M E D I C I N E S I N D E V E L O P M E N T | 2 0 2 3 R E P O R T

Mental Illness

More Than 160 Medicines in Development for a Wide Range of Mental Illnesses
Mental illness refers to a broad spectrum of health conditions affecting mood, thinking and behavior. These conditions
include depression, bipolar disorder, schizophrenia, substance use disorder, anxiety disorders, eating disorders, obsessive
compulsive disorder and post-traumatic stress disorder, among others. Each of these illnesses often varies in its degree
of severity, ranging from mild to moderate to severe, and may occur together. In severe cases, mental illnesses can cause
serious functional impairment and substantially interfere with or place limits on life activities –– these are considered serious
mental illnesses (SMI).i Regardless of severity, mental illness can often get in the way of one’s personal and professional
relationships and limit one’s quality of life.

In light of this, biopharmaceutical research companies have made tremendous strides towards understanding mental
illnesses and developing innovative medicines. With over 160 medicines in development, biopharmaceutical researchers
are seeking to leverage a growing scientific understanding of the brain to develop new treatments and bring therapeutic
advances for patients who are not helped by current treatments, or for those who may experience negative side effects.

Nearly Young adults

JUST THE
FACTS
1 in 5 aged 18-25 years had the highest
prevalence of mental illness in 2020
U.S. adults live with a mental illness
(52.9 million in 2020).i 30.6%. i

Having a serious mental illness The average expected lifetime societal costs
reduces average life expectancy by associated with being diagnosed with serious

10 - 20
mental illness by the age of 25 is

years. ii $1.85M. iii

Trends in Mental Illness
Mental illnesses continue to impose a heavy health
and economic toll in the U.S. Not only are millions
of individuals, families and communities impacted
by mental illness, but the total spending from all
public and private sources to treat mental and
substance use disorders costs society nearly $300
billion annually.iv Furthermore, rates of mental
illness diagnoses, severe complications from these
illnesses, addiction and suicide continue to rise.

Due to the ongoing burden of mental illnesses, Promise of the Pipeline

severe complications, most notably suicide, have
been increasing among adults. Researchers are working on cutting-edge medicines for patients with
mental illness. Today there are 163 medicinesix in development by
• In 2019, nearly 5% of adults (12 million) had biopharmaceutical research companies to help the millions of Americans
serious thoughts of suicide.v suffering from a mental illness. The promise of the pipeline is represented
• The national rate of adults experiencing suicidal across a wide range of mental illnesses, including:
ideation has increased every year since 2011.v
• 54 for depression, which affects 8.4% of adults and 17% of adolescents
• Though there have been some recent declines
aged 12 to 17 in the U.S.x Depression, otherwise known as major
in adult suicide rates, suicide remains the 12th
depressive disorder or clinical depression, is one of the most common
leading cause of death in the U.S. today.vi
mental illnesses in the U.S. It causes persistent feelings of sadness or
Evidence suggests more adolescents and young loss of interest that can interfere with daily activities such as sleeping,
adults are experiencing serious psychological eating or working. In order to be diagnosed with depression, the
distress, major depression and suicidal thoughts symptoms must be present for at least two weeks. There are several
and behaviors relative to the mid-2000s. types of depression that manifest differently or develop under unique
circumstances, such as: persistent depressive disorder, postpartum
• In 2019, about one in six students reported depression, psychotic depression and seasonal affective disorder.
making a suicide plan in the past year, a 44%
increase since 2009.vii • 35 for schizophrenia, which affects less than 1% of U.S. adults.xi
Schizophrenia is a mental disorder characterized by disruptions in
Too often, mental illnesses and substance use
thought processes, perceptions, emotional responsiveness and social
disorders, such as addiction, go hand in hand. In
interactions. Although schizophrenia is not as common as other mental
2020 alone:
disorders, the symptoms can be very disabling to daily life.
• Nearly 15% (40 million) of Americans aged 12
years or older reported having a substance use • 35 for anxiety disorders, with more than a third of adults in the U.S.
disorder in the past year—including alcohol use reporting anxiety during their lifetime.xii Most people occasionally
disorder and illicit drug use disorder.viii experience anxiety related to specific life events, but anxiety disorders
• 17 million American adults reported having both involve more than a temporary worry or fear. For a person with an anxiety
a mental illness and a substance use disorder.v disorder, the anxiety does not go away and can get worse over time. The
• Nearly six million Americans had both a SMI and symptoms can interfere with daily activities such as job performance,
a substance use disorder.v school, work and relationships. There are several types of anxiety
disorders, including generalized anxiety disorder, panic disorder, phobia-
related disorders (e.g., the fear of flying, heights or needles), social
anxiety disorder and separation anxiety disorder.

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• 33 for substance use disorders. Over 40 million Americans aged 12 and older—or 14.5% of the U.S. population—reported having
a substance use disorder—including alcohol use disorder and illicit drug use disorder.ix Treatment of substance use disorders
is complicated by the fact that many people with these disorders also often struggle with other mental illnesses. Due to
fundamental changes that occur in the brain, which disrupt the ability to control impulses in patients struggling with addiction,
substance use disorders are regarded as mental illnesses. As stated previously, 17 million American adults reported having
both a substance use disorder and another mental illness.ix The presence of co-occurring substance use disorders and another
mental illness can increase symptom severity, complicate treatment and create medication adherence challenges.

• 13 for bipolar disorder, which affect about 2.8% of adults and 2.9% of adolescents in the U.S.xiii Bipolar disorder, also known
as manic-depressive disorder, causes dramatic shifts in mood, energy, activity levels and the ability to carry out day-to-day
tasks.

• 8 for attention-deficit/hyperactivity disorder (ADHD), which is one the most common childhood disorders with a lifetime
prevalence of 11.0% in children aged 4 to 17 and 8.7% in adolescents aged 13 to 18. ADHD affects 4.4% of adults in the
U.S.xiv ADHD is marked by difficulty staying focused, paying attention, hyperactivity, and/or impulsivity that interferes with
functioning or development.

Innovative Medicines in the Pipeline

The development of new and effective treatments for patients with mental illness can be very challenging. Despite certain
challenges, researchers have many innovative medicines in development. Some of the 163 innovative potential new medicines
include:

• An oral kappa opioid receptor (KOR) antagonist is in development as an adjunctive treatment for major depressive
disorder. KOR antagonists play an important role in helping regulate stress and mood. Kappa opioid receptors are involved
in anxiety-like, dysphoric, aversive and drug-seeking behavioral responses.xv KOR antagonists block kappa-opioid receptors
and reduce these responses, producing antidepressant and anti-addictive effects.

• A once-daily, two-week treatment in development for postpartum depression and major depressive disorder is a
neuroactive steroid (a naturally occurring steroid that impacts behavior) GABA (gamma aminobutyric acid) receptor
modulator. The GABA system is a critical neurotransmitter signaling pathway that is responsible for information flow within
the intricate circuits of the brain and central nervous system. The GABA system contributes significantly to regulating
central nervous system function and dysfunction known to be at the core of numerous psychiatric disorders.xvi

• A medicine in development for post-traumatic stress disorder (PTSD) is an inhibitor of the transient receptor potential
(TRP) channels 4 and 5. TRP channels are expressed in the brain and implicated in the innate fear function (innate fear helps
humans avoid or escape dangerous situations). TRP channels are involved in anxiety-like behavior. For example, TRPC5
increases the activity of the hormone CCK (cholecystokinin), which increases neuronal anxiety.xvii By inhibiting the activity
of TRPC4/5 and therefore reducing CCK activity, depressive and anxiety behaviors are suppressed. The medicine is also in
development for major depressive disorder and borderline personality disorder.

• A medicine in development for schizophrenia is an agonist of trace amine-associated receptor 1 (TAAR1). TAAR1 plays a
significant role in regulating neurotransmission of dopamine, norepinephrine and serotonin in the central nervous system.
Studies show that TAAR1 activation could reduce the side effects of currently marketed antipsychotics, such as movement
disorders, weight gain and cardiometabolic disease.xviii

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Challenges to Developing New Medicines
Developing medicines to treat psychiatric conditions has some of the lowest probabilities of success in drug development.
These challenges are due in part to a poor understanding of the underlying pathology of these diseases and treatment response
as well as the extremely diverse nature of the diseases themselves, which often manifest differently in different people.xix

Researchers are seeking to leverage a growing understanding of the brain to develop new treatments and bring therapeutic
advances for patients who are not helped by current treatments, or for those who may experience negative side effects. Current
studies are examining how existing treatments work in the brain and identifying biomarkers that can be used to improve
diagnoses, measure disease progression, and assess a patient’s response to therapies. Biomarkers are also being increasingly
used to find new therapeutic targets through identification of the mechanisms contributing to mental illness.

Biomarkers
A biomarker (short for biological marker) is a measure used to evaluate how the
body is functioning. Biomarkers have multiple applications in health care, including
diagnosing diseases, understanding how a disease progresses and measuring how a
body is responding to a treatment.

As more biomarkers are identified, they have the potential to greatly enhance the
drug development process by providing researchers with new ways to measure
disease activity, enable patient selection and stratification in clinical trials and
improve the development of more personalized treatments — particularly where
multiple biomarkers can inform the use of targeted drug combinations.

Biomarkers can also allow researchers to better understand how effective a

treatment is against a disease with clinical endpoints that are difficult to define,
providing clinicians with additional informative measurements and identify
differences in responses between individuals or subpopulations.

