Fragile X Syndrome Market to Experience Notable Growth in Forecast Span by 2034, DelveInsight Predicts | Novartis, Neuren Pharma, Roche, Seaside Therapeutics, Inc., Marinus Pharma, Lysogene

The Key Fragile X Syndrome Companies in the market include - Zynerba Pharmaceuticals, Confluence Pharmaceuticals, Tetra Therapeutics, Neuren Pharmaceuticals, Healx, Craig Erickson, Zynerba Pharmaceuticals, Nova Mentis Life Science, and others.

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

To Know in detail about the Fragile X Syndrome market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Fragile X Syndrome Market Forecast [https://www.delveinsight.com/sample-request/fragile-x-syndrome-fxs-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Some of the key facts of the Fragile X Syndrome Market Report:

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The Fragile X Syndrome market size is anticipated to grow with a significant CAGR during the study period (2020-2034)

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In February 2025, US biopharmaceutical company Spinogenix has released topline results from a Phase II trial of SPG601 for Fragile X syndrome (FXS), a genetic disorder associated with autism and intellectual disability, in adult male patients. The randomized, placebo-controlled study assessed a single dose of SPG601 against a placebo in ten adult men exhibiting key characteristics of FXS.

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In February 2025, A single dose of Spinogenix's investigational oral therapy, SPG601, significantly reduced abnormal brain activity in men with Fragile X syndrome, according to topline results from a Phase 2a trial. Findings from the placebo-controlled study (NCT06413537) were also presented earlier this month at the National Institutes of Health Fragile X Centers of Excellence Update.

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In November 2024, Chris Peetz, the CEO of Mirum, highlighted the company's strong performance in the third quarter, noting growth across all three commercial medicines, particularly the acceleration of LIVMARLI PFIC sales. He also emphasized significant progress in the clinical pipeline, including the granting of breakthrough designation for volixibat in PBC and the initiation of the EXPAND study for LIVMARLI in other cholestatic pruritus indications. Additionally, the rare genetic neurology franchise is advancing, with a December 28 PDUFA date for chenodiol for CTX and the addition of Phase 2-ready MRM-3379 for Fragile X syndrome.

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In October 2024, Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) will present an extensive update on its pipeline during its Investor Day event today, highlighting new data from its orexin-2 receptor agonist and next-generation pitolisant programs, along with long-term extension data from its pitolisant program for idiopathic hypersomnia. The company will also share updates on its strategic acquisitions in Fragile X syndrome (FXS) and rare epilepsies, which have bolstered its late-stage development pipeline.

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In May 2024, Spinogenix, Inc., a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to restore synapses and enhance the lives of patients globally, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to SPG601 for the treatment of Fragile X Syndrome (FXS).

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In April 2024, Spinogenix received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase II clinical trial of SPG601 for Fragile X Syndrome (FXS). This approval coincides with the European Commission granting orphan drug status to Shionogi's zatolmilast (BPN14770).

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DelveInsight's epidemiology model estimates that the total diagnosed prevalent cases of FXS in the 7MM were around 122,000 in 2023. This figure is expected to grow during the forecast period (2024-2034) due to heightened awareness, improved screening, and advancements in genetic testing.

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In 2023, the US had the highest number of diagnosed prevalent cases of FXS, totaling around 71,000 cases, whereas Spain reported the lowest, with nearly 5,900 cases.

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In 2023, among the EU4 and the UK, Germany had the highest number of diagnosed prevalent cases of FXS, with about 9,700 cases, followed by France with around 7,900 cases and the UK with nearly 7,800 cases.

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In 2023, around 42,000 males and 29,000 females in the US were diagnosed with FXS, indicating a greater prevalence in males than in females.

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In Japan, in 2023, there were about 5,700 cases in the 0-11 age group, 2,300 cases in the 12-17 age group, and 5,000 cases among individuals over 18, reflecting differences in prevalence across age groups.

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Key Fragile X Syndrome Companies: Zynerba Pharmaceuticals, Confluence Pharmaceuticals, Tetra Therapeutics, Neuren Pharmaceuticals, Healx, Craig Erickson, Zynerba Pharmaceuticals, Nova Mentis Life Science, and others

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Key Fragile X Syndrome Therapies: Zygel, Acamprosate, BPN14770, Trofinetide, Sulindac (HLX-0201), Gaboxadol, ZYN002, Psilocybin, and others

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The Fragile X Syndrome epidemiology based on gender analyzed that males are affected more as compared to females, in the case of Fragile X Syndrome (FXS)

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

Fragile X Syndrome Overview

Fragile X Syndrome is a genetic disorder caused by a mutation in the FMR1 gene on the X chromosome. It is the most common inherited cause of intellectual disability and a leading genetic cause of autism. FXS primarily affects males, but females can also be impacted, though often less severely. Symptoms include developmental delays, learning difficulties, behavioral challenges, anxiety, and physical features like a long face, prominent ears, and flexible joints. There is no cure, but early interventions such as therapy, educational support, and medications can help manage symptoms and improve quality of life.

