The Menkes disease market remained small but showed gradual growth in 2023, with the United States leading the 7MM, accounting for approximately USD 7 million in market size and expected to expand further by 2034. The overall 7MM market was valued at around USD 7.9 million, entirely driven by standard-of-care treatments.
Diagnosed prevalence is projected to increase due to advances in genetic testing, expanded screening programs, improved disease awareness, better survival rates, and genetic and environmental factors. In 2023, the US represented about 54% of diagnosed cases, followed by Japan (11%), while France accounted for the largest share in Europe (9%). Despite a rising prevalence—approximately 177 diagnosed cases across the 7MM in 2023, there remains a significant unmet need, as no approved disease-specific therapies are currently available for Menkes disease.
DelveInsight’s “Menkes Disease Market Insights, Epidemiology, and Market Forecast-2034” report delivers an in-depth understanding of Menkes Disease, historical and forecasted epidemiology as well as the Menkes Disease market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.
The Menkes Disease market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Menkes Disease market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Menkes Disease treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Menkes Disease market.
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Some facts of the Menkes disease report are:
- In 2023, the market size of Menkes Disease was highest in the US among the 7MM accounting for approximately USD 7 million that is further expected to increase by 2034.
- The overall market was covered by Standard of Care, making up the total Menkes Disease market of around USD 7.9 million in 2023, in the 7MM.
- Menkes Disease companies working in the market are – Cyprium Therapeutics and Sentynl Therapeutics, and others.
- As per DelveInsight’s assessment, in 2023, nearly 177 diagnosed prevalent cases of Menkes Disease were estimated in the 7MM. These cases are anticipated to increase by 2034. The US accounted for the highest cases.
- In January 2026, Zydus Lifesciences has received FDA approval for Zycubo®, establishing it as the first approved therapy in the United States for Menkes disease treatment. The drug has shown significant survival improvement in clinical studies, representing a major breakthrough in rare disease therapeutics and addressing critical unmet medical needs for patients with this genetic disorder.
- In January 2026, Sentynl Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved Zycubo (copper histidinate) injection as the first FDA-approved treatment for Menkes disease in pediatric patients. Zycubo is a subcutaneous copper replacement therapy designed to bypass the genetic defect that prevents intestinal copper absorption, enabling improved copper utilization in the body.
Menkes Disease Overview
Menkes disease is a rare, inherited neurodegenerative disorder caused by mutations in the ATP7A gene, leading to impaired copper absorption and distribution in the body. The disease primarily affects infants and young children, with symptoms typically appearing within the first few months of life. Clinical features include seizures, developmental delay, failure to thrive, hypotonia, characteristic kinky hair, and progressive neurological deterioration. Menkes disease also affects connective tissue, blood vessels, bones, and the nervous system. Without early treatment, the condition is often fatal in early childhood, highlighting a significant unmet medical need despite advances in diagnosis and care.
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Menkes Disease Market Outlook
In 2023, the total Menkes disease market across the 7MM was valued at approximately USD 7.9 million and is projected to grow steadily through 2034. Market expansion will be supported by improved diagnosis, rising awareness, and the expected launch of targeted therapy, with France leading EU market share.
Disorders of copper homeostasis have been recognized for decades and are linked to serious human diseases across the lifespan. Menkes disease, also known as kinky hair disease, is a rare, rapidly progressive neurodegenerative disorder of infancy characterized by seizures, developmental regression, failure to thrive, and distinctive hair abnormalities. Disease progression is often unpredictable and aggressive, and prognosis remains poor. Without access to copper replacement therapy, survival typically does not extend beyond 3.5 years.
Current management relies on standard-of-care approaches, including off-label copper supplements such as copper histidine or copper chloride, along with antiepileptic drugs and supportive therapies. Despite these interventions, there is no approved targeted treatment for Menkes disease, underscoring a significant unmet medical need.
Advances in therapeutic development are opening new opportunities, with CUTX-101 emerging as the most promising candidate in the clinical pipeline. Its anticipated approval is expected to positively impact patient outcomes and drive market growth, especially alongside increased awareness and early disease screening.
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Menkes Disease Epidemiology
In 2023, an estimated 177 diagnosed prevalent cases of Menkes disease were reported across the 7MM, with prevalence expected to rise by 2034. The United States accounted for the largest share of cases. Within Europe, France led with 26% of diagnosed cases, followed by Germany and the UK at 24% each, while Spain reported the lowest share at 11%. Japan recorded approximately 19 diagnosed prevalent cases in the same year, highlighting the ultra-rare nature of the disease across all major markets.
Menkes Disease Epidemiology Segmentation
- Prevalent Cases of Menkes Disease
- Diagnosed Prevalent Cases of Menkes Disease
- Severity-specific Diagnosed Prevalent Cases of Menkes Disease
- Etiology-specific Diagnosed Prevalent Cases of Menkes Disease
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Menkes Disease Pipeline Development Activities
The Menkes Disease report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses Menkes Disease key players involved in developing targeted therapeutics.
Menkes Disease Therapeutics Assessment
Major key companies are working proactively in the Menkes Disease Therapeutics market to develop novel therapies which will drive the Menkes Disease treatment markets in the upcoming years are Cyprium Therapeutics, Sentynl Therapeutics and several others.
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Menkes Disease Report Key Insights
1. Menkes Disease Patient Population
2. Menkes Disease Market Size and Trends
3. Key Cross Competition in the Menkes Disease Market
4. Menkes Disease Market Dynamics (Key Drivers and Barriers)
5. Menkes Disease Market Opportunities
6. Menkes Disease Therapeutic Approaches
7. Menkes Disease Pipeline Analysis
8. Menkes Disease Current Treatment Practices/Algorithm
9. Impact of Emerging Therapies on the Menkes Disease Market
Table of Contents
1. Key Insights
2. Executive Summary
3. Menkes Disease Competitive Intelligence Analysis
4. Menkes Disease Market Overview at a Glance
5. Menkes Disease Disease Background and Overview
6. Menkes Disease Patient Journey
7. Menkes Disease Epidemiology and Patient Population
8. Menkes Disease Treatment Algorithm, Current Treatment, and Medical Practices
9. Menkes Disease Unmet Needs
10. Key Endpoints of Menkes Disease Treatment
11. Menkes Disease Marketed Products
12. Menkes Disease Emerging Therapies
13. Menkes Disease Seven Major Market Analysis
14. Attribute Analysis
15. Menkes Disease Market Outlook (7 major markets)
16. Menkes Disease Access and Reimbursement Overview
17. KOL Views on the Menkes Disease Market
18. Menkes Disease Market Drivers
19. Menkes Disease Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer
About DelveInsight
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