PharmaPoint: Attention Deficit Hyperactivity Disorder (ADHD) – Global Drug Forecast and Market Analysis to 2024

Attention deficit hyperactivity disorder (ADHD) is characterized by excessive levels of inattention, impulsivity, and hyperactivity, either alone or in combination that have a significant social impact through disruptions at school, work, home, and in relationships. The majority of children with the disorder will continue to experience symptoms into adolescence. 30-50% of children diagnosed with ADHD continue to have problems into adulthood resulting in 2-5% of adults having ADHD.

Growth is expected in the global ADHD marketplace, despite the market being widely genericized. This will be driven largely by the anticipated launch of assets from the heavily populated ADHD pipeline, as these products offer clinical advantages that will drive strong uptake. Furthermore, the number of drug-treated patients will increase over the forecast period, driven by increased treatment rates throughout the 7MM, particularly in the adult age group.

Scope

Overview of ADHD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

Annualized ADHD market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024.

Key topics covered include market characterization, unmet needs, R&D and clinical trials assessment, late stage clinical trial analysis and implications for the ADHD therapeutics market.

Pipeline analysis: focus on 13 late-stage pipeline ADHD drugs discussing emerging trends as well as an overview of earlier phase drugs.

Analysis of the current and future market competition in the global ADHD therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Highlights

The ADHD market has been dominated by stimulant therapy, with only three approved non-stimulant drugs approved that cannot compete with stimulant drugs in terms of efficacy. Due to lack of evidence for long-term safe use of stimulants, non-stimulants are becoming increasingly popular in the 7MM. Both stimulant and non-stimulant therapies are anticipated to reach the market within the forecast period. How will these change the market overall during the forecast period? Will stimulants maintain market dominance in 2024?

The current late stage ADHD pipeline is heavily populated, drugs designed to satisfy what GlobalData has identified as unmet needs. Which of these will have the biggest impact on the market? What strategies are developers undertaking to penetrate this crowded market?

ADHD is becoming increasingly recognized, particularly n the adult population, leading to increase number in treated patients across the 7MM. How will these changes impact the growth of the future market?

Companies mentioned

Alcobra

Amarantus

Curemark

Eli Lilly*

Highland Therapeutics*

Janssen*

Mallinckrodt

Medice

Neos Therapeutics

Neurovance

Nextwave Pharmaceuticals

Novartis*

Noven Pharmaceuticals

Pfizer+

Recordati

Rhodes Pharmaceuticals

Shionogi

Shire*

Sunovion ...

Alcobra

Amarantus

Curemark

Eli Lilly*

Highland Therapeutics*

Janssen*

Mallinckrodt

Medice

Neos Therapeutics

Neurovance

Nextwave Pharmaceuticals

Novartis*

Noven Pharmaceuticals

Pfizer+

Recordati

Rhodes Pharmaceuticals

Shionogi

Shire*

Sunovion Pharmaceuticals

Supernus Pharmaceuticals

Tris Pharma+

UCB

  • Have received company profile

+Have received joint profile

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

2.3Upcoming Related Reports

3Disease Overview

3.1Etiology ...

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

2.3Upcoming Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.2Classification

3.2.1Predominantly Inattentive Type

3.2.2Predominantly Hyperactive-Impulsive Type

3.2.3Combined Type

3.2.4Other Specified ADHD Type

3.2.5Unspecified Type

3.2.6Severity

3.3Symptoms

3.4Prognosis

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.3Global Trends

4.3.1US

4.3.25EU

4.3.3Japan

4.4Forecast Methodology

4.4.1Sources Used Tables

4.4.2Forecast assumptions and methods

4.4.3Sources Not Used

4.5Epidemiological Forecast for ADHD (2014–2024)

4.5.1Diagnosed Prevalent Cases of ADHD

4.5.2Age-Specific Diagnosed Prevalent Cases of ADHD

4.5.3Sex-Specific Diagnosed Prevalent Cases of ADHD

4.5.4Age-Standardized Prevalence of ADHD

4.5.5Diagnosed Prevalent Cases of ADHD by Subtype

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

5Disease Management

5.1Diagnosis and Treatment Overview

5.1.1Diagnosis

5.1.2Treatment Guidelines and Leading Prescribed Drugs

5.1.3Clinical Practice

5.2US

5.35EU

5.4Japan

6Competitive Assessment

6.1Overview

6.2Product Profiles – Amphetamine (Stimulant)

6.2.1Dextroamphetamine

6.2.2Desoxyn (methamphetamine)

6.2.3Adderall XR (Mixed amphetamine Salts)

6.2.4Vyvanse (lisdexamphetamine dimesylate)

6.2.5Dyanavel XR (Liquid Amphetamine XR)

6.2.6Adzenys XR-ODT (Amphetamine Extended Release-Orally Disintegrating Tablet)

6.3Product Profiles – Methylphenidate (Stimulant)

6.3.1Ritalin LA

6.3.2Concerta

6.3.3Medikinet XL

6.3.4Metadate CD

6.3.5Methylin

6.3.6Focalin

6.3.7Daytrana

6.3.8Quillivant XR/Quillichew

6.3.9Aptensio XR

6.4Product Profiles – Non-stimulants

6.4.1Strattera (Atomoxetine Hydrochloride)

6.4.2Intuniv (Guanfacine Hydrochloride)

6.4.3Kapvay (Clonidine)

6.4.4Other Therapeutic Classes

7Unmet Need and Opportunity Analysis

7.1Overview

7.2More Effective, Longer-Lasting, and/or Non-stimulant Treatment Options

7.2.1Unmet Need

7.2.2Gap Analysis

7.2.3Opportunity

7.3Clinically Relevant, Head-to-Head Comparisons

7.3.1Unmet Need

7.3.2Gap Analysis

7.3.3Opportunity

7.4Improved Diagnostic Tests

7.4.1Unmet Need

7.4.2Gap Analysis

7.4.3Opportunity

7.5Education and Recognition of ADHD

7.5.1Unmet Need

7.5.2Gap Analysis

7.5.3Opportunity

7.6Discontinuation and Long-Term Safety of Stimulants

7.6.1Unmet Need

7.6.2Gap Analysis

7.6.3Opportunity

8Pipeline Assessment

8.1Overview

8.2Clinical Trial Mapping

8.2.1Clinical Trials by Class

8.3Overview of Promising Drugs in Clinical Development

8.4Promising Amphetamine Drugs in Clinical Development

8.4.1NT-0201 (Liquid Amphetamine XR)

8.4.2SHP-465 (Triple-Bead Mixed Amphetamine Salts)

8.4.3HLD-100 (Dextroamphetamine MR)

8.4.4Amphetamine Transdermal System (Dextroamphetamine)

8.5Promising Methylphenidate Drugs in Clinical Development

8.5.1Cotempla XR-ODT (Extended-Release ODT Methylphenidate)

8.5.2Benjorna (Methylphenidate Hydrochloride MR)

8.6Promising Non-stimulant Drugs in Clinical Development

8.6.1SEP-225289 (Dasotraline)

8.6.2Centanafadine SR

8.6.3SPN-810 (Molindone Hydrochloride ER)

8.6.4SPN-812 (Viloxazine Hydrochloride)

8.6.5Metadoxine ER

8.6.6Eltoprazine

8.6.7CM-4612

8.7Other Drugs in Development

9Current and Future Players

9.1Overview

9.2Trends in Corporate Strategy

9.3Company Profiles

9.3.1Shire

9.3.2Novartis

9.3.3Janssen

9.3.4Eli Lilly

9.3.5Pfizer/Tris Pharma

9.3.6Highland Therapeutics

10Market Outlook

10.1Global Markets

10.1.1Forecast

10.1.2Drivers and Barriers – Global Issues

10.2US

10.2.1Forecast

10.2.2Key Events

10.2.3Drivers and Barriers

10.35EU

10.3.1Forecast

10.3.2Key Events

10.3.3Drivers and Barriers

10.4Japan

10.4.1Forecast

10.4.2Key Events

10.4.3Driver and Barriers

11Appendix

11.1Bibliography

11.2Abbreviations

11.3Methodology

11.4Forecasting Methodology

11.4.1Diagnosed ADHD Patients

11.4.2Percent Drug-Treated Patients

11.4.3Launch and Patent Expiry Dates

11.4.4General Pricing Assumptions

11.4.5Individual Drug Assumptions

11.4.6Generic Erosion

11.4.7Pricing of Pipeline Agents

11.5Primary Research – KOLs Interviewed for This Report

11.6Primary Research – Prescriber Survey

11.7About the Authors

11.7.1Analyst

11.7.2Therapy Area Director

11.7.3Epidemiologists

11.7.4Managing Epidemiologists

11.7.5Global Director of Therapy Analysis and Epidemiology

11.8About GlobalData

11.9Contact Us

11.10Disclaimer

List of Tables

Table 1: Classification of ADHD According to the DSM-V and ICD-10-CM

Table 2: Symptoms of ADHD

Table 3: Prognosis and Risks Associated with ADHD

Table ...

