Mental health is no longer just a personal issue; it’s a national emergency with staggering human and economic costs. An estimated 59.3 million adults in the US – about 1 in 5 Americans – live with a mental health condition, affecting not only individual well-being but also families, communities, and the economy. Serious mental health conditions alone cost the US an estimated $280 billion annually. As the federal government reconfigures how mental health services are structured and delivered, there is a pivotal moment for industry leaders—especially pharmaceutical companies—to step forward. The cracks in our mental health system are widening, and technology may be one of the few tools capable of scaling support fast enough to meet the need.
While not a singular solution, pharmaceutical interventions play a crucial role in managing many mental health conditions. The CDC estimates that 16.5% of Americans take a prescription medication for their mental health. These medicines are essential to managing a range of mental health conditions that would otherwise pose an even larger burden. Given this significant reliance, the imperative to improve patient access and therapeutic adherence suggests an unprecedented opportunity to proactively safeguard and innovate against the current mental health infrastructure.
To achieve this, industry partners can embrace a leadership role by exploring innovative delivery models that meet patients where they are. Expanding into digital therapeutics, telehealth platforms, and mobile apps to enhance access to care and support patient self-management can strengthen the existing supply chain and promote its adaptability. Since the COVID-19 pandemic, telemedicine use has skyrocketed, with an estimated 37% of Americans utilizing telemedicine in the last 12 months. Recent studies concluded there is no observable difference in patient clinical outcomes between mental telehealth services in comparison to in-person visits. Simultaneously, mental health-targeted apps are rapidly being developed and downloaded, emphasizing the value and need for digital mental health innovations.
However, this rapid download and development poses its own issue: there are over 10,000 mental health-related apps available for download, but fewer than 5% of these apps have published evidence supporting their effectiveness. These apps range from meditation and mindfulness to mood trackers, online therapy interfaces, automated cognitive behavioral therapy, stress management, and mental health community platforms. However, the lack of evidence prevents mental health providers from recommending effective digital tools, and many patients find themselves in a download fatigue, causing confusion, underuse, and sometimes harm.
The next frontier of digital transformation isn’t about deploying more apps; it’s about the strategic consolidation of our digital ecosystems. We must move beyond a fragmented landscape towards fewer, more powerful platforms capable of delivering exponential scale and impact. Therefore, pharma has an unprecedented opportunity to invest in the clinical validation of mental health digital tools to generate evidence for these innovations. Strategies to do this include funding randomized controlled trials (RCTs) or other clinical studies that assess the access and utilization of mental health digital apps, as well as their effectiveness in treating mental health concerns.
These strategies could assess more than just effectiveness; proper evaluation could generate evidence on how these digital interventions perform across diverse populations and care settings, while simultaneously demonstrating potential cost-effectiveness. However, before data can be generated, partnerships with health systems, payers, and community-based organizations will be critical to embed these tools into care delivery pathways and ensure accurate measurement. With adequate and compelling evidence, digital mental health platforms have the potential to serve as adjuncts alongside traditional pharmacological treatments.
By promoting and scaling patient-centered, evidence-driven, digital innovations, pharmaceutical companies can not only play a decisive role in ensuring that individuals can continue to receive the treatment they need, there is also a distinct possibility to position themselves as leaders in reinforcing critical infrastructure that is vital to delivering quality mental health care in the US.
Policy Cheat Sheet
- US Department of Health and Human Services (HHS): A department of the federal government that provides essential human services, such as social services and emergency preparedness and response. HHS is tasked with protecting the health and well-being of US citizens.
- Substance Abuse and Mental Health Services Administration (SAMHSA): A federal agency currently housed under HHS, which leads government efforts to improve behavioral health in the US.
- National Institute of Mental Health (NIMH): A federal agency that leads the research for mental health disorders in the US. NIMH is the largest funder of mental health research globally.
- Implementing the President’s Department of Government Efficiency’s Workforce Optimization Initiative: Executive order signed by President Donald Trump, which calls for a restructuring of HHS.
- Make America Healthy Again (MAHA): A public health initiative focused on improving health outcomes across the United States by addressing systemic barriers to care, promoting preventative health practices, and encouraging bipartisan support for evidence-based health policies. The campaign often emphasizes reducing chronic disease, increasing access to affordable care, and supporting underserved communities.
Upcoming Events
| Event | Date | Location | Description |
| NatCon25 | May 5-7 | Philadelphia, US | NatCon25 is the largest conference in mental health and substance use, offering three days of learning, networking, and entertainment. At the conference, you have the opportunity to connect with nearly 6,000 peers and hear from 500+ speakers representing different fields – from policy leaders and medical directors to social workers, CEOs, and clinicians. |
| American Psychiatric Association Annual Meeting | May 17-21 | LA, US | The theme of 2025’s meeting is “Lifestyle for Positive Mental and Physical Health.” The meeting is designed for both psychiatrists and all mental health professionals and advocates. |
| International Conference on Mental Health and Psychiatry | May 19-20 | Rome, Italy | 2025’s theme, “Global Collaboration in Mental Health and Psychiatry for a Healthier Future,” highlights the collective commitment to advancing the field of mental health and elevating its prominence within the global psychiatric agenda. The conference provides a platform for leading experts, researchers, clinicians, and doctors from around the world to exchange ideas, showcase groundbreaking research, and explore innovative solutions. |
Industry Updates
Johnson & Johnson is set to acquire all outstanding shares of a neurosciences biopharmaceutical company, Intra-Cellular Therapies, for around $14.6 billion. Intra-Cellular Therapies is focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders. With this acquisition, J&J will get access to Intra-Cellular Therapies’ CAPLYTA (lumateperone), a once-daily oral therapy approved to treat adults with schizophrenia, as well as depressive episodes associated with bipolar I or II disorder.
AbbVie said it will post a $3.5 billion impairment charge related to last year’s $8.7 billion bet on Cerevel Therapeutics following the failure of the deal’s key drug candidate. AbbVie said at the end of last year that the Cerevel drug, emraclidine, missed the key goal in a pair of mid-stage studies in schizophrenia. In announcing the Cereval deal in late 2023, AbbVie said it believed emraclidine had the potential to transform the schizophrenia treatment landscape. AbbVie said last month that a third late-stage study of tavapadon, another Cerevel drug candidate, hit its key goals in the neurodegenerative disorder Parkinson’s disease.
Bristol-Myers Squibb’s (BMS) schizophrenia drug Cobenfy has hit a phase 3 setback. Cobenfy as an adjunctive treatment to atypical antipsychotics failed to show superior efficacy versus placebo with atypical, according to results from the phase 3 Arise trial. The drug was approved by the FDA to treat schizophrenia in September 2024 and was the centerpiece in BMS’ $14 billion acquisition of Karuna Therapeutics. Some analysts have dramatically lowered their 2030 sales estimate for Cobenfy from $5.8 billion to $2.6 billion following the Arise trial flop, while others suggest that it is still possible for Cobenfy to reach over $5 billion in annual sales.
Boehringer Ingelheim has spotlighted two promising therapeutics in its mental health pipeline. The first is iclepertin, a GlyT1 inhibitor designed to address cognitive impairment associated with schizophrenia. Phase 3 results for iclepertin are expected next year. The second therapeutic is a negative allosteric modulator (NAM) of NR2b, which is advancing to late-stage testing for major depressive disorder. Additionally, it is in earlier stages of development for borderline personality disorder and post-traumatic stress disorder.