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Fragile X Syndrome (FXS) - Market Insights, Epidemiology, and Market Forecast - 2028

  • ID: 4911961
  • Drug Pipelines
  • January 2020
  • Region: Global
  • 135 pages
  • DelveInsight
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FEATURED COMPANIES

  • Neuren Pharmaceuticals
  • Ovid Therapeutics
  • Tetra Therapeutics
  • Zynerba Pharmaceuticals
  • MORE
The ‘Fragile X Syndrome (FXS)- Market Insights, Epidemiology, and Market Forecast-2028’ report deliver an in-depth understanding of the disease, historical & forecasted epidemiology as well as the market trends of Fragile X Syndrome in the United States, EU5 (Germany, Spain, Italy, France and the United Kingdom), and Japan. The Report provides the current treatment practices, emerging drugs, market share of the individual therapies, the current and forecasted market size of Fragile X Syndrome from 2017 to 2028 segmented by seven major markets.

Fragile X Syndrome is a genetic disease due to a CGG trinucleotide expansion, called as full mutation (greater than 200 CGG repeats), in the fragile X mental retardation 1 gene locus Xq27.3. This leads to a hyper-methylated region in the gene promoter therefore silencing it and lowering the expression levels of the fragile X mental retardation 1, a protein involved in synaptic plasticity and maturation. It is considered as the most common inherited cause of intellectual disability.

Individuals with Fragile X Syndrome are present with intellectual disability, autism, hyperactivity, long face, large or prominent ears, and macroorchidism at puberty and thereafter. Most of the young children with Fragile X Syndrome will present with language delay, sensory hyperarousal and anxiety.

Geography Covered
  • The United States
  • EU5 (Germany, France, Italy, Spain, and the United Kingdom)
  • Japan
Study Period: 2017–2028.

Fragile X Syndrome - Disease Understanding and Treatment Algorithm

Fragile X Syndrome causes intellectual disability, behavioral and learning challenges and various physical characteristics. Though Fragile X Syndrome occurs in both genders, males are more frequently affected than females, and generally with greater severity. Life expectancy is not affected in people with Fragile X Syndrome because there are usually no life-threatening health concerns associated with the condition.

As one of the most common cause of inherited intellectual disability, Fragile X Syndrome occurs in 1 in every 4000 males and 1 in every 8000 females. The average age of male Fragile X Syndrome diagnosis is 35-37 months and females Fragile X Syndrome diagnosis is 42 months.

Fragile X Syndrome Epidemiology

The Fragile X Syndrome epidemiology division provides insights about historical and current patient pool and forecasted trend for every 7 major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders (KOL).

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology (Total Diagnosed Prevalence of Fragile X Syndrome in 7MM, Gender-Specific Prevalence of Fragile X Syndrome in 7MM, and Age-Specific Prevalence of Fragile X Syndrome), scenario of Fragile X Syndrome in the 7MM covering United States, EU5 countries (Germany, Spain, Italy, France and United Kingdom) and Japan from 2017–2028.

According to this research, the total prevalent cases of Fragile X Syndrome in the 7MM was found to be 117,962 in 2017. The diagnosed prevalence of Fragile X Syndrome in the 7MM is expected to increase during the study period of 2017-2028 due to increase in the awareness of the condition.

Fragile X Syndrome Drug Chapters

This segment of the Fragile X Syndrome report encloses the detailed analysis of marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

In the absence of any approved therapy for the treatment for Fragile X Syndrome, the current market size of Fragile X Syndrome is mainly dependent on various specialized therapies, such as speech and language therapy, occupational therapy, physical therapy and drug therapies. The most frequently prescribed therapeutic drug classes are psychotropic drugs, such as antidepressants, stimulants, tranquilizers, and antipsychotics, that are often used to treat disorders such as hyperactivity, anxiety, and inattention.

Interventional services, like speech-language therapy, occupational therapy, physical therapy, special education services, and behavior management are commonly utilized to address specific behaviors and developmental issues, and comorbid conditions, such as ASD, anxiety, attention-deficit/hyperactivity disorder (ADHD), seizures, and others.

Antipsychotic drugs generally are helpful in clinical settings to target irritability, aggression, mood instability, and perseverative behaviors in both male individuals and female individuals with Fragile X Syndrome. Risperidone is the most frequently used antipsychotic drug in the past and was effective clinically, with high response rates for aggressive behavior in older male individuals with Fragile X Syndrome and other irritable, aberrant, and undesired behaviors in young boys with Fragile X Syndrome and autistic traits. Aripiprazole is the second most frequently used atypical antipsychotic agent used in Fragile X Syndrome, with the highest overall response rate for an individual-antipsychotic and the lowest concern about weight gain.

