Acute Heart Failure - Market Insights, Epidemiology, and Market Forecast - 2034

Key Highlights:

• The AHF market is anticipated to sustain a steady Compound Annual Growth Rate (CAGR) during the forecast period (2025-2034). The AHF market is set for robust, sustained growth, fueled by a wave of innovative therapies, cutting-edge diagnostics, and rising disease awareness. Emerging treatments and smarter diagnostic tools are not only expanding options but also driving earlier detection and better outcomes, while the growing patient pool keeps market momentum strong.
• The surge in AHF cases is fueled by an aging population, rising rates of hypertension, diabetes, and obesity, and improved survival after heart attacks, which leaves more people at risk for heart failure. The COVID-19 pandemic also reversed prior declines in heart failure mortality, especially impacting older adults and certain ethnic groups.
• Current acute heart failure treatment prioritizes rapid symptom relief with diuretics and vasodilators, while long-term management hinges on tailored guideline-directed therapies like beta-blockers and SGLT2 inhibitors. Despite advances, challenges remain in reducing rehospitalizations and mortality, highlighting the need for early intervention and personalized care strategies.
• Acute heart failure continues to challenge clinicians with high rehospitalization and mortality rates, particularly among patients with preserved ejection fraction. Existing treatments often focus on symptom relief but struggle to halt disease progression or target underlying inflammation. Early diagnosis remains difficult, and innovative therapies are needed to improve long-term survival and quality of life.
• The future market for AHF is expected to remain relatively less-competitive. Only a limited number of companies, including Implicit Bioscience with atibuclimab (IC14), and Eli Lily with MOUNJARO (tirzepatide), among others, are currently advancing their pipeline assets across various stages of development to drive market growth in the coming years. With the expected approval of these therapies during the forecast period (2025-2034), the overall therapeutic market of AHF is likely to witness a rise at a significant CAGR.
• In December 2024, the US FDA approved the commencement of a clinical study of Implicit Bioscience's monoclonal anti-CD14 antibody atibuclimab in patients with acute decompensated heart failure (ADHF).

DelveInsight's comprehensive report titled "AHF - Market Insights, Epidemiology, and Market Forecast - 2034" offers a detailed analysis of AHF. The report presents historical and projected epidemiological data covering total incident cases of AHF, gender-specific incident cases of AHF, age-specific incident cases of AHF, and treated cases of AHF. In addition to epidemiology, the market report encompasses various aspects related to the patient population. These aspects include the diagnosis process, prescription patterns, physician perspectives, market accessibility, treatment options, and prospective developments in the market across seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, spanning from 2020 to 2034.

The report analyzes the existing treatment practices and unmet medical requirements in AHF. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the market.

AHF Overview

AHF is a sudden, serious condition where the heart cannot pump blood effectively, most often affecting people over the age of 65. It is not directly caused by medications, but rather by underlying heart problems and age-related changes, with certain drugs potentially increasing the risk. Both men and women can develop acute heart failure, though risk rises with age. The condition is not associated with autoimmune diseases but may occur alongside other chronic health issues.

The primary symptoms of AHF include sudden shortness of breath, swelling in the legs, ankles, or feet, and rapid weight gain due to fluid buildup. Individuals may experience extreme fatigue, difficulty lying flat without feeling breathless, and a persistent cough, often worse at night. Other signs can include a racing or irregular heartbeat, chest discomfort, and a feeling of weakness or confusion, especially in older adults. These symptoms tend to appear quickly and can worsen rapidly, requiring prompt medical attention.

AHF Diagnosis and Treatment Algorithm

Diagnosing AHF is often challenging due to overlapping symptoms with other conditions. Clinicians rely on a rapid assessment of symptoms such as sudden breathlessness, swelling, and fatigue, along with a detailed medical history and physical examination.

Key diagnostic tools include blood tests for cardiac markers, chest X-ray, ECG, and echocardiography to evaluate heart structure and function. The Framingham criteria, which require specific combinations of major and minor clinical signs, are frequently used to support the diagnosis. Imaging and laboratory tests help rule out other causes and identify potential triggers, while a prompt response to initial treatment can further confirm AHF.

AHF is a rapid onset or acute worsening of symptoms and/or signs of heart failure, associated with elevated plasma levels of natriuretic peptides. It requires immediate medical management and, usually, urgent hospital admission. It can be a first occurrence of AHF (de novo) or, more frequently, acute decompensation of chronic heart failure (ADHF). Treatment of ADHF and cardiogenic shock in the setting of acute coronary syndrome and management of refractory heart failure (including inadequate response to diuretic therapy) are discussed separately. Management of right ventricular MI, which typically presents with hypotension and clear lungs, is also discussed separately.

