Anticoagulant Reversal Drugs Market

Anticoagulant Reversal Drugs Market outlook (2022-2032)

In FY 2022, the Anticoagulant Reversal Drugs market reached a valuation of US$ 989.0 Million and is likely to register a Y-o-Y growth rate of 13.0% in 2023, closing at US$ 1,137.35 Million. Furthermore, across the 2022-2032 period of assessment, growth is expected to accelerate at a whopping 15.0% CAGR, reaching US$ 4,601.22 Million.

Report Attributes	Details
Anticipated Base Year Value (2022)	US$ 989.0 Million
Expected Market Value (2023)	US$ 1,137.35 Million
Projected Forecast Value (2033)	US$ 4,601.22 Million
Global Growth Rate (2022-2032)	15.0% CAGR
Expected Growth Rate of the North American Market (2022-2032)	14.8% CAGR
Anticipated Growth Rate of the Asia Pacific Market (2022-2032)	14.7% CAGR
Prominent Service Players	Bausch Health Companies, Inc. Pfizer, Inc. Fresenius Kabi AG Amneal Pharmaceuticals, Inc. Boehringer Ingelheim GmbH CSL Limited Octapharma AG Portola Pharmaceuticals, Inc. Perosphere Pharmaceuticals, Inc.

Bleeding disorders can happen as a result of some medications, such as blood thinner, which includes warfarin, heparin, and aspirin. The high risk of bleeding varies with the anticoagulant agent used. According to the National Center for Biotechnology Information (NCBI) data, the occurrence of bleeding for patients taking warfarin has been projected at 15-20% each year.

Life-threatening bleeding because of warfarin has been projected at a rate of 1-3% per year. Thus, the increase in demand for anticoagulant therapies is further creating potential opportunities for reversal agents for anticoagulants.

2017-2021 Revenue Analysis of Anticoagulant Reversal Drugs Market vs. Growth Outlook 2022-2032

According to Fact.MR, market research and competitive intelligence provider, the global market for anticoagulant reversal drugs expanded at a 7.7% CAGR from 2017 to 2022, topping US$ 860.0 Million as of 2021.

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.

Moreover, rise in usage of reversal agents for life-threatening conditions or uncontrolled bleeding is projected to drive the global market size in the near future. Increase in cases of bleeding is anticipated to lead to unmet clinical needs owing to the unavailability of specific reversal agents.

Key Market Drivers Influencing Anticoagulant Reversal Drugs Industry Expansion

Increase in Bleeding Disorders among People to Foster Market Growth Prospects

Several bleeding disorders include blood clots, hemophilia A and B, and Von Willebrand disease (VWD). As per the data by the National Hemophilia Foundation (NHF), approximately 30,000 to 33,000 people are surviving in the U.S. with hemophilia and 60% of them suffer from severe hemophilia.

The CDC reports that around 400 babies are annually born with hemophilia A. This disease called Von Willebrand disease is one of the most common bleeding disorders affecting 1 in every 100 people.

There are tremendous complications of bleeding disorders that affect blood clotting and might result in extreme bleeding inside and outside the patient’s body. This enables the need for anticoagulants, which gives rise to the demand for anticoagulant reversal drugs during uncontrolled bleeding.

Rise in the Population of Elderly People to Fuel the Market Growth

According to the World Health Organization (WHO), people over the age of 65 are the fastest demographic segment in the world. Between 2000 and 2050, the proportion of the world's population over the age of 60 is expected to double, increasing from about 11% to 22%.

As per the reports of the CDC, approximately 2% of people below 65 years of age have atrial fibrillation, while 9% of people who are above 65 years of age have the disease. It is also estimated that almost 12.1 million people will develop atrial fibrillation by 2030. As a result, the growing elderly population is driving the global market growth during the forecast period.

Key Challenges encountered by Anticoagulant Reversal Drugs Industry

High Expenditure Cost of Coagulant Reversal Drugs to Hamper the Market Growth

The huge expenditure on anticoagulant reversal drugs is one of the major factors that is anticipated to hinder the growth of the market over the analysis period.

As per the American College of Cardiology, 4-F PCC (Kcentra) helps in treating bleeding cases caused by rivaroxaban and apixaban and it is dosed at 50 units/kg. Its average wholesale price is USD 2.90 per unit, therefore treating a patient whose weight is 100 kg would cost around USD 14,500.

Side Effects of Medicines to Affect the Market Growth

Some types of medicines can adversely affect the health of the population, especially the elderly. Sometimes, it may result in excessive bleeding and the higher dosage can lead to many complications. Therefore, the side effects of drugs limit the expansion of the global market.

Region-wise Analysis

How will North America Perform in the Global Anticoagulant Reversal Drugs Industry Landscape?

Increase in Prevalence of Cardiovascular Diseases to Boost the Market Growth

North America held the largest revenue share of 41.1% in 2021 and is expected to maintain the lead throughout the forecast period. The U.S. accounted for the leading share in the North American market. Key factors contributing to its growth include high healthcare expenditure and favorable healthcare reimbursement policies for costly drugs. In addition, the easy availability of these reversal drugs during emergency conditions and growing cases of surgery and higher approvals of drugs are some factors that are driving the regional market.

