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The global mavacamten capsules market size was valued at USD 875.2 million in 2025 and is projected to reach USD 1.06 billion in 2026, expanding to USD 3.85 billion by 2034, growing at a CAGR of 17.5% during the forecast period (2026-2034).
Camzyos (generic name Mavacamten) is Bristol Myers Squibb's new drug used to treat the cause of hypertrophic cardiomyopathy (HCM), a new step in cardiovascular medicine. The drug, which was initially developed by MyoKardia and subsequently acquired by Bristol Myers Squibb in a USD 13.1 billion acquisition in April 2022, was approved by the U.S. FDA for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in April 2022. In contrast, other treatments used to treat heart failure are aimed at relieving symptoms but not treating the underlying mechanism of heart failure that causes too much cardiac muscle contraction.
The drug selectively inhibits cardiac myosin ATPase activity which decreases the creation of force-producing action-myosin cross-bridges during contraction of the heart. This reduces hypercontractility, left ventricular outflow tract obstruction, poorer diastolic filling, and reduced cardiac efficiency. Mavacamten provides a precision-medicine solution to help manage one of the most prevalent inherited cardiac conditions by targeting the effects of sarcomere gene mutations.
Clinically, significant improvements were seen in exercise capacity, symptom severity and quality of life in clinical trials, such as EXPLORER-HCM and VALOR-HCM. The therapy also led to a decreased requirement for invasive septal reduction procedures and ensured that many patients were spared from surgery. These results indicate that the cardiac remodeling and gradient reduction effects of mavacamten could be disease-modifying.
Because of its mechanism of action that affects contractility, mavacamten is distributed under a Risk Evaluation and Mitigation Strategy (REMS) program that mandates periodic heart monitoring using an echocardiogram. Prescribing is usually restricted to specialist cardiac clinics, and distribution is conducted through certified specialty pharmacies. In this structured framework, patient safety is ensured and the implementation of a paradigm-shifting therapy that is changing the therapeutic landscape of HCM worldwide.
| Report Coverage | Details |
|---|---|
| Base Year | 2025 |
| Base Year Value | USD 875.2 Million |
| Forecast Value | USD 3.85 Billion |
| CAGR | 17.5% |
| Forecast Period | 2025-2034 |
| Historical Data | 2022-2025 |
| Largest Market | North America |
| Fastest Growing Market | Europe |
| Segments Covered | By Indication, Patient Type, Line of Therapy, Dosage Strength, Distribution Channel, End-User |
| Region Covered | North America, Europe, Asia Pacific, Middle East & Africa, Latin America |
| Countries Covered | US, Canada, Mexico, UK, Germany, France, Italy, Spain, Netherlands, China, Japan, India, Australia, South Korea, Brazil, Argentina, UAE, Saudi Arabia, South Africa |
| Key Market Playes | Bristol Myers Squibb, Cytokinetics Inc., Edgewise Therapeutics, Specialty Pharmacy Networks |
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The primary force behind the growth of the mavacamten market lies in the fact that hypertrophic cardiomyopathy is amongst the most seriously under-diagnosed cardiovascular diseases, in which despite the proven prevalence rate of about 1 out of 500 persons (indicating 20 million cases of HCM worldwide), only 15–20% of patients are diagnosed. The reasons for this under-diagnosis include the diversity in the clinical picture of the disease that varies from asymptomatic forms to heart failure symptoms, insufficient knowledge on the part of general practitioners about the diagnostic criteria for HCM, and poor use of cardiac imaging methods.
Systematic efforts towards educating people about the risks associated with hypertrophic cardiomyopathy through awareness campaigns, the use of AI-driven electrocardiogram screening tests, and inclusion of genetic screening methods during cardiovascular assessment helping identify previously undiagnosed hypertrophic cardiomyopathy (HCM) patients. According to the guidelines issued by the American Heart Association and the European Society of Cardiology from 2020 to 2023, the recommended diagnostic approach included echocardiogram screening, genetic screening, and cardiopulmonary exercise tests.
Aging populations leading to the discovery of cases of latent hypertrophic cardiomyopathy presenting heart failure symptoms, genetic cascade testing programs detecting cases from relatives of an index case, and better survival rates among individuals with structural heart disease result in continuous growth in the number of cases requiring disease-modifying drugs for treatment purposes. The increased awareness about how hypertrophic cardiomyopathy can affect people from different races across the globe with varied genetic makeup is widening market possibilities.
