In recent years, the global heparin market has encountered several challenges, including product contamination and disruptions in the supply chain. Despite these setbacks, heparin’s importance has ensured its ongoing presence in the market, with major companies like Baxter and Pfizer maintaining a strong foothold. According to Inkwood Research, the global heparin market is expected to project a CAGR of 4.01% during the forecast period, 2024-2032.
Furthermore, heparin’s binding capability endows it with anti-inflammatory and anti-viral properties. Consequently, an expanding range of conditions suitable for heparin-based treatments is anticipated to fuel demand for the product and its derivatives in the coming years. Subsequently, pharmaceutical firms and research organizations have been investing in synthetic formulations and manufacturing techniques. This has yielded several hopeful contenders, with some advancing to more advanced developmental stages.
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However, this blog focuses on the three generations of heparin products.
The first-generation heparin, UFH, is sourced from the mucosal tissue of pigs or the lungs or intestines of cows, with an average molecular weight (MWavg) of around 19,000 Daltons. The second-generation heparin product, low-molecular-weight heparin (LMWH), is derived from UFH through controlled chemical or enzymatic breakdown, resulting in an MWavg ranging from approximately 3500 to 6000 Daltons. The third generation of heparin products, ultra (U)LMWH, primarily comprises chemically synthesized variants.
Global Heparin Market: Three Generations of Heparin Products
• Unfractionated Heparin (UFH)
Commercially available unfractionated heparin (UFH) is extracted from animal tissues. The purification process of heparin from these tissues, which is the sole source for the industrial production of both UFH and low molecular weight heparins (LMWHs), is an established method. The commercial production techniques for pharmaceutical-grade heparins are closely guarded industrial secrets. Typical industrial processes can be divided into five steps: collection and stabilization of the starting material; digestion and release of heparin from proteoglycans; capture and recovery of the heparin; purification and bleaching; and isolation and drying.
UFH was once commonly used for the prevention and treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE). It is safe for treating patients with renal failure, and if necessary, its effects can be neutralized using protamine. Although effective for these purposes, UFH has pharmacokinetic, biophysical, and biological limitations. Due to its high charge and relatively high molecular weight, UFH cannot pass through membranes and is administered parenterally, primarily intravenously.
UFH is still used in kidney dialysis and heart-lung machines. Heparin is preferred as an anticoagulant because it is inexpensive and often more reliable than oral anticoagulants. Additionally, heparin does not cross the placenta and has a very short onset of action. Beyond its anticoagulant activity, heparin also exhibits other pharmacological properties, such as antilipidemic actions, tumor growth inhibition, regulation of angiogenesis, and antimicrobial, antiparasitic, anti-inflammatory, and antiviral activities.
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• Low Molecular Weight Heparin (LMWH)
Low Molecular Weight Heparin (LMWH) is produced by the controlled breakdown of larger Unfractionated Heparin (UFH) chains using chemical or enzymatic methods. LMWH differs from UFH in terms of molecular weight (MW), plasma clearance, tissue factor pathway inhibitor (TFPI) release, and bioavailability. The elimination half-life of LMWH is 3–6 hours after subcutaneous (s.c.) administration and is dose-independent, unlike UFH. This allows LMWH to be administered based on weight without the need for laboratory monitoring.
LMWH offers several advantages over UFH. It has high subcutaneous bioavailability, meaning it is effectively absorbed when administered under the skin. Additionally, LMWH has a longer half-life and binds less to plasma proteins, endothelial cells, and macrophages, which makes its effects last longer and more predictable. It can be administered once or twice daily, providing convenience and ensuring a continuous antithrombotic effect without the need for laboratory monitoring. LMWH also binds less to platelet factor 4 (PF4), reducing the risk of heparin-induced immune thrombocytopenia (HIT). Furthermore, it causes less activation of osteoclasts, resulting in a lower frequency of osteopenia.
LMWH is as effective as UFH in preventing and treating venous thromboembolism and is also used for stroke and unstable angina. In anticoagulant therapy following mechanical heart valve replacement, and in cases where oral anticoagulants are contraindicated, LMWH is as effective as UFH.
LMWH can only be used at low doses in patients with renal failure. Over time, the indications for LMWH have expanded to include thromboprophylaxis in high-risk abdominal surgery and medical patients, treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), acute coronary syndromes (ACS), and superficial vein thrombophlebitis.
• Ultra-Low Molecular Weight Heparin (ULMWH)
ULMWHs are synthetic products that can be absorbed when injected under the skin and consist of five to ten saccharide units. Due to their high cost and limited clinical uses, ULMWHs account for a small fraction of the clinically used LMWH and UFH. Their shorter chain length significantly lowers the risk of Heparin-induced thrombocytopenia (HIT)
The clinically approved ULMWHs include Fondaparinux (Arixtra) and Idraparinux. Arixtra is a synthetic pentasaccharide that selectively inhibits coagulation factor Xa. Fondaparinux is used for the prevention and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). Idraparinux is a long-acting synthetic pentasaccharide, similar to fondaparinux but with an extended half-life. It has been investigated for use in preventing thromboembolic events but is less commonly used compared to fondaparinux. (Source)
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Global Heparin Market Future: What to Expect?
Anticoagulant therapy is crucial for preventing and treating thromboembolic diseases. Heparin and its derivatives are essential anticoagulants used worldwide. Recent advancements in synthesis, biotechnology, metabolic engineering, and analysis have led to new methods for producing structurally defined heparin derivatives with high efficiency.
In the past five years, innovative chemical and chemoenzymatic techniques have been developed to create LMWH, ULMWH, and bioengineered heparins. These advances are significant for enhancing the understanding of the structural differences between porcine and bovine heparins and for developing new, safer, and improved heparins and related products from both animal and non-animal sources using advanced chemoenzymatic and metabolic engineering technologies. These characteristics are projected to define the product developments in the global heparin market.
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FAQs:
1. What factors are influencing the future growth of the heparin market?
A: The future growth of the heparin market is influenced by several key factors. Firstly, increasing incidences of cardiovascular diseases and thromboembolic disorders worldwide are driving the demand for anticoagulant medications like heparin. Additionally, advancements in pharmaceutical research and development are leading to the discovery of novel therapeutic applications for heparin, expanding its market potential. Moreover, rising healthcare expenditure in emerging economies and the growing geriatric population contribute to sustained market growth.
2. How is the heparin market expected to evolve in terms of product innovation and regulation?
A: The heparin market is witnessing significant innovation in product development, particularly in the production of low-molecular-weight heparin (LMWH) and ultra-low-molecular-weight heparin (U-LMWH). These newer variants offer improved efficacy and safety profiles compared to traditional unfractionated heparin (UFH), driving adoption across various therapeutic indications.
