GBI Research has released the pharma report, “ADHD Therapeutics to 2020 Broadened Diagnostic Criteria and Growing Adult Prevalence to Drive Market Growth despite Patent Expirations” Changes in diagnostic criteria have reduced the symptom threshold for diagnosis and finally bring the acceptance of adult ADHD to the clinical setting, enabling those previously unable to obtain a diagnosis to be diagnosed for ADHD treatment. In the case of adult ADHD, 4.1% of US adults are believed to suffer from ADHD, 41.3% of these cases are classified as severe and would be eligible for therapeutic intervention.

The current ADHD therapeutics market is flooded with generics and dominated by the use of Extended-Release (ER) stimulant drugs which have superseded short-acting, Immediate-Release (IR) formulations. With dose titration per patient, ER stimulants are usually effective in 70-90% of patients. However, all stimulants apart from Vyvanse come with potential for abuse. Non-stimulants are used for those who are poor-responders, have poor cardiac history or prefer non-stimulant medication however their efficacy is lacking in comparison. Currently, 10% of adult patients are using a combination of ER and IR treatment for an additional duration, representing an unmet need within this growing ADHD segment.

The current developmental pipeline addresses these gaps in the market, with three potential non-stimulants entering the market during the forecast period and SHP465, which aims to address the unmet need in the adult ADHD segment with its tailored duration of action. In spite of anticipated drug approvals, patents expirations and increased generic competition will cause ACoT to remain fairly static and even decrease across some nations.

As a result, the global market is not expected to be driven by drug approvals, but primarily by a growing prevalence, increase in rates of diagnosis, and therefore eligible treatment population. Global market revenues are forecast to rise at a CAGR of 4.8% to $9.4 billion by 2020.

Scope

The report analyzes the incidence of ADHD, current options for its treatment, pipeline, market forecasts and deals surrounding ADHD therapeutics.The report covers and includes –

• A brief introduction into ADHD, symptoms, diagnosis, epidemiology, etiology, pathophysiology, economic implications of their treatment and the current treatment options for the condition.
• An analysis of the currently marketed ADHD drugs, including recent sales figures, safety and efficacy data of the drugs and a discussion of the likely performance of each drug within the forecast period.
• Comprehensive reviews of the pipeline for ADHD drugs, including individual analysis of a number of late-stage pipeline drugs that have the potential to enter the market in the forecast period. The pipeline is analyzed on the basis of phase distribution, molecule type and mechanism of action.
• Additional statistical analysis of clinical trial duration, size and attrition rate by phase and mechanism of action.
• An in-depth, multi-scenario forecast model for the ADHD drugs market in the US, Canada, UK, France, Germany, Italy, Spain and Japan. Each model is based on the anticipated performance of both marketed drugs and any expected to be approved within the forecast period, and takes into account drug cost, patent expiration, efficacy, safety and likely prescription volumes.
• A detailed discussion of drivers and barriers for the ADHD market
• An in-depth analysis of licensing and co-development deals involving drugs indicated in ADHD, including an in-depth outline of key deals.

Reasons to buy

The report will assist business development and enable marketing executives to strategize their product launches, by allowing them to –

• Understand the key signaling pathways and molecular targets currently under investigation in drug development for ADHD.
• Gain an in-depth view of the current status of the ADHD therapeutics pipeline, including the most common molecule types and molecular targets in development.
• Observe trends in clinical trial duration and size amongst clinical phases and mechanisms of action, and use the clinical trial attrition rate analysis to assess the risk profiles of current and/or future developmental programs for ADHD therapeutics.
• Assess the potential clinical and commercial impact of current late-stage pipeline molecules in the ADHD therapeutics market.
• Analyze current and past deals surrounding ADHD therapeutics, including their value, year of deal and in-depth details of key deals within the ADHD market.

