Overview

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

Key Takeaways

• Datamonitor Healthcare estimates that in 2021, there were 452.5 million prevalent cases of attention deficit hyperactivity disorder (ADHD) in people aged five years and older worldwide, and forecasts that number to increase to 490.4 million prevalent cases by 2030.
• Approved drugs in the ADHD space target dopamine, dopamine reuptake, norepinephrine (noradrenaline), norepinephrine (noradrenaline) reuptake/transporter, nicotinic acetylcholine receptors, serotonin 5-HT1 receptor, serotonin 5-HT7 receptor, and the alpha 2 adrenergic receptor. The vast majority of approved therapies are administered via the oral route.
• The highest proportion of industry-sponsored drugs in active clinical development for ADHD are in Phase II, with two drugs in the NDA/BLA stage.
• Therapies in development for ADHD focus on a wide variety of targets. The majority of pipeline drugs for ADHD are administered via the oral route, with one drug being tested in a transdermal formulation.
• High-impact upcoming events for drugs in the ADHD space comprise topline Phase IIa trial results for MM-120, topline Phase III trial results for centanafadine, estimated PDUFA dates for AR19, d-ATS, and Qelbree, and an expected patent expiration for Adzenys XR-ODT.
• The overall likelihood of approval of a Phase I ADHD asset is 11.7%, and the average probability a drug advances from Phase III is 72.7%. Drugs, on average, take 9.5 years from Phase I to approval, compared to 9.6 years in the overall psychiatry space.
• The distribution of clinical trials across Phase I–IV indicates that the majority of trials for ADHD have been in the late phases of development, with 53% of trials in Phase III–IV, and 47% in Phase I–II.
• The US has a substantial lead in the number of ADHD clinical trials globally. Germany leads the major European markets, while Japan has the top spot in Asia.
• Clinical trial activity in the ADHD space is dominated by completed trials. Takeda has the highest number of completed clinical trials for ADHD, with 160 trials.
• Takeda leads industry sponsors with the highest overall number of clinical trials for ADHD, followed by Eli Lilly