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TIM-3-Next Generation Immunotherapy - Competitive Landscape and Market Forecast - 2035

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  • 75 Pages
  • April 2020
  • Region: Global
  • DelveInsight
  • ID: 5010947
UP TO OFF until Dec 31st 2022
‘TIM-3-Next Generation Immunotherapy - Competitive Landscape and Market Forecast-2035' report delivers an in-depth understanding of the TIM-3 as well as the market trends of TIM-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 TIM-3-Next Generation Immunotherapy from 2022 to 2035 segmented by seven major markets. This report discusses the recent findings on TIM-3, the role it plays in regulating immune responses in different cell types and the rationale for targeting TIM-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

TIM-3-Next Generation Immunotherapy Disease 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.

TIM-3 is a co-inhibitory receptor that is expressed on IFN-γ-producing T cells, FoxP3+ Treg cells and innate immune cells (macrophages and dendritic cells) where it has been shown to suppress their responses upon interaction with their ligand(s). TIM-3 has gained prominence as a potential candidate for cancer immunotherapy, where it has been shown that in vivo blockade of TIM-3 with other check-point inhibitors enhances anti-tumor immunity and suppresses tumor growth in several preclinical tumor models.

TIM-3, as a negative regulatory immune checkpoint, is detected in different types of immune cells, including T cells, regulatory T cells (Tregs), dendritic cells (DCs), B cells, macrophages, nature killer (NK) cells, and mast cells. TIM-3 is a type I membrane protein and consists of 281 amino acids. It comprises an extracellular domain, a single transmembrane domain, and a C-terminal cytoplasmic tail.

TIM-3 Ligands

TIM-3 has four ligands, including galectin-9 (Gal-9), carcinoembryonic antigen cell adhesion molecule 1 (CEACAM-1), high-mobility group protein B1 (HMGB1), and phosphatidylserine (PS). Gal-9 was the first to be identified. It is a carbohydrate binding protein, specifically recognizing the structure of N-linked sugar chains in the TIM-3 immunoglobulin variable (IgV) domain. TIM-3/Gal-9 can inhibit cancer immunity by negatively regulating T-cell immunity. The connection of the TIM-3 IgV domain with Gal-9 can terminate T helper 1 (Th1) immune responses.

TIM-3 signaling

In the absence of ligand-mediated Tim-3 signaling, the Tyr 256 and Tyr 263 in the C-terminal tail of Tim-3 bind to Bat3. In this state, Bat3 recruits the catalytically active form of Lck, thereby forming an intracellular molecular complex with Tim-3 that preserves and potentially promotes T cell signaling and represses Tim-3-mediated cell death and exhaustion.

Interactions between Tim-3 ligands (Galectin 9), and Tim-3 leads to phosphorylation of Tyr 256 and Tyr 263 and release of Bat-3 from the Tim-3 tail, thereby promoting Tim-3-mediated T cell inhibition by allowing binding of SH2 domain-containing Src kinases (Lck/Fyn/Other proteins) and subsequent regulation of TCR signaling. Because Fyn and Bat3 bind to the same domain in the Tim-3 cytoplasmic tail, a likely molecular switch between Tim-3-Bat3 and Tim-3-Fyn probably triggers the switch of Tim-3 function from being permissive to TCR signaling to inhibition of proximal TCR signaling.

Rationale for Targeting TIM-3

Combined use of antagonistic anti-TIM-3 antibodies with agonistic antibodies to pro-stimulatory molecules on tumor-specific T cells, such as CD137, has demonstrated long-term protection in a murine model of ovarian cancer. This therapeutic regimen of using Tim-3 blockade with activation of a pro-stimulatory molecule on T cells could be exploited in the future to obtain objective anti-tumor responses in patients. One could expect that further exploratory studies would reveal additional exciting anti-TIM-3 immunotherapeutic approaches to treat cancers.

Targeting TIM-3 along with other checkpoint inhibitors or combining TIM-3 inhibition with new immunotherapeutic approaches that activate cancer-specific T-cell stimulatory molecules has high potential for developing modalities with durable clinical benefit. In addition, TIM-3 blockade may also induce an anti-tumor immune response and mediate tumor regression in situations where anti-PD-1 or anti-CTLA4 does not work, such as in colorectal carcinomas. The key challenge in moving forward is to develop reliable strategies and indications under which combination therapies should be tested. Given the fact that PD-1 blockade may lead to upregulation of TIM-3, blockade of TIM-3 following development of adaptive resistance to PD-1 or other checkpoint inhibitors holds promise in developing combination therapies in which anti- TIM-3 is a key component.

