LAG-3阻害剤の世界市場：薬剤売上と臨床試験に関する洞察（2029年）

近年、がん治療では、既存の治療効果を向上させることを目的とした新規アプローチが数多く見られるようになっています。大幅な進歩にもかかわらず、化学療法や放射線療法などの標準療法は、多くのがん患者にとって長期的な寛解や治癒を達成できないことが多いです。その結果、研究者たちは新規の治療アプローチに注目しており、そのひとつが免疫チェックポイントタンパク質LAG-3（Lymphocyte Activation Gene-3）を標的とするものです。現在、いくつかのLAG-3阻害剤が臨床試験中であり、市販されているのは1剤のみですが、LAG-3阻害剤市場は、世界のがん患者の増加と製薬会社や研究者によるこの新薬クラスへの関心の高まりにより、今後数年間でかつてない速度で成長すると予想されています。

LAG-3は、T細胞やNK細胞を含む多くの免疫細胞の表面に存在する共抑制性受容体です。その主な役割は、免疫反応を制御し、自己免疫疾患の原因となる過剰活性化を防ぐことです。しかしながら、がんの場合、腫瘍細胞はLAG-3を利用して免疫監視を回避することができ、腫瘍細胞の増殖と転移を抑制することができます。LAG-3の過剰発現とアップレギュレーションは様々な悪性腫瘍で見られ、抗腫瘍免疫応答の阻害に寄与し、腫瘍の成長と進行を可能にしていると考えられています。この発見により、LAG-3ががん治療の有望な治療標的として研究される基礎が築かれました。

米国と中国はLAG-3阻害剤の分野におけるパイオニアとして台頭し、いくつかの阻害剤の研究開発および臨床試験の拠点となっています。これは、これらの国々にLAG-3阻害剤の開発に取り組む複数の企業や研究機関が存在することに加え、それぞれの政府が製薬業界に有利な環境を整えるために一貫した支援を行っていることに起因しています。その結果、LAG-3阻害剤を取り巻く環境は拡大し、EU、日本、韓国を含む他の多くの国々がLAG-3阻害剤の知識基盤に大きく貢献するようになっています。

当レポートは、世界のLAG-3阻害剤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 LAG-3阻害剤のイントロダクション

• LAG-3阻害剤の概要
• 作用機序
• LAG-3標的治療アプローチ

第2章 世界のLAG-3阻害剤の臨床試験概要

• 相別
• 国別
• 企業別
• 適応症別
• 優先度別
• 患者セグメント

第3章 世界のLAG-3阻害剤市場のシナリオ

第4章 LAG-3阻害剤市場の地域別分析

• 韓国
• オーストラリア
• カナダ
• 日本
• 英国
• 欧州
• 中国
• 米国

第5章 LAG-3阻害剤市場開発、適応症別

• リンパ腫
• 悪性黒色腫
• 肺がん
• 大腸がん
• 頭頸部がん
• 食道がん

第6章 オプデュアラグ（ニボルマブ&レラトリマブ-rmbw）- 概要、価格、投与量、販売分析

第7章 LAG-3阻害剤の併用戦略

第8章 世界のLAG-3阻害剤の臨床試験概要、企業、国、適応症、相別

• 研究
• 前臨床
• 第I相
• 第I/II相
• 第II相
• 第II/III相
• 第III相

第9章 上市済みLAG-3阻害剤の臨床的洞察

第10章 LAG-3阻害剤の世界市場力学

• 市場の促進要因
• 市場の課題

第11章 競合情勢

• Abeome Corporation
• ABL Bio
• Agenus
• Akeso Biopharma
• AnaptysBio
• Bristol-Myers Squibb
• EpimAb Biotherapeutics
• F-star Therapeutics
• Immutep
• Incyte Corporation
• Innovent Biologics
• Merck
• Roche
• Shanghai Fosun Pharmaceutical
• Y-Biologics

