Anticoagulant Reversal Drugs Market

The global anticoagulant reversal drugs market size was valued at USD 1.01 Billion in 2022 and is anticipated to reach USD 3.30 Billion by 2031, expanding at a CAGR of 14.3% during the forecast period, 2023-2031. The growth of the market is attributed to the rising approval and new launches of new therapies to meet the treatment demand for the increasing prevalence of bleeding disorders.

Moreover, the market is being driven by the approval and introduction of new anticoagulant reversal medicines. In May 2018, the US Food and Drug Administration (FDA) authorized Portola Pharmaceuticals' Andexxa as the first factor Xa inhibitor antidote.

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The condition of uncontrolled or life-threatening bleeding necessitates the use of an anticoagulant reversal medicine, the patients on apixaban (Eliquis) or rivaroxaban use this reversal agent (Xarelto). Moreover, in August 2019, the pharmaceutical company announced the first sale of Ondexxya in Europe, owing to a higher percentage of patients taking Factor Xa inhibitors in Europe than in the US.

Andexxa has been designated as a breakthrough therapy by the FDA as well as an orphan medication in the US. Anticoagulant drugs, also known as blood thinning agents, are medications that aid in the reduction or prevention of blood coagulation and are often used to treat thrombosis.

Anticoagulant reversal medications such as Idarucizumab, are widely used to reverse anticoagulant effects in patients who have experienced a bleeding event or who have received an excessive dose of anticoagulant medication. Blood clots, Hemophilia A and B, and Von Willebrand disease are only a few example of the bleeding disorders (VWD).

According to the National Hemophilia Foundation (NHF), there are approximately 30,000 to 33,000 people in the US suffering from the disorder, with 60 percent of them are having severe stage of the disease. According to the CDC, around 400 newborns are born with Hemophilia A each year while one in every 100 persons is infected from Von Willebrand disease, which is one of the most common bleeding illnesses. 

Bleeding disorders cause abnormal blood coagulation, which can lead to excessive bleeding both inside and outside the patient's body. Atrial fibrillation, coronary artery disease, ischemic stroke, deep vein thrombosis, and pulmonary embolism are a few health conditions that require anticoagulant therapy.

According to the CDC, around 2% of persons under the age of 65 in the US have atrial fibrillation and it will be almost 12.1 million people by 2030. According to the health organization, around 60,000-100,000 Americans die each year from deep vein thrombosis or pulmonary embolism.

Anticoagulant Reversal Drugs Market Trends, Drivers, Restraints, and Opportunities

• Increasing prevalence of bleeding disorders and rising cases of abnormal blood coagulation are projected to boost the market growth during the forecast period.
• Rising development of new medications and favourable regulations from government regulatory bodies encouraging the adoption of anticoagulant therapy are anticipated to propel the market growth during the forecast period.
• Rapid development of innovative technology and rising establishment of advanced research centers for drug discovery present major drivers for the market.
• High cost of the therapy and several complications of excessive bleeding for using blood thinning drugs such as Heparin, Aspirin, and Warfarin are key challenges that can hamper the market growth.
• Ongoing massive R&D activities to improve the laboratory clinics for drug testing and development of new effective drug therapy are expected to create lucrative opportunities for the market in the coming years.

Scope of Anticoagulant Reversal Drugs Market Report

The report on the global anticoagulant reversal drugs market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Anticoagulant Reversal Drugs Market Segment Insights

Product Types Segment Analysis

Based on product types, the global anticoagulant reversal drugs market is divided into prothrombin complex concentrates, phytonadione, andexanet alfa, idarucizumab, protamine, and others. The idarucizumab segment accounted for a market share of more than 35.5% in 2020 and is expected to represent a key share of the market during the forecast period due to the high revenue generation by idarucizumab.

However, the andexanet alfa segment is anticipated to expand at a rapid pace during the forecast period owing to the high demand for andexanet alfa in the treatment for excessive bleeding disorders. The Centers for Medicare & Medicaid Services (CMS) assigned Andexxa a permanent J-code in April 2020, easing reimbursement system for the product in hospital outpatient settings. This presents a key driver for the segment expansion during the projected period.

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Distribution Channels Segment Analysis

On the basis of distribution channels, the market is segregated into hospital pharmacy, retail pharmacy, and online pharmacy. The hospital pharmacy segment is expected to account for a key share of the market during the forecast period owing to the fact that hospitals are the principal diagnostic and treatment sites for various forms of bleeding diseases.

The segment is also being driven by uncontrolled bleeding in emergency situations. In 2020, the retail pharmacy, which includes specialty pharmacies and other retail pharmacies, represented as the second-largest segment of the market.

Specialty medications are increasingly becoming an essential and rising penetration of retail pharmacies in emerging nations with limited access to hospitals and online pharmacies are key drivers for the segment growth.

Regional Analysis

In terms of regions, the anticoagulant reversal drugs market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. Asia Pacific is anticipated to expand at an impressive CAGR during the forecast period owing to rising governments’ initiatives for healthcare infrastructure development from emerging economies such as China and India, which have a big target population.

Furthermore, growing awareness and increasing cases of bleeding diseases in the region are driving to raise the demand for anticoagulant reversal medications. On the other hand, North America, representing with a revenue share of more than 40.2 percent in 2020, is predicted to constitute a large market share during the projected period.

High healthcare spending and favorable healthcare reimbursement rules for expensive pharmaceuticals especially in the US are two key factors driving the regional market expansion.
 

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Segments

The global anticoagulant reversal drugs market has been segmented on the basis of

Product Types

• Prothrombin Complex Concentrates
• Phytonadione
• Andexanet Alfa
• Idarucizumab
• Protamine
• Others

Distribution Channels

• Hospital Pharmacy
• Retail Pharmacy
• Online Pharmacy

Regions

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

Key Players

• 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

Competitive Landscape

Key players competing in the 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.; and Fresenius Kabi AG. To achieve a considerable market share, key players are pursuing several strategic efforts such as new product development and collaborations. For example,

• In April 2018, Boehringer Ingelheim announced that its Praxbind has received FDA approval (idarucizumab), which was a Pradaxa-specific reversal agent.