三特异性抗体的全球市场：临床试验与市场前景（2024）

在过去的几十年里，随着单一特异性和双特异性抗体等抗体药物发现治疗的出现，免疫治疗领域的蓝图被认为是未来主义的。在 FDA 批准第一个单株抗体利妥昔单抗用于治疗非何杰金氏淋巴瘤患者后，这项研究得到了推动。儘管单特异性抗体取得了巨大成功，但它们也存在许多缺陷，例如仅针对一种类型的抗原并且对治疗的抗药性增加，使得很难使用针对体内多种抗原或外来入侵者的治疗。发展。近年来，三特异性抗体因其同时靶向三种抗原的能力而成为有前景的治疗靶标，使其成为干预各种疾病的潜在游戏规则改变者。

迄今为止，市面上还没有三特异性抗体，但未来几年内可能会有少量三特异性抗体获得批准。三特异性抗体可以同时结合三种不同的抗原，提高靶向肿瘤细胞的精确度和有效性。

目前有超过 50 种三特异性抗体正在进行临床前和临床试验，用于治疗癌症、传染病、眼科疾病等。然而，研究人员相信，三特异性抗体的临床开发将在未来几年迅速推进，扩展到自体免疫疾病等新的治疗领域。随着我们对三特异性抗体的瞭解不断加深，作用机制和蛋白质工程的创新将会加速，针对精确疾病生物学和分子机制的三特异性构建体的非常规设计也将加速。

本报告检视了全球三特异性抗体市场，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的竞争格局。

目录

第1章 三特异性抗体作为标靶治疗

第2章 三特异性抗体的临床进展及未来商业化前景

第3章 三特异性抗体临床及市场发展趋势分析

• 美国
• 中国
• EU
• 英国
• 日本
• 澳大利亚

第4章 三特异性抗体的治疗临床趋势（依适应症）

• 癌症
• 病毒感染
• 眼病

第5章 全球三特异性抗体临床试验概况

• 依国家
• 相别
• 依公司
• 依指示
• 依患者细分

第6章 依公司、国家、适应症和阶段分析全球三特异性抗体临床试验。

• 研究
• 临床前
• 第一阶段
• 一期/二期

第7章 三特异性抗体市场动态

• 市场驱动力
• 市场课题

第8章 三特异性抗体市场的最新趋势：联盟、收购、合作与投资

第9章 不断发展的三特异性抗体组合方法

第10章 用于开拓三特异性抗体开发的平台

第11章 竞争格局

• AbbVie
• Antibody Studio
• Beijing Mabworks Biotech
• Biocytogen Pharmaceuticals
• Chimagen Biosciences
• Chiome Bioscience
• Genor Biopharma
• GT Biopharma
• Harpoon Therapeutics
• Ichnos Sciences
• KisoJi Biotechnology
• L and L Biopharma
• Lyvgen Biopharma
• Numab
• OPKO Health
• Sanofi
• Sichuan Baili Pharmaceuticals
• TG ImmunoPharma

Global Trispecific Antibodies Clinical Trials & Market Outlook 2024 Report Highlights:

• Trispecific Antibodies In Clinical Trials: > 50 Antibodies
• Majority Of Antibodies Developed For Multiple Myeloma: 8 Antibodies
• Trispecific Antibodies Clinical Trials Insight By Company, Country, Indication & Phase
• Platforms Used For Pioneering Trispecific Antibody
• China Dominating Trispecific Antibodies Clinical Trials: >20 Antibodies
• Competitive Landscape: Insight On 18 Companies

The blueprint in the domain of immunotherapy has perceived futuristic with the advent of antibody founded therapy, like monospecific and bispecific antibodies, in the past decenniums. The investigation has picked up its gait after the FDA approval of the first monoclonal antibody, rituximab, for the management of patients suffering from non-Hodgkin's lymphoma. Albeit, the monospecific antibodies have demonstrated gigantic triumph, there comes a number of pitfalls, such as their ability to target only one type of antigens as well as increased therapy resistance, urges the need to develop more therapies that will target more than one antigen or foreign foe inside the person's body. In the recent years, trispecific antibody has emerged as a promising therapeutic target due to its plausibility in targeting 3 antigens at the same time, making it a game changer candidate for intervention in various ailments.

To date, no trispecific antibody have been launched in the market; however, it is probable that handful of trispecific antibodies will be approved in the imminent years. Founded on the accomplishment of monospecific antibodies, healthcare professionals have developed trispecific antibody, which can simultaneously bind to three different antigens at the same time, enhancing the precision and effectiveness of targeting tumor cells; representing a groundbreaking innovation in the field of cancer immunotherapy.

