ヘパリン起因性血小板減少症市場 - 市場の洞察、疫学、市場予測：2034年

主なハイライト

• ヘパリン起因性血小板減少症の市場規模は、2023年に1億2,800万米ドル程度になると推定されます。
• ヘパリン起因性血小板減少症は、ヘパリン治療開始後5～14日目に起こる血小板数の急激な減少を特徴とします。これは主に血小板第4因子（PF4）とヘパリンに対する抗体の形成別引き起こされます。
• ヘパリン起因性血小板減少症の診断は、臨床評価、臨床検査、4Tsスコアリングシステムの組み合わせに基づいて行われます。臨床検査には、血小板数の測定、抗PF4/ヘパリン抗体の検出、血小板活性化を評価する機能的アッセイなどが含まれます。
• ヘパリン起因性血小板減少症の管理には、すべての形態のヘパリンを直ちに中止し、直接トロンビン阻害薬（例えば、アルガトロバン、ビバリルジン）または第Xa因子阻害薬（例えば、フォンダパリヌクス、ダナパロイド）などの代替非ヘパリン抗凝固薬の投与を開始することが必要です。非ヘパリン系抗凝固療法への移行中は、血小板数、血栓症の臨床症状、出血性合併症の綿密なモニタリングが不可欠です。
• 主要7ヶ国では、アルガトロバンが2023年に6,200万米ドルの最大市場シェアを占めました。
• ヘパリン起因性血小板減少症の治療には、単一療法であるVLX-1005（Veralox Therapeutics）が研究されています。2022年6月、VLX-1005は良好な第I相試験結果に基づき、FDAからファスト・トラック指定を受けました。
• 2023年には、ヘパリン起因性血小板減少症の診断された偶発症例が約22万800例記録されました。主要7ヶ国中、米国が診断された症例数で最大のシェアを占め、全体の約51％を占めています。
• EU4ヶ国および英国では、ドイツがヘパリン起因性血小板減少症の症例数で最も多く、次いでフランスが症例数全体の約23％を占めています。
• 2023年、米国におけるヘパリン曝露タイプ別におけるヘパリン起因性血小板減少症の総症例は、未分画ヘパリン（UFH）で～107,000例、低分子量ヘパリン（LMWH）で～6,000例と推定されました。

ヘパリン起因性血小板減少症レポートサマリー

• 当レポートは、疫学セグメントと予測に関する広範な知識を提供し、診断率、疾患の進行、治療ガイドラインにおける将来の潜在的な成長について深い理解を示します。これらの側面に関する包括的な洞察を提供し、主題の徹底的な評価を可能にします。
• さらに、現在の管理技術や新たな治療法に関する包括的な説明や、現在の治療状況に影響を与え、全体的な市場シフトをもたらすであろう後期（第II相）および著名な治療法の詳細なプロファイルが報告書に記載されています。
• また、ヘパリン起因性血小板減少症市場の包括的な分析を網羅し、その市場規模（2020年～2034年）の過去および予測について詳細な検証を行っています。また、治療薬の市場シェア、詳細な前提条件、調査手法の根拠も記載しています。また、主要7ヶ国地域における薬剤のアウトリーチも掲載しています。
• 本レポートには、SWOT分析、様々な病院や著名大学の専門家を含む専門家の洞察/KOLの見解、患者の旅、主要7ヶ国ヘパリン起因性血小板減少症市場の形成と推進に役立つ治療嗜好などの動向を理解することで、事業戦略を策定する際に強みとなる定性的洞察が含まれています。

ヘパリン起因性血小板減少症は、一般的に使用される抗凝固薬であるヘパリンの投与によって引き起こされる、重篤で生命を脅かす可能性のある免疫介在性の有害反応です。ヘパリン起因性血小板減少症は、ヘパリン治療開始後5～14日目に起こる血小板数の急激な減少を特徴とします。これは主に血小板第4因子（PF4）とヘパリンの複合体に対する抗体の形成によって引き起こされます。これらの抗体は血小板の活性化を誘導し、血栓促進状態と静脈および動脈血栓症リスクの上昇をもたらします。

