首頁 > 市場調查報告書 > 製藥

生物製劑

市場調查報告書

商品編碼

2040974

全球 LAG-3標靶治療市場：市場規模、已通過核准治療方法劑量、專利、銷售額和臨床試驗洞察（2031 年）

Global LAG-3 Targeting Therapy Market Size, Approved Therapy Dosage, Patent, Sales & Clinical Trials Insight 2031

出版日期: 2026年05月01日 | 出版商:

KuicK Research | 英文 180 Pages | 商品交期: 最快1-2個工作天內

價格

簡介目錄圖表

全球 LAG-3標靶治療市場：市場規模、已通過核准治療方法劑量、專利、銷售和臨床試驗洞察（2031 年）報告結果和亮點

全球 LAG-3標靶治療市場機會：到 2031 年超過 50 億美元
全球市場規模洞察：2022年至2031年
深入了解已通過核准的LAG-3標靶治療。
2022年及2026年第一季年度及季銷售額分析
臨床試驗中 LAG-3標靶治療的見解：超過 35 篇文章
按公司、國家、適應症和階段分類的 LAG-3標靶治療臨床試驗的見解。
多年來，針對 LAG-3 的主要標靶治療已啟動並完成
競爭格局

LAG-3標靶治療的必要性及本報告的意義

隨著First-in-Class抗LAG-3療法獲得監管部門核准，全球抗LAG-3療法市場已從實驗階段邁入商業化階段。 Opduralag是此治療類別中唯一核准的藥物，它首次在臨床上證實LAG-3是除PD-1和CTLA-4之外，免疫療法中一個有效的查核點。這將為未來免疫療法聯合治療的發展奠定基礎。

然而，儘管雙重查核點抑制劑上市時間相對較短，但其在黑色素瘤治療中的快速應用以及醫生的廣泛認可使其表現強勁，預計到2025年全球銷售額將超過10億美元。目前，美國是該市場最大的收入來源，這得益於其較早採用抗LAG-3療法以及免疫療法的高普及率。然而，該市場仍高度集中，隨著新適應症和聯合治療的推出，預計將顯著成長。

本報告旨在為投資者、製藥公司及其他相關人員提供LAG-3領域發展現狀的系統性概述。報告涵蓋了該領域的商業性成功、臨床趨勢、競爭格局和未來成長前景等資訊。

報告中包含對臨床試驗的深入分析

本報告全面說明了LAG-3標靶分子臨床開發的最新進展，使相關人員能夠評估此新型免疫查核點的臨床進展。報告涵蓋了從早期臨床試驗到晚期臨床試驗（包括註冊階段試驗）的各個開發階段的臨床研究。報告主要關注LAG-3標靶藥物在固體癌（如黑色素瘤、非小細胞肺癌（NSCLC）、標靶藥物和頭頸癌）患者對現有免疫療法的抗藥性方面的應用。

在LAG-3標靶治療（尤其是LAG-3和PD-1抑制劑）的臨床開發中，聯合治療仍然是主要策略。基於聯合免疫療法的概念，一些處於後期研發階段的藥物，例如fianlimab和cemiplimab的聯合療法，正在進行臨床試驗，作為黑色素瘤和非小細胞肺癌的潛在治療方法。同時，一些新型雙特異性藥物正在研究中，這些藥物能夠同時靶向PD-1和LAG-3，旨在透過單一藥物增強免疫系統活性。免疫療法研究的其他有前景的領域包括LAG-3、PD-1和CTLA-4的三重聯合治療，以及癌症疫苗和溶瘤病毒等創新治療方法。

引領 LAG-3標靶治療研發的領導企業

LAG-3領域的發展得益於大型製藥企業和生技公司之間的合作。例如，百時美施貴寶（BMS）和再生元（Regeneron）等領先公司正利用其現有的免疫腫瘤學基礎，探索針對多種癌症類型的LAG-3聯合治療。這些公司目前主要致力於II期及以後的臨床試驗，同時也正在探索更廣泛的適應症。

同時，像Y-Biologics、Immutep和Fontacea Pharmaceutical這樣的小規模生物技術公司也參與了早期創新和開發。這些生物技術公司致力於利用雙特異性和多特異性抗體，例如在將LAG-3路徑與TIGIT或TIM-3路徑結合的專案中。

