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 non-core 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.

Table Of Contents

1 Table of Contents
1 Table of Contents 9


2 Introduction 16
2.1 Catalyst 16
2.2 Related Reports 16
2.3 Upcoming Related Reports 16
3 Disease Overview 17
3.1 Etiology and Pathophysiology 17
3.1.1 Etiology 17
3.1.2 Pathophysiology 18
3.2 Symptoms 19
3.2.1 Core Symptoms 20
3.2.2 Associated Non-Core Symptoms 22
3.3 Diagnosis 28
3.3.1 DSM-IV and DSM-V 28
3.3.2 ICD-10 Diagnosis 32
3.3.3 Diagnostic Tests 33
4 Epidemiology 36
4.1 Disease Background 36
4.2 Risk Factors and Comorbidities 37
4.2.1 Intake of certain drugs during pregnancy increases the risk of ASD in children 38
4.2.2 Gestational complications elevate the risk of ASD 40
4.2.3 Familial history of psychiatric disorders in first-degree relatives is a strong predictor of ASD 41
4.2.4 Increasing maternal age raises the risk of ASD compared with increasing paternal age 44
4.2.5 Boys are more likely to develop ASD than girls 46
4.2.6 Neuropsychiatric disorders are highly prevalent in autistic patients 47
4.3 Global Trends 49
4.3.1 US 49
4.3.2 5EU 50
4.4 Forecast Methodology 51
4.4.1 Sources Used 52
4.4.2 Sources Not Used 54
4.4.3 Forecast Assumptions and Methods, Prevalent Cases 55
4.5 Epidemiological Forecast for ASD (2012-2022) 57
4.5.1 Diagnosed Prevalent Cases of ASD 57
4.5.2 Age-Specific Diagnosed Prevalent Cases of ASD 59
4.5.3 Sex-Specific Diagnosed Prevalent Cases of ASD 61
4.5.4 Age-Standardized Diagnosed Prevalence of ASD 62
4.5.5 Diagnosed Prevalent Cases of ASD by Subtype 63
4.6 Discussion 65
4.6.1 Epidemiological Forecast Insight 65
4.6.2 Limitations of the Analysis 67
4.6.3 Strengths of the Analysis 68
5 Current Treatment Options 69
5.1 Overview 69
5.1.1 Psychotropic Medication 71
5.2 Product Profiles - Major Brands 79
5.2.1 Risperidone 79
5.2.2 Abilify (aripiprazole) 82
6 Unmet Needs Assessment and Opportunity Analysis 86
6.1 Overview 86
6.2 Unmet Needs Analysis 87
6.2.1 Lack of Efficacious Therapies for the Core ASD Symptoms 87
6.2.2 More approved treatment options for the associated non-core symptoms of ASD 92
6.2.3 Improved early diagnosis in high-functioning autistic children 94
6.2.4 Poor Diagnosis of Autistic Females and Adult Males 97
6.2.5 Diagnostic Biomarkers for ASD 99
6.3 Opportunity Analysis 101
6.3.1 Development of Alternative Antipsychotic Drugs for ASD 101
6.3.2 Label Expansion of Other CNS Drugs 103
6.3.3 Treatments to Improve Language Skills 104
6.3.4 Treatments Targeting Sleep Problems, Sensory Overload, and Anxiety 105
6.3.5 Medications Suitable for Young Autistic Children 106
7 Research and Development Strategies 109
7.1 Overview 109
7.1.1 Correcting an Excitation-Inhibition Imbalance at the Synapse 110
7.1.2 The Oxytocin-Vasopressin Pathway 112
7.1.3 Alternative Therapies and Digestive Aids 115
7.2 Patient-Compatible Drug Formulations 117
7.3 EU-AIMS 119
7.4 Clinical Trial Design 120
7.4.1 Diagnosis and Relevant Inclusion Criteria 120
7.4.2 Current Clinical Trial Design 121
7.4.3 Recruiting Trial Participants 123
8 Pipeline Assessment 125
8.1 Overview 125
8.2 Promising Drugs in Clinical Development 126
8.2.1 CM-AT 126
8.2.2 Latuda 133
8.2.3 Serelsa/AT-001 140
8.2.4 Namenda 145
8.2.5 RG-7314 149
8.3 Innovative Early-Stage Approaches 153
8.3.1 NMDAR Modulation 154
8.3.2 TSO 155
8.3.3 Syntocinon 157
8.3.4 Stem Cell Therapy 158
9 Pipeline Valuation Analysis 159
9.1 Clinical Benchmarking of Key ASD Pipeline Drugs 160
9.2 Commercial Benchmarking of Key ASD Pipeline Drugs 162
9.3 Competitive Assessment 164
9.4 Top-Line Five-Year Forecast 164
9.4.1 US 168
9.4.2 5EU 170
10 Appendix 172
10.1 Bibliography 172
10.2 Abbreviations 197
10.3 Methodology 202
10.4 Forecasting Methodology 202
10.4.1 Diagnosed and Drug-Treated Autistic Patients 202
10.4.2 Drugs Included in Each Therapeutic Class 203
10.4.3 Key Launch and Patent Expiry Dates 203
10.4.4 General Pricing Assumptions 204
10.4.5 Individual Drug Assumptions 204
10.4.6 Generic Erosion 208
10.4.7 Drug Dosage Assumptions 208
10.5 Physicians and Specialists Included in This Study 210
10.6 About the Authors 211
10.6.1 Authors 211
10.6.2 Epidemiologist 212
10.6.3 Global Head of Healthcare 212
10.7 About GlobalData 213
10.8 Disclaimer 213

