Lag-3-next Generation Immunotherapy Market to Witness Growth by 2032, Estimates DelveInsight | Companies- Bristol-Myers Squibb, Merck Sharp & Dohme Corp., MacroGenics, Immutep, Incyte Corporation, F-star Therapeutics, EpimAb Biotherapeutics, Roche, Xencor

DelveInsight's "Lag-3-next Generation Immunotherapy Market Insights, Epidemiology, and Market Forecast-2032" report delivers an in-depth understanding of Lag-3-next Generation Immunotherapy, historical and forecasted epidemiology as well as the Lag-3-next Generation Immunotherapy market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.

The Lag-3-next Generation Immunotherapy market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Lag-3-next Generation Immunotherapy market size from 2019 to 2032, segmented by seven major markets. The Report also covers current Lag-3-next Generation Immunotherapy treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Lag-3-next Generation Immunotherapy market.

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Some of the key facts from the Lag-3-next Generation Immunotherapy Market Report:
The market size of LAG-3 in the 7MM is expected to rise from ~USD 588 million in 2025 to reach ~USD 6,092 million by 2035, at a CAGR of 26.3% during the study period.
The United States accounts for the largest market size compared to the EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan. In the United States, the market size of LAG-3 is anticipated to rise from ~USD 20 million in 2022 to reach ~USD 3,783 million by 2035.
Among the EU5 countries, Germany had the largest market size while Spain had the smallest market size for LAG-3 therapies. By 2035, the market size is anticipated to reach ~USD 472 million and ~USD 224 million for Germany and Spain, respectively.
In 2024, Japan accounted for a market size of ~USD 1 million, which is expected to reach ~USD 572 million by 2035.

Lag-3-next Generation Immunotherapy: An Overview
The main treatment options in the case of cancer include chemotherapy, radiotherapy, surgery, hormone therapy, stem cell transplant, immunotherapy, Chimeric Antigen Receptor (CAR) T-Cell Therapy, and targeted therapy. These treatments may be used individually or in combination with one another. With the development and approval of these new treatment options, the survival of cancer patients has also improved.

Among all the choices mentioned above, immunotherapy is at the forefront of cancer research thanks to the broad clinical successes of immune check point-targeted monoclonal antibodies. Immunotherapies have demonstrated efficacy across different cancer types. Immune checkpoint inhibitors such as CTLA-4, PD-1, and PD-L1 have become a mainstay of cancer treatment. However, numerous cancer patients fail to respond, despite the promising impact of cancer immunotherapy targeting CTLA4 and PD1/PDL1.

Cancer research organizations, universities, and pharmaceutical companies are always coming up with innovations to solve such obstacles. LAG-3 (CD223) is regarded as one among them. LAG-3 is involved in various cancers, autoimmune disorders, and other illnesses. LAG-3 is a cell-surface molecule expressed on effector T cells and regulatory T cells (Tregs) and controls T-cell response, activation, and growth. Preclinical research and clinical trial findings indicate that inhibiting LAG-3 may restore effector activity of depleted T cells and perhaps increase an antitumor response. Clinical evidence also shows that LAG-3 works synergistically with PD1/PDL1. LAG-3 might be a very promising immune checkpoint inhibitor in the future.

Opdualag, a new, first-in-class, fixed-dose combination of nivolumab and relatlimab, administered as a single intravenous infusion, was approved by the US FDA to treat adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. The approval is based on Phase II/III RELATIVITY-047 trial, comparing Opdualag (n = 355) to nivolumab alone (n = 359).

Currently, many companies are focusing on the LAG-3 immune checkpoint in their search for novel approaches to treat malignant tumors and autoimmune disorders, many of which are now in clinical development. 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.

Some challenges, such as precedence of failure of emerging therapies in the autoimmune space, the economic burden on cancer patients due to premium pricing, as well as knowledge gaps, may impede the commercial expansion of LAG-3 therapeutics. Competition from new technologies in the same space can be another major challenge.

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Lag-3-next Generation Immunotherapy Market

Cancer is a generic term for a large group of diseases that can affect any part of the body. One of its outlining features is the speedy creation of abnormal cells that grow beyond their usual boundaries. These cells can then invade adjoining parts of the body and spread to other organs; the latter process is called metastasis.