At present, more than 50 trispecific antibodies are lately in the preclinical together with clinical studies for the treatment of cancer, infectious diseases, and eye diseases. Nevertheless, researchers believed that the clinical conduit of trispecific antibody is proposed to perceive swift development in the years ahead and will likely expand into additional therapeutic areas like autoimmune diseases, and beyond. As progression in trispecific antibody understanding, mode of action in addition to protein engineering innovations upsurges; simultaneously, the unconventional design of trispecific constructs tailored to precise disease biology and molecular mechanisms will expand.

Accompanied that, the presences of giant pharma companies, such as Roche/ Genentech, Chugai Pharmaceutical, Genor Biopharma, Johnson & Johnson, Merck, Gilead Sciences, Xencor, Numab Therapeutics others, signifies that the sector of trispecific antibodies will prosper further in the forthcoming years as the involvement of giant stakeholders aid to conduct multiple research studies.

Over and above, pharmaceutical companies as well as biotechnology corporations are progressively engaging in strategic collaborations, investments, in addition to acquisitions to influence corresponding expertise and resources in trispecific antibody development domain. These partnerships accelerate research and development, optimize clinical trial design, and enhance market penetration. For instance, in May 2024, Merck has acquired EyeBio with an investment of US$ 3 Billion in order to advance the sector of trispecific antibody. Furthermore, Gilead Science and Merus collaboration deal to discover novel antibody-based trispecific t-cell engagers in March 2024 is another such example.

For the treatment of cancer disorders, a diverse landscape of trispecific antibody candidates is currently under evaluation to treat solid tumors and hematological cancer diseases. However, in the recent years, scientists have expanded the clinical application of trispecific antibody beyond cancer and can be utilized to treat other indications such as eye disorders, viral infections and other, specifying novel avenue. Given their biological complexity as well as anticipated premium pricing, the segment of trispecific assets could feasibly generate multi billion-dollar peak sales in forthcoming years among successful programs.

Looking further ahead, the commercial global market of trispecific antibody is intensifying at a farfetched pace owing to the market drivers like the rising population, involvement of stakeholders, ongoing pre-clinical and clinical trials, augment in technological advancement in immunotherapies domain, rise in awareness for immuno oncology therapy, together with increase in investments and licensing deals. Presently, the US as well as China have become the front runner up in the segment of trispecific immuno therapy due to the rising research in addition to clinical trials.

Table of Contents

1. Trispecific Antibody As Targeted Therapy

2. Trispecific Antibody Current Clinical Development & Future Commercialization Outlook

• 2.1 Current Market Development Scenario
• 2.2 Future Market Commercialization Outlook

3. Trispecific Antibody Clinical & Market Development Trend Analysis by Region

• 3.1 US
• 3.2 China
• 3.3 EU
• 3.4 UK
• 3.5 Japan
• 3.6 Australia

4. Trispecific Antibodies Therapeutic Clinical Tends By Indications

• 4.1 Cancer
  • 4.1.1 Breast Cancer
  • 4.1.2 Colorectal Cancer
  • 4.1.3 Lung Cancer
  • 4.1.4 Multiple Myeloma
  • 4.1.5 Lymphoma
  • 4.1.6 Leukemia
• 4.2 Viral Infections
• 4.3 Eye Diseases

5. Global Trispecific Antibodies Clinical Trials Overview

• 5.1 By Country
• 5.2 By Phase
• 5.3 By Company
• 5.4 By Indication
• 5.5 By Patient Segment

6. Global Trispecific Antibodies Clinical Trials Insight By Company, Country, Indication & Phase

• 6.1 Research
• 6.2 Preclinical
• 6.3 Phase I
• 6.4 Phase I/II

7. Trispecific Antibody Market Dynamics

• 7.1 Market Drivers
• 7.2 Market Challenges

8. Recent Trends in Trispecific Antibody Market: Partnerships, Acquisitions, Collaboration, & Investments

9. Combinations Approaches for Bourgeoning Trispecific Antibody

• 9.1 Immunotherapy
• 9.2 Radiotherapy

10. Platforms Used For Pioneering Trispecific Antibody

• 10.1 Tavotek Biotherapeutics - TavoSelect Platform
• 10.2 Tavotek Biotherapeutics - TavoPrecise Platform
• 10.3 Purple Biotech - Tribody Antibody Platform
• 10.4 Simcere Zaiming's - T-Cell Engager Polyspecific Antibody Technology Platform
• 10.5 Ichnos Sciences - BEAT Platform
• 10.6 Molecular Partners - DARPin Platform
• 10.7 Merus - Triclonics Platform

