헤파린 유발 혈소판 감소증 시장 : 시장 인사이트, 역학 및 시장 예측(2034년)

Key Highlights:

• The heparin-induced thrombocytopenia market size in the 7MM is estimated to be around ~USD 128 million, in 2023.
• Heparin-induced thrombocytopenia is characterized by a rapid decrease in platelet count occurring 5-14 days after the initiation of heparin therapy. It is primarily caused by the formation of antibodies against platelet factor 4 (PF4) and heparin.
• The diagnosis of Heparin-induced thrombocytopenia is based on a combination of clinical assessment, laboratory tests, and the 4Ts scoring system. Laboratory tests include measuring platelet count, detecting anti-PF4/heparin antibodies, and functional assays to assess platelet activation.
• The management of Heparin-induced thrombocytopenia involves immediate discontinuation of all forms of heparin and initiation of alternative non-heparin anticoagulants, such as direct thrombin inhibitors (e.g., argatroban, bivalirudin) or factor Xa inhibitors (e.g., fondaparinux, danaparoid). Close monitoring of platelet counts, clinical signs of thrombosis, and bleeding complications is essential during the transition to non-heparin anticoagulation.
• In the 7MM, Argatroban accounted for the largest market share of ~USD 62 million in 2023.
• A single therapy, VLX-1005 (Veralox Therapeutics), is being investigated for treating Heparin-induced thrombocytopenia. In June 2022, VLX-1005 received fast track designation from the FDA, based on the positive Phase I results.
• In 2023, approximately 220,800 diagnosed incident cases of Heparin-induced thrombocytopenia were recorded. Among the 7MM, the United States holds the largest share of diagnosed incident cases, making up around 51% of the total cases.
• Among EU4 and the UK, Germany recorded highest incident cases of Heparin-induced thrombocytopenia, followed by France, contributing approximately 23% of the total incident cases.
• In 2023, the total incident cases of Heparin-induced thrombocytopenia in type-specific heparin exposure in the US were estimated to be ~107,000 and ~6,000 cases for unfractionated heparin (UFH) and low molecular-weight heparin (LMWH), respectively.

Heparin-induced Thrombocytopenia Report Summary

• The report offers extensive knowledge regarding the epidemiology segments and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
• Additionally, an all-inclusive account of the current management techniques and emerging therapies and the elaborative profiles of late-stage (Phase II) and prominent therapies that would impact the current treatment landscape and result in an overall market shift has been provided in the report.
• The report also encompasses a comprehensive analysis of the Heparin-induced thrombocytopenia market, providing an in-depth examination of its historical and projected market size (2020 - 2034). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The report also includes drug outreach coverage in the 7MM region.
• The report includes qualitative insights that provide an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, and treatment preferences that help shape and drive the 7MM Heparin-induced thrombocytopenia market.

Heparin-induced Thrombocytopenia Treatment Market

Heparin-induced Thrombocytopenia Overview

Heparin-induced thrombocytopenia is a severe and potentially life-threatening immune-mediated adverse reaction triggered by the administration of heparin, a commonly used anticoagulant medication. Heparin-induced thrombocytopenia is characterized by a rapid decrease in platelet count occurring 5-14 days after the initiation of heparin therapy. It is primarily caused by the formation of antibodies against the complex of platelet factor 4 (PF4) and heparin. These antibodies induce platelet activation, leading to a prothrombotic state and an increased venous and arterial thrombosis risk.

Two forms of heparin are widely used: unfractionated heparin (UFH) and low molecular weight heparin (LMWH). LMWH consists of only short chains of the polysaccharide, and is obtained by fractionation of polymeric heparin. LMWH differs from unfractionated heparin in a number of ways, including the need for only once or twice daily dosing; the absence of monitoring the activated partial thromboplastin time (aPTT); and the lower risk of Heparin-induced thrombocytopenia. In addition, the anticoagulant effect of heparin is reversible with protamine sulfate, whereas its effect on LMWH is limited.

Heparin-induced Thrombocytopenia Diagnosis

Making a rapid and confirmed diagnosis of Heparin-induced thrombocytopenia is challenging and of utmost importance. The criteria for diagnosis of Heparin-induced thrombocytopenia include:

• Normal platelet count before the commencement of heparin
• Thrombocytopenia is defined as a drop in platelet count by 30% to <100 X 109/L or a drop of >50% from the patient's baseline platelet count
• The onset of thrombocytopenia typically 5-10 days after initiation of heparin treatment, which can occur earlier with previous heparin exposure (within 100 days)
• Acute thrombotic event
• The exclusion of other causes of thrombocytopenia
• The resolution of thrombocytopenia after cessation of heparin
• Heparin-induced thrombocytopenia antibody seroconversion.

