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Transcript
Brochure
More information from http://www.researchandmarkets.com/reports/2773981/
OpportunityAnalyzer: Autism Spectrum Disorder - Opportunity Analysis and
Forecasts to 2018
Description:
OpportunityAnalyzer: Autism Spectrum Disorder - Opportunity Analysis and Forecasts to 2018
Summary
Autism Spectrum Disorders (ASD) is a chronically underserved market currently dominated by the two
approved drugs, both of which are antipsychotics. There is off-label use of a multitude of other drugs which
target different core and non-core symptoms of ASD. Since this disorder can first become apparent in very
young children there is a need for medications which are safe and effective in the pediatric population. The
ASD market is expected to grow remain relatively flat between 2012 and 2018, which is predominantly due
to various drug patent expiration, and the introduction of novel therapies in the US and EU countries is not
anticipated to offset this expected decline in the market. The new treatments will target some key unmet
needs but opportunities will remain for drugs which can effectively target any of the many core and noncore symptoms of ASD, as well as offering an improved safety profile over currently used drugs.
Highlights
Key Questions Answered
- The ASD market is marked by the presence of a number of unmet needs in current treatments. What are
the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the ASD
market?
- The late-stage ASD pipeline is filled with diverse therapies and novel routes of administration. Which drug
will have a significant impact on the ASD market. Which of these drugs will have the highest CAGR, and why?
- The current ASD market is dominated by antipsychotics, many of which are used off-label. How will the
introduction of numerous first-in-class drugs change the treatment landscape? How will the drug treatment
rates change over the next five years? What are the key drivers and barriers to this change?
Key Findings
- The main driver of the ASD market will be the introduction of first-in-class drugs which target core ASD
symptoms, which will increase the market size following their uptake. The introduction of another
antipsychotic will strengthen the market growth.
- An additional driver for the ASD market is the assignment of orphan drug status to several ASDs drugs.
- The biggest barrier for growth in the ASD market will be patent expiration of marketed and pipeline drugs,
with rapid genericization expected in some markets.
- Significant opportunities remain for further drug development in the ASD market due to the large unmet
need for novel safe and efficacious drugs for the pediatric population.
Scope
- Overview of ASD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment
guidelines.
- Annualized ASD therapeutics market revenue, annual cost of therapy and treatment usage pattern data
from 2012 and forecast for six years to 2018.
- Key topics covered include market characterization, unmet needs, R&D and clinical trials assessment, late
stage clinical trial analysis and implications for the ASD therapeutics market.
- Pipeline analysis: focus on the five late-stage pipeline ASD drugs discussing emerging trends as well as
overview of earlier phase drugs.
- Analysis of the current and future market competition in the global ASD 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
- 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. Additionally a list of
acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the global uveitis
therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments,
and companies likely to impact the global uveitis therapeutics market in 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.
- Track drug sales in the global ASD therapeutics market from 2012-2018.
- Organize your sales and marketing efforts by identifying the market categories and segments that present
maximum opportunities for consolidations, investments and strategic partnerships.
Contents:
1 Table of Contents
1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Catalyst
2.2 Related Reports
2.3 Upcoming Related Reports
3 Disease Overview
3.1 Etiology and Pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
3.2 Symptoms
3.2.1 Core Symptoms
3.2.2 Associated Non-Core Symptoms
3.3 Diagnosis
3.3.1 DSM-IV and DSM-V
3.3.2 ICD-10 Diagnosis
3.3.3 Diagnostic Tests
4 Epidemiology
4.1 Disease Background
4.2 Risk Factors and Comorbidities
4.2.1 Intake of certain drugs during pregnancy increases the risk of ASD in children
4.2.2 Gestational complications elevate the risk of ASD
4.2.3 Familial history of psychiatric disorders in first-degree relatives is a strong predictor of ASD
4.2.4 Increasing maternal age raises the risk of ASD compared with increasing paternal age
4.2.5 Boys are more likely to develop ASD than girls
4.2.6 Neuropsychiatric disorders are highly prevalent in autistic patients
4.3 Global Trends
4.3.1 US
4.3.2 5EU
4.4 Forecast Methodology
4.4.1 Sources Used
4.4.2 Sources Not Used
4.4.3 Forecast Assumptions and Methods, Prevalent Cases
4.5 Epidemiological Forecast for ASD (2012-2022)
4.5.1 Diagnosed Prevalent Cases of ASD
4.5.2 Age-Specific Diagnosed Prevalent Cases of ASD
4.5.3 Sex-Specific Diagnosed Prevalent Cases of ASD
4.5.4 Age-Standardized Diagnosed Prevalence of ASD
4.5.5 Diagnosed Prevalent Cases of ASD by Subtype
4.6 Discussion
4.6.1 Epidemiological Forecast Insight
4.6.2 Limitations of the Analysis
4.6.3 Strengths of the Analysis
5 Current Treatment Options
5.1 Overview
5.1.1 Psychotropic Medication
5.2 Product Profiles - Major Brands
5.2.1 Risperidone
5.2.2 Abilify (aripiprazole)
6 Unmet Needs Assessment and Opportunity Analysis
6.1 Overview
6.2 Unmet Needs Analysis
6.2.1 Lack of Efficacious Therapies for the Core ASD Symptoms
6.2.2 More approved treatment options for the associated non-core symptoms of ASD
6.2.3 Improved early diagnosis in high-functioning autistic children
6.2.4 Poor Diagnosis of Autistic Females and Adult Males
6.2.5 Diagnostic Biomarkers for ASD
6.3 Opportunity Analysis
6.3.1 Development of Alternative Antipsychotic Drugs for ASD
6.3.2 Label Expansion of Other CNS Drugs
6.3.3 Treatments to Improve Language Skills
6.3.4 Treatments Targeting Sleep Problems, Sensory Overload, and Anxiety
6.3.5 Medications Suitable for Young Autistic Children
7 Research and Development Strategies
7.1 Overview
7.1.1 Correcting an Excitation-Inhibition Imbalance at the Synapse
7.1.2 The Oxytocin-Vasopressin Pathway
7.1.3 Alternative Therapies and Digestive Aids
7.2 Patient-Compatible Drug Formulations
7.3 EU-AIMS
7.4 Clinical Trial Design
7.4.1 Diagnosis and Relevant Inclusion Criteria
7.4.2 Current Clinical Trial Design
7.4.3 Recruiting Trial Participants
8 Pipeline Assessment
8.1 Overview
8.2 Promising Drugs in Clinical Development
8.2.1 CM-AT
8.2.2 Latuda
8.2.3 Serelsa/AT-001
8.2.4 Namenda
8.2.5 RG-7314
8.3 Innovative Early-Stage Approaches
8.3.1 NMDAR Modulation
8.3.2 TSO
8.3.3 Syntocinon
8.3.4 Stem Cell Therapy
9 Pipeline Valuation Analysis
9.1 Clinical Benchmarking of Key ASD Pipeline Drugs
9.2 Commercial Benchmarking of Key ASD Pipeline Drugs
9.3 Competitive Assessment
9.4 Top-Line Five-Year Forecast
9.4.1 US
9.4.2 5EU
10 Appendix
10.1 Bibliography
10.2 Abbreviations
10.3 Methodology
10.4 Forecasting Methodology
10.4.1 Diagnosed and Drug-Treated Autistic Patients
