Medicines designed to treat psychiatric conditions may have a statistically lower chance of succeeding in drug development than most other disease areas, but that doesn’t seem to put off biopharmas. In fact, there are at least 163 medicines targeting mental illness already in the clinic or awaiting FDA review, according to a report (PDF) from the Pharmaceutical Research and Manufacturers of America (PhRMA).
The latest figures mark a slight increase from 2019—the last time PhRMA published a report (PDF) on the mental illness pipeline—when the number of therapies in development stood at 138.
The need is obvious: In 2020, 1 in 5 U.S. adults (52.9 million) experienced at least one mental illness, according to the National Institutes of Health. COVID-19 pandemic exacerbated the issue, with about 4 in 10 American adults reporting symptoms of anxiety or depressive disorder in 2021, a significant increase from the 1 in 10 adults reporting symptoms before the outbreak, according to the Kaiser Family Foundation.
Each condition also imposes a substantial economic burden: The average expected lifetime societal cost tied to receiving a serious mental illness diagnosis by the age of 25 is $1.85 million, according to PhRMA, while the total spending from all public and private sources to treat mental and substance use disorders costs the U.S. almost $300 billion every year.
However, developing new drugs for psychiatric conditions can be more challenging, because the underlying pathology of the diseases, alongside treatment response, are less understood than other diseases. The conditions are also extremely diverse and can manifest very differently in different people.
Despite these hurdles, many biotechs exist primarily to tackle mental health conditions. Potential treatments for depression, including postpartum depression and major depressive disorder, currently make up the largest sect of the mental illness pipeline, with 54 in the works. Alto Neuroscience, Sage Therapeutics and Relmada Therapeutics are a few of the companies chugging away at potential depression treatments.
The second largest pipeline areas are schizophrenia and anxiety disorders, with 35 investigative medicines each. Biotech players working in these spaces include Karuna Therapeutics—which is preparing for the potential launch of its much-hyped schizophrenia med KarXT—and Vistagen Therapeutics, which is working on a social anxiety nasal spray.
The rest of the pipeline is made up of 33 investigational treatments for substance abuse disorders, 13 for bipolar disorder and eight aimed at attention-deficit/hyperactivity disorder, according to PhRMA.
While the industry group sees strong promise for mental illness treatments, the organization admonished the U.S. government’s price setting provisions in the Inflation Reduction Act (IRA), arguing that the policy will weaken future industry R&D efforts, therefore decreasing the chances of development and availability of future treatments. The organization urged policymakers to work together to mitigate unintended consequences of the IRA on future innovation.
PhRMA also argued that additional policy reforms are needed to help demolish significant barriers patients face to accessing quality care, including reducing stigma around mental illness, bolstering the behavioral health workforce, improving access to treatment, ensuring insurance works as intended and stronger enforcement of mental health parity laws.