헤파린 유발 혈소판 감소증 시장 : 시장 인사이트, 역학 및 시장 예측(2034년)
Heparin-induced Thrombocytopenia - Market Insight, Epidemiology, and Market Forecast - 2034
상품코드 : 1705107
리서치사 : DelveInsight
발행일 : On Demand Report
페이지 정보 : 영문 200 Pages
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한글목차

주요 하이라이트

헤파린 유발 혈소판 감소증 보고서 개요

헤파린 유발성 혈소판 감소증은 일반적으로 사용되는 항응고제인 헤파린의 투여로 인해 발생하는 심각하고 생명을 위협할 수 있는 면역 매개성 부작용입니다. 헤파린 유발 혈소판 감소증은 헤파린 치료 시작 후 5-14일째에 혈소판 수가 급격히 감소하는 것이 특징입니다. 이는 주로 혈소판 4인자(PF4)와 헤파린의 복합체에 대한 항체 형성에 의해 발생합니다. 이러한 항체는 혈소판 활성화를 유도하여 혈전 촉진 상태와 정맥 및 동맥 혈전증 위험 증가를 초래합니다.

미분획 헤파린(UFH)과 저분자 헤파린(LMWH)의 두 가지 유형이 널리 사용되고 있으며, LMWH는 고분자 헤파린을 분획하여 얻은 단쇄 다당류로 구성되어 있습니다. 혈소판 응집 시간(aPTT)을 모니터링할 필요가 없고, 헤파린으로 인한 혈소판 감소증의 위험이 낮다는 점 등 여러 가지 면에서 차이가 있습니다. 또한, 헤파린의 항응고 효과는 황산 프로타민으로 가역적인 반면, LMWH의 효과는 제한적입니다.

헤파린 유발 혈소판 감소증의 신속하고 확실한 진단은 어렵고 가장 중요합니다. 헤파린 유발성 혈소판 감소증의 진단 기준은 다음과 같습니다:

일반적인 치료법으로는 직접 비경구용 트롬빈 억제제(알가트로반, 데시루딘, 비바리루딘)와 간접 비경구용 제 Xa인자 억제제(다나파로이드 또는 폰다팔리눅스)가 있습니다. 직접 경구용 항응고제(DOACs)는 최근 급성 헤파린 유발 혈소판 감소증과 혈전증을 동반한 헤파린 유발 혈소판 감소증에 대한 대안으로 떠오르고 있습니다. 추가 혈전증을 예방하는 것은 필수적입니다. 따라서 헤파린을 예방적 목적으로만 투여하더라도 환자는 일반적으로 다른 항응고제로 치료받게 됩니다.

와파린은 반감기가 짧은 단백질 C와 S를 억제하여 초기에는 응고항진 상태가 되므로 단기적으로는 사용하지 않는 것이 좋습니다. 헤파린 유발성 혈소판 감소증 진단 시 환자가 와파린을 복용하고 있다면 비타민 K를 통한 역치료가 권장됩니다. 직접 경구용 항응고제는 와파린에 비해 식이 제한이 적고 약물 상호 작용이 적으며 특별한 모니터링이 필요하지 않기 때문에 직접 경구용 항응고제는 와파린보다 더 간단한 치료 옵션으로 간주됩니다.

Veralox Therapeutics, Sandoz, Fresenius Kabi, Hikma Pharm 등 다양한 주요 기업들이 헤파린 유발 혈소판감소증 치료제 시장을 주도하고 있습니다. 국가별 및 치료제별 시장 규모는 다음과 같습니다.

세계 주요 7개국 헤파린 유발성 혈소판감소증 시장에 대해 조사했으며, 시장 개요, 역학, 환자 동향, 새로운 치료법, 2034년까지 시장 규모 예측, 미충족 의료 수요 등을 조사하여 전해드립니다.

목차

제1장 주요 인사이트

제2장 보고서 서론

제3장 헤파린 유발 혈소판 감소증(HIT) 시장 개요

제4장 헤파린 유발 혈소판 감소증(HIT) 주요 요약

제5장 주요 이벤트

제6장 질환 배경과 개요

제7장 헤파린 유발 혈소판 감소증 치료

제8장 조사 방법

제9장 헤파린 유발 혈소판 감소증 역학과 환자 인구

제10장 헤파린 유발 혈소판 감소증 환자 동향

제11장 헤파린 유발 혈소판 감소증 출시 약제

제12장 헤파린 유발 혈소판 감소증 새로운 치료법

제13장 헤파린 유발 혈소판 감소증(HIT) : 주요 7개국 시장 분석

제14장 KOL(Key Opinion Leader)의 견해

제15장 SWOT 분석

제16장 헤파린 유발 혈소판 감소증의 미충족 요구

제17장 시장 접근과 상환

제18장 부록

제19장 DelveInsight의 서비스 내용

제20장 면책사항

LSH
영문 목차

영문목차

Key Highlights:

Heparin-induced Thrombocytopenia Report Summary

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:

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.

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.

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 Report Key Strengths

Heparin-induced Thrombocytopenia Report Assessment

Key Questions for Heparin-induced Thrombocytopenia Market

Table of Contents

1. Key Insights

2. Report Introduction

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

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

5. Key Events

6. Disease Background and Overview

7. Treatment of Heparin-induced Thrombocytopenia

8. Methodology

9. Heparin-induced Thrombocytopenia Epidemiology and Patient Population

10. Heparin-induced Thrombocytopenia Patient Journey

11. Heparin-induced Thrombocytopenia Marketed Therapies

12. Heparin-induced Thrombocytopenia Emerging Therapies

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

14. KOL Views

15. SWOT Analysis

16. Heparin-induced Thrombocytopenia Unmet Needs

17. Market Access and Reimbursement

18. Appendix

19. DelveInsight Capabilities

20. Disclaimer

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