Schizophrenia Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• The prevalent cases of schizophrenia are projected to increase during the forecast period (2023-2034) due to the rising awareness regarding mental illness and improvements in diagnosis.
• During the initial phases of schizophrenia, symptoms lack specificity and coincide with other mental health issues or typical fluctuations in behavior. Disease diagnosis is often delayed due to attached stigma and fear. This gap in the prevalent and diagnosed population of schizophrenia often leads to delays in initial treatment.
• At present, there is no cure for schizophrenia, and treatment primarily focuses on managing symptoms and preventing relapses. In some cases, hospitalization may be needed. The mainstay of treatment includes medication and psychosocial therapy that can help manage the condition. Pharmacological therapy plays a vital role in treating this disease, where many mono and combination pharmacological therapies are available for treating schizophrenia symptoms.
• Antipsychotic drugs, integral to pharmacological therapy, dominate the market and are categorized into first and second generations. Notably, second-generation antipsychotics (SGA), comprised of the US FDA-approved medications, are favored over their first-generation (FGA) counterparts.
• The market is replete with antipsychotic drugs utilizing diverse routes of administration (ROA), with a primary focus on dopamine modulation, establishing them as the conventional approach to treating schizophrenia. The US FDA-approved oral antipsychotics like CAPLYTA (lumateperone), VRAYLAR (cariprazine), LYBALVI (olanzapine and samidorphan), REXULTI (brexpiprazole), LATUDA (lurasidone hydrochloride), along with other oral therapies such as FANAPT and ABILIFY MYCITE.
• The competitive landscape is undergoing dynamic changes with the approval of generic versions for drugs like LATUDA (lurasidone hydrochloride), leading to a substantial decline in its market revenue during the forecasted years.
• In 2022, the US had the largest market size of Schizophrenia among the 7MM, accounting for approximately USD 5,749.0 million. This is expected to increase further by 2034.

The “Schizophrenia - Market Insights, Epidemiology, and Market Forecast - 2034” report delivers an in-depth understanding of Schizophrenia, historical and forecasted epidemiology, as well as the Schizophrenia market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Schizophrenia market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Schizophrenia market size from 2020 to 2034. The report also covers Schizophrenia treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Schizophrenia Understanding and Treatment Algorithm

Schizophrenia Overview

According to the World Health Organization (WHO), schizophrenia is a complex, long term and severe mental disorder characterized by a range of different psychological symptoms, including abnormalities in perception, thinking, emotions, and behavior. Contrary to public perception, schizophrenia is not a split or multiple personality. Besides, it is not caused by childhood experiences, poor parenting, or lack of willpower, nor are the symptoms identical in each patient. In addition, the vast majority of people with schizophrenia are not violent and do not pose a danger to others
Schizophrenia is a severe mental illness affecting about 1% of Americans, impacting thinking, emotions, decision-making, and social interaction. Onset typically occurs in late teens to early 20s for men and late 20s to early 30s for women.

Schizophrenia diagnosis

Diagnosing schizophrenia is not easy. Sometimes using drugs, such as methamphetamines or LSD, can cause a person to have schizophrenia-like symptoms. The difficulty of diagnosing this illness is compounded by the fact that many people diagnosed do not believe they have it. Lack of awareness is a common symptom of schizophrenia and greatly complicates treatment.

While no single physical or lab test can diagnose schizophrenia, a healthcare provider who evaluates the symptoms and the course of a person’s illness over 6 months can help ensure a correct diagnosis. The health care provider must rule out other factors such as brain tumors, possible medical conditions, and other psychiatric diagnoses, such as bipolar disorder. To be diagnosed with schizophrenia, a person must have two or more of the following symptoms occurring persistently in the context of reduced functioning: delusions, hallucinations, disorganized speech, disorganized or catatonic behavior, and negative symptoms.

Schizophrenia treatment

Schizophrenia is a lifelong condition, but effective treatment can help a person manage the symptoms, prevent relapses, and avoid hospitalization. Schizophrenia requires lifelong treatment, even when symptoms have subsided. Treatment with medications and psychosocial therapy can help manage the condition; in some cases, hospitalization may be needed. A psychiatrist experienced in treating schizophrenia guides treatment. The treatment team also may include a psychologist, social worker, psychiatric nurse, and possibly a case manager to coordinate care. The full-team approach may be available in clinics with expertise in schizophrenia treatment.

