라이신 탈메틸화효소 1(LSD1)- 표적 집단, 경쟁 구도, 시장 예측(2034년)

Key Highlights:

• Lysine demethylase 1 (LSD1) plays a role in mediating the expression of genes involved in cancer and non-cancer diseases such as viral infections, and cardiovascular and neurodegenerative disorders.
• It is ubiquitously overexpressed in many types of cancers (breast, gastric, prostate, hepatocellular, and esophageal cancer, acute myeloid leukemia, and others) leading to a block of differentiation and increase of proliferation, migration, and invasiveness at a cellular level.
• In January 2023, the FDA granted an orphan drug designation to JBI-802 for the treatment of patients with small-cell lung cancer and acute myeloid leukemia.
• Many irreversible novel LSD1 inhibitors (bomedemstat and iadademstat) are in development along with numerous reversible inhibitors for LSD1 such as SP-2577 (seclidemstat).
• Key players in the LSD1 Inhibitor market include Oryzon Genomics, Salarius Pharmaceuticals, Jubilant Therapeutics, Merck, and others.
• LSD1 is essential for proper neuronal function, and its impairment has been linked to neurodegenerative conditions like Alzheimer's disease (AD), frontotemporal dementia (FTD), and tauopathies. Nevertheless, further in-depth research is needed to evaluate its potential as a therapeutic target for brain and neurological disorders.

DelveInsight's "Lysine demethylase 1 (LSD1) - Target Population, Competitive Landscape, and Market Forecast - 2034" report delivers an in-depth understanding of the LSD1 Inhibitor, historical and competitive landscape as well as the LSD1 Inhibitors market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The LSD1 inhibitors market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM LSD1 inhibitors market size from 2020 to 2034. The report also covers current LSD1 inhibitors treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

LSD1 inhibitors Understanding

LSD1 Inhibitors Overview

LSD1, also known as KDM1A, belongs to the monoamine oxidase (MAO) family and shares a sequence similarity with monoamine oxidases A and B (MAO-A, MAO-B), as well as a similarity with polyamine oxidase (PAO). LSD1 inhibitors can be grouped into covalent and non-covalent agents. Each group includes some hybrid compounds, able to inhibit LSD1 in addition to other target(s) at the same time (dual or multitargeting compounds). In tumor cells, the overexpression of LSD1 induces abnormal cell proliferation, thereby facilitating the rapid growth and extensive dissemination of tumors. Effectively inhibiting the expression or function of LSD1 can mitigate the proliferation and dissemination of tumor cells, thereby markedly enhancing the therapeutic efficacy against cancer. Consequently, LSD1 has emerged as a compelling target for the development of anti-tumor drugs.

LSD1 has been found significantly overexpressed in many solid tumors, including prostate, breast, small cell lung cancer, bladder cancer, medulloblastoma, neuroblastoma, glioma, and sarcomas, as well as hematological malignancies, such as acute myeloid leukemia.

LSD1 Inhibitors Epidemiology

The LSD1 inhibitors epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total incident cases of selected indication for LSD1 inhibitors, total eligible patient pool for LSD1 inhibitors in selected indication, total treated cases in selected indication for LSD1 inhibitors in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.

LSD1 Inhibitors Drug Chapters

The drug chapter segment of the LSD1 inhibitors reports encloses a detailed analysis of LSD1 inhibitors late-stage, mid-stage, and early-stage pipeline drugs. It also helps understand the LSD1 inhibitors' clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Emerging Drugs

Seclidemstat (SP-2577): Salarius Pharmaceuticals

Seclidemstat is a novel oral reversible inhibitor of the LSD1 enzyme and has received fast-track, orphan drug, and rare pediatric disease designations for Ewing sarcoma from the FDA. In addition to the MDACC investigator-initiated clinical trial, seclidemstat has been studied in a company-sponsored Phase I/II clinical trial evaluating its use in combination with TC for the treatment of relapsed/refractory Ewing sarcoma.

Bomedemstat: Imago Biosciences/Merck (MSD)

Bomedemstat (MK-3543) is an investigational small molecule, irreversible LSD 1 inhibitor being developed by Merck. LSD 1 regulates the proliferation of hematopoietic stem cells, playing an essential role in cell differentiation and maturation. Bomedemstat is being evaluated in a wide range of MPNs, including essential thrombocythemia, myelofibrosis and polycythemia. Bomedemstat has US Food and Drug Administration Orphan Drug and Fast Track Designations for the treatment of ET and myelofibrosis (MF), Orphan Drug Designation for the treatment of acute myeloid leukemia and Priority Medicines scheme designation by the European Medicines Agency for the treatment of MF.

