Vutrisiran (2026-2031) - Growth Driven by Expanding Treatment Adoption for ATTR Amyloidosis
Dublin, Aug. 20, 2026 (GLOBE NEWSWIRE) -- "Vutrisiran - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2026-2031)" has been added to ResearchAndMarkets.com's offering.
Vutrisiran Market Projected to Reach USD 9.64 Billion by 2031, Growing at a 26.9% CAGR
The global vutrisiran market was valued at USD 2.31 billion in 2025 and is estimated to increase from USD 2.93 billion in 2026 to USD 9.64 billion by 2031. This represents a compound annual growth rate of 26.9% during the 2026-2031 forecast period. Market growth is being driven by expanded use across hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN) and transthyretin amyloid cardiomyopathy (ATTR-CM), improving diagnosis rates, broader specialist adoption, and growing demand for quarterly subcutaneous therapy.
Expanded ATTR-CM Approval Strengthens Vutrisiran Market Growth
Vutrisiran's transition from a polyneuropathy-focused treatment to a therapy serving both hATTR-PN and ATTR-CM represents the most significant near-term growth driver. The U.S. Food and Drug Administration's March 2025 decision made vutrisiran the first RNA interference therapy approved for ATTR-CM, establishing an early competitive advantage in this treatment setting.
Clinical results from the HELIOS-B program reinforced vutrisiran's disease-modifying profile. The study reported a 28% reduction in the combined endpoint of all-cause mortality and recurrent cardiovascular events across the overall patient population. Among patients not receiving background transthyretin stabilizers, the reduction reached 33%. Cardiovascular magnetic resonance imaging also identified amyloid regression in 22% of treated patients, compared with no observed regression in the placebo group.
Regulatory expansion across Europe, Canada, and Japan during 2025 and 2026 has continued to broaden the eligible treatment population. As a result, the vutrisiran market is increasingly connected to the substantially larger cardiology population rather than relying primarily on the established hereditary polyneuropathy segment.
Improved Transthyretin Amyloidosis Diagnosis Supports Patient Growth
Rising diagnosis rates are expected to play a central role in long-term vutrisiran market expansion. Transthyretin amyloidosis remains underdiagnosed in routine clinical practice, particularly among patients with wild-type ATTR cardiomyopathy. A 2025 U.S. study found that only 44% to 54% of Medicare patients with ATTRwt-CM received the recommended non-invasive diagnostic pathway combining technetium-99m pyrophosphate scintigraphy with complete monoclonal protein testing.
Cardiologists and heart failure specialists are becoming increasingly important referral sources as ATTR-CM screening is incorporated into cardiovascular care pathways. Alnylam Pharmaceuticals' March 2026 collaboration with Viz.ai is intended to support earlier identification and referral through an FDA-cleared echocardiography artificial intelligence platform available across 2,000 U.S. hospitals. Continued diagnostic improvement could significantly expand the treated population and support sustained vutrisiran market growth.
Pricing and Reimbursement Remain Key Market Restraints
High therapy costs and reimbursement requirements remain substantial barriers to broader adoption. Annual vutrisiran treatment costs are estimated at between USD 450,000 and USD 500,000. Ireland's National Centre for Pharmacoeconomics did not initially recommend reimbursement at the submitted price for hATTR-PN, with access progressing only after confidential pricing negotiations in May 2024.
Canada's Drug Agency supported reimbursement for ATTR-CM in 2026 through a unanimous 13-0 vote, although its recommendation included conditions reflecting ongoing cost-effectiveness concerns. These developments demonstrate that regulatory approval does not automatically result in immediate market access. The potential introduction of lower-cost tafamidis generics from 2027 could also influence treatment sequencing, particularly in countries that apply step-therapy requirements or maintain strict rare disease budgets.
ATTR Cardiomyopathy Emerges as the Fastest-Growing Indication
hATTR polyneuropathy accounted for 72.4% of the vutrisiran market in 2025, supported by its earlier approval and established treatment base since 2022. Long-term HELIOS-A extension findings published in 2026 demonstrated sustained neurological benefits after more than four years of continuous treatment, supporting patient retention and continued clinical use.
ATTR cardiomyopathy, however, is projected to record a 29.5% CAGR through 2031 and become the leading indication by the end of the forecast period. This shift is moving the center of the vutrisiran market from neurology toward cardiology. The larger ATTR-CM patient population, increasing cardiac amyloidosis awareness, and expanding specialist engagement are expected to accelerate adoption.
A HELIOS-B subgroup analysis involving East Asian patients found that efficacy and safety outcomes among Japanese and Korean participants were consistent with the broader study population. These findings strengthen the clinical and commercial outlook for vutrisiran across major Asia-Pacific markets.
North America Leads as Asia-Pacific Records the Fastest Expansion
North America held 74.8% of the global vutrisiran market in 2025, led by the United States. FDA approval for ATTR-CM expanded the prescriber base to include cardiologists and heart failure specialists, while an estimated U.S. population of more than 75,000 potential ATTR-CM patients indicates considerable remaining treatment opportunity. Canada also advanced regional access following Health Canada's December 2025 ATTR-CM approval and a positive reimbursement recommendation in 2026.
Europe continues to expand following European Commission approval in June 2025, although adoption varies according to national reimbursement schedules. Developments in the Netherlands and an expanded GENESIS Pharma partnership covering Denmark, Finland, Norway, and Sweden are supporting broader regional availability.
Asia-Pacific is forecast to achieve the fastest regional growth, with a 30.8% CAGR through 2031. Japan's comparatively high ATTR-CM prevalence, supportive clinical evidence, and ongoing regulatory progress position the region as a major future growth market. South America, the Middle East, and Africa remain earlier-stage opportunities, with future adoption dependent on stronger diagnostic capacity, specialist networks, and reimbursement infrastructure.
Key Topics Covered:
1 INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET LANDSCAPE
4.1 Market Overview
4.2 Market Drivers
4.2.1 Expanding Approved Use Across hATTR-PN and ATTR-CM
4.2.2 Rising Diagnosis Rates for Transthyretin Amyloidosis
4.2.3 Preference for Quarterly Subcutaneous Disease-Modifying Therapy
4.2.4 Broader Cardiologist and Neurologist Adoption After Label Expansion
4.2.5 Stronger Referral Pathways Through Amyloidosis Centers of Excellence
4.2.6 Payer Support for High-Value Rare Disease Therapies
4.3 Market Restraints
4.3.1 High Annual Therapy Cost and Reimbursement Friction
4.3.2 Limited Patient Pool and Slow Diagnostic Conversion
4.3.3 Competing TTR Stabilizers and RNAi Therapies
4.3.4 Need for Specialized Infusion or Injection Site Coordination
4.4 Value Chain Analysis
4.5 Supply Chain Analysis
4.6 Regulatory Landscape
4.7 Technological Outlook
4.8 Porter's Five Forces Analysis
4.8.1 Bargaining Power of Suppliers
4.8.2 Bargaining Power of Buyers
4.8.3 Threat of New Entrants
4.8.4 Threat of Substitutes
4.8.5 Intensity of Competitive Rivalry
5 MARKET SIZE AND GROWTH FORECASTS
5.1 By Indication
5.1.1 hATTR Polyneuropathy
5.1.2 ATTR Cardiomyopathy
5.2 By Distribution Channel
5.2.1 Hospital Pharmacies
5.2.2 Retail Pharmacies
5.2.3 Online Pharmacies
5.3 By End User
5.3.1 Hospitals
5.3.2 Specialty Clinics
5.3.3 Home Care Settings
5.3.4 Academic and Research Institutes
5.4 By Geography
5.4.1 North America
5.4.1.1 United States
5.4.1.2 Canada
5.4.1.3 Mexico
5.4.2 Europe
5.4.2.1 Germany
5.4.2.2 United Kingdom
5.4.2.3 France
5.4.2.4 Italy
5.4.2.5 Spain
5.4.2.6 Rest of Europe
5.4.3 Asia-Pacific
5.4.3.1 China
5.4.3.2 India
5.4.3.3 Japan
5.4.3.4 South Korea
5.4.3.5 Australia
5.4.3.6 Rest of Asia-Pacific
5.4.4 South America
5.4.4.1 Brazil
5.4.4.2 Argentina
5.4.4.3 Rest of South America
5.4.5 Middle East and Africa
5.4.5.1 GCC
5.4.5.2 South Africa
5.4.5.3 Rest of Middle East & Africa
6 COMPETITIVE LANDSCAPE
6.1 Market Concentration
6.2 Market Share Analysis
6.3 Strategic Moves
6.4 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
6.4.1 Alnylam Pharmaceuticals, Inc.
7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK
7.1 White-Space and Unmet-Need Assessment
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