The market for anticoagulant reversal drugs is projected to experience strong growth, with a forecasted compound annual growth rate (CAGR) of 15.3% from 2018 to 2028. This growth can be attributed to the urgent requirement to reverse the effects of anticoagulants during emergency surgeries and episodes of severe bleeding. The approval of novel oral anticoagulants (NOACs) and the increased use of factor Xa inhibitors have contributed to the prevention and treatment of various medical conditions, including stroke, pulmonary embolism, atrial fibrillation, and deep vein thrombosis (DVT). However, this surge in usage has also resulted in an upsurge in hospital admissions and fatalities due to bleeding complications associated with anticoagulation. Data from the Centers for Disease Control and Prevention (CDC) reveals that in 2016 alone, approximately 117,000 hospitalizations and nearly 2,000 monthly deaths in the U.S. were attributed to bleeding related to anticoagulant or factor Xa inhibitor use. These alarming statistics have prompted extensive research and development into anticoagulant reversal agents, with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) granting priority status and fast-track approvals for certain antidotes. This market overview provides a comprehensive analysis of each segment for the period from 2016 to 2028, using 2017 as the base year.
With the increasing utilization of anticoagulants and factor Xa inhibitors, healthcare providers are facing a growing demand for effective and efficient reversal agents. This has led to a rise in the global demand for anticoagulant reversal drugs, particularly in developed countries such as the United States and Europe.
The growing elderly population and the rising prevalence of cardiovascular diseases have also contributed to the expansion of the anticoagulant reversal drug market. As the population ages, the risk of developing conditions that require anticoagulation, such as atrial fibrillation and DVT, increases as well. This has resulted in a higher demand for anticoagulants, thereby creating the need for effective reversal agents.
Key market trends and drivers:
The incidence of bleeding disorders has been increasing, with gastrointestinal (GI) hemorrhage accounting for nearly half of major bleeding incidents. Intracranial hemorrhage (ICH) is another significant ailment, especially among patients undergoing treatment with direct-acting oral anticoagulants (DOAC). Moreover, trends such as a rise in heart attack cases, sedentary lifestyles, and a growing elderly population are contributing to market growth. Additionally, the occurrence of atrial fibrillation (AFib), Von Willebrand disease (VWD), anemia, and other blood coagulation disorders is driving the demand for anticoagulant reversal drugs.
According to the World Health Organization (WHO), the global demographic segment over 65 years of age is rapidly expanding. It is projected that from 2000 to 2050, the proportion of the world’s population over 60 will double from about 11% to 22%. Data from the Centers for Disease Control and Prevention (CDC) shows that approximately 2% of people under 65 years and 9% over 65 years are affected by atrial fibrillation, with an estimated 12.1 million people expected to be affected by 2030. Therefore, the increasing elderly population is a significant driver of the global anticoagulant reversal drug market.
Bleeding disorders such as blood clots, hemophilia A and B, and Von Willebrand disease (VWD) are also prevalent. According to the National Hemophilia Foundation (NHF), between 30,000 and 33,000 people in the U.S. live with hemophilia, with 60% of these cases being severe. The CDC also reports that about 400 infants are born with hemophilia A annually. Von Willebrand disease is a common disorder, affecting 1 in 100 people. The complexities of these bleeding disorders necessitate the use of anticoagulants, which in turn increases the demand for anticoagulant reversal drugs in cases of uncontrolled bleeding.
Market growth is also driven by recent drug approvals. The U.S. FDA approved Portola Pharmaceutical, Inc.’s Andexxa in May 2018, the first factor Xa inhibitor reversal agent. Andexxa has demonstrated significant clinical efficacy during trials by effectively reversing the anticoagulation effects of rivaroxaban (Xarelto) and apixaban (Eliquis) during uncontrolled bleeding and life-threatening scenarios. As the use of factor Xa inhibitors increases, so does the market for Andexxa. Other significant contributors to the market include Idarucizumab and Prothrombin Complex Concentrates due to their extensive use in critical situations. Notably, Idarucizumab, approved in 2015, was the only drug capable of reversing the anticoagulant effects of dabigatran etexilate mesylate.