這些合作關係對於塑造產業格局至關重要。生物技術公司正與大型製藥公司合作。這使它們能夠透過各種夥伴關係加速研發進程並進行臨床試驗。

針對 LAG-3 的治療方法的未來前景

目前，針對非小細胞肺癌（NSCLC）、大腸直腸癌、胃癌和其他固體癌的多項臨床試驗正在進行中，因此，未來市場成長預計主要來自黑色素瘤以外的其他適應症。隨著證據的積累，預計LAG-3抑制劑將在特定癌症類型的聯合治療一線免疫療法中發揮更廣泛的作用。

基於生物標記的患者篩選是另一個潛在的成長要素。與傳統的查核點抑制劑不同，LAG-3抑制劑已在明確定義的免疫表現型中進行了測試，這有望提高療效並最佳化藥物定位策略。這將有助於改善醫保報銷和誘導治療的動態。

從投資和製藥公司的角度來看，LAG-3 屬於早期免疫療法領域，風險降低方面正開始取得進展。預計到 2025 年，已有一款已通過核准藥物的年銷售額將超過 10 億美元，這表明該領域正處於類似於傳統查核點抑制劑的多階段擴張週期的早期階段。這既帶來了短期商業性前景的明朗性，也帶來了長期的研發管線潛力。

Global LAG-3 Targeting Therapy Market Opportunity: > USD 5 Billion By 2031
Global Market Size Insight: 2022 Till 2031
Approved LAG-3 Targeting Therapy Dosage, Pricing & Sales Insight
Annual & Quarterly Sales Insight: 2022 - Q1'2026
Insight On LAG-3 Targeting Therapies In Clinical Trials: > 35 Therapies
LAG-3 Targeting Therapies Clinical Trials Insight By Company, Country, Indication & Phase
Key LAG-3 Targeting Therapies Initiation & Completion Year
Competitive Landscape

Need For LAG-3 Targeting Therapies & Why This Report?

The global market for anti-LAG-3 therapy has advanced to the commercial stage from being experimental, on account of the availability of the first-in-class anti-LAG-3 therapy that has received regulatory approval. The only approved drug in this category of therapies is Opdualag, representing the first clinical validation of LAG-3 as an actionable checkpoint in immunotherapies beyond just PD-1 and CTLA-4. It serves as the basis for the development of future combinations in immunotherapy treatment.

However, despite its relatively early market stage, it has experienced high performance, registering global sales exceeding US$ 1 Billion in 2025, on account of rapid uptake in melanoma therapy applications as well as physicians' acceptance of dual checkpoint inhibitors. Currently, the leading revenue generator in the market is the US, as it was the early adopter of anti-LAG-3 therapies and benefits from high immunotherapy uptake. However, there remains a high degree of market concentration, with substantial growth potential anticipated due to new indications and combinations being brought into the fold.

The objective of this report is to offer investors, pharmaceutical organizations, and other parties a systematic outlook on the developing LAG-3 space. The report encompasses information on its commercial success, clinical trends, competition, and future growth prospects within the field.

Clinical Trials Insight Included In Report

The report offers a comprehensive understanding of the latest developments in the clinical development of LAG-3 targeting molecules, allowing interested parties to make an assessment of the clinical advancement of this novel immune checkpoint. This report covers clinical studies at various stages of development, including early-stage clinical studies and later-stage clinical studies, including registration-stage clinical trials. The report mainly covers the use of LAG-3 targeting agents to overcome resistance in existing immunotherapy treatment options for patients with solid tumors, including melanoma, NSCLC, gastric cancer, and head and neck cancers.

Combination therapies remain the main approach in the clinical development of LAG-3 targeting therapies, specifically LAG-3 and PD-1 inhibition. Further expanding on the concept of combination immunotherapies, late-stage drugs like fianlimab in combination with cemiplimab is undergoing trials for its potential treatment of melanoma and non-small cell lung cancer, whereas new bispecific drugs targeting PD-1 and LAG-3 simultaneously are currently under investigation to boost the activity of the immune system with a single drug. The other promising area of immunotherapy studies includes triple therapy that involves a combination of LAG-3, PD-1, and CTLA-4, among other innovative forms of therapy such as cancer vaccines and oncolytic viruses.

Major Companies Driving LAG-3 Targeting Therapies R&D

The landscape of LAG-3 is driven by large pharmaceutical firms in conjunction with biotechnology firms. Major players, for instance, BMS, Regeneron, and others, are using their existing immuno-oncology backbone to explore LAG-3 combinations across different cancer types. Their main emphasis is to work on clinical trial stages beyond Phase II and also explore label extension.

