LAG-3 Immunotherapies Market Set for Rapid Growth in the Coming 10 Years Across the 7MM as Next-Generation Therapies Advance | DelveInsight

The LAG-3 next-generation therapies market is expected to grow in the upcoming years owing to the potential entry of major LAG-3 candidates and their readily uptake, increase in incident cases of various solid tumors, increase in PD-1/PD-L1 relapsed/refractory cases in various cancers, label-expansion in multiple cancer types, robust and unique pipeline (anti-LAG-3 monoclonal, bispecific antibodies and, soluble LAG-3 molecule), and improvement in the outcome of patients.

/EIN News/ -- New York, USA, Feb. 25, 2025 (GLOBE NEWSWIRE) -- LAG-3 Immunotherapies Market Set for Rapid Growth in the Coming 10 Years Across the 7MM as Next-Generation Therapies Advance | DelveInsight 

The LAG-3 next-generation therapies market is expected to grow in the upcoming years owing to the potential entry of major LAG-3 candidates and their readily uptake, increase in incident cases of various solid tumors, increase in PD-1/PD-L1 relapsed/refractory cases in various cancers, label-expansion in multiple cancer types, robust and unique pipeline (anti-LAG-3 monoclonal, bispecific antibodies and, soluble LAG-3 molecule), and improvement in the outcome of patients.

DelveInsight’s LAG-3 Next-generation Immunotherapies Market Size, Target Population, Competitive Landscape & Market Forecast report includes a comprehensive understanding of current treatment practices, emerging LAG-3 next-generation immunotherapies, market share of individual therapies, and current and forecasted LAG-3 next-generation immunotherapies market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Key Takeaways from the LAG-3 Next-generation Immunotherapies Market Report

• As per DelveInsight’s analysis, the LAG-3 next-generation immunotherapies market is expected to grow significantly in the 7MM by 2034.
• LAG-3 levels are significantly overexpressed in NSCLC. It was found that in NSCLC, intratumoral Tregs cells presented increased expression of inhibitory molecules including LAG-3, CTLA-4, and PD-1.
• NSCLC is the most common type of lung cancer, accounting for 80─90% of all lung cancer cases. DelveInsight estimates that there were ~202,000 cases in the US in 2023.
• Leading LAG-3 immunotherapies companies such as Merck, Adaptimmune, Regeneron Pharmaceuticals, Immutep, F-star Therapeutics, and others are developing novel LAG-3 next-generation immunotherapies that can be available in the market in the coming years.
• Some of the key LAG-3 next-generation immunotherapies in the pipeline include Favezelimab, ADP-A2M4CD8, Fianlimab, Eftilagimod Alpha, FS118, and others. 

Discover which therapies are expected to grab the LAG-3 market share @ LAG-3 Market and Competitive Landscape Report

LAG-3 Next-generation Immunotherapies Market Dynamics

The market for next-generation immunotherapies targeting LAG-3 is experiencing rapid growth, driven by its potential to enhance immune checkpoint blockade strategies. LAG-3 is a critical immune checkpoint receptor involved in T-cell exhaustion, particularly in the tumor microenvironment, making it a promising target for cancer immunotherapy. Companies are investing heavily in LAG-3 inhibitors and bispecific antibodies, often in combination with PD-1/PD-L1 checkpoint inhibitors, to boost antitumor immune responses. The recent FDA approvals of LAG-3 inhibitors, such as relatlimab in combination with nivolumab, have further validated this target, accelerating clinical development across the industry.

A key market driver is the increasing incidence of cancers that exhibit immune resistance mechanisms, particularly solid tumors like melanoma, NSCLC, and colorectal cancer. Combination therapies involving LAG-3 inhibitors are showing improved efficacy over monotherapies, making them attractive to pharmaceutical companies and investors. Additionally, the expanding understanding of LAG-3’s role in autoimmune diseases is leading to the exploration of its inhibitors in conditions such as multiple sclerosis and rheumatoid arthritis, broadening the market potential beyond oncology.

Despite the excitement, challenges persist in the LAG-3 immunotherapy market. The competitive landscape is intensifying, with multiple biotech firms and pharmaceutical giants racing to bring their candidates to market. Furthermore, while combination therapies are promising, they pose regulatory and pricing complexities, as healthcare systems must evaluate the cost-effectiveness of multi-drug regimens. Biomarker-driven patient selection remains a critical hurdle, as not all tumors exhibit LAG-3-mediated immune suppression, necessitating robust companion diagnostic strategies.

Strategic partnerships and acquisitions are shaping the market dynamics, with larger pharmaceutical companies collaborating with smaller biotechs to accelerate clinical trials and commercialization. Emerging biotechs with innovative LAG-3 approaches, such as bispecific antibodies and dual checkpoint inhibitors, are attractive acquisition targets. Additionally, advancements in next-generation sequencing and AI-driven drug discovery are expediting the identification of optimal patient populations and novel LAG-3-targeting compounds.