However, these pharmacologic treatments target only the behavioral symptoms and not the cognitive/language impairments or the underlying brain deficits.

Several companies are working robustly on many new therapies, such as BPN14770 (Tetra Therapeutics), Cannabidiol (Zynerba Pharmaceuticals), OV101 (Ovid Therapeutics), Acamprosate (Confluence Pharmaceuticals), and Trofinetide (Neuren Pharmaceuticals) and others. These all are anticipated to enter the Fragile X Syndrome market by 2028.

Fragile X Syndrome Market Outlook

The Fragile X Syndrome market outlook of the report helps to build the detailed comprehension of the historic, current and forecasted trend of the market by analyzing the impact of current therapies on the market, unmet needs, drivers and barriers and demand of better technology.

According to this research, the market of Fragile X Syndrome in 7MM was found to be approximately USD 33.51 Million in 2017.

Fragile X Syndrome market size in the United States accounted for approx. 66% of the total market in 2017. The US led the market in 2017, followed by the EU5 and Japan respectively.

Fragile X Syndrome Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the market or will get launched in the market during the study period from 2017-2028. The analysis covers market uptake by drugs; patient uptake by therapies and sales of each drug.

Currently, the market of Fragile X Syndrome depends on off-label psychotropic drugs, such as antidepressants, stimulants, tranquilizers, antipsychotics and others.

Various therapies are in the late stage of development by various companies such as BPN14770 (Tetra Therapeutics), Cannabidiol (Zynerba Pharmaceuticals), OV101 (Ovid Therapeutics), Acamprosate (Confluence Pharmaceuticals), and Trofinetide (Neuren Pharmaceuticals) for patients with Fragile X Syndrome. All these therapies are expected to enter the market during the forecast period 2019-2028.

Fragile X Syndrome Report Insights
  • Patient Population of Fragile X Syndrome
  • Therapeutic Approaches
  • Pipeline Analysis
  • Market Size and Trends
  • Market Opportunities
  • Impact of upcoming Therapies
Fragile X Syndrome Report Key Strengths
  • 10 Year Forecast
  • 7MM Coverage
  • Epidemiology Segmentation
  • Drugs Uptake
  • Highly Analyzed Market
  • Key Cross Competition
Fragile X Syndrome Report Assessment
  • Current Treatment Practices
  • Unmet Needs
  • Detailed Pipeline Product Profiles
  • Market Attractiveness
  • Market Drivers and Barriers
Key Benefits
  • This report will help to develop Business Strategies by understanding the trends shaping and driving Fragile X Syndrome market
  • Organize sales and marketing efforts by identifying the best opportunities for Fragile X Syndrome market
  • To understand the future market competition in the Fragile X Syndrome market
Note: Product cover images may vary from those shown
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FEATURED COMPANIES

  • Neuren Pharmaceuticals
  • Ovid Therapeutics
  • Tetra Therapeutics
  • Zynerba Pharmaceuticals
  • MORE
1. Key Insights

2. Fragile X Syndrome (FXS): Market Overview at a Glance
2.1. Total Market Share (%) Distribution of FXS in 2017
2.2. Total Market Share (%) Distribution of FXS in 2028

3. Disease Background and Overview: Fragile X Syndrome (FXS)
3.1. Introduction
3.2. Genomics
3.3. Symptoms
3.4. Clinical Features
3.5. Diagnosis
3.6. Fragile X and Newborn Screening
3.6.1. Recommendations for Diagnostic Testing
3.6.2. Differential Diagnosis

