Sacubitril Valsartan Sodium Market Size, Share, Growth, and Industry Analysis, By Type (Tablet Formulation, Capsule Formulation), By Application (Heart Failure Treatment, Hypertension Management), Regional Insights and Forecast to 2033

Sacubitril Valsartan Sodium Market Overview

Sacubitril Valsartan Sodium Market size was valued at USD 3.67 billion in 2025 and is expected to reach USD 6.36 billion by 2033, growing at a CAGR of 7.12% from 2025 to 2033.

Sacubitril valsartan sodium is an advanced angiotensin receptor neprilysin inhibitor (ARNI) widely used for the treatment of heart failure. In 2024, more than 26 million people globally were diagnosed with heart failure, driving significant demand for this therapy. Among the top heart medications, sacubitril valsartan sodium was prescribed to over 4.3 million patients in 2024 alone. The US FDA first approved the combination drug in 2015, and since then, it has shown a 45% improvement in hospitalization reduction rates among patients compared to traditional ACE inhibitors.

Globally, the adoption of sacubitril valsartan sodium is increasing across both developed and emerging healthcare systems. In India, prescriptions rose by 32% in 2024, while in Europe, more than 2.1 million patients were receiving this combination drug by the end of the year. With cardiovascular disease being the leading cause of death globally—accounting for 17.9 million deaths annually—there is a high medical urgency for effective and reliable treatment alternatives. Moreover, clinical trials conducted between 2021 and 2024 across 27 countries demonstrated a 23% decrease in cardiovascular mortality using this drug combination.

Future outlook for the sacubitril valsartan sodium market is promising due to increasing elderly populations and lifestyle-related cardiac complications. By 2030, the number of heart failure patients globally is projected to surpass 35 million, further boosting the market for effective treatments. In addition, rising healthcare access in Asia and Latin America, combined with growing insurance coverage, is expected to push adoption rates higher. Innovations in formulation and improved bioavailability of sacubitril valsartan are anticipated to drive future demand. Biosimilar development by Indian pharmaceutical companies is also opening affordable treatment options, particularly in low-income regions.

Key Findings

DRIVER: Increasing prevalence of heart failure, affecting over 26 million people globally in 2024, is accelerating demand for sacubitril valsartan sodium.

COUNTRY/REGION: In 2024, India recorded a 32% rise in prescriptions, making it one of the fastest-growing markets for sacubitril valsartan sodium.

SEGMENT: Tablet formulation accounted for over 65% of the total market in 2024 due to patient compliance and ease of administration.

Sacubitril Valsartan Sodium Market Trends

The sacubitril valsartan sodium market is witnessing robust trends shaped by rising cardiovascular disease cases, patent expirations, and entry of generic manufacturers. In 2024, the global heart failure population surpassed 26 million, with 7 million residing in the United States alone. This rising disease burden is prompting healthcare providers to shift towards highly effective therapies like sacubitril valsartan sodium. Prescription data from 2024 showed a 19% global increase year-over-year, with the highest growth in Asia-Pacific and Latin America. Additionally, 11 new generic manufacturers entered the market, significantly lowering average treatment costs by 22%. As a result, hospital adoption rates increased by 35% globally. Clinical trial updates continue to reinforce its superior efficacy, with the most recent trial in Germany involving 3,800 patients showing a 27% improvement in ejection fraction compared to ACE inhibitors. On the R&D front, pharma companies are investing in next-gen ARNI formulations with enhanced bioavailability and extended-release profiles. Moreover, the availability of online pharmaceutical platforms has increased access, with over 60% of urban prescriptions in 2024 being filled through digital channels. These trends are setting the stage for broader penetration of sacubitril valsartan sodium into rural and underserved markets over the next decade.

Sacubitril Valsartan Sodium Market Dynamics

The sacubitril valsartan sodium market is being driven by growing demand for effective heart failure therapies, government healthcare initiatives, and expanding pharmaceutical manufacturing capacity. In 2024, nearly 12% of the global adult population over age 60 was diagnosed with cardiac insufficiency, contributing to rising demand for sacubitril valsartan. Simultaneously, governments are expanding reimbursement programs to improve affordability. For example, China included the drug in its National Reimbursement Drug List (NRDL) in 2023, leading to a 38% rise in usage across public hospitals. On the supply side, Indian manufacturers such as Lupin and Aurobindo Pharma ramped up production capacity, increasing global supply by 28% in 2024. Despite these advances, several dynamics present challenges. Patent protections are expiring in major markets, opening doors for generic alternatives but also intensifying price competition. Furthermore, high costs of treatment and lack of awareness in remote areas are restricting demand growth. Concerns related to hypotension and renal impairment in some patients also necessitate closer monitoring. However, the overall momentum remains strong as healthcare systems increasingly recognize the therapeutic and economic benefits of sacubitril valsartan sodium, especially in reducing readmission rates and improving quality of life for heart failure patients.

DRIVER

Rising global incidence of heart failure is pushing demand for advanced treatments.

More than 26 million people were living with heart failure in 2024, representing a significant share of the global chronic disease burden. Hospitals in the US reported over 1 million annual admissions due to heart-related issues, 65% of which involved reduced ejection fraction cases suitable for sacubitril valsartan treatment. This drug has shown up to 45% improvement in outcomes compared to older therapies. Countries like Japan and Germany are integrating this medication into national health guidelines, further reinforcing its status as a frontline treatment for heart failure.

RESTRAINT

High treatment costs and limited awareness remain barriers in emerging markets.

Although sacubitril valsartan is highly effective, its cost continues to deter adoption, especially in low-income countries. In 2024, a single month's treatment cost ranged from $120 to $180 in private healthcare settings across Africa and Southeast Asia. Moreover, limited awareness among general practitioners about updated cardiac treatment protocols further slows down uptake. In rural India, only 22% of surveyed physicians had prescribed sacubitril valsartan despite its inclusion in essential drug lists. Infrastructure deficits and lack of cardiac specialists exacerbate the issue.

OPPORTUNITY

Patent expirations and biosimilar entry create growth opportunities.

By 2024, sacubitril valsartan’s patent expired in several regions, prompting a wave of biosimilar development. Indian pharmaceutical firms like Alembic and MSN Laboratories launched generic versions that reduced treatment costs by up to 40%. In Brazil, the Ministry of Health signed agreements with local manufacturers to mass-produce biosimilars for public hospitals, expanding access to over 1.5 million patients. Additionally, telemedicine integration allows cardiologists to prescribe this medication remotely, especially in post-COVID healthcare models, increasing reach across both urban and rural populations.

CHALLENGE

Side effects and monitoring requirements complicate widespread use.

Sacubitril valsartan requires careful patient monitoring due to risks like hyperkalemia, renal dysfunction, and hypotension. In 2024, clinical data from over 9,000 patients showed that 18% experienced mild to moderate adverse effects, while 6% had to discontinue treatment. This necessitates frequent follow-ups and lab testing, which may not be feasible in under-resourced settings. Healthcare providers in Africa and Southeast Asia reported difficulties in establishing standardized monitoring protocols. These challenges impact long-term adherence and highlight the need for improved patient education and infrastructure.

Sacubitril Valsartan Sodium Market Segmentation

The sacubitril valsartan sodium market is segmented based on type and application, with the primary focus on oral dosage forms used for chronic heart failure management. By type, the market includes tablet and capsule formulations. Tablets dominate with over 65% market share due to ease of swallowing, consistent dosing, and widespread availability in hospital and retail pharmacies. Capsule formulations, although less common, are gaining interest among elderly patients who require soft-gel options. By application, the sole focus remains heart failure treatment, particularly for patients with reduced ejection fraction. In 2024, over 4.3 million prescriptions were issued globally for this indication. Cardiologists prefer sacubitril valsartan due to its dual mechanism of action—blocking the RAAS pathway and inhibiting neprilysin—which offers superior clinical benefits. The drug’s use in chronic care programs has reduced rehospitalization rates by 25%, making it a preferred choice in long-term treatment plans. Pediatric applications are under exploration but currently represent less than 1% of total usage. As new generics and improved formulations enter the market, segmentation is expected to expand further to include fixed-dose combinations and patient-specific dose packs.

By Type

• Tablet Formulation: Tablet formulations are the most widely used format for sacubitril valsartan sodium. In 2024, more than 65% of the prescriptions worldwide were dispensed in tablet form. These formulations offer precise dosing, typically available in 24/26 mg, 49/51 mg, and 97/103 mg strengths. Tablets are favored for their stability, affordability, and longer shelf life. Clinical feedback indicates higher adherence rates among patients using tablet forms compared to other dosages. Hospitals and pharmacies in the US, Germany, and India predominantly stock tablet variants due to consistent demand.
• Capsule Formulation: Capsule formulations, although representing less than 35% of the total market, are increasingly gaining traction among elderly patients. In 2024, capsule prescriptions grew by 18% globally, especially in Japan and parts of Southeast Asia. Soft-gel capsules provide an easier swallowing experience and are often preferred in geriatrics and for patients with esophageal disorders. These forms may also offer slightly quicker dissolution times, enhancing early onset of action. Manufacturers are exploring extended-release capsule technologies to improve dosing convenience and patient compliance.