Patient Perspective
The more than 160 medicines in development for mental illness today seek to employ the latest in scientific treatment advances
to the benefit of patients for years to come. Patients facing a mental illness are grateful for the treatments available and in
development:

“I am a proud mom to three beautiful “Going to college can be a whirlwind “I see a variety of patients from my
girls, and they have brought so much of emotions from class loads to social work in mental health counseling
joy and happiness to my life. But pressures to finding your first job. Being and psychiatric care. While one
like many new mothers, I dealt with a student during the pandemic added medication may work for someone
postpartum anxiety and depression even more mental challenges for me like battling one mental health
following their births. It is a scary heighted levels of anxiety, depression, challenge, another patient with the
feeling, but thanks to innovative and even insomnia. I am grateful for the same condition might not have the
treatments and medications available, medications that are available to help, same results. It is imperative that
my life, and the lives of many others, and I am hopeful that even more solutions new options continue to be found
has changed for the better.” can be found so all students can have a so that anyone who is suffering
— Camryn M., Texas fulfilling college experience.” can find relief.”
—Vishnu B., Michigan —Maya W., Florida

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Impact of COVID-19 on Mental Illness
The COVID-19 pandemic negatively impacted the mental health of countless individuals and exacerbated existing burdens
faced by people already suffering from mental illnesses. During the pandemic, about four in 10 American adults have reported
symptoms of anxiety or depressive disorder.xx This number has significantly increased from one in 10 adults reporting symptoms
prior to the pandemic.
The pandemic has also widened the gender gap in terms of mental health
stressors that adversely impact women. Research shows while the COVID-19
pandemic has had a negative impact on the mental health of all Americans,
women often bear a disproportionate share. Gender roles, family caregiving
responsibilities for children and elderly family members, combined with
workforce participation all contribute to unique mental health challenges
faced by women. One survey of 1,000 U.S. adults found that 64% of female Trends in Mental Illness
respondents reported an increase in stress during the pandemic and 52% During the Pandemic
reported that their stress and anxiety has translated into a physical health • More than half of adults in the U.S.
concern (e.g., unhealthy eating and/or exercising habits.)xxiii report their mental health has been
negatively impacted by the pandemic,
due to worry and stress over the virus—
Telehealth resulting in difficulty sleeping or eating
and increases in alcohol consumption or
Telehealth, when used appropriately, can play an important role in
substance use.xxi
supporting access to health care. The expanded use of telehealth
provides a tremendous opportunity to not only reduce the access barriers • Emergency room visits for drug
(e.g., limited distribution of behavioral health providers in rural areas), but overdoses and suicide attempts were
it may also reduce the stigma that many experience in accessing an in- 36% and 26% higher, respectively,
person treatment provider. While significant progress has been made in compared to prior to the pandemic.xxii
reducing barriers to telehealth access, safeguards are needed to ensure • During the first year of the pandemic,
patient care and quality are maintained. more than 17% of youth experienced a
major depressive episode.ix

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Health Equity: Access and Coverage
While mental illnesses can affect anyone at any time, not everyone has access to adequate mental health care. Fewer
than half of all adults in the U.S. receive treatment for their mental illness, with racial and ethnic minorities receiving
treatment at lower rates than non-Hispanic whites. African Americans and Hispanic Americans access mental health
services at about half the rate of whites, and Asian Americans at about a third of the rate of whites.xxiv Reasons for these
discrepancies include limited access to treatment, attitudes toward seeking treatment, poor quality care, community
stigma towards mental illnesses, under representation of minority health care providers, bias in the treatment setting,
language barriers and inadequate health care coverage.

Although prevalence of certain mental illnesses are not generally higher among racial and ethnic minority groups, these
groups are often less likely to receive treatment services.

As a result of these inequities, between 2016 and 2020, there have been an estimated 116,722 excess premature mental
and behavioral health-related deaths among racial and ethnically minoritized groups and indigenous populations—
amounting to $278 billion in excess cost burden to society.xxv

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 Medicines in Development for Mental Illness

Anxiety Disorders 35

Attention-Deficit/Hyperactivity Disorder 8

Bipolar Disorders 13

Depression 54

Others 14

Schizophrenia 35

Substance Use Disorders 33

0 10 20 30 40 50 60

PHASE I PHASE II PHASE III APPLICATION SUBMITTED

* Some medicines may be in more than one category.

Mental Health Resources

If you or someone you know has a mental illness, is struggling emotionally or has concerns about their mental health, there
are ways to get help. Call 911 if you or someone you know is in immediate danger or go to the nearest emergency room.