Looking ahead, the LAG-3 immunotherapy market is expected to witness significant expansion, particularly as more combination therapies receive regulatory approvals. The success of these therapies in overcoming immune resistance and enhancing long-term survival rates will be crucial in determining their widespread adoption. As competition intensifies, companies that can optimize patient selection, demonstrate strong clinical differentiation, and navigate pricing pressures will likely emerge as leaders in this evolving landscape.

LAG-3 Next-generation Immunotherapies Treatment Market 

Cancer immunotherapy and the tumor microenvironment have been central to research for decades. Targeting immune checkpoints, particularly PD-1 and its ligand PD-L1, has revolutionized the treatment of advanced cancers. However, the challenge of low response rates has shifted the focus toward exploring the tumor microenvironment for alternative therapeutic targets. Notably, the inhibitory immune checkpoint LAG-3 has emerged as a promising candidate. Ongoing clinical trials are advancing LAG-3 immunotherapy, and combining anti-LAG-3 with anti-PD-1 has shown promising results in overcoming PD-1 resistance.  

LAG-3 (CD223) is a key immune checkpoint receptor that inhibits T-cell activation and cytokine secretion, helping to maintain immune homeostasis. It differentially regulates various lymphocyte populations, and its interaction with MHC-II may serve as a bidirectional inhibitory signal between immune and tumor cells. Overexpression of LAG-3 in T-cells can shield MHC-II-expressing melanoma cells from drug-induced or FAS-mediated apoptosis through the MAPK/ERK and PI3K/AKT survival pathways. Additionally, LAG-3-expressing regulatory T cells (Tregs) may suppress dendritic cell (DC) function through an immune tyrosine-based activation motif (ITAM)-modulated pathway, involving FcγRγ and ERK-mediated recruitment of SHP-1.

OPDUALAG, developed by Bristol Myers Squibb, is a novel, first-in-class fixed-dose combination therapy for melanoma. It comprises nivolumab, a PD-1 inhibitor, and relatlimab, a LAG-3 inhibitor, and is administered via intravenous infusion. For adults and pediatric patients aged 12 years and older who weigh at least 40 kg, the recommended dosage is 480 mg of nivolumab and 160 mg of relatlimab, given intravenously every four weeks until disease progression or intolerable side effects occur.

In March 2022, the US FDA approved OPDUALAG for treating unresectable or metastatic melanoma in patients aged 12 and older. This approval was based on data from the Phase II/III RELATIVITY-047 trial, which evaluated OPDUALAG against nivolumab monotherapy.

In September 2022, the European Commission (EC) approved OPDUALAG as a first-line treatment for advanced (unresectable or metastatic) melanoma in adults and adolescents (12 years and older) whose tumors have PD-L1 expression levels below 1%.

Learn more about the FDA-approved LAG-3 next-generation immunotherapies @ Approved LAG-3 Immunotherapies 

Key Emerging LAG-3 Next-generation Immunotherapies and Companies

Some of the drugs in the pipeline include Favezelimab (Merck), ADP-A2M4CD8 (Adaptimmune), Fianlimab (Regeneron Pharmaceuticals), Eftilagimod Alpha (Immutep), and FS118 (F-star Therapeutics) among others.

Merck's Favezelimab (MK-4280) is a humanized IgG4 monoclonal antibody targeting LAG-3, designed to block its interaction with MHC Class II. It is being developed in combination with KEYTRUDA for the treatment of solid tumors and hematologic malignancies. Phase I trial results demonstrated that favezelimab, either alone or with pembrolizumab, had a manageable safety profile with no treatment-related fatalities. The combination therapy, including MK-4280A, showed encouraging antitumor activity, particularly in patients with PD-L1 CPS ≥1 tumor, compared to monotherapy. Currently, the drug is undergoing Phase III evaluation (NCT05064059) for colorectal cancer and Phase II trials (NCT03516981) for NSCLC.

Fianlimab (REGN3767) is an immune checkpoint inhibitor being developed by Regeneron Pharmaceuticals and Sanofi for the treatment of solid tumors and blood cancers. By blocking immune checkpoints, therapies like REGN3767 enhance the immune response, strengthening the body's ability to combat cancer. When combined with LIBTAYO, Fianlimab has demonstrated significant and lasting tumor responses in key patient groups with advanced melanoma.

Eftilagimod Alpha is a recombinant protein composed of a dimer of LAG-3, designed to be soluble rather than cell-surface-expressed. It has been granted Fast Track Designation by the US FDA for first-line treatment of HNSCC and NSCLC. In November 2022, Immutep announced a Clinical Trial Collaboration and Supply Agreement with Merck KGaA, Darmstadt, Germany, and Pfizer for a new Phase I study in urothelial cancer, known as INSIGHT-005. In June 2023, Immutep secured a US patent titled “Combined Preparations for Eftilagimod Alpha in Combination with a PD-1 Pathway Inhibitor for the Treatment of Cancer or Infection.” 