List of Tables

• Table 3-1: China - Ongoing Clinical Trials for LAG-3 Inhibitors
• Table 3-2: US - Some Ongoing Clinical Trials for LAG-3 Inhibitors
• Table 4-1: Lymphoma - Some Ongoing Clinical Trials for LAG-3 Inhibitors
• Table 4-2: Melanoma - Some Ongoing Clinical Trials for LAG-3 Inhibitors
• Table 5-1: Opdualag - Maximum Infusion Volumes and Concentration Ranges by Patient Group
• Table 5-2: Opdualag - Recommended Dosage Modifications for Adverse Reactions
• Table 6-1: Ongoing Preclinical & Clinical trials for Combination of LAG-3 inhibitors

List of Figures

• Figure 1-1: LAG-3/MHC Class II Signaling Pathway
• Figure 12: LAG-3 Inhibitor - Mechanism of Action
• Figure 1-3: Binding Efficacy of Bispecific Antibodies
• Figure 2-1: Global - LAG-3 Inhibitor Clinical Trials By Phase (Numbers), 2024 - 2029
• Figure 2-2: Global - LAG-3 Inhibitor Clinical Trials By Country (Numbers), 2024 - 2029
• Figure 2-3: Global - LAG-3 Inhibitor Clinical Trials By Company (Numbers), 2024 - 2029
• Figure 2-4: Global - LAG-3 Inhibitor Clinical Trials By Indication (Numbers), 2024 - 2029
• Figure 2-5: Global - LAG-3 Inhibitor Clinical Trials By Priority Status (Numbers), 2024 - 2029
• Figure 2-6: Global - LAG-3 Inhibitor Clinical Trials By Patient Segment (Numbers), 2024 - 2029
• Figure 3-1: Global - LAG 3 Inhibitor Market (US$ Million), 2022 & 2023
• Figure 3-2: Global - LAG 3 Inhibitor Market By Region(US$ Million), 2023
• Figure 3-3:Global - LAG 3 Inhibitor Market By Region (%), 2023
• Figure 3-4: Global - LAG 3 Inhibitor Market By Region (US$ Million), Q1'2024
• Figure 3-5: Combination of Anti-LAG-3 Antibody with a Virus-Like Drug Conjugate (VDC), AU-011
• Figure 3-6: Aspects Determining LAG-3 Inhibitor Future
• Figure 3-7: Global - LAG 3 Inhibitor Market Forecast (US$ Million), 2024 - 2029
• Figure 4-1 ABL501 Phase I (NCT05101109) Study - Initiation & Completion Year
• Figure 4-2: Y Biologics Preclinical LAG-3 Candidate
• Figure 4-3 NCT06259162 Study - Initiation & Completion Year
• Figure 4-4 LBL-007 Phase I/II (NCT03744468) Study - Initiation & Completion Year
• Figure 4-5 Relatlimab & Nivolumab Phase II (NCT05418972) Study - Initiation & Completion Year
• Figure 4-6 Eftilagimod Alpha (IMP321) With Pembrolizumab Phase II (NCT03625323) Study - Initiation & Completion Year
• Figure 4-7 Fianlimab & Cemiplimab Phase III (NCT05352672) Study - Initiation & Completion Year
• Figure 4-8: Canada- Features Prompting LAG-3 Inhibitor Market
• Figure 4-9: Relatlimab With or Without Nivolumab Phase I (NCT02966548) Study - Initiation & Completion Year
• Figure 4-10: Relatlimab - Ongoing Studies Indication & Location Insights
• Figure 4-11: Margetuximab in Combination With INCMGA00012 & Chemotherapy Phase II/III (NCT04082364) Study - Initiation & Completion Year
• Figure 4-12: FS118 Phase I/II (NCT03440437) Study - Initiation & Completion Year
• Figure 4-13: Europe Research Institutes & Hospitals Conducting LAG-3 Inhibitor Clinical Trials
• Figure 4-14: INCAGN02385 & INCAGN02390 Phase II (NCT05287113) Study - Initiation & Completion Year