LSD1 Inhibitors Market Outlook

LSD1 has emerged as a promising therapeutic target for various cancers, including acute myeloid leukemia, small-cell lung cancer, and several other cancer types. Elevated levels of LSD1 have been noted in these malignancies, contributing to cancer cell proliferation, invasion, migration, and differentiation. Pharmacological inhibition of LSD1 using small molecule inhibitors has shown effectiveness, with inhibitors either irreversibly or reversibly binding to LSD1. Irreversible LSD1 inhibitors typically feature the TCP structure, interacting covalently with the FAD cofactor to achieve inhibition. LSD1's dysregulation or overexpression has been implicated in metastasis and tumorigenesis across a spectrum of cancers, including prostate, breast, bladder cancer, medulloblastoma, neuroblastoma, glioma, sarcomas, and hematological malignancies like AML. This broad involvement underscores LSD1's significant role in cancer pathogenesis and its potential as a therapeutic target. Pharmaceutical inhibition of LSD1 has shown promise as a treatment strategy for cancer. Current research is evaluating several TCP-based LSD1 inhibitors for their therapeutic potential. Additionally, natural products have also demonstrated effectiveness as LSD1 inhibitors. These natural products fall into categories such as cyclic peptides, protoberberine alkaloids, polyphenols, and unsaturated carbonyl compounds, expanding the repertoire of potential therapeutic agents targeting LSD1.

Due to the important involvements of LSD1 in carcinogenesis, and the numerous ways with which it interferes with various signaling pathways, targeting lysine demethylases and in particular LSD1 is becoming a promising treatment option for cancer patients.

Key players, including Oryzon Genomics, Salarius Pharmaceuticals, Jubilant Therapeutics, Merck, and others, are involved in developing drugs for LSD1 inhibitors for various indications.

LSD1 Inhibitors Drugs Uptake

This section focuses on the uptake rate of emerging LSD1 inhibitors expected to be launched in the market during 2025-2034.

LSD1 Inhibitors Pipeline Development Activities

The report provides insights into different therapeutic candidates in different Phases of development. It also analyzes key players involved in developing targeted therapeutics.

The presence of numerous drugs under different stages is expected to generate immense opportunity for LSD1 Inhibitors market growth over the forecast period.

Pipeline development activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for LSD1 inhibitors emerging therapies.

The increasing strategic collaborations among major market players to enhance the growth of their pipeline products are anticipated to drive market expansion.

KOL Views

To keep up with current and future market trends, we take Industry Experts' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on the LSD1 Inhibitors evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.

DelveInsight's analysts connected with 25+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the University of Texas MD Anderson Cancer Center, American Lung Association, Wings for Ewing Sarcoma, etc. were contacted.

Their opinion helps understand and validate LSD1 Inhibitor market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug.

In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Medicaid, the Children's Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services, and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Key Updates on LSD1 Inhibitors

• In June 2024, Salarius Pharmaceuticals announced that investigators at the University of Texas MD Anderson Cancer Center's Leukemia Department presented clinical data on seclidemstat in patients with MDS and CMML at the 2024 European Hematology Association (EHA) Hybrid Congress.
• In August 2024, Merck announced the initiation of Shorespan-007, a pivotal Phase III clinical trial evaluating bomedemstat, an investigational orally available lysine-specific demethylase 1 (LSD1) inhibitor, for the treatment of patients with essential thrombocythemia (ET) who have previously not received cytoreductive therapy.
• In January 2025, The Recursion announced that the US Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for a Phase I/II clinical trial of REC-4539, a potential best-in-class LSD1 inhibitor for small-cell lung cancer (SCLC) and other potential indications

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of the LSD1 inhibitors, explaining its mechanism, and emerging LSD1 inhibitors.
• Comprehensive insight into the competitive landscape, and forecasts, the future growth potential, drug uptake, and drug information have been provided.
• Additionally, an all-inclusive account of emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current landscape.
• A detailed review of the LSD1 Inhibitors market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis expert insights/KOL views, and treatment preferences that help shape and drive the 7MM LSD1 Inhibitor market.