ヘパリンには未分画ヘパリン（UFH）と低分子ヘパリン（LMWH）の2種類が広く使用されています。LMWHは多糖の短鎖のみからなり、高分子ヘパリンの分画によって得られます。LMWHは未分画ヘパリンと異なり、1日1～2回の投与で済むこと、活性化部分トロンボプラスチン時間（aPTT）をモニターする必要がないこと、ヘパリン起因性血小板減少症のリスクが低いことなど、多くの点で異なります。さらに、ヘパリンの抗凝固作用は硫酸プロタミンで可逆的であるのに対し、LMWHの効果は限定的です。

ヘパリン起因性血小板減少症の迅速かつ確実な診断は、困難であり、最も重要です。ヘパリン起因性血小板減少症の診断基準は以下の通りです：

• ヘパリン投与開始前の血小板数が正常
• こと血小板減少症とは、血小板数が30％減少して100X 109/L
• 未満になった場合、あるいはベースラインの血小板数から50％以上減少した場合
• 血小板減少の他の原因の除外
• ヘパリン投与中止後の血小板減少の消失
• ヘパリン誘発性血小板減少抗体血清転換

一般的な治療法としては、直接非経口トロンビン阻害薬（アルガトロバン、デシルジン、またはビバリルジン）および間接非経口第Xa因子阻害薬（ダナパロイドまたはフォンダパリヌクス）があります。直接経口抗凝固薬（DOACs）は、急性ヘパリン起因性血小板減少症や血栓症を伴うヘパリン起因性血小板減少症における代替薬として最近台頭してきています。さらなる血栓症を予防することは不可欠です。そのため，たとえヘパリンが予防的措置としてのみ投与されたとしても，患者は通常，別の抗凝固薬で治療されます。

ワルファリンは、半減期の短いプロテインCとSを阻害することにより、初期に凝固亢進状態になるため、短期的には使用しない方がよいとされています。ヘパリン起因性血小板減少症の診断時に患者がワルファリンを服用していた場合は、ビタミンKによる逆治療が推奨されます。ワルファリンと比較して、直接経口抗凝固薬は食事制限が少なく、薬物-薬物相互作用の数も少なく、特別なモニタリングを必要としないため、直接経口抗凝固薬はワルファリンよりも簡便な治療選択肢と考えられています。

Veralox Therapeutics、Sandoz、Fresenius Kabi、Hikma Pharmなど、様々な主要企業がヘパリン起因性血小板減少症の治療状況をリードしています。国別および治療法別の市場規模の詳細は以下の通りです。

• 主要7ヶ国のヘパリン起因性血小板減少症市場は、2023年には約1億2,800万米ドルになると推定されます。
• 米国は主要7ヶ国の市場全体の約50%を占めています。
• 2023年には、EU4ヶ国と英国の中でドイツが最大の市場シェアを占め、市場全体の約40%を占めました。
• 2023年、日本は市場規模に約300万米ドル寄与し、2034年まで安定した成長が予測されます。

当レポートでは、主要7ヶ国におけるヘパリン起因性血小板減少症市場について調査し、市場の概要とともに、疫学、患者動向、新たな治療法、2034年までの市場規模予測、および医療のアンメットニーズなどを提供しています。

目次

第1章 重要な洞察

第2章 報告書のイントロダクション

第3章 ヘパリン起因性血小板減少症（HIT）市場概要

• 2020年のヘパリン起因性血小板減少症（HIT）の国別市場シェア（％）
• 2034年のヘパリン起因性血小板減少症（HIT）の国別市場シェア（％）
• 2020年のヘパリン起因性血小板減少症（HIT）の治療法別市場シェア（％）
• 2034年のヘパリン起因性血小板減少症（HIT）の治療法別市場シェア（％）

第4章 ヘパリン起因性血小板減少症（HIT）のエグゼクティブサマリー

第5章 主要なイベント

第6章 疾患の背景と概要

• 医薬品としてのヘパリンとヘパリンの様々な形態
• HITのタイプ
• 兆候と症状
• リスク要因
• ヘパリン起因性血小板減少症（HIT）の病態生理学
• ヘパリン起因性血小板減少症の臨床症状と合併症
• ヘパリン起因性血小板減少症の診断
• 診断ガイドライン

