Cyclin Dependent Kinase Like 5 Cdkl5 Deficiency Disorder Market

DelveInsight's "Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder - Market Insights, Epidemiology, and Market Forecast-2030" report delivers an in-depth understanding of the Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder, historical and forecasted epidemiology as well as the Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.


The Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder market report provides current treatment practices, emerging drugs, Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder market share of the individual therapies, current and forecasted Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder market Size from 2017 to 2030 segmented by seven major markets. The Report also covers current Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses the underlying potential of the market.


Geography Covered

  • The United States
  • EU5 (Germany, France, Italy, Spain, and the United Kingdom)
  • Japan


Study Period: 2017-2030


Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Disease Understanding and Treatment Algorithm

CDKL5 deficiency disorder (CDD) is a rare developmental epileptic encephalopathy (DEE), X-linked genetic condition which results in early-onset, difficult to control seizures and severe neuro-developmental impairment. CDKL5 stands for cyclin-dependent kinase-like 5 and mutations in this gene were first identified as disease-causing in 2004. CDD was previously not considered as a separate indication; rather, it was assumed to be an atypical form of Rett Syndrome.


The CDKL5 gene provides instructions for making proteins that are essential for normal brain and neuron development. The condition was previously known as serine/threonine-protein kinase 9 (STK9), and it has been classified as DEE because the genetic change causes epileptic activity as well as severe impairment of the development.


The CDKL5 gene is located on the X chromosome. The X chromosome is one of the sex chromosomes; females have two X’s, and males have one X and one Y chromosome. Although many identified patients are males, because of the location of the gene, this disorder mainly affects females. Affected males may have more severe symptoms than females.


Diagnosis 

The most prominent feature of the CDKL5 disorder is the early onset of seizures. The onset of seizures can happen within the first hours, days, weeks or months. Children have been diagnosed with CDKL5 with seizures starting as late as 8 months and in some cases, up to the 2 years. Some mothers have described feeling seizures in the prenatal period.


For infants being seen for the first time, the CDKL5 diagnosis is most often made after a clinical workup for causes of early-life seizures, including genetic testing. For older children, the diagnosis is likely made in the process of revisiting potential causes for epilepsy and neurodevelopmental disorder, using the same kind of genetic testing.


With the introduction of more sophisticated genetic testing, CDKL5 disorder is now being diagnosed in children at a relatively early age. Genetic testing prior to 2009, which sequenced the gene, would not necessarily have picked up deletions. Several individuals subsequently diagnosed with CDKL5 disorder previously were given a negative result. Therefore, a child with the phenotype who has previously tested negative, yet does not have a genetic diagnosis, should be re-tested to include deletion and duplication testing of the CDKL5 gene. The diagnosis is based on a simple blood test. More recently, some labs use a buccal swab of the cheek. The blood or saliva swab is then sent to a special laboratory that performs the genetic test. Recently, CDKL5 testing has become widely available in epilepsy and developmental delay genetic panels, thereby allowing testing of multiple potential disease-causing genes all at the same time at a cost similar to just testing the CDKL5 gene alone.


Treatment 

Seizures in CDLK5 disorder are difficult to treat, but it is important to note that some people do well on anticonvulsant monotherapy (one drug at a time). In contrast, others need adjunctive therapy (more than one medication). No single seizure medication has proven to be most effective in controlling seizures in these children. It is relatively typical for a child to require many medication trials. Steroid treatment and the ketogenic diet have been used in the treatment course of some children. Vagus nerve stimulation is also often considered with CDKL5-related seizures. If all other therapies have failed, and a seizure focus can be isolated, surgery may be an option in some situations.


The spectrum of disability and health needs vary widely with people affected by CDKL5 disorder. The conditions are life-shortening due to the complications associated with, but not limited to, the seizure disorder, orthopedic, gastrointestinal issues and autonomic dysfunction. These may require long-term care and attention. Families should work with their primary healthcare physician or specialists to access support services in their community for medically fragile and/or developmentally challenged individuals.


DelveInsight’s CDD market report gives a thorough understanding of CDD by including details such as disease definition, causes, mechanism, biomarkers, and diagnosis.

Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Epidemiology  

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology include Prevalence of CDD, Diagnosed Prevalence of CDD, Gender-specific Diagnosed Prevalence of CDD, and clinical characteristics of CDD scenario of CDD in the 7MM covering the United States, EU5 countries (Germany, Spain, Italy, France and the United Kingdom) and Japan from 2017 to 2030. 