Table 1: Classification of ADHD According to the DSM-V and ICD-10-CM

Table 2: Symptoms of ADHD

Table 3: Prognosis and Risks Associated with ADHD

Table 4: Risk Factors and Comorbidities for ADHD

Table 5: 7MM, Sources of Epidemiological Data Used to Forecast Diagnosed Prevalent Cases of ADHD

Table 6: 7MM, Sources of Epidemiological Data Used to Forecast Diagnosed Prevalent Cases of ADHD by Subtype, Ages 3?17 Years

Table 7: 7MM, Sources of Epidemiological Data Used to Forecast Diagnosed Prevalent Cases of ADHD by Subtype, Ages =18 Years

Table 8: 7MM, Sources Not Used in Epidemiological Analysis of ADHD

Table 9: 7MM, Diagnosed Prevalent Cases of ADHD, Both Sexes, Ages =3 Years, Select Years, 2014–2024

Table 10: 7MM, Age-Specific Diagnosed Prevalent Cases of ADHD, Both Sexes, N (Row%), 2014

Table 11: 7MM, Sex-Specific Diagnosed Prevalent Cases of ADHD, Ages =3 Years, N (Row %), 2014

Table 12: 7MM, Diagnosed Prevalent Cases of ADHD, by Subtype, Ages 3–17 Years, Children and Adolescents, N (Row %), 2014

Table 13: 7MM, Diagnosed Prevalent Cases of ADHD, by Subtype, Ages =18 Years, Adults, N (Row %), 2014