On the other hand, the small biotech companies, like Y-Biologics, Immutep, and Fontacea Pharmaceutical, are involved in early stage innovations and developments. These biotech firms are working on the use of bispecific and multispecific antibodies. This can be seen in projects involving the LAG-3 pathway in combination with the TIGIT or TIM-3 pathways.

These collaborations are crucial in shaping the industry landscape. Biotech companies are collaborating with big players in the pharmaceutical industry. This helps in speeding up development processes as well as conducting clinical trials through various partnerships.

Future Outlook For LAG-3 Targeting Therapies

Future market growth is expected to come largely from indications outside of melanoma, as multiple clinical trials are underway for NSCLC, colorectal cancer, gastric cancer, and other solid tumors. As the evidence base develops, the expectation is that LAG-3 inhibitors will become components of more expansive first-line immunotherapy combinations in certain cancer types.

Biomarker-based patient selection is another potential second growth driver. In contrast to previous checkpoint inhibitors, LAG-3 inhibitors are being tested in well-defined immune phenotypes, which should increase efficacy and refine positioning strategies. This should help to facilitate better reimbursement and adoption dynamics.

From an investment and pharma company perspective, LAG-3 provides an early-stage immunotherapy category that has begun to de-risk. Given one approved drug's sales surpassing USD 1 Billion per year (2025), the category appears to be entering its early phases of a multiphase expansion cycle akin to previous checkpoint inhibitor categories, providing both short-term commercial clarity and long-term pipeline potential.

1. Research Methodology

2. Introduction to LAG-3 Targeting Therapies

2.1 LAG-3 As Therapeutic Target
2.2 LAG-3 Targeting Therapies - Mechanism Of Action
2.3 LAG-3 Targeting Approaches

3. Combination Strategies For LAG-3 Targeting Therapies

4. Global LAG-3 Targeting Therapy Market Scenario

4.1 Current Market Outlook
4.2 Future Market Outlook

5. LAG-3 Targeting Therapy Market Regional Analysis

5.1 US
5.2 EU
5.3 China
5.4 Australia
5.5 UK
5.6 Japan
5.7 Canada
5.8 South Korea

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

6.1 Overview & Patent Insight
6.2 Pricing & Dosing
6.3 Sales Insight

7. Global LAG-3 Targeting Therapies Clinical Trials Overview

7.1 By Phase
7.2 By Country
7.3 By Company
7.4 By Indication
7.5 By Priority Status

8. Global LAG-3 Targeting Therapies 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 LAG3 Inhibitor Clinical Insight

10. LAG-3 Targeting Therapy - Development Trends By Indication

10.1 Cancer
- 10.1.1 Hematological Malignancies
- 10.1.2 Solid Tumors
10.2 Autoimmune & Inflammatory Diseases
10.3 Microbial Infections

11. Global LAG-3 Targeting Therapy Market Dynamics

11.1 Market Drivers
11.2 Market Challenges

12. Competitive Landscape

12.1 ABL Bio
12.2 Agenus
12.3 Akeso Biopharma
12.4 Bristol-Myers Squibb
12.5 EpimAb Biotherapeutics
12.6 Immutep
12.7 Innovent Biologics
12.8 Regeneron
12.9 Shanghai Henlius Biotech
12.10 Y-Biologics