4. Epidemiology and Patient Population: Fragile X Syndrome
4.1. Key Findings
4.2. Total Diagnosed Prevalent cases of Fragile X Syndrome in 7MM
4.3. United States
4.3.1. Assumptions and Rationale
4.3.2. Total Diagnosed Prevalent Cases of Fragile X Syndrome (FXS) in the United States
4.3.3. Gender-Specific Cases of Fragile X Syndrome (FXS) in the United States
4.3.4. Age-Specific Cases of Fragile X Syndrome (FXS) in the United States
4.4. EU5
4.5. Assumptions and Rationale
4.6. Germany
4.6.1. Total Diagnosed Prevalent Cases of Fragile X Syndrome (FXS) in Germany
4.6.2. Gender-Specific Cases of Fragile X Syndrome (FXS) in Germany
4.6.3. Age-Specific Cases of Fragile X Syndrome (FXS) in Germany
4.7. France
4.7.1. Total Diagnosed Prevalent Cases of Fragile X Syndrome (FXS) in France
4.7.2. Gender-Specific Cases of Fragile X Syndrome (FXS) in France
4.7.3. Age-Specific Cases of Fragile X Syndrome (FXS) in France
4.8. Italy
4.8.1. Total Diagnosed Prevalent Cases of Fragile X Syndrome (FXS) in Italy
4.8.2. Gender-Specific Cases of Fragile X Syndrome (FXS) in Italy
4.8.3. Age-Specific Cases of Fragile X Syndrome (FXS) in Italy
4.9. Spain
4.9.1. Total Diagnosed Prevalent Cases of Fragile X Syndrome (FXS) in Spain
4.9.2. Gender-Specific Cases of Fragile X Syndrome (FXS) in Spain
4.9.3. Age-Specific Cases of Fragile X Syndrome (FXS) in Spain
4.10. United Kingdom (UK)
4.10.1. Total Diagnosed Prevalent Cases of Fragile X Syndrome in the United Kingdom
4.10.2. Gender-Specific Cases of Fragile X Syndrome in the United Kingdom
4.10.3. Age-Specific Cases of Fragile X Syndrome (FXS) in the United Kingdom
4.11. Japan
4.11.1. Assumptions and Rationale
4.11.2. Total Diagnosed Prevalent Cases of Fragile X Syndrome (FXS) in Japan
4.11.3. Gender-Specific Cases of Fragile X Syndrome (FXS) in Japan
4.11.4. Age-Specific Cases of Fragile X Syndrome (FXS) in Japan

5. Current Treatment

6. Unmet Need

7. Emerging Drugs
7.1. Key Cross Competition
7.2. Cannabidiol: Zynerba Pharmaceuticals
7.2.1. Product Description
7.2.2. Other Developmental Activities
7.2.3. Clinical Development
7.2.4. Safety and Efficacy
7.2.5. Product Profile
7.3. Acamprosate: Confluence Pharmaceuticals
7.3.1. Product Description
7.3.2. Other Developmental Activities
7.3.3. Clinical Development
7.3.4. Safety and Efficacy
7.3.5. Product Profile
7.4. BPN14770: Tetra Therapeutics
7.4.1. Product Description
7.4.2. Other Developmental Activities
7.4.3. Clinical Development
7.4.4. Safety and Efficacy
7.4.5. Product Profile
7.5. OV101: Ovid Therapeutics
7.5.1. Product Description
7.5.2. Other Developmental Activities
7.5.3. Clinical Development
7.5.4. Safety and Efficacy
7.5.5. Product Profile
7.6. Trofinetide: Neuren Pharmaceuticals
7.6.1. Product Description
7.6.2. Other Developmental Activities
7.6.3. Clinical Development
7.6.4. Safety and Efficacy
7.6.5. Product Profile

8. Market Size: Fragile X Syndrome
8.1. Key Findings
8.2. Total Market Size of Fragile X Syndrome in 7MM
8.3. Total Market Size of Fragile X Syndrome by Therapies in 7MM

9. Market Outlook: 7 MM
9.1. United States
9.1.1. The total market size of Fragile X Syndrome in the US
9.1.2. Total Market Size of Fragile X Syndrome by Therapies in the US
9.2. EU5
9.3. Germany
9.3.1. The total market size of Fragile X Syndrome in Germany
9.3.2. Total Market Size of Fragile X Syndrome by Therapies in Germany
9.4. France
9.4.1. The total market size of Fragile X Syndrome in France
9.4.2. Total Market Size of Fragile X Syndrome by Therapies in France
9.4.3. Italy
9.4.4. The total market size of Fragile X Syndrome in Italy
9.4.5. Total Market Size of Fragile X Syndrome by Therapies in Italy
9.5. Spain
9.5.1. The total market size of Fragile X Syndrome in Spain
9.5.2. Total Market Size of Fragile X Syndrome by Therapies in Spain
9.6. United Kingdom
9.6.1. The total market size of Fragile X Syndrome in the UK
9.6.2. Total Market Size of Fragile X Syndrome by Therapies in the UK
9.7. Japan
9.7.1. The total market size of Fragile X Syndrome in Japan
9.7.2. Total Market Size of Fragile X Syndrome by Therapies in Japan

