Menkes Disease Market to Witness Promising Upswing by 2034, DelveInsight Forecasts | Cyprium Therapeutics and Sentynl Therapeutics, Cyprium Therapeutics, Inc.

The Key Menkes Disease Companies in the market include - Cyprium Therapeutics and Sentynl Therapeutics, Cyprium Therapeutics, Inc., and others.

DelveInsight's "Menkes Disease Market Insights, Epidemiology, and Market Forecast-2034 report offers an in-depth understanding of the Menkes Disease, historical and forecasted epidemiology as well as the Menkes Disease market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

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Some of the key facts of the Menkes Disease Market Report:

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The Menkes Disease market size was valued ~8 million in 2023 and is anticipated to grow with a significant CAGR during the study period (2020-2034).

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In September 2025, The FDA has accepted the NDA submission for CUTX-101 (copper histidinate for Menkes disease) under priority review, with a PDUFA target date of September 30, 2025. In December 2023, the asset transfer of CUTX-101 to Sentynl Therapeutics, a wholly owned subsidiary of Zydus Lifesciences Ltd., was completed. Cyprium Therapeutics, the subsidiary that developed CUTX-101, will retain full ownership of any FDA Priority Review Voucher granted upon NDA approval.

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In January 2025, Sentynl Therapeutics, Inc., a U.S.-based biopharma company fully owned by Zydus Lifesciences Ltd. (Zydus Group), along with Fortress Biotech, Inc. (Nasdaq: FBIO), announced that the U.S. FDA has accepted and granted Priority Review to Sentynl's New Drug Application (NDA) for CUTX-101, a treatment candidate for Menkes disease. This rare, X-linked recessive pediatric disorder results from mutations in the ATP7A copper transporter gene. Estimates place its prevalence between 1 in 34,810 and 1 in 8,664 live male births.

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In January 2025, Fortress Biotech, Inc. (Nasdaq: FBIO) and its majority-owned subsidiary, Cyprium Therapeutics, Inc., announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for CUTX-101 (Copper Histidinate). The therapy is intended for the treatment of Menkes disease, a rare X-linked recessive pediatric condition caused by mutations in the ATP7A copper transporter gene.

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The Standard of Care accounted for the entire market, which was valued at approximately USD 7.9 million in 2023 across the 7MM.

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According to our assessment, there were approximately 177 diagnosed prevalent cases of Menkes Disease in the 7MM in 2023, with expectations for these numbers to rise by 2034. The US had the highest number of cases.

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Among European countries in 2023, France had the highest diagnosed prevalent cases of Menkes Disease at 26%, followed by Germany and the UK, each with 24%. Conversely, Spain had the lowest diagnosed prevalence, accounting for 11%.

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In 2023, the US represented the largest share of diagnosed Menkes disease cases in the 7MM, with 54%, followed by Japan, which accounted for approximately 11%. Among European countries, France had the highest number of cases, representing about 9% of the total 7MM cases.

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In 2023, France held the largest market share in the EU4 and UK region with 27%, while Spain had the smallest share at 12%.

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The 7MM treatment market currently lacks an approved targeted therapy for Menkes Disease. However, with the anticipated launch of CUTX-101 by 2025, the market is expected to see significant growth.

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Key Menkes Disease Companies: Cyprium Therapeutics and Sentynl Therapeutics, Cyprium Therapeutics, Inc., and others

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Key Menkes Disease Therapies: CUTX-101, Copper Histidinate, and others

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The Menkes Disease epidemiology based on gender analyzed that Menkes Disease usually affects male neonates through unaffected carrier women. It may occurs in females, related to unusual genetic circumstances

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The Menkes Disease market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Menkes Disease pipeline products will significantly revolutionize the Menkes Disease market dynamics.

Menkes Disease Overview

Menkes disease is an X-linked inherited fatal infantile neurodegenerative condition. Mutations in the ATP7A gene, which is in charge of carrying copper throughout the body, result in this inherited X-linked recessive illness.

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Menkes Disease Epidemiology

The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Menkes Disease Epidemiology Segmentation:

The Menkes Disease market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:

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Total Prevalence of Menkes Disease

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Prevalent Cases of Menkes Disease by severity

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Gender-specific Prevalence of Menkes Disease

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Diagnosed Cases of Episodic and Chronic Menkes Disease

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Menkes Disease Drugs Uptake and Pipeline Development Activities

The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Menkes Disease market or expected to get launched during the study period. The analysis covers Menkes Disease market uptake by drugs, patient uptake by therapies, and sales of each drug.

Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.

The report also covers the Menkes Disease Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Menkes Disease Therapies and Key Companies

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Copper Histidinate: Cyprium Therapeutics, Inc.

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CUTX-101: Cyprium Therapeutics and Sentynl Therapeutics

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Menkes Disease Market Drivers

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Submission of NDA of CUTX-101

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Increasing awareness among families who have a history of Menkes

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Parents of affected babies understand the rarity of the disease and allow their children to be a part of the trial

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Ongoing development of screening techniques

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Ongoing development of gene therapy

Menkes Disease Market Barriers

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Clinical challenges in the early diagnosis of disease

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Inability to trace the carrier mother

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Insufficient number of studies to estimate the exact number of Menkes patients

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Insufficient number of researches for the treatment of Menkes disease

Scope of the Menkes Disease Market Report

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Study Period: 2020-2034

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Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

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Key Menkes Disease Companies: Cyprium Therapeutics and Sentynl Therapeutics, Cyprium Therapeutics, Inc., and others

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Key Menkes Disease Therapies: CUTX-101, Copper Histidinate, and others

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Menkes Disease Therapeutic Assessment: Menkes Disease current marketed and Menkes Disease emerging therapies

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Menkes Disease Market Dynamics: Menkes Disease market drivers and Menkes Disease market barriers

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Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies

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Menkes Disease Unmet Needs, KOL's views, Analyst's views, Menkes Disease Market Access and Reimbursement

To know more about Menkes Disease companies working in the treatment market, visit @ Menkes Disease Clinical Trials and Therapeutic Assessment [https://www.delveinsight.com/sample-request/menkes-disease-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Table of Contents

1. Menkes Disease Market Report Introduction

2. Executive Summary for Menkes Disease

3. SWOT analysis of Menkes Disease

4. Menkes Disease Patient Share (%) Overview at a Glance

5. Menkes Disease Market Overview at a Glance

6. Menkes Disease Disease Background and Overview

7. Menkes Disease Epidemiology and Patient Population

8. Country-Specific Patient Population of Menkes Disease

9. Menkes Disease Current Treatment and Medical Practices

10. Menkes Disease Unmet Needs

11. Menkes Disease Emerging Therapies

12. Menkes Disease Market Outlook

13. Country-Wise Menkes Disease Market Analysis (2020-2034)

14. Menkes Disease Market Access and Reimbursement of Therapies

15. Menkes Disease Market Drivers

16. Menkes Disease Market Barriers

17. Menkes Disease Appendix

18. Menkes Disease Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

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