Direct Oral Anticoagulants (DOACs) Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Drug Type (Factor Xa Inhibitors, Direct Thrombin Inhibitors), By Indication (Atrial Fibrillation (AF), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Stroke Prevention, Others), By End User (Hospitals & Clinics, Ambulatory Surgical Centers, Home Care Settings, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 33.36 Billion
CAGR (2026-2031)	7.65%
Fastest Growing Segment	Atrial Fibrillation (AF)
Largest Market	North America
Market Size (2031)	USD 51.92 Billion

Market Overview

The Global Direct Oral Anticoagulants (DOACs) Market will grow from USD 33.36 Billion in 2025 to USD 51.92 Billion by 2031 at a 7.65% CAGR. Direct Oral Anticoagulants are specialized therapeutic agents that selectively inhibit specific coagulation proteins, such as thrombin or Factor Xa, to prevent the formation of blood clots. The market for these pharmaceuticals is expanding rapidly, driven by the aging global population and the rising incidence of thromboembolic conditions like atrial fibrillation and deep vein thrombosis. Additionally, the clinical shift away from traditional Vitamin K antagonists supports growth, as patients and providers increasingly favor the predictable pharmacokinetics and reduced monitoring requirements of newer options. According to the American Heart Association, in 2024, cardiovascular disease accounted for approximately one out of every three deaths globally, highlighting the urgent and sustained demand for effective stroke prevention and thrombosis management strategies.

However, market expansion faces a substantial hurdle regarding the risk of major bleeding events associated with these potent medications. Although reversal agents are available, their high acquisition cost and limited accessibility in emerging economies frequently deter widespread adoption, presenting a significant challenge to the universal uptake of these advanced anticoagulant therapies.

Key Market Drivers

The rising prevalence of atrial fibrillation and venous thromboembolism, particularly within an aging global demographics, constitutes the primary catalyst for market expansion. As life expectancy increases, the incidence of these thromboembolic conditions rises significantly, necessitating effective long-term anticoagulation strategies to mitigate the risk of stroke and systemic embolism. This demographic trend creates a consistent and expanding patient pool requiring chronic therapeutic intervention. According to the Centers for Disease Control and Prevention, May 2024, in the 'Atrial Fibrillation' report, it is projected that 12.1 million people in the United States will have atrial fibrillation by 2030, underscoring the intensifying burden of this condition. This projection highlights the urgent necessity for accessible and effective treatments to manage the associated risks in this growing vulnerable population.

Simultaneously, the market is being driven by the superior clinical profile and convenience of these therapies compared to traditional Vitamin K antagonists. Healthcare providers and patients are increasingly prioritizing these newer agents because they offer predictable pharmacokinetics and eliminate the burdensome requirement for routine International Normalized Ratio monitoring. This widespread shift in clinical preference is quantitatively evidenced by the commercial performance of leading drugs in this class. According to Bristol Myers Squibb, February 2024, in the '2023 Annual Report', the company reported worldwide revenues of $12.2 billion for its leading oral anticoagulant, reflecting the robust demand for these advanced therapeutic options. The safety assurance provided by these medications is critical, given the high stakes of coagulation disorders. According to the World Stroke Organization, in 2024, over 12 million people worldwide experience a stroke each year, a statistic that reinforces the vital importance of adopting effective preventative anticoagulation measures.

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Key Market Challenges

The growth of the Global DOACs Market is significantly impeded by the inherent risk of major bleeding events associated with these potent therapies. The potential for uncontrolled hemorrhaging, particularly intracranial and gastrointestinal bleeding, creates substantial hesitation among clinicians when prescribing for high-risk patient groups. This caution is compounded by the economic burden of safety management; although reversal agents are available, their prohibitive acquisition costs often render them inaccessible in many healthcare systems. Consequently, providers in cost-constrained environments frequently forgo these advanced agents to avoid the financial risks associated with managing potential complications.

The magnitude of this safety concern is underscored by recent data highlighting the burden on healthcare services. According to the Centers for Disease Control and Prevention, in 2024, anticoagulants were the leading cause of emergency department visits for adverse drug events, accounting for approximately 21% of these critical encounters. This high frequency of medication-related emergencies necessitates resource-intensive hospitalizations, directly offsetting the perceived clinical advantages of DOACs. The convergence of clinical safety risks and the high cost of emergency reversal therapies continues to restrict market penetration, particularly in developing economies.

Key Market Trends

The Emergence of Generic DOAC Formulations Following Patent Expirations is fundamentally reshaping the competitive landscape, particularly in European markets where exclusivity periods for major brands have recently concluded. This structural shift is forcing a transition from high-margin branded therapies to cost-effective bioequivalent alternatives, significantly impacting the revenue streams of established pharmaceutical leaders. As regulatory bodies increasingly approve these generic options, the market is experiencing widespread price erosion, which paradoxically expands patient access in cost-sensitive regions while challenging the commercial dominance of originator drugs. The financial implication of this trend is already visible in the performance of major market players. According to Bristol Myers Squibb, February 2024, in the 'Press release of Bristol-Myers Squibb Company dated February 2, 2024', international revenues for its leading anticoagulant Eliquis were $975 million, representing a decrease of 3% when adjusted for foreign exchange, primarily driven by lower average net selling prices and generic erosion in several European countries.

