According to a new market report published by Transparency Market Research Heparin Market - Europe Industry Analysis, Size, Share, Growth, Trends and Forecast, 2014 - 2022" the Heparin Market Europe was valued at USD 2,004.5 million in 2013 and is estimated to reach USD 3,148.0 million by 2022 growing with a CAGR of 5.2% from 2014 to 2022.
Heparin, an anticoagulant drug is commonly employed during and after surgeries for treating lungs, heart, and circulatory disorders wherein chances of clot formation is high. Most commercial forms of heparin are extracted from porcine intestine or bovine lungs. Heparin is preferably administered via intravenously or subcutaneously as compared to oral forms due to its low absorption in human intestine. Biological activity of heparin depends on antithrombin III, which bind and deactivate serum clotting factor leading to anti-coagulation effect. Globally heparin is the second most leading anticoagulant after warfarin.
The report on Heparin Market Europe has been studied from two aspects: by product and by country. The market by product is further analyzed for three product segments i.e. unfractionated heparin, low molecular weight heparin (LMWHs) and ultra-low molecular weight heparin (ULMWHs). Whereas the market by country has been studied for five major European countries; Germany, France, United Kingdom, Italy, Spain. The Rest of the Europe represents cumulative national markets of the other parts of Europe. The study illustrates that demand for low molecular weight heparin owing to its better absorption and wider range of application area is growing at a rapid pace. Additionally LMWHs accounts for a major share in treatment and prophylaxis of venous thromboembolism (VTE) which includes both deep vein thrombosis (DVT) and pulmonary embolism (PE).
According to Bayer HealthCare, venous blood clots are responsible for more deaths in Europe every year compared to deaths caused due to breast cancer, prostate cancer, and HIV/AIDS collectively. Additionally, the overall inpatient cost in Europe following VTE is approximately USD 1,968 (EUR 1,804) after three months and USD 3,512 (EUR 3,220) after 12 months. Therefore, frequent/on-time prophylaxis of this condition is essential to reduce the overall cost of treatment. Apart from application in VTE, low molecular weight heparin plays a major role during and after surgical procedures as a measure to prevent formation of blood clots. Unfractionated heparin is the most primitive form which is majorly consumed in hospital setting. The prime applicability of unfractionated heparin is during dialysis. However, the market is steadily shifting towards heparin free dialysis procedures. Although heparin free dialysis is not a new concept in the market, yet it diminishes the chances of bleeding disorders which occurs due to prolonged use of unfractionated heparin. The advent of ultra-low molecular weight heparin (ULMWHs) is relatively new as compared to LMWHs and unfractionated heparin. ULMWHs are structurally similar to low molecular weight heparin yet their monosaccharide/oligosaccharide compositions and average molecular weights differ considerably due the variable anticoagulant activities. Majority of the research studies in Europe are now focused on ultra-low molecular weight heparin as a comparative study with LMWHs for treatment of neurological disorders and cancer associated coagulation ailments. Success of these clinical trials is expected to augment the market in coming years.
Geographically the market is majorly driven by developed European countries such as France, Germany and United Kingdom. Germany accounted for largest market share in 2013 among the EU5 countries. Key growth attributors for German heparin market include its high consumption, large population base and increasing number of surgical procures such as knee replacement, hip surgeries, and cardiovascular surgeries among others. Additionally, high incidence and prevalence of VTE in Germany is another factor augmenting the growth and consumption of heparin based formulation in last few years. According to the VITAE study, around 460,000 people in France develop DVT, including 300,000 cases of PE. It is anticipated that about 370,000 deaths occur due to VTE in France each year. Moreover, the Government of France plans to increase the retirement age from 60 to 62 years by 2018 with an intention to increase the support ratio. Extended work life in stressful conditions increases the risk of thrombosis and heart disorders. According to the National Health Services (NHS), one in three patients who undergo hip or knee replacement without thrombophylaxis develops asymptomatic DVT, while one in 30 suffer from symptomatic VTE in the U.K. Whereas, Spain, Italy and Rest of the Europe market comparatively low contribution yet in near future as the economic conditions and healthcare expenditure improves the demand and usage pattern in these countries will augment in the forthcoming years.
Overall, major drivers contributing to growth of the Europe market include ban from China imports of heparin APIs post over sulfated chondroitin sulfate adulteration issue which caused more than 100 deaths in the U.S. Hence manufactures are now focusing on establishing manufacturing and processing plants in Europe to curtail the cost and enhance the product quality. Additionally the incidences of clotting disorders in growing at a rapid pace owing to which demand for heparin is expected to grow in near future. Interestingly, the age profile in EU is expected to change drastically in the next few decades. The EU population is projected to reach 517 million in 2060. Nearly one third of the citizens would be aged 65 years and above by that time. As aging is a major contributing factor for coagulation disorders which is expected to grow the market in near future. Biosimilar based heparin products would be an upcoming opportunity for both new and existing players. Establishment of regulatory framework for biosimilars in the European Union for the marketing authorization is likely to augment the demand for biosimilar-based heparin products in the next few years. The European Medicines Agency (EMA) has published a product-specific guideline and a concept paper for LMWH biosimilars. Some of the key players profiled in this report include Dr. Reddy's Laboratories Ltd., GlaxoSmithKline plc, Leo Pharma A/S, Pfizer, Inc., Sanofi S.A., and Syntex S.A. are profiled in this report.
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