With rapidly changing lifestyles, increasing consumption of tobacco and smoking, more exposure to sun and other types of radiation, viruses, and other infections, cancer cases per year are rising. As per World Health Organization (WHO, 2021), cancer is a leading cause of death worldwide, which accounted for nearly 10 million deaths in 2020. Given the severity of the condition, cancer has been a focal point for R&D for decades, and the treatment paradigm has improved significantly with time. Cancer treatment primarily comprises surgery, radiation therapy, chemotherapy, hormone therapy, targeted therapy, and immunotherapy. However, death rates are relatively high even with several treatment options, as these therapies have some limitations and cannot target every patient. Few cancer therapies face the challenge of accessing targets deep within tumor tissue; on the other hand, some cause serious adverse effects. Cancer immunotherapies targeting inhibitory coreceptors programmed cell death 1 (PD-1) and cytotoxic T lymphocyte antigen 4 (CTLA-4) have significantly improved the outcomes of patients with diverse cancer types, revolutionizing cancer treatment. The success of these therapies verified that inhibitory coreceptors serve as critical checkpoints for immune cells not to attack the tumor cells and self-tissues. However, response rates are typically lower, and immune-related adverse events (irAEs) are also observed in patients administered with immune checkpoint inhibitors. As a result of these treatment-related unmet needs, researchers have been developing next-generation immunotherapies - a game-changer in cancer treatment. Pharmaceutical companies have an intense competition to develop novel immunotherapies such as LAG-3, where current treatment choices are not working.

Companies like Bristol-Myers Squibb (relatlimab [BMS-986016]) and Merck Sharp & Dohme Corp. (favezelimab [MK-4280]), Immutep (eftilagimod alpha [IMP321]), Incyte Corporation (INCAGN02385), F-star Therapeutics (FS118), EpimAb Biotherapeutics (EMB-02), Roche (RG6139 [RO7247669]), Xencor (XmAb22841 [XmAb841]), AnaptysBio/GlaxoSmithKline (Encelimab [TSR-033]), Macrogenics (Tebotelimab [MGD013]), Regeneron Pharmaceuticals/Sanofi (Fianlimab [(REGN3767]), Symphogen (Sym022) and others are involved in the development of LAG-3 therapies. For the peak share estimation of below mentioned forecasted therapies, factors like the probability of success, precedence of trial failure and therapy effect, current unmet need, competition from established current key players, and emerging novel targets such as TIM-3 agents, B3-H7 agents, IDO-1 agents, SIRP agents, STING, CSF-1R CD40, TIGIT, and others are considered. Several intratumoral therapies are also coming into the market, targeting PD-refractory Pool, are also considered. Drugs in the early phase with less visibility on clinical evidence have assigned a low probability of success. With several potential therapies being investigated for the management of LAG-3, it is safe to predict that the treatment space will experience a significant impact during the forecast period of 2022-2035. According to DelveInsight, the LAG-3 market in 7MM is expected to witness a major change in the study period 2019-2035.

According to DelveInsight, the Lag-3-next Generation Immunotherapy market in 7MM is expected to witness a major change in the study period 2019-2032.

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Lag-3-next Generation Immunotherapy Epidemiology

The Lag-3-next Generation Immunotherapy epidemiology section provides insights into the historical and current Lag-3-next Generation Immunotherapy patient pool and forecasted trends for seven individual major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the Lag-3-next Generation Immunotherapy market report also provides the diagnosed patient pool, trends, and assumptions.

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LAG-3 Emerging Drugs

Favezelimab (MK-4280) by Merck is a humanized, IgG4 anti-LAG-3 monoclonal antibody that prevents LAG-3 from binding to its major ligand, MHC Class II. MK-4280 is being evaluated as monotherapy and in combination with KEYTRUDA in clinical trials to treat solid tumors and hematologic malignancies. The Phase I study revealed that favezelimab alone or in combination with pembrolizumab had a manageable safety profile, with no treatment-related deaths. Promising antitumor activity was observed with combination therapy, including MK-4280A, compared with monotherapy, most notably in PD-L1 CPS ≥1 tumor patients. In November 2021, the company recently initiated a Phase III study co-formulated favezelimab/pembrolizumab (MK-4280A) versus standard of care in subjects with previously treated metastatic PD-L1 positive colorectal cancer (MK-4280A-007).

