Heparin-Induced Thrombocytopenia - Market Insight, Epidemiology and Market Forecast - 2032

Key Highlights

• 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.
• 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.
• A clinical diagnosis with the 4Ts scoring system used for diagnosing HIT (score =4 indicates a very likely diagnosis) usually precedes the laboratory evaluation. There are two general categories of laboratory assays to diagnose HIT. The immunoassay is the first step and acts as a screening test to rule HIT out. Next, a functional assay establishes the diagnosis. These include enzyme-linked immunosorbent assay (ELISA) and serotonin release assay (SRA).
• Treatment options are focused on inhibiting thrombin formation or direct thrombin inhibition. If the clinical diagnosis is suspected or confirmed by laboratory analysis, heparin should be stopped immediately, including UFH and LMWH, heparin flushes, and any heparin-coated lines or infusions. Next, an alternative anticoagulant must be initiated to prevent or treat HIT-induced thrombosis.
• As far as the epidemiology of Heparin-induced Thrombocytopenia (HIT) is concerned, it was found that the United States accounted for ~217,000 of the total cases of Heparin-induced Thrombocytopenia (HIT) testing in the 7MM in 2022.
• The market size captured by the United States was the largest among the 7MM countries. It was found that the United States accounted for ~50% of the total market size captured by the 7MM region in 2022.
• A single therapy, VLX-1005 (Veralox Therapeutics), is being investigated for treating heparin-induced thrombocytopenia (HIT).

Report Summary

• The report covers a segment of key events describing the latest developments from a treatment point of view, including designations, collaboration, and agreements, etc., as well as a descriptive overview of Heparin-induced Thrombocytopenia (HIT), explaining the definition of Heparin-induced Thrombocytopenia (HIT), types and risk factors involved in Heparin-induced Thrombocytopenia (HIT), pathophysiology, and the treatment of Heparin-induced Thrombocytopenia (HIT).
• 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 and emerging therapies and the elaborative profiles of late-stage (Phase III and 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 (HIT) market, providing an in-depth examination of its historical and projected market size (2019-2032). 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 (HIT) market.

The Current key player is Veralox Therapeutics. The details of the country and therapy-wise market size have been provided below

• In 2022, the United States accounted for the largest market size among the 7MM countries, making ~50% of the total market size of the 7MM.
• Among the 7MM countries, Spain had the market size in 2022, accounting for ~2% of the market size in the 7MM region.
• In EU4 and the UK region, Germany accounted for the largest market size, making up ~40% of the total market size of the EU4 region.
• In 2022, US Argatroban had the highest market size among all the marketed drugs, making up ~77% of the total market size.

Heparin-induced Thrombocytopenia (HIT) Drug Chapters

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.

Marketed Therapies

ANGIOMAX (bivalirudin)

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

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) Market Outlook

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) Disease Understanding and Treatment

Heparin-induced Thrombocytopenia (HIT) Overview

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.

Heparin-induced Thrombocytopenia (HIT) diagnosis

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.

Heparin-induced Thrombocytopenia (HIT) treatment

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.

Heparin-induced Thrombocytopenia (HIT) Epidemiology

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.

• In 2022, there was a total of ~111,000 incident cases of Heparin-Induced Thrombocytopenia (HIT), which is expected to increase by 2032 in the United States.
• In 2022, the total cases of Thrombosis in Heparin Induced Thrombocytopenia (HIT) in 7MM were ~106,000 cases.

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.

The publisher has 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.

The team of analysts 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.

Qualitative Analysis

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.

Market Access and Reimbursement

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:

• 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, the Children's 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.
• In the EU4 and the UK, publicly funded health systems exist. The major EU4 and UK organizations include IQWIG and G-BA, HAS, AIFA, AEMPS, and NICE in Germany, France, Italy, Spain, and the UK.
• Germany allows medicines to be priced freely for up to 1-year, followed by its market authorization. In this 1-year, the Market Authorization Holder (MAH) submits the dossier, which helps in HTA decision-making. The assessment in Germany requires a comparator, and the decision is also concerning the comparator.
• In France, HAS uses the ratings of ASMR for improvement in existing therapies and SMR for a new drug. An ASMR rating is assigned based on the drug's improvement of medical benefit compared to the current standard of care. ASMR I, II, and III mean faster market access with price notification instead of negotiation and consistent price all over Europe, ASMR IV means that the drug is to be priced equal to the comparator, and ASMR V rating means that the drug is to be priced lower than the comparator. However, an SMR rating is given on the product's medical benefit to determine whether the drug should be reimbursed. A 65%-100%, 30%, 15%, and 0% reimbursement is given to drugs with SMR ratings of Important, Moderate, Mild, and Insufficient, respectively.
• In Italy, AIFA negotiates the price with MAH, and the drug is classified into two categories. Class A and H for full reimbursement of essential drugs and drugs dispensed only in hospitals, respectively, and Class C for drugs without reimbursement. Whereas, in Spain, reimbursement is compulsory, and once AEMPS gives clearance to the labels, the MAH has to initiate the reimbursement evaluation.
• In the UK, reimbursement decisions are taken based on cost-effectiveness. NICE recommendations are very rigorous and are highly influential and referenced globally. Currently, NICE uses a GBP 20,000-30,000 threshold per quality-adjusted life year (QALY) for reimbursing new drugs in the National Health Service (NHS). The Quality-Adjusted Life Year (QALY) measures the value and benefit of health outcomes. QALY gives an idea of how many extra months or years of the life of a reasonable quality a person might gain as a result of treatment.
• In Japan, reimbursement decisions are determined by the Central Social Insurance Medical Council (Chuikyo), a separate body designated by the Ministry of Health, Labor, and Welfare (MHLW). Repricing of a drug happens every 2 years, with an additional off-year repricing in between the 2 years conducted since 2016. Once a new drug or device is approved for marketing, it is normally listed for reimbursement within a few months and marketed immediately after that.

Heparin-induced Thrombocytopenia (HIT) Report Insights

• Patient Population
• Therapeutic Approaches
• Heparin-induced Thrombocytopenia (HIT) Market Size and Trends
• Existing Market Opportunity

Heparin-induced Thrombocytopenia (HIT) Report Key Strengths

• Ten-year Forecast
• The 7MM Coverage
• Heparin-induced Thrombocytopenia (HIT) Epidemiology Segmentation
• Key Cross Competition

Heparin-induced Thrombocytopenia (HIT) Report Assessment

• Current Treatment Practices
• Unmet Needs
• Market Attractiveness
• Qualitative Analysis (SWOT)

Key Questions Answered

• Would there be any changes observed in the current treatment approach?
• Will there be any improvements in Heparin-induced Thrombocytopenia (HIT) management recommendations?
• Would technical advances pave the way for future tests and therapies for Heparin-induced Thrombocytopenia (HIT)?
• Would the diagnostic testing space experience a significant impact and lead to a positive shift in the treatment landscape of Heparin-induced Thrombocytopenia (HIT)?
• What are the cost and pricing variations observed for approved therapies and the following diagnostic pattern to diagnose Heparin-induced Thrombocytopenia (HIT)?