Anti-Neprilysin Drugs Market Size & Share Analysis - Growth Trends and Forecast (2026 - 2031)

Global Anti-Neprilysin Drugs Market Trends and Insights

Rising Prevalence of Chronic Heart Failure & Hypertension

Worldwide heart-failure prevalence touched 64 million people in 2024 and continues to climb, largely because populations are aging and hypertension control remains inconsistent.^{[1]World Health Organization, “Heart Failure Statistics 2024,” WHO, who.in}The American Heart Association counted 6.9 million U.S. adults living with the condition in 2024, estimating that one in five Americans will develop heart failure during their lifetime. Direct medical spending in the United States reached USD 30.7 billion in 2024, a burden that elevates payers’ interest in drug classes shown to curb hospitalization.^{[2]Centers for Disease Control and Prevention, “Heart Failure Facts,” CDC, cdc.gov} Asia-Pacific is experiencing the fastest case-count expansion as urban diets high in sodium collide with limited blood-pressure screening, yet reimbursement gaps slow uptake. The persistence of high mortality—projected to reach 8 million global deaths by 2030—keeps attention fixed on therapies with proven survival benefit.

Guideline Inclusion of Sacubitril/Valsartan (ARNI)

In 2024 the American College of Cardiology designated ARNI as preferred first-line treatment for HFrEF, replacing long-standing ACE inhibitor and ARB standards.^{[3]American College of Cardiology, “2024 Expert Consensus Decision Pathway,” ACC, acc.org} European guidelines mirrored that upgrade, although payer rules differ across member states, slowing uniform rollout. U.S. hospital formularies responded by making ARNI the default heart-failure therapy, yet insurers still enforce prior-authorization hurdles that delay initiation. In single-payer systems such as Ireland and the United Kingdom, budget caps create local restrictions, demonstrating how clinical endorsement alone does not guarantee access. Even so, guideline elevation supports steady prescription growth and strengthens the class in negotiations with health plans.

Regulatory Expansion into HFpEF & Pediatrics

The U.S. FDA’s 2021 label broadening to include chronic heart-failure patients with ejection fractions below normal unlocked a clinically significant HFpEF population previously underserved by pharmacotherapy. Pediatric approvals in the United States (2019) and Japan (2024), plus a granule formulation launched in April 2024, further extended reach to younger cohorts. Although the PARAGON-HF trial narrowly missed its primary endpoint, post-hoc analyses guided regulators toward nuanced HFpEF indications. These progressive approvals enlarge the eligible pool and offer headroom for sales momentum despite looming generic erosion.

Once-Daily Next-Gen Small-Molecule NEP Inhibitors

Pipeline agents seek to simplify dosing and address theoretical amyloid-beta accumulation concerns. Regeneron’s REGN5381 activates natriuretic peptide receptor 1 directly, avoiding neprilysin blockade and aiming for once-daily or even less frequent regimens. Phase-3-stage candidates are absent, so commercial impact sits beyond the current forecast window, yet R&D disclosures signal where competitive play is heading. The prospect of differentiated mechanisms may restrain the long-run price-cutting ability of generics.

Patent Expiry & Generic Erosion of Entresto

A Delaware court decision in July 2025 cleared Alembic, MSN, Laurus, and Lupin to launch generic sacubitril/valsartan, ending Novartis’s bid for exclusivity through 2026. Branded cardiovascular drugs typically lose 30-50% price inside the first year of multi-source competition, and European approvals such as Teva’s Irish listing in September 2025 set the stage for wider erosion. Novartis still holds method-of-use patents into the 2030s, but they cannot block generic marketing for on-label indications, so volume share is likely to slide toward 20-30% by 2028 unless a next-generation product emerges.

High Therapy Cost & Reimbursement Barriers

Entresto’s U.S. list price topped USD 6,000 per patient annually in 2024, triggering prior-authorization hurdles that delay starts and create administrative drag. In single-payer systems, cost-effectiveness ceilings push payers to limit use. The U.K. National Institute for Health and Care Excellence placed the incremental cost-effectiveness ratio near its upper payment threshold, leading some National Health Service trusts to stagger adoption. Out-of-pocket costs in lower-middle-income economies still exceed household income for many patients, restricting uptake until generics penetrate.

Segment Analysis

By Drug Type: Small Molecules Hold Sway While Biologics Catch Up

Small-molecule inhibitors retained 76.23% of 2025 revenue because sacubitril/valsartan lacks a differentiated competitor. Biologic antibodies and peptides, however, are tracking the fastest 8.46% CAGR and could erode this dominance from 2029 onward. The anti-neprilysin drugs market size for biologics is expected to grow meaningfully once the first late-phase candidates read out pivotal data. Manufacturing cost remains a hurdle, yet expanded peptide and antibody capacity in the United States and Europe is lowering barriers.

The anti-neprilysin drugs market has room for next-generation classes that avoid angioedema and cognitive-safety debates. Regeneron’s natriuretic peptide receptor agonist shows early promise, but material commercial impact lies beyond the forecast window. Without near-term replacements, generics will seize share from branded small molecules first, followed by eventual disruption as biologics prove value.

Note: Segment shares of all individual segments available upon report purchase

By Indication: HFrEF Dominates, HFpEF Surges

HFrEF delivered 61.53% of 2025 sales thanks to unequivocal survival data and class-I guideline placement. HFpEF/HFmrEF, however, is the fastest-growing indication, rising at 7.34% and expected to narrow the gap by 2031. The anti-neprilysin drugs market share for HFpEF could jump once ongoing real-world studies validate outcomes in higher-ejection-fraction patients. Pediatric approvals widen the total treated pool further, albeit from a smaller base.

Systemic hypertension remains a niche, and pain or CNS disorders are still exploratory. Nevertheless, label expansions broaden payers’ willingness to reimburse, creating incremental volume even if per-patient profit compresses under generic pricing.

By Dosage Form: Tablets Prevail While Injectables Surface

Tablets made up 86.35% of revenue in 2025, buoyed by three strength options that support titration. The anti-neprilysin drugs market size for injectables is rising at a 6.77% CAGR, though from a low base, mainly because biologic candidates require parenteral routes. Pediatric granule formulations help niche sub-groups but do not shift overall dollar mix. As generic tablets proliferate, innovators may push subcutaneous biologics to reclaim premium pricing.

Note: Segment shares of all individual segments available upon report purchase

By Distribution Channel: Hospital Pharmacies Still Lead But Online Channels Accelerate

Hospital pharmacies controlled 52.42% of 2025 revenue, reflecting initiation during inpatient stays. Online and specialty outlets, however, will grow quickest at 8.97% on the back of mail-order convenience and integrated remote-monitoring packages. As generics hit shelves, prior-authorization barriers shrink, steering volume away from hospitals toward retail and digital channels that handle high-throughput dispensing.

Geography Analysis

North America’s leadership rests on robust diagnosis rates, guideline adherence, and higher disposable income, yet the Inflation Reduction Act will negotiate Medicare prices from 2026, trimming topline by 10-15% for branded therapies. Canada’s provincial formularies offer generally favorable coverage, although Québec caps annual growth in public-drug spending, nudging Novartis toward risk-sharing deals.

Europe transitions into a value-driven phase. While Germany maintains unrestricted access, Southern and Eastern member states apply tighter budget controls. Ireland’s early generic listing showcases the speed with which competitive entry can reshape drug spending. Expect further price compression once pan-European tenders gain momentum.

Asia-Pacific is the undisputed growth engine. Japan’s pediatric clearance and China’s expanded National Reimbursement Drug List reinforce volume, but average selling price is lower because of local procurement rules. The Philippines’ 2024 approval signals Southeast Asia’s widening access, though affordability remains a sticking point in Vietnam and Indonesia.

Middle East and Africa are nascent. The United Arab Emirates’ National Succinct Statement in 2024 points to gradual uptake, but the region’s heart-failure infrastructure is still developing. South America offers selective pockets of strength—Brazil’s public procurement and private insurance ¬ uptake—yet macroeconomic volatility in Argentina and other markets curbs visibility.