The global cardiomyopathy market is experiencing unprecedented growth, with projections indicating a compound annual growth rate (CAGR) of 6.13% during 2025-2035. This expansion is primarily driven by the rising prevalence of cardiovascular diseases and breakthrough developments in novel therapeutic approaches that promise to transform patient outcomes.
Regulatory Milestones Signal Market Momentum
In December 2024, Cytokinetics achieved a significant regulatory milestone when the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for aficamten, a cardiac myosin inhibitor designed to treat obstructive hypertrophic cardiomyopathy (HCM). Under the Prescription Drug User Fee Act (PDUFA), the FDA assigned a standard review process with a target action date of September 26, 2025, without plans to convene an advisory committee.
The European regulatory pathway is also advancing, as the European Medicines Agency (EMA) validated Cytokinetics' Marketing Authorization Application (MAA) for aficamten in December 2024. This validation initiates the review process by the Committee for Medicinal Products for Human Use (CHMP) for potential European approval.
Novel Therapeutic Approaches Reshape Treatment Landscape
The cardiomyopathy treatment paradigm is evolving beyond traditional therapies like beta-blockers, ACE inhibitors, and diuretics. Gene therapies, cell-based treatments, and advanced pharmacological interventions represent innovative treatment options that address the underlying mechanisms of disease.
Scientists are exploring DNA mutation repair using CRISPR and other genetic engineering tools, while stem cell therapies and regenerative medicines offer potential for tissue regeneration in damaged heart tissue. These approaches aim to reduce disease progression and improve patient survival rates.
Cardiac myosin inhibitors, exemplified by mavacamten and the emerging aficamten, represent a targeted molecular approach. Mavacamten, marketed as Camzyos by Bristol Myers Squibb, is already FDA-approved for symptomatic obstructive hypertrophic cardiomyopathy (oHCM). As a selective cardiac myosin inhibitor, it reduces overactive heart muscle contraction, improving blood flow and alleviating symptoms such as shortness of breath and fatigue.
Expanding Pipeline Addresses Diverse Cardiomyopathy Types
The therapeutic pipeline extends beyond hypertrophic cardiomyopathy to address various forms of the disease. Pfizer's Tafamidis is approved for transthyretin amyloid cardiomyopathy (ATTR-CM), working by stabilizing the transthyretin (TTR) protein to prevent harmful amyloid deposits in the heart.
Emerging therapies include Imbria Pharmaceuticals' IMB-1018972 (Ninerafaxstat), an oral modulator of myocardial energetics that targets mitochondrial function to optimize energy production in heart cells. In April 2024, Imbria shared results from its Phase 2 IMPROVE-HCM clinical trial testing ninerafaxstat in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM) at the American College of Cardiology's Annual Scientific Session.
Precision Cardiology Emerges as Growth Driver
The market is witnessing expansion into precision cardiology, with companies targeting genetic causes of heart diseases. In November 2024, Avidity Biosciences announced its expansion beyond rare skeletal muscle disorders into precision cardiology, advancing two fully owned candidates: AOC 1086 for phospholamban (PLN) cardiomyopathy and AOC 1072 for PRKAG2 Syndrome.
Strategic partnerships are accelerating development, as demonstrated by Bayer's November 2024 collaboration with Cytokinetics to acquire rights in Japan for aficamten. This partnership enhances Bayer's cardiovascular portfolio while expanding treatment access for HCM patients.
Market Dynamics and Regional Leadership
The cardiomyopathy market growth is fueled by multiple factors including rapid urbanization, physical inactivity, and unhealthy diets that contribute to obesity, diabetes, and hypercholesterolemia. Improved diagnostic technologies such as echocardiography and cardiac MRI enable earlier detection, while cutting-edge treatment options including implantable devices like pacemakers and defibrillators support comprehensive patient management.
The United States represents the largest patient pool and biggest market for cardiomyopathy treatment, followed by major European markets including Germany, France, the United Kingdom, Italy, and Spain, as well as Japan. Wide-scale awareness programs and funding from governments and private organizations for cardiomyopathy research are promoting market growth across these regions.
Long-term Efficacy Data Supports Market Confidence
Clinical evidence continues to support the therapeutic potential of novel treatments. In September 2024, Bristol Myers Squibb released new long-term data from the EXPLORER-LTE cohort of the MAVA-Long-Term Extension (LTE) study, assessing Camzyos (mavacamten) efficacy in adult patients with symptomatic obstructive hypertrophic cardiomyopathy categorized as New York Heart Association (NYHA) class II-III.
The convergence of rising disease prevalence, innovative therapeutic approaches, and supportive regulatory environments positions the cardiomyopathy market for sustained growth through 2035, with the potential to significantly improve outcomes for patients suffering from these debilitating heart conditions.
