Increasing number of people suffering from venous thromboembolism (VTE) is subsequently resulting in rising demand for heparin. For instance, according to the American Heart Association Inc. (AHA), the study published in Burden of Thrombosis in 2016 reports that majority of the data on the incidence and mortality of venous thromboembolism (VTE) comes from high-income countries, especially North America.
The U.S. unfractionated heparin market is expected to exhibit a CAGR of 4.5% over the forecast period (2019 – 2027).
Figure 1. Global U.S. Unfractionated Heparin Market Value (US$ Mn), by Region, 2018
Source: Coherent Market Insights Analysis (2019)
Favorable government regulations for heparin is expected to boost growth of the U.S. unfractionated heparin market
The global U.S. unfractionated heparin market is expected to gain significant traction, owing to favorable regulatory scenario. For instance, according to Medicare Prescription Source Benefit Manual: Chapter 6: 2016, Medicare Part- D states that source (extraction of heparin) used for heparin production must be used for a medically-accepted indication, which facilitates the diagnosis or treatment of illness or injury. Moreover, if a source works on medical equipment or devices and is not used for a medically-accepted indication of therapeutic value on the body, it cannot satisfy the definition of a Part D source. A heparin flush is not used to treat a patient for a medically-accepted indication, but rather to dissolve possible blood clots around an infusion line. Therefore, heparin’s use in this instance is not therapeutic but instead, is necessary to make durable medical equipment work. Heparin would therefore not be a Part D source when used in a heparin flush.
Moreover, in 2014, the American Society of Health-System Pharmacists (ASHP) issued the policy for safe and effective use of heparin in neonatal care, which was reviewed by the Council on Therapeutics and by the Board of Directors.
Figure 2. Global U.S. Unfractionated Heparin Market Share (%), by Product Type, 2019 and 2027
Source: Coherent Market Insights Analysis (2019)
Increasing cases of thrombosis and adoption of strategies such as mergers and collaborations by market players are expected to drive the market growth
The U.S. is expected to exhibit growth in the market, owing to increasing cases of deep-vein thrombosis (DVT). For instance, according to the National Center for Biotechnology Information (NCBI), the study published in 2018 reported that in the U.S., 200,000 people develop venous thrombosis annually and of those, 50,000 cases are complicated by pulmonary embolism. It is expected that the annual incidence of deep-vein thrombosis (DVT) is 80 cases per 100,000 with a prevalence of lower limb deep-vein thrombosis (DVT) in 1 case per 1,000 population.
The adoption of inorganic growth strategies by players is also boosting the market growth, For instance, in September 2019, Eisai and Nichi-Iko (parent company of Sagent Pharmaceuticals, Inc.) entered into a collaboration agreement. Under this agreement, Eisai and Nichi-Iko aims to enhance their pharmaceutical business in China by introducing high quality generic drugs in the country. Eisai will address a broader range of medical needs in China by further strengthening its China-based generic business.
Major players operating in the global U.S. unfractionated heparin market include Pfizer, Inc., Sagent Pharmaceuticals, Inc., B. Braun Melsungen AG, Baxter International Inc., and Bayer AG.
Unfractionated heparin (UFH) is a natural protein in human body which supports to thin the blood by combining with antithrombin. Unfractionated heparin binds to antithrombin, which enhances the ability of inhibiting the most potential clotting factors in the body, which are factor Xa and factor IIa, within minutes. Unlike other heparins that break the clot, unfractionated heparin inhibits the formation of new clots. This allows the body to dissolve the existing blood clots.
Unfractionated heparin (UFH) is highly preferred for patients at high risk of bleeding complications due to its short activity and reversibility. It is less dependent on the kidneys for excretion when compared to other heparins, which makes it the choice for morbidly obese patients, underweight patients, and known or potential renal diseases. This heparin has more advantages than disadvantages, which makes it more potential heparin than others. Advantages such as rapid access in the blood stream, which prevents clot formation. . It quickly diminishes when the infusion or injections are stopped and it is the most cost-effective heparin formulation when compared to others. These factors are expected to drive growth of the U.S. unfractionated heparin market over the forecast period.
The U.S. unfractionated heparin market is expected to witness significant growth over the forecast period, owing to increasing incidence of thromboembolic disorders. For instance, as per the data published by the Centers for Disease Control and Prevention (CDC) in February 2018, 900,000 people are affected (1 to 2 per 1,000) each year with deep venous thromboembolism and pulmonary embolism (DVT/PE) in the U.S.
Favorable regulatory framework for unfractionated heparin is also expected to drive the market growth. For instance, American Society of Health-System Pharmacists (ASHP) issued a policy for safe and effective use of heparin in neonatal patients. This policy was reviewed and approved in 2014 by the Council on Therapeutics and by the Board of Directors. The policy supported development and use of nationally standardized concentrations of heparin while using for maintenance and flush of peripheral and central venous lines in neonatal patients.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.