10. Market Drivers

11. Market Barriers

12. KOL Views

13. Appendix
13.1. Report Methodology

14. Researcher Capabilities

15. Disclaimer

16. About the Publisher

List of Tables
Table 1: Individuals for Whom Testing Should Be Considered for Fragile X syndrome diagnosis
Table 2: Total Diagnosed Prevalent cases of Fragile X Syndrome in 7MM (2017–2028)
Table 3: Total Diagnosed Prevalent Cases of Fragile X Syndrome in the US (2017–2028)
Table 4: Gender-Specific Cases of Fragile X Syndrome in the US (2017–2028)
Table 5: Age-Specific Cases of Fragile X Syndrome in the US (2017–2028)
Table 6: Total Diagnosed Prevalent Cases of Fragile X Syndrome in Germany (2017–2028)
Table 7: Gender-Specific Cases of Fragile X Syndrome in Germany (2017–2028)
Table 8: Age-Specific Cases of Fragile X Syndrome in Germany (2017–2028)
Table 9: Total Diagnosed Prevalent Cases of Fragile X Syndrome in France (2017–2028)
Table 10: Gender-Specific Cases of Fragile X Syndrome in France (2017–2028)
Table 11: Age-Specific Cases of Fragile X Syndrome in France (2017–2028)
Table 12: Total Diagnosed Prevalent Cases of Fragile X Syndrome in Italy (2017–2028)
Table 13: Gender-Specific Cases of Fragile X Syndrome in Italy (2017–2028)
Table 14: Age-Specific Cases of Fragile X Syndrome in Italy (2017–2028)
Table 15: Total Diagnosed Prevalent Cases of Fragile X Syndrome in Spain (2017–2028)
Table 16: Gender-Specific Cases of Fragile X Syndrome in Spain (2017–2028)
Table 17: Age-Specific Cases of Fragile X Syndrome in Spain (2017–2028)
Table 18: Total Diagnosed Prevalent Cases of Fragile X Syndrome in the UK (2017–2028)
Table 19: Gender-Specific Cases of Fragile X Syndrome in the UK (2017–2028)
Table 20: Age-Specific Cases of Fragile X Syndrome in the UK (2017–2028)
Table 21: Total Diagnosed Prevalent Cases of Fragile X Syndrome in Japan (2017–2028)
Table 22: Gender-Specific Cases of Fragile X Syndrome in Japan (2017–2028)
Table 23: Age-Specific Cases of Fragile X Syndrome in Japan (2017–2028)
Table 24: Summary of medical problems and management
Table 25:Emerging Drugs Analysis
Table 26: Cannabidiol, Clinical Trial Description, 2019
Table 27: Acamprosate, Clinical Trial Description, 2019
Table 28: BPN14770, Clinical Trial Description, 2019
Table 29: OV101, Clinical Trial Description, 2019
Table 30: Trofinetide, Clinical Trial Description, 2019
Table 31: Total Market Size of Fragile X Syndrome in 7MM in USD Million (2017-2028)
Table 32: Total Market Size of FXS by Therapies in 7MM in USD Million (2017-2028)
Table 33: Total Market size of Fragile X Syndrome in the US (2017–2028)
Table 34: Total Market Size of FXS by Therapies in the US, in USD Million (2017-2028)
Table 35: Total Market size of Fragile X Syndrome in Germany (2017–2028)
Table 36: Total Market Size of FXS by Therapies in Germany, in USD Million (2017-2028)
Table 37: Total Market size of Fragile X Syndrome in France (2017–2028)
Table 38: Total Market Size of FXS by Therapies in France, in USD Million (2017-2028)
Table 39: Total Market size of Fragile X Syndrome in Italy (2017–2028)
Table 40: Total Market Size of FXS by Therapies in Italy, in USD Million (2017-2028)
Table 41: Total Market size of Fragile X Syndrome in Spain (2017–2028)
Table 42: Total Market Size of FXS by Therapies in Spain, in USD Million (2017-2028)
Table 43: Total Market size of Fragile X Syndrome in the UK (2017–2028)
Table 44: Total Market Size of FXS by Therapies in the UK, in USD Million (2017-2028)
Table 45: Total Market size of Fragile X Syndrome in Japan (2017–2028)
Table 46: Total Market Size of FXS by Therapies in Japan, in USD Million (2017-2028)