• Figure 4-15: IMP321 with Immunotherapeutic/Targeted/Chemotherapeutic Agents Phase I (NCT03252938) Study - Initiation & Completion Year
• Figure 4-16: Sym021 With Sym022 or Sym023 Phase I (NCT04641871) Study - Initiation & Completion Year
• Figure 4-17: Tobemstomig with Atezolizumab, Bevacizumab & Tiragolumab Phase I/II (NCT05908786) Study - Initiation & Completion Year
• Figure 4-18: AK129 Phase 1 (NCT05645276) Study - Initiation & Completion Year
• Figure 4-19: LBL-007 Phase 1 (NCT04640545) Study - Initiation & Completion Year
• Figure 5-1: Opdualag Phase 1/2 (NCT05255601) Study - Initiation & Completion Year
• Figure 5-2: INCAGN02385 Phase 1 (NCT06290622) Study - Initiation & Completion Year
• Figure 5-3: Favezelimab Phase 1/2 (NCT03598608) Study - Initiation & Completion Year
• Figure 5-4: Fianlimab Phase 3 (NCT05352672) Study - Initiation & Completion Year
• Figure 5-5: Fianlimab Phase 3 (NCT05608291) Study - Initiation & Completion Year
• Figure 5-6: INCAGN02385 Phase 1/2 (NCT04370704) Study - Initiation & Completion Year
• Figure 5-7: XmAb22841 Phase 1 (NCT05695898) Study - Initiation & Completion Year
• Figure 5-8: Fianlimab Phase 2/3 (NCT05785767) Study - Initiation & Completion Year
• Figure 5-9: Fianlimab Phase 2/3 (NCT05800015) Study - Initiation & Completion Year
• Figure 5-10: Fianlimab Phase 2 (NCT03916627) Study - Initiation & Completion Year
• Figure 5-11: Fianlimab Phase 2 (NCT06161441) Study - Initiation & Completion Year
• Figure 5-12: HLX26 Phase 2 (NCT05787613) Study - Initiation & Completion Year
• Figure 5-13: Favezelimab Phase 3 (NCT05064059) Study - Initiation & Completion Year
• Figure 5-14: Fianlimab Phase 2 (NCT06205836) Study - Initiation & Completion Year
• Figure 5-15: Relatlimab Phase 2 (NCT03642067) Study - Initiation & Completion Year
• Figure 5-16: Relatlimab Phase 2 (NCT04080804) Study - Initiation & Completion Year
• Figure 5-17: FS118 Phase 1/2 (NCT03440437) Study - Initiation & Completion Year
• Figure 5-18: Tobemstomig Phase 1/2 (NCT04140500) Study - Initiation & Completion Year
• Figure 5-19: Tobemstomig Phase 2 (NCT04785820) Study - Initiation & Completion Year
• Figure 5-20: Relatlimab Phase 1 (NCT03044613) Study - Initiation & Completion Year
• Figure 6-1: Opdualag - Approval Year by Region
• Figure 6-2: Opdualag - Estimated Minimum Market Exclusivity Date, 2024
• Figure 6-3: US - Cost per Unit & Supply of Opdualag (US$), June'2024
• Figure 6-4: EU - Cost per Unit & Supply of Opdualag (US$), June'2024
• Figure 6-5: Global - Opdualag Annual Sales (US$ Million), 2022-2023
• Figure 6-6: Global - Opdualag Sales by Region (US$ Million), 2023
• Figure 6-7: Global - Opdualag Annual Sales by Region (%), 2023
• Figure 6-8: Global - Opdualag Quarterly Sales (US$ Million), Q1'2024
• Figure 6-9: Global - Opdualag Quarterly Sales (US$ Million), Q1-Q4'2023
• Figure 6-10: US - Opdualag Quarterly Sales (US$ Million), 2023
• Figure 6-11: ROW - Opdualag Quarterly Sales (US$ Million), 2023
• Figure 7-1: Overview to LAG-3 Combinations
• Figure 10-1: LAG-3 Inhibitor - Market Drivers
• Figure 10-2: LAG-3 Inhibitor - Market Challenges

