Fragile X Syndrome Market - Opportunity Analysis, key Trends and Forecast to 2026

"The Latest Research Report OpportunityAnalyzer: Fragile X Syndrome - Opportunity Analysis and Forecasts to 2026 provides information on pricing, market analysis, shares, forecast, and company profiles for key industry participants. - MarketResearchReports.biz"

In this report, GlobalData analyzes the nuances of the Fragile X Syndrome (FXS) treatment landscape and provides detailed insights into the market dynamics of this highly competitive space. The analysis also includes the evaluation of the commercial and clinical profiles of pipeline drugs, and their sales forecasts for the Fragile X Syndrome indication over the 2016-2026 period.

Although a relatively rare disease, Fragile X Syndrome has a distinct underlying genetic cause. Early intervention is key to the prognosis of the patient, yet there are currently no approved therapies specifically for Fragile X Syndrome. Instead, symptoms are managed on a case-by-case basis. In addition, a high rate of late-stage pipeline drugs have failed in clinical trials, meaning there are currently only four drugs with the potential to be launched during the forecast period. However, these drugs have a high potential for fast uptake in the market, as they would be the only approved therapies for Fragile X syndrome available and they each target their unique set of symptoms associated with the disease; the fast uptake of these pipeline drugs will be a principal driver of growth over the forecast period. However, lucrative opportunities remain for companies and products that improve upon one or more of unmet needs that will remain after the forecast period.

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Scope

- Overview of FXS, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Annualized FXS therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in three patient segments (0-9 Year Olds, 10-19 Year Olds, 20+ Year Olds), forecast from 2016 to 2026.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the FXS therapeutics market.
- Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for FXS therapy. The most promising candidates in Phase IIb and Phase III developments are profiled.
- Analysis of the current and future market competition in the global FXS therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the global FXS therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global FXS therapeutics market in the future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

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Table of Contents

1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 8

2 Executive Summary 9
2.1 The FXS Market Will Experience Double-Digit Growth from 2016 to 2026 10
2.2 R&D Within the FXS Market 11
2.3 The First Therapies Approved Specifically for Fragile X Are on the Horizon 12
2.4 Market Opportunities for New Entrants 12
2.5 The Launch of Late-Stage Pipeline Drugs Will Be the Principal Driver of Sales Growth 13
2.6 What Do Physicians Think? 14

3 Introduction 16
3.1 Catalyst 16
3.2 Related Reports 16

4 Disease Overview 17
4.1 Etiology and Pathophysiology 17
4.1.1 Etiology 17
4.1.2 Pathophysiology 21
4.2 Classification or Staging Systems 24
4.3 Symptoms 25
4.4 Quality of Life 29

5 Epidemiology 31
5.1 Disease Background 31
5.2 Risk Factors and Comorbidities 31
5.3 Global and Historical Trends 32
5.4 Forecast Methodology 33
5.4.1 Sources 33
5.4.2 Forecast Assumptions and Methods 34
5.5 Epidemiological Forecast for FXS (2016-2026) 35
5.5.1 Diagnosed Prevalent Cases of FXS 35
5.5.2 Age-Specific Diagnosed Prevalent Cases of FXS 36
5.5.3 Sex-Specific Diagnosed Prevalent Cases of FXS 37
5.6 Discussion 38
5.6.1 Epidemiological Forecast Insight 38
5.6.2 Limitations of Analysis 38
5.6.3 Strengths of Analysis 39

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6 Current Treatment Options 40
6.1 Overview 40
6.2 Diagnosis and Treatment 40
6.2.1 Diagnosis 40
6.2.2 Treatment Guidelines and Leading Prescribed Drugs 43
6.3 Clinical Practice 47
6.4 Selective Serotonin Reuptake Inhibitors 49
6.4.1 Overview 49
6.4.2 Efficacy and Safety 50
6.4.3 SWOT Analysis 51
6.5 Other Antidepressants 51
6.5.1 Overview 51
6.5.2 Efficacy and Safety 53
6.5.3 SWOT Analysis 55
6.6 Psychostimulants 55
6.6.1 Overview 55
6.6.2 Efficacy 57
6.6.3 Safety 58
6.6.4 SWOT Analysis 59
6.7 Atypical Antipsychotics 59
6.7.1 Overview 59
6.7.2 Efficacy 60
6.7.3 Safety 62
6.7.4 SWOT Analysis 63
6.8 Anticonvulsants 63
6.8.1 Overview 63
6.8.2 Efficacy 66
6.8.3 Safety 67
6.8.4 SWOT Analysis 69
6.9 Lithium 70
6.9.1 Overview 70
6.9.2 Efficacy 71
6.9.3 Safety 72
6.9.4 SWOT Analysis 73
6.10 Other Therapeutic Classes 73

7 Unmet Needs and Opportunity Assessment 74
7.1 Overview 74
7.2 Medication Specifically Approved for FXS Treatment 75
7.2.1 Unmet Need 75
7.2.2 Gap Analysis 76
7.2.3 Opportunity 76
7.3 Improved Efficacy and Safety Profile of Current Treatments 77
7.3.1 Unmet Need 77
7.3.2 Gap Analysis 78
7.3.3 Opportunity 79
7.4 Improved Clinical Trial Design 79
7.4.1 Unmet Need 79
7.4.2 Gap Analysis 82
7.4.3 Opportunity 82
7.5 Early Diagnosis Capability for Early Intervention and Improved Prognosis 82
7.5.1 Unmet Need 82
7.5.2 Gap Analysis 83
7.5.3 Opportunity 84

8 R&D Strategies 85
8.1 Overview 85
8.1.1 Modulating Inhibitory Neurotransmission 86
8.1.2 Modulating Excitatory Neurotransmission 87
8.1.3 Other Therapeutic Approaches 87
8.2 Clinical Trial Design 88
8.2.1 Lack of High-Quality Outcome Measures 89
8.2.2 Biomarkers for FXS 89
8.2.3 Consensus on Outcome Measures 90

9 Pipeline Assessment 92
9.1 Overview 92
9.2 Acamprosate Calcium 95
9.2.1 Overview 95
9.2.2 Efficacy 97
9.2.3 Safety 98
9.2.4 SWOT Analysis 99
9.3 Cannabidiol (ZYN002) 99
9.3.1 Overview 99
9.3.2 Efficacy 101
9.3.3 Safety 102
9.3.4 SWOT Analysis 103
9.4 Ganaxolone 104
9.4.1 Overview 104
9.4.2 Efficacy 105
9.4.3 Safety 106
9.4.4 SWOT Analysis 107
9.5 Trofinetide 107
9.5.1 Overview 107
9.5.2 Efficacy 109
9.5.3 Safety 110
9.5.4 SWOT Analysis 111
9.6 Innovative Early-Stage Approaches 111
9.6.1 Bryostatin-1 112
9.6.2 Gaboxadol 112
9.6.3 AMO-01 112

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