Lag 3 Next Generation Immunotherapy Competitive Landscape

DelveInsight’s ‘LAG-3-Next Generation Immunotherapy—Competitive Landscape and Market Forecast–2035’ report delivers an in-depth understanding of the LAG-3 as well as the market trends of LAG-3-Next Generation Immunotherapy in the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

The report provides the upcoming drugs, market share of this target by indications, forecasted market size of LAG-3-Next Generation Immunotherapy from 2022 to 2035 segmented by seven major markets. This report discusses the recent findings on LAG-3, the role it plays in regulating immune responses in different cell types and the rationale for targeting LAG-3 for effective cancer immunotherapy. The report also covers the current scenario, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.


Geography Covered

• The United States

• EU5 (Germany, France, Italy, Spain, and the United Kingdom)

• Japan


Study Period: 2022–2035


LAG-3-Next Generation Immunotherapy Understanding

Cancer immunotherapy (CI) is rapidly advancing and can now be considered to be the “fifth pillar” of cancer therapy, joining the ranks of surgery, cytotoxic chemotherapy, radiation, and targeted therapy. The CI which has sparked the most interest involves antibodies to inhibitory immune checkpoint molecules. Fighting cancer with immunotherapy has revolutionized treatment for some patients and therapies targeting the immune checkpoint molecules such as CTLA-4 and PD-1 have achieved durable responses in melanoma, renal cancer, Hodgkin’s diseases and lung cancer. However, the success rate of these treatments has been low and a large number of cancers, including colorectal cancer remain largely refractory to CTLA-4 and PD-1 blockade.

Lymphocyte-activation gene 3 (LAG-3) is an immune checkpoint receptor protein found on the cell surface of effector T cells and regulatory T cells (Tregs) and functions to control T cell response, activation, and growth. T cells are a type of white blood cell that are part of the immune system. Activation of cytotoxic T cells by antigens enables them to kill unhealthy or foreign cells. It binds MHCII molecules and modulates T-cell function than either CTLA-4 or PD-1. It acts by regulating CD8+ Tcell expansion in immune reactions that have already been initiated (inhibitory signal) and also, by increasing the Treg cell activity.

The inhibitory immune checkpoint lymphocyte activation gene-3 (LAG-3) holds considerable potential. LAG-3 suppresses T cells activation and cytokines secretion, thereby ensuring immune homeostasis. It exerts differential inhibitory impacts on various types of lymphocytes and shows a remarkable synergy with PD-1 to inhibit immune responses. Targeting LAG-3 immunotherapy is moving forward in active clinical trials, and combination immunotherapy of anti-LAG-3 and anti-PD-1 has shown exciting efficacy in fighting PD-1 resistance. Herein, we shed light on the significance of LAG-3 in the tumor microenvironment, highlight its role to regulate different lymphocytes, interplay with other immune checkpoints especially PD-1, and emphasize new advances in LAG-3-targeted immunotherapy.


LAG-3 structure

LAG-3 is a transmembrane protein with structural homology to CD4, in which it includes four extracellular IgG domains. The membrane-distal IgG domain contains a short amino acid sequence, the so-called extra loop that is not found in other IgG superfamily proteins. The intracellular domain contains a unique amino acid sequence (KIEELE) that is required for LAG-3 to exert a negative effect on T cell function. LAG-3 can be cleaved at the connecting peptide (CP) by metalloproteases to generate a soluble form, which is detectable in serum


LAG-3 and Immune Function

After a T cell is activated to kill its target cell, LAG-3 expression is increased to turn off the immune response, so that the T cell does not go on to attack healthy cells. Inhibition of the immune response is accomplished through the binding of LAG-3 to an antigen-presenting complex called MHC II, which together signal the T cell to stop activation and multiplication.


LAG-3 and T Cell Exhaustion

However, in certain situations where T cells experience prolonged exposure to an antigen, such as cancer or chronic infection, the T cells become desensitized and lose their ability to activate and multiply in the presence of the antigen.


Interactions with Other Pathways

Preclinical studies suggest that targeting the LAG-3 pathway in combination with other potentially complementary immune pathways may be a key strategy to more effectively activate the antitumor immune response.


Role Of LAG-3 in Autoimmune Disorders

Beyond the inhibitory activity of LAG-3 on different types of lymphocytes, LAG-3 may also be necessary to negativelyregulate autoimmunity in many disease-prone environments. For instance, loss of LAG-3 substantially can accelerate type 1 diabetes in Non-Obese Diabetic (NOD) mice with 100% incidence. LAG-3 deficient mice can exhibit increased antigen-reactive CD4+ and CD8+ T cells infiltration in the islets, accompanied by invasive and rapid insulitis.


