North America Edaravone Injection Market was valued at USD 0.15 Billion in 2022 and is projected to reach USD 0.25 Billion by 2030, growing at a CAGR of 6.9% from 2024 to 2030.
The North American edaravone injection market has witnessed significant growth, primarily driven by its application in treating amyotrophic lateral sclerosis (ALS). ALS is a progressive neurodegenerative disease affecting nerve cells responsible for muscle control, leading to muscle weakness and atrophy. The U.S. Food and Drug Administration (FDA) approved edaravone, marketed as RADICAVA®, in 2017, offering hope to thousands of ALS patients.
Since its approval, RADICAVA® has been administered to over 16,000 individuals in the U.S., accumulating more than 2 million days of therapy. This widespread adoption underscores the critical role edaravone plays in ALS management. The treatment regimen involves 28-day cycles, with each 60 mg dose delivered via a 60-minute intravenous infusion. The initial cycle consists of daily infusions for 14 consecutive days, followed by a two-week drug-free period. Subsequent cycles involve daily infusions for 10 days within a 14-day period, also followed by a two-week drug-free interval.
In response to the demand for more convenient administration methods, an oral formulation, RADICAVA ORS®, received FDA approval in 2022. This innovation has been embraced by the ALS community, with over 16,000 patients treated and more than 2 million days of therapy recorded. The oral suspension is taken daily for 14 consecutive days, followed by a 14-day drug-free period during the initial cycle. Subsequent cycles involve daily doses for 10 days within a 14-day period, followed by a 14-day drug-free interval. Patients are advised to take RADICAVA ORS® in the morning after overnight fasting, refraining from eating or drinking (except water) for one hour post-administration.
From an industry perspective, the production and distribution of edaravone injections require stringent adherence to regulatory standards. Manufacturers must ensure bioequivalence and therapeutic equivalence to the reference listed drug. For instance, Gland Pharma received FDA approval in 2024 for its generic edaravone injection, available in 30 mg/100 ml and 60 mg/100 ml single-dose bags. The company plans to launch the product through its marketing partner within the fiscal year 2025.
Quality control is paramount, as hypersensitivity reactions, including anaphylaxis, have been reported. Both RADICAVA® and RADICAVA ORS® contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening asthmatic episodes in susceptible individuals. Therefore, careful monitoring for hypersensitivity reactions is essential, and any occurrence necessitates immediate discontinuation of the drug and appropriate medical intervention.
In conclusion, the North American edaravone injection market continues to evolve, driven by advancements in treatment formulations and a commitment to meeting stringent industry requirements. This progress offers hope to ALS patients and underscores the importance of innovation and quality in pharmaceutical development.
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Mitsubishi Tanabe Pharma
By the year 2030, the scale for growth in the market research industry is reported to be above 120 billion which further indicates its projected compound annual growth rate (CAGR), of more than 5.8% from 2023 to 2030. There have also been disruptions in the industry due to advancements in machine learning, artificial intelligence and data analytics There is predictive analysis and real time information about consumers which such technologies provide to the companies enabling them to make better and precise decisions. The Asia-Pacific region is expected to be a key driver of growth, accounting for more than 35% of total revenue growth. In addition, new innovative techniques such as mobile surveys, social listening, and online panels, which emphasize speed, precision, and customization, are also transforming this particular sector.
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Growing demand for below applications around the world has had a direct impact on the growth of the North America Edaravone Injection Market
Hospital
Pharmacy
Based on Types the Market is categorized into Below types that held the largest Edaravone Injection market share In 2023.
20ml
100ml
North America (United States, North America and Mexico)
Europe (Germany, UK, France, Italy, Russia, Turkey, etc.)
Asia-Pacific (China, Japan, Korea, India, Australia, Indonesia, Thailand, Philippines, Malaysia and Vietnam)
South America (Brazil, Argentina, Columbia, etc.)
Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)
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1. Introduction of the North America Edaravone Injection Market
Overview of the Market
Scope of Report
Assumptions
2. Executive Summary
3. Research Methodology of Verified Market Reports
Data Mining
Validation
Primary Interviews
List of Data Sources
4. North America Edaravone Injection Market Outlook
Overview
Market Dynamics
Drivers
Restraints
Opportunities
Porters Five Force Model
Value Chain Analysis
5. North America Edaravone Injection Market, By Type
6. North America Edaravone Injection Market, By Application
7. North America Edaravone Injection Market, By Geography
North America
Europe
Asia Pacific
Rest of the World
8. North America Edaravone Injection Market Competitive Landscape
Overview
Company Market Ranking
Key Development Strategies
9. Company Profiles
10. Appendix
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