Low Molecular Weight Heparin (LMWH) is a class of anticoagulant medications used in the prevention of blood clots and treatment of venous thromboembolism and myocardial infarction. It is derived from unfractionated heparin (UFH) by chemical or enzymatic depolymerisation. LMWH offers higher anticoagulant effect and higher bioavailability compared to UFH. It is also used in case of complicated pregnancy, as it eliminates risk of crossing the placental membrane.
The global low molecular weight heparin market size was valued at US$ 2,882.6 Mn in 2017, and is expected to witness a CAGR of 6.7% during the forecast period (2018 – 2026).
Global Low Molecular Weight Heparin Market: Competitive Landscape
Major players operating in the global low molecular weight heparin market include, Pfizer, Inc., LEO Pharma A/S, Sanofi S.A., Teva Pharmaceutical Industries Ltd., Amphastar Pharmaceuticals Inc., Abbott Laboratories, Aspen Pharmacare Holdings, Laboratorios Farmaceuticos ROVI SA, Changzhou Qianhong Biopharma, and Intrapharm Laboratories.
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Global Low Molecular Weight Heparin Market: Drivers
Benefits of LMWH over UFH are expected to boost growth of the global low molecular weight heparin market during the forecast period. UFH or standard heparin can only be administered to hospitalized patients under monitoring as its action varies from patient to patient. However, LMWH can be used subcutaneously once a day, without any monitoring. Moreover, LMWHs have more predictable pharmacokinetic properties as compared to UFH, which allows LMWHs to be administered in fixed doses and without the need for dose adjustment based on laboratory monitoring.
The mean molecular weight of LMWH fractions is around 3,500–8,000 daltons compared to 15,000 daltons in UFH material. Therefore, LMWH less often induce immuno-allergic thrombocytopenia, a severe side-effect of UFH. LMWH offers other advantages such as better bioavailability, predictable dose response, and longer plasma half-life compared to UFH. LMWH offers several non-anticoagulant properties such as anti-tumor, anti-inflammatory, and anti-proliferative (in pathologies such as nephrotic syndrome and Alzheimer’s disease).
Increasing launch of generics of LMWH is also expected to aid in growth of the market. For instance, according to Hospital Pharmacy Europe: November 2016, several pharmaceutical companies in Argentina, Brazil, Chile, Columbia, Egypt, Ecuador, Georgia, India, Morocco, Myanmar, Peru, The Philippines, South Korea, Tunisia, Turkey, the U.S., and Venezuela produce copies of enoxaparin. These companies are also focused on R&D of biosimilars of enoxaparin. Australia and Europe have specific regulatory requirements for approval of biosimilar LMWHs. Africa is currently not included so far in this development.
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Global Low Molecular Weight Heparin Market: Restraints
Adverse effects of LMWH are expected to hamper growth of the global low molecular weight heparin market. Heparin induced thrombocytopenia (HIT), an adverse reaction occurring during treatment with heparin, is associated with inconsistent increase in the clotting causing further complications. According to the American Society of Hematology, 2017, HIT is heparin’s most clinically relevant non-hemorrhagic complication. Furthermore, adults receiving heparin formulation for medical or general surgical indications are at higher risk for HIT than pediatric or obstetric patients.
Global Low Molecular Weight Heparin Market: Regional Analysis
Europe is expected to hold dominant position in the global low molecular weight heparin market over the forecast period. This is owing to high adoption of LMWHs such as enoxaparin, dalteparin, tinzaparin, and certoparin and product approvals in the region. For instance, in July 2016, the European Medicines Agency (EMA) authorized the introduction and marketing of Thorinane and Inhixa, biosimilars of Low Molecular Weight Heparin (LMWH), enoxaparin.
Moreover, in Europe, there are several regulations on the application of LMWHs biosimilars and its approval process. For instance, in 2014, the Committee for Medicinal Products for Human Use (CHMP) of the EMA issued the ‘Guideline on similar biological medicinal products’ CHMP/437/04 Rev. 1, with the purpose of describing the concept of similar biological medicinal products and to outline the general principles to be applied.
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