Table 14: Rating Scales Used for ADHD

Table 15: Treatment Guidelines for Disease ADHD

Table 16: Most Prescribed Drugs for ADHD by Class in the Global Markets, 2014

Table 17: Country Profile – US

Table 18: Country Profile – 5EU

Table 19: Country Profile – Japan

Table 20: Leading Treatments for ADHD, 2015

Table 21: Product Profile — Dextroamphetamine

Table 22: Dextroamphetamine SWOT Analysis, 2015

Table 23: Global Sales Forecasts ($m) for Dextroamphetamine, 2014–2024

Table 24: Product Profile – Desoxyn

Table 25: Desoxyn SWOT Analysis, 2015

Table 26: Global Sales Forecasts ($m) for Desoxyn, 2014–2024

Table 27: Product Profile – Adderall XR

Table 28: Adderall XR SWOT Analysis, 2015

Table 29: Global Sales Forecasts ($m) for Adderall XR, 2014–2024

Table 30: Product Profile – Vyvanse

Table 31: Vyvanse SWOT Analysis, 2015

Table 32: Global Sales Forecasts ($m) for Vyvanse, 2014–2024

Table 33: Product Profile – Dyanavel XR

Table 34: Dyanavel SWOT Analysis, 2015

Table 35: Global Sales Forecasts ($m) for Dyanavel XR, 2014–2024

Table 36: Product Profile – Adzenys XR-ODT

Table 37: Adzenys XR-ODT SWOT Analysis, 2015

Table 38: Global Sales Forecasts ($m) for Adzenys XR-ODT, 2014–2024

Table 39: Product Profile – Ritalin LA

Table 40: Ritalin LA SWOT Analysis, 2015

Table 41: Global Sales Forecasts ($m) for Ritalin LA, 2014–2024

Table 42: Product Profile – Concerta

Table 43: Concerta SWOT Analysis, 2015

Table 44: Global Sales Forecasts ($m) for Concerta, 2014–2024

Table 45: Product Profile – Medikinet XL

Table 46: Medikinet SWOT Analysis, 2015

Table 47: Global Sales Forecasts ($m) for Medikinet XL, 2014–2024

Table 48: Product Profile – Metadate CD

Table 49: Incidence of TEAEs in a Pool of 3–4 Week Clinical Trials – Metadate CD

Table 50: Metadate CD SWOT Analysis, 2015

Table 51: Global Sales Forecasts ($m) for Metadate CD, 2014–2024

Table 52: Product Profile – Methylin

Table 53: Methylin SWOT Analysis, 2015

Table 54: Global Sales Forecasts ($m) for Methylin, 2014–2024

Table 55: Product Profile – Focalin

Table 56: TEAEs – Focalin

Table 57: TEAEs – Focalin XR

Table 58: Focalin SWOT Analysis, 2015

Table 59: Global Sales Forecasts ($m) for Focalin and Focalin XR, 2014–2024

Table 60: Product Profile – Daytrana

Table 61: Daytrana SWOT Analysis, 2015

Table 62: Global Sales Forecasts ($m) for Daytrana, 2014–2024

Table 63: Product Profile – Quillivant XR

Table 64: Quillichew Primary Efficacy Result

Table 65: Quillivant XR SWOT Analysis, 2015

Table 66: Global Sales Forecasts ($m) for Quillivant XR/Quillichew, 2014–2024

Table 67: Product Profile – Aptensio XR

Table 68: Summary of the Parallel Group Study – Aptensio XR

Table 69: Aptensio XR SWOT Analysis, 2015

Table 70: Global Sales Forecasts ($m) for Aptensio XR, 2014–2024

Table 71: Product Profile – Strattera

Table 72: Acute and Maintenance Efficacy Studies – Strattera

Table 73: Common TEAEs reported in acute trials in children and adolescents – Strattera

Table 74: Common TEAEs reported in acute trials in adults – Strattera

Table 75: Strattera SWOT Analysis, 2015

Table 76: Global Sales Forecasts ($m) for Strattera, 2014–2024

Table 77: Product Profile – Intuniv

Table 78: Fixed Dose Studies– Intuniv

Table 79: Intuniv SWOT Analysis, 2015

Table 80: Global Sales Forecasts ($m) for Intuniv, 2014–2024

Table 81: Product Profile – Kapvay

Table 82: Kapvay SWOT Analysis, 2015

Table 83: Global Sales Forecasts ($m) for Kapvay, 2014–2024

Table 84: Unmet Need and Opportunity in ADHD

Table 85: Drugs in Development, 2016

Table 86: Comparison of Therapeutic Classes in Development for ADHD, 2014–2024

Table 87: Product Profile – Liquid Amphetamine XR, NT-0201

Table 88: NT-0201 SWOT Analysis, 2015

Table 89: Global Sales Forecasts ($m) for NT-0201, 2014–2024

Table 90: Product Profile – Triple-Bead Mixed Amphetamine Salts (SHP-465)