LSD1 Inhibitor Report Insights

• LSD1 Inhibitor Targeted Patient Pool
• Therapeutic Approaches
• LSD1 Inhibitor Pipeline Analysis
• LSD1 Inhibitor Market Size and Trends
• Existing and future Market Opportunity

LSD1 Inhibitor Report Key Strengths

• Eleven years Forecast
• The 7MM Coverage
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

LSD1 Inhibitor Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint analysis)

Key Questions:

• What was the LSD1 Inhibitor total market size, the market size by therapies, market share (%) distribution, and what would it look like in 2034? What are the contributing factors for this growth?
• Which drug is going to be the largest contributor in 2034?
• Which is the most lucrative market for LSD1 inhibitors?
• What are the pricing variations among different geographies?
• What are the risks, burdens, and unmet needs of treatment for tumors harboring LSD1 inhibitors? What will be the growth opportunities across the 7MM for the patient population of LSD1 inhibitors?
• What are the key factors hampering the growth of the LSD1 Inhibitors market?
• What key designations have been granted to the therapies for LSD1 Inhibitor therapies?
• Patient acceptability in terms of preferred therapy options as per real-world scenarios?

Reasons to buy:

• The report will help develop business strategies by understanding the latest trends and changing dynamics driving the LSD1 Inhibitor market.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with expected sales of emerging products in the US, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of indication-wise current and emerging therapies under the conjoint analysis section to provide visibility around leading indications.
• Highlights of Access and Reimbursement policies, barriers to accessibility, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of LSD1 Inhibitors

4. Key Events

5. Market Forecast Methodology

6. LSD1 Inhibitors Market Overview at a Glance in the 7MM

• 6.1. Market Share (%) Distribution by Therapies in 2027
• 6.2. Market Share (%) Distribution by Therapies in 2034

7. LSD1 Inhibitors: Background and Overview

• 7.1. Introduction
• 7.2. Treatment

8. Target Patient Pool

• 8.1. Key Findings
• 8.2. Assumptions and Rationale: 7MM
• 8.3. Epidemiology Scenario in the 7MM
• 8.4. Total Cases in Selected Indications for LSD1 Inhibitors in the 7MM
• 8.5. Total Eligible Patient Pool for LSD1 Inhibitors in Selected Indications in the 7MM
• 8.6. Total Treated Cases in Selected Indications for LSD1 Inhibitors in the 7MM

9. Emerging Therapies

• 9.1. Key Competitors
• 9.2. Seclidemstat (SP-2577): Salarius Pharmaceuticals
  • 9.2.1. Product Description
  • 9.2.2. Other developmental activities
  • 9.2.3. Clinical development
  • 9.2.4. Safety and efficacy
• 9.3. Bomedemstat: Imago Biosciences/Merck (MSD)
  • 9.3.1. Product Description
  • 9.3.2. Other developmental activities
  • 9.3.3. Clinical development
  • 9.3.4. Safety and efficacy

10. LSD1 Inhibitor: Seven Major Market Analysis

• 10.1. Key Findings
• 10.2. Market Outlook
• 10.3. Conjoint Analysis
• 10.4. Key Market Forecast Assumptions
  • 10.4.1. Cost Assumptions and Rebates
  • 10.4.2. Pricing Trends
  • 10.4.3. Analogue Assessment
  • 10.4.4. Launch Year and Therapy Uptakes
• 10.5. Total Market Size of LSD1 Inhibitors in the 7MM
• 10.6. Market Size of LSD1 Inhibitors by Indication in the7MM
• 10.7. Market Size of LSD1 Inhibitors by Therapies in the7MM
• 10.8. The United States Market Size
  • 10.8.1. Market Size of LSD1 Inhibitors by Indication in the United States
  • 10.8.2. Market Size of LSD1 Inhibitors by Therapies in the United States
• 10.9. EU4 and the UK Market Size
  • 10.9.1. Market Size of LSD1 Inhibitors by Indication in EU4 and the UK
  • 10.9.2. Market Size of LSD1 Inhibitors by Therapies in EU4 and the UK
• 10.10. Japan Market Size
  • 10.10.1. Market Size of LSD1 Inhibitors by Indication in Japan
  • 10.10.2. Market Size of LSD1 Inhibitors by Therapies in Japan

11. Market Access and Reimbursement

12. SWOT Analysis

13. KOL Views

14. Unmet Needs

15. Appendix

• 15.1. Bibliography
• 15.2. Report Methodology

16. DelveInsight Capabilities

17. Disclaimer

18. About DelveInsight