When anticoagulant therapy needs to be reversed or neutralised due to bleeding problems, an overdose of anticoagulant therapy, or unexpected surgery, anticoagulant reversal drugs are required. Anticoagulant reversal is a key step in the treatment of patients who are taking an anticoagulant and are experiencing life-threatening bleeding. The reversal medications recommended by doctors are determined by the patient's anticoagulant of choice. Direct oral anticoagulants (DOACs) consists of dabigatran etexilate, a direct thrombin inhibitor, and specific inhibitors of stimulated coagulation factor X (apixaban, betrixaban, edoxaban, and rivaroxaban). DOACs are linked with lower rates of main and serious bleeding events compared with warfarin. In an emergency situation, clinicians need to attain rapid reversal of anticoagulation effects of the DOACs. Idarucizumab and andexanet alfa, which reverse the anticoagulant effects of dabigatran and FXa inhibitors are DOAC reversal drugs.
The global anticoagulant reversal drugs market is estimated to be valued at US$ 861.6 million in 2021 and is expected to exhibit a CAGR of 14.9% during the forecast period (2021-2028)
Figure 1. Global Anticoagulant Reversal Drugs Market Share (%) in Terms of Value, By Product Type, 2021
Key players operating in the global anticoagulant reversal drugs market are focusing on acquisitions and mergers, which is expected to drive the market growth.
Increasing acquisition provides the opportunity to expand commercial range of anticoagulant reversal drugs, which is expected to drive the market growth during the forecast period. For instance, in May 2020, Alexion Pharmaceuticals, Inc. announced acquisition of Portola Pharmaceuticals, Inc. The acquisition includes Andexx [coagulation factor Xa (recombinant), inactivated-zhzo], branded as Ondexxya, a Factor Xa inhibitor reversal medication. Alexion Pharmaceuticals, Inc. acquired Portola through a tender offer and subsequent merger with Odyssey Merger Sub Inc. Near-term diversification will be added by this acquisition to Alexion’s commercial portfolio.
|Base Year:||2020||Market Size in 2021:||US$ 861.6 Mn|
|Historical Data for:||2017 to 2020||Forecast Period:||2021 to 2028|
|Forecast Period 2021 to 2028 CAGR:||14.9%||2028 Value Projection:||US$ 2,282.7 Mn|
Portola Pharmaceuticals, Boehringer Ingelheim, CSL Behring, Bausch Health Companies Inc., Octapharma AG, Dr. Reddy's Laboratories, AMAG Pharmaceuticals, Inc., Pfizer, Inc., SGPharma Pvt. Ltd., Alps Pharmaceutical Ind. Co., Ltd., Fresenius Kabi AG, Mundipharma International Limited, and Hisamitsu Pharmaceutical Co., Inc
|Restraints & Challenges:||
Figure 2. Global Anticoagulant Reversal Drugs Market Share (%), By Distribution Channel, 2021
Increasing requirement of anticoagulants for blood-related disorders boost the demand for anticoagulant reversal drugs in case of uncontrolled bleeding, which is anticipated to drive the market growth.
Increasing demand for anticoagulant reversal drugs in case of uncontrolled bleeding is expected to drive the market growth during the forecast period. Some of the common bleeding disorders include blood clots, Von Willebrand disease, and hemophilia A and B. One out of 100 individuals are affected by Von Willebrand disease as it is a very common bleeding disorder. Bleeding disorders can cause undesirable bleeding from the patient’s body as well as affect blood clotting. For instance, there are around 30,000 to 33,000 people in the U.S. who are suffering from hemophilia and approximately 60% of them are suffering from acute hemophilia, according to the National Hemophilia Foundation (NHF).
Global Anticoagulant Reversal Drugs Market– Impact of Coronavirus (COVID-19) Pandemic
The unanticipated COVID-19 epidemic had a significant beneficial influence on anticoagulant reversal medicines, with an increase in the number of research and development efforts focused primarily on COVID-19 infection. For instance, about ten clinical trials are now underway to assess the efficacy of factor Xa inhibitors in COVID-19 patients, as revealed by a paper published in the American Journal of Cardiovascular Drugs, in 2020. The development of methods for the parenteral delivery of these medicines that are useful in the treatment of severe COVID-19 patients. As a result, the COVID-19 pandemic will drive the global anticoagulant medication market throughout the projection period.
Global Anticoagulant Reversal Drugs Market: Restraint
The high cost of anticoagulant reversal drugs is one of the restraining factor that is expected to hinder the market growth during the forecast period. 4-F PCC (Kcentra) supports in treating bleeding cases due to apixaban and rivaroxaban and it is administered at 50 units/k, according to the American College of Cardiology. Its average wholesale price is US$ 2.90 per unit, thus treating a patient whose weight is 100 kg that cost about US$ 14,500.
Major players operating in the global anticoagulant reversal drugs market include Portola Pharmaceuticals, Boehringer Ingelheim, CSL Behring, Bausch Health Companies Inc., Octapharma AG, Dr. Reddy's Laboratories, AMAG Pharmaceuticals, Inc., Pfizer, Inc., SGPharma Pvt. Ltd., Alps Pharmaceutical Ind. Co., Ltd., Fresenius Kabi AG, Mundipharma International Limited, and Hisamitsu Pharmaceutical Co., Inc.
Anticoagulation drug therapy is prescribed in patients who are suffering from a venous atrial fibrillation (AF), thromboembolism, mechanical valve replacement, and other coagulation disorders such as antiphospholipid antibody syndrome and Factor V Leiden. In some instances, such as unexpected surgery or anticoagulant overdose, anticoagulant reversal drugs are necessary to reverse the impact of anticoagulation. Increased frequency of cerebral & gastrointestinal haemorrhage and new technology add-on status (NTAP) granted to certain medicines, which focuses on the development of specialised drugs for anticoagulation reversal. Fresh frozen plasma is frequently used to counteract the effects of warfarin, although complete reversal takes six to 24 hours. Prothrombin complex concentrates (PCCs) can be utilised in more urgent situations since they give full anticoagulation reversal in 15-20 minutes.
Several reversal medicines have been developed for patients using newer oral anticoagulants. However, it should be emphasised that these newer anticoagulants have short half-lives (5-17 hours), and reversal is rarely indicated. Reversal medicines have a risk of life-threatening thrombosis and should be used only under the supervision of a professional with experience in their usage and/or in a patient who is at urgent danger of death from bleeding. In most cases, a single dosage is administered. However, dosing may be repeated in exceptional cases when the oral anticoagulant remains in the blood for a prolonged period of time, such as severe renal failure.
Increasing spending in research and development is anticipated to propel the anticoagulant reversal drugs market growth during the forecast period. For instance, in December 2020, Octa Pharma USA released the findings of clinical study conducted to assess the safety and efficacy of fibryga, a Human Fibrinogen Lyophilized Powder for Reconstitution recommended for intravenous use in the treatment of congenital and acquired bleeding disorders, in the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.