Heparin-induced Thrombocytopenia Treatment

Common treatment modalities include direct parenteral thrombin inhibitors (argatroban, Desirudin, or bivalirudin) and indirect parenteral factor Xa inhibitors (danaparoid or fondaparinux). Direct oral anticoagulants (DOACs) are recently emerging as an alternative in acute Heparin-induced thrombocytopenia or Heparin-induced thrombocytopenia with thrombosis. It is essential to prevent additional thrombosis. Therefore, patients are usually treated with an alternative anticoagulant, even if heparin was given only as a prophylactic measure.

Warfarin is avoided in the short term due to its initial hypercoagulable state via inhibition of proteins C and S, which have short half-lives. If the patient was on warfarin during Heparin-induced thrombocytopenia diagnosis, reversal with vitamin K is recommended. Compared with warfarin, direct oral anticoagulants have fewer dietary restrictions, a lower number of drug-drug interactions, and do not require specific monitoring; thus, direct oral anticoagulants are considered a more convenient treatment option than warfarin.

Heparin-induced Thrombocytopenia Market

Various key players are leading the treatment landscape of Heparin-induced thrombocytopenia, such as like Veralox Therapeutics, Sandoz, Fresenius Kabi, Hikma Pharm and others. The details of the country-wise and therapy-wise market size have been provided below.

• The market of heparin-induced thrombocytopenia in the 7MM is estimated to be around ~USD 128 million, in 2023.
• The United States comprised roughly 50% of the overall market within the 7MM
• In 2023, among the EU4 and the UK, Germany held the largest market share, comprising approximately 40% of the total market size.
• In 2023, Japan contributed approximately ~USD 3 million to the market size, with expectations of steady growth projected until 2034.

Heparin-induced Thrombocytopenia Drug Chapters

The section dedicated to drugs in the Heparin-induced thrombocytopenia report provides an in-depth evaluation of late-stage pipeline drugs (Phase II) related to Heparin-induced thrombocytopenia.

The drug chapters section provides valuable information on various aspects related to clinical trials of Heparin-induced thrombocytopenia, such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. Furthermore, it presents the most recent news updates and press releases on drugs targeting Heparin-induced thrombocytopenia

Heparin-induced Thrombocytopenia Marketed Therapies

ANGIOMAX (bivalirudin): Sandoz

Bivalirudin is an inhibitor of thrombin, an essential factor within the coagulation cascade crucial to thrombus formation, and is used as an anticoagulant. Bivalirudin reversibly binds thrombin, free as well as clot bound, at the catalytic site and the anion-binding exosite, thereby preventing the formation and activation of fibrin, Factor XIIIa, and other coagulation factors. Administered intravenously, Bivalirudin is indicated for use in patients undergoing percutaneous coronary intervention (PCI), including patients with Heparin-induced thrombocytopenia or heparin-induced thrombocytopenia and thrombosis syndrome (Heparin-induced thrombocytopeniaTS). Its short duration of effect makes it convenient for those with bleeding risks or undergoing additional procedural interventions and needing a rapid cessation of drug effect.

Argatroban: Sandoz/Fresenius Kabi/Hikma Pharm

Argatroban, a small molecule, is a synthetic direct thrombin inhibitor. It is an anticoagulant in individuals with thrombosis and heparin-induced thrombocytopenia. It reversibly binds to the catalytic site of thrombin and directly and reversibly blocks its ability to activate clotting Factors V, VIII, and XII. Argatroban is given intravenously, metabolized in the liver, and has a half-life of about 50 min. Because of its hepatic metabolism, it may be used in patients with renal dysfunction.

Heparin-induced Thrombocytopenia Emerging Therapies

VLX-1005: Veralox Therapeutics

VLX-1005 is a first-in-class and selective small molecule inhibitor 12-lipoxygenase, a key target within the arachidonic acid pathway. It blocks the 12-LOX pathway responsible for platelet activation in Heparin-induced thrombocytopenia. It is administered through the IV and oral route; preclinical data has demonstrated that VLX-1005 halts the immune-driven platelet activation and thrombosis, thus offering the potential of lifesaving treatment for patients with Heparin-induced thrombocytopenia.

