Fitusiran Market
Fitusiran Market Size, Share & Industry Analysis, By Disease Indication (Hemophilia A, Hemophilia B, and Hemophilia with inhibitors (A or B)), By Manufacturing Type (Pharmaceuticals & Healthcare, Food & Beverage, Cosmetics & Skincare, Chemical & Polymer Industry), and Forecast Period 2025-2035
Fitusiran market is experiencing a CAGR of 7.0% during the forecast period, driven by the rising prevalence of hemophilia and related bleeding disorders worldwide. Fitusiran, an RNA interference (RNAi) therapeutic, targets antithrombin to rebalance hemostasis in hemophilia patients, offering a promising alternative to conventional factor replacement therapies. This innovative mechanism is propelling significant demand for its active pharmaceutical ingredient (API) in both clinical and commercial manufacturing sectors.
Key segments in the Fitusiran Market include:
- By Application: Primarily for hemophilia A and B treatment, with ongoing clinical trials exploring broader applications.
Geographically, North America dominates the market owing to advanced healthcare infrastructure, high R&D expenditure, and favorable regulatory frameworks. The European market is also growing steadily with the increasing adoption of novel therapies, followed by the Asia-Pacific region, where rising awareness and improving healthcare facilities are opening new opportunities.
Key players driving the Fitusiran market include pharmaceutical giants and specialized API manufacturers such as Alnylam Pharmaceuticals (the innovator of Fitusiran), Lonza Group, Wuxi Biologics, Samsung Biologics, and Catalent Pharma Solutions. These companies are focusing on strategic partnerships, capacity expansion, and technological advancements to strengthen their market positions.
In summary, the Fitusiran market is set for significant expansion, powered by innovative RNAi therapies, strategic collaborations, and growing patient populations requiring effective hemophilia treatment options.
Recent Development
- In March 2025, Alnylam Pharmaceuticals received FDA approval for Qfitlia (fitusiran), its sixth RNAi therapeutic. The drug is the first to lower antithrombin, a protein that inhibits blood clotting, to promote thrombin generation to prevent bleeds. Qfitlia is used for routine prophylaxis in adults and pediatric patients with hemophilia A or B. The drug was discovered in 2017 and is the sixth Alnylam-discovered medicine using its RNAi therapeutic platform to be approved to date.
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Report Scope & Segmentation
- Introduction
- Overview of Fitusiran API
- Key Manufacturing Types & Industry Use Cases
- Market Scope & Study Objectives
- Market Overview
- Global Market Size & Growth Trends (Historical & Forecast)
- Demand-Supply Dynamics
- Segmental Outlook
- By Disease Indication
- Hemophilia A
- Hemophilia B
- Hemophilia with inhibitors (A or B)
- By Manufacturing Type
- In-house manufacturing
- Contract Manufacturing Organizations (CMOs)
- Price Analysis
- Current Price Trends (Per kg & Per Ton)
- Price Fluctuation Factors (Raw Material Costs, Production, Trade Tariffs)
- Regional Price Comparison (North America, Europe, Asia-Pacific, and Other)
- Trade Analysis
- Major Exporting & Importing Countries
- Trade Volume & Value Statistics
- Impact of Trade Regulations & Policies
- Regional Analysis
- North America (US and Canada)
- Europe (UK, Germany, France, Italy, Spain, and the Rest of Europe)
- Asia-Pacific (China, Japan, South Korea, Taiwan, India, and Rest of Asia-Pacific)
- Rest of the World (Latin America, and Middle East, and Africa)
- Competitive Landscape
- Top Global Manufacturers & Production Capacity
- Company Profiles & Key Developments
- Alnylam Pharmaceuticals
- Sanofi
- Agilent Technologies
- Nitto Denko Avecia
- Thermo Fisher Scientific
- WuXi STA
- CordenPharma
- Bachem
- Mergers, Acquisitions & Investments
- Regulatory & Compliance Factors
- FDA, REACH, and Other Regulatory Frameworks
- Environmental & Safety Considerations
- Emerging Policies Impacting Market Growth
- Conclusion & Strategic Recommendations
- Key Takeaways for Stakeholders
- Market Entry Strategies
- Frequently Asked Questions
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