Key Findings

This section provides glimpses of the CDD epidemiology in the 7MM.

  • In the 7MM, the total prevalent population of CDD was estimated to be 16,397 cases in 2017.
  • The total diagnosed prevalent population of CDD in the seven major markets was 3,584 in 2017, which is expected to increase in the forecast period
  • The United States accounted for the maximum diagnosed prevalent population among the 7MM in 2017
  • In EU5 countries, Germany accounted for the highest diagnosed cases of CDD while Spain had the lowest diagnosed prevalent population in 2017
  • In 2017, the total diagnosed prevalence of CDD in the United States was 208 in males and 1,315 in females
  • There are several types of clinical characteristics of CDD, among which, mainly eight types of characteristics are frequently observed. As per the estimates 1,234, 716, 1,142, 1,218, 1,317, 1,080, 976, 1,295, patients were affected by epileptic spasms, hypsarrhythmia, cortical visual impairment, hand stereotypies, gastrointestinal symptoms, constipation, reflux, and sleep difficulties in 2017.


Country Wise- Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Epidemiology 

The epidemiology segment also provides the Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. 


Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Drug Chapters

Drug chapter segment of the Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder report encloses the detailed analysis of Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder 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.


Marketed Drugs 

The report provides the details of the marketed product available for Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder treatment. 


Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Emerging Drugs 


TAK935/OV935 (soticlestat): Takeda/Ovid Therapeutics

TAK935/OV935 (soticlestat) is undergoing phase II clinical development trial, which is being developed by Takeda in collaboration with Ovid Therapeutics for the treatment of CDD. OV935/TAK-935 is a potent, highly-selective, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H) being investigated as an antiepileptic drug (AED). CH24H is predominantly expressed in the brain, where it plays a central role in cholesterol homeostasis. CH24H converts cholesterol to 24-hydroxycholesterol (24HC), which then exits the brain into the blood plasma circulation.


Ganaxolone: Marinus Pharmaceuticals

Marinus Pharmaceuticals is developing Ganaxolone, which is in phase III for the treatment of CDD. It is a synthetic analog of allopregnanolone, an endogenous neurosteroid produced in the central nervous system that modulates the brain neurotransmitter GABA. It is an allosteric modulator of GABAA receptors acting through binding sites which are distinct from the benzodiazepine binding site. The drug is currently being developed in three different dose forms (IV, capsule, and liquid) intended to maximize therapeutic reach to adult and pediatric patient populations in both acute and chronic care settings. The drug has also received orphan drug designation by the EU and the USFDA.

Products detail in the report…


Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Market Outlook

Currently, there are no approved therapies for CDD. The treatment landscape of CDD includes multidisciplinary care, including antiepileptic drugs, anticonvulsants, physiotherapy, occupational therapy, neurological speech therapy, and dietetics. Therapeutic methods in patients with CDD are based on symptomatic drug use to control the most problematic complaints that increase disability and to increase the possibility for the development of the individual patient. A multidisciplinary team approach is the most effective way to deliver necessary treatments aimed at maximizing the individual’s abilities and facilitating any skills that may be emerging. Emphasis should be placed on early intervention therapies such as physical therapy, occupational therapy, and speech and augmentative communication therapy. Important aspects of management include psychosocial support for the family, development of an appropriate education plan, and assessment of available community resources.


Seizures are a major problem for patients with CDD because they are usually severe and difficult to control with medication. No one anti-seizure medication has been found to be uniformly effective to treat CDD. A combination of anti-seizure medications may offer periods of seizure‐freedom lasting anywhere from a few weeks to a few years. Antiepileptic and anticonvulsants medications are given as the first-line treatment to the patients one by one, and if the seizures relapse in such a situation, second-line medications are preferred.


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


This segment gives a thorough detail of CDD market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria’s, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated market data are presented with relevant tables and graphs to give a clear view of the market at first sight.


According to DelveInsight, CDD 7MM market is expected to change in the study period 2017–2030.


Key Findings

  • The market size of CDD the seven major markets is USD 5.95 Million in 2017.
  • According to Delveinsight estimates, the United States accounts for the highest market size of CDD, in comparison to Japan and EU5 (the United Kingdom, Germany, Italy, France, and Spain).
  • Among the EU5 countries, Germany had the highest market size in 2017.
  • Among 7MM, Japan accounts for the third-highest market size during the forecast period 2017–2030, at a CAGR of 27.37%, which is expected to grow due to launch of emerging therapies.


Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Drugs Uptake

This section focusses on the rate of uptake of the potential drugs recently launched in the Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder market or expected to get launched in the market during the study period 2017-2030. The analysis covers Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder market uptake by drugs; patient uptake by therapies; and sales of each drug.    \


This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allow the comparison of the drugs on the basis of market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.


Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Pipeline Development Activities 

The report provides insights into different therapeutic candidates in Phase II, and Phase III stage. It also analyses Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder key players involved in developing targeted therapeutics. 


Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing, patent details and other information for Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder emerging therapies.


Reimbursement Scenario in Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In a report, we take reimbursement into consideration to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy. 


KOL- Views 

To keep up with current market trends, we take KOLs and SME's opinion working in Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs. 


Competitive Intelligence Analysis 

We perform Competitive and Market Intelligence analysis of the Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Market by using various Competitive Intelligence tools that include - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies etc. The inclusion of the analysis entirely depends upon the data availability.


Scope of the Report

  • The report covers the descriptive overview of Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder, explaining its causes, signs and symptoms, pathophysiology, diagnosis and currently available therapies
  • Comprehensive insight has been provided into the Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder epidemiology and treatment in the 7MM
  • Additionally, an all-inclusive account of both the current and emerging therapies for Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
  • A detailed review of Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder market; historical and forecasted is included in the report, covering drug outreach in the 7MM
  • The report provides an edge while developing business strategies, by understanding trends shaping and driving the global Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder market


Report Highlights

  • CDD market is anticipated to increase at a CAGR of 26.68% for the study period 2017–2030.
  • The United States accounted for more than half (53.60%) of the market share in the 7MM.
  • Ganaxolone is projected to lead the market with the largest market share in 2030.
  • In the coming years, CDD market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
  • The companies and academics are working to assess challenges and seek opportunities that could influence CDD R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
  • Major players are involved in developing therapies for CDD. Launch of emerging therapies will significantly impact the CDD market.
  • Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key competitors, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.


Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Report Insights

  • Patient Population
  • Therapeutic Approaches
  • Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Pipeline Analysis
  • Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Market Size and Trends
  • Market Opportunities
  • Impact of upcoming Therapies


Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Report Key Strengths

  • 11 Years Forecast
  • 7MM Coverage 
  • Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Epidemiology Segmentation
  • Key Cross Competition 
  • Highly Analyzed Market
  • Drugs Uptake


Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Report Assessment

  • Current Treatment Practices
  • Unmet Needs
  • Pipeline Product Profiles
  • Market Attractiveness
  • Market Drivers and Barriers


Key Questions

Market Insights:

  • What was the Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder market share (%) distribution in 2017 and how it would look like in 2030?
  • What would be the Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder total market size as well as market size by therapies across the 7MM during the forecast period (2017-2030)?
  • What are the key findings pertaining to the market across 7MM and which country will have the largest Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder market size during the forecast period (2017-2030)?
  • At what CAGR, the Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder market is expected to grow in 7MM during the forecast period (2017-2030)?
  • What would be the Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder market outlook across the 7MM during the forecast period (2017-2030)?
  • What would be the Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder market growth till 2030, and what will be the resultant market Size in the year 2030?
  • How would the market drivers, barriers and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

  • What is the disease risk, burden and unmet needs of the Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder?
  • What is the historical Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
  • What would be the forecasted patient pool of Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
  • What will be the growth opportunities in the 7MM with respect to the patient population pertaining to Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder?
  • Out of all 7MM countries, which country would have the highest prevalent population of Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder during the forecast period (2017-2030)?
  • At what CAGR the population is expected to grow in 7MM during the forecast period (2017-2030)?

Current Treatment Scenario, Marketed Drugs and Emerging Therapies:

  • What are the current options for the Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder treatment, along with the approved therapy?
  • What are the current treatment guidelines for the treatment of Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder in the USA, Europe, and Japan?
  • What are the Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety and efficacy, etc.?
  • How many companies are developing therapies for the treatment of Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder?
  • How many therapies are developed by each company for Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder treatment?
  • How many are emerging therapies in mid-stage, and late stage of development for Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder treatment?
  • What are the key collaborations (Industry - Industry, Industry - Academia), Mergers and acquisitions, licensing activities related to the Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder therapies? 
  • What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies? 
  • What are the clinical studies going on for Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder and their status?
  • What are the key designations that have been granted for the emerging therapies for Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder?
  • What are the global historical and forecasted market of Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder?