This drug is being studied in a Phase II (NCT05785819) trial to evaluate its efficacy and safety in treating Heparin-induced thrombocytopenia.

In June 2023, Veralox Therapeutics announced the appointment of Jonathan Mow as the company's new chief executive officer. Mr. Mow's appointment came as Veralox secured USD 24 million in funding to advance VLX-1005 through a Phase IIa proof-of-concept study evaluating its impact on Heparin-induced thrombocytopenia.

Heparin-induced Thrombocytopenia Market Outlook

The primary treatment approach involves discontinuing unfractionated heparin (UFH) or low molecular-weight heparin (LMWH) in patients suspected of or diagnosed with Heparin-induced thrombocytopenia, and initiating therapy with an alternative anticoagulant. LMWH is not an appropriate alternative if Heparin-induced thrombocytopenia develops during treatment with UFH because of cross-reactivity. Argatroban and bivalirudin are both non-cross reacting. Danaparoid demonstrates cross reactivity, which is rarely observed in vivo while fondaparinux is highly immunogenic but is not well recognized by anti-fondaparinux-PF4 antibodies generated during exposure, suggesting that it should be associated with a low risk of developing Heparin-induced thrombocytopenia. Warfarin, especially when used in isolation, can increase the risk of microvascular thrombosis in Heparin-induced thrombocytopenia and its introduction should be delayed until there has been substantial resolution of the thrombocytopenia.

Several novel oral anticoagulants also exist (e.g. rivaroxaban,dabigatran,apixaban), and preliminary evidence suggests that they may be beneficial for Heparin-induced thrombocytopenia, particularly in cases refractory to standard therapies. However, these agents have not been fully assessed for treatment of patients with Heparin-induced thrombocytopenia and none have FDA approval for use in Heparin-induced thrombocytopenia

In conclusion, despite the lack of appropriate treatment in the current treatment landscape, many potential therapies with novel mechanisms are expected to enter the market, resolving a dire unmet need and leading to significant improvement in the treatment outcome of Heparin-induced thrombocytopenia patients. Hence, with the upcoming availability of new treatment options and increasing healthcare spending across the 7MM, the treatment scenario is expected to experience significant growth during the forecast period (2024-2034).

Heparin-induced Thrombocytopenia Epidemiology

The Heparin-induced thrombocytopenia epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Incident Cases, type-specific Cases, Age-specific Cases, total cases of Heparin-induced thrombocytopenia in the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034.

• In 2023, the total incident cases of Heparin Induced Thrombocytopenia (Heparin-induced thrombocytopenia) in type-specific heparin exposure in the US were estimated to be ~107,000 and ~6,000 cases for UFW and LMWH.
• In 2023, Germany accounted for approximately 38% of the total incident Heparin-induced thrombocytopenia cases, among EU4 and the UK.
• In 2023, there were ~1,500, ~27,800, and ~84,000 cases of Heparin Induced Thrombocytopenia (Heparin-induced thrombocytopenia) in the US, in 19 years and below, 20 years to 59 years and 60 years and above, respectively.
• In 2023, there were total ~7,700 incident cases of Heparin Induced Thrombocytopenia (Heparin-induced thrombocytopenia), in Japan.

KOL Views

To stay abreast of the latest trends in the market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.

We have reached out to industry experts to gather insights on various aspects of Heparin-induced thrombocytopenia, including the evolving treatment landscape, patients' reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts we contacted included medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan.

Our team of analysts at Delveinsight connected with more than 15 KOLs across the 7MM. We contacted institutions such as the Division of Hematology and Laboratory of Hematology, Department of Clinical Laboratory Medicine, Stanford University School of Medicine, etc., among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the Heparin-induced thrombocytopenia market, which will assist our clients in analyzing the overall epidemiology and market scenario.

Heparin-induced Thrombocytopenia 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 disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

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

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 route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, a final weightage score is decided, based on which the emerging therapies are ranked.

Heparin-induced Thrombocytopenia Market Access and Reimbursement

Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.

