U.S. Atrial Fibrillation Market Size, Share & Industry Analysis, By Drug Class (Anticoagulants and Anti-arrhythmic Drugs), By Route of Administration (Oral, Intravenous, and Others), By Distribution Channel (Hospital Pharmacies, Online Pharmacies, and Retail Pharmacies), and Country Forecast, 2024-2032

The U.S. atrial fibrillation market size was worth USD 5.51 billion in 2023 and is projected to grow at a CAGR of 3.9% during the forecast period. 

The increasing prevalence of Atrial Fibrillation (AFib) among the U.S. population is one of the prominent factors raising the demand for atrial fibrillation drugs. Furthermore, the increasing burden of various secondary factors such as high blood pressure, obesity, and increasing age, among others, is also contributing to the increased risk of developing the condition which is one of the most common forms of cardiac arrhythmia.

• According to the Centers for Disease Control and Prevention 2022 data, an estimated 454,000 patients suffering from atrial fibrillation are hospitalized each year in the country. In addition, according to the data, approximately 12.1 million people in the U.S. are likely to suffer from AFib in 2030.

Moreover, the growth of the U.S. atrial fibrillation market is supported by growing investments from pharmaceutical manufacturers to launch new drugs to treat atrial fibrillation, increasing initiatives by government organizations to promote research, and rising approval of drugs, among others.

The impact of COVID-19 on the market was negligible owing to the increasing preference of healthcare professionals to recommend pharmacotherapy as treatment options rather than surgeries during the pandemic.

U.S. Atrial Fibrillation Market Trends

Rising Emphasis to Develop Novel Drugs for Treating Atrial Fibrillation

The atrial fibrillation treatment witnessed a revolution with the introduction of technologically advanced anticoagulants, and anti-arrhythmic drugs. The rising prevalence of the condition is posing a burden on the healthcare systems. Increasing adoption of these drugs and rising recommendation of these drugs by governments to prevent atrial fibrillation-associated stroke are raising the demand for effective anticoagulants.

Furthermore, at present, there is a shift among healthcare professionals toward novel drugs, which is further increasing the demand for treatment. In order to meet the rising demand, the manufacturers are intensively focusing on developing and launching new drugs.

• In September 2022, Anthos Therapeutics received the fast-track designation from the U.S. FDA for its investigational drug, abelacimab, a fully human monoclonal antibody indicated for the treatment of AFib.

U.S. Atrial Fibrillation Market Growth Factors

Increasing Burden of Geriatric Population Coupled with Rising Hypertension to Augment Market Growth

The increasing burden of the aging population in the country is one of the key factors raising the risk of developing atrial fibrillation in the population. Many researchers have demonstrated the risk of this condition significantly increases with age due to structural and electrical remodeling in the atrial myocardium.

• For instance, according to the “American Health Ranking” report published by the United Health Foundation, an estimated 16.8% (55.8 million) of the U.S. population is aged 65 years and above. Moreover, according to the data, the proportion of the old age population is likely to increase to 22% by the year 2040.

Additionally, the increasing prevalence of chronic disorders such as diabetes, hypertension, and others, which are common among the senior population, contributes to the increased chances of developing AFib, hence raising the demand for effective drugs.

• According to the Centers for Disease Control and Prevention, about 37.0 million people in the U.S. are diagnosed with uncontrollable hypertension.

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According to the 2022 data published by the U.S. Census Bureau, 2022 American Community Survey 5-year Estimates, Maine had the highest percentage of older people living in the U.S., followed by Florida, West Virginia, and other states.

RESTRAINING FACTORS

Increase in Recent Product Recalls Coupled with the Presence of Alternative Treatment Regimens to Impede Market Growth

Despite the rising investment in research and development by manufacturers to develop and launch new drugs for atrial conditions, the rise in recent product recalls is impeding the demand for these drugs in the U.S. atrial fibrillation market. The U.S. FDA mainly recalls the drugs due to safety concerns, mislabeling, defective manufacturing processes, presence of contamination, and others.

• For instance, in August 2023, the U.S. FDA recalled a single lot of Digoxin tablets 0.25 mg and a single lot of tablets with a strength of 0.125 mg due to mislabeling. The tablet bottles are incorrectly labeled, which is likely to cause either overdosing or underdosing among patients.

