Parkinson's Disease Psychosis Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• The Parkinson’s disease Psychosis (PDP) market is projected to witness consistent growth throughout the forecast period (2024-2034). The market size of PDP in the 7MM is expected to increase, driven by better diagnosis and the launch of emerging therapies.
• The analyst's analysis estimates that among the total diagnosed prevalent cases of PDP in 7MM approximately 52% of cases were from the US. As per our estimations, in 2023, the US accounted for nearly 484 thousand diagnosed prevalent cases of Parkinson’s disease Psychosis.
• The total market size of the PDP treatment market is anticipated to experience growth during the forecast period due to the emergence of new and effective treatments, namely, NUPLAZID.
• The market for therapeutics targeting PDP is projected to experience robust growth, at a significant compound annual growth rate (CAGR) from 2024 to 2034. This dynamic expansion reflects increasing demand for advanced treatment options and underscores the growing investment in addressing this serious condition.
• In September 2023, Acadia Pharmaceuticals reported a label update for NUPLAZID (pimavanserin) following US FDA revisions, clarifying its use in Parkinson’s disease patients experiencing hallucinations and delusions, with or without dementia. This update aligns with the drug’s existing indication without introducing new findings.

The market for PDP is shaped by several critical factors, including the increasing prevalence of genetic disorders and heightened awareness about rare diseases. Advances in genomic research and growing investments in rare disease therapies are driving market growth. Nonetheless, challenges such as limited funding for research, high costs of novel treatments, and rigorous regulatory hurdles remain significant obstacles. Moreover, the substantial unmet need for effective PDP treatments underscores a major gap in the current therapeutic landscape, presenting a prime opportunity for companies to innovate and address the needs of a diverse patient population.

This report delivers an in-depth understanding of the PDP, historical and forecasted epidemiology and the PDP market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

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

Geography Covered

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

Study Period: 2020-2034

Disease Understanding and Treatment Algorithm

PDP Overview

Psychosis is a serious mental health condition characterized by a loss of contact with reality, impacting thoughts and emotions. According to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) and the International Classification of Diseases, Tenth Revision (ICD-10), psychosis appears in various disorders, including schizophrenia, bipolar disorder with psychotic features, and Parkinson’s disease.

In the DSM-5, psychotic disorders are defined more by clinical syndromes than by specific diseases and are differentiated primarily by their duration (for instance, symptoms of schizophrenia last at least six months, while brief psychotic disorder symptoms last less than a month), symptom types (schizophrenia presents multiple psychotic symptoms, while delusional disorder features only delusions), the relationship of psychotic symptoms to mood disturbances (whether they occur during or after mood episodes), and their underlying causes (including substance use or medical conditions like epilepsy, Systemic Lupus Erythematosus, tumors, or dementias). In clinical terms, "psychotic symptoms" refer to cognitive or perceptual dysfunctions such as delusions or hallucinations, while "psychotic disorder" indicates a condition where these symptoms fulfill specific diagnostic criteria.

PDP Diagnosis

Despite various theories regarding its causes and underlying mechanisms, the diagnosis of psychotic disorders remains primarily clinical. It relies heavily on the patient's history, observed behaviors, subjective experiences, and findings from the mental status examination. Diagnostic tests, such as neuroimaging, electroencephalography (EEG), genetic testing, toxicology screenings, and serological evaluations, are generally reserved for select patients - typically those experiencing their first episode of psychosis or exhibiting symptoms linked to preexisting neurodegenerative disorders, medical issues, or substance abuse. While some of these tests can highlight differences between psychotic individuals and those without mental disorders, none are reliably sensitive or specific enough to diagnose psychosis on an individual level. However, they do help uncover biological principles related to the pathophysiology of psychosis.

PDP Treatment

The management of a psychotic patient varies greatly depending on the origins of the psychosis. A psychiatrist should evaluate any patient experiencing an episode of psychosis. Antipsychotic medications are the gold-standard treatment for psychotic episodes and disorders, and the choice, dosing, and administration of the medication will largely depend on the scenario. Antipsychotics are generally the treatment for schizophrenia spectrum disorders. Initial dosing should be at a low dose and titrated up as needed. Of note, there has been a long-standing debate about whether second-generation antipsychotics are more efficacious than first-generation.