簡介目錄圖表

List of Figures

Figure 2-1: LAG-3/MHC Class II Signaling Pathway
Figure 2-2: LAG-3 Targeted Therapy Landscape - Milestones
Figure 2-3: LAG-3 Inhibitor - Mechanism Of Action
Figure 2-4: LAG-3 Agonist - Mechanism Of Action
Figure 2-5: LAG-3 Depletion - Mechanism Of Action
Figure 2-6: Bispecific Antibodies - Binding Efficacy
Figure 3 1: Possible LAG-3 Combinations
Figure 4-1: Global - LAG 3 Targeting Therapy Market (US$ Million), 2022-2026
Figure 4-2: Global - LAG 3 Targeting Therapy Market By Region (US$ Million), Q1'2026
Figure 4-3: Global - LAG 3 Targeting Therapy Market By Region (US$ Million), 2025
Figure 4-4: Global - Quarterly LAG 3 Targeting Therapy Market (US$ Million), 2025
Figure 4-5: Global - LAG 3 Targeting Therapy Market By Region (%), 2024
Figure 4-6: Global - LAG 3 Targeting Therapy Market Forecast (US$ Million), 2026-2031
Figure 4-7: Global LAG-3 Targeting Therapy Market - Future Outlook
Figure 5-1: EU - Research Institutes & Hospitals Conducting LAG-3 Therapy Clinical Trials
Figure 6-1: Opdualag - Approval Year by Region
Figure 6-2: Opdualag - Estimated Minimum Market Exclusivity Year By Region
Figure 6-3: US - Cost Per Unit & Supply Of Opdualag (US$), May'2026
Figure 6-4: UK - Cost Per Unit & Supply Of Opdualag (US$), May'2026
Figure 6-5: Global - Opdualag Annual Sales (US$ Million), 2022-2026
Figure 6-6: Global - Opdualag Annual Sales By Region (US$ Million), Q1'2026
Figure 6-7: Global - Opdualag Quarterly Sales (US$ Million), 2025
Figure 6-8: US - Opdualag Annual Sales (US$ Million), 2024-2026
Figure 6-9: US - Opdualag Quarterly Sales (US$ Million), 2025
Figure 6-10: ROW - Opdualag Sales (US$ Million), 2024-2026
Figure 6-11: ROW - Opdualag Quarterly Sales (US$ Million), 2025
Figure 6-12: Opdualag - US v/s ROW Sales (US$ Million), 2024
Figure 6-13: Global - Opdualag Sales (US$ Million), 2024
Figure 6-14: US - Opdualag Sales (US$ Million), 2022-2024
Figure 6-15: US - Opdualag Sales (US$ Million), Q1-Q4'2024
Figure 6-16: ROW - Opdualag Sales (US$ Million), 2022-2024
Figure 6-17: ROW - Opdualag Sales (US$ Million), Q1-Q4'2024
Figure 7-1: Global - LAG-3 Inhibitor Clinical Trials By Phase (Numbers), 2026-2031
Figure 7-2: Global - LAG-3 Inhibitor Clinical Trials By Country (Numbers), 2026-2031
Figure 7-3: Global - LAG-3 Inhibitor Clinical Trials By Company (Numbers), 2026-2031
Figure 7-4: Global - LAG-3 Inhibitor Clinical Trials By Indication (Numbers), 2026-2031
Figure 7-5: Global - LAG-3 Inhibitor Clinical Trials By Priority Status (Numbers), 2026-2031
Figure 10-1: RELATIVITY-047 Phase 2/3 (NCT03470922) Study - Initiation & Completion Year
Figure 10-2: AK129-102 Phase 1/2 (NCT06642792) Study - Initiation & Completion Year
Figure 10-3: AK129-102 Phase 1/2 (NCT05137054) Study - Initiation & Completion Year
Figure 10-4: R3767-ONC-2235 Phase 2/3 (NCT05785767) Study - Initiation & Completion Year
Figure 10-5: R3767-ONC-2236 Phase 2/3 (NCT05800015) Study - Initiation & Completion Year
Figure 10-6: R2810-ONC-1866 Phase 2 (NCT03916627) Study - Initiation & Completion Year
Figure 10-7: R2810-ONC-2266 Phase 2 (NCT06161441) Study - Initiation & Completion Year
Figure 10-8: J23155 Phase 2 (NCT06205836) Study - Initiation & Completion Year
Figure 10-9: RELATIVITY-104 Phase 2 (NCT04623775) Study - Initiation & Completion Year
Figure 10-10: RELATIVITY-1093 Phase 3 (NCT06561386) Study - Initiation & Completion Year
Figure 10-11: J1714 Phase 1b (NCT03044613) Study - Initiation & Completion Year
Figure 10-12: HCC 18-139 Phase 2 (NCT04080804) Study - Initiation & Completion Year
Figure 10-13: CA209-1451 Phase 2 (NCT06624475) Study - Initiation & Completion Year
Figure 10-14: MIA2023/490 Phase 2 (NCT06288191) Study - Initiation & Completion Year
Figure 10-15: MIA2023/489 Phase 2 (NCT06151236) Study - Initiation & Completion Year
Figure 10-16: IMP761-P001 Phase 1 (NCT06637865) Study - Initiation & Completion Year
Figure 11-1: Global LAG-3 Targeting Therapy Market - Drivers & Opportunities
Figure 11-2: Global LAG-3 Targeting Therapy Market - Challenges & Restraints

List of Tables

Table 3-1: Ongoing Preclinical & Clinical Trials For Combination of LAG-3 inhibitors
Table 5-1: Immutep - Active Patents By Region
Table 6-1: Opdualag - Maximum Infusion Volumes & Concentration Ranges By Patient Group
Table 6-2: Opdualag - Recommended Dosage Modifications For Adverse Reactions

02-2729-4219

+886-2-2729-4219