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

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

2 PharmaPoint: Attention Deficit Hyperactivity Disorder (ADHD) - Global Drug Forecast and Market Analysis to 2024 BioPortfolio has been marketing business and market research reports from selected publishers for over fifteen years. BioPortfolio offers a personal service to our customers with dedicated research managers who will work with you to source the best report for your needs. Based in the UK, BioPortfolio is well positioned to coordinate our customers' orders sourced from over 50 global report publishers. We are pleased to present details of this report to assist your buying decision and administrative process. You will find easy-to-use How To Buy information on the last page of this document. We look forward to being of service to you. If you have bulk and/or recurring requirements, please get in touch - we can liaise with publishers to obtain sample pages and negotiate discounts on your behalf. Phone: +44 (0) or reportstore@bioportfolio.com 2

3 PharmaPoint: Attention Deficit Hyperactivity Disorder (ADHD) - Global Drug Forecast and Market Analysis to 2024 PharmaPoint: Attention Deficit Hyperactivity Disorder (ADHD) - Global Drug Forecast and Market Analysis to 2024 Summary 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 % 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. Highlights Key Questions Answered - 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 nonstimulant 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? Key Findings - The main driver of growth in the ADHD market will be the increase in the number of drug-treated patients, driven by an increase in treatment rates expected to 2024, particularly in the adult age group. - Lack of awareness and recognition of ADHD leads to misdiagnosis; this has acted as a barrier to appropriate treatment for ADHD. - The arrival of new therapies across the 7MM will increase treatment rates and provide alternative options for 3

4 many patients, particularly those who have difficulty or who dislike swallowing pills and those who choose nonstimulant therapy. - One of the key unmet needs in the ADHD market of additional treatment options will be somewhat satisfied by the emerging pipeline assets during the forecast. Despite the increasingly competitive nature of the ADHD market, lucrative opportunities remain for products that target unmet needs. In addition, providing clinically relevant, head-to-head comparisons is an important consideration for companies developing drugs to treat these patients. 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 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. Reasons to buy The report will enable you to - - 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 ADHD therapeutics market. - Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global ADHD 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 ADHD therapeutics market from Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships. Additional Details Publisher : Global Data 4

5 Reference : GDHC125PIDR Number of Pages : 369 Report Format : PDF Publisher Information : 5

6 Table Of Contents for PharmaPoint: Attention Deficit Hyperactivity Disorder (ADHD) - Global Drug Forecast and Market Analysis to Table of Contents1 Table of Contents List of Tables List of Figures 242 Introduction Catalyst Related Reports Upcoming Related Reports 273 Disease Overview Etiology and Pathophysiology Etiology Pathophysiology Classification Predominantly Inattentive Type Predominantly Hyperactive-Impulsive Type Combined Type Other Specified ADHD Type Unspecified Type Severity Symptoms Prognosis 364 Epidemiology Disease Background Risk Factors and Comorbidities Global Trends US EU Japan Forecast Methodology Sources Used Tables Forecast assumptions and methods Sources Not Used Epidemiological Forecast for ADHD ( ) Diagnosed Prevalent Cases of ADHD Age-Specific Diagnosed Prevalent Cases of ADHD Sex-Specific Diagnosed Prevalent Cases of ADHD Age-Standardized Prevalence of ADHD Diagnosed Prevalent Cases of ADHD by Subtype Discussion Epidemiological Forecast Insight Limitations of the Analysis Strengths of the Analysis 765 Disease Management Diagnosis and Treatment Overview Diagnosis Treatment Guidelines and Leading Prescribed Drugs Clinical Practice US EU Japan 956 Competitive Assessment Overview Product Profiles - Amphetamine (Stimulant) Dextroamphetamine Desoxyn (methamphetamine) Adderall XR (Mixed amphetamine Salts) Vyvanse (lisdexamphetamine dimesylate) Dyanavel XR (Liquid Amphetamine XR) Adzenys XR-ODT (Amphetamine Extended Release-Orally Disintegrating Tablet) Product Profiles - Methylphenidate (Stimulant) Ritalin LA Concerta Medikinet XL Metadate CD Methylin Focalin Daytrana Quillivant XR/Quillichew Aptensio XR Product Profiles - Nonstimulants Strattera (Atomoxetine Hydrochloride) Intuniv (Guanfacine Hydrochloride) Kapvay (Clonidine) Other Therapeutic Classes 1917 Unmet Need and Opportunity Analysis Overview More Effective, Longer-Lasting, and/or Non-stimulant Treatment Options Unmet Need Gap Analysis Opportunity Clinically Relevant, Head-to-Head Comparisons Unmet Need Gap Analysis Opportunity Improved Diagnostic Tests Unmet Need Gap Analysis Opportunity Education and Recognition of ADHD Unmet Need Gap Analysis Opportunity Discontinuation and Long- Term Safety of Stimulants Unmet Need Gap Analysis Opportunity 2058 Pipeline Assessment Overview Clinical Trial Mapping Clinical Trials by Class Overview of Promising Drugs in Clinical Development Promising Amphetamine Drugs in Clinical Development NT-0201 (Liquid Amphetamine XR) SHP-465 (Triple-Bead Mixed Amphetamine Salts) HLD-100 (Dextroamphetamine MR) Amphetamine Transdermal System (Dextroamphetamine) Promising Methylphenidate Drugs in Clinical Development Cotempla XR-ODT (Extended-Release ODT Methylphenidate) Benjorna (Methylphenidate Hydrochloride MR) Promising Non-stimulant Drugs in Clinical Development SEP (Dasotraline) Centanafadine SR SPN-810 (Molindone Hydrochloride ER) SPN-812 (Viloxazine Hydrochloride) Metadoxine ER Eltoprazine CM Other Drugs in Development 2709 Current and Future Players Overview Trends in Corporate Strategy Company Profiles Shire Novartis Janssen Eli Lilly Pfizer/Tris Pharma Highland Therapeutics Market Outlook Global Markets Forecast Drivers and Barriers - Global Issues US Forecast Key Events Drivers and Barriers EU Forecast Key Events Drivers and Barriers Japan Forecast Key Events Driver and Barriers Appendix Bibliography Abbreviations Methodology Forecasting Methodology Diagnosed ADHD Patients Percent Drug-Treated Patients Launch and Patent Expiry Dates General Pricing Assumptions Individual Drug Assumptions Generic Erosion Pricing of Pipeline Agents Primary Research - KOLs Interviewed for This Report Primary Research - Prescriber Survey About the Authors Analyst Therapy Area Director Epidemiologists Managing Epidemiologists

