PUBLISHER: DelveInsight | PRODUCT CODE: 1337637
PUBLISHER: DelveInsight | PRODUCT CODE: 1337637
The Current key player is Veralox Therapeutics. The details of the country and therapy-wise market size have been provided below.
The section dedicated to drugs in the Heparin-induced Thrombocytopenia (HIT) report provides an in-depth evaluation of the marketed and pipeline drugs related to HIT. Argatroban, Danaparoid, and Bivalirudin are the few drugs used to treat HIT in the 7MM region. There is an emerging therapy, the detailed coverage of the same has been provided in the report.
The drug chapters section provides valuable information on various aspects related to clinical trials of HIT, including specific details, such as the pharmacological mechanisms of the drugs involved, agreements and partnerships, 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 HIT.
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; it is administered intravenously. It is indicated for use in patients undergoing percutaneous coronary intervention (PCI), including patients with heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS). Its short duration of effect makes it appealing for those with bleeding risks or undergoing additional procedural interventions and needing a rapid cessation of drug effect.
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 (HIT) is a pharmacological response that causes thrombocytopenia and an increased venous or arterial thrombosis risk. It is induced by heparin-dependent platelet-activating antibodies that recognize platelet factor 4 (PF4) bound to heparin as a "self" protein. Platelet activation, as a result, is related to enhanced thrombin production. Platelet count drops typically begin 5-10 days after initiating heparin, while a quick platelet count drop might occur in a patient with antibodies from recent heparin usage. Surprisingly, despite a history of HIT, the transience of HIT antibodies allows for safe heparin re-exposure in certain individuals (for example, heart surgery patients).
The main treatment principle is that patients with a high suspicion of, or proven, HIT discontinue UFH or LMWH and commence treatment with an alternative non-cross reacting anticoagulant. The initial anticoagulant treatment of HIT should be the same whether or not it is already complicated by thrombosis at the time of diagnosis. LMWH is not an appropriate alternative if HIT develops during treatment with UFH because there is cross-reactivity in vivo in approximately 50% of cases.
Argatroban and bivalirudin are both non-cross reacting. Danaparoid demonstrates cross-reactivity in vitro, which is only rarely evidenced 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 HIT. Warfarin, especially when used in isolation, can increase the risk of microvascular thrombosis in HIT, and its introduction should be delayed until there has been substantial resolution of thrombocytopenia. It should then be introduced with an overlap of the alternative anticoagulant. Where argatroban is being used, care is required in interpreting the International Normalized Ratio (INR).
Several novel oral anticoagulants also exist (e.g., rivaroxaban, dabigatran, apixaban), and preliminary evidence suggests that they may benefit HIT, particularly in cases refractory to standard therapies. However, these agents have not been fully assessed for treating patients with HIT, and none have FDA approval for use in HIT.
According to a Gruel et al. (2020) study, 144 patients with defined HIT were included. In the study conducted, argatroban was administered to 10.4% of patients (n = 15), danaparoid sodium was given to 72.9% of patients (n = 105), and fondaparinux was administered to 7.6% of the patients (n = 11). Around 2.8% of the patients (n = 4) received Vitamin K antagonists. Whereas, lepirudin was administered to a single patient.
According to a study by Patel et al. (2015), out of 2,408 matched patients, 709 (29.4%) received bivalirudin, and 1,699 (70.6%) received argatroban. From the study, it was concluded that among patients with suspected HIT, the use of argatroban compared to bivalirudin was associated with a decreased risk of major bleeding but was similar for thrombosis, amputation, and mortality risk.
There is a dearth of approved therapies for HIT. It has been more than 20 years since the launch of marketed therapies for HIT. A rise in awareness of HIT will expand the market further as such patients seek appropriate treatment. There are upcoming therapies currently in the pipeline, such as VLX-1005. Thus, a positive shift is expected to drive the overall HIT market.
Heparin-induced thrombocytopenia (HIT) is a fascinating, complex, and partially obscure immunological syndrome. It is a severe complication that can occur in patients exposed to any form or amount of heparin products. Heparin is a medication commonly used to prevent blood clots; however, the immune system can trigger heparin to cause blood clots and thrombocytopenia, leading to HIT. A fall in platelet counts and a hypercoagulable state characterize HIT. Heparin-induced thrombocytopenia is often suspected in patients recently treated with heparin. Platelet counts decline within 5-10 days in patients with no previous heparin exposure and may decline precipitously (within hours) in patients with recent heparin exposure.
This life-threatening disorder is characterized by platelet-activating antibodies recognizing multimolecular complexes bound to unfractionated heparin or low-molecular-weight heparin. Patients with heparin-induced thrombocytopenia present with mild thrombocytopenia or a 50% decrease in platelet count from baseline. Thrombosis complications (termed heparin-induced thrombocytopenia with thrombosis) develop in 20-50% of patients and may affect arterial and venous systems, even after heparin is discontinued.
Establishing HIT diagnosis in patients with complicated medical conditions can be challenging. Other causes of thrombocytopenia, such as bacterial infection, drugs other than heparin, and bone marrow disease, should be excluded, and platelet counts should recover after discontinuing heparin. Diagnosing HIT in patients who have undergone recent cardiac surgery is particularly difficult. Since, in such patients, the prevalence of heparin-dependent antibodies is high (up to 25-50%), thrombocytopenia is common, and other medications causing thrombocytopenia could be administered.
Making a rapid and confirmed diagnosis of HIT is challenging and of utmost importance. It requires the association of clinical parameters to estimate the pretest probability and laboratory assays to confirm or infirm the diagnosis. It is established by clinical evaluation and is confirmed with antibody immunoassays.
The diagnosis of heparin-induced thrombocytopenia is based on the clinical setting: a platelet count of 200,000 may have decreased enough in a post-operative case to indicate platelet consumption. Briefly, current cornerstones of HIT management are (i) an immediate cessation of any heparin administration and (ii) the introduction of non-heparin therapeutic anticoagulation.
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 HIT or HIT 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.
The Heparin-induced Thrombocytopenia (HIT) epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Incident Cases of HIT, Total incident Cases of HIT in type-specific Heparin exposure, Age-specific Cases of HIT, and Total Cases of Thrombosis in HIT in the 7MM covering the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2019 to 2032.
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 (HIT), 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 different KOLs from various countries. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the Heparin-induced Thrombocytopenia (HIT) market, which will assist our clients in analyzing the overall epidemiology and market scenario.
We conduct qualitative and market intelligence analysis by employing the SWOT analysis approach. Within the SWOT analysis framework, we assess the strengths, weaknesses, opportunities, and threats pertaining to various aspects such as disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies. This analysis provides a comprehensive evaluation of the current situation and helps identify areas of advantage, areas for improvement, potential opportunities, and potential challenges in the specified domains.
Reimbursement may be referred to as the price negotiation between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending drug use. These recommendations vary widely throughout the seven major markets, even for the same drug. A summary of various important rules in the process used by the organizations in their respective country is as follows: