Anticoagulant Reversal Drugs Market Size, Share & Trends Analysis Report By Product Type (Prothrombin Complex Concentrates, Phytonadione, Andexanet Alfa, Idarucizumab, Protamine), By Distribution Channel (Hospital Pharmacy, Retail Pharmacy, Online Pharmacy) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2024-2032

Market Overview

The global anticoagulant reversal drugs market size was valued at USD 880.92 million in 2021 and is expected to reach USD 2970.44 in 2030 expanding at a compound annual growth rate (CAGR) of 14.46% from 2022 to 2030.

Anticoagulant medications, also known as blood thinning agents, are pharmacological drugs that aid in decreasing or preventing the coagulation of blood. These drugs are often used in the treatment of thrombosis. Blood thinning agents are another name for anticoagulant pills. Anticoagulant reversal medications such as Idarucizumab are used to reverse the effects of anticoagulants when they are administered in situations in which bleeding complications develop or when an excessive amount of anticoagulant treatment has been administered. Anticoagulant reversal medicines are necessary in order to reverse the impact of anticoagulation in some circumstances, such as when unforeseen surgery, an overdose of anticoagulant treatment, or uncontrolled bleeding occurs. Medical problems such as venous thromboembolism, atrial fibrillation (AF), mechanical valve replacement, and other coagulation abnormalities such as antiphospholipid antibody syndrome and Factor V Leiden are treated with anticoagulant reversal medicines. Patients diagnosed with AFib make extensive use of oral anticoagulants due to their high level of efficacy in the prevention of thromboembolism. However, the use of anticoagulants is associated with an increased risk of bleeding in AFib patients; hence, anticoagulant reversal medications are prescribed to these patients in order to reduce or eliminate the risk of bleeding.

Market Dynamics

Global anticoagulant reversal drugs market drivers

The rising need for anticoagulants due to blood-related illnesses is predicted to fuel market expansion

The expansion of the market is anticipated to be driven during the forecast period by the rising demand for anticoagulant reversal medications that may be used in the event of uncontrolled bleeding. Clots in the blood, Von Willebrand disease, and the bleeding diseases hemophilia A and B are examples of some of the most prevalent bleeding disorders. Because it is such a prevalent bleeding illness, Von Willebrand disease affects approximately one person out of every one hundred people. Disorders that induce bleeding can prevent blood from clotting normally and can cause the patient to experience uncontrolled bleeding from the body. According to the National Hemophilia Foundation, there are around 30,000 to 33,000 persons in the United States who are afflicted with haemophilia, and roughly 60% of these people are afflicted with acute haemophilia (NHF).

The key competitors in the worldwide anticoagulant reversal medication market are concentrating on mergers and acquisitions, which is anticipated to fuel market expansion

The rising number of mergers and acquisitions has the possibility of expanding the commercial range of anticoagulant reversal medications, which is anticipated to be the primary factor driving market expansion over the course of the forthcoming time period. For example, Alexion Pharmaceuticals, Inc. made the announcement that they will be acquiring Portola Pharmaceuticals, Inc. in May 2020. This purchase contains the medicine Andexx (coagulation factor Xa (recombinant), inactivated-zhzo), which is marketed under the trade name Ondexxya and acts as a Factor Xa inhibitor reversal agent. Through a combination of a tender offer and a later merger with Odyssey Merger Sub Inc., Alexion Pharmaceuticals, Inc. was able to purchase Portola. The commercial portfolio of Alexion will receive some diversity soon as a result of this purchase.

Increase in atrial fibrillation rate (afib)

Patients diagnosed with AFib make extensive use of oral anticoagulants due to their high level of efficacy in the prevention of thromboembolism. However, the use of anticoagulants is associated with an increased risk of bleeding in AFib patients; hence, anticoagulant reversal medications are prescribed to these patients in order to reduce or eliminate the risk of bleeding.

According to the Centers for Disease Control and Prevention (CDC), in the United States in 2018, atrial fibrillation was noted on about 175,326 death certificates, and it was listed as the leading cause of death in approximately 25,845 of those fatalities. In addition to that, it has also been predicted that there would be 12.1 million persons in the United States who have AFib by the year 2030.

Furthermore, the European Society of Cardiology (ESC) reports that in 2016, 7.6 million adults over the age of 65 in the EU suffered from atrial fibrillation. This figure will rise by 89% to reach 14.4 million by the year 2060. In a similar vein, the Stroke Association's State of the Nation 2017 report states that more than one million people in the UK are affected by atrial fibrillation.

Anticoagulant reversal drugs market restraints

The high price of anticoagulant reversal medications is one of the factors that is predicted to serve as a restraint on the growth of the market over the course of the period covered by the forecast. According to the American College of Cardiology's recommendations, the dose of 4-F PCC (Kcentra) that is used to treat patients who have had bleeding as a side effect of apixaban or rivaroxaban is 50 units/k. Its typical wholesale price is $2.90 USD per unit, which means that the cost of treating a patient whose weight is 100 kg would be around $14,500 USD.

Regional Analysis

In 2019, North America had the greatest revenue share, at 39.62%, and it is anticipated that it will continue to hold this position for the duration of the projection period. Within the North American market, the United States held the largest share. A high level of healthcare expenditure as well as advantageous healthcare reimbursement regulations for expensive pharmaceuticals is two of the most important reasons leading to its expansion. In addition, the rapid accessibility of these reversal medications in times of critical need is a major factor boosting demand in the regional market.

During the period covered by the forecast, growth in the Asia Pacific is anticipated to be the most rapid overall. The existence of a sizable target demographic in growing economies like China and India has been a major factor in considerably supporting the expansion of the regional market. The demand for anticoagulant reversal medications in this region is being driven in part by the growing awareness of bleeding disorders in the region as well as the rising prevalence of bleeding disorders in the region.

Segmental Analysis

In 2019, the idarucizumab segment held the greatest share of the market at 36.77%, and it is projected that it will continue to hold this position throughout the forecast period. This might be added to the fact that idarucizumab generates a significant amount of money in important regions. The market may be broken down into several different categories, such as prothrombin complex concentrates, phytonadione (vitamin K), andexanet alfa, idarucizumab, protamine, and others, depending on the kind of product being sold.

As a result of the approval of andexanet alfa and its subsequent introduction in major regions, it is projected that the andexanet alfa sector will develop at a profitable CAGR over the course of the projection year. The Centers for Medicare & Medicaid Services (CMS) will assign a permanent J-code for Andexxa in April of 2020. This will be easier for hospitals to reimburse patients for their use of the medication in outpatient settings. Considering this, it is projected that a favourable reimbursement landscape for andexanet alfa in major markets would support the segment's growth for the duration of the projection period.

In 2019, the hospital pharmacy had the majority of the market share, accounting for 49.2%. This is because hospitals are the principal sites for the diagnosis and treatment of many forms of bleeding problems, and they are the only places where these conditions may be treated. The uncontrolled bleeding that might occur in life-threatening situations is another factor pushing the industry. Retail pharmacies, hospital pharmacies, and internet pharmacies are the three primary sub-segments that comprise this industry on the basis of the distribution channel.

In 2019, the share that was contributed by retail pharmacies was the second greatest. There are specialty pharmacies as well as conventional retail pharmacies in this category. In the pharmacy industry of the future, specialty medications will play a significant and more crucial role. Additionally, it is possible that the expansion of this market sector is the result of the high penetration of retail pharmacies in developing economies, which often have restricted access to hospitals and online pharmacies.

Recent Developments

• The Phase 1 clinical study for the assessment of the reversal of the anticoagulant effect of the medication JNJ-70033093 by 4-Factor Prothrombin Complex Concentrate (4F-PCC) and Recombinant Human Factor VIIa started in July 2020 by Janssen Research & Development LLC.
• Andexxa, a recombinant coagulation factor Xa, was given a permanent J-code (J7169) by the Centers for Medicare & Medicaid Services (CMS) in July 2020, allowing coverage in hospital outpatient settings. This was disclosed by Portola Pharmaceuticals Inc.