List of Figures
Figure 1: The four alleles of the human FMR1 gene
Figure 2: Behavioral features of Fragile X Syndrome
Figure 3: Physical features of Fragile X Syndrome
Figure 4: Use of molecular techniques for Fragile X Syndrome (FXS) diagnosis
Figure 5: Total Diagnosed Prevalent cases of Fragile X Syndrome in 7MM (2017–2028)
Figure 6: Total Diagnosed Prevalent Cases of Fragile X Syndrome in the US (2017–2028)
Figure 7: Gender-Specific Cases of Fragile X Syndrome in the US (2017–2028)
Figure 8: Age-Specific Cases of Fragile X Syndrome in the US (2017–2028)
Figure 9: Total Diagnosed Prevalent Cases of Fragile X Syndrome in Germany (2017–2028)
Figure 10: Gender-Specific Cases of Fragile X Syndrome in Germany (2017–2028)
Figure 11: Age-Specific Cases of Fragile X Syndrome in Germany (2017–2028)
Figure 12: Total Diagnosed Prevalent Cases of Fragile X Syndrome in France (2017–2028)
Figure 13: Gender-Specific Cases of Fragile X Syndrome in France (2017–2028)
Figure 14: Age-Specific Cases of Fragile X Syndrome in France (2017–2028)
Figure 15: Total Diagnosed Prevalent Cases of Fragile X Syndrome in Italy (2017–2028)
Figure 16: Gender-Specific Cases of Fragile X Syndrome in Italy (2017–2028)
Figure 17: Age-Specific Cases of Fragile X Syndrome in Italy (2017–2028)
Figure 18: Total Diagnosed Prevalent Cases of Fragile X Syndrome in Spain (2017–2028)
Figure 19: Gender-Specific Cases of Fragile X Syndrome in Spain (2017–2028)
Figure 20: Age-Specific Cases of Fragile X Syndrome in Spain (2017–2028)
Figure 21: Total Diagnosed Prevalent Cases of Fragile X Syndrome in the UK (2017–2028)
Figure 22: Gender-Specific Cases of Fragile X Syndrome in the UK (2017–2028)
Figure 23: Age-Specific Cases of Fragile X Syndrome in the UK (2017–2028)
Figure 24: Total Diagnosed Prevalent Cases of Fragile X Syndrome in Japan (2017–2028)
Figure 25: Gender-Specific Cases of Fragile X Syndrome in Japan (2017–2028)
Figure 26: Age-Specific Cases of Fragile X Syndrome in Japan (2017–2028)
Figure 27: Unmet Need
Figure 28: Total Market Size of Fragile X Syndrome in 7MM in USD Million (2017-2028)
Figure 29: Total Market Size of FXS by Therapies in 7MM in USD Million (2017-2028)
Figure 30: Market size of Fragile X Syndrome in the US (2017–2028)
Figure 31: Total Market Size of FXS by Therapies in the US, in USD Million (2017-2028)
Figure 32: Market size of Fragile X Syndrome in Germany (2017–2028)
Figure 33: Total Market Size of FXS by Therapies in Germany, in USD Million (2017-2028)
Figure 34: Market size of Fragile X Syndrome in France (2017–2028)
Figure 35: Total Market Size of FXS by Therapies in France, in USD Million (2017-2028)
Figure 36: Market size of Fragile X Syndrome in Italy (2017–2028)
Figure 37: Total Market Size of FXS by Therapies in Italy, in USD Million (2017-2028)
Figure 38: Market size of Fragile X Syndrome in Spain (2017–2028)
Figure 39: Total Market Size of FXS by Therapies in Spain, in USD Million (2017-2028)
Figure 40: Market size of Fragile X Syndrome in the UK (2017–2028)
Figure 41: Total Market Size of FXS by Therapies in the UK, in USD Million (2017-2028)
Figure 42: Market size of Fragile X Syndrome in Japan (2017–2028)
Figure 43: Total Market Size of FXS by Therapies in Japan, in USD Million (2017-2028)
Figure 44: Market Drivers
Figure 45:Market Barriers

Note: Product cover images may vary from those shown
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  • Tetra Therapeutics
  • Zynerba Pharmaceuticals
  • Ovid Therapeutics
  • Confluence Pharmaceuticals
  • Neuren Pharmaceuticals
Note: Product cover images may vary from those shown
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