허혈재관류 손상 시장 : 인사이트, 역학, 예측(-2034년)

Key Highlights:

• Ischemia-reperfusion injury (IRI) is defined as the paradoxical worsening of cellular dysfunction and death that occurs following the restoration of blood flow to previously ischemic tissues. Major causes of IRI include organ transplantation, recovery from cardiac arrest, and thrombolysis.
• Potential therapies for IRI include pharmacological treatments, ischemic preconditioning, and the use of medical gases or vitamin therapy, all of which may aid in developing effective strategies to mitigate IR injury.
• In November 2024, Faraday Pharmaceuticals announces completion of enrollment in Pivotal Phase III IOCYTE AMI-3 trial of FDY-5301.
• Data presented at ASN Kidney Week on October, 2024, in San Diego from the ATMIRe study a first-in-human, Phase I/IIa trial demonstrated that iCM012, used for ex-vivo treatment of preserved kidneys, showed a favorable safety and promising efficacy in mitigating IRI and preserving allograft function over a 12-month follow-up.
• There are currently no therapies specifically approved for IRI due to numerous obstacles including the injury's multifaceted nature, difficulty translating findings from animal studies, challenges in determining the optimal treatment timing, limited biomarker availability, patient variability, and complexities in designing clinical trials.
• The pipeline for treating IRI is robust, with emerging therapies such as FDY-5301 (Faraday Pharmaceuticals), Nelonemdaz (GNT Pharma), and iCM012 (iCoat Medical AB) currently in development to provide safe and effective treatment options.

DelveInsight's "IRI Market - Market Insight, Epidemiology and Market Forecast - 2034" report delivers an in-depth analysis of IRI epidemiology, market, and clinical development in IRI. In addition to this, the report provides historical and forecasted epidemiology and market data as well as a detailed analysis of the IRI market trends in the United States, EU4 (Germany, France, Italy, and Spain ), and the United Kingdom, and Japan.

The IRI market report provides real-world prescription pattern analysis, emerging drugs assessment, market share, and uptake/adoption pattern of individual therapies, as well as historical and forecasted IRI market size from 2020 to 2034 in 7MM. The report also covers current IRI treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's underlying potential.

Geography Covered:

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

Ischemia Reperfusion Injury Understanding and Treatment Algorithm

Ischemia Reperfusion Injury Overview and Diagnosis

IRI occurs when blood supply is restored to tissue after a period of ischemia, causing paradoxical tissue damage despite the return of oxygen and nutrients. The underlying mechanism involves mitochondrial dysfunction during ischemia, leading to ATP depletion, ion pump failure, cellular swelling, and metabolic acidosis. Upon reperfusion, a surge in reactive oxygen species (ROS) production occurs due to impaired antioxidant defenses, triggering oxidative stress, endothelial dysfunction, and a strong inflammatory response. This results in cell death through multiple pathways including apoptosis, necrosis, and autophagy, and can cause local tissue injury as well as systemic effects such as multiple organ dysfunction. IRI is a major concern in clinical conditions such as myocardial infarction, stroke, organ transplantation, and limb ischemia, presenting significant therapeutic challenges.

The diagnosis of IRI is primarily clinical, based on recent ischemic events followed by reperfusion, such as after revascularization procedures or organ transplantation. While no definitive biomarkers exist, laboratory tests may show elevated markers of tissue injury-such as creatine kinase or troponins in cases of myocardial involvement. Imaging modalities like MRI or CT can help assess tissue damage and rule out other complications. Diagnosis often depends on recognizing symptoms of reperfusion injury-such as pain, swelling, or organ dysfunction-and excluding other potential causes

Ischemia Reperfusion Injury Treatment

Treatment of IRI focuses on minimizing the duration of ischemia and carefully managing the reperfusion phase to reduce oxidative stress and inflammation. Supportive care includes maintaining oxygenation, controlling pain, and managing edema. Investigational therapies include ischemic and remote ischemic conditioning, antioxidants, and agents targeting molecular pathways involved in reactive oxygen species (ROS) production and cell death. Experimental models have also shown promise with hyperbaric oxygen therapy and pharmacological inhibitors of enzymes such as NADPH oxidase and xanthine oxidase.

Ischemia Reperfusion Injury Epidemiology

As the market is derived using a patient-based model, the IRI epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Incident Cases of Ischemia Reperfusion Injury in the 7MM, Organ-specific Incident Cases of Ischemia Reperfusion Injury in the 7MM, Age-specific Incident Cases of Ischemia Reperfusion Injury in the 7MM, Gender-specific Incident Cases of Ischemia Reperfusion Injury in the 7MM in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.