TIM-3-Next Generation Immunotherapy Drug Chapters

This segment of the TIM-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 Symphogen, GlaxoSmithKline, Novartis, Bristol-Myers Squibb/ Ono Pharmaceuticals, BeiGene, Incyte Biosciences/Agenus, Roche, Eli Lilly and many others will significantly increase the market during the forecast period (2022-2035).

The expected launch of emerging therapies, such as TSR-022, MBG453, ONO-7807/BMS-986258, BGB-A425 +/- Tislelizumab, Sym023, INCAGN2390, RG7769/RO7121661, LY3321367, Sym022 and other treatments, would lead to a significant increase in the market size during the forecast period (2022-2035).

TIM-3-Next Generation Immunotherapy Emerging Drugs

Sym023: Symphogen

Sym023 is a mAb that binds TIM3 and induces activation of immune cells. Currently, Sym023 (targeting TIM3) is being investigated in Phase 1 trials in combination with Sym021 (targeting PD1) and as single antibody. TIM3 and PD1 are immune checkpoints playing important roles in regulating immune responses, including the body's immune response to tumor cells.

TSR-022: Tesaro

TSR-022 is an investigational drug that is under development by GlaxoSmithKline. Initially, Tesaro is developing this drug for the treatment of various tumors. This drug is currently under phase II development for the treatment of melanoma stage III, melanoma Stage IV, adult primary liver cancer, advanced adult primary liver cancer, and localized unresectable adult primary liver cancer.

MBG453: Novartis

MBG453 is an immunotherapy that Novartis is developing to treat solid tumors and hematologic cancers, which form in the blood or immune system. MBG453 inhibits TIM-3, a protein found on the surface of certain immune T-cells. Its full scientific name is T-cell immunoglobulin and mucin-domain-containing-3. MBG453 binds to TIM-3 on the surface of T-cells, releasing the brakes that the tumor applied to the immune system. This allows it to function normally against cancer cells, reducing tumor growth.

Novartis is conducting Phase 1/2 clinical trials of MBB453 as a treatment for several types of cancer.


An antibody against the inhibitory T-cell receptor T-cell immunoglobulin and mucin domain-containing protein 3 (TIM-3; TIM3; hepatitis A virus cellular receptor 2; HAVCR2), with potential immune checkpoint inhibitory and antineoplastic activities. Following administration, anti-TIM-3 antibody BMS-986258 binds to TIM-3 that is expressed on certain T cells, including tumor infiltrating lymphocytes (TILs). This abrogates T-cell inhibition, activates antigen-specific T lymphocytes and enhances cytotoxic T-cell-mediated tumor cell lysis, which together result in decreased tumor growth. TIM-3, a transmembrane protein and immune checkpoint receptor, is associated with tumor-mediated immune suppression.

LY3321367: Eli Lilly and Company

LY3321367 mAb targets TIM-3 on immune cells and LY3300054 mAb targets PD-L1 on tumor cells and tumor-infiltrating immune cells. According to the clinical trial results, LY3321367 is well tolerated as a monotherapy and in combination with LY3300054. The [dose-limiting toxicity] for LY3321367 combination therapy is 1,200-mg intravenous infusions [once every 2 weeks] for cycles 1-2; 600-mg infusions [once every 2 weeks] starting at cycle 3 onward.”

TIM-3-Next Generation Immunotherapy Market Outlook

The TIM-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 TIM-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 the publisher, the TIM-3-Next Generation Immunotherapy market is expected to generate USD 1,218 Million in the year 2035 with a significant CAGR in the forecast period (2022─2035).

Key Findings
  • According to the publisher's analysis, the market is expected to show positive growth due to the launch of potential upcoming therapies in the TIM-3 target during the forecast period (2022-2035).
  • According to the publisher's analysis, NSCLC will occupy the major market share that is 39.08% by 2035. Also, the total market size for TIM-3 by indications is expected to be USD 1,218 Million by 2035 respectively.

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

The publisher performs Competitive and Market Intelligence analysis of the TIM-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 TIM-3-Next Generation Immunotherapy, explaining its pathophysiology, and current trends in the research.
  • Additionally, an all-inclusive account of emerging therapies for TIM-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 TIM-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 TIM-3-Next Generation Immunotherapy market.