LAG-3 in Cancer Immunotherapy

LAG-3 (CD223) is a cell surface molecule expressed on activated T cells, NK cells, B cells and plasmacytoid dendritic cells that plays an important but incompletely understood role in the function of these lymphocyte subsets. In addition, the interaction between LAG-3 and its major ligand, Class II MHC, is thought to play a role in modulating dendritic cell function. Recent preclinical studies have documented a role for LAG-3 in CD8 T cell exhaustion and blockade of the LAG-3/Class II interaction using a LAG-3 Ig fusion protein is being evaluated in a number of clinical trials in cancer patients.


LAG-3-Next Generation Immunotherapy Drug Chapters

This segment of the LAG-3-Next Generation Immunotherapy report encloses the detailed analysis of late-stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the indication-specific clinical trial details, expressive pharmacological actions, agreements and collaborations, approval and awards, advantages and disadvantages of each included drug, and the latest news and press releases.

The major key players such as MacroGenics/Zai Lab, Bristol-Myers Squibb/Ono Pharmaceuticals, Immutep, Novartis, Merck, F-star Therapeutics, Regeneron, Xencor, Incyte Biosciences/Agenus, Roche, GlaxoSmithKline, Innovent Biologics (Suzhou) Co. Ltd. and others will significantly increase the market during the forecast period (2022–2035).  

The expected launch of emerging therapies, such as MGD013, Relatlimab, Eftilagimod Alpha (IMP321), LAG525, MK-4280, FS118, REGN3767, XmAb22841, INCAGN2385, RO7247669, TSR-033, IBI110 and other treatments, would lead to a significant increase in the market size during the forecast period (2022–2035).


LAG-3-Next Generation Immunotherapy Emerging Drugs


MGD013: MacroGenics

MGD013 which is being developed by MacroGenics is an IgG4κ bispecific DART molecule that binds to PD-1 and LAG-3 concomitantly or independently and disrupts non-redundant inhibitory pathways to restore shattered T-cell function further. The drug is the first in a series of product candidates that distinguish in the multiple immune regulatory targets. The drug is currently being evaluated in a phase II/III study in which the dose and schedule have been established and dose-expansion has been initiated in up to nine tumor types.


LAG525: Novartis

LAG525 (anti-LAG-3, also known as IMP701) which is under development by Novartis is an investigational immunotherapy being developed to potentially treat a range of solid tumors. The drug is a humanized form of IMP701 is currently being evaluated in five phase I and phase II clinical trials in combination with Novartis’ PD-1 inhibitor spartalizumab for the treatment of various cancers.


Relatlimab (BMS-986016): Bristol-Myers Squibb

Relatlimab (previously known as BMS-986016) is a cancer immunotherapy being developed by Bristol-Myers Squibb (BMS). The treatment has already shown benefit in melanoma patients and is also being tested in other cancers. Immunotherapies use the body’s own immune system to fight cancer, instead of directly attacking cancer cells.

Eftilagimod Alpha (IMP321): Immutep

Eftilagimod alpha (IMP321), a soluble dimeric recombinant form of LAG-3, is a first-in-class antigen presenting cell activator under clinical development. By stimulating dendritic cells through MHC class II molecules, IMP321 was proven to induce sustained immune responses. Combining active immunotherapy with a standard cytotoxic chemotherapy regimen represents a promising novel strategy that might lead to therapeutic improvements in metastatic breast cancer.


MK-4280: Merck

A humanized, immunoglobulin G4 (IgG4) monoclonal antibody (MAb) directed against the inhibitory receptor lymphocyte activation gene-3 protein (LAG3), with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, the anti-LAG3 monoclonal antibody MK-4280 binds to LAG3 expressed on tumor-infiltrating lymphocytes (TILs) and blocks its binding with major histocompatibility complex (MHC) class II molecules expressed on tumor cells. This activates antigen-specific T lymphocytes and enhances cytotoxic T-cell-mediated tumor cell lysis, which leads to a reduction in tumor growth. LAG3, a member of the immunoglobulin superfamily (IgSF), is expressed on various immune cells, and negatively regulates both proliferation and activation of T cells. Its expression on TILs is associated with tumor-mediated immune suppression.

Further drug information is provided in the detailed report


LAG-3-Next Generation Immunotherapy Market Outlook

The LAG-3-Next Generation Immunotherapy market outlook helps to cultivate a detailed comprehension of the historical, current and forecasted market trends by analyzing the market, unmet needs, drivers and barriers, and demand for better technology.