第7章 ヘパリン起因性血小板減少症の治療

• 代替抗凝固療法
• 凝固療法の代替療法および補助療法
• 治療ガイドライン

第8章 調査手法

第9章 ヘパリン起因性血小板減少症の疫学と患者人口

• 主な調査結果
• 仮定と根拠
• 主要7ヶ国におけるヘパリン起因性血小板減少症（HIT）の総発症例数
• 米国
• EU4ヶ国と英国
• 日本

第10章 ヘパリン起因性血小板減少症の患者動向

第11章 ヘパリン起因性血小板減少症の上市済み薬剤

• ANGIOMAX（ビバリルジン）：Sandoz
• アルガトロバン：Sandoz/Fresenius Kabi/Hikma Pharm

第12章 ヘパリン起因性血小板減少症の新たな治療法

• 主要なクロス競合：新興治療法
• VLX-1005：Veralox Therapeutics

第13章 ヘパリン起因性血小板減少症（HIT）：主要7ヶ国市場分析

• 主な調査結果
• 市場見通し
• 主要な市場予測の前提条件
• 主要な市場予測の前提条件
• 主要7ヶ国におけるヘパリン起因性血小板減少症（HIT）の総市場規模
• 主要7ヶ国におけるヘパリン起因性血小板減少症（HIT）の市場規模（治療法別）
• 米国市場規模
• EU4ヶ国と英国
• 日本市場規模

第14章 KOLの見解

第15章 SWOT分析

第16章 ヘパリン起因性血小板減少症のアンメットニーズ

第17章 市場アクセスと償還

• 米国
• EU4ヶ国と英国
• 日本

第18章 付録

第19章 DelveInsightのサービス内容

第20章 免責事項

List of Tables

• Table 1: Summary of Heparin-induced Thrombocytopenia, Market, and Epidemiology (2020-2034)
• Table 2: Key Events
• Table 3: Types of Heparin-induced Thrombocytopenia
• Table 4: Clinical Manifestations of Heparin-induced Thrombocytopenia
• Table 5: The 4Ts Score: Estimating the Pretest Probability of Heparin-induced Thrombocytopenia
• Table 6: Total Incident Cases of Heparin-induced Thrombocytopenia (HIT) in the 7MM (2020-2034)
• Table 7: Total Incident Cases of Heparin-induced Thrombocytopenia (HIT) in the United States (2020-2034)
• Table 8: Total Incident Cases of Heparin-induced Thrombocytopenia (HIT) in Type-specific Heparin Exposure in the United States (2019 -2032)
• Table 9: Age-Specific Cases of Heparin-induced Thrombocytopenia (HIT) in the United States (2020-2034)
• Table 10: Total Cases of Thrombosis in Heparin Induced Thrombocytopenia (HIT) in the United States (2020-2034)
• Table 11: Total Incident Cases of Heparin-induced Thrombocytopenia (HIT) in EU4 and the UK (2020-2034)
• Table 12: Total Incident Cases of Heparin-induced Thrombocytopenia (HIT) in Type-specific Heparin Exposure in EU4 and the UK (2020-2034)
• Table 13: Age-specific Cases of Heparin-induced Thrombocytopenia (HIT) in Type-specific Heparin Exposure in EU4 and the UK (2020-2034)
• Table 14: Total Cases of Thrombosis in Heparin-induced Thrombocytopenia (HIT) in EU4 and the UK (2020-2034)
• Table 15: Total Incident Cases of Heparin-induced thrombocytopenia (HIT) in Japan (2020-2034)
• Table 16: Total Incident Cases of Heparin-induced Thrombocytopenia (HIT) in Type-specific Heparin exposure in Japan (2020-2034)
• Table 17: Age-specific Cases of Heparin Induced Thrombocytopenia (HIT) in Japan (2020-2034)
• Table 18: Total Cases of Thrombosis in Heparin Induced Thrombocytopenia (HIT) in Japan (2019- 2032)
• Table 19: Approved Generic Version of ANGIOMAX (Bivalirudin - Injectable; IV)
• Table 20: Incidences of in-hospital Endpoints in BAT Trial
• Table 21: Approved Generic Version of Argatroban
• Table 22: Efficacy Results of Study 1
• Table 23: Key cross competition - Emerging Therapies
• Table 24: VLX-1005, Clinical Trial Description, 2023
• Table 25: Key Market Forecast Assumptions for VLX-1005
• Table 26: Total Market Size of Heparin-induced Thrombocytopenia (HIT) in the 7MM in USD million (2020-2034)
• Table 27: Market Size of Heparin-induced Thrombocytopenia (HIT) by Therapies in the 7MM in USD million (2020-2034)
• Table 28: Total Market Size of Heparin-induced Thrombocytopenia (HIT) in the United States in USD million (2020-2034)
• Table 29: Market Size of Heparin-induced Thrombocytopenia (HIT) by Therapies in the United States in USD million (2020-2034)
• Table 30: Total Market Size of Heparin-induced Thrombocytopenia (HIT) in EU4 and the UK in USD million (2020-2034)
• Table 31: Market Size of Heparin-induced Thrombocytopenia (HIT) by Therapies in EU4 and the UK in USD million (2020-2034)
• Table 32: Total Market Size of Heparin-induced Thrombocytopenia (HIT) in Japan in USD million (2020-2034)
• Table 33: Market Size of Heparin-induced Thrombocytopenia (HIT) by Therapies in Japan in USD million (2020-2034)

