Global Unfractionated Heparin Market is segmented By Source (Bovine, Porcine, Others), By Application (Deep venous thromboembolism, Arterial fibrillation, Renal impairment, Coronary artery disease), By End User (Hospital, Clinics, Academic and Research Organizations), By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2024-2031
Market Overview
The "Global Unfractionated Heparin Market" is predicted to reach at a high CAGR during the forecast period (2024-2031).
Heparin is a natural agent used to prevent clot formation in the vessels. Two types of heparins are widely used, unfractionated heparin (UFH) and low molecular weight heparin (LMWH). Unfractionated Heparin is a fast-acting blood thinner that works together with antithrombin, a natural protein in the body, to block cloth formation. The heparin market growth is owing to the rising incidence of coagulation disorders and substantial growth in the number of people suffering from chronic disease. Heparin comes as a solution (liquid) to be injected intravenously (into a vein) or deeply under the skin and as a dilute (less concentrated) solution to be injected into intravenous catheters. Heparin should not be injected into a muscle. Heparin is sometimes injected one to six times a day and sometimes given as a slow, continuous injection into the vein. When Heparin is used to prevent blood clots from forming in intravenous catheters, it is usually used when the catheter is first put in place, and every time that blood is drawn out of the catheter or medication is given through the catheter.
Source: DataM Intelligence Analysis (2020)
Market Dynamics
The global unfractionated heparin market growth is accelerated by the growing incidence of thromboembolic disorders, such as deep vein thrombosis and pulmonary embolism. Moreover, the health organizations are engaged in increasing their awareness, which might eventually increase the unfractionated heparin market in the future. Many biopharmaceutical companies are developing innovative medicines to enhance the therapeutic potential of Heparin and reduce its side effects.
The increasing prevalence rate of thromboembolic disorders is expected to drive the growth in the forecast period
The increasing prevalence rate of thromboembolic disorders and increasing awareness towards the use of unfractionated Heparin, ease of use and low cost are expected to boost its market. These reasons are driving the growth of the market in the forecast period. According to data by the Centers for Disease Control and Prevention (CDC), in February 2018, around 900,000 people are affected (1 to 2 per 1,000) each year in the U.S. due to the deep venous thromboembolism and Pulmonary Embolism (DVT/PE). This review of 16 trials in 34,369 non‐surgical patients who suffered an acute medical illness found that Heparin reduced the number of patients suffering DVTs
Low cost and immediate action are expected to drive the market growth
UFH is the preferred treatment for patients at high risk of bleeding complications due to its short activity and reversibility. Specifically, UFH binds to antithrombin and enhances its ability to inhibit two of the body's most potent clotting factors – factor Xa and factor IIa – usually within minutes. As with all forms of Heparin, UFH doesn't break down clots, but it keeps them from growing and stops new ones from forming. It is also less reliant on the kidneys for excretion than other heparins, so it is the treatment of choice for morbidly obese patients, significantly underweight individuals, and any other patients with known or potential renal disease. It has a long history of clinical use and can be rapidly reversed by protamine. Apart from its use as an anticoagulant, there has been growing interest in the potential applications of Heparin for other purposes over the years. These applications range from anti-inflammatory and anti-tumor applications to preventing infectious disease and using nanocarriers for drug delivery.
Side effects related to the drug is likely to hinder the market growth
The adverse effects of unfractionated Heparin during treatment pose a major restraint for the growth of the unfractionated heparin market. Heparin-induced thrombocytopenia (HIT), an adverse reaction occurring during treatment with Heparin, is associated with an inconsistent increase in the clotting causing further complications. UFH and LMWH therapy are associated with a high rate of drug-related problems and side effects due to their inherent pharmacological properties or human errors. Thrombocytopenia, bleeding events, and osteopenia are the three most common drug-related problems associated with Heparin and LMWH therapy. These side effects often complicate treatment and increase the overall cost of care. The Institute for Safe Medication Practices has classified both UFH and LMWH as high-alert drugs. Approximately 2.1 percent of the total records submitted to the MedMARx national error database were related to UFH; 4.5-5.5 percent of the reported errors were harmful To instance, according to the American Society of Hematology data in 2017, Heparin-induced thrombocytopenia (HIT) is Heparin's most clinically relevant non-hemorrhagic complication.
Furthermore, adults receiving heparin formulations for further medical or general surgical indications are at much higher risk for HIT than pediatric or obstetric patients. This restricts market growth. The FDA receives approximately 400,000 reports of adverse drug events per year. In a study analyzing 300,000 events occurring in 2005, 3.6% (approx. 11,0000 events in one year) were related to Heparin, and harm was caused in 275 cases. In 36% of cases, the error was due to the wrong dose or quantity. 18% of the time, the error was due to an overdose of 100x or more. The estimated cost of these Heparin-related errors is approximately $150M/year, but this number is likely deficient. Annually the U.S. spends $4.2B a year due to medical errors, and 3.6% of these errors are related to Heparin. However, heparin mistakes tend to be much more costly than, say, mistakes with less risky medications. Blood clots form when certain parts of your blood thicken, forming a semi-solid mass. An injury may trigger this process or sometimes occur inside a blood vessel that doesn't have an apparent injury. The precise number of people affected by DVT(deep vein thrombosis)/P.E. (pulmonary embolism) is unknown. However, as many as 900,000 people could be affected (1 to 2 per 1,000) each year in the United States. Among people who have had a DVT, one-third to one-half will have long-term complications such as swelling, pain, discoloration, and scaling in the affected limb.