Antipsychotics have also been shown to be most effective in treating the psychotic symptoms of drug-induced psychosis, mania, delirium, the psychotic features of depression, as well as the psychotic features of dementia and other neurologic conditions. Of course, beyond acute psychosis, treating the underlying cause is always an appropriate course of action. Antipsychotic medications have been demonstrated to be most effective in positive symptoms of psychosis discussed earlier (hallucinations, delusions, disorganized thoughts, and behavior) and less useful for negative symptoms. They can also demonstrate significant side effects, including

extrapyramidal symptoms and dangerous QT prolongation. Of note, clozapine and olanzapine have been shown to reduce the risk of suicide in psychotic patients.

PDP Epidemiology

As the market is derived using the patient-based model, the PDP epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Prevalent Cases of Parkinson’s disease, Total Diagnosed Prevalent Cases of PDP, Total Treated Cases of PDP in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan, from 2020 to 2034. As per the analyst's estimations, the total diagnosed prevalent cases of PDP in the 7MM was approximately 911,371 cases in 2023 and are projected to decrease during the forecast period.

• The total diagnosed prevalent cases of Parkinson’s disease in the 7MM were 2.71 million in 2023 and are expected to increase at a CAGR of 2.2%.
• In 2023, Japan contributed 257 thousand diagnosed prevalent cases of Parkinson’s disease, representing almost 9% of the total diagnosed prevalence across the 7MM.
• Among the 7MM, EU4 and the UK accounted for nearly 353 thousand diagnosed prevalent cases of PDP, and these cases are expected to increase during the forecast period (2024-2034).
• Among EU4 and the UK, Germany had the highest diagnosed prevalent population of PDP, with 134 thousand cases, followed by France and Italy in 2023. On the other hand, the UK had the lowest diagnosed prevalent population in EU4 and the UK in 2023.
• In Japan, there were around 73 thousand diagnosed prevalent cases of PDP in 2023. These cases are expected to increase at a significant CAGR.

PDP Drug Chapters

The drug chapter segment of the PDP report encloses a detailed analysis of PDP marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also understands PDP 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.

Emerging Drugs

ENT-012: Enterin Inc.

ENT-012 is undergoing Phase IIa clinical trials to evaluate its efficacy and safety in treating psychosis associated with Parkinson's disease. This phase focuses on assessing the drug's ability to reduce the severity of psychotic symptoms, measured through the Scale for the Assessment of Positive Symptoms (SAPS). Preliminary results suggest that ENT-012 is generally well-tolerated, with side effects similar to those of other SSRIs, such as gastrointestinal disturbances, headaches, and fatigue. The trial is designed to gather more comprehensive data on its impact on patients, and results are expected in the near future.

PDP Market Outlook

Parkinson's disease Psychosis (PDP) is a complex condition characterized by the emergence of psychotic symptoms, such as hallucinations and delusions, in patients with Parkinson's disease. The treatment landscape for PDP is still evolving, as the interplay between neurodegeneration and psychosis complicates the establishment of standardized treatment protocols. Currently, there are no universally approved therapies specifically for PDP, and management primarily focuses on alleviating symptoms while ensuring the patient's overall well-being.

Symptomatic treatment is critical in managing PDP, which often requires a careful balance between addressing psychotic symptoms and minimizing the exacerbation of motor issues commonly associated with Parkinson's disease. Antipsychotic medications are frequently prescribed, but many traditional options can worsen motor symptoms, making the choice of treatment particularly challenging. As a result, newer medications like ENT-012, a selective serotonin reuptake inhibitor, are being explored to provide effective symptom relief without negatively impacting motor function.

In addition to pharmacological management, a multidisciplinary approach is essential for comprehensive care. Psychological support, including cognitive-behavioral therapy, can help patients cope with the emotional and cognitive aspects of their condition. Occupational and speech therapies are also valuable for enhancing daily functioning and communication skills, thereby improving the patient's quality of life.

Ongoing research into the underlying mechanisms of PDP is paving the way for innovative treatment options. Investigational therapies, including ENT-012, are being evaluated in clinical trials to determine their effectiveness and safety. These efforts aim to identify new pharmacological approaches that specifically target the serotonergic system to mitigate psychotic symptoms more effectively.