10.4.2 Drugs Included in Each Therapeutic Class
10.4.3 Key Launch and Patent Expiry Dates
10.4.4 General Pricing Assumptions
10.4.5 Individual Drug Assumptions
10.4.6 Generic Erosion
10.4.7 Drug Dosage Assumptions
10.5 Physicians and Specialists Included in This Study
10.6 About the Authors
10.6.1 Authors
10.6.2 Epidemiologist
10.6.3 Global Head of Healthcare
10.7 About Us
10.8 Disclaimer
1.1 List of Tables
Table 1: Associated Non-Core symptoms associated with ASD
Table 2: Major Differences in the Autism Diagnostic Criteria Between the DSM-IV and the DSM-V
Table 3: Comparison Between the DSM-IV/DSM-IV-TR and the ICD-10 for Different ASDs
Table 4: Risk Factors and Comorbidities Associated with ASD
Table 5: Sources of Diagnosed Prevalence Data Used in the Epidemiological Forecast for ASD and Its
Subtypes
Table 6: 6MM, Diagnosed Prevalent Cases of ASD, Boys and Girls, Ages 0-19 Years, N, Selected Years, 20122022
Table 7: 6MM, Diagnosed Prevalent Cases of ASD, by Age, Boys and Girls, N (Row %), 2012
Table 8: 6MM, Diagnosed Prevalent Cases of ASD, by Sex, Ages 0-19 Years, N, Row (%), 2012
Table 9: 6MM, Diagnosed Prevalent Cases of ASD, by Subtype, N (%), 2012
Table 10: Current Treatment Options for ASD
Table 11: Product Profile - Risperidone
Table 12: Risperidone SWOT Analysis, 2014
Table 13: Product Profile - Abilify
Table 14: Abilify SWOT Analysis, 2014
Table 15: Overall Unmet Needs - Current Level of Attainment
Table 16: Late-Stage ASD Pipeline, 2014
Table 17: Product Profile - CM-AT
Table 18: CM-AT SWOT Analysis, 2014
Table 19: Product Profile - Latuda
Table 20: Latuda SWOT Analysis, 2014
Table 21: Product Profile - Serelsa/ AT-001
Table 22: Serelsa/AT-001 SWOT Analysis, 2014
Table 23: Product Profile - Namenda
Table 24: Namenda SWOT Analysis, 2014
Table 25: Product Profile - RG-7314
Table 26: RG-7314 SWOT Analysis, 2014
Table 27: Early-Stage ASD Pipeline, 2014
Table 28: Clinical Benchmarking of Key ASD Pipeline Drugs, 2012-2018
Table 29: Commercial Benchmarking of Key ASD Pipeline Drugs, 2012-2018
Table 30: Top-Line Sales Forecasts ($m) for the ASD Market 2012-2018
Table 31: Country-Specific CAGRs for the Key ASD Drugs, 2012-2018
Table 32: Key Events Impacting Sales for ASD, 2012-2018
Table 33: ASD Market - Drivers and Barriers, 2012-2018
Table 34: Key Launch and Patent Expiry Dates in the ASD Market, 2012-2018
Table 35: Children’s Average Weights (kg), 6MM
1.2 List of Figures
Figure 1: Core and Non-Core Symptoms of ASD and Their Interrelationships.
Figure 2: Total Prevalence of ASD, Age Eight Years, Boys and Girls, 2000-2008
Figure 3: 6MM, Prevalent Cases of Diagnosed ASD, Ages 0-19 Years, Boys and Girls, N, 2012-2022
Figure 4: 6MM, Diagnosed Prevalent Cases of Diagnosed ASD, by Age, Boys and Girls, N, 2012
Figure 5: 6MM, Diagnosed Prevalent Cases of ASD, by Sex, Ages 0-19 Years, N, 2012
Figure 6: 6MM, Age-Standardized Diagnosed Prevalence (%) of ASD, Ages 0-19 Years, Boys and Girls, 2012
Figure 7: 5EU, Diagnosed Prevalent Cases of ASD, by Subtypes, Ages 0-19 Years, Boys and Girls, N, 2012
Figure 8: ASD treatment Overview
Figure 9: Competitive Assessment of the Key Late-Stage Pipeline ASD Drugs, 2012-2018
Figure 10: Shifting Distribution of Global Drug Sales in ASD Market, 2012-2018
Figure 11: Market Share for ASD Drugs by Region, 5EU and 6MM, 2012 and 2018
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