The major depressive disorder (MDD) market across the eight major markets (8MM: US, France, Germany, Italy, Spain, UK, Japan, and Canada) is poised to grow at a compound annual growth rate (CAGR) of 7.4% from $4.7bn in 2019 to $9.6bn in 2029, according to GlobalData’s recently published report, Major Depressive Disorder: Eight-Market Drug Forecast and Market Analysis – Update.

This growth will be driven by an increase in the patient share of several recently approved drugs, including Johnson & Johnson’s Spravato and Axsome Therapeutics’ Auvelity, as well as the anticipated introduction of eight late-stage pipeline products.

GlobalData, a leading data and analytics company, has identified that some of the key unmet needs in the MDD market are for products that have improved efficacy and safety profiles, and which can show rapid antidepressant effects when compared with available treatments.

Spravato was first approved in the US in 2019 for treatment-resistant depression, and then for patients with moderate-to-severe MDD and acute suicidal behaviour/ideation in 2020.

Although it was the first antidepressant with a fast onset of action to enter the MDD market, acting within hours in some patients, this competitive edge is offset by its high cost of therapy, limited patient population, and requirement for two hours of patient observation after administration.

Meanwhile, Axsome Therapeutics’ Auvelity was the first oral fast-acting antidepressant to enter the MDD market when it was approved by the US Food and Drug Administration in 2022.

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By GlobalData

With sustained improvements in depressive symptoms seen starting from one week of treatment, GlobalData expects Auvelity to have a strong uptake in the US market where it is forecast to be the top-selling drug in MDD, with sales of approximately $1.53bn forecast in 2029.

The MDD market is a crowded and competitive market with a large number of products, the majority of which are available as inexpensive generics.

The new pipeline products will have significantly higher costs of therapy when compared with these generic products, which will drive market growth.

Additionally, many of these pipeline products have novel mechanisms of action (MOAs) that will help them to compete in the highly crowded market space.

GlobalData forecasts that the late-stage pipeline products could drive combined sales of approximately $3.25bn by 2029 in the 8MM.

GlobalData also anticipates that the most promising pipeline product will be Johnson & Johnson’s aticaprant, which has the potential to see strong uptake due to its novel MOA and focus on anhedonia, a hard-to-treat symptom of MDD.

GlobalData forecasts that aticaprant could generate global sales of approximately $670.63m by 2029.

While the overall MDD market is expected to see good growth to 2029, continued generic erosion will be an important barrier.

Several key products, including Lundbeck/Takeda Pharmaceuticals’ Trintellix, which was the top-selling drug in the MDD market in 2019 with sales of $904.0m, and Otsuka/Lundbeck’s Rexulti, will face patent expiries during the forecast period with the entry of cheaper generics, resulting in sales erosion for these products.

Generic erosion is expected to be particularly significant in the Japan MDD market, with the patent expiries of Lundbeck’s Lexapro, Eli Lilly’s Cymbalta, and Pfizer’s Effexor XR occurring early in the forecast period, resulting in generic erosion in the selective serotonin reuptake inhibitor and serotonin-norepinephrine reuptake inhibitor drug classes.

A further barrier to growth in the Japan MDD market is the decreasing prevalent MDD population over the forecast period, as Japan is the only market in the 8MM expected to see a negative CAGR.

In 2019, the US represented the largest market for MDD, with 70.7% of the 8MM’s sales, due to its larger MDD population and the high price of medication in the country.

With two of the eight pipeline products anticipated to launch in the US only, in addition to the fact that Auvelity is currently only marketed in the US, the US is expected to maintain its dominance in this space and increase its proportion of global sales to 83.8% in 2029.