Global LAG-3 Inhibitors Market, Drug Sales & Clinical Trials Insight 2029 Report Highlights:

• Global LAG-3 Inhibitors Market Opportunity: > USD 3 Billion By 2029
• Global & Regional Market Analysis
• Commercially Approved LAG-3 Inhibitors: 1
• Dosing, Pricing & Sales Insight On Approved LAG-3 Inhibitor
• Insight On All LAG-3 Inhibitors In Trials: > 40
• Global LAG3 Inhibitors clinical Trials Insight By Company, Country, Indication & Phase
• Competitive Landscape: Insight on 15 Key Companies

In recent years, cancer treatment has witnessed a number of novel approaches aimed at improving the therapeutic effects of existing treatments. Despite substantial advances, standard therapies such as chemotherapy and radiation have frequently failed to achieve long-term remission or cure for a large number of cancer patients. As a result, researchers have focused on novel treatment approaches, one of which targets the immunological checkpoint protein LAG-3 (Lymphocyte Activation Gene-3). Several LAG-3 inhibitors are currently in clinical trials, and while only 1 is commercially available, the LAG-3 inhibitors market is expected to grow at an unprecedented rate in the coming years due to rising cancer cases worldwide and increased interest in this emerging drug class by pharmaceutical companies and researchers.

LAG-3 is a co-inhibitory receptor found on the surface of many immune cells, including T and NK cells. Its principal role is to regulate the immune response and prevent over-activation, which can lead to autoimmune diseases. However, in the setting of cancer, tumor cells can use LAG-3 to avoid immune surveillance, allowing them to grow and spread unabated. Overexpression and upregulation of LAG-3 have been seen in a variety of malignancies, and it is thought to contribute to the inhibition of anti-tumor immune responses, allowing tumor growth and progression. This discovery has laid the groundwork for investigating LAG-3 as a promising therapeutic target for cancer treatments.

In 2022, Bristol-Myers Squibb (BMS) made history when the US FDA authorized its medicine Opdualag, a fixed-dose antibody combination of relatlimab (anti-LAG-3) and nivolumab (anti-PD-1) for the treatment of melanoma. The findings from the RELATIVITY-047 clinical trial were utilized to submit the Biologics License Application (BLA) for approval. This signified the regulatory approval of the first-in-class immune checkpoint inhibitor combination targeting LAG-3. Opdualag is currently approved in the US, the European Union, and a few other nations, with approval pending in a few more.

Opdualag has had a successful market debut, with revenues increasing quarter after quarter, indicating its therapeutic effectiveness and acceptance by both medical experts and patients. BMS reported total sales of more than US$ 600 million in 2023, and global sales of around US$ 200 million in the first quarter of 2024, a 76% increase over the same time in 2023. Furthermore, since its acceptance, the United States has regularly accounted for a sizable share of its revenue.

On the clinical front, numerous candidates are now in various levels of clinical development and evaluation, with Favezelimab and Fianlimab, developed by Regeneron and Merck, respectively, emerging as the LAG-3 inhibitors that have advanced the most in clinical studies. Both candidates are now undertaking many Phase 3 clinical trials for the treatment of various solid and hematological malignancies. In addition to these, Opdualag is also being tested in late-stage clinical trials in a variety of cancer indications, with melanoma subtypes accounting for a large portion of this.

Other companies, including Incyte Corporation, Xencor, Roche, Symphogen, and invoX Pharma, are also undertaking early-stage clinical trials for their prospective LAG-3 inhibitors, indicating that drug developers are becoming interested in this novel kind of immune checkpoint inhibitor. Many research institutions and universities have helped to further these clinical studies by serving as collaborators or trial sites. These include the Sidney Kimmel Comprehensive Cancer Center, Fudan University Shanghai Cancer Center, UPMC Hillman Cancer Center, Multiple Myeloma Research Consortium, Sun Yat-sen University, Emory University, University of California, and University of Colorado, among others.

The US & China have emerged as pioneers in the field of LAG-3 inhibitors, serving as research, development, and clinical trial hubs for several of these inhibitors. This can be attributed to the fact that these countries are home to several companies and research institutes working on the development of LAG-3 inhibitors, as well as the consistent support provided by their respective governments to create a favorable environment for their pharmaceutical industries. As a result, the landscape of LAG-3 inhibitors has expanded, with players from many other locations, including the EU, Japan, and South Korea, emerging as significant contributors to the LAG-3 inhibitor knowledge base.

In conclusion, LAG-3 has emerged as an intriguing therapeutic target in cancer, opening up new avenues for improving immunotherapy efficacy. Ongoing clinical trials, notably those looking at combination therapy with immunotherapies, are critical for determining the full potential of LAG-3 inhibition in lung cancer treatment. As the research advances, the future promises hope for more effective and individualized treatment choices, ultimately improving the prognosis and quality of life for those suffering from this deadly disease.

Table of Contents

1. Introduction to LAG-3 Inhibitor

• 1.1 Overview Of LAG-3 inhibitor
• 1.2 Mechanism of Action
• 1.3 LAG-3 Targeted Therapy Approaches

2. Global LAG-3 Inhibitor Clinical Trials Overview

• 2.1 By Phase
• 2.2 By Country
• 2.3 By Company
• 2.4 By Indication
• 2.5 By Priority Status
• 2.6 Patient Segment

3. Global LAG-3 Inhibitors Market Scenario

• 3.1 Current Market Outlook (2022 Till Q1'2024)
• 3.2 Future Market Outlook (2024 - 2029)

4. LAG-3 Inhibitor Market Regional Analysis

• 4.1 South Korea
• 4.2 Australia
• 4.3 Canada
• 4.4 Japan
• 4.5 UK
• 4.6 Europe
• 4.7 China
• 4.8 US

5. LAG-3 Inhibitor Market Development By Indications

• 5.1 Lymphoma
• 5.2 Melanoma
• 5.3 Lung Cancer
• 5.4 Colorectal Cancer
• 5.5 Head & Neck Cancer
• 5.6 Esophageal Cancer

6. Opdualag (Nivolumab & Relatlimab-rmbw) - Overview, Pricing, Dosing & Sales Analysis

• 6.1 Overview
• 6.2 Pricing & Dosing
• 6.3 Sales (2022 Till Q1'2024)

7. Combination Stratagems for LAG-3 Inhibitors

8. Global LAG-3 Inhibitors clinical Trials Insight By Company, Country, Indication & Phase

• 8.1 Research
• 8.2 Preclinical
• 8.3 Phase I
• 8.4 Phase I/II
• 8.5 Phase II
• 8.6 Phase II/III
• 8.7 Phase III

9. Marketed LAG-3 Inhibitor Clinical insight

10. Global LAG-3 Inhibitors Market Dynamics

• 10.1 Market Drivers
• 10.2 Market Challenges

11. Competitive Landscape

• 11.1 Abeome Corporation
• 11.2 ABL Bio
• 11.3 Agenus
• 11.4 Akeso Biopharma
• 11.5 AnaptysBio
• 11.6 Bristol-Myers Squibb
• 11.7 EpimAb Biotherapeutics
• 11.8 F-star Therapeutics
• 11.9 Immutep
• 11.10 Incyte Corporation
• 11.11 Innovent Biologics
• 11.12 Merck
• 11.13 Roche
• 11.14 Shanghai Fosun Pharmaceutical
• 11.15 Y-Biologics