• The prevalence of reperfusion injury is directly proportional to the duration for which ischemia remains. It has been shown through studies that those receiving thrombolytic therapy within 1 hour had a 51% infarct size reduction compared to the 31% reduction seen in those receiving treatment after 1 to 2 hours.
• 55-60% of ischemic strokes affect women. In the US and Europe, women not only have a higher incidence of stroke but also experience more severe outcomes and higher mortality, particularly in older age groups.
• The condition occurs in about 15% of all lung transplant recipients and has a mortality rate in excess of 40%.
• According to the World Stroke Organization (WSO) (2022), ~58% of ischemic stroke occurs in people under 70 years of age.
• According to the European Medicines Agency, IRI associated with cardiac arrest is estimated to affect around 4 in 10,000 people, translating to approximately 205,000 individuals.

Ischemia Reperfusion Injury Drug Chapters

The drug chapter segment of the IRI report encloses a detailed analysis of IRI marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the IRI pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Emerging Drugs

FDY-5301: Faraday Pharmaceuticals

FDY-5301 is a formulation of sodium iodide designed to reduce IRI. It works by catalytically destroying hydrogen peroxide, which is naturally generated as a response to acute ischemia-reperfusion injury and contributes to loss of muscle mass and function. FDY-5301 reduce infarct size, improve cardiac function, and skeletal muscle function.

In November 2024, Faraday Pharmaceuticals announces completion of enrollment in Pivotal Phase III IOCYTE AMI-3 trial of FDY-5301.

Nelonemdaz: GNT Pharma

Nelonemdaz is a promising neuroprotective agent that has shown potential in reducing brain damage after stroke or cardiac arrest. It works through a multi-target mechanism of action, selectively inhibiting the NR2B subunit of the NMDA receptor and scavenging free radicals as an antioxidant. Unlike non-selective NMDA receptor inhibitors, nelonemdaz has demonstrated a favorable safety profile, not causing adverse effects such as psychoses in normal people and stroke patient.

Currently, the drug is in Phase III study of its clinical trial for the treatment of ischemia reperfusion injury.

Ischemia Reperfusion Injury Market Outlook

IRI is a critical condition that occurs when blood supply returns to tissue after a period of ischemia (restricted blood flow), leading to inflammation, oxidative stress, and cellular damage. It is a key contributor to poor outcomes in conditions such as myocardial infarction, stroke, organ transplantation, cardiac arrest, and major surgeries. Despite its widespread clinical relevance, there are currently no FDA-approved therapies specifically indicated for IRI, making it a high-priority area for therapeutic innovation. Current treatments are mainly supportive, aimed at restoring perfusion quickly and minimizing damage through general measures like anti-inflammatory agents, reperfusion strategies, or controlled hypothermia. However, these approaches do not directly counteract the molecular drivers of reperfusion injury, such as reactive oxygen species (ROS), mitochondrial dysfunction, and inflammatory cytokines.

Several emerging therapies are now being developed to address this gap. FDY-5301 by Faraday Pharmaceuticals is a promising investigational therapy designed to reduce myocardial injury by modulating oxidative stress in acute cardiac IRI. Nelonemdaz, developed by GNT Pharma, is a novel dual-action neuroprotective agent that combines antioxidant and NMDA receptor antagonism, and is currently in clinical development for stroke-related IRI. iCM012 from iCoat Medical AB is an endothelial-protective biologic targeting vascular inflammation and tissue damage during reperfusion, especially in surgical and organ transplant settings.

Ischemia Reperfusion Injury Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025-2034, which depends on the competitive landscape, safety, and efficacy data, along with the order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Ischemia Reperfusion Injury Pipeline Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II stages. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

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

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry Leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including Medical/Scientific Writers, Professors, and Others.

DelveInsight's analyst IRI connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as Wayne State University School of Medicine, and University of Michigan etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or IRI market trends.

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 evaluating the efficacy of treatments for IRI, both primary and secondary outcomes are assessed; primary endpoints typically include reduction in infarct size, improved tissue viability, and preserved organ function, while secondary outcomes may involve biomarkers of oxidative stress, inflammatory responses, and overall survival rates.

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 IRI 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, 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, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs IRI more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

• The report covers a segment of key events, an executive summary, descriptive overview of IRI, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts IRI, the future growth potential of diagnosis rate, and disease progression along treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the IRI 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 and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM IRI market.