Reasons to buy

  • The report will help in developing business strategies by understanding trends shaping and driving the Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder market
  • To understand the future market competition in the Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder market and Insightful review of the key market drivers and barriers
  • Organize sales and marketing efforts by identifying the best opportunities for Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom) and Japan
  • Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors
  • Organize sales and marketing efforts by identifying the best opportunities for Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder market
  • To understand the future market competition in the Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder market

1. Key Insights

2. Executive Summary of Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder

3. Competitive Intelligence Analysis for Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder

4. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder: Market Overview at a Glance

4.1. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Total Market Share (%) Distribution in 2017

4.2. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Total Market Share (%) Distribution in 2030

5. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder: Disease Background and Overview

5.1. Introduction

5.2. Sign and Symptoms 

5.3. Pathophysiology 

5.4. Risk Factors 

5.5. Diagnosis 

6. Patient Journey

7. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Epidemiology and Patient Population

7.1. Epidemiology Key Findings

7.2. Assumptions and Rationale: 7MM

7.3. Epidemiology Scenario: 7MM

7.3.1. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Epidemiology Scenario in the 7MM (2017-2030)

7.4. United States Epidemiology

7.4.1. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Epidemiology Scenario in the United States (2017-2030)

7.5. EU-5 Country-wise Epidemiology

7.5.1. Germany Epidemiology

7.5.1.1. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Epidemiology Scenario in Germany (2017-2030)

7.5.2. France Epidemiology

7.5.2.1. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Epidemiology Scenario in France (2017-2030)

7.5.3. Italy Epidemiology

7.5.3.1. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Epidemiology Scenario in Italy (2017-2030)

7.5.4. Spain Epidemiology

7.5.4.1. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Epidemiology Scenario in Spain (2017-2030)

7.5.5. United Kingdom Epidemiology

7.5.5.1. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Epidemiology Scenario in the United Kingdom (2017-2030)

7.5.6. Japan Epidemiology

7.5.6.1. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Epidemiology Scenario in Japan (2017-2030)

8. Treatment Algorithm, Current Treatment, and Medical Practices

8.1. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Treatment and Management

8.2. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Treatment Algorithm 

9. Unmet Needs

10. Key Endpoints of Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Treatment

11. Marketed Products

11.1. List of Marketed Products in the 7MM

11.2. Drug Name: Company Name

11.2.1. Product Description

11.2.2. Regulatory Milestones

11.2.3. Other Developmental Activities

11.2.4. Pivotal Clinical Trials

11.2.5. Summary of Pivotal Clinical Trial

List to be continued in report

12. Emerging Therapies

12.1. Key Cross

12.2. Drug Name: Company Name

12.2.1. Product Description

12.2.2. Other Developmental Activities

12.2.3. Clinical Development

12.2.4. Safety and Efficacy

12.2.5. Product Profile

List to be continued in report

13. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder: Seven Major Market Analysis

13.1. Key Findings

13.2. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Market Size in 7MM

13.3. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Market Size by Therapies in the 7MM

14. Attribute analysis

15. 7MM: Market Outlook

15.1. United States: Market Size

15.1.1. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Total Market Size in the United States

15.1.2. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Market Size by Therapies in the United States

15.2. EU-5 countries: Market Size and Outlook

15.3. Germany Market Size

15.3.1. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Total Market Size in Germany

15.3.2. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Market Size by Therapies in Germany

15.4. France Market Size

15.4.1. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Total Market Size in France

15.4.2. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Market Size by Therapies in France

15.5. Italy Market Size

15.5.1. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Total Market Size in Italy

15.5.2. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Market Size by Therapies in Italy

15.6. Spain Market Size

15.6.1. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Total Market Size in Spain

15.6.2. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Market Size by Therapies in Spain

15.7. United Kingdom Market Size

15.7.1. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Total Market Size in the United Kingdom

15.7.2. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Market Size by Therapies in the United Kingdom

15.8. Japan Market Outlook

15.8.1. Japan Market Size

15.8.2. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Total Market Size in Japan

15.8.3. Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder Market Size by Therapies in Japan

16. Access and Reimbursement Overview of Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder

17. KOL Views

18. Market Drivers

19. Market Barriers

20. Appendix

20.1. Bibliography

20.2. Report Methodology

21. DelveInsight Capabilities

22. Disclaimer

23. About DelveInsight

*The table of contents is not exhaustive; the final content may vary. 