The marketing success of mavacamten is underpinned by clinical data indicating the disease-modifying effects that go further than improving symptoms to affect the natural history of HCM via cardiac remodeling, changes in biomarkers, and blocking disease progression. According to the EXPLORER-HCM trial results, the administration of mavacamten led to a statistically significant decrease in levels of N-terminal pro-brain natriuretic peptide and cardiac troponin I, both markers indicating myocardial wall stress and cardiomyocyte damage.
Cardiac magnetic resonance imaging studies showed a decrease in left ventricle mass, a favorable effect on the diastolic function indices, and positive changes in myocardial metabolism characteristic of the reverse of pathological hypertrophy due to the correction of sarcomere hypercontraction. In the EXPLORER-LTE long-term follow-up study, there was evidence of sustainable effectiveness of the therapy over several years, which made the hypothesis of progressive reduction of remodeling due to persistent sarcomere blockade plausible.
VALOR-HCM study showed that mavacamten was able to obviate the requirement for septal reduction surgery in 82% of patients meeting the guideline indications through its proven ability to provide significant economic benefit to the healthcare system, helping patients avoid procedures associated with a 0.5–3% mortality risk, considerable morbidity with complications such as complete heart block needing a permanent pacemaker, and cost of more than USD 75,000 to 125,000 per procedure.
The greatest limitation facing the growth of mavacamten from a business perspective is the Risk Evaluation and Mitigation Strategy (REMS), which mandates that thorough safety surveillance should be conducted to ensure that the left ventricular ejection fraction is not reduced below 50%. Although vital given the way that mavacamten works to reduce cardiac contractility, this is a major burden as it limits prescription to specific cardiology settings.
Echocardiographic monitoring requires evaluations at baseline, 4 weeks, 8 weeks, 12 weeks, and every 12 weeks thereafter pose logistical challenges for patients and healthcare facilities in geographic regions where echocardiography is not readily available or for patients with difficulty in accessing such diagnostic facilities. These requirements can result in delayed therapy because of the scheduling required, adherence issues due to inability of patients to keep up with their follow-ups, and restricted prescribing of mavacamten to cardiologists with easy access to echocardiography and enrolled in REMS.
REMS requirements restricting prescribers from writing mavacamten prescriptions except those cardiologists enrolled in REMS represent significant obstacles for general cardiologists who see occasional cases of HCM patients who find it difficult to enroll into a complicated program. Requirements limiting dispensing to REMS-certified pharmacies from dispensing mavacamten except those which are enrolled in REMS creates restrictions for rural or unserved areas.
The most revolutionary business development is regulatory submission to extend the label for use in non-obstructive hypertrophic cardiomyopathy, where symptoms result from diastolic dysfunction, myocardial stiffness, and high filling pressures without a dynamic outflow obstruction. Patients who have non-obstructive hypertrophic cardiomyopathy make up about 30% of all hypertrophic cardiomyopathy cases and have very few pharmacologic treatment choices available, leading to a great unmet medical need which mavacamten may help address.
Label expansion with EXPLORER-HCM2, a study of mavacamten in symptomatic non-obstructive hypertrophic cardiomyopathy, constitutes a highly important label expansion strategy that may double the addressable population while ensuring complete coverage in patients with all types of hypertrophic cardiomyopathy. Positive outcomes in this trial will allow the company to create a common platform of therapy for the leading genetic disease of the heart, dramatically improving revenues and sales, as well as closing the gaps in the current treatment paradigm.
Another option for label expansion relates to heart failure with preserved ejection fraction, in which the mechanism of reduced sarcomere contractility may be used as a treatment method in other diseases involving impaired myocardial relaxation and increased filling pressures. Clinical trials in this indication will allow expanding the use of mavacamten to substantially larger patient numbers, allowing creation of multi-billion-dollar revenue expansion opportunities.
The introduction of AI technologies in echocardiographic evaluation and cardiac magnetic resonance imaging have been revolutionizing mavacamten monitoring through providing standardized and automated calculations of the left ventricular ejection fraction, outflow gradient, and diastolic function measures that minimize inter-operator variability to make the monitoring process more efficient. AI-powered ultrasound systems facilitate image acquisition by providing real-time feedback and using automated calculation methods that guarantee consistency.