The treatment of AHF is well defined in the guidelines and has been demonstrated to improve life expectancy in affected patients. However, for AHF, diuretics, oxygen, and current vasodilators are widely used but have not been shown to reduce mortality.

Pharmacotherapy for AHF includes various class of drugs like, Angiotensin-converting enzyme (ACE), inhibitors, Angiotensin-receptor blockers (ARB), beta blockers (beta-adrenergic receptor-blocking agents), Aldosterone antagonists, SGLT2 Inhibitors, diuretics etc. being common treatments.

AHF Epidemiology

The epidemiology section of the AHF market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.

This section also presents the data with relevant tables and graphs, offering a clear and concise view of the incidence of AHF. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.

Key Findings

As per the secondary research, in the US, 4.5 to 4.9/1000 people are admitted for heart failure as a primary diagnosis every year, putting the number of AHF admissions in the United States at 1.5 million yearly, ≈25% of patients with heart failure.

According to National Heart Failure Audit (NHFA), a 2024 real-world analysis in the UK estimated that the incidence of confirmed index heart failure admissions was found to be 65,679.

As per a research study, out of 3,132,337 eligible patients, 123,925 had heart failure: a prevalence of 3.96%. Of these, 26,368 had newly diagnosed heart failure: an incidence of 655/100,000 persons at risk. Incidence increased with age and was similar regardless of sex.

The epidemiology of AHF is expected to change during the forecast period (2025-2034).

AHF Market Outlook

The AHF therapeutics market is further expected to increase by the major drivers, such as the rising population, technological advancements, and upcoming therapies in the forecast period (2025-2034).

With ongoing research and continued dedication, the future holds hope for even more effective treatments and, ultimately, a cure for this challenging condition. According to DelveInsight, the AHF market in the 7MM is expected to change significantly during the forecast period 2025-2034.

AHF Drug Chapters

Marketed AHF Drugs

INPEFA (sotagliflozin): Lexicon Pharmaceuticals

INPEFA, a novel agent that inhibits sodium-glucose cotransporter SGLT1 as well as SGLT2, received marketing approval from the US FDA in May 2023 for reducing the risk for cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in patients with heart failure, and also for preventing these same events in patients with type 2 diabetes, chronic kidney disease (CKD), and other cardiovascular disease risk factors.

FARXIGA (dapagliflozin): AstraZenca

FARXIGA is the first in this particular drug class, sodium-glucose co-transporter 2 (SGLT2) inhibitors, to be approved to treat adults with New York Heart Association's functional class II-IV heart failure with reduced ejection fraction.

In 2020, the US FDA approved FARXIGA (dapagliflozin) oral tablets for adults with heart failure with reduced ejection fraction to reduce the risk of cardiovascular death and hospitalization for heart failure.

Emerging AHF Drugs

The AHF market is expected to experience gradual changes, mainly due to the limited availability of emerging therapies in this area. Some of the drugs in the pipeline include tirzepatide (MOUNJARO), and atibuclimab (IC14), among others.

Atibuclimab (IC14): Implicit Bioscience

IC14, a monoclonal antibody developed by Implicit Bioscience, is currently advancing through clinical development for the treatment of AHF. By targeting CD14, a key co-receptor involved in the innate immune response and inflammatory signaling, IC14 aims to modulate the excessive immune activation associated with AHF. This therapeutic strategy offers a novel pathway distinct from traditional heart failure treatments. With early studies demonstrating promising anti-inflammatory effects, IC14 holds potential as a targeted option for patients who do not respond adequately to standard therapies.

In December 2024, the US FDA approved Implicit Bioscience's monoclonal antibody atibuclimab (IC14) for a clinical study in patients with acute decompensated heart failure (ADHF). The first ADHF patient treated with IC14 responded very well to a single dose, marking a promising development for this severe form of acute heart failure.

MOUNJARO (tirzepatide): Eli Lily

Tirzepatide, a long-acting agonist of glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptors, causes considerable weight loss, but data are lacking with respect to its effects on cardiovascular outcomes.

In November 2024, the company announced detailed results from the SUMMIT Phase III trial showing tirzepatide significantly reduced the risk of worsening heart failure events in adults with HFpEF and obesity. Patients treated with tirzepatide also experienced notable improvements in heart failure symptoms and physical limitations.

Tirzepatide showed a 38% reduction in the risk of heart failure outcomes, assessed as a composite endpoint, compared to placebo. Risk of hospitalization for heart failure was reduced by 56%

AHF Market Segmentation

DelveInsight's 'AHF - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a detailed outlook of the current and future AHF market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.