Report Highlights
  • In the coming years, TIM-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 TIM-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 TIM-3-Next Generation Immunotherapy market.
  • A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for the TIM-3-Next Generation Immunotherapy market.
  • The 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.

TIM-3-Next Generation Immunotherapy Report Insights
  • Therapeutic Approaches
  • Market Size and Trends
  • Market Opportunities
  • Impact of upcoming therapies

TIM-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

TIM-3-Next Generation Immunotherapy Report Assessment
  • Unmet Needs
  • Market Attractiveness
  • Market Drivers and Barriers
  • Competitive Intensity of TIM-3-Next Generation Immunotherapy
  • Market Competition of TIM-3-Next Generation Immunotherapy
  • Technological innovations in TIM-3-Next Generation Immunotherapy
  • Multivariate analysis of the key players in the TIM-3-Next Generation Immunotherapy
  • Pipeline Therapeutics
  • Future Prospects and Challenges in TIM-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 TIM-3-Next Generation Immunotherapy Market share (%) distribution in 2022, and how would it look like in 2035?
  • What would be the TIM-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 TIM-3-Next Generation Immunotherapy market size during the forecast period (2022─2035)?
  • At what CAGR, the TIM-3-Next Generation Immunotherapy market is expected to grow in 7MM during the forecast period (2022─2035)?
  • What would be the TIM-3-Next Generation Immunotherapy market outlook across the 7MM during the forecast period (2022─2035)?
  • What would be the TIM-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?

Reasons to Buy
  • This report will help to develop Business Strategies by understanding the trends shaping and driving the TIM-3-Next Generation Immunotherapy market
  • Organize sales and marketing efforts by identifying the best opportunities for TIM-3-Next Generation Immunotherapy market
  • To understand the future market competition in the TIM-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.

Table of Contents

1. Key Insights2. Executive Summary3. Competitive Intensity of TIM-3-Next Generation Immunotherapy4. Market Competition of TIM-3-Next Generation Immunotherapy5. Technological innovations in TIM-3-Next Generation Immunotherapy6. Multivariate analysis of the key players in TIM-3-Next Generation Immunotherapy
7. TIM-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. TIM-3
10. Future Prospects and Challenges in TIM-3-Next Generation Immunotherapy
10.1. Current Clinical Challenges in Immunotherapies
10.2. Future direction of improving response rates of Immunotherapy
11. SWOT Analysis12. Epidemiology and Forecasting Assumptions
13. Emerging Drugs
13.1. Target indications of TIM-3
13.2. TSR-022: GlaxoSmithKline
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. ONO-7807/BMS-986258: 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. BGB-A425 +/- Tislelizumab: BeiGene
13.5.1. Drug Description
13.5.2. Clinical Development
13.5.3. Product Profile
13.6. INCAGN2390: Incyte Biosciences/Agenus
13.6.1. Product Description
13.6.2. Other Developmental Activities
13.6.3. Clinical Development
13.6.4. Product Profile
13.7. Sym023: Symphogen
13.7.1. Product Description
13.7.2. Other Developmental Activities
13.7.3. Clinical Development
13.7.4. Product Profile
13.8. RG7769/RO7121661: Roche
13.8.1. Product Description
13.8.2. Other Developmental Activities
13.8.3. Clinical Development
13.8.4. Product Profile
13.9. LY3321367: Eli Lilly
13.9.1. Product Description
13.9.2. Other Developmental Activities
13.9.3. Clinical Development
13.9.4. Product Profile
13.10. Sym022: Symphogen
13.10.1. Product Description
13.10.2. Other Developmental Activities
13.10.3. Clinical Development
13.10.4. Product Profile
14. Assessment by Indication15. Assessment by Route of Administration16. Assessment by Stage and Indication17. Assessment by stage and Route of Administration
18. TIM-3-7 Major Market Analysis
18.1. Market Outlook in the 7MM
18.1.1. Total Market size of TIM-3 in 7MM
18.1.2. Market Size of TIM-3 by indication in 7MM
19. Market Drivers20. Market Barriers
21. Appendix
21.1. Report Methodology
22. Capabilities23. Disclaimer24. About the Publisher

Companies Mentioned

A selection of companies mentioned in this report includes:

  • GlaxoSmithKline
  • Novartis
  • Bristol-Myers Squibb/ Ono Pharmaceuticals
  • BeiGene
  • Incyte Biosciences/Agenus
  • Symphogen
  • Roche
  • Eli Lilly
  • Symphogen