7 Global Director of Therapy Analysis and Epidemiology About GlobalData Disclaimer 368 7

8 List Of Tables in PharmaPoint: Attention Deficit Hyperactivity Disorder (ADHD) - Global Drug Forecast and Market Analysis to List of Tables Table 1: Classification of ADHD According to the DSM-V and ICD-10-CM 33 Table 2: Symptoms of ADHD 36 Table 3: Prognosis and Risks Associated with ADHD 37 Table 4: Risk Factors and Comorbidities for ADHD 40 Table 5: 7MM, Sources of Epidemiological Data Used to Forecast Diagnosed Prevalent Cases of ADHD 44 Table 6: 7MM, Sources of Epidemiological Data Used to Forecast Diagnosed Prevalent Cases of ADHD by Subtype, Ages 3 17 Years 46 Table 7: 7MM, Sources of Epidemiological Data Used to Forecast Diagnosed Prevalent Cases of ADHD by Subtype, Ages 18 Years 47 Table 8: 7MM, Sources Not Used in Epidemiological Analysis of ADHD 61 Table 9: 7MM, Diagnosed Prevalent Cases of ADHD, Both Sexes, Ages 3 Years, Select Years, Table 10: 7MM, Age-Specific Diagnosed Prevalent Cases of ADHD, Both Sexes, N (Row%), Table 11: 7MM, Sex-Specific Diagnosed Prevalent Cases of ADHD, Ages 3 Years, N (Row %), Table 12: 7MM, Diagnosed Prevalent Cases of ADHD, by Subtype, Ages 3-17 Years, Children and Adolescents, N (Row %), Table 13: 7MM, Diagnosed Prevalent Cases of ADHD, by Subtype, Ages 18 Years, Adults, N (Row %), Table 14: Rating Scales Used for ADHD 79 Table 15: Treatment Guidelines for Disease ADHD 81 Table 16: Most Prescribed Drugs for ADHD by Class in the Global Markets, Table 17: Country Profile - US 88 Table 18: Country Profile - 5EU 93 Table 19: Country Profile - Japan 98 Table 20: Leading Treatments for ADHD, Table 21: Product Profile - Dextroamphetamine 105 Table 22: Dextroamphetamine SWOT Analysis, Table 23: Global Sales Forecasts ($m) for Dextroamphetamine, Table 24: Product Profile - Desoxyn 109 Table 25: Desoxyn SWOT Analysis,

9 Table 26: Global Sales Forecasts ($m) for Desoxyn, Table 27: Product Profile - Adderall XR 113 Table 28: Adderall XR SWOT Analysis, Table 29: Global Sales Forecasts ($m) for Adderall XR, Table 30: Product Profile - Vyvanse 119 Table 31: Vyvanse SWOT Analysis, Table 32: Global Sales Forecasts ($m) for Vyvanse, Table 33: Product Profile - Dyanavel XR 123 Table 34: Dyanavel SWOT Analysis, Table 35: Global Sales Forecasts ($m) for Dyanavel XR, Table 36: Product Profile - Adzenys XR-ODT 128 Table 37: Adzenys XR-ODT SWOT Analysis, Table 38: Global Sales Forecasts ($m) for Adzenys XR-ODT, Table 39: Product Profile - Ritalin LA 134 Table 40: Ritalin LA SWOT Analysis, Table 41: Global Sales Forecasts ($m) for Ritalin LA, Table 42: Product Profile - Concerta 138 Table 43: Concerta SWOT Analysis, Table 44: Global Sales Forecasts ($m) for Concerta, Table 45: Product Profile - Medikinet XL 143 Table 46: Medikinet SWOT Analysis, Table 47: Global Sales Forecasts ($m) for Medikinet XL, Table 48: Product Profile - Metadate CD 148 Table 49: Incidence of TEAEs in a Pool of 3-4 Week Clinical Trials - Metadate CD 149 Table 50: Metadate CD SWOT Analysis, Table 51: Global Sales Forecasts ($m) for Metadate CD, Table 52: Product Profile - Methylin 152 Table 53: Methylin SWOT Analysis, Table 54: Global Sales Forecasts ($m) for Methylin, Table 55: Product Profile - Focalin 155 Table 56: TEAEs - Focalin 157 9

10 Table 57: TEAEs - Focalin XR 157 Table 58: Focalin SWOT Analysis, Table 59: Global Sales Forecasts ($m) for Focalin and Focalin XR, Table 60: Product Profile - Daytrana 160 Table 61: Daytrana SWOT Analysis, Table 62: Global Sales Forecasts ($m) for Daytrana, Table 63: Product Profile - Quillivant XR 164 Table 64: Quillichew Primary Efficacy Result 165 Table 65: Quillivant XR SWOT Analysis, Table 66: Global Sales Forecasts ($m) for Quillivant XR/Quillichew, Table 67: Product Profile - Aptensio XR 168 Table 68: Summary of the Parallel Group Study - Aptensio XR 169 Table 69: Aptensio XR SWOT Analysis, Table 70: Global Sales Forecasts ($m) for Aptensio XR, Table 71: Product Profile - Strattera 174 Table 72: Acute and Maintenance Efficacy Studies - Strattera 176 Table 73: Common TEAEs reported in acute trials in children and adolescents - Strattera 178 Table 74: Common TEAEs reported in acute trials in adults - Strattera 179 Table 75: Strattera SWOT Analysis, Table 76: Global Sales Forecasts ($m) for Strattera, Table 77: Product Profile - Intuniv 183 Table 78: Fixed Dose Studies- Intuniv 184 Table 79: Intuniv SWOT Analysis, Table 80: Global Sales Forecasts ($m) for Intuniv, Table 81: Product Profile - Kapvay 188 Table 82: Kapvay SWOT Analysis, Table 83: Global Sales Forecasts ($m) for Kapvay, Table 84: Unmet Need and Opportunity in ADHD 194 Table 85: Drugs in Development, Table 86: Comparison of Therapeutic Classes in Development for ADHD, Table 87: Product Profile - Liquid Amphetamine XR, NT

11 Table 88: NT-0201 SWOT Analysis, Table 89: Global Sales Forecasts ($m) for NT-0201, Table 90: Product Profile - Triple-Bead Mixed Amphetamine Salts (SHP-465) 216 Table 91: SHP-465 SWOT Analysis, Table 92: Global Sales Forecasts ($m) for SHP-465, Table 93: Product Profile - HLD Table 94: HLD-100 SWOT Analysis, Table 95: Global Sales Forecasts ($m) for HLD-100, Table 96: Product Profile - Dextroamphetamine Transdermal Patch 226 Table 97: Dextroamphetamine Transdermal Patch SWOT Analysis, Table 98: Global Sales Forecasts ($m) for ATS, Table 99: Product Profile - Cotempla XR-ODT 230 Table 100: Cotempla XR-ODT SWOT Analysis, Table 101: Global Sales Forecasts ($m) for Cotempla XR-ODT, Table 102: Product Profile - Benjorna 234 Table 103: Benjorna SWOT Analysis, Table 104: Global Sales Forecasts ($m) for Benjorna, Table 105: Product Profile - Dasotraline 239 Table 106: Dasotraline SWOT Analysis, Table 107: Global Sales Forecasts ($m) for dasotraline, Table 108: Product Profile - Centanafadine SR 244 Table 109: Centanafadine SR SWOT Analysis, Table 110: Global Sales Forecasts ($m) for centanafadine SR, Table 111: Product Profile - SPN Table 112: SPN-810 SWOT Analysis, Table 113: Global Sales Forecasts ($m) for SPN-810, Table 114: Product Profile - Viloxazine 253 Table 115: Viloxazine SWOT Analysis, Table 116: Global Sales Forecasts ($m) for Pipeline Viloxazine, Table 117: Product Profile - Metadoxine ER 258 Table 118: Metadoxine ER SWOT Analysis,

12 Table 119: Global Sales Forecasts ($m) for Metadoxine ER, Table 120: Product Profile - Eltoprazine 263 Table 121: Eltoprazine SWOT Analysis, Table 122: Global Sales Forecasts ($m) for Eltoprazine, Table 123: Product Profile - CM Table 124: CM-4612 SWOT Analysis, Table 125: Global Sales Forecasts ($m) for CM-4612, Table 126: Drugs in Development, Table 127: Key Companies in the ADHD Market in the 7MM, Table 128: Shire s ADHD Portfolio Assessment, Table 129: Novartis ADHD Portfolio Assessment, Table 130: Janssen s ADHD Portfolio Assessment, Table 131: Eli Lilly s ADHD Portfolio Assessment, Table 132: Pfizer/Tris Pharma s ADHD Portfolio Assessment, Table 133: Highland Therapeutics ADHD Portfolio Assessment, Table 134: Global Sales Forecasts ($m) for ADHD, Table 135: ADHD Market - Global Drivers and Barriers, Table 136: Sales Forecasts ($m) for ADHD in the US, Table 137: Key Events Impacting Sales for ADHD in the US, Table 138: ADHD Market - Drivers and Barriers in the US, Table 139: Sales Forecasts ($m) for ADHD in the 5EU, Table 140: Key Events Impacting Sales for ADHD in the 5EU, Table 141: ADHD Market - Drivers and Barriers in the 5EU, Table 142: Sales Forecasts ($m) for ADHD in Japan, Table 143: Key Events Impacting Sales for ADHD in Japan, Table 144: ADHD Market - Drivers and Barriers in Japan, Table 145: Key ADHD Launch Dates 350 Table 146: Key ADHD Patent Expiries 350 Table 147: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country,

13 List Of Figures, Charts and Diagrams in PharmaPoint: Attention Deficit Hyperactivity Disorder (ADHD) - Global Drug Forecast and Market Analysis to List of Figures Figure 1: 7MM, Diagnosed Prevalent Cases of ADHD, Both Sexes, Ages 3 Years, Selected Years, Figure 2: 7MM, Age-Specific Diagnosed Prevalent Cases of ADHD, Both Sexes, Figure 3: 7MM, Sex-Specific Diagnosed Prevalent Cases of ADHD, Ages 3 Years, Figure 4: 7MM, Age-Standardized Diagnosed Prevalence of ADHD, Ages 3 Years, Figure 5: 7MM, Diagnosed Prevalent Cases of ADHD, by Subtype, Ages 3-17 Years, Children and Adolescents, N, Figure 6: 7MM, Diagnosed Prevalent Cases of ADHD, by Subtype, Ages 18 Years, Adults, N, Figure 7: Treatment Algorithm for ADHD in the 7MM 80 Figure 8: ADHD Therapeutics - Class of Therapy, Figure 9: ADHD - Phase II-III Pipeline, Figure 10: Competitive Assessment of Late-Stage Pipeline Agents in ADHD, Figure 11: Clinical and Commercial Positioning of NT Figure 12: Clinical and Commercial Positioning of SHP Figure 13: Clinical and Commercial Positioning of HLD Figure 14: Clinical and Commercial Positioning of ATS 227 Figure 15: Clinical and Commercial Positioning of Cotempla XR-ODT 231 Figure 16: Clinical and Commercial Positioning of Benjorna 236 Figure 17: Clinical and Commercial Positioning of Dasotraline 241 Figure 18: Clinical and Commercial Positioning of Centanafadine SR 245 Figure 19: Clinical and Commercial Positioning of SPN Figure 20: Clinical and Commercial Positioning of Viloxazine 254 Figure 21: Clinical and Commercial Positioning of Metadoxine ER 260 Figure 22: Clinical and Commercial Positioning of Eltoprazine 264 Figure 23: Clinical and Commercial Positioning of CM Figure 24: Global Sales of Branded Products for ADHD by Company, Figure 25: Company Portfolio Gap Analysis in ADHD, Figure 26: Shire SWOT Analysis in ADHD,

14 Figure 27: Novartis SWOT Analysis in ADHD, Figure 28: Janssen SWOT in ADHD, Figure 29: Eli Lilly SWOT Analysis in ADHD, Figure 30: Pfizer/Tris Pharma SWOT Analysis in ADHD, Figure 31: Highland Therapeutics SWOT Analysis in ADHD, Figure 32: Global Sales for ADHD by Country, 2014 and Figure 33: Global Sales for ADHD by Drug Class, 2014 and Figure 34: Sales for ADHD by Drug Class in the US, 2014 and Figure 35: Sales for ADHD by Drug Class in the 5EU, 2014 and Figure 36: Sales for ADHD by Drug Class in Japan, 2014 and

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