Additionally, shifting preference of patients toward natural treatment regimens and supplements to maintain the heart rate also poses a limitation to the U.S. atrial fibrillation market growth.

U.S. Atrial Fibrillation Market Segmentation Analysis

By Drug Class Analysis

Based on the drug class, the market is segmented into anticoagulants, and anti-arrhythmic drugs. The anticoagulants segment accounted for the highest market share in 2023 and is anticipated to continue its dominance during the forecast period. The increasing recommendation of direct oral anticoagulants by government organizations for managing the condition among patients is one of the key factors contributing to the high market share.

Furthermore, increasing approval of anticoagulants and the growing focus of the key players on developing effective anticoagulants, among others, also bolster the segment’s growth.

• In December 2019, the U.S. FDA approved the generic version of Eliquis developed by Micro Labs Limited and Mylan Pharmaceuticals Inc.

By Route of Administration Analysis

Based on the route of administration, the market is fragmented into oral, intravenous, and others. The oral segment accounted for the largest share in 2023. The wide availability of oral drugs, increasing adoption, rigorous clinical trials performed by key players, and increasing approvals are some factors driving the growth of the market.

• In May 2023, Bristol-Myers Squibb Company received the U.S. FDA fast-track designation for its drug, milvexian, an oral factor Xia indicated for patients suffering from AFib.

By Distribution Channel Analysis

On the basis of the segmentation by distribution channel, the market can be segmented into retail pharmacies, online pharmacies, and hospital pharmacies.

The segment of online pharmacies is projected to witness the highest CAGR during the forecast period of 2024-2032. Some of the contributive factors of the growth of the online pharmacies segment include lesser wait times, increased accessibility to medications and greater convenience, and the element of privacy and confidentiality.

Also, the opening of new online pharmacies offering patients easy access at the affordable rates is contributing to the increased surge in the patients’ preference for these distribution channels.

• In January 2022, Mark Cuban launched an online pharmacy called Mark Cuban Cost Plus Drug Company (MCCPDC) in the U.S., offering patients drugs at affordable prices. 

KEY INDUSTRY PLAYERS

The market is semi-consolidated with a few players such as Bayer AG, Sanofi, and Bristol-Myers Squibb Company, leading the U.S. atrial fibrillation market share. Their substantial product portfolios, robust distribution networks, and ongoing initiatives to enhance product offerings and brand visibility contribute significantly to their considerable market revenue share.

For instance, in May 2023, Bayer AG received the U.S. fast-track designation for its investigational drug, asundexian to treat patients suffering from atrial fibrillation.

Some other players, such as Pfizer, Inc., Johnson & Johnson Services, Inc., Par Pharmaceutical, and others, are also operating in the market. Their efforts involve heightened investments in the introduction of novel drugs, coupled with a strategic shift toward participating in business activities such as mergers, acquisitions, and partnerships. These initiatives play a crucial role in fortifying their positions within the market.

LIST OF TOP ATRIAL FIBRILLATION COMPANIES IN U.S./ LIST OF TOP ATRIAL FIBRILLATION COMPANIES:

• Johnson & Johnson Services, Inc. (U.S.)


• Pfizer Inc. (U.S.)


• Bayer AG (Germany)


• Bristol-Myers Squibb Company (U.S.)


• Par Pharmaceutical (U.S.)


• Sanofi (France)


• DAIICHI SANKYO COMPANY, LIMITED (Japan)


• Boehringer Ingelheim International GmbH (Germany)

KEY INDUSTRY DEVELOPMENTS:

• October 2023: Milestone Pharmaceuticals announced the submission of a new drug application (NDA) to the U.S. FDA for its drug etripamil, a calcium channel blocker intended for the treatment of patients suffering from AFib.


• February 2023: Zydus Lifesciences received the U.S. FDA approval for its generic drug apixaban with strengths of 2.5 and 5 mg. Through this approval, the company aimed to increase its product portfolio. Apixaban is one of the most prescribed anticoagulants for the treatment of atrial fibrillation.


• June 2022: HUYA Bioscience International, LLC launched a phase 2 clinical trial for its investigational drug HBI-3000 for treating patients with AFib.

REPORT COVERAGE

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The report provides a detailed U.S. atrial fibrillation market analysis. The atrial fibrillation market report focuses on key aspects such as leading companies, drug class, and route of administration. Besides this, the report offers insights into the market trends and highlights key industry developments. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth of the market in recent years.

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