List of Tables:

Table 1: Summary of CDKL5 Deficiency Disorder (CDD), Epidemiology, and Key Events (2017–2030)

Table 2: Symptoms of CDD

Table 3: Common clinical characteristics and proposed minimal diagnostic criteria

Table 4: Total Prevalent Population of CDD in the 7MM (2017–2030)

Table 5: Total Diagnosed Prevalent Population of CDD in the 7MM (2017–2030)

Table 6: Prevalence of CDD in the United States (2017–2030)

Table 7: Diagnosed Prevalence of CDD in the United States (2017–2030)

Table 8: Gender-specific Diagnosed Prevalence of CDD in the United States (2017–2030)

Table 9: Clinical Characteristics of CDD in the United States (2017–2030)

Table 10: Prevalence of CDD in Germany (2017–2030)

Table 11: Diagnosed Prevalence of CDD in Germany (2017–2030)

Table 12: Gender-specific Diagnosed Prevalence of CDD in Germany (2017–2030)

Table 13: Clinical Characteristics of CDD in Germany (2017–2030)

Table 14: Prevalence of CDD in France (2017–2030)

Table 15: Diagnosed Prevalence of CDD in France (2017–2030)

Table 16: Gender-specific Diagnosed Prevalence of CDD in France (2017–2030)

Table 17: Clinical Characteristics of CDD in France (2017–2030)

Table 18: Prevalence of CDD in Italy (2017–2030)

Table 19: Diagnosed Prevalence of CDD in Italy (2017–2030)

Table 20: Gender-specific Diagnosed Prevalence of CDD in Italy (2017–2030)

Table 21: Clinical Characteristics of CDD in Italy (2017–2030)

Table 22: Prevalence of CDD in Spain (2017–2030)

Table 23: Diagnosed Prevalence of CDD in Spain (2017–2030)

Table 24: Gender-specific Diagnosed Prevalence of CDD in Spain (2017–2030)

Table 25: Clinical Characteristics of CDD in Spain (2017–2030)

Table 26: Prevalence of CDD in the United Kingdom (2017–2030)

Table 27: Diagnosed Prevalence of CDD in the United Kingdom (2017–2030)

Table 28: Gender-specific Diagnosed Prevalence of CDD in the United Kingdom (2017–2030)

Table 29: Clinical Characteristics of CDD in the United Kingdom (2017–2030)

Table 30: Prevalence of CDD in Japan (2017–2030)

Table 31: Diagnosed Prevalence of CDD in Japan (2017–2030)

Table 32: Gender-specific Diagnosed Prevalence of CDD in Japan (2017–2030)

Table 33: Clinical Characteristics of CDD in Japan (2017–2030)

Table 34: Comparison of Emerging Drugs

Table 35: Preclinical/Discovery phase products

Table 36: Ganaxolone, Clinical Trial Description,2020

Table 37: Soticlestat, Clinical Trial Description, 2020

Table 38: Fintepla, Clinical Trial Description,2020

Table 39: Translarna (ataluren), Clinical Trial Description,2020

Table 40: Key Market Assumptions for Ganaxolone

Table 41: Key Market Assumptions for Soticlestat

Table 42: Seven Major Market Size of CDKL5 Deficiency Disorder (CDD) in USD Million (2017–2030)

Table 43: Market size of CDD by therapies in the 7MM, in USD Million (2017–2030)

Table 44: United States Market Size of CDD, USD Million (2017–2030)

Table 45: Market size of CDD by therapies in the United States, in USD Million (2017–2030)

Table 46: Market Size of CDD in Germany, in USD Million (2017–2030)

Table 47: Market size of CDD by therapies in Germany, in USD Million (2017–2030)

Table 48: Market Size of CDD in France, in USD Million (2017–2030)

Table 49: Market size of CDD by therapies in France, in USD Million (2017–2030)

Table 50: Market Size of CDD in Italy, in USD Million (2017–2030)

Table 51: Market size of CDD by therapies in Italy, in USD Million (2017–2030)

Table 52: Market Size of CDD in Spain, in USD Million (2017–2030)

Table 53: Market size of CDD by therapies in Spain, in USD Million (2017–2030)

Table 54: Market Size of CDD in the UK, in USD Million (2017–2030)

Table 55: Market size of CDD by therapies in the UK, in USD Million (2017–2030)

Table 56: Market Size of CDD in Japan, in USD Million (2017–2030)

Table 57: Market size of CDD by therapies in Japan, in USD Million (2017–2030)

List of Figures:

Figure 1: CDKL5 Deficiency Disorder (CDD) SWOT Analysis

Figure 2: Location of CDKL5 gene

Figure 3: X linked dominant inheritance

Figure 4: A schematic of the CDKL5 protein with variants from individuals with CDD evaluated in the CDKL5 Centers of Excellence (COEs)

Figure 5: Physiological CDKL5 substrates control cytoskeletal function.

