領域有哪些?
3. 雙特異性抗體市場的技術趨勢和法規結構是什麼?
4.雙特異性抗體市場主要廠商的市場佔有率為何?
5. 進入雙特異性抗體市場的合適型態和策略手段是什麼?
[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?