Global Low Molecular Weight Heparin Market – Global Industry Insights
Low Molecular Weight Heparins (LMWH) are a form of pharmacological anticoagulant intervention which are derived from UFH by chemical or enzymatic depolymerisation to yield fragments that are around one third the size of heparin. Low molecular weight heparin is used for prophylaxis of deep vein thrombosis and pulmonary embolism, or thrombosis occurring in a broad spectrum of clinical indications, including general or orthopaedic surgery, neurosurgery, trauma, unstable angina, and myocardial infarction. LMWHs are However, it is associated with higher anticoagulant effect and provides higher bioavailability after subcutaneous administration, as compared to unfractionated heparin (UFH), for thromboembolic indications. Low molecular weight heparin is the most suitable anticoagulant 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 Share (%), By Drug: 2018 & 2026
Source: Coherent Market Insights Analysis (2019)
Increasing Advantages of Low Molecular Weight Heparin over Unfractionated Heparin is expected to drive the Market Growth during the Forecast Period
Unfractionated heparin or standard heparin varies in action from patient to patient. Thus, it can only be administered to hospitalized patients under monitoring, while low molecular weight heparins (LMWHs) can be used subcutaneously once a day, without requirement for monitoring.
Furthermore, LMWHs have more predictable pharmacokinetic properties as compared to unfractionated heparin (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, as compared with 15,000 daltons in unfractionated material. As low-molecular-weight fractions of heparin react less with platelets than high-molecular-weight fractions, it was also expected that LMWH would less often induce immuno-allergic thrombocytopenia, a severe side-effect of UFH that is often complicated by arterial thrombosis.
Such advantages of low molecular weight heparin over unfractionated heparin are driving growth of the low molecular weight heparin market. Furthermore, properties such as better bioavailability, predictable dose response, and longer plasma half-life than unfractionated heparin, makes low molecular weight heparin a better candidate for anticoagulant therapy. This in turn is fuelling demand for low molecular weight heparin, and thus it is expected to boost the market growth over the forecast period.
Global Low Molecular Weight Heparin Market Share (%), By Application: 2018 & 2026
Source: Coherent Market Insights Analysis (2019)
Increasing Introduction of Biosimilar LMWH Anticoagulants Globally is Expected to Aid in the Market Growth
LMWH usage is expected to increase over the forecast period, due to a number of other non-anticoagulant properties. These include anti-tumor, anti-inflammatory, and anti-proliferative actions (in pathologies such as nephrotic syndrome and Alzheimer’s disease). The patents of LMWHs have now expired. However, the market potential for LMWHs is witnessing growth, owing to increasing use in a number of Western European countries and emerging economies and its potential indications, such as thromboprophylaxis, Venous thromboembolism (VTE), anticoagulation treatment during pregnancy, among others. Enoxaparin is the bestselling LMWH worldwide. Therefore, pharmaceutical companies in many countries are focused on producing generic forms of LMWH.
According to Hospital Pharmacy Europe: November 2016; several pharmaceutical companies produce copies of enoxaparin in Argentina, Brazil, Chile, Columbia, Egypt, Ecuador, Georgia, India, Morocco, Myanmar, Peru, The Philippines, South Korea, Tunisia, Turkey, the U.S., and Venezuela. Pharmaceutical companies from these countries are also engaged in research and development activities to produce a biosimilar of enoxaparin. This generates high competition in the LMWHs market.
Pharmaceutical companies produced either as biosimilars or named generic versions of the branded LMWH. Specifically, copies of enoxaparin are available in North and Latin America and Asian countries. In Australia and Europe, regulatory bodies developed specific requirements for approval of biosimilar LMWHs. Africa is currently not included so far in this development.
Adverse effects of low molecular weight heparin during treatment is a major restraint for growth of the LMWH market. Heparin induced thrombocytopenia (HIT), an adverse reaction occurring during treatment with heparin, is associated with inconsistent increase in the clotting causing further complications. Heparin-induced thrombocytopenia (HIT) is an adverse reaction that can occur during treatment with heparin. Increasing epidemic of Heparin-induced thrombocytopenia (HIT) due to application of heparin is restricting the growth of market.
For instance, according to the data published in American Society of Hematology in 2017, Heparin-induced thrombocytopenia (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.
Among regions, Europe is expected to be the most lucrative region in the low molecular weight heparin market over the forecast period, due to low molecular weight heparin being majorly used heparin type in Europe, owing to its advantage over unfractionated heparin. Low molecular weight heparins such as enoxaparin, dalteparin, tinzaparin, and certoparin are majorly sold heparin drugs in Europe.
Government regulatory authorities are imposing regulations on the application of LMWHs biosimilars and its approval process. Increasing engagement of regulatory bodies in authorizing LMWH biosimilar in these markets is expected to drive growth of the market. 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.
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.
Key players operating in the 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.
Low Molecular Weight Heparin (LMWH) has several advantages over other heparin such as longer and more predictable activity than Unfractionated Heparin (UFH) and can be self-administrated at home via subcutaneous injection, reducing or eliminating hospital stays, thereby no regular blood monitoring required. Furthermore, heparins do not cross the placenta or harm the fetus, so they are the preferred anticoagulants for pregnant women who experience or who are at heightened risk of – blood clots. These advantages make LMWH as the most preferred heparin in inhibiting clotting factors.
Increasing number of people are being affected with Deep Vein Thrombosis (DVT) which will subsequently increase demand for LMWH. For instance, according to National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention (CDC), February 2018; the precise number of people affected by DVT/PE is unknown, although as many as 900,000 people could be affected (1 to 2 per 1,000) each year in the U.S.
Furthermore, increasing engagement of government healthcare regulatory bodies in developing and delivering effective and cost-effective low molecular weight heparin molecule products in the market is expected to propel the growth of the market. For instance, in 2014, American Society of Health-System Pharmacists (ASHP) issued the policy for safe and effective use of heparin in neonatal patients thereby supporting the development and use of nationally standardized concentrations of heparin when used for maintenance and flush of peripheral and central venous lines in neonatal patients.
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