A bleeding disorder is a state in which the normal clotting function of blood is adversely affected. On an injury to the body, blood normally starts to clot to prevent major loss of blood. Occasionally, certain situations prevent blood from clotting properly, which can result in heavy or prolonged bleeding. Bleeding disorders can cause abnormal bleeding both outside and inside of the body. Some disorders can drastically increase the amount of blood lost by the body. Others cause bleeding to follow under the skin or in vigorous organs, such as the brain. Normal blood clotting involves blood components called ‘platelets’ and as many as there are 20 different plasma proteins in body called as blood clotting or coagulation factors. These factors interact with other chemicals to form a substance called fibrin which stops bleeding. Complications can occur when certain factors are low or missing in body. Bleeding problems can range from mild to severe. Some bleeding disorders are present at time of birth and some are passed through families (inherited).

According to American Society of Hematology, in 2016, around 20,000 people in the U.S. suffer from hemophilia, a condition that is predominantly observed in males.  Hemophilia is the most well-known inherited bleeding disorder, although it is rather rare. On the other hand, many people are affected by von Willebrand disease, the most common inherited bleeding disorder in the U.S. caused by clotting proteins. This disease can affect both males and females and is found in nearly 1% of the U.S. population. And according to the Centers for Disease Control and Prevention (CDC) statistics, in the U.S. around 400 newborns suffer from hemophilia every year.

Generic products to be the growth factor for bleeding disorders treatment market

The bleeding disorder treatment market is driven by the large customer base, growing awareness about the bleeding disorders and available cures, and favorable compensation policies. Patent expiry of existing brands will also provide generic drug manufacturers opportunities to enter the lucrative bleeding disorder therapeutics market. Market for bleeding disorder treatment is mostly focused towards western countries of North America and Europe, owing to the high price of branded drugs. Low cost drugs will help in market penetration in under developed and developing countries, where patients cannot afford high cost of medical treatment.  Hence, availability of cheap generic drugs will boost market growth in the countries of Middle East and Africa, Asia-Pacific (APAC), and Latin America.

North America is estimated to contribute the largest share of the market throughout the forecast period. The market in APAC is estimated to register the highest growth during the forecast period, owing to increasing awareness of these disorders in the emerging economies such as India and China.

The global bleeding disorder treatment market is highly competitive in nature. Technological advances will expand the boundaries of the market by adding new products such as Shire  launched Vonvendi in the U.S. (In 2016), bringing the first recombinant von Willebrand factor treatment to market eight months after winning approval from the Food and Drug Administration(FDA). Key players operating in the global bleeding disorders treatment market are Bayer Healthcare, Biogen Idec, Novo Nordisk, Xenetic Biosciences, Shire, Sanofi, Cangene Corporation, CSL Behring, Alnylam Pharmaceuticals, Pfizer, Inc., Novo Nordisk, Amgen, Inc., Janssen Pharmaceuticals, and Octapharma.

Key Developments:

  • In February 2020, Novo Nordisk A/S launched Esperoct, an anti-hemophilic factor in U.S. for the treatment of adults and children with hemophilia A i.e., to reduce as well as control the bleeding episodes even during surgery.
  • In December 2019, Johnson and Johnson in collaboration with Spanish multinational, Grifols, produced Vistaseal biological sealant, which is a blood stopping protein spray and is designed to quickly seal and control bleeding during complicated surgeries where suturing, ligature or cauterization cannot be applied. The spray consist of two clotting, human fibrinogen and thrombin, which helps in the sealing of the wound.
  • In 2018, on the occasion of 70th anniversary of National Hemophilia Foundation (NHF), a Red Tie Campaign was launched in order to create awareness about the bleeding disorders. The main aim of the campaign was to increase the accessibility of the quality healthcare to the patient suffering from bleeding disorders by providing them health insurance with life time benefits.
  • In 2018, European Association for Hemophilia and Allied Disorders formed a working group on women and bleeding disorders after receiving the approval for the proposal. The aim of the working group is to educate the healthcare providers and understand the needs of the women with bleeding disorders.
  • In 2017, LFB Biopharmaceuticals launched FibCLOT, the human fibrinogen concentrate. FibCLOT is effective in patients with congenital hypo- or afibrinogenaemia and who have high tendency to bleed.
  • In 2017, Pfizer launched Hemocraft, a modification of the video game Minecraft, especially for children who are 8-16 years old. The game educates the children about the importance of integrating treatment in their daily lives.
  • In 2017, another modification by Pfizer involves the development of HemMobile Striiv Wearable wrist band, for the patients suffering from hemophilia. The device helps to track daily activity levels and also monitors heart rate. The device integrates with the Pfizer’s existing HemMobile app, which helps people to monitor their bleeding episodes.
  • In June 2016, a scientist working at Kingston Health Sciences Center (KGHRI) launched a website “Let’s Talk Period”, where the women need fill the “self- administered bleeding assessment” (Self – BAT) form in order to diagnose whether they are suffering from bleeding disorders or not. The website also directs the women to the referral centers where they can consult with the respective doctors for the effective treatment.

Bleeding Disorders Treatment Market Taxonomy

By Type of Disorder,

  • Hemophilia A
  • Hemophilia B
  • von Willebrand Disease (vWD)

By Drug Class

  • Plasma Derived Coagulation Factor Concentrates
  • Recombinant Coagulation Factor Concentrate
  • Desmopressin
  • Antifibrinolytics
  • Fibrin sealants
  • Others

By Region

  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • Middle East
  • Africa
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