Table 91: SHP-465 SWOT Analysis, 2015

Table 92: Global Sales Forecasts ($m) for SHP-465, 2014–2024

Table 93: Product Profile – HLD-100

Table 94: HLD-100 SWOT Analysis, 2015

Table 95: Global Sales Forecasts ($m) for HLD-100, 2014–2024

Table 96: Product Profile – Dextroamphetamine Transdermal Patch

Table 97: Dextroamphetamine Transdermal Patch SWOT Analysis, 2015

Table 98: Global Sales Forecasts ($m) for ATS, 2014–2024

Table 99: Product Profile – Cotempla XR-ODT

Table 100: Cotempla XR-ODT SWOT Analysis, 2015

Table 101: Global Sales Forecasts ($m) for Cotempla XR-ODT, 2014–2024

Table 102: Product Profile – Benjorna

Table 103: Benjorna SWOT Analysis, 2015

Table 104: Global Sales Forecasts ($m) for Benjorna, 2014–2024

Table 105: Product Profile – Dasotraline

Table 106: Dasotraline SWOT Analysis, 2015

Table 107: Global Sales Forecasts ($m) for dasotraline, 2014–2024

Table 108: Product Profile – Centanafadine SR

Table 109: Centanafadine SR SWOT Analysis, 2015

Table 110: Global Sales Forecasts ($m) for centanafadine SR, 2014–2024

Table 111: Product Profile – SPN-810

Table 112: SPN-810 SWOT Analysis, 2015

Table 113: Global Sales Forecasts ($m) for SPN-810, 2014–2024

Table 114: Product Profile – Viloxazine

Table 115: Viloxazine SWOT Analysis, 2015

Table 116: Global Sales Forecasts ($m) for Pipeline Viloxazine, 2014–2024

Table 117: Product Profile – Metadoxine ER

Table 118: Metadoxine ER SWOT Analysis, 2015

Table 119: Global Sales Forecasts ($m) for Metadoxine ER, 2014–2024

Table 120: Product Profile – Eltoprazine

Table 121: Eltoprazine SWOT Analysis, 2015

Table 122: Global Sales Forecasts ($m) for Eltoprazine, 2014–2024

Table 123: Product Profile – CM-4612

Table 124: CM-4612 SWOT Analysis, 2015

Table 125: Global Sales Forecasts ($m) for CM-4612, 2014–2024

Table 126: Drugs in Development, 2016

Table 127: Key Companies in the ADHD Market in the 7MM, 2014

Table 128: Shire’s ADHD Portfolio Assessment, 2015

Table 129: Novartis’ ADHD Portfolio Assessment, 2015

Table 130: Janssen’s ADHD Portfolio Assessment, 2015

Table 131: Eli Lilly’s ADHD Portfolio Assessment, 2015

Table 132: Pfizer/Tris Pharma’s ADHD Portfolio Assessment, 2015

Table 133: Highland Therapeutics’ ADHD Portfolio Assessment, 2016

Table 134: Global Sales Forecasts ($m) for ADHD, 2014–2024

Table 135: ADHD Market – Global Drivers and Barriers, 2014?2024

Table 136: Sales Forecasts ($m) for ADHD in the US, 2014–2024

Table 137: Key Events Impacting Sales for ADHD in the US, 2014–2024

Table 138: ADHD Market – Drivers and Barriers in the US, 2014?2024

Table 139: Sales Forecasts ($m) for ADHD in the 5EU, 2014–2024

Table 140: Key Events Impacting Sales for ADHD in the 5EU, 2014–2024

Table 141: ADHD Market – Drivers and Barriers in the 5EU, 2014?2024

Table 142: Sales Forecasts ($m) for ADHD in Japan, 2014–2024

Table 143: Key Events Impacting Sales for ADHD in Japan, 2014–2024

Table 144: ADHD Market – Drivers and Barriers in Japan, 2014?2024

Table 145: Key ADHD Launch Dates

Table 146: Key ADHD Patent Expiries

Table 147: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country, 2016

List of Figures

Figure 1: 7MM, Diagnosed Prevalent Cases of ADHD, Both Sexes, Ages =3 Years, Selected Years, 2014–2024

Figure 2: 7MM, Age-Specific Diagnosed Prevalent Cases of ...

Figure 1: 7MM, Diagnosed Prevalent Cases of ADHD, Both Sexes, Ages =3 Years, Selected Years, 2014–2024

Figure 2: 7MM, Age-Specific Diagnosed Prevalent Cases of ADHD, Both Sexes, 2014

Figure 3: 7MM, Sex-Specific Diagnosed Prevalent Cases of ADHD, Ages =3 Years, 2014

Figure 4: 7MM, Age-Standardized Diagnosed Prevalence of ADHD, Ages =3 Years, 2014

Figure 5: 7MM, Diagnosed Prevalent Cases of ADHD, by Subtype, Ages 3–17 Years, Children and Adolescents, N, 2014

Figure 6: 7MM, Diagnosed Prevalent Cases of ADHD, by Subtype, Ages =18 Years, Adults, N, 2014

Figure 7: Treatment Algorithm for ADHD in the 7MM

Figure 8: ADHD Therapeutics – Class of Therapy, 2016

Figure 9: ADHD – Phase II–III Pipeline, 2016

Figure 10: Competitive Assessment of Late-Stage Pipeline Agents in ADHD, 2014–2024

Figure 11: Clinical and Commercial Positioning of NT-0201

Figure 12: Clinical and Commercial Positioning of SHP-465

Figure 13: Clinical and Commercial Positioning of HLD-100

Figure 14: Clinical and Commercial Positioning of ATS

Figure 15: Clinical and Commercial Positioning of Cotempla XR-ODT

Figure 16: Clinical and Commercial Positioning of Benjorna

Figure 17: Clinical and Commercial Positioning of Dasotraline

Figure 18: Clinical and Commercial Positioning of Centanafadine SR

Figure 19: Clinical and Commercial Positioning of SPN-810

Figure 20: Clinical and Commercial Positioning of Viloxazine

Figure 21: Clinical and Commercial Positioning of Metadoxine ER

Figure 22: Clinical and Commercial Positioning of Eltoprazine

Figure 23: Clinical and Commercial Positioning of CM-4612

Figure 24: Global Sales of Branded Products for ADHD by Company, 2014–2024

Figure 25: Company Portfolio Gap Analysis in ADHD, 2014–2024

Figure 26: Shire SWOT Analysis in ADHD, 2014–2024

Figure 27: Novartis SWOT Analysis in ADHD, 2014–2024

Figure 28: Janssen SWOT in ADHD, 2014–2024

Figure 29: Eli Lilly SWOT Analysis in ADHD, 2014–2024

Figure 30: Pfizer/Tris Pharma SWOT Analysis in ADHD, 2014–2024

Figure 31: Highland Therapeutics SWOT Analysis in ADHD, 2014–2024

Figure 32: Global Sales for ADHD by Country, 2014 and 2024

Figure 33: Global Sales for ADHD by Drug Class, 2014 and 2024

Figure 34: Sales for ADHD by Drug Class in the US, 2014 and 2024

Figure 35: Sales for ADHD by Drug Class in the 5EU, 2014 and 2024

Figure 36: Sales for ADHD by Drug Class in Japan, 2014 and 2024

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