Figure 6: Total Prevalent Patient Population of CDD in the 7MM (2017–2030)

Figure 7: Total Diagnosed Prevalent Patient Population of CDD in the 7MM (2017–2030)

Figure 8: Prevalence of CDD in the United States (2017–2030)

Figure 9: Diagnosed Prevalence of CDD in the United States (2017–2030)

Figure 10: Gender-specific Diagnosed Prevalence of CDD in the United States (2017–2030)

Figure 11: Clinical Characteristics of CDD in the United States (2017–2030)

Figure 12: Prevalence of CDD in Germany (2017–2030)

Figure 13: Diagnosed Prevalence of CDD in Germany (2017–2030)

Figure 14: Gender-specific Diagnosed Prevalence of CDD in Germany (2017–2030)

Figure 15: Clinical Characteristics of CDD in Germany (2017–2030)

Figure 16: Prevalence of CDD in France (2017–2030)

Figure 17: Diagnosed Prevalence of CDD in France (2017–2030)

Figure 18: Gender-specific Diagnosed Prevalence of CDD in France (2017–2030)

Figure 19: Clinical Characteristics of CDD in France (2017–2030)

Figure 20: Prevalence of CDD in Italy (2017–2030)

Figure 21: Diagnosed Prevalence of CDD in Italy (2017–2030)

Figure 22: Gender-specific Diagnosed Prevalence of CDD in Italy (2017–2030)

Figure 23: Clinical Characteristics of CDD in Italy (2017–2030)

Figure 24: Prevalence of CDD in Spain (2017–2030)

Figure 25: Diagnosed Prevalence of CDD in Spain (2017–2030)

Figure 26: Gender-specific Diagnosed Prevalence of CDD in Spain (2017–2030)

Figure 27: Clinical Characteristics of CDD in Spain (2017–2030)

Figure 28: Prevalence of CDD in the United Kingdom (2017–2030)

Figure 29: Diagnosed Prevalence of CDD in the United Kingdom (2017–2030)

Figure 30: Gender-specific Diagnosed Prevalence of CDD in the United Kingdom (2017–2030)

Figure 31: Clinical Characteristics of CDD in the United Kingdom(2017–2030)

Figure 32: Prevalence of CDD in Japan (2017–2030)

Figure 33: Diagnosed Prevalence of CDD in Japan (2017–2030)

Figure 34: Gender-specific Diagnosed Prevalence of CDD in Japan (2017–2030)

Figure 35: Clinical Characteristics of CDD in Japan (2017–2030)

Figure 36: Unmet Needs of CDD

Figure 37: Seven Major Market Size of CDKL5 Deficiency Disorder (CDD) in USD Million (2017–2030)

Figure 38: Market size of CDKL5 Deficiency Disorder (CDD) by Therapies in the 7MM (2017–2030)

Figure 39: Market Size of CDD in the United States, USD Millions (2017–2030)

Figure 40: Market size of CDD by Therapies in the US, in USD Million (2017–2030)

Figure 41: Market Size of CDD in Germany, USD Million (2017–2030)

Figure 42: Market size of CDD by therapies in Germany, in USD Million (2017–2030)

Figure 43: Market Size of CDD in France, USD Million (2017–2030)

Figure 44: Market size of CDD by therapies in France, in USD Million (2017–2030)

Figure 45: Market Size of CDD in Italy, USD Million (2017–2030)

Figure 46: Market size of CDD by therapies in Italy, in USD Million (2017–2030)

Figure 47: Market Size of CDD in Spain, USD Million (2017–2030)

Figure 48: Market Size of CDD by therapies in Spain, in USD Million (2017–2030)

Figure 49: Market Size of CDD in the UK, USD Million (2017–2030)

Figure 50: Market Size of CDD by therapies in the UK, in USD Million (2017–2030)

Figure 51: Market Size of CDD in Japan, USD Million (2017–2030)

Figure 52: Market size of CDD by therapies in Japan, in USD Million (2017–2030)

Figure 53: Market Drivers

Figure 54: Market Barriers

  • Marinus Pharmaceuticals: Ganaxolone
  • Ovid Therapeutics/Takeda: Soticlestat
  • Zogenix: Fintepla (ZX008)
  • PTC Therapeutics: Translarna (ataluren)
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