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Anticoagulant reversal drugs, despite their significant therapeutic potential, present challenges that may hinder the global market’s expansion. A crucial consideration is the potential side effects associated with these medications. Particularly in the elderly population, these drugs can sometimes result in excessive bleeding and other complications due to high dosages, thereby limiting market growth.
Equally important is the high cost associated with these drugs, which poses a significant barrier to market expansion. The substantial financial burden of anticoagulant reversal drugs can discourage potential users and impede market growth.
This report on the global anticoagulant reversal drugs market provides comprehensive details on recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, and market share. It also offers insights into the influence of domestic and localized market players, emerging revenue opportunities, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, and technological innovations in the market.
For further information on the global anticoagulant reversal drugs market, please contact Data Bridge Market Research for an analyst brief. Our team can provide guidance in making informed market decisions to facilitate market growth.
It is worth noting that the substantial cost of therapy and anticoagulant reversal drugs may restrict the market’s growth. The high expense could render these medications unaffordable for patients in dire need, potentially reducing demand, especially during economic crises in various countries.
Competitive Analysis
The global market for anticoagulant reversal drugs offers a competitive landscape, detailing a comprehensive overview of various competitors. The specifics provided include company overviews, financial metrics, revenue generated, market potential, investments in research and development, new market initiatives, global footprints, production sites and facilities, production capacities, strengths and weaknesses, product launches, product range and diversity, as well as application dominance. These data points are exclusively related to the companies’ focus on the global anticoagulant reversal drug market.
Key market participants in the anticoagulant reversal drugs sector encompass:
Pfizer Inc. (U.S.)
AstraZeneca (U.K.)
Bristol-Myers Squibb Company (U.S.)
Reddy’s Laboratories Ltd. (India)
Endo International plc (Ireland)
Teva Pharmaceutical Industries Ltd. (Israel)
Sun Pharmaceutical Industries Ltd. (India)
Mylan N.V. (U.S.)
Novartis AG (Switzerland)
Lupin (India)
Cipla Inc. (India)
Aurobindo Pharma (India)
Sanofi (France)
Merck & Co., Inc. (U.S.)
Amneal Pharmaceuticals LLC. (U.K.)
Alvogen (U.S)
Bausch Health Companies Inc. (U.S.)
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In July 2022, a UNC Charlotte researcher developed a new anticoagulant platform that can be used during heart surgeries.
In March 2022, Ondexxya (andexanet alfa) from AstraZeneca was approved in Japan for patients treated with the Factor Xa (FXa) inhibitors apixaban, rivaroxaban, or edoxaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
In October 2021, Alveron Pharma BV raised EUR 3.9 million to fund the continued development of OKL-1111, a first-in-class drug to treat anticoagulant-related bleeding.
In July 2020, VarmX, a renowned biotech company, raised EUR 32 million in Series B financing to develop an innovative reversal agent for the treatment and prevention of severe bleeding in patients on oral anticoagulants.
In January 2019, AMAG Pharmaceuticals completed the acquisition of Perosphere Pharmaceuticals. Through this acquisition, AMAG acquired the global rights to Perosphere’s next-generation anticoagulant reversal candidate, Ciraparantag.
Segmentations Analysis
By Drug Class
Prothrombin Complex Concentrates (PCC)
Vitamin K,
Protamine,
Tranexmic Acid,
Desmopressin,
Idarucizumab,
Andexxa
others
By Distribution Channel
Hospital Pharmacy
Retail Pharmacy
Online Pharmacy
By Geographically
North America
US
Canada
Europe
Germany
France
UK
Italy
Spain
Rest of Europe
Asia Pacific
China
Japan
India
South Korea
South-east Asia
Rest of Asia Pacific
Latin America
Brazil
Mexico
Rest of Latin America
Middle East and Africa
GCC Countries
South Africa
Rest of the Middle East and Africa
Chapter 1. Preface
1.1. Report Description
1.1.1. Study Purpose
1.1.2. Target Audience
1.1.3. USP and Key Offerings
1.2. Research Scope
1.3. Research Methodology
1.3.1. Phase I – Secondary Research
1.3.2. Phase II – Primary Research
1.3.3. Phase III – Expert Panel Review
1.3.4. Assumptions
1.4. Market Segmentation
Chapter 2. Executive Summary
2.1. Global ARD Market Portraiture
2.2. Global ARD Market, by Drug Class, (US$ Mn)
2.3. Global ARD Market, by Geography, (US$ Mn)
Chapter 3. Anticoagulant Reversal Drugs (ARD): Market Dynamics and Outlook
3.1. Market Overview
3.2. Drivers
3.3. Challenges
3.4. Opportunities
3.5. Attractive Investment Proposition, by Geography,
3.6. Competitive Analysis: Global ARD Market, by Key Players,
Chapter 4. Global Anticoagulant Reversal Drugs (ARD) Market, by Drug Class, (US$ Mn)
4.1. Overview
4.2. Prothrombin Complex Concentrates (PCC)
4.3. Vitamin K
4.4. Protamine
4.5. Tranexmic Acid
4.6. Desmopressin
4.7. Idarucizumab
4.8. Andexxa
4.9. Pipeline Analysis
4.9.1. Phase III Drugs
4.9.1.1. Octaplex
4.9.2. Phase I and II Drugs (Tabular Representation)
Chapter 5. Global Anticoagulant Reversal Drugs (ARD) Market, by Geography, (US$ Mn)
5.1. North America ARD Market Analysis,
5.1.1. North America ARD Market, by Drug Class, (US$ Mn)
5.1.2. North America ARD Market, by Country, (US$ Mn)
5.1.2.1. U.S.
5.1.2.2. Canada
5.2. Europe ARD Market Analysis,
5.2.1. Europe ARD Market, by Drug Class, (US$ Mn)
5.2.2. Europe ARD Market, by Country/Region, (US$ Mn)
5.2.2.1. U.K.
5.2.2.2. Germany
5.2.2.3. Rest of Europe
5.3. Asia Pacific ARD Market Analysis,
5.3.1. Asia Pacific ARD Market, by Drug Class, (US$ Mn)
5.3.2. Asia Pacific ARD Market, by Country/Region, (US$ Mn)
5.3.2.1. China
5.3.2.2. Japan
5.3.2.3. Rest of Asia Pacific
5.4. Latin America ARD Market Analysis,
5.4.1. Latin America ARD Market, by Drug Class, (US$ Mn)
5.4.2. Latin America ARD Market, by Country/Region, (US$ Mn)
5.4.2.1. Brazil
5.4.2.2. Mexico
5.4.2.3. Rest of Latin America
5.5. Middle East & Africa ARD Market,
5.5.1. Middle East & Africa ARD Market, by Drug Class, (US$ Mn)
5.5.2. Middle East & Africa ARD Market, by Region, (US$ Mn)
5.5.2.1. GCC
5.5.2.2. Rest of Middle East & Africa
Chapter 6. Company Profiles
6.1. Boehringer Ingelheim GmbH
6.1.1. Business Description
6.1.2. Financial Information (Subject to Data Availability)
6.1.3. Product Portfolio
6.1.4. News Coverage
6.2. Fresenius Kabi AG
6.3. Pfizer, Inc.
6.4. Bausch Health Companies, Inc.
6.5. Amneal Pharmaceuticals, Inc.
6.6. CSL Behring Limited
6.7. Octapharma AG
6.8. Portola Pharmaceuticals, Inc.
6.9. Perosphere Pharmaceuticals, Inc.
6.10. Ferring Pharmaceuticals
List of Figures
FIG 1. Anticoagulant Reversal Drugs (ARD) Market: Research Methodology
FIG 2. ARD: Market Segmentation
FIG 3. Global ARD Market, by Drug Class, (US$ Mn)
FIG 4. Global ARD Market, by Geography, (US$ Mn)
FIG 5. Attractive Investment Proposition, by Geography,
FIG 6. Competitive Analysis: Global ARD Market, by Key Players,
FIG 7. Global Prothrombin Complex Concentrates (PCC) for ARD Market, (US$ Mn)
FIG 8. Global Vitamin K for ARD Market, (US$ Mn)
FIG 9. Global Protamine for ARD Market, (US$ Mn)
FIG 10. Global Tranexmic Acid for ARD Market, (US$ Mn)
FIG 11. Global Desmopressin for ARD Market, (US$ Mn)
FIG 12. Global Idarucizumab for ARD Market, (US$ Mn)
FIG 13. Global Andexxa for ARD Market, (US$ Mn)
FIG 14. Global Octaplex for ARD Market, (US$ Mn)
FIG 15. U.S. ARD Market, (US$ Mn)
FIG 16. Canada ARD Market, (US$ Mn)
FIG 17. U.K. ARD Market, (US$ Mn)
FIG 18. Germany ARD Market, (US$ Mn)
FIG 19. Rest of Europe ARD Market, (US$ Mn)
FIG 20. China ARD Market, (US$ Mn)
FIG 21. Japan ARD Market, (US$ Mn)
FIG 22. Rest of Asia Pacific ARD Market, (US$ Mn)
FIG 23. Brazil ARD Market, (US$ Mn)
FIG 24. Mexico ARD Market, (US$ Mn)
FIG 25. Rest of Latin America ARD Market, (US$ Mn)
FIG 26. GCC ARD Market, (US$ Mn)
FIG 27. Rest of Middle East & Africa ARD Market, (US$ Mn)
List of Tables
TABLE 1 Global Anticoagulant Reversal Drugs (ARD) Market Portraiture
TABLE 2 Global ARD Market, by Drug Class, (US$ Mn)
TABLE 3 Global Phase I and II Drug for ARD Market
TABLE 4 Global ARD Market, by Geography, (US$ Mn)
TABLE 5 North America ARD Market, by Drug Class, (US$ Mn)
TABLE 6 North America ARD Market, by Country, (US$ Mn)
TABLE 7 Europe ARD Market, by Drug Class, (US$ Mn)
TABLE 8 Europe ARD Market, by Country/Region, (US$ Mn)
TABLE 9 Asia Pacific ARD Market, by Drug Class, (US$ Mn)
TABLE 10 Asia Pacific ARD Market, by Country/Region, (US$ Mn)
TABLE 11 Latin America ARD Market, by Drug Class, (US$ Mn)
TABLE 12 Latin America ARD Market, by Country/Region, (US$ Mn)
TABLE 13 Middle East & Africa ARD Market, by Drug Class, (US$ Mn)
TABLE 14 Middle East & Africa ARD Market, by Region, (US$ Mn)
TABLE 15 Boehringer Ingelheim GmbH: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 16 Fresenius Kabi AG: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 17 Pfizer, Inc.: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 18 Bausch Health Companies, Inc.: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 19 Amneal Pharmaceuticals, Inc.: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 20 CSL Behring Limited: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 21 Octapharma AG: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 22 Portola Pharmaceuticals, Inc.: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 23 Perosphere Pharmaceuticals, Inc.: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
TABLE 24 Ferring Pharmaceuticals: Company Snapshot (Business Description; Financial Information; Product Portfolio; Key Developments)
Frequently Asked Questions:
What is the size of Anticoagulant Reversal Drugs Market?
The market for Anticoagulant Reversal Drugs Market is expected to reach US$ XX Bn By 2028.
What is the Anticoagulant Reversal Drugs Market CAGR?
The Anticoagulant Reversal Drugs Market is expected to see significant CAGR growth over the coming years, at 15.3%.
What is the Forecast period considered for Anticoagulant Reversal Drugs Market?
The report is forecasted from 2018-2028.
What is the base year considered for Anticoagulant Reversal Drugs Market?
The base year of this report is 2018.
Who are the major players in this market?
Boehringer Ingelheim GmbH, Fresenius Kabi AG, Bausch Health Companies, Inc., Pfizer, Inc., CSL Behring Limited, Octapharma AG, Portola Pharmaceuticals, Inc., Perosphere Pharmaceuticals, Inc are some of the major players in the global market.
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