Supportive care remains a cornerstone of managing PDP, involving palliative care to address pain and improve overall quality of life. Genetic counseling can also play a role in providing families with information about the condition and its implications. Support groups and advocacy organizations are vital resources, offering emotional support, practical advice, and information on the latest research and treatment options.

Overall, the treatment landscape for PDP is marked by a combination of symptomatic management, ongoing research, and supportive care. While there is currently no definitive cure, advancements in clinical trials and emerging therapies offer hope for more effective and targeted treatment strategies in the future. Collaborative efforts among healthcare professionals, researchers, and patient organizations are crucial in improving outcomes for individuals affected by this challenging condition. The total market size of the PDP treatment market is anticipated to experience growth during the forecast period due to the emergence of new and effective treatments.

PDP Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in the market during 2020-2034.

PDP Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. 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 PDP emerging therapies.

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 the secondary research. Industry Experts were contacted for insights on PDP evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from University of Texas Health Science Center, San Antonio, US, Johns Hopkins University, Baltimore, US, Harvard Medical School, Boston, US, Georgetown University, Washington DC, US, University of Heidelberg, Germany, IU International University, Erfurt, Fondation Fondamental, Créteil, France, Università di Palermo, Palermo, Italy, King’s College, London, Tokyo University Hospital, Tokyo, Kyoto University Hospital, Japan, and others.

The analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or PDP market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

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 approved and 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.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and 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 global drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, 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, descriptive overview of PDP, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
• 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 PDP market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the 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 Parkinson’s Disease Psychosis market.

PDP Report Insights

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

PDP Report Key Strengths

• 11 years Forecast
• The 7MM Coverage
• PDP Epidemiology Segmentation
• Key Cross Competition
• Attribute Analysis
• Drugs Uptake and Key Market Forecast Assumptions

PDP 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 PDP total market size, the market size by therapies, and market share (%) distribution in 2020, and how would it all look in 2034? What are the contributing factors for this growth?
• What unmet needs are associated with the current treatment market of PDP?
• What are the patents of emerging therapies for PDP?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and 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 PDP? What will be the growth opportunities across the 7MM concerning the patient population of PDP?
• What is the historical and forecasted Parkinson’s disease Psychosis patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Why do only limited patients appear for diagnosis?
• Which country is more prevalent for Parkinson’s disease Psychosis and why?
• What factors are affecting the diagnosis of the indication?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for treating PDP? What are the current guidelines for treating Parkinson’s disease Psychosis in the US and Europe?
• How many companies are developing therapies for treating PDP?
• How many emerging therapies are in the mid-stage and late stage of development for treating PDP?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What are the key designations that have been granted for the emerging therapies for PDP?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.
• What are the 7MM historical and forecasted markets of PDP?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the PDP 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.
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies that will help get ahead of competitors.
• Detailed analysis and ranking of potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders 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.

Frequently Asked Questions

1. What is the forecast period covered in the report?

The PDP Epidemiology and Market Insight report for the 7MM covers the forecast period from 2024 to 2034, providing a projection of market dynamics and trends during this timeframe.

2. Who are the key players in the PDP market?

The PDP market is sparse. The major players are Enterin Inc. which are currently developing drugs for the treatment of PDP, the rest of the market is now contributed with off-label therapies.

3. How is the market size estimated in the forecast report?

The market size is estimated through data analysis, statistical modeling, and expert opinions. It may consider factors such as incident cases, treatment costs, revenue generated, and market trends.

4. What is the key driver of the PDP market?

The increase in prevalent and diagnosed prevalent cases of PDP is attributed to the current population size.

5. What is the expected impact of emerging therapies or advancements in PDP treatment on the market?

Introducing new therapies, advancements in diagnostic techniques, and innovations in treatment approaches can significantly impact the PDP treatment market. Market forecast reports may provide analysis and predictions regarding the potential impact of these developments.

6. Does the report provide insights into the competitive landscape of the market?

The market forecast report may include information on the competitive landscape, profiling key market players, their product offerings, partnerships, and strategies, and helping stakeholders understand the competitive dynamics of the PDP market.