COVID-19 Impact Analysis
At the beginning of the COVID-19 outbreak, millions of people got affected, and significant countries worldwide prohibited production and work. Except for some medical supplies and life support product industries, many others got affected. This lead to both positive and negative impacts on the market. As the outbreak of COVID-19 has been critical, there has been a drastic increase in the number of patients suffering from COVID-19, associated with respiratory diseases. Therefore the demand for Heparin in the market has seen an increase. It helps to subdue respiratory inflation, and thin the blood of those with the risk of a blood clot Coronavirus 2 (SARS-CoV2/ Severe Acute Respiratory Syndrome Corona Virus 2) infection has emerged as a global health crisis. Incidence of the thromboembolic disease is reported to be high in SARS-CoV2 disease. It is seen in many organ systems ranging from cutaneous thrombosis to pulmonary embolism, stroke or coronary thrombosis, sometimes with catastrophic outcomes. Evidence points towards a crucial role of thromboembolism, hypercoagulability and over-production of proinflammatory cytokines mimicking a "cytokine storm," which leads to multiorgan failure. This brief narrative review highlights the pathophysiology and risk factors of thromboembolic disease and provides a framework for anticoagulation management based on the current evidence. Hence with the rising rate of the cases, there will be a significant rise in the demand for Heparin in the market growth over the forecast period.
Market Segment Analysis
By source, the market is segmented into bovine and porcine. The porcine segment dominates the market as it's the only permitted Heparin derived from an animal-based source, whereas the bovine segment has a lower share of the market. One of the significant reasons for porcine domination in the market was the ban of bovine in the U.S. and Europe region post-1990s due to the spread of bovine spongiform encephalopathy (BSE) disease in cattle. Heparin (porcine)solution is given by injection into a vein or under the skin directed by a doctor.
The market can be segmented into deep venous thromboembolism arterial fibrillation, renal impairment, and coronary artery disease based on its applications. Among these, coronary artery disease is the highest owing to the increasing prevalence and more incidence of heart-related disease. According to statistics published in the American Heart Association, in 2018, around XXX million American adults were suffering from some form of cardiovascular disease. In addition, around 1 in every three deaths are caused by cardiovascular disease in the U.S., accounting for around 2,300 deaths per day. Venous thromboembolism (VTE) is expected to be the fastest-growing segment over the forecast period. Venous thromboembolism is segmented into pulmonary embolism (P.E.) and deep vein thrombosis (DVT). According to the facts published in the International Society on Thrombosis and Haemostasis, Inc., around 10 million cases of VTE are recorded globally every year, and around 544,000 VTE-related deaths are observed every year in Europe.
Source: DataM Intelligence Analysis (2020)
Based on the end-user analysis, the unfractionated heparin market is divided into hospitals, clinics and research organizations. Hospitals are expected to account for the highest share of the market in the forecast period due to greater dependency on health care professionals for prescription of Heparin. Clinics account as the second-highest segment in the forecast period during the use of it in dialysis clinics.
Geographical Share
The unfractionated heparin market has been segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.
North America holds a leading position in the global unfractionated heparin market, owing to the increasing prevalence of deep venous thromboembolism and Pulmonary Embolism in the region. The demand for anticoagulant drugs is on the rise across the U.S. due to its dependence on most of the necessary surgeries on Heparin.
Evolving heparin market in Middle-East
Drug utilization evaluation of unfractionated Heparin in a cardiac care unit in Iran focused on evaluating and improving the medication use process to achieve optimal patient outcomes. This study aimed to assess the pattern of unfractionated Heparin (UFH) utilization in a cardiac care unit. The data showed that the rate of achieving activated partial thromboplastin time (aPTT) in the early stages did not give the expected results yet was satisfactory.
The unfractionated market in the Asia Pacific is projected to grow in the forecast period. Pulmonary embolism (P.E.) in Asians is uncertain but undoubtedly underestimated due to the increase in this risk. The demand and use of Heparin are on the rise in this region.
Competitive Landscape
Unfractionated heparin market is inclusive for both international and local companies. Many biopharmaceutical companies are developing innovative medicines to enhance the therapeutic potential of Heparin. Market with more funds for research and better distribution system have established their position in the market. An increase in government funding for research and production has also played a role in the heparin market. Some of the key players operating in the global unfractionated heparin market are B. Braun Melsungen AG, Pfizer, Inc., Baxter International Inc., Siemens Ag and Sagent Pharmaceuticals
Sagent Pharmaceuticals
Overview: Sagent Pharmaceuticals is a manufacturer of injectables and biosimilars. Sagent offers more than 60 injectable products across the anti-infective, oncology and critical care categories. Sagent has created a unique, global network of resources, comprised of rapid development capabilities, sophisticated manufacturing and innovative drug-delivery technologies, quickly yielding an extensive portfolio of pharmaceutical products that fulfill patients' evolving needs. All of Sagent's products feature PreventIV Measures packaging and labelling. Sagent's approach to packaging and labeling may help reduce the risk of medication errors. In 2007 Sagent first formed and launched its first injectable product. According to IMS, 2009 U.S. sales of all forms of unfractionated Heparin approximated $306 million. Sagent will launch the product immediately. As with all Sagent's products, Heparin is also latex-free and features the Company's proprietary PreventIV MeasuresTM packaging and labelling, which aids users in distinguishing between the nine presentations. PreventIV Measures are Sagent's, a patient-driven approach to product labeling and packaging to prevent medication errors. It incorporates unique labels and carton designs, cap and label colors, and barcoding to identify and differentiate the product and the dosage.
Product Portfolio: The Company's portfolio consists of diverse therapeutic categories and packaging, including vials, syringes, and premix bags.
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- Visualize the composition of the unfractionated heparin segmentation by source, applications, end-use and globally, highlighting the critical commercial assets and players.
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