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

Heparin-induced Thrombocytopenia Report Insights

• Heparin-induced Thrombocytopenia Patient Population
• Heparin-induced Thrombocytopenia Therapeutic Approaches
• Heparin-induced thrombocytopenia Market Size and Trends
• Existing Market Opportunity

Heparin-induced Thrombocytopenia Report Key Strengths

• Eleven -year Forecast
• The 7MM Coverage
• Heparin-induced thrombocytopenia Epidemiology Segmentation
• Key Cross Competition

Heparin-induced Thrombocytopenia Report Assessment

• Current Heparin-induced Thrombocytopenia Treatment Practices
• Reimbursements
• Heparin-induced Thrombocytopenia Market Attractiveness
• Qualitative Analysis (SWOT, Unmet needs)
• Heparin-induced Thrombocytopenia Market Drivers
• Heparin-induced Thrombocytopenia Market Barriers

Key Questions for Heparin-induced Thrombocytopenia Market

• Would there be any changes observed in the current treatment approach?
• Will there be any improvements in Heparin-induced thrombocytopenia management recommendations?
• Would research and development advances pave the way for future tests and therapies for Heparin-induced thrombocytopenia?
• Would the diagnostic testing space experience a significant impact and lead to a positive shift in the treatment landscape of Heparin-induced thrombocytopenia?
• What kind of uptake will the new therapies witness in coming years in Heparin-induced thrombocytopenia patients?

Table of Contents

1. Key Insights

2. Report Introduction

3. Heparin-induced Thrombocytopenia (HIT) Market Overview at a Glance

• 3.1. Market Share (%) Distribution of Heparin-induced Thrombocytopenia (HIT) by Countries in 2020
• 3.2. Market Share (%) Distribution of Heparin-induced Thrombocytopenia (HIT) by Countries in 2034
• 3.3. Market Share (%) Distribution of Heparin-induced Thrombocytopenia (HIT) by Therapies in 2020
• 3.4. Market Share (%) Distribution of Heparin-induced Thrombocytopenia (HIT) by Therapies in 2034

4. Executive Summary of Heparin-induced Thrombocytopenia (HIT)

5. Key Events

6. Disease Background and Overview

• 6.1. Heparin as a Medication and Different Forms of Heparin
• 6.2. Types of HIT
  • 6.2.1. HIT Type I
  • 6.2.2. HIT Type II
• 6.3. Signs and Symptoms
• 6.4. Risk Factors
• 6.5. Pathophysiology of Heparin-induced Thrombocytopenia (HIT)
  • 6.5.1. Antigen Formation: Platelet Factor 4-Heparin (PF4/H) Complexes
  • 6.5.2. Anti-PF4/H Antibodies Synthesis
  • 6.5.3. Antigen Formation on the Platelet Surface and Platelet Activation
  • 6.5.4. Other Cells Beyond Platelets Involved in HIT Prothrombotic State
• 6.6. Clinical Presentation and Complications of Heparin-induced Thrombocytopenia
• 6.7. Diagnosis of Heparin-induced Thrombocytopenia
  • 6.7.1. Clinical Diagnosis
  • 6.7.2. Laboratory Diagnosis
  • 6.7.3. Differential Diagnosis
  • 6.7.4. Diagnostic Algorithm
• 6.8. Diagnostic Guidelines
  • 6.8.1. Guidelines on the Diagnosis of HIT: Second Edition

7. Treatment of Heparin-induced Thrombocytopenia

• 7.1. Alternative Anticoagulation
  • 7.1.1. Argatroban
  • 7.1.2. Bivalirudin
  • 7.1.3. Desirudin
  • 7.1.4. Fondaparinux
  • 7.1.5. Danaparoid
  • 7.1.6. Direct Oral Anticoagulants
  • 7.1.7. Vitamin K Antagonists
• 7.2. Alternatives and Adjuvants to Coagulation
  • 7.2.1. Therapeutic Plasmapheresis (TPE)
  • 7.2.2. Intravenous Immunoglobulin (IVIG)
• 7.3. Treatment Guidelines
  • 7.3.1. American Society of Hematology Guidelines for Management of Venous Thromboembolism: Heparin-induced Thrombocytopenia
  • 7.3.2. Guidelines on the Diagnosis and Management of Heparin-induced Thrombocytopenia: Second Edition
  • 7.3.3. American College of Chest Physicians Evidence-based Clinical Practice Guidelines on Treatment and Prevention of Heparin-induced Thrombocytopenia
  • 7.3.4. Japanese Journal of Thrombosis and Hemostasis: Diagnosis and Treatment Guidelines for Heparin-induced Thrombocytopenia

