Market Spotlight: Attention Deficit Hyperactivity Disorder (ADHD)​

This Market Spotlight report covers the Attention Deficit Hyperactivity Disorder (ADHD) market, comprising key pipeline and marketed drugs, clinical trials, upcoming and regulatory events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Takeaways

• Datamonitor Healthcare 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%.
• The majority of approved drugs in the ADHD space target dopamine, dopamine reuptake, norepinephrine (noradrenaline), norepinephrine (noradrenaline) reuptake/transporter, and alpha 2 adrenergic receptor. The majority of approved therapies are administered via the oral route, however, a few products are available in topical and intranasal formulations.
• The majority of industry-sponsored drugs in active clinical development for ADHD are in Phase II, with only two drugs in NDA/BLA phase.
• Therapies in mid-to-late stage development for ADHD focus on a wide variety of targets. All the pipeline drugs in mid-to-latestage development for ADHD are administered via the oral route, except for d-ATS and ND0801, which are transdermal formulations.
• High-impact upcoming events for drugs in the ADHD space include topline Phase II and Phase III trial results, pivotal efficacy study results, expected patent expirations, as well as the FDA’s decision on NDAs.
• There were 14 licensing and asset acquisition deal agreements during 2013–18. Impax Laboratories’ acquisition of certain assets related to generic products from Teva and Allergan, for $586m, was the largest deal during the period.
• The US parent patents of Concerta (composition) and Metadate CD (formulation) are set to expire in 2018 and 2020, respectively, opening the door to generic entry within the next five years.
• Vyvanse’s (lisdexamfetamine dimesylate) sales have ranked highest in the ADHD space during 2012–17, and are forecast to remain the highest during the forecast period (2018–22).
• The clinical trials distribution across Phase I–IV indicates that the majority of trials for ADHD have been in late phases of development, with 46% of trials in Phase I–II, and 54% in Phase III–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 has the highest number of completed clinical trials for ADHD, with 145 trials.
• Shire leads the industry sponsors with by far the highest number of clinical trials for ADHD, followed by Eli Lilly and Johnson & Johnson