三重特異性抗体の世界市場：臨床試験と市場の見通し（2024年）

免疫療法の領域における青写真は、過去数十年の間に、単特異抗体や二特異抗体のような抗体創薬治療の出現によって未来的なものと認識されるようになっています。FDAが非ホジキンリンパ腫患者の治療に最初のモノクローナル抗体であるリツキシマブを承認した後、この研究はその歩みを速めました。単特異性抗体は大きな成功を収めましたが、1種類の抗原しか標的としないことや治療抵抗性の増加など、多くの落とし穴があり、体内の複数の抗原や外敵を標的とする治療法を開発する必要性が生じています。近年、三重特異性抗体は、同時に3つの抗原を標的とすることが可能であることから、有望な治療標的として浮上しており、様々な疾患への介入を可能にするゲームチェンジャー候補となっています。

現在までのところ、三重特異性抗体は上市されていませんが、数年以内に数少ない三重特異性抗体が承認される可能性があります。三重特異性抗体は、同時に3つの異なる抗原に結合することができ、腫瘍細胞を標的にする精度と効果を高めることができます。

現在、50以上の三重特異性抗体が、がん、感染症、眼病などの治療のために、前臨床試験と臨床試験が行われています。とはいえ、研究者たちは、三重特異性抗体の臨床開発は今後数年で急速に進展し、自己免疫疾患のような新たな治療領域、さらにはそれ以上の領域へと拡大していくだろうと考えています。三特異抗体の理解が進むにつれ、作用機序やタンパク質工学の技術革新が加速し、同時に、正確な疾患生物学や分子メカニズムに合わせた三特異コンストラクトの型破りなデザインも拡大していくと思われます。

当レポートは、世界の三重特異性抗体市場について調査し、市場の概要とともに、薬剤動向、臨床試験動向、地域別動向、および市場に参入する企業の競合情勢などを提供しています。

目次

第1章 標的治療としての三重特異性抗体

第2章 三重特異性抗体の現在の臨床開発と将来の商業化の見通し

第3章 三重特異性抗体の臨床および市場開発動向分析、地域別

• 米国
• 中国
• EU
• 英国
• 日本
• オーストラリア

第4章 三重特異性抗体の治療的臨床傾向、適応症別

• がん
• ウイルス感染
• 眼疾患

第5章 世界三重特異性抗体臨床試験の概要

• 国別
• 相別
• 企業別
• 適応症別
• 患者セグメント別

第6章 企業、国、適応症、相別の世界三重特異性抗体臨床試験の洞察

• 研究
• 前臨床
• 第I相
• 第I/II相

第7章 三重特異性抗体市場力学

• 市場の促進要因
• 市場の課題

第8章 三重特異性抗体市場の最近の動向：提携、買収、コラボレーション、投資

第9章 成長中の三重特異性抗体の組合せアプローチ

第10章 三重特異性抗体の先駆的開発に使用されたプラットフォーム

第11章 競合情勢

• 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

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)

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