This segment gives a thorough detail of LAG-3-Next Generation Immunotherapy market trend of each late-stage pipeline therapy by evaluating their impact based on the annual cost of treatment, inclusion and exclusion criteria’s, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market, and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear picture of the market at first sight.

According to DelveInsight, the LAG-3-Next Generation Immunotherapy market is expected to generate USD 7,009 Million in the year 2035 with a significant CAGR in the forecast period (2022─2035).


Key Findings

• According to Delveinsight’s analysis, the market is expected to show positive growth due to the launch of potential upcoming therapies in the LAG-3 target during the forecast period (2022–2035).

• According to Delveinsight’s analysis, NSCLC will occupy the major market share that is 98.81% by 2035. Also, the total market size for LAG-3 by indications is expected to be USD 3,421 Million by 2035.


KOL Views

To keep up with current market trends, we take KOLs and SME’s opinion working for third-generation immunotherapies in various indications through primary research to fill the data gaps and validate our secondary research. Their opinion helps us to understand and verify current and emerging therapies treatment patterns or current market trends. It will also support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.


Competitive Intelligence Analysis

We perform Competitive and Market Intelligence analysis of the LAG-3-Next Generation Immunotherapy market by using various Competitive Intelligence tools that include – SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the availability of the data.


Scope of the report

• The report covers the descriptive overview of LAG-3-Next Generation Immunotherapy, explaining its pathophysiology, and current trends in the research.

• Additionally, an all-inclusive account of emerging therapies for LAG-3-Next Generation Immunotherapy is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.

• A detailed review of LAG-3-Next Generation Immunotherapy market; historical and forecasted is included in the report, covering drug outreach in the 7MM.

• The report provides an edge while developing business strategies, by understanding trends shaping and driving the LAG-3-Next Generation Immunotherapy market.


Report Highlights

• In the coming years, LAG-3-Next Generation Immunotherapy market is set to change due to the Addition of new emerging technologies for the development of targeted therapies, personalized drug therapies with combinational therapies to enhance the efficacy, Increasing funding for R&D expense; which would expand the market size to enable the drug manufacturers to penetrate more into the market.

• The companies and researchers are working to overcome the challenges and seek opportunities that could help them to develop specific therapies for the treatment of various indications by using LAG-3-Next Generation Immunotherapy. The therapies under development are focused on novel approaches to treat/improve the disease condition.

• Launch of emerging therapies will significantly impact the LAG-3-Next Generation Immunotherapy market.

• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for the LAG-3-Next Generation Immunotherapy market.

• Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key competitors, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.


LAG-3-Next Generation Immunotherapy Report Insights

• Therapeutic Approaches

• Market Size and Trends

• Market Opportunities

• Impact of upcoming therapies


LAG-3-Next Generation Immunotherapy Report Key Strengths

• 14-Year Forecast

• 7MM Coverage

• Drugs Uptake

• Highly Analyzed Market

• Key Cross Competition

• Market Size by Country

• Market Size by Therapy


LAG-3-Next Generation Immunotherapy Report Assessment

• Unmet Needs

• Market Attractiveness

• Market Drivers and Barriers

• Competitive Intensity of LAG-3-Next Generation Immunotherapy

• Market Competition of LAG-3-Next Generation Immunotherapy

• Technological innovations in LAG-3-Next Generation Immunotherapy

• Multivariate analysis of the key players in the LAG-3-Next Generation Immunotherapy

• Pipeline Therapeutics

• Future Prospects and Challenges in LAG-3-Next Generation Immunotherapy

• SWOT Analysis

• Assessment by Product Type

• Assessment by Stage Type

• Assessment by Route of Administration

• Comparative Analysis


Key Questions

• What was the LAG-3-Next Generation Immunotherapy Market share (%) distribution in 2022, and how would it look like in 2035?

• What would be the LAG-3-Next Generation Immunotherapy total market size as well as market size by indications across the 7MM during the forecast period (2022─2035)?

• What are the key findings pertaining to the market across 7MM and which country will have the largest LAG-3-Next Generation Immunotherapy market size during the forecast period (2022─2035)?

• At what CAGR, the LAG-3-Next Generation Immunotherapy market is expected to grow in 7MM during the forecast period (2022─2035)?

• What would be the LAG-3-Next Generation Immunotherapy market outlook across the 7MM during the forecast period (2022─2035)?

• What would be the LAG-3-Next Generation Immunotherapy market growth till 2035, and what will be the resultant market size in the year 2035?

• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

• How does the market size look like for the market size by indications for each 7MM? And what is the revenue this treatment option expected to garner in the various indications?

• Where the emerging therapies are focusing more? 


Reason to buy

• This DelveInsight report will help to develop Business Strategies by understanding the trends shaping and driving the LAG-3-Next Generation Immunotherapy market

• Organize sales and marketing efforts by identifying the best opportunities for LAG-3-Next Generation Immunotherapy market

• To understand the future market competition in the LAG-3-Next Generation Immunotherapy market and Insightful review of the key market drivers and barriers.

• Identification of strong upcoming players in the market will help in planning strategies that will help in getting ahead of competitors.


What is Lymphocyte-activation gene 3 (LAG-3)?

Lymphocyte-activation gene 3 (LAG-3) is an immune checkpoint receptor protein found on the cell surface of effector T cells and regulatory T cells (Tregs) and functions to control T cell response, activation, and growth. T cells are a type of white blood cell that are part of the immune system. Activation of cytotoxic T cells by antigens enables them to kill unhealthy or foreign cells. It binds MHCII molecules and modulates T-cell function than either CTLA-4 or PD- 1. It acts by regulating CD8+ Tcell expansion in immune reactions that have already been initiated (inhibitory signal) and also, by increasing the Treg cell activity


What is the forecasted market size of LAG-3-Next Generation Immunotherapy market?

The LAG-3-Next Generation Immunotherapy market is expected to generate USD 7,009 Million in the year 2035.


What is the structure of LAG-3?

LAG-3 is a transmembrane protein with structural homology to CD4, in which it includes four extracellular IgG domains. The membrane-distal IgG domain contains a short amino acid sequence, the so-called extra loop that is not found in other IgG superfamily proteins. The intracellular domain contains a unique amino acid sequence (KIEELE) that is required for LAG-3 to exert a negative effect on T cell function. LAG-3 can be cleaved at the connecting peptide by metalloproteases to generate a soluble form, which is detectable in serum


Which drugs are involved in the LAG-3-Next Generation Immunotherapy market?

MGD013, Relatlimab, Eftilagimod Alpha (IMP321), LAG525, MK-4280, FS118, REGN3767, XmAb22841, INCAGN2385, RO7247669, TSR-033, IBI110 are involved in significantly increasing the market size of LAG-3-Next Generation Immunotherapy


Which companies are developing drugs for LAG-3-Next Generation Immunotherapy?

MacroGenics, Zai Lab, Bristol-Myers Squibb,Ono Pharmaceuticals, Immutep, Novartis, Merck, F-star Therapeutics, Regeneron, Xencor, Incyte Biosciences, Agenus, Roche, GlaxoSmithKline, Innovent Biologics (Suzhou) Co. Ltd. are developing drugs for LAG-3-Next Generation Immunotherapy