Ultrasound technology that incorporates the assistance of AI could eventually provide distributed monitoring systems that decrease the logistical challenges of REMS program compliance without sacrificing the level of safety monitoring. Algorithms designed to analyze patient echocardiograms, biomarkers, and outcomes from these therapies are being constructed in order to help predict optimum dosing regimens as well as patients who are likely to experience ejection fraction decreases.
The market share for North America is estimated at USD 578.4 million in 2025 and is expected to expand at a compound annual growth rate of 16.8% till 2034. The US alone holds about 92% share of the total revenues generated in the region, thanks to FDA approval leading to market entry from 2022, REMS program infrastructure, and the presence of specialist HCM centers with expertise in prescribing and managing the drug. More than 40 accredited centers of excellence by the Hypertrophic Cardiomyopathy Association in major medical schools aid commercial adoption.
The U.S. market also benefits from the well-developed framework of specialty pharmacies with REMS certification that deliver patient support services such as adherence monitoring, echocardiography appointments, insurance help, and adverse event management to improve patient outcomes on complex cardiovascular specialty medication. Bristol Myers Squibb’s proven market access infrastructure in the form of patient assistance programs, hub services, and payer interactions via oncology and specialty medicine.
The Medicare Part D specialty tier coverage and commercial insurance coverage after favorable coverage decisions from leading payers will provide a framework of affordability for mavacamten while manufacturer patient assistance programs would help to bridge cost-sharing obligations for eligible patients. The regulatory precedent set through the drug’s approval would help competitors enter the category of cardiac myosin inhibitors.
Europe is the fastest-growing regional market with 19.2% CAGR up to 2034. The region is projected to have a revenue of USD 186.5 million in 2025 following the regulatory clearance by European Medicines Agency and gradual reimbursement decision-making processes in countries such as Germany, France, UK, Italy, and Spain that have existing expertise in hypertrophic cardiomyopathy care and healthcare infrastructure. According to the 2023 European Society of Cardiology guidelines for hypertrophic cardiomyopathy provide clinical justification for prescribing.
Early German benefit assessment using the AMNOG process created frameworks for payment based on recognition of the value mavacamten offers while also balancing cost-effective pricing. The technology appraisal of the United Kingdom’s National Institute for Health and Care Excellence evaluated the cost-effectiveness of mavacamten compared to existing treatment options, which included septal reduction treatment, resulting in positive recommendations and access by the National Health Service.
Hypertrophic cardiomyopathy registries and collaboration across Europe produce evidence to facilitate efficient use of mavacamten in addition to facilitating the health technology assessment process across member countries. The centralized evaluation for approval conducted by the European Medicines Agency allows for timely entry into the EU marketplace, with national-level reimbursement negotiations determining uptake rates.
The Asia Pacific region exhibits accelerated growth, accounting for a CAGR of 21.3%, till 2034, estimated at USD 82.1 million in 2025, owing to approval in Japan, China, South Korea, and Australia where there is a presence of large patient population, development of healthcare infrastructure, and expertise in cardiovascular medicine. The approval of the Pharmaceuticals and Medical Devices Agency in Japan along with health insurance coverage provides market access fundamentals within a developed healthcare environment.
China has the potential for massive long-term opportunity, owing to the 2.8 million estimated hypertrophic cardiomyopathy patients coupled with growing capability within genetic testing infrastructure to facilitate systematic patient identification. It is important to focus on regulatory submission in China, as well as interacting with key opinion leaders in the region, to harness the growth potential in the Asia Pacific.
The improvements in regional healthcare infrastructure along with the development of capacity to provide specialized treatment for heart-related disorders, coupled with increasing focus on precision medicine, provide an environment that is conducive for the introduction of mavacamten.
The market share held by Obstructive Hypertrophic Cardiomyopathy is 89% and is worth USD 779.1 million by 2025, posting a CAGR of 17.2% from 2026 to 2034 on account of the FDA indication that provides a strong regulatory and commercial base for the use of mavacamten.
The market share held by Non-Obstructive Hypertrophic Cardiomyopathy is 8%, with revenues at USD 70.0 million in 2025, as it represents mainly studies under investigation and compassionate use, with a CAGR projection of 24.8% through 2034 due to positive results generated by the EXPLORER-HCM2 trial. Other Sarcomeric Cardiomyopathies hold 3% of the market share, which includes heart failure with preserved ejection fraction.
The 5 mg capsule is the most widely prescribed form with a market share of 42%, which acts as the maintenance dose after proper titration from the starting 2.5 mg capsule dose. The 2.5 mg capsule has a market share of 28%, and its role is to act as the starting dose for initial titration while maintaining minimal ejection fraction reduction risks.
The 10 mg capsule accounts for 22% of the market and is prescribed for patients requiring higher doses to have effective control of their symptoms and to reduce outflow tract gradients. The 15 mg capsule accounts for 8% of the market and is prescribed for patients who need the highest prescribed doses.
The Specialty Pharmacies hold the largest market share, accounting for 82%, which is equivalent to USD 717.7 million in the year 2025. This large market share is attributed to the requirements of REMS that include certified dispensing, patient support services, and coordinated safety monitoring. Hospital Pharmacies take 14% of the market share, mainly due to the initiation of therapy by integrated health systems.
Retail Pharmacies hold a 3% market share. These are pharmacies for people who have easy access to channels in some of the selected integrated health systems. Finally, Online Pharmacies hold a market share of 1%.
The Academic Medical Centers & Tertiary Care Hospitals are one of the most significant end-users with 64% market share worth USD 560.1 million in 2025 because of the presence of expertise in hypertrophic cardiomyopathy, echocardiography monitoring, and REMS program in academic medical centers. The Specialized Cardiology Practices are the second most dominant with 22% market share but will exhibit the highest Compound Annual Growth Rate (CAGR) of 18.9%. This is because more cardiologists will start acquiring expertise in the disease as time progresses.
The Ambulatory Cardiology Clinics contribute 10% market share with patients receiving special treatment from cardiologists. Community hospitals account for 4% of the market as more cardiologists enroll in the REMS program.
The mavacamten capsules market on a global scale demonstrates concentrated competition characterized by dominance in the Bristol Myers Squibb market due to first-mover advantage, extensive evidence from pivotal clinical trials, well-developed REMS infrastructure, and pipeline products addressing labeling issues. Competition is intensifying due to Cytokinetics’ aficamten being the most significant competitor due to the existence of convincing Phase III clinical data from SEQUOIA-HCM and REDWOOD-HCM trials.
Differentiation is based upon comparative efficacy, monitoring concerns, drug interactions, ease of dosing, and full patient support services. The ability to have reduced dosing due to aficamten’s increased half-life as well as its different CYP450 interactions can offer competitive strengths compared to mavacamten, which already possesses real-world use.
EDG-7500 by Edgewise Therapeutics is one such competitive program under development at an earlier stage for a comparable indication through cardiac myosin inhibition. Furthermore, other cardiac myosin inhibitor programs offered by several biotech companies will present further long-term competitive considerations.
June 2026: Bristol Myers Squibb reports positive data from phase three trial (EXPLORER-HCM2) assessing mavacamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy with statistically significant improvements in peak oxygen consumption and Kansas City Cardiomyopathy Questionnaire scores which support filing of a supplemental NDA application to expand the labeling of the drug with a potential increase of 50% of patients eligible.
May 2026: The U.S. FDA accepts supplemental NDA filing for mavacamten by Bristol Myers Squibb for the treatment of non-obstructive hypertrophic cardiomyopathy with priority review designation with potential to be approved in Q4 2026.
April 2026: Clinical benefits of extended mavacamten treatment observed in the EXPLORER-LTE study extension trial, reported at the American College of Cardiology Scientific Sessions, showed evidence of sustained benefits over a period of 6 years with persistent reduction in the left ventricular outflow tract gradients and biomarker benefits, confirming the disease-modifying potential of the treatment.
March 2026: European regulatory authorities updated mavacamten monitoring recommendations, allowing reduced echocardiographic monitoring frequency for clinically stable patients after prolonged treatment, based on long-term safety evidence.
February 2026: Positive results from the Phase III SEQUOIA-HCM trial on aficamten for obstructive hypertrophic cardiomyopathy were reported by Cytokinetics, showing non-inferiority to mavacamten in the direct head-to-head comparison but having a potential to differentiate in terms of dose flexibility and drug interaction.
January 2026: The drug’s marketing authorization application by China’s National Medical Products Administration came after a successful Phase III clinical trial program for the drug in the region. This comes amid a growing number of cases of hypertrophic cardiomyopathy in China.
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01 Jul 2026
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