Ischemia Reperfusion Injury Report Insights

• Patient Population
• Therapeutic Approaches
• IRI Pipeline Analysis
• IRI Market Size and Trends
• Existing and Future Market Opportunity

Ischemia Reperfusion Injury Report Key Strengths

• 10-Years Forecast
• 7MM Coverage
• IRI Epidemiology Segmentation
• Key Cross Competition
• Conjoint Analysis
• Drugs Uptake and Key Market Forecast Assumptions

Ischemia Reperfusion Injury Report Assessment

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

FAQs:

• What is the historical and forecasted IRI patient pool/patient burden in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Which combination treatment approaches will have a significant impact on the IRI drug treatment market size?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the current and emerging options for the treatment of IRI?
• How many companies are developing therapies for the treatment of IRI?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the IRI market.
• Insights on patient burden/disease Incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• 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 reported sales of approved 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 class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, 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. Epidemiology and Market Forecast Methodology

4. Ischemia Reperfusion Injury: Market Overview at a Glance

• 4.1. Market Size (%) of Ischemia Reperfusion Injury in 2020
• 4.2. Market Size (%) of Ischemia Reperfusion Injury in 2034

5. Executive Summary

6. Key Events

7. Disease Background and Overview: Ischemia Reperfusion Injury

• 7.1. Introduction
• 7.2. Causes
• 7.3. Pathophysiology
• 7.4. Symptoms
• 7.5. Risk Factor
• 7.6. Diagnosis

8. Treatment and Management

• 8.1. Treatment Guidelines

9. Epidemiology and Patient Population

• 9.1. Key Findings
• 9.2. Assumptions and Rationale
• 9.3. Total incident cases of Ischemia Reperfusion Injury:7MM
• 9.4. The United States
  • 9.4.1. Total Incident Cases of Ischemia Reperfusion Injury in the United States
  • 9.4.2. Organ-specific Incident Cases of Ischemia Reperfusion Injury in the United States
  • 9.4.3. Age-specific Incident Cases of Ischemia Reperfusion Injury in the United States
  • 9.4.5. Gender-specific Incident Cases of Ischemia Reperfusion Injury in the United States
• 9.5. EU4 and the UK
  • 9.5.1. Total Incident Cases of Ischemia Reperfusion Injury in EU4 and the UK
  • 9.5.2. Organ-specific Incident Cases of Ischemia Reperfusion Injury in EU4 and the UK
  • 9.5.3. Age-specific Incident Cases of Ischemia Reperfusion Injury in EU4 and the UK
  • 9.5.4. Gender-specific Incident Cases of Ischemia Reperfusion Injury in EU4 and the UK
• 9.6. Japan
  • 9.6.1. Total Incident cases of Ischemia Reperfusion Injury in Japan
  • 9.6.2. Organ-specific Incident Cases of Ischemia Reperfusion Injury in Japan
  • 9.6.3. Age-specific Incident Cases of Ischemia Reperfusion Injury in Japan
  • 9.6.4. Gender-specific Incident Cases of Ischemia Reperfusion Injury in Japan

10. Patient Journey

11. Emerging Therapies

• 11.1. Key Cross Competition
• 11.2. FDY-5301: Faraday Pharmaceuticals
  • 11.2.1. Product Description
  • 11.2.2. Other Development Activities
  • 11.2.3. Clinical Development Activities
  • 11.2.4. Safety and Efficacy
  • 11.2.5. Analyst View

12. Ischemia Reperfusion Injury: Market Size

• 12.1. Key Findings
• 12.2. Market Outlook
• 12.3. Conjoint Analysis
• 12.4. Key Market Forecast Assumptions
  • 12.4.1. Cost Assumptions and Rebates
  • 12.4.2. Pricing Trends
  • 12.4.3. Analogue Assessment
  • 12.4.4. Launch Year and Therapy Uptake
• 12.5. Total Ischemia Reperfusion Injury Market Analysis: 7MM
• 12.6. United States
  • 12.6.1. Total Market Size of Ischemia Reperfusion Injury in the United States
  • 12.6.2. Market Size of Ischemia Reperfusion Injury by Therapies in the United States
• 12.7. EU4 and the UK
  • 12.7.1. Total Market Size of Ischemia Reperfusion Injury in EU4 and the UK
  • 12.7.2. Market Size of Ischemia Reperfusion Injury by Therapies in EU4 and the UK
• 12.8. Japan
  • 12.8.1. Total Market Size of Ischemia Reperfusion Injury in Japan
  • 12.8.2. Market Size of Ischemia Reperfusion Injury by Therapies in Japan

13. Unmet Needs

14. SWOT Analysis

15. KOL Views

16. Market Access and Reimbursement

• 16.1. United States
• 16.2. EU4 and the UK
• 16.3. Japan

17. Appendix

• 17.1. Bibliography
• 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight