Vutrisiran Market
Report ID: SQMIG35H2401
Report ID: SQMIG35H2401
sales@skyquestt.com
USA +1 351-333-4748
Report ID:
SQMIG35H2401 |
Region:
Global |
Published Date: December, 2025
Pages:
186
|Tables:
88
|Figures:
71
Global Vutrisiran Market size was valued at USD 496.0 million in 2024 and is poised to grow from USD 558.5 million in 2025 to USD 1443.2 million by 2033, growing at a CAGR of 12.6% during the forecast period (2026-2033).
The global vutrisiran market statistics is witnessing strong growth, driven by robust clinical momentum and therapeutic promise with its RNAi-based mechanism significantly reduces transthyretin protein burden in hereditary and wild‑type ATTR amyloidosis, which in turn contributed to regulatory approvals in multiple major markets and expands its label to cover cardiomyopathy. Then compound that with increased awareness of diagnostic testing, a higher prevalence of disease, and directed investments in R&D, and you can certainly see the growth trajectory for the Market.
Nevertheless, some restraints can inhibit global vutrisiran market strategies. The high treatment cost and usually quarterly administration limits patient access, particularly in lower income areas, and payers remain highly scrutinous regarding coverage as reimbursements are often value based. In addition, the diagnostic difficulties and low disease awareness lead to underdiagnosis and delayed treatment initiation, and a shortage of specialized clinical staff slows uptake. The lack of long-term safety data and limited head-to-head trials with existing therapies continue to engender hesitance in both physicians and payers to fully accept positioning as a first line of therapy.
How are Emerging Technologies like AI and IOT Transforming the Vutrisiran Market?
With the integration of AI and IoT, the vutrisiran ecosystem improved accuracy to drug delivery, smarter monitoring in the clinical development of the studies, and better efficiency in manufacturing, and distribution. AI modeling in drug development has sped up the design of nanoscale carriers that may deliver innovative RNAi therapies like vutrisiran directly and specifically, with great overall personalized delivery desired and minimized side effects. In drug manufacturing, IoT-enabled sensors in the production environment generally support Pharma 4.0 conceptual frameworks of real-time monitoring combined with AI-provided predictive action. These systems produce improved quality in manufacturing, minimize downtime events, and better batch consistency for RNAi agents.
In April 2025, NTT DATA, in partnership with the Digital Twin Consortium, kicked off a Digital Twin–Enabled Microfactory pilot that focused on biologics manufacturing leveraging AI-driven insights and IoT sensors on PLC-controlled equipment to optimize real-time process conditions, identify anomalies, and conduct predictive maintenance which will lead to decreased downtime and a more consistent production outcome. This represents a major step for RNAi therapies that can lead to a baseline that everyone can consistently defy and will pave the way for an ease of integrating smart process systems.
Market snapshot - 2026-2033
Global Market Size
USD 490 Million
Largest Segment
Injectable
Fastest Growth
Oral
Growth Rate
12% CAGR
To get more insights on this market click here to Request a Free Sample Report
Global Vutrisiran Market is segmented by Drug Class, Route of Administration, Patient Demographics, Distribution Channel and region. Based on Drug Class, the market is segmented into Antisense Oligonucleotide, Nucleic Acids, Nucleotide, Nucleoside and Other Drug Classes. Based on Route of Administration, the market is segmented into Oral, Injectable and Subcutaneous. Based on Patient Demographics, the market is segmented into Pediatric, Adult and Geriatric. Based on Distribution Channel, the market is segmented into Hospital Pharmacies, Retail Pharmacies, Online Pharmacies and Other Distribution Channels. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.
What Key Feature Gives Injectable Formulations Edge in Vutrisiran Market?
Based on the global vutrisiran market forecast, injectable formulations have a dominant position in the vutrisiran market. The injectable modality reflects the mechanisms of RNAi, which require targeted delivery via subcutaneous injection, self-administration in the comfort of home, quarterly dosing convenience, and high clinical acceptance compared to oral forms. Injectable delivery ensures accurate dosing; consistent TTR knockdown, and high patient compliance are all drivers of steady growth.
The oral formulation is the fastest‑growing sub‑segment driven by greater patient preference for a non-invasive treatment along with the convenience of a pill regimen, better adherence, and the industry's push towards patient‑centered routes of administration. Due to the maturation and regulatory pathway opportunities of oral RNAi platforms, this trend of growth is expected to continue.
Which is the Fastest-Growing Sub-Segment in the Vutrisiran Market?
The genetic disorders indicated account for market share within the therapeutic area breakdown. Vutrisiran has been approved for hereditary ATTR polyneuropathy, originally, a genetic condition driving the early adoption and revenue generation. The growing diagnosis of hATTR, the trial performance against polyneuropathy, and the fact that Vutrisiran is a first line of RNAi therapy for genetic disorders all lend themselves to this dominant position. The increase in genetic testing and awareness is also an additional driver of uptake.
Cardiovascular diseases are the fastest growing market segment, relying on expanding the FDA's approval of vutrisiran (Amvuttra) for transthyretin amyloid cardiomyopathy. With its ability to reduce mortality and cardiovascular events, vutrisiran can compete as a firstline therapy in cardiac ATTR. This approval and clinical benefit enable rapid adoption and accelerated growth in cardiovascular applications.
To get detailed segments analysis, Request a Free Sample Report
What Makes North America a Leader in the Vutrisiran Market?
As per the global vutrisiran market analysis, North America continues to dominate the vutrisiran market due to its established biotechnology infrastructure, the high incidence levels of transthyretin amyloidosis, and available access to rare disease diagnostics. The growing public health awareness campaigns and continued investigation into RNAi therapies will also come to bear on its market lead. North America will continue to lead sales and adoption rates throughout the world as patient screening continues to expand.
US Vutrisiran Market
The U.S. leads the North American vutrisiran market forecast due to a combination of early vutrisiran approvals, exceptional healthcare expenditures, and productive clinical research ecosystems. The previously mentioned expanded indications for vutrisiran in cardiac amyloidosis, allowing physicians to treat a patient's neurological and cardiac symptoms, as well as payers endorsing the treatment and specialty access points, adds to the speed to patient access and experience ultimately boosting the U.S.'s dominance in the worldwide vutrisiran landscape.
Canada Vutrisiran Market
Canada is growing quickly as a North American vutrisiran market outlook. The expansion of national genetic screening programs and more proactive uptake of RNAi therapies under provincial drug plans has also improved access for patients, notably due to the inclusion of vutrisiran under several provincial public health formularies, which is a significant achievement toward equality access. Continued clinical collaborations and awareness initiatives will sustain the momentum of the market and continue to increase the prescribing of this class of drug.
What Infrastructure Investments are Fueling Growth in Europe?
Europe is the fastest growing market for vutrisiran because of robust health systems, growing global interest in ATTR, and regional cooperation around rare disease care. Clinical uptake of vutrisiran is developing rapidly, aided by strong patient advocacy and the addition of vutrisiran to public formularies. Germany and France and the UK are the leading players in the market, and they each have made different contributions to advancing research, clinical guidelines and accessibility to the market.
Germany Vutrisiran Market
Germany is also the largest European vutrisiran market regional outlook as Germany has the best diagnostic infrastructure, more developed reimbursement channels, a higher rare disease detection rate, and a wider range of access to national health insurance programs as with vutrisiran, which allowed for a much broader access to therapy by a larger group of patients. Overall, the physicians' familiarity with RNAi therapies and the number of specialized amyloidosis centers all contribute to Germany being the largest vutrisiran market in Europe.
France Vutrisiran Market
France is experiencing rapid development, perhaps propelled by its central government-led healthcare model, including funding for rare diseases. These have both accelerated clinician uptake and encourage patients to initiate treatment. In addition, the combination of greater genetic screening, and an increase of clinical trials linked to transthyretin amyloidosis, will also see patient repurposing through quicker entry points into the regional treatment centers, positioning France with strong momentum in this segment.
UK Vutrisiran Market
The U.K. is advancing in the European vutrisiran market regional forecast, stimulated by genetic screening implementation programs with increased NHS acceptance of new therapies, and inclusion of RNAi drugs in clinical policy guidelines. A step forward was the recommendation of vutrisiran by national health technology assessment organizations against eligible patient populations under rare disease mandates, which expedited coverage and access.
What Type of Development is Driving Vutrisiran Demand in Asia Pacific?
The Asia Pacific region is acquiring global vutrisiran market share in space. Countries have been enhancing their rare disease infrastructure and investing in RNAi Research and Development. Japan and South Korea are developing regulatory and clinical trial ecosystems to support advanced therapy development. Increasing government initiatives, biotechnology funding, and awareness are reducing historical diagnostic barriers. The respective attitudinal trends in ATTR-related diseases are driving diagnoses and thus demand for next generation therapies like vutrisiran in the region.
Japan Vutrisiran Market
Japan leads the vutrisiran market in the Asia Pacific region due to its top-tier biotech sector, strong regulatory science, and focus on precision medicine. Their approval facilitates several other RNAi-based drugs for neurology and cardiology, including vutrisiran, to go through a fast-track approval process. Additionally, centralized insurance coverage, second nature for physicians when using amyloidosis therapies, government help, and disease-specific patient registries facilitate patient identification and access to specific therapies.
South Korea Vutrisiran Market
South Korea is distinguished as the fastest-growing marketplace in the Asia Pacific sector. The South Korean market is characterized by a strategic focus on biopharma and healthcare digitization. Academic-industry collaboration is escalating rapidly, encouraging earlier diagnosis of ATRT and widening access to therapeutics such as vutrisiran. South Korea has also integrated AI more effectively than any other country in the marketplace with diagnostic and hospital networks, which will hasten the growth of the existing ATTR patient population.
To know more about the market opportunities by region and country, click here to
Buy The Complete Report
Vutrisiran Market Drivers
Increasing Diagnosis and Awareness of hATTR Amyloidosis
Strong Efficacy and Favorable Safety Profile of Vutrisiran
Vutrisiran Market Restraints
High Cost of Treatment and Reimbursement Challenges
Limited Patient Population and Diagnostic Delays
Request Free Customization of this report to help us to meet your business objectives.
The global vutrisiran market outlook is highly competitive, with key players including Alnylam Pharmaceuticals, AstraZeneca, and Ionis. Alnylam Pharmaceuticals commercial success of vutrisiran (Amvuttra) was predicated by differentiated RNAi delivery and early regulatory successes. Its strategy is predicated on deep clinical validation, like phase III data that showed 28–33% lower mortality risk. Ionis Pharmaceuticals partnered with AstraZeneca to work on eplontersen, which is showing promise in the ATTR‑CM trials. In the meantime, long-time players like Pfizer still have specialty volume around the stabilizer drugs, Vyndaqel/Vyndamax; however, RNAi therapy is slowly altering the market landscape.
As per the global vutrisiran industry analysis, startups have emerged to disrupt the industry as new entrants target innovative RNAi therapeutics in growing partnerships with academic institutions to expedite the conduct of clinical trials, an emerging player seeks to improve delivery mechanisms for enhanced delivery and customizes therapies for rare diseases. With their nimble approaches and focus on niche markets, they are able to disrupt the field and introduce more competition in this high growth segment of the RNAi therapeutics marketplace.
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
As per SkyQuest analysis, the global vutrisiran industry is experiencing rapid expansion of the RNAi therapeutics market is due to improvements in RNA interference (RNAi) therapeutics and increasing demand for more targeted treatments for rare diseases, such as hereditary transthyretin-mediated amyloidosis (hATTR). Growth drivers include increased healthcare expenditures, expedited development and approvals of therapies, and the rising prevalence of genetic disorders. Nevertheless, the RNAi therapeutics market may be limited by high development cost, complicated processes for production, and complex regulatory pathways.
Regardless of these constraints, new technologies such as AI and IoT are changing the landscape of the market, and transforming drug discovery, clinical trials, and patient monitoring in real time. They do this by allowing for better predictive analytics with AI technologies in research, and data collection of patient compliance using IoT features, while allowing for remote patient participation.
| Report Metric | Details |
|---|---|
| Market size value in 2024 | USD 496.0 million |
| Market size value in 2033 | USD 1443.2 million |
| Growth Rate | 12.6% |
| Base year | 2024 |
| Forecast period | 2026-2033 |
| Forecast Unit (Value) | USD Million |
| Segments covered |
|
| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
|
To get a free trial access to our platform which is a one stop solution for all your data requirements for quicker decision making. This platform allows you to compare markets, competitors who are prominent in the market, and mega trends that are influencing the dynamics in the market. Also, get access to detailed SkyQuest exclusive matrix.
Table Of Content
Executive Summary
Market overview
Parent Market Analysis
Market overview
Market size
KEY MARKET INSIGHTS
COVID IMPACT
MARKET DYNAMICS & OUTLOOK
Market Size by Region
KEY COMPANY PROFILES
Methodology
For the Vutrisiran Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Vutrisiran Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Vutrisiran Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Vutrisiran Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
REQUEST FOR SAMPLE
REQUEST FREE CUSTOMIZATION
Global Vutrisiran Market size was valued at USD 490 Million in 2023 poised to grow between USD 548.8 Million in 2024 to USD 1.36 Billion by 2032, growing at a CAGR of 12% in the forecast period (2025-2032).
The global vutrisiran market outlook is highly competitive, with key players including Alnylam Pharmaceuticals, AstraZeneca, and Ionis. Alnylam Pharmaceuticals commercial success of vutrisiran (Amvuttra) was predicated by differentiated RNAi delivery and early regulatory successes. Its strategy is predicated on deep clinical validation, like phase III data that showed 28–33% lower mortality risk. Ionis Pharmaceuticals partnered with AstraZeneca to work on eplontersen, which is showing promise in the ATTR‑CM trials. In the meantime, long-time players like Pfizer still have specialty volume around the stabilizer drugs, Vyndaqel/Vyndamax; however, RNAi therapy is slowly altering the market landscape. 'Merck & Co. (USA)', 'Roche (Switzerland)', 'Sanofi (France)', 'AstraZeneca (UK/Sweden)', 'Teva Pharmaceuticals (Israel)', 'Pfizer (USA)', 'Ionis Pharmaceuticals (USA)', 'Alnylam Pharmaceuticals (USA)', 'Bristol-Myers Squibb (USA)', 'Genzyme (USA – Subsidiary of Sanofi)', 'GSK (GlaxoSmithKline) (UK)', 'AbbVie (USA)', 'Novartis (Switzerland)', 'Regeneron Pharmaceuticals (USA)', 'Eli Lilly and Company (USA)'
The increasing global incidences of hereditary transthyretin-mediated (hATTR) amyloidosis, due to improved diagnostic methods, genetic testing, and physician awareness, is the major pull for the global vutrisiran market revenue. The demand for effective interventions like Vutrisiran, which functions as the root cause of the disease, will greatly increase as we have more accurate identification of patients.
Advancements in RNAi Therapeutics: A key trend driving the global vutrisiran market is the persistent momentum in RNA interference (RNAi) therapeutics. These innovations include delivery mechanisms, potency, and safety of RNAi drugs that are proving effective for the treatment of genetic diseases like hATTR amyloidosis, of which Vutrisiran is now at the front leading the way to further applications.
What Makes North America a Leader in the Vutrisiran Market?
Want to customize this report? This report can be personalized according to your needs. Our analysts and industry experts will work directly with you to understand your requirements and provide you with customized data in a short amount of time. We offer $1000 worth of FREE customization at the time of purchase.
Feedback From Our Clients
USA (+1) 351-333-4748