Simultaneously, the Clinical Development of Next-Generation Factor XI Inhibitors represents a pivotal advancement aimed at decoupling hemostasis from thrombosis management. Unlike current DOACs that carry a risk of major bleeding, these novel agents are designed to prevent pathologic thrombus formation while sparing the coagulation mechanisms necessary for injury repair. This safety-centric innovation addresses the critical unmet need for anticoagulants that can be safely administered to high-risk populations, such as those requiring concomitant antiplatelet therapy. The clinical promise of this class is substantiated by recent trial results. According to Anthos Therapeutics, November 2024, in the 'Anthos Therapeutics Shares New Analysis from the Landmark AZALEA-TIMI 71 Study', the novel Factor XI inhibitor abelacimab demonstrated a substantial 67% reduction in bleeding events for patients on antiplatelet therapy compared to the standard-of-care rivaroxaban, highlighting its potential to redefine safety standards.

Segmental Insights

The Atrial Fibrillation segment represents the fastest-growing category within the Global Direct Oral Anticoagulants Market. This trend is primarily driven by the increasing prevalence of irregular heartbeats among the aging global population, which necessitates effective stroke prevention strategies. Clinical preference has shifted significantly as guidelines from organizations like the European Society of Cardiology recommend these newer oral therapies over traditional vitamin K antagonists due to their favorable safety profiles and ease of administration. Consequently, the combination of rising patient diagnoses and favorable regulatory support reinforces the rapid adoption of these drugs for managing atrial fibrillation.

Regional Insights

North America maintains a leading position in the global Direct Oral Anticoagulants market due to the high incidence of cardiovascular diseases, including atrial fibrillation and deep vein thrombosis. This dominance is reinforced by favorable healthcare reimbursement structures that improve patient affordability and access to medication. Additionally, the United States Food and Drug Administration grants timely approvals for new therapeutic indications, which supports continuous market expansion. Recommendations from the American Heart Association favoring these newer therapies over traditional anticoagulants further solidify the region's strong market standing.

Recent Developments

• In November 2025, Bayer reported positive top-line results from the Phase 3 OCEANIC-STROKE clinical trial evaluating asundexian, its investigational oral Factor XIa inhibitor. The study met its primary efficacy and safety endpoints, demonstrating that the drug, when administered alongside antiplatelet therapy, significantly reduced the risk of ischemic stroke compared to placebo in patients with a history of non-cardioembolic ischemic stroke or high-risk transient ischemic attack. The company highlighted that the treatment achieved these results without a significant increase in major bleeding events, reinforcing the potential of this next-generation therapy in the Global Direct Oral Anticoagulants (DOACs) Market.
• In November 2025, Bristol Myers Squibb and Johnson & Johnson announced the discontinuation of the Phase 3 Librexia-ACS clinical trial, which was evaluating milvexian in patients with recent acute coronary syndrome. The decision followed a recommendation from an independent data monitoring committee, which determined during a pre-planned interim analysis that the study was unlikely to meet its primary efficacy endpoint. Despite this setback, the companies confirmed that the broader development program for this oral Factor XIa inhibitor remains active, with two other Phase 3 studies in atrial fibrillation and secondary stroke prevention continuing as planned.
• In January 2025, Anthos Therapeutics announced the publication of detailed results from the Phase 2 AZALEA-TIMI 71 study, which highlighted the superior safety profile of abelacimab compared to standard-of-care direct oral anticoagulants. The data revealed that the novel Factor XI inhibitor reduced major or clinically relevant non-major bleeding by approximately 62% compared to rivaroxaban in patients with atrial fibrillation. The study, which had been halted early due to the overwhelming reduction in bleeding events, provides significant clinical evidence supporting the development of safer anticoagulation therapies that decouple hemostasis from thrombosis.
• In June 2024, Adalvo announced the successful launch of its generic rivaroxaban film-coated tablets in the United Kingdom following the expiry of market exclusivity for the reference brand, Xarelto. The newly introduced product is indicated for the prevention of atherothrombotic events in adult patients after acute coronary syndrome or with coronary artery disease, as well as for the prevention of venous thromboembolism. This launch represents a key commercial development in the Global Direct Oral Anticoagulants (DOACs) Market, increasing the accessibility of critical cardiovascular treatments through more affordable generic options.

Key Market Players

• Bayer AG
• Boehringer Ingelheim International GmbH
• Bristol Myers Squibb Company
• Pfizer Inc.
• Sanofi
• Zhejiang Huahai Pharmaceutical Co. Ltd.
• Janssen Global Services, LLC
• Aspen Pharmacare Holdings Limited
• Astellas Pharma Inc.
• Lupin Pharmaceutical, Inc.

By Drug Type	By Indication	By End User	By Region
Factor Xa Inhibitors Direct Thrombin Inhibitors	Atrial Fibrillation (AF) Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE) Stroke Prevention Others	Hospitals & Clinics Ambulatory Surgical Centers Home Care Settings Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Direct Oral Anticoagulants (DOACs) Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Direct Oral Anticoagulants (DOACs) Market , By Drug Type:

• Factor Xa Inhibitors
• Direct Thrombin Inhibitors

• Direct Oral Anticoagulants (DOACs) Market , By Indication:

• Atrial Fibrillation (AF)
• Deep Vein Thrombosis (DVT)
• Pulmonary Embolism (PE)
• Stroke Prevention
• Others

• Direct Oral Anticoagulants (DOACs) Market , By End User:

• Hospitals & Clinics
• Ambulatory Surgical Centers
• Home Care Settings
• Others

• Direct Oral Anticoagulants (DOACs) Market , By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE