The attention deficit hyperactivity disorder (ADHD) market across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) is poised to decline at a negative compound annual growth rate (CAGR) of 0.9% from $11.9bn in 2022 to $10.9bn in 2032, according to GlobalData’s recently published report, Attention Deficit Hyperactivity Disorder (ADHD): Opportunity Assessment and Forecast. This decline will be driven by patent expiries, anticipated generic launches in five of the 7MM (the US, Germany, Spain, the UK, and Japan), and limited innovator entrants.

Due to having the largest number of available products, higher drug prices, and the largest ADHD population, the US market accounted for approximately 90% of the ADHD market in the 7MM in 2022, at $10.7bn. This is expected to rise to 91% by 2032. Among the 29 ADHD branded products forecast within GlobalData’s report, ten are anticipated to lose their patent protection during 2022–2032. These ten products accounted for $3.5bn in US sales in 2022. An additional two patent expiries are due to occur in Japan for Takeda’s Vyvanse (lisdexamfetamine dimesylate) and Intuniv (guanfacine hydrochloride). In Germany, Spain, and the UK, only Vyvanse’s patent is due to expire during 2022–2032. France and Italy do not have any anticipated patent expiries of ADHD products during the forecast period.

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Vyvanse has the largest overall market size of all branded ADHD products, having achieved approximately $2.5bn in sales in the five major markets where it was available in 2022 (the US, Japan, Germany, Spain, and the UK). Its US patent expired in 2023, and generic lisdexamfetamine dimesylate products launched shortly after. However, they did not see the level of uptake typical of new generic launches in the US market, where payers encourage the prescription of generic products over branded products where possible. This is due to shortages affecting the ADHD market, especially the supply of active pharmaceutical ingredients (APIs) required for the manufacturing of generic products. GlobalData believes the API shortages are likely to be resolved by 2027, with generic uptake levels returning to normal by then. This will result in significant sales erosions of branded products.

Four late-stage (Phase IIb/III) pipeline agents targeting core ADHD symptoms are expected to launch in the US market within the forecast period: Cingulate’s CTx-1301, Axsome Therapeutic’s solriamfetol hydrochloride, Otsuka’s centanafadine SR, and Neurocentria’s NRCT-101SR. These are all anticipated to launch in 2026 and will drive moderate market growth, together amounting to approximately $395m in sales by 2032. CTx-1301 is expected to steal patient share from long-acting methylphenidate products while the three other pipeline agents are expected to compete against the marketed non-stimulants. However, all four pipeline agents are only forecast to launch in the US market during the forecast period, although centanafadine SR is in a Phase I trial in Japan. Additionally, US key opinion leaders (KOLs) interviewed by GlobalData noted a hesitancy to use new products due to the perception that they typically do not provide any added benefits to what is currently available on the market. This could be considered true for the pipeline agents that are due to launch during the forecast period as they are not looking to show improvements in efficacy above the currently marketed products, but rather a differentiation in terms of increased duration of action and reduction of side effects. Since innovator agents are often priced at a premium upon entry into the market, KOLs have expressed a fear of the sharp rise of prices after the initial promotion incentives are withdrawn. This makes inexpensive generic products a more attractive option and will likely limit the uptake of novel entrants.

The most significant market driver is the fact that the growing awareness of adult ADHD is expected to raise the number of total treated cases across the 7MM from approximately 10.7 million cases in 2022, to 11.1 million cases by 2032. Some KOLs expected to see an increase in the use of ADHD products such as methylphenidate products specifically not because of any changes in the management algorithm but rather because the diagnosis of adult ADHD is increasing.

Despite a forecast overall increase in the patient population and the launch of four pipeline products in the US, the barriers to market growth are expected to overwhelm the drivers, leading to an overall decline in ADHD market value. The principal among these barriers is patent expiries and the launch and likely high uptake of generics, particularly lisdexamfetamine dimesylate generics.

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