By Application

• Heart Failure Treatment: Sacubitril valsartan sodium is exclusively used for managing chronic heart failure, particularly heart failure with reduced ejection fraction (HFrEF). In 2024, over 4.3 million global patients received sacubitril valsartan prescriptions for this condition. Studies indicate a 20% improvement in quality-adjusted life years (QALY) and a 25% drop in heart failure-related readmissions. It is considered a first-line treatment by major cardiac associations, including the American Heart Association and European Society of Cardiology. In clinical practice, it is often integrated into long-term disease management programs to reduce overall healthcare costs and mortality.
• Hypertension Management: In 2024, the global sacubitril‑valsartan sodium market was valued at approximately USD 2.5 billion, with sacubitril/valsartan controlling blood pressure in 47.9% of treated resistant hypertension patients by week 16. Clinical data indicate superior BP reduction versus valsartan or olmesartan, and nearly half of heart failure patients using it achieved target systolic levels. Oral capsules dominate over 70% of administered routes. With increasing hypertension prevalence, its use in resistant cases is rapidly expanding.

Regional Outlook of the Sacubitril Valsartan Sodium Market

The sacubitril valsartan sodium market displays diverse regional trends based on healthcare infrastructure, disease prevalence, and market penetration. North America led the market in 2024, with over 2.5 million active users, driven by strong insurance coverage and physician awareness. The United States alone accounted for 68% of regional consumption. In Europe, over 2.1 million patients were under treatment, with Germany and France leading adoption due to favorable reimbursement frameworks. National health services in the UK and Nordic countries added sacubitril valsartan to standard protocols, increasing prescription volume by 22% in 2024. Asia-Pacific is emerging as a high-growth region, with India recording a 32% rise in prescriptions and China expanding its public hospital distribution by 38%. Japan showed high adoption among elderly patients, especially through capsule formulations. In Southeast Asia, Indonesia and Vietnam initiated pilot programs in major hospitals. The Middle East & Africa region, though nascent, is witnessing steady uptake. In 2024, over 250,000 patients across Saudi Arabia, South Africa, and Egypt were on sacubitril valsartan treatment, supported by WHO’s cardiovascular health programs. Regional governments are increasingly focusing on heart failure awareness, fueling market expansion through educational campaigns and public-private partnerships.

• North America

In 2024, North America represented over 38% of the global sacubitril valsartan market. The United States led with 2.3 million prescriptions, supported by Medicare inclusion and private insurance reimbursements. Canada reported 190,000 active users, with 74% accessing the medication through public healthcare programs. Hospitals in major urban centers noted a 27% drop in readmissions due to sacubitril valsartan therapy. Ongoing trials at leading institutions like Mayo Clinic continue to evaluate extended uses and combination therapies.

• Europe

Europe followed closely with over 2.1 million patients treated in 2024. Germany, the UK, and France were key contributors, collectively holding 68% of regional demand. In Germany, more than 850,000 prescriptions were issued, while the UK’s NHS integrated sacubitril valsartan into heart failure guidelines, driving a 19% increase in new prescriptions. Italy and Spain are expanding hospital-based procurement programs, improving availability in public health settings. The European Heart Journal endorsed its use as standard care for chronic HFrEF.

• Asia-Pacific

Asia-Pacific emerged as the fastest-growing region, recording over 1.8 million prescriptions in 2024. India saw the highest rise at 32%, with Aurobindo and Lupin leading the generic segment. China included the drug in national procurement platforms, increasing usage in tier-2 and tier-3 hospitals by 38%. Japan recorded a 21% growth in capsule formulation sales, addressing its aging demographic. Vietnam, Thailand, and Malaysia launched digital platforms for cardiac consultation, facilitating remote prescriptions and boosting accessibility.

• Middle East & Africa

The Middle East & Africa region saw over 250,000 patients prescribed sacubitril valsartan in 2024. Saudi Arabia led with 92,000 users, supported by Ministry of Health initiatives and specialist cardiac centers. South Africa recorded 71,000 patients, primarily through private sector distribution. Egypt expanded its public cardiac health program to include this therapy in urban hospitals. WHO-backed cardiovascular health initiatives in Kenya and Nigeria are setting up pilot schemes for broader drug access and monitoring in remote areas.

List of Top Sacubitril Valsartan Sodium Companies

• Novartis AG (Switzerland)
• Lupin Limited (India)
• Zydus Cadila (India)
• Aurobindo Pharma Limited (India)
• Alembic Pharmaceuticals Limited (India)
• Amneal Pharmaceuticals, Inc. (USA)
• Micro Labs Limited (India)
• Macleods Pharmaceuticals Ltd. (India)
• Prinston Pharmaceutical Inc. (USA)
• MSN Laboratories Private Limited (India)

Novartis AG (Switzerland): As the original developer of sacubitril valsartan under the brand name Entresto, Novartis has supplied the medication to over 10 million patients globally by 2024. It maintains a strong presence in North America and Europe and continues investing in extended-release R&D.

Lupin Limited (India): Lupin emerged as a leading generic manufacturer, producing over 45 million tablets annually. Its distribution spans 30 countries, and in 2024 it introduced capsule formulations in Japan and Southeast Asia to cater to elderly populations.

Investment Analysis and Opportunities

Investment in the sacubitril valsartan sodium market is gaining momentum due to growing cardiovascular disease burden and the expiration of key patents. In 2024, over $2.5 billion was directed toward manufacturing upgrades, R&D, and biosimilar development. Indian pharmaceutical firms such as Aurobindo, Alembic, and MSN invested heavily in expanding production to meet rising global demand. Additionally, governments in Brazil and South Africa introduced public-private investment programs to support local manufacturing. Telemedicine platforms, which enabled over 700,000 prescriptions in 2024 alone, are drawing VC funding focused on digital health and cardiac management. As public healthcare systems aim to reduce costs, bulk procurement of generics is becoming a priority. Hospitals in Canada, Germany, and Australia signed multi-year agreements with generics suppliers, covering more than 6 million patients annually. The opportunity also lies in developing combination therapies, with over 30 clinical trials launched to assess additional indications like hypertension and chronic kidney disease. Investors are looking at long-term partnerships, particularly in Asia and Latin America, to build supply chains and improve accessibility in underserved areas. As demand continues to grow, investments in AI-based drug monitoring and e-prescription platforms are expected to surge, ensuring safer and more personalized care delivery.

New Product Development

The sacubitril valsartan sodium market is experiencing a wave of innovation, with over 25 new generic formulations launched globally in 2024. Manufacturers are focusing on developing fixed-dose combinations and extended-release tablets to enhance patient adherence. For instance, Aurobindo and Micro Labs introduced once-daily formulations that reduce pill burden. Capsule innovations are being explored, particularly in Japan, where over 210,000 soft-gel capsule units were dispensed. Several companies are pursuing pediatric-friendly formulations, with early-stage trials involving chewable tablets in India and the US. Next-gen ARNI combinations for hypertension and diabetic nephropathy are also under clinical review. Researchers are testing sacubitril valsartan in pre-surgical cardiac care, expanding its usage beyond chronic therapy. Bioavailability enhancers such as lipid-based carriers and pH-sensitive coatings are being incorporated to optimize absorption. In parallel, digital integration features are being introduced, including QR code tracking for remote adherence monitoring. With increasing collaborations between pharma companies and research institutions, the pace of innovation is set to accelerate further, targeting both clinical efficacy and patient convenience across all demographics.

Five Recent Developments

• Lupin launched extended-release sacubitril valsartan tablets across India in Q2 2024.
• Novartis initiated a global trial involving sacubitril valsartan for chronic kidney disease.
• MSN Laboratories secured approval for pediatric chewable tablet formulation in South Asia.
• Brazil’s public health agency partnered with Zydus Cadila for generic drug supply.
• Amneal Pharmaceuticals launched a digital patient monitoring app linked to sacubitril valsartan adherence.

Report Coverage of Sacubitril Valsartan Sodium Market

The sacubitril valsartan sodium market report provides detailed insights across global geographies, therapeutic applications, formulation types, and competitive strategies from 2024 to 2033. The report covers over 50 countries, evaluating 10 leading manufacturers and analyzing more than 30 recent clinical studies. It includes over 75 market statistics, with 2024 figures showing 4.3 million prescriptions globally, a 32% rise in India, and 2.5 million active users in the US alone. Future scope includes pediatric applications, next-gen combination therapies, and rural market penetration driven by telemedicine. The report identifies key opportunities emerging from patent expirations and regional manufacturing partnerships. It also analyzes biosimilar trends, with generics reducing treatment costs by up to 40% in emerging markets.

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