1.1 List of Tables
Table 1: Associated Non-Core symptoms associated with ASD 22
Table 2: Major Differences in the Autism Diagnostic Criteria Between the DSM-IV and the DSM-V 29
Table 3: Comparison Between the DSM-IV/DSM-IV-TR and the ICD-10 for Different ASDs 37
Table 4: Risk Factors and Comorbidities Associated with ASD 38
Table 5: Sources of Diagnosed Prevalence Data Used in the Epidemiological Forecast for ASD and Its Subtypes 52
Table 6: 6MM, Diagnosed Prevalent Cases of ASD, Boys and Girls, Ages 0-19 Years, N, Selected Years, 2012-2022 58
Table 7: 6MM, Diagnosed Prevalent Cases of ASD, by Age, Boys and Girls, N (Row %), 2012 60
Table 8: 6MM, Diagnosed Prevalent Cases of ASD, by Sex, Ages 0-19 Years, N, Row (%), 2012 61
Table 9: 6MM, Diagnosed Prevalent Cases of ASD, by Subtype, N (%), 2012 64
Table 10: Current Treatment Options for ASD 70
Table 11: Product Profile - Risperidone 80
Table 12: Risperidone SWOT Analysis, 2014 82
Table 13: Product Profile - Abilify 83
Table 14: Abilify SWOT Analysis, 2014 85
Table 15: Overall Unmet Needs - Current Level of Attainment 87
Table 16: Late-Stage ASD Pipeline, 2014 126
Table 17: Product Profile - CM-AT 130
Table 18: CM-AT SWOT Analysis, 2014 132
Table 19: Product Profile - Latuda 137
Table 20: Latuda SWOT Analysis, 2014 139
Table 21: Product Profile - Serelsa/ AT-001 143
Table 22: Serelsa/AT-001 SWOT Analysis, 2014 144
Table 23: Product Profile - Namenda 147
Table 24: Namenda SWOT Analysis, 2014 149
Table 25: Product Profile - RG-7314 151
Table 26: RG-7314 SWOT Analysis, 2014 153
Table 27: Early-Stage ASD Pipeline, 2014 154
Table 28: Clinical Benchmarking of Key ASD Pipeline Drugs, 2012-2018 160
Table 29: Commercial Benchmarking of Key ASD Pipeline Drugs, 2012-2018 162
Table 30: Top-Line Sales Forecasts ($m) for the ASD Market 2012-2018 165
Table 31: Country-Specific CAGRs for the Key ASD Drugs, 2012-2018 165
Table 32: Key Events Impacting Sales for ASD, 2012-2018 168
Table 33: ASD Market - Drivers and Barriers, 2012-2018 171
Table 34: Key Launch and Patent Expiry Dates in the ASD Market, 2012-2018 203
Table 35: Children’s Average Weights (kg), 6MM 208

1.2 List of Figures
Figure 1: Core and Non-Core Symptoms of ASD and Their Interrelationships. 19
Figure 2: Total Prevalence of ASD, Age Eight Years, Boys and Girls, 2000-2008 50
Figure 3: 6MM, Prevalent Cases of Diagnosed ASD, Ages 0-19 Years, Boys and Girls, N, 2012-2022 58
Figure 4: 6MM, Diagnosed Prevalent Cases of Diagnosed ASD, by Age, Boys and Girls, N, 2012 60
Figure 5: 6MM, Diagnosed Prevalent Cases of ASD, by Sex, Ages 0-19 Years, N, 2012 62
Figure 6: 6MM, Age-Standardized Diagnosed Prevalence (%) of ASD, Ages 0-19 Years, Boys and Girls, 2012 63
Figure 7: 5EU, Diagnosed Prevalent Cases of ASD, by Subtypes, Ages 0-19 Years, Boys and Girls, N, 2012 65
Figure 8: ASD treatment Overview 71
Figure 9: Competitive Assessment of the Key Late-Stage Pipeline ASD Drugs, 2012-2018 164
Figure 10: Shifting Distribution of Global Drug Sales in ASD Market, 2012-2018 166
Figure 11: Market Share for ASD Drugs by Region, 5EU and 6MM, 2012 and 2018 167

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Company Profiles

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Pfizer Inc.

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Eli Lilly and Co.

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