8. Methodology

9. Heparin-induced Thrombocytopenia Epidemiology and Patient Population

• 9.1. Key Findings
• 9.2. Assumptions and Rationale
• 9.3. Total Incident Cases of Heparin-induced Thrombocytopenia (HIT) in the 7MM
• 9.4. The United States
  • 9.4.1. Total Incident Cases of Heparin-induced Thrombocytopenia (HIT) in the United States
  • 9.4.2. Total Incident Cases of Heparin-induced Thrombocytopenia (HIT) in Type-specific Heparin Exposure in the United States
  • 9.4.3. Age-Specific Cases of Heparin-induced Thrombocytopenia (HIT) in the United States
  • 9.4.4. Total Cases of Thrombosis in Heparin-induced Thrombocytopenia (HIT) in the United States
• 9.5. EU4 and the UK
  • 9.5.1. Total Incident Cases of Heparin-induced Thrombocytopenia (HIT) in EU4 and the UK
  • 9.5.2. Total Incident Cases of Heparin-induced Thrombocytopenia (HIT) in Type-specific Heparin Exposure in EU4 and the UK
  • 9.5.3. Age-specific Cases of Heparin-induced Thrombocytopenia (HIT) in EU4 and the UK
  • 9.5.4. Total Cases of Thrombosis in Heparin-induced Thrombocytopenia (HIT) in EU4 and the UK
• 9.6. Japan
  • 9.6.1. Total Incident Cases of Heparin-induced Thrombocytopenia (HIT) in Japan
  • 9.6.2. Total Incident Cases of Heparin-induced Thrombocytopenia (HIT) in Type-specific Heparin Exposure in Japan
  • 9.6.3. Age-specific Cases of Heparin-induced Thrombocytopenia (HIT) in Japan
  • 9.6.4. Total Cases of Thrombosis in Heparin-induced Thrombocytopenia (HIT) in Japan

10. Heparin-induced Thrombocytopenia Patient Journey

11. Heparin-induced Thrombocytopenia Marketed Therapies

• 11.1. ANGIOMAX (bivalirudin): Sandoz
  • 11.1.1. Product Description
  • 11.1.2. Regulatory Milestones
  • 11.1.3. Other Developmental Activities
  • 11.1.4. Safety and Efficacy
• 11.2. Argatroban: Sandoz/Fresenius Kabi/Hikma Pharm
  • 11.2.1. Product Description
  • 11.2.2. Regulatory Milestones
  • 11.2.3. Safety and Efficacy

12. Heparin-induced Thrombocytopenia Emerging Therapies

• 12.1. Key Cross Competition: Emerging Therapies
• 12.2. VLX-1005: Veralox Therapeutics
  • 12.2.1. Product Description
  • 12.2.2. Other Developmental Activities
  • 12.2.3. Clinical Developmental Activities

13. Heparin-induced Thrombocytopenia (HIT): Seven Major Market Analysis

• 13.1. Key Findings
• 13.2. Market Outlook
• 13.3. Key Market Forecast Assumptions
• 13.4. Key Market Forecast Assumptions
• 13.5. Total Market Size of Heparin-induced Thrombocytopenia (HIT) in the 7MM
• 13.6. Market Size of Heparin-induced Thrombocytopenia (HIT) by Therapies in the 7MM
• 13.7. United States Market Size
  • 13.7.1. Total Market Size of Heparin-induced Thrombocytopenia (HIT) in the United States
  • 13.7.2. Market Size of Heparin-induced Thrombocytopenia (HIT) by Therapies in the United States
• 13.8. EU4 and the UK
  • 13.8.1. Total Market Size of Heparin-induced Thrombocytopenia (HIT) in EU4 and the UK
  • 13.8.2. Market Size of Heparin-induced Thrombocytopenia (HIT) by Therapies in EU4 and the UK
• 13.9. Japan Market Size
  • 13.9.1. Total Market Size of Heparin-induced Thrombocytopenia (HIT) in Japan
  • 13.9.2. Market Size of Heparin-induced Thrombocytopenia (HIT) by Therapies in Japan

14. KOL Views

15. SWOT Analysis

16. Heparin-induced Thrombocytopenia Unmet Needs

17. Market Access and Reimbursement

• 17.1. The United States
  • 17.1.1. Centre for Medicare and Medicaid Services (CMS)
• 17.2. EU4 and the UK
  • 17.2.1. Germany
  • 17.2.2. France
  • 17.2.3. Italy
  • 17.2.4. Spain
  • 17.2.5. The United Kingdom
• 17.3. Japan
  • 17.3.1. MHLW

18. Appendix

• 18.1. Bibliography
• 18.2. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer