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Global Bleeding Disorders Treatment Market

Bleeding disorders are a group of conditions in which there is a problem with the blood clotting process of the body. These disorders can lead to heavy and prolonged bleeding after an injury. Bleeding can also begin on its own. Some bleeding disorders are present at birth and are passed down through families (inherited). Others develop from illnesses, such as vitamin K deficiency, severe liver disease, and treatments, such as the use of drugs to stop blood clots (anticoagulants) or the long-term use of antibiotics.

Market Size & Growth Rate:

The bleeding disorders treatment was valued at USD 12.8 billion in 2021 and is projected to reach USD 18.6 billion by 2027, with a CAGR of 7.6% over the forecast period 2022-2027. The growth could be attributed to the return of demand to pre-pandemic levels, increasing authorization of novel & innovative medicines, extensive research, disease prevalence, and immunotherapies.

Market Dynamics:

  • The factors driving the growth of the bleeding disorder treatment market are the rise in the prevalence of liver disorders, anemia, and other blood coagulation disorders. The increasing awareness of bleeding disorders treatment and improving healthcare infrastructure in developing countries will also fuel the scope of market growth.

  • According to WFH (World Federation of Hemophilia) data-2021, the estimated prevalence at birth and the current live birth population globally from UNICEF (at least 130 million babies are born each year), approximately 20,000 new cases of hemophilia is reported worldwide each year, of which 7,000 are severe.

  • In addition, the estimated and present world male population of 7.8 billion, the anticipated number of patients with hemophilia worldwide is 815,100, about 276,900 of them are seriously ill.

  • Von Willebrand disease, the most common inherited bleeding disorder in the United States caused by clotting proteins, affects a large number of people. This disease affects both men and women and affects nearly 1% of the population in the United States. According to the Centers for Disease Control and Prevention (CDC), approximately 400 newborns in the United States are affected by haemophilia each year.

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Global Bleeding Disorders in 2020

According to WFH-2021, the number of patients with hemophilia-A is projected to major growth rate, followed by Von Willebrand disease across the globe, as hemophilia-A is the first line of impact for bleeding disorders treatment platforms.

Market Drivers:

  • Growing prevalence of hemophilia across the globe

  • The increasing prevalence of hemophilia contributing to the rising demand for treatment options is one of the prime factors driving the hemophilia treatment market expansion.

  • Severe patients need a regular hemophilia treatment regimen to maintain enough clotting factors in the bloodstream to prevent bleeding. As per the Centers for Disease Control and Prevention, hemophilia A affects 1 in 5,000 male births each year in the U.S. This considerable prevalence is set to dramatically impact the market since the number of dependent patients requiring quality care is increasing.

  • Moreover, patients that receive proper care are expected to develop fewer illness conditions and experience a lower risk of severe bleeding. Thus, the continuously increasing patient number has significantly boosted the demand for hemophilia treatment that in turn will increase the product adoption rate

  • The increase in research and development activities and growing awareness

  • Increasing the demand for recombinant coagulation factor concentrate

Challenges:

  • The side effects of the medication are anticipated to hamper the market growth

  • The adverse effects of bleeding disorder therapeutics are anticipated to restrict the market growth during the forecast period. For instance, the use of coagulation factor concentrates in the treatment of hemophilia may lead to the development of alloantibodies that work against factor VIII or factor IX.

  • The development of such alloantibodies occurs in around 15% to 35% of patients suffering from hemophilia A. Even though around 50% of the factor VIII or factor IX inhibitors are low tier, the high tier inhibitors can lead to increased severity of hemophilia, resulting in a greater risk of excessive bleeding to the patient.

  • Moreover, treatment using plasma-derived products can increase the risks of transmitting blood-borne pathogens such as prions and HIV, if the screening process is not conducted appropriately.

  • Shortage of clinicians & unfavorable reimbursement situations hampering the market growth

  • The high cost associated with the hemophilia treatment

Competitive Landscape:

CSL Behring (U.S.), Grifols International (U.S.), Octapharma (Switzerland), Pfizer (U.S.), Biogen Idec, Xenetic Biosciences (U.S.), Sanofi (France), Cangene Corporation (Canada), Alnylam Pharmaceuticals (U.S.)Amgen U.S), Johnson & Johnson Services, Inc. (U.S.), Novartis AG (Switzerland), Akorn Operating Company LLC (U.S.), Bausch & Lomb Incorporated (Canada), AbbVie Inc. (U.S.),  Prestige Consumer Healthcare Inc. (U.S.), Thea Laboratories (France),  Wellona Pharma (India),   Bayer AG (Germany), Zydus Group, Amneal Pharmaceuticals LLC (India), OASIS Medical (U.S.), Alcon (Switzerland), and Santen Pharmaceutical Co., Ltd. (Japan)

Key Developments:

Competitors in the global bleeding disorders market are engaged in regulatory approvals, the development of new services, and acquisition & collaborative agreements with other companies. A few expansion strategies are adopted by players operating in the bleeding disorders market.

  • In February 2020, Novo Nordisk launched Esperoct, an anti-hemophilic factor in the U.S. for the treatment of adults & children with hemophilia A and to control bleeding issues even during surgery.

  • In March 2019, Biotest AG received regulatory approval from 13 European countries for its product offering for the treatment of Hemophilia-A.

  • In December 2019, Johnson and Johnson collaboration with Spanish multinational, Grifols, introduce a Vistaseal biological sealant, which is a blood-stopping protein spray that controls bleeding during complicated surgeries where suturing, and ligature cannot be applied.

  • In December 2019, Bayer AG has collaborated for three-year with the children’s hospital. The main motto of collaboration is “The development of small molecules to treat hemophilia A and B”.

  • In 2018, on the occasion of the 70th anniversary of the National Hemophilia Foundation (NHF), a Red Tie Campaign was launched to create awareness about bleeding disorders and increase the accessibility of quality healthcare to patients suffering from bleeding disorders by providing them with health insurance, and lifetime benefits.

  • In 2018, European Association for Hemophilia and Allied Disorders formed a working group on women and bleeding disorders after receiving approval for the proposal. The working group focuses on educating healthcare providers and understanding the needs of women with bleeding disorders.         

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