The therapy is being investigated for multiple solid tumors, including NSCLC, HNSCC, and metastatic breast cancer. Its strong safety profile supports various combination therapies, such as anti-PD-[L]1 immunotherapy and chemotherapy. Notably, the determination of the optimal biological dose in the AIPAC-003 trial aligns with the FDA’s Project Optimus initiative and holds significance for the broader efti program.

The anticipated launch of these emerging are poised to transform the next-generation immunotherapies market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the next-generation immunotherapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

To know more about LAG-3 next-generation immunotherapies clinical trials, visit @ LAG-3 Next-generation Immunotherapies in Development 

LAG-3 Immunotherapies Overview

LAG-3 is an immune checkpoint receptor that is critical in regulating T-cell activity and immune response. It is primarily expressed in activated T cells, natural killer (NK) cells, and regulatory T-cells (Tregs), where it functions to suppress excessive immune activation. By inhibiting T-cell proliferation and cytokine production, LAG-3 helps maintain immune homeostasis but also contributes to immune evasion in cancer. Given its similarity to PD-1 and CTLA-4, LAG-3 has emerged as a promising target for immunotherapy, particularly in combination with other checkpoint inhibitors to enhance anti-tumor immune responses.

LAG-3-targeting immunotherapies, including monoclonal antibodies and bispecific antibodies, aim to block its suppressive function, thereby reactivating exhausted T cells and boosting the immune system’s ability to fight cancer. Relatlimab, in combination with nivolumab, has shown clinical efficacy in treating advanced melanoma, marking a breakthrough in dual checkpoint blockade strategies. Beyond oncology, LAG-3 inhibitors are being explored for autoimmune diseases, where modulation of LAG-3 could help restore immune balance. As research progresses, LAG-3 immunotherapies hold significant potential to enhance cancer treatment outcomes and expand the range of immune-mediated therapies.

LAG-3 Immunotherapies Epidemiology Segmentation

Head and neck cancer accounts for about 4% of all cancers in the United States. In 2023, an estimated 66,920 people (49,190 men and 17,730 women) were diagnosed with head and neck cancer. The LAG-3 next-generation immunotherapies market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into:

• Total Incident Cases of Selected Indications for LAG-3 Immunotherapies
• Total Eligible Patient Pool for LAG-3 Immunotherapies
• Total Treated Cases in Selected Indications for LAG-3 Immunotherapies

Download the report to understand what epidemiologists are saying about LAG-3 immunotherapies patient trends in 7MM @ LAG-3 Immunotherapies Patient Pool

LAG-3 Next-generation Immunotherapies Report Metrics	Details
Study Period	2020–2034
LAG-3 Next-generation Immunotherapies Report Coverage	7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]
Key LAG-3 Next-generation Immunotherapies Companies	Merck, Adaptimmune, Regeneron Pharmaceuticals, Immutep, F-star Therapeutics, and others
Key LAG-3 Next-generation Immunotherapies in the Pipeline	Favezelimab, ADP-A2M4CD8, Fianlimab, Eftilagimod Alpha, FS118, and others

Scope of the LAG-3 Next-generation Immunotherapies Market Report

• LAG-3 Next-generation Immunotherapies Therapeutic Assessment: LAG-3 Next-generation Immunotherapies current marketed and emerging therapies
• LAG-3 Next-generation Immunotherapies Market Dynamics: Conjoint Analysis of Emerging LAG-3 Next-generation Immunotherapies Drugs
• Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
• Unmet Needs, KOL’s views, Analyst’s views, LAG-3 Next-generation Immunotherapies Market Access and Reimbursement

Discover more about LAG-3 next-generation immunotherapies in development @ LAG-3 Next-generation Immunotherapies Clinical Trials

Table of Contents

1.	LAG-3 Next-generation Immunotherapies Market Key Insights
2.	LAG-3 Next-generation Immunotherapies Market Report Introduction
3.	Executive Summary of LAG-3 Next-generation Immunotherapies
4.	Key Events
5.	LAG-3 Next-generation Immunotherapies Market Forecast Methodology
6.	LAG-3 Next-generation Immunotherapies Market Overview at a Glance in the 7MM
7.	LAG-3 Next-generation Immunotherapies: Background and Overview
8.	LAG-3 Next-generation Immunotherapies Target Patient Pool
9.	LAG-3 Next-generation Immunotherapies Marketed Drugs
10.	LAG-3 Next-generation Immunotherapies Emerging Drugs
11.	Seven Major LAG-3 Next-generation Immunotherapies Market Analysis
12.	LAG-3 Next-generation Immunotherapies Market Access and Reimbursement
13.	SWOT Analysis
14.	KOL Views
15.	Unmet Needs
16.	Appendix
17.	DelveInsight Capabilities
18.	Disclaimer
19.	About DelveInsight

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