Schizophrenia Epidemiology

As the market is derived using a patient-based model, the Schizophrenia epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total prevalent cases of schizophrenia, total diagnosed prevalent cases of schizophrenia, gender-specific diagnosed prevalent cases of schizophrenia, and severity-specific diagnosed prevalent cases of schizophrenia in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• In the 7MM, the total prevalent cases of Schizophrenia were estimated to be approximately 6,029,994 in 2022, of which the US accounted for around 45.05%, while EU4 and the UK accounted for nearly 37.36%, and Japan accounted for approximately 17.59% of the total prevalent cases.
• Among the 7MM, the US accounted for nearly 37.20% of the total diagnosed prevalent cases of Schizophrenia, with nearly 1,412,470 cases in 2022. These cases are expected to increase during the study period (2020-2034).
• As per the analysis, EU4 and the UK accounted for around 1,588,816 diagnosed prevalent cases of Schizophrenia in 2022. These cases are expected to change during the study period (2020-2034)
• Among the EU4 and the UK, Germany accounted for the highest prevalent cases of Schizophrenia, representing nearly 28.50% of the cases, followed by the UK, and France, while Spain had the least cases in 2022
• According to estimates based on the epidemiology model, Schizophrenia exhibits a higher male preponderance than females in the US. Of the total diagnosed prevalent cases in the US, nearly 53.63% were males and 46.37% were females, in 2022.
• In the US, when the diagnosed prevalent cases of Schizophrenia were segmented based on severity, the mild group accounted for nearly 567,336 cases, in 2022. As per the analysis, these cases are expected to increase, and the moderate group contributed around 37.03% of the diagnosed prevalent cases, while the severe group contributed a minimum of 22.81% respectively in 2022.
• In 2022, among the 7MM, Japan had the second highest cases of Schizophrenia, contributing approximately 17.59% to the total prevalent cases of Schizophrenia.

Schizophrenia Drug Chapters

The drug chapter segment of the Schizophrenia report encloses a detailed analysis of Schizophrenia-marketed drugs and mid to late-stage (Phase III and Phase II) pipeline drugs. It also helps to understand the Schizophrenia clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Marketed Drugs

ABILIFY MAINTENA (aripiprazole): Otsuka Pharmaceutical/Lundbeck

ABILIFY MAINTENA (aripiprazole) for extended-release injectable suspension, an IM depot formulation of aripiprazole, is a sterile lyophilized powder that, when reconstituted with sterile water for injection, forms an injectable suspension that can be administered monthly. ABILIFY MAINTENA is an atypical antipsychotic for treating schizophrenia. The mechanism of action of aripiprazole in the treatment of schizophrenia and bipolar I disorder is unknown. The efficacy of aripiprazole could be mediated through a combination of partial agonist activity at dopamine D2 and serotonin 5-HT1A receptors and antagonist activity at 5-HT2A receptors.

In March 2013, the FDA approved ABILIFY MAINTENA (aripiprazole) for extended-release injectable suspension, an intramuscular depot formulation for treating schizophrenia. In September 2014, the FDA approved a pre-filled dual-chamber syringe for ABILIFY MAINTENA. In December 2014, the FDA approved the labeling update of ABILIFY MAINTENA for treating acutely relapsed adults with schizophrenia. In November 2013, the EMA approved ABILIFY MAINTENA (aripiprazole) for extended-release injectable suspension-an intramuscular depot formulation indicated for treating schizophrenia, and in March 2015, ABILIFY received regulatory approval in Japan for the manufacture and marketing of ABILIFY in 300 mg and 400 mg vials and in 300 mg and 400 mg dual-chamber syringe extended-release Injectable Suspension.

Emerging Drugs

Ulotaront (SEP-363856): Sumitomo Pharma/Otsuka Pharmaceuticals

Ulotaront (SEP-363856) is a trace amine-associated receptor 1 (TAAR1) agonist with serotonin 5-HT1A agonist activity, jointly developed by Sunovion Pharma and PsychoGenics, which is a small-molecule oral agent that does not bind to dopamine D2 or serotonin 5-HT2A receptors. Sunovion discovered Ulotaront in collaboration with PsychoGenics using it is in vivo phenotypic SmartCube platform and associated artificial intelligence algorithms.

In May 2019, the US FDA granted BTD for SEP-363856 for the treatment of people with schizophrenia.

Note: Further emerging therapies and their detailed assessment will be provided in the final report.

Drug Class Insights

Treatment for schizophrenia typically involves a combination of medication and psychosocial interventions aimed at managing the condition effectively. Pharmacotherapy plays a pivotal role in addressing schizophrenia symptoms, with a wide array of mono and combination pharmacological options available. Antipsychotic medications, categorized into first-generation (FGAs) and second-generation (SGAs), are commonly prescribed as first-line treatments. Some treatment approaches may involve a combination of antipsychotics and antiepileptic medications, tailored to specific patient groups. Both oral antipsychotics (OAP) and long-acting injectable therapies (LAI) are accessible options within each generation of antipsychotics. In clinical practice, a blend of both FGAs and SGAs is often utilized to effectively manage schizophrenia symptoms.

First-generation antipsychotics (FGAs) encompass medications such as chlorpromazine, fluphenazine, haloperidol, and perphenazine. FGAs are associated with frequent and potentially significant neurological side effects, including the risk of developing tardive dyskinesia, a movement disorder that may or may not be reversible. Consequently, second-generation antipsychotic (SGA) medications are generally preferred due to their lower propensity for serious side effects compared to FGAs. SGAs, including REXULTI/RXULTI (brexpiprazole), CAPLYTA (lumateperone), LATUDA (lurasidone hydrochloride), SAPHRIS (asenapine), ABILIFY MYCITE (aripiprazole tablets with sensor), VRAYLAR/REAGILA (cariprazine), SECUADO (asenapine), INVEGA SUSTENNA/TRINZA/HAYFERA (paliperidone palmitate), ARISTADA/ARISTADA INITIO (aripiprazole lauroxil), PERSERIS (risperidone), FANAPT (iloperidone), LYBALVI (olanzapine and samidorphan), among others, are generally favored due to their lower risk of side effects.

Schizophrenia Market Outlook

Schizophrenia is a severe and chronic mental disorder characterized by distorted thinking, perception, emotions, language, sense of self, and behavior. Its impact extends beyond patients to family members, caregivers, and society due to its lifelong nature and the likelihood of relapses. The disorder progresses through stages, including prodromal, active, and residual, each marked by specific symptoms such as hallucinations, suspiciousness, delusions, depression, withdrawal, anxiety, and difficulty concentrating. The treatment options for schizophrenia include medication (antipsychotics), psychological counseling and social support, cognitive behavioral therapy, and electroconvulsive therapy (ECT).

At present, various companies have embarked on clinical trials to explore novel treatment options for schizophrenia. Prominent industry players, including Boehringer Ingelheim, Karuna Therapeutics, Acadia Pharmaceuticals, Reviva Pharmaceuticals, Minerva Neurosciences, and Newron Pharmaceuticals, among others, are advancing their products through the late phases of clinical development. The schizophrenia therapeutics landscape is undergoing a notable influx of potential emerging drugs, each presenting unique mechanisms and strategic approaches in the quest for more effective treatment options. This dynamic scenario reflects a concerted effort within the industry to address the complexities of schizophrenia through innovative and diverse therapeutic interventions.

The current market segmentation is based on the therapies prescribed. The drugs that are being used in the present market include CAPLYTA (lumateperone), VRAYLAR (US)/REAGILA (EU) (cariprazine), LATUDA (lurasidone), REXULTI (US/JP)/RXULTI (EU), and others are included. These are the major segments covered in the forecast model.

Several key players are evaluating their lead candidates in different stages of clinical development like Ulotaront (SEP-363856) by Sumitomo Pharma/Otsuka Pharmaceuticals. The market for Schizophrenia is expected to experience positive growth.

• The total market size of Schizophrenia in the 7MM was approximately USD 7,972.0 million in 2022 and is projected to increase during the forecast period (2023-2034).
• The market size of Schizophrenia in the US was approximately USD 5,749.0 million in 2022, which is anticipated to increase due to the increasing awareness of the disease and the launch of the emerging therapy.
• The total market size of EU4 and the UK was calculated to be approximately USD 1,547.1 million in 2022, which was nearly 19.41% of the total market revenue for the 7MM.
• According to these estimates, among EU4 and the UK, Germany accounted for the highest market with approximately USD 432.0 million in 2022, followed by the UK with approximately USD 389.4 million in the respective year, while Spain accounted for the lowest market in 2022.
• According to the analysis, in the US, among the currently used therapies, VRAYLAR, generated a revenue of approximately USD 772.4 million, while INVEGA Products, which includes INVEGA SUSTENNA, INVEGA TRINZA, and INVEGA HAFYERA (paliperidone palmitate) generated a revenue of USD 2,686.3 million, in 2022, followed by other therapies.
• In 2022, Japan with a revenue of approximately 675.9 million, which was nearly 8.48% of the total market revenue for the 7MM, which is expected to increase significantly by 2034.

Schizophrenia Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. For example, Sumitomo Pharma and Otsuka’s Ulotaront (SEP-363856), a trace amine-associated receptor 1 (TAAR1) agonist with serotonin 5-HT1A agonist activity, jointly developed by Sunovion Pharma and PsychoGenics is expected to enter the US market in 2028 with a “slow-medium” uptake.