1. Key Insights

2. Executive Summary

3. Competitive Intensity of LAG-3-Next Generation Immunotherapy

4. Market Competition of LAG-3-Next Generation Immunotherapy

5. Technological innovations in LAG-3-Next Generation Immunotherapy

6. Multivariate analysis of the key players in LAG-3-Next Generation Immunotherapy

7. LAG-3-Next Generation Immunotherapy Market Overview at a Glance

7.1. Market Share (%) Distribution of Next-Generation Immunotherapy in 2035

8. Pipeline Therapeutics Analysis (Active Products)

9. Overview: Next Generation Immunotherapy

9.1. Immune Checkpoint Inhibitors

9.2. LAG-3

10. Future Prospects and Challenges in LAG-3-Next Generation Immunotherapy

10.1. Current Clinical Challenges in Immunotherapies

10.2. Future direction of improving response rates of Immunotherapy

11. SWOT Analysis

12. Epidemiology and Forecasting Assumptions

13. Emerging Drugs

13.1. Target indications of LAG-3

13.2. MGD013: MacroGenics/Zai Lab

13.2.1. Drug Description

13.2.2. Other Developmental Activities

13.2.3. Clinical Development

13.2.4. Product Profile

13.3. MBG453: Novartis

13.3.1. Product Description

13.3.2. Other Developmental Activities

13.3.3. Clinical Development

13.3.4. Product Profile

13.4. Relatlimab: Bristol-Myers Squibb/Ono Pharmaceuticals

13.4.1. Product Description

13.4.2. Other Developmental Activities

13.4.3. Clinical Development

13.4.4. Product Profile

13.5. Eftilagimod Alpha (IMP321): Immutep

13.5.1. Drug Description

13.5.2. Clinical Development

13.5.3. Product Profile

13.6. LAG525: Novartis

13.6.1. Product Description

13.6.2. Other Developmental Activities

13.6.3. Clinical Development

13.6.4. Product Profile

13.7. MK-4280: Merck

13.7.1. Product Description

13.7.2. Other Developmental Activities

13.7.3. Clinical Development

13.7.4. Product Profile

13.8. REGN3767: Regeneron

13.8.1. Product Description

13.8.2. Other Developmental Activities

13.8.3. Clinical Development

13.8.4. Product Profile

13.9. FS118: F-star Therapeutics

13.9.1. Product Description

13.9.2. Other Developmental Activities

13.9.3. Clinical Development

13.9.4. Product Profile

13.10. XmAb22841: Xencor

13.10.1. Product Description

13.10.2. Other Developmental Activities

13.10.3. Clinical Development

13.10.4. Product Profile

13.11. INCAGN2385: Incyte Biosciences/Agenus

13.11.1.  Product Description

13.11.2.  Other Developmental Activities

13.11.3.  Clinical Development

13.11.4.  Product Profile

13.12. RO7247669: Roche

13.12.1.  Product Description

13.12.2.  Other Developmental Activities

13.12.3.  Clinical Development

13.12.4.  Product Profile

13.13. TSR-033: GlaxoSmithKline

13.13.1.  Product Description

13.13.2.  Other Developmental Activities

13.13.3.  Clinical Development

13.13.4.  Product Profile

13.14. IBI110: Innovent Biologics (Suzhou) Co. Ltd.

13.14.1.  Product Description

13.14.2.  Other Developmental Activities

13.14.3.  Clinical Development

13.14.4.  Product Profile

14. Assessment by Indication

15. Assessment by Route of Administration

16. Assessment by Stage and Indication

17. Assessment by stage and Route of Administration

18. LAG-3-7 Major Market Analysis

18.1. Market Outlook in the 7MM

18.1.1. Total Market size of LAG-3 in 7MM

18.1.2. Market Size of LAG-3 by indication in 7MM

19. Market Drivers

20. Market Barriers

21. Appendix

21.1. Report Methodology

22. DelveInsight Capabilities

23. Disclaimer

24. About DelveInsight

Table 1: Competitive Intensity of LAG-3-Next Generation Immunotherapy

Table 2: Timeline of selected key events in modern cancer immunology

Table 3: Assessment by Indication Type

Table 4: Assessment by Stage and Indication Type

Table 5: Assessment by Route of Administration

Table 6: Assessment by Stage and Route of Administration

Table 7: MGD013, Clinical Trial Description, 2020

Table 8: Relatlimab, Clinical Trial Description, 2020

Table 9: Eftilagimod Alpha (IMP321), Clinical Trial Description,2020

Table 10: LAG525, Clinical Trial Description, 2020

Table 11: MK-4280, Clinical Trial Description,2020

Table 12: FS118, Clinical Trial Description,2020

Table 13: REGN3767, Clinical Trial Description,2020

Table 14: XmAb22841, Clinical Trial Description,2020

Table 15: INCAGN2385, Clinical Trial Description,2020

Table 16: RO7247669, Clinical Trial Description,2020

Table 17: TSR-033, Clinical Trial Description,2020

Table 18: IBI110, Clinical Trial Description,2020

Figure 1: Competitive Intensity of LAG-3-Next Generation Immunotherapy

Figure 2: Market Competition of LAG-3-Next Generation Immunotherapy

Figure 3: Technological innovations in LAG-3-Next Generation Immunotherapy

Figure 4: Multivariate analysis of the key players in LAG-3-Next Generation Immunotherapy

Figure 5: LAG-3-Next Generation Immunotherapy Market Overview at a Glance

Figure 6: Pipeline Therapeutics Analysis (Active Products)

Figure 7: SWOT Analysis

Figure 8: Assessment by Indication

Figure 9: Assessment by Stage and Indication

Figure 10: Assessment by Route of Administration

Figure 11: Assessment by Stage and Route of Administration

Figure 12: Unmet Needs

Figure 13: Total Market size of LAG-3 in 7MM

Figure 14: Market Size of LAG-3 by indication in 7MM

Figure 15: Market Drivers

Figure 16: Market Barriers

• MacroGenics/Zai Lab

• Novartis

• Bristol-Myers Squibb/Ono Pharmaceuticals

• Immutep

• Novartis

• Merck

• Regeneron

• F-star Therapeutics

• Xencor

and many more.

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