Table of Contents

1 Table of Contents 4
1.1 List of Tables 6
1.2 List of Figures 7

2 Introduction 8
2.1 Disease Introduction 8
2.2 Symptoms 9
2.3 Epidemiology 9
2.4 Etiology 10
2.5 Pathophysiology 11
2.5.1 Diagnosis Rating Scales 14
2.5.2 DSM-5 Criteria for ADHD 15
2.5.3 ICD-10 Criteria for Hyperkinetic Disorder 17
2.6 Treatment 18
2.6.1 Treatment Algorithm 19

3 Marketed Products 20
3.1 Stimulant Drugs 21
3.1.1 Adderall XR – Shire 21
3.1.2 Concerta – Janssen Pharmaceuticals 22
3.1.3 Daytrana – Noven Pharmaceuticals 23
3.1.4 Focalin XR – Novartis 25
3.1.5 Ritalin LA – Novartis 26
3.1.6 Provigil – Teva Pharmaceutical 26
3.1.7 Quillivant XR– Pfizer Pharmaceuticals 27
3.1.8 Vyvanse – Shire 28
3.2 Non-stimulant Drugs 29
3.2.1 Strattera – Eli Lilly 29
3.2.2 Intuniv – Shire 30
3.2.3 Kapvay – Concordia Pharmaceuticals 31
3.3 Comparative Efficacy and Safety 32

4 ADHD Pipeline 34
4.1 Overview 34
4.2 Mechanisms of Action in the Pipeline 36
4.3 Clinical Trials 39
4.3.1 Attrition Rate 39
4.3.2 Clinical Trial Duration 41
4.3.3 Clinical Trial Size 43
4.3.4 Comparative Clinical Trial Metrics Analysis 46
4.3.5 SHP465 – Shire 47
4.3.6 NT-0202 – Neos Therapeutics 47
4.3.7 Edivoxetine – Eli Lilly 48
4.3.8 NWP09 – Pfizer 49
4.3.9 NT-0102 – Neos Therapeutics 50
4.3.10 Metadoxine ER – Alcobra 50
4.3.11 SPN-812 – Supernus Pharmaceuticals 51
4.3.12 Dextroamphetamine Transdermal – Noven Pharmaceuticals 52
4.4 Comparative Efficacy and Safety 53

5 Market Forecast to 2020 56
5.1 Global Market 57
5.2 North America 60
5.2.1 Treatment Usage Patterns 60
5.2.2 Annual Cost of Treatment 61
5.2.3 Market Size 62
5.3 Leading Five EU Countries (EU5) 63
5.3.1 Treatment Usage Patterns 63
5.3.2 Annual Cost of Treatment 64
5.3.3 Market Size 65
5.4 Japan 66
5.4.1 Treatment Usage Patterns 66
5.4.2 Annual Cost of Treatment 66
5.4.3 Market Size 66
5.5 Drivers and Barriers 68
5.5.1 Drivers 68
5.5.2 Barriers 69

6 Deals and Strategic Consolidations 70
6.1 Overview 70
6.2 Co-development Deals 72

7 Appendix 75
7.1 Market Definition 80
7.2 Abbreviations 80
7.3 References 81
7.4 Research Methodology 86
7.4.1 Secondary Research 87
7.4.2 Marketed Product Profiles 87
7.4.3 Late-Stage Pipeline Candidates 88
7.4.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 88
7.4.5 Product Competitiveness Framework 88
7.4.6 Pipeline Analysis 88
7.4.7 Forecasting Model 89
7.4.8 Deals Data Analysis 90
7.5 Contact Us 90
7.6 Disclaimer 91

List of Tables

Table 1: Common Assessment Scales Used to Aid ADHD Diagnosis 14
Table 2: DSM-5 Criteria for Attention Deficit Hyperactivity Disorder 15
Table 3: ICD-10 Criteria for Attention Deficit Hyperactivity Disorder 17
Table 4: ADHD Therapeutics Market, Global, Pipeline, Discovery, 2014 75
Table 5: ADHD Therapeutics Market, Global, Pipeline, Preclinical, 2014 75
Table 6: ADHD Therapeutics Market, Global, Pipeline, Phase I, 2014 75
Table 7: ADHD Therapeutics Market, Global, Pipeline, Phase II, 2014 76
Table 8: ADHD Therapeutics Market, Global, Pipeline, Phase III, 2014 76
Table 9: ADHD Theapeutics Market, Global, Pipeline, Pre-Registration, 2014 76
Table 10: ADHD Therapeutics Market, Global, Market Forecast, 2013-2020 77
Table 11: ADHD Therapeutics Market, US, Market Forecast, 2013-2020 77
Table 12: ADHD Therapeutics Market, Canada, Market Forecast, 2013-2020 78
Table 13: ADHD Therapeutics Market, UK, Market Forecast, 2013-2020 78
Table 14: ADHD Therapeutics Market, France, Market Forecast, 2013-2020 78
Table 15: ADHD Therapeutics Market, Germany, Market Forecast, 2013-2020 79
Table 16: ADHD Therapeutics Market, Italy, Market Forecast, 2013-2020 79
Table 17: ADHD Therapeutics Market, Spain, Market Forecast, 2013-2020 79
Table 18: ADHD Therapeutics Market, Japan, Market Forecast, 2013-2020 79

List of Figures

Figure 1: ADHD Treatment Algorithm 19
Figure 2: ADHD Therapeutics Market, Marketed Products, Heat Map, 2013 33
Figure 3: ADHD Therapeutics Market, Global, Pipeline (%), 2013 35
Figure 4: ADHD Therapeutics Market, Global, Pipeline Distribution by Mechanism of Action and Program Type, 2013 36
Figure 5: ADHD Therapeutics Market, Global, Pipeline Distribution by Mechanism of Action (Tier 1) and Stage of Development, 2013 37
Figure 6: ADHD Therapeutics Market, Global, Pipeline Distribution by Mechanism of Action (Tier 2) and Stage of Development, 2013 38
Figure 7: ADHD Therapeutics Market, Global, Pipeline, Attrition Rate (%), 2013 40
Figure 8: ADHD Therapeutics Market, Global, Attrition Rate by Mechanism of Action (%), 2013 41
Figure 9: ADHD Therapeutics Market, Global, Pipeline, Clinical Trial Duration (months), 2013 42
Figure 10: ADHD Therapeutics Market, Global, Pipeline, Clinical Trial Duration by Mechanism (months), 2013 43
Figure 11: ADHD Therapeutics Market, Global, Pipeline, Clinical Trial Size, 2013 44
Figure 12: ADHD Therapeutics Market, Global, Pipeline, Clinical Trial Size per Product by Mechanism of Action, 2013 45
Figure 13: ADHD Therapeutics Market, Global, Pipeline, Size by Clinical Trial by Mechanism of Action, 2013 46
Figure 14: ADHD Therapeutics Market, Global, Pipeline, Mechanism of Action Heat Map, 2013 47
Figure 15: ADHD Therapeutics Market, Global, Sales Forecast for Edivoxetine ($m), 2016–2020 49
Figure 16: ADHD Therapeutics Market, Global, Sales Forecast for Metadoxine ER ($m), 2017–2020 51
Figure 17: ADHD Therapeutics Market, Global, Sales Forecast for SPN-812 ($m), 2019–2020 52
Figure 18: ADHD Therapeutics Market, Promising Pipeline Molecules, Heat Map 54
Figure 19: ADHD Therapeutics Market, Marketed Products, Heat Map, 2013 55
Figure 20: ADHD Therapeutics Market, Global, Treatment Patterns (million), 2013–2020 57
Figure 21: ADHD Therapeutics Market, Global, Market Size ($bn), 2013–2020 58
Figure 22: ADHD Therapeutics Market, Global, 2013–2020 59
Figure 23: ADHD Therapeutics Market, North America, Treatment Patterns, 2013–2020 60
Figure 24: ADHD Therapeutics Market, North America, Annual Cost of Treatment ($), 2013–2020 61
Figure 25: ADHD Therapeutics Market, North America, Market Size ($m), 2013–2020 62
Figure 26: ADHD Therapeutics Market, Top Five EU Countries, Treatment Patterns, 2013–2020 63
Figure 27: ADHD Therapeutics Market, Top Five EU Countries, Annual Cost of Treatment ($), 2013–2020 64
Figure 28: ADHD Therapeutics Market, Top Five EU Countries, Market Size ($m), 2013–2020 65
Figure 29: ADHD Therapeutics Market, Japan, 2013–2020 67
Figure 30: ADHD Therapeutics Market, Global, Major Licensing Deals by Year and Value, 2006–2014 70
Figure 31: ADHD Therapeutics Market, Global, Major Licensing Deals, 2006–2014 71
Figure 32: ADHD Therapeutics Market, Global, Major Co-developments Distribution, 2006–2014 72
Figure 33: ADHD Therapeutics Market, Global, Major Co-developments by Year and Phase, 2006–2014 73