The global heparin market size was USD 6.76 Billion in 2020 and is expected to register a CAGR of 1.4% during the forecast period. Increasing use of heparin to treat and prevent blood clots after surgery or during blood transfusion, rising incidence of atrial fibrillation and coronary artery disease, and increasing research activities to explore potential of heparin in treatment of inflammation, infertility, and infectious diseases are key factors expected to drive market revenue growth over the forecast period. Heparin is used as a parenteral or subcutaneous agent to treat and prevent thromboemobolic events and is widely used in hospitals for various off-label indications.
In addition, a range of polysaccharides derived from heparin and from related structures have been found to interact with various biological pathways, indicative of their wide therapeutic uses other than coagulation. Extensive research and development are underway to assess other activities of heparin and related drugs for a broad range of clinical indications such as in the treatment of inflammatory diseases, and this can further fuel revenue growth of the market to a significant extent over the forecast period.
Heparin has been used as an anticoagulant for over eight decades and is a naturally occurring polysaccharide from the family of glycosaminoglycans that are abundantly present in mast cells. The anticoagulant activity of heparin is due to the action of a specific pentasaccharide sequence that acts with antithrombin, which is a plasma coagulation factor inhibitor. Recent research studies have indicated that heparin may have robust antineoplastic activity, which is distinct and independent of its anticoagulant activity. Heparin is used in the prevention and treatment of venous thromboembolism in cancer patients, with clinical studies suggesting better prognosis and survival for cancer patients undergoing heparin anticoagulant therapy. In addition, administering heparin through nasal route has resulted in efficient management of injury caused by smoke inhalation in fire survivors. Heparin reduces acute lung injury that contributes to morbidity and mortality.
Heparin has also been used topically or systemically to treat burns as studies report heparin can promote tissue repair and inhibit inflammation in burn patients. Heparin and pentosan polysulphate have beneficial activity during the treatment of interstitial cystitis and have shown potential in treatment and prevention of protracted labour. Over the recent years, there has been an increasing interest in developing heparin-based anticoagulants that do not require parenteral administration in effective management for conditions such as chronic inflammatory diseases. In addition, heparin has been successfully administered in validation studies of needle-free injection devices that are designed to reduce pain and inconvenience associated with regular administration of such substances and present a viable alternative to traditional subcutaneous injection of heparin and potentially contribute to market growth over the forecast period.
Increasing research activities have generated new insights into the potential ways of bioengineering and synthesis of heparin and heparin-like molecules to meet the growing demand for safe applications and minimizing concerns regarding shortages in the current supply chain. Surface modification of nanoparticles with heparin has boosted their diagnostic and therapeutic applications in oncology, and advancements in nanomedicine are expected to further fuel revenue growth of the market going ahead. However, increasing incidence of complications such as bleeding, thrombocytopenia, and other injection site reactions associated with chronic heparin administration can restrain market growth to a certain extent over the forecast period.
Driver: Increasing research to explore other clinical roles of heparin is a key factor driving market growth
Heparin is one of the most widely used pharmaceutical anticoagulant that effectively reduces clotting risks and thromboembolism events. Introduction of low-molecular weight heparin has made heparin an indefensible drug for major surgeries. Heparin also alters cytokine levels and can mitigate the effects of sudden release of cytokines caused by infection or sudden trauma. In the recent past, advancements in biosynthesis of heparin-related structures such as employment of recombinant enzymes, have enabled production of heparin sequences and controlled preparation of heparin analogues that can be used for a wide range of experimental purposes. Heparin has also been extensively studied for its role in neurodegenerative diseases, as it affects the accumulation of α-synuclein in Parkinson’s disease and inhibits the production of toxic Aβ fragments. Heparin modulates fibril formation and better understanding of the mechanisms that underlie such events can open up new routes for prevention of toxic fibril formation and accumulation. New approaches are being developed and investigated to understand and exploit non-anticoagulant actions of heparin for a wide range of diseases, and number of heparin-like substances are in clinical development. Increasing investment and focus on exploring the therapeutic and clinical potential of heparin and heparin-like substances is a major factor expected to contribute to revenue growth of the market going ahead.
