Vutrisiran - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2026-2031)

The vutrisiran market size was valued at USD 2.31 billion in 2025 and estimated to grow from USD 2.93 billion in 2026 to reach USD 9.64 billion by 2031, at a CAGR of 26.9% during the forecast period 2026-2031. This report is Segmented by Indication (hATTR Polyneuropathy, ATTR Cardiomyopathy), Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), End User (Hospitals, Specialty Clinics, Home Care Settings, Academic and Research Institutes), and Geography (North America, Europe, Asia-Pacific, South America, Middle East and Africa). The Market Forecasts are Provided in Terms of Value (USD).

Global Vutrisiran Market Trends and Insights

Expanding Approved Use Across hATTR-PN and ATTR-CM

Vutrisiran moved from a polyneuropathy-only product to a therapy used in both hATTR-PN and ATTR-CM, and that shift is the strongest near-term growth driver for the vutrisiran market. The March 2025 FDA decision gave Alnylam the first RNAi approval in ATTR-CM, which created an early lead before any comparable silencer reached the same setting. HELIOS-B showed a 28% reduction in the combined endpoint of all-cause mortality and recurrent cardiovascular events in the overall population, and the reduction reached 33% in patients not using background TTR stabilizers. The same program also reported amyloid regression on cardiovascular magnetic resonance imaging in 22% of treated patients, while no regression was seen in placebo groups, which strengthened the disease-modifying profile supporting the vutrisiran market. Regulatory expansion in Europe, Canada, and Japan kept adding new treated populations through 2025 and 2026, and that pace is faster than many rare disease launches achieve. As a result, the vutrisiran market is no longer tied only to a narrow hereditary neuropathy base and is now linked to a broader cardiology treatment pool.

Rising Diagnosis Rates for Transthyretin Amyloidosis

The vutrisiran market still depends heavily on better diagnosis because ATTR amyloidosis remains underdetected in routine practice. A 2025 U.S. study found that only 44% to 54% of Medicare patients with ATTRwt-CM received the recommended non-invasive pathway that combines 99mTc-PYP scintigraphy with complete monoclonal protein testing. That gap shows that the commercial ceiling is still set more by patient finding than by treatment awareness alone in the vutrisiran market. Cardiologists have become the main referral source for ATTR-CM, and screening is moving deeper into heart failure workups as awareness improves. Alnylam’s March 2026 work with Viz.ai uses an FDA-cleared echocardiography AI tool across 2,000 U.S. hospitals, which directly targets earlier case finding and referral coordination. Better diagnostic conversion should widen the treated population over time and keep the vutrisiran market tied to care-pathway expansion rather than to label expansion alone.

High Annual Therapy Cost and Reimbursement Friction

The biggest commercial brake on the vutrisiran market is treatment cost, with annual therapy pricing estimated at USD 450,000 to USD 500,000. Ireland’s National Centre for Pharmacoeconomics did not support reimbursement at the submitted price for hATTR-PN, and access moved forward only after confidential price negotiations in May 2024. Canada’s Drug Agency supported reimbursement for ATTR-CM in 2026 with a 13-0 vote, but it attached conditions that reflect cost-effectiveness pressure common in rare disease funding. Those payer steps show that regulatory approval does not automatically translate into fast penetration across the vutrisiran market. From 2027 onward, lower-cost tafamidis generics could become the first option in some systems before access to vutrisiran is granted, especially where step therapy rules are strict. That dynamic could slow near-term uptake in price-sensitive countries even when demand drivers for the vutrisiran market remain favorable.

Other drivers and restraints analyzed in the detailed report include:

• Preference for Quarterly Subcutaneous Disease-Modifying Therapy
• Broader Cardiologist and Neurologist Adoption After Label Expansion
• Limited Patient Pool and Slow Diagnostic Conversion

Segment Analysis

hATTR Polyneuropathy held 72.4% of the vutrisiran market in 2025, which reflected its earlier approval and its established treatment base since 2022. Long-term HELIOS-A extension data published in 2026 confirmed sustained neurological benefit after more than 4 years of continuous treatment, which supports retention in this part of the vutrisiran industry. That durable benefit keeps hATTR-PN clinically important even as the revenue mix changes over time. At the same time, ATTR Cardiomyopathy is projected to expand at 29.5% CAGR through 2031, which makes it the strongest growth engine within the vutrisiran market. The cardiomyopathy pool is larger than the hereditary neuropathy pool, and awareness programs around cardiac amyloidosis are widening faster than older neuropathy referral patterns.

ATTR Cardiomyopathy is expected to move into the lead by the end of the forecast period, which changes the center of the vutrisiran industry from neurology toward cardiology. A dedicated HELIOS-B subgroup analysis in East Asian patients showed efficacy and safety results in Japanese and Korean patients that were consistent with the broader trial population. That evidence supports the commercial case in Japan and also strengthens future access discussions in other Asia-Pacific markets. The 22% amyloid regression rate seen on cardiac imaging adds a structural recovery message that has not been central to stabilizer therapy positioning. This is why the vutrisiran market is being shaped less by legacy indication history and more by the broader scale of ATTR-CM treatment adoption.

Complete Report Scope:

• By Indication
  • hATTR Polyneuropathy
  • ATTR Cardiomyopathy
• By Distribution Channel
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
• By End User
  • Hospitals
  • Specialty Clinics
  • Home Care Settings
  • Academic and Research Institutes
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • South Korea
    • Australia
    • Rest of Asia-Pacific
  • South America
    • Brazil
    • Argentina
    • Rest of South America
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa

Geography Analysis

North America held 74.8% of the vutrisiran market share in 2025, with the United States remaining the most advanced commercial setting for ATTR treatment. The March 2025 FDA approval for ATTR-CM expanded the prescriber base beyond neurologists and brought cardiologists and heart failure specialists directly into the uptake path. Alnylam’s estimate of more than 75,000 potential ATTR-CM patients in the United States shows that the vutrisiran market still has a large untreated pool even after rapid revenue growth. Canada added another important step when Health Canada approved AMVUTTRA for ATTR-CM in December 2025 and Canada’s Drug Agency followed with a positive reimbursement recommendation in 2026.

Europe is an expanding region for the vutrisiran market because the June 2025 European Commission approval created the regulatory base for wider commercial rollout. Uptake still moves at different speeds because each country follows its own reimbursement timetable after central approval. The Netherlands moved to expand reimbursement conditions to cover ATTR-CM, which shows that payer discussions are following the label expansion. The June 2026 expansion of the GENESIS Pharma partnership into Denmark, Finland, Norway, and Sweden also extends reach into a region with meaningful ATTR-CM prevalence and established rare disease care pathways.

Asia-Pacific is projected to deliver the fastest vutrisiran market size growth at 30.8% CAGR through 2031, supported by Japan’s high ATTR-CM prevalence and regulatory progress. A 2025 systematic review estimated Japan’s ATTR-CM prevalence at 100 cases per million per year, which was the highest level among the tracked countries cited in the source set. The East Asian HELIOS-B subgroup also showed that Japanese and Korean patients had efficacy and safety outcomes consistent with the full study population. That evidence supports the regional case for the vutrisiran market as more cardiology programs in Asia-Pacific begin to evaluate access and reimbursement. South America and the Middle East and Africa still represent earlier-stage opportunities because diagnostic depth, specialist networks, and reimbursement systems are less developed than in North America, Europe, and Japan.

List of Companies Covered in this Report:

• Alnylam Pharmaceuticals

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support