- The author estimates that in 2016, there were 175.1 million prevalent cases of attention deficit hyperactivity disorder (ADHD) in people aged 5-44 years worldwide, and forecasts that number to increase to 185.5 million prevalent cases by 2025.
- The worldwide prevalence of ADHD among children aged 5-19 years is estimated to be 5.29%, while the prevalence among adults aged 20-44 years is estimated to be 2.80%.
- A majority of industry-sponsored drugs in active clinical development for ADHD are in Phase II.
- Therapies in mid-to-late stage development for ADHD focus on targets such as dopamine reuptake, norepinephrine (noradrenaline) reuptake/transporter, dopamine 2 receptor, iron, metabotropic glutamate receptor subtypes such as 1, 3, 5, 7, and 8, nicotinic acetylcholine receptor, and serotonin receptors such as 5-HT1, 5-HT3, 5-HT7, and 5-HT2A. Among these therapies, Benjorna (methylphenidate) is closest to market.
- The majority of the pipeline drugs in mid-to-late-stage development for ADHD are administered via the oral route.
- The majority of approved drugs in the ADHD space target dopamine, dopamine reuptake, norepinephrine (noradrenaline), norepinephrine (noradrenaline) reuptake/transporter, and alpha 2 adrenergic receptor. Most of the drugs are commonly administered via the oral route, however, a few products are available in topical and intranasal formulations.
- High-impact upcoming events for drugs in the ADHD space include the US Food and Drug Administration (FDA) decisions on New Drug Applications (NDAs), topline Phase II/III and Phase III trial results, and a patent expiration.
- Licensing and asset acquisition activity involving ADHD drugs has been weak during 2012-17, with only 13 deals occurring over this time period. Impax Pharmaceuticals’ acquisition of certain assets related to generic products from Teva and Allergan, for $586m, was the largest deal during the 2012-17 period.
- Vyvanse’s (lisdexamfetamine dimesylate) sales have ranked highest in the ADHD space during 2012-16 and are forecasted to remain the highest during the forecast period (2017-22).
- The clinical trials distribution across Phase I-IV indicates an even distribution of trials across the phases, with 23% each in Phase I and Phase II, 33% in Phase III, and 21% in Phase IV.
- The US has a substantial lead in the number of ADHD clinical trials globally. Germany leads the major EU markets, while Japan has the top spot in Asia.
- Clinical trial activity in the ADHD space is dominated by completed trials. Shire and Eli Lilly have the highest number of completed clinical trials for ADHD.
2 DISEASE BACKGROUND
- ADHD subtypes
- Non-pharmacological therapy
- Pharmacological therapy
5 PIPELINE DRUGS
6 MARKETED DRUGS
- Approvals by country
8 LICENSING AND ASSET ACQUISITION DEALS
9 PARENT PATENTS
10 REVENUE OPPORTUNITY
11 CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Recent events
- Prescription information
List of Figures
Figure 1: Trends in prevalent cases of ADHD, 2016-25
Figure 2: Pipeline drugs for ADHD in the US
Figure 3: Pipeline drugs for ADHD, by company
Figure 4: Pipeline drugs for ADHD, by drug type
Figure 5: Pipeline drugs for ADHD, by classification
Figure 6: Key upcoming events in ADHD
Figure 7: Licensing and asset acquisition deals in ADHD
Figure 8: Parent patents in ADHD
Figure 9: Clinical trials in ADHD
Figure 10: Top 10 drugs for clinical trials in ADHD
Figure 11: Top 10 companies for clinical trials in ADHD
Figure 12: Trial locations in ADHD
Figure 13: ADHD trials status
Figure 14: ADHD trials sponsors, by phase
List of Tables
Table 1: Prevalent cases of ADHD, 2016-25
Table 2: Pipeline drugs for ADHD in the US
Table 3: Marketed drugs for ADHD
Table 4: Approvals by country for ADHD
Table 5: Historical global sales, by drug ($m), 2012-16
Table 6: Forecasted global sales, by drug ($m), 2017-22