AHF Market Size by Countries

The AHF market size is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. In 2024, the United States held a significant share of the overall 7MM (Seven Major Markets) AHF market, primarily attributed to the country's higher incidence of the condition and the elevated cost of the available treatments. This dominance is projected to persist, especially with the potential early introduction of new products.

AHF Market Size by Therapies

AHF Market Size by Therapies is categorized into current and emerging markets for the study period 2020-2034.

AHF Drugs Uptake

This section focuses on the sales uptake of potential AHF drugs that have recently been launched or are anticipated to be launched in the AHF market between 2020 and 2034. It estimates the market penetration of AHF drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the AHF market.

The emerging AHF therapies are analyzed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the AHF market.

AHF Market Access and Reimbursement

DelveInsight's 'AHF - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a descriptive overview of the market access and reimbursement scenario of AHF.

This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.

KOL Views

To keep up with current AHF market trends and fill gaps in secondary findings, we interview KOLs and SMEs' working in the AHF domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or AHF market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the AHF unmet needs.

AHF: KOL Insights

DelveInsight's analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as European Society of Emergency Medicine, UK, University Hospital Tubingen, Germany, University of Barcelona, Spain, Society of Academic Emergency Medicine, UK, Momentum Research, UK, Department of Anesthesiology and Critical Care and Burn Unit, France and Improuvant Emergency Care FHU, France, among others.

"The prevention of heart failure must be prioritized, especially in high-risk populations. With therapies like SGLT2 inhibitors, we have tools that go beyond glycemic control - they modify the trajectory of disease itself."

"Acute heart failure is not just an exacerbation - it is a signal of instability in a chronic, progressive disease. Every hospitalization is an opportunity to reassess and intensify therapy."

"The most transformative development in recent years is the recognition that SGLT2 inhibitors confer cardiovascular and renal benefits independent of glycemic control. Their use in heart failure with reduced ejection fraction is now foundational."

Competitive Intelligence Analysis

We conduct a Competitive and Market Intelligence analysis of the AHF Market, utilizing various Competitive Intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.

AHF Pipeline Development Activities

The report offers an analysis of therapeutic candidates in Phase II and III stages and examines companies involved in developing targeted therapeutics for AHF. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.

Pipeline Development Activities

The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging AHF therapies.

AHF Report Insights

• AHF Patient Population
• Therapeutic Approaches
• AHF Pipeline Analysis
• AHF Market Size and Trends
• AHF Market Opportunities
• Impact of Upcoming Therapies

AHF Report Key Strengths

• 10 Years Forecast
• The 7MM Coverage
• AHF Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed AHF Market
• AHF Drugs Uptake

AHF Report Assessment

• AHF Current Treatment Practices
• Unmet Needs
• AHF Pipeline Product Profiles
• AHF Market Attractiveness

Key Questions:

• How common is AHF?
• What are the key findings of AHF epidemiology across the 7MM, and which country will have the highest number of patients during the study period (2020-2034)?
• What are the currently available treatments for AHF?
• What are the disease risk, burden, and unmet needs of AHF?
• At what CAGR is the AHF market and its epidemiology is expected to grow in the 7MM during the forecast period (2025-2034)?
• How would the unmet needs impact the AHF market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of AHF in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?
• Among EU4 and the UK, which country will have the highest number of patients during the forecast period (2025-2034)?
• How many companies are currently developing therapies for the treatment of AHF?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the AHF market.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of current treatment in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Frequently Asked Questions:

1. What are the treatment goals for AHF?

The primary goals in treating AHF are to rapidly stabilize the patient by relieving symptoms such as fluid overload and breathlessness, restore adequate cardiac function, and prevent organ damage. Long-term objectives include reducing hospital readmissions, improving survival, and optimizing quality of life through guideline-directed therapies and patient education.

2. What are the challenges in managing AHF?

Key challenges in AHF management include the need for rapid and accurate diagnosis due to overlapping symptoms with other conditions, tailoring therapy to individual patient profiles, and managing complications such as kidney dysfunction. Additionally, ensuring adherence to long-term therapy and addressing the limited efficacy of some treatments in patients with preserved ejection fraction remain ongoing concerns.

3. What are the key factors driving the growth of the AHF market?

Growth in the AHF market is driven by rising incidence due to an aging population and prevalent risk factors like hypertension and diabetes, as well as advances in diagnostics and the introduction of novel therapies. Increased awareness and ongoing research into targeted treatments are also expanding therapeutic options and market potential.

4. How will the AHF Market and Epidemiology Forecast Report benefit the clients?

The report delivers comprehensive insights into epidemiological trends, current and emerging therapies, market dynamics, and regulatory landscapes across major regions. This enables stakeholders to make informed decisions, identify business opportunities, and strategically position themselves to capitalize on the evolving AHF market.