In the region, the United States holds the largest market share due to the accelerated drug approval initiative by the USFDA, and the initiation of various prevention programs and awareness workshops for blood disorders by the Centers for Disease Control and Prevention, which is expected to drive the market growth in this region.

Furthermore, the high prevalence of cardiovascular diseases in the United States drives the studied market. According to the American Heart Association, every 40 seconds, an American will have a myocardial infarction, and coronary events are estimated to occur in about 1,055,000 individuals, including 720,000 new and 335,000 recurrent coronary events in 2019 in the United States. According to Fact.MR, North America is expected to expand at a CAGR of 14.8% until 2032.

How will the Growth of Anticoagulant Reversal Drugs Market Escalate across Asia Pacific?

Increasing Geriatric Population to Enhance the Market Prospects

The market in Asia Pacific is projected to grow at a rapid pace during the forecast period. Increase in geriatric population in Japan and China, high prevalence & rise in incidence rates of arterial fibrillation, and new product commercialization are anticipated to propel the market in Asia Pacific during the forecast period.

In addition, increasing awareness and rising incidence of bleeding disorders are propelling the demand for anticoagulant reversal drugs in this region. Asia-Pacific leads the market due to the developing healthcare facilities, large number of generic manufacturer and rise in government initiatives and specialist communities.

Other key factors contributing to the market growth in the region include high healthcare expenditure and favorable healthcare reimbursement policies for costly drugs. In addition, the easy availability of these reversal drugs during emergency conditions is driving the regional market. According to Fact.MR, Asia Pacific is expected to expand at a CAGR of 14.7% until 2032.

Region-wise Forecast CAGRs for the Anticoagulant Reversal Drugs Market

Region	CAGR
North America	14.8%
Asia Pacific	14.7%
Europe	14.6%
Middle East & Africa	14.5%
Latin America	14.4%

Category-wise Insights

Which is the Most Sought-after Product Category?

Increased Usage of Idarucizumab Drug to Boost the Segment’s Growth

In terms of product, Idarucizumab segment is prospective to earn greater traction, expanding at a CAGR of 14.3% over the forecast period. Idarucizumab market segment for anticoagulant reversal drugs accounted for the largest revenue share in 2020, and likely to witness the highest growth rate over the analysis period.

This high share is attributed to its high potential and legacy drug being effective. Moreover, the drug is in more demand due to its high efficacy and specificity. However, the Andexanet alfa segment is projected to witness the highest growth rate over the assessment period. The expected growth is due to the approval of the anticoagulant reversal drug in key geographic markets.

For instance, in 2020, the Centers for Medicare & Medicaid Services (CMS) allocated a permanent reimbursement code J for the concerned drug Andexxa, facilitating an easy reimbursement system for the drug in the outpatient settings. Hence, a favorable reimbursement scenario for the drug in the major developed markets is projected to support the segment’s market growth prospects in anticoagulant reversal drugs industry.

Which Segment to Remain Dominant in the Distribution Channel Category?

Hospital Pharmacy Segment to Enhance Growth Prospects

Based on distribution channel, hospital pharmacy segment dominated the market with a 52.2% share in 2021. This is attributed to the fact that hospitals are the primary centers for the diagnosis and treatment of different types of bleeding disorders. Uncontrolled bleeding during emergency conditions is further driving the segment. In terms of distribution channel, the segment is prospective to earn greater traction, expanding at a CAGR of 14.5% over the forecast period.

Anticoagulant Reversal Drugs Market- Competitive Landscape

Prominent players in the Anticoagulant Reversal Drugs Industry are taking advantage of the rapidly increasing demand in various applications. To further their outreach, players are relying on collaborations, partnerships and acquisitions with existing small, medium and large-scale vendors. Some prominent market developments are as follows:

• In October 2021, Alveron Pharma BV raised EUR 3.9 Mn 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 Mn in series B financing to develop an innovative reversal agent for the treatment and prevention of severe bleeding in patients on oral anticoagulants.
• In July 2020, Janssen Research and Development LLC began the Phase 1 clinical trial for the evaluation of the reversal of the anticoagulation effect of the drug JNJ-70033093 by 4-Factor Prothrombin Complex Concentrate (4F-PCC) and Recombinant Human Factor VIIa.
• In July 2020, Portola Pharmaceuticals Inc. announced the establishment of a permanent J-code (J7169) by the Centers for Medicare & Medicaid Services (CMS) for Andexxa, a recombinant coagulation factor Xa, which allows reimbursement in the hospital outpatient settings.

Key Segments Covered in the Anticoagulant Reversal Drugs Industry Survey

• By Product :

  • Prothrombin Complex Concentrates
  • Vitamin K
  • Protamine
  • Tranexamic Acid
  • Idarucizumab
  • Andexxa
  • Others

• By Distribution Channel :

  • Hospital Pharmacies
  • Retail Pharmacies
  • Others

• By Region :

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