Schizophrenia Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

Pipeline development activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for Schizophrenia.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on Schizophrenia's evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.

The analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the American Psychiatric Association, US, University of Maryland School of Medicine, Baltimore, US, Department of Psychiatry and Behavioral Medicine, Louisiana State University, University of Lyon, Lyon, France, University of Bari Aldo Moro, Italy, and National Center of Neurology and Psychiatry, Tokyo, Japan were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Schizophrenia market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Physician’s View

According to our primary research analysis, despite advancements in the treatment of schizophrenia, significant unmet needs persist in effectively managing this complex disorder. One primary challenge lies in achieving optimal symptom control and functional recovery for all individuals, as responses to existing therapies can vary widely among patients. Additionally, while antipsychotic medications remain the cornerstone of treatment, many individuals experience inadequate efficacy or intolerable side effects, highlighting the need for novel therapeutic options with improved efficacy and tolerability profiles. Furthermore, addressing the cognitive deficits and negative symptoms associated with schizophrenia, which often contribute to long-term disability and impaired quality of life, remains a major challenge. Additionally, there is a need for interventions that target the underlying neurobiological mechanisms of the disorder, as current treatments primarily address symptom management rather than disease modification. Enhancing access to evidence-based psychosocial interventions and support services, particularly in community settings, is also crucial for promoting long-term recovery and reducing the burden of schizophrenia on individuals, families, and society.

According to a KOL in the US, there are no therapies that can effectively address the complex combination of positive and negative symptoms, mood, and cognitive impairment associated with schizophrenia. As a result, emerging therapies have focused on developing a drug that targets both the serotonin and dopamine receptor signaling systems in order to treat schizophrenia and its comorbid symptoms more effectively.

As per another KOL, all persons with schizophrenia need drugs some of the time and most will do better with continued use of medication to help control symptoms and prevent relapse. However, the drugs are not effective for all aspects of the illness. Cognitive behavioral therapy may help with certain symptoms, and supportive psychotherapy can support personal strengths and improve quality of life.

Another KOL found that lack of efficacy is a common cause of treatment discontinuation. Although available antipsychotics can alleviate positive symptoms by blocking striatal dopamine D2 receptors, a significant number of patients fail to improve psychotic symptoms with these agents, as do rates of treatment resistance in first-episode patients compared to a community sample of chronic patients.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance incidence of overall adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation, and others.

Further, the therapies’ safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

The high cost of therapies for the treatment is a major factor restraining the growth of the drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.

The reimbursement challenges related to medical care and treatment for individuals with Schizophrenia can be significant as it often requires specialized medical attention, covering the costs of diagnosis, treatment, and ongoing care. Health insurance plans may not fully cover limited coverage of some medical treatments, and therapies specific to Schizophrenia. This can result in high out-of-pocket expenses for families seeking the best care for their loved ones. Moreover, it requires specialized care from healthcare providers with expertise. Finding and accessing such specialists may be challenging, and the associated costs may not always be fully reimbursed by insurance.

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of Schizophrenia, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Schizophrenia, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Schizophrenia market.

Schizophrenia report insights

• Patient Population
• Therapeutic Approaches
• Schizophrenia Pipeline Analysis
• Schizophrenia Market Size and Trends
• Existing and Future Market Opportunity

Schizophrenia report key strengths

• 12 years Forecast
• The 7MM Coverage
• Schizophrenia Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Drugs Uptake and Key Market Forecast Assumptions

Schizophrenia report assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions

Market Insights

• What was the total market size of Schizophrenia, the market size of Schizophrenia by therapies, and market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
• How will Ulotaront (SEP-363856), Brilaroxazine (RP5063), and others affect the treatment paradigm of Schizophrenia?
• How will Ulotaront (SEP-363856) compete with upcoming products and marketed therapies?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for approved and marketed therapies?
• How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of Schizophrenia? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Schizophrenia?
• What is the historical and forecasted Schizophrenia patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• Out of the countries mentioned above, which country would have the highest diagnosed prevalent Schizophrenia population during the forecast period (2023-2034)?
• What factors are contributing to the growth of Schizophrenia cases?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of Schizophrenia? What are the current clinical and treatment guidelines for treating Schizophrenia?
• How many companies are developing therapies for the treatment of Schizophrenia?
• How many emerging therapies are in the mid-stage and late stage of development for treating Schizophrenia?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What is the cost burden of current treatment on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the accessibility issues of approved therapy in the US?
• What is the 7MM historical and forecasted market of Schizophrenia?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Schizophrenia market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• The distribution of historical and current patient share is based on real-world prescription data in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identifying upcoming solid players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies for Schizophrenia, barriers to accessibility of approved therapy, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.