Summary

KEY INSIGHTS
AMZ001 is a new topical gel formulation of diclofenac, developed specifically to treat knee osteoarthritis (OA) pain. With a high-strength concentration of 3.06% diclofenac sodium, AMZ001 stands out in the osteoarthritis medication landscape due to its targeted approach, offering effective localized pain relief with a single daily application (QD). Its targeted design helps reduce systemic exposure and minimizes the adverse effects typically associated with oral non-steroidal anti-inflammatory drugs (NSAIDs).
This drug is developed by Amzell BV, a specialized virtual pharmaceutical development company. Amzell BV focuses on advancing candidate or repurposed drugs and medical devices from the proof-of-concept stage through to registration for commercialization. Founded in 2016 and headquartered in Hoofddorp, Netherlands, Amzell BV is part of the larger Frederik Paulsen business network, which includes various healthcare enterprises, including Ferring Pharmaceuticals.
MARKET POTENTIAL AND POSITIONING
AMZ001 is positioned as a strong competitor in the osteoarthritis treatment market, especially for patients looking for effective pain relief with reduced risk of systemic side effects. The gel's high-strength formulation and single daily application regimen provide a competitive edge over other topical NSAIDs, which may require more frequent application or have lower active ingredient concentrations.
The topical NSAIDs in osteoarthritis treatment are poised for growth as patients and healthcare providers increasingly seek alternatives to oral therapies, which are associated with a higher risk of GI and cardiovascular adverse effects. AMZ001’s unique formulation could further capture a significant share of this market, particularly among patients who are either intolerant of or wish to avoid oral NSAIDs.
REGIONAL ANALYSIS
Inkwood Research offers an analysis of seven key markets:
• United States
o Osteoarthritis (OA) is the most prevalent form of arthritis in the United States, affecting millions of adults and considerably impacting their quality of life. According to the Centers for Disease Control and Prevention (CDC), over 32.5 million adults in the United States are affected by osteoarthritis.
o The prevalence of osteoarthritis (OA) rises with age, making it especially common among older adults. However, younger individuals can also be affected, particularly if they have had joint injuries or other risk factors such as obesity. Women are more prone to developing OA than men, particularly after the age of 50.
• Germany
• France
• United Kingdom
• Italy
• Spain
• Japan

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Table of Contents

TABLE OF CONTENTS
1. INTRODUCTION TO THE REPORT
2. AMZ001 OVERVIEW
2.1. PRODUCT DETAIL
2.2. CLINICAL DEVELOPMENT
2.2.1. CLINICAL STUDIES
2.2.2. CLINICAL TRIALS INFORMATION
2.2.3. SAFETY AND EFFICACY
2.3. PRODUCT PROFILE
3. COMPETITIVE LANDSCAPE
3.1. MARKETED THERAPIES
3.2. LATE-STAGE EMERGING THERAPIES
4. AMZ001 MARKETS ASSESSMENT
4.1. MARKET OUTLOOK OF AMZ001 IN OSTEOARTHRITIS
5. 7 MAJOR MARKET’S ANALYSIS
5.1. MARKET SIZE OF AMZ001 IN THE 7 MAJOR MARKETS FOR OSTEOARTHRITIS
5.2. 7 COUNTRY ANALYSIS
5.2.1. MARKET SIZE OF AMZ001 IN UNITED STATES FOR OSTEOARTHRITIS
5.2.2. MARKET SIZE OF AMZ001 IN GERMANY FOR OSTEOARTHRITIS
5.2.3. MARKET SIZE OF AMZ001 IN FRANCE FOR OSTEOARTHRITIS
5.2.4. MARKET SIZE OF AMZ001 IN ITALY FOR OSTEOARTHRITIS
5.2.5. MARKET SIZE OF AMZ001 IN SPAIN FOR OSTEOARTHRITIS
5.2.6. MARKET SIZE OF AMZ001 IN UNITED KINGDOM FOR OSTEOARTHRITIS
5.2.7. MARKET SIZE OF AMZ001 IN JAPAN FOR OSTEOARTHRITIS
6. SWOT ANALYSIS
7. ANALYST PERSPECTIVE