The list of tables is not exhaustive; a detailed list of tables will be provided in the final report...

List of Figures

• Figure 1: Signs and Symptoms of HIT
• Figure 2: Mechanism
• Figure 3: Pathophysiology of Heparin-induced Thrombocytopenia
• Figure 4: Diagnostic Algorithm for Heparin-induced Thrombocytopenia
• Figure 5: Comparison of Some Alternative Parenteral Non-heparin Anticoagulants
• Figure 6: Comparison of Alternative Treatment Options
• Figure 7: Total Incident cases of Heparin-induced Thrombocytopenia (HIT) in the 7MM (2020-2034)
• Figure 8: Total Incident Cases of Heparin-induced Thrombocytopenia (HIT) in the United States (2020-2034)
• Figure 9: Total Incident Cases of Heparin-induced Thrombocytopenia (HIT) in Type-Specific Heparin exposure in the United States
• Figure 10: Age-Specific Cases of Heparin-induced Thrombocytopenia (HIT) in the United States (2020-2034)
• Figure 11: Total Cases of Thrombosis in Heparin Induced Thrombocytopenia (HIT) in the United States (2020-2034)
• Figure 12: Total Incident Cases of Heparin-induced Thrombocytopenia (HIT) in EU4 and the UK (2020-2034)
• Figure 13: Total Incident Cases of Heparin-induced Thrombocytopenia (HIT) in Type-specific Heparin Exposure in EU4 and the UK
• Figure 14: Age-Specific Cases of Heparin-induced Thrombocytopenia (HIT) in EU4 and the UK (2020-2034)
• Figure 15: Total Cases of Thrombosis in Heparin-induced Thrombocytopenia (HIT) in EU4 and the UK (2020-2034)
• Figure 16: Total Incident cases of Heparin-induced Thrombocytopenia (HIT) in Japan (2020-2034)
• Figure 17: Total Incident Cases of Heparin-induced Thrombocytopenia (HIT) in Type-specific Heparin exposure in Japan
• Figure 18: Age-specific Cases of Heparin Induced Thrombocytopenia (HIT) in Japan (2020-2034)
• Figure 19: Total Cases of Thrombosis in Heparin-induced Thrombocytopenia (HIT) in Japan (2020-2034)
• Figure 20: Total Market Size of Heparin-induced Thrombocytopenia (HIT) in the 7MM (2020-2034)
• Figure 21: Market Size of Heparin-induced Thrombocytopenia (HIT) by Therapies in the 7MM (2020-2034)
• Figure 22: Total Market Size of Heparin-induced Thrombocytopenia (HIT) in the United States in USD million (2020-2034)
• Figure 23: Market Size of Heparin-induced Thrombocytopenia (HIT) by Therapies in the United States in USD million (2020-2034)
• Figure 24: Total Market Size of Heparin-induced Thrombocytopenia (HIT) in EU4 and the UK in USD million (2020-2034)
• Figure 25: Market Size of Heparin-induced Thrombocytopenia (HIT) by Therapies in EU4 and the UK in USD million (2020-2034)
• Figure 26: Total Market Size of Heparin-induced Thrombocytopenia (HIT) in Japan (2020-2034)
• Figure 27: Market Size of Heparin-induced Thrombocytopenia (HIT) by Therapies in Japan (2020-2034)
• Figure 28: Unmet Needs
• Figure 29: Health Technology Assessment
• Figure 30: Reimbursement Process in Germany
• Figure 31: Reimbursement process in France
• Figure 32: Reimbursement process in Italy
• Figure 33: Reimbursement process in Spain

The list of figures is not exhaustive; a detailed list of figures will be provided in the final report...

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