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Fragile X Syndrome 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.

Fragile X Syndrome Epidemiology Segmentation:

The Fragile X Syndrome market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:

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Total Prevalence of Fragile X Syndrome

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Prevalent Cases of Fragile X Syndrome by severity

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Gender-specific Prevalence of Fragile X Syndrome

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Diagnosed Cases of Episodic and Chronic Fragile X Syndrome

Download the report to understand which factors are driving Fragile X Syndrome epidemiology trends @ Fragile X Syndrome Epidemiology Forecast [https://www.delveinsight.com/sample-request/fragile-x-syndrome-fxs-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Fragile X Syndrome Drugs Uptake and Pipeline Development Activities

The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Fragile X Syndrome market or expected to get launched during the study period. The analysis covers Fragile X Syndrome 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 Fragile X Syndrome 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.

Fragile X Syndrome Therapies and Key Companies

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Zygel: Zynerba Pharmaceuticals

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Acamprosate: Confluence Pharmaceuticals

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BPN14770: Tetra Therapeutics

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Trofinetide: Neuren Pharmaceuticals

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Sulindac (HLX-0201): Healx

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Gaboxadol: Craig Erickson

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ZYN002: Zynerba Pharmaceuticals

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Psilocybin: Nova Mentis Life Science

Discover more about therapies set to grab major Fragile X Syndrome market share @ Fragile X Syndrome Treatment Market [https://www.delveinsight.com/sample-request/fragile-x-syndrome-fxs-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Fragile X Syndrome Market Strengths

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Growing Research and development are increasing the demand for FXS treatment.

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Advances in DNA technology, including CRISPRCas9, have been used to correct the expanded CGG repeat in induced pluripotent stem cells. Eventually, it might be possible to add these corrected stem cells into the central nervous systems of those with FXS

Fragile X Syndrome Market Opportunities

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The rise in the prevalence of FXS stimulates the research and development of the drug, as it is likely to provide an appropriate environment for newer products to be profitable.

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Increasing population gives a lucrative opportunity to increase the awareness and innovation of therapeutics to drive FXS market.

Scope of the Fragile X Syndrome 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 Fragile X Syndrome Companies: Zynerba Pharmaceuticals, Confluence Pharmaceuticals, Tetra Therapeutics, Neuren Pharmaceuticals, Healx, Craig Erickson, Zynerba Pharmaceuticals, Nova Mentis Life Science, and others

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Key Fragile X Syndrome Therapies: Zygel, Acamprosate, BPN14770, Trofinetide, Sulindac (HLX-0201), Gaboxadol, ZYN002, Psilocybin, and others

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Fragile X Syndrome Therapeutic Assessment: Fragile X Syndrome current marketed and Fragile X Syndrome emerging therapies

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Fragile X Syndrome Market Dynamics: Fragile X Syndrome market drivers and Fragile X Syndrome 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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Fragile X Syndrome Unmet Needs, KOL's views, Analyst's views, Fragile X Syndrome Market Access and Reimbursement

To know more about Fragile X Syndrome companies working in the treatment market, visit @ Fragile X Syndrome Clinical Trials and Therapeutic Assessment [https://www.delveinsight.com/sample-request/fragile-x-syndrome-fxs-market?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=gpr]

Table of Contents

1. Fragile X Syndrome Market Report Introduction

2. Executive Summary for Fragile X Syndrome

3. SWOT analysis of Fragile X Syndrome

4. Fragile X Syndrome Patient Share (%) Overview at a Glance

5. Fragile X Syndrome Market Overview at a Glance

6. Fragile X Syndrome Disease Background and Overview

7. Fragile X Syndrome Epidemiology and Patient Population

8. Country-Specific Patient Population of Fragile X Syndrome

9. Fragile X Syndrome Current Treatment and Medical Practices

10. Fragile X Syndrome Unmet Needs

11. Fragile X Syndrome Emerging Therapies

12. Fragile X Syndrome Market Outlook

13. Country-Wise Fragile X Syndrome Market Analysis (2020-2034)

14. Fragile X Syndrome Market Access and Reimbursement of Therapies

15. Fragile X Syndrome Market Drivers

16. Fragile X Syndrome Market Barriers

17. Fragile X Syndrome Appendix

18. Fragile X Syndrome 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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