Restraint: Rising incidence of heparin-induced thrombocytopenia is a key factor restraining market growth
Heparin-induced thrombocytopenia is an adverse reaction that manifests as a prothrombotic disorder associated with antibody-mediated platelet activation. Major factors influencing this condition are type and preparation of heparin and heparin-exposed patient pool. Post-operative patient pool is at a higher risk owing to lack of evidence supporting efficiency of low-molecular-weight or unfractionated heparin to prevent deep vein thrombosis and pulmonary embolism after surgical interventions. Heparin-induced thrombocytopenia is a potentially serious and morbid complication of heparin therapy and can occur after any amount of heparin administration, including parenteral, subcutaneous, and even with insertion of heparin-bonded pulmonary artery catheters. This leads to suspension of heparin administration and can limit use of heparin in postoperative patients, which can restrain market growth to a certain extent over the forecast period.
Product Type Outlook:
Based on product type, the global heparin market has been segmented into unfractionated heparin, low molecular weight heparin, and ultra-low molecular weight heparin. Low-molecular weight heparin segment is expected to account for largest revenue share over the forecast period, attributable to increasing use of low molecular weight heparin in prophylaxis of venous thromboembolic disease. Low-molecular weight heparin is derived from controlled chemical or enzymatic cleavage of unfractionated heparin, which leads to the generation of fragments of lower molecular weight and more predictable action as compared to unfractionated heparin. This results in a better adverse reaction profile, less requirement for monitoring, higher bioavailability, and potential for outpatient administration.
Low-molecular weight heparin is the standard of care in many indications, replacing the standard unfractionated heparin administration. Low-molecular weight heparin can also be self-administered at home through subcutaneous injection, which in turn reduces or eliminates the need for hospital stays. Low-molecular weight heparin (LMWH) is widely preferred in obstetrics owing to its lower incidence of bleeding and other complications during pregnancy, is used in treatment for cancer-related blood clots, and is temporarily used to help patients transition to long-term oral anticoagulant therapy. These are some other key factors expected to continue to drive revenue growth of this segment. Low-molecular weight heparins also have low interactions with platelets, which significantly reduces the risk of bleeding and heparin-induced thrombocytopenia and have been shown to have higher efficacy as prophylactic agents in high-risk patients undergoing surgical interventions.
Route of Administration Outlook:
Based on route of administration, the global heparin market has been segmented into intravenous and subcutaneous. Subcutaneous route of administration segment is expected to register significant revenue growth over the forecast period. Heparin is generally administered subcutaneously so that it is released slowly into the body. Subcutaneous administration of heparin is preferred when slow and continuous absorption of drug is needed. Slow injection of subcutaneous heparin results in significantly less pain and enhances patient comfort. Slow administration of heparin allows subcutaneous tissue to accommodate the injected volume, which results in reduced pressure, capillary bleeding, and site pain, and reduces probability of other damage. In addition, low-molecular weight heparin is chiefly administered through subcutaneous route, which is another factor contributing to revenue growth of the segment. Subcutaneous injections of low-molecular weight heparin are also used for treating deep vein thrombosis in outpatient settings with low risk of recurrent thromboembolism or bleeding complications.
Based on application, the global heparin market has been segmented into coronary artery disease, venous thromboembolism, atrial fibrillation, renal impairment, and others. Venous thromboembolism (VTE) segment is expected to account for a considerably large revenue share over the forecast period, attributable to rising incidence of venous thromboembolism caused by various other chronic diseases and increasing use of low-molecular weight heparin to treat VTE. Unfractionated and low-molecular-weight heparin have been approved by the FDA for treatment of venous thromboembolism.