Resource Contact Information

988 Suicide & Crisis Lifeline call or text 988

Crisis Text Line text “HELLO” to 741741

Veterans Crisis Line call 1-800-273-TALK (8255) and press or text 838255

Disaster Distress Helpline call or text 1-800-985-5990

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Sources:

i National Institute of Mental Health (NIMH). Mental Illness. https://www.nimh.nih.gov/health/statistics/mental-illness

ii World Health Organization (WHO). Management of Physical Health Conditions in Adults with Severe Mental Disorders. https://www.who.int/publications/i/
item/978-92-4-155038-3
iii Seabury et. al. Measuring the Lifetime Costs of Serious Mental Illness and the Mitigating Effects of Educational Attainment. https://www.healthaffairs.org/
doi/10.1377/hlthaff.2018.05246
iv Substance Abuse and Mental Health Services Administration. (SAMHSA). Projections of National Expenditures for Treatment of Mental and Substance Use
Disorders. https://store.samhsa.gov/sites/default/files/d7/priv/sma14-4883.pdf
v SAMHSA. Addressing Suicidal Thoughts and Behaviors in Substance Use Treatment. https://store.samhsa.gov/sites/default/files/pep20-06-04-005.pdf
vi American Foundation for Suicide Prevention. Suicide Statistics. https://afsp.org/suicide-statistics/
vii Centers for Disease Control and Prevention (CDC). Mental Health Dashboard – Adolescent and School Health. https://www.cdc.gov/healthyyouth/mental-
health/index.htm
viii SAMHSA. Results from the 2020 National Survey on Drug Use and Health. https://www.samhsa.gov/data/sites/default/files/reports/rpt35325/
NSDUHFFRPDFWHTMLFiles2020/2020NSDUHFFR1PDFW102121.pdf
ix Number of medicines obtained through public, government and industry sources, and the Adis “R&D Insight” database; current as of January 2, 2023.
x NIMH. Major Depression. https://www.nimh.nih.gov/health/statistics/major-depression
xi NIMH. Schizophrenia. https://www.nimh.nih.gov/health/statistics/schizophrenia
xii NIMH. Any Anxiety Disorder. https://www.nimh.nih.gov/health/statistics/any-anxiety-disorder
xiii NIMH. Bipolar Disorder. https://www.nimh.nih.gov/health/statistics/bipolar-disorder
xiv NIMH. Attention-Deficit/Hyperactivity Disorder (ADHD). https://www.nimh.nih.gov/health/statistics/attention-deficit-hyperactivity-disorder-adhd
xv Van’t Veer and Carlezon. Role of Kappa-opioid Receptors in Stress and Anxiety -Related Behavior. https://www.ncbi.nlm.nih.gov/pmc/articles/
PMC3770816/
xvi Cleveland Clinic. Gamma-Aminobutyric Acid. https://my.clevelandclinic.org/health/articles/22857-gamma-aminobutyric-acid-gaba
xvii Zhao and Simasko. Role of Transient Receptor Potential Channels in Cholecystokinin-Induced Activation of Cultured Vagal Afferent Neurons. https://www.
ncbi.nlm.nih.gov/pmc/articles/PMC2954709/
xviii Dedic et. Al. Therapeutic Potential of TAAR1 Agonists in Schizophrenia: Evidence from Preclinical Models and Clinical Studies. https://www.ncbi.nlm.nih.
gov/pmc/articles/PMC8704992/
xix Zhu, Tong. Challenges of Psychiatry Drug Development and the Role of Human Pharmacology Models in Early Development: A Drug Developer’s
Perspective. https://www.frontiersin.org/articles/10.3389/fpsyt.2020.562660/full
xx Kaiser Family Foundation (KFF). The Implications of COVID-19 for Mental Health and Substance Use. https://www.kff.org/report-section/the-implications-
of-covid-19-for-mental-health-and-substance-use-issue-brief/
xxi KFF. The Implications of COVID-19 for Mental Health and Substance Use. https://www.kff.org/coronavirus-covid-19/issue-brief/the-implications-of-covid-
19-for-mental-health-and-substance-use/
xxii Government Accountability Office (GAO). Behavioral Health: Patient Access, Provider Claims Payment, and the Effects of the COVID-19 Pandemic. https://
www.gao.gov/products/gao-21-437r
xiii Athena Health. Female and Millennial Patients Most Likely to Worry about Provider Perceptions, New Research Finds. https://www.athenahealth.com/
press-releases/female-and-millennial-patients-most-likely-to-worry-about-provider-perceptions-new-research-finds
xiv SAMHSA. Racial/Ethnic Differences in Mental Health Service Use Among Adults. https://www.samhsa.gov/data/sites/default/files/
MHServicesUseAmongAdults/MHServicesUseAmongAdults.pdf
xv Satcher Health Leadership Institute. The Economic Burden of Mental Health Inequities in the United States Report. https://satcherinstitute.org/wp-
content/uploads/2022/09/The-Economic-Burden-of-Mental-Health-Inequities-in-the-US-Report-Final-single-pages.V3.pdf

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