Eftilagimod Alpha (IMP321) by Immutep is a recombinant protein consisting of a dimer of LAG-3 that has been engineered to be soluble rather than expressed on the surface of cells. It is a first-in-class antigen-presenting cell (APC) activator, proven to induce sustained immune responses in cancer patients when used at a low dose, as a cancer vaccine adjuvant, or at higher doses to get a systemic effect (i.e., general APC activation). The drug binds to a subset of MHC class II molecules to mediate antigen-presenting cells and CD8 T-cell activation. Investigators hypothesized that the stimulation of the dendritic cell network and subsequent T-cell recruitment could lead to stronger antitumor responses when combined with pembrolizumab vs. pembrolizumab alone. In addition, it has been shown to be safe and well-tolerated, thus making it an ideal combination partner for other drugs or drug candidates. The clinical trials with eftilagimod alpha are combined with either chemotherapy or immunotherapy. AIPAC-003 for Metastatic Breast Cancer (Chemo - IO) is planned. The trial has also received positive feedback from EMA. In addition, FDA discussion is also ongoing as planned.

Leramilimab (LAG525) by Novartis is a therapeutic antagonist antibody originally developed by Immutep S.A. (now Immutep S.A.S.) to target LAG-3 and LAG525, a humanized form of IMP701. The antibody controls signaling pathways in both effector T cells and regulatory T cells (Treg). The antibody activates effector T cells by blocking inhibitory signals that would otherwise switch them off. The antibody also inhibits Treg function, which normally prevents T cells from responding to antigen stimulation. Both mechanisms of action prevent the immune system from responding to and killing cancer cells. Other antagonist LAG-3 antibodies in development target only the effector T-cell pathway but do not address the Treg pathway. LAG525 is being evaluated in several Phase I and/or Phase II clinical trials in combination with spartalizumab, Novartis' programmed cell death 1 (PD1) inhibitor to treat various cancers.

INCAGN2385 is a monoclonal antibody that blocks the binding of LAG-3 with its MHC class II ligand, being developed by Agenus and Incyte Corporation. LAG-3 is a checkpoint protein expressed on the surface of certain immune system cells. LAG-3 modulates signaling between immune cells and their targets. When LAG-3 is activated, the immune response is suppressed. Antibodies that block LAG-3 can block this inhibitory signal, thereby boosting the immune system's response to cancer cells. LAG-3 acts synergistically with other checkpoint modulators. This suggests antibodies against LAG-3 may be valuable as combination therapies. This is why the company believes that LAG-3 checkpoint inhibitors may have potential in both combination and monotherapy settings. LAG-3 checkpoint inhibitor is part of the global alliance with Incyte. The program is funded by Incyte, with Agenus eligible for potential milestones and royalties ranging from 6% to 12%, subject to a reduction for certain third-party obligations. In addition, the clinical proof of concept study associated with INCAGN2385 is being used in combination to treat participants with advanced malignancies.

FS118 by F-star Therapeutics is a potentially first-in-class dual checkpoint inhibitor developed to overcome tumor evasion mechanisms promoted by two highly immunosuppressive pathways, LAG-3 and PD-L1. Despite the clinical progress made with PD-L1 therapies, the upregulation of other immune checkpoints in cancer, such as LAG-3, plays a vital role in promoting resistance to these drugs. Therapeutic antibodies that target the immune checkpoints (LAG-3) and PD-1 have shown increased clinical antitumor activity when given in combination. FS118 has shown in clinical trials and preclinical studies that it blocks both PD-L1 and LAG-3 simultaneously and has an additional mechanism of action to promote the shedding of LAG-3 from the surface of immune cells. Expanding the FS118 clinical development into checkpoint naïve, biomarker enriched NSCLC, and DLBCL patients will broaden the clinical reach of this exciting LAG-3 & PD-L1 targeting bispecific antibody. This adds to the ongoing checkpoint inhibitor relapsed head and neck cancer study that is anticipated to report data in mid-2022. Currently, the drug is in Phase I/II trial in patients with advanced tumors to determine the efficacy in participants with squamous cell carcinoma of the head and neck (SCCHN). As per the company presentation, the Initial data from the NSCLC CPI-naïve trial is expected to release between H1 and H2-2023. In addition, initial data from the DLBCL CPI-naïve trial is expected to be released in H2-2023.

MGD013 (Tebotelimab), which is under development by MacroGenics, is an investigational, bispecific DART molecule designed to independently or coordinately block PD-1 and LAG-3 checkpoint molecules to sustain or restore the function of exhausted T cells for the treatment of cancer. MacroGenics has presented data from a Phase I study of tebotelimab in 205 patients with advanced or solid and hematologic neoplasms. Although the results, based on 152 evaluable responses, were unspectacular, tebotelimab effector cell activation was enhanced when combined with margetuximab. In data released last November, across multiple advanced HER2+ tumor types, an ORR of 28.6% was observed, with 64.3% of patients experiencing a decrease in tumor size when tebotelimab was combined with Margenza. As per the company pipeline portfolio, the drug is in the Phase I developmental stage; however, combination studies are also ongoing and in the late clinical stage of development.

Lag-3-next Generation Immunotherapy Pipeline Development Activities

The Lag-3-next Generation Immunotherapy report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses Lag-3-next Generation Immunotherapy key players involved in developing targeted therapeutics.

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Lag-3-next Generation Immunotherapy Therapeutics Assessment

Major key companies such as Bristol-Myers Squibb, Merck Sharp & Dohme Corp., MacroGenics, Immutep, Incyte Corporation, F-star Therapeutics, EpimAb Biotherapeutics, Roche, Xencor, AnaptysBio, GlaxoSmithKline, Regeneron Pharmaceuticals, Sanofi, Symphogen, and others are working proactively in the Lag-3-next Generation Immunotherapy Therapeutics market to develop novel therapies which will drive the Lag-3-next Generation Immunotherapy treatment markets in the upcoming years.

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Lag-3-next Generation Immunotherapy Report Key Insights

1. Lag-3-next Generation Immunotherapy Patient Population
2. Lag-3-next Generation Immunotherapy Market Size and Trends
3. Key Cross Competition in the Lag-3-next Generation Immunotherapy Market
4. Lag-3-next Generation Immunotherapy Market Dynamics (Key Drivers and Barriers)
5. Lag-3-next Generation Immunotherapy Market Opportunities
6. Lag-3-next Generation Immunotherapy Therapeutic Approaches
7. Lag-3-next Generation Immunotherapy Pipeline Analysis
8. Lag-3-next Generation Immunotherapy Current Treatment Practices/Algorithm
9. Impact of Emerging Therapies on the Lag-3-next Generation Immunotherapy Market

Table of Contents

1. Key Insights
2. Executive Summary
3. Lag-3-next Generation Immunotherapy Competitive Intelligence Analysis
4. Lag-3-next Generation Immunotherapy Market Overview at a Glance
5. Lag-3-next Generation Immunotherapy Disease Background and Overview
6. Lag-3-next Generation Immunotherapy Patient Journey
7. Lag-3-next Generation Immunotherapy Epidemiology and Patient Population
8. Lag-3-next Generation Immunotherapy Treatment Algorithm, Current Treatment, and Medical Practices
9. Lag-3-next Generation Immunotherapy Unmet Needs
10. Key Endpoints of Lag-3-next Generation Immunotherapy Treatment
11. Lag-3-next Generation Immunotherapy Marketed Products
12. Lag-3-next Generation Immunotherapy Emerging Therapies
13. Lag-3-next Generation Immunotherapy Seven Major Market Analysis
14. Attribute Analysis
15. Lag-3-next Generation Immunotherapy Market Outlook (7 major markets)
16. Lag-3-next Generation Immunotherapy Access and Reimbursement Overview
17. KOL Views on the Lag-3-next Generation Immunotherapy Market
18. Lag-3-next Generation Immunotherapy Market Drivers
19. Lag-3-next Generation Immunotherapy Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer

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