Clinical trials have suggested that heparin significantly reduces the number of patients suffering from deep vein thrombosis (DVT), which is a type of venous thromboembolism. Low-molecular weight heparin administered in patients with acute medical illnesses results in development of fewer DVTs and lesser bleeding complications. In addition, low-molecular weight heparin and unfractionated heparin are effective and safe in prevention of venous thromboembolism and are widely used in thromboprophylaxis in surgical patients with a drastic reduction in the occurrence of fatal pulmonary embolism. These key factors have further boosted adoption of low-molecular weight heparin for venous thromboembolism and is expected to fuel revenue growth of the segment.
Distribution Channel Outlook:
Based on distribution channel, the global heparin market has been segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies segment is expected to register steady revenue CAGR over the forecast period, attributable to increasing admission of patients with acute medical illnesses and chronic conditions, growing number of surgical procedures performed in hospitals, availability of high-end services and enhanced access to medications, rising prescriptions of heparin from healthcare professionals, and increasing administration of heparin in outpatient settings. In addition, availability of cost-effective heparin injections, increasing patient trust in pharmacists and healthcare professionals, and rising expenditure on healthcare facilities are some other key growth driving factors.
Based on regional analysis, North America is expected to account for a significantly large revenue share in the global market over the forecast period, attributable to rising demand for heparin due to increasing number of cardiovascular disorders such as atrial fibrillation and myocardial infarction, presence of established healthcare infrastructure, availability of high-quality medical facilities and services, development of robust outpatient facilities, availability of skilled professionals, and presence of key market players in the region.
Asia Pacific market revenue is expected to expand at a CAGR of 7.6% over the forecast period, attributable presence of large patient pool, rising investment in healthcare sector to develop robust infrastructure, increasing prevalence of heart diseases and other chronic conditions, growing geriatric population, and rising presence of key manufacturers in the region. In addition, availability of cost-effective synthetic and semi-synthetic heparin mimetics used to prevent blood clots during surgical interventions and increasing R&D activities to boost applications of heparin are some other factors expected to drive revenue growth of the market in the region.
The global heparin market is fragmented with presence of several players operating on a global and regional scale. Key players are engaged in product development and strategic alliances to cater to growing global demand and gain a robust footing in the market. Major companies in the market include Pfizer Inc., Dr. Reddy’s Laboratories Ltd., Teva Pharmaceutical Industries Ltd., Sanofi SA, B. Braun Melsungen AG, GlaxoSmithKline PLC, LEO Pharma A/S, Aspen Holdings, Fresenius SE & Co. KGaA, and Viatris Inc.
In a study published in JAMA Internal Medicine, results suggested that therapeutic-dose of low-molecular weight heparin reduced the risk and probability of blood clots and death in comparison with the standard of care among hospitalized COVID-19 patients. The clinical trial was a multicenter, randomized HEP-COVID trial that included 253 adults who were undergoing treatment in 12 academic centers across the United States between May 2020 and May 2021. The patients were divided according to ICU and non-ICU status, and over 124 patients were randomly assigned to standard prophylactic or intermediate-dose low-molecular weight heparin or unfractionated heparin. 129 patients were assigned to therapeutic-dose enoxaparin, which was administered subcutaneously twice a day. The HEP-COVID trial aims to offer high-quality evidence that favors therapeutic-dose heparin as primary prevention of blood clots and mortality among high-risk hospitalized COVID-19 patients.
Segments Covered in the Report:
This report offers historical data and forecasts revenue growth at a global, regional, and country level, and provides analysis of the market trends in each of the sub-segments from 2019 to 2030. For the purpose of this report, Reports and Data has segmented the global heparin market based on product type, route of administration, application, distribution channel, and region:
Heparin Market Report Scope
Segments covered By Product Type Outlook, Route of Administration, Application Outlook, Distribution Channel Outlook, Regional Outlook
By Product Type Outlook
Low Molecular Weight Heparin
Ultra-low Molecular Weight Heparin
By Route of Administration
By Application Outlook
Coronary Artery Disease
By Distribution Channel Outlook
Middle East & Africa