11. Competitive Landscape

• 11.1 AbbVie
• 11.2 Antibody Studio
• 11.3 Beijing Mabworks Biotech
• 11.4 Biocytogen Pharmaceuticals
• 11.5 Chimagen Biosciences
• 11.6 Chiome Bioscience
• 11.7 Genor Biopharma
• 11.8 GT Biopharma
• 11.9 Harpoon Therapeutics
• 11.10 Ichnos Sciences
• 11.11 KisoJi Biotechnology
• 11.12 L and L Biopharma
• 11.13 Lyvgen Biopharma
• 11.14 Numab
• 11.15 OPKO Health
• 11.16 Sanofi
• 11.17 Sichuan Baili Pharmaceuticals
• 11.18 TG ImmunoPharma

List of Figures

• Figure 1-1: Trispecific Antibody as Targeted Therapy
• Figure 2-1: Strategies to Develop Next Generation Trispecific Antibody
• Figure 2-2: Aspects Influencing Future of Trispecific Antibody
• Figure 3-1: CB307 Phase I Study (NCT04839991) - Initiation & Completion Year
• Figure 3-2: SAIL66 Phase I Study (NCT05735366) - Initiation & Completion Year
• Figure 4-1: BR115 Phase I Study (NCT06388902) - Initiation & Completion Year
• Figure 4-2: NM32-2668 Phase I Study (NCT06299163) - Initiation & Completion Year
• Figure 4-3: Trispecific Antibody Benefit to Treat Colorectal Cancer
• Figure 4-4: Chimagen Biosciences Pipeline
• Figure 4-5: HPN328 (MK-6070) with Atezolizumab Phase I/II Study (NCT04471727) - Initiation & Completion Year
• Figure 4-6: Genor Biopharma Pipeline
• Figure 4-7: GB263T Phase I/II Study (NCT05332574) - Initiation & Completion Year
• Figure 4-8: SIM0500 Phase I Study (NCT06375044) - Initiation & Completion Year
• Figure 4-9: JNJ-79635322 Phase I Study (NCT05652335) - Initiation & Completion Year
• Figure 4-10: MBS314 Phase I/II Study (NCT06232096) - Initiation & Completion Year
• Figure 4-11: Trispecific Antibodies FDA Designations
• Figure 4-12: HPN217 Phase I Study (NCT04184050) - Initiation & Completion Year
• Figure 4-13: PIT565 Phase I Study (NCT05397496) - Initiation & Completion Year
• Figure 4-14: JNJ-80948543 Phase I Study (NCT05424822) - Initiation & Completion Year
• Figure 4-15: 1A46/ BR110 Phase I/II Study (NCT05987605) - Initiation & Completion Year
• Figure 4-16: KL-HIV-Tri01 Phase I Study (NCT06117657) - Initiation & Completion Year
• Figure 4-17: Restoret (EYE103) - Tetravalent, Tri-Specific Antibody Binding Sites
• Figure 4-18: Restoret/ EYE103 Phase I/II Study (NCT05919693) - Initiation & Completion Year
• Figure 4-19: Eluminex Ophthalmics Clinical Trispecific Pipeline for Eye Ailments
• Figure 5-1: Global - Trispecific Antibodies Clinical Trials by Country, 2024
• Figure 5-2: Global - Trispecific Antibodies Clinical Trials by Phase, 2024
• Figure 5-3: Global - Trispecific Antibodies Clinical Trials by Company
• Figure 5-4: Global - Trispecific Antibodies Clinical Trials by Indication, 2024
• Figure 5-5: Global - Trispecific Antibodies Clinical Trials by Patient Segment, 2024

Figure 7-1 : Trispecific Antibody - Market Drivers

• Figure 7-2: Key Players in Trispecific Antibody Market
• Figure 7-3: Trispecific Antibody - Market Challenges
• Figure 9-1: JNJ-87801493 with JNJ-80948543 & JNJ-75348780 Phase I Study (NCT06139406) - Initiation & Completion Year
• Figure 9-2: Radiolabelled CB307/ 89Zr-CB307 Phase I Study (NCT05836623) - Initiation & Completion Year
• Figure 10-1: Purple Biotech - Tribody Antibody Platform
• Figure 10-2: DARPin Platform - Molecular Partners
• Figure 10-3: Merus - Triclonics Platform
• Figure 11-1: GT Biopharma - Clinical Pipeline

List of Tables

• Table 3-1: US -Ongoing Clinical Trials for Trispecific Antibodies (May'2024)
• Table 3-2: EU -Ongoing Clinical Trials for Trispecific Antibodies (May'2024)
• Table 3-3